81_FR_85383 81 FR 85156 - Uniform Compliance Date for Food Labeling Regulations

81 FR 85156 - Uniform Compliance Date for Food Labeling Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 227 (November 25, 2016)

Page Range85156-85157
FR Document2016-28333

The Food and Drug Administration (FDA or we) is establishing January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.

Federal Register, Volume 81 Issue 227 (Friday, November 25, 2016) 
[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Rules and Regulations]
[Pages 85156-85157]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011]


Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2020, as the uniform compliance date for food labeling 
regulations that are issued between January 1, 2017, and December 31, 
2018. We periodically announce uniform compliance dates for new food 
labeling requirements to minimize the economic impact of label changes.

DATES: This rule is effective November 25, 2016. Submit electronic or 
written comments by January 24, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2000-N-0011 for ``Uniform Compliance Date for Food Labeling 
Regulations.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov/ or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Center for Food Safety 
and Applied Nutrition (HFS-24), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2112.

SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring 
changes in the labeling of food. If the effective dates of these 
labeling changes were not coordinated, the cumulative economic impact 
on the food industry of having to respond separately to each change 
would be substantial. Therefore, we periodically have announced uniform 
compliance dates for new food labeling requirements (see, e.g., the 
Federal Register of October 19, 1984 (49 FR 41019); December 24, 1996 
(61 FR 67710); December 27, 1996 (61 FR 68145); December 23, 1998 (63 
FR 71015); November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 
79851); December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 
74349); December 15, 2010 (75 FR 78155); November 28, 2012 (77 FR

[[Page 85157]]

70885); and December 10, 2014 (79 FR 73201)). Use of a uniform 
compliance date provides for an orderly and economical industry 
adjustment to new labeling requirements by allowing sufficient lead 
time to plan for the use of existing label inventories and the 
development of new labeling materials.
    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.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, 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 Agencies 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). We believe that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The establishment of a uniform compliance date does not in itself 
lead to costs or benefits. We will assess the costs and benefits of the 
uniform compliance date in the regulatory impact analyses of the 
labeling rules that take effect at that date.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. Because the final rule does not impose 
compliance costs on small entities, we certify that the final rule will 
not have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before issuing ``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 $146 million, using the most current (2015) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we have concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive Order and, consequently, a federalism summary 
impact statement is not required.
    This action is not intended to change existing requirements for 
compliance dates contained in final rules published before January 1, 
2017. Therefore, all final rules published by FDA in the Federal 
Register before January 1, 2017, will still go into effect on the date 
stated in the respective final rule. We generally encourage industry to 
comply with new labeling regulations as quickly as feasible, however. 
Thus, when industry members voluntarily change their labels, it is 
appropriate that they incorporate any new requirements that have been 
published as final regulations up to that time.
    In rulemaking that began with publication of a proposed rule on 
April 15, 1996 (61 FR 16422), and ended with a final rule on December 
24, 1996, we provided notice and an opportunity for comment on the 
practice of establishing uniform compliance dates by issuance of a 
final rule announcing the date. Receiving no comments objecting to this 
practice, FDA finds any further advance notice and opportunity for 
comment or delayed effective date unnecessary for establishment of the 
uniform compliance date. Nonetheless, under 21 CFR 10.40(e)(1), we are 
providing an opportunity for comment on whether the uniform compliance 
date established by this final rule should be modified or revoked. 
Interested parties will have an opportunity to comment on the 
compliance date for each individual food labeling regulation as part of 
the rulemaking process for that regulation.
    The new uniform compliance date will apply only to final FDA food 
labeling regulations that require changes in the labeling of food 
products and that publish after January 1, 2017, and before December 
31, 2018. Those regulations will specifically identify January 1, 2020, 
as their compliance date. All food products subject to the January 1, 
2020, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2020. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2020, we will 
determine for that regulation an appropriate compliance date, which 
will be specified when the final regulation is published.

