This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

71041 

Vol. 70, No. 226 

Friday, November 25, 2005 

1The requirements in section 403(r)(2) of the act, 

for all nutrient content claims, apply to foods and 

food labeling unless an exemption applies for the 

food or the claim under section 403(r)(2) of the act, 

another section of the act, or FDA regulations. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. 2004P–0183] 

Food Labeling: Nutrient Content 

Claims, Expansion of the Nutrient 

Content Claim ‘‘Lean’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its food labeling regulations for 

the expanded use of the nutrient content 

claim ‘‘lean’’ on the labels of foods 

categorized as ‘‘mixed dishes not 

measurable with a cup’’ that meet 

certain criteria for total fat, saturated fat, 

and cholesterol content. This proposal 

responds to a nutrient content claim 

petition submitted by Nestle ́ Prepared 

Foods Co. (Nestle ́) under the Federal 

Food, Drug, and Cosmetic Act (the act). 

This action also is being taken to 

provide reliable information that would 

assist consumers in maintaining healthy 

dietary practices. 

DATES: Submit written or electronic 

comments by February 8, 2006. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2004P–0183, 

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 number 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 

additional information on submitting 

comments, 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, 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: 

Vincent de Jesus, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1774. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Petitions and Grounds 

III. Proposed Action 

A. Need for Regulations 

B. Proposed Amendments 

IV. Preliminary Regulatory Impact 

Analysis 

A. Need for Regulation 

B. Regulatory Options 

C. Benefits 

D. Costs 

V. Regulatory Flexibility Analysis 

VI. Unfunded Mandates 

VII. Federalism 

VIII. Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Comments 

XI. References 

I. Background 

On November 8, 1990, President 

George H.W. Bush signed into law the 

Nutrition Labeling and Education Act of 

1990 (the 1990 amendments) (Public 

Law 101–535), which amended the 

Federal Food, Drug, and Cosmetic Act 

(the act). Section 403(r)(1)(A) of the act 

(21 U.S.C. 343(r)(1)(A)), which was 

added by the 1990 amendments, states 

that a food is misbranded if it is 

intended for human consumption which 

is offered for sale and for which a claim 

is made in its label or labeling that 

expressly or implicitly characterizes the 

level of any nutrient of the type required 

to be declared in nutrition labeling, 

unless such claim uses terms defined in 

regulations by FDA under section 

403(r)(2)(A) of the act.1 In 1993, FDA 

established regulations that 

implemented the 1990 amendments (58 

FR 2066 through 2941, January 6, 1993). 

Among these regulations, § 101.13 (21 

CFR 101.13) sets forth general principles 

for nutrient content claims (see 58 FR 

2302, January 6, 1993). Other sections in 

part 101, subpart D (21 CFR part 101, 

subpart D), define specific nutrient 

content claims, such as ‘‘free,’’ ‘‘low,’’ 

‘‘reduced,’’ ‘‘light,’’ ‘‘good source,’’ 

‘‘high,’’ and ‘‘more,’’ for a variety of 

nutrients and include several synonyms 

for each of the defined terms. In 

addition, § 101.69 outlines the 

procedures for petitioning the agency to 

authorize additional nutrient content 

claims. 

In the 1991 proposed rule for 

‘‘Nutrient Content Claims, General 

Principles, Petitions, Definition of 

Terms’’ (the general principles proposal) 

(56 FR 60421, November 27, 1991), FDA 

did not include a definition for ‘‘lean.’’ 

However, in the same issue of the 

Federal Register, the Food Safety and 

Inspection Service (FSIS) of the U.S. 

Department of Agriculture (USDA) 

issued a proposed rule that included a 

definition for ‘‘lean’’ for labeling 

individual foods and meal-type 

products (a collective term used for 

meal and main dish products) 

71042 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

2USDA also defined ‘‘extra lean,’’ which FDA 

later defined by regulation, in addition to ‘‘lean.’’

However, Nestle ́ did not request a definition for 

‘‘extra lean’’ in its petition. 

3Specifically, in order to be eligible to bear a 

claim, seafood and game meat products must 

contain less than 10 grams (g) total fat, 4.5 g or less 

of saturated fat, and less than 95 milligrams (mg) 

cholesterol per reference amount customarily 

consumed (RACC) and per 100 g, and for meals and 

main dishes, per 100 g and per labeled serving. 

4 If the ‘‘mixed dish not measurable with a cup’’

food were packaged in a way such that it met all 

of the requirements for a main dish, as specified in 

§ 101.13(m), it could be considered a ‘‘main dish’’

and would be eligible to bear a ‘‘lean’’ claim under 

FDA’s current regulations. 

containing meat and poultry (56 FR 

60302, November 27, 1991).2 After 

evaluating the comments to the general 

principles proposal, FDA determined 

that seafood, game meat, meal products, 

and main dish products that it regulated 

had a contribution to the diet that was 

similar to the USDA-regulated products 

and that FDA should establish a 

definition for ‘‘lean’’ for such products. 

Consequently, FDA defined ‘‘lean’’ for 

seafood, game meat, meal, and main 

dish products (§ 101.62(e)) in the final 

rule for nutrient content claims (58 FR 

2302) using the same criteria that USDA 

used in its final rule for the ‘‘lean’’

claim (58 FR 632, January 6, 1993).3

FDA’s definition of ‘‘lean’’ includes 

flesh foods, such as seafood and game 

meat products, which are foods that are 

similar to USDA-regulated meat and 

poultry products, and also includes 

meal-type products (i.e., main dishes 

and meal products) which are included 

in the USDA definition. FDA’s 

definition of ‘‘lean,’’ however, does not 

extend to other individual foods 

including ‘‘mixed dishes not measurable 

with a cup.’’ Such dishes, e.g., burritos, 

egg rolls, enchiladas, pizza, quiches, 

and sandwiches, are generally similar to 

the foods subject to the definition of 

‘‘main dish’’ (§ 101.13(m)) but do not 

meet the weight criterion for ‘‘main 

dish’’ foods (6 ounces (oz) per labeled 

serving). The reference amount 

customarily consumed (RACC) for 

‘‘mixed dishes not measurable with a 

cup’’ is 140 grams (g) (5 oz) (§ 101.12(b), 

table 2), which is 1 oz less than the 6 

oz per labeled serving required to 

qualify as a ‘‘main dish.’’4 Thus, food 

products that are categorized as ‘‘mixed 

dishes not measurable with a cup’’ and 

that weigh less than 6 oz are not eligible 

to bear a ‘‘lean’’ nutrient content claim 

under § 101.62(e). 

FDA has authority to define the 

nutrient content claim ‘‘lean’’ for foods 

categorized as ‘‘mixed dishes not 

measurable with a cup.’’ FDA may take 

this action under section 403(r) of the 

act. FDA, by regulation, may define 

terms to be used for nutrient content 

claims that characterize the level of total 

fat, saturated fat, and cholesterol in 

these foods. Section 403(r) of the act 

authorizes the agency to issue 

regulations defining terms for use in 

nutrient content claims and establishes 

a process through which a person can 

petition the agency to define terms to 

characterize the level of a nutrient for 

use in a nutrient content claim (see 

section 403(r)(2)(A)(i) and (r)(4) of the 

act). Section 403(r)(1)(A) of the act states 

that a food is misbranded if it bears a 

claim that characterizes the level of a 

nutrient of the type required to be in 

nutrition labeling unless the claim uses 

terms which are defined in FDA 

regulations adopted under section 

403(r)(2) of the act. The proposed rule, 

if finalized as proposed, will define the 

term ‘‘lean’’ for use on ‘‘mixed dishes 

not measurable with a cup’’ that are 

regulated by FDA and that meet the 

criteria in the rule for total fat, saturated 

fat, and cholesterol. 

II. Petitions and Grounds 

FDA received a nutrient content claim 

petition from Nestle ́ (Docket No. 2004P–

0183) (Ref. 1) requesting that the agency 

amend the nutrient content claim 

regulation for ‘‘lean’’ (§ 101.62(e)) to 

include ‘‘mixed dishes not measurable 

with a cup’’ as defined in the ‘‘reference 

amounts customarily consumed per 

eating occasion’’ regulation (§ 101.12), 

based on certain qualifying criteria for 

total fat, saturated fat, and cholesterol. 

Nestle ́ submitted the petition on January 

9, 2004, under section 403(r)(4) of the 

act and § 101.69. In accordance with 

section 403(r)(4)(A)(i) of the act and 

§ 101.69(m)(3), FDA filed the Nestle ́

petition on April 22, 2004. This 

proposed rule responds to Nestle ́’s 

request that FDA define the term ‘‘lean’’

for ‘‘mixed dishes not measurable by a 

cup.’’

In its petition, Nestle ́ contended that 

American eating habits have changed 

significantly since FDA authorized the 

‘‘lean’’ claim in 1993. Nestle ́ argued 

that, in the past decade, convenience 

has been an emerging theme with 

consumers and cited market research 

studies by NPD Group showing that the 

percentage of meals that are completely 

homemade has decreased, while the use 

of ready-to-eat and frozen foods has 

steadily risen. Nestle ́ also cited a 2003 

survey by the market research group 

Information Resources, Inc. (IRI), in 

which consumers identify ‘‘speed/ease 

of preparation’’ as the most important 

factor in their food choices and assert 

that this is even more important than 

price. Nestle ́ presented additional data 

from IRI and NPD Group showing that 

consumers are eating fewer complete 

traditional meals, eating more snacks, 

and spending less time preparing meals 

at home. Nestle ́ also suggested that 

consumers are more interested in 

nutrition and healthy foods, as 

evidenced by an increased consumer 

demand for nutritious food selections. 

Nestle ́ cited surveys by the Natural 

Marketing Institute (NMI) in which twothirds of Americans indicate they are 

eating healthier than they used to and 

that one-third of Americans choose food 

primarily based on nutritional content. 

One of the surveys indicated that 54 

percent of adults read nutrition labels 

most or all of the time. 

Furthermore, Nestle ́ cited a trend in 

substantially increased portion sizes 

over the past 30 years, as determined by 

USDA data from the Nationwide Food 

Consumption Survey and the 

Continuing Survey of Food Intake by 

Individuals. This trend, they said, is 

demonstrated by the increase in sizes of 

food items such as cheeseburgers, 

increasing from 5.8 oz to 7.2 oz, and 

salty snacks, increasing from 1.0 oz to 

1.6 oz, between 1977 and 1996. Nestle ́

suggests that allowing a ‘‘lean’’ nutrient 

content claim on foods in the category 

of ‘‘mixed dishes not measurable with a 

cup’’ that have smaller portion sizes 

than many other food alternatives 

would provide consumers with readily 

recognizable healthful alternatives to 

other foods with larger portion sizes. 

Nestle ́ argued that manufacturers who 

want to encourage portion control by 

marketing healthier food options with 

smaller portion sizes are hindered by 

the current FDA regulations limiting the 

‘‘lean’’ nutrient content claim to 

seafood, game meat, main dish, and 

meal products. These regulations do not 

allow for foods that may be similar to 

main dish and meal products but with 

slightly smaller portion sizes (e.g., 

‘‘mixed dishes not measurable with a 

cup’’) to have a ‘‘lean’’ claim. Because 

of this, Nestle ́ believes that the number 

of healthy, portable food options 

available to consumers has been limited. 

The FDA regulations, Nestle ́ stated, 

have acted as an impediment for 

consumers to choose healthy foods that 

are similar to meal-type products but, 

because of their smaller portion sizes, 

do not qualify as meal-type products 

that are eligible for the ‘‘lean’’ nutrient 

content claim. Nestle ́ asserted that these 

trends of convenience and healthier 

eating call for an expansion of the 

‘‘lean’’ definition to include foods 

identified as ‘‘mixed dishes not 

measurable with a cup’’ and also that 

this expansion may offer consumers 

healthy food options that do not have 

increasingly larger portion sizes. 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71043 

5Nestle ́ refers to the IOM AMDRs for current 

dietary recommendations (see Attachment 20 of the 

petition (Ref. 1)). The AMDR for total fat intake is 

between 20 and 35 percent of calories for adults. 

This range also corresponds to the 

recommendations provided in the 2005 Dietary 

Guidelines for Americans (Ref. 2). Nestle ́ noted that 

the midpoint is 27.5 percent and rounds this 

number up to 30 percent. This value of 30 percent 

is consistent with the current DRV for fat 

established by FDA. 

6Nestle ́ refers to the dietary recommendation 

provided by the NIH, NHLBI, National Cholesterol 

Education Program (see Attachment 25 of the 

petition (Ref. 1)). 

In its petition, Nestle ́ also pointed out 

the lack of consistency between FDA 

and USDA regulations regarding the 

claim ‘‘lean.’’ Nestle ́ stated that USDAregulated individual foods and mealtype products, which contain meat and 

poultry, are permitted to bear the ‘‘lean’’

claim under USDA regulations (9 CFR 

317.362(e) and 381.462(e), respectively). 

Nestle ́ noted that, unlike FDA, USDA 

does not limit the use of the ‘‘lean’’

claim to specific individual foods. Thus, 

any meat or poultry product subject to 

USDA regulation, including those that 

are similar to foods in FDA’s category of 

‘‘mixed dishes not measurable with a 

cup’’ category and that meet the USDA 

nutrient requirements, may bear the 

‘‘lean’’ claim. Nestle ́ asserted that, 

although there is a distinction between 

the types of foods regulated by the 

USDA and FDA, consumers are unlikely 

to be aware of such a distinction. 

Therefore, Nestle ́ stated that there 

should be some consistency across the 

requirements for nutrient content 

claims. It contended that an amended 

definition for ‘‘lean’’ for use on ‘‘mixed 

dishes not measurable with a cup’’

would reduce the disparity between 

FDA and USDA regulations. Nestle ́ also 

stated that the expansion of the ‘‘lean’’

claim advances the FDA ‘‘Initiative on 

Consumer Health Information for Better 

Nutrition’’ by contributing to the goal of 

making sure that consumers have access 

to the latest information when making 

decisions about their diet. 

