[Federal Register Volume 60, Number 217 (Thursday, November 9, 1995)]
[Proposed Rules]
[Pages 56540-56547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27712]



=======================================================================
-----------------------------------------------------------------------

[[Page 56541]]


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: Proposed 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: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to remove 
the standards of identity for sweetened condensed skimmed milk, lowfat 
milk, skim (nonfat) milk, acidified lowfat milk, acidified skim 
(nonfat) milk, cultured lowfat milk, cultured skim (nonfat) milk, sour 
half-and-half, acidified sour half-and-half, lowfat yogurt, nonfat 
yogurt, and lowfat cottage cheese, based in part, on petitions filed 
jointly by the Milk Industry Foundation (MIF) and the Center for 
Science in the Public Interest (CSPI). FDA also is proposing to remove 
the standards of identity for evaporated skimmed milk and lowfat dry 
milk based on a petition filed by the American Dairy Products Institute 
(ADPI). Removal of these food standards of identity would permit the 
products covered by these regulations to be manufactured and labeled in 
accordance with the general definition and standard of identity (the 
general standard) in the regulations for foods named by use of a 
nutrient content claim and a standardized term. These products would 
then be named in a manner that is consistent with the agency's 
definitions of the terms ``lowfat'' and ``nonfat'' established in 
response to the Nutrition Labeling and Education Act of 1990 (the 1990 
amendments). This action will provide for consistency in the 
nomenclature and labeling of these nutritionally modified milk products 
and other foods bearing ``lowfat'' and ``nonfat'' claims and will 
promote honesty and fair dealing in the interest of consumers.
    The agency also is proposing to amend 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 action also is a part of the agency's ongoing review of 
existing regulations under President Clinton's Regulatory Reinvention 
Initiative.

DATES: Comments by January 23, 1996. FDA proposes that any final rule 
that may issue based on this proposal, unless stayed by the filing of 
proper objections, become effective January 1, 1998. Compliance may 
begin on the date of publication of the final rule in the Federal 
Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Nannie H. Rainey, 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 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, FDA established definitions for specific nutrient 
content claims in part 101 (21 CFR part 101) together with principles 
for their use (58 FR 2302, January 6, 1993). In addition, at the same 
time, FDA published a final rule (58 FR 2302 at 2431), that 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 traditional standardized term, for 
example, ``sour cream.''
    As FDA noted in that final rule, certain standards of identity for 
dairy products already incorporate terms such as ``nonfat,'' ``light,'' 
and ``lowfat'' in the names of the foods, including the standards for 
lowfat dry milk (Sec. 131.123 (21 CFR 131.123)), nonfat dry milk 
(Sec. 131.125 (21 CFR 131.125)), nonfat dry milk fortified with 
vitamins A and D (Sec. 131.127 (21 CFR 131.127)), lowfat milk 
(Sec. 131.135 (21 CFR 131.135)), acidified lowfat milk (Sec. 131.136 
(21 CFR 131.136), cultured lowfat milk (Sec. 131.138 (21 CFR 131.138)), 
light cream (Sec. 131.155 (21 CFR 131.155)), lowfat yogurt 
(Sec. 131.203 (21 CFR 131.203)), nonfat yogurt (Sec. 131.206 (21 CFR 
131.206)), and lowfat cottage cheese (Sec. 133.131 (21 CFR 133.131)). 
In addition, there are 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. For example, skim milk (Sec. 131.143 (21 CFR 
131.143)), acidified skim milk (Sec. 131.144 (21 CFR 131.144)), and 
cultured skim milk (Sec. 131.146 (21 CFR 131.146)) may be labeled as 
``nonfat milk,'' ``acidified nonfat milk,'' and ``cultured nonfat 
milk,'' respectively. Some of the names in these standards are 
inconsistent with the definitions for the corresponding nutrient 
content claims established 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 Health and Human Services. 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. According to the legislative history, 
this exemption was included in the law because Congress recognized the 
possibility that nomenclature and nutrient content claims requirements 
in preexisting standards of identity might conflict with the nutrient 
content claim definitions adopted under the 1990 amendments (H. Rept. 
101-538, 101st Cong., 2d sess. 22, June 13, 1990). The legislative 
history went on to state that to the extent that those standards 
provide requirements that are different from the definitions in the 
regulations issued by FDA under the 1990 amendments, one basic purpose 
of the 1990 amendments will be partially undermined (id.). However, the 
legislative history affirmed that the Secretary of Health and Human 
Services (and, by delegation, FDA) has the authority to correct this 
problem by amending the standards of identity to conform with the 
regulations issued under section 403(r) of the act (id.).
    The agency stated in the final rule establishing the general 
standard (58 FR 2431 at 2444) 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 it adopted. 
Alternatively, the agency stated that it could delete some of the 
standards and allow the foods defined by these standards to be named 

[[Page 56542]]
using a nutrient content claim with a standardized term in accordance 
with the general standard (Sec. 130.10). The proposed actions set out 
below are intended, in part, to implement the latter option.

