82 FR 45753 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 189 (October 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45753-45756 | |
| FR Document | 2017-21019 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Proposed Rules] [Pages 45753-45756] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21019] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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 [[Page 45755]] 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] ---------------------------------------------------------------------------------------------------------------- Net benefits Discount rate Foregone (cost savings- (percent) Cost savings benefits foregone benefits) ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- 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 [[Page 45756]] 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
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on December 5, 2016, at 81 FR 87686) ADDRESSES: You may submit comments and Serving Sizes of Foods That Can
(annualized costs of $154 million); and on the extension of the compliance Reasonably Be Consumed at One Eating
20. The FMCSA’s final rule on Minimum period as follows. Please note that late, Occasion; Dual-Column Labeling;
Training Requirements for Entry-Level
Commercial Motor Vehicle Operators (RIN:
untimely filed comments will not be Updating, Modifying, and Establishing
2126–AB66) (published on December 8, considered. Electronic comments must Certain Reference Amounts Customarily
2016, at 81 FR 88732) (annualized costs of be submitted on or before November 1, Consumed; Serving Size for Breath
$368 million). 2017. The https://www.regulations.gov Mints; and Technical Amendments;
[FR Doc. 2017–21101 Filed 9–29–17; 8:45 am] electronic filing system will accept Extension of Compliance Date.’’
BILLING CODE 4910–9X–P
comments until midnight Eastern Time Received comments, those filed in a
at the end of November 1, 2017. timely manner (see ADDRESSES), will be
Comments received by mail/hand placed in the docket and, except for
delivery/courier (for written/paper those submitted as ‘‘Confidential
DEPARTMENT OF HEALTH AND
submissions) will be considered timely Submissions,’’ publicly viewable at
HUMAN SERVICES
if they are postmarked or the delivery https://www.regulations.gov or at the
Food and Drug Administration service acceptance receipt is on or Dockets Management Staff between 9
before that date. a.m. and 4 p.m., Monday through
21 CFR Part 101 Friday.
Electronic Submissions
• Confidential Submissions—To
[Docket Nos. FDA–2012–N–1210 and FDA– Submit electronic comments in the submit a comment with confidential
2004–N–0258] following way: information that you do not wish to be
RIN 0910–ZA49 • Federal eRulemaking Portal: made publicly available, submit your
https://www.regulations.gov. Follow the comments only as a written/paper
Food Labeling: Revision of the instructions for submitting comments. submission. You should submit two
Nutrition and Supplement Facts Labels Comments submitted electronically, copies total. One copy will include the
and Serving Sizes of Foods That Can including attachments, to https:// information you claim to be confidential
Reasonably Be Consumed at One www.regulations.gov will be posted to with a heading or cover note that states
Eating Occasion; Dual-Column the docket unchanged. Because your ‘‘THIS DOCUMENT CONTAINS
Labeling; Updating, Modifying, and comment will be made public, you are CONFIDENTIAL INFORMATION.’’ We
Establishing Certain Reference solely responsible for ensuring that your will review this copy, including the
Amounts Customarily Consumed; comment does not include any claimed confidential information, in our
Serving Size for Breath Mints; and confidential information that you or a consideration of comments. The second
Technical Amendments; Proposed third party may not wish to be posted, copy, which will have the claimed
Extension of Compliance Dates such as medical information, your or confidential information redacted/
anyone else’s Social Security number, or blacked out, will be available for public
AGENCY: Food and Drug Administration, confidential business information, such
HHS. viewing and posted on https://
as a manufacturing process. Please note www.regulations.gov. Submit both
ACTION: Proposed rule. that if you include your name, contact copies to the Dockets Management Staff.
SUMMARY: The Food and Drug information, or other information that If you do not wish your name and
Administration (FDA or we) is identifies you in the body of your contact information to be made publicly
proposing to extend the compliance comments, that information will be available, you can provide this
dates by approximately 1.5 years for the posted on https://www.regulations.gov. information on the cover sheet and not
final rules providing updated nutrition • If you want to submit a comment in the body of your comments and you
information on the label of food, with confidential information that you must identify this information as
including dietary supplements; defining do not wish to be made available to the ‘‘confidential.’’ Any information marked
a single-serving container; requiring public, submit the comment as a as ‘‘confidential’’ will not be disclosed
dual-column labeling for certain written/paper submission and in the except in accordance with 21 CFR 10.20
containers; updating, modifying, and manner detailed (see ‘‘Written/Paper and other applicable disclosure law. For
establishing certain reference amounts Submissions’’ and ‘‘Instructions’’). more information about FDA’s posting
customarily consumed (RACCs); and Written/Paper Submissions of comments to public dockets, see 80
amending the label serving size for Submit written/paper submissions as FR 56469, September 18, 2015, or access
breath mints. The final rules appeared follows: the information at: https://www.gpo.gov/
in the Federal Register of May 27, 2016. • Mail/Hand delivery/Courier (for fdsys/pkg/FR-2015-09-18/pdf/2015-
We are taking this action because, after written/paper submissions): Dockets 23389.pdf.
