[Federal Register Volume 61, Number 225 (Wednesday, November 20, 1996)]
[Rules and Regulations]
[Pages 58991-59002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29485]


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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

[[Page 58995]]

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

[[Page 58996]]

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