    Dated: November 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28333 Filed 11-23-16; 8:45 am]
 BILLING CODE 4164-01-P

85156 Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Rules and Regulations accepted accounting principles Electronic Submissions information you claim to be confidential consistently applied. Notwithstanding Submit electronic comments in the with a heading or cover note that states the foregoing, or anything in the following way: ‘‘THIS DOCUMENT CONTAINS instructions to appendix A of this part • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The to the contrary, a commodity pool https://www.regulations.gov/. Follow Agency will review this copy, including operator of a pool that meets the the instructions for submitting the claimed confidential information, in conditions specified in § 4.22(d)(2)(i) to comments. Comments submitted its consideration of comments. The present and compute the commodity electronically, including attachments, to second copy, which will have the pool’s financial statements contained in https://www.regulations.gov/ will be claimed confidential information the Annual Report other than in posted to the docket unchanged. redacted/blacked out, will be available accordance with United States generally for public viewing and posted on Because your comment will be made accepted accounting principles and has https://www.regulations.gov/. Submit public, you are solely responsible for filed notice pursuant to § 4.22(d)(2)(iii) both copies to the Division of Dockets ensuring that your comment does not may also use the alternative accounting Management. If you do not wish your include any confidential information principles, standards or practices name and contact information to be that you or a third party may not wish identified in the notice in reporting made publicly available, you can to be posted, such as medical information required to be reported provide this information on the cover information, your or anyone else’s pursuant to paragraph (c)(1) of this sheet and not in the body of your Social Security number, or confidential section. comments and you must identify this business information, such as a * * * * * manufacturing process. Please note that information as ‘‘confidential.’’ Any Issued in Washington, DC, on November if you include your name, contact information marked as ‘‘confidential’’ 21, 2016, by the Commission. information, or other information that will not be disclosed except in Robert N. Sidman, identifies you in the body of your accordance with 21 CFR 10.20 and other Deputy Secretary of the Commission. comments, that information will be applicable disclosure law. For more posted on https://www.regulations.gov/. information about FDA’s posting of Note: The following appendix will not comments to public dockets, see 80 FR appear in the Code of Federal Regulations. • If you want to submit a comment with confidential information that you 56469, September 18, 2015, or access do not wish to be made available to the the information at: http://www.fda.gov/ Appendix to Commodity Pool Operator regulatoryinformation/dockets/ Financial Reports—Commission Voting public, submit the comment as a written/paper submission and in the default.htm. Summary Docket: For access to the docket to manner detailed (see ‘‘Written/Paper On this matter, Chairman Massad and Submissions’’ and ‘‘Instructions’’). read background documents or the Commissioners Bowen and Giancarlo voted electronic and written/paper comments in the affirmative. No Commissioner voted in Written/Paper Submissions received, go to https:// the negative. www.regulations.gov/ and insert the [FR Doc. 2016–28388 Filed 11–23–16; 8:45 am] Submit written/paper submissions as follows: docket number, found in brackets in the BILLING CODE 6351–01–P heading of this document, into the • Mail/Hand delivery/Courier (for written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food and/or go to the Division of Dockets DEPARTMENT OF HEALTH AND Management, 5630 Fishers Lane, Rm. and Drug Administration, 5630 Fishers HUMAN SERVICES 1061, Rockville, MD 20852. Lane, Rm. 1061, Rockville, MD 20852. Food and Drug Administration • For written/paper comments FOR FURTHER INFORMATION CONTACT: submitted to the Division of Dockets Philip L. Chao, Center for Food Safety 21 CFR Part 101 Management, FDA will post your and Applied Nutrition (HFS–24), Food comment, as well as any attachments, and Drug Administration, 5001 Campus [Docket No. FDA–2000–N–0011] except for information submitted, Dr., College Park, MD 20740, 240–402– marked and identified, as confidential, 2112. Uniform Compliance Date for Food if submitted as detailed in SUPPLEMENTARY INFORMATION: We Labeling Regulations ‘‘Instructions.’’ periodically issue regulations requiring AGENCY: Food and Drug Administration, Instructions: All submissions received changes in the labeling of food. If the HHS. must include the Docket No. FDA– effective dates of these labeling changes ACTION: Final rule. 2000–N–0011 for ‘‘Uniform Compliance were not coordinated, the cumulative Date for Food Labeling Regulations.’’ economic impact on the food industry SUMMARY: The Food and Drug Received comments will be placed in of having to respond separately to each Administration (FDA or we) is the docket and, except for those change would be substantial. Therefore, establishing January 1, 2020, as the submitted as ‘‘Confidential we periodically have announced uniform compliance date for food Submissions,’’ publicly viewable at uniform compliance dates for new food labeling regulations that are issued https://www.regulations.gov/ or at the labeling requirements (see, e.g., the between January 1, 2017, and December Division of Dockets Management Federal Register of October 19, 1984 (49 31, 2018. We periodically announce between 9 a.m. and 4 p.m., Monday FR 41019); December 24, 1996 (61 FR uniform compliance dates for new food through Friday. 67710); December 27, 1996 (61 FR labeling requirements to minimize the • Confidential Submissions—To 68145); December 23, 1998 (63 FR ehiers on DSK5VPTVN1PROD with RULES economic impact of label changes. submit a comment with confidential 71015); November 20, 2000 (65 FR DATES: This rule is effective November information that you do not wish to be 69666); December 31, 2002 (67 FR 25, 2016. Submit electronic or written made publicly available, submit your 79851); December 21, 2006 (71 FR comments by January 24, 2017. comments only as a written/paper 76599); December 8, 2008 (73 FR ADDRESSES: You may submit comments submission. You should submit two 74349); December 15, 2010 (75 FR as follows: copies total. One copy will include the 78155); November 28, 2012 (77 FR VerDate Sep<11>2014 14:00 Nov 23, 2016 Jkt 241001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\FR\FM\25NOR1.SGM 25NOR1

