Lowfat and Skim Milk Products, Lowfat and Nonfat Yogurt Products, Lowfat Cottage Cheese: Revocation of Standards of Identity; Food Labeling, Nutrient Content Claims for Fat, Fatty Acids, and Cholesterol Content of Food

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 131, and 133

[Docket Nos. 95P-0125, 95P-0250, 95P-0261, and 95P-0293]

Lowfat and Skim Milk Products, Lowfat and Nonfat Yogurt Products,

Lowfat Cottage Cheese: Revocation of Standards of Identity; Food

Labeling, Nutrient Content Claims for Fat, Fatty Acids, and Cholesterol

Content of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is removing the

standards of identity for various lowfat milk, sour half-and-half, and

cottage cheese products, based in part on a petition filed jointly by

the Milk Industry Foundation (MIF) and the Center for Science in the

Public Interest (CSPI), and a petition filed by the American Dairy

Products Institute (ADPI). FDA is also amending the standard of

identity for dry cream; deferring action on its proposal to revoke the

standards of identity for lowfat and nonfat yogurt; and amending the

nutrient content claims regulations for fat, fatty acids, and

cholesterol content to provide for ``skim'' as a synonym for ``nonfat''

when used in labeling milk products. This rule will provide for

consistency in the nomenclature and labeling of most nutritionally

modified milk products and other foods bearing ``lowfat'' and

``nonfat'' claims; promote honesty and fair dealing in the interest of

consumers; increase flexibility for manufacturers of lower-fat dairy

products; and increase product choices available to consumers. This

action is a part of the agency's ongoing review of existing regulations

under President Clinton's Regulatory Reinvention Initiative.

DATES: Effective January 1, 1998, except as to any provisions in

revised parts 131 and 133 (21 CFR parts 131 and 133) that may be stayed

by, or as a result of, the filing of proper objections. Compliance may

begin on November 20, 1996. If any provisions are stayed, FDA will

publish timely notification in the Federal Register. Written objections

and requests for a hearing for parts 131 and 133 by December 20, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

[[Page 58992]]

FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food

Safety and Applied Nutrition (HFS-158), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. Background

A. Regulatory History

One of the main purposes of the Nutrition Labeling and Education

Act of 1990 (the 1990 amendments) (Pub. L. 101-535), which amended the

Federal Food, Drug, and Cosmetic Act (the act), was to establish the

circumstances in which claims that describe the nutrient content of

food could be made. In response to the mandates of the 1990 amendments,

in part 101 (21 CFR part 101), FDA established definitions for specific

nutrient content claims together with principles for their use

(hereinafter referred to as the nutrient content claims final rule) (58

FR 2302, January 6, 1993). In addition, in the Federal Register of

January 6, 1993 (58 FR 2431), FDA published a final rule, entitled

``Food Standards: Requirements for Foods Named by Use of a Nutrient

Content Claim and a Standardized Term'' (hereinafter referred to as the

general standard final rule), which established the general standard in

Sec. 130.10 (21 CFR 130.10) for foods named by use of a nutrient

content claim defined in part 101, such as ``nonfat,'' ``lowfat,''

``reduced fat,'' ``light,'' or ``reduced calorie,'' in conjunction with

a standardized term, for example, ``sour cream.''

As FDA noted in that final rule, certain standards of identity for

dairy products incorporate terms such as ``nonfat,'' ``light,'' and

``lowfat'' in the names of the foods, such as the standards for lowfat

dry milk (Sec. 131.123), nonfat dry milk (Sec. 131.125), nonfat dry

milk fortified with vitamins A and D (Sec. 131.127), lowfat milk

(Sec. 131.135), acidified lowfat milk (Sec. 131.136), cultured lowfat

milk (Sec. 131.138), light cream (Sec. 131.155), lowfat yogurt

(Sec. 131.203), nonfat yogurt (Sec. 131.206), and lowfat cottage cheese

(Sec. 133.131). The agency has also established standards for skim milk

products that provide for use of the synonym ``nonfat'' in place of the

term ``skim'' in the names of these foods. The use of the terms

``nonfat,'' ``light,'' and ``lowfat'' in some of the names in these

standards are inconsistent with the definitions established for the

same terms as nutrient content claims under the 1990 amendments.

Under section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)), a

food is misbranded if it bears a claim that characterizes the level of

any nutrient unless the claim is made using terms defined by the

regulations of the Secretary of the Department of Health and Human

Services (the Secretary). Section 403(r)(5)(C) of the act provides an

exemption from this requirement, however, for nutrient content claims

that are part of the name of a food that is defined by a standard of

identity that was issued before enactment of the 1990 amendments.

However, the legislative history of the 1990 amendments affirmed that

the Secretary (and, by delegation FDA) has the authority to amend the

standards of identity to conform with the regulations issued under

section 403(r) of the act (H. Rept. 101-538, 101st Cong., 2d sess. 22

(1990)).

The agency stated in the general standard final rule that, at a

later date, it would consider amending the existing standards of

identity for foods that use nutrient content claims in their names to

make the content requirements for these foods consistent with the

claims definitions that it adopted (58 FR 2431 at 2444). The agency

stated that, alternatively, it could delete some of the standards and

allow the foods defined by these standards to be named using a nutrient

content claim with a standardized term in accordance with the general

standard (Sec. 130.10).

B. Petitions

Two petitions dated May 10, 1995 (Docket No. 95P-0125) and August

2, 1995 (Docket No. 95P-0250), respectively, were filed by MIF and

CSPI. These petitions requested that the agency revoke the standards of

identity for lowfat milk (Sec. 131.135) and skim milk (Sec. 131.143),

as well as those for certain related lower-fat dairy products in parts

131 and 133 (i.e., sweetened condensed skimmed milk (Sec. 131.122),

acidified lowfat milk (Sec. 131.136), cultured lowfat milk

(Sec. 131.138), acidified skim (nonfat) milk (Sec. 131.144), cultured

skim (nonfat) milk (Sec. 131.146), sour half-and-half (Sec. 131.185),

acidified sour half-and-half (Sec. 131.187), lowfat yogurt

(Sec. 131.203), nonfat yogurt (Sec. 131.206), and lowfat cottage cheese

(Sec. 133.131)). The petitions requested that FDA regulate these

products under the general standard in Sec. 130.10. Subsequently, ADPI

filed a petition (Docket No. 95P-0261) requesting that the agency

revoke the standards of identity for two additional products in part

131, evaporated skimmed milk (Sec. 131.132) and lowfat dry milk

(Sec. 131.123), and that it amend the standard of identity for dry

cream in Sec. 131.149 by removing the reference to Sec. 131.135 (the

lowfat milk standard). The petitioners stated that the purpose of their

request is to promote consistency in the use of nutrient content claims

concerning fat on food labels and to remove product specifications that

potentially conflict with authorized nutrient content claims applicable

to foods in general.

MIF submitted a third petition, dated August 2, 1995 (Docket No.

95P-0293), requesting that, if FDA revokes the standards for skim milk

products, it concurrently amend the nutrient content claims regulations

in Sec. 101.62 to permit the continued use of the term ``skim'' as a

synonym for the term ``nonfat.'' A similar petition, dated August 10,

1995 (Docket No. 95P-0293), was submitted by ADPI.

C. Regulatory Reinvention Initiative--Review of Regulations

This final rule is a part of a larger agency project being

undertaken in response to President Clinton's memorandum of March 4,

1995, to heads of departments and agencies, entitled ``Regulatory

Reinvention Initiative.'' This memorandum, among other things, directs

departments and agencies to do a page-by-page review of their

regulations and to eliminate or revise those that are outdated or

otherwise in need of reform. The review of the standards of identity

for dairy products revealed that a number of the products that are

defined by individual standards in parts 131 and 133 could be more

appropriately covered by the general standard in Sec. 130.10.

D. The Proposal

In the Federal Register of November 9, 1995 (60 FR 56541), FDA

proposed (hereinafter referred to as the November 9, 1995, proposal) to

remove those standards cited by the MIF, CSPI, and ADPI petitions that

are inconsistent with food labeling regulations established under the

1990 amendments and that are unnecessary in light of the general

standard in Sec. 130.10. Interested parties were given until January

23, 1996, to comment on the proposal.

