[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Proposed Rules]
[Pages 11791-11793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03835]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 78, No. 34 / Wednesday, February 20, 2013 /
Proposed Rules
[[Page 11791]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 131
[Docket No. FDA-2009-P-0147]
Flavored Milk; Petition to Amend the Standard of Identity for
Milk and 17 Additional Dairy Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments, data, and information.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
International Dairy Foods Association (IDFA) and the National Milk
Producers Federation (NMPF) have filed a petition requesting that the
Agency amend the standard of identity for milk and 17 other dairy
products to provide for the use of any safe and suitable sweetener as
an optional ingredient. FDA is issuing this notice to request comments,
data, and information about the issues presented in the petition.
DATES: Submit either written or electronic comments by May 21, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
P-0147 by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper or CD-ROM submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. IDFA and NMPF Petition
The IDFA and NMPF jointly submitted a citizen petition (Ref. 1) on
March 16, 2009, requesting that FDA amend the standard of identity in
part 131 (21 CFR part 131) for milk (Sec. 131.110). Specifically, the
petition requests that FDA amend Sec. 131.110(c)(2) to allow the use
of ``any safe and suitable'' sweetener in optional characterizing
flavoring ingredients used in milk.\1\ The petition also requests that
FDA similarly amend the standards of identity for 17 other milk and
cream products. Those standards (hereinafter referred to as the
``additional dairy standards'') are as follows: Acidified milk (Sec.
131.111), cultured milk (Sec. 131.112), sweetened condensed milk
(Sec. 131.120), nonfat dry milk (Sec. 131.125), nonfat dry milk
fortified with vitamins A and D (Sec. 131.127), evaporated milk (Sec.
131.130), dry cream (Sec. 131.149), heavy cream (Sec. 131.150), light
cream (Sec. 131.155), light whipping cream (Sec. 131.157), sour cream
(Sec. 131.160), acidified sour cream (Sec. 131.162), eggnog (Sec.
131.170), half-and-half (Sec. 131.180), yogurt (Sec. 131.200), lowfat
yogurt (Sec. 131.203), and nonfat yogurt (Sec. 131.206). The petition
asks that the standards of identity for these products be amended to
provide for the use of any safe and suitable sweetener in the optional
ingredients.\2\
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\1\ Section 131.110(c)(2) currently allows the use of
``nutritive sweetener'' in optional characterizing flavoring
ingredients used in milk.
\2\ The National Yogurt Association (NYA) submitted a citizen
petition on February 18, 2000 (Docket No. FDA-2000-P-0126) that
requested that FDA make similar changes to the standards of identity
for yogurt and cultured milk. Among other requested changes, the NYA
petition asked that FDA amend the standards of identity for yogurt
and cultured milk to permit the use of all safe and suitable
sweeteners, while also revoking the standards of identity for lowfat
and nonfat yogurt. In 2009, FDA proposed to grant the petition in
part, and to deny it in part. See ``Milk and Cream Products and
Yogurt Products; Proposal to Revoke the Standards for Lowfat and
Nonfat Yogurt and to Amend the Standard for Yogurt'' (74 FR 2443,
January 15, 2009). Thus, FDA has already requested comments on
issues that are similar to the issues IDFA and NMPF raise with
respect to yogurt, lowfat yogurt, nonfat yogurt, and cultured milk,
and is addressing those issues through the rulemaking initiated in
response to NYA's petition. Therefore, FDA is not currently
requesting comments on IDFA and NMPF's suggested amendments to the
yogurt, lowfat yogurt, nonfat yogurt, and cultured milk standards.
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IDFA and NMPF request their proposed amendments to the milk
standard of identity to allow optional characterizing flavoring
ingredients used in milk (e.g., chocolate flavoring added to milk) to
be sweetened with any safe and suitable sweetener--including non-
nutritive sweeteners such as aspartame. IDFA and NMPF state that the
proposed amendments would promote more healthful eating practices and
reduce childhood obesity by providing for lower-calorie flavored milk
products. They state that lower-calorie flavored milk would
particularly benefit school children who, according to IDFA and NMPF,
are more inclined to drink flavored milk than unflavored milk at
school. As further support for the petition, IDFA and NMPF state that
the proposed amendments would assist in meeting several initiatives
aimed at improving the nutrition and health profile of food served in
the nation's schools. Those initiatives include state-level programs
designed to limit the quantity of sugar served to children during the
school day. Finally, IDFA and NMPF argue that the proposed amendments
to the milk standard of identity would promote honesty and fair dealing
in the marketplace and are therefore appropriate under section 401 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341).
The petition acknowledges that the use of non-nutritive sweeteners
in optional characterizing flavoring
[[Page 11792]]
ingredients in milk is allowed under the existing regulatory scheme,
with certain additional requirements. The regulatory framework
governing the naming of standardized foods that do not fully comply
with the relevant standards of identity changed with the passage of the
Nutrition Labeling and Education Act of 1990 and FDA's rulemaking
establishing the Agency's requirements for foods named by use of a
nutrient content claim and a standardized term (Sec. 130.10 (21 CFR
130.10)). Section 130.10(d) allows the addition of safe and suitable
ingredients to a food named by use of a nutrient content claim and a
standardized term when these ingredients are used to, among other
things, add sweetness to ensure that the modified food is not inferior
in performance characteristic to the standardized food even if such
ingredients are not specifically provided for by the relevant food
standard. Therefore, while the milk standard of identity in Sec.