To accomplish the request to include 

‘‘mixed dishes not measurable with a 

cup’’ in an amended definition of 

‘‘lean’’ in § 101.62(e), Nestle ́ suggested 

two different possible methods for 

determining the criteria that could 

apply for the total fat, saturated fat, and 

cholesterol content of such dishes 

eligible to bear the claim. For each of 

these methods, Nestle ́ took into 

consideration the reference intakes for 

fat for adults and for children that were 

established by the Institute of Medicine 

(IOM) of the National Academies, i.e., 

acceptable macronutrient distribution 

ranges of 20 to 35 percent of energy 

intake from fat for adults and 25 to 40 

percent intake from fat for children 

(IOM, Dietary Reference Intakes for 

Energy, Carbohydrate, Fiber, Fat, Fatty 

Acids, Cholesterol, Protein, and Amino 

Acids, 2002). Nestle ́ also considered the 

FDA-established daily reference value 

(DRV) for total fat of 65 g, which is 

based on a reference caloric intake of 

2,000 calories, that is used in nutrition 

labeling (§ 101.9(c)(9)). With regard to 

saturated fat and cholesterol, Nestle ́

considered the IOM’s recommendation 

‘‘that saturated fatty acids * * * and 

cholesterol consumption be as low as 

possible while consuming a 

nutritionally adequate diet,’’ as well as 

the FDA-established DRV for saturated 

fatty acids of 20 g and the DRV for 

cholesterol of 300 mg, based on a 

reference caloric intake of 2,000 

calories, that is used in nutrition 

labeling (§ 101.9(c)(9)). 

The first possible method suggested 

by Nestle ́ uses the existing ‘‘lean’’

nutrient criteria for main dishes as the 

basis of the definition. Nestle ́ proposes 

new criteria for total fat, saturated fat, 

and cholesterol based on the percentage 

of the proportion of an estimated weight 

for ‘‘mixed dishes not measurable with 

a cup’’ and the minimum weight of a 

main dish product that is eligible for a 

‘‘lean’’ claim. In short, Nestle ́ stated that 

the reduction in the nutrient criteria 

would be in proportion to the reduction 

in weight between the average weight of 

‘‘mixed dishes not measurable with a 

cup,’’ which is 132.53 g in their 

estimation, and the minimum weight of 

a meal-type product, which is 6 oz 

(170.1 g). The percentage of the 

proportion of these weights (132.53 g / 

170.1 g x 100) equals 0.78 or 78 percent. 

Seventy-eight percent of the current 

nutrient criterion value for fat (10 g fat 

multiplied by 78 percent) would result 

in nutrient value of 7.8 g fat. Seventyeight percent of the current nutrient 

criterion value for saturated fat (4.5 g sat 

fat multiplied by 78 percent) equals 3.5 

g saturated fat. Seventy-eight percent of 

the current nutrient criterion value for 

cholesterol (95 milligrams (mg) 

cholesterol multiplied by 78 percent) 

equals 74.1 mg cholesterol. This would 

translate into unrounded criteria for 

‘‘lean’’ for ‘‘mixed dishes not 

measurable by a cup’’ of: 7.8 g total fat, 

3.5 g saturated fat, and 74.1 mg 

cholesterol. Nestle ́ applied these criteria 

on a per-RACC basis. Nestle ́ stated that 

the foods in this category play a smaller 

role in the diet compared to meal-type 

products and believed that the more 

restrictive ‘‘lean’’ criteria in its petition 

were appropriate. The RACC for ‘‘mixed 

dishes not measurable with a cup’’ is 

140 g. Thus, the practical effect of 

applying Nestle ́’s suggested nutrient 

criteria on a per-RACC basis makes the 

levels more restrictive (proportionally) 

for ‘‘mixed dishes not measurable with 

a cup’’ than for main dishes. For 

example, the 7.8 g total fat per 140 g 

would be equivalent, proportionally, to 

5.6 g fat per 100 g. The current main 

dish total fat criterion is 10 g per 100 g 

and per labeled serving. 

The second possible method 

suggested by Nestle ́ would determine 

the nutrient criteria for ‘‘lean’’ according 

to Nestle ́’s estimated calorie 

contribution of ‘‘mixed dishes not 

measurable with a cup’’ in the total diet. 

Nestle ́ looked at 34 grocery store-bought 

food items categorized as ‘‘mixed dishes 

not measurable with a cup’’ and 

determined that the average number of 

calories per 100 g was 214.41 calories. 

Taking the current dietary 

recommendation of 30 percent5 of 

calories from fat, Nestle ́ established that 

30 percent of calories from fat in ‘‘mixed 

dishes not measurable with a cup’’

(214.41 calories multiplied 30 percent) 

would equal 64.32 calories per 100 g 

from fat. The calories from fat converted 

to grams of fat (64.32 calories from fat 

/ 9 calories of fat per g) would equal 

7.15 g of fat per 100 g. Following the 

same calculation for determining total 

fat, 10 percent of calories from saturated 

fat6 (214.41 calories multiplied by 10 

percent) equals 21.441 calories per 100 

g and converted to saturated fat grams 

(21.441 calories / 9 calories saturated fat 

per g) equals 2.382 g saturated fat per 

100 g. There are no cholesterol intake 

guideline criteria expressed as a 

percentage of calories comparable to the 

fat and saturated fat guidelines, thus, 

the cholesterol criteria would be derived 

from the current main dish criteria in 

the same way described in the first 

method, which equaled 74.1 mg 

cholesterol. This would translate into 

criteria for ‘‘lean’’ for ‘‘mixed dishes not 

measurable by a cup’’ as follows: 7.15 g 

total fat (7 g rounded), 2.382 g saturated 

fat (2.5 g rounded), and 74.1 mg 

cholesterol (75 mg rounded). Although 

Nestle ́ calculated the criteria using this 

method on a per-100 g basis, Nestle ́

applied the criteria for purposes of 

determining eligibility of foods to bear 

the ‘‘lean’’ claim on a per-RACC basis. 

The criteria are proportionally more 

restrictive for ‘‘mixed dishes not 

measurable with a cup’’ than for main 

dishes, and slightly more restrictive 

than the other method Nestle ́ set forth 

in its petition. For this method, 7 g total 

fat per 140 g would be equivalent, 

proportionally, to 5 g fat per 100 g. 

71044 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

7ACNielsen Syndicated Data, see Attachment 7 of 

the petition (Ref. 1). 

III. Proposed Action 

A. Need for Regulations 

As stated earlier, in the proposed rule 

for nutrition labeling (56 FR 60302, 

November 27, 1991), FSIS proposed the 

‘‘lean’’ claim for meat and poultry 

products. Because all the products that 

USDA regulates with regard to nutrition 

labeling consist in whole or in part of 

meat and poultry (with certain 

exceptions for some egg products), 

USDA permits use of the term ‘‘lean’’

across the spectrum of foods whose 

nutrition labeling it regulates (provided 

they meet the nutrient requirements for 

the claim). FDA adopted a regulation 

similar to the FSIS regulation for the 

nutrient content claim ‘‘lean’’ for use on 

seafood, game meat, meal products, and 

main dish products (§ 101.62(e)). The 

current FDA regulations do not allow 

for use of the claim ‘‘lean’’ on ‘‘mixed 

dishes not measurable with a cup’’

because they are considered individual 

foods for which there is no ‘‘lean’’

definition other than for seafood and 

game meat. Moreover, the FDA 

regulations do not allow for the use of 

the claim ‘‘lean’’ on a food in the 

category of ‘‘mixed dishes not 

measurable with a cup’’ when the 

product as packaged does not meet the 

minimum weight criterion to qualify as 

a ‘‘main dish.’’ The current FDA 

regulations thus prohibit a manufacturer 

from labeling FDA-regulated ‘‘mixed 

dishes not measurable with a cup’’ with 

a ‘‘lean’’ claim, while manufacturers are 

able to use the claim on such foods that 

are regulated by USDA. For example, a 

food such as a starch based wrap, with 

chicken, broccoli, and cheddar cheese 

that is subject to USDA regulation, is 

able to bear a ‘‘lean’’ claim under USDA 

regulations, but a similar wrap with just 

broccoli and cheese and without 

chicken, that would not be subject to 

USDA regulation, could not bear a 

‘‘lean’’ claim under current FDA 

regulations. 

FDA has reviewed Nestle ́’s petition 

and appreciates its concerns about the 

differences between current FDA and 

USDA regulations as to the eligibility for 

a ‘‘lean’’ nutrient content claim for 

foods in the category of ‘‘mixed dishes 

not measurable with a cup.’’ In the 

nutrient content claims final rule (58 FR 

2302 at 2343), in providing a definition 

for the term ‘‘lean’’ for seafood and 

game meat and meal-type products, the 

agency stated that such a definition 

would enable consumers to compare the 

nutritional values of products that may 

serve as substitutes for one another in 

creating a balanced diet. Because of the 

requirement in § 101.13(m) that, among 

other things, products must weigh a 

minimum of 6 oz in order to be 

considered main dish products, and that 

by current regulation only seafood and 

game meat and meals and main dish 

products may bear the ‘‘lean’’ claim, 

FDA acknowledges that a whole group 

of products (namely ‘‘mixed dishes not 

measurable with a cup’’) may be 

prohibited from bearing the ‘‘lean’’

claim because of the prohibition on 

using the claim on individual foods 

other than seafood and game meat that 

do not meet the criteria for main dishes, 

including the 6 oz weight criterion. 

FDA acknowledges Nestle ́’s argument, 

as demonstrated by the data submitted 

in the petition, that these types of 

products, which include egg rolls, 

burritos, and other handheld sandwichlike products, have found their way into 

the American diet and serve as a 

convenient ‘‘meals-on-the-go’’ eating 

option that is consistent with America’s 

changing lifestyle. They provide a ‘‘heat 

and eat,’’ no-utensils-required, 

alternative to other types of food 

products. As market research by 

ACNielsen Syndicated Data indicates,7

the sandwiches/snacks category has 

seen significant growth in the past 5 

years, with a 43-percent increase in 

dollar sales since 1999. As such, this 

category has become a well established 

product category that consumers have 

come to rely on. 

FDA also acknowledges Nestle ́’s 

arguments that there is a growing 

interest in healthful alternatives to 

traditional food options, including 

vegetarian alternatives. This interest is 

demonstrated by a 30-percent increase 

in sales in the past year, according to 

ACNielsen, in the ‘‘Frozen Sandwich 

and Snack, Nutrition category’’ and 

even by the increasing markets for 

‘‘meal-replacement bars’’ and ‘‘liquid 

meal-replacements.’’ Although not 

included in the ‘‘mixed dishes not 

measurable with a cup’’ category of 

foods, the increasing markets for the 

meal-replacement bars and liquid mealreplacement foods support the trend of 

Americans choosing more portable 

foods, especially foods that consumers 

consider healthful alternatives. 

In evaluating the information that 

Nestle ́ presented in its petition, FDA 

acknowledges that portable food 

products, particularly those that are 

nutrient (i.e., fat, saturated fat, and 

cholesterol) and portion controlled, 

serve a useful purpose in assisting 

consumers in selecting a diet that is 

consistent with current dietary 

recommendations (i.e., IOM acceptable 

macronutrient distribution ranges, DRVs 

established by FDA, and the 2005 

Dietary Guidelines for Americans). 

The agency has tentatively concluded 

that providing for a ‘‘lean’’ claim on 

‘‘mixed dishes not measurable with a 

cup’’ will provide consumers with a 

means to distinguish, in this well 

established category, among the variety 

of portion controlled products so that 

they may select those products that are 

limited in fat, saturated fat, and 

cholesterol as opposed to their ‘‘full fat’’

alternatives. The agency acknowledges 

the potential that ‘‘mixed dishes not 

measurable with a cup’’ that are eligible 

to bear a ‘‘lean’’ claim offer in delivering 

a convenient food that can provide 

nutritional benefits and help improve 

the quality of Americans’ diets. 

In its petition, Nestle ́ suggested that 

by allowing ‘‘mixed dishes not 

measurable with a cup’’ to bear a ‘‘lean’’

claim, these products would provide a 

way of addressing ever-expanding 

portion sizes and the accompanying 

increase in caloric levels by allowing 

manufacturers to encourage portion 

control by marketing healthier food 

options with smaller portion sizes. 

Nestle ́ suggested that this category of 

product will offer more choices to 

consumers looking for healthful foods 

with small portion sizes. More healthful 

food choices in this category may 

encourage the consumption of small 

portions and thus aid in addressing the 

problem of excess calorie intake. 

As opposed to frozen entrees that 

qualify as meal-type products which are 

limited in size with the entire package 

and contain as few as 6 oz, however, 

many ‘‘mixed dishes not measurable by 

a cup’’ are packaged two to a package, 

or about 10 oz per package. 

Consequently, the agency is concerned 

that rather than eating just one of the 

portions provided, thus limiting portion 

size, consumers may instead consume 

the entire package, thus doubling their 

caloric and nutrient intake as opposed 

to lowering it. The agency particularly 

seeks information and data, as 

comments to this proposed rule, about 

whether consumers may eat an entire 

package of these multi-pack ‘‘mixed 

dishes not measurable with a cup’’ that 

may result in excess calorie intake, 

rather than improved portion control of 

healthier food options that is a desired 

outcome of this proposed rule, if 

finalized as proposed. 

The agency has tentatively concluded 

that providing a ‘‘lean’’ definition for 

‘‘mixed dishes not measurable with a 

cup’’ will provide more consistency 

with similar USDA products and help 

consumers construct a diet that is 

consistent with current dietary 

recommendations (i.e., keeping dietary 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71045 

intake of total fat, saturated fat, and 

cholesterol limited). Therefore, as 

discussed in the following section, the 

agency is proposing such a definition. 

