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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations www.govinfo.gov/content/pkg/FR-201509-18/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, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Carrol Bascus, Center for Food Safety and Applied Nutrition HFS24, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240402
3835.
SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring changes in the labeling of food. If the compliance 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
70885; December 10, 2014 79 FR
73201; November 25, 2016 81 FR
85156; and December 20, 2018 83 FR
65294. 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
25.30k 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, Executive Order 13771, the Regulatory Flexibility Act 5

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U.S.C. 601612, and the Unfunded Mandates Reform Act of 1995 Pub. L.
1044. 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 final rule is not a significant regulatory action as defined by 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 us to analyze regulatory options that would minimize any significant 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.
The Unfunded Mandates Reform Act of 1995 section 202a requires us to 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 $156 million, using the most current 2019 Implicit Price Deflator for the Gross Domestic Product.
This final rule would not result in an expenditure in any year that meets or exceeds 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
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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, 2021. Therefore, all final rules published by FDA in the Federal Register before January 1, 2021, 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 61
FR 67710 together the 1996
rulemaking, 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. We received no comments objecting to this practice during the 1996 rulemaking, nor have we received comments objecting to this practice since we published a uniform compliance date final rule on December 20, 2018. Therefore, we find good cause to dispense with issuance of a proposed rule inviting comment on the practice of establishing the uniform compliance date because such prior notice and comment are unnecessary. 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. Consequently, FDA
finds any further advance notice and opportunity for comment unnecessary for establishment of the uniform compliance date. Nonetheless, under 21
CFR 10.40e1, we are providing an opportunity for comment on whether the uniform compliance date established by this final rule should be modified or revoked.
In addition, we find good cause for this final rule to become effective on the date of publication of this action. A
delayed effective date is unnecessary in this case because the establishment of a uniform compliance date does not impose any new regulatory requirements on affected parties.
Instead, this final rule provides affected parties with notice of our policy to identify January 1, 2024, as the compliance date for final food labeling regulations that require changes in the labeling of food products and that publish on or after January 1, 2021, and on or before December 31, 2022, unless
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