B. MIF and CSPI Petitions

    This proposal also responds to two petitions filed by MIF and CSPI, 
dated May 10, 1995 (Docket No. 95P-0125) and August 2, 1995 (Docket No. 
95P-0250). The May 10, 1995, petition, requests that the agency revoke 
the standard of identity for lowfat milk in Sec. 131.135 and the 
standard of identity for skim milk in Sec. 131.143 and to regulate 
these products under the general standard in Sec. 130.10. The August 2, 
1995, petition, which references the May 10, 1995, petition, requests 
that the agency revoke the standards of identity for 10 additional 
products (i.e., sweetened condensed skimmed milk (Sec. 131.122 (21 CFR 
131.122)), acidified lowfat milk (Sec. 131.136), cultured lowfat milk 
(Sec. 131.138), acidified skim (or nonfat) milk (Sec. 131.144), 
cultured skim (or nonfat) milk (Sec. 131.146), sour half-and-half 
Sec. 131.185 (21 CFR 131.185)), acidified sour half-and-half 
Sec. 131.187 (21 CFR 131.187)), lowfat yogurt (Sec. 131.203), nonfat 
yogurt (Sec. 131.206), and lowfat cottage cheese (Sec. 133.131)) that 
include nutrient content claims in their names. The petitioners stated 
that the purpose of the petitions is to promote consistency in the use 
of nutrient content claims concerning fat on food labels.
    To provide for the continued use of the term ``skim'' in the 
labeling of these skim milk products if FDA were to revoke the 
standards for these foods as requested, MIF and CSPI submitted a third 
petition, dated August 2, 1995, which requests that the agency amend 
the nutrient content claims regulations in Sec. 101.62 to permit the 
use of the term ``skim'' as a synonym for the term ``nonfat.'' That 
petition was filed under Docket No. 95P-0293.

C. Niagara County Healthy Heart Program Petition

    FDA also received a petition from the Niagara County Healthy Heart 
Program (Docket No. 93P-0089) that requests that the agency amend the 
standards of identity for lowfat milk (Sec. 131.135), acidified lowfat 
milk (Sec. 131.136), and cultured lowfat milk (Sec. 131.138) by 
deleting the two upper-levels for milkfat content in these foods. These 
standards currently provide for the following fat levels: \1/2\, 1, 
1\1/2\, or 2 percent milkfat. The petitioner stated that milkfat levels 
of 1\1/2\ or 2 percent provided by these standards result in products 
that contain more than 3 grams (g) fat per serving and that, thus, are 
inconsistent with the agency's definition of ``low fat.'' In addition, 
the petitioner claimed that these exceptions in the standards of 
identity have the potential to confuse consumers and therefore should 
be removed.
    The agency notes that if the standards of identity for the lowfat 
milk products are revoked, as proposed below, the need to remove the 
upper-limits for milkfat (1\1/2\ and 2 percent) in these standards will 
be rendered moot. However, if the comments do not support revocation of 
the lowfat milk standards, the agency will consider alternative actions 
such as those suggested by the petitioner as a means of correcting the 
inconsistency between the standards in Secs. 131.135, 131.136, and 
131.138, and the nutrient content claims regulations in 
Sec. 101.62((b)(2) regarding the use of the term ``low fat'' on food 
labels.

D. ADPI Petitions

    This proposal also responds to two petitions filed by ADPI. One 
ADPI petition, filed on August 11, 1995 (Docket No. 95P-0261), requests 
that the agency revoke the standards of identity for evaporated skimmed 
milk in (Sec. 131.132 (21 CFR 131.132)) and lowfat dry milk in 
Sec. 131.123 and amend the standard of identity for dry cream in 
(Sec. 131.149 (21 CFR 131.149)) by removing the reference to 
Sec. 131.135 (the lowfat milk standard, which is being proposed for 
revocation). According to the petitioner, their suggested change would 
remove the lower-fat evaporated milk and dry milk standards that 
contain product specifications that potentially conflict with approved 
nutrient content claims applicable to foods in general. The petition 
would also amend the dry cream standard so as to bring it into 
conformity with the other suggested changes in the milk product 
standards.
    The other ADPI petition (Docket No. 95P-0293, dated August 10, 
1995) requests that the agency provide for use of the term ``skim'' as 
a synonym for ``nonfat'' in Sec. 101.62. ADPI stated that providing for 
this term would allow use of the familiar term ``skim'' in the name of 
the lower fat evaporated milk product if the existing standard in 
Sec. 131.132 is revoked, and this product is manufactured and labeled 
in conformance with the general definition and standard of identity in 
Sec. 130.10.

