81_FR_76535 81 FR 76323 - Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used To Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments

81 FR 76323 - Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used To Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 212 (November 2, 2016)

Page Range76323-76325
FR Document2016-26407

The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive comments, particularly data and other information, on the appropriate reference amount customarily consumed (RACC) and product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored), and products that can be used to fill cupcakes and other desserts, such as cakes and pastries. We are taking this action in part because we have recently issued a final rule updating certain RACCs, and we have also received a citizen petition asking that we either issue a guidance recognizing that ``nut cocoa-based spreads'' fall within the ``Honey, jams, jellies, fruit butter, molasses'' category for purposes of RACC determination; or amend the regulation to establish a new RACC category for ``nut cocoa- based spreads'' with an RACC of 1 tablespoon (tbsp.). We also are taking this action in response to a request to amend our serving size regulations to establish an RACC and product category for cupcake filling.

Federal Register, Volume 81 Issue 212 (Wednesday, November 2, 2016)
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Proposed Rules]
[Pages 76323-76325]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-N-2938]


Reference Amount Customarily Consumed for Flavored Nut Butter 
Spreads and Products That Can Be Used To Fill Cupcakes and Other 
Desserts, in the Labeling of Human Food Products; Request for 
Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
establishment of a docket to receive comments, particularly data and 
other information, on the appropriate reference amount customarily 
consumed (RACC) and product category for flavored nut butter spreads 
(e.g., cocoa, cookie, and coffee flavored), and products that can be 
used to fill cupcakes and other desserts, such as cakes and pastries. 
We are taking this action in part because we have recently issued a 
final rule updating certain RACCs, and we have also received a citizen 
petition asking that we either issue a guidance recognizing that ``nut 
cocoa-based spreads'' fall within the ``Honey, jams, jellies, fruit 
butter, molasses'' category for purposes of RACC determination; or 
amend the regulation to establish a new RACC category for ``nut cocoa-
based spreads'' with an RACC of 1 tablespoon (tbsp.). We also are 
taking this action in response to a request to amend our serving size 
regulations to establish an RACC and product category for cupcake 
filling.

DATES: Comments must be received on or before January 3, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified as 
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2938 for ``Reference Amount Customarily Consumed for 
Flavored Nut Butter Spreads (e.g., cocoa, cookie, and coffee flavored), 
and Products That Can Be Used To Fill Cupcakes and Other Desserts, in 
the Labeling of Human Food Products; Request for Information and 
Comments.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on http://www.regulations.gov. Submit both

[[Page 76324]]

copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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: Cherisa Henderson, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Flavored Nut Butter Spreads (e.g., cocoa, cookie, and coffee 
flavored)