II. Summary of and Response to Comments to Proposal

FDA received 15 letters, each containing one or more comments, on

the November 9, 1995, proposal. The majority of comments supported the

proposal. A few comments expressed concerns about, or included

suggestions for, implementing the proposed revocations. Several

comments addressed issues outside the scope of the proposal (e.g.,

amending the milk solids content requirements in whole

[[Page 58993]]

milk) that will not be discussed here. A summary of the comments and

the agency's responses follow.

A. ``Skim'' as a Synonym for ``Nonfat''

As noted in the November 9, 1995, proposal (60 FR 56541 at 56543),

MIF and CSPI stated that most products currently labeled as ``nonfat

milk'' would be eligible to retain that name under the general standard

because these products generally contain less than 0.5 gram (g) of fat

per serving, which would comply with the definition of ``nonfat'' in

Sec. 101.62(b)(1)(i). However, the fat content claims regulations in

Sec. 101.62 do not authorize the use of the term ``skim.''

Consequently, at the request of the petitioners, and because of its

historic use in dairy product nomenclature, FDA proposed to amend the

fat content claims regulations in Sec. 101.62(b)(1)(i) to provide for

``skim'' as a synonym for ``nonfat'' when used in labeling milk

products.

1. All comments that addressed this issue supported FDA's proposal

to provide for the use of the term ``skim.'' Several comments

maintained that most consumers understand that ``skim'' and ``nonfat''

have the same meaning. Other comments noted consumers' reliance on the

term ``skim'' to readily identify nonfat milk products.

Thus, given the support expressed in comments to the November 9,

1995, proposal, and given consumer reliance on the term ``skim'' to

identify nonfat milk products, FDA is amending its claims regulations

under sections 403(r) and 701(a) of the act (21 U.S.C. 371(a)) to

provide for the use of the term ``skim'' as a synonym for ``nonfat'' in

describing milk products (Sec. 101.62(b)(1)). Because of the history of

use of the term ``skim'' to identify nonfat milk products, FDA

concludes that providing for continued use of this term to identify

nonfat milk products will minimize consumer confusion and facilitate

trade.

B. Dry Cream

As noted in the November 9, 1995, proposal (60 FR 56541 at 56542),

ADPI requested that the agency amend the standard of identity for dry

cream in Sec. 131.149 by removing the reference to Sec. 131.135 (the

lowfat milk standard, which FDA proposed to revoke). The petitioner

maintained that the requested change would bring the standard for dry

cream into conformity with the other suggested changes in the milk

product standards. FDA agreed with ADPI that, because it was proposing

to delete the standard of identity for lowfat milk (Sec. 131.135),

reference to that standard should be deleted from the standard of

identity for dry cream (60 FR 56541 at 56545). Therefore, the agency

proposed to amend the standard of identity for dried cream to remove

the reference to the standard of identity for lowfat milk. FDA did not

receive any comments on this proposed action. Consequently, FDA is

amending the standard of identity for dry cream in Sec. 131.149, in the

manner that it proposed.

C. Percent Fat Declaration

As noted in the November 9, 1995, proposal (60 FR 56541 at 56544),

MIF stated in its petition that it views the indication of the milkfat

percentage before the name of the product as an indispensable aspect of

lower-fat milk labeling because consumers have come to rely so heavily

on these numbers to differentiate among milk products. The petitioner

further stated that it would not be requesting the revocation of the

lower-fat milk standards if it believed that such an action would

affect milk processors' ability to state the milkfat percentage in the

name of the foods.

FDA responded to this concern in the November 9, 1995, proposal,

noting that while standards of identity require that the percentage of

milkfat be declared as part of the name of the food (e.g., lowfat

cottage cheese (Sec. 133.131(b)(2)), there is no provision requiring

percentage declaration of milkfat content in the name of the food under

Sec. 130.10. However, under Sec. 101.13(i), manufacturers may continue

to declare fat content as part of the name of the food for lower-fat

milk products, and on the labels of other products, when such

statements are not misleading.

2. Two comments expressed concern about percent fat labeling in

general but stated that, in the case of reduced fat and lowfat milk

products, special circumstances mitigate these concerns. These comments

noted that, under Sec. 130.10, lower-fat milks, originally exempt from

the 1990 amendments, will need to comply with the claims requirements.

Thus, percentage fat declaration would appear only on labels of milk

products that qualify to make a fat content claim (i.e., that contain

at least 25 percent less fat compared to whole milk). The comments also

noted that fat content per serving is provided in nutrition labeling,

and that products labeled as ``reduced fat'' must also bear a

comparative statement comparing the amount of fat per serving of the

food with the amount of fat in the reference food (Sec. 101.62(b)(4)).

The comments concluded that, therefore, percent fat declaration on

labels of milk products that are lower in fat than whole milk would not

be misleading.

FDA agrees with the comments that the nutrient content claims

requirements (Sec. 101.13(i)(1)) will be sufficient to ensure that,

when percent fat labeling in the names of reduced fat and lowfat milk

products characterizes the level of fat in the food, such statements

are consistent with the terms defined under the act. Furthermore, under

Sec. 101.13(i)(3), foods that do not meet the requirements for a

nutrient content claim (e.g., whole milk containing 3.25 percent

milkfat) may still bear statements about the percent milkfat in the

food provided that the statement does not in any way implicitly

characterize the level of fat in the food, and that it is not false or

misleading in any respect.

D. Light Cream

In the November 9, 1995, proposal (60 FR 56541 at 56545), the

agency noted that standards of identity for two cream products contain

the term ``light'' in the name of the foods, i.e., light cream in

Sec. 131.155 and light whipping cream in Sec. 131.157. FDA noted that

these products have a different texture than the higher fat cream

product, heavy cream, defined in Sec. 131.150. Because of the long

history of use of these names (since 1940), FDA did not propose to

change these standards. However, FDA requested comment on the

appropriateness of these names and on whether consumers find the use of

the term ``light'' in the names of these foods to be misleading. The

agency stated that if comments demonstrated that amendment of these

regulations is necessary, such action would be the subject of a later

rulemaking.

3. One comment objected to the continued use of the term ``light''

in the names ``light cream'' and ``light whipping cream.'' The comment

maintained that retaining the term ``light'' in the names of these

foods would undermine the agency's attempt to make all dairy products

subject to the same nutrient content claim definitions as other food

products. The comment did not, however, include any data or other

evidence that consumers find the use of the term ``light'' in the names

of these foods to be misleading.

As the agency noted in the nutrient content claims final rule (58

FR 2302 at 2359), the term ``light'' can be used to describe physical

or sensory characteristics of a food (e.g., to describe color or

texture). The agency also stated that, to the extent that the term

``light'' had become part of the statement of identity (i.e., it

describes characteristics of a food), use of the term would not be

considered a nutrient content claim (58 FR 2302 at 2359). FDA notes

that the

[[Page 58994]]

standards of identity for light cream (Sec. 131.155) and light whipping

cream (Sec. 131.157) describe foods that differ from heavy cream

(Sec. 131.150) in that they are less dense. The agency acknowledges

that light cream and light whipping cream also contain less milkfat

compared to heavy cream, and that it is this difference in fat content

that is largely responsible for differences in the density of these

products. However, FDA does not have any evidence, nor did the comment

provide any, that the use of the term ``light'' in the names of these

standardized foods is misleading. Therefore, FDA is not persuaded that

there is a need to amend or revoke the standards of identity for light

cream or light whipping cream. However, FDA reiterates that if it is

demonstrated that amendment of these regulations is necessary to

prevent consumers from being misled, such action will be the subject of

a future rulemaking.

E. Deviations From Traditional Products

4. A few comments expressed concern about how the composition of

traditional dairy products may change under the general standard. One

comment questioned the impact of this action on consumer acceptance of

new products, while another comment stated that FDA may need to educate

consumers about the possible changes in ingredients and characteristics

of foods to which they have become accustomed.

FDA acknowledges that this action will permit products to be

formulated in ways that were not previously allowed. For example,

Sec. 130.10 will allow a product named ``nonfat milk'' to contain

flavors, colors, and texturizers that provide defatted milk with the

sensory properties of whole milk. The standard of identity for nonfat

milk does not permit the addition of such flavors, colors, and

texturizers. Some manufacturers may continue to produce foods under

Sec. 130.10 that are identical to the traditional lower-fat dairy

products to which consumers have become accustomed, except that

nutrient content claims in the name of the food (e.g., nonfat milk or

lowfat cottage cheese) will be subject to the claims requirements.

