[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Proposed Rules]
[Pages 2443-2460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. FDA-2000-P-0126] (formerly Docket No. 2000P-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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revoke 
its regulations on 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 (the NYA). FDA tentatively 
concludes that this action will promote honesty and fair dealing in the 
interest of consumers and, to the extent practicable, will achieve 
consistency with existing international standards of identity for 
yogurt.

DATES: Submit comments by March 31, 2009.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2000-
P-0126, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://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 Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. Current Standards of Identity for Yogurt, Lowfat Yogurt, and 
Nonfat Yogurt
    B. The National Yogurt Association Petition

[[Page 2444]]

    C. The Advance Notice of Proposed Rulemaking
    D. Comments on the ANPRM
II. The Proposal
    A. Legal Authority/Statutory Directive
    B. Proposed Amendments
    1. Yogurt
    2. Revocation of the Standards of Identity for Lowfat and Nonfat 
Yogurts
    C. NYA's Recommended Amendments to the Standard of Identity for 
Cultured Milk
III. Analysis of Economic Impacts
    A. Preliminary Regulatory Impact Analysis
    B. Initial Regulatory Flexibility Analysis
    C. Unfunded Mandates Reform Act of 1995
IV. Federalism
V. Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Comments
VIII. References

I. Background

A. Current Standards of Identity for Yogurt, Lowfat Yogurt, and Nonfat 
Yogurt

    In the Federal Register of January 30, 1981 (46 FR 9924), FDA 
published a final rule establishing standards of identity for yogurt 
(Sec.  131.200 (21 CFR 131.200)), lowfat yogurt (Sec.  131.203 (21 CFR 
131.203)), and nonfat yogurt (Sec.  131.206 (21 CFR 131.206). 
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 that 
raised genuine and substantial issues of fact that must be resolved 
through a public hearing, FDA stayed the effective date for provisions 
regarding certain milk products and eggnog as well as the following: 
(1) Those provisions of Sec. Sec.  131.200(c)(1), 131.203(c)(1), and 
131.206(c)(1) (redesignated as Sec. Sec.  131.200(d)(1), 131.203(d)(1), 
and 131.206(d)(1), respectively) that restricted the type of milk-
derived ingredients that may be used to increase the nonfat solids 
content of cultured milk and yogurts to those listed in these sections; 
(2) those provisions of Sec. Sec.  131.200(a), 131.203(a), and 
131.206(a) that excluded the use of reconstituted dairy ingredients as 
basic ingredients in the manufacture of yogurts; (3) those provisions 
of Sec. Sec.  131.200(c), 131.203(c), and 131.206(c) (redesignated as 
Sec. Sec.  131.200(d), 131.203(d), and 131.206(d), respectively) 
insofar as they excluded the addition of preservatives to yogurts; (4) 
those provisions of Sec. Sec.  131.200(a), 131.203(a), and 131.206(a) 
that set a minimum titratable acidity of 0.9 percent, expressed as 
lactic acid; and (5) the provision in Sec.  131.200(a) that the 3.25 
percent minimum milkfat level applies to yogurt after the addition of 
one or more of the optional sources of milk solids not fat listed in 
Sec.  131.200(c)(1) (redesignated as Sec.  131.200(d)(1)) (47 FR 41519 
at 41523, September 21, 1982). To date, due to competing priorities and 
limited resources, FDA has not held a public hearing to resolve these 
issues and the effective date for these provisions remains stayed. 
Therefore, these provisions were never in effect. Consequently, 
cultured milk and yogurts may deviate from the relevant standards in 
the previously mentioned respects. For example, although the current 
standards do not permit the use of certain ingredients such as 
preservatives or a reconstituted dairy ingredient as a basic 
ingredient, because of the stayed provisions, FDA has not taken 
enforcement action against the use of these ingredients in yogurt, 
lowfat yogurt, or nonfat yogurt. Similarly, yogurt is not required to 
meet the 0.9 percent minimum titratable acidity requirement in stayed 
provisions Sec. Sec.  131.200(a), 131.203(a), and 131.206(a).

B. The National Yogurt Association Petition

    The NYA submitted a citizen petition on February 18, 2000 (Docket 
No. FDA-2000-P-0126 (formerly Docket No. 2000P-0685); hereafter 
referred to as the petition) requesting that FDA revoke the standards 
of identity in part 131 (21 CFR part 131) for lowfat yogurt (Sec.  
131.203) and nonfat yogurt (Sec.  131.206) and amend the standards of 
identity for yogurt (Sec.  131.200) and cultured milk (Sec.  131.112).
    In its petition, NYA stated that its recommended standard 
establishes that yogurt is a food product containing a minimum level of 
certain live and active cultures; takes into account current industry 
practices; recognizes the need to allow for use of future technologies; 
and establishes a clear, consistent, modernized, and flexible yogurt 
standard that would benefit both industry and consumers. Specifically, 
NYA recommended a yogurt standard that (1) requires a minimum level of 
active cultures of 10\7\ colony-forming units (CFU) per gram (g); (2) 
requires an acidity of pH 4.6 or lower; (3) requires a minimum level of 
total dairy ingredients of 51 percent; (4) provides for pre-culture 
homogenization and pasteurization; (5) permits the use of reconstituted 
milk and whey protein concentrate as ``standard dairy ingredients;'' 
(6) provides for the use of any milk-derived ingredients as optional 
dairy ingredients; (7) permits the use of safe and suitable sweeteners, 
emulsifiers, and preservatives; (8) permits the optional use of any 
safe and suitable ingredients added for nutritional or functional 
purpose; and (9) makes provisions for lowfat and nonfat yogurts based 
on total fat content of the food per reference amount customarily 
consumed (RACC).
    In addition, NYA requested that the current standard of identity 
for cultured milk be amended to ``conform'' to its recommended standard 
for yogurt. Specifically, NYA recommended that FDA revise the cultured 
milk standard to (1) provide for the alternate term ``fermented milk;'' 
(2) require a minimum level of total dairy ingredients of 51 percent; 
(3) permit the use of reconstituted milk and whey protein concentrate 
as ``standard dairy ingredients;'' (4) provide for the use of any milk-
derived ingredients as ``optional dairy ingredients;'' (5) permit the 
use of safe and suitable sweeteners, emulsifiers, and preservatives; 
and (6) permit the use of any safe and suitable ingredients added for 
nutritional or functional purposes.
    NYA pointed out that several provisions of the standards of 
identity for cultured milk, yogurt, lowfat yogurt, and nonfat yogurt 
are currently stayed (47 FR 41519) (as discussed in section I.A of this 
document). NYA contended that these stayed provisions create multiple 
gaps in the standards for which no guidelines exist and, as a result, 
the integrity of the food ``yogurt'' is not maintained.
    According to NYA, yogurt has been characterized for centuries by 
its live and active cultures and, thus, a minimum content of live and 
active cultures is crucial to the yogurt standard of identity to 
promote honesty and fair dealing in the interest of consumers. NYA 
noted that consumers identify yogurt with live and active cultures and 
expect yogurt to contain a significant amount of these cultures when 
they purchase the product but have no assurance under the current 
standard that the yogurt will contain such cultures. NYA maintained 
that its recommended standard recognizes the defining characteristics 
of yogurt and establishes that yogurt is a product of fermentation of 
certain characterizing cultures and that the finished food contains a 
significant quantity of these live and active cultures, consistent with 
consumer expectations.

[[Page 2445]]

    NYA also stated that the recommended amendments to the standard for 
cultured milk would further serve consumer interest. Under its proposed 
actions, NYA maintained that foods otherwise satisfying the standard of 
identity for yogurt that do not contain the required level of the 
characterizing live and active cultures would not be named ``yogurt;'' 
rather, they would be named ``cultured milk'' or ``fermented milk.'' 
Consequently, NYA stated, consumers would not be misled into believing 
that these foods contain a significant amount of live and active 
cultures.
    NYA also maintained that its recommended amendments would ensure 
that aspects of yogurt labeling, such as the use of nutrient content 
claims, are consistent with the requirements of the Nutrition Labeling 
and Education Act of 1990 (NLEA) (Public Law 101-535). NYA stated that 
its recommended standard maintains the three yogurt types (full fat, 
lowfat, and nonfat yogurts) so manufacturers can continue to make 
lowfat and nonfat yogurts without meeting the nutritional equivalence 
requirement described in Sec.  130.10(b) (21 CFR 130.10(b)). In 
addition, NYA maintained that its recommended standard would change the 
milkfat content requirements of lowfat and nonfat yogurts to be 
consistent with the nutrient content claim requirements for the terms 
``low fat'' and ``nonfat'' established under the NLEA and codified in 
Sec.  101.62(b) (21 CFR 101.62(b)).
    Additionally, NYA noted that food technology has advanced and 
industry practices related to yogurt manufacturing have changed since 
the yogurt standards have been in place. Consequently, NYA asserted 
that the current yogurt standards impede the yogurt industry and do not 
allow manufacturers to implement advances in food technology. NYA 
stated that its recommended standard establishes a modernized, flexible 
standard of identity for yogurt that takes into account current 
industry practices and recognizes the need to allow for use of future 
technologies.

C. The Advance Notice of Proposed Rulemaking

    In the Federal Register of July 3, 2003 (68 FR 39873), FDA 
published an advance notice of proposed rulemaking (ANPRM) consistent 
with section 701(e)(1) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 371(e)(1)), which directs the Secretary of Health and 
Human Services (the Secretary) to publish proposals made by petition to 
amend or repeal a dairy food standard so long as the petition includes 
reasonable grounds for the action requested, and to provide interested 
persons with an opportunity to present their views. In the ANPRM, FDA 
requested comment by October 1, 2003, on whether the actions proposed 
in the petition would promote honesty and fair dealing in the interest 
of consumers. In response to a request to allow additional time to 
comment, FDA reopened the comment period on October 29, 2003 (68 FR 
61639). The reopened comment period ended on January 27, 2004.
    In the ANPRM, FDA requested data and information concerning the 
need for, and the appropriateness of, the amendments requested by NYA, 
including the revocation of the standards for lowfat and nonfat yogurt 
and the revision of the standards for yogurt and cultured milk. FDA 
specifically requested comment on several provisions set forth in the 
petition, including those related to the use of any safe and suitable 
ingredient added for nutritional or functional purposes, the 
measurement of acidity of yogurt, the presence of live and active 
cultures in yogurt, and vitamin A addition to yogurt, and the need to 
amend the cultured milk standard of identity to conform to NYA's 
recommended yogurt standard.
    FDA pointed out in the ANPRM that NYA recommended a number of 
changes to the standards of identity for yogurt and cultured milk. 
First, NYA recommended that FDA permit the use of any safe and suitable 
ingredient added for nutritional or functional purposes. NYA stated 
that this provision is necessary to maintain enough flexibility in the 
standards to permit the use of novel ingredients as they are developed. 
FDA acknowledged the need for food standards to permit flexibility in 
food technology so long as that technology does not alter the basic 
nature or essential characteristics of the food. FDA stated that the 
existing provisions in Sec.  130.10 already provide for the addition of 
substances for nutritional purposes to standardized foods. FDA also 
noted that flexibility in the use of ingredients for functional 
purposes may be achieved by specifying the ingredients by functional 
use category, e.g., ``emulsifiers'' or ``preservatives,'' rather than 
by listing the specific ingredients. FDA asked for comment on the need 
for any functional ingredient categories, in addition to the ones 
recommended in the petition, in the manufacture of yogurt.
    Second, NYA recommended a maximum pH of 4.6 for yogurt, stating 
that this level reflects the lower end of titratable acidity levels 
found in common industry practice and that measuring pH, rather than 
titratable acidity expressed as lactic acid, reflects the current 
industry practice and is a more accurate and convenient method of 
measuring acidity. FDA asked for comment both on the maximum pH 
recommended by NYA and the use of pH rather than titratable acidity to 
measure the acidity of yogurt.
    Third, NYA recommended that FDA require a specific amount of live 
and active cultures in yogurt based on an assertion that consumers 
expect yogurt to contain significant amounts of live and active 
cultures. In its recommended new yogurt standard, NYA required yogurt 
to contain a minimum of 10\7\ CFU/g of live and active cultures at the 
time of manufacture. NYA also suggested that manufacturers may test 
their yogurt products to demonstrate that the products, under proper 
distribution and storage conditions, would be expected to contain at 
least 10\6\ CFU/g of live and active cultures through the 
manufacturer's designated code life for the product and at the 
anticipated time of consumption. FDA asked for comment on the following 
topics: (1) Whether the presence of live and active cultures is an 
essential characteristic of yogurt and, if so, in what amounts; (2) the 
appropriateness of NYA's suggested provision that manufacturers ``may'' 
conduct tests to ensure the presence of live and active cultures 
through the assigned code life for the product; and (3) whether NYA's 
recommended standard of identity for yogurt would adequately ensure the 
presence of appropriate amounts of live and active cultures in yogurt 
throughout the shelf life of the product and at the point of purchase 
or consumption. FDA also asked whether any alternative provisions may 
be needed to fulfill this requirement.
    In addition, FDA sought comment on vitamin A addition to lowfat and 
nonfat yogurt. FDA previously proposed to revoke a number of lowfat and 
nonfat standards, i.e., Sec. Sec.  131.122 (sweetened condensed skimmed 
milk), 131.123 (lowfat dry milk), 131.132 (evaporated skimmed milk), 
131.135 (lowfat milk), 131.136 (acidified lowfat milk), 131.138 
(cultured lowfat milk), 131.143 (skim milk), 131.144 (acidified skim 
milk), 131.146 (cultured skim milk), 131.185 (sour half-and-half), 
131.187 (acidified sour half-and-half), 131.203 (lowfat yogurt), 
131.206 (nonfat yogurt), and 133.131 (lowfat cottage cheese) to ensure 
that the use of nutrient content claims in the labeling of these 
products would be consistent with the provisions of the NLEA (60 FR 
56541, November 9, 1995). FDA revoked all of the previously