    Under section 403(q)(1)(A)(i) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(1)(A)(i)), food that is 
intended for human consumption and offered for sale must bear nutrition 
information that provides a serving size that reflects the amount of 
food customarily consumed (i.e., the RACC) and is expressed in a common 
household measure that is appropriate to the food (unless an exception 
applies). We established RACCs for specific product categories in a 
final rule that appeared in the Federal Register on January 6, 1993, 
entitled ``Food Labeling; Serving Sizes'' (58 FR 2229, ``1993 final 
rule''). In the 1993 final rule, FDA provided nine general principles 
and factors for establishing RACCs in 21 CFR 101.12(a) to ensure that 
foods that have similar dietary usage, product characteristics, and 
customarily consumed amounts have a uniform reference amount.
    The 1993 final rule included a reference (Ref. 1) to a memorandum 
to the file entitled ``List of products for each product category,'' 
which listed ``Nutella'' as an example of a product in the product 
category ``Other dessert toppings, e.g., fruits, syrups, spreads, 
marshmallow cream, nuts, dairy and non-dairy whipped toppings'' (see 58 
FR 2229 at 2268). The conclusion that ``Nutella'' belongs in the 
``Other dessert toppings, e.g., fruits, syrups, spreads, marshmallow 
cream, nuts, dairy and non-dairy whipped toppings'' category with an 
RACC of two tbsp. was based on a consumer survey conducted in 1991 that 
showed a significant number of respondents used ``Nutella'' as a 
dessert topping, particularly for ice cream.
    In the Federal Register of March 3, 2014, we published a proposed 
rule entitled, ``Food Labeling: Serving Sizes of Foods That Can 
Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; 
Updating, Modifying, and Establishing Certain Reference Amounts 
Customarily Consumed; Serving Size for Breath Mints; and Technical 
Amendments'' (79 FR 11990, ``2014 proposed rule''). The 2014 proposed 
rule proposed to update and modify certain RACCs for previously 
established product categories and establish RACCs for new products and 
product categories. The 2014 proposed rule provided no specific 
discussion with respect to ``Nutella.'' After publication of the 
proposed rule, on March 4, 2014, we received a citizen petition that 
requested we either: (1) Issue guidance recognizing that ``nut cocoa-
based spreads'' fall within the ``Honey, jams, jellies, fruit butter, 
molasses'' category for purposes of RACC determination or (2) amend 
Sec.  101.12 to establish a new product category for ``nut cocoa-based 
spreads'' with an RACC of one tbsp. (Docket No. FDA-2014-P-0263.) Based 
on the information provided, which included data pertaining 
specifically to ``Nutella,'' we understand that the petition intended 
``Nutella'' to be incorporated into a category described as ``nut 
cocoa-based spreads.'' The petitioner submitted results of a consumer 
usage survey that the petitioner had commissioned through a marketing 
research firm. The survey included 722 mothers who purchased 
``Nutella'' in the past 3 months. The survey found that, on average, 74 
percent of ``Nutella'' use was associated with spreading the product on 
bread, including toast and in making sandwiches, and that two percent 
of use was as a topping for ice cream. The petition also included the 
results of an analysis of the National Health and Nutrition Examination 
Survey (NHANES) 2003-2010 consumption data for individuals aged 4 years 
or older (n = 43). The reported mean, median, and mode consumption 
amounts from this analysis for ``Nutella,'' including similar products 
used as chocolate-flavored hazelnut spreads, were 22.6 grams (g) (about 
1 tbsp.), 18 g (1 tbsp.), and 18 g (1 tbsp.), respectively.
    On March 10, 2016, we received a comment in response to the 2014 
proposed rule in which a report prepared by a scientific consulting 
firm analyzed the NHANES data from 2003 through 2012 among participants 
aged 1 year and older for ``Nutella'' and other similar products used 
as chocolate-flavored hazelnut spreads (n = 92) (Ref. 2). The comment 
stated that the results showed that the mean, median, and mode 
consumption amounts were 28.6 g, 18 g (about 1 tbsp.), and 12 g, 
respectively. The comment included a report of an online survey 
designed to estimate the amount of ``Nutella'' typically consumed in an 
eating occasion. The comment asserted that the survey was administered 
to a representative sample of the U.S. population aged 18 to 80 years, 
with an average age of 27.3 years. Four hundred and thirty respondents 
consumed ``Nutella'' in the year before the survey was administered, 
and these respondents reported 824 eating occasions. Based on the 
categorical consumption amount selections weighted by the frequency of 
such amount consumed, the comment concluded that median consumption per 
eating occasion was 18.5 g (about 1 tbsp.), that the mean consumption 
per eating occasion was 32.6 g, and that almost half of the eating 
occasions (46.9 percent) involved using the product as a spread with 
bread or toast, as compared to use with crackers or cookies (17.2 
percent), use by itself (13.9 percent), use as a spread for fruit (10.8 
percent), use as a spread over pancakes or waffles (8.2 percent), and 
other uses (3 percent). The report concluded that the median 
consumption amount from both analyses was one tbsp., consistent with 
the RACC of one tbsp. that we had established for sweet spreads for 
bread such as honey, jams, and jellies.
    Following the receipt of the citizen petition and comment, in the 
Federal Register of May 27, 2016, we published a final rule entitled, 
``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed 
At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and 
Establishing Certain Reference Amounts Customarily Consumed; Serving 
Size for Breath Mints; and Technical Amendments'' (81 FR 34000) (``2016 
final rule''). The 2016 final rule updated and modified certain

[[Page 76325]]

RACCs for previously established product categories and established 
RACCs for new products and product categories. The preamble to the 2016 
final rule explained in the response to the comment on nut cocoa-based 
spreads that the primary usage of hazelnut spread, which was a 
reference to nut cocoa-based spreads such as ``Nutella'' discussed in 
the comment, is as a spread for bread instead of as a dessert topping 
(81 FR 34000 at 34029 to 34030). However, with respect to specific 
assertions raised in the March 10, 2016, comment, we responded that, 
while we recognize a need for an RACC for hazelnut spread outside of 
the dessert product category,'' and agreed that the primary usage of 
hazelnut spread is as a spread for bread instead of as a dessert 
topping because the proposed rule was silent about an RACC for hazelnut 
spread, and because we intended to provide the opportunity for public 
comment on this specific issue, we intended to consider whether to move 
hazelnut spread to a different appropriate product category in a future 
rulemaking'' (81 FR 34000 at 34029). This notification of request for 
comments represents the first step of our evaluation of the appropriate 
RACC and product category for flavored nut butter spreads (e.g., cocoa, 
cookie, and coffee flavored), which we consider to include ``nut cocoa-
based spread'' as described in the citizen petition and comment to the 
2014 proposed rule.

