Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations 15097 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0551; FRL–9348–01– 

OCSPP] 

Tetraacetylethylenediamine (TAED) 

and Its Metabolite 

Diacetylethylenediamine (DAED); 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

exemption from the requirement of a 

tolerance for residues of 

tetraacetylethylenediamine (TAED) and 

its metabolite diacetylethylenediamine 

(DAED) by expanding its use in or on all 

food commodities, when used as a 

fungicide and bactericide in accordance 

with label directions and good 

agricultural practices. The Lubrizol 

Corporation, 29400 Lakeland Blvd., 

Wickliffe, OH 44092, submitted a 

petition, pursuant to section 408(d) of 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR 180.1327. 40 CFR 

180.1327 currently provides for an 

exemption from the requirement of a 

tolerance for residues of the pesticide, 

tetraacetylethylenediamine (TAED), and 

its metabolite diacetylethylenediamine 

(DAED), in or on rice and strawberries, 

when used as a fungicide and 

bactericide in accordance with label 

directions and good agricultural 

practices. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

tetraacetylethylenediamine (TAED) or 

its metabolite diacetylethylenediamine 

(DAED) when used in accordance with 

this exemption. 

DATES: This regulation is effective 

March 17, 2022. Objections and requests 

for hearings must be received on or 

before May 16, 2022 and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2021–0551, is 

available at https://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2021–0551 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before May 

16, 2022. Addresses for mail and hand 

delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2021–0551, by one of the following 

methods: 

• Federal eRulemaking Portal: 

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

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be CBI 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at https://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of September 

22, 2021 (86 FR 52624) (FRL–8792–03– 

OCSPP), EPA issued a document 

pursuant to FFDCA section 408(d)(3), 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide tolerance petition (PP 

9F8781) by The Lubrizol Corporation, 

29400 Lakeland Blvd., Wickliffe, OH, 

44092. The petition requested that 40 

CFR 180.1327 be amended by amending 

the existing exemption from the 

requirement of a tolerance for residues 

of tetraacetylethylenediamine (TAED) 

and its metabolite 

diacetylethylenediamine (DAED) by 

expanding it to in or on all food 

commodities, when used as a fungicide 

and bactericide in accordance with label 

directions and good agricultural 

practices. That document referenced a 


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summary of the petition prepared by the 

petitioner, The Lubrizol Corporation, 

which is available in the docket, https:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ Additionally, 

FFDCA section 408(b)(2)(D) requires 

that the Agency consider ‘‘available 

information concerning the cumulative 

effects of a particular pesticide’s 

residues’’ and ‘‘other substances that 

have a common mechanism of toxicity.’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

harm to human health. If EPA is able to 

determine that a tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, an 

exemption from the requirement of a 

tolerance may be established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for TAED and DAED 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with TAED and DAED 

follows. 

A. Toxicological Profile 

TAED is an analiphatic amide that is 

approved as a pesticide active 

ingredient for food and non-food uses. 

It is also is listed by the Food and Drug 

Administration (FDA) for use as a 

bleaching agent in the manufacture of 

food-contact paper and paperboard 

products (21 CFR 176.170). 

TAED rapidly degrades to form 

diacetylethylenediamine (DAED), 

peroxyacetic acid (PAA), and hydrogen 

peroxide when exposed to water. DAED 

is considered to be of similar or less 

toxicity than TAED. Hydrogen peroxide 

and peroxyacetic acid are exempt from 

the requirement of a tolerance under 40 

CFR 180.1197 and 180.1196(c), 

respectively. Food uses for TAED in or 

on rice and strawberries are supported 

by 40 CFR 180.1327, which currently 

provides for an exemption from the 

requirement of a tolerance for residues 

TAED and DAED in or on rice and 

strawberries, when used as a fungicide 

and bactericide in accordance with label 

directions and good agricultural 

practices. As a non-food pesticidal use, 

TAED is used on various non-bearing 

fruit trees, ornamentals and grasses. For 

all uses, dietary exposure to TAED is 

expected to be minimal due to TAED’s 

physical and chemical properties and 

ready biodegradation in the 

environment. 

