[Federal Register Volume 59, Number 177 (Wednesday, September 14, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22646]


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[Federal Register: September 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 135

[Docket No. 88P-0251]

 

Frozen Desserts: Removal of Standards of Identity for Ice Milk 
and Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice 
Cream and Frozen Custard and Goat's Milk Ice Cream

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to remove the standard of identity for ice milk; to amend 
the standard of identity for ice cream and frozen custard to provide 
for the use in these foods of safe and suitable sweeteners and of skim 
milk that may be concentrated, and from which part or all of the 
lactose has been removed by a safe and suitable procedure; and to amend 
the standard of identity for ice cream and frozen custard to provide 
for the optional use of hydrolyzed milk proteins as stabilizers in the 
food at a level not to exceed 3 percent by weight to ice cream mix 
containing not less that 20 percent total milk solids, provided that 
any whey and modified whey products used contribute, singly or in 
combination, not more than 25 percent by weight of the total nonfat 
milk solids content of the finished food. To ensure consistency with 
the removal of the standard of identity for ice milk and the changes in 
the standard of identity for ice cream and frozen custard, FDA also is 
removing the standard of identity for goat's milk ice milk and making 
comparable changes in the standard of identity for goat's milk ice 
cream, which cross-references the standard of identity for ice cream 
and frozen custard. FDA finds that these actions will promote honesty 
and fair dealing in the interest of consumers. FDA is also requiring 
that all sweeteners other than nutritive carbohydrate sweeteners used 
in these foods be declared as part of the name of the food. This 
requirement will terminate after a period of 3 years. After that time, 
the use of these sweeteners will only have to be reflected in the 
ingredient statement for these products.

DATES: Effective September 14, 1995; written objections and requests 
for a hearing by October 14, 1994. Compliance with this regulation may 
begin on September 14, 1994.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Margaret E. Cole, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 6, 1993 (58 FR 520), FDA 
published a proposed rule: (1) To remove the standards of identity for 
ice milk (Sec. 135.120 (21 CFR 135.120)) and goat's milk ice milk 
(Sec. 135.125 (21 CFR 135.125)); and (2) to amend the standards of 
identity for ice cream and frozen custard (Sec. 135.110 (21 CFR 
135.110)) and, by cross-reference, goat's milk ice cream (Sec. 135.115 
(21 CFR 135.115)) to provide for the use in these foods of safe and 
suitable sweeteners and of skim milk that may be concentrated and from 
which part or all of the lactose has been removed by a safe and 
suitable procedure. The agency also requested information on the use of 
other milk-derived protein ingredients such as milk protein 
hydrolysates. Interested persons were given until March 8, 1993, to 
comment.

II. Comments and the Agency's Responses

    In response to the proposal, FDA received 46 letters, each 
containing one or more comments from food companies, ingredient 
suppliers, industry trade associations, State government agencies, and 
consumers. All of the comments favored the removal of the standards of 
identity for ice milk (Sec. 135.120) and goat's milk ice milk 
(Sec. 135.125). One comment addressed an issue (i.e., the need for 
uniformity in the size, style, and color of the type used in food 
labeling) that is outside the scope of this proposal and that will not 
be discussed here.
    Several comments suggested modifications in, or were opposed to, 
various provisions of the proposal to amend the standards of identity 
for ice cream (Sec. 135.110) and, by cross-reference, goat's milk ice 
cream (Sec. 135.115). A summary of these comments and the agency's 
responses follow.