Alternatively, some manufacturers may choose to formulate new products,

e.g., a nonfat milk product with the sensory characteristics of whole

milk.

Further, some individuals may prefer a new food to a traditional

food, whereas others may prefer the traditional food. It is not the

function of the agency to determine the likes or dislikes of consumers.

Rather, the function of the agency is to ensure that foods are safe,

and that labeling is informative and not misleading. Section 130.10

provides for proper labeling of these foods and their ingredients.

Adequate product labeling, including defined nutrient content claims,

label statements required to accompany certain claims, nutrition

labeling, and ingredient declaration, will enable consumers to

distinguish traditional foods from modified versions of these products.

5. One comment maintained that the driving force behind the

petitioners' request to revoke the standards of identity for lower-fat

dairy products is to allow manufacturers to use ``non-dairy fillers''

in lower-fat dairy products made under the general standard, thus

cheapening the standardized products.

FDA disagrees with the comment's contention that this action would

promote the cheapening of products covered by standards of identity. As

noted in response to the preceding comment, this action will permit

products to be formulated in ways that were not previously allowed.

However, Sec. 130.10 contains a number of provisions to ensure that

modified foods named by use of a nutrient content claim and a

standardized term bear a close enough resemblance to the standardized

food to warrant use of the term. For example, ingredients required by

the standard must be present in the substitute food and may not be

replaced by a similar ingredient from another source. Ingredients

prohibited by the standard are also prohibited in modified foods made

under the general standard. Ingredients not provided for, and

ingredients used in excess of the levels provided for, by the standard

must be identified, at least in the ingredient declaration.

Furthermore, in the preamble for the general standard final rule (58 FR

2431 at 2439), FDA specifically provided examples of circumstances in

which certain ingredients, such as caseinate, would, or would not, be

appropriate for use in dairy products made under Sec. 130.10. FDA

concludes, therefore, that the provisions set out in Sec. 130.10 are

adequate in this regard.

F. Vitamin Addition--Milk Products

As noted in the November 9, 1995, proposal (60 FR 56541 at 56545),

under the existing standards of identity for lowfat and skim milk

products in part 131, vitamin A addition is mandatory, while vitamin D

addition is optional. Vitamin A is required to be added to a level of

2,000 International Units (IU) per quart (500 IU or 10 percent of the

daily value (DV) per reference amount customarily consumed (RACC)).

When vitamin D is added to lower-fat milk products, the level must be

400 IU per quart (100 IU or 25 percent of the DV per RACC). However,

under the general standard, the only requirement for lower-fat milk

products is that they not be nutritionally inferior to milk as defined

in Sec. 131.110. The standard of identity for whole milk provides for

the optional addition of vitamin A to a level of not less than 2,000 IU

per quart and vitamin D to a level of 400 IU per quart. Because the

addition of these nutrients to whole milk is optional, their addition

at these levels to lower-fat milks under Sec. 130.10 would also be

optional.

On average, whole milk, before fortification, contains

approximately 6 percent of the DV of vitamin A per RACC. Thus, lower-

fat milks made according to Sec. 130.10 may contain less vitamin A than

currently required under the standards of identity for lowfat and skim

milks.

6. Two comments urged FDA to retain current levels of vitamin A and

D in lower-fat milk products to ensure that reduced fat, lowfat, and

nonfat milk contain sufficient amounts of these vitamins. These

comments noted the importance of standardized, lower-fat milks as a

dietary source of vitamins A and D. One comment expressed concern that,

in the absence of the standards of identity, the levels of vitamins A

and D in lower-fat milk products would decline. Another comment

appeared to believe that revoking the standards of identity for lower-

fat milks would allow these products to have less vitamin A and D than

whole milk. Based on this assumption, the comment stated that some

consumers may be discouraged from drinking the lower-fat milks. One

comment acknowledged that, while the addition of vitamin D is currently

optional for all milk products, most fluid milk (up to 95 percent) is

fortified to contain 400 IU per quart. However, the comment urged FDA

to take the opportunity of this rulemaking to make the addition of

vitamin D mandatory for all fluid milk.

In contrast, another comment stated that revoking the standards of

identity for lower-fat milk products would not diminish the nutritional

benefits of these foods. This comment maintained that the current milk

fortification practices would almost certainly continue in the absence

of the specific standards of identity for lower-fat milks. In support

of its contention, the comment noted that the general standard

(Sec. 130.10(b)) requires that a food named by use of a nutrient

content claim and a standardized term be nutritionally equivalent to

its

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standardized counterpart. The comment stated that since the process of

removing fat from milk unavoidably removes some vitamin A, processors

will have to add some amount of vitamin A to lower-fat milk products to

bring their vitamin A levels at least up to the level naturally found

in whole milk (i.e., approximately 6 percent of the DV per RACC).

However, under the applicable terms of the whole milk standard

(Sec. 131.110), processors will still have the option of fortifying

lower-fat milk products with vitamin A up to 10 percent of the DV per

RACC.

The comment maintained that, in the absence of standards of

identity, several incentives remain for fortifying lower-fat milk

products to the current level (10 percent of the DV). First, ``good

source'' nutrient content claims (Sec. 101.54(c)) require that a food

contain at least 10 percent of the DV for the subject nutrient. In

contrast, if processors choose to add vitamin A only to the level

normally found in milk before fortification, they cannot make claims

about vitamin A content (e.g., ``vitamin A added''). The comment noted

that consumers have become accustomed to seeing the presence of vitamin

A highlighted in the labeling of lowfat and skim milk. The comment

further noted that industry-wide promotional efforts focus on the high

levels of essential nutrients in lower-fat milk products. Consequently,

any change in fortification practices would disrupt marketing and

partially undermine nutrition based promotional campaigns. Finally,

according to the comment, the primary cost of vitamin A fortification

is not the vitamin itself but the equipment needed to add the vitamin,

as well as the analytical processes required to ensure quality control.

The comment argued that it is, therefore, highly unlikely that a

processor of lower-fat milks would choose to add only enough vitamin A

to achieve the percent of the DV for the required nutritional

equivalency and forego the obvious benefits of fortifying its products

to 10 percent of the DV per RACC.

This comment also noted that almost all of the fluid milk sold in

this country is vitamin D fortified, even though the addition of

vitamin D is optional under the standards of identity for whole milk,

lowfat milk, and skim milk. The comment concluded that any concerns

that processors will cease to fortify lower-fat milk products, simply

because such fortification is no longer technically required, are

unjustified.

FDA disagrees with the comment that stated that lower-fat milk

products made under the general standard may contain lower levels of

vitamins A and D when compared to unfortified whole milk. As noted in

the November 9, 1995, proposal (60 FR 56541 at 56545), and reiterated

in this preamble, lower-fat dairy products made according to the

general standard may not be nutritionally inferior to the full fat

product that they resemble and for which they substitute. Therefore,

FDA concludes that concerns that lower-fat milk products will contain

lower levels of vitamins A and D when compared to whole milk are

unfounded. The question, rather, is whether deleting the standards for

lowfat and skim milk products would likely result in a change in the

levels or frequency of addition of vitamins A and D to these foods.

FDA knows of no evidence that supports the contention that revoking

the standards of identity, as proposed, will cause manufacturers of

lower-fat milks to discontinue fortifying these products at the current

levels. On the contrary, current industry practice of fortifying nearly

all milk products with vitamin D, even though vitamin D addition is

optional, evidences that fortification at the current level is likely

to continue, even in the absence of an affirmative requirement.

Furthermore, as noted by the latter comment, there is considerable

incentive (e.g., the use of label statements and promotional programs)

to continue the practice of adding vitamin A at the current levels. The

agency concludes, therefore, that the provisions of Secs. 130.10(b) and

101.3(e) are adequate, and that special provisions (beyond the

nutritional equivalency requirements of Sec. 130.10) are not necessary,

to ensure that lower-fat milk products continue to serve as an

important dietary source of vitamins A and D. However, if this action

were to result in significant changes in the current industry practice

of adding vitamins A and D to lower-fat milk products, and changes were

to adversely affect the levels of these vitamins in the diet, FDA would

consider amending its regulations to require fortification of lowfat,

reduced fat, and nonfat milk products manufactured under Sec. 130.10.

