[Federal Register: September 27, 2005 (Volume 70, Number 186)]
[Proposed Rules]
[Page 56409-56417]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se05-31]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 135
[Docket Nos. 2003P-0132 and 2000P-1491 (formerly 03P-0132 and 00P-
1491)]
Frozen Desserts; Petition to Revoke Standards for Goat's Milk Ice
Cream and Mellorine and to Amend Standards for Ice Cream and Frozen
Custard, Sherbet, and Water Ices; Petition to Amend Standards for
Parmesan and Reggiano Cheese
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 the
following two petitions have
[[Page 56410]]
been filed: A petition requesting that the agency revoke the standards
of identity for goat's milk ice cream and mellorine, and amend the
standards of identity for ice cream and frozen custard, sherbet, and
water ices in numerous respects; and a petition requesting that the
agency amend the standard of identity for parmesan and reggiano cheese
to decrease the minimum curing time from 10 months to 6 months. The FDA
is issuing an advance notice of proposed rulemaking (ANPRM) to request
comments to determine whether the action proposed in the petitions
would promote honesty and fair dealing in the interest of consumers.
DATES: Submit written or electronic comments by December 27, 2005.
ADDRESSES: You may submit comments, identified by Docket Nos. 2003P-
0132 and 2000P-1491, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
<bullet> FAX: 301-827-6870.
<bullet> 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 or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). or Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.fda.gov/ohrms/dockets/default.htm, including any personal
information provided. For detailed instructions on submitting comments
and additional information on the rulemaking process, 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.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), 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: Catalina Ferr[eacute]-Hockensmith,
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:
I. The International Ice Cream Association (IICA) Petition
IICA submitted a citizen petition on March 31, 2003, requesting
that FDA revoke the standards of identity in part 135 (21 CFR part 135)
for goat's milk ice cream (Sec. 135.115) and mellorine (Sec.
135.130), amend the current standard of identity for ice cream and
frozen custard (Sec. 135.110), amend the standard of identity for
sherbet (Sec. 135.140), and amend the standard of identity for water
ices (Sec. 135.160).
In its petition, IICA states that its proposed amendments to the
frozen desserts standards of identity improve efficiency by bringing
these standards of identity up to current technological standards.
Specifically, IICA's proposed amendments to the frozen desserts
regulations in part 135, establish definitions for the following terms:
(1) Ultrapasteurized, (2) milk (to include filtered milk), (3) nonfat
milk, (4) milk-derived protein, and (5) milk-derived ingredients. In
addition, IICA's proposed ice cream and frozen custard standard would
permit, among other things, the use of any safe and suitable milk-
derived ingredients as well as milk from other animal sources and would
require source declaration when milk other than cow's milk is used
(e.g., goat, sheep). IICA's proposed amendments would also provide for
``alternate make'' procedures and would change the minimum requirements
of fat and protein content. For frozen custard, French ice cream, and
French custard ice cream, the IICA proposal provides for a minimum of
1.4 percent egg yolk. Further, IICA's proposed amendments would require
the use of specific Association of Official Analytical Chemists
International (AOAC) analytical methods for determination of fat and
protein content. Finally, IICA's proposed amendments would provide that
the manufacturer may determine whether a natural or artificial flavor
provides the characterizing flavor for purposes of labeling and would
provide for collective common or usual names for some milk-derived
ingredients.
IICA also proposes that many of the proposed changes to the ice
cream and frozen custard standard be applied to the sherbet standard.
IICA's proposed amendments to the sherbet standard included allowing
for use of the following: (1) Any safe and suitable milk-derived
ingredients; (2) milk from animals other than cows, whose source would
be reflected in the product name; (3) safe and suitable sweeteners; and
(4) ``alternate make'' procedures. IICA also proposes minimum and/or
maximum requirements for milk-derived protein, milkfat and fruit
content.
IICA's proposed amendments to the water ices standard provide for
the use of safe and suitable ingredients and optional fruit-
characterizing ingredients and remove the requirement that the product
is aerated or stirred while freezing.
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 product food standard, as 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 IICA'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.
A. Grounds for the Suggested Changes for Ice Cream and Frozen Custard,
Goat's Milk Ice Cream, Mellorine, Sherbet, and Water Ices Standards
IICA asserts that the proposed changes to the frozen desserts
standards of identity would increase efficiency by reducing unnecessary
regulatory burdens and would allow manufacturers to take advantage of
new manufacturing and ingredient technologies. IICA states that these
changes would allow manufacturers to reduce costs and to pass these
savings on to consumers. IICA contends that the proposed changes would
result in a finished product nutritionally equivalent to products
manufactured according to the current standard; therefore, no economic
harm or consumer deception would result from the proposed amendments.
IICA also maintains that
[[Page 56411]]
the proposed amendments to the standards would reduce FDA's expenses
because newly developed ingredients could be used without having to
amend the standards for each change while still ensuring consumer
health and safety.
IICA's proposed amendments to the ice cream and frozen custard and
sherbet standards provide for the use of safe and suitable milk-derived
ingredients rather than providing an extensive list of ingredients
permitted as is done in the current standards. IICA asserts that this
would streamline the current standards. Moreover, IICA notes that its
proposed amendment to the ice cream and frozen custard standard, which
provides for seven categories of milk derived ingredients to be
declared on labels under common names, would allow manufacturers to
adjust their formulas based on ingredient availability within each
class of ingredients without the need to print new labels. In addition,
IICA asserts, that because the nutritional profile of ice cream is
based on a protein equivalent, consumers will not be deceived by the
proposed categories because the final product will be nutritionally
equivalent regardless of the individual ingredient within the class
that is used.
