[Federal Register Volume 68, Number 128 (Thursday, July 3, 2003)]
[Proposed Rules]
[Pages 39873-39877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. 00P-0685]


Milk and Cream Products and Yogurt Products; Petition to Revoke 
Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend Standards 
for Yogurt and Cultured Milk

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
petition has been filed requesting that the agency revoke the standards 
of identity for lowfat yogurt and nonfat yogurt; amend the standard of 
identity for yogurt in numerous respects, including incorporation of 
provisions for lowfat and nonfat yogurt; and amend the standard of 
identity for cultured milk in numerous respects, including allowing for 
the use of the alternate term ``fermented milk.'' We request comment on 
whether the actions requested by the petition would promote honesty and 
fair dealing in the interest of consumers.

DATES: Submit written or electronic comments by October 1, 2003.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. The petition is available for review at 
the Division of Dockets Management or electronically on FDA's Web site 
at http://www.fda.gov/ohrms/dockets/98fr/00p-0685-cp00001.pdf. You may 
also request a copy of the petition from the Division of Dockets 
Management.

FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Office of Nutritional 
Products, Labeling, and Dietary Supplements, Center for Food Safety and 
Applied Nutrition (HFS-820), Food and Drug

[[Page 39874]]

Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.

SUPPLEMENTARY INFORMATION:

I. The Petition

    The National Yogurt Association (NYA) submitted a citizen petition 
on February 18, 2000, 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), amend the current standard 
of identity for yogurt (Sec.  131.200), and amend the standard of 
identity for cultured milk (Sec.  131.112).
    In its petition, NYA stated that its proposed standard establishes 
that: (1) Yogurt is a food product containing a minimum level of 
certain live and active cultures; (2) takes into account current 
industry practices; (3) recognizes the need to allow for use of future 
technologies; and (4) establishes a clear, consistent, modernized, and 
flexible yogurt standard that would benefit both industry and 
consumers. Specifically, NYA's proposed yogurt standard: (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 preculture homogenization and pasteurization; (5) permits the use 
of reconstituted milk and whey protein concentrate (WPC) as ``standard 
dairy ingredients''; (6) provides for the use of any milk-derived 
ingredients under 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 the proposed standard for yogurt. Specifically, NYA's 
proposed amendments to the cultured milk standard: (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 WPC as ``standard dairy ingredients''; (4) provide for the use 
of any milk-derived ingredient under 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 a nutritional or functional purpose.
    FDA is publishing this document in accordance 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 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. FDA tentatively finds that 
NYA's petition presents reasonable grounds. Therefore, FDA requests 
comment on whether the actions proposed in the petition would promote 
honesty and fair dealing in the interest of consumers.

II. Grounds for the Suggested Changes to Yogurt, Lowfat Yogurt, Nonfat 
Yogurt, and Cultured Milk Standards

    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, September 21, 1982). The stayed 
provisions are: (1) Those provisions of Sec. Sec.  131.112(d)(1), 
131.200(c)(1), 131.203(c)(1), and 131.206(c)(1) that restrict the type 
of milk-derived ingredients that may be used, to those so named, to 
increase the nonfat solids content of cultured milk and yogurts; (2) 
those provisions of Sec. Sec.  131.200(a), 131.203(a), and 131.206(a) 
that exclude the use of reconstituted dairy ingredients as the basic 
ingredient in the manufacture of yogurts; (3) those provisions of 
Sec. Sec.  131.200(c), 131.203(c), and 131.206(c) insofar as they 
exclude 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). 
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 proposed 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.
    NYA also stated that the proposed 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 proposal 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 
proposed 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 
as described in Sec.  130.10 (21 CFR 130.10). In addition, NYA 
maintained that its proposed standard would change the milkfat content 
requirements of lowfat and nonfat yogurts to ``directly parallel'' the 
nutrient content claim requirements for the terms ``lowfat'' and 
``nonfat'' established under the NLEA (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 proposed standard establishes a modernized, flexible 
standard of identity for yogurt, taking into account current industry 
practices and recognizing the need to allow for use of future 
technologies.

