4634 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

* 1. Memorandum from S. West-Barnette, 

Division of Food Ingredients, Regulatory 

Review Branch, to M. Honigfort, Division 

of Food Ingredients, Regulatory Review 

Branch, June 6, 2024. 

2. SCF. Reports of the Scientific Committee 

for Food (21st series), 1989. Available at: 

http://ec.europa.eu/food/fs/sc/scf/ 

reports/scf_reports_21.pdf (accessed 

January 16, 2024). 

3. JECFA, Evaluation of Certain Food 

Additives and Contaminants: Thirtyseventh Report, 1991. Available at: 

https://www.who.int/publications/i/ 

item/9241208066 (accessed January 16, 

2024). 

4. JECFA, Safety Evaluation of Certain Food 

Additives: Eighty-sixth Report, 2020. 

Available at: https://www.who.int/ 

publications/i/item/9789240004580 

(accessed January 16, 2024). 

* 5. CFSAN CAC Full Committee Review, 

Memorandum of Meeting, October 15, 

2019. 

* 6. Memorandum from J. Gingrich, Division 

of Food Ingredients, Toxicology Review 

Branch, to S. West-Barnette, Division of 

Food Ingredients, Regulatory Review 

Branch, June 18, 2024. 

* 7. Memorandum from D. Doell, Chemistry 

Review Group, Division of Petition 

Review (DPR), Office of Food Additive 

Safety (OFAS), CFSAN, FDA, to J. 

Kidwell, Regulatory Review Group I, 

DPR, OFAS, CFSAN, FDA, September 

18, 2015. 

List of Subjects in 21 CFR Part 74 

Color additives, Cosmetics, Drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 74 is 

amended as follows: 

PART 74—LISTING OF COLOR 

ADDITIVES SUBJECT TO 

CERTIFICATION 

■ 1. The authority citation for part 74 

continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 343, 

348, 351, 352, 355, 361, 362, 371, 379e. 

§ 74.303 [Removed] 

■ 2. Remove § 74.303. 

■ 3. Revise § 74.1303 to read as follows: 

§ 74.1303 FD&C Red No. 3. 

(a) Identity. (1) The color additive 

FD&C Red No. 3 is principally the 

monohydrate of 9 (o-carboxyphenyl)-6- 

hydroxy-2,4,5,7-tetraiodo-3H-xanthen-3- 

one, disodium salt, with smaller 

amounts of lower iodinated 

fluoresceins. 

(2) Color additive mixtures for 

ingested drug used made with FD&C 

Red No. 3 may contain only those 

diluents that are suitable and that are 

listed in part 73 of this chapter as safe 

for use in color additive mixtures for 

coloring ingested drugs. 

(b) Specifications. FD&C Red No. 3 

shall conform to the following 

specifications and shall be free from 

impurities other than those named to 

the extent that such other impurities 

may be avoided by good manufacturing 

practice: 

(1) Volatile matter (at 135 °C) and 

chlorides and sulfates (calculated as the 

sodium salts), total not more than 13 

percent. 

(2) Water-insoluble matter, not more 

than 0.2 percent. 

(3) Unhalogenated intermediates, total 

not more than 0.1 percent. 

(4) Sodium iodide, not more than 0.4 

percent. 

(5) Triiodoresorcinol, not more than 

0.2 percent. 

(6) 2(2′,4′-Dihydroxy-3′, 5′- 

diiodobenzoyl) benzoic acid, not more 

than 0.2 percent. 

(7) Monoiodofluoresceins not more 

than 1.0 percent. 

(8) Other lower iodinated 

fluoresceins, not more than 9.0 percent. 

(9) Lead (as Pb), not more than 10 

parts per million. 

(10) Arsenic (as As), not more than 3 

parts per million. 

(11) Total color, not less than 87.0 

percent. 

(c) Uses and restrictions. FD&C Red 

No. 3 may be safely used for coloring 

ingested drugs in amounts consistent 

with good manufacturing practice. 

(d) Labeling. The label of the color 

additive and any mixtures prepared 

therefrom intended solely or in part for 

coloring purposes shall conform to the 

requirements of § 70.25 of this chapter. 

(e) Certification. All batches of FD&C 

Red No. 3 shall be certified in 

accordance with regulations in part 80 

of this chapter. 

§ 74.1303 [Removed] 

■ 4. Effective January 18, 2028 remove 

§ 74.1303. 

Dated: January 10, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00830 Filed 1–15–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 16 

[Docket No. TTB–2025–0001; Notice No. 