[[Page 2446]]

mentioned standards except for lowfat yogurt and nonfat yogurt on 
November 20, 1996 (61 FR 58991). FDA delayed final action on its 
proposal to revoke these standards for 120 days because of the 
technical difficulties and economic considerations associated with 
their revocation (61 FR 58991 at 58999). FDA acknowledged that, if the 
standards for lowfat and nonfat yogurts were revoked, modifying the 
standardized food yogurt to make the nutrient content claims ``lowfat'' 
or ``nonfat'' under the provisions of Sec.  130.10 would require 
vitamin A addition to make the product nutritionally equivalent to full 
fat yogurt. FDA also acknowledged that such a vitamin addition 
requirement could potentially result in significant relabeling, 
reformulation, and equipment costs to manufacturers. The agency 
believed that its decision to defer, for a limited time, action on the 
standards of identity for yogurt products would provide an appropriate 
balance between the problem the industry was facing and consumers' 
interest in consistently and fairly labeled foods. FDA also advised of 
its intention at the end of the 120-day period to move to resolve the 
inconsistencies between the use of the terms ``lowfat'' and ``nonfat'' 
in the names of standardized yogurt and the definitions for these terms 
established under the nutrient content claims regulations (61 FR 58991 
at 58999). As FDA noted in the ANPRM, this issue is yet to be resolved. 
In fact, the 1995 proposed rule to revoke the lowfat and nonfat yogurt 
products was subsequently withdrawn (69 FR 68831, November 26, 2004) as 
part of the agency initiative to withdraw certain proposed actions that 
were over 5 years old and no longer considered viable candidates for 
final action at that time. This action was taken to reduce the agency's 
regulatory backlog and focus its resources on public health issues 
current at that time.
    According to the yogurt standard recommended by NYA, manufacturers 
would continue to be able to make lowfat and nonfat yogurts without 
having to meet the nutritional equivalence requirement. FDA asked 
whether the yogurt industry is better able and equipped to meet the 
nutritional equivalence requirements of Sec.  130.10 than it was in 
1996, when FDA deferred action on this issue. FDA also asked for 
comment on the need and appropriateness of continuing to exempt yogurt, 
unlike other standardized foods making low fat and nonfat nutrient 
content claims, from the nutritional equivalence requirement.
    Finally, NYA recommended that FDA revise the current standard of 
identity for cultured milk (Sec.  131.112) so that if the food 
otherwise meets the yogurt standard but does not contain the 
characterizing cultures at the required levels, then the food would 
qualify as cultured milk or could alternatively be named ``fermented 
milk.'' FDA pointed out in the ANPRM that the standard of identity for 
cultured milk has been in place for several decades and, in light of 
consumer experience with cultured milk, the agency asked for comment on 
the need to amend the standard for cultured milk and the 
appropriateness of the amendments requested by NYA.

D. Comments on the ANPRM

    In response to the ANPRM, FDA received a total of 65 responses, 
each containing one or more comments, from industry, trade 
associations, consumers, government, and academia. Overall, comments 
from industry broadly supported the need to modernize the yogurt 
standards to allow recent technological advances in food processing and 
to incorporate flexibility in yogurt manufacturing while preserving the 
basic nature and essential characteristics of yogurt. One milk 
producers' association opposed revising the current yogurt or cultured 
milk standards, while several consumers expressed concerns on different 
provisions recommended by NYA.
    Comments from industry strongly supported the establishment of a 
single yogurt standard that provides for varying levels of fat content 
and that reflects today's manufacturing practices while taking into 
account the stayed provisions of the current yogurt standards. These 
comments also expressed broad support of NYA's petition to the extent 
that the amended standard would expressly permit those industry 
practices that are not now restricted under the stayed provisions of 
the current standard. For example, some comments stated that, since 
certain provisions of the current yogurt standards were stayed, 
virtually all domestically-produced yogurt utilizes reconstituted dairy 
ingredients as basic ingredients and, therefore, these comments 
recommended that the modernized yogurt standard account for this 
typical industry practice. Similarly, the comments stated that, since 
certain other provisions were stayed, a wide range of milk-derived 
ingredients that provide a technical or functional purpose are used as 
optional ingredients in the manufacture of yogurt, and several comments 
from industry supported NYA's recommended amendment that would permit 
this practice. There was also broad support to amend the standards to 
bring the fat content of lowfat and nonfat yogurts in line with the 
provisions of the NLEA.
    While in agreement with NYA that the yogurt standards need to be 
modernized, some other comments opposed some of the amendments sought 
by NYA. For example, NYA recommended that yogurt contain a specific 
amount of live and active cultures. Some comments from industry and 
academia supported this requirement and noted the health benefits 
associated with live and active cultures in yogurt. However, other 
industry comments strongly opposed requiring that yogurt contain live 
and active cultures. These comments did not agree with NYA that live 
and active cultures are an essential characteristic of ``yogurt'' nor 
did they agree with NYA that consumers expect a minimum live and active 
culture content of 10\6\ CFU/g or any other specified amount. These 
comments pointed out that NYA neither presented any evidence to support 
its contention that consumers expect a certain specified amount of live 
and active cultures in yogurt nor provided a technical rationale or 
criteria to evaluate whether the proposed 10\6\ CFU/g is the 
appropriate level. In addition, one major trade association noted in 
its comments that members of its organization were unable to reach an 
agreement on whether the presence of live and active cultures is an 
essential characteristic of yogurt and whether the amount of cultures 
recommended by NYA is the appropriate level.
    Similarly, comments to other provisions that NYA requested in its 
petition also were mixed. NYA's recommended revisions to the standards 
would not permit heat treatment of yogurt after culturing and would 
require yogurt that is heat-treated after culturing to be named 
``cultured milk'' or ``fermented milk'' rather than ``yogurt, heat-
treated after culturing'' as is permitted by the current standards. 
While some comments from the domestic industry supported this 
provision, others from industry, both domestic and international, and 
one comment from a foreign government strongly opposed this provision. 
They stated that processors should be permitted to market heat-treated 
yogurt, provided that the heat treatment is appropriately declared on 
the label, as is the current practice, and that changing the name of 
this food now to ``cultured milk'' or ``fermented milk'' would be 
confusing to consumers.
    With respect to NYA's recommended provision that would permit 
yogurt to contain non-nutritive sweeteners and be labeled simply 
``yogurt'' without a specific declaration of the non-nutritive

[[Page 2447]]

sweetener in the name of the food, comments were varied. While comments 
from industry supported this provision, several consumers and at least 
one State government agency strongly opposed this provision, stating 
that consumers have become accustomed to identification of aspartame in 
the name of the food \1\ and that removal of this identification would 
be misleading to consumers and could prove harmful to those individuals 
with phenylketonuria.
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    \1\ Specifically concerning the labeling of lowfat and nonfat 
yogurts that are sweetened with aspartame, the agency previously 
advised that provided the lowfat and nonfat yogurt products conform 
to the relevant standards of identity prior to the addition of 
aspartame, the descriptors ``lowfat (or nonfat) yogurt with 
aspartame sweetener'' and ``lowfat (or nonfat) yogurt sweetened with 
aspartame'' are acceptable statements of identity for these products 
(Ref. 1).
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    Several consumers, dairy farmers, and milk producers, and one State 
government agency strongly opposed NYA's recommended provisions that 
any milk-derived ingredient should be permitted as an optional 
ingredient and that any safe and suitable ingredient should be 
permitted for a nutritional or functional purpose. These comments cited 
concerns including the use of imported, cheaper, and inferior quality 
substances, which would adversely affect the quality of the yogurt; the 
potential health risks associated with unregulated, imported products; 
and the unfair economic disadvantage to U.S. dairy plants.
    Comments were varied on the use of whey protein concentrate as a 
basic ingredient and the minimum amount of dairy ingredients by weight 
of yogurt. Most comments from industry supported the use of whey 
protein concentrate as a basic ingredient but other comments, primarily 
from consumers and dairy farmers, opposed this provision, citing 
product quality concerns. With respect to NYA's recommended provision 
that yogurt contain a minimum of 51 percent dairy ingredients by weight 
of yogurt, comments from an industry group supported the provision, but 
other comments from consumers expressed concern that this provision 
could allow yogurt to contain up to 49 percent non-dairy ingredients 
and still be characterized as ``yogurt.'' The existing standards for 
yogurt, lowfat yogurt, and nonfat yogurt do not include requirements 
with respect to the proportion of dairy ingredients in the finished 
food. Rather, the standards restrict the use of non-dairy ingredients 
to a limited and specific list of substances that fulfill a technical 
or functional purpose.
    With respect to NYA's recommended amendments to the cultured milk 
standard, a few comments supported, while several other comments from 
industry (both domestic and international) and milk producers opposed 
NYA's recommended provisions. The comments that opposed the amendments 
stated that it would not be appropriate to amend the cultured milk 
standard simply to include products that do not fit into the NYA's 
recommended yogurt standard and that have never been considered by the 
industry or consumers to be cultured milk. Some of these comments also 
noted that NYA's petition did not address the consumer confusion that 
might occur from including semisolid yogurt-type products (that 
otherwise meet NYA's recommended yogurt standard but do not contain the 
characterizing cultures at the specified levels) in the cultured milk 
standard, which has long been associated with fluid products. A major 
trade association also noted that its members could not reach agreement 
on this issue. Specific comments will be discussed in the proposed 
amendment section where appropriate.

II. The Proposal

A. Legal Authority/Statutory Directive

    Section 401 of the act (21 U.S.C. 341) directs the Secretary to 
issue regulations fixing and establishing for any food a reasonable 
definition and standard of identity, quality, or fill of container 
whenever in the judgment of the Secretary such action will promote 
honesty and fair dealing in the interest of consumers. Under section 
701(e) of the act, any action for the amendment or repeal of any 
definition and standard of identity under section 401 of the act for 
any dairy product (e.g., yogurt) shall be begun by a proposal made 
either by the Secretary on his own initiative or by petition of any 
interested persons, showing reasonable grounds therefor, filed with the 
Secretary.