B. Proposed Amendments 

In proposing a definition for the use 

of the nutrient content claim ‘‘lean’’ by 

eligible foods classified as ‘‘mixed 

dishes not measurable with cup,’’ the 

agency considered the following 

options: (1) Require the existing FDA 

nutrient requirements used by other 

FDA-regulated foods that are eligible for 

a ‘‘lean’’ claim, such as meal-type 

products; (2) require the existing USDA 

requirements for individual foods that 

are eligible to bear a ‘‘lean’’ claim (such 

foods would include foods in the 

‘‘mixed dishes not measurable with a 

cup’’ category); (3) require either of the 

two methods for determining nutrient 

values proposed by the petitioner; or (4) 

require new nutrient requirements for 

‘‘mixed dishes not measurable with a 

cup.’’

In evaluating the various options, 

FDA considered whether it was 

appropriate to apply the nutrient criteria 

to only the RACC for ‘‘mixed dishes not 

measurable with a cup’’ and not to both 

the RACC and per 100 g as is currently 

used for seafood and game meat. Foods 

in the ‘‘mixed dish not measurable with 

a cup’’ category have a single RACC. 

Foods considered ‘‘seafood’’ or ‘‘game 

meat’’ have multiple RACCs that differ 

depending on their use. The 

requirements for a ‘‘lean’’ claim for 

seafood or game meat are on a per-RACC 

and per-100 g basis. The use of the 100 

g basis, in addition to the per-RACC 

basis, prevents some of the 

inconsistency that could occur within 

an entire category of products with 

multiple RACCs (i.e., canned fish with 

a 55 g RACC and a fish entre ́e that has 

a much larger 140 g RACC do not end 

up with the same exact nutrient 

requirements). The ‘‘mixed dish not 

measurable with a cup’’ category of 

individual foods, however, has only one 

RACC and does not need to have an 

additional 100 g basis requirement to 

insure consistency of application. Thus, 

the agency tentatively concludes that 

the requirements for a ‘‘lean’’ claim for 

foods considered ‘‘mixed dishes not 

measurable with a cup’’ will need to be 

based on a per-RACC basis only. 

The agency first considered the 

options of requiring the existing 

nutrient requirements for other FDAregulated foods that are eligible to bear 

the ‘‘lean’’ claim and the USDA nutrient 

requirements for a ‘‘lean’’ claim for 

individual foods. The agency decided 

not to propose these options. The 

current nutrient criteria for these 

options are less than 10 g fat, 4.5 g or 

less saturated fat, and less than 95 mg 

of cholesterol per RACC and per 100 g 

for seafood and game meat or for mealtype products, per 100 g and per labeled 

serving. As explained in the following 

paragraphs, the agency determined that 

it would be appropriate to consider 

nutrient criteria that differ from the 

current requirements. In addition, when 

establishing nutrient criteria for the 

category of ‘‘mixed dishes not 

measurable with a cup’’ that are eligible 

to bear the ‘‘lean’’ claim, the agency 

determined that it would only apply the 

nutrient criteria to the RACC (140 g) and 

not to both the RACC and per 100 g as 

it does for the individual foods (seafood 

and game meat) currently eligible to 

bear the ‘‘lean’’ claim. Further, when 

applying the current nutrient criteria to 

the RACC of 140 g, the agency 

determined that the nutrient criteria for 

fat, saturated fat, and cholesterol would 

be more restrictive than necessary for 

these foods to be considered ‘‘lean’’

when considered in the context of the 

total daily diet. Therefore, the agency 

decided not to propose the current 

nutrient criteria to the RACC for ‘‘mixed 

dishes not measurable with a cup.’’

FDA adopted the USDA nutrient 

requirements for ‘‘lean,’’ in the 1993 

nutrient content claim final rule (58 FR 

2302 at 2342), for seafood and game 

meats and for meal-type and main dish 

products because, in part, the agency 

recognized that seafood and game 

products play a comparable role in the 

diet to that of meat and poultry products 

and like meat and poultry products, 

contribute to the total dietary intake of 

fat, saturated fat, and cholesterol. In 

addition, FDA-regulated meal-type 

products are consumed in the same 

manner as USDA-regulated meal-type 

products covered by the FSIS rule on 

the ‘‘lean’’ claim. FDA determined that 

the equivalent definition of these terms 

would enable consumers to compare the 

nutritional values of meat products and 

meal-type products that may serve as 

substitutes for one another in a balanced 

diet (58 FR 2302 at 2343). The levels of 

total fat and saturated fat that were 

chosen by USDA for the ‘‘lean’’ criteria 

were based on a ratio of saturated fat to 

total fat that would be 40 percent, which 

is representative of the ratio of saturated 

fat to total fat inherent in ruminant 

muscle (58 FR 2302 at 2342). 

The agency has concluded, however, 

that not all of the factors considered in 

the 1993 final rule apply to the foods in 

the FDA-regulated category ‘‘mixed 

dishes not measurable with a cup.’’ The 

‘‘mixed dishes not measurable with a 

cup’’ category may not play a 

comparable role in the diet to that of 

meat and poultry products; may not 

contribute to the total dietary intake of 

fat, saturated fat, and cholesterol like 

meat and poultry products; and may not 

be consumed in the same manner as 

USDA-regulated meal-type products. 

FDA-regulated ‘‘mixed dishes not 

measurable with a cup,’’ which are 

similar in composition to meal and 

main dish products (i.e., they are multicomponent products), are smaller in 

size compared to the meal-type 

products. The agency believes that, 

although similar in composition to 

meal-type products, the restriction in 

size of the products in this category 

results in a different role in the diet than 

meal-type products. These foods are 

likely to be chosen by consumers to 

reduce portion sizes of meals for a 

reduced calorie contribution, or as 

healthy snack alternatives to those 

‘‘mixed dishes not measurable with a 

cup’’ that are higher in fats. Because of 

their size requirements, meal-type 

products comprise a larger percent (in 

weight and in calories) of the daily diet 

than ‘‘mixed dishes not measurable’’ do. 

Further, the foods that FDA regulates in 

this category include those that have no 

meat, poultry, seafood, or game meat as 

ingredients and, therefore, it would be 

appropriate for these foods to have 

lower fat criteria than foods in those 

categories, based on their dissimilar 

ingredient contents and smaller calorie 

contribution. While it is possible that 

foods in the ‘‘mixed dishes not 

measurable with a cup’’ category could 

have similar nutrient profiles to USDAregulated meat and poultry products 

(e.g., an entre ́e-type turnover containing 

cheese), many foods that fall into this 

category, especially those foods that do 

not contain any cheese, would have 

very different total fat, saturated fat, and 

cholesterol profiles. Therefore, because 

foods in the category of ‘‘mixed dishes 

not measurable with a cup’’ may not 

make the same contribution to the total 

dietary fat, saturated fat, and cholesterol 

and have a different role in the total diet 

as other FDA-regulated foods in this 

category or as other USDA-regulated 

individual foods in this category, FDA 

has tentatively concluded that the 

nutrient criteria ‘‘lean’’ for ‘‘mixed 

dishes not measurable with a cup’’

should not necessarily be the same as 

the criteria used for other individual 

foods and for meal-type products. 

Applying the current nutrient criteria 

to the RACC for ‘‘mixed dishes not 

measurable with a cup’’ (i.e., less than 

10 g fat per 140 g, 4.5 g or less saturated 

fat per 140 g, and less than 95 mg 

cholesterol per 140 g) results in criteria 

that, proportionally on a per-100 g basis, 

71046 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

are comparable to the two methods 

proposed by the petitioner. The nutrient 

criteria for this option, when computed 

on a per-100 g basis, would be less than 

7.1 g fat, 3.2 g or less saturated fat, and 

less than 68 mg cholesterol. However, a 

main dish (170 g portion) that met the 

current nutrient criteria for a ‘‘lean’’

claim would contribute less than 5.9 g 

total fat, 2.6 g or less saturated fat, and 

less than 56 mg cholesterol per 100 g 

(see discussion infra in footnote 8 of this 

document). Given the smaller portion 

sizes of ‘‘mixed dishes not measurable 

with a cup,’’ different composition than 

similar USDA-regulated foods, and 

different contribution to the total daily 

diet, ‘‘mixed dishes not measurable with 

a cup’’ labeled as ‘‘lean’’ should not be 

contributing proportionally more fat, 

saturated fat, and cholesterol than a 

main dish that bears the ‘‘lean’’ claim. 

If ‘‘mixed dishes not measurable with a 

cup’’ did contribute proportionally more 

fat, saturated fat, and cholesterol per 

100 g product consumed, consumers 

who may include more lean ‘‘mixed 

dishes not measurable with a cup’’ in 

their diets would inadvertently be 

consuming more of these fats. Therefore, 

the agency tentatively decided not to 

propose this option. 

The agency also considered the 

nutrient criteria based on the two 

different methods that Nestle ́ described 

in its petition to calculate the nutrient 

requirements for the ‘‘lean’’ definition. 

The agency decided not to propose 

these options. These methods are 

described in section II of this document. 

One method described by Nestle ́ uses 

the existing requirements for total fat, 

saturated fat, and cholesterol content in 

the nutrient content claim ‘‘lean’’ for 

meal-type products and reduces those 

requirements for ‘‘mixed dishes not 

measurable with a cup’’ in proportion to 

the reduction in portion size. ‘‘Mixed 

dishes not measurable with a cup’’ are 

multi-component foods that are similar 

to main dish and meal products, but 

smaller in size. In describing this 

method in its petition, Nestle ́ assumed 

an estimated average weight of 132.53 g 

for foods in this category compared to 

the 170.1 g (6 oz) minimum weight 

criterion for main dishes. This resulted 

in nutrient criteria of 7.8 g fat, 3.5 g 

saturated fat, and 74.1 mg cholesterol. 

These criteria are applied on a perRACC basis. When the nutrient criteria 

are applied on a per-RACC basis and 

then computed on a per-100 g basis to 

compare with the other options, the 

nutrient criteria are less than 5.6 g fat 

per 100 g, 2.5 g or less saturated fat per 

100 g, and less than 53 mg cholesterol 

per 100 g. These values are slightly 

more restrictive than what the agency is 

proposing to require and more 

restrictive than necessary for consumers 

to be able to maintain a diet that is 

within the current dietary 

recommendations for fat, saturated fat, 

and cholesterol, as discussed in the 

proposed option. Further, Nestle ́ did not 

describe the basis for its estimated 

average weight of ‘‘mixed dishes not 

measurable with a cup’’ as 132.53 g 

when calculating the nutrient criteria. 

Thus, Nestle ́ provided no rationale for 

why a portion size of 132.53 g should 

be used in computing the nutrient 

criteria in lieu of the RACC of 140 g for 

‘‘mixed dishes not measurable with a 

cup.’’ Consequently, for all these 

reasons, FDA tentatively decided not to 

propose the nutrient requirements for 

‘‘lean’’ based on Nestle ́’s assumed 

average weight for ‘‘mixed dishes not 

measurable with a cup.’’

The other method suggested by Nestle ́

determined nutrient values (based on 

recommended intakes) using an 

estimated calorie contribution of foods 

in the ‘‘mixed dishes not measurable 

with a cup’’ category as the basis of the 

definition. This suggested method 

relates current dietary recommendations 

for the percentage of nutrients in the 

overall diet to the percentage 

distribution of the nutrients in the 

individual food item (e.g., the current 

dietary recommendation of 30 percent 

fat in the diet would result in the 

product containing 30 percent of its 

calories from fat). This method of 

determining nutrient requirements is 

problematic for a number of reasons. 

One reason is that such a method is not 

one FDA has used to determine nutrient 

requirements for nutrient content 

claims. Additionally, recommendations 

for intake of these nutrients expressed 

as a percentage of calories are available 

for only total fat and saturated fat. 

Intake of cholesterol has no such 

recommendation. Consequently, this 

suggested method is used only for 

determining the requirements of two of 

the three nutrients, with the cholesterol 

requirement being determined using the 

alternate method suggested by Nestle ́. 

Therefore, the determination of the 

nutrient requirements is not consistent 

using this method. Also, Nestle ́

calculated the nutrients on a per-100 g 

basis but proposed to apply them on a 

per-RACC basis. It is unclear why Nestle ́

calculated the requirements in this way, 

as opposed to originally calculating the 

requirements on a per-RACC basis 

(using the RACC of 140 g). To determine 

the total fat requirement, for example, 

Nestle ́ determined how many calories 

were in 100 g of an average ‘‘mixed dish 

not measurable with a cup’’ (214.4 

calories / 100 g), calculated 30 percent 

of this value (64.32 calories), converted 

calories to gram weight (7.147 g fat), and 

applied this value to a per-RACC basis. 

Using the method as suggested by the 

petitioner (when the nutrient criteria are 

applied on a per-RACC basis and then 

computed on a per-100 g basis to 

compare with the other options), the 

nutrient criteria from this method are 

less than 5 g fat per 100 g, 2.5 g or less 

saturated fat, and less than 53 mg 

cholesterol per 100 g. These values are 

slightly more restrictive than what the 

agency is proposing to require and more 

restrictive than necessary for consumers 

to be able to maintain a diet that is 

within current dietary recommendations 

for fat, saturated fat, and cholesterol, as 

discussed in the proposed option. For 

all these reasons, the agency tentatively 

decided not to propose the nutrient 

criteria derived using this method. 