A. Safe and Suitable Ingredients

1. Sweeteners
    FDA proposed (58 FR 520 at 523 and 524) to amend the standards of 
identity for ice cream and, by cross-reference, goat's milk ice cream 
to permit the use of safe and suitable sweeteners (Sec. 135.110(a)(1) 
and Sec. 135.115(a)) as long as the presence of sweeteners other than 
nutritive carbohydrate sweeteners is declared by their common or usual 
name on the principal display panel of the label as part of the 
statement of identity, and as long as the labeling of ice cream 
products sweetened with such sweeteners complies with the applicable 
provisions of Sec. 105.66 (21 CFR 105.66) (proposed Sec. 135.110(e)(7) 
and proposed Sec. 135.115(c)(2)). The agency specifically requested 
comments on the need for, and appropriateness of, these proposed 
changes. The comments generally supported permitting alternative 
sweeteners (safe and suitable sweeteners other than nutritive 
carbohydrate sweeteners) in ice cream. Some comments, however, 
questioned the proposed declaration requirements for alternative 
sweeteners. These comments are addressed below.
    1. Several comments opposed the requirement that the presence of 
alternative sweeteners be declared in the statement of identity, as 
provided in proposed Sec. 135.110(e)(7). These comments stated that the 
existing regulations for the labeling of specific alternative 
sweeteners adequately inform consumers of the presence of alternative 
sweeteners in foods. These comments also expressed the view that there 
is no need to establish special front panel labeling requirements for 
alternative sweeteners in ice cream, and that such a requirement would 
contribute to label clutter on products in which manufacturers use more 
than one alternative sweetener in their formulation.
    These comments noted that the proposed declaration requirement 
singles out ice cream for special labeling that is not applied to other 
standardized foods, and that such a requirement also singles out 
alternative sweeteners for special labeling that is not applied to 
other ingredients, including nutritive carbohydrate sweeteners. These 
comments further argued that milk and dairy components, not sugar, are 
the defining characteristics of ice cream. These comments expressed the 
view that use of the name ``ice cream'' with a nutrient content claim 
in the statement of identity, and the obligatory referral statement 
that directs consumers to the information panel, would signal to 
consumers that the product differs from the traditional standardized 
food.
    FDA proposed to require that alternative sweeteners be declared by 
their common or usual name on the principal display panel of the label 
as part of the statement of identity because of the agency's tentative 
conclusion that ice cream sweetened with alternative sweeteners is a 
distinctly different product than that sweetened with nutritive 
carbohydrate sweeteners. The agency proposed this requirement to ensure 
that ice cream sweetened with alternative sweeteners is clearly 
distinguishable from the traditional food, and so that consumers who 
want to avoid ice cream that contains alternative sweeteners will be 
able to do so. In the proposal, the agency tentatively concluded that 
it is necessary to inform consumers of the presence of alternative 
sweeteners in ice cream under sections 201(n) and 403(a) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(n) and 343(a)).
    Based on its consideration of the comments, the agency has 
confirmed its view that consumers should be advised through labeling on 
the principal display panel of the label or other labeling, including 
restaurant menus and ice cream shop and parlor listings, when ice cream 
products are made with sweeteners other than nutritive carbohydrate 
sweeteners. Currently, such products are labeled as ``frozen desserts'' 
or by some other name that is not confusingly similar to the 
standardized term ``ice cream.'' When the amendments to Secs. 135.110 
and 135.115 set forth below become effective, products that differ from 
traditional ice cream in that they contain alternative sweeteners would 
be subject to being labeled simply as ``ice cream'' but for the 
clarification of the differences between these products and traditional 
ice cream that the agency has decided to require.
    FDA does not agree that the existing regulations for the labeling 
of specific alternative sweeteners adequately inform consumers of the 
presence of these sweeteners in ice cream. It is true that 
manufacturers must declare the presence of aspartame and of saccharin 
in a food on the food label. The label of ice cream that contains 
aspartame will have to bear either on the principal display panel or on 
the information panel in a prominent and conspicuous manner the 
statement: ``PHENYLKETONURICS: CONTAINS PHENYLALANINE,'' as specified 
in Sec. 172.804(e)(2) (21 CFR 172.804(e)(2)). The label of ice cream 
that contains saccharin will have to bear in a conspicuous place on 
such label and labeling as proximate as possible to the name of such 
food, the statement: ``USE OF THIS PRODUCT MAY BE HAZARDOUS TO YOUR 
HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN DETERMINED TO 
CAUSE CANCER IN LABORATORY ANIMALS,'' as specified in section 403(o)(2) 
of the act (21 U.S.C. 343(o)(2)). In neither case, however, is there a 
specific requirement that the statements appear on the principal 
display panel of the ice cream label as is the case under 
Sec. 135.110(f)(7) (proposed as Sec. 135.110(e)(7)). Further, there is 
no legal or regulatory requirement for special labeling statements on 
the principal display panel to inform consumers that ice cream contains 
other alternative sweeteners (e.g., sorbitol, acesulfame K). Without 
Sec. 135.110(f)(7), there need not be anything on the principal display 
panel to call consumers' attention to the presence of alternative 
sweeteners in ice cream. Thus, FDA finds that there would not be 
adequate notice of the presence of these sweeteners without this 
provision.
    FDA does not agree that the declaration requirement singles out ice 
cream sweetened with alternative sweeteners for special labeling. FDA 
has established a number of standards of identity specifically for 
artificially sweetened versions of traditional foods, such as canned 
fruits, so that the artificially sweetened versions of these foods are 
distinguishable from their traditional counterparts that are sweetened 
with nutritive carbohydrate sweeteners. These artificially sweetened 
versions of traditional foods are identified as such through label 
declaration on the principal display panel.
    As an example, the standard of identity in Sec. 145.170 (21 CFR 
145.170) for canned peaches provides for the addition of safe and 
suitable nutritive carbohydrate sweeteners (e.g., corn sirup, invert 
sugar sirup, sugar, dried glucose sirup, or cane sirup) to the packing 
medium. The name of this food is ``peaches'' as prescribed in 
Sec. 145.170(a)(4). By contrast, the standard of identity in 
Sec. 145.171 (21 CFR 145.171) for artificially sweetened canned peaches 
conforms to the definition and standard of identity in Sec. 145.170 for 
canned peaches except that it provides for the use of water 