131.110 only provides for the use of ``nutritive sweetener'' in an
optional characterizing flavor, milk may contain a characterizing
flavor that is sweetened with a non-nutritive sweetener if the food's
label bears a nutrient content claim (e.g., ``reduced calorie'') and
the non-nutritive sweetener is used to add sweetness to the product so
that it is not inferior in its sweetness property compared to its
standardized counterpart. However, IDFA and NMPF argue that nutrient
content claims such as ``reduced calorie'' are not attractive to
children, and maintain that consumers can more easily identify the
overall nutritional value of milk products that are flavored with non-
nutritive sweeteners if the labels do not include such claims. Further,
the petitioners assert that consumers do not recognize milk--including
flavored milk--as necessarily containing sugar. Accordingly, the
petitioners state that milk flavored with non-nutritive sweeteners
should be labeled as milk without further claims so that consumers can
``more easily identify its overall nutritional value.''
As to the additional dairy standards, IDFA and NMPF state that
administrative efficiency counsels in favor of similar changes. As long
as FDA is dedicating resources to amending the standard of identity for
milk, they argue, the Agency should also amend the standards for these
products at the same time. They state that it is most efficient to
consider all of the proposals together. According to the petition, the
requested changes to the additional dairy standards present the same
issues as the milk standard, and it is therefore appropriate to
consider all of the requested changes together.
II. Request for Comments
FDA requests that interested persons submit comments, data, and
information concerning the need for, and the appropriateness of,
amending the standard of identity for milk and the additional dairy
standards. FDA specifically requests comment and supporting data, as
appropriate, on the following matters:
1. The petition states that amending the standard of identity for
milk (Sec. 131.100) to allow the use of ``any safe and suitable''
sweetener in optional characterizing flavoring ingredients would
promote honesty and fair dealing in the interest of consumers by
creating consistency in the naming of flavored milk products because
flavored milk could contain a non-nutritive sweetener without bearing a
nutrient content claim (e.g., ``reduced sugar'') as part of its name.
Would the proposed amendments promote honesty and fair dealing in the
interest of consumers?
2. If the standard of identity for milk is amended as requested by
petitioners, milk manufacturers could use non-nutritive sweeteners in
flavored milk without a nutrient content claim in its labeling. Will
the inclusion of the non-nutritive sweeteners in the ingredient
statement provide consumers with sufficient information to ensure that
consumers are not misled regarding the characteristics of the milk they
are purchasing?
3. The petition states that flavored milk labels that bear nutrient
content claims such as ``reduced calorie'' are unattractive to
children. What, if any, data are available on children's purchase
habits with regard to flavored milks labeled as ``reduced calorie
flavored milk,'' ``no sugar added,'' ``less sugar,'' etc?
4. The petition states that if FDA dedicates resources to amending
the standard of identity for milk, for purposes of administrative
efficiency the Agency should also amend the Additional Dairy Standards
because the issues presented are the same with respect to the use of
non-nutritive sweeteners. Would amending the Additional Dairy Standards
as requested promote honesty and fair dealing in the interest of
consumers? If the labels of these products do not bear nutrient content
claims, would the inclusion of non-nutritive sweeteners in the
ingredient statements provide consumers with sufficient information to
distinguish between the two types of products (i.e., sweetened with
nutritive versus non-nutritive sweeteners) so that consumers are not
misled? \3\
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\3\ Although FDA requests comments relevant to the IDFA and NMPF
petition, FDA does not seek comments regarding the requested
amendments to the standards of identity for yogurt, lowfat yogurt,
nonfat yogurt, and cultured milk. FDA has already sought and
collected comments regarding similar amendments to those standards
in a proposed rulemaking. See 74 FR 2443.
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5. The petition notes that ice cream is permitted to contain either
a nutritive or non-nutritive sweetener without the label bearing a
nutrient content claim or otherwise distinguishing the two types of
products from one another. Are the considerations underlying FDA
amendments to the standard of identity for ice cream \4\ applicable to
the requested amendments to the standard of identity for milk or the
Additional Dairy Standards?
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\4\ FDA amended the standard of identity for ice cream to allow
for ``any safe and suitable sweetener'' to be used in ice cream. See
``Frozen Desserts: Removal of Standards of Identity for Ice Milk and
Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice
Cream and Frozen Custard and Goat's Milk Ice Cream'' (59 FR 47072,
September 14, 1994) (Ref 2). Before FDA's amendment, the standard
provided only for ``nutritive carbohydrate sweeteners.''
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6. If the standard of identity for milk and the Additional Dairy
Standards are amended in the manner requested by the petition, what
will be the effect on search costs \5\ for consumers who would like to
determine whether a product contains a nutritive or non-nutritive
sweetener?
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\5\ Search costs include the time and energy it would take an
average consumer to read a label and determine whether the product
contained the nutritive sweetener or the artificial sweetener.
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After reviewing the comments received, FDA will further evaluate
the need for, and appropriateness of, the amendments requested by IDFA
and NMPF and will decide what further actions are appropriate. For a
copy of the petition filed by IDFA and NMPF please go to: http://www.regulations.gov and insert ``Docket No. FDA-2009-P-0147'' into the
``Search'' box.
(Authority: 21 U.S.C. 321 et seq.)
III. References
FDA has placed the following references on display. To view the
references, go to http://www.regulations.gov and insert the docket
number(s), found in brackets in the heading of this document, into the
``Search'' box. The references may also be seen in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
1. International Dairy Foods Association and the National Milk
Producers Federation, Citizen Petition, March 16, 2009.
[[Page 11793]]
2. ``Frozen Desserts: Removal of Standards of Identity for Ice Milk
and Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice
Cream and Frozen Custard and Goat's Milk Ice Cream'' (59 FR 47072,
September 14, 1994).
Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03835 Filed 2-19-13; 8:45 am]
BILLING CODE 4160-01-P