[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Proposed Rules]
[Pages 45753-45756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21019]
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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]
RIN 0910-ZA49
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; Proposed Extension of
Compliance Dates
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
extend the compliance dates by approximately 1.5 years for the final
rules providing updated nutrition information on the label of food,
including dietary supplements; defining a single-serving container;
requiring dual-column labeling for certain containers; updating,
modifying, and establishing certain reference amounts customarily
consumed (RACCs); and amending the label serving size for breath mints.
The final rules appeared in the Federal Register of May 27, 2016. We
are taking this action because, after careful consideration, we have
tentatively determined that additional time would help ensure that all
manufacturers covered by the final rules have guidance from FDA to
address, for example, certain technical questions we received after
publication of the final rules, and that they are able to complete and
print updated Nutrition Facts labels for their products before they are
expected to be in compliance with the final rules.
DATES: Submit either electronic or written comments on the proposed
rule by November 1, 2017.
ADDRESSES: You may submit comments on the extension of the compliance
period as follows. Please note that late, untimely filed comments will
not be considered. Electronic comments must be submitted on or before
November 1, 2017. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
November 1, 2017. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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 Nos.
FDA-2012-N-1210 and FDA-2004-N-0258 for ``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; Extension of Compliance Date.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff 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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. 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:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paula Trumbo, Center for Food Safety
and Applied Nutrition (HFS-830), Food and Drug Administration, 5001
Campus
[[Page 45754]]
Dr., College Park, MD 20740, 240-402-2579.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Description of the Proposed Rule
III. Proposed Compliance Dates
IV. Economic Analysis of Impacts
V. Analysis of Environmental Impact
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. References
I. Background
In the Federal Register of May 27, 2016 (81 FR 33742 and 81 FR
34000), we published two final rules entitled ``Food Labeling: Revision
of the Nutrition and Supplement Facts Labels'' (the Nutrition Facts
Label Final Rule) and ``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 Final Rule). The Nutrition Facts Label
Final Rule revises the Nutrition Facts label by:
Removing the declaration of ``Calories from fat'' because
current science supports a view that the type of fat is more relevant
than overall total fat intake in increased risk of chronic diseases;
Requiring the declaration of the gram amount of ``Added
Sugars'' in a serving of a product, establishing a Daily Reference
Value (DRV), and requiring the percent Daily Value (DV) declaration for
added sugars;
Changing ``Sugars'' to ``Total Sugars'' and requiring that
``Includes `X' g Added Sugars'' be indented and declared directly below
``Total Sugars'' on the label;
Updating the list of vitamins and minerals of public
health significance. For example, the Nutrition Facts Label Final Rule
requires the declaration of vitamin D and potassium and permits, rather
than requires, the declaration of vitamins A and C;
Updating certain reference values used in the declaration
of percent DVs of nutrients on the Nutrition Facts and Supplement Facts
labels;
Revising the format of the Nutrition Facts and Supplement
Facts labels to increase the prominence of the term ``Calories;''
Removing the requirement for the footnote table listing
the reference values for certain nutrients for 2,000 and 2,500 calorie
diets; and
Requiring the maintenance of records to support the
declarations of certain nutrients under specified circumstances.
The Serving Size Final Rule requires all containers, including
containers of products with ``large'' RACCs (i.e., products with RACCs
of at least 100 grams (g) or 100 milliliters (mL)), containing less
than 200 percent of the RACC to be labeled as a single-serving
container. Except for when certain exceptions apply, the Serving Size
Final Rule further requires that containers and units that contain at
least 200 percent and up to and including 300 percent of the RACC be
labeled with a column of nutrition information within the Nutrition
Facts label that lists the quantitative amounts and percent DVs for the
entire container, in addition to the required column listing the
quantitative amounts and percent DVs for a serving that is less than
the entire container (i.e., the serving size derived from the RACC).
The Serving Size Final Rule also updates, modifies, and establishes
RACCs for certain foods and product categories.
II. Description of the Proposed Rule
We are proposing to extend the compliance date for manufacturers
with $10 million or more in annual food sales in the final rules
published on May 27, 2016, from July 26, 2018, to January 1, 2020, and
the compliance date for manufacturers with less than $10 million in
annual food sales in the final rules published on May 27, 2016, from
July 26, 2019, to January 1, 2021.