artificially sweetened with saccharin, with sodium saccharin, or with a 
combination of both, as the packing medium. The name of this food is 
``artificially sweetened peaches.''
    Traditionally, sugar (or other nutritive carbohydrate sweeteners), 
as well as milk and cream (or dairy products of equivalent 
composition), defines the food known as ``ice cream.'' In establishing 
the standard of identity for ice cream, the findings of fact (August 8, 
1950, 15 FR 5112 at 5114) gave the following definition of ice cream:
    Ice cream is the common and usual name of the frozen product 
made from cream or a mixture of milk and cream (or a combination of 
dairy products of equivalent composition), sweetened with sugar or 
other suitable sweetening agent, and containing natural or imitation 
flavorings or other food ingredients, such as cocoa, fruit, and 
nuts, to characterize it as a kind of ice cream.
Although the findings of fact stated that sugar is the most common 
sweetening agent in ice cream, the findings of fact also stated that a 
number of other nutritive carbohydrate sweeteners (e.g., dextrose, 
invert sugar, corn sirup, maple sirup, honey, brown sugar) are suitable 
for sweetening ice cream.
    Based on the foregoing, the agency believes that consumers have 
traditionally understood that ``ice cream'' is a food that is sweetened 
with nutritive carbohydrate sweeteners. The agency is adopting 
Secs. 135.110(f)(7) and 135.115(c)(2) to ensure that consumers will be 
able to distinguish the traditional food that is sweetened with 
nutritive carbohydrate sweeteners from ice cream sweetened with 
alternative sweeteners. The common or usual name of the latter food is 
``ice cream sweetened with --------------------,'' the blank being 
filled in with the common or usual name of any alternative sweeteners 
used in the food.
    FDA advises that, as a consequence of this action, modified ice 
cream products made in conformance with the general definition and 
standard of identity in Sec. 130.10 (21 CFR 130.10) that are named by 
use of a nutrient content claim and the standardized term, and that 
contain alternative sweeteners, must include the common or usual names 
of these sweeteners in their statement of identity, e.g., ``reduced fat 
ice cream sweetened with ----------------,'' the blank being filled 
with the common or usual name of any alternative sweeteners used in the 
food.
    The agency finds that Secs. 135.110(f)(7) and 135.115(c)(2) will 
provide for adequate notice to consumers that safe and suitable 
sweeteners other than nutritive carbohydrate sweeteners are present in 
the ice cream or goat's milk ice cream, and that the information 
required under these provisions is necessary to allow consumers to make 
informed purchasing decisions in the marketplace. Thus, FDA concludes 
that this action will promote honesty and fair dealing in the interest 
of consumers, and the agency is amending these regulations accordingly, 
as set forth below.
    FDA concludes, however, that labeling to distinguish ice cream 
products sweetened with alternative sweeteners from those sweetened 
with nutritive carbohydrate sweeteners will not be necessary after 
consumers have become aware of the fact that some ice cream products 
are made with nutritive carbohydrate sweeteners, and others with 
alternative sweeteners, and have had a period of time to become 
familiar with such foods. Thus, the regulations set out below 
(Secs. 135.110(f)(7) and 135.115(c)(2)) only require that the name of 
the alternative sweeteners be included as part of the name of the food 
for 3 years following the effective date of the regulation. At the end 
of 3 years, this requirement will terminate, and the presence of 
alternative sweeteners will only have to be declared as part of the 
ingredient list. FDA believes that 3 years is an adequate amount of 
time for people to become aware that ``ice cream'' may be made with 
either nutritive carbohydrate sweeteners or alternative sweeteners, and 
thus that it is necessary to check the ingredient list. Three years 
represented the amount of time necessary for ``canola oil'' to become 
the accepted common or usual name for low-erucic acid rapeseed oil (see 
50 FR 3755, January 21, 1985 and 53 FR 52652, December 29, 1988). Based 
on this precedent, the agency finds that a similar amount of time is 
appropriate here.
    2. One comment objected to the proposed labeling requirement that 
ice cream sweetened with alternative sweeteners be labeled to comply 
with the requirements of Sec. 105.66.
    In the proposal, FDA noted that foods that are sweetened with one 
or more artificial sweeteners are foods for special dietary use under 
Sec. 105.3(a)(2). The agency proposed in Sec. 135.110(e)(7) for ice 
cream, and in Sec. 135.115(c)(2) for goat's milk ice cream, to require 
that when these foods are sweetened with alternative sweeteners, they 
must be labeled to comply with the requirements of Sec. 105.66 because 
FDA anticipated that these foods would be represented for special 
dietary use because of their usefulness in helping to reduce or 
maintain body weight. Such foods must comply with the labeling 
requirements of Sec. 105.66 (i.e., they must bear special labeling 
statements such as ``low calorie'' and ``reduced calorie'').
    FDA acknowledges that the requirements prescribed in Sec. 105.66 
may not always apply to the labeling of ice cream sweetened with 
alternative sweeteners. There may be instances in which ice cream 
sweetened with alternative sweeteners will not purport to be, or will 
not be represented to be, for special dietary use because of its 
usefulness in reducing or maintaining body weight. For instance, a 
manufacturer may replace all of the nutritive carbohydrate sweeteners 
in ice cream with alternative sweeteners but not reduce the fat content 
sufficiently for the food to be ``reduced calorie,'' or a manufacturer 
may replace some of the nutritive carbohydrate sweeteners in ice cream 
with alternative sweeteners but not reduce the level of nutritive 
carbohydrate sweeteners sufficiently for the food to be ``reduced 
calorie.'' Therefore, even though the ice cream is sweetened with 
alternative sweeteners, it would not qualify for the use of terms such 
as ``low calorie'' or ``reduced calorie'' or another comparative 
caloric claim in compliance with part 101 because the manufacturer has 
not reduced the fat or carbohydrate levels in the food sufficiently to 
permit the use of such terms on the food label. The agency recognizes 
that, in such instances, the food need not be labeled in compliance 
with Sec. 105.66. However, in instances in which ice cream sweetened 
with alternative sweeteners does purport to be, or is represented, for 
special dietary use because of its usefulness in reducing or 
maintaining weight, it must bear special label statements in accordance 
with Sec. 105.66. If ice cream sweetened with alternative sweeteners is 
represented for special dietary use because of its usefulness in the 
diet of diabetics, the food must be labeled to comply with the 
requirements of Sec. 105.67.
    Therefore, to reflect these facts, FDA has revised proposed 
Sec. 135.110(e)(7) (redesignated as Sec. 135.110(f)(7)) to delete the 
