Proposed Rules on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and 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; Public Meeting, 30763-30766 [2014-12362]
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Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Proposed Rules
Issued in Washington, DC, on May 22,
2014, by the Commission.
Christopher J. Kirkpatrick,
Deputy Secretary of the Commission.
II. Reopening of Comment Period
emcdonald on DSK67QTVN1PROD with PROPOSALS
position limits for 28 exempt and
agricultural commodity futures and
option contracts, and physical
commodity swaps that are
‘‘economically equivalent’’ to such
contracts (as such term is used in CEA
section 4a(a)(5)).6 The Aggregation
Proposal generally sets out proposed
changes to the third component of the
position limits regime.7
In order to provide interested parties
with an opportunity to comment on the
Aggregation Proposal during the
comment period on the Position Limits
Proposal, the Commission extended the
comment period for the Aggregation
Proposal to February 10, 2014, the same
end date as the comment period for the
Position Limits Proposal.8
Comment letters received on the
Position Limits Proposal are available at
https://comments.cftc.gov/
PublicComments/
CommentList.aspx?id=1436. Comment
letters received on the Aggregation
Proposal are available at https://
comments.cftc.gov/PublicComments/
CommentList.aspx?id=1427.
Proposed Rules on Food Labeling:
Revision of the Nutrition and
Supplement Facts Labels and 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;
Public Meeting
Subsequent to publication of the
Position Limits Proposal and the
Aggregation Proposal, the Commission
directed staff to schedule a June 19,
2014, public roundtable to consider
certain issues regarding position limits
for physical commodity derivatives. The
roundtable will focus on hedges of a
physical commodity by a commercial
enterprise, including gross hedging,
cross-commodity hedging, anticipatory
hedging, and the process for obtaining a
non-enumerated exemption. Discussion
will include the setting of spot month
limits in physical-delivery and cashsettled contracts and a conditional spotmonth limit exemption. Further, the
roundtable will include discussion of:
the aggregation exemption for certain
ownership interests of greater than 50
percent in an owned entity; and
aggregation based on substantially
identical trading strategies. As well, the
Commission invites comment on
whether to provide parity for wheat
contracts in non-spot month limits.
In light of the roundtable, the
Commission is reopening the comment
periods for the Position Limit Proposal
and the Aggregation Proposal. Thus,
both comment periods will reopen on
June 12, 2014, and end on July 3, 2014.
6 See Position Limits for Derivatives, 78 FR 75680
(Dec. 12, 2013).
7 See Aggregation of Positions, 78 FR 68946 (Nov.
15, 2013).
8 See 79 FR 2394 (Jan. 14, 2014).
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Note: The following appendix will not
appear in the Code of Federal Regulations.
Appendix to Position Limits for
Derivatives and Aggregation of
Positions Reopening of Comment
Periods—Commission Voting Summary
On this matter, Acting Chairman Wetjen
and Commissioner O’Malia voted in the
affirmative. No Commissioner voted in the
negative.
[FR Doc. 2014–12427 Filed 5–28–14; 8:45 am]
BILLING CODE 6351–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. FDA–2012–N–1210 and FDA–
2004–N–0258]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of public meeting.
The Food and Drug
Administration (FDA or we) is
announcing a public meeting to discuss
two proposed rules aimed at updating
nutrition information and serving size
requirements on the nutrition facts
labels to provide consumers with
information that could be used to
maintain healthy dietary practices. The
purpose of the public meeting is to
inform the public of the provisions of
the proposed rules and the rulemaking
process (including how to submit
comments, data, and other information
to both dockets) as well as solicit oral
stakeholder and public comments on
the proposed rules and to respond to
questions about the proposed rules.
DATES: See ‘‘How to Participate in the
Public Meeting’’ in the SUPPLEMENTARY
INFORMATION section of this document
for dates and times of the public
meeting, closing dates for advance
registration, requesting special
SUMMARY:
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30763
accommodations due to disability, and
information on deadlines for submitting
either electronic or written comments to
FDA’s Division of Dockets Management.