7. One comment expressed concern about difficulties that might be

encountered in determining whether a food complies with the

requirements of Sec. 130.10. The comment noted, for example, that,

under this provision, lower-fat milk products named by use of a

nutrient content claim and a standardized term have to be compared to

whole milk. The comment maintained that regulatory agencies would

generally need to run comparison tests using a particular

manufacturer's whole milk to determine whether the manufacturer's

lower-fat product is nutritionally equivalent to the standardized food.

The comment pointed out, however, that some manufacturers do not

produce whole milk. Therefore, the comment urged FDA to provide for the

use of an industry average as a reference food or to provide specific

nutrient content requirements for lower-fat milk products made under

Sec. 130.10. The comment suggested that the nutrient requirements

(i.e., for vitamin content) be similar to what is currently required in

the standards for lower-fat milks.

FDA agrees that it will be necessary to compare the levels of

essential nutrients in lower-fat milk products named by use of a

nutrient content claim and a standardized term to the nutrient profile

of the standardized food. However, the agency advises that it is not

necessary for a manufacturer to process whole milk for FDA to ensure

that a lower-fat milk is nutritionally equivalent to the food for which

it substitutes. FDA set out principles for determining an appropriate

reference food in Sec. 101.13(j)(1)(ii). For example, the comparison

product may be the manufacturer's regular product or that of another

manufacturer, an average value determined from the top three national

(or regional) brands, or a market basket norm. Though

Sec. 101.13(j)(1)(ii) specifically applies to reference foods used to

make a relative nutrient content claim (e.g., ``reduced fat''), the

options therein would be applicable to nutrient comparisons to

determine nutritional equivalency. Furthermore, FDA noted in the

general standard final rule (58 FR 2431 at 2435), that nutrient values

in a current valid composite data base can be used for standardized

products. In that final rule, the agency acknowledged that target

levels for nutrients necessary to determine nutritional equivalency of

a food will depend on the specific foods being compared (58 FR 2431 at

2436). However, FDA determined that it would not be appropriate, beyond

the provisions of Sec. 130.10(b), to mandate specific levels of

nutrients that must be added to substitute foods.

Much of the concern raised in the comment apparently comes from the

fact that there may be wide variations in vitamin A content of milk

because of seasonal and other factors. As noted in the November 9,

1995, proposal (60 FR 56541 at 56545), vitamin A levels in milk in

winter have been reported to range from 500 to 1,000 IU per quart,

while in summer (pasture), these levels range from 2,000 to 3,000 IU

per quart. However, FDA does not expect that processors will choose to

recalibrate equipment for vitamin fortification of

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lower-fat milk products to accommodate daily or seasonal fluctuations

in the vitamin A content of the processor's whole milk. Rather, the

agency expects that manufacturers will choose the simplest option

available to them, such as fortifying products to be nutritionally

equivalent to the level of vitamin A listed in a composite data base.

This approach would also be the simplest option from a regulatory

standpoint.

FDA concludes that the requirement in Sec. 130.10(b) that the

modified product must not be nutritionally inferior, as defined in

Sec. 101.3(e)(4), to the standardized product is adequate, and that,

therefore, it is not necessary to specify further the required amounts

of essential nutrients that must be added to lower-fat milk products.

G. Vitamin Addition--Dairy Products Other Than Milk

8. One comment supported the proposal to make nutrient content

claims for the referenced dairy products consistent with nutrient

content claims for fat in other foods. However, the comment suggested

that, in its current form, FDA's proposal would unduly penalize

manufacturers of lower-fat yogurt products without any corresponding

benefit to either public health or consumer awareness. The comment

stated that full fat yogurt, before fortification, contains between 0.2

and 0.8 percent of the reference daily intake (RDI) for vitamin D. This

is less than a ``measurable amount,'' as defined in

Sec. 101.3(e)(4)(ii). Therefore, vitamin D fortification (currently

optional for all standardized yogurt products) would not be required

for lower-fat yogurt products made under Sec. 130.10. However, the

comment stated that full fat yogurt contains between 2 and 14 percent

of the RDI for vitamin A. In contrast, lowfat and nonfat yogurt contain

between 0.9 and 6 percent and between 0.2 and 1 percent, respectively,

of the RDI for vitamin A. Therefore, some amount of vitamin A would

need to be added to most lower-fat yogurt products for the food to be

nutritionally equivalent to full fat yogurt. The comment hypothesized

that, therefore, a processor of a lower-fat yogurt that contains 1

percent of the RDI of vitamin A may be forced to fortify its product

with 3 percent of the RDI for vitamin A to reach the 4 percent level

found in some full fat yogurt. The comment maintained that such

fortification (i.e., adding 3 percent of the RDI for vitamin A) is not

dietetically significant. The comment further argued that, although the

vitamin A fortification requirement would add little in terms of

dietary value, it would impose a significant financial burden on yogurt

manufacturers.

Another comment noted that sour half-and-half contains 2 percent of

the DV for vitamin A compared to 4 percent of the DV in full fat sour

cream. The comment maintained that requiring fortification at such low

levels would impose a significant cost on manufacturers with relatively

little benefit for consumers.

Conversely, several comments expressed concern about maintaining

requirements that will ensure that modified foods are not nutritionally

inferior to the food for which they substitute. In fact, one comment

urged FDA to make the addition of vitamin D mandatory in yogurt. The

comment stated that many consumers use yogurt as a substitute for milk

and assume that the two foods are nutritionally equivalent, when, in

fact, yogurt products generally do not contain vitamin D.

In response to the latter comment, FDA notes that vitamin D is

currently optional in all standardized yogurt products. Therefore, it

would also be optional in yogurt products made under Sec. 130.10. To

amend the standard for yogurt to make addition of vitamin D mandatory

is outside the scope of this rulemaking. However, as mentioned below in

comment 12 of this document, FDA is in the process of evaluating all of

its regulations pertaining to standards of identity. The comment's

suggestion may have relevance in a future rulemaking as a part of that

initiative.

The agency is not persuaded by the comments that maintained that

the nutritional equivalency requirements for lower-fat dairy products

made under Sec. 130.10 (e.g., lowfat yogurt or sour cream) will be of

little benefit to consumers. As noted in comments, full fat yogurt may

contain as much as 14 percent of the RDI for vitamin A, making the food

a good source of vitamin A. Furthermore, the diet is made up of a

variety of foods, not all of which are a ``good source'' (i.e., contain

10 percent or more of the DV) of a particular nutrient. Even when

nutrients are present in lesser amounts, the nutritive value of a food

may make a significant contribution to meeting dietary goals. However,

as noted in the December 28, 1995, final rule entitled ``Food Labeling;

Reference Daily Intakes'' (60 FR 67164 at 67170), adequacy of intake of

a particular nutrient or public health concerns are not criteria for

determining whether a substitute food is nutritionally inferior to the

food for which it substitutes. Rather, Sec. 101.3(e)(4)(i) defines

nutritional inferiority as any reduction in the content of an essential

nutrient that is present in a measurable amount (excluding fat or

calories). Section 101.3(e)(4)(ii) defines a measurable amount of an

essential nutrient in a food as 2 percent or more of the daily

reference value (DRV) of protein listed under Sec. 101.9(c)(7)(iii), of

potassium listed under Sec. 101.9(c)(9), and of the RDI of any vitamin

or mineral listed under Sec. 101.9(c)(8)(iv). The agency considers, per

Sec. 101.9(a)(4), a measurable amount to be a significant amount for

this purpose. Therefore, consistent with the agency's longstanding

definition of nutritional inferiority in Sec. 101.3(e)(4), FDA

concludes that a 2 percent or greater reduction in the RDI for vitamin

A in lower-fat sour cream or lower-fat yogurt products is significant,

and that such a reduction will make these foods nutritionally inferior

to the foods for which they substitute.

9. One comment maintained that application of Secs. 130.10 and

101.3(e) to lower-fat dairy products will impose, for the first time, a

requirement that well established, standardized products (e.g., lowfat

and nonfat yogurt and sour half-and-half) be nutritionally equivalent

to their full fat counterparts. The comment argued that even the final

rule revoking the standard of identity for ice milk (hereinafter

referred to as the 1994 final regulation) (59 FR 47072, September 14,

1994) did not have this overall effect. According to the comment, the

lower-fat ice cream products created by that action were not

established, standardized products bearing a new name but were

essentially ``new'' products created by the revisions.