statement that ice cream sweetened with safe and suitable sweeteners 
other than nutritive carbohydrate sweeteners must be labeled to comply 
with the requirements of Sec. 105.66 and to state instead: ``If the 
food purports to be or is represented for special dietary use, it shall 
bear labeling in accordance with the requirements of part 105 of this 
chapter.'' In addition, the agency has made a similar revision to 
Sec. 135.115(c)(2) for goat's milk ice cream.
    3. One comment expressed concern that FDA would require ingredients 
that are not found in traditional ice cream, such as safe and suitable 
sweeteners other than nutritive carbohydrate sweeteners, to be 
identified by an asterisk in the ingredient statement on the label of 
ice cream in accordance with the general definition and standard of 
identity in Sec. 130.10.
    This comment is incorrect. In Sec. 130.10, FDA established 
requirements for foods named by use of a nutrient content claim and a 
standardized term. The comment specifically refers to the requirement 
in Sec. 130.10(f)(2) that ingredients used to produce such a food, but 
that are not provided for in the standard of identity for the 
traditional food that the new food resembles, and for which it 
substitutes, be identified with an asterisk in the statement of 
ingredients. The agency is amending the ice cream standard in 
Sec. 135.110(a)(1) to provide for the use of safe and suitable 
sweeteners, both nutritive and nonnutritive, in ice cream. Thus, safe 
and suitable sweeteners other than nutritive carbohydrate sweeteners 
are now provided for in the standard of identity for ``ice cream.'' As 
a result, Sec. 130.10(f)(2) does not apply to safe and suitable 
alternative sweeteners, such as aspartame or acesulfame K, used in a 
modified ice cream product. As a result, in making a ``reduced 
calorie'' ice cream, manufacturers who replace some or all of the 
nutritive carbohydrate sweeteners in the food with one or more safe and 
suitable alternative sweeteners will not need to identify these safe 
and suitable sweeteners with an asterisk in the ingredient statement on 
the label of the modified product although they will need to identify 
these sweeteners on the principal display panel for the next 3 years.
2. Dairy Ingredients
    The standard of identity for ice cream (Sec. 135.110) provides for 
the optional use of one or more of the specific dairy ingredients 
listed in Sec. 135.110(b). In view of the wide range of optional dairy 
ingredients listed by name or by the process by which they are derived 
in Sec. 135.110(b), FDA invited comments on whether the specific names 
should be deleted from Sec. 135.110(b), and whether the standard should 
be amended to provide for the use of any safe and suitable dairy 
ingredient (58 FR 520 at 525). In addition, the agency specifically 
requested that any comments supporting the use of a collective term 
such as ``dairy ingredient'' provide a definition for the term that 
will facilitate proper interpretation of any regulation that may 
result.
    4. Several comments requested that FDA revise Sec. 135.110(b) to 
provide for the use of any safe and suitable dairy ingredient. The 
comments stated that the current list of specific optional dairy 
ingredients unnecessarily limits the types of dairy ingredients that 
may be used in ice cream products and impedes the development of 
innovative technologies for the production of new ingredients for use 
in ice cream products.
    One comment suggested that the term ``dairy ingredient'' be defined 
as an ingredient processed by any safe and suitable process from cow's 
or goat's milk. Another comment merely stated that the definition of 
``dairy ingredient'' should include ingredients that have the same 
physical composition that occurs in natural milk, as well as 
ingredients that have been modified physically but that have not been 
substantially altered chemically.
    In establishing the standard of identity for ice cream, the 
findings of fact (15 FR 5112 at 5114) stated that ice cream is 
essentially a sweetened milk and cream product, and that it is made 
from cream, or a mixture of milk and cream (or a combination of dairy 
products of equivalent composition) and sugar or other suitable 
sweetening agent. The ice cream standard included a specific listing of 
optional dairy ingredients that FDA considered to be suitable for use 
in ice cream. These dairy ingredients were restricted to the following: 
Cream, butter, milk, concentrated milk, evaporated milk, sweetened 
condensed milk, dried milk, skim milk, concentrated (evaporated or 
condensed) skim milk, superheated condensed skim milk, sweetened 
condensed skim milk, dried skim milk, sweet cream buttermilk, condensed 
sweet cream buttermilk, dried sweet cream buttermilk, and sweetened 
skim milk which has been concentrated and from which part of the 
lactose has been removed after crystallization. However, in 
establishing the ice cream standard, FDA also recognized that certain 
ingredients that were derived in part from milk, but that were no 
longer equivalent in composition to milk, were not suitable for use in 
ice cream because they were so changed that they had lost the 
characteristics of milk and cream, including a large proportion of 
their water-soluble vitamins and minerals (15 FR 5112 at 5115). Thus, 
to ensure the integrity of ice cream, the agency did not provide for 
the use of such ingredients in the food.
    Since the standard of identity for ice cream was first published, 
technological advances in the dairy industry have increased the number, 
variety, and availability of ingredients derived from dairy sources. 
These developments have made less and less obvious the boundary between 
dairy ingredients and other ingredients that may be derived from dairy 
sources but that are not dairy ingredients.
    Over the years, the list of optional dairy ingredients permitted in 
ice cream has gradually grown to include various forms of milk, skim 
milk, cream, butter, and whey products, although there are certain 
restrictions on the level of use of the last type of ingredients (i.e., 
any whey and modified whey products used can contribute, singly or in 
combination, not more than 25 percent by weight of the total milk 
solids content of the finished food (Sec. 135.110(b)). In addition, the 
ice cream standard permits the optional use of caseinates with certain 
restrictions on their levels of use in the food (i.e., they may be 
added to ice cream mix containing not less than 20 percent total milk 
solids (Sec. 135.110(c)), but FDA does not consider caseinates to be 
dairy ingredients.
    FDA finds that to ensure the integrity of ice cream, any definition 
for the term ``dairy ingredient'' must differentiate between dairy 
ingredients and other ingredients that may be derived from dairy 
sources but that are not suitable as replacements for the milk solids 
in ice cream, or that are suitable only when used in limited amounts 
because they are no longer equivalent in composition to milk and cream. 
In the manufacture of these dairy-derived ingredients such as 
caseinates, changes are made that make them different from milk and 
cream. For example, in making caseinates, the calcium normally present 