In its petition, IICA proposes removing the maximum 25-percent
restriction on whey solids in ice cream and frozen custard to allow for
any combination of safe and suitable dairy-derived ingredients. IICA
contends that, by removing the 25-percent cap on whey solids, more whey
proteins can be used to satisfy the minimum protein requirement. In
addition, IICA asserts that whey proteins have a higher nutritional
value than other milk proteins and higher protein digestibility than
milk.
Further, IICA proposes replacing the minimum nonfat milk solids
requirements contained in the current ice cream and frozen custard and
sherbet standards with a minimum milk-derived protein percentage based
on the proportionate amount of fat in the foods. IICA contends that a
milk-derived protein requirement is easier to measure, and thus, the
requirement is easier to enforce than a minimum nonfat milk solids
requirement.
In its petition, IICA proposes a new provision for ``alternate
make'' in the manufacture of ice cream and frozen custard and sherbet.
IICA states that the proposed amendment for an ``alternate make''
provision in certain frozen desserts is consistent with the alternate
make provisions in cheese standards. IICA further states that the
``alternate make'' provision would be confined to those processes that
produce a finished product that is equivalent to the product made by
traditional procedures regarding physical, chemical (including
nutritional) and organoleptic properties. IICA also states that
including an ``alternate make'' provision would provide flexibility to
use improvements in food technology in the manufacture of ice cream,
frozen custard, and sherbet without having to amend the standard.
In its petition, IICA also proposes removing the current ice cream
and frozen custard standard requirement regarding the amounts of
fruits, fruit juice and nut meats present, at or below which an
artificial flavor simulating a characterizing flavor is deemed the
predominant flavor for purposes of naming the product. Also, IICA
proposes changing the levels of fruit content in sherbet at or below
which the artificial flavor is deemed to predominate over the fruit
ingredient in characterizing the flavor of the product. IICA proposes
changing these levels from a minimum of 2-percent for citrus sherbets,
6-percent for berry sherbets, and 10-percent for sherbets prepared with
other fruits to a 2-percent minimum content for all fruits to allow
greater flexibility in developing new and exotic flavors. IICA asserts
that intense flavors, when used in combination with bland flavors,
overpower the bland flavors if used at the 10-percent level currently
required for sherbet prepared with fruits other than citrus and berry.
IICA also proposes to delete the standard for goat's milk ice cream
and instead to provide for declaration of the source-animal for milk in
ice cream when the milk is from an animal other than cow. IICA states
that having separate standards of identity is unnecessarily duplicative
and limits possibilities for the use of milk from other source animals.
In addition, IICA proposes to revoke the mellorine standard. IICA
asserts that mellorine is not in great demand. IICA further states
that, if the mellorine standard is revoked, frozen dairy desserts
formulated by replacing milkfat with vegetable fat may still be
manufactured but would be labeled with a common or usual name that is
more descriptive, such as ``frozen dessert'' or ``frozen dairy
dessert,'' if the milk solids predominate. IICA contends that these
names would allow manufacturers more flexibility to address consumer
demand and more accurately describe the product.
Finally, IICA proposes to provide for the use of safe and suitable
ingredients in the water ices standard rather than providing an
extensive list of ingredients permitted as is done in the current
standard. IICA also proposes the use of optional fruit-characterizing
ingredients in water ices.
B. Matters of Particular Interest to FDA Regarding IICA's Petition
FDA requests that interested persons submit data and information
concerning the need for, and the appropriateness of, revoking the
standards for goat's milk ice cream and mellorine and amending the
standards for ice cream and frozen custard, sherbet, and water ices as
proposed by IICA. FDA specifically requests comment and supporting
data, as appropriate, on the following provisions set forth in the
petition:
1. The use of filtered milk in the making of frozen desserts;
2. The use of any safe and suitable milk-derived ingredients in the
manufacture of frozen desserts;
3. The use of milk from source animals other than cows in the
making of ice cream and frozen custard and sherbet;
4. The use of ``alternate make'' procedures in the manufacture of
ice cream and frozen custard and sherbet;
5. A minimum weight requirement of 4 pounds per gallon for reduced
fat ice cream;
6. A minimum milk-derived protein requirement based on the amount
of fat;
7. The removal of the requirement of the maximum 25-percent
restriction on whey solids in ice cream and frozen custard;
8. The removal of the requirements for the amounts of fruits, fruit
juices, and nut meats needed to determine if an artificial flavor
simulating a characterizing flavor is the predominant flavor when
naming an ice cream or frozen dessert product, and providing that the
manufacturer may determine whether the natural or artificial flavor
ingredients provide the characterizing flavor of the product for
purposes of labeling;
9. The establishment of categories of ingredients to be declared on
labels under common names for ice cream and frozen custard;
10. The removal of the restrictions on ingredients in goat's milk
ice cream;
11. The use of a 2-percent minimum level of fruit content in
sherbet.
After reviewing the comments received, FDA will further evaluate
the need for, and appropriateness of, each of the amendments requested
by IICA and will decide what further actions are appropriate. To
facilitate comment, in the following paragraphs FDA discusses some of
the amendments requested by IICA.