E. Regulatory Reinvention Initiative--Review of Regulations

    In addition, this proposal 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'' (Ref. 1). This memorandum, among other things, 
directs departments and agencies to do a page-by-page review of 
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 has revealed that a number of the products that are 
defined by individual standards in parts 131 and 133 (21 CFR parts 131 
and 133) could be more appropriately covered by the general standard in 
Sec. 130.10. Thus, the agency is proposing to remove those standards 
cited by the MIF, CSPI, and ADPI that are inconsistent with food 
labeling policy established under the 1990 amendments and that are 
unnecessary in light of the general standard in Sec. 130.10.

II. Grounds for the Petitions

A. Removal of Standards

    The petitioners pointed out that the regulations that FDA 
promulgated in response to the 1990 amendments defined ``nonfat'' and 
``low fat'' in ways that are in conflict with the standards of identity 
for certain dairy products, e.g., skim (nonfat) milk and lowfat milk 
products. The nutrient content claims regulations 
(Sec. 101.62(b)(1)(i)) require that to qualify to bear the term 
``nonfat,'' a food must have less than 0.5 g of fat per reference 
amount customarily consumed. Conversely, the standards of identity for 
skim milk and the related cultured and acidified skim milk products in 
Secs. 131.143(a), 131.144(a), and 131.146(a), for example, allow these 
``nonfat'' milk products to have up to 0.5 percent milkfat, which 
translates to 1.2 g of fat per 8 fluid ounce serving, that is, per 
reference amount customarily consumed. Similarly, whereas ``low fat'' 
foods (Sec. 101.62(b)(2)(i)(A)) generally must have 3 g or less of fat 
per reference amount customarily consumed, the standards for ``lowfat'' 
milk products in Secs. 131.135(a), 131.136(a), and 131.138(a), for 
example, allow these foods to contain as much as 2 percent milkfat, or 
5 g of fat per reference amount customarily consumed (up to 60 percent 
more than is permitted under the definition for the claim).
    Thus, the petitioners stated, if a term such as ``low fat'' has one 
meaning when applied to foods in general and a 

[[Page 56543]]
different meaning when applied to a widely-consumed staple food such as 
milk, the result might well be confusion in the minds of many consumers 
as to the significance of the term. They further noted that the 
Institute of Medicine, in ``Nutrition Labeling: Issues and Directions 
for the 1990's,'' p. 251, 1990, stated that ``the message conveyed by 
quantitative descriptors should be consistent, clear, and reliable * * 
* [L]ow sodium, for example, should have the same meaning, whether it 
is applied to soup, frozen peas, or meat.''
    MIF and CSPI urged FDA to repeal the standards of identity for 
lowfat milk, skim milk, and certain related dairy products and to make 
the use of nutrient content claims for fat in the names of these dairy 
products consistent with the use of nutrient content claims for fat on 
other foods. The petitioners asserted that this action would enhance 
the public health because it would eliminate consumer confusion about 
the significance of these claims and would facilitate comparisons 
between these dairy products and other foods.
    In further support of their petitions, ADPI, MIF, and CSPI pointed 
to the agency's expressed intention to establish consistency in 
nutrient content claims as evidenced by its rejection of comments 
urging it to define ``low fat'' differently for different foods. The 
petitioners noted that in the proposed rule to establish definitions 
for nutrient content claims (56 FR 60478 at 60487 and 60488, November 
27, 1991), the agency explained:

    The use of different criteria for different food categories has 
several disadvantages that affect both consumers and the food 
industry. When different criteria are used for different categories 
of foods, consumers cannot use the nutrient content claims to 
compare products across categories and will likely find it difficult 
to use the descriptor in substituting one food for another in their 
diets. * * * Furthermore, by having different criteria for different 
food categories, it would be possible that some foods that did not 
qualify to use the descriptor would have a lower fat content than 
foods in other categories that did qualify. This situation would 
contribute to consumer confusion and misunderstanding.