236] 

Civil Monetary Penalty Inflation 

Adjustment—Alcoholic Beverage 

Labeling Act 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notification of civil monetary 

penalty adjustment. 

SUMMARY: This document informs the 

public that the maximum penalty for 

violations of the Alcoholic Beverage 

Labeling Act (ABLA) is being adjusted 

in accordance with the Federal Civil 

Penalties Inflation Adjustment Act of 

1990, as amended. Prior to the 

publication of this document, any 

person who violated the provisions of 

the ABLA was subject to a civil penalty 

of not more than $25,561, with each day 

constituting a separate offense. This 

document announces that this 

maximum penalty is being increased to 

$26,225. 

DATES: The new maximum civil penalty 

for violations of the ABLA takes effect 

on January 16, 2025 and applies to 

penalties that are assessed after that 

date. 

FOR FURTHER INFORMATION CONTACT: 

Vonzella C. Johnson, Regulations and 

Rulings Division, Alcohol and Tobacco 

Tax and Trade Bureau, 1310 G Street 

NW, Box 12, Washington, DC 20005; 

(202) 508–0413. 

Background 

Statutory Authority for Federal Civil 

Monetary Penalty Inflation Adjustments 

The Federal Civil Penalties Inflation 

Adjustment Act of 1990 (the Inflation 

Adjustment Act), Public Law 101–410, 

104 Stat. 890, 28 U.S.C. 2461 note, as 

Act of 2015, Public Law 114–74, section 

701, 129 Stat. 584, requires the regular 

adjustment and evaluation of civil 

monetary penalties to maintain their 

deterrent effect and helps to ensure that 

penalty amounts imposed by the 

Federal Government are properly 

accounted for and collected. A ‘‘civil 

monetary penalty’’ is defined in the 

Inflation Adjustment Act as any penalty, 

fine, or other such sanction that is: (1) 

For a specific monetary amount as 

provided by Federal law, or has a 

maximum amount provided for by 

Federal law; (2) assessed or enforced by 

an agency pursuant to Federal law; and 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4635 

(3) assessed or enforced pursuant to an 

administrative proceeding or a civil 

action in the Federal courts. 

The Inflation Adjustment Act, as 

amended, requires agencies to adjust 

civil monetary penalties by the inflation 

adjustment described in section 5 of the 

Inflation Adjustment Act. The Act also 

provides that any increase in a civil 

monetary penalty shall apply only to 

civil monetary penalties, including 

those whose associated violation 

predated such an increase, which are 

assessed after the date the increase takes 

effect. 

The Inflation Adjustment Act, as 

amended, provides that the inflation 

adjustment does not apply to civil 

monetary penalties under the Internal 

Revenue Code of 1986 or the Tariff Act 

of 1930. 

Alcoholic Beverage Labeling Act 

The Alcohol and Tobacco Tax and 

Trade Bureau (TTB) administers the 

Federal Alcohol Administration Act 

(FAA Act) pursuant to section 1111(d) 

of the Homeland Security Act of 2002, 

codified at 6 U.S.C. 531(d). In addition, 

the Secretary of the Treasury has 

delegated certain administrative and 

enforcement authorities to TTB through 

Treasury Order 120–01. 

The FAA Act contains the Alcoholic 

Beverage Labeling Act (ABLA) of 1988, 

Public Law 100–690, 27 U.S.C. 213– 

219a, which was enacted on November 

18, 1988. Section 204 of the ABLA, 

codified in 27 U.S.C. 215, requires that 

a health warning statement appear on 

the labels of all containers of alcoholic 

beverages manufactured, imported, or 

bottled for sale or distribution in the 

United States, as well as on containers 

of alcoholic beverages that are 

manufactured, imported, bottled, or 

labeled for sale, distribution, or 

shipment to members or units of the 

U.S. Armed Forces, including those 

located outside the United States. 

The health warning statement 

requirement applies to containers of 

alcoholic beverages manufactured, 

imported, or bottled for sale or 

distribution in the United States on or 

after November 18, 1989. The statement 

reads as follows: 

Government Warning: (1) According to the 

Surgeon General, women should not drink 

alcoholic beverages during pregnancy 

because of the risk of birth defects. (2) 

Consumption of alcoholic beverages impairs 

your ability to drive a car or operate 

machinery and may cause health problems. 