The agency disagrees with the comment's contention that this

rulemaking will, for the first time, require fortification of

traditional lower-fat dairy products to achieve nutritional equivalency

to their full fat counterparts. A number of the standards of identity

for lower-fat dairy products contain provisions to ensure that the

foods are at least nutritionally equivalent to the full fat version of

the food (e.g., lowfat and skim milk must contain not less than 2,000

IU vitamin A (Secs. 131.135 and 131.143)). Furthermore, before

establishing the general standard, FDA issued more than 150 temporary

marketing permits (TMP's) for the market testing of lower-fat dairy

products such as ``light eggnog,'' ``light sour cream,'' ``nonfat sour

cream,'' and ``nonfat cottage cheese.'' One of the criteria used in

evaluating the acceptability of these test products was that they be

nutritionally equivalent to the full fat standardized food.

[[Page 58997]]

Since the agency adopted Sec. 130.10, there has been a

proliferation of lower-fat dairy products labeled by use of a

standardized term in conjunction with a nutrient content claim (e.g.,

``light sour cream'') that are nutritionally equivalent to the full fat

foods. Therefore, FDA disagrees with the comment and notes that there

are several examples of lower-fat dairy products that resemble and

substitute for full fat standardized foods and that are fortified to be

nutritionally equivalent to the foods for which they substitute.

The nutritional equivalence requirement in Sec. 130.10 follows, in

large measure, the approach embodied in Sec. 101.3(e) with respect to

substitute foods. The authority for Sec. 101.3 is section 403(c) of the

act. When this section of the act was adopted in 1938, Congress was

seeking to protect the consumer from the uninformed purchase of an

inferior substitute product that could be mistaken for the traditional

food product (38 FR 2138, January 19, 1973). In 1973, in a proposal

pertaining to ``imitation foods,'' the agency noted that vast strides

in food technology had taken place since section 403(c) had been

enacted, and that since 1938 many new wholesome and nutritious food

products had entered the marketplace, some of which resembled and

substituted for traditional foods (38 FR 2138). The agency stated that

it was no longer the case that such products were necessarily inferior

to the traditional foods for which they substituted. However, FDA still

believed that the consumer must be protected from unwittingly

purchasing a product that is different from what he or she may

reasonably expect (38 FR 2138).

FDA continues to believe that, as substitute products proliferate,

it is important to ensure that these products contain essential

nutrients in amounts consistent with the reference food, so that

consumers can continue to have confidence that a varied diet will

supply adequate nutrition. This principle, that substitute foods must

not be nutritionally inferior to the foods for which they substitute,

was incorporated into the general standard final rule, in which FDA

stated that foods having significantly less essential nutrients than

the standardized food for which they are named are not modified

versions of the standardized food, do not comply with the requirements

of the general standard, and must be labeled as ``imitation'' (58 FR

2431 at 2435).

Finally, FDA is not convinced by the comment that revoking the

standards of identity for lower-fat dairy products in parts 131 and 133

differs from the rulemaking to revoke the standard of identity for ice

milk so that such products could be labeled as nutritionally modified

versions of ice cream under Sec. 130.10 in the 1994 final regulation.

Specifically, FDA disagrees with the comment's contention that the

final rule revoking the standard for ice milk did not affect a

standardized product because ice milk was not being sold under that

name. FDA notes that a number of companies were marketing the

standardized product ``ice milk'' before the 1994 final regulation made

it possible to market this product either as ``reduced fat'' or ``low

fat'' ice cream (Ref. 1) depending on the level of fat in the product.

The effect of the 1994 final regulation was to provide for the labeling

of lower-fat ice cream products, such that the product names are

consistent with the requirements for nutrient content claims, the food

for which the product substitutes is clearly identified, and the

substitute food is nutritionally equivalent to the standardized food

(ice cream).

10. One comment argued that, because standardized lower-fat yogurt

and sour cream products have never been nutritionally equivalent to the

full fat standardized foods, continued consumption of unfortified

versions of these products will not result in any unanticipated

diminution of vitamin A intake by consumers, nor would it deprive

consumers of nutrients that they were previously obtaining.

FDA disagrees with the comment's contention that, because

nutritional equivalency with the full fat food has not been required

heretofore in some standardized lower-fat dairy products, failure to

add this requirement now will not diminish the nutrient value of the

food or its contribution to the diet. This view would only be true if

dietary patterns were static. However, consumers' tastes, dietary

needs, and knowledge about nutritional content of foods change. There

are numerous ongoing educational programs designed to encourage

consumers to eat a healthier diet (e.g., a diet lower in fat) and to

encourage increased calcium consumption (from such sources as dairy

products) by that part of the population at risk for osteoporosis. The

nutrient intake of consumers who are now switching from full fat to

lower-fat dairy products, and of those who are increasing their

consumption of dairy products by eating lowfat or nonfat foods, may

indeed be decreased. FDA notes, for example, that the consumption of

yogurt products increased more than fivefold between 1970 and 1993

(Ref. 1). As the population ages, dietary recommendations will take on

even greater significance. Therefore, FDA cannot agree that exempting

lower-fat dairy products from the requirement that they be

nutritionally equivalent to the full fat foods for which they

substitute would not have an adverse effect on the diet of consumers.

Furthermore, FDA has promised consumers since 1973 that substitute

foods will be nutritionally equivalent to the foods for which they

substitute, or that if they are not, this fact is to be revealed on the

label. In the general standard final rule (58 FR 2431 at 2435), FDA

stated that all nutrients that are considered in determining the status

of a food under Sec. 101.9(c)(7)(iv) are important. FDA also stated

that any measurable reduction in an essential nutrient is significant,

and that if a food is nutritionally inferior to the standardized food,

it cannot be labeled as a modified version of the food but, rather, as

an ``imitation.'' The comments have not provided any reason to

establish an exemption from the agency's general approach for lower-fat

yogurt or sour cream products.

11. One comment stated that vitamin A fortification frequently has

a negative impact on the taste of dairy products. The comment

maintained that vitamin A fortification could, therefore, drive some

consumers away from the lower-fat products to which they were

accustomed in favor of higher fat products in which the naturally

occurring vitamin A does not cause a taste problem. The comment did

not, however, provide any data in support of its contention.

FDA is not persuaded by the comment that there exist sufficient

technical difficulties (e.g., taste considerations) that would warrant

exempting lower-fat dairy products made under Sec. 130.10 from the

requirement that they be nutritionally equivalent to the standardized

food. The agency notes that that requirement did not prevent

manufacturers from submitting scores of applications for TMP's.

Furthermore, the agency does not have any information that vitamin A

fortification has been a significant impediment to the manufacture or

marketing of lower-fat dairy products as part of the market tests

conducted before or after the enactment of the 1990 amendments or under

Sec. 130.10.

12. One comment that objected to requiring lower-fat dairy products

to be nutritionally equivalent to the full fat version of the foods

supported the basic proposition that foods bearing names that include a

defined nutrient content claim should conform to the requirements for

that claim as defined by FDA. However, it disagreed with the

[[Page 58998]]

agency's proposed approach of revoking standards of identity for lower-

fat dairy products and subjecting them to the general standard and with

the requirement that they not be nutritionally inferior, as defined in

Sec. 101.3(e)(4), to the standardized food in parts 131 and 133. As an

alternative, the comment suggested that FDA consider amending either

Sec. 101.3(e) or Sec. 130.10 such that fortification would not be

required at low levels. A second alternative suggested by the comment

would be to combine into one standard the existing standards of

identity for each group of dairy products, specifying the particular

fat levels applicable to reduced fat, lowfat, and nonfat versions of

the food. Finally, the comment suggested that FDA could leave the

standards of identity for lower-fat dairy products in place but amend

them by reducing the maximum milkfat percentages to levels that

correspond with the nutrient content claims requirements. For example,

the maximum milkfat content requirement for lowfat yogurt in

Sec. 131.203 could be reduced from 2 percent to 1.3 percent so that the

food would contain no more than 3 g fat per reference amount as

required for a ``low fat'' claim.