B. Proposed Amendments

    Based on all available information, including the information 
presented in the petition and the comments to the ANPRM, FDA is 
proposing to amend the yogurt standard and revoke the lowfat and nonfat 
yogurt standards to promote honesty and fair dealing in the interest of 
consumers. This proposal is also consistent with FDA's proposed general 
principles for modernizing food standards (70 FR 29214, May 20, 2005). 
In addition, consistent with 21 CFR 130.6, which states that food 
standards adopted by the Codex Alimentarius Commission will be reviewed 
by FDA (and either will be accepted, with or without change, or will 
not be accepted), FDA reviewed the Codex Standard for Fermented Milks 
(CODEX STAN 243-2003) (herein after referred to as the Codex Standard) 
(Ref. 2), which encompasses the standard for ``yoghurt'' and provides 
that yoghurt may be spelled as appropriate in the country of retail 
sale. FDA reviewed the Codex Standard to harmonize, to the extent 
feasible, the proposed amendments with Codex provisions for 
``yoghurt,'' while preserving the integrity, quality, and economic 
value that U.S. consumers expect of yogurt.
    FDA tentatively concludes that the proposed amendments are 
necessary to modernize the current yogurt standard to permit 
flexibility and provide for technological advances in yogurt 
production, while preserving the basic nature and essential 
characteristics of yogurt consistent with consumer expectations and 
thus protecting consumer interest. FDA considered the different 
amendments recommended by NYA and tentatively concluded that some of 
NYA's recommended amendments are not consistent with the basic nature 
and essential characteristics of yogurt or cultured milk. Each of the 
amendments recommended by NYA and FDA's tentative conclusions are 
discussed here.
1. Yogurt
    a. Milkfat and milk solids not fat content of yogurt. The current 
standard of identity for yogurt requires a minimum milkfat content of 
3.25 percent and a minimum milk solids not fat content of 8.25 percent 
in yogurt prior to the addition of bulky flavoring ingredients (Sec.  
131.200(a)). In response to an objection to the January 30, 1981, final 
rule that applying the milkfat minimum to yogurt which has been made to 
contain milk solids not fat at a level higher than the minimum 
requirement of the standard will discourage manufacturers from using 
higher levels of milk solids not fat in yogurt because such addition 
would then require the use of more milkfat, FDA stayed the requirement 
that the minimum milkfat level is applied after the addition of 
optional dairy ingredients. FDA pointed out that the minimum 3.25 
percent milkfat and the 8.25 percent milk solids not fat requirements 
apply prior to the addition of any bulky flavors and that while other 
optional dairy ingredients may be used to increase the milk solids not 
fat content of yogurt to above 8.25 percent, the standard does not 
provide for a

[[Page 2448]]

proportionate decrease in the minimum milkfat content. FDA determined 
that whether the minimum milkfat requirement of 3.25 percent should 
apply to yogurt before or after the addition of optional dairy 
ingredients used to increase the milk solids not fat content should be 
resolved through a public hearing and stayed that requirement pending a 
public hearing (47 FR 41519 at 41521).
    NYA did not recommend a specific total fat content for yogurt. 
However, NYA requested that any level of fat above the level considered 
``low fat'' (per Sec.  101.62(b)(2)) should be permitted in a product 
named ``yogurt.'' Accordingly, NYA recommended that the total fat 
content of yogurt should be any level higher than 3.0 g per 225 g. NYA 
also noted that its recommended provision would measure the fat content 
on a finished food basis and, therefore, would provide consumers with 
more accurate information about the yogurt's actual fat content.
    Some comments in response to the ANPRM supported retaining the 
current 3.25 percent minimum milkfat content of yogurt and noted that 
this level is consistent with the fat content requirement for milk. FDA 
notes that NYA's recommended minimum fat content of 3.0 g per 225 g 
would equate to lowering the current minimum milkfat content of 3.25 
percent to about 1.3 percent. NYA did not provide adequate 
justification for this change to the minimum fat content of yogurt. FDA 
agrees with NYA that it is appropriate to revise the existing lowfat 
and nonfat yogurt standards of identity to conform these foods with the 
nutrient content claims requirements for ``low fat'' and ``non fat,'' 
respectively, as discussed further in section II.B.2 of this document. 
However, NYA did not provide a justification for lowering the minimum 
fat content of yogurt that is named simply ``yogurt'' and whose 
labeling does not bear a claim related to its fat content. Furthermore, 
the yogurt standard with the minimum 3.25 percent milkfat requirement 
has been in place for over two decades (although the application of 
this level after the addition of optional dairy ingredients was stayed) 
and appears to be used in the manufacture of full-fat yogurts available 
in the marketplace today. According to the U.S. Department of 
Agriculture (USDA) National Nutrient Database for Standard Reference, 
Release 19 (2006), the total fat content of ``yogurt, plain, whole 
milk'' is 3.25 percent (Ref. 3), consistent with the minimum milkfat 
requirement of the current standard of identity for yogurt. With 
respect to the minimum milk solids not fat content of yogurt, neither 
NYA nor comments in response to the ANPRM requested a revision to the 
current requirement of 8.25 percent. In addition, FDA does not have any 
data or information to suggest that there is a need to reconsider the 
current requirement of a minimum of 8.25 percent milk solids not fat in 
yogurt. Therefore, FDA is maintaining the current requirements of a 
minimum amount of 3.25 percent milkfat and 8.25 percent milk solids not 
fat in yogurt.
    With respect to the measurement of these components in yogurt, NYA 
requested that the minimum milk solids not fat content of 8.25 percent 
be derived from basic dairy ingredients and, therefore, that this 
requirement be applied prior to the addition of any permitted optional 
ingredients. We agree that the optional dairy ingredients may be used 
to increase the milk solids not fat levels above the minimum required 
8.25 percent, not to meet this minimum level. FDA previously clarified 
this purpose of the provision in the final rule establishing the 
current standard that permits optional milk-derived ingredients to 
increase the nonfat milk solids content (46 FR 9924 at 9927). In 
addition, as FDA noted in 1982, while Sec.  131.200(a) of the current 
yogurt standard provides for the use of optional dairy ingredients to 
increase the milk solids not fat levels above the minimum required 8.25 
percent, this provision was not intended to provide nor does it provide 
for a proportionate decrease in the minimum milkfat content of yogurt 
(47 FR 41519 at 41521).
    FDA also believes that the addition of bulky flavoring ingredients 
such as fruits and fruit preparations lowers the milkfat and milk 
solids not fat levels of the resultant flavored yogurt. Therefore, to 
ensure the quality and compositional characteristics of the finished 
flavored yogurt, the milkfat and milk solids not fat requirements 
should apply to the yogurt portion prior to the addition of bulky 
flavoring ingredients. Comments in response to the ANPRM did not 
provide any specific comments on this issue. Furthermore, applying the 
milkfat and milk solids not fat requirements prior to the addition of 
flavoring ingredients only is consistent with the Codex Standard, which 
applies milkfat, milk protein, and other compositional criteria to the 
fermented milk part only, before flavoring ingredients are added.
    For these reasons, FDA tentatively concludes that requiring a 
minimum milkfat content of 3.25 percent and a milk solids not fat 
content of 8.25 percent in yogurt prior to the addition of any bulky 
flavoring ingredients would promote honesty and fair dealing in the 
interest of consumers by ensuring the overall quality and composition 
of yogurt that may or may not contain added flavoring ingredients. 
Therefore, FDA is proposing to require in Sec.  131.200(a) that yogurt 
have a minimum milkfat content of 3.25 percent and a minimum milk 
solids not fat content of 8.25 percent before the addition of bulky 
flavoring ingredients. FDA seeks comment on the need for and 
appropriateness of the following provisions: (1) A minimum milkfat 
content of 3.25 percent in yogurt, (2) a minimum milk solids not fat 
content of 8.25 percent, and (3) the application of these two 
compositional requirements prior to the addition of bulky flavoring 
ingredients.
    b. Acidity of yogurt. FDA stayed those portions of the standards of 
identity for yogurt, lowfat yogurt, and nonfat yogurt (Sec. Sec.  
131.200(a), 131.203(a), and 131.206(a), respectively) that required a 
minimum titratable acidity of 0.9 percent. These standards also allow 
an equivalent potentiometric method to be used to determine acidity 
(i.e., a pH value) in lieu of the Association of Official Analytical 
Chemists International (AOAC) titration method that is specified in the 
standards. FDA stayed these provisions in response to an objection to 
the January 30, 1981, final rule that the required acidity was too high 
for some consumers' taste and that 0.75 percent is the common industry 
practice. The agency stated that until such time as this issue is 
resolved, yogurt, lowfat yogurt, and nonfat yogurt will not be required 
to meet the 0.9 percent minimum level of titratable acidity (47 FR 
41519 at 41522).
    NYA requested that yogurt contain a minimum titratable acidity of 
0.7 percent prior to the addition of optional ingredients and stated 
that this level reflects the lower end of titratable acidity commonly 
used by industry today. This lower acidity level is also supported by 
comments in response to the ANPRM. NYA also requested that the yogurt 
standard specify the acidity requirement as a determination of pH 
rather than titratable acidity because measuring pH reflects current 
industry practice and is a more accurate and convenient method than 
measuring titratable acidity. NYA recommended a maximum pH of 4.6. FDA 
believes 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. 
FDA believes that providing for the measurement of acidity in yogurt as 
a determination of

[[Page 2449]]

its pH as well as its titratable acidity will introduce flexibility in 
the yogurt standard. FDA recognizes that each method may pose certain 
challenges in its application to yogurt. For example, the addition of 
flavors and colors may interfere with the precise determination of the 
colorimetric endpoint of titration. By providing for both pH and 
titratable acidity measurements, the standard gives manufacturers the 
flexibility to choose a method that best suits their product.
    With respect to the application of this acidity requirement, NYA 
requested that the acidity requirement should apply prior to the 
addition of any permitted optional ingredients, including dairy 
ingredients added for technical or functional purposes, microbial 
cultures, sweeteners, and flavoring ingredients. The stayed provisions 
that required a minimum titratable acidity would have applied prior to 
the addition of bulky flavors only. FDA believes that the addition of 
bulky flavoring ingredients such as fruits and fruit preparations may 
significantly impact the acidity of the resultant flavored yogurt. 
Therefore, to ensure the overall quality and sensory characteristics of 
the finished flavored yogurt, the acidity requirement should apply to 
the yogurt portion prior to the addition of bulky flavoring 
ingredients. FDA does not believe that it is appropriate to exclude the 
other permitted optional ingredients such as safe and suitable cultures 
and optional dairy ingredients from the point at which acidity is 
measured, as these ingredients can be important contributors to the 
culturing process and acidity development of yogurt. In addition, 
applying the acidity requirement prior to the addition of bulky 
flavoring ingredients only is consistent with the Codex Standard, which 
applies the compositional criteria in the case of flavored fermented 
milks to the fermented milk part only.
    For these reasons, FDA tentatively concludes that a minimum 
titratable acidity of yogurt of 0.7 percent or a maximum pH of 4.6 is 
appropriate. FDA also tentatively concludes that applying the acidity 
requirement to yogurt prior to the addition of bulky flavoring 
ingredients promotes honesty and fair dealing in the interest of 
consumers by ensuring the overall quality and sensory characteristics 
of yogurt. Therefore, FDA is proposing to revise Sec.  131.200(a) to 
require that, before the addition of bulky flavors, yogurts have either 
a minimum titratable acidity of 0.7 percent or a maximum pH of 4.6. FDA 
is interested in comments on the appropriateness of the proposed level 
and measurement of acidity. In the proposed yogurt standard, FDA has 
also reformatted this paragraph to be clear, simple, and easy to use by 
both manufacturers and FDA officials that enforce compliance with the 
standards.
    c. Live and active cultures in yogurt. The current standards of 
identity for yogurt, lowfat yogurt, and nonfat yogurt (Sec. Sec.  
131.200, 131.203, and 131.206, respectively) do not require the 
presence of a specific amount of live and active cultures in yogurt, 
lowfat yogurt, or nonfat yogurt. NYA recommended that FDA revise the 
yogurt standards to require a specified amount of live and active 
cultures and that heat treatment should not be permitted after 
culturing because it destroys the live and active cultures in yogurt. 
NYA submitted data obtained from consumer surveys to support its 
argument that consumers expect ``yogurt'' to contain live and active 
cultures. While the NYA consumer surveys adequately show that consumers 
believe that yogurt is a healthful food, FDA does not agree that the 
data submitted support its argument that consumers are generally aware 
of the presence of live cultures in yogurt or that they expect yogurt 
to contain live cultures (Ref. 4).
    In the absence of convincing data demonstrating that the presence 
of live and active cultures is a characteristic that consumers expect 
in yogurt, FDA does not have a basis to require live and active 
cultures in yogurt at the time of manufacture or at the retail level. 
Therefore, FDA is not proposing that yogurt must contain a specified 
amount of live and active cultures.
    However, based on the petitioner's request as well as some comments 
in response to the ANPRM, there appears to be interest among 
manufacturers in distinguishing their yogurt products from other yogurt 
products on the basis of the level of live and active cultures in the 
food. In the interest of providing a flexible standard that allows for 
appropriate product diversity and provides for truthful and 
nonmisleading labeling of yogurt that contains a set amount of live and 
active cultures, FDA is proposing (1) in Sec.  131.200(a) that yogurt 
that is not heat-treated may contain a minimum of 10\7\ CFU/g of live 
and active cultures at the time of manufacture of the yogurt with a 
reasonable expectation that yogurt contains live and active cultures at 
a level of 10\6\ CFU/g at the retail level through the manufacturer's 
assigned shelf life of the product and (2) in Sec.  131.200(f)(3) to 
permit an optional labeling statement such as ``contains live and 
active cultures'' or another appropriate descriptor on such yogurt that 
is not heat-treated after culturing and that contains the specified 
amount of live and active cultures.
    These levels of live and active cultures are as proposed by the 
petitioner. The Codex Standard, on the other hand, establishes a 
minimum amount of microorganisms constituting the starter culture of 
10\7\ CFU/g of yogurt. FDA seeks comment on the appropriateness of 
providing for special labeling statements on yogurt products that 
contain a certain minimum level of live and active cultures and the 
appropriateness of a minimum level of 10\6\ CFU[sol]g throughout the 
shelf life of the food as the basis for the special labeling 
statements.
    d. Heat treatment of yogurt after culturing. The current yogurt 
standards do permit heat treatment after culturing, provided the phrase 
``heat-treated after culturing'' follows the name of the food in the 
labeling of these products (Sec. Sec.  131.200(f)(1)(ii), 
131.203(f)(1)(iii), and 131.206(f)(1)(ii), respectively). During the 
adoption of the yogurt standards, FDA reviewed extensively the question 
of whether the standards should permit heat treatment of the product 
after the culturing process. FDA acknowledged in its June 10, 1977, 
proposal that yogurt is a cultured product containing microorganisms 
but that in some cases, yogurt is heat-treated after culturing to kill 
these microorganisms and extend the shelf life of the food (42 FR 29919 
at 29920, June 10, 1977). FDA also opined that ``except for destroying 
the microorganisms, these foods retain essentially the same 
characteristic attributes'' of traditional yogurt and, therefore, 
proposed to preserve the food ``yogurt'' unqualified in its traditional 
form that is not heat-treated after culturing and to provide for 
appropriate labeling ``to inform consumers when yogurt has been heat-
treated after culturing'' (42 FR 29919 at 29920). In response to 
comments to that proposed rule, FDA further advised in a final rule 
that ``it is in the best interest of both consumers and international 
trade to permit heat treatment of yogurts and to require auxiliary 
labeling to inform consumers that the product has been heat-treated'' 
(46 FR 9924 at 9931).
    NYA's consumer survey data do not support the argument that heat 
treatment following culturing is inconsistent with consumer 
expectations of a food named ``yogurt.'' FDA has no evidence nor is it 
aware of any information that suggests that the name ``yogurt,'' when 
appropriately qualified by the phrase ``heat-treated after culturing,'' 
is misleading to consumers in that they believe this food