B. Products Used as a Filling for Cupcakes and Other Desserts

    In response to the 2014 proposed rule, one comment requested that 
we establish an RACC for icing intended for use as cupcake filling. In 
the preamble to the 2016 final rule, we said that we recognize a need 
for an RACC for this specific food product as well as for other types 
of cake or pastry fillings,'' but we further explained that, because 
the proposed rule was silent about an RACC for cupcake filling, and 
because we intended to provide the opportunity for public comment on 
this specific issue, we intend to establish an RACC for this product 
category in future rulemaking'' (81 FR 34000 at 34029). This 
notification of request for comments represents the first step of our 
evaluation of the appropriate RACC and product category for products 
used as a filling for cupcakes and other desserts.

II. Other Issues for Consideration

    We invite interested persons to comment on the appropriate RACC and 
product category for flavored nut butter spreads (e.g., cocoa, cookie, 
and coffee flavored), and products used as fillings for cupcakes and 
other desserts, such as cakes and pastries. In responding to the 
specific questions identified in this notice, please provide additional 
data and information that you believe we should consider. Please 
thoroughly explain your reasoning and provide data and other 
information to support your comments and responses to these questions. 
If you submit data, please also provide information regarding the type 
of survey or study conducted, research methodology, sampling frame, 
results of statistical analyses, and any other information needed to 
interpret the data.
    We are particularly interested in responses to the following 
questions:
     What additional data and information are available to 
determine the customary consumption amounts of and appropriate product 
category for flavored nut butter spreads (e.g., cocoa, cookie, and 
coffee flavored)?
     What is the major intended use of flavored nut butter 
spreads (e.g., cocoa, cookie, and coffee flavored)?
     What other products on the market, if any, are similar to 
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored)? 
What product characteristics make these products similar? What dietary 
usage makes these products similar? Which product categories do 
flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored) 
compete with or take market share and volume from? What data and 
information are available regarding the customary consumption amounts 
and product category for these similar products?
     What additional data and information are available 
regarding the customary consumption amounts and product category of 
products used as fillings for cupcakes and other desserts, such as 
cakes and pastries?
     What is the major intended use of fillings for cupcakes 
and other desserts, such as cakes and pastries?
     What other products on the market, if any, are similar to 
cupcake filling, such as cakes and pastries fillings? What product 
characteristics make these products similar? What dietary usage makes 
these products similar? Which product categories do fillings for 
cupcakes and other desserts, such as cakes and pastries, compete with 
or take market share and volume from? What data and information are 
available regarding the customary consumption amounts and product 
category for these similar products?

III. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov.

    1. Park, Y., Memorandum to the File, List of Products for Each 
Product Category, October 8, 1992.
    2. Ferrero Inc., Comment to the Food Labeling: Serving Sizes of 
Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual 
Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Proposed Rule. August 1, 
2014.

    Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26407 Filed 11-1-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                  Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Proposed Rules                                           76323