[[Page 39875]]

III. Matters of Particular Interest to FDA

    FDA requests that interested persons submit data and information 
concerning the need for, and the appropriateness of, revoking the 
standards for lowfat and nonfat yogurt and amending the standards for 
yogurt and cultured milk. FDA specifically requests comment on the 
following provisions set forth in the petition:
    1. A single standard of identity for yogurt, which includes 
provisions for lowfat and nonfat yogurts;
    2. A minimum of 10\7\ CFU/g of live and active characterizing 
cultures at the time of manufacture of yogurt;
    3. An acidity of pH 4.6 or lower, rather than the current 
requirement of titratable acidity expressed as lactic acid in yogurt;
    4. The use of optional milk-derived ingredients after 
pasteurization and culturing of yogurt;
    5. The use of reconstituted dairy ingredients and WPC as basic 
dairy ingredients in yogurt, and the specifications related to WPC, 
when used;
    6. The optional use of any milk-derived ingredient that provides a 
technical or functional purpose in yogurt;
    7. The minimum dairy ingredients content requirement of 51 percent 
of the total weight of yogurt;
    8. The use of any safe and suitable nutritive or nonnutritive 
sweeteners in yogurt;
    9. The use of safe and suitable emulsifiers in yogurt;
    10. The use of safe and suitable preservatives in yogurt;
    11. The use of any safe and suitable ingredient added for a 
nutritional or functional purpose in yogurt;
    12. The use of the descriptor ``nonfat'' on a yogurt that may 
contain less than 0.5 g of total fat per RACC (i.e., 225 g for yogurt 
(21 CFR 101.12));
    13. The use of the descriptor ``lowfat'' on a yogurt that may 
contain at least 0.5 g but not more than 3.0 g total fat per RACC; and
    14. The need to amend the standard for cultured milk to provide for 
the alternate term ``fermented milk'' and to make it consistent with 
any changes made in the standard for yogurt, and the appropriateness of 
the proposed amendments to the standard for cultured milk.
    After reviewing the comments received, FDA will determine the need 
for, and appropriateness of, each of the amendments requested by NYA 
and will decide what actions are appropriate. To facilitate comment, in 
the following paragraphs FDA discusses some of the amendments requested 
by NYA.
    1. The standards for yogurt and cultured milk proposed by NYA 
permit the use of any safe and suitable ingredient added for a 
nutritional or functional purpose. NYA states that this provision is 
necessary to maintain enough flexibility in the standards to permit the 
use of novel ingredients as they are developed. 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. 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. FDA also 
notes that flexibility in the use of ingredients for a functional 
purpose may be achieved by specifying the ingredients by functional use 
category, e.g., ``emulsifiers'' or ``preservatives,'' rather than by 
listing the specific ingredients. FDA seeks comment on the need for any 
functional ingredient categories, in addition to the ones proposed by 
the petition, in the manufacture of yogurt.
    2. NYA proposed amendments to the current standard of identity for 
cultured milk (Sec.  131.112) to provide for the alternate term 
``fermented milk'' and to allow the use of currently prohibited 
ingredients that would be permitted by NYA's proposed standard for 
yogurt. NYA stated that under its proposed amendments, if the food 
otherwise meets the yogurt standard of identity but does not contain 
the characterizing cultures at the required levels, then the food 
qualifies as cultured milk or fermented milk. The standard of identity 
for cultured milk has been in place for several decades. In light of 
consumer experience with the standard for cultured milk, FDA solicits 
comment on the need to amend it and the appropriateness of the 
amendments requested by NYA.
    3. The current standards for yogurt, lowfat yogurt, and nonfat 
yogurt permit heat treatment after culturing, with the requirement that 
such treatment be declared in the name of the food. FDA notes that 
NYA's proposed standard does not allow for heat treatment after 
culturing, and seeks comment on the appropriateness of omitting this 
provision.
    4. NYA proposed a maximum pH of 4.6 for yogurt and stated that this 
level reflects the lower end of titratable acidity levels found in 
common industry practice. NYA also stated 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 seeks comment both on the acidity level proposed 
by NYA and the use of pH rather than titratable acidity.
    5. FDA notes NYA's assertion that consumers expect yogurt to 
contain significant amounts of live and active cultures, as well as 
NYA's proposed requirement to measure live and active cultures at the 
time of manufacture. NYA proposed 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 (i.e., shelf life) for the product 
and at the anticipated time of consumption. However, as a legal 
requirement, NYA proposed a minimum of 10\7\ CFU/g at the time of 
manufacture because, NYA maintained, once the products enter the stream 
of commerce, products are subject to different distribution and storage 
conditions that are not within the manufacturer's control. FDA seeks 
comment on: (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 proposed 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 
proposed 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 seeks comment on any alternative provisions 
that may be needed to fulfill this requirement.
    Finally, FDA seeks comment on vitamin A fortification. FDA 
previously proposed to revoke a number of lowfat and nonfat standards 
in parts 131 and 133 (21 CFR part 133) (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