ADDRESSES: See ‘‘How to Participate in
the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for this
meeting, registering to make oral
comments, to register by phone, or to
submit a notice of participation by mail,
fax, or email: Cindy de Sales, The Event
Planning Group, LLC, 7910 Woodmont
Ave., Suite 310, Bethesda, MD 20814,
240–316–3207, FAX: 240–316–3201,
email: cindy@tepgevents.com.
For general questions about this
meeting or for special accommodations
due to disability, contact: Juanita Yates,
Center for Food Safety and Applied
Nutrition (HFS–005), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1731, email: Juanita.yates@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Nutrition Facts Label Proposed Rule
After the passage of the Nutrition
Labeling and Education Act of 1990
(NLEA) (Pub. L. 101–535), which added
section 403(q) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 343(q), we issued various
regulations related to nutrition
information on food labels, including
regulations requiring the declaration of
certain nutrients, regulations specifying
the format for nutrition labeling,
regulations setting reference values for
use in declaring nutrient content for
certain nutrients, and regulations
exempting certain products from
nutrition labeling (see 21 CFR 101.9). In
addition, after the passage of the Dietary
Supplement Health and Education Act
of 1994 (Pub. L. 103–417), we amended
our food labeling regulations to
establish requirements for the nutrition
labeling of dietary supplements
(§ 101.9(j)(6) and 21 CFR 101.36).
Section 403(q) of the FD&C Act specifies
certain nutrients to be declared in
nutrition labeling, and authorizes the
Secretary of Health and Human Services
to require other nutrients to be declared
if the Secretary determines that a
nutrient will provide information
regarding the nutritional value of such
food that will assist consumers in
maintaining healthy dietary practices.
The Secretary also has discretion under
section 403(q) of the FD&C Act to
remove, by regulation and under certain
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Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Proposed Rules
circumstances, nutrient information that
is otherwise explicitly required in food
labeling under this section.
In the Federal Register of March 3,
2014 (79 FR 11879), we published a
proposed rule entitled ‘‘Food Labeling:
Revision of the Nutrition and
Supplement Facts Labels’’ (the Nutrition
Facts label proposed rule). In the
Nutrition Facts label proposed rule, we
proposed to revise our regulations to
update, among other things, the
nutrients that are required and/or
permitted to be declared and the daily
values, as applicable, for required and
permitted nutrients; amend
requirements for foods represented or
purported to be specifically for children
under the age of 4 years and pregnant
and lactating women and establish
nutrient reference values specifically for
these population subgroups; and update
the format of the Nutrition Facts label.
We based the proposed rule on the latest
science and public health information,
dietary recommendations of the most
recent consensus reports, and public
comments received in response to
advance notices of proposed
rulemaking.
B. Serving Size Proposed Rule
After the passage of the NLEA, we
issued various regulations related to
serving size requirements (see § 101.9
and 21 CFR 101.12). Since we
established those regulations,
developments have compelled us to reevaluate our regulations on serving sizes
and determine whether and what, if
any, revisions are needed to ensure that
the Nutrition Facts label meets its
intended goal of helping consumers
maintain healthy dietary practices.
Specifically, such developments include
the availability of newer consumption
data, research showing that amounts of
food consumed by the American public
have changed, and recent consumer
research on the use and understanding
of the Nutrition Facts label.
Therefore, in the Federal Register of
March 3, 2014 (79 FR 11989), 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’’ (the serving size
proposed rule). In the serving size
proposed rule, we proposed to amend
the definition of a single-serving
container; require dual-column labeling
for certain packages; update and modify
certain reference amounts customarily
consumed (RACCs); add several food
products and food product categories to
the RACCs for the general food supply;
amend the label serving size for breath
mints; and make technical amendments
to various aspects of the serving size
regulations.
II. Purpose and Format of the Public
Meeting
FDA is holding the public meeting on
the Nutrition Facts label and serving
size proposed rules to inform the public
of the provisions of the proposed rules
and the rulemaking process (including
how to submit comments, data, and
other information to both dockets) as
well as solicit oral stakeholder and
public comments on the proposed rules
and to respond to questions about the
proposed rules. In general, the meeting
format will include introductory
presentations by FDA with time to hear
stakeholder perspectives, questions and
public comments.