                                               Secretary of the Commission, 888 First                  DEPARTMENT OF HEALTH AND                              third party may not wish to be posted,
                                               Street NE., Washington, DC 20426.                       HUMAN SERVICES                                        such as medical information, your or
                                                 52. All comments will be placed in                                                                          anyone else’s Social Security number, or
                                                                                                       Food and Drug Administration                          confidential business information, such
                                               the Commission’s public files and may
                                                                                                                                                             as a manufacturing process. Please note
                                               be viewed, printed, or downloaded                       21 CFR Part 101                                       that if you include your name, contact
                                               remotely as described in the Document
                                                                                                       [Docket No. FDA–2016–N–2938]                          information, or other information that
                                               Availability section below. Commenters                                                                        identifies you in the body of your
                                               on this proposal are not required to                                                                          comments, that information will be
                                                                                                       Reference Amount Customarily
                                               serve copies of their comments on other                                                                       posted on http://www.regulations.gov.
                                                                                                       Consumed for Flavored Nut Butter
                                               commenters.                                             Spreads and Products That Can Be                        • If you want to submit a comment
                                               VI. Document Availability                               Used To Fill Cupcakes and Other                       with confidential information that you
                                                                                                       Desserts, in the Labeling of Human                    do not wish to be made available to the
                                                 53. In addition to publishing the full                Food Products; Request for                            public, submit the comment as a
                                               text of this document in the Federal                    Information and Comments                              written/paper submission and in the
                                               Register, the Commission provides all                                                                         manner detailed (see ‘‘Written/Paper
                                                                                                       AGENCY:    Food and Drug Administration,              Submissions’’ and ‘‘Instructions’’).
                                               interested persons an opportunity to
                                                                                                       HHS.
                                               view and/or print the contents of this                                                                        Written/Paper Submissions
                                                                                                             Notification of request for
                                                                                                       ACTION:
                                               document via the Internet through the                                                                            Submit written/paper submissions as
                                                                                                       comments.
                                               Commission’s Home Page (http://                                                                               follows:
                                               www.ferc.gov) and in the Commission’s                   SUMMARY:   The Food and Drug                             • Mail/Hand delivery/Courier (for
                                               Public Reference Room during normal                     Administration (FDA or we) is                         written/paper submissions): Division of
                                               business hours (8:30 a.m. to 5:00 p.m.                  announcing the establishment of a                     Dockets Management (HFA–305), Food
                                               Eastern time) at 888 First Street NE.,                  docket to receive comments,                           and Drug Administration, 5630 Fishers
                                               Room 2A, Washington, DC 20426.                          particularly data and other information,              Lane, Rm. 1061, Rockville, MD 20852.
                                                 54. From the Commission’s Home
                                                                                                       on the appropriate reference amount                      • For written/paper comments
                                                                                                       customarily consumed (RACC) and                       submitted to the Division of Dockets
                                               Page on the Internet, this information is
                                                                                                       product category for flavored nut butter              Management, FDA will post your
                                               available on eLibrary. The full text of
                                                                                                       spreads (e.g., cocoa, cookie, and coffee              comment, as well as any attachments,
                                               this document is available on eLibrary                  flavored), and products that can be used              except for information submitted,
                                               in PDF and Microsoft Word format for                    to fill cupcakes and other desserts, such             marked and identified as confidential, if
                                               viewing, printing, and/or downloading.                  as cakes and pastries. We are taking this             submitted as detailed in ‘‘Instructions.’’
                                               To access this document in eLibrary,                    action in part because we have recently                  Instructions: All submissions received
                                               type the docket number excluding the                    issued a final rule updating certain                  must include the Docket No. FDA–
                                               last three digits of this document in the               RACCs, and we have also received a                    2016–N–2938 for ‘‘Reference Amount
                                               docket number field.                                    citizen petition asking that we either                Customarily Consumed for Flavored Nut
                                                 55. User assistance is available for                  issue a guidance recognizing that ‘‘nut               Butter Spreads (e.g., cocoa, cookie, and
                                               eLibrary and the Commission’s Web site                  cocoa-based spreads’’ fall within the                 coffee flavored), and Products That Can
                                               during normal business hours from the                   ‘‘Honey, jams, jellies, fruit butter,                 Be Used To Fill Cupcakes and Other
                                               Commission’s Online Support at (202)                    molasses’’ category for purposes of                   Desserts, in the Labeling of Human Food
                                               502–6652 (toll free at 1–866–208–3676)                  RACC determination; or amend the                      Products; Request for Information and
                                               or email at ferconlinesupport@ferc.gov,                 regulation to establish a new RACC                    Comments.’’ Received comments will be
                                               or the Public Reference Room at (202)                   category for ‘‘nut cocoa-based spreads’’              placed in the docket and, except for
                                               502–8371, TTY (202) 502–8659. Email                     with an RACC of 1 tablespoon (tbsp.).                 those submitted as ‘‘Confidential
                                                                                                       We also are taking this action in                     Submissions,’’ publicly viewable at
                                               the Public Reference Room at
                                                                                                       response to a request to amend our                    http://www.regulations.gov or at the
                                               public.referenceroom@ferc.gov.
                                                                                                       serving size regulations to establish an              Division of Dockets Management
                                                 By direction of the Commission.                       RACC and product category for cupcake                 between 9 a.m. and 4 p.m., Monday
                                                 Issued: October 20, 2016.                             filling.                                              through Friday.
                                               Nathaniel J. Davis, Sr.,                                DATES: Comments must be received on                      • Confidential Submissions—To
                                                                                                       or before January 3, 2017.                            submit a comment with confidential
                                               Deputy Secretary.
                                                                                                       ADDRESSES: You may submit comments                    information that you do not wish to be
                                               [FR Doc. 2016–26227 Filed 11–1–16; 8:45 am]
                                                                                                       as follows:                                           made publicly available, submit your
                                               BILLING CODE 6717–01–P                                                                                        comments only as a written/paper
                                                                                                       Electronic Submissions                                submission. You should submit two
                                                                                                         Submit electronic comments in the                   copies total. One copy will include the
                                                                                                       following way:                                        information you claim to be confidential
                                                                                                         • Federal eRulemaking Portal: http://               with a heading or cover note that states
                                                                                                       www.regulations.gov. Follow the                       ‘‘THIS DOCUMENT CONTAINS
                                                                                                       instructions for submitting comments.                 CONFIDENTIAL INFORMATION.’’ We
                                                                                                       Comments submitted electronically,                    will review this copy, including the
ehiers on DSK5VPTVN1PROD with PROPOSALS