in the naturally occurring casein of milk may be replaced with sodium. 
In addition, if casein or caseinates alone are used to replace the 
protein of milk, the protein quality of the ice cream may be decreased 
because the protein efficiency ratio for whole milk protein is higher 
than that for casein.
    The definitions for ``dairy ingredient'' that were suggested by the 
comments do not distinguish dairy ingredients from dairy-derived 
ingredients. Without an adequate definition for this term, FDA is 
hesitant to expand the list of optional ingredients permitted for use 
in ice cream in Sec. 135.110(b) to allow for ``dairy ingredients'' 
because of the problems that use of the term will engender. Thus, the 
agency is retaining the list of optional dairy ingredients that may be 
used in ice cream and is not providing for the general category 
designation of safe and suitable dairy ingredients in Sec. 135.110(b).
3. Milk Protein Hydrolysates
    In the Federal Register of January 22, 1991 (56 FR 2149), FDA 
published an advance notice of proposed rulemaking (ANPRM) announcing 
the filing of petitions that requested, among other things, the 
establishment of new standards of identity for ``lowfat ice cream'' and 
``nonfat ice cream'' and a change in the name of the standardized food 
known as ``ice milk'' to ``reduced fat ice cream.'' Interested persons 
were given until March 25, 1991, to comment.
    One comment received in response to the ANPRM requested that FDA 
amend the ice cream standard in Sec. 135.110 to provide for the use of 
safe and suitable milk-derived protein ingredients other than 
caseinates, provided that the milk solids content minimums required by 
the standards are otherwise met (58 FR 520 at 525). The comment stated 
that these ``other milk protein ingredients'' include milk protein 
hydrolysates (enzyme-modified milk protein) and milk protein isolates 
(caseinates and whey protein co-isolates). The comment maintained that 
the use of milk proteins other than caseinates contributes to aeration 
of frozen lowfat dairy desserts, thereby improving the body and texture 
of these products, and that their use will not reduce the nutritional 
value of standardized dairy products. It further stated that these 
ingredients are safe and suitable for use in other nonstandardized 
foods such as frozen yogurt, coffee whiteners, infant formulas, 
fortified cereals, and medical foods.
    In the proposal, FDA acknowledged that milk protein hydrolysates 
are generally recognized as safe (GRAS) and are now used in many foods 
(58 FR 520 at 525). The agency specifically invited comments on the 
nature of, and the need for, milk protein hydrolysates in ice cream; on 
the proposed levels of use for these ingredients; on their suitability 
to perform technical functions in the food; and on any possible adverse 
effects from their use. The agency stated that it would consider 
providing for the use of these ingredients in any final regulation that 
resulted from the proposal if the comments that it received on this 
issue adequately supported the need for these ingredients in ice cream.
    FDA already provides for the optional use of modified whey 
products, which would include whey protein isolates, as well as for the 
optional use of caseinates, in ice cream within the limitations set 
forth in the ice cream standard. The ice cream standard in 
Sec. 135.110(b) permits the use of modified whey products that are GRAS 
for use in the food, provided that any whey and modified whey products 
used contribute, singly or in combination, not more than 25 percent by 
weight of the total nonfat milk solids content of the finished food. 
Further, the ice cream standard permits the optional use of caseinates 
in ice cream mix containing not less than 20 percent total milk solids.
    5. One comment suggested that FDA permit the optional use of safe 
and suitable milk-derived proteins, such as milk protein hydrolysates, 
in ice cream at levels of 1 to 3 percent. Concerning the nature of milk 
protein hydrolysates, the comment stated that these products are 
produced by light enzymatic hydrolysis of casein; that they are high in 
protein (85 percent); and that they have the same nutritional value as 
the caseinates from which they are derived. The comment stated that 
milk protein hydrolysates may be used in ice cream to stabilize the 
food, i.e., to improve its body and texture; to enhance aeration; and 
to impart resistance to heat shock. The comment also noted that, in 
addition to the nonstandardized foods listed previously, milk protein 
hydrolysates have been used in nonstandardized frozen desserts and 
confectionery nougats. The comment stated that, while these milk 
protein hydrolysates provide a similar degree of stabilization as 
nondairy optional ingredients such as vegetable gums, they are 
nutritionally superior to those ingredients.
    FDA acknowledges that hydrolyzed milk proteins, like vegetable 
gums, may be used to stabilize foams in foods. In addition, FDA 
recognizes that they also may be used to enhance aeration and to 
improve body and texture of products such as nougats and frappes. These 
ingredients are also generally recognized as safe for use in infant 
formulas, as well as in other food products. Thus, the agency finds 
that it is appropriate to provide for their use as stabilizers in ice 
cream. Therefore, the agency is revising the ice cream standard to 
permit the optional use of hydrolyzed milk proteins, in addition to 
optional caseinates, in ice cream when the milk solids content minimum 
provided for in the standard is met.
    Accordingly, the agency is amending Sec. 135.110 by revising 
paragraph (a) and adding new paragraph (d) to provide for the optional 
use of hydrolyzed milk proteins as stabilizers. Based upon the 
information submitted with the comment on this matter, FDA is providing 
in Sec. 135.110(d) that hydrolyzed milk proteins may be used at a level 
not to exceed 3 percent by weight of ice cream mix containing not less 
that 20 percent of total milk solids (see Sec. 135.110(a)(2)). Any whey 
or modified whey products contained in the milk protein hydrolysates 
must fall within the limitations in Sec. 135.110(b) on the total level 
of whey products in ice cream; that is, singly or in combination, they 
must not contribute more than 25 percent by weight of the total nonfat 
milk solids content of the finished food.
    Because the comment did not submit any information concerning the 
use of hydrolyzed milk proteins in goat's milk ice cream, the agency is 
not providing for their use in goat's milk ice cream in Sec. 135.115.
    FDA advises that all protein hydrolysates used in foods must be 
declared in the list of ingredients by a common or usual name that is 
specific to the ingredient and that includes the identity of the food 
source from which the protein was derived. Thus, when hydrolyzed milk 
proteins are used in ice cream, the declaration of these ingredients on 
the food label shall comply with the requirements in 21 CFR 102.22. 
``Hydrolyzed casein'' and ``hydrolyzed whey protein'' would be 
acceptable common or usual names for products derived from casein or 
whey protein, whereas ``hydrolyzed milk protein'' would not be an 
acceptable name.