III. How To Participate in the Public
Meeting
The meeting will be held on June 26,
2014, from 8:30 a.m. to 5 p.m. Eastern
Standard Time (EST) at the Jefferson
Auditorium, U.S. Department of
Agriculture (USDA), Wing 5 Entrance,
14th and Independence Ave. SW.,
Washington, DC 20024. FDA encourages
all persons who wish to attend the
meeting to register in advance of the
meeting. There is no fee to register for
the public meeting, and registration will
be on a first-come, first-served basis.
Early registration is recommended
because seating is limited.
If you preregister and would like to
make an oral presentation at the
meeting, please submit a request when
you preregister. Due to the anticipated
high level of interest in presenting
public comment and limited time
available, FDA will allocate time
(typically 3 to 4 minutes) to each
speaker to make an oral presentation.
Speakers will be limited to making oral
remarks; there will not be an
opportunity to display materials such as
slide shows, videos, or other media
during the meeting. We would like to
maximize the number of individuals
who make a presentation at the meeting
and will do our best to accommodate all
persons who wish to make a
presentation or express their opinions at
the meeting.
FDA encourages persons and groups
who have similar interests to
consolidate their information for
presentation by a single representative.
After reviewing the oral presentation
requests, FDA will notify each
participant before the meeting if their
presentation request is granted, and, if
so, the approximate time their
presentation is scheduled to begin and
remind them of the presentation format
(e.g., 3-minute oral presentation without
visual media).
While oral presentations from specific
individuals and organizations will be
limited to a certain length of time due
to time constraints during the public
meeting, stakeholders may submit
electronic or written comments
discussing any issues of concern to the
dockets for the proposed rules. All
relevant data and documentation should
be submitted with the comments to the
relevant docket, i.e., Nutrition Facts
label proposed rule, Docket No. FDA–
2012–N–1210 https://
www.regulations.gov/
#!documentDetail;D=FDA-2012-N-12100002, or serving size proposed rule,
Docket No. FDA–2004–N–0258 https://
www.regulations.gov/
#!documentDetail;D=FDA-2004-N-02580006.
Table 1 of this document provides
information on participation in the
public meeting.
emcdonald on DSK67QTVN1PROD with PROPOSALS
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO DOCKETS FOR THE
PROPOSED RULES
Date
Attend public meeting ......
VerDate Mar<15>2010
Electronic address
June 26, 2014, from 8:30
a.m. to 5 p.m. EST.
16:51 May 28, 2014
Jkt 232001
PO 00000
Please preregister at
https://www.fda.gov/
Food/NewsEvents/
WorkshopsMeetings
Conferences/default.htm.
Frm 00017
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Address
Other information
Jefferson Auditorium,
U.S. Department of Agriculture (USDA), Wing
5 Entrance, 14th and
Independence Ave.
SW., Washington, DC
20024. Photo ID Required.
Registration check-in begins at
8 a.m.
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TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO DOCKETS FOR THE
PROPOSED RULES—Continued
Date
Electronic address
Address
Other information
View Web cast .................
June 26, 2014, from 8:30
a.m. to 5 p.m. EST.
Please preregister at
..........................................
https://www.fda.gov/
Food/NewsEvents/
WorkshopsMeetings
Conferences/default.htm.
Individuals who wish to
We encourage the use of
participate in person or
electronic registration, if
via Web Cast are
possible.1
asked to preregister at
https://www.fda.gov/
Food/NewsEvents/
WorkshopsMeetings
Conferences/default.htm.
Juanita Yates, email: Jua- See For Further Infornita.yates@fda.hhs.gov.
mation Contact.
Preregister ........................
Register by June 20,
2014.
Request special accommodations due to disability.
Request to make oral
presentation.
Request by June 12,
2014.
Register by June 12,
2014.
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetingsConferences/default.htm.2
..........................................
Submit electronic or written comments.
Submit comments by August 1, 2014.
Federal eRulemaking
Portal: https://www.regulations.gov. Follow the
instructions for submitting comments.