[[Page 39876]]

cottage cheese) (60 FR 56541, November 9, 1995)) to ensure that the use 
of nutrient content claims in the labeling of these products would be 
consistent with the provisions of the NLEA. In the final rule (61 FR 
58991, November 20, 1996), FDA revoked all of the previously mentioned 
standards except for lowfat yogurt and nonfat yogurt. 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 fortification to make the product nutritionally equivalent to 
full fat yogurt. FDA also acknowledged that such a fortification 
requirement could potentially result in significant relabeling, 
reformulation, and equipment costs to manufacturers. The agency had 
hoped that the 120-day deferral would provide an appropriate balance 
between the problem the industry was facing and consumers' interest in 
consistently and fairly labeled foods. Unfortunately, this issue has 
not been resolved. According to the yogurt standard proposed by NYA, 
manufacturers would continue to be able to make lowfat and nonfat 
yogurts without having to meet the nutritional equivalence requirement. 
FDA seeks comment on 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 seeks comment on the need and appropriateness of continuing to 
exempt yogurt from the nutritional equivalence requirement, unlike 
other standardized foods making lowfat and nonfat nutrient content 
claims.

IV. NYA Requested Amendments

    The requested amendments of the yogurt standard and the cultured 
milk standard submitted by NYA are set forth in the following 
paragraphs. The following language is as suggested by NYA; FDA has made 
only minor nonsubstantive changes. FDA will evaluate the need and 
appropriateness of these regulations proposed by NYA following the 
receipt of public comments.
    NYA's suggested standard of identity for yogurt is as follows:

Section 131.200 Yogurt.