B. Lactose Reduction in or Removal from Dairy Ingredients by Alternate 
Technologies

    One comment received in response to the ANPRM requested that FDA 
revise Sec. 135.110(b) to replace the phrase ``skim milk that has been 
concentrated and from which part of the lactose has been removed by 
crystallization'' with ``skim milk [that] may be concentrated and from 
which part of the lactose has been removed by crystallization, 
ultrafiltration, or other approved technologies.'' In the proposal, FDA 
tentatively found that it would be appropriate to amend the ice cream 
standard to permit the addition of concentrated skim milk from which 
part of the lactose has been removed by ultrafiltration. The agency 
stated that it also appeared to be appropriate to provide for the 
removal of part or all of the lactose by any safe and suitable 
procedure in order to give manufacturers the opportunity to use state-
of-the-art processing technologies as long as the nutritional quality 
of the resulting food is not detrimentally affected. It stated that 
this approach will minimize the need to revise the standard should 
other acceptable procedures be developed for lactose reduction or 
removal at a later date. Accordingly, FDA proposed to amend 
Sec. 135.110(b) in the ice cream standard to provide for the addition 
to the food of skim milk that may be concentrated and from which part 
or all of the lactose has been removed by a safe and suitable 
procedure.
    6. All of the comments on this provision supported it. One comment, 
however, requested that ultrafiltration for lactose reduction be 
extended to other suitable dairy ingredients because skim milk is not 
the only milk-based dairy ingredient that can be processed by 
ultrafiltration to remove lactose.
    FDA recognizes that ultrafiltration can be used to remove part or 
all of the lactose from milk-based dairy ingredients other than skim 
milk. However, in the proposal, the agency did not foreshadow any 
changes in the ice cream standard to provide for the use of 
ultrafiltration to remove part or all of the lactose from any optional 
dairy ingredient listed in Sec. 135.110(b) other than ``skim milk, that 
may be concentrated, and from which part or all of the lactose has been 
removed by a safe and suitable procedure.'' Therefore, the modification 
in Sec. 135.110 requested by this comment is outside the scope of this 
rulemaking. Persons interested in providing, in ice cream, for the use 
of additional ingredients that are processed by ultrafiltration to 
remove lactose may petition the agency to amend the standard.
    Therefore, FDA is amending Sec. 135.110(b) of the ice cream 
standard, as proposed, to allow for the use of skim milk that may be 
concentrated, and from which part or all of the lactose has been 
removed by a safe and suitable procedure, in the food.

C. Additional Comments

    7. One comment suggested an alternative scheme of nomenclature for 
ice cream products based on percentage milkfat. The comment suggested 
that products bearing the term ``nonfat'' would contain 0 percent 
milkfat; products bearing the term ``lowfat,'' greater than 0 but less 
than 3 percent milkfat; products bearing the term ``reduced fat,'' 3 to 
7 percent milkfat; and products bearing the name ``ice cream,'' greater 
than 7 percent milkfat.
    This request is outside the scope of the proposal. In the Federal 
Register of January 6, 1993, FDA published a number of final rules 
establishing food labeling regulations that, in part, were intended to 
eliminate consumer confusion by establishing definitions for nutrient 
content claims. In one of these final rules (58 FR 2302), FDA 
established uniform, consistent definitions for a number of nutrient 
content claims, including terms for specific fat content claims, and 
prescribed the specific labeling that must accompany these claims. 
Terms for specific fat content claims such as ``nonfat,'' ``lowfat,'' 
and ``reduced fat'' are defined in Sec. 101.62. In defining terms for 
specific nutrient content claims, the agency carefully considered each 
claim to ensure that it would be meaningful to consumers.
    In another final rule (58 FR 2431), FDA amended its general 
provisions for food standards to provide a general definition and 
standard of identity for foods named by the use of a nutrient content 
claim defined in part 101 (such as ``fat free'') in conjunction with a 
traditional standardized name (e.g., ``ice cream''). In accordance with 
Sec. 130.10, specific fat content claims defined in Sec. 101.62 may be 
used in conjunction with the standardized term ``ice cream'' for foods 
that resemble and substitute for ice cream but that contain less fat 
(both milkfat and total fat) than traditional ice cream.
    Thus, the agency has addressed in separate rulemakings (58 FR 2302 
and 58 FR 2431) the types of nutrient content claims that can be used 
to indicate the amount of fat present in foods, including ice cream 
products. Further, in this final rule, the agency is removing the 
standard of identity for ice milk, so that a reduced fat ice cream 
product that complies with the existing standard of identity for ice 
milk no longer needs to be labeled ``ice milk'' and may now be labeled 
as ``reduced fat ice cream.''
    FDA notes that the percentage milkfat basis for the labeling of ice 
cream products suggested by the comment is inconsistent with the 
definitions that the agency has established in its food labeling 
regulations. Further, the agency believes that the adoption of the 
suggested alternative scheme of nomenclature for ice cream products 
could result in consumer confusion about the nature of the food. 
Therefore, FDA concludes that an alternative scheme of nomenclature for 
ice cream products, as suggested by the comment, would neither promote 
uniformity and consistency in the food labeling nor minimize confusion 
among consumers. Thus, the agency is not making the requested change in 
the regulations set out below.
    8. One comment stated that under existing FDA regulations, frozen 
dairy products containing 7 to 10 percent milkfat have no standard of 
identity.
    This comment is no longer correct now that the regulation (58 FR 
2431) amending the general provisions for food standards to prescribe a 
general definition and standard of identity for foods named by the use 
of a nutrient content claim in conjunction with a traditional 
standardized name has been finalized. Under Sec. 130.10, FDA-defined 
nutrient content claims for fat content, such as ``reduced fat,'' 
``lowfat,'' and ``nonfat,'' can be used in conjunction with the name of 
a traditional standardized food such as ``ice cream'' for foods that 
resemble and substitute for ice cream but that contain less milkfat 
than traditional ice cream. Therefore, manufacturers may be able to use 
an appropriate term such as ``reduced fat'' in conjunction with the 
standardized name ``ice cream'' to name ice cream products containing 
greater than 7 percent but less than 10 percent milkfat, provided that 
the use of the term complies with Sec. 130.10 and is not false or 
misleading to consumers. For example, if the manufacturer's regular 
vanilla ice cream contains 12 percent milkfat, and the manufacturer 
reduces the fat level of the product by 25 percent, the new version of 
the product would contain 9 percent milkfat, which falls in the range 
of milkfat that the comment mentioned (i.e., greater than 7 percent but 
less than 10 percent). The manufacturer would be able to label the new 
version of the product with the term ``reduced fat'' because the 
product would contain 25 percent less fat per serving than the 
manufacturer's regular vanilla ice cream.
    9. FDA received from a law firm a request for an advisory opinion 
(Docket No. 93A-0493), dated December 10, 1993, as to whether a frozen 
dessert product that contains less than 2 percent milkfat and more than 
2 percent total fat may be labeled as ``reduced fat ice cream.'' The 
law firm represents a company that desires to avoid using the name 
``ice milk'' on the label of its product.
    Before issuance of this final rule, ``ice milk'' was defined in 
Sec. 135.120 as a frozen dessert that contained more than 2 percent 
milkfat and not more than 7 percent milkfat. With the issuance of the 
January 1993 final rules, however, a frozen dessert product that 
contained less than 2 percent milkfat and more than 2 percent total 
fat, such as that described by the law firm, could have been eligible 
to be labeled as ``reduced fat ice cream'' in accordance with 
Sec. 130.10(a), because it contained less than 2 percent milkfat, but 
provided that: (1) Any additional fat (above the 2 percent maximum 
level for milkfat) in the food was there as a component of a flavoring 
constituent, e.g., fat from nut meats, butterscotch, or chocolate, and 
not as a replacement of milkfat, and (2) the food was made in 
compliance with the provisions of Sec. 130.10. The product described in 
the request was outside the scope of the ice milk standard and would 
have had to comply with the provisions of Sec. 130.10(b), (c), and (d) 
with respect to nutrients, performance characteristics, permitted 
ingredients, and labeling. FDA notes that replacement of the milkfat of 
ice cream with fats from other sources is contrary to Sec. 130.10(d)(2) 
because it would alter the dairy character of the food.
    If the product described in the request complied with Sec. 130.10, 
it would have been named, ``reduced fat'' or ``low fat'' ice cream. The 
product would have qualified for the use of the ``reduced fat'' claim, 
as defined in Sec. 101.62(b)(4), as part of its name because the total 
level of fat contained in the product would have been at least 25 
percent less fat than ice cream. On the other hand, the product could 
have borne the ``low fat'' claim as defined in Sec. 101.62(b)(2) as 
part of its name if it contained less than 3 grams of total fat per 
reference amount customarily consumed.
    The agency points out that now, with the removal of the ice milk 
standard in this final rule, the foregoing is still the case except 
that modified ice cream products that contain levels of milkfat within 
the range of that previously prescribed by the standard of identity for 
ice milk (i.e., more than 2 percent but not more than 7 percent) may 
also be labeled as ``reduced fat ice cream,'' provided that these 
products comply with the provisions of Sec. 130.10.