Mail/Hand delivery/Courier (for paper submissions): Division of
Dockets Management
(HFA–305), Food and
Drug Administration,
5360 Fishers Lane, rm.
1061, Rockville, MD
20852.
The Web cast will have closed
captioning.
There is no registration fee for
the public meeting.
We will grant requests made
on the day of the meeting to
make an oral presentation
as time permits. Information
on requests to make an oral
presentation may be posted
without change to https://
www.regulations.gov, including any personal information.
Identify your comments with
the appropriate docket number (Docket No. FDA–012–
N–1210 https://www.regulations.gov/#!documentDetail;D=FDA-2012-N-12100002 for Nutrition Facts label
proposed rule or Docket No.
FDA–2004–N–0258 https://
www.regulations.gov/
#!documentDetail;D=FDA2004-N-0258-0006 for serving size proposed rule). We
encourage you to submit
electronic comments by
using the Federal
eRulemaking Portal.
emcdonald on DSK67QTVN1PROD with PROPOSALS
1 You may also register via email, mail, or fax. Please include your name, title, firm name, address, and phone and fax numbers in your registration information and send to: Cindy de Sales, The Event Planning Group, LLC, 7910 Woodmont Avenue, suite 310, Bethesda, MD 20814,
240–316–3207, FAX: 240–316–3201, email: cindy@tepgevents.com.
2 You may also request to make an oral presentation at the public meeting via email. Please include your name, title, firm name, address, and
phone and fax numbers, and send to Cindy de Sales (see FOR FURTHER INFORMATION CONTACT).
IV. Comments, Transcripts, and
Recorded Video
Information and data, including any
personal information, submitted to FDA
during the public meeting and the
comment period for the proposed rules
will become part of the administrative
record for the relevant rulemaking. This
information and data will be accessible
to the public at https://
www.regulations.gov and between 9
a.m. and 4 p.m., Monday through
Friday, at the Division of Dockets
Management (see Addresses in table 1).
Regardless of attendance at the public
meeting, interested persons may submit
to FDA’s Division of Dockets
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16:51 May 28, 2014
Jkt 232001
Management (see Addresses in table 1)
either electronic or written comments.
You only need to send one set of
comments. Identify the comments with
the appropriate docket number (Docket
No. FDA–2012–N–1210 for the
Nutrition Facts label proposed rule or
Docket No. FDA–2004–N–0258 for the
serving size proposed rule). If you have
comments pertaining to both proposed
rules, submit them separately for each
rule to ensure consideration.
The transcript of the proceedings from
the public meeting will become part of
the administrative record for each of the
rulemakings. As soon as the transcript is
ready, we will make it available at
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https://www.regulations.gov and at
https://www.fda.gov/Food/. It may also
be viewed between 9 a.m. and 4 p.m.,
Monday through Friday, at the Division
of Dockets Management (see Addresses
in table 1). The transcript will also be
available in either hardcopy or on CD–
ROM after submission of a Freedom of
Information request. Send written
requests to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
Additionally, FDA will be video
recording the public meeting. Once the
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Federal Register / Vol. 79, No. 103 / Thursday, May 29, 2014 / Proposed Rules
consideration, but must be received no
later than August 1, 2014. Please see the
SUPPLEMENTARY INFORMATION section of
this notice for dates of tribal
consultation sessions and public
meetings.
recorded video is available, you can
access it at https://www.fda.gov/Food/.
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12362 Filed 5–28–14; 8:45 am]
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 83
[K00103 12/13 A3A10; 134D0102DR–
DS5A300000–DR.5A311.IA000113; Docket
ID: BIA–2013–0007]
RIN 1076–AF18
Federal Acknowledgment of American
Indian Tribes
Bureau of Indian Affairs,
Interior.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
revise regulations governing the process
and criteria by which the Secretary
acknowledges an Indian tribe. The
revisions seek to make the process and
criteria more transparent, promote
consistent implementation, and increase
timeliness and efficiency, while
maintaining the integrity of the process.
The current process has been criticized
as ‘‘broken’’ or in need of reform.
