4628 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

The revisions and addition read as 

follows: 

§ 220.46 Medical evidence. 

(a) Acceptable medical sources. The 

Board needs reports about the 

claimant’s impairment(s) from 

acceptable medical sources. Acceptable 

medical sources are— 

(1) Licensed physicians (medical or 

osteopathic doctors); 

(2) Licensed or certified psychologists 

at the independent practice level; 

(3) Licensed or certified school 

psychologists, or other licensed or 

certified individuals with another title 

who perform the same function as a 

school psychologist in a school setting 

(for impairments of intellectual 

disability, learning disabilities, and 

borderline intellectual functioning 

only); 

(4) Licensed optometrists (for 

impairments of visual disorders, or for 

the measurement of visual acuity and 

visual fields only, depending on the 

scope of practice in the State in which 

the optometrist practices); 

(5) Licensed podiatrists (for 

impairments of the foot only, or foot and 

ankle only, depending on the scope of 

practice in the State in which the 

podiatrist practices); 

(6) Qualified speech-language 

pathologists (for speech or language 

impairments only.) For this source, 

qualified means that the speechlanguage pathologist must be licensed 

by the State professional licensing 

agency, or be fully certified by the State 

education agency in the State in which 

the speech-language pathologist 

practices, or hold a Certificate of 

Clinical Competence in SpeechLanguage Pathology from the American 

Speech-Language-Hearing Association; 

(7) Licensed audiologists (for 

impairments of hearing loss, auditory 

processing disorders, and balance 

disorders within the licensed scope of 

practice only); 

(8) Licensed Advanced Practice 

Registered Nurses or other licensed 

advance practice nurses with another 

title (for impairments within the 

individual’s licensed scope of practice 

only); 

(9) Licensed Physician Assistants/ 

Physician Associates (for impairments 

within the individual’s licensed scope 

of practice); or 

(10) Persons authorized to furnish a 

copy or summary of the records of a 

medical facility. Generally, the copy or 

summary should be certified as accurate 

by the custodian or by any authorized 

employee of the Railroad Retirement 

Board, Social Security Administration, 

Department of Veterans Affairs, or State 

agency. 

(b) Other medical sources. Individuals 

who are licensed as healthcare workers 

by a State and are working within the 

scope of practice permitted under State 

or Federal law, other than acceptable 

medical sources identified in paragraph 

(a) of this section, are other medical 

sources. Examples include licensed 

clinical social workers, naturopaths, and 

chiropractors. The Board will accept 

and consider evidence from other 

medical sources about the claimant’s 

impairment(s) and the effect on the 

claimant’s ability to work, but the 

presence of a medically determinable 

physical or mental impairment must be 

established with objective medical 

evidence from an acceptable medical 

source as defined in paragraph (a) of 

this section. 

(c) * * * 

(6) * * * 

(i) Statements about what the 

claimant can still do despite his or her 

impairment(s) based on the medical 

source’s findings on factors in 

paragraphs (c)(1) through (5) of this 

section (except in disability claims for 

remarried widow’s and surviving 

divorced spouses). (See § 220.112). 

(ii) Statements about what the 

claimant can still do (based on the 

medical source’s findings on factors in 

paragraphs (c)(1) through (5) of this 

section) should describe— 

* * * * * 

(d) Completeness. The medical 

evidence, including the clinical and 

laboratory findings, must be complete 

and detailed enough for the Board to 

determine whether the claimant is 

disabled. Specifically, it must allow the 

Board to determine— 

* * * * * 

(e) Evidence from treating medical 

sources. A statement by or the opinion 

of the claimant’s treating medical source 

will not determine whether the claimant 

is disabled. However, the medical 

evidence provided by a treating medical 

source will be considered by the Board 

in making a disability decision. A 

treating medical source is a medical 

source to whom the claimant has been 

going for treatment on a continuing 

basis. The claimant may have more than 

one treating medical source. The Board 

may use consulting physicians or other 

medical consultants for specialized 

examinations or tests, to obtain more 

complete evidence, and to resolve any 

conflicts. A consulting physician is a 

doctor (often a specialist) to whom the 

claimant is referred for an examination 

once or on a limited basis. (See § 220.50 

for an explanation of when the Board 

may request a consultative 

examination.) 

(f) Information from non-medical 

sources. Information from other sources 

may also help the Board understand 

how an impairment affects the 

claimant’s ability to work. Other sources 

include— 

(1) Public and private social welfare 

agency personnel; 

(2) Family members, caregivers, 

friends, and neighbors of the claimant; 

(3) Educational personnel such as 

teachers, counselors, and daycare center 

workers; 

(4) Railroad and nonrailroad 

employers; and, 

(5) The claimants themselves. 

Dated: January 7, 2025. 

By Authority of the Board. 