FDA notes that it published an advance notice of proposed

rulemaking (ANPRM) in the Federal Register of December 29, 1995 (60 FR

67492), announcing that it intends to review its regulations pertaining

to standards of identity, quality, and fill of container and asking for

comment on the utility of these regulations. Among the regulations on

which the agency requested comment were those pertaining to the

labeling of imitation and substitute foods in Sec. 101.3(e) (60 FR

67492 at 67502). Further, in another ANPRM that FDA published in the

Federal Register of June 12, 1996 (61 FR 29701 at 29702), the agency

requested comments on certain regulations pertaining to food labeling,

including the provisions for labeling imitation and substitute foods

set out in Sec. 101.3(e).

In the June 12, 1996, ANPRM, FDA noted that, in 1973, the agency

proposed that ``imitation'' only be applied to substitute foods that

are nutritionally inferior to the foods for which they substitute (38

FR 2143 at 2148), and that, in its final regulation (38 FR 20702,

August 2, 1973), FDA confirmed this view and defined ``nutritional

inferiority'' as the reduction in the content of an essential nutrient

that is present in a measurable amount (Sec. 101.3(e)(4)). In the June

12, 1996, ANPRM, FDA requested comment on the appropriateness of the

current definition of nutritional inferiority for the purpose of

determining whether a food is an imitation. FDA noted that it had not

reevaluated its definition of nutritional inferiority for purposes of

imitation labeling when it recently revised these regulations to

accommodate new RDI's for several nutrients (60 FR 67164), but that it

had raised the question in the December 29, 1995, ANPRM on standards of

identity. The agency further noted that it would evaluate any proposed

changes in its policy on labeling of imitation foods in light of any

changes that it ultimately decides to make in its approach to standards

of identity and common or usual name regulations.

Therefore, FDA is not proposing to amend its requirements in the

general standard (Sec. 130.10(b)) or in Sec. 101.3(e) that require

fortification of a modified food to restore nutrient levels so that the

product is not nutritionally inferior as defined in Sec. 101.3(e)(4),

as requested by the comment. However, if FDA receives comments to the

December 29, 1995, or June 12, 1996, ANPRM's suggesting changes in its

treatment of imitation and substitute foods, it will consider such

changes as part of those rulemakings.

Additionally, while modifying the existing standards as suggested

by the comment could achieve consistency between milkfat content

requirements in the standards of identity and the definitions for

nutrient content claims for fat, this change would not address fat from

sources other than milkfat (e.g., bulky flavors containing fat can

increase total fat content such that the food would not comply with the

requirements for the claim). Furthermore, the claims requirements

contain provisions in addition to nutrient content requirements (e.g.,

explanatory label statements). However, foods covered by a standard of

identity are exempt from the claims requirements (section 403(r)(5)(C)

of the act), while most other nutritionally modified foods are covered.

Thus, the comment's suggestion would neither promote uniformity in food

labeling nor minimize consumer confusion. It makes more sense to choose

an approach that will, as much as possible, provide for uniform

treatment of all nutritionally modified foods.

As noted above in comments 9 and 10 of this document, some

nutritionally modified versions of standardized dairy products are

already being made under Sec. 130.10. Many of the products that

resemble or purport to be (i.e., have similar functional, physical, and

sensory properties as) the standardized, lower-fat food, but that do

not comply with the standard of identity for the food because their fat

content falls outside of the ranges provided for in the current

standards (e.g., nonfat sour cream), would not be covered by any of the

approaches suggested by the comment. Therefore, formulation and

labeling requirements for similar foods within a product class would

continue to be different. Such a situation could lead to consumer

confusion and to inefficient enforcement of the act.

In contrast, taking the approach suggested in the petitions and

proposed by the agency, i.e., deleting the standards for lower-fat

dairy products and providing for their composition and labeling in

accordance with the general standard, will provide maximum flexibility

for manufacturers in using new ingredients and technologies and

increased product choices for consumers. Therefore, the agency

concludes that this approach most closely fulfills the goals of the

President's reinventing government initiative of simplifying

regulations and easing the burden on the regulated industry.

13. Two comments objected that the proposed rule that would require

lower-fat yogurt to be fortified with vitamin A to the level in full

fat yogurt. The comments argued that such a requirement would make

little sense because full fat yogurt is not widely marketed in this

country. (One comment maintained that full fat yogurt constitutes less

than 1 percent of the yogurt market in the United States.) These

comments argued that, because full fat yogurt is not widely marketed,

the purpose for the nutritional equivalence requirement in Sec. 130.10,

i.e., to ensure that foods that substitute for traditional products

contain essential nutrients in amounts consistent with the reference

food, does not apply. These comments argued that, because consumers are

not replacing full fat yogurt with lower-fat yogurt products but rather

are consuming lower-fat yogurt as their primary product, it is not only

inappropriate but also unnecessary to require that lower-fat yogurt

products be nutritionally equivalent to full fat yogurt. Conversely,

several comments noted that full fat yogurt is a significant source of

vitamin A, containing up to 14 percent of the RDI.

FDA disagrees with comments that argued that requiring a substitute

food to be nutritionally equivalent to a product that is rarely

marketed (i.e., full fat yogurt) is inappropriate. Market share is not

a criterion for deciding the traditional food for which the new food

named in accordance with Sec. 130.10 substitutes. Foods named in

accordance with Sec. 130.10 use the name of the

[[Page 58999]]

traditional standardized food and a nutrient content claim that

describes how the new food deviates from the traditional food. Thus, in

the case of ``lowfat'' or ``nonfat yogurt'' that is named in accordance

with Sec. 130.10, the traditional standardized food is ``yogurt'' as

defined in Sec. 131.200.

Further, as FDA noted in the general standard final rule (58 FR

2431 at 2436), a food may resemble or substitute for more than one food

(e.g., nonfat cottage cheese may substitute for cottage cheese

(Sec. 133.128) or for dry curd cottage cheese (Sec. 133.129)). However,

the food may not be nutritionally inferior to the standardized food

whose name is used in the identity statement for the substitute food.

If the agency were to revoke the standards for both lowfat and nonfat

yogurt, lower-fat yogurt products made under Sec. 130.10 would have to

be nutritionally equivalent to the standardized food (i.e., yogurt)

whose name is used in the identity statement of the foods.

FDA advises that such a result is fully consistent with the

regulatory approach that FDA has taken since 1973. As FDA stated above

in comments 9 and 10 of this document, since that time, consumers have

had the assurance that substitute foods are nutritionally equivalent to

the foods for which they substitute, or that, if they are not, this

fact is disclosed on the label, i.e., by the use of the term

``imitation.'' Furthermore, it would be inconsistent to use the fat

level of full fat yogurt for claims purposes (the name ``lowfat

yogurt'' implies that there is a yogurt that is not lowfat, or else the

food would have to be called ``yogurt, a lowfat food''), but not for

purposes of establishing a nutrient baseline (i.e., the vitamin A

level). Therefore, the agency rejects this argument.

At the same time, the agency recognizes that, for some dairy

product manufacturers, this final rule will result in relabeling,

reformulation, and equipment costs. Whether, and to what extent, a

manufacturer incurs costs as a result of this final rule will depend,

in part, on the types of products that the manufacturer produces and

whether those products are in compliance with the nutrient content

claim requirements.

FDA notes, however, that yogurt is unique among the products listed

in the proposal in that both of the following conditions apply. First,

the existing standards of identity for yogurt products do not require

vitamin addition. Secondly, these standards cover nearly the full range

of possible fat contents (i.e., full fat yogurt, lowfat yogurt, and

nonfat yogurt). In contrast, the standards of identity for cottage

cheese, for example, are limited to full fat and lowfat foods. Thus,

historically, the yogurt industry has not had the same need to produce

modified versions of the standardized food under TMP's or under the

general standard as manufacturers of other standardized dairy products

have had to do to make lowfat and nonfat products. To cite another

example, although the standards for fluid milk products in part 131

cover a wide range of fat levels, vitamin A addition is mandatory in

the lower fat foods, and the industry voluntarily adds vitamin D to

almost all milk products. Thus, although fluid milk products have

generally not been produced under TMP's or the general standard, the

milk industry has the experience and equipment necessary for adding

vitamins to lower-fat milk products to meet the nutritional equivalency

requirements of Sec. 130.10(b). In contrast, yogurt manufacturers have

significantly less experience in producing products that are fortified

with vitamin A.