Specifically, the process has been
criticized as too slow (a petition can
take decades to be decided), expensive,
burdensome, inefficient, intrusive, less
than transparent and unpredictable. The
proposed rule would reform the process
by, among other things,
institutionalizing a phased review that
allows for faster decisions; reducing the
documentary burden; allowing for a
hearing on the proposed finding to
promote transparency and process
integrity; establishing the Assistant
Secretary’s final determination as final
for the Department to promote
efficiency; and establishing objective
standards, where appropriate, to ensure
transparency and predictability. This
publication also announces the dates
and locations for tribal consultation
sessions and public meetings on this
proposed rule.
DATES: Comments on this rule must be
received by August 1, 2014. Comments
on the information collections
contained in this proposed regulation
are separate from those on the
substance of the rule. Comments on the
information collection burden should be
received by June 30, 2014 to ensure
emcdonald on DSK67QTVN1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
16:51 May 28, 2014
You may submit comments
by any of the following methods:
—Federal rulemaking portal: https://
www.regulations.gov. The rule is
listed under the agency name ‘‘Bureau
of Indian Affairs.’’ The rule has been
assigned Docket ID: BIA–2013–0007.
—Email: consultation@bia.gov. Include
the number 1076–AF18 in the subject
line.
—Mail or hand delivery: Elizabeth
Appel, Office of Regulatory Affairs &
Collaborative Action, U.S. Department
of the Interior, 1849 C Street NW., MS
4141, Washington, DC 20240. Include
the number 1076–AF18 on the
envelope.
Please note that none of the following
will be considered or included in the
docket for this rulemaking: comments
received after the close of the comment
period (see DATES); comments sent to an
address other than those listed above; or
anonymous comments.
Comments on the information
collections contained in this proposed
regulation are separate from those on
the substance of the rule. Send
comments on the information collection
burden to OMB by facsimile to (202)
395–5806 or email to the OMB Desk
Officer for the Department of the
Interior at OIRA_Submission@
omb.eop.gov. Please send a copy of your
comments to the person listed in the
ADDRESSES:
BILLING CODE 4160–01–P
Jkt 232001
FOR FURTHER INFORMATION CONTACT
section of this notice.
Please see the SUPPLEMENTARY
INFORMATION section of this notice for
locations of tribal consultation sessions
and public meetings.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Appel, Director, Office of
Regulatory Affairs & Collaborative
Action, (202) 273–4680;
elizabeth.appel@bia.gov. You may
review the information collection
request online at https://
www.reginfo.gov. Follow the
instructions to review Department of the
Interior collections under review by
OMB.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
This proposed rule would
comprehensively revise part 83 to
comply with plain language standards,
using a question-and-answer format.
The proposed rule would update the
Part 83 criteria to include objective
PO 00000
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standards and improve the processing of
petitions for Federal acknowledgment of
Indian tribes. The proposed rule is
limited to Part 83 and does not affect
federal acknowledgment under any
other statutory or administrative
authorities. Primary revisions to the
process would:
• Provide for a series of reviews that
may result in the issuance of proposed
findings and final determinations earlier
in the process;
• Separate the Departmental review
into three main steps whereby:
Æ The Office of Federal
Acknowledgment (OFA) first reviews
the petition and issues a proposed
finding;
Æ If the proposed finding is negative
and the petitioner elects to have a
hearing before a judge with the Office of
Hearings and Appeals (OHA), the OHA
judge issues a recommended decision to
the Assistant Secretary-Indian Affairs;
Æ The Assistant Secretary reviews the
record, including (if applicable) an OHA
judge’s recommended decision, and
issues a final determination. The final
determination is final for the
Department and any challenges to the
final determination would be pursued
in United States District Court.
• Remove the Interior Board of Indian
Appeals (IBIA) process by which a final
determination can be reconsidered on
certain grounds.
• Allow, in limited circumstances, a
petitioner previously denied under the
regulations to re-petition under the
revised rules.
Revisions to the criteria for
acknowledgement would eliminate the
need for a petitioner to demonstrate that
third parties identified the petitioner as
a tribe (although this evidence may be
submitted in support of other criteria,
including (b) (Community) and (c)
(Political authority)). The proposed rule
would require petitioners to provide a
brief narrative with evidence of the
group’s existence at some point during
historical times. The revisions would
also define ‘‘historical’’ to be prior to,
but as late as, 1900, and require
evidence of criteria (b) (Community)
and (c) (Political Authority) from 1934
to the present.