Stephanie Hillyard, 

Secretary to the Board. 

[FR Doc. 2025–00515 Filed 1–15–25; 8:45 am] 

BILLING CODE 7905–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 74 

[Docket No. FDA–2023–N–0437] 

Color Additive Petition From Center for 

Science in the Public Interest, et al.; 

Request To Revoke Color Additive 

Listing for Use of FD&C Red No. 3 in 

Food and Ingested Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is granting 

a color additive petition submitted by 

Center for Science in the Public Interest, 

et al., by repealing the color additive 

regulations that permit the use of FD&C 

Red No. 3 in foods (including dietary 

supplements) and in ingested drugs. 

The petitioners provided data 

demonstrating that this additive induces 

cancer in male rats. Therefore, FDA is 

revoking the authorized uses in food 

and ingested drugs of FD&C Red No. 3 

in the color additive regulations. 

DATES: This order is effective January 

15, 2027, except for amendatory 

instruction 4, which is effective January 

18, 2028. If any provisions are delayed 

or stayed by the filing of proper 

objections, FDA will publish such 

notification in the Federal Register. 

Submit either electronic or written 

objections and requests for a hearing on 

the order by February 18, 2025. See 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4629 

section X for further information on the 

filing of objections. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of February 18, 2025. Objections 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Objections submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

objection will be made public, you are 

solely responsible for ensuring that your 

objection 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 

objection, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an objection 

with confidential information that you 

do not wish to be made available to the 

public, submit the objection 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 objections 

submitted to the Dockets Management 

Staff, FDA will post your objection, 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– 

2023–N–0437 for ‘‘Color Additive 

Petition from Center for Science in the 

Public Interest, et al.; Request to Revoke 

Color Additive Listing for Use of FD&C 

Red No. 3 in Food and Ingested Drugs.’’ 

Received objections, 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, 240–402–7500. 

• Confidential Submissions—To 

submit an objection with confidential 

information that you do not wish to be 

made publicly available, submit your 

objections 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 objections. 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 objections 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.govinfo.gov/content/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, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Shayla West-Barnette, Office of Premarket Additive Safety, Human Foods 

Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1262; 

or Alexandra Beliveau, Office of Policy, 

Regulations, and Information, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Introduction 

II. Background 

A. Statutory and Regulatory Background of 

Color Additive Regulation 

B. Chemical Identity and Nomenclature of 

FD&C Red No. 3 

C. History of FDA’s Regulatory Actions for 

FD&C Red No. 3 

III. Summary and Context of Determination 

IV. Evaluation of Petition 

V. Comments on the Notice of Petition 

VI. Conclusion 

VII. Public Disclosure 

VIII. Analysis of Environmental Impacts 

IX. Paperwork Reduction Act of 1995 

X. Objections 

XI. References 

I. Introduction 

In the Federal Register of February 

17, 2023 (88 FR 10245), we announced 

that we filed a color additive petition 

(CAP 3C0323) jointly submitted by the 

Center for Science in the Public Interest, 

Breast Cancer Prevention Partners, 

Center for Environmental Health, Center 

for Food Safety, Chef Ann Foundation, 

Children’s Advocacy Institute, 

Consumer Federation of America, 

Consumer Reports, Defend Our Health, 

Environmental Defense Fund, 

Environmental Working Group, 

Feingold Association of the United 

States, Food & Water Watch, Healthy 

Babies Bright Futures, Life Time 

Foundation, Momsrising, Prevention 

Institute, Public Citizen, Public Health 

Institute, Public Interest Research 

Group, Real Food for Kids, Lisa Y. 

Lefferts, Linda S. Birnbaum, and Philip 

J. Landrigan, c/o Mr. Jensen Jose, 1250 

I Street NW, Ste 500, Washington, DC 

20005 (the petitioners). 

The petition proposed that we repeal 

the color additive regulations for FD&C 

Red No. 3 in § 74.303 (21 CFR 74.303), 

which permits the use of FD&C Red No. 

3 in foods (including dietary 

supplements), and § 74.1303 (21 CFR 

74.1303), which permits the use of 

FD&C Red No. 3 in ingested drugs. The 

notice of petition gave interested parties 

until April 18, 2023, to submit 

comments on the filed color additive 

petition. In response to a written request 

submitted to the docket, we extended 

the comment period to May 18, 2023 (88 

FR 19026, March 30, 2023). This order 

granting the request to revise the 

regulations to no longer provide for 

these uses of FD&C Red No. 3 responds 

to the petition. 