[[Page 2450]]

to be ``yogurt'' that is not heat-treated after culturing. Therefore, 
FDA is not persuaded that heat treatment after culturing should be 
prohibited by the yogurt standard. Accordingly, FDA is retaining in 
Sec.  131.200(a) the provision that permits heat treatment of yogurt 
after culturing to extend the shelf life of the food.
    A review of the data that NYA submitted to support its assertion of 
consumer expectations of live and active cultures as a characteristic 
of yogurt also provides some information about consumers' understanding 
of the term ``heat-treated after culturing.'' Although the surveys had 
several methodological limitations, the data suggest that consumers do 
not fully understand the meaning of the term ``heat-treated after 
culturing'' on yogurt products (Ref. 4). However, no further 
information or reasons for this finding can be ascertained; for 
example, it is possible that consumers do not relate the heat treatment 
statement to its impact on specific attributes of the food. If 
consumers generally do not expect ``yogurt'' to contain live and active 
cultures, as suggested by NYA's survey data, it is likely that they do 
not associate the descriptor ``heat-treated after culturing'' with its 
effect on live and active cultures in the food. With the exception of 
these initial data, FDA does not have factual information or data that 
would lead us to conclude at this time that ``heat-treated after 
culturing'' is not an appropriate accompanying statement for yogurt 
that is heat-treated after culturing. ``Heat-treated after culturing'' 
is a truthful statement that accurately and adequately describes the 
basic identity of the food. Further, FDA provided for the use of this 
phrase since the time the yogurt standards were adopted in 1981 and 
some manufacturers appear to be using this descriptor in the labeling 
of their products. Most consumer comments that FDA received at the time 
of adoption of these standards expressed approval of the labeling 
statement ``heat-treated after culturing'' to differentiate between 
heat-treated and non-heat-treated yogurts (46 FR 9924 at 9931). FDA did 
not receive any consumer comments in response to the ANPRM that 
expressed a lack of understanding or other concerns with this 
descriptor in the labeling of yogurts. Therefore, FDA is maintaining 
the current descriptor ``heat-treated after culturing'' to accompany 
the name of the food for yogurt that undergoes heat treatment after the 
culturing process. However, to enhance consumer understanding of this 
phrase, provide more meaningful information about the impact of the 
heat treatment on specific attributes of the food, and distinguish 
these products from traditional yogurt, FDA advises that manufacturers 
may consider using additional truthful and nonmisleading statements, 
such as ``does not contain live and active cultures,'' in the labeling 
of their heat-treated yogurt products.
    e. Use of reconstituted milk forms as basic dairy ingredients. The 
current standards of identity for yogurt, lowfat yogurt, and nonfat 
yogurt (Sec. Sec.  131.200, 131.203, and 131.206, respectively) do not 
provide for the use of reconstituted dairy ingredients as basic dairy 
ingredients in their manufacture. FDA stayed those portions of 
Sec. Sec.  131.200(a), 131.203(a), and 131.206(a)) insofar as they 
exclude the use of reconstituted dairy ingredients as basic ingredients 
in the manufacture of yogurts in response to an objection to the 
January 30, 1981, final rule that yogurt manufacturers in Florida and 
the Southeastern States will be adversely affected because the fluid 
milk supplies in these States are often insufficient for use in yogurt 
manufacture (47 FR 41519 at 41521). FDA also stated that until such 
time as this issue is resolved, the use of reconstituted dairy 
ingredients as basic ingredients in the manufacture of yogurt, lowfat 
yogurt, or nonfat yogurt will not be the basis for regulatory action 
(47 FR 41519 at 41521).
    According to NYA, manufacturers have routinely used reconstituted 
dairy ingredients in the manufacture of yogurts. Comments in response 
to the ANPRM also stated that reconstituted dairy ingredients are 
currently used as basic ingredients in the manufacture of yogurts and 
recommended that FDA adopt a modernized yogurt standard that permits 
this typical industry practice. FDA is not aware of any data or other 
information that would suggest that the use of reconstituted forms of 
permitted dairy ingredients, i.e., cream, milk, partially skimmed milk, 
and skim milk, has an adverse effect on yogurt quality or safety. 
Moreover, FDA's standards currently permit the use of reconstituted 
forms of dairy ingredients as basic ingredients in the manufacture of 
other standardized dairy foods, such as cheeses and related cheese 
products, ice cream, and frozen custard. Seeing no technical or safety 
concerns, FDA tentatively concludes that it is appropriate to permit 
reconstituted forms of cream, milk, partially skimmed milk, and skim 
milk as basic ingredients in the manufacture of yogurt and its lower 
fat versions. Therefore, FDA is proposing to revise Sec.  131.200 to 
permit reconstituted forms of cream, milk, partially skimmed milk, and 
skim milk as basic ingredients by (1) redesignating current Sec.  
131.200(c) as proposed Sec.  131.200(b), (2) renaming the heading of 
newly proposed Sec.  131.200(b) as ``Basic dairy ingredients'' instead 
of ``Optional dairy ingredients'' because the proposed new nomenclature 
better describes the proposed provision, and (3) revising newly 
proposed Sec.  131.200(b) to include the reconstituted versions of the 
dairy ingredients permitted in current Sec.  131.200(c). FDA seeks 
comment on the need for and appropriateness of this proposed provision.
    f. Use of safe and suitable milk-derived ingredients as optional 
dairy ingredients. Stayed portions of the standards of identity for 
yogurt, lowfat yogurt, and nonfat yogurt listed the optional milk-
derived ingredients (i.e., concentrated skim milk, nonfat dry milk, 
buttermilk, whey, lactose, lactalbumins, lactoglobulins, and whey 
modified by partial or complete removal of lactose and/or minerals) 
that can be used for the purpose of increasing the nonfat solids 
content of these foods above the minimum required 8.25 percent, 
provided 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 these optional ingredients (Sec. Sec.  
131.200(c)(1), 131.203(c)(1), and 131.206(c)(1); redesignated as 
Sec. Sec.  131.200(d)(1), 131.203(d)(1), and 131.206(d)(1)). FDA stayed 
these provisions in response to objections to the January 30, 1981, 
final rule that these provisions preclude the use of other safe, 
nutritional, and functional milk-derived ingredients and that there 
appears to be no rational factual basis for the omission of traditional 
ingredients such as partially delactosed skim milk, partially 
hydrolyzed whey, and other safe and suitable ingredients (47 FR 41519).
    NYA stated that manufacturers currently use a variety of safe and 
suitable milk-derived ingredients for the purpose of increasing the 
nonfat solids content of yogurts. FDA is not aware of any data or other 
information that would suggest that expanding the current list of 
optional milk-derived ingredients to permit the use of any safe and 
suitable milk-derived ingredient, under the conditions stated in the 
current standard to maintain the nutritional quality of yogurt, would 
have an adverse effect on the overall quality or safety of yogurt. FDA 
believes that it is appropriate to incorporate technological 
flexibility into standards so long as the basic nature and essential 
characteristics of the food are not

[[Page 2451]]

adversely affected. Therefore, FDA is proposing to permit the optional 
use of any safe and suitable milk-derived ingredient as an optional 
dairy ingredient in the manufacture of yogurt to increase the nonfat 
solids content of the food above the minimum required 8.25 percent, 
provided the ratio of protein to total nonfat solids of the food and 
the protein efficiency ratio of protein present in the food are not 
decreased as a result of the use of such ingredients. Specifically, FDA 
is proposing, in new Sec.  131.200(c), ``Optional dairy ingredients,'' 
to permit other safe and suitable milk-derived ingredients to be used 
to increase the nonfat solids content of the food, provided the ratio 
of protein to total nonfat solids of the food and the protein 
efficiency ratio of protein present in the food are not decreased as a 
result of the use of such ingredients. FDA seeks comment on the need 
for and appropriateness of this proposed provision.
    g. Use of safe and suitable cultures in addition to the 
characterizing bacterial cultures. The current standards of identity 
for yogurt, lowfat yogurt, and nonfat yogurt (Sec. Sec.  131.200, 
131.203, and 131.206, respectively) do not prohibit the use of 
bacterial cultures in addition to the two characterizing lactic acid-
producing bacteria, Lactobacillus bulgaricus and Streptococcus 
thermophilus. However, the standards do not explicitly state that other 
bacterial cultures are permitted. NYA requested that FDA revise the 
yogurt standard to clearly permit the use of other safe and suitable 
bacterial cultures in addition to the characterizing bacterial 
cultures. FDA tentatively concludes that explicitly providing for the 
use of other optional bacterial cultures will enhance the clarity of 
the yogurt standard. Therefore, FDA is proposing to clarify in new 
Sec.  131.200(d)(1) that optional safe and suitable cultures may be 
used only in addition to the required characterizing bacterial cultures 
specified in the standard.
    h. Use of sweeteners. The current standards of identity for yogurt, 
lowfat yogurt, and nonfat yogurt currently provide for the optional use 
of certain nutritive carbohydrate sweeteners, specifically: Sugar (beet 
or cane), invert sugar, brown sugar, refiner's syrup, molasses (other 
than blackstrap), high fructose corn syrup, fructose, fructose syrup, 
maltose, maltose syrup, dried maltose syrup, malt extract, dried malt 
extract, malt syrup, dried malt syrup, honey, maple sugar, and any of 
the sweeteners listed in 21 CFR part 168, except table syrup 
(Sec. Sec.  131.200(d)(2), 131.203(d)(2), and 131.206(d)(2), 
respectively, as redesignated in the September 21, 1982 final rule (47 
FR 41519)). The term ``sweetened'' must accompany the name of yogurt, 
lowfat yogurt, and nonfat yogurt that is sweetened without the addition 
of characterizing flavor with any one or more of these permitted 
sweeteners (Sec. Sec.  131.200(f)(1)(i), 131.203(f)(1)(ii), and 
131.206(f)(1)(i), respectively, as redesignated in the September 21, 
1982, final rule (47 FR 41519)).
    NYA requested that FDA revise the current yogurt standards to 
permit ``safe and suitable sweeteners'' without specifying a list, as 
is permitted for ice cream (21 CFR 135.110(a)(1)), with the sweetener 
being declared in the ingredient statement of the food so that non-
nutritive sweeteners may be used in yogurt without a specific 
declaration of its presence in the name of the food. NYA argued that 
under current regulations, manufacturers are able to use non-nutritive 
sweeteners in yogurt that is modified to be eligible to bear a nutrient 
content claim, for example, ``reduced calorie yogurt,'' without a 
specific declaration of the presence of the non-nutritive sweetener in 
the name of the food. Consumer comments to the ANPRM strongly opposed 
this NYA recommendation and requested that the presence of non-
nutritive sweeteners be declared in the name of the food.
    The regulatory framework governing the naming of standardized foods 
that do not fully comply with the relevant standards of identity 
changed with the passage of the NLEA in 1990 and the subsequent 
establishment of the agency's requirements for foods named by use of a 
nutrient content claim and a standardized term (Sec.  130.10). 
Specifically, Sec.  130.10(d) permits the addition of safe and suitable 
ingredients to a standardized food modified to be eligible to bear 
defined nutrient content claims when these ingredients are needed to, 
among other things, add sweetness to ensure that the modified food is 
not inferior in performance characteristic to the standardized food 
even though these ingredients are not specifically permitted by an 
individual food standard.
    In addition, these non-nutritive sweeteners must only be declared 
by their common or usual names in the ingredient statement as required 
by Sec.  101.4(a) (21 CFR 101.4(a)), as their presence in the 
standardized food is not required to be declared within the name of the 
food. Therefore, for example, a product named ``light sweetened 
yogurt'' or ``reduced calorie sweetened yogurt'' may contain non-
nutritive sweeteners to add sweetness to the product so that it is not 
inferior in its sweetness property compared to its standardized 
counterpart, sweetened yogurt. The provisions of Sec.  130.10 do not 
require these yogurt products to declare the presence of such non-
nutritive sweeteners within the name of these foods. The same is true 
for other standardized foods modified under Sec.  130.10; for example, 
``light ice cream'' and ``reduced calorie sweet chocolate.''
    There are, however, certain exceptions where the regulatory 
framework governing the naming of standardized foods that do not fully 
comply with the relevant standards of identity was not changed by NLEA 
or the establishment of Sec.  130.10. For example, a few artificially 
sweetened foods are governed by standards of identity that establish 
the phrase ``artificially sweetened'' as a part of the statement of 
identity of these foods (for example, ``artificially sweetened canned 
pears'' (see 21 CFR 145.176)). FDA may consider appropriate actions in 
the future to bring these particular standardized foods in conformity 
with NLEA. With the exception of these standardized artificially 
sweetened foods, foods that are made using non-nutritive sweeteners are 
not required to declare the presence of the non-nutritive sweetener 
within the name of the food. Per the ingredient labeling requirements 
of Sec.  101.4(a), the non-nutritive sweetener is declared by its 
common or usual name in the ingredient statement of the food. Where 
special labeling requirements are necessary for the safe use of a non-
nutritive 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 regulation(s). For 
example, labels of foods that contain aspartame are required to bear 
the statement ``PHENYLKETONURICS: CONTAINS PHENYLALANINE'' either on 
the principal display panel or on the information panel, in accordance 
with 21 CFR 172.804. This regulation also requires that the statement 
shall appear prominently and conspicuously in contrast to other printed 
matter on the label. Any new sweetening ingredients developed and 
permitted for use in foods in the future will be required to be labeled 
in accordance with similar new labeling or other requirements necessary 
for the safe use of the sweetener.
    FDA recognizes that there is considerable interest in the special 
labeling requirements for artificial sweeteners when used in foods in 
general. Over the years, FDA has been asked to require the disclosure 
of