                                                                                                       including attachments, to http://                     claimed confidential information, in our
                                                                                                       www.regulations.gov will be posted to                 consideration of comments. The second
                                                                                                       the docket unchanged. Because your                    copy, which will have the claimed
                                                                                                       comment will be made public, you are                  confidential information redacted/
                                                                                                       solely responsible for ensuring that your             blacked out, will be available for public
                                                                                                       comment does not include any                          viewing and posted on http://
                                                                                                       confidential information that you or a                www.regulations.gov. Submit both


                                          VerDate Sep<11>2014   14:23 Nov 01, 2016   Jkt 241001   PO 00000   Frm 00009   Fmt 4702   Sfmt 4702   E:\FR\FM\02NOP1.SGM   02NOP1


                                               76324              Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Proposed Rules

                                               copies to the Division of Dockets                       ‘‘Nutella’’ as an example of a product in             older (n = 43). The reported mean,
                                               Management. If you do not wish your                     the product category ‘‘Other dessert                  median, and mode consumption
                                               name and contact information to be                      toppings, e.g., fruits, syrups, spreads,              amounts from this analysis for
                                               made publicly available, you can                        marshmallow cream, nuts, dairy and                    ‘‘Nutella,’’ including similar products
                                               provide this information on the cover                   non-dairy whipped toppings’’ (see 58                  used as chocolate-flavored hazelnut
                                               sheet and not in the body of your                       FR 2229 at 2268). The conclusion that                 spreads, were 22.6 grams (g) (about 1
                                               comments and you must identify this                     ‘‘Nutella’’ belongs in the ‘‘Other dessert            tbsp.), 18 g (1 tbsp.), and 18 g (1 tbsp.),
                                               information as ‘‘confidential.’’ Any                    toppings, e.g., fruits, syrups, spreads,              respectively.
                                               information marked as ‘‘confidential’’                  marshmallow cream, nuts, dairy and                       On March 10, 2016, we received a
                                               will not be disclosed except in                         non-dairy whipped toppings’’ category                 comment in response to the 2014
                                               accordance with 21 CFR 10.20 and other                  with an RACC of two tbsp. was based on                proposed rule in which a report
                                               applicable disclosure law. For more                     a consumer survey conducted in 1991                   prepared by a scientific consulting firm
                                               information about FDA’s posting of                      that showed a significant number of                   analyzed the NHANES data from 2003
                                               comments to public dockets, see 80 FR                   respondents used ‘‘Nutella’’ as a dessert             through 2012 among participants aged 1
                                               56469, September 18, 2015, or access                    topping, particularly for ice cream.                  year and older for ‘‘Nutella’’ and other
                                               the information at: http://www.fda.gov/                    In the Federal Register of March 3,                similar products used as chocolate-
                                               regulatoryinformation/dockets/                          2014, we published a proposed rule                    flavored hazelnut spreads (n = 92) (Ref.
                                               default.htm.                                            entitled, ‘‘Food Labeling: Serving Sizes              2). The comment stated that the results
                                                  Docket: For access to the docket to                                                                        showed that the mean, median, and
                                                                                                       of Foods That Can Reasonably Be
                                               read background documents or the                                                                              mode consumption amounts were 28.6
                                                                                                       Consumed at One-Eating Occasion;
                                               electronic and written/paper comments                                                                         g, 18 g (about 1 tbsp.), and 12 g,
                                                                                                       Dual-Column Labeling; Updating,
                                               received, go to http://                                                                                       respectively. The comment included a
                                                                                                       Modifying, and Establishing Certain
                                               www.regulations.gov and insert the                                                                            report of an online survey designed to
                                                                                                       Reference Amounts Customarily
                                               docket number, found in brackets in the                                                                       estimate the amount of ‘‘Nutella’’
                                                                                                       Consumed; Serving Size for Breath
                                               heading of this document, into the                                                                            typically consumed in an eating
                                                                                                       Mints; and Technical Amendments’’ (79
                                               ‘‘Search’’ box and follow the prompts                                                                         occasion. The comment asserted that the
                                                                                                       FR 11990, ‘‘2014 proposed rule’’). The
                                               and/or go to the Division of Dockets                                                                          survey was administered to a
                                                                                                       2014 proposed rule proposed to update
                                               Management, 5630 Fishers Lane, Rm.                                                                            representative sample of the U.S.
                                                                                                       and modify certain RACCs for                          population aged 18 to 80 years, with an
                                               1061, Rockville, MD 20852.                              previously established product