Section 204 of the ABLA also 

specifies that the Secretary of the 

Treasury shall have the power to ensure 

the enforcement of the provisions of the 

ABLA and issue regulations to carry 

them out. In addition, section 207 of the 

ABLA, codified in 27 U.S.C. 218, 

provides that any person who violates 

the provisions of the ABLA is subject to 

a civil penalty of not more than $10,000, 

with each day constituting a separate 

offense. 

Most of the civil monetary penalties 

administered by TTB are imposed by 

the Internal Revenue Code of 1986, and 

thus are not subject to the inflation 

adjustment mandated by the Inflation 

Adjustment Act. The only civil 

monetary penalty enforced by TTB that 

is subject to the inflation adjustment is 

the penalty imposed by the ABLA at 27 

U.S.C. 218. 

TTB Regulations 

The TTB regulations implementing 

the ABLA are found in 27 CFR part 16, 

and the regulations implementing the 

Inflation Adjustment Act with respect to 

the ABLA penalty are found in 27 CFR 

16.33. This section indicates that, in 

accordance with the ABLA, any person 

who violates the provisions of this part 

is subject to a civil penalty of not more 

than $10,000. Further, pursuant to the 

provisions of the Federal Civil Penalties 

Inflation Adjustment Act of 1990, as 

amended, this civil penalty is subject to 

periodic cost-of-living adjustments. 

Accordingly, any person who violates 

the provisions of 27 CFR part 16 is 

subject to a civil penalty of not more 

than the amount listed at https://

www.ttb.gov/laws-regulations-andpublic-guidance/other/penalties. Each 

day constitutes a separate offense. 

To adjust the penalty, § 16.33(b) 

indicates that TTB will provide notice 

in the Federal Register and at the 

website mentioned above of cost-ofliving adjustments to the civil penalty 

for violations of 27 CFR part 16. 

Penalty Adjustment 

In this document, TTB is publishing 

its yearly adjustment to the maximum 

ABLA penalty, as required by the 

amended Inflation Adjustment Act. 

As mentioned earlier, the ABLA 

contains a maximum civil monetary 

penalty. For such penalties, section 5 of 

the Inflation Adjustment Act indicates 

that the inflation adjustment is 

determined by increasing the maximum 

penalty by the cost-of-living adjustment. 

The cost-of-living adjustment means the 

percentage increase (if any) between the 

Consumer Price Index for All Urban 

Consumers (CPI–U) for the October 

preceding the date of the adjustment 

and the prior year’s October CPI–U. 

The CPI–U in October 2023 was 

307.671, and the CPI–U in October 2024 

was 315.664. The rate of inflation 

between October 2023 and October 2024 

was therefore 2.598 percent. When 

applied to the current ABLA penalty of 

$25,561 this rate of inflation yields a 

raw (unrounded) inflation adjustment of 

$664.0748. Rounded to the nearest 

dollar, the inflation adjustment is $664, 

meaning that the new maximum civil 

penalty for violations of the ABLA will 

be $26,225. 

The new maximum civil penalty will 

apply to all penalties that are assessed 

after January 16, 2025. TTB has also 

updated its web page at https://

www.ttb.gov/laws-regulations-andpublic-guidance/other/penalties to 

reflect the adjusted penalty. 

Dated: January 10, 2025. 

Amy R. Greenberg, 

Acting Assistant Administrator, Headquarters 

Operations. 

[FR Doc. 2025–00912 Filed 1–15–25; 8:45 am] 

BILLING CODE 4810–31–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 257 

[EPA–HQ–OLEM–2020–0107; FRL–7814.1– 

04–OLEM] 

RIN 2050–AH34 

Hazardous and Solid Waste 

Management System: Disposal of Coal 

Combustion Residuals From Electric 

Utilities; Legacy CCR Surface 

Impoundments; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA or the Agency) is taking 

direct final action to correct errors and 

clarify several provisions published in 

the Federal Register on May 8, 2024. 

This May 8, 2024 rule (Legacy Final 

Rule) established regulatory 

requirements for legacy coal combustion 

residuals (CCR) surface impoundments 

and CCR management units, among 

other things, under the Resource 

Conservation and Recovery Act (RCRA). 

DATES: This final rule is effective on 

May 16, 2025 without further notice 

unless EPA receives adverse comment 

by March 17, 2025. If EPA receives 

adverse comment, the Agency will 

publish a timely withdrawal in the 

Federal Register informing the public 

about the specific regulatory paragraph 

or amendment that will not take effect. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OLEM–2020–0107. All 

documents in the docket are listed on 


ddrumheller on DSK120RN23PROD with RULES1