careful consideration, we have Management Staff (HFA–305), Food and Docket: For access to the docket to
tentatively determined that additional Drug Administration, 5630 Fishers read background documents or the
time would help ensure that all Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments
manufacturers covered by the final rules • For written/paper comments received, go to https://
have guidance from FDA to address, for submitted to the Dockets Management www.regulations.gov and insert the
example, certain technical questions we Staff, FDA will post your comment, as docket number, found in brackets in the
received after publication of the final well as any attachments, except for heading of this document, into the
sradovich on DSK3GMQ082PROD with PROPOSALS
rules, and that they are able to complete information submitted, marked and ‘‘Search’’ box and follow the prompts
and print updated Nutrition Facts labels identified, as confidential, if submitted and/or go to the Dockets Management
for their products before they are as detailed in ‘‘Instructions.’’ Staff, 5630 Fishers Lane, Rm. 1061,
expected to be in compliance with the Instructions: All submissions received Rockville, MD 20852.
final rules. must include the Docket Nos. FDA– FOR FURTHER INFORMATION CONTACT:
DATES: Submit either electronic or 2012–N–1210 and FDA–2004–N–0258 Paula Trumbo, Center for Food Safety
written comments on the proposed rule for ‘‘Food Labeling: Revision of the and Applied Nutrition (HFS–830), Food
by November 1, 2017. Nutrition and Supplement Facts Labels and Drug Administration, 5001 Campus
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completion of this rulemaking, we incremental costs associated with new The principal benefit of this proposed
intend to exercise enforcement regulations shall, to the extent permitted rule to extend the compliance dates is
discretion with respect to the current by law, be offset by the elimination of the reduction in the costs to industry of
July 26, 2018, and July 26, 2019, existing costs associated with at least meeting the compliance dates of the
compliance dates. two prior regulations. This proposed Nutrition Facts Label Final Rule and the
rule is expected to be an Executive Serving Size Final Rule. This reduction
IV. Economic Analysis of Impacts
Order 13771 deregulatory action. Details in costs can be attributed to a reduction
We have examined the impacts of this on the estimated cost savings of this in the relabeling and reformulation costs
proposed rule under Executive Order proposed rule can be found in the rule’s of the Nutrition Facts Label and Serving
12866, Executive Order 13563, economic analysis. Size Final Rules. We estimate that, at
Executive Order 13771, the Regulatory the mean, the present value of the
The Regulatory Flexibility Act
Flexibility Act (5 U.S.C. 601–612), and benefits (i.e., cost savings) of this
requires us to analyze regulatory options
the Unfunded Mandates Reform Act of proposed rule to extend the compliance
that would minimize any significant
1995 (Pub. L. 104–4). Executive Orders dates over the next 20 years is $1.0
impact of a rule on small entities when
12866 and 13563 direct us to assess all billion using either a 3 percent or 7
‘‘the agency publishes a general notice
costs and benefits of available regulatory percent discount rate (2016$). This is
of proposed rulemaking’’ (5 U.S.C.