II. Background 

A. Statutory and Regulatory Background 

of Color Additive Regulation 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes us to regulate 

‘‘color additives’’ (see section 721(b) of 


ddrumheller on DSK120RN23PROD with RULES1
4630 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

the FD&C Act (21 U.S.C. 379e(b))). The 

FD&C Act defines ‘‘color additive’’ as ‘‘a 

material which . . . is a dye, pigment, 

or other substance made by a process of 

synthesis or similar artifice, or 

extracted, isolated, or otherwise 

derived, with or without intermediate or 

final change of identity, from a 

vegetable, animal, mineral, or other 

source, and . . . [that] when added or 

applied to a food, drug, or cosmetic, or 

to the human body or any part thereof, 

is capable (alone or through reaction 

with [an]other substance) of imparting 

color thereto . . . The term ‘‘color’’ 

includes black, white, and intermediate 

grays . . .’’ (see section 201(t) of the 

FD&C Act (21 U.S.C. 321(t))). Color 

additives used in or on a food, drug, 

cosmetic, or certain medical devices are 

deemed unsafe and prohibited except to 

the extent that we approve their use (see 

section 721(a) of the FD&C Act). Certain 

color additives must be certified by FDA 

(see section 721(c) of the FD&C Act). 

The FD&C Act provides a process 

through which any person who wishes 

to use a color additive in or on food, 

drugs, certain devices, or cosmetics, 

may submit a petition proposing the 

issuance of a color additive regulation 

listing such use with supporting 

information. A color additive petition 

may also be submitted to propose the 

amendment or repeal of any existing 

color additive regulation (see section 

721(b)(5)(C) and (d) of the FD&C Act). In 

response to a color additive petition, 

FDA may issue a regulation listing a 

color additive for use in or on food, 

drugs, devices, or cosmetics only if it 

determines that the additive is suitable 

and safe for such use (see section 

721(b)(2)(A) of the FD&C Act). FDA’s 

determination that a color additive is 

safe means that there is convincing 

evidence that establishes with 

reasonable certainty that no harm will 

result from the intended condition of 

use of the color additive (21 CFR 

70.3(i)), which we refer to as ‘‘a 

reasonable certainty of no harm.’’ This 

safety standard is referred to as the 

‘‘general safety clause’’ for color 

additives. To determine whether a color 

additive is safe under the general safety 

clause, the FD&C Act requires FDA to 

consider, among other relevant factors: 

(1) probable consumption of, or other 

relevant exposure from, the additive and 

of any substance formed in or on food, 

drugs or device, or cosmetics because of 

the use of the additive; (2) cumulative 

effect, if any, of such additive ‘‘in the 

diet of man or animals,’’ taking into 

account the same or any chemically or 

pharmacologically related substance or 

substances in such diet; and (3) safety 

factors recognized by experts ‘‘as 

appropriate for the use of animal 

experimentation data’’ (see section 

721(b)(5)(A) of the FD&C Act). 

In addition, section 721(b)(5)(B) of the 

FD&C Act, often referred to as the 

Delaney Clause, deems color additives 

unsafe under certain circumstances. The 

Delaney Clause consists of two parts. 

The first part (section 721(b)(5)(B)(i) of 

the FD&C Act) pertains specifically to 

ingested color additives. The second 

part (section 721(b)(5)(B)(ii) of the FD&C 

Act) applies to noningested color 

additives. For purposes of our review of 

this petition, we reviewed these uses of 

FD&C Red No. 3 under the first part 

because these uses result in ingestion. 

Section 721(b)(5)(B)(i) of the FD&C Act 

states that a color additive shall be 

deemed unsafe for any use which will 

or may result in ingestion of all or part 

of such additive, if the additive is found 

by the Secretary to induce cancer when 

ingested by man or animal, or if it is 

found by the Secretary, after tests which 

are appropriate for the evaluation of the 

safety of additives for use in food, to 

induce cancer in man or animal. Courts 

have concluded that the Delaney Clause 

completely bans additives found to 

induce cancer in humans or animals. In 

Public Citizen v. Young, 831 F.2d 1108, 

1122 (D.C. Cir. 1987), the court held that 

Congress intended for the Delaney 

Clause to be ‘‘extraordinarily rigid,’’ to 

protect the public from cancer-causing 

substances without exception, rejecting 

FDA’s argument that a particular color 

additive should be approved because it 

did not pose more than a de minimis 

cancer risk; see also Les v. Reilly, 968 

F.2d 985, 986 (9th Cir. 1992) (holding 

that the Environmental Protection 

Agency’s refusal to revoke regulations 

permitting the use of certain pesticides, 

which were regulated as food additives 

at the time of the court decision and 

subject to a similarly worded Delaney 

Clause for food additives, on the 

grounds that they pose a de minimis 

cancer risk, is contrary to the provisions 

of the Delaney Clause). 