The agency tentatively decided to 

determine new nutrient requirements 

specific to the ‘‘mixed dishes not 

measurable with a cup’’ category and to 

use the RACC for ‘‘mixed dishes not 

measurable with a cup’’ in deriving the 

nutrient criteria. As discussed earlier in 

this document, the agency wants to 

ensure that ‘‘mixed dishes not 

measurable with a cup’’ that are labeled 

‘‘lean’’ will help consumers construct a 

diet that is consistent with current 

dietary recommendations. Thus, 

consumers who incorporate these 

products into their diets as healthy 

snacks or choose smaller portions for 

controlled calorie intake at meals 

should be able to keep their dietary 

intake of total fat, saturated fat, and 

cholesterol at or below the DRVs 

established by FDA and within current 

ranges set forth in the IOM acceptable 

macronutrient distribution ranges 

(AMDRs) and the 2005 Dietary 

Guidelines for Americans. Because 

FDA-regulated foods within the category 

‘‘mixed dishes not measurable with a 

cup’’ do not necessarily contribute to 

the diet in the same manner as mealtype products regulated by FDA (e.g., 

they are not used as meal replacements, 

and would not necessarily have the 

same fat, saturated fat, and cholesterol 

content as the USDA-regulated 

counterparts), we have tentatively 

concluded that the nutrient criteria 

should be more restrictive than these 

other products to reflect the 

contribution to the overall diet and the 

different fat content. 

FDA determined that it could achieve 

better criteria, which would enable 

consumers to maintain intakes of fat 

within current dietary recommendations 

without being as restrictive as the other 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71047 

8 If a food qualifying as a main dish meets the perlabeled-serving basis for a ‘‘lean’’ claim, it also 

meets the per-100 g basis. For example, a main dish 

with a 170 g labeled serving size containing less 

than 10 g fat, 4.5 g or less saturated fat, and less 

than 95 mg cholesterol per labeled serving could 

bear a lean claim because it meets both the perlabeled-serving basis and the per-100 g basis (i.e., 

the food would contain less than 5.8 g fat, 2.6 g or 

less saturated fat, and less than 55.9 mg cholesterol 

per 100 g). However, a food qualifying as a main 

dish that meets the per-100 g basis for a ‘‘lean’’

claim might not meet the per-labeled-serving basis. 

For example, a main dish containing 10 g fat, 4.5 

g saturated fat, and 95 mg cholesterol per 100 g 

would contain 17 g fat, 7.7 g saturated fat, and 162 

mg cholesterol per 170 g labeled serving. 

9For example, a 170 g main dish that meets the 

nutrient content criteria of less than 10 g per 

labeled serving of 170 g, 4.5 or less saturated fat per 

170 g, and less than 95 mg cholesterol per labeled 

serving of 170 g would provide less than 5.8 g fat, 

2.6 g or less saturated fat, and less than 55.9 mg 

cholesterol per 100 g. As a comparison, a mixed 

dish that contains less than 8 g fat, 3.5 g or less 

saturated fat, and less than 80 mg cholesterol would 

provide less than 5.7 g fat, 2.5 g or less saturated 

fat, and less than 57 mg cholesterol per 100 g. 

options, by basing the nutrient criteria 

for fat, saturated fat, and cholesterol on 

the current criteria for main dishes, but 

applying the criteria to the RACC (140 

g) for ‘‘mixed dishes not measurable 

with a cup’’ rather than the minimum 

weight for main dishes (170.1 g). The 

agency chose the main dish minimum 

weight requirement of 170.1 g (6 oz) for 

use in its calculations, rather than the 

283.4 g (10 oz) minimum weight 

requirement for meal products, because 

main dishes are closer to ‘‘mixed dishes 

not measurable with a cup’’ in portion 

size and contribution to the overall diet. 

The current regulations require main 

dish products bearing a ‘‘lean’’ claim to 

have less than 10 g total fat, 4.5 g or less 

saturated fat, and less than 95 mg 

cholesterol per 100 g and per labeled 

serving. Because the minimum weight 

criterion for main dishes and the RACC 

for ‘‘mixed dishes not measurable with 

a cup’’ are both considered a serving 

and much closer in portion size than 

meal products at 10 oz, the agency 

decided that using the nutrient criteria 

based on the minimum weight for main 

dishes would be appropriate for 

calculating the criteria for ‘‘mixed 

dishes not measurable with a cup.’’

Further, to be eligible for a ‘‘lean’’

nutrient content claim, a main dish 

must meet the nutrient criteria on a perlabeled-serving basis.8 Thus, the agency 

chose the serving size for a main dish 

that would have to meet the nutrient 

criteria for ‘‘lean’’ (i.e., 170 g) as a basis 

to establish the criteria for ‘‘mixed 

dishes not measurable with a cup’’ per 

RACC. The RACC for ‘‘mixed dishes not 

measurable with a cup’’ is 140 g (5 oz). 

FDA proposes to establish the fat, 

saturated fat, and cholesterol criteria for 

the definition of ‘‘lean’’ for ‘‘mixed 

dishes not measurable with a cup’’ by 

calculating the percent of the proportion 

of the weight of the RACC for ‘‘mixed 

dishes not measurable with a cup’’ (140 

g) to the minimum weight of main 

dishes (170.1 g) and multiplying the 

percent by the nutrient criteria for fat, 

saturated fat, and cholesterol for main 

dishes. The proportion in weight is 140 

g / 170.1 g, which equals 0.82 or 82 

percent. Eighty-two percent of the 

current nutrient criterion value for fat 

(10 g fat multiplied by 82 percent) 

equals a nutrient value of 8.2 g fat per 

RACC. Eighty-two percent of the current 

nutrient criterion value for saturated fat 

(4.5 g sat fat multiplied by 82 percent) 

equals 3.69 g saturated fat. Eighty-two 

percent of the current nutrient criterion 

value for cholesterol (95 mg cholesterol 

multiplied by 82 percent) equals 77.9 

mg cholesterol. This proportional 

reduction results in rounded values of 8 

g total fat, 3.5 g saturated fat, and 80 mg 

cholesterol. Calculating the proposed 

nutrient criteria for ‘‘mixed dishes not 

measurable with a cup’’ per RACC from 

the current nutrient content criteria on 

the minimum weight for main dishes 

provides proposed criteria for ‘‘mixed 

dishes not measurable with a cup’’ that 

are comparable in their contribution of 

fat, saturated fat, and cholesterol on a 

per-100 g basis to that contributed by 

main dishes on a per-100 g basis.9 The 

proposed nutrient criteria are less 

restrictive than the other options 

considered and would potentially allow 

more foods for increased consumer 

choice. Consumers could achieve a diet 

using ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ that is 

consistent with current dietary 

recommendations. 

Therefore, to bear a ‘‘lean’’ claim, 

FDA proposes in § 101.62(e)(2) that food 

items falling within the RACC for 

‘‘mixed dishes not measurable with a 

cup’’ must have less than 8 g total fat, 

3.5 g or less saturated fat, and less than 

80 mg cholesterol per RACC. The 

agency is proposing to revise current 

§ 101.62(e) to include the proposed 

provision. FDA requests comments on 

these criteria for ‘‘mixed dishes not 

measurable with a cup.’’

In proposing the nutrient 

requirements, the agency considered 

including a requirement for trans fat, 

but decided against including it in this 

proposal. Currently, there is no daily 

value for trans fatty acids, but it is well 

known that trans fatty acids increase 

serum total- and LDL-cholesterol levels. 

FDA has issued an advanced notice of 

proposed rulemaking (ANPRM) to 

solicit comments on establishing trans 

fat nutrient content claims; to establish 

qualifying criteria for trans fat in current 

nutrient content claims for saturated 

fatty acids and cholesterol, lean and 

extra lean claims, and health claims that 

contain a message about cholesterolraising lipids; and, in addition, to 

establish disclosure and disqualifying 

criteria to help consumers make healthy 

food choices. The agency also solicited 

comment on whether it should consider 

statements about trans fat, either alone 

or in combination with saturated fat and 

cholesterol, as a footnote in the 

Nutrition Facts panel or as a disclosure 

statement in conjunction with claims 

(68 FR 41507, July 11, 2003). FDA 

believes that it would be premature to 

consider a specific trans fat nutrient 

requirement for use of the nutrient 

content claim ‘‘lean’’ by eligible foods 

classified as ‘‘mixed dishes not 

measurable with a cup,’’ until it has 

evaluated the merits of a level of trans 

fat based on the data and information it 

is currently evaluating in the context of 

the ANPRM. 

Pending issuance of a final rule 

defining the ‘‘lean’’ nutrient content 

claim that characterizes the fat, 

saturated fat, and cholesterol content in 

qualifying foods that fall within the 

RACC established for ‘‘mixed dishes not 

measurable with a cup,’’ FDA intends to 

consider the exercise of its enforcement 

discretion on a case by case basis when 

the ‘‘lean’’ nutrient content claim in 

food labeling is based on the definition 

in this proposed rule and when the 

labeling containing such a claim is not 

otherwise false or misleading. The act’s 

enforcement provisions commit 

complete discretion to the Secretary 

(and by delegation to FDA) to decide 

how and when they should be 

exercised. Heckler v. Chaney, 470 U.S. 

821 at 835 (1985); see also Schering 

Corp. v. Heckler, 779 F.2d 683 at 685–

86 (D.C. Cir. 1985) (stating that the 

provisions of the act ‘‘authorize, but do 

not compel the FDA to undertake 

enforcement activity’’). Until the agency 

issues a final rule for the ‘‘lean’’ nutrient 

content claim for foods classified as 

‘‘mixed dishes not measurable with a 

cup,’’ the agency believes that its 

exercise of enforcement discretion will 

help alleviate consumer confusion by 

encouraging greater consistency and 

uniformity in the marketplace for such 

claims, and thereby assist consumers in 

making informed dietary choices about 

their fat, saturated fat, and cholesterol 

intake. 

IV. Preliminary Regulatory Impact 

Analysis 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866. Executive Order 12866 directs 

71048 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). 

Executive Order 12866 classifies a rule 

as significant if it meets any one of a 

number of specified conditions, 

including having an annual effect on the 

economy of $100 million, adversely 

affecting a sector of the economy in a 

material way, adversely affecting 

competition, or adversely affecting jobs. 

A regulation is also considered a 

significant regulatory action if it raises 

novel legal or policy issues. The agency 

believes that this proposed rule is not a 

significant regulatory action as defined 

by the Executive order. 

A. Need for Regulation 

Unlike foods classified as either meal 

products or main dish products, many 

foods classified as ‘‘mixed dishes not 

measurable with a cup’’ are not 

currently allowed to make a ‘‘lean’’

nutrient content claim because the 

RACC is less than 6 oz. Allowing a 

‘‘lean’’ nutrient content claim on the 

labels of ‘‘mixed dishes not measurable 

with a cup’’ may facilitate more 

nutritious eating choices by consumers. 

Moreover, better choices regarding fat, 

saturated fat, and cholesterol 

consumption are especially important 

considering current concern with 

obesity, other diseases related to being 

overweight, and heart disease. Finally, 

USDA currently allows the ‘‘lean’’ claim 

on all foods that they regulate, including 

individual foods, and allowing the 

claim on FDA-regulated foods would 

increase consistency in allowable claims 

between the two agencies. 

B. Regulatory Options 

We considered the following 

regulatory options: (1) Take no new 

regulatory action; (2) adopt Nestle ́’s 

petitioned criteria for fat, saturated fat, 

and cholesterol; (3) extend the current 

FDA criteria for making a ‘‘lean’’ claim 

for ‘‘meal products’’ and ‘‘main dish 

products’’ to ‘‘mixed dishes not 

measurable with a cup,’’ and (4) adopt 

the proposed criteria for fat, saturated 

fat, and cholesterol contents necessary 

for making a ‘‘lean’’ claim for ‘‘mixed 

dishes not measurable with a cup.’’ FDA 

requests comments on benefits, costs, 

and any other aspects of these (and any 

other) alternatives. 

Option 1: Take No New Regulatory 

Action 

The first regulatory option, take no 

action, would require denying the 

Nestle ́ petition requesting that FDA 

authorize a nutrient content claim 

‘‘lean’’ for ‘‘mixed dishes not 

measurable with a cup.’’ Taking no 

regulatory action to amend the 

definition of ‘‘lean’’ is the state of the 

world and our baseline. By convention, 

we treat the option of taking no new 

regulatory action as the baseline for 

determining the costs and benefits of the 

other options. Therefore, we associate 

neither costs nor benefits with this 

option. The consequences of taking no 

action are reflected in the costs and 

benefits of the other options. 

Option 2: Propose Nestle ́’s Petitioned 

Criteria for Fat, Saturated Fat, and 

Cholesterol 

A second option is to allow ‘‘mixed 

dishes not measurable with a cup’’ to 

make a ‘‘lean’’ claim based on criteria 

derived from the Nestle ́ petition. In that 

petition two methods are used to derive 

the criteria for fat, saturated fat, and 

cholesterol contents for allowing a 

‘‘lean’’ claim for ‘‘mixed dishes not 

measurable with a cup.’’ One method is 

to establish ‘‘lean’’ criteria for fat, 

saturated fat, and cholesterol contents of 

‘‘mixed dishes not measurable with a 

cup’’ with an estimated average weight 

of 132.53 g, proportional to existing 

criteria for ‘‘lean’’ ‘‘meal products’’ with 

minimum weights of 170.1 g. This 

method produces criteria of 7.8 g of total 

fat, 3.5 g of saturated fat, and 74.1 

milligrams (mg) of cholesterol per RACC 

(140 g). The second method uses an 

estimated average calorie contribution 

of 214 calories from ‘‘mixed dishes not 

measurable with a cup’’ and the 

recommendations for dietary fat intake 

reported by IOM and recommendations 

from the National Cholesterol Education 

Program on saturated fat intake. This 

method produces criteria of 7 g of total 

fat, 2.5 g of saturated fat, and 75 mg of 

cholesterol per RACC. We use the 

criteria for fat, saturated fat, and 

cholesterol contents from the latter, 

more restrictive method for analyzing 

the regulatory impact for this option. 

This option is the most restrictive of 

the all options considered in terms of 

allowable fat, saturated fat, and 

cholesterol contents and would result in 

the greatest percent reduction in fat 

content in the ‘‘mixed dishes not 

measurable with a cup’’ category 

compared to the other three options. 

However, the market share of all FDAregulated ‘‘mixed dishes not measurable 

with a cup’’ expected to make a ‘‘lean’’

claim under this option (6 percent) and 

the reduction in total dietary fat 

consumption may be the lowest 

compared to the other options. While 

the costs of this option would be 

voluntarily incurred, we estimate the 

extent of resources allocated to new 

product development, reformulation, 

relabeling, and discontinued product 

lines would be the lowest compared to 

the other options. 