alternatives and, when regulation is illustrated in table 1. Extending the
601(2)). We have analyzed the proposed
necessary, to select regulatory compliance dates by approximately 1.5
rule under the Regulatory Flexibility
approaches that maximize net benefits years would reduce the estimated
Act and propose to certify that, because
(including potential economic, benefits of the Nutrition Facts Label and
the proposed rule only would extend
environmental, public health and safety, Serving Size Final Rules because it
and other advantages; distributive the compliance dates for the Nutrition
would delay the realization by
impacts; and equity). Executive Order Facts Label and Serving Size Final
consumers of the full annual welfare
13771 requires that the costs associated Rules, the proposed rule would not have
gains of the Nutrition Facts Label and
with significant new regulations ‘‘shall, a significant economic impact on a
Serving Size Final Rules. More
to the extent permitted by law, be offset substantial number of small entities. specifically, an extension of the
by the elimination of existing costs The Unfunded Mandates Reform Act compliance dates would delay the
associated with at least two prior of 1995 (section 202(a)) requires us to incorporation of the provisions of the
regulations.’’ We believe that this prepare a written statement, which Nutrition Facts Label and Serving Size
proposed rule is a significant regulatory includes an assessment of anticipated Final Rules by food manufacturers into
action as defined by Executive Order costs and benefits, before proposing their products. We estimate that, at the
12866. ‘‘any rule that includes any Federal mean, the present value of the forgone
Executive Order 13771, entitled mandate that may result in the benefits of this proposed rule to extend
‘‘Reducing Regulation and Controlling expenditure by State, local, and tribal the compliance dates over the next 20
Regulatory Costs,’’ was issued on governments, in the aggregate, or by the years is $0.9 billion using either a 3
January 30, 2017. Section 2(a) of private sector, of $100,000,000 or more percent or 7 percent discount rate
Executive Order 13771 requires an (adjusted annually for inflation) in any (2016$). This is also presented in table
Agency, unless prohibited by law, to one year.’’ The current threshold after 1. We estimate that, at the mean, the
identify at least two existing regulations adjustment for inflation is $148 million, present value of the net benefits (that is,
to be repealed when the Agency using the 2016 Implicit Price Deflator cost savings minus forgone benefits) of
publicly proposes for notice and for the Gross Domestic Product. We this proposed rule to extend the
comment or otherwise promulgates a have determined that the proposed rule compliance dates over the next 20 years
new regulation. In furtherance of this would not result in any expenditure by is $0.1 billion using either a 3 percent
requirement, section 2(c) of Executive industry in any year that meets or or 7 percent discount rate (2016$). This
Order 13771 requires that the new exceeds this amount. 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]
Net benefits
(cost
Discount rate Foregone
Cost savings savings¥
(percent) benefits foregone
benefits)
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
Notes: Cost savings to industry, foregone benefits to consumers, and net benefits reflect mean estimates. This proposed rule to extend the
sradovich on DSK3GMQ082PROD with PROPOSALS
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 original Regulatory Impact Analysis for with that approach (see 2016 Regulatory
the same methodology for estimating the Final Rules. We previously Impact Analysis at 79 n.34) but have not
costs and benefits that we used in the acknowledged potential shortcomings received comments about ways to
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![45756 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Proposed Rules
improve that analysis. We thus follow ADDRESSES) and is available for viewing delivery to: Director, Regulation Policy
the same basic approach here. by interested persons between 9 a.m. and Management (00REG), Department
The full analysis of economic impacts and 4 p.m., Monday through Friday; it of Veterans Affairs, 810 Vermont Ave.
is available in the docket for this is also available electronically at https:// NW., Room 1063B, Washington, DC
proposed rule (Ref. 1) and at https:// www.regulations.gov. FDA has verified 20420; or by fax to (202) 273–9026.
www.fda.gov/AboutFDA/Reports the Web site addresses, as of the date (This is not a toll-free telephone
ManualsForms/Reports/Economic this document publishes in the Federal number.) Comments should indicate
Analyses. Register, but Web sites are subject to that they are submitted in response to
V. Analysis of Environmental Impact change over time. ‘‘RIN 2900–AQ06-Authority of Health
1. United States Department of Health and Care Providers to Practice Telehealth.’’
We have determined under 21 CFR Copies of comments received will be
Human Services. United States Food and
25.30(k) that this action is of a type that Drug Administration. Preliminary available for public inspection in the
does not individually or cumulatively Regulatory Impact Analysis, Preliminary Office of Regulation Policy and
have a significant effect on the human Regulatory Flexibility Analysis for Management, Room 1068, between the
environment. Therefore, neither an Proposed Rule on ‘‘Food Labeling: hours of 8:00 a.m. and 4:30 p.m.,
environmental assessment nor an Revision of the Nutrition and Monday through Friday (except
environmental impact statement is Supplement Facts Labels and Serving holidays). Please call (202) 461–4902 for
required. Sizes of Foods That Can Reasonably Be
Consumed At One Eating Occasion;
an appointment. (This is not a toll-free
VI. Paperwork Reduction Act of 1995 Dual-Column Labeling; Updating, telephone number.) In addition, during
Modifying, and Establishing Certain the comment period, comments may be
This proposed rule contains no viewed online through the Federal
Reference Amounts Customarily
collection of information. Therefore, Consumed; Serving Size for Breath Docket Management System (FDMS) at
clearance by the Office of Management Mints; and Technical Amendments; http://www.regulations.gov.