[[Page 2452]]

artificial sweeteners on the principal display panel in addition to the 
ingredient list. The agency considers the safety of artificial 
sweeteners as part of the food additive review process and has and will 
continue to establish special labeling or packaging requirements where 
necessary for the safe use of these ingredients. FDA does not object to 
manufacturers voluntarily declaring on the principal display panel that 
the product is artificially sweetened nor does the agency object to 
truthful and nonmisleading statements to inform consumers of yogurt 
that is made using non-nutritive sweeteners.
    For these reasons, FDA tentatively concludes that providing for the 
use of any safe and suitable sweetening ingredients, in lieu of the 
current allowance for certain nutritive carbohydrate sweeteners, 
introduces flexibility in the manufacture of yogurt without adversely 
affecting the basic nature and essential characteristics of yogurt. 
Therefore, FDA is proposing (1) in Sec.  131.200(d)(2) to provide for 
the use of any safe and suitable sweeteners in yogurt and (2) to revise 
Sec.  131.200(f)(1)(i) accordingly to replace the term ``nutritive 
carbohydrate sweetener'' with ``sweetener(s)''. Consumers would 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. However, FDA tentatively concludes that there is no basis 
to require the declaration of a non-nutritive sweetener, when used, as 
part of the name of yogurt. FDA specifically seeks comment on the 
appropriateness of this tentative decision. Comments that address FDA's 
tentative decision should include sound scientific and factual data or 
information that supports the positions presented in the comments.
    i. Use of stabilizers and emulsifiers. The current standards of 
identity for yogurt, lowfat yogurt, and nonfat yogurt provide for the 
use of stabilizers but do not provide for the use of emulsifiers 
(Sec. Sec.  131.200(d)(5), 131.203(d)(5), and 131.206(d)(5), 
respectively). NYA stated that permitting the use of emulsifiers in 
addition to stabilizers would provide more opportunities for product 
development and innovation in the yogurt industry. A few comments in 
response to the ANPRM supported the use of emulsifiers along with the 
use of stabilizers, which are currently permitted by the standards. FDA 
does not have any safety or quality concerns with the use of 
emulsifiers in yogurt, provided that they are used within good 
manufacturing practice, where there is a need for the ingredient, and 
within any limitations specified by relevant FDA food additive or 
generally recognized as safe substance regulations. For these reasons, 
FDA has tentatively concluded that providing for the use of emulsifiers 
in addition to stabilizers permits flexibility in the manufacture of 
yogurt without adversely affecting the basic nature or essential 
characteristics of yogurt. Therefore, FDA is proposing to revise Sec.  
131.200(d)(5) to permit the use of safe and suitable emulsifiers in 
addition to the current allowance for the use of stabilizers as 
optional ingredients in the manufacture of yogurt.
    j. Use of preservatives. The current standards of identity for 
yogurt, lowfat yogurt, and nonfat yogurt (Sec. Sec.  131.200, 131.203, 
and 131.206, respectively) do not list preservatives as permitted 
ingredients in the manufacture of yogurt, lowfat yogurt, or nonfat 
yogurt. FDA stayed those portions of Sec. Sec.  131.200(c), 131.203(c), 
and 131.206(c) (redesignated as Sec. Sec.  131.200(d), 131.203(d), and 
131.206(d), respectively) insofar as they exclude the addition of 
preservatives in response to objections to the January 30, 1981, final 
rule that preservatives such as potassium sorbate and sorbic acid 
should be permitted to prohibit the growth of yeasts and molds and to 
extend the shelf life of the foods (47 FR 41519). FDA stated that until 
this issue is resolved, the appropriate use of preservatives in these 
foods would not be the basis for regulatory action (47 FR 41519 at 
41522). While NYA stated that the use of preservatives will provide 
flexibility in the manufacture of yogurt and comments from industry 
supported their use, stating that preservatives help maintain the 
product's integrity through shipping and storage, at least one consumer 
group and some consumers opposed their use, citing product quality 
concerns. However, these comments did not provide any data to support 
their position. Nor does FDA have any data that indicate that 
appropriate use of preservatives, particularly in the case of yogurts 
that are heat-treated after culturing to have an extended shelf life, 
has an adverse effect on the quality or characteristics of yogurt. In 
addition, the Codex Standard permits the use of preservatives in the 
fermented milks that are heat-treated after fermentation. For these 
reasons, FDA has tentatively concluded that providing for the optional 
and appropriate use of preservatives permits flexibility in the 
manufacture of yogurt without adversely affecting the basic nature or 
essential characteristics of yogurt. Therefore, FDA is proposing in 
Sec.  131.200(d)(6) to permit the use of safe and suitable 
preservatives as optional ingredients in the manufacture of yogurt. FDA 
seeks comment on the need for and appropriateness of this proposed 
provision. Specifically, FDA seeks comment on (1) whether it is 
appropriate to permit the use of safe and suitable preservatives in the 
manufacture of yogurt and (2) whether such provision should limit the 
use of preservatives in only those yogurts that are heat-treated after 
culturing, consistent with the Codex Standard.
    k. Use of optional milk-derived ingredients after pasteurization 
and culturing. The current standards of identity for yogurt, lowfat 
yogurt, and nonfat yogurt require the other optional dairy ingredients, 
when used, to be included in the culturing process and do not provide 
for the use of optional milk-derived ingredients after pasteurization 
(Sec. Sec.  131.200(a), 131.203(a), and 131.206 (a), respectively). NYA 
requested that FDA revise the yogurt standards to allow the use of 
optional milk-derived ingredients after the pasteurization and 
culturing steps in the manufacture of yogurt. Comments to the ANPRM 
both supported and opposed the NYA recommendation. Some of the opposing 
comments expressed safety concerns with adding milk-derived ingredients 
after pasteurization. The agency is not persuaded by NYA's argument, 
nor did NYA submit any convincing evidence that could overcome the 
agency's and some of the comments' concern about the safety issues that 
would arise with the use of milk-derived ingredients after 
pasteurization of the yogurt mix. FDA is also not convinced of the need 
for, nor is it aware of, the advantages provided by the use of milk-
derived ingredients after the culturing process. Therefore, FDA is not 
proposing to provide for the use of optional milk-derived ingredients 
following pasteurization and culturing processes as requested by NYA.
    l. Use of whey protein concentrate as a basic ingredient. The 
current standards of identity for yogurt, lowfat yogurt, and nonfat 
yogurt do not allow the use of whey protein concentrate as a basic 
ingredient (Sec. Sec.  131.200(c), 131.203(c), and 131.206(c), 
respectively). NYA requested that FDA revise the yogurt standards to 
allow the use of whey protein concentrate as a basic ingredient. NYA 
asserted that the inclusion of whey protein concentrate in yogurt 
products is standard industry practice and should be included in the 
yogurt standards. NYA also mistakenly believes that the stayed 
provisions of Sec. Sec.  131.200(d), 131.203(d), and 131.206(d) would 
have permitted its inclusion. Comments to the ANPRM

[[Page 2453]]