[[Page 56412]]
IICA proposes amending the current standards of identity for frozen
desserts (part 135) to provide for a definition of ``milk'' that
includes ``filtered milk'' for use in the manufacture of frozen
desserts. IICA also proposes allowing categories of ingredients to be
declared on labels under a common name. For example, IICA proposes
allowing filtered milk in dried and liquid form to be labeled as
``milk.'' Currently, filtered milk is not allowed in the manufacture of
frozen desserts. FDA solicits comment on the need to amend the standard
to provide for the use of filtered milk in the making of frozen
desserts, and whether all forms or only specific forms of filtered milk
should be permitted. FDA also solicits comments on the importance of
filtered milk for the basic nature and essential characteristics of ice
cream. The basic nature of the food is directly related to consumer
expectations and beliefs about the food. The essential characteristics
of a food are those that define or distinguish a food or describe the
distinctive properties of a food. Although the essential
characteristics of a food may contribute to achieving the basic nature
of that food or may be relevant to meeting certain consumer
expectations about the food, they differ from the basic nature of the
food in that consumers may not be aware of the essential
characteristics that make the food what it is.
The standards for ice cream and frozen custard, sherbet, and water
ices proposed by IICA permit the use of any safe and suitable
ingredient added to accomplish a specific function. FDA recognizes the
need for food standards to permit flexibility in food technology, as
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 (part
130) 21 CFR 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 proposed amendment permitting the use of any safe and suitable
ingredient to accomplish a specific function in the manufacture of
frozen desserts.
IICA proposes replacing the minimum nonfat milk solids requirement
contained in the current ice cream and frozen custard and sherbet
standards with a minimum milk-derived protein requirement based on the
amount of fat because the nonfat milk solids cannot be differentiated
from other solids in the foods. FDA seeks comments on the following:
(1) The necessity and appropriateness of this proposed amendment; (2)
whether this amendment would be consistent with the basic nature and
essential characteristics of ice cream and frozen custard and sherbet;
(3) whether the proposed minimum milk-derived protein content
requirement should replace the current minimum nonfat milk solids
requirement or be implemented in addition to the current requirement
for a minimum nonfat milk solids; and (4) how replacing a minimum
nonfat milk solid requirement with a minimum milk-derived protein
requirement would affect the compositional and nutritional profile of
the product.
In its petition, IICA proposes to provide for the use of any safe
and suitable milk-derived ingredient, such as components or fractions
of milk including, milkfat, milk protein, milk sugars and minerals in
the manufacture of frozen desserts. IICA asserts this would allow for
the use of newly developed ingredients without having to amend the
standard. FDA solicits comment on the appropriateness of this proposed
amendment, and on whether it would be consistent with the basic nature
and essential characteristics of frozen desserts.
IICA proposes creating categories of ingredients to be declared on
labels under a common name to allow manufacturers to adjust their
formulas based on ingredient availability without the need to print new
labels. In addition, IICA asserts that the milk-derived ingredients in
the proposed categories are nutritionally and functionally equivalent
when used in frozen desserts, and therefore, consumers would not be
deceived by the proposed categories because the final product would be
nutritionally equivalent regardless of the individual ingredient within
the class that is used. We seek comment on the appropriateness of this
amendment requested by IICA. Specifically, FDA seeks comment on whether
consumers would be confused by category names on frozen desserts when
compared to other dairy products or non-dairy products and whether
category names as described in the petition would inform consumers
about the specific ingredients that are used to make the food. In
addition, if considered appropriate, should collective names be
permitted for all the categories in the petition? Why or why not? Would
consumers be confused, misled or deprived of material information?
IICA also proposes including a new provision for ``alternate make''
procedures in the manufacture of frozen desserts. IICA states that this
provision is necessary to provide flexibility to permit the use of
improvements in food technology without having to amend the standards.
However, IICA did not submit information about any current ``alternate
make'' procedures. We request information describing ``alternate make''
procedures in the making of ice cream currently available and on the
consistency of those procedures with the basic nature and essential
characteristics of ice cream. In addition, if ``alternate make''
procedures are allowed, is the framework currently used for cheese
standards appropriate for ice cream?
The current standard for ice cream and frozen custard has a maximum
25 percent restriction on whey solids. The IICA proposed standard
removes the maximum 25-percent restriction on whey solids in ice cream
and frozen custard to allow for any combination of safe and suitable
dairy-derived ingredients, provided the proposed minimum milk-derived
protein content is satisfied. FDA requests comment on the following:
(1) The appropriateness of removing the maximum 25-percent restriction
on whey solids to allow for any combination of safe and suitable dairy-
derived ingredients, provided the minimum milk-derived protein content
is satisfied; (2) any concerns with using whey protein as a main
ingredient in the manufacture of ice cream and frozen custard; (3) any
information that supports the contention in the petition that whey
protein currently used in the market is of higher nutritional value,
higher quality and protein digestibility than protein currently used in
ice cream and custard; and (4) whether the use of more than 25-percent
whey ingredients is consistent with the basic nature and essential
characteristics of ice cream and frozen custard.
IICA proposes removing the amounts of fruits, fruit juices, and nut
meats in the ice cream and frozen custard standard used to determine
whether an artificial flavor simulating a characterizing flavor is the
predominant flavor when naming the product. IICA states that under its
proposed amendments, the manufacturer would
[[Page 56413]]
determine whether the natural or artificial flavor ingredients provides
the characterizing flavor of the product and would label the product
accordingly. In its petition, IICA also proposes changing the
requirements in sherbet for the amounts of fruit or fruit juice from a
minimum of 6-percent for berry sherbets and a minimum of 10-percent for
sherbets from other fruits to a minimum of 2-percent. FDA implemented
the current requirement for determining whether the fruit ingredient or
artificial flavor is the characterizing flavor of the food in 1964 when
a final rule on frozen desserts was published. We recognize that there
have been advancements in food technology, and we question whether this
requirement is still necessary. Specifically, FDA seeks comment on the
following: (1) Whether standard amounts of fruits, fruit juices, and
nut meats are needed to determine if an artificial flavor simulates a
characterizing flavor when naming the product; (2) other alternatives
to the current requirements in the standard and to the petitioner's
proposed amendment that would ensure products are labeled in a way that
would not be misleading to consumers; and (3) whether it is appropriate
to allow manufacturers to determine whether the fruit ingredient or
artificial flavor predominates in characterizing the flavor of the
product and label the product accordingly.