                                               FOR FURTHER INFORMATION CONTACT:                                                                              average age of 27.3 years. Four hundred
                                                                                                       categories and establish RACCs for new                and thirty respondents consumed
                                               Cherisa Henderson, Center for Food                      products and product categories. The
                                               Safety and Applied Nutrition (HFS–                                                                            ‘‘Nutella’’ in the year before the survey
                                                                                                       2014 proposed rule provided no specific               was administered, and these
                                               830), Food and Drug Administration,                     discussion with respect to ‘‘Nutella.’’
                                               5001 Campus Dr., College Park, MD                                                                             respondents reported 824 eating
                                                                                                       After publication of the proposed rule,               occasions. Based on the categorical
                                               20740, 240–402–1450.                                    on March 4, 2014, we received a citizen
                                               SUPPLEMENTARY INFORMATION:
                                                                                                                                                             consumption amount selections
                                                                                                       petition that requested we either: (1)                weighted by the frequency of such
                                               I. Background                                           Issue guidance recognizing that ‘‘nut                 amount consumed, the comment
                                                                                                       cocoa-based spreads’’ fall within the                 concluded that median consumption
                                               A. Flavored Nut Butter Spreads (e.g.,                   ‘‘Honey, jams, jellies, fruit butter,
                                               cocoa, cookie, and coffee flavored)                                                                           per eating occasion was 18.5 g (about 1
                                                                                                       molasses’’ category for purposes of                   tbsp.), that the mean consumption per
                                                  Under section 403(q)(1)(A)(i) of the                 RACC determination or (2) amend                       eating occasion was 32.6 g, and that
                                               Federal Food, Drug, and Cosmetic Act                    § 101.12 to establish a new product                   almost half of the eating occasions (46.9
                                               (the FD&C Act) (21 U.S.C.                               category for ‘‘nut cocoa-based spreads’’              percent) involved using the product as
                                               343(q)(1)(A)(i)), food that is intended for             with an RACC of one tbsp. (Docket No.                 a spread with bread or toast, as
                                               human consumption and offered for sale                  FDA–2014–P–0263.) Based on the                        compared to use with crackers or
                                               must bear nutrition information that                    information provided, which included                  cookies (17.2 percent), use by itself (13.9
                                               provides a serving size that reflects the               data pertaining specifically to                       percent), use as a spread for fruit (10.8
                                               amount of food customarily consumed                     ‘‘Nutella,’’ we understand that the                   percent), use as a spread over pancakes
                                               (i.e., the RACC) and is expressed in a                  petition intended ‘‘Nutella’’ to be                   or waffles (8.2 percent), and other uses
                                               common household measure that is                        incorporated into a category described                (3 percent). The report concluded that
                                               appropriate to the food (unless an                      as ‘‘nut cocoa-based spreads.’’ The                   the median consumption amount from
                                               exception applies). We established                      petitioner submitted results of a                     both analyses was one tbsp., consistent
                                               RACCs for specific product categories in                consumer usage survey that the                        with the RACC of one tbsp. that we had
                                               a final rule that appeared in the Federal               petitioner had commissioned through a                 established for sweet spreads for bread
                                               Register on January 6, 1993, entitled                   marketing research firm. The survey                   such as honey, jams, and jellies.
                                               ‘‘Food Labeling; Serving Sizes’’ (58 FR                 included 722 mothers who purchased                       Following the receipt of the citizen
                                               2229, ‘‘1993 final rule’’). In the 1993                 ‘‘Nutella’’ in the past 3 months. The                 petition and comment, in the Federal
                                               final rule, FDA provided nine general                   survey found that, on average, 74                     Register of May 27, 2016, we published
                                               principles and factors for establishing                 percent of ‘‘Nutella’’ use was associated             a final rule entitled, ‘‘Food Labeling:
                                               RACCs in 21 CFR 101.12(a) to ensure                     with spreading the product on bread,                  Serving Sizes of Foods That Can
                                                                                                       including toast and in making
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                                               that foods that have similar dietary                                                                          Reasonably Be Consumed At One Eating
                                               usage, product characteristics, and                     sandwiches, and that two percent of use               Occasion; Dual-Column Labeling;
                                               customarily consumed amounts have a                     was as a topping for ice cream. The                   Updating, Modifying, and Establishing
                                               uniform reference amount.                               petition also included the results of an              Certain Reference Amounts Customarily
                                                  The 1993 final rule included a                       analysis of the National Health and                   Consumed; Serving Size for Breath
                                               reference (Ref. 1) to a memorandum to                   Nutrition Examination Survey                          Mints; and Technical Amendments’’ (81
                                               the file entitled ‘‘List of products for                (NHANES) 2003–2010 consumption                        FR 34000) (‘‘2016 final rule’’). The 2016
                                               each product category,’’ which listed                   data for individuals aged 4 years or                  final rule updated and modified certain