both favored and opposed permitting the inclusion of whey protein 
concentrate in yogurt products. The comments that favored permitting 
its use in yogurt products cited their function as stabilizers while 
those opposed questioned the need for its inclusion.
    FDA clarifies that the 1982 stayed provisions include paragraph 
(d)(1) of the current yogurt standard (Sec.  131.200), which limits the 
use of optional milk-derived ingredients to the ones specifically 
listed under that paragraph. The list of basic milk ingredients in 
paragraph (c) of the current yogurt standard was not among the 
provisions that were stayed and, therefore, the current standard makes 
no allowance for the use of whey protein concentrate as a basic 
ingredient in yogurt. FDA agrees with the comments that question the 
need for allowing the use of whey protein concentrate as a basic 
ingredient in yogurt. FDA believes that use of whey protein concentrate 
as a basic ingredient in yogurt is not consistent with the basic nature 
of yogurt. This is consistent with the agency's recent tentative 
decision not to permit milk protein concentrates as a basic ingredient 
in standardized cheese (which is noted in a recent proposal to permit 
fluid ultrafiltered milk in standardized cheeses and related cheese 
products; 70 FR 60751, October 19, 2005). Some comments that supported 
this provision cited the function of whey protein concentrates as 
stabilizers. FDA notes that the agency does not object to the use of 
safe and suitable stabilizers in yogurt and the current standard 
provides for the use of stabilizers as an optional ingredient in 
yogurt. FDA has no evidence at this time to support the amendment of 
the list of permitted basic ingredients in yogurt to include whey 
protein concentrate. Therefore, FDA is not proposing to provide for the 
use of whey protein concentrate as a basic ingredient in yogurt as 
requested by NYA.
    m. Percent dairy ingredients. The current standards of identity for 
yogurt, lowfat yogurt, and nonfat yogurt (Sec. Sec.  131.200, 131.203, 
and 131.206, respectively) do not require a minimum of 51 percent of 
dairy ingredients in these foods. NYA requested that FDA revise the 
yogurt standards to include this requirement to ensure that the 
predominant ingredients in yogurt are from dairy sources. One trade 
association supported the inclusion of this requirement while a few 
other comments questioned the appropriateness of the 51 percent 
requirement. Comments that opposed this requirement expressed concern 
that under such a requirement, yogurts could contain up to 49 percent 
non-dairy ingredients. FDA is not convinced that there is a need to 
require a minimum amount of dairy ingredients to ensure that dairy 
ingredients are the primary ingredients of yogurt. 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. FDA tentatively 
concludes that these provisions adequately ensure that appropriate 
amounts of dairy ingredients are used in the manufacture of yogurt. 
Therefore, FDA is not proposing to require a minimum amount of dairy 
ingredients in yogurt as requested by NYA.
    n. Use of any safe and suitable ingredient that serves a 
nutritional or functional purpose. The current standards of identity 
for yogurt, lowfat yogurt, and nonfat yogurt (Sec. Sec.  131.200, 
131.203, and 131.206, respectively) do not permit the optional use of 
any safe and suitable ingredient for a nutritional or functional 
purpose. NYA requested that FDA revise the yogurt standards to allow 
for such safe and suitable ingredients so that there would be enough 
flexibility in the standards to permit the use of novel ingredients as 
they are developed in the future. Comments to the ANPRM both favored 
and opposed the NYA recommendation. The comments that supported NYA's 
recommended provision stated that it would allow for future advances in 
ingredient technology while other comments that opposed this provision 
stated that it could lead to the use of inferior quality ingredients.
    FDA recognizes the need for food standards to permit flexibility in 
food technology, so long as that technology does not alter the basic 
nature or essential characteristics of the food (68 FR 39873 at 39875). 
However, FDA does not believe that there is a need for a broad 
provision to permit any safe and suitable ingredient for a nutritional 
or functional purpose as recommended by NYA. The existing regulatory 
framework governing standardized foods already provides for the 
addition of substances for a nutritional purpose. Under the provisions 
of Sec.  130.10, standardized foods may be modified to contain 
nutrients not specifically permitted by the relevant standard of 
identity and to make an expressed nutrient content claim defined by FDA 
regulation.
    As for the use of ingredients for a functional purpose, the 
proposed yogurt standard provides for the use of specific functional 
categories of ingredients such as emulsifiers and stabilizers. FDA 
tentatively concludes that a provision that broadly permits any safe 
and suitable ingredient for functional purposes is not necessary and 
the lack of comments in response to its request in the ANPRM on the 
need for any functional categories of ingredients in addition to the 
ones that NYA proposed supports the agency's tentative conclusion. As 
explained earlier in this section of the document, FDA is proposing to 
provide for the use of specific functional ingredient categories such 
as emulsifiers and stabilizers and will consider future requests made 
under 21 CFR 10.30 for amendments for ingredient categories that are 
not included in the proposed yogurt standard. However, FDA is not 
persuaded at this time that a provision that broadly permits any safe 
and suitable ingredient for a technical purpose is needed in addition 
to the proposed specific functional ingredient categories. Therefore, 
FDA is not proposing to permit any safe and suitable ingredient for a 
nutritional or functional purpose in yogurt as requested by NYA.
    o. Methods of analysis. The current standards of identity for 
yogurt, lowfat yogurt, and nonfat yogurt list 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) (Sec. Sec.  131.200(e), 131.203(e), and 131.206(e), 
respectively). FDA is proposing to revise Sec.  131.200(e) to update 
these methods to incorporate by reference the ``Official Methods of 
Analysis of AOAC International,'' 18th Ed. (2005). In addition, FDA is 
proposing that the pH of yogurt, when used to determine the acidity of 
yogurt, be determined using the method described in Sec.  114.90(a) (21 
CFR 114.90(a)). Finally, FDA is proposing that the live and active 
cultures content of yogurt be determined using the aerobic plate count 
methods described in Chapter 3 of FDA's Bacteriological Analytical 
Manual, January 2001 Edition. FDA seeks comment on the appropriateness 
of the proposed methods and any alternate methods that should be 
considered in lieu of or in addition to the methods proposed in Sec.  
131.200(e).
    p. Vitamins and minerals as optional ingredients. The current 
standards of identity for yogurt, lowfat yogurt, and nonfat yogurt 
provide for optional fortification of these foods with vitamins A and D 
(Sec. Sec.  131.200(b), 131.203(b), and 131.206(b), respectively). If 
vitamins A and/or D are added for this purpose, the standards require 
these vitamins to be present in

[[Page 2454]]

amounts of 2,000 International Units (IU) of vitamin A and/or 400 IU of 
vitamin D per quart (or 946 milliliters) of the food. In addition, in 
Sec. Sec.  131.200(f)(1)(iii), 131.203(f)(1)(iv), and 
131.206(f)(1)(iii), the standards require the phrase ``vitamin A'' or 
``vitamin A added,'' or ``vitamin D'' or ``vitamin D added,'' or 
``vitamins A and D added,'' as appropriate, to accompany the name of 
the food.
    NYA requested that FDA retain this provision for the optional 
fortification of yogurt with vitamins A and/or D. NYA also requested 
that the levels of fortification also be retained. However, NYA stated 
that yogurt is rarely measured by quart and, therefore, listed the 
minimum amounts of vitamins A and D fortification in terms of yogurt's 
reference amount customarily consumed (RACC), i.e., 225 g (21 CFR 
101.12). Comments in response to the ANPRM did not specifically address 
this provision.
    In Sec.  101.54(e) (21 CFR 101.54(e)), FDA has established 
requirements for claims related to the fortification of foods with 
certain nutrients, including vitamins and minerals. These requirements 
apply to any food (unless otherwise in conflict with the requirements 
specified in a standard of identity) that contains added vitamins or 
minerals for the purpose of making a relative labeling claim such as 
``fortified'' or ``added.'' According to the provisions of this 
regulation, a relative claim such as ``fortified'' or ``added'' may be 
made in the labeling of a food, provided that the food contains at 
least 10 percent more of the reference daily intake for vitamins and 
minerals per RACC compared to an appropriate reference food.
    This requirement currently applies to yogurts that bear a 
fortification claim with respect to vitamins or minerals other than 
vitamins A and D. When yogurt is fortified with vitamins A and D, the 
requirements for the optional use of these two vitamins specified in 
the yogurt standard apply. FDA points out that the provision for the 
optional fortification of yogurt with vitamins A and D was established 
in 1981 prior to the implementation of the NLEA and the adoption of the 
certain nutrient content and relative claims regulations, including 
Sec.  101.54. FDA believes that it is appropriate to apply the 
provisions of Sec.  101.54(e) to vitamins A and D fortification of 
yogurt as they currently apply to fortification of yogurt with other 
vitamins and minerals and as they currently also apply to vitamin and 
mineral fortification of other foods. FDA also believes that the 
modernization of the yogurt standard should include bringing the 
outdated vitamins A and D fortification provisions in conformity with 
the applicable relative claims provisions and thus ensure consistency 
in the use of these claims in the labeling of foods. Therefore, FDA is 
proposing to revoke Sec.  131.200(b), which provides for specific 
optional amounts of vitamins A and/or D in yogurt, and Sec.  
131.200(f)(1)(iii), which provides for special labeling of yogurt that 
contains vitamins A and D in accordance with Sec.  131.200(b). FDA 
seeks comment on the need for and appropriateness of this tentative 
decision. Specifically, FDA seeks comment on (1) whether the agency 
should retain current Sec.  131.200(b) and, if so, what the legal or 
scientific justification for retaining this provision is, and (2) the 
appropriateness of applying Sec.  101.54(e) to yogurt fortified with 
vitamins A and/or D.
2. Revocation of the Standards of Identity for Lowfat and Nonfat 
Yogurts
    NYA and most of the comments to the ANPRM requested that FDA 
establish a single, modernized standard of identity for yogurt that 
would provide for lower-fat versions of the food rather than the 
current fragmented standards for yogurt, lowfat yogurt, and nonfat 
yogurt. NYA and some comments also expressed that providing for lowfat 
and nonfat yogurts within a single yogurt standard of identity would 
preclude the need to apply the ``nutritional equivalence'' requirements 
of Sec.  130.10 to the lowfat and nonfat yogurts. NYA stated that 
imposing the nutritional equivalence requirement on lowfat and nonfat 
yogurt would pose an unnecessary and substantial cost to the yogurt 
industry.
    Establishing a single standard for yogurt and providing for 
variations of the food within the standard is consistent with the 
general principles that FDA proposed for modernizing food standards. A 
single standard would maintain a uniform set of requirements for all 
yogurt products, whether they are full-fat or lower-fat versions, while 
providing flexibility and ease of compliance to manufacturers. 
Therefore, FDA is proposing to revoke the standards of identity for 
lowfat yogurt (Sec.  131.203) and nonfat yogurt (Sec.  131.206). 
However, rather than establishing separate requirements for ``lowfat 
yogurt'' and ``nonfat yogurt'' within the yogurt standard of identity, 
FDA is proposing that lower-fat versions of yogurt may be produced 
under the current provisions of Sec.  130.10.
    Section 130.10 sets out requirements for foods that are named by 
use of an FDA-defined nutrient content claim and a standardized term. 
In 1993, FDA established Sec.  130.10, among several other regulations 
implementing the provisions of the NLEA, to assist consumers in 
maintaining healthy dietary practices by providing for modified 
versions of standardized foods that bear descriptive names that are 
meaningful to consumers. Under the provisions of Sec.  130.10, 
manufacturers may modify standardized foods to make them eligible to 
bear a nutrient content claim that is defined by FDA regulation, for 
example: ``reduced fat sour cream,'' ``light margarine,'' or ``low fat 
cheddar cheese.'' One of the provisions of this regulation requires 
that such modified foods be restored in their nutrient content such 
that the modified food is not nutritionally inferior to the 
standardized version (see Sec.  130.10(b)).
    Following the codification of Sec.  130.10, FDA revoked a number of 
lowfat and nonfat dairy food standards, including those for lowfat and 
nonfat milk products and lowfat cheeses, to ensure that the use of 
nutrient content claims in the labeling of these products would be 
consistent with the provisions of the NLEA. FDA also proposed to revoke 
the standards for lowfat and nonfat yogurts; however, based on comments 
received at that time, FDA delayed final action on its proposal to 
revoke these standards for 120 days because of the technical 
difficulties and economic considerations associated with their 
revocation (61 FR 58991 at 58999). FDA acknowledged that if the 
standards for lowfat and nonfat yogurts were revoked, modifying the 
standardized food yogurt to make the nutrient content claims ``lowfat'' 
or ``nonfat'' under the provisions of Sec.  130.10 would require 
addition of vitamin A to make the product nutritionally equivalent to 
full-fat yogurt. FDA also acknowledged that such a nutrient addition 
requirement could potentially result in significant relabeling, 
reformulation, and equipment costs to manufacturers. FDA advised of its 
intention to move to resolve this matter at the end of the 120-day 
period. However, as FDA noted in the ANPRM, the agency has not resolved 
this issue.
    Many of the comments in response to the ANPRM did not offer any 
specific comments on this issue. A few, however, recommended that FDA 
should not apply the provisions of Sec.  130.10 to yogurt. These 
comments were concerned with over-fortification should FDA require that 
lowfat and nonfat yogurts be restored to the vitamin A levels found in 
full-fat yogurt. These comments did not provide any factual information 
or data to support their stated concern of vitamin A over-
fortification.
    FDA believes that it is appropriate to apply the provisions of 
Sec.  130.10 to

[[Page 2455]]