Therefore, although FDA concludes that vitamin A addition will not

result in insurmountable technical difficulties, the agency

acknowledges that it may take some time for the yogurt industry to

overcome any problems it may encounter in fortifying lower-fat yogurt

products. Furthermore, because the yogurt industry has generally not

heretofore produced vitamin fortified lower-fat yogurt products,

manufacturers who produce only yogurt may well not possess the

equipment necessary for vitamin fortification. One comment maintained

that 69 percent of the yogurt industry produces only yogurt. In the

analysis of impacts section of this preamble, using data from the same

comment, FDA estimates that the cost of vitamin metering equipment for

the yogurt industry could be as high as $52 million. In contrast, FDA

estimates that the total cost of this regulation to the rest of the

dairy industry will be approximately $2.7 million. Therefore, FDA

believes that revoking the lower-fat dairy standards as proposed would

likely impose a disproportionately larger financial burden on yogurt

manufacturers compared to the rest of the dairy industry.

Taking into consideration the technical difficulties and economic

considerations associated with the agency's proposal to revoke the

standards for lowfat and nonfat yogurt, the agency finds that fairness

suggests that it should delay final action on its proposal to revoke

these standards. Therefore, FDA is deferring action on its proposal to

revoke the standards of identity for lowfat yogurt and nonfat yogurt

for 120 days. During that period, the yogurt industry will have an

opportunity to meet with the agency and to discuss its progress in

addressing the vitamin A problems. FDA believes that a 120-day deferral

will provide an appropriate balance between the problems the industry

faces and consumers' interest in consistently and fairly labeled foods.

FDA advises that, at the end of the 120-day period, the agency

intends to move to resolve the inconsistencies between use of the terms

``lowfat'' and ``nonfat'' in the names of standardized yogurt and the

definitions for these terms established under the nutrient content

claims regulations. FDA further advises that deferring action on the

proposal to revoke the standards of identity for lowfat and nonfat

yogurt does not change the agency's conclusions with regard to deleting

the other standards of identity for lower-fat dairy products.

The agency does not believe that its decision to defer, for a

limited time, action on the standards of identity for yogurt products

will pose a serious problem for consumers because essentially all

nonfat yogurt, and the majority of lowfat yogurt, already complies with

the nutrient content claims requirements with respect to fat in that

they contain less than 0.5 and 3.0 g fat per RACC, respectively. In

contrast, approximately two-thirds of the lowfat milk products are 2

percent milk and, therefore, contain up to 60 percent more fat than is

permitted under the definition for ``lowfat'' (Ref. 1).

H. Effective Date

14. One comment objected to the proposed effective date of January

1, 1998. The comment stated that an effective date of January 1, 1998,

is overly generous. It maintained that this final rule could have a

significant impact on American's health and should be implemented as

quickly as possible. The comment urged the agency to move up the

effective date of the final rule to January 1, 1997.

FDA agrees that this final rule should be implemented as quickly as

possible. However, FDA disagrees that the proposed effective date,

January 1, 1998, would represent an unduly long compliance period. To

minimize the economic impact of required label changes, FDA

periodically announces uniform effective dates for new food labeling

requirements. On April 15, 1996, FDA published a proposed rule (61 FR

16422) to establish January 1, 1998, as its new uniform effective date

for all food labeling regulations that

[[Page 59000]]

issue before January 1, 1997. Thus, FDA has placed this change on the

same schedule as virtually all other regulatory changes made before

December 31, 1996. Given the exemption in the act for claims on

standardized foods (section 403(r)(5)(C)), FDA sees no basis for an

earlier date.

I. Other Actions--Unresolved Hearing Issue on the Lowfat Milk and Skim

Milk Standards

As noted in the November 9, 1995, proposal (60 FR 56541 at 56546),

FDA published a notice of hearing on objections in the Federal Register

of October 6, 1983 (48 FR 45545), to a final rule (45 FR 81734,

December 12, 1980) concerning the standards of identity for lowfat milk

and skim milk (Docket Nos. 81N-204F and 76N-0175). The hearing was

granted on four issues, three of which were resolved. The remaining

issue, dealing with labeling requirements of the standardized foods,

i.e, the reasonableness of the decision to prohibit use of the terms

``protein fortified'' and ``fortified with protein'' on labels of

lowfat milk and skim milk products containing not less than 10 percent

milk-derived nonfat milk solids), has been rendered moot by this final

rule which removes the standards of identity for lowfat milk and skim

milk in Secs. 131.135 and 131.143. No further rulemaking procedures

regarding the stayed provisions are necessary.

III. Conclusions Regarding Comments

After review and consideration of the comments it received in

response to the November 9, 1995, proposal, FDA concludes that no

evidence or information has been presented that would provide a basis

for altering the agency's tentative conclusion that it should remove

the standards of identity for sweetened condensed skimmed milk

(Sec. 131.122), lowfat dry milk (Sec. 131.123), evaporated skimmed milk

(Sec. 131.132), lowfat milk (Sec. 131.135), acidified lowfat milk

(Sec. 131.136), cultured lowfat milk (Sec. 131.138), skim (nonfat) milk

(Sec. 131.143), acidified skim (nonfat) milk (Sec. 131.144), cultured

skim (nonfat) milk (Sec. 131.146), sour half-and-half (Sec. 131.185),

acidified sour half-and-half (Sec. 131.187), and lowfat cottage cheese

(Sec. 133.131); that it should amend the standard of identity for dry

cream (Sec. 131.149) by removing the reference to the lowfat milk

standard; and that it should amend the nutrient content claims

regulations for fat, fatty acids, and cholesterol content (Sec. 101.62)

to provide for ``skim'' as a synonym for ``nonfat'' when used in

labeling milk products.

Therefore, in this final rule, FDA is removing these standards of

identity and amending the standard of identity for dry cream, as

proposed. In addition, FDA is amending the nutrient content claims

regulations for fat, fatty acids, and cholesterol content to provide

for ``skim'' as a synonym for ``nonfat'' when used in labeling milk

products. FDA is not revoking the standards of identity for lowfat and

nonfat yogurt at this time.

Because this rulemaking involves the removal and amendment of

standards of identity for dairy products, it is subject to the formal

rulemaking procedures of section 701(e) of the act. Section 701(e) of

the act requires that the agency provide an opportunity for objections

to the final rule. If any objections raise issues of material fact, the

agency is to hold a formal evidentiary hearing on those issues.

IV. Analysis of Impacts

Although this rule is issued in accordance with the formal

rulemaking provisions of 5 U.S.C. 556 and 557, and is, therefore,

exempted from the economic analysis requirements of Executive Order

12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), FDA has

examined the economic implications of this rulemaking.

A. Label Changes

There are approximately 1,600 lowfat milk and 770 skim (nonfat)

milk stock keeping units (SKU's) currently on the market. As a result

of this rule, all milks currently using the terms ``lowfat'' and

``nonfat'' (or ``skim'') in their names must comply with the nutrient

content claim requirements for those terms. Some of these products are

already in compliance with the claim requirements. Any milk not in

compliance with the nutrient content claim requirements for ``lowfat''

or ``nonfat'' must be relabeled. According to the petitioners, most

products currently labeled as ``nonfat milk'' would be eligible to

retain that name. However, many products currently labeled as ``lowfat

milk'' (i.e., products containing more than 1 percent milkfat) would

not be eligible to retain that name and must be relabeled.

Approximately 1,000 lowfat milk SKU's will need to be relabeled.

This regulation will also require changes in the labels of sour

half-and-half, acidified sour half-and-half, and, potentially, in

labels of lowfat cottage cheese products. There are approximately 16

sour half-and-half SKU's and approximately 420 lowfat cottage cheese

SKU's. There are no acidified sour half-and-half products in FDA's data

base. FDA estimates that approximately 192 lowfat cottage cheese

product SKU's do not comply with FDA's nutrient content claims

definitions and will, therefore, require relabeling. However, all sour

half-and-half products (16 SKU's) will need to be relabeled under the

general standard to be named using a nutrient content claim and the

name of the standardized food (e.g., ``reduced fat sour cream'').

There are approximately 570 firms manufacturing products affected

by this regulation. Of these firms, approximately 440 are small firms

with fewer than 500 employees.

The costs of the relabeling associated with this final rule include

administrative, redesign, and inventory disposal costs. The

administrative costs are estimated to be $850 per small firm and $6,300

per large firm. The total administrative costs associated with this

proposed regulation are approximately $1 million.

