[Federal Register Volume 70, Number 186 (Tuesday, September 27, 2005)]
[Proposed Rules]
[Pages 56409-56417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19194]


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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