III. Conclusions

    After review and consideration of the comments received in response 
to the proposal, FDA concludes that no evidence or information has been 
presented that would provide a basis for altering the agency's 
tentative determination that it should remove the standards of identity 
for ice milk (Sec. 135.120) and goat's milk ice milk (Sec. 135.125), 
and that it should amend the standards of identity for ice cream 
(Sec. 135.110) and goat's milk ice cream (Sec. 135.115) to provide for 
the use in the food of safe and suitable sweeteners and of skim milk 
that may be concentrated and from which part or all of the lactose has 
been removed by a safe and suitable procedure.
    Therefore, in this final rule, FDA is removing the standards of 
identity for ice milk (Sec. 135.120) and goat's milk ice milk 
(Sec. 135.125) as proposed and amending the standards of identity for 
ice cream (Sec. 135.110) and goat's milk ice cream (Sec. 135.115) as 
proposed with the following exceptions: (1) Ice cream sweetened with 
alternative sweeteners, or goat's milk ice cream sweetened with 
alternative sweeteners, needs to bear labeling in accordance with the 
requirements of part 105 only if the food purports to be or is 
represented for special dietary use; (2) the name of the alternative 
sweetener need only be included as part of the name of the food on the 
principal display panel of the label for a period of 3 years; and (3) 
hydrolyzed milk proteins may be used as optional stabilizers in ice 
cream at a level not to exceed 3 percent by weight in ice cream mix 
containing not less that 20 percent total milk solids, provided that 
any whey and modified whey products used contribute, singly or in 
combination, not more than 25 percent by weight of the total nonfat 
milk solids content of the finished food.
    In addition, FDA has made other minor editorial revisions in the 
text of the final rule for internal consistency. The agency deleted the 
language ``or may not'' from the last sentence in Sec. 135.110(a)(1) of 
the ice cream standard and redesignated Sec. 135.110(d) through (f) of 
the ice cream standard as Sec. 135.110(e) through (g).
    Because this rulemaking involves the removal and amendment of 
standards for dairy products, it is subject to the formal rulemaking 
procedures of section 701(e) of the act (21 U.S.C. 371(e)). Section 
701(e) of the act, unlike the informal rulemaking procedures of section 
701(a) of the act, requires that the agency provide an opportunity for 
objections to the final rule. If any objection raises issues of 
material fact, the agency is to hold a formal evidentiary hearing on 
those issues.

IV. Analysis of Impacts

    FDA has examined the impact of this final rule to amend the 
standards of identity for ice cream and goat's milk ice cream and to 
repeal the standards of identity for ice milk and goat's milk ice cream 
in 21 CFR part 135 as required by Executive Order 12866 and the 
Regulatory Flexibility Act. Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety effects; distributive impacts and equity). The 
Regulatory Flexibility Act (Pub. L. 96-354) requires that the agency 
analyze options for regulatory relief for small businesses. FDA finds 
that this final rule is not a significant regulatory action as defined 
by Executive Order 12866. In compliance with the Regulatory Flexibility 
Act, the agency certifies that this final rule will not have a 
significant impact on a substantial number of small businesses.

V. Environmental Impact

    FDA has previously considered the environmental effects of this 
rule as announced in the proposed rule. No new information or comments 
have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.

VI. Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before October 14, 1994, file with the Dockets 
Management Branch (address above) written objections thereto. Each 
objection shall be separately numbered, and each numbered objection 
shall specify with particularity the provisions of the regulation to 
which objection is made and the grounds for the objection. Each 
numbered objection for which a hearing is requested shall specifically 
so state. Failure to request a hearing for any particular objection 
shall constitute a waiver of the right to a hearing on that objection. 
Each numbered objection for which a hearing is requested shall include 
a detailed description and analysis of the specific factual information 
intended to be presented in support of the objection in the event that 
a hearing is held. Failure to include such a description and analysis 
for any particular objection shall constitute a waiver of the right to 
a hearing on the objection. Three copies of all documents shall be 
submitted and shall be identified with the docket number found in 
brackets in the heading of this document. Any objections received in 
response to the regulation may be seen in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish 
notice of the objections that the agency has received or lack thereof 
in the Federal Register.