Option 3: Extend the Current Criteria for 

Fat, Saturated Fat, and Cholesterol for 

‘‘Lean’’

A third option is to extend the same 

criteria of less than 10 g of total fat, 4.5 

g of saturated fat, and 95 mg of 

cholesterol per 100 g and per labeled 

serving currently used to allow the 

‘‘lean’’ claim for ‘‘meal products’’ or 

‘‘main dish products,’’ to allow ‘‘mixed 

dishes not measurable with a cup’’ to 

make a ‘‘lean’’ claim on a per-RACC 

basis. This is the least restrictive of the 

options considered here in terms of 

allowable fat, saturated fat, and 

cholesterol content and would result in 

a smaller percent reduction in fat 

content in the ‘‘mixed dishes not 

measurable with a cup’’ category than 

under the other three options. In 

addition, the market share of all FDAregulated ‘‘mixed dishes not measurable 

with a cup’’ expected to make a ‘‘lean’’

claim under this option (10 percent), 

and the reduction in total dietary fat 

consumption may be the highest of the 

options. While the costs of this option 

would be voluntarily incurred, we 

estimate the extent of resources 

allocated to new product development, 

reformulation, relabeling, and 

discontinued product lines to be the 

highest of the options. 

Option 4: The Proposed Regulatory 

Action 

A fourth option is to allow ‘‘mixed 

dishes not measurable with a cup’’ to 

contain a ‘‘lean’’ claim based on the 

proposed criteria of 8 g of total fat, 3.5 

g or less of saturated fat, and 80 mg of 

cholesterol per RACC. This option may 

be considered moderately restrictive 

compared to the other options in terms 

of allowable fat, saturated fat, and 

cholesterol content, and may result in a 

moderate percent reduction in fat 

content in the ‘‘mixed dishes not 

measurable with a cup’’ category 

compared with the other three options. 

In addition, the market share for all 

FDA-regulated ‘‘mixed dishes not 

measurable with a cup’’ expected to 

make a ‘‘lean’’ claim under this option 

(8 percent), and the reduction in total 

dietary fat consumption may be 

considered moderate compared with the 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71049 

other options as well. While the costs of 

this option would be voluntarily 

incurred, we estimate the resources 

allocated to new product development, 

reformulation, relabeling, and 

discontinued product lines to be 

moderate relative to the other options. 

C. Benefits 

The benefits from this proposed rule 

would derive from the ability of 

consumers to make healthier dietary 

choices among the foods in the category 

of ‘‘mixed dishes not measurable with a 

cup’’ based on the fat content of these 

foods, when such foods bear the ‘‘lean’’

nutrient content claim. The ‘‘lean’’

claim makes it easier for consumers to 

find foods in this category that do not 

exceed a certain amount of fat, saturated 

fat, and cholesterol. If consumers 

substitute ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ for other foods 

in this category that are higher in fat, we 

would expect them to benefit from the 

improved ability to maintain healthy 

weights and stay within recommended 

intakes for fat, saturated fat, and 

cholesterol. We estimate the health 

benefits from this proposed rule would 

come from the reduction in total fat, 

saturated fat, and cholesterol 

consumption that would result. 

Reduced fat, saturated fat, and 

cholesterol consumption would be 

expected to help consumers maintain 

healthier body weights. 

1. An Overview of Likely ‘‘Lean’’

‘‘Mixed Dishes Not Measurable With a 

Cup’’

The expected effects of the proposed 

rule would be small because there are a 

small number of ‘‘mixed dishes not 

measurable with a cup’’ under FDA 

regulatory authority that would be 

eligible to make the ‘‘lean’’ claim, 

should one be allowed. Although foods 

classified as ‘‘mixed dishes not 

measurable with a cup’’ that are subject 

to USDA regulatory oversight are 

currently allowed to make a ‘‘lean’’

claim, we think that very few foods such 

as many sandwiches, burritos, pizza 

pockets, and egg rolls that are currently 

subject to FDA regulatory oversight, 

would qualify for the ‘‘lean’’ claim 

based on the criteria in any of the 

regulatory options. The Nestle ́ petition 

identified the rapidly growing frozen 

sandwich and snack category as 

containing likely candidate products 

within ‘‘mixed dishes not measurable 

with a cup’’ for making the ‘‘lean’’

claim, should one be allowed. For 

example, according to the Nestle ́

petition, growth in ‘‘mixed dishes not 

measurable with a cup’’ that make a 

‘‘lean’’ claim could likely come from the 

Weight Watchers Smartwiches, Amy’s 

Pocket Sandwiches, and Nestle ́’s Lean 

Pockets product lines (Ref. 1). 

2. Structure of the Benefits Analysis 

To estimate the reduction in fat 

consumption that would result from the 

regulatory options, we first estimate the 

current share of total food consumption 

in the ‘‘mixed dishes not measurable 

with a cup’’ category. We estimate the 

total consumption of all ‘‘mixed dishes 

not measurable with a cup’’ and the 

total consumption of all food. Total food 

consumption is from food prepared and 

consumed in the home as well as from 

food served and consumed away from 

home. We then estimate the fraction of 

that total that would be subject to FDA 

‘‘lean’’ labeling requirements. We 

develop a conceptual framework to 

estimate the share of ‘‘mixed dishes not 

measurable with a cup’’ that is likely to 

make a new ‘‘lean’’ claim, and use 

published information on the market 

share of products that make ‘‘fat’’ claims 

to estimate the maximum market share 

of ‘‘lean’’ ‘‘mixed dishes not measurable 

with a cup.’’ We estimate the percent 

reduction in total dietary fat intake that 

would result from consuming newly 

allowed ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ instead of 

alternative food products. Alternatives 

to ‘‘mixed dishes not measurable with a 

cup’’ that make the ‘‘lean’’ claim could 

be any other ‘‘mixed dish not 

measurable with a cup’’ including those 

under the regulatory oversight of USDA. 

Finally, we discuss important 

considerations that may affect the 

distribution of the reduction in dietary 

fat intake across consumers of different 

overweight status. 

3. Estimating Current Consumption of 

‘‘Mixed Dishes Not Measurable With a 

Cup’’ Subject to FDA Regulatory 

Oversight 

We used the data from the 1997 U.S. 

Economic Census and North American 

Industry Classification System (NAICS) 

code 4451 for grocery stores to estimate 

current consumption of all ‘‘mixed 

dishes not measurable with a cup’’ (Ref. 

3). We then refined that estimate so that 

it includes only those ‘‘mixed dishes not 

measurable with a cup’’ that are subject 

to FDA regulatory oversight. The use of 

only NAICS 4451 for this purpose may 

underestimate true consumption of 

‘‘mixed dishes not measurable with a 

cup’’ to the extent that there are other 

NAICS codes that also contain sales of 

these products. However, sales of these 

products reported in other NAICS codes 

are probably small. 

We used merchandise lines 103 

(Frozen foods (including packaged foods 

sold in frozen state)), 106 (Bakery 

products not baked on the premises, 

except frozen), and 124 (all other meals 

and snacks) within NAICS 4451 as the 

basis to estimate current consumption of 

‘‘mixed dishes not measurable with a 

cup.’’ We assume that half of all frozen 

foods from merchandise line 103 are 

either frozen meal products and main 

dish products, or frozen ‘‘mixed dishes 

not measurable with a cup’’ with RACCs 

of 140 g (about 5 oz); we further assume 

that two-thirds of that total is for frozen 

meal products and main dish products 

and one-third is for frozen ‘‘mixed 

dishes not measurable with a cup.’’

Consequently, we estimate that within 

merchandise line 103 there were 

approximately $3.2 billion in annual 

sales of frozen ‘‘mixed dishes not 

measurable with a cup’’ in 1997. 

We used a similar framework to 

estimate current consumption of ‘‘mixed 

dishes not measurable with a cup’’ with 

RACCs of 140 g (about 5 oz) for 

merchandise lines 106 and 124. We 

assume that three-quarters of the sales 

reported for NAICS 4451, merchandise 

line 106, are for cakes, pies, cookies, 

and related items, while one-quarter of 

the sales from this line are for ‘‘mixed 

dishes not measurable with a cup’’ (e.g., 

quiches and entre ́e-type turnovers). 

Consequently, we estimate the total 

annual sales of ‘‘mixed dishes not 

measurable with a cup’’ from that 

category to be approximately $1.8 

billion. Finally, we assume that half of 

all sales of merchandise line 124 are for 

‘‘mixed dishes not measurable with a 

cup,’’ which leads us to estimate that 

approximately $1.3 billion in annual 

sales of ‘‘mixed dishes not measurable 

with a cup’’ came from that 

merchandise line in 1997. 

Based on the analysis in the previous 

paragraphs, our estimate of total 

consumption of ‘‘mixed dishes not 

measurable with a cup,’’ derived from 

total sales from that category, is 

approximately $6.3 billion (i.e., $3.2 

billion plus $1.8 billion plus $1.3 

billion, rounded to the nearest 100 

million) for 1997. We estimate that half 

of this total is subject to USDA 

regulatory oversight, while half would 

be subject to the ‘‘lean’’ requirements 

outlined in the policy options 

considered in this analysis. 

Consequently, we estimate that total 

consumption of ‘‘mixed dishes not 

measurable with a cup’’ subject to FDA 

regulatory oversight is approximately 

$3.2 billion (i.e., $6.3 billion / 2, 

rounded to the nearest 100 million). 

71050 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

4. The Share of Total Food 

Consumption From ‘‘Mixed Dishes Not 

Measurable With a Cup’’ Subject to FDA 

Regulatory Oversight 

Total food consumption consists of 

food purchased at retail grocery and 

other establishments and consumed 

elsewhere, and food consumed at food 

service establishments. From the 1997 

U.S. Economic Census, total sales of all 

groceries and other foods for human 

consumption off-the-premises reported 

for NAICS 4451 were about $274 billion 

(Ref. 3). Consequently, we estimate that 

consumption of ‘‘mixed dishes not 

measurable with a cup’’ subject to FDA 

regulatory oversight represents 

approximately 1.2 percent of all 

consumption of food purchased for 

consumption off-the-premises ($3.2 

billion / $274 billion). 

We used USDA data to estimate the 

fraction of total food consumed (both inhome as well as away-from-home 

consumption) that is subject to 

packaged food labeling requirements 

(in-home consumption exclusively) in 

order to estimate the percent of total 

food consumed from ‘‘mixed dishes not 

measurable with a cup.’’ The percentage 

of food consumed away from home is 

estimated as 43 percent of total U.S. 

food consumption expenditures based 

on the 2003 consumer price index for 

food computed by the Economic 

Research Service (Ref. 4). Consequently, 

we estimate that 57 percent of food 

consumed is purchased for 

consumption at home (i.e., 100 percent 

- 43 percent), and that the universe of 

‘‘mixed dishes not measurable with a 

cup’’ that could potentially make a 

‘‘lean’’ claim accounts for 

approximately 0.67 percent of total 

consumption (1.2 percent x 57 percent). 

For the purpose of this analysis, we 

assume that the fraction of total food 

purchases at retail outlets from ‘‘mixed 

dishes not measurable with a cup’’ has 

not significantly changed since 1997. 

5. The Conceptual Model for Estimating 

Consumption of ‘‘Lean’’ ‘‘Mixed Dishes 

Not Measurable With a Cup’’

We assume that the demand for 

‘‘mixed dishes not measurable with a 

cup,’’ like that for other food categories, 

depends on nutrition attributes, 

consumer taste, and price, and that 

consumers will optimize their food 

choices by substituting among these 

characteristics. A study by Teisl and 

Levy found evidence that consumers 

substitute among nutrient, price, and 

taste characteristics in their food 

choices (Ref. 5). In general, consumers 

prefer the taste of foods that are higher 

in fat content (all else equal), and 

studies have documented that those 

foods are lower in cost per calorie 

compared with foods with lower fat 

contents (Ref. 6). Drewnowski and 

Specter report evidence suggesting that 

nutrition-conscious consumers will pay 

a premium for food products they 

perceive as being relatively nutritious at 

the expense of taste (Ref. 6). These 

researchers suggest that balanced diets 

lower in fat and refined sugars are 

generally more expensive than diets 

higher in fat and refined sugar. 

We estimate that demand for ‘‘mixed 

dishes not measurable with a cup’’

making ‘‘lean’’ claims will come from 

health-conscious consumers who are 

assumed to value the nutritional 

characteristics of ‘‘lean’’ ‘‘mixed dishes 

not measurable with a cup’’ over the 

taste characteristics of other ‘‘mixed 

dishes not measurable with a cup.’’ We 

do not have the quantitative data and 

other information on consumer 

preferences for taste and nutritious 

characteristics that would allow us to 

directly estimate consumers’

substitution between nutrition and taste, 

but we know that the demand for more 

nutritious products in the ‘‘mixed 

dishes not measurable with a cup’’

category will increase as the nutritious 

content of the products increase, 

assuming that taste characteristics and 

prices are held constant. Consequently, 

we estimate that the demand for ‘‘lean’’

‘‘mixed dishes not measurable with a 

cup’’ will depend on the fat, saturated 

fat, and cholesterol contents relative to 

that of all other ‘‘mixed dishes not 

measurable with a cup.’’

In this analysis, we isolated fat 

content as the property of interest. In 

order to generate a plausible estimate of 

the demand for ‘‘mixed dishes not 

measurable with a cup’’ under FDA 

regulatory oversight that would make a 

‘‘lean’’ claim, we make the following 

assumptions: 

• We assume a positive relationship 

between fat content and consumer taste, 

so that near current levels of 

consumption of ‘‘mixed dishes not 

measurable with a cup,’’ a reduction in 

fat content leads to a reduction in 

consumer preference, all else the same. 