    (a) Description. Yogurt is the food produced by culturing one or 
more of the standard dairy ingredients specified in paragraph (b) of 
this section. Yogurt contains at least 10\7\ CFU/g active yogurt 
cultures, at the time of manufacture, of the characterizing lactic 
acid-producing bacteria, Lactobacillus delbrueckii subsp. Bulgaricus 
and Streptococcus thermophilus, and the manufacturer may have 
records demonstrating that, under proper conditions of distribution 
and storage, the yogurt will contain at least 10\6\ CFU/g live and 
active cultures through the manufacturer's assigned code life (i.e., 
shelf life) for the product. One or more of the optional ingredients 
specified in paragraph (c) of this section may also be added. All 
ingredients used are safe and suitable. Yogurt, before the addition 
of optional ingredients specified in paragraph (c) of this section, 
contains not less than 8.25 percent milk solids not fat from the 
standard dairy ingredients specified in paragraph (b) of this 
section, and has a pH of 4.6 or lower. Dairy ingredients comprise at 
least 51 percent of the food's overall ingredients by weight. The 
food may be homogenized and the ingredients specified in paragraph 
(b) of this section shall be pasteurized or ultra-pasteurized prior 
to the addition of the characterizing yogurt bacterial cultures.
    (b) Standard dairy ingredients. Cream, milk, partially skimmed 
milk, skim milk, or the reconstituted versions of these standard 
dairy ingredients may be used alone or in combination. Whey protein 
concentrate (WPC), minimum protein concentrate 34 percent, may be 
used if the total quantity of WPC used in this paragraph and 
paragraph (c) of this section does not result in a quantity of WPC 
that exceeds 25 percent of the total milk solids not fat. When one 
or more of the ingredients specified in this paragraph is used, it 
shall be included in the culturing process.
    (c) Optional dairy ingredients. (1) Dairy ingredients. Any milk-
derived ingredients used for technical or functional purposes.
    (2) Optional safe and suitable cultures, in addition to the 
characterizing cultures.
    (3) Safe and suitable sweeteners.
    (4) Flavoring ingredients.
    (5) Color additives.
    (6) Stabilizers and emulsifiers.
    (7) Preservatives.
    (8) Vitamins and minerals.
    (i) If added, vitamin A shall be present in a minimum quantity 
of 500 International Units (IU) per reference amount customarily 
consumed (RACC).
    (ii) If added, vitamin D shall be present in a minimum quantity 
of 100 IU per RACC.
    (9) Any safe and suitable ingredients added for nutritional or 
functional purposes.
    (d) Methods of analysis. (1) Enumeration of live and active 
cultures--As determined by the method prescribed by the 
International Dairy Federation.
    (2) Milk solids not fat content--Calculated using the following 
methods from the ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' 15th Ed. (Copies are available 
from the Association of Official Analytical Chemists, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, or available 
for inspection at the Office of the Federal Register, 800 North 
Capitol St., NW., suite 700, Washington, DC). Subtract the milkfat 
content (as determined by the method prescribed in section 16.059 
``Roese-Gottlieb Method (Reference method) (11)--Official Final 
Action, under the heading ``Fat'') from the total milk solids 
content (as determined by the method prescribed in section 16.032, 
``Method I--Official Final Action,'' under the heading ``Total 
Solids'').
    (3) pH--As determined under Sec.  114.90(a) of this chapter, 
``Potentiometric method for the determination of pH.''
    (e) Nomenclature. (1) If the food contains the amount of live 
and active Lactobacillus delbrueckii subsp. Bulgaricus and 
Streptococcus thermophilus cultures as indicated in paragraph (a) of 
this section, the food is ``yogurt,'' except:
    (i) If the finished food complies with the requirements of Sec.  
101.62(b)(4)(i) of this chapter, and is not ``lowfat yogurt'' or 
``nonfat yogurt,'' then the food must comply with Sec.  
101.62(b)(4)(ii) of this chapter, and the name of the food is 
``reduced fat yogurt.''
    (ii) If the finished food contains at least 0.5 g, but not more 
than 3.0 g, total fat per RACC, then the name of the food is 
``lowfat yogurt.''
    (iii) If the finished food contains less than 0.5 g total fat 
per RACC, the name of the food is ``nonfat yogurt.''
    (2) 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.
    (3) 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 phrase ``vitamin A'' or ``vitamin A added,'' or 
``vitamin D'' or ``vitamin D added,'' as appropriate. The word 
``vitamin'' may be abbreviated ``vit.''
    (f) Declaration of ingredients. 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.
    NYA's suggested standard of identity for cultured milk is as 
follows:

Section 131.112 Cultured Milk/Fermented Milk.

    (a) Description. Cultured milk or fermented milk is the food 
produced by culturing one or more of the standard dairy ingredients 
specified in paragraph (b) of this section with characterizing 
microbial organisms. One or more of the optional ingredients 
specified in paragraph (c) of this section may also be added. All 
ingredients used are safe and suitable. Cultured milk or fermented 
milk, before the addition of optional ingredients specified in 
paragraph (c) of this section, contains not less than 8.25 percent 
milk solids not fat from the standard dairy ingredients specified in 
paragraph (b) of this section, and has a titratable acidity of not 
less than 0.5 percent, expressed as lactic acid, before the addition 
of bulky flavors. Dairy ingredients comprise at least 51 percent of 
the food's overall ingredients by weight. The food may be 
homogenized and the ingredients specified in paragraph (b) of this

[[Page 39877]]

