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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations TABLE 3ANNUAL COSTS TO SMALL FIRMS OF FINAL YOGURT RULEContinued Millions 2019$
Discount rate %

Annual Cost of Final Yogurt Rule Per Small Firm

3
7

Low $

High $
0.3
0.4

2.7
3.2

Notes: 24-month compliance period.

5. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 UMRA Pub. L. 1044 section 202a 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 $158
million, using the most current 2020
Implicit Price Deflator for the Gross Domestic Product. We do not expect this rule to result in any 1-year expenditure that will meet or exceed this amount.
We estimate that the annual costs of the final rule to small yogurt manufacturers will be between approximately $3.1 million to $24.6
million, discounted at 3 percent in 2019
dollars. At a 7 percent discount rate, we estimate that the annual costs of the final rule will be between $3.6 and $28.8 million. Based on our analysis, we do not expect the final rule to reach the current UMRA threshold of $158
million. We also do not expect the estimated costs of the rule to be disproportionately incurred by any State, local, or tribal government.
The full analysis of economic impacts is available in the docket for this final rule and at https www.fda.gov/aboutfda/reports/economic-impact-analysesfda-regulations.

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VI. Federalism We have analyzed the final rule in accordance with the principles set forth in Executive Order 13132. Section 4a 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. 3431 is an express preemption
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provision. Section 403Aa 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 commerce1
any requirement for a food which is the subject of a standard of identity established under section 401 that is not identical to such standard of identity or that is not identical to the requirement of section 403g.
The final rule makes changes to the standards of identity for yogurt, lowfat yogurt, and nonfat yogurt. The final rule has preemptive effect under section 403Aa1 of the FD&C Act in that it precludes States from issuing any requirements for yogurt that are not identical to the requirements of the final rule. Section 403Aa1 of the FD&C Act displaces both State legislative requirements and State common law duties Riegel v. Medtronic, 128 S. Ct.
999 2008. In addition, as with any Federal requirement, if a State law requirement makes compliance with both Federal law and State law impossible, or would frustrate Federal objectives, the State requirement would be preempted. See Geier v. American Honda Co., 529 U.S. 861 2000; English v. General Electric Co., 496 U.S. 72, 79
1990; Florida Lime & Avocado Growers, Inc., 373 U.S. 132, 14243
1963; Hines v. Davidowitz, 312 U.S.
52, 67 1941.
VII. Analysis of Environmental Impact We have determined under 21 CFR
25.32a 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.
VIII. Paperwork Reduction Act of 1995
The final rule contains no collection of information. Therefore, clearance by Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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IX. Consultation and Coordination With Indian Tribal Governments We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.
X. Objections This rule is effective as shown in the section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff see ADDRESSES either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provisions to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https www.regulations.gov. We will DATES

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