• We assume a continuum of fat 

contents in all ‘‘mixed dishes not 

measurable with a cup’’ that make fat 

claims, and estimate the maximum 

market share based on where the ‘‘lean’’

criteria fall within that continuum. We 

assume the continuum in fat contents 

range from a low represented by the 

low-fat criteria (i.e., 3 g per RACC, or 

140 g) to a high represented by the 

average fat content of ‘‘mixed dishes not 

eligible to make any fat claim.’’

• We assume ‘‘mixed dishes not 

measurable with a cup’’ that make a 

‘‘lean’’ claim will contain less fat, have 

different taste characteristics, and be 

priced at a premium (all else the same) 

over ‘‘mixed dishes not measurable with 

a cup’’ with higher fat contents, 

including some that make fat claims but 

are ineligible to make a ‘‘lean’’ claim. 

• We assume that the maximum 

market share for ‘‘lean’’ ‘‘mixed dishes 

not measurable with a cup’’ will be 

proportional to the fat contents of other 

‘‘mixed dishes not measurable with a 

cup’’ making fat claims based on where 

‘‘lean’’ criteria fall within the 

continuum of fat contents. In other 

words, we assume that fat content 

drives market share within the segment 

of the market making claims about fat. 

• We assume that all demand for 

‘‘lean’’ ‘‘mixed dishes not measurable 

with a cup’’ will come from consumers 

of similar foods in this category that 

contain higher fat contents (including 

those with reduced fat nutrient content 

claims as well as those that do not make 

nutrient content claims) and have better 

taste. Current consumers of similar 

‘‘mixed dishes not measurable with a 

cup’’ except for their higher fat contents 

may prefer ‘‘lean’’ mixed dishes because 

of their more nutritious, lower fat 

characteristics. Moreover, consumers of 

similar ‘‘mixed dishes not measurable 

with a cup’’ except for their lower fat 

contents, such as low-fat products may 

instead choose similar ‘‘lean’’ ‘‘mixed 

dishes not measurable with a cup’’

because of taste. 

We estimated the maximum potential 

market share for ‘‘lean’’ ‘‘mixed dishes 

not measurable with a cup’’ using 

published information on the market 

share for all FDA-regulated products 

that make ‘‘fat’’ claims. ‘‘Mixed dishes 

not measurable with a cup’’ with fat 

contents lower than ‘‘lean’’ ‘‘mixed 

dishes not measurable with a cup’’

would have smaller market shares, 

while those that make fat claims but 

have higher fat contents than ‘‘lean’’

mixed dishes not measurable with a 

cup’’ would have greater market shares 

up to an estimated maximum potential 

market share. In a study using the 2001 

Food Label and Package Survey data, 

LeGault et al. found that 33.7 percent of 

all FDA-regulated product sales were 

from products that had some type of 

nutrient content claim, and that 17.2 

percent of all product sales had some 

type of reduced fat claim (i.e., fat free, 

low or reduced fat, lite, etc.) (Ref. 7). We 

assume that the maximum share of all 

FDA-regulated ‘‘mixed dishes not 

measurable with a cup’’ that could make 

a ‘‘lean’’ claim is 17.2 percent. 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71051 

6. Estimating the Market Share of 

‘‘Lean’’ ‘‘Mixed Dishes Not Measurable 

With a Cup’’

We estimate the market share for 

‘‘lean’’ ‘‘mixed dishes not measurable 

with a cup’’ based on the lower fat 

contained in such products that would 

be eligible to bear the ‘‘lean’’ claim 

under each policy option, compared 

with the average for ‘‘mixed dishes not 

measurable with a cup’’ that are likely 

consumption-substitutes. We estimate 

the average nutrient contents in ‘‘mixed 

dishes not measurable with a cup’’ of 

likely consumption-substitutes using 

the nutrient contents of several ‘‘mixed 

dishes not measurable with a cup’’ that 

are reported in the USDA National 

Nutrient Database for Standard 

Reference (Ref. 8). Our sample of likely 

consumption-substitute ‘‘mixed dishes 

not measurable with a cup’’ is drawn 

from likely candidate products, similar 

to those suggested in the Nestle ́ petition, 

in the Weight Watchers Smartwich, 

Amy’s Pocket Sandwich, and Nestle ́’s 

Lean Pockets product lines. The 

nutrient contents reported in the table 1 

of this document include several 

different fresh and frozen sandwich 

products, and are reported on a per-140 

g basis rather than per-100 g basis as in 

the USDA database. This modification 

allows us to better compare the levels of 

fat, saturated fat, and cholesterol in 

these ‘‘mixed dishes not measurable 

with a cup’’ with the ‘‘lean’’

requirements specified in each policy 

option. We implicitly assume that the 

distribution of nutrient contents of the 

reported items is representative of that 

for all likely substitute ‘‘mixed dishes 

not measurable with a cup.’’

To incorporate uncertainty in our 

estimates we assume that fat, saturated 

fat, and cholesterol contents of ‘‘mixed 

dishes not measurable with a cup’’ are 

lognormally distributed with means 

equal to the averages of the reported 

contents, and standard deviations equal 

to the natural logarithm of the standard 

deviations of the reported contents 

across the ‘‘mixed dishes not 

measurable with a cup.’’ The lognormal 

distribution is appropriate to use 

because it incorporates the idea that 

relatively few candidate consumptionsubstitute ‘‘mixed dishes not 

measurable with a cup’’ would have 

nutrient levels much different from the 

mean as would be implied by the use of 

a normal distribution. The parameters 

that describe the lognormal distribution 

are the natural logarithms of the mean 

and variance in the data. The 5 percent 

(low) and 95 percent (high) estimates 

are reported along with the average 

contents in table 1 of this document. 

TABLE 1.—NUTRIENT CONTENTS OF SOME LIKELY SUBSTITUTES FOR ‘‘LEAN’’ ‘‘MIXED DISHES NOT MEASURABLE WITH A

CUP’’ 

One Serving Total Fat 

(g per 140 g RACC) 

Saturated Fat 

(g per 140 g RACC) 

Cholesterol 

(mg per 140 g RACC) 

Hot Pockets, Beef and Cheddar Stuffed Sandwich, frozen 20 9 52 

Libby’s Spreadables Ready to Serve Sandwich Salads, shelf stable 13 3 36 

Hot Pockets, Ham and Cheese Stuffed Sandwich, frozen 16 6 55 

Sunny Fresh, Pre-Cooked Frozen Egg and Cheese Biscuit 13 3 157 

Lean Pockets Glazed Chicken Supreme Stuffed Sandwiches, frozen 7 2 25 

Weight Watchers On-The-Go Chicken, Broccoli, and Cheddar Pocket 

Sandwich, frozen 6 2 14 

Average 12 4 56 

5 percent (low) 10 3 50 

95 percent (high) 15 5 63 

Option 2: Industry proposed 7 3 75 

Option 3: Extension of current criteria for ‘‘meal products’’ 10 4 .5 95 

Option 4: FDA proposed 8 3 .5 80 

Low fat 3 

The maximum fat content that would 

be allowed under option 2 is between 47 

and 70 percent of the average (i.e., (7 / 

15) x 100 and 7 / 10 x 100) with a mean 

of 58 percent of the average fat content 

of the foods assumed to be likely 

substitute ‘‘mixed dishes not 

measurable with a cup,’’ and for option 

3 the maximum fat content for ‘‘lean’’ is 

between 67 and 100 percent (i.e., (10 / 

15) x 100 and (10 / 10) x 100) with a 

mean of 83 percent of the average fat 

content of the foods assumed to be 

likely consumption-substitute ‘‘mixed 

dishes not measurable with a cup.’’ FDA 

proposed maximum fat content for 

‘‘lean’’ is between 53 and 80 percent 

(i.e., (8 / 15) x 100 and (8 / 10) x 100) 

with a mean of 67 percent of the average 

fat content of the foods assumed to be 

likely consumption-substitute ‘‘mixed 

dishes not measurable with a cup.’’ The 

maximum fat content for ‘‘low fat’’ is 

about 25 percent of the average content 

of the foods listed (i.e., 3 / 12 x 100). 

We note that these estimates of the 

difference in fat contents between 

‘‘lean’’ ‘‘mixed dishes not measurable 

with a cup’’ and likely consumptionsubstitute ‘‘mixed dishes not 

measurable with a cup’’ may understate 

the true difference to the extent that 

some ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ will have fat 

contents below the maximum allowed, 

which is the value used in the 

computation. 

Based on an assumed continuum of 

fat contents ranging from 25 percent of 

71052 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

the average (low-fat) to the average fat 

content in likely consumptionsubstitute ‘‘mixed dishes not 

measurable with a cup’’ not eligible to 

make fat claims we estimate a market 

share for ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ of 6 percent 

using the industry-petitioned criteria 

(i.e., (58 percent - 25 percent) x 17.2 

percent of mixed dishes that have 

reduced fat claims, rounded to the 

nearest percent); 10 percent using the 

criteria in option 3 (i.e., (83 percent - 25 

percent) x 17.2 percent of mixed dishes 

that have reduced fat claims, rounded to 

the nearest percent); and 7 percent using 

the proposed criteria (i.e., 67 percent - 

25 percent) x 17.2 percent of mixed 

dishes that have reduced fat claims, 

rounded to the nearest percent). In order 

to incorporate uncertainty in our 

estimate of market share, we assume a 

uniform distribution with a range of 0 

to 8 percent using FDA-proposed 

criteria, from 0 to 7 percent using the 

industry-proposed criteria, and from 0 

to 10 percent by extending the current 

criteria for ‘‘main dish products.’’ The 

estimated ‘‘lean’’ market share and 

estimated fat contents relative to likely 

consumption-substitute ‘‘mixed dishes 

not measurable with a cup’’ are 

summarized in table 2 of this document. 

TABLE 2.—FAT CONTENT RELATIVE TO LIKELY CONSUMPTION-SUBSTITUTES AND THE MARKET SHARE FOR ‘‘LEAN’’ ‘‘MIXED

DISHES NOT MEASURABLE WITH A CUP’’

Fat Content in ‘‘Lean’’ Relative to the Average 

Fat Content in Likely Consumption-Substitute 

‘‘Mixed Dishes Not Measurable With a Cup’’

Market Share of ‘‘Lean’’

‘‘Mixed Dishes Not Measurable With a Cup’’

Option 2: Industry-petitioned Low: 47 percent 

High: 70 percent 

Average: 58 percent 

0 to 7 percent 

Option 3: Extending current criteria for ‘‘main dish products’’ Low: 67 percent 

High: 100 percent 

Average: 83 percent 

0 to 10 percent 

Option 4: FDA proposed Low: 53 percent 

High: 80 percent 

Average: 67 percent 

0 to 8 percent 

7. Estimating the Reduction in Fat 

Consumption From Allowing the 

‘‘Lean’’ Claim 

The use of the estimated market share 

for ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ may overstate 

the reduction in fat consumption if 

many consumers already consume FDAregulated products that would be 

eligible for the ‘‘lean’’ claim (without 

the claim on the label). Moreover, it is 

possible that some consumers may 

switch to ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ once they 

become available, from the ‘‘low-fat’’

alternatives they currently consume 

because of better taste. We estimate that 

one-half of all consumption of ‘‘lean’’

‘‘mixed dishes not measurable with a 

cup’’ would be from consumers that 

would switch from other ‘‘mixed dishes 

not measurable with a cup’’ that contain 

the same amount or less fat. 

Table 3 of this document shows the 

expected ‘‘lean’’ market share, percent 

reduction in fat consumption from the 

‘‘mixed dishes not measurable with a 

cup’’ category, and the percent 

reduction in fat consumption relative to 

current total fat consumption for each 

option considered here. Based on the 

criteria for fat, saturated fat, and 

cholesterol contents stated in each 

policy option, we estimate that the total 

amount of fat consumed for 0 to 7 

percent of ‘‘mixed dishes not 

measurable with a cup’’ will decline by 

between 10 and 24 percent (i.e., [(1 - 

0.80) x 100] / 2, and [(1 - 0.53) x 100)] 

/ 2) with a mean of 17 percent under the 

proposed option. For option 3, 

extending the current criteria for ‘‘main 

dish products’’ we expect the total 

amount of fat consumed for 0 to 12 

percent of ‘‘mixed dishes not 

measurable with a cup’’ to decline by 

between 0 and 17 percent (i.e., [(1 - 1) 

x 100] / 2, and [(1 - 0.67) x 100)] / 2), 

with a mean of 9 percent. Under the 

industry petitioned option we expect 

the total amount of fat consumed for 0 

to 6 percent of ‘‘mixed dishes not 

measurable with a cup’’ to decline by 

between 15 and 26 percent (i.e., [(1 - 

0.70) x 100] / 2, and [(1 - 0.47) x 100)] 

/ 2), with a mean of 21 percent. 

Because ‘‘mixed dishes not 

measurable with a cup’’ that are subject 

to FDA labeling requirements make up 

approximately 0.67 percent of total 

consumption, we estimate that total fat 

consumption could decline by about 

0.01 percent (i.e., 8 percent of ‘‘mixed 

dishes not measurable with a cup’’ x 17 

percent fat reduction (using the mean) x 

0.67 percent of total consumption 

rounded to the nearest hundredth) using 

the FDA proposed ‘‘lean’’ criteria, 

assuming that consumers do not 

increase their consumption of other 

foods including main dishes with 

weights over 6 oz and other foods with 

higher fat contents. 