There is a similar Delaney Clause 

provision for food additives under 

section 409(c)(3) of the FD&C Act (21 

U.S.C. 348(c)(3)), which states that no 

food additive shall be deemed safe if it 

is found to induce cancer when ingested 

by man or animal. In revoking certain 

authorizations for food additives under 

the Delaney Clause, FDA stated that the 

Delaney Clause limits FDA’s discretion 

to determine the safety of food 

additives. FDA stated that the Delaney 

Clause prevents FDA from finding a 

food additive to be safe if it has been 

found to induce cancer when ingested 

by humans or animals, ‘‘regardless of 

the probability, or risk, of cancer 

associated with exposure to the additive 

or of the extent to which the 

experimental conditions of the animal 

study or the carcinogenic mode of 

action provide insight into the health 

effects of human consumption and use 

of the additive in question’’ (83 FR 

50490 at 50492, October 9, 2018). 

Section 721(d) of the FD&C Act 

provides for the issuance, amendment, 

or repeal of regulations authorizing the 

use of a color additive, and, among 

other things, it specifies that the safety 

provisions of section 721(b)(5) apply to 

such actions. For FDA to grant a petition 

that seeks repeal of a color additive 

regulation based upon new data 

concerning the safety of the color 

additive, such data must be adequate for 

FDA to conclude that there is no longer 

a reasonable certainty of no harm for the 

intended use of the color additive or 

that it must be deemed unsafe under the 

Delaney Clause. 

B. Chemical Identity and Nomenclature 

of FD&C Red No. 3 

Our regulation, at § 74.303, describes 

FD&C Red No. 3 as 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. The color is also called 

erythrosine or other names, including 

Colour Index (C.I.) Acid Red 51; C.I. No. 

45430; and C.I. Food Red 14. FD&C Red 

No. 3 is required to be certified by FDA 

that it complies with §§ 74.303 and 

74.1303. The designation ‘‘FD&C Red 

No. 3’’ is permitted only for those 

batches of the color additive that have 

been certified by FDA. 

C. History of FDA’s Regulatory Actions 

for FD&C Red No. 3 

FD&C Red No. 3, as erythrosine, was 

first listed in 1907 under the provisions 

of the Food and Drugs Act of 1906 (Food 

Inspection Decision 76), and later 

provisionally listed in 1960 as Red No. 

3 for food, drug, and cosmetic use (25 

FR 9759, October 12, 1960) (see also Ref. 

1). In 1969, FD&C Red No. 3 was 

permanently listed for use in food and 

ingested drugs (34 FR 7446, May 8, 

1969), now codified in §§ 74.303 and 

74.1303. In 1990, FDA did not extend 

the provisional listing of FD&C Red No. 

3 for use in cosmetics and externally 

applied drugs (55 FR 3516, February 1, 

1990) based on thyroid neoplasia in rat 

carcinogenicity studies, which 

terminated this listing. The decision did 

not revoke the existing permanent 

listing for food and ingested drugs from 

1969. 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4631 

III. Summary and Context of 

Determination 

We have evaluated the data and 

information submitted in the petition as 

well as other relevant data. FDA finds 

that FD&C Red No. 3 can induce cancer 

in male rats, through a rat specific 

hormonal mechanism. Therefore, we are 

revoking the listings providing for these 

uses of this color additive under section 

721(b)(5)(B) of the FD&C Act as a matter 

of law, as described further below. 

IV. Evaluation of Petition 

The petitioners state that FD&C Red 

No. 3 has been shown to induce cancer 

in male laboratory rats. The petitioners 

discuss multiple regulatory conclusions 

that FD&C Red No. 3 is carcinogenic in 

male rats, which are based on some in 

vivo studies. Specifically, data reported 

in the publication entitled ‘‘Lifetime 

Toxicity/Carcinogenicity Study of FD&C 

Red No. 3 (erythrosine) in Rats’’ by 

Borzelleca et al., a compilation of two 

separate chronic toxicity and 

carcinogenicity studies, was published 

in 1987. These conclusions include a 

1990 conclusion from FDA (55 FR 3520, 

February 1, 1990); a 1983 National 

Toxicology Program (NTP) 

subcommittee conclusion; a 1989 

European Commission’s Scientific 

Committee for Food report (Ref. 2); and 

Joint Food and Agricultural 

Organization/World Health 

Organization (FAO/WHO) Expert 

Committee on Food Additives (JECFA) 

conclusions (Refs. 3 and 4). 

FDA evaluated the data cited by the 

petitioner, as well as other available 

data. Based on our review of this data 

and information, we conclude that the 

Delaney Clause applies because FD&C 

Red No. 3 has been found to ‘‘induce 

cancer when ingested by . . . animal.’’ 