We emphasize that this proposed rule would only extend the
compliance dates. Therefore, comments to this proposed rule should
pertain to the extension of the compliance dates only. We are proposing
to extend the compliance dates for the Nutrition Facts Label Final Rule
and the Serving Size Final Rule, consistent with our authority in
sections 403(q) and 701(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 343(q) and 371(a), respectively).
III. Proposed Compliance Dates
This proposed rule would extend the compliance date for
manufacturers with $10 million or more in annual food sales in the
final rules published on May 27, 2016, from July 26, 2018, to January
1, 2020, and the compliance date for manufacturers with less than $10
million in annual food sales in the final rules published on May 27,
2016, from July 26, 2019, to January 1, 2021. We are taking this action
because, after careful consideration, we have tentatively determined
that additional time would help ensure that all manufacturers covered
by the rules have guidance from FDA to address, for example, certain
technical questions we received after publication of the final rules
(see Docket No. FDA-2016-D-4414 (pertaining to a draft guidance
entitled ``Questions and Answers on the Nutrition and Supplement Facts
Labels Related to the Compliance Date, Added Sugars, and Declaration of
Quantitative Amounts of Vitamins and Minerals: Guidance for
Industry'')), and that they are able to complete and print updated
Nutrition Facts labels for their products before they are expected to
be in compliance with the rules. Companies and trade associations with
members covered by the rules have informed us that they have
significant concerns about their ability to update all their labels by
the compliance dates due to issues regarding (among other things) the
need for upgrades to labeling software, the need to obtain nutrition
information from suppliers, the number of products that would need new
labels, and a limited time for reformulation of products. Consequently,
we are proposing to extend the compliance dates to provide more time to
comply with the Nutrition Facts Label and the Serving Size Final Rules.
We propose extending the compliance date by approximately 1.5 years for
both categories of manufacturers as a means to balance the importance
of ensuring that industry has sufficient time to comply with complex
new requirements, and the importance of decreasing costs, against the
importance of minimizing the transition period during which consumers
will see both the old and the new versions of the label in the
marketplace.
We are taking this action consistent with Executive Orders 13771
and 13563 and in response to the continued concern that companies and
trade associations have shared with us regarding the time needed for
implementation of the final rules and the need for FDA to provide
further guidance to manufacturers subject to the final rules.
Consistent with the policies set forth in these executive orders with
respect to reducing burdens, reducing costs, maintaining flexibility,
and improving effectiveness, we are therefore proposing to extend the
compliance date for manufacturers with $10 million or more in annual
food sales to January 1, 2020, and the compliance date for
manufacturers with less than $10 million in annual food sales to
January 1, 2021.
Our goal is to complete this rulemaking as quickly as possible.
However, we are aware that firms are working under the current
compliance dates to come into compliance. Pending
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completion of this rulemaking, we intend to exercise enforcement
discretion with respect to the current July 26, 2018, and July 26,
2019, compliance dates.
IV. Economic Analysis of Impacts
We have examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is a significant regulatory action as
defined by Executive Order 12866.
Executive Order 13771, entitled ``Reducing Regulation and
Controlling Regulatory Costs,'' was issued on January 30, 2017. Section
2(a) of Executive Order 13771 requires an Agency, unless prohibited by
law, to identify at least two existing regulations to be repealed when
the Agency publicly proposes for notice and comment or otherwise
promulgates a new regulation. In furtherance of this requirement,
section 2(c) of Executive Order 13771 requires that the new incremental
costs associated with new regulations shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with at
least two prior regulations. This proposed rule is expected to be an
Executive Order 13771 deregulatory action. Details on the estimated
cost savings of this proposed rule can be found in the rule's economic
analysis.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities when ``the agency publishes a general notice of proposed
rulemaking'' (5 U.S.C. 601(2)). We have analyzed the proposed rule
under the Regulatory Flexibility Act and propose to certify that,
because the proposed rule only would extend the compliance dates for
the Nutrition Facts Label and Serving Size Final Rules, the proposed
rule would not have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the 2016 Implicit Price Deflator
for the Gross Domestic Product. We have determined that the proposed
rule would not result in any expenditure by industry in any year that
meets or exceeds this amount.