yogurt as they currently apply to all other standardized foods, 
including standardized dairy foods. FDA points out that it deferred 
action on this issue in 1996 to enable the yogurt industry to be better 
able and equipped to meet the nutritional equivalence requirements of 
Sec.  130.10. FDA sees no reason to continue to exempt lowfat and 
nonfat yogurts from the nutritional equivalence requirements that apply 
to all other standardized foods that make lowfat or nonfat nutrient 
content claims. Further, FDA received no data nor is it aware of any 
information to support the concern of over-fortification. Yogurt made 
with whole milk contains 27 microg retinol activity equivalents (RAE) 
(a unit measurement of vitamin A) per 100 g compared to 14 microg RAE/
100 g in lowfat yogurt and 2 microg RAE/100 g in nonfat yogurt (USDA 
National Nutrient Database for Standard Reference--Release 19) (Ref. 
3). Restoring the levels of vitamin A in lowfat and nonfat yogurts 
would require adding vitamin A in amounts necessary to increase the 
level of vitamin A in these foods to about 27 microg RAE/100 g, with 
reasonable deviations from this level permitted by FDA labeling 
regulations. According to the Institute of Medicine (IOM), the median 
intake of vitamin A ranges from 744 to 811 microg RAE/day for men and 
530 to 716 microg RAE/day for women, with about 26 and 34 percent of 
this vitamin A activity provided by provitamin A carotenoids among men 
and women, respectively. These median intake levels are well below the 
IOM-established tolerable upper intake level (UL) for adults of 3,000 
microg/day of preformed vitamin A (Ref. 5). According to a USDA report, 
the vitamin A content per capita per day in the U.S. food supply 
remained at a relatively constant level over the past two decades, 
ranging from 1,220 microg RAE in 1980 to 1,260 microg RAE in 2000 (Ref. 
6). More specifically, the vitamin A content of the food supply did not 
change significantly since 1996 (1280 RAE), when FDA deferred action on 
revoking the lowfat and nonfat yogurt standards because of concerns 
about industry capability to restore vitamin A levels of yogurt. 
Moreover, although per capita consumption of all yogurt has steadily 
increased during this time from 5.9 pounds in 1996 to 8.2 pounds in 
2003 (Ref. 7) (these data were not categorized based on fat content of 
the yogurt), the contribution of yogurt to daily vitamin A intake would 
not be expected to be altered significantly if the nutritional 
equivalency requirements of Sec.  130.10 were to apply to lowfat and 
nonfat yogurts. For example, if all of the 8.2 pounds of yogurt 
consumed per capita in 2003 were to contain vitamin A levels equivalent 
to that found in full-fat yogurt, the vitamin A contribution of that 
amount of yogurt would be about 1,005 microg RAE vitamin A per capita 
per year or 2.7 microg RAE/day. Considering that the vitamin A content 
of the food supply is about 1,260 microg RAE per capita per day, the 
calculated contribution of yogurt (assuming all yogurt has vitamin A at 
levels found in full-fat yogurt) of about 2.7 microg RAE per capita per 
day is small. Therefore, subjecting yogurt to the nutritional 
equivalency provisions of Sec.  130.10 is not expected to raise the 
overall vitamin A content of the food supply significantly.
    After considering all relevant issues, including the safety 
concerns related to vitamin A addition, FDA tentatively concludes that 
the best approach is to revoke the existing lowfat and nonfat yogurt 
standards and to permit the modification of the standardized food 
yogurt to bear nutrient content claims, including ``low fat'' and 
``nonfat,'' under the existing provisions of Sec.  130.10. Further, 
under this proposal, manufacturers would be able to continue to make 
yogurt products bearing other nutrient content claims, such as 
``reduced fat yogurt'' or ``light yogurt'' under the provisions of 
Sec.  130.10.
    Accordingly, for the reasons stated in this section, FDA is 
proposing to do the following:
    (1) Amend the yogurt standard of identity in 21 CFR 131.200 to:
    (a) Provide for the use of reconstituted forms of cream, milk, 
partially skimmed milk, and skim milk as basic dairy ingredients;
    (b) Permit the use of any safe and suitable milk-derived 
ingredients to increase the nonfat solids content, provided such 
addition does not adversely affect the protein quality or content of 
the food;
    (c) Apply the minimum milkfat content of 3.25 percent and minimum 
milk solids not fat content of 8.25 percent prior to the addition of 
bulky flavoring ingredients;
    (d) Require an acidity of yogurt of either a titratable acidity of 
not less than 0.7 percent expressed as lactic acid or a pH of 4.6 or 
lower;
    (e) Permit the use of any safe and suitable cultures in addition to 
the required characterizing bacterial cultures specified in the 
standard;
    (f) Permit the use of any safe and suitable sweetening ingredients;
    (g) Permit the use of any safe and suitable emulsifiers in addition 
to stabilizers;
    (h) Permit the use of any safe and suitable preservatives;
    (i) Require yogurt that is not heat-treated and is labeled with the 
phrase ``contains live and active cultures'' or other appropriate 
descriptor to contain live and active cultures of 10\7\ CFU/g at the 
time of manufacture with a reasonable expectation of 10\6\ CFU/g 
throughout the manufacturer's assigned shelf life of the food;
    (j) Revoke the provisions within the standard that permit the 
addition of vitamins A and D and state the labeling requirements such 
that these vitamins may be added to yogurt under Sec.  101.54(e);
    (k) Update the methods of analysis for milkfat and total solids 
contents and titratable acidity to incorporate by reference the 
Official Methods of Analysis of AOAC International 18th Ed. (2005);
    (l) Provide that the pH of yogurt, when used to determine the 
acidity of yogurt, be determined using the method described in Sec.  
114.90(a); and
    (m) Provide that the live and active cultures content of yogurt be 
determined using the aerobic plate count methods described in Chapter 3 
of FDA's Bacteriological Analytical Manual, January 2001 Edition and
    (2) Revoke the lowfat yogurt and nonfat yogurt standards of 
identity in Sec. Sec.  131.203 and 131.206, respectively, such that the 
standardized food yogurt in proposed Sec.  131.200 could be modified to 
produce lower-fat versions under the current provisions of Sec.  
130.10, which describe the requirements for foods named by use of a 
nutrient content claim (including ``low fat'' and ``fat free'') and a 
standardized term (such as ``yogurt'').
As explained previously, FDA tentatively concludes that these 
amendments are appropriate and will promote honesty and fair dealing in 
the interest of consumers.
    Pending issuance of a final rule amending the existing standard of 
identity for yogurt and revoking the existing lowfat and nonfat yogurt 
standards of identity, FDA intends to consider the exercise of its 
enforcement discretion on a case-by-case basis when yogurt products are 
in compliance with the standard of identity proposed in this proposed 
rule and when the labeling of such products is not otherwise false or 
misleading. The act's enforcement provisions commit complete discretion 
to the Secretary (and by delegation to FDA) to decide how and when they 
should be exercised (Heckler v. Chaney, 470 U.S. 821 at 835 (1985); 
Schering Corp. v. Heckler, 779 F.2d 683 at 685-86 (D.C. Cir. 1985) 
(stating that the

[[Page 2456]]

provisions of the act ``authorize, but do not compel the FDA to 
undertake enforcement activity'')). Until the agency issues a final 
rule amending the current yogurt standard and revoking the current 
lowfat and nonfat yogurt standards, the agency believes that its 
exercise of enforcement discretion will help alleviate the confusion 
that the petitioner contends has resulted due to the existence of the 
stayed provisions of the current yogurt standards. In addition, the 
agency believes that its exercise of enforcement discretion will also 
provide a clear and flexible standard and encourage greater consistency 
and uniformity in the marketplace for yogurt products, and thereby 
assist consumers in making informed product choices.

C. NYA's Recommended Amendments to the Standard of Identity for 
Cultured Milk

    NYA requested that FDA revise the current standard of identity for 
cultured milk (Sec.  131.112) to (1) provide for the alternate term 
``fermented milk;'' (2) require a minimum level of total dairy 
ingredients of 51 percent; (3) permit the use of reconstituted milk and 
whey protein concentrate as ``standard dairy ingredients;'' (4) provide 
for the use of any milk-derived ingredients as ``optional dairy 
ingredients;'' (5) permit the use of safe and suitable sweeteners, 
emulsifiers, and preservatives; and (6) permit the use of any safe and 
suitable ingredients added for nutritional or functional purpose.
    FDA tentatively concludes that NYA did not provide a sufficient 
basis to amend the cultured milk standard. NYA did not provide a 
rationale for its proposed amendments to the cultured milk standard 
other than to simply fit into the standard for ``cultured milk'' those 
yogurt products that would not be permitted to be named ``yogurt'' 
under NYA's recommended standard for yogurt. Nor did NYA address, as a 
number of comments to the ANPRM pointed out, the consumer confusion 
that might occur from including semisolid yogurt-type products (that 
would not qualify as ``yogurt'' under NYA's recommended yogurt 
standard) in the cultured milk standard, which has long been associated 
with fluid cultured milk products.

III. Analysis of Economic Impacts

A. Preliminary Regulatory Impact Analysis

    We are publishing this proposed rule under the formal rulemaking 
process. Executive Order 12866 does not require us to analyze the costs 
and benefits of proposed rules that we publish under this rulemaking 
process.

B. Initial Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this proposed rule may generate compliance 
costs for some small firms, the agency believes that this proposed rule 
would have a significant economic impact on a substantial number of 
small entities. FDA requests comment on this issue. The following 
analysis, in conjunction with the preamble, constitutes the agency's 
initial regulatory flexibility analysis as required by the Regulatory 
Flexibility Act.
    One requirement of the Regulatory Flexibility Act is a succinct 
statement of any objectives of the rule. As stated previously in this 
analysis, with this rule the agency intends to amend the yogurt 
standard and revoke the lowfat and nonfat yogurt standards to promote 
honesty and fair dealing in the interest of consumers. The proposed 
amendments are intended to modernize the current yogurt standards to 
permit flexibility and provide for technological advances in yogurt 
production, while preserving the basic nature and essential 
characteristics of yogurt consistent with consumer expectations and 
thus protecting consumer interest.
Regulatory Options
    We considered the following regulatory options:
    (1) Take no action,
    (2) Take the proposed action,
    (3) Take the proposed action except for the acidity requirements,
    (4) Take the proposed action except for applying the nutritional 
equivalency provisions to lowfat and nonfat yogurt, and
    (5) Take the proposed action except for the minimum live and active 
cultures requirements for yogurt bearing labeling such as ``Contains 
Live and Active Cultures''.
Option One: Take No Action
    We can only define costs relative to a baseline. We usually select 
the option of taking no action as the baseline because it helps readers 
identify the costs of actions that change the status quo. By 
definition, the baseline itself has no costs.
Option Two: Take the Proposed Action
    This proposed regulation would affect yogurt manufacturing firms in 
North American Industry Classification System (NAICS) code 311511, 
Fluid Milk Manufacturing. The Small Business Administration defines a 
small business in NAICS code 311511 as a business with 500 or fewer 
employees. This proposed regulation would not affect firms that 
manufacture nonstandardized products such as frozen yogurt (NAICS code 
311520: Ice Cream and Frozen Dessert Manufacturing) and dried yogurt-
style mixes (NAICS code 311514: Dry, Condensed, and Evaporated Dairy 
Product Manufacturing), or products that contain yogurt as an 
ingredient (miscellaneous NAICS codes). We request comment on the types 
of firms that would be affected by this proposed rule.
    We searched an online commercial database, D&B Dun's Market 
Identifiers, for firms in NAICS code 311511 that had the word 
``yogurt'' in the description of the firm's activity and 500 or fewer 
employees and found 34 firms. We also searched for manufacturing 
establishments using the same procedure and found 33 manufacturing 
establishments. We are only interested in firms that actually operate 
manufacturing establishments, so we estimate that 33 small firms 
manufacture yogurt.
    Our analysis of existing requirements and the proposed requirements 
suggests that only three provisions of this proposed rule might require 
some small firms to change their current activity. The other provisions 
of this proposed rule are either consistent with current requirements 
or provide additional flexibility to firms beyond that available under 
current requirements. For purposes of this analysis, we only associate 
costs with those proposed provisions that might require some small 
firms to change their current activity: We do not classify as costs of 
this proposed rule any voluntary costs that some small firms may 
undergo because they choose to change their manufacturing practices in 
ways that would be newly permitted by the proposed regulation. We 
request comments on the provisions of this proposed rule that might 
require small firms to change their current activity. The three 
provisions that we believe might require some small firms to change 
their current activity are as follows:
     The proposed 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. The requirement that yogurt have a 
minimum titratable acidity of 0.9 percent was stayed, and yogurts in 
the current marketplace are not subject to this acidity requirement.

[[Page 2457]]