Specifically, some in vivo studies have 

shown FD&C Red No. 3 can induce 

thyroid tumors in male rats. Thyroid 

tumors in male rats appear to result 

from perturbation in the hypothalamicpituitary-thyroid hormonal axis (Refs. 5 

and 6). These perturbations are initiated 

by an increase in circulating thyroid 

stimulating hormone (TSH), causing 

follicular hyperplasia, which has the 

potential to develop into thyroid tumors 

(Refs. 5 and 6). Thus, increased TSH 

levels appears to be a key event for 

thyroid tumor development from FD&C 

Red No. 3 exposure in male rats (Refs. 

5 and 6). 

Based on the available data and 

information, FD&C Red No. 3-induced 

thyroid tumors in male rats are of 

limited relevance to humans. FDA’s 

Center for Food Safety and Applied 

Nutrition (CFSAN)’s Cancer Assessment 

Committee (CAC) concluded that while 

studies show FD&C Red No. 3 induces 

thyroid tumors in male rats, the risk of 

developing such tumors in humans at 

low exposure levels from the current 

uses is unlikely (Ref. 5). FD&C Red No. 

3 is likely not genotoxic (in other words, 

it is not directly DNA reactive) (Refs. 5 

and 6). FD&C Red No. 3 appears to 

induce thyroid tumors in male rats 

through a key event—an increase in 

circulating TSH—and rodents show 

much higher sensitivity to such 

perturbations compared to humans 

(Refs. 5 and 6). There is no conclusive 

available clinical evidence that 

demonstrates increased TSH levels 

either promote or actively cause thyroid 

carcinogenesis in humans (Refs. 5 and 

6). Further, studies in humans to date 

have failed to show convincing 

evidence that FD&C Red No. 3 exposure 

results in consistent perturbations in 

any thyroid hormone levels, including 

TSH (Refs. 5 and 6). FDA estimated the 

highest exposure for FD&C Red No. 3 

from the approved uses as a color 

additive in conventional food, dietary 

supplements, and ingested drugs to be 

0.25 milligrams per kilogram of 

bodyweight per day (mg/kg bw/day) 

(Ref. 7). When compared against the No 

Observed Adverse Effect Level for 

thyroid hormone effects associated with 

thyroid tumors in male rats of 35.8 mg/ 

kg bw/day, a 210-fold margin of 

exposure was derived (Ref. 5). Based on 

the available data and information, FDA 

and other regulatory agencies including 

JECFA, the European Food Safety 

Authority (EFSA), and the Food 

Standards Australia New Zealand 

(FSANZ) have concluded that FD&C 

Red No. 3-induced thyroid tumors in 

rats are of limited relevance to humans 

(Refs. 5 and 6). In addition, the 

carcinogenicity of FD&C Red No. 3 was 

not observed when tested in other 

animals including female rats and either 

sex of mice, gerbils, or dogs (Refs. 5 and 

6). 

Despite its limited relevance to 

humans, the cumulative data and 

information show that high exposure to 

FD&C Red No. 3 induces thyroid tumors 

in male rats (Refs. 5 and 6). 

V. Comments on the Notice of Petition 

FDA received a number of comments 

in response to the notice of filing of the 

petition. Most comments expressed 

general support for revocation of the 

regulations for FD&C Red No. 3, without 

providing any additional information. 

We summarize and respond to 

relevant portions of comments in this 

order. To make it easier to identify 

comments and FDA’s responses to the 

comments, the word ‘‘Comment’’ will 

appear in parenthesis before the 

description of the comment, and the 

word ‘‘Response’’ will appear in 

parentheses before FDA’s response. We 

have also numbered each comment to 

help distinguish between different 

comments. The number assigned to each 

comment is for organizational purposes 

only and does not signify the comment’s 

value, importance, or the order in which 

it was submitted. 

(Comment 1) Several comments 

argued that the Delaney Clause does not 

apply because the scientific 

community’s understanding of the 

carcinogenicity potential of FD&C Red 

No. 3 has evolved since inclusion of the 

Delaney Clause in the FD&C Act and 

since FDA’s conclusion (55 FR 3520) 

that FD&C Red No. 3 induces cancer in 

male rats. Some comments argue that 

FDA has discretion to exercise scientific 

judgment in determining whether FD&C 

Red No. 3 induces cancer for purposes 

of the Delaney Clause. 

(Response 1) We agree that a large 

body of literature has been published 

since FDA’s conclusion that FD&C Red 

No. 3 induces cancer in male rats. We 

have reviewed the currently available 

data and information pertaining to the 

safety of FD&C Red No. 3 as a color 

additive and concluded that the FD&C 

Red No. 3-induced thyroid tumors in 

male rats are of limited relevance to 

humans (Refs. 5 and 6). However, the 

current literature continues to support 

the finding that high exposure to FD&C 

Red No. 3 induces cancer in male rats 

(Ref. 6). Because of this finding, we 

disagree that FDA has discretion to 

determine that FD&C Red No. 3 does not 

induce cancer under the Delaney 

Clause. The language of the Delaney 

Clause is straightforward. Under the 

general safety clause for color additives, 

FDA has discretion to review a number 

of factors to determine whether a color 

additive is safe (section 721(b)(5)(A) of 

the FD&C Act). However, for ingested 

color additives that are shown ‘‘to 

induce cancer in man or animal,’’ the 

Delaney Clause limits FDA’s discretion 

and requires that FDA conclude that the 

color additive is not safe as a matter of 

law. 