    The petitioners claimed that this reasoning, which led FDA to adopt 
uniform definitions for nutrient content claims, should lead the agency 
to revoke the standards of identity for lower-fat fluid milk and yogurt 
products. These standards establish criteria for the use of the terms 
``lowfat'' and ``nonfat'' in milk product labeling that are 
inconsistent with the criteria applicable to the labeling of other 
foods. Consequently, according to the petitioners, the regulations 
currently contain precisely what FDA has determined to avoid: Different 
definitions of ``low fat'' for different foods.
    The petitioners cited the legislative history of the 1990 
amendments as indicating that Congress anticipated that FDA would take 
action to make the nutrient content claims in standards of identity 
consistent with those in the regulations established under the 1990 
amendments. They also referred to the agency's recognition that it may 
be appropriate to revoke the standards of identity containing nutrient 
content claims, such as ``lowfat milk'' and ``skim (nonfat) milk,'' and 
to subject these foods to the same regulations as other foods (58 FR 
2431 at 2444).
    The petitioners noted that if the agency were to eliminate the 
standards of identity for ``lowfat milk'' and ``skim milk'' products, 
these lower-fat milk products would be labeled according to the general 
standard in Sec. 130.10. They would be named by a nutrient content 
claim defined by regulation (such as ``nonfat,'' ``fat free,'' ``low 
fat,'' or ``reduced fat'') in conjunction with the standardized name 
for whole milk (i.e., ``milk'') in Sec. 131.110(e)(21 CFR 131.110(e)).
    MIF and CSPI also stated that revocation of the standards of 
identity for sour half-and-half and acidified sour half-and-half would 
advance Congress's goal of making fat content claims clear and 
consistent. They claimed that the sour half-and-half products and the 
counterpart full-fat sour cream products are equivalent in every way 
except for fat content, and except for the fact that the lower-fat sour 
cream product names do not include the term ``sour cream.'' They 
contended that because processors are required to use the standardized 
name, e.g., ``sour half-and-half,'' ``cultured sour half-and-half,'' or 
``acidified sour half-and-half,'' as appropriate, the relationship 
between these products and their full-fat counterparts, ``sour cream,'' 
``cultured sour cream,'' or ``acidified sour cream,'' is obfuscated. 
Therefore, the petitioners asked that the standards for the sour half-
and-half products be revoked.

B. Other Issues

    The petitioners stated that two issues needed to be addressed for 
the revocation of the standards for ``lowfat milk'' and ``skim milk'' 
to result in labels for the products that can be easily understood by 
consumers.
    The petitioners maintained that most products currently labeled as 
``nonfat milk'' would be eligible to retain that name under the general 
standard because nonfat milk contains less than 0.5 g of fat per 
serving, in accordance with the definition of the term ``nonfat'' in 
Sec. 101.62(b)(1)(i). However, the petitioners noted that these 
products could not be called ``skim milk'' under the general standard 
because the fat content claims regulations in Sec. 101.62 do not 
authorize the use of the term ``skim.'' They stated that a significant 
number of processors presently use the nomenclature ``skim milk,'' and 
that ``skim'' is the term by which many consumers distinguish between 
nonfat milk and all other forms of milk. The loss of authority to use 
this traditional and widely recognized name would thus be extremely 
disruptive. MIF stated that in view of widespread consumer reliance on 
the name ``skim milk,'' it regards the approval of the descriptor 
``skim'' (as a synonym for ``nonfat'') as essential to its continuing 
support of the revocation of the skim milk standard.
    MIF and CSPI also requested that the agency revoke the standard of 
identity for sweetened condensed skimmed milk (Sec. 131.122). The 
petitioners stated that if the agency provides for the synonym ``skim'' 
in Sec. 101.62, sweetened condensed skimmed milk could be manufactured 
and labeled under Sec. 130.10 and could be named using the term 
``skim'' in a manner that is consistent with other nonfat milk 
products.
    The second issue to be resolved, according to the petitioners, 
concerns declaration of the percentage of milkfat in the name of the 
food. The petitioners suggested that they expected the authority to 
state the milkfat percentage before the name on product labels to 
continue under the general standard because section 3(b)(1)(A)(iv) of 
the 1990 amendments dictates that the regulations ``shall permit 
statements describing the amount and percentage of nutrients in food 
which are not misleading and are consistent with the terms defined'' 
under the act. The petitioners pointed out that the general nutrient 
content claims regulations in Sec. 101.13(i) implement this provision 
by providing that:

    * * * the label or labeling of a product may contain a statement 
about the amount or percentage of a nutrient if: (1) The use of the 
statement on the food implicitly characterizes the level of the 
nutrient in the food and is consistent with a definition for a claim 
* * * or (3) The statement does not in any way implicitly 
characterize the level of the nutrient in the food and it is not 
false or misleading in any respect * * *.

    MIF claimed that although the term ``implicitly characterizes'' is 
somewhat ambiguous, it is clear that a percentage figure can be used if 
it is consistent with the appropriate nutrient content claim (e.g., 
``2% reduced fat''; ``1% lowfat''). 