IICA proposes amending the current standard of identity for sherbet
to provide for a 2-percent minimum fruit content. Under the current
sherbet standard, the minimum amount of fruit content is not less than
2-percent for citrus sherbets, 6-percent for berry sherbets, and 10-
percent for sherbets prepared with other fruits. FDA solicits comment
on changing the varying minimum levels of fruit content in sherbet to a
2-percent minimum content for all types of fruit and on what technical
impact such an amendment would have on the finished product. FDA also
solicits comments on the consistency of the existing and proposed
minimum fruit content levels with the basic nature and essential
characteristics of citrus sherbet, berry sherbets, and other relevant
sherbets.
FDA further solicits comments on whether any other requirements
that are currently in the standards for frozen deserts including ice
cream, frozen custard, water ice, and sherbet are not needed to ensure
that products bearing these terms on their labels conform to the basic
nature and essential characteristics of these products. FDA also
requests information on the costs associated with any unnecessary
elements or on the cost savings associated with eliminating them.
FDA solicits comments on the impact of the recommended changes in
food standards on manufacturers of frozen deserts and, in particular,
on small manufacturers. The relevant impacts include both direct
effects, such as labeling costs and changes in production costs, as
well as indirect effects, such as any impact on the sales of products
affected by these changes.
FDA solicits comments on any paperwork burden from generating the
recommended changes in food standards.
In addition, while we ask for comment on specific petition
provisions, we would accept comment on other aspects of the frozen
desserts standards. Please submit copies of supportive data along with
your comments.
On May 20, 2005, FDA published a proposed rule entitled ``Food
Standards; General Principles and Food Standards Modernization''
(hereinafter referred to as the ``food standards proposal'') (70 FR
29214) that proposes to establish a set of general principles to
modernize food standards. While we recognize that we are proposing this
advance notice of proposed rulemaking (ANPRM) before the food standards
proposal is finalized, we encourage the public to consider the proposed
general principles in the food standards proposal when commenting on
this ANPRM.
C. International Ice Cream Association Requested Amendments
The requested amendments of the ice cream and frozen custard
standard, the sherbet standard, and the water ices standard submitted
by IICA are set forth in the following paragraphs. The following
language is as suggested by IICA; FDA has made only minor
nonsubstantitve changes. FDA will further evaluate the need and
appropriateness of these regulations proposed by IICA following the
receipt of public comments.
IICA's suggested standard of identity for ice cream and frozen
custard is as follows:
Subpart A--General Provisions
Sec. 135.3 Definitions.
For the purposes of this part:
(a) A pasteurized mix is one in which every particle of the mix has
been heated in properly operated equipment to one of the temperatures
specified in the table in this section and held continuously at or
above that temperature for the specified time (or other time/
temperature relationship which has been demonstrated to be equivalent
thereto in microbial destruction):
------------------------------------------------------------------------
Temperature Time
------------------------------------------------------------------------
155 [deg]F 30 min.
------------------------------------------------------------------------
175 [deg]F 25 sec.
------------------------------------------------------------------------
180 [deg]F 15 sec.
------------------------------------------------------------------------
191 [deg]F 1 sec.
------------------------------------------------------------------------
204 [deg]F 0.05 sec.
------------------------------------------------------------------------
212 [deg]F 0.01 sec.
------------------------------------------------------------------------
(b) Ultra-pasteurized when used to describe a dairy product means
that such product shall have been thermally processed at or above 280
[deg]F for at least 2 seconds, either before or after packaging, so as
to produce a product which has an extended shelf life under
refrigerated conditions.
(c) Milk means the lacteal secretion, practically free from
colostrum, obtained by the complete milking of one or more healthy
cows, which may be clarified and may be adjusted by separating part of
the fat therefrom; concentrated milk, filtered milk, reconstituted
milk, and dry whole milk. Water in sufficient quantity to reconstitute
concentrated and dry forms may be added.
(d) Nonfat milk means skim milk, concentrated skim milk, filtered
skim milk, reconstituted skim milk and nonfat dry milk. Water in a
sufficient quantity to reconstitute concentrated forms may be added.
(e) Milk-derived protein means casein and/or whey protein(s) and
its constituents, fractions, hydrolysates or polymers derived from
milk.
(f) Milk-derived ingredients means any ingredient derived from milk
or any component or fraction of milk such as milkfat, milk proteins
defined in 135.3(e), milk sugars and minerals.
[42 FR 19127 at 19132, April 12, 1977]
Subpart B--Requirements for Specific Standardized Frozen Desserts
Sec. 135.110 Ice Cream and frozen custard.
(a) Description. (1) Ice cream is produced by freezing, while
stirring, a pasteurized aerated mix consisting of safe and suitable
milk-derived ingredients alone or in combination; 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. The use of milk and milk products from cows as well
as other milk source animals (e.g., goat, sheep) is permitted. Water
may be added, or water may be removed from the mix. Safe and suitable
non-dairy
[[Page 56414]]
derived ingredients that serve a useful function may be added. Ice
cream is sweetened with safe and suitable sweeteners and may be
characterized by the addition of flavoring ingredients.
(2) Ice cream is a food prepared by the procedures set forth in
paragraph (a) of this section, or by any other procedure which produces
a finished product which has essentially the same physical, chemical
and organoleptic characteristics.
