Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 56409 

(a) A short account of the progress of 

drug development including a 

description of studies initiated, ongoing, 

and completed, and a short summary of 

the status or results of such studies; 

(b) A description of the 

investigational plan for the coming year, 

as well as any anticipated difficulties in 

development, testing, and marketing; 

and 

(c) A brief discussion of any changes 

that may affect the MUMS-designated 

drug status of the product. For example, 

situations in which testing data 

demonstrate that the proposed intended 

use is inappropriate due to unexpected 

issues of safety or effectiveness. 

§ 516.31 Scope of MUMS-drug exclusive 

marketing rights. 

(a) After conditional approval or 

approval of an application for a MUMSdesignated drug in the dosage form and 

for the intended use for which MUMSdrug designation has been granted, FDA 

will not conditionally approve or 

approve another application or 

abbreviated application for the same 

drug in the same dosage form for the 

same intended use before the expiration 

of 7 years after the date of conditional 

approval or approval as stated in the 

approval letter from FDA, except that 

such an application can be 

conditionally approved or approved 

sooner if, and at such time as, any of the 

following occurs: 

(1) FDA terminates the MUMS-drug 

designation and associated exclusive 

marketing rights under § 516.29; or 

(2) FDA withdraws or proposes to 

withdraw the conditional approval or 

approval of the application for the drug 

for any reason; or 

(3) The sponsor with exclusive 

marketing rights provides written 

consent to FDA to conditionally 

approve or approve another application 

before the expiration of 7 years; or 

(4) The sponsor fails to assure a 

sufficient quantity of the drug in 

accordance with section 573 of the act 

and § 516.36. 

(b) If an application for a MUMS drug 

cannot be approved until the expiration 

of the period of exclusive marketing of 

a MUMS-designated drug, FDA will so 

notify the sponsor in writing. 

§ 516.34 FDA recognition of exclusive 

marketing rights. 

(a) FDA will send the sponsor (or the 

permanent-resident U.S. agent, if 

applicable) timely written notice 

recognizing exclusive marketing rights 

when an application for a MUMSdesignated drug has been conditionally 

approved or approved. The written 

notice will inform the sponsor of the 

requirements for maintaining MUMSdesignated drug exclusive marketing 

rights for the full 7-year term. This 

notice will generally be contained in the 

letter conditionally approving or 

approving the application. 

(b) When an application is 

conditionally approved or approved for 

a MUMS-designated drug that qualifies 

for exclusive marketing rights, FDA will 

publish this information in the Federal 

Register at the time of the conditional 

approval or approval. This notice will 

generally be contained in the notice of 

conditional approval or approval of the 

application. 

§ 516.36 Insufficient quantities of MUMSdesignated drugs. 

(a) Under section 573 of the act, 

whenever the FDA has reason to believe 

that sufficient quantities of a 

conditionally-approved or approved, 

MUMS-designated drug to meet the 

needs for which the drug was 

designated cannot be assured by the 

sponsor, the FDA will so notify the 

sponsor of this possible insufficiency 

and will offer the sponsor the following 

options, one of which must be exercised 

by a time that FDA specifies: 

(1) Provide FDA information and data 

regarding how the sponsor can assure 

the availability of sufficient quantities of 

the MUMS-designated drug within a 

reasonable time to meet the needs for 

which the drug was designated; or 

(2) Provide FDA in writing the 

sponsor’s consent for the conditional 

approval or approval of other 

applications for the same drug before 

the expiration of the 7-year period of 

exclusive marketing rights. 

(b) If, within the time that FDA 

specifies, the sponsor fails to consent to 

the conditional approval or approval of 

other applications and if FDA finds that 

the sponsor has not shown that it can 

assure the availability of sufficient 

quantities of the MUMS-designated drug 

to meet the needs for which the drug 

was designated, FDA will issue a 

written order terminating designation of 

the MUMS drug and the associated 

exclusive marketing rights. This order 

will state FDA’s findings and 

conclusions and will constitute final 

agency action. An order terminating 

designation and associated exclusive 

marketing rights may issue whether or 

not there are other sponsors that can 

assure the availability of alternative 

sources of supply. Such an order will 

not withdraw the conditional approval 

or approval of an application. Once 

terminated under this section, neither 

designation, nor exclusive marketing 

rights may be reinstated. 

§ 516.52 Availability for public disclosure 

of data and information in requests. 

(a) FDA will not publicly disclose the 

existence of a request for MUMS-drug 

designation under section 573 of the act 

prior to final FDA action on the request 

unless the existence of the request has 

been previously publicly disclosed or 

acknowledged. 

(b) Whether or not the existence of a 

pending request for designation has 

been publicly disclosed or 

acknowledged, no data or information 

in the request are available for public 

disclosure prior to final FDA action on 

the request. 

(c) Except as provided in paragraph 

(d) of this section, upon final FDA 

action on a request for designation, the 

public availability of data and 

information in the request will be 

determined in accordance with part 20 

of this chapter and other applicable 

statutes and regulations. 

(d) In accordance with § 516.28, FDA 

will make a cumulative list of all 

MUMS-drug designations available to 

the public and update such list 

periodically. In accordance with 

§ 516.29, FDA will give public notice of 

the termination of all MUMS-drug 

designations. 

Subpart C—[Reserved] 

Subpart D—[Reserved] 

Dated: August 31, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–19196 Filed 9–26–05; 8:45 am] 

BILLING CODE 4160–01–S 

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. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that the following two petitions have 

56410 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 

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: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• 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: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. 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 Ferre ́-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 (§ 135.115) and mellorine 

(§ 135.130), amend the current standard 

of identity for ice cream and frozen 

custard (§ 135.110), amend the standard 

of identity for sherbet (§ 135.140), and 

amend the standard of identity for water 

ices (§ 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) milkderived 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 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 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 dairyderived 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 milkderived 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. 

56412 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 

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 milkderived 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 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 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 

§ 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 °F 30 min. 

175 °F 25 sec. 

180 °F 15 sec. 

191 °F 1 sec. 

204 °F 0.05 sec. 

212 °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 °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 

§ 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 

56414 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 

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 § 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 milkderived 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 milkderived 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 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 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 § 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 § 101.22(c) or (k) 

of this chapter. Voluntary declaration of 

all colors used in ice cream and frozen 

custard is recommended. 

§ 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 nonfruitcharacterizing ingredients specified in 

paragraph (c) of this section. 

56416 Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 

(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 fruitcharacterizing 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 

§ 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. 

§ 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 

§ 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 milkderived ingredient and no egg 

ingredient, other than egg white, is 

used. 

(b) Optional fruit-characterizing 

ingredients. The optional fruitcharacterizing 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 

§§ 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) 

(§ 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 § 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. 

Federal Register / Vol. 70, No. 186 / Tuesday, September 27, 2005 / Proposed Rules 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: 

§ 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