With regard to the overall 

toxicological profile, TAED is of 

minimal toxicity. Based on acute 

studies, TAED is of low acute oral 

toxicity and acute inhalation toxicity 

(Toxicity Category IV), low acute dermal 

toxicity (Toxicity Category III) and is 

non-irritating to the skin and eye 

(Toxicity Category IV). The chemical is 

not a skin sensitizer. DAED is 

considered to be of similar or less 

toxicity than TAED. All data 

requirements were satisfied by guideline 

studies for subchronic toxicity (90-day 

oral, 90-day inhalation and 90-day 

dermal), developmental toxicity, 

reproductive toxicity and mutagenicity 

data requirements. There were no 

adverse subchronic effects for any oral 

or dermal routes of exposure. The active 

ingredient was determined to be nonmutagenic, and no adverse effects were 

identified relative to either 

developmental toxicity or reproductive 

toxicity. Based on this toxicological 

profile, EPA did not identify any 

toxicological endpoints of concern for 

TAED. 

B. Toxicological Points of Departure/ 

Levels of Concern 

No toxicological endpoint of concern 

has been identified for TAED or DAED. 

C. Exposure Assessment 

1. Dietary exposure from food, feed 

uses, and drinking water. As part of its 

qualitative risk assessment for TAED, 

the Agency considered the potential for 

dietary exposure to residues of TAED 

and its degradate, DAED. EPA 

concludes that dietary (food and 

drinking water) exposures are likely to 

be negligible, due to the short half-life 

and biodegradable nature of TAED and 

DAED. Further, biodegradation of TAED 

and DAED yields the products water, 

nitrate, and ammonia, which are all 

found naturally in the environment and 

readily metabolized by microorganisms. 

2. From non-dietary exposure. A 

revaluation of the risk of occupational 

and residential (non-dietary) exposure 

to TAED and DAED was not conducted 

at this time. Previous EPA risk 

assessments support the uses on 

currently approved TAED product 

labels. 

3. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found that TAED or DAED share a 

common mechanism of toxicity with 

any other substances, and they do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed TAED and 

DAED do not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s website at https://

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

FFDCA Section 408(b)(2)(C) provides 

that EPA shall retain an additional 

tenfold (10X) margin of safety for infants 

and children in the case of threshold 

effects to account for prenatal and 

postnatal toxicity and the completeness 

of the database on toxicity and exposure 


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Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations 15099 

unless EPA determines based on reliable 

data that a different margin of safety 

will be safe for infants and children. 

This additional margin of safety is 

commonly referred to as the FQPA 

safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. An FQPA safety 

factor is not required at this time for 

TAED and its metabolite, DAED, 

because EPA has conducted a 

qualitative dietary assessment based on 

low toxicity and anticipated negligible 

exposure to the active ingredient. 

E. Aggregate Risk 

Based on the available data and 

information, the EPA has concluded 

that a qualitative aggregate risk 

assessment is appropriate to support the 

pesticidal use of TAED and its 

metabolite, DAED, and that risks of 

concern are not anticipated from 

aggregate exposure to the substance or 

its metabolite, DAED. This conclusion is 

based on the low toxicity of the active 

ingredient and expected rapid 

degradation of TAED and DAED in the 

environment. 

A full explanation of the data upon 

which EPA relied and its risk 

assessment based on those data can be 

found within the July 22, 2021, 

document entitled ‘‘Human Health 

Dietary Risk Assessment to Support a 

Tolerance Exemption Amendment for 

Warwick AG610 (EPA Reg. No. 59825– 

6), Containing 92% 

Tetraacetylethylenediamine as its 

Active Ingredient.’’ This document, as 

well as other relevant information, is 

available in the docket for this action as 

described under ADDRESSES. 

IV. Determination of Safety for U.S. 

Population, Infants and Children 

Based on the Agency’s assessment, 

EPA concludes that there is reasonable 

certainty that no harm will result to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of TAED. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established an 

MRL for tetraacetylethylenediamine 

(TAED) or its metabolite 

diacetylethylenediamine (DAED). 