(3) Ice cream contains not less than 1.6 pounds of total solids to
the gallon, and weighs not less than 4.5 pounds to the gallon, except
where the ice cream is a fat reduced ice cream as defined by applicable
sections of Sec. 130.10, reduced fat ice cream shall weigh not less
than 4.0 pounds per gallon. Ice cream contains not less than 10-percent
milkfat, nor less than 2.95 percent milk-derived protein, except that
when it contains milkfat above 10-percent minimum, it may contain the
following milkfat, milk-derived protein levels specified in the table
in this section. The protein to meet the minimum milk-derived protein
requirement shall be provided by milk-derived ingredients, and shall
have a protein efficiency ratio (PER) not less than that of whole milk
protein (108 percent of casein) as determined by the method prescribed
in the most recent edition of AOAC Approved Methods for the following
protein levels.
------------------------------------------------------------------------
Percent Milkfat Minimum Percent Milk-Derived Protein
------------------------------------------------------------------------
10 2.95
------------------------------------------------------------------------
11 2.66
------------------------------------------------------------------------
12 2.36
------------------------------------------------------------------------
13 2.07
------------------------------------------------------------------------
14 1.77
------------------------------------------------------------------------
Except that when one or more bulky flavors are used, the weight of
milkfat is not less than 10-percent of the remainder obtained by
subtracting the weight of the bulky flavors from the weight of the
finished food; but in no case is the weight of milkfat less than 7.5
percent of the weight of the finished food, nor is the milk-derived
protein content less than 1.8 percent of the weight of the finished
food. Except in the case of frozen custard, ice cream contains less
than 1.4 percent egg yolk solids by weight of the food, exclusive of
the weight of any bulky flavoring ingredients used. Frozen custard,
french ice cream or french custard ice cream shall contain at a minimum
1.4 percent egg yolk solids by weight of the finished food: Provided,
however, that when bulky flavors are added the egg yolk solids content
of frozen custard, french ice cream or french custard ice cream may be
reduced in proportion to the amount by weight of the bulky flavors
added, but in no case is the content of egg yolk solids in the finished
food less than 1.12-percent. A product containing egg yolk solids of at
least 1.4 percent, the maximum set forth in this paragraph for ice
cream, may be marketed if labeled as specified by paragraph (c) of this
section.
(4) When calculating the minimum amount of milkfat and milk-derived
protein required in the finished food, the solids of chocolate or cocoa
used shall be considered a bulky flavoring ingredient. In order to make
allowance for additional sweetening ingredients needed when certain
bulky ingredients are used, the weight of chocolate or cocoa solids
used may be multiplied by 2.5; the weight of fruit or nuts used may be
multiplied by 1.4; and the weight of partially or wholly dried fruits
or fruit juices may be multiplied by appropriate factors to obtain the
original weights before drying and this weight may be multiplied by
1.4.
(b) Methods of analysis. (1) The fat content shall be determined by
using the Mojonnier method prescribed in the most current edition of
the ``Official Methods of Analysis of AOAC INTERNATIONAL'' as the
reference method. Copies may be obtained from AOAC INTERNATIONAL, First
Union National Bank Lockbox, PO Box 75198, Baltimore, MD 21275-5198, or
may be examined 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/code_of_federal_regulation/ibr_locations.html.
(2) The protein content shall be determined by one of the following
methods: ``Nitrogen Official Final Action,'' Kjeldahl Method, Section
16.285, or Dye Binding Method, Section 16.286 found in the most current
edition of the ``Official Methods of Analysis of AOAC INTERNATIONAL''
as the reference method.
(3) PER shall be determined by the method: ``Biological Evaluation
of Protein Quality--Official Final Action, sections 43.212-43.216''
found in the most current edition of the ``Official Methods of Analysis
of AOAC INTERNATIONAL'' as the reference method.
(c) Nomenclature. (1) When the food is made exclusively from cows
milk, the name of the food is ``ice cream;'' except that when the egg
yolk solids content of the food is in excess of that specified for ice
cream by paragraph (a) of this section, the name of the food is
``frozen custard'' or ``french ice cream'' or ``French custard ice
cream.'' When the food is made exclusively from the milk of a single
milk source animal other than cows (e.g., goats), the name of the food
is ``----milk ice cream,'' or as appropriate, ``frozen----milk
custard,'' ``french----milk ice cream,'' ``french custard----milk ice
cream'' (the blank being filled in with the name of the milk source
animal, e.g., ``goat's milk ice cream''). When the food is partially
made with milk or milk products from milk source animals other than
cows, the name of the food is accompanied by the phrase ``made with----
milk'' (the blank being filled in with name(s) of all milk source
animals).
(2)(i) If the food contains no artificial flavor, the name on the
principal display panel or panels of the label shall be accompanied by
the common or usual name of the characterizing flavor, e.g.,
``vanilla,'' in letters not less than one-half the height of the
letters used in the words ``ice cream.''
(ii) If the food contains both a natural characterizing flavor and
an artificial flavor simulating it, and if the natural flavor
predominates, the name on the principal display panel or panels of the
label shall be accompanied by the common name of the characterizing
flavor, in letters not less than one-half the height of the letters
used in the
[[Page 56415]]
words ``ice cream,'' followed by the word ``flavored,'' in letters not
less than one-half the height of the letters in the name of the
characterizing flavor, e.g., ``Vanilla flavored,'' or ``Peach
flavored,'' or ``Vanilla flavored and Strawberry flavored.''
(iii) If the food contains both a natural characterizing flavor and
an artificial flavor simulating it, and if the artificial flavor
predominates, or if artificial flavor is used alone the name on the
principal display panel or panels of the label shall be accompanied by
the common name of the characterizing flavor in letters not less than
one-half the height of the letters used in the words ``ice cream,''
preceded by ``artificial'' or ``artificially flavored,'' in letters not
less than one-half the height of the letters in the name of the
charactering flavor, e.g., ``artificial Vanilla,'' or ``artificially
flavored Strawberry'' or ``artificially flavored Vanilla and
artificially flavored Strawberry.''