TABLE 3.—MARKET SHARE AND PERCENT REDUCTION IN FAT CONSUMPTION FROM NEWLY LABELED ‘‘LEAN’’ ‘‘MIXED

DISHES NOT MEASURABLE WITH A CUP’’

Expected Market Share of 

‘‘Lean’’ ‘‘Mixed Dishes Not 

Measurable With a Cup’’

Mean Percent Reduction in 

Fat in ‘‘Mixed Dishes Not 

Measurable With a Cup’’

Subject to FDA Oversight 

Mean Percent Reduction in Total 

Fat Consumption 

Option 2: Industry-petitioned 6 percent 21 percent 0.0084 percent 

Option 3: Extending current criteria for ‘‘main dish products’’ 10 percent 9 percent 0.0141 percent 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71053 

TABLE 3.—MARKET SHARE AND PERCENT REDUCTION IN FAT CONSUMPTION FROM NEWLY LABELED ‘‘LEAN’’ ‘‘MIXED

DISHES NOT MEASURABLE WITH A CUP’’—Continued 

Expected Market Share of 

‘‘Lean’’ ‘‘Mixed Dishes Not 

Measurable With a Cup’’

Mean Percent Reduction in 

Fat in ‘‘Mixed Dishes Not 

Measurable With a Cup’’

Subject to FDA Oversight 

Mean Percent Reduction in Total 

Fat Consumption 

Option 4: FDA proposed 8 percent 17 percent 0.0113 percent 

As table 3 of this document shows, 

the reduction in fat consumption 

resulting from this proposed rule is 

likely to be quite small. Additional 

factors may mitigate further the 

reduction in fat intake resulting from 

the proposed rule. Because consumers 

may increase their consumption of other 

foods with higher fat and cholesterol 

contents to compensate for the lower fat 

and cholesterol contents of ‘‘lean’’

‘‘mixed dishes not measurable with a 

cup,’’ the mean estimated reduction in 

total fat and cholesterol consumption 

may be less than 0.01 percent. 

Moreover, we may be overestimating the 

reduction in fat consumption by not 

accounting for the increase in fat intake 

for current consumers of lower fat 

substitutes who, given the opportunity, 

would choose ‘‘lean’’ ‘‘mixed dishes not 

measurable with a cup’’ because of their 

perceived better taste. To incorporate 

uncertainty in the estimate, we assume 

the reduction in fat consumption from 

this proposed rule to be uniformly 

distributed between 0 and 0.02 percent, 

with 0.01 percent as the mean. 

8. The Distribution of Obese and 

Overweight Consumers Across Income 

Groups 

The distribution of overweight and 

obese consumers across income groups 

may be important when valuing the 

benefits from the proposed rule. 

Drewnowski and Spector find evidence 

that the highest rates of obesity occur 

among population groups with the 

highest poverty rates and the least 

education (Ref. 6). If the obesity rates 

are negatively related to income and 

education, and if low income consumers 

respond more to the higher prices than 

the lower fat contents of ‘‘lean’’

products, then the overall benefits from 

this proposed rule may be lower than 

anticipated. 

Prices for ‘‘lean’’ products will be 

higher than those for products with no 

nutrient content claim. For example, 

data collected by FDA on market shares 

for frozen dinners making nutrient 

content claims suggests an estimated 

average price of $2.92 per product, for 

a $0.32 price premium on frozen 

dinners making a ‘‘healthy’’ claim 

compared with frozen dinners of 

comparable size making a less stringent 

nutrient content claim (Ref. 9). We 

interpret this premium to imply that 

consumers of those frozen dinners place 

a $0.32 price premium (or 12.3 percent) 

per dinner on ‘‘nutrition’’

characteristics. Assuming that 

consumers hold the same preferences 

for taste and nutrition characteristics for 

‘‘mixed dishes not measurable with a 

cup’’ as they do for frozen dinners, we 

estimate a price premium (all else the 

same) for ‘‘mixed dishes not measurable 

with a cup’’ that make a ‘‘lean’’ claim 

to be somewhere between 0 and 12.3 

percent (note we estimate that the 

‘‘nutritious’’ premium may be lower 

than 12.3 percent because the nutrition 

criteria required for a ‘‘lean’’ claim are 

less stringent than that required for the 

‘‘healthy’’ claim). 

Consuming foods with lower fat 

content helps consumers who are not 

overweight with few health risks to 

maintain recommended fat intakes, and 

helps overweight and obese consumers 

at higher risk to reduce their fat intakes 

to recommended levels. Because obese 

people have the highest health risks, the 

benefits from reducing their fat 

consumption are acute and immediate, 

while those for reducing the dietary fat 

intake for trim consumers with low 

health risks are latent and realized only 

after a long period of time. We assume 

that the benefits obtained from this 

proposed rule by low-risk consumers 

will be smaller than those obtained by 

overweight and other high-risk 

consumers. If the obese population is 

disproportionately represented by lower 

income consumers, then that income 

groups’ relatively large response to the 

higher prices for ‘‘lean’’ ‘‘mixed dishes 

not measurable with a cup’’ will result 

in reduced benefits. 

Consequently, the health benefits 

derived from the enhanced ability of 

consumers to make healthier dietary 

choices among foods in the category of 

‘‘mixed dishes not measurable with a 

cup’’ subject of FDA regulatory 

oversight based on their fat contents, 

when such foods bear the ‘‘lean’’

nutrient content claim will be small. 

The category of ‘‘mixed dishes not 

measurable with a cup’’ comprises only 

1.3 percent of total food consumption, 

and we estimated that between 0 and 7 

percent of this category would actually 

bear a ‘‘lean’’ claim under the FDA 

proposed rule. Finally, we estimated 

that consumers would reduce their 

consumption of fat by between 0 and 

0.02 percent of current fat consumption 

with passage of the proposed rule. 

D. Costs 

The costs incurred by manufacturers 

of ‘‘mixed dishes not measurable with a 

cup’’ who choose to label their products 

as ‘‘lean’’ would be voluntarily incurred 

because no manufacturer would incur 

them if it weren’t profitable to do so. 

Nevertheless, we do anticipate an 

allocation of resources devoted to 

product reformulation, relabeling, new 

product development, and the 

discontinuation of product lines, as a 

result of this proposed rule, and that the 

magnitude of this resource allocation is 

important for characterizing the broader 

economic impact on society. 

The voluntarily incurred costs of the 

proposed rule include costs of 

reformulating and relabeling ‘‘mixed 

dishes not measurable with a cup’’ that 

would be newly able to make the ‘‘lean’’

claim, as well as the costs from 

discontinued production and new 

product development. ‘‘Mixed dishes 

not measurable with a cup’’ that 

currently satisfy the proposed ‘‘lean’’

criteria, but as yet, are not permitted to 

make the claim, would only incur 

labeling costs from this proposed rule, 

while those that reformulate will incur 

both reformation and labeling costs. The 

reformulating process includes 

laboratory testing of recipes that meet 

the required ‘‘lean’’ criteria, researching 

market prices and availability of new 

ingredients and necessary equipment, 

production testing in increasingly large 

batch sizes, and finally, consumer 

testing and marketing evaluations. At 

any stage in the process a product may 

be dropped from reformulation 

consideration. Products that undergo a 

portion of the process, but that are 

eventually dropped from consideration 

also constitute a reformulation cost. 

Labeling costs for ‘‘lean’’ products 

include the costs of testing food 

products to verify that the levels of fat, 

saturated fat, and cholesterol in the 

71054 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

package are consistent with the ‘‘lean’’

claim, as well as the fixed and variable 

printing costs for the new label and the 

storage costs associated with disposing 

old labels. 

We used the FDA Reformulation Cost 

Model (Ref. 10), the FDA Decision to 

Reformulate Model (Ref. 11), and the 

FDA Labeling Cost Model (Ref. 12) to 

estimate the reformulation and labeling 

costs from making ‘‘lean’’ claims on 

‘‘mixed dishes not measurable with a 

cup.’’ Data from NAICS 311412, Frozen 

Specialties NEC, incorporated in the 

Reformulation Cost Model were used in 

simulations to estimate the 

reformulation costs of ‘‘mixed dishes 

not measurable with a cup.’’ The total 

costs computed for the broad NAICS 

code are adjusted to account for the 

fraction of products within that category 

that are subject to FDA regulatory 

oversight and estimated to make the 

‘‘lean’’ claim for each option. 

Based on the earlier framework used 

to estimate the size of the market for 

‘‘mixed dishes not measurable with a 

cup,’’ we assume that 50 percent of the 

products in NAICS 311412 are ‘‘mixed 

dishes not measurable with a cup,’’ half 

are subject to FDA regulatory oversight, 

and 8 percent of those products will 

either reformulate in order to meet the 

‘‘lean’’ criteria, or only relabel if they 

already meet the ‘‘lean’’ criteria. We 

assume a uniform distribution between 

0 and 0.08 of the market share for 

‘‘lean’’ ‘‘mixed dishes not measurable 

with a cup’’ (subject to FDA regulatory 

oversight) for the proposed option, and 

a uniform distribution between 0 and 

0.07 for the industry-petitioned option. 

We justify the wide range because of the 

uncertainty surrounding our 

assumptions. 

Using FDA’s Decision to Reformulate 

Model, we estimate that between 80 and 

100 percent of the affected products 

using the ‘‘lean’’ label for ‘‘mixed dishes 

not measurable with a cup’’ will be 

reformulated products. The estimates 

generated from that model are derived 

from interviews with experts on the 

probability of reformulation by NAICS 

code or product category. Estimates at 

the lower end of the range (i.e., closer 

to 80 percent) represent those products 

that would incur higher reformulation 

costs if major ingredient substitutions 

are necessary to meet the ‘‘lean’’ criteria. 

At this range of difficulty the Decision 

to Reformulate Model estimates that 

between 5 and 6 percent of ‘‘mixed 

dishes not measurable with a cup’’

would be discontinued because the net 

benefits to the company from their 

reformulation are lower than those for 

their discontinuation. Estimates at the 

higher end of the range (i.e., closer to 

100 percent) represent those products 

that require only minor but critical 

ingredient substitutions. No product 

lines would be terminated at this end of 

the range. 

We assume that the fraction of the 

‘‘lean’’ market that would incur 

reformulation costs is uniformly 

distributed between 80 and 100 percent, 

with the fraction that only requires 

relabeling estimated as the remainder 

(i.e., between 0 and 20 percent). We 

used the average of the estimates 

generated from the Reformulation Cost 

Model for 80 and 100 percent 

reformulation rates. The estimates 

generated by the Reformulation Cost 

Model are derived from experts’

information on detailed reformulation 

costs by NAICS code including market 

research, product testing, consumer 

testing, and marketing costs and are 

reported as low, middle, and high 

values. We characterize uncertainty in 

our simulation by assuming triangular 

distributions for the 80 and 100 percent 

reformulation rates generated from the 

Reformulation Cost Model, using the 

reported low, middle, and high values 

from that model as the low, medium, 

and high parameters in that distribution. 

We assume that the costs of product 

lines that become discontinued are due 

to insufficient consumer demand, and 

those for new product development if 

this proposed rule were issued are equal 

to each other. This reflects the 

assumption that growth in the number 

of ‘‘mixed dishes not measurable with a 

cup’’ will not change as a result of this 

proposed rule. The Reformulation Cost 

Model estimates that for major 

ingredient substitution requirements 

between 5 and 6 percent of product 

lines will be discontinued. We assume 

the costs of products that are 

discontinued and those for new product 

development are both uniformly 

distributed between 0 and 6 percent of 

the costs of reformulation. 

We ran the Reformulation Cost Model 

for the case when minor and noncritical 

ingredient substitutions are necessary 

(in which case, 100 percent of the 

market will be reformulated products) 

and also for the case when minor but 

critical ingredient substitutions are 

necessary (in which case, 80 percent of 

the market will be reformulated 

products). The relabeling costs are 

estimated from FDA’s Labeling Cost 

Model, which also generates cost 

estimates by NAICS code. We further 

characterize uncertainty in our 

simulation by assuming a triangular 

distribution for labeling costs (for 

between 0 and 20 percent of the ‘‘lean’’

market) using the estimates of the low, 

medium, and high costs generated from 

the Labeling Cost Model as the low, 

medium, and high parameters in that 

distribution. 

Table 4 of this document reports 

ranges for estimates of reformulation 

costs, labeling costs, discontinued 

product line costs, and total costs for the 

proposed and industry-petitioned 

options, and for time periods of 12 and 

24 months for each option. The range 

reported for reformation costs from the 

proposed rule incorporates uncertainties 

in both the estimate of the ‘‘lean’’

market share, the probability for 

reformulation, and the reformulation 

costs generated by the Reformulation 

Cost Model. The range reported for the 

labeling costs from the proposed rule 

incorporates uncertainty in the 

estimates of the ‘‘lean’’ market share, 

reformulation costs, and the labeling 

costs generated by the Labeling Cost 

Model. The range of estimates reported 

for costs from discontinued product 

lines and new product development 

incorporate uncertainty in the estimates 

of the ‘‘lean’’ market share, 

reformulation costs, as well as the 

fraction of discontinued product lines 

generated from the Probability of 

Reformulation Model. The range of 

estimates of total costs reported in table 

4 reflects uncertainties in the estimates 

of all of the individual costs 

components. The low and high 

estimates in the respective ranges are 

the 5- and 95-percent levels computed 

by the computer simulation software 

@RiskTM, given the distributional 

assumptions made for each of the 

component costs. 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71055 

TABLE 4.—VOLUNTARILY INCURRED CHANGE-OVER COSTS FOR MAKING A ‘‘LEAN’’ CLAIM

Proposed Option 

(8% Market Share) 

Option 2: Industry-Petition 

(6% Market Share) 

Option 3: Extend Current Criteria 

to ‘‘Mixed Dishes Not Measurable 

With a Cup’’ (10% Market Share) 

12-month 

compliance 

(dollars) 

24-month 

compliance 

(dollars) 

12-month 

compliance 

(dollars) 

24-month 

compliance 

(dollars) 

12-month 

compliance 

(dollars) 

24-month 

compliance 

(dollars) 

Reformulation costs 

low 657,000 423,000 365,000 267,000 821,000 529,000 

mean 7,801,000 4,880,000 4,235,000 3,149,000 9,751,000 6,100,000 

high 16,249,000 10,617,000 8,541,000 6,749,000 20,311,000 13,271,000 

Labeling costs 

low 12,000 14,000 7,000 9,000 15,000 18,000 

mean 306,000 158,000 197,000 102,000 382,000 198,000 

high 885,000 914,000 549,000 680,000 1,106,000 1,143,000 

Discontinued 

low 7,000 4,000 4,000 3,000 8,000 5,000 

mean 234,000 146,000 127,000 94,000 293,000 183,000 

high 665,000 400,000 355,000 276,000 832,000 500,000 

New product development 

low 3,000 2,000 2,000 1,000 4,000 3,000 

mean 117,000 73,000 54,000 40,000 146,000 92,000 

high 333,000 200,000 152,000 118,000 416,000 250,000 

Total costs 

low 1,095,000 749,000 583,000 441,000 1,369,000 936,000 

mean 8,574,000 5,331,000 4,686,000 8,026,000 10,718,000 6,664,000 

high 17,690,000 10,892,000 9,862,000 7,353,000 22,112,000 13,615,000 

Table 5 of this document reports the 

annualized change-over costs for the 

proposed rule, which we computed 

assuming the discount rates of 3 and 7 

percent over an infinite time horizon for 

assumed 12- and 24-month periods for 

relabeling and reformulation. For a 12- 

month period all costs are assumed to 

be incurred in the beginning of the 

second year. For a 24-month period all 

costs are assumed to be incurred in the 

beginning of the third year. Because 

producers choose the time period for the 

reformulation and relabeling of 

products, the actual time periods for the 

changes can be of any length, with the 

costs differing from those in table 5. 