Federal Register / Vol. 81, No. 227 / Friday, November 25, 2016 / Rules and Regulations 85157 70885); and December 10, 2014 (79 FR million, using the most current (2015) 2020, as their compliance date. All food 73201)). Use of a uniform compliance Implicit Price Deflator for the Gross products subject to the January 1, 2020, date provides for an orderly and Domestic Product. We do not expect compliance date must comply with the economical industry adjustment to new this final rule to result in any 1-year appropriate regulations when initially labeling requirements by allowing expenditure that would meet or exceed introduced into interstate commerce on sufficient lead time to plan for the use this amount. or after January 1, 2020. If any food of existing label inventories and the We have analyzed this final rule in labeling regulation involves special development of new labeling materials. accordance with the principles set forth circumstances that justify a compliance We have determined under 21 CFR in Executive Order 13132. We have date other than January 1, 2020, we will 25.30(k) that this action is of a type that determined that the rule does not determine for that regulation an does not individually or cumulatively contain policies that have substantial appropriate compliance date, which have a significant effect on the human direct effects on the States, on the will be specified when the final environment. Therefore, neither an relationship between the National regulation is published. environmental assessment nor an Government and the States, or on the Dated: November 18, 2016. environmental impact statement is distribution of power and required. responsibilities among the various Leslie Kux, This final rule contains no collections levels of government. Accordingly, we Associate Commissioner for Policy. of information. Therefore, clearance by have concluded that the rule does not [FR Doc. 2016–28333 Filed 11–23–16; 8:45 am] the Office of Management and Budget contain policies that have federalism BILLING CODE 4164–01–P under the Paperwork Reduction Act of implications as defined in the Executive 1995 is not required. Order and, consequently, a federalism We have examined the impacts of the summary impact statement is not DEPARTMENT OF HOMELAND final rule under Executive Order 12866, required. SECURITY Executive Order 13563, the Regulatory This action is not intended to change Flexibility Act (5 U.S.C. 601–612), and existing requirements for compliance Coast Guard the Unfunded Mandates Reform Act of dates contained in final rules published 1995 (Pub. L. 104–4). Executive Orders before January 1, 2017. Therefore, all 33 CFR Part 110 12866 and 13563 direct Agencies to final rules published by FDA in the [Docket Number USCG–2016–0110] assess all costs and benefits of available Federal Register before January 1, 2017, regulatory alternatives and, when will still go into effect on the date stated RIN 1625–AA01 regulation is necessary, to select in the respective final rule. We generally regulatory approaches that maximize encourage industry to comply with new Anchorage Grounds; Delaware Bay net benefits (including potential labeling regulations as quickly as and River, Philadelphia, PA economic, environmental, public health feasible, however. Thus, when industry AGENCY: Coast Guard, DHS. and safety, and other advantages; members voluntarily change their ACTION: Final rule. distributive impacts; and equity). We labels, it is appropriate that they believe that this final rule is not a incorporate any new requirements that SUMMARY: The Coast Guard is revising significant regulatory action under have been published as final regulations the anchorage regulations for the Executive Order 12866. up to that time. Delaware