(3)(i) If the food is subject to the requirements of paragraph
(c)(2)(ii) of this section or if it contains any artificial flavor not
simulating the characterizing flavor, the label shall also bear the
words ``artificial flavor added'' or ``artificial----flavor added,''
the blank being filled with the common name of the flavor simulated by
the artificial flavor in letters of the same size and prominence as the
words that precede and follow it.
(ii) Wherever the name of the characterizing flavor appears on the
label so conspicuously as to be easily seen under customary conditions
of purchase, the words prescribed by this paragraph shall immediately
and conspicuously precede or follow such name, in a size reasonably
related to the prominence of the name of the charactering flavor and in
any event the size of the type is not less than 6-point on packages
containing less than 1 pint, not less than 8-point on packages
containing at least 1 pint by less than one-half gallon, not less than
10-point on packages containing at least one-half gallon by less than 1
gallon, and not less than 12-point on packages containing 1 gallon or
over: Provided, however, that where the characterizing flavor and a
trademark or brand are presented together, other written, printed, or
graphic matter that is a part of or is associated with the trademark or
brand, may intervene if the required words are in such relationship
with the trademark or brand as to be clearly related to the
characterizing flavor: And provided further, that if the finished
product contains more than one flavor of ice cream subject to the
requirements of this paragraph, the statements required by this
paragraph need appear only once in each statement of characterizing
flavors present in such ice cream, e.g., ``Vanilla flavored, Chocolate,
and Strawberry flavored, artificial flavors added.''
(4) If the food contains both a natural characterizing flavor and
an artificial flavor simulating the characterizing flavor, any
reference to the natural characterizing flavor shall, except as
otherwise authorized by this paragraph, be accompanied by a reference
to the artificial flavor, displayed with substantially equal
prominence, e.g., ``strawberry and artificial strawberry flavor.''
(5) An artificial flavor simulating the characterizing flavor shall
be deemed to predominate:
(i) In the case of vanilla beans or vanilla extract used in
combination with vanillin if the amount of vanillin used is greater
than 1 ounce per unit of vanilla constituent, as that term is defined
in Sec. 169.3(c) of this chapter.
(ii) In determining the characterizing flavor of products other
than those in paragraph 5(i) of this section, it shall be incumbent on
the manufacturer to conclude whether the natural or artificial flavor
intensity predominates. The manufacturer shall determine which flavor
is present in the greatest intensity and label the product accordingly.
For example, strawberry ice cream consists of a combination of natural
strawberries and artificial strawberry flavor. If the natural
strawberry component was stronger in flavor intensity it would be
deemed to predominate, and the ice cream would be labeled ``strawberry
flavored.'' If, on the other hand, the artificial strawberry flavor
component was stronger in flavor intensity, the artificial flavor
component would be deemed to predominate, and the ice cream would be
labeled ``artificially flavored strawberry'' or ``artificial
strawberry.''
(iii) In the case of two or more fruits or fruit juices, or nut
meats or both, used in combination with artificial flavors simulating
the natural flavors and dispersed throughout the food, if the quantity
of any fruit or fruit juice or nut meat is not sufficient to
characterize the flavor, the products would be labeled as ``a blend of
artificial and natural fruit and/or nut flavoring.''
(6) If two or more flavors of ice cream are distinctively combined
in one package, e.g., ``Neapolitan'' ice cream, the applicable
provisions of this standard shall govern each flavor of ice cream
comprising the combination.
(7) 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.
(d) 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, except that:
(1) Milk, concentrated milk, evaporated milk, dried milk, filtered
milk in liquid and dried form, may be declared as ``milk.''
(2) Nonfat milk, skim milk, condensed skim milk, evaporated skim
milk, nonfat dried milk, filtered nonfat milk in liquid and dried form
may be declared as ``nonfat milk.''
(3) Buttermilk, sweet cream buttermilk, condensed sweet cream
buttermilk and dried sweet cream buttermilk may be declared as
``buttermilk.''
(4) Cream, whey cream, dried cream, plastic cream (sometimes known
as concentrated milkfat) may be declared as ``cream.''
(5) Butter, butter oil, and anhydrous milk fat may be declared as
``butter fat.''
(6) Milk-derived protein such as casein, whey protein and its
constituents, fractions, hydrolysates or polymers derived from milk,
except filtered milk, may be declared as ``milk proteins.''
(7) Whey, concentrated whey, reconstituted whey and dried whey may
be declared as ``whey.''
(e) Under section 403(k) of the Federal Food, Drug, and Cosmetic
Act, artificial color need not be declared in ice cream, except as
required by Sec. 101.22(c) or (k) of this chapter. Voluntary
declaration of all colors used in ice cream and frozen custard is
recommended.
Sec. 135.140 Sherbet.
(a) Description. (1) Sherbet is produced by freezing, while
stirring, an aerated pasteurized mix consisting of safe and suitable
milk-derived ingredients alone or in combination; and excluding other
food fats, except such as are added in small amounts to accomplish
specific functions or are natural components of flavoring ingredient
used. The use of milk and milk products from cows as well as other milk
source animals (e.g., goat, sheep) is permitted. Water may be added, or
water may be removed from the mix. Safe and suitable non-dairy derived
ingredients may be added that serve a useful function. Sherbet is
sweetened with safe and suitable sweeteners and is characterized by the
addition of one or more of the optional fruit-characterizing
ingredients specified in paragraph (b) of this section or one or more
of the optional nonfruit-characterizing ingredients specified in
paragraph (c) of this section.