(Comment 2) Several comments 

argued that the Delaney Clause does not 

apply because FD&C Red No. 3 is nongenotoxic and induces tumors through a 

secondary mechanism. The comments 

assert that FDA’s action to terminate the 

provisional listing FD&C Red No. 3 in 

1990 was because there was inadequate 

evidence at the time to demonstrate that 

FD&C Red No. 3 was non-genotoxic, and 

now that there is evidence 

demonstrating that FD&C Red No. 3 is 

non-genotoxic, FDA has discretion to 


ddrumheller on DSK120RN23PROD with RULES1
4632 Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 

determine that FD&C Red No. 3 does not 

cause cancer. 

(Response 2) We agree that FD&C Red 

No. 3 is non-genotoxic based on the 

available data and information. FD&C 

Red No. 3 induces tumors in male rats 

through a key event (increased TSH 

production) (Ref. 6). We refer to the 

increase in TSH levels as a ‘‘key event’’ 

and not as a secondary mechanism 

because the exact mechanism of FD&C 

Red No. 3-induced carcinogenesis in 

male rats has not been determined. 

Nonetheless, we disagree with the 

comments’ assertion that the Delaney 

Clause does not apply. As we concluded 

in our 2018 action revoking the 

authorizations of certain food additives 

under a similarly worded Delaney 

Clause, the Delaney Clause does not 

differentiate between non-genotoxic and 

genotoxic carcinogens (83 FR 50490 at 

50501). Nor does the Delaney Clause 

permit FDA to find an ingested color 

additive safe for human consumption if 

the color additive has been found to 

induce cancer in animals. Consistent 

with our conclusion in revoking certain 

food additive approvals based on the 

Delaney Clause (83 FR 50490), FDA 

concludes that the Delaney Clause 

limits FDA’s discretion to determine the 

safety of color additives that are 

intended to be ingested (such as the use 

of FD&C Red No. 3 in food and ingested 

drugs) in that it prevents FDA from 

finding such a color additive to be safe 

if it has been found to induce cancer 

when ingested by humans or animals, 

regardless of the probability, or risk, of 

cancer associated with exposure to the 

additive or of the extent to which the 

experimental conditions of the animal 

study or the carcinogenic mode of 

action provide insight into the health 

effects of human consumption and use 

of the additive in question. 

(Comment 3) One comment argued 

that the evidence demonstrating that 

FD&C Red No. 3 induces thyroid tumors 

in male rats is insufficient to invoke the 

Delaney Clause. 

(Response 3) We disagree. Again, we 

acknowledge the large body of 

published literature that does not show 

FD&C Red No. 3 inducing cancer in 

female rats, or multiple other animal 

species, including humans (Refs. 5 and 

6). However, under the Delaney Clause, 

these negative findings do not outweigh 

or negate the positive findings of the 

two chronic feeding studies. Because 

FD&C Red No. 3 has been found to 

induce tumors in male rats, FDA must 

revoke the regulations providing for 

these uses of the color additive as a 

matter of law. 

(Comment 4) One comment argued 

that the Delaney Clause does not apply 

because the dose range used for the two 

chronic feeding studies in rats render 

the positive findings unreliable. 

Specifically, the comment asserts that in 

its 1990 order, the study FDA relied on 

was unreliable because the dose of 

FD&C Red No. 3 exceeded the maximum 

tolerated dose. The comment asserts 

that this violates the testing guidelines 

of the National Cancer Institute. 

(Response 4) We disagree. The two 

chronic feeding studies in rats were 

appropriately designed and considered 

to be positive bioassays (Ref. 5). These 

two studies reported within a single 

manuscript were considered appropriate 

and not to have exceeded the maximum 

tolerated dose (MTD) per current 

guidance (Redbook 2000, Chapters 

II.C.5.A. and IV.C.7. or IV.C.8) (Ref. 5). 

Redbook 2000 uses the NTP’s definition 

of MTD, which states that the MTD is 

‘‘that dose which, when given for the 

duration of the chronic study as the 

highest dose, will not shorten the 

treated animals’ longevity from any 

toxic effects other than the induction of 

neoplasms.’’ The data that was deemed 

to demonstrate FD&C Red No. 3 is 

carcinogenic in male rats used a 

maximum dose of 4 percent (Borzelleca 

et al., 1987), which did not impact the 

longevity of the treated animals’ life 

spans, resulted in no systemic toxic 

effects other than the induction of 

neoplasms, and did not cause 

unacceptable side effects. Thus, the 

dose scheme used by Borzelleca et al. 