Bay and River. The Coast The establishment of a uniform In rulemaking that began with Guard conducted a review of the compliance date does not in itself lead publication of a proposed rule on April Delaware Bay and River anchorage to costs or benefits. We will assess the 15, 1996 (61 FR 16422), and ended with grounds to support increased traffic and costs and benefits of the uniform a final rule on December 24, 1996, we vessel size. The changes to this compliance date in the regulatory provided notice and an opportunity for regulation will eliminate unusable impact analyses of the labeling rules comment on the practice of establishing anchorage grounds and provide that take effect at that date. uniform compliance dates by issuance additional usable grounds to support The Regulatory Flexibility Act of a final rule announcing the date. current and future port demands and requires Agencies to analyze regulatory Receiving no comments objecting to this enhance the overall navigation safety of options that would minimize any practice, FDA finds any further advance this critical component of the maritime significant economic impact of a rule on notice and opportunity for comment or transportation system. small entities. Because the final rule delayed effective date unnecessary for DATES: This rule is effective December does not impose compliance costs on establishment of the uniform 27, 2016. small entities, we certify that the final compliance date. Nonetheless, under 21 ADDRESSES: To view documents rule will not have a significant CFR 10.40(e)(1), we are providing an economic impact on a substantial opportunity for comment on whether mentioned in this preamble as being number of small entities. the uniform compliance date available in the docket, go to http:// Section 202(a) of the Unfunded established by this final rule should be www.regulations.gov, type USCG–2016– Mandates Reform Act of 1995 requires modified or revoked. Interested parties 0110 in the ‘‘SEARCH’’ box and click that Agencies prepare a written will have an opportunity to comment on ‘‘SEARCH.’’ Click on Open Docket statement, which includes an the compliance date for each individual Folder on the line associated with this assessment of anticipated costs and food labeling regulation as part of the rule. benefits, before issuing ‘‘any rule that rulemaking process for that regulation. FOR FURTHER INFORMATION CONTACT: If includes any Federal mandate that may The new uniform compliance date you have questions on this rule, call or ehiers on DSK5VPTVN1PROD with RULES result in the expenditure by State, local, will apply only to final FDA food email Lieutenant Commander Tiffany and tribal governments, in the aggregate, labeling regulations that require changes Johnson, U.S. Coast Guard, Fifth Coast or by the private sector, of $100,000,000 in the labeling of food products and that Guard District, Waterways Management or more (adjusted annually for inflation) publish after January 1, 2017, and before Branch, telephone (757) 398–6516, in any one year.’’ The current threshold December 31, 2018. Those regulations email Tiffany.A.Johnson@uscg.mil. after adjustment for inflation is $146 will specifically identify January 1, SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 14:00 Nov 23, 2016 Jkt 241001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\FR\FM\25NOR1.SGM 25NOR1


Document Created: 2016-11-23 23:18:03
Document Modified: 2016-11-23 23:18:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective November 25, 2016. Submit electronic or written comments by January 24, 2017.
ContactPhilip L. Chao, Center for Food Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2112.
FR Citation81 FR 85156 
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