[[Page 56544]]
MIF stated 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 between milk products. MIF further stated that 
it would not be proposing 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 customary 
manner.
    The petitioners also discussed the nutritional aspect of deleting 
the lower-fat milk, sour cream, and cottage cheese products standards 
of identity, stating that this aspect of the proposed action would not 
require additional action. They claimed that the only distinction of 
note between the milk standard and the lower-fat dairy product 
standards (e.g., lowfat milk and skim milk products), in relation to 
nutritional content, is that vitamin A fortification to 10 percent of 
the daily value (DV) is optional under the milk standard but mandatory 
under the lower-fat milk standards. The petitioners stated that, even 
if the skim milk and lowfat milk product standards were revoked, 
vitamin A fortification of these products to 10 percent of the DV would 
remain mandatory under the general standard.
    The petitioners noted that because vitamin A is fat soluble, the 
process of removing fat from milk unavoidably removes some vitamin A. 
As a result, all commonly marketed lower-fat fluid milk products would 
be required to have at least some added vitamin A in order to meet the 
general standard's requirement that they not be nutritionally inferior 
to milk (Sec. 130.10(b)). Moreover, they noted, the milk standard in 
Sec. 131.110(b)(1) states that if vitamin A is added, it must be added 
to the 10 percent DV level. Consequently, the petitioners concluded, 
lower-fat milk products, labeled according to the general standard, 
would have to be vitamin A fortified up to 10 percent of the DV. They 
concluded that elimination of the lower-fat milk product standards 
would have no practical effect on the nutritional benefit of these 
products.
    ADPI maintained that revocation of the standards for evaporated 
skimmed milk and lowfat dry milk will not result in inferior dairy 
products because these foods are produced by removal of water from 
dairy products or are mixtures of other dairy products where water has 
been removed to some extent. ADPI further stated that besides water, 
the other key variable in evaporated milk and dry milk is fat. By 
revoking the standards for evaporated skimmed milk and lowfat dry milk, 
ADPI concluded that the amount of fat present in the products would be 
communicated through the use of terms (i.e., nutrient content claims) 
that would be consistent with the same terms applied to other foods. 
The remaining nutritional attributes of these foods would remain 
unchanged.

III. Proposed Actions

A. Removal of Standards

    FDA agrees with the petitioners that the requested changes are 
consistent with the agency's stated intent to have consistent 
definitions across food categories for nutrient content claims. 
Accordingly, FDA is proposing to repeal the standards of identity for 
the lower-fat milk, sweetened condensed milk, evaporated milk, dry 
milk, sour cream (i.e., sour half-and-half or acidified sour half-and-
half), and yogurt products, in Secs. 131.122, 131.123, 131.132, 
131.135, 131.136, 131.138, 131.143 131.144, 131.146, 131.185, 131.187, 
131.203, and 131.206, and lowfat cottage cheese in Sec. 133.131 that 
include nutrient content claims in their names. Repeal of the standards 
of identity for the lower-fat dairy products would allow these foods to 
bear the nutrient content claims ``reduced fat,'' ``lowfat,'' or 
``nonfat'' in conjunction with the standardized term ``milk,'' 
``sweetened condensed milk,'' ``evaporated milk,'' ``dry milk,'' ``sour 
cream,'' or ``yogurt'' provided that they comply with the general 
standard in Sec. 130.10. This standard in turn would require that all 
such products bearing these nutrient content claims comply with the 
definitions established for the claims in Sec. 101.62. Thus, consumers 
would be presented with information on the fat content of the modified 
milk, sour cream, and yogurt products that is consistent with that on 
other foods and that will enable them to select much more readily those 
products that will provide, in the case of ``low fat'' foods, 3 g or 
less of fat per reference amount customarily consumed, or, in the case 
of ``nonfat'' or ``fat free'' foods, those products that contain less 
than 0.5 g of fat per reference amount and per labeled serving, than 
they are able to do under the existing standards.
    MIF and CSPI suggested that milk products that are currently 
labeled as ``2 percent lowfat milk'' or ``1.5 percent lowfat milk,'' 
and which would not be entitled to bear that name after the standard of 
identity for lowfat milk is removed, could be labeled as ``2 percent 
reduced fat milk'' or ``1.5 percent reduced fat milk.'' The agency 
agrees that a declaration of the percentage of fat is permitted under 
the nutrient content claims regulations in Sec. 101.13(i). It also 
agrees that continuing the percentage fat declaration as part of the 
name would assist consumers in recognizing these milk and yogurt 
products when the nutrient content claim in the names of these foods is 
changed from ``lowfat'' to ``reduced fat'' under the general standard 
(i.e, ``reduced fat milk, 2 percent milkfat,'' or ``reduced fat milk, 2 
percent fat''). The agency points out that if it adopts this proposed 
action, unlike under the existing standards, e.g., in Secs. 131.135 and 
131.143, which provide that the name include a declaration of the 
percentage of milkfat, the percentage fat declaration in the name under 
Sec. 130.10 will be on a total fat basis (milkfat and any fat from 
added optional ingredients).
    ADPI and MIF requested that FDA provide for the continued use of 
the name ``skim milk'' as an alternative to ``nonfat milk'' after the 
standards of identity for skim milk products are repealed. They pointed 
out that the regulations in Sec. 101.62(b) do not provide for the use 
of ``skim'' as a synonym for ``nonfat'' or ``fat free.'' Thus, the name 
``skim milk'' would not be available to producers of skim milk when 
that product is made under the general standard. ADPI also requested 
that the term ``skim'' be provided as a synonym for ``nonfat,'' so that 
the lower-fat evaporated milk product can be labeled in a manner that 
is consistent with the labeling of other lower-fat fluid milk products.
    The agency has considered these requests and is proposing to amend 
the regulations pertaining to nutrient content claims for fat in 
Sec. 101.62(b)(1) to include ``skim'' as a synonym for ``nonfat'' in 
characterizing the level of fat in modified milk products. FDA notes 
that several standards in part 131 for skim milk products (i.e., skim 
milk, acidified skim milk, and cultured skim milk in Secs. 131.143, 
131.144, and 131.146) currently provide for the use of either 
``nonfat'' or ``skim'' (or ``skimmed'' in the case of sweetened 
condensed milk and evaporated milk) in the names of these products. 
Based on their history of use in dairy product nomenclature, the agency 
tentatively concludes that consumers understand the name ``skim milk'' 
to mean the same as ``nonfat milk''. Thus, the agency is proposing 
under sections 403(r) and 701(a) of the act (21 U.S.C. 371(a)) to 
include the term ``skim,'' when used to describe milk products, as a 
synonym for ``nonfat'' in Sec. 101.62(b)(1), as set forth below.
    FDA notes that in the absence of a specific standard of identity 
for the 