The agency estimates that the changes required by this final

regulation will result in a simple two-color label redesign. Also,

because firms will have a minimum of 1 year to comply, redesign costs

will be reduced by the fact that they can incorporate mandated changes

with previously planned label changes. Redesign costs of this

regulation are estimated at $1,200 per label or a total of $1.5

million.

An additional cost category is the label inventory loss associated

with the transition from old to new labels. The cost of label inventory

loss depends on average label inventory and the length of the

compliance period. FDA is establishing an effective date for this final

regulation that will provide approximately 1 year for firms to make any

necessary changes. A 1-year compliance period is sufficient to allow

producers of milk, sour half-and-half, and cottage cheese to use up

existing stocks of labels. Therefore, label inventory disposal costs

will be zero.

B. Vitamin Addition

Two comments to the November 9, 1995, proposal objected to the

absence of a discussion in the economic analysis section of the costs

of fortification for lower-fat yogurt and sour half-and-half. One

comment suggested that the cost to obtain and install vitamin metering

equipment would be $250,000 per plant. Additionally, using information

provided in the same comment, FDA estimates the cost of obtaining and

adding vitamin A to be $100 per item per year.

FDA acknowledges that it neglected to consider these costs when

analyzing the impact of the proposed rule. FDA notes

[[Page 59001]]

that the recurring cost of obtaining and adding vitamin A will apply to

nearly all lower-fat dairy products because the removal of fat also

unavoidably removes some vitamin A. However, the cost of obtaining

equipment necessary to add vitamins to lower-fat dairy products will

only be incurred by those plants that do not already possess such

equipment (i.e., those firms that do not currently manufacture other

standardized or nonstandardized products to which they routinely add

vitamins).

As previously stated in this preamble, FDA has issued over 150

TMP's for the market testing of lower-fat dairy products such as

``light eggnog,'' ``light sour cream,'' ``nonfat sour cream,'' and

``nonfat cottage cheese.'' FDA required that these test products be

nutritionally equivalent to the full fat, standardized food. The

proliferation of requests for TMP's indicates that, in spite of the

costs of fortification, many dairy product manufacturers considered the

ability to market modified foods named by use of a nutrient content

claim and a standardized term to be of benefit to them and to

consumers.

As noted earlier, most fluid milk products (approximately 95

percent) are currently fortified. FDA does not expect this rule to have

a significant impact on the fortification practices for milk products.

Therefore, this final rule will not impose significant costs of vitamin

fortification of lower-fat milk products. Furthermore, lower-fat yogurt

and sour cream products were the only products noted by comments to the

November 9, 1995, proposal for which comments claimed the fortification

requirements would be burdensome.

According to FDA data, the 16 sour half-and-half products currently

on the market represent 12 brands. Products made under the general

standard, e.g., ``light sour cream'' or ``nonfat sour cream'' are sold

under 11 of those 12 brands. Because these products are currently being

made under Sec. 130.10, the firms producing these products should

already possess the necessary equipment for vitamin fortification and

will only bear the cost of obtaining and adding vitamin A. The one firm

producing only sour half-and-half may need to purchase equipment for

vitamin addition. Therefore, the cost of requiring fortification of

sour half-and-half products may be approximately $0.25 million in the

first year and $1,600 in each subsequent year.

One comment stated that 69 percent of the yogurt industry produces

only standardized yogurt and, therefore, will have to purchase vitamin

metering equipment. Thus, it is possible that the cost to the yogurt

industry to meet the fortification requirement could be as high as $52

million (300 plants X 0.69 (percent of plants that need to purchase

equipment) X $250,000 (for equipment) plus a total of $240,000 per year

to obtain and add vitamin A). The agency notes it has not fully

evaluated these figures.

C. Conclusion of Analysis

The agency estimates that the total costs of this regulation will

be approximately $2.7 million. Because FDA is deferring action on the

standards of identity for lower-fat yogurt products, this assessment

does not include costs to the yogurt industry in the costs of this

final rule. The agency believes that consumers will benefit from this

regulation because it will provide consistency in the nomenclature of

both standardized and nonstandardized foods that bear nutrient content

claims. The agency also believes that firms will benefit from this

regulation in that it provides for greater flexibility than current

standards of identity allow.

V. Environmental Impact

The agency has determined under 21 CFR 25.24(b)(1) 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.

VI. Objections

Any person who will be adversely affected by this regulation may at

any time on or before December 20, 1996, file with the Dockets

Management Branch (address above) written objections thereto. Each

objection shall be separately numbered, and each numbered objection

shall specify with particularity the provisions of the regulation to

which objection is made and the grounds for the objection. Each

numbered objection on which a hearing is requested shall specifically

so state. Failure to request a hearing for any particular objection

shall constitute a waiver of the right to a hearing on that objection.

Each numbered objection for which a hearing is requested shall include

a detailed description and analysis of the specific factual information

intended to be presented in support of the objection in the event that

a hearing is held. Failure to include such a description and analysis

for any particular objection shall constitute a waiver of the right to

a hearing on the objection. Three copies of all documents shall be

submitted and shall be identified with the docket number found in

brackets in the heading of this document. Any objections received in

response to the regulation may be seen in the Dockets Management Branch

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

VII. References

The following reference has been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

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

1. Summary of market and consumption data for lower-fat dairy

products, Laina Bush, Center for Food Safety and Applied Nutrition,

FDA, 1996.

List of Subjects

21 CFR Part 101

Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 131

Cream, Food grades and standards, Milk, Yogurt.

21 CFR Part 133

Cheese, Food grades and standards, Food labeling.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, parts 101,

131, and 133 are amended as follows:

PART 101--FOOD LABELING

1. The authority citation for 21 CFR part 101 continues to read as

follows:

Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

2. Section 101.62 is amended by revising the introductory text of

paragraph (b)(1) to read as follows:

Sec. 101.62 Nutrient content claims for fat, fatty acid, and

cholesterol content of foods.

* * * * *

(b) * * * (1) The terms ``fat free,'' ``free of fat,'' ``no fat,''

``zero fat,'' ``without fat,'' ``negligible source of fat,'' or

``dietarily insignificant source of fat'' or, in the case of milk

products, ``skim'' may be used on the label or in labeling of foods,

provided that:

* * * * *

PART 131--MILK AND CREAM

3. The authority citation for 21 CFR part 131 continues to read as

follows:

Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,

379e).

[[Page 59002]]

Sec. 131.122 [Removed]

4. Section 131.122 Sweetened condensed skimmed milk is removed from

subpart B.

Sec. 131.123 [Removed]

5. Section 131.123 Lowfat dry milk is removed from subpart B.

Sec. 131.132 [Removed]

6. Section 131.132 Evaporated skimmed milk is removed from subpart

B.

Sec. 131.135 [Removed]

7. Section 131.135 Lowfat milk is removed from subpart B.

Sec. 131.136 [Removed]

8. Section 131.136 Acidified lowfat milk is removed from subpart B.

Sec. 131.138 [Removed]

9. Section 131.138 Cultured lowfat milk is removed from subpart B.

Sec. 131.143 [Removed]

10. Section 131.143 Skim milk is removed from subpart B.

Sec. 131.144 [Removed]

11. Section 131.144 Acidified skim milk is removed from subpart B.

Sec. 131.146 [Removed]

12. Section 131.146 Cultured skim milk is removed from subpart B.

13. Section 131.149 is amended by revising the second sentence of

paragraph (a) to read as follows:

Sec. 131.149 Dry cream.

(a) * * * Alternatively, dry cream may be obtained by blending dry

milks as defined in Secs. 131.125(a) and 131.147(a) with dry cream as

appropriate: Provided, That the resulting product is equivalent in

composition to that obtained by the method described in the first

sentence of this paragraph. * * *

* * * * *

Sec. 131.185 [Removed]

14. Section 131.185 Sour half-and-half is removed from subpart B.

Sec. 131.187 [Removed]

15. Section 131.187 Acidified sour half-and-half is removed from

subpart B.

PART 133--CHEESE AND RELATED CHEESE PRODUCTS

16. The authority citation for 21 CFR part 133 continues to read as

follows:

Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,

379e).

Sec. 133.131 [Removed]

17. Section 133.131 Lowfat cottage cheese is removed from subpart

B.

Dated: November 12, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96-29485 Filed 11-19-96; 8:45 am]

BILLING CODE 4160-01-F