[[Page 56416]]
(2) Sherbet is a food prepared by the procedure set forth in
paragraph (a)(3) of this section, or by any other procedure, which
produces a finished product, which has essentially the same physical,
chemical and organoleptic characteristics.
(3) Sherbet weighs not less than 6 pounds to the gallon. The
milkfat content is not less than 1 percent nor more than 2-percent. The
milk-derived protein content is not less than 0.295 percent and not
greater than 1.18 percent in the case of 1 percent milkfat or not
greater than 0.89 percent in the case of 2-percent milkfat.
(b) Optional fruit-characterizing ingredients. The optional fruit-
characterizing ingredients referred to in paragraph (a) of this section
are any mature fruit or the juice of any mature fruit. The fruit or
fruit juice used may be fresh, frozen, canned, concentrated, or
partially or wholly dried. The quantity of fruit ingredients used is
such that, in relation to the weight of the finished sherbet, the
weight of fruit or fruit juice, as the case may be (including water
necessary to reconstitute partially or wholly dried fruits or fruit
juices to their original moisture content), is not less than 2-percent.
For the purpose of this section, tomatoes and rhubarb are considered as
kinds of fruit.
(c) Optional nonfruit characterizing ingredients. Optional nonfruit
characterizing ingredients may be used.
(d) Nomenclature. (1) The name of each sherbet is as follows:
(i) When the food is made exclusively from cows milk, the name of
each fruit sherbet is ``----sherbet,'' the blank being filled in with
the common name of the fruit or fruits from which the fruit ingredients
used are obtained. When the names of two or more fruits are included,
such names shall be arranged in order of predominance, if any, by
weight of the respective fruit ingredients used.
(ii) When the food is made exclusively from cows milk, the name of
each nonfruit sherbet is ``----sherbet,'' the blank being filled in
with the common or usual name or names of the characterizing flavor or
flavors; for example, ``peppermint,'' except that if the characterizing
flavor used is vanilla, the name of the food is ``----sherbet,'' the
blank being filled in as specified by Sec. 135.110(e)(2) and (5)(i).
(iii) When the food is made exclusively from the milk of a single
milk source animal other than cows (e.g., goats), the name of the food
is specified as in paragraphs (d)(1)(i) and (ii) of this section,
except that the phrase ``----milk'' shall immediately precede the word
``sherbet'' (the blank being filled in with the name of the milk source
animal, e.g., ``goat's milk ice cream''). When the food is partially
made with milk or milk products from milk source animals other than
cows, the name of the food is accompanied by the phrase ``made with --
--milk'' (the blank being filled in with the name(s) of all milk source
animals).
(2) When the optional ingredients, artificial flavoring, or
artificial coloring are used in sherbet, they shall be named on the
label as follows:
(i) If the flavoring ingredient or ingredients consists exclusively
of artificial flavoring, the label designation shall be ``artificially
flavored.''
(ii) If the flavoring ingredients are a combination of natural and
artificial flavors, the label designation shall be ``artificial and
natural flavoring added.''
(iii) The label shall designate artificial coloring by the
statement ``artificially colored,'' ``artificial coloring added,''
``with added artificial coloring,'' or ``----, an artificial color
added,'' the blank being filled in with the name of the artificial
coloring used.
(e) Characterizing flavor(s). Wherever there appears on the label
any representation as to the charactering flavor or flavors of the food
and such flavor or flavors consist in whole or in part of artificial
flavoring, the statement required by paragraphs (d)(2)(i) and
(d)(2)(ii) of this section, as appropriate, shall immediately and
conspicuously precede or follow such representation, without
intervening written, printed, or graphic matter (except that the word
``sherbet'' may intervene) in a size reasonably related to the
prominence of the name of the characterizing flavor and in any event
the size of the type is not less than 6-point on packages containing
less than 1 pint, not less than 8-point on packages containing at least
1 pint but less than one-half gallon, not less than 10-point on
packages containing at least one-half gallon but less than 1 gallon,
and not less than 12-point on packages containing 1 gallon or over.
(f) Display of statements required by paragraph (d)(2). Except as
specified in paragraph (e) of this section, the statements required by
paragraph (d)(2) of this section shall be set forth on the principal
display panel or panels of the label with such prominence and
conspicuousness as to render them likely to be read and understood by
the ordinary individual under customary conditions of purchase and use.
(g) Label declaration. Each of the ingredients used shall be
declared on the label as required by the applicable sections of parts
101 and 130 of this chapter.
Sec. 135.160 Water Ices.
(a) Description. Water ices are the foods each of which is prepared
from safe and suitable ingredients and complies with all the provisions
of Sec. 135.140(a)(1) and (a)(2), except that stirring while freezing
or aerating is not required, and the mix need not be pasteurized, and
no milk or milk-derived ingredient and no egg ingredient, other than
egg white, is used.
(b) Optional fruit-characterizing ingredients. The optional fruit-
characterizing ingredients referred to in paragraph (a) of this section
are any mature fruit or the juice of any mature fruit. The fruit or
fruit juice used may be fresh, frozen, canned, concentrated, or
partially or wholly dried. For the purpose of this section, tomatoes
and rhubarb are considered as kinds of fruit.
(c) Optional nonfruit characterizing ingredients. Optional nonfruit
characterizing ingredients may be used.
(d) Nomenclature. The name of the food is ``----ice,'' the blank
being filled in, the same manner as specified in Sec. Sec.
135.140(d)(2)(i) and (ii) and (iii)(e), (f), and (g), as appropriate.