The Department is defining historical
as 1900 or earlier based in part on the
Department’s experience over its nearly
40 years in implementing the
regulations that any group that has
proven its existence in 1900 has proven
its existence prior to that time.
Accordingly, the Department seeks
comment on easing the documentary
and administrative burdens and
providing flexibility by defining
historical as 1900 or earlier rather than
E:\FR\FM\29MYP1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Proposed Rules]
[Pages 30763-30766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12362]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. FDA-2012-N-1210 and FDA-2004-N-0258]
Proposed Rules on Food Labeling: Revision of the Nutrition and
Supplement Facts Labels and 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;
Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting to discuss two proposed rules aimed at updating
nutrition information and serving size requirements on the nutrition
facts labels to provide consumers with information that could be used
to maintain healthy dietary practices. The purpose of the public
meeting is to inform the public of the provisions of the proposed rules
and the rulemaking process (including how to submit comments, data, and
other information to both dockets) as well as solicit oral stakeholder
and public comments on the proposed rules and to respond to questions
about the proposed rules.
DATES: See ``How to Participate in the Public Meeting'' in the
SUPPLEMENTARY INFORMATION section of this document for dates and times
of the public meeting, closing dates for advance registration,
requesting special accommodations due to disability, and information on
deadlines for submitting either electronic or written comments to FDA's
Division of Dockets Management.
ADDRESSES: See ``How to Participate in the Public Meeting'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for this meeting, registering to
make oral comments, to register by phone, or to submit a notice of
participation by mail, fax, or email: Cindy de Sales, The Event
Planning Group, LLC, 7910 Woodmont Ave., Suite 310, Bethesda, MD 20814,
240-316-3207, FAX: 240-316-3201, email: cindy@tepgevents.com.
For general questions about this meeting or for special
accommodations due to disability, contact: Juanita Yates, Center for
Food Safety and Applied Nutrition (HFS-005), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email: Juanita.yates@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Nutrition Facts Label Proposed Rule
After the passage of the Nutrition Labeling and Education Act of
1990 (NLEA) (Pub. L. 101-535), which added section 403(q) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q),
we issued various regulations related to nutrition information on food
labels, including regulations requiring the declaration of certain
nutrients, regulations specifying the format for nutrition labeling,
regulations setting reference values for use in declaring nutrient
content for certain nutrients, and regulations exempting certain
products from nutrition labeling (see 21 CFR 101.9). In addition, after
the passage of the Dietary Supplement Health and Education Act of 1994
(Pub. L. 103-417), we amended our food labeling regulations to
establish requirements for the nutrition labeling of dietary
supplements (Sec. 101.9(j)(6) and 21 CFR 101.36). Section 403(q) of
the FD&C Act specifies certain nutrients to be declared in nutrition
labeling, and authorizes the Secretary of Health and Human Services to
require other nutrients to be declared if the Secretary determines that
a nutrient will provide information regarding the nutritional value of
such food that will assist consumers in maintaining healthy dietary
practices. The Secretary also has discretion under section 403(q) of
the FD&C Act to remove, by regulation and under certain
[[Page 30764]]
circumstances, nutrient information that is otherwise explicitly
required in food labeling under this section.
In the Federal Register of March 3, 2014 (79 FR 11879), we
published a proposed rule entitled ``Food Labeling: Revision of the
Nutrition and Supplement Facts Labels'' (the Nutrition Facts label
proposed rule). In the Nutrition Facts label proposed rule, we proposed
to revise our regulations to update, among other things, the nutrients
that are required and/or permitted to be declared and the daily values,
as applicable, for required and permitted nutrients; amend requirements
for foods represented or purported to be specifically for children
under the age of 4 years and pregnant and lactating women and establish
nutrient reference values specifically for these population subgroups;
and update the format of the Nutrition Facts label. We based the
proposed rule on the latest science and public health information,
dietary recommendations of the most recent consensus reports, and
public comments received in response to advance notices of proposed
rulemaking.
