[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]
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[[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.
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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