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                                                                  Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Proposed Rules                                                 76325

                                               RACCs for previously established                        flavored), and products used as fillings              Management (see ADDRESSES) and are
                                               product categories and established                      for cupcakes and other desserts, such as              available for viewing by interested
                                               RACCs for new products and product                      cakes and pastries. In responding to the              persons between 9 a.m. and 4 p.m.,
                                               categories. The preamble to the 2016                    specific questions identified in this                 Monday through Friday; they are also
                                               final rule explained in the response to                 notice, please provide additional data                available electronically at http://
                                               the comment on nut cocoa-based                          and information that you believe we                   www.regulations.gov.
                                               spreads that the primary usage of                       should consider. Please thoroughly                      1. Park, Y., Memorandum to the File, List
                                               hazelnut spread, which was a reference                  explain your reasoning and provide data               of Products for Each Product Category,
                                               to nut cocoa-based spreads such as                      and other information to support your                 October 8, 1992.
                                               ‘‘Nutella’’ discussed in the comment, is                comments and responses to these                         2. Ferrero Inc., Comment to the Food
                                               as a spread for bread instead of as a                   questions. If you submit data, please                 Labeling: Serving Sizes of Foods That Can
                                               dessert topping (81 FR 34000 at 34029                   also provide information regarding the                Reasonably Be Consumed at One-Eating
                                               to 34030). However, with respect to                     type of survey or study conducted,                    Occasion; Dual Column Labeling; Updating,
                                               specific assertions raised in the March                 research methodology, sampling frame,                 Modifying, and Establishing Certain
                                               10, 2016, comment, we responded that,                                                                         Reference Amounts Customarily Consumed;
                                                                                                       results of statistical analyses, and any              Proposed Rule. August 1, 2014.
                                               while we recognize a need for an RACC                   other information needed to interpret
                                               for hazelnut spread outside of the                      the data.                                               Dated: October 27, 2016.
                                               dessert product category,’’ and agreed                     We are particularly interested in                  Leslie Kux,
                                               that the primary usage of hazelnut                      responses to the following questions:                 Associate Commissioner for Policy.
                                               spread is as a spread for bread instead                    • What additional data and                         [FR Doc. 2016–26407 Filed 11–1–16; 8:45 am]
                                               of as a dessert topping because the                     information are available to determine                BILLING CODE 4164–01–P
                                               proposed rule was silent about an RACC                  the customary consumption amounts of
                                               for hazelnut spread, and because we                     and appropriate product category for
                                               intended to provide the opportunity for                 flavored nut butter spreads (e.g., cocoa,
                                               public comment on this specific issue,                  cookie, and coffee flavored)?                         DEPARTMENT OF DEFENSE
                                               we intended to consider whether to                         • What is the major intended use of
                                                                                                                                                             Office of the Secretary
                                               move hazelnut spread to a different                     flavored nut butter spreads (e.g., cocoa,
                                               appropriate product category in a future                cookie, and coffee flavored)?
                                                                                                          • What other products on the market,               32 CFR Part 221
                                               rulemaking’’ (81 FR 34000 at 34029).
                                               This notification of request for                        if any, are similar to flavored nut butter            [Docket ID: DOD–2015–OS–0054]
                                               comments represents the first step of                   spreads (e.g., cocoa, cookie, and coffee
                                               our evaluation of the appropriate RACC                  flavored)? What product characteristics               RIN 0790–AJ36
                                               and product category for flavored nut                   make these products similar? What
                                               butter spreads (e.g., cocoa, cookie, and                dietary usage makes these products                    DoD Identity Management
                                               coffee flavored), which we consider to                  similar? Which product categories do                  AGENCY:  Under Secretary of Defense for
                                               include ‘‘nut cocoa-based spread’’ as                   flavored nut butter spreads (e.g., cocoa,             Personnel and Readiness (USD(P&R)),
                                               described in the citizen petition and                   cookie, and coffee flavored) compete                  DoD.