[[Page 56545]]
lower-fat sweetened condensed milk product or evaporated milk product, 
manufacturers will be provided greater flexibility in selecting the fat 
levels for these foods when they are made under the general standard. 
As in the case of the other lower-fat milk and yogurt products, the 
nutrient content claims used in the naming these foods under 
Sec. 130.10 will be consistent with those used in the labeling of other 
foods, thereby decreasing the potential for consumer confusion as to 
the meaning of these nutrient content claims on food labels.
    FDA also is proposing to remove the standard of identity for lowfat 
cottage cheese in Sec. 133.131. The petitioners stated that virtually 
all lowfat cottage cheese on the market has less than 3 g of fat per 
the reference amount customarily consumed of 110 g. If so, this food 
could continue to be labeled as ``lowfat cottage cheese'' under the 
general standard. The agency notes that the standard of identity for 
lowfat cottage cheese in Sec. 133.131(b)(2) requires that the 
percentage of milkfat in the food be declared as part of the name of 
the food. Thus, if Sec. 133.131 is removed, there will be no provision 
requiring percentage declaration of milkfat content in conjunction with 
the name of this food. However, because the name of the food includes a 
nutrient content claim, a declaration of the amount of fat per 
reference amount customarily consumed will appear in the nutrition 
facts statement on the label. Thus, consumers will continue to have 
access to information on the fat content of the lowfat cottage cheese 
that can be used in making purchasing decisions. On the other hand, 
manufacturers may continue to declare fat content as part of the name 
of the food as has been suggested by the petitioners for lowfat milk 
products.
    The agency notes that standards of identity for two cream products 
contain the term ``light'' in the names of the foods, light cream in 
Sec. 131.155 and light whipping cream in Sec. 131.157 (21 CFR 131.157). 
FDA is not proposing to change these standards at this time. The agency 
tentatively concludes that no change is necessary in the names of these 
foods because of their long history of use, since 1940. These names 
connote a difference in the texture of these products compared to the 
higher fat cream product defined in 21 CFR 131.150, heavy cream. In 
addition, light cream, which contains not less than 18 percent but less 
than 30 percent milkfat is often labeled by one of its alternative 
standardized names, as ``table cream'' or ``coffee cream.'' Light 
whipping cream, which contains not less than 30 percent but less than 
36 percent milkfat, is distinguished from heavy whipping cream, which 
contains 30 percent or more of milkfat, not only by its lower fat 
content but by its lighter, less dense texture on whipping. The agency 
requests comments 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. If comments demonstrate that amendment of these 
regulations is necessary, such action will be the subject of a later 
rulemaking.
    As noted by ADPI, the standard of identity for dry cream 
(Sec. 131.149) provides that the food is obtained by removal of water 
only from pasteurized milk or cream or a mixture thereof, which may 
have been homogenized. The standard also provides that dry cream may be 
obtained by blending dry milks as defined in Secs. 131.123(a), 
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 preceding sentence. Because 
this proposal would remove the standard of identity for lowfat dry milk 
in Sec. 131.123, ADPI requests that the dry cream standard be amended 
to delete that reference. The agency also recognizes the need to delete 
the reference in Sec. 131.123 and is proposing to make the change as 
set out below.
    FDA is not proposing to revoke the standards of identity for nonfat 
dry milk and nonfat dry milk fortified with vitamins A and D, in 
Secs. 131.125 and 131.127, respectively, because the use of the term 
``nonfat'' in the names of these foods does not conflict with the 
definition of the term ``nonfat'' in Sec. 101.62(b)(1). In addition, 
the agency notes that ``nonfat dry milk,'' as defined by the Nonfat Dry 
Milk, Milk Act of July 2, 1956, does not contain added vitamins A and 
D. Retention of these standards will minimize confusion as to whether 
these vitamins may be added to the food.