(1987) fits the FDA Redbook 2000 

definition of MTD. Furthermore, while 

rats may not be an ideal model to assess 

the carcinogenicity potential of FD&C 

Red No. 3 in humans, these chronic 

feeding studies do reasonably 

demonstrate that FD&C Red No. 3 

induces thyroid tumors in male rats. 

These studies are sufficient to invoke 

the Delaney Clause because the Delaney 

Clause is not limited to inducing cancer 

in humans. 

(Comment 5) One comment requested 

that FDA convene a Color Additive 

Advisory Committee if FDA delists 

FD&C Red No. 3 on the basis of the 

Delaney Clause. 

(Response 5) We decline to convene 

the meeting requested by the comment. 

Section 721(b)(5)(c)(i) of the FD&C Act 

states that any person who will be 

adversely affected by a proposal if 

placed into effect may request, within 

the specified time period, that the 

petition or order be referred to an 

advisory committee for a report and 

recommendations with respect to any 

matter arising under subparagraph (B) 

(here, the Delaney clause, (B)(i)) that is 

involved in the proposal) and that 

requires the exercise of scientific 

judgment. Upon such request, the 

Secretary must appoint an advisory 

committee. FDA’s determination that 

FD&C Red No. 3 has been shown to 

cause cancer in laboratory animals is 

based on a comprehensive review of all 

relevant carcinogenicity studies (Ref. 6). 

After reviewing these studies, FDA did 

not find there to be a genuine debate 

regarding the science—specifically, that 

FD&C Red No. 3 induced cancer in male 

rats. Thus, FDA’s conclusion that FD&C 

Red No. 3 has been shown to cause 

cancer in laboratory animals is not a 

matter that requires referral to an 

advisory committee because it did not 

require the exercise of scientific 

judgment. 

(Comment 6) A couple of comments 

stated that the highest dietary exposure 

to FD&C Red No. 3 is below the 

Acceptable Daily Intake (ADI) and 

therefore, dietary exposure from its use 

as a food color additive does not present 

a safety concern. Another comment 

stated that because of the relatively low 

dietary exposure to FD&C Red No. 3, 

revoking the regulations authorizing its 

use would not significantly reduce risk 

to the public. 

(Response 6) Based on our evaluation 

of the dietary exposure to FD&C Red No. 

3 and the available scientific evidence, 

we conclude that FD&C Red No. 3 meets 

the safety standard of a reasonable 

certainty of no harm required for a color 

additive (see Refs. 6 and 7). We derived 

a 210-fold margin of exposure between 

the highest dietary exposure to FD&C 

Red No. 3 (0.25 mg/kg bw/d) and the No 

Observed Adverse Effect Level chosen 

by the CAC (35.8 mg/kg bw/d) (Ref. 6). 

We agree that the highest dietary 

exposure to FD&C Red No. 3 is below 

the ADI established by JECFA in 2018 

(6 mg/kg bw/d). We also agree with 

JECFA’s conclusion that the possibility 

of developing thyroid tumors in humans 

at low dietary exposure levels from the 

current uses of FD&C Red No. 3 is 

unlikely (Ref. 6). However, as a matter 

of law (see section 721(b)(5)(B) of the 

FD&C Act), we must revoke the 

regulations authorizing the uses of 

FD&C Red No. 3 because it has been 

shown to induce cancer in male rats. 

(Comment 7) Several comments stated 

that the findings that FD&C Red No. 3 

induces cancer in male rats are not 

applicable to humans and, therefore, do 

not indicate that the color additive 

would induce tumors in humans. These 

comments asserted that the conclusions 

of other regulatory agencies and 

authoritative risk assessment bodies 

support that the use of FD&C Red No. 

3 is unlikely to cause tumors in humans. 

(Response 7) We agree that there are 

physiological differences between rats 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 90, No. 10 / Thursday, January 16, 2025 / Rules and Regulations 4633 

and humans that require 

contextualization when extrapolating 

the relevance of animal studies to 

humans. There is no conclusive 

evidence that increased TSH 

production—a key event for tumor 

induction in male rats—causes thyroid 

carcinogenesis in humans (see Ref. 6). 

Furthermore, studies in humans have 

not demonstrated that dietary exposure 

to FD&C Red No. 3 causes consistent 

perturbations of TSH or other hormones. 