section shall be pasteurized or ultra-pasteurized prior to the 
addition of the microbial cultures.
    (b) Standard dairy ingredients. Cream, milk, partially skimmed 
milk, skim milk, or the reconstituted versions of any of these 
standard dairy ingredients may be used. Whey protein concentrate 
(WPC), minimum protein concentrate 34 percent, may be used if the 
total quantity of WPC used in this paragraph and paragraph (c) of 
this section does not result in a quantity of WPC that exceeds 25 
percent of the total milk solids not fat. When one or more of the 
ingredients specified in this paragraph is used, it shall be 
included in the culturing process.
    (c) Optional ingredients. (1) Dairy ingredients. Any milk-
derived ingredients used for technical or functional purposes.
    (2) Aroma- and flavor-producing microbial culture.
    (3) Safe and suitable sweeteners.
    (4) Flavoring ingredients.
    (5) Color additives that do not impart a color simulating that 
of milkfat or butterfat.
    (6) Stabilizers and emulsifiers.
    (7) Preservatives.
    (8) Vitamins and minerals.
    (i) If added, vitamin A shall be present in a minimum quantity 
of 500 IU per RACC.
    (ii) If added, vitamin D shall be present in a minimum quantity 
of 100 IU per RACC.
    (9) Butterfat or milkfat, which may or may not contain color 
additives, in the form of flakes or granules.
    (10) Salt.
    (11) Citric acid, in a maximum amount of 0.15 percent by weight 
of the milk used, or an equivalent amount of sodium citrate, as a 
flavor precursor.
    (12) Any safe and suitable ingredients added for nutritional or 
functional purposes.
    (d) Methods of analysis. (1) Milk solids not fat content--
Calculated using the following methods from the ``Official Methods 
of Analysis of the Association of Official Analytical Chemists,'' 
15th Ed. (Copies are available from the Association of Official 
Analytical Chemists, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2417, or available for inspection at the 
Office of the Federal Register, 800 North Capitol St., NW., suite 
700, Washington, DC). Subtract the milkfat content (as determined by 
the method prescribed in section 16.059 ``Roese-Gottlieb Method 
(Reference method) (11)--Official Final Action, under the heading 
``Fat'') from the total milk solids content (as determined by the 
method prescribed in section 16.032, ``Method I--Official Final 
Action,'' under the heading ``Total Solids'').
    (2) Titratable acidity--As determined by the method prescribed 
in section 16.023, ``Acidity (2)--Official Final Action,'' or by an 
equivalent potentiometric method.
    (e) Nomenclature. (1) The name of the food is ``cultured milk'' 
or ``fermented milk,'' except:
    (i) If the finished food complies with the requirements of Sec.  
101.62(b)(4)(i) of this chapter, and is not ``lowfat fermented 
milk'' or ``lowfat cultured milk'' or ``nonfat fermented milk'' or 
``nonfat cultured milk,'' then the food must comply with Sec.  
101.62(b)(4)(ii) of this chapter, and the name of the food is 
``reduced fat fermented milk'' or ``reduced fat cultured milk.''
    (ii) If the finished food contains at least 0.5 g, but not more 
than 3.0 g, total fat per RACC, then name of the food is ``lowfat 
fermented milk'' or ``lowfat cultured milk.''
    (iii) If the finished food contains less than 0.5 g total fat 
per RACC, the name of the food is ``nonfat fermented milk'' or 
``nonfat cultured milk.''
    (2) 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.
    (3) The name of the food shall be accompanied by a declaration 
such as a traditional name of the food or the generic name of the 
organisms used, thereby indicating the presence of the 
characterizing microbial organisms or ingredients, e.g., ``kefir 
cultured milk,'' ``acidophilus fermented milk,'' or when 
characterizing ingredients such as those in paragraphs (c)(2), 
(c)(9), (c)(10), and (c)(11) of this section and lactic acid-
producing organisms are used, the food may be named ``cultured 
buttermilk.''
    (4) 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 flavoring.
    (ii) The phrase ``vitamin A'' or ``vitamin A added,'' or 
``vitamin D'' or ``vitamin D added,'' or ``vitamin A and D added,'' 
as appropriate. The word ``vitamin'' may be abbreviated ``vit.''
    (5) The parenthetical phrase ``(heat-treated after culturing)'' 
shall follow the name of the food if the dairy ingredients have been 
heat-treated after culturing.
    (f) Declaration of ingredients. 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.

V. 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. If you base your comments on 
scientific evidence or data, please submit copies of the specific 
information along with your comments. The petition and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

VI. Authority

    This advance notice of proposed rulemaking is issued under sections 
201, 401, 403, 409, 701, and 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, and 379e), and under 
the authority of the Commissioner of Food and Drugs, as redelegated to 
the Director, Center for Food Safety and Applied Nutrition.

    Dated: June 3, 2003.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 03-16789 Filed 7-2-03; 8:45 am]
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