II. Kraft Foods, Inc. (Kraft Foods) Petition
Kraft Foods submitted a citizen petition dated August 28, 2000,
requesting that FDA amend the current standard of identity in part 133
(21 CFR part 133) for parmesan and reggiano cheese (hereinafter
parmesan cheese) (Sec. 133.165). In its petition, Kraft Foods proposed
that the minimum curing time for parmesan cheese be reduced from 10
months to 6 months, by changing the last sentence of Sec. 133.165(a)
from ``[i]t is cured for not less than 10 months'' to ``[i]t is cured
for not less than 6 months.''
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
Kraft Foods' 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.
[[Page 56417]]
A. Grounds for the Suggested Change to the Parmesan Cheese Standard
In the Federal Register of February 21, 1973 (34 FR 4710), FDA
found that reducing the minimum curing time of parmesan cheese from 14
months to 10 months increased productivity, improved product
consistency, and reduced production costs with no material disadvantage
to consumers. Based on these findings, the standard of identity for
parmesan cheese was amended to reduce the required curing time from a
minimum of 14 months to a period of not less than 10 months. According
to Kraft Foods, technology has continued to improve and parmesan cheese
is now able to be produced within a curing period of 6 months. Kraft
Foods submits that consistent with the 1973 findings, FDA should, for
essentially the same reasons, amend the parmesan cheese standard to
reduce its required curing period to not less than 6 months.
In April of 1999, Kraft Foods was issued a temporary marketing
permit (TMP) for market testing its ``100% Grated Parmesan Cheese''
cured for 6 months (64 FR 16743, April 6, 1999). In November of 1999,
FDA issued Sartori Foods Corp. a TMP to market test its 6-month cured
``Grated Parmesan Cheese'' (64 FR 60820, November 8, 1999). On August
28, 2000, Kraft Foods submitted to FDA an application for extension of
its TMP accompanied by a petition to amend the parmesan cheese
standard. As stated in the Federal Register (65 FR 83040, December 29,
2000), an extension was granted to allow for continuous data collection
on consumer acceptance of the products while the agency took action on
the petition to amend the standard.
In its petition, Kraft Foods states that its make procedure
involves the use of an improved enzyme technology but is otherwise
consistent with the make procedure and curing techniques Kraft Foods
has followed for many years. Using commercially-available safe and
suitable enzymes (21 CFR 133.165(b)) and the current make procedure,
Kraft Foods states that it is possible to produce fully-cured parmesan
cheese suitable for grating in 6 months, rather than the 10-month
minimum curing time currently required by the standard of identity.
Kraft Foods states that the modern manufacturing procedures,
commercially-available enzymes, and modern equipment that it uses are
generally available to enable any knowledgeable processor through the
utilization of adequate scientific research and experimentation to
produce parmesan cheese conforming with the standard of identity in the
shorter 6-month curing time.
According to its petition, through periodic evaluation of product,
Kraft Foods determined that parmesan cheese cured for 6 months is
physically and organoleptically equivalent to current parmesan cheese
cured for 10 months. In addition, Kraft Foods conducted organoleptic
evaluations through consumer taste panels that confirmed that the
grated 6-month cured product is considered by consumers to be
equivalent (i.e., in taste, texture and cooking properties) to grated
parmesan cheese currently available to consumers. Kraft Foods also
states that the shortened curing time has no effect on the nutrition
profile of the product.
Although not specifically addressed in its petition, Kraft Foods
briefly addressed the issue of safety in its TMP application. In its
TMP application, Kraft Foods stated that its 6-month cured parmesan
cheese product is ``just as wholesome and nondeleterious as other such
cheeses available to consumers.'' FDA relied on the representations
made in the petitioner's application in approving the TMP, and we
tentatively concluded, at that time, that the shortened time period
would not affect the safety of the product, i.e., there is not a safety
concern.
Kraft Foods states that there is a substantial economic benefit
from reducing the curing time from 10 months to 6 months. Kraft Foods
states that the proposed amendment would reduce the cost of inventory
and reduce losses from damage during the additional 4-month holding
period; therefore, the shorter curing time may also make it possible
for manufacturers to devote some of their production resources to the
manufacture of other cheese products, thereby maximizing the use of
plant resources and increasing production efficiencies. Kraft Foods
also maintains that the substantial curing/holding times required to
produce parmesan cheese effectively mean that the cost of entry into
the parmesan cheese production business is quite high. Kraft Foods
notes that in the long run, reducing the curing time for this product
will significantly reduce the costs of entry into the business, in
turn, creating the opportunity for greater competition, which benefits
consumers, who are best served by a marketplace in which there is more,
rather than less, competition.
B. Matters of Particular Interest to FDA Regarding Kraft Foods'
Petition
FDA requests that interested persons submit data and information
concerning the need for, and the appropriateness of, amending the
standard for parmesan cheese. FDA specifically requests comment on
whether the proposed amendment will affect the basic nature,
organoleptical, safety or physical properties of parmesan cheese. FDA
requests comments, especially from small business, on Kraft Food's
statement that this change will reduce cost barriers to entry into the
marketplace.
C. Kraft Foods Requested Amendment
The requested amendment of the parmesan cheese standard submitted
by Kraft Foods is set forth in the following paragraph:
Sec. 133.165 Parmesan and reggiano cheese.
(a) * * * It is cured for not less than 6 months.
* * * * *
FDA will evaluate the need and appropriateness of the proposed
regulation following the receipt of public comments.
III. 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. 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.
IV. 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: September 16, 2005.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and
Applied Nutrition.
[FR Doc. 05-19194 Filed 9-26-05; 8:45 am]
BILLING CODE 4160-01-S