The principal benefit of this proposed rule to extend the
compliance dates is the reduction in the costs to industry of meeting
the compliance dates of the Nutrition Facts Label Final Rule and the
Serving Size Final Rule. This reduction in costs can be attributed to a
reduction in the relabeling and reformulation costs of the Nutrition
Facts Label and Serving Size Final Rules. We estimate that, at the
mean, the present value of the benefits (i.e., cost savings) of this
proposed rule to extend the compliance dates over the next 20 years is
$1.0 billion using either a 3 percent or 7 percent discount rate
(2016$). This is illustrated in table 1. Extending the compliance dates
by approximately 1.5 years would reduce the estimated benefits of the
Nutrition Facts Label and Serving Size Final Rules because it would
delay the realization by consumers of the full annual welfare gains of
the Nutrition Facts Label and Serving Size Final Rules. More
specifically, an extension of the compliance dates would delay the
incorporation of the provisions of the Nutrition Facts Label and
Serving Size Final Rules by food manufacturers into their products. We
estimate that, at the mean, the present value of the forgone benefits
of this proposed rule to extend the compliance dates over the next 20
years is $0.9 billion using either a 3 percent or 7 percent discount
rate (2016$). This is also presented in table 1. We estimate that, at
the mean, the present value of the net benefits (that is, cost savings
minus forgone benefits) of this proposed rule to extend the compliance
dates over the next 20 years is $0.1 billion using either a 3 percent
or 7 percent discount rate (2016$). This is shown in table 1.
Table 1--Summary of the Cost Savings to Industry and Foregone Benefits to Consumers of This Proposed Rule To
Extend the Compliance Dates
[In billions of 2016]
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Net benefits
Discount rate Foregone (cost savings-
(percent) Cost savings benefits foregone
benefits)
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Present Value................................... 3 $1.0 $0.9 $0.1
7 1.0 0.9 0.1
Annualized Amount............................... 3 0.07 0.06 0.01
7 0.09 0.08 0.01
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Notes: Cost savings to industry, foregone benefits to consumers, and net benefits reflect mean estimates. This
proposed rule to extend the compliance dates would extend the compliance dates of the Nutrition Facts Label
and Serving Size Final Rules by approximately 1.5 years. Annualized Amount = Amount/Annualizing Factor. 3
percent annualizing factor = 14.88. 7 percent annualizing factor = 10.59. The annualizing factors are
calculated by summing the inverse of 1 plus the discount rate to the power of the year (t = 1 through t = 20).
For purposes of this analysis, we use the same methodology for
estimating costs and benefits that we used in the original Regulatory
Impact Analysis for the Final Rules. We previously acknowledged
potential shortcomings with that approach (see 2016 Regulatory Impact
Analysis at 79 n.34) but have not received comments about ways to
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improve that analysis. We thus follow the same basic approach here.
The full analysis of economic impacts is available in the docket
for this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
This proposed rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
VII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive Order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the FD&C Act (21 U.S.C. 343-1)
is an express preemption provision. Section 403A(a) of the FD&C Act
provides that: ``* * * no State or political subdivision of a State may
directly or indirectly establish under any authority or continue in
effect as to any food in interstate commerce--(4) any requirement for
nutrition labeling of food that is not identical to the requirement of
section 403(q) * * *.'' The express preemption provision of section
403A(a) of the FD&C Act does not preempt any State or local requirement
respecting a statement in the labeling of food that provides for a
warning concerning the safety of the food or component of the food
(section 6(c)(2) of the Nutrition Labeling and Education Act of 1990,
Pub. L. 101-535, 104 Stat. 2353, 2364 (1990)). If this proposed rule is
made final, the final rule would create requirements that fall within
the scope of section 403A(a) of the FD&C Act.
VIII. References
The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. United States Department of Health and Human Services. United
States Food and Drug Administration. Preliminary Regulatory Impact
Analysis, Preliminary Regulatory Flexibility Analysis for Proposed
Rule 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;
Extension of Compliance Dates.'' September 2017. Available from
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.
Dated: September 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21019 Filed 9-29-17; 8:45 am]
BILLING CODE 4164-01-P