B. Serving Size Proposed Rule
After the passage of the NLEA, we issued various regulations
related to serving size requirements (see Sec. 101.9 and 21 CFR
101.12). Since we established those regulations, developments have
compelled us to re-evaluate our regulations on serving sizes and
determine whether and what, if any, revisions are needed to ensure that
the Nutrition Facts label meets its intended goal of helping consumers
maintain healthy dietary practices. Specifically, such developments
include the availability of newer consumption data, research showing
that amounts of food consumed by the American public have changed, and
recent consumer research on the use and understanding of the Nutrition
Facts label.
Therefore, in the Federal Register of March 3, 2014 (79 FR 11989),
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'' (the serving size proposed rule). In the
serving size proposed rule, we proposed to amend the definition of a
single-serving container; require dual-column labeling for certain
packages; update and modify certain reference amounts customarily
consumed (RACCs); add several food products and food product categories
to the RACCs for the general food supply; amend the label serving size
for breath mints; and make technical amendments to various aspects of
the serving size regulations.
II. Purpose and Format of the Public Meeting
FDA is holding the public meeting on the Nutrition Facts label and
serving size proposed rules to inform the public of the provisions of
the proposed rules and the rulemaking process (including how to submit
comments, data, and other information to both dockets) as well as
solicit oral stakeholder and public comments on the proposed rules and
to respond to questions about the proposed rules. In general, the
meeting format will include introductory presentations by FDA with time
to hear stakeholder perspectives, questions and public comments.
III. How To Participate in the Public Meeting
The meeting will be held on June 26, 2014, from 8:30 a.m. to 5 p.m.
Eastern Standard Time (EST) at the Jefferson Auditorium, U.S.
Department of Agriculture (USDA), Wing 5 Entrance, 14th and
Independence Ave. SW., Washington, DC 20024. FDA encourages all persons
who wish to attend the meeting to register in advance of the meeting.
There is no fee to register for the public meeting, and registration
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited.
If you preregister and would like to make an oral presentation at
the meeting, please submit a request when you preregister. Due to the
anticipated high level of interest in presenting public comment and
limited time available, FDA will allocate time (typically 3 to 4
minutes) to each speaker to make an oral presentation. Speakers will be
limited to making oral remarks; there will not be an opportunity to
display materials such as slide shows, videos, or other media during
the meeting. We would like to maximize the number of individuals who
make a presentation at the meeting and will do our best to accommodate
all persons who wish to make a presentation or express their opinions
at the meeting.
FDA encourages persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the oral presentation requests, FDA
will notify each participant before the meeting if their presentation
request is granted, and, if so, the approximate time their presentation
is scheduled to begin and remind them of the presentation format (e.g.,
3-minute oral presentation without visual media).
While oral presentations from specific individuals and
organizations will be limited to a certain length of time due to time
constraints during the public meeting, stakeholders may submit
electronic or written comments discussing any issues of concern to the
dockets for the proposed rules. All relevant data and documentation
should be submitted with the comments to the relevant docket, i.e.,
Nutrition Facts label proposed rule, Docket No. FDA-2012-N-1210 https://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0002, or serving
size proposed rule, Docket No. FDA-2004-N-0258 https://www.regulations.gov/#!documentDetail;D=FDA-2004-N-0258-0006.
Table 1 of this document provides information on participation in
the public meeting.
Table 1--Information on Participation in the Meeting and on Submitting Comments to Dockets for the Proposed
Rules
----------------------------------------------------------------------------------------------------------------
Date Electronic address Address Other information
----------------------------------------------------------------------------------------------------------------
Attend public meeting........... June 26, 2014, Please preregister Jefferson Registration check-
from 8:30 a.m. to at https:// Auditorium, U.S. in begins at 8
5 p.m. EST. www.fda.gov/Food/ Department of a.m.
NewsEvents/ Agriculture
WorkshopsMeetings (USDA), Wing 5
Conferences/ Entrance, 14th
default.htm. and Independence
Ave. SW.,
Washington, DC
20024. Photo ID
Required.