                                               comment to the 2014 proposed rule.                      with or take market share and volume                  ACTION: Proposed rule.
                                                                                                       from? What data and information are
                                               B. Products Used as a Filling for
                                                                                                       available regarding the customary                     SUMMARY:   This rulemaking establishes
                                               Cupcakes and Other Desserts
                                                                                                       consumption amounts and product                       implementation guidelines for DS Logon
                                                  In response to the 2014 proposed rule,               category for these similar products?                  to provide a secure means of
                                               one comment requested that we                              • What additional data and                         authentication to applications
                                               establish an RACC for icing intended for                information are available regarding the               containing personally identifiable
                                               use as cupcake filling. In the preamble                 customary consumption amounts and                     information (PII) and personal health
                                               to the 2016 final rule, we said that we                 product category of products used as                  information (PHI). This will allow
                                               recognize a need for an RACC for this                   fillings for cupcakes and other desserts,             beneficiaries and other individuals with
                                               specific food product as well as for                    such as cakes and pastries?                           a continuing affiliation with DoD to
                                               other types of cake or pastry fillings,’’                  • What is the major intended use of                update pay or health-care information in
                                               but we further explained that, because                  fillings for cupcakes and other desserts,             a secure environment. This service can
                                               the proposed rule was silent about an                   such as cakes and pastries?                           be accessed by active duty, National
                                               RACC for cupcake filling, and because                      • What other products on the market,               Guard and Reserve, and Commissioned
                                               we intended to provide the opportunity                  if any, are similar to cupcake filling,               Corps members of the uniformed
                                               for public comment on this specific                     such as cakes and pastries fillings? What             services when separating from active
                                               issue, we intend to establish an RACC                   product characteristics make these                    duty or from the uniformed service.
                                               for this product category in future                     products similar? What dietary usage
                                                                                                                                                             DATES: Comments must be received by
                                               rulemaking’’ (81 FR 34000 at 34029).                    makes these products similar? Which
                                               This notification of request for                        product categories do fillings for                    January 3, 2017.
                                               comments represents the first step of                   cupcakes and other desserts, such as                  ADDRESSES: You may submit comments,
                                               our evaluation of the appropriate RACC                  cakes and pastries, compete with or take              identified by docket number and/or RIN
                                               and product category for products used                  market share and volume from? What                    number and title, by any of the
                                                                                                                                                             following methods:
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                                               as a filling for cupcakes and other                     data and information are available
                                               desserts.                                               regarding the customary consumption                      • Federal Rulemaking Portal: http://
                                                                                                       amounts and product category for these                www.regulations.gov. Follow the
                                               II. Other Issues for Consideration                                                                            instructions for submitting comments.
                                                                                                       similar products?
                                                  We invite interested persons to                                                                               • Mail: Department of Defense, Office
                                               comment on the appropriate RACC and                     III. References                                       of the Deputy Chief Management
                                               product category for flavored nut butter                   The following references are on                    Officer, Directorate for Oversight and
                                               spreads (e.g., cocoa, cookie, and coffee                display in the Division of Dockets                    Compliance, 4800 Mark Center Drive,


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Document Created: 2016-11-02 01:41:03
Document Modified: 2016-11-02 01:41:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification of request for comments.
DatesComments must be received on or before January 3, 2017.
ContactCherisa Henderson, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.
FR Citation81 FR 76323 

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