and Budget under the Paperwork Extension of Compliance Dates.’’ FOR FURTHER INFORMATION CONTACT:
Reduction Act of 1995 is not required. September 2017. Available from http://
Kevin Galpin, MD, Executive Director
www.fda.gov/AboutFDA/Reports
VII. Federalism ManualsForms/Reports/Economic Telehealth Services, Veterans Health
We have analyzed this proposed rule Analyses. Administration Office of Connected
in accordance with the principles set Care, 810 Vermont Avenue NW.,
Dated: September 26, 2017.
forth in Executive Order 13132. Section Washington, DC 20420. (404) 771–8794.
Anna K. Abram, (This is not a toll-free number.)
4(a) of the Executive Order requires
Deputy Commissioner for Policy, Planning, Kevin.Galpin@va.gov.
Agencies to ‘‘construe * * * a Federal Legislation, and Analysis.
statute to preempt State law only where SUPPLEMENTARY INFORMATION: Section
[FR Doc. 2017–21019 Filed 9–29–17; 8:45 am]
the statute contains an express 7301 of title 38, United States Code
BILLING CODE 4164–01–P (U.S.C.), establishes the general
preemption provision or there is some
other clear evidence that the Congress functions of the Veterans Health
intended preemption of State law, or Administration (VHA) within VA, and
where the exercise of State authority DEPARTMENT OF VETERANS establishes that its primary function is
conflicts with the exercise of Federal AFFAIRS to ‘‘provide a complete medical and
authority under the Federal statute.’’ hospital service for the medical care and
Section 403A of the FD&C Act (21 38 CFR Part 17 treatment of veterans, as provided in
U.S.C. 343–1) is an express preemption RIN 2900–AQ06 this title and in regulations prescribed
provision. Section 403A(a) of the FD&C by the Secretary [of Veterans Affairs
Act provides that: ‘‘* * * no State or Authority of Health Care Providers To (Secretary)] pursuant to this title.’’ 38
political subdivision of a State may Practice Telehealth U.S.C. 7301(b). In carrying out this
directly or indirectly establish under function, VHA must ensure that patient
AGENCY: Department of Veterans Affairs. care is appropriate and safe and its
any authority or continue in effect as to
any food in interstate commerce—(4) ACTION: Proposed rule. health care providers meet or exceed
any requirement for nutrition labeling of generally accepted professional
SUMMARY: The Department of Veterans
food that is not identical to the standards for patient care. In addition,
Affairs (VA) proposes to amend its
requirement of section 403(q) * * *.’’ because VA is a national health care
medical regulations by standardizing
The express preemption provision of provider, VHA must ensure that
the delivery of care by VA health care
section 403A(a) of the FD&C Act does beneficiaries receive the same high level
providers through telehealth. This rule
not preempt any State or local of care and access to care no matter
would ensure that VA health care
requirement respecting a statement in where, in a State, a beneficiary or health
providers provide the same level of care
the labeling of food that provides for a care provider is located at the time the
to all beneficiaries, irrespective of the
warning concerning the safety of the health care is provided.
State or location in a State of the VA The Secretary is responsible for the
food or component of the food (section health care provider or the beneficiary.
6(c)(2) of the Nutrition Labeling and proper execution and administration of
This proposed rule would achieve all laws administered by the Department
Education Act of 1990, Pub. L. 101–535, important Federal interests by and for the control, direction, and
sradovich on DSK3GMQ082PROD with PROPOSALS
104 Stat. 2353, 2364 (1990)). If this increasing the availability of mental
proposed rule is made final, the final management of the Department,
health, specialty, and general clinical including agency personnel and
rule would create requirements that fall care for all beneficiaries.
within the scope of section 403A(a) of management matters. See 38 U.S.C. 303.
DATES: Comments must be received on To this end, Congress authorized the
the FD&C Act.
or before November 1, 2017. Secretary ‘‘to prescribe all rules and
VIII. References ADDRESSES: Written comments may be regulations which are necessary or
The following reference is on display submitted through http:// appropriate to carry out the laws
in the Dockets Management Staff (see www.Regulations.gov by mail or hand- administered by the Department and are
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Document Created: 2017-09-30 04:41:22
Document Modified: 2017-09-30 04:41:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Submit either electronic or written comments on the proposed rule by November 1, 2017. | |
| Contact | Paula Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2579. | |
| FR Citation | 82 FR 45753 | |
| RIN Number | 0910-ZA49 |
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