B. Vitamin Addition

    The agency disagrees with the MIF's and CSPI's interpretation of 
the impact of revoking the standards of identity for lowfat and skim 
milk on the requirements for addition of vitamins A and D to lowfat 
milk or nonfat milk that conform to Sec. 130.10. Under the existing 
standards 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 DV per reference amount 
customarily consumed). When vitamin D is added, the level must be 400 
IU per quart (100 IU or 25 percent of the DV per reference amount 
customarily consumed). 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. 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 (Ref. 2). Vitamin D levels range from 5 to 15 IU 
(Ref. 2). Because the removal of milkfat from milk in the production of 
the lower-fat milk products removes corresponding amounts of the 
naturally occurring fat soluble vitamins, some amount of these two 
vitamins would have to be added for the lower-fat products to comply 
with the general standard. However, under Sec. 101.3(e), the amount 
required to be added is only that necessary to make the level in the 
lower-fat milk products at least equivalent to that in whole milk.
    Because the addition of both vitamins A and D to whole milk is 
optional, the requirements for levels of 2,000 IU of vitamin A and 400 
IU of vitamin D per quart would not apply to products under the general 
standard. Although such levels would be permitted, they would not be 
required. Addition of vitamins A and D to these levels would be 
permitted because milk under Sec. 131.110 can contain these amounts and 
be named for example ``milk, vitamins A and D added.'' The lower-fat 
milks could have equivalent levels and be named for example ``reduced 
fat milk, vitamins A and D added,'' or ``nonfat milk, vitamin A 
added,'' as appropriate.
    The same rationale applies to vitamin addition in the lower- fat 
yogurt products, in which both vitamin A and vitamin D addition is 
optional. There are no provisions for addition of vitamins to sweetened 
condensed skimmed milk. However, when the food is made under 
Sec. 130.10, it must not be nutritionally inferior to sweetened 
condensed milk. Lower-fat evaporated milk products, however, must be 
fortified with vitamin D because addition of vitamin D in evaporated 
milk is mandatory.
    The agency requests comment on whether current levels of vitamins A 
and D in the lower-fat milk products need to be maintained. 
Specifically, the agency requests information on levels of vitamins A 
and D currently in the milk supply and on the changes in these levels, 
if any, that are likely to occur if the standards of identity for the 
lowfat milk and skim milk products are 

[[Page 56546]]
revoked. Information should include: (1) The percentage of milk 
currently optionally fortified with one or both vitamins and the 
likelihood of that changing; and (2) the percentage of lower-fat milk 
products currently so fortified, and the likelihood that the 
fortifications would continue if they were optional. Based on the 
information received in comments, FDA will consider whether special 
provisions are necessary (beyond the nutritional equivalency 
requirements of Sec. 130.10) to require fortification of lowfat, 
reduced fat, and nonfat milk products manufactured under Sec. 130.10.

C. Other Action--Unresolved Hearing Issue on the Lowfat Milk and Skim 
Milk Standards

    In the Federal Register of October 6, 1983 (48 FR 45545), FDA 
published a notice of hearing on objections 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 have been resolved 
(51 FR 40313, November 6, 1986). One 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 not been resolved. However, if a final rule is issued to 
remove the standards of identity for lowfat milk and skim milk in 
Secs. 131.135 and 131.143, this unresolved issue will be rendered moot, 
and no further rulemaking procedures regarding the stayed provision 
will be necessary.