[[Page 30765]]
View Web cast................... June 26, 2014, Please preregister .................. The Web cast will
from 8:30 a.m. to at https:// have closed
5 p.m. EST. www.fda.gov/Food/ captioning.
NewsEvents/
WorkshopsMeetings
Conferences/
default.htm.
Preregister..................... Register by June Individuals who We encourage the There is no
20, 2014. wish to use of electronic registration fee
participate in registration, if for the public
person or via Web possible.\1\ meeting.
Cast are asked to
preregister at
https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request special accommodations Request by June Juanita Yates, See For Further ..................
due to disability. 12, 2014. email: Information
Juanita.yates@fda Contact.
.hhs.gov.
Request to make oral Register by June https://www.fda.gov/ .................. We will grant
presentation. 12, 2014. Food/NewsEvents/ requests made on
WorkshopsMeetings the day of the
Conferences/ meeting to make
default.htm.\2\ an oral
presentation as
time permits.
Information on
requests to make
an oral
presentation may
be posted without
change to https://www.regulations.gov ov, including any
personal
information.
Submit electronic or written Submit comments by Federal Mail/Hand delivery/ Identify your
comments. August 1, 2014. eRulemaking Courier (for comments with the
Portal: https:// paper appropriate
www.regulations.g submissions): docket number
ov. Follow the Division of (Docket No. FDA-
instructions for Dockets 012-N-1210 https://
submitting Management (HFA- www.regulations.g
comments. 305), Food and ov/
Drug #!documentDetail;
Administration, D=FDA-2012-N-1210-
5360 Fishers 0002 for
Lane, rm. 1061, Nutrition Facts
Rockville, MD label proposed
20852. rule or Docket
No. FDA-2004-N-
0258 https://www.regulations.gov/#!documentDetail;
D=FDA-2004-N-0258-
0006 for serving
size proposed
rule). We
encourage you to
submit electronic
comments by using
the Federal
eRulemaking
Portal.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via email, mail, or fax. Please include your name, title, firm name, address, and
phone and fax numbers in your registration information and send to: Cindy de Sales, The Event Planning Group,
LLC, 7910 Woodmont Avenue, suite 310, Bethesda, MD 20814, 240-316-3207, FAX: 240-316-3201, email:
cindy@tepgevents.com.
\2\ You may also request to make an oral presentation at the public meeting via email. Please include your name,
title, firm name, address, and phone and fax numbers, and send to Cindy de Sales (see FOR FURTHER INFORMATION
CONTACT).
IV. Comments, Transcripts, and Recorded Video
Information and data, including any personal information, submitted
to FDA during the public meeting and the comment period for the
proposed rules will become part of the administrative record for the
relevant rulemaking. This information and data will be accessible to
the public at https://www.regulations.gov and between 9 a.m. and 4 p.m.,
Monday through Friday, at the Division of Dockets Management (see
Addresses in table 1).
Regardless of attendance at the public meeting, interested persons
may submit to FDA's Division of Dockets Management (see Addresses in
table 1) either electronic or written comments. You only need to send
one set of comments. Identify the comments with the appropriate docket
number (Docket No. FDA-2012-N-1210 for the Nutrition Facts label
proposed rule or Docket No. FDA-2004-N-0258 for the serving size
proposed rule). If you have comments pertaining to both proposed rules,
submit them separately for each rule to ensure consideration.
The transcript of the proceedings from the public meeting will
become part of the administrative record for each of the rulemakings.
As soon as the transcript is ready, we will make it available at https://www.regulations.gov and at https://www.fda.gov/Food/. It may also be
viewed between 9 a.m. and 4 p.m., Monday through Friday, at the
Division of Dockets Management (see Addresses in table 1). The
transcript will also be available in either hardcopy or on CD-ROM after
submission of a Freedom of Information request. Send written requests
to the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Additionally, FDA will be video recording the public meeting. Once
the
[[Page 30766]]
recorded video is available, you can access it at https://www.fda.gov/Food/.
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12362 Filed 5-28-14; 8:45 am]
BILLING CODE 4160-01-P