     The proposed application of the nutritional equivalency 
provisions of Sec.  130.10 to lowfat and nonfat yogurt, which would 
require firms to fortify their lowfat and nonfat yogurt with vitamin A. 
Currently, we do not require lowfat and nonfat yogurt to be 
nutritionally equivalent to regular yogurt.
     The proposed requirement that yogurt bearing optional 
labeling statements such as ``contains live and active cultures'' must 
contain a minimum of 10\7\ CFU/g of live and active cultures at the 
time of manufacture of the yogurt with a reasonable expectation that 
the yogurt will contains live and active cultures at a level of 10\6\ 
CFU/g through the manufacturer's assigned shelf life of the product. 
Currently, we do not require yogurt with labeling such as ``contains 
live and active cultures'' to contain any particular minimum level of 
live and active cultures.
    With respect to the requirements relating to acidity, we believe 
that all or nearly all yogurt currently on the market has a titratable 
acidity well above the proposed minimum cutoff of 0.7 percent 
titratable acidity, usually in the range of 1.0 to 1.3, and a pH level 
well below the proposed maximum level of 4.6, usually in the range of 
4.1 to 4.3. Some comments in response to the ANPRM said that the 
proposed minimum titratable acidity percentage and maximum pH level 
reflect current industry practice. Nevertheless, some yogurt produced 
by small manufacturers might not meet one of these acidity 
requirements. If a yogurt did not meet one of these requirements, then 
the manufacturer would need to change its manufacturing process to 
produce yogurt that complies with the acidity requirement. Potential 
ways to increase the acidity of the product include increasing the 
amount of yogurt cultures and/or increasing the time and/or temperature 
of fermentation. We do not have sufficient information to estimate the 
costs of taking such steps. However, the likelihood that any plants 
would need to take these steps is very low. Therefore, we estimate that 
the proposed acidity requirements would generate minimal or no 
compliance costs.
    We previously analyzed the costs associated with applying the 
nutritional equivalency provisions of Sec.  130.10 to lowfat and nonfat 
yogurt, which may require some small yogurt manufacturing firms to 
fortify their lowfat and nonfat yogurt with vitamin A, in a final rule 
that revoked standards of identity for several low fat and nonfat dairy 
products (61 FR 58991). In that analysis, we estimated this provision 
would generate a one-time cost of up to $52 million. We based that 
estimate on comments that suggested that 69 percent of yogurt 
manufacturers at that time produced only standardized yogurt and did 
not have the necessary vitamin metering equipment to add vitamins to 
their product and a comment that said that the necessary equipment 
would cost $250,000 per plant. We estimated there were 300 yogurt-
producing plants of all sizes in 1996. We also estimated a one-time 
present value of $240,000 for the annual cost of adding vitamin A, 
which is the only vitamin that we assumed manufacturers would need to 
add to yogurt. We arrived at the total estimate of $52 million as 
follows: [(300 yogurt manufacturing plants x 69 percent of plants 
needing equipment = 207 plants needing equipment) x $250,000 per plant 
for equipment] + $240,000 total present value for obtaining and adding 
vitamin A (61 FR 58991 at 59001).
    FDA experts on the yogurt manufacturing industry believe that the 
cost for small firms to add vitamins to yogurt would be significantly 
lower now. Our current estimate is that the total cost to set up the 
necessary equipment would be no more than $50,000 per plant. In 
addition, some small plants may vat pasteurize and add vitamins 
manually to the batch of yogurt base before pasteurizing and 
fermenting. These plants would not need to purchase additional 
equipment. Therefore, we now estimate that equipment costs to add 
vitamins would be between $0 and $50,000 per plant.
    As previously stated, we estimated that there are 33 small firms 
that manufacture yogurt. We do not know how many of these plants 
produce only yogurt and, therefore, do not already have the equipment 
necessary to add vitamins. In the absence of other information, we 
retain the information that we received in 1996 that 69 percent of 
yogurt-producing plants do not have the necessary equipment. In that 
case, approximately 23 small yogurt producing plants might need to buy 
equipment to add vitamins to yogurt. We do not know how many of these 
plants could add vitamins manually without needing additional 
equipment. Therefore, we estimate that the total equipment cost for 
these 23 plants would be between $0 and $1.15 million (23 x $50,000). 
These 23 plants represent 11 percent of the 207 yogurt producing plants 
of all sizes that we estimated in 1996 would need to buy the necessary 
equipment. If we scale down our previous estimate of the one-time 
present value of $240,000 for the annual cost of adding vitamin A by 
the number of small plants that may need to buy equipment to add 
vitamins to lowfat or nonfat yogurt, then the one-time present value 
would be approximately $27,000. Therefore, our total estimate of the 
cost to add vitamin A is between $0 and $1 million, i.e., [(33 small 
yogurt manufacturing plants x 69 percent of plants needing equipment = 
23 plants needing equipment) x $50,000 per plant] + [($240,000 total 
present value for obtaining and adding vitamin A for 207 plants 
operated by firms of all sizes) x (23 plants operated by small firms / 
207 plants operated by firms of all sizes)]. We request comments on our 
estimate of the number of small firms that would need equipment to add 
vitamins, the cost of this equipment, and the cost of adding vitamin A. 
We also request comments on whether the proposed rule would require any 
small firms to add any nutrients other than vitamin A to yogurt.
    We do not know how many yogurt products currently have labeling 
such as ``contains live and active cultures'' but do not meet the 
proposed requirements relating to levels of live and active cultures. 
We estimated the one-time cost of changing all yogurt labels using a 
computer model developed for that purpose [FDA Labeling Cost Model. 
Final Report. Revised January 2003. Research Triangle Institute.] The 
estimated cost was $9 million to $21 million. However, some yogurt is 
produced by firms that are not small businesses. We again searched D&B 
Dun's Market Identifiers, for all firms in NAICS code 311511 that had 
the word ``yogurt'' in the description of the firm's activity and found 
a total of 46 firms. We estimated earlier that 33 of these are small 
manufacturing firms. Therefore, approximately 72 percent of the firms 
manufacturing yogurt are small. We assume that all firms produce 
roughly the same number of yogurt products so that labeling costs are 
roughly similar across firms. Under this assumption, the potential 
labeling costs for small firms are approximately 72 percent of the 
potential labeling costs for all firms, or $6 million to $15 million. 
We do not know how many yogurt products produced by small firms bear 
labeling such as ``contains live and active cultures.'' Therefore, we 
estimate one-time labeling costs for small firms to be $0 to $15 
million.
    In summary, we estimate the proposed rule would generate costs for 
small firms of $0 to $1 million for installing vitamin metering 
equipment and adding vitamin A to some lowfat and nonfat yogurt and $0 
to $15 million to change the labels on some yogurt

[[Page 2458]]

products that bear labeling such as ``contains live and active 
cultures.'' Therefore, we estimate total costs of $0 million to $16 
million. This amounts to an average cost of approximately $0 to 
$498,000 for each of the 23 small firms that need vitamin metering 
equipment and $0 to $450,000 for each of the 10 small firms that do 
not.
Option Three: Take the Proposed Action Except For the Acidity 
Requirements
    Eliminating the acidity requirements would eliminate the costs 
associated with meeting those proposed requirements. In our discussion 
of Option Two, we estimated those costs to be minimal or zero. 
Therefore, we estimate total costs under this option to be $0 million 
to $16 million.
Option Four: Take the Proposed Action Except For Applying the 
Nutritional Equivalency Provisions to Lowfat and Nonfat Yogurt
    Eliminating the application of the nutritional equivalency 
provisions to lowfat and nonfat yogurt would eliminate the costs 
associated with meeting those proposed requirements. In our discussion 
of Option Two, we estimated those costs to be $0 to $1 million. 
Therefore, we estimate total costs under this option to be $0 to $15 
million.
Option Five: Take the Proposed Action Except For the Minimum Live and 
Active Cultures Requirements for Yogurt Bearing Labeling Such As 
``Contains Live and Active Cultures''
    Eliminating the proposed minimum live and active cultures 
requirement for yogurt bearing labeling such as ``contains live and 
active cultures'' would eliminate the costs associated with meeting 
that proposed requirement. In our discussion of Option Two, we 
estimated those costs to be $0 to $15 million. Therefore, we estimate 
total costs under this option to be $0 to $1 million.

C. Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) requires that agencies 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 $130 million, using the most current (2007) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this proposed rule to result in any 1-year expenditure that 
would meet or exceed this amount.

IV. Federalism

    FDA has analyzed this proposed 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 act (21 U.S.C. 343-1) is an express preemption 
provision. Section 403A(a) of the act (21 U.S.C. 343-1(a)) 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). * * *''
    This proposed rule, if finalized as proposed, would make changes to 
the existing standards of identity for yogurt, lowfat yogurt, and 
nonfat yogurt. Although any final rule would have a preemptive effect 
in that it would preclude States from issuing any requirements for the 
standard of identity of yogurt that are not identical to the 
requirements of the final rule, this preemptive effect is consistent 
with what Congress set forth in section 403A of the act. Section 
403A(a)(1) of the 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).

V. Environmental Impact

    The agency has 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.

VI. Paperwork Reduction Act of 1995

    FDA concludes that the provisions of this proposed rule are not 
subject to review by the Office of Management and Budget because they 
do not constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3220).

VII. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)
    1. Letter to Mr. Stuart M. Pape, Patton, Boggs, & Blow from FDA, 
November 23, 1988.
    2. Codex Standard for Fermented Milks (CODEX STAN 243-2003).
    3. U.S. Department of Agriculture, Agricultural Research 
Service. 2006. USDA National Nutrient Database for Standard 
Reference, Release 19. Yogurt, plain, whole milk; yogurt, plain, low 
fat; yogurt, plain, skim milk.
    4. Verrill L.A., Memo to file--Consumer research on standards 
for yogurt submitted by the National Yogurt Association, January 27, 
2006.
    5. Dietary reference intakes for vitamin A, vitamin K, arsenic, 
boron, chromium, copper, iodine, iron, manganese, molybdenum,

[[Page 2459]]

nickel, silicon, vanadium, and zinc. 2000. Pages 82-161. Food and 
Nutrition Board, Institute of Medicine, National Academy Press, 
Washington, DC.
    6. Gerrior S., Bente L., and Hiza H. 2004. Nutrient Content of 
the U.S. Food Supply, 1909-2000. Home Economics Research Report No. 
56. Table 2. U.S. Department of Agriculture, Center for Nutrition 
Policy and Promotion.
    7. USDA ERS. Food availability spreadsheets. Fluid milk and 
cream--per capita consumption, pounds. Updated December 21, 2004. 
Accessed online at: http://www.ers.usda.gov/Data/FoodConsumption/FoodAvailSpreadsheets.htm December 28, 2005.

List of Subjects in 21 CFR Part 131

    Cream, Food grades and standards, Milk, Yogurt, Incorporation by 
reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director of the Center for Food Safety and Applied 
Nutrition, it is proposed that 21 CFR part 131 be amended as follows:

PART 131--MILK AND CREAM

    1. The authority citation for 21 CFR part 131 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
    2. Revise Sec.  131.200 to read as follows:


Sec.  131.200  Yogurt.

    (a) Description. Yogurt is the food produced by culturing one or 
more of the basic dairy ingredients specified in paragraph (b) of this 
section and any of the optional dairy ingredients specified in 
paragraph (c) of this section with a characterizing bacterial culture 
that contains the lactic acid-producing bacteria, Lactobacillus 
delbrueckii subsp. bulgaricus and Streptococcus thermophilus. The 
ingredients specified in paragraphs (b) and (c) of this section shall 
be pasteurized or ultra-pasteurized prior to 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. The food may be homogenized. Yogurt may be heat-treated after 
culturing to extend the shelf life of the food. 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. Yogurt that is not heat-treated 
after culturing may contain a minimum level of live and active cultures 
of 10\7\ colony-forming units per gram (CFU/g) at the time of 
manufacture with a reasonable expectation of 10\6\ CFU/g through the 
manufacturer's assigned shelf life of the product.
    (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 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 
shall 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) Sweeteners.
    (3) Flavoring ingredients.
    (4) Color additives.
    (5) Stabilizers and emulsifiers.
    (6) Preservatives.
    (e) Methods of analysis. (1) The following referenced methods of 
analysis are from the ``Official Methods of Analysis of AOAC 
International,'' 18th Ed. (2005). They 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 
notice of change in the Federal Register and the material must be 
available to the public. All approved material is available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Also, it is available for 
inspection at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2163, 
and is available from the Association of Official Analytical Chemists 
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 
20877.
    (i) Milk solids not fat--Calculated by subtracting the milkfat 
content from the total solids content using the methods prescribed in 
section 33.2.45, ``AOAC Official Method 990.21 Solids-Not-Fat in Milk 
by Difference between Total Solids and Fat Contents.''
    (ii) Titratable acidity--As determined by the method prescribed in 
section 33.2.06, ``AOAC Official Method 947.05 Acidity of Milk 
Titrimetric Method.''
    (2) pH--As determined by the potentiometric method described in 
Sec.  114.90(a) of this chapter.
    (3) Live and active cultures--As determined by the aerobic plate 
count methods described in Chapter 3 of FDA's Bacteriological 
Analytical Manual, January 2001 Edition. Chapter 3 of FDA's 
Bacteriological Analytical Manual, January 2001 Edition, is located at 
http://www.cfsan.fda.gov/~ebam/bam-3.html. The method is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The 
FDA will request approval to incorporate by reference any updates to 
this Web site. The FDA will change the date of the Web site in this 
paragraph with each update. You may obtain a copy from the Division of 
Microbiology (HFS-710), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or you may examine a copy at the Center for Food Safety and 
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 
20740, 301-436-2163, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulation/ibr_locations.html.
    (f) Nomenclature. The name of the food is ``yogurt''. The name of 
the food shall be accompanied by a declaration indicating the presence 
of any characterizing flavoring as specified in Sec.  101.22 of this 
chapter.
    (1) The following terms shall 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 sweetener is added without the 
addition of characterizing flavor.
    (ii) The parenthetical phrase ``(heat-treated after culturing)'' 
shall follow the name of the food if the dairy ingredients have been 
heat-treated after culturing.
    (2) The term ``homogenized'' may appear on the label if the dairy 
ingredients used are homogenized.
    (3) The name of the food may be accompanied by the phrase 
``contains live and active cultures'' or another appropriate descriptor 
if the food contains the amount of live and active cultures specified 
in paragraph (a) of this section.

[[Page 2460]]

    (g) Label declaration. Each of the ingredients used in the food 
shall be declared on the label as required by the applicable sections 
of parts 101 and 130 of this chapter.


Sec.  131.203  [Removed]

    3. Remove Sec.  131.203.


Sec.  131.206  [Removed]

    4. Remove Sec.  131.206.

    Dated: January 9, 2009.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. E9-736 Filed 1-12-09; 4:15 pm]
BILLING CODE 4160-01-S