List of Subjects in 21 CFR Part 135

    Food grades and standards, Food labeling, Frozen foods, Ice cream.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
135 is amended as follows:

PART 135--FROZEN DESSERTS

    1. The authority citation for 21 CFR part 135 is revised to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).

    2. Section 135.110 is amended by revising paragraphs (a)(1) and 
(b), by redesignating paragraphs (d) through (f) as paragraphs (e) 
through (g), and by adding new paragraphs (d) and (f)(7) to read as 
follows:


Sec. 135.110  Ice cream and frozen custard.

    (a) Description. (1) Ice cream is a food produced by freezing, 
while stirring, a pasteurized mix consisting of one or more of the 
optional dairy ingredients specified in paragraph (b) of this section, 
and may contain one or more of the optional caseinates specified in 
paragraph (c) of this section subject to the conditions hereinafter set 
forth, one or more of the optional hydrolyzed milk proteins as provided 
for in paragraph (d) of this section subject to the conditions 
hereinafter set forth, and other safe and suitable nonmilk-derived 
ingredients; and excluding other food fats, except such as are natural 
components of flavoring ingredients used or are added in incidental 
amounts to accomplish specific functions. Ice cream is sweetened with 
safe and suitable sweeteners and may be characterized by the addition 
of flavoring ingredients.
* * * * *
    (b) Optional dairy ingredients. The optional dairy ingredients 
referred to in paragraph (a) of this section are: Cream; dried cream; 
plastic cream (sometimes known as concentrated milkfat); butter; butter 
oil; milk; concentrated milk; evaporated milk; sweetened condensed 
milk; superheated condensed milk; dried milk; skim milk; concentrated 
skim milk; evaporated skim milk; condensed skim milk; superheated 
condensed skim milk; sweetened condensed skim milk; sweetened condensed 
part-skim milk; nonfat dry milk; sweet cream buttermilk; condensed 
sweet cream buttermilk; dried sweet cream buttermilk; skim milk, that 
may be concentrated, and from which part or all of the lactose has been 
removed by a safe and suitable procedure; skim milk in concentrated or 
dried form that has been modified by treating the concentrated skim 
milk with calcium hydroxide and disodium phosphate; and whey and those 
modified whey products (e.g., reduced lactose whey, reduced minerals 
whey, and whey protein concentrate) that have been determined by FDA to 
be generally recognized as safe (GRAS) for use in this type of food. 
Water may be added, or water may be evaporated from the mix. The sweet 
cream buttermilk and the concentrated sweet cream buttermilk or dried 
sweet cream buttermilk, when adjusted with water to a total solids 
content of 8.5 percent, has a titratable acidity of not more than 0.17 
percent, calculated as lactic acid. The term ``milk'' as used in this 
section means cow's milk. Any whey and modified whey products used 
contribute, singly or in combination, not more than 25 percent by 
weight of the total nonfat milk solids content of the finished food. 
The modified skim milk, when adjusted with water to a total solids 
content of 9 percent, is substantially free of lactic acid as 
determined by titration with 0.1N NaOH, and it has a Ph value in the 
range of 8.0 to 8.3.
* * * * *
    (d) Optional hydrolyzed milk proteins. One or more of the optional 
hydrolyzed milk proteins referred to in paragraph (a) of this section 
may be added as stabilizers at a level not to exceed 3 percent by 
weight of ice cream mix containing not less that 20 percent total milk 
solids, provided that any whey and modified whey products used 
contribute, singly or in combination, not more than 25 percent by 
weight of the total nonfat milk solids content of the finished food. 
Further, when hydrolyzed milk proteins are used in the food, the 
declaration of these ingredients on the food label shall comply with 
the requirements of Sec. 102.22 of this chapter.
* * * * *
    (f) * * *
    (7) Until September 14, 1998, when safe and suitable sweeteners 
other than nutritive carbohydrate sweeteners are used in the food, 
their presence shall be declared by their common or usual name on the 
principal display panel of the label as part of the statement of 
identity in letters that shall be no less than one-half the size of the 
type used in the term ``ice cream'' but in any case no smaller than 
one-sixteenth of an inch. If the food purports to be or is represented 
for special dietary use, it shall bear labeling in accordance with the 
requirements of part 105 of this chapter.
* * * * *
    3. Section 135.115 is amended by revising paragraph (a), by 
redesignating the text of paragraph (c) as paragraph (c)(1), and by 
adding new paragraph (c)(2) to read as follows:


Sec. 135.115  Goat's milk ice cream.

    (a) Description. Goat's milk ice cream is the food prepared in the 
same manner prescribed in Sec. 135.110 for ice cream, and complies with 
all the provisions of Sec. 135.110, except that the only optional dairy 
ingredients that may be used are those in paragraph (b) of this 
section; caseinates and hydrolyzed milk proteins may not be used; and 
paragraphs (f)(1) and (g) of Sec. 135.110 shall not apply.
* * * * *
    (c) * * *
    (2) Until September 14, 1998, when safe and suitable sweeteners 
other than nutritive carbohydrate sweeteners are used in the food, 
their presence shall be declared by their common or usual name on the 
principal display panel of the label as part of the statement of 
identity in letters that shall be no less than one-half the size of the 
type used in the term ``goat's milk ice cream'' but in any case no 
smaller than one-sixteenth of an inch. If the food purports to be or is 
represented for special dietary use, it shall bear labeling in 
accordance with the requirements of part 105 of this chapter.
* * * * *


Sec. 135.120  [Removed]

    4. Section 135.120 Ice milk is removed from subpart B.


Sec. 135.125  [Removed]

    5. Section 135.125 Goat's milk ice milk is removed from subpart B.

    Dated: September 7, 1994.
 William K. Hubbard,
 Interim Deputy Commissioner for Policy.
[FR Doc. 94-22646 Filed 9-13-94; 8:45 am]
BILLING CODE 4160-01-F