In fact, studies in humans demonstrate 

a lack of effects on the thyroid. Based 

on the scientific evidence, we agree that 

the thyroid tumors observed in male rats 

are of limited relevance to humans, and 

we note that JECFA, EFSA, and the 

FSANZ have also reached this same 

conclusion (Ref. 6). However, as stated 

earlier, we must revoke the regulations 

authorizing the uses of FD&C Red No. 3 

because it has been shown to induce 

cancer in male rats (see section 

721(b)(5)(B) of the FD&C Act). The 

Delaney Clause prevents us from finding 

its use to be safe, regardless of the extent 

to which the experimental conditions of 

the animal study provide insight into 

the health effects of human 

consumption and use of the color 

additive in question. 

(Comment 8) One comment asserts 

that FDA is required to consider 

reasonable alternatives to revoking the 

color additive listings for FD&C Red No. 

3. The comment also asserts that the 

‘‘proposed rule does not indicate 

whether FDA investigated this issue of 

reasonably viable alternatives to FD&C 

Red. 3.’’ 

(Response 8) Under section 721(b) of 

the FD&C Act, a color additive may not 

be marketed unless FDA determines that 

the additive is suitable and safe for such 

use. Under section 721(b)(5)(B) of the 

FD&C Act, also referred to as the 

Delaney Clause, a color additive shall be 

deemed unsafe, and shall not be listed, 

if certain conditions are met. As FDA 

has determined that the Delaney Clause 

applies to the authorized uses of FD&C 

Red No. 3, FDA does not have discretion 

to consider alternatives to revoking the 

color additive listing, and that is true 

regardless of whether there are 

‘‘reasonably viable alternatives’’ for this 

color additive. 

(Comment 9) One comment asserts 

that FDA did not disclose the relevant 

studies in the filing notice. 

(Response 9) We disagree. As required 

under section 721(d)(1), FDA is required 

to publish ‘‘notice of the proposal made 

by the petition . . . in general terms.’’ 

Furthermore, we note that the petition, 

which was included in the public 

docket, included citations to the 

relevant studies. 

VI. Conclusion 

Upon review of the available 

information, we have determined that 

the information provided in the petition 

and other publicly available relevant 

data demonstrate that FD&C Red No. 3 

has been shown to cause cancer in 

laboratory animals. Under the Delaney 

Clause this finding of carcinogenicity 

renders the color additive ‘‘unsafe’’ as a 

matter of law. FDA is revoking the 

authorizations for this substance as a 

color additive to no longer provide for 

the use of FD&C Red No. 3 in food and 

ingested drugs. Therefore, we are 

amending 21 CFR part 74 as set forth in 

this document. We consider this action 

to also partially respond to CSPI’s 2008 

citizen petition (Docket No. FDA–2008– 

P–0349). 

Because the effective date for the 

removal of § 74.303 will occur before 

the effective date for the removal of 

§ 74.1303, we are also amending 

§ 74.1303 to add the identity and 

specifications from § 74.303(a)(1) and 

(b), which are currently referenced in 

§ 74.1303(a). This amendment will 

become effective on the effective date 

for the removal of § 74.303. 

Upon the removal of these color 

additive listings, FDA will no longer 

provide certificates for FD&C Red No. 3. 

In accordance with 21 CFR 80.32(h), all 

certificates for existing batches and 

portions of batches of FD&C Red No. 3 

will cease to be effective for use in food 

on the effective date for the removal of 

§ 74.303 and for use in ingested drugs 

on the effective date for the removal of 

§ 74.1303, and any lots of FD&C Red No. 

3 will be regarded as uncertified after 

the relevant date(s). Use of FD&C Red 

No. 3 after its certificate ceases to be 

effective will result in such food or 

ingested drugs being adulterated. When 

FD&C Red No. 3 has been used in food 

or ingested drugs while its certificate is 

still effective, such food or ingested 

drugs will not be regarded as 

adulterated by reason of the use of such 

color additive. 

VII. Public Disclosure 

In accordance with § 71.15 (21 CFR 

71.15), the petition and the documents 

that we considered and relied upon in 

reaching our decision to approve the 

petition will be made available for 

public disclosure (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 71.15, we will delete from the 

documents any materials that are not 

available for public disclosure. 

VIII. Analysis of Environmental 

Impacts 

We have determined under 21 CFR 

25.32(m) 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. 

IX. Paperwork Reduction Act of 1995 

This order contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

X. Objections 

This order is effective as shown in the 

DATES section, except as to any 

provisions that may be stayed by the 

filing of proper objections under 

sections 701(e)(2) and 721(d) of the 

FD&C Act (21 U.S.C. 371(e)(2) and 

379e(d)). 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 provision(s) 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 

publish notice of the objections that we 

have received or lack thereof in the 

Federal Register. 

XI. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 


ddrumheller on DSK120RN23PROD with RULES1
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