IV. Economic Impact

    FDA has examined the economic implications of the proposed rule 
amending 21 CFR parts 101, 131, and 133 as required by Executive Order 
12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches which maximize net benefits (including 
potential economic, environmental, public health and safety and other 
advantages; distributive impacts; and equity). The Regulatory 
Flexibility Act requires that the agency analyze options for regulatory 
relief for small businesses. FDA finds that this proposed rule is not a 
significant rule as defined by Executive Order 12866. In accordance 
with the Regulatory Flexibility Act, the agency certifies that the 
proposed rule will not have a significant impact on a substantial 
number of small businesses.
    There are approximately 1,350 lowfat and 570 skim (nonfat) milk 
products currently on the market. These products correspond to 
approximately 3,500 lowfat milk and 1,600 nonfat milk stockkeeping 
units (SKU's). If this rule is finalized as proposed, all milk products 
currently using the terms ``lowfat'' and ``nonfat'' will have to comply 
with the definitions established for those claims. Any milk product not 
labeled in compliance with the term ``lowfat'' or ``nonfat'' will have 
to 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'' will not be 
eligible to retain that name and will have to be relabeled as ``reduced 
fat milk''. Specifically, products containing more than 1 percent 
milkfat and currently labeled ``lowfat'' will have to be relabeled. 
There are approximately 750 such products and approximately 2,225 
SKU's.
    Potentially, this regulation will also require changes in the 
labeling of evaporated skimmed milk, lowfat dry milk, sour half-and-
half, acidified sour half-and-half, lowfat and nonfat yogurts, and 
lowfat cottage cheese. There are approximately 5 evaporated skimmed 
milk products and 8 SKU's, 1 lowfat dry milk product and 4 SKU's, 12 
sour half-and-half products and 16 SKU's, approximately 119 lowfat 
yogurts and 1,294 SKU's, approximately 91 nonfat yogurts and 813 SKU's, 
and approximately 142 lowfat cottage cheese products and 436 SKU's. 
There are no acidified sour half-and-half products in FDA's database. 
FDA estimates that almost none of the nonfat yogurts and lowfat cottage 
cheeses will require relabeling because these products most likely meet 
FDA's definitions for ``lowfat'' and ``nonfat''. However, the sour 
half-and-half products will require relabeling with the term ``reduced 
fat'' in conjunction with the term ``sour cream.'' FDA estimates that 
most of the lowfat yogurts contain too much fat to retain the term 
``lowfat'' and will either be relabeled or reformulated.
    There are four categories of costs associated with a mandatory 
relabeling: Administrative, analytical, redesign, and inventory 
disposal costs. The administrative costs associated with a labeling 
regulation are the dollar value of the incremental administrative 
effort expended in order to comply with a regulation. The magnitude of 
administrative costs to a representative firm is a function of several 
variables including the scope and intricacy of the regulation (positive 
relationship), the number of distinct products, and the length of the 
compliance period associated with the regulation (inverse 
relationship). This proposed regulation is not anticipated to be an 
intricate regulation. The administrative costs associated with a 
nonintricate regulation with a compliance period in excess of 1 year is 
$850 per small/medium firm and $6,300 per large firm. The total 
administrative costs associated with this proposed regulation are 
approximately $2.2 million.
    Analytical tests are typically performed by technical personnel 
employed by firms or at independent laboratories. These costs consist 
of tests to determine nutrient and food component quantities required 
by various labeling provisions. The agency does not anticipate that 
this rule will cause any analytical testing. Because milk products are 
already subject to nutrition labeling requirements, firms should 
already be aware of the fat content of their products.
    Incremental redesign costs depend on the type of printing process 
used, the complexity of the label change, and the length of the 
compliance period. Because printing activities are specific to 
individual labels, computing incremental printing effort on a per-SKU 
basis is necessary. The agency estimates that the changes required by 
this proposed regulation will result in a simple two-color label 
change. Also, because firms will have in excess of 1 year to comply, 
redesign costs will be reduced by the fact that they can incorporate 
mandated changes with previously planned label changes. Total redesign 
costs of the proposed regulation are estimated at $3 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 proposing an effective date that would allow 
for over 1 year for firms to comply with any final rule that may result 
from this rulemaking. A 1-year compliance period is sufficient to allow 
producers of milk, yogurt, sour half-and-half, and cottage cheese 
products to use up existing stocks of labels. Therefore, label 
inventory disposal costs will be zero. The agency estimates that the 
total costs of this proposed regulation will be approximately $5 
million.
    The agency believes that consumers will benefit from this 
regulation because it will provide consistency in the 

[[Page 56547]]
nomenclature of both standardized and nonstandardized foods that bear 
nutrient content claims relating to their fat content.

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. Comments

    Interested persons may, on or before January 23, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

VII. References

    1. Memorandum entitled ``Regulatory Reinvention Initiative'' from 
President Clinton to heads of departments and agencies, March 4, 1995.
    2. Jenness, Robert and Patton, Stuart, Principles of Dairy 
Chemistry, John Wiley and Sons, Inc., NY, pp. 403-404, 1959.

List of Subjects

21 CFR Part 101

    Food labeling, 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, it is 
proposed that 21 CFR parts 101, 131, and 133 be 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 Packing 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) ``Fat content claims.'' (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).


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.


Sec. 131.203  [Removed]

    16. Section 131.203 Lowfat yogurt is removed from subpart B.


Sec. 131.206  [Removed]

    17. Section 131.206 Nonfat yogurt is removed from subpart B.

PART 133--CHEESES AND RELATED CHEESE PRODUCTS

    18. 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]

    19. Section 133.131 Lowfat cottage cheese is removed from subpart 
B.

    Dated: October 27, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-27712 Filed 11-8-95; 8:45 am]
BILLING CODE 4160-01-P