[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