From our labeling cost and 

reformulation models, however, we 

expect that costs would be substantially 

higher for time periods under 12 

months, and substantially lower for time 

periods over 24 months. We also expect 

that the time periods chosen would be 

shorter and the costs higher, the greater 

the perceived consumer response to 

these product claims. 

TABLE 5.—ANNUALIZED VOLUNTARILY

INCURRED CHANGE-OVER COSTS

FOR PROPOSED RULE

12-Month 

Period 

24-Month 

Period 

3 percent discount rate 

5 percent (low) $32,000 $21,000 

mean $250,000 $151,000 

95 percent (high) $515,000 $308,000 

7 percent discount rate 

5 percent (low) $72,000 $46,000 

TABLE 5.—ANNUALIZED VOLUNTARILY

INCURRED CHANGE-OVER COSTS

FOR PROPOSED RULE—Continued 

12-Month 

Period 

24-Month 

Period 

mean $561,000 $326,000 

95 percent (high) $1,158,000 $666,000 

V. Regulatory Flexibility Analysis 

FDA has examined the economic 

implications of this proposed rule as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612). The Regulatory 

Flexibility Act requires that agencies 

analyze regulatory options that would 

minimize any significant impact of a 

rule on small entities. The proposed 

rule, if finalized, would permit firms to 

add a ‘‘lean’’ claim to their labels if their 

products meet certain criteria. Small 

71056 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 

firms may voluntary add this claim if 

they so choose. No small firm, however, 

will choose to bear the cost of adding 

the ‘‘lean’’ claim to its product labels 

unless the firm believes that it will lead 

to increased sales of its product 

sufficient to justify the costs. The rule 

would not mandate that firms make any 

labeling changes. This proposed rule, if 

finalized, would not impose compliance 

costs on any small business. Therefore, 

the agency certifies that the proposed 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

VI. Unfunded Mandates 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4) requires that agencies 

prepare a written statement which 

includes an assessment of anticipated 

costs and benefits, before proposing 

‘‘any rule that includes a Federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $115 million, 

using the most current (2003) Implicit 

Price Deflator for the Gross Domestic 

Product (GDP) (i.e., $100 million x 

[2003 Implicit GDP deflator / 1995 GDP 

deflator]). FDA does not expect this 

proposed rule to result in any 1-year 

expenditure that would meet or exceed 

this amount, and has determined that 

this proposed rule does not constitute a 

significant rule under the Unfunded 

Mandates Reform Act. 

VII. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has tentatively concluded that 

the rule does not contain policies that 

have federalism implications as defined 

in the Executive order and, 

consequently, a federalism summary 

impact statement is not required. 

VIII. Environmental Impact 

FDA has determined under 21 CFR 

25.32(p) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

IX. Paperwork Reduction Act of 1995 

FDA has tentatively concluded that 

this proposed rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

X. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. If you base 

your comments on scientific evidence or 

data, please submit copies of the 

specific information along with your 

comments. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

XI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site addresses, but we are not 

responsible for subsequent changes to 

the Web sites after this document 

publishes in the Federal Register.) 

1. Petition to expand ‘‘lean’’ nutrient 

content claim, submitted by Nestle ́ Prepared 

Foods Corp., January 4, 2004. 

2. U.S. Department of Health and Human 

Services and U.S. Department of Agriculture, 

Dietary Guidelines for Americans, 2005. 

3. U.S. Census Bureau, 1997 Economic 

Census, December 17, 2002. 

4. Economic Research Service, http:// 

www.ers.usda.gov/Briefing/ 

CPIFoodAndExpenditures/Data/ 

cpiforecasts.htm, accessed November 8, 

2004. 

5. Teisl, M., and A. Levy, ‘‘Does Nutrition 

Labeling Lead to Healthier Eating?’’ Journal 

of Food Distribution Research, October 1997. 

6. Drewnowski, A., and S. Specter, 

‘‘Poverty and Obesity: The Role of Energy 

Density and Energy Costs,’’ The American 

Journal of Clinical Nutrition, vol. 79, 1:6–16, 

January 2004. 

7. LeGault, L., M. Brandt, N. McCabe, C. 

Adler, A. Brown, and S. Brecher, ‘‘2000–2001 

Food Label and Package Survey: An Update 

on Prevalence of Nutrition Labeling and 

Claims on Processed, Packaged Foods,’’

Journal of the American Dietetic Association, 

104:952–958, 2004. 

8. USDA, National Nutrient Database for 

Standard Reference, Release 18 (2005), http:// 

www.nal.usda.gov/fnic/foodcomp/search/, 

accessed on September 15, 2005. 

9. Mancini, D., FDA, Center for Food Safety 

and Applied Nutrition, memorandum to file, 

May 23, 2002. 

10. RTI International, Cost of 

Reformulating Foods and Cosmetics, Final 

Report, prepared for Ed Puro, FDA, Center for 

Food Safety and Applied Nutrition, prepared 

by White, W.J., E. Gledhill, S. Karns, and M. 

Muth, RTI Project Number 08184.003, July 

2002. 

11. RTI International, Modeling the 

Decision to Reformulate Foods and 

Cosmetics, Final Report, prepared for David 

Zorn, FDA, Center for Food Safety and 

Applied Nutrition, prepared by Muth, M., S. 

Karns, D. Anderson, M. Coglaiti, and M. 

Fanjoy, RTI Project Number 08184.005, 

October 2003. 

12. RTI International, FDA Labeling Cost 

Model, Final Report, prepared for Amber 

Jessup, FDA, Center for Food Safety and 

Applied Nutrition, prepared by Muth, M., E. 

Gledhill, and S. Karns, RTI Project Number 

06673.010, January 2003. 

List of Subjects in 21 CFR Part 101 

Food labeling, Nutrition, Reporting 

and recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 101 be amended as follows: 

PART 101—FOOD LABELING 

1. The authority citation for 21 CFR 

part 101 continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 21 

U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 

243, 264, 271. 

2. Section 101.62 is amended by 

revising paragraph (e) to read as follows: 

§ 101.62 Nutrient content claims for fat, 

fatty acid, and cholesterol content of foods. 

* * * * * 

(e) ‘‘Lean’’ and ‘‘extra lean’’ claims. 

(1) The term ‘‘lean’’ may be used on the 

label or in labeling of foods, except meal 

products as defined in § 101.13(l) and 

main dish products as defined in 

§ 101.13(m), provided that the food is a 

seafood or game meat product and, as 

packaged, contains less than 10 g total 

fat, 4.5 g or less saturated fat, and less 

than 95 mg cholesterol per reference 

amount customarily consumed and per 

100 g; 

(2) The term defined in paragraph 

(e)(1) of this section may be used on the 

label or in labeling of a mixed dish not 

measurable with a cup as defined in 

table 2 of § 101.12(b), provided that the 

food contains less than 8 g total fat, 3.5 

g or less saturated fat, and less than 80 

mg cholesterol per reference amount 

customarily consumed; 

(3) The term defined in paragraph 

(e)(1) of this section may be used on the 

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Proposed Rules 71057 

label or in labeling of meal products as 

defined in § 101.13(l) or main dish 

products as defined in § 101.13(m), 

provided that the food contains less 

than 10 g total fat, 4.5 g or less saturated 

fat, and less than 95 mg cholesterol per 

100 g and per labeled serving; 

(4) The term ‘‘extra lean’’ may be used 

on the label or in labeling of foods, 

except meal products as defined in 

§ 101.13(l) and main dish products as 

defined in § 101.13(m), provided that 

the food is a discrete seafood or game 

meat product and as packaged contains 

less than 5 g total fat, less than 2 g 

saturated fat, and less than 95 mg 

cholesterol per reference amount 

customarily consumed and per 100 g; 

and 

(5) The term defined in paragraph 

(e)(4) of this section may be used on the 

label or in labeling of meal products as 

defined in § 101.13(l) and main dish 

products as defined in § 101.13(m), 

provided that the food contains less 

than 5 g of fat, less than 2 g of saturated 

fat, and less than 95 mg of cholesterol 

per 100 g and per labeled serving. 

* * * * * 

Dated: November 18, 2005. 

Michael M. Landa, 

Deputy Director for Regulatory Affairs, Center 

for Food Safety and Applied Nutrition. 

[FR Doc. 05–23293 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9, 122, 123, 124, and 125 

[OW–2004–0002, FRL–8002–3] 

RIN 2040–AD70 

National Pollutant Discharge 

Elimination System Proposed 

Regulations To Establish 

Requirements for Cooling Water Intake 

Structures at Phase III Facilities; 

Notice of Data Availability 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of data availability. 

SUMMARY: On November 24, 2004, EPA 

published proposed regulations to 

establish requirements for cooling water 

intake structures at Phase III facilities 

under section 316(b) of the Clean Water 

Act (CWA). EPA proposed the following 

three options for defining which 

existing facilities would be subject to 

uniform national requirements, based 

on the facility’s design intake flow 

threshold and source waterbody type: 

The facility has a total design intake 

flow of 50 million gallons per day 

(MGD) or more, and withdraws from 

any waterbody; the facility has a total 

design intake flow of 200 MGD or more, 

and withdraws from any waterbody; or 

the facility has a total design intake flow 

of 100 MGD or more and withdraws 

specifically from an ocean, estuary, tidal 

river, or one of the Great Lakes. The 

proposed rule would also establish 

national section 316(b) requirements for 

new offshore oil and gas extraction 

facilities. This notice of data availability 

(NODA) summarizes significant data 

EPA received or collected since 

publication of the proposed rule and 

discusses how EPA may use this data in 

revising its analyses. EPA solicits public 

comment on the information presented 

in this notice and the record supporting 

this notice. 

DATES: Comments on this notice of data 

availability must be received or 

postmarked on or before midnight 

December 27, 2005. 

ADDRESSES: Comments may be 

submitted by mail addressed to Water 

Docket, Environmental Protection 

Agency, Mailcode: 4101T, 1200 

Pennsylvania Ave., NW., Washington, 

DC, 20460, Attention Docket ID No OW–

2004–0002. Comments may also be 

submitted electronically, or by hand 

delivery. Follow the detailed 

instructions as provided in Section B.1 

of the SUPPLEMENTARY INFORMATION

section to file comments electronically. 

FOR FURTHER INFORMATION CONTACT: For 

additional technical information contact 

Paul Shriner at (202) 566–1076. For 

additional economic information 

contact Erik Helm at (202) 566–1066. 

For additional biological information 

contact Ashley Allen at (202) 566–1012. 

The e-mail address for the above 

contacts is rule.316b@epa.gov. 

SUPPLEMENTARY INFORMATION: 

General Information 

A. How Can I Get Copies of This 

Document and Other Related 

Information? 

1. Docket. EPA has established an 

official public docket for this action 

under Docket ID No. OW–2004–0002. 

The official public docket consists of the 

documents specifically referenced in 

this action, any public comments 

received, and other information related 

to this action. Although a part of the 

official docket, the public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The official public docket is the 

collection of materials that is available 

for public viewing at the Water Docket 

in the EPA Docket Center, (EPA/DC) 

EPA West, Room B102, 1301 

Constitution Ave., NW., Washington, 

DC. The EPA Docket Center Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the Water Docket is (202) 

566–2426. 

2. Electronic Access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. 

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, EPA Dockets. You may use EPA 

Dockets at http://www.epa.gov/edocket/ 

to submit or view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Once in the system, select ‘‘search,’’

then key in the appropriate docket 

identification number. 

Certain types of information will not 

be placed in the EPA Dockets. 

Information claimed as CBI and other 

information whose disclosure is 

restricted by statute, which is not 

included in the official public docket, 

will not be available for public viewing 

in EPA’s electronic public docket. EPA’s 

policy is that copyrighted material will 

not be placed in EPA’s electronic public 

docket but will be available only in 

printed, paper form in the official public 

docket. To the extent feasible, publicly 

available docket materials will be made 

available in EPA’s electronic public 

docket. When a document is selected 

from the index list in EPA Dockets, the 

system will identify whether the 

document is available for viewing in 

EPA’s electronic public docket. 

Although not all docket materials may 

be available electronically, you may still 

access any of the publicly available 

docket materials through the docket 

facility identified in Section A.1. EPA 

intends to work towards providing 

electronic access to all of the publicly 

available docket materials through 

EPA’s electronic public docket. 

For public commenters, it is 

important to note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing in EPA’s electronic public 

docket as EPA receives them and 

without change, unless the comment 

contains copyrighted material, CBI, or 

other information whose disclosure is 

restricted by statute. When EPA