VI. Conclusions 

Therefore, EPA is amending the 

currently established exemption for 

residues of tetraacetylethylenediamine 

(TAED) and its metabolite 

diacetylethylenediamine (DAED) to 

include use in or on all food 

commodities—no longer limiting food 

use to strawberries and rice, when used 

as a fungicide and bactericide in 

accordance with label directions and 

good agricultural practices. 

VII. Statutory and Executive Order 

Reviews 

This action amends an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 


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15100 Federal Register / Vol. 87, No. 52 / Thursday, March 17, 2022 / Rules and Regulations 

1The Department recently proposed a technical 

correction to 45 CFR 155.206(i) to add language that 

would cross-reference to the authority to implement 

annual inflation-related increases to CMPs pursuant 

to the 2015 Act. See Patient Protection and 

Affordable Care Act; HHS Notice of Benefit and 

Payment Parameters for 2023; Proposed Rule, 87 FR 

584 at 640–641, 721 (Jan. 5, 2022). To date, no 

CMPs have been imposed under this authority, but 

any that are would reflect the current inflationary 

adjusted amount as required by the 2015 Act and 

would be calculated in accordance with applicable 

OMB guidance to all Executive Departments on the 

implementation of the 2015 Act. 

2See, e.g., the Patient Protection and Affordable 

Care Act; Exchange and Insurance Market 

Standards for 2015 and Beyond; Final Rule, 79 FR 

30239 at 30262–30270 (May 27, 2014). 

Dated: March 10, 2022. 

Charles Smith, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Revise § 180.1327 to read as 

follows: 

§ 180.1327 Tetraacetylethylenediamine 

(TAED) and its metabolite 

Diacetylethylenediamine (DAED); 

Exemption from the Requirement of a 

Tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the pesticide, 

tetraacetylethylenediamine (TAED), and 

its metabolite diacetylethylenediamine 

(DAED), in or on all food commodities, 

when used as a fungicide and 

bactericide in accordance with label 

directions and good agricultural 

practices. 

[FR Doc. 2022–05530 Filed 3–16–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 102 

RIN 0991–AC33 

Annual Civil Monetary Penalties 

Inflation Adjustment 

AGENCY: Office of the Assistant 

Secretary for Financial Resources, 

Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Department of Health and 

Human Services is updating its 

regulations to reflect required annual 

inflation-related increases to the civil 

monetary penalty amounts in its 

regulations, under the Federal Civil 

Penalties Inflation Adjustment Act 

Improvements Act of 2015; adding 

references to new penalty authorities; 

and making technical changes to correct 

errors in the regulation. 

DATES: 

Effective date: This final rule is 

effective March 17, 2022. 

Applicability date: The adjusted civil 

monetary penalty amounts apply to 

penalties assessed on March 17, 2022, r 

if the violation occurred on or after 

November 2, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Katrina Brisbon, Acting Deputy 

Assistant Secretary, Office of 

Acquisitions, Office of the Assistant 

Secretary for Financial Resources, Room 

536–H, Hubert Humphrey Building, 200 

Independence Avenue SW, Washington, 

DC 20201; (202) 260–6677. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 (section 701 of Pub. L. 114–74) 

(the ‘‘2015 Act’’) amended the Federal 

Civil Penalties Inflation Adjustment Act 

of 1990 (Pub. L. 101–410, 104 Stat. 890 

(1990)), which is intended to improve 

the effectiveness of civil monetary 

penalties (CMPs) and to maintain the 

deterrent effect of such penalties, 

requires agencies to adjust the CMPs for 

inflation annually. 

The Department of Health and Human 

Services (HHS) lists the CMP authorities 

and the amounts administered by all of 

its agencies in tabular form in 45 CFR 

102.3, which was issued in an interim 

final rule published in the September 6, 

2016, Federal Register (81 FR 61538). 

Annual adjustments were subsequently 

published on February 3, 2017 (82 FR 

9175), October 11, 2018 (83 FR 51369), 

November 5, 2019 (84 FR 59549), 

January 17, 2020 (85 FR 2869), and 

November 15, 2021 (86 FR 62928). 

II. Calculation of Annual Inflation 

Adjustment 

The annual inflation adjustment for 

each applicable CMP is determined 

using the percent increase in the 

Consumer Price Index for all Urban 

Consumers (CPI–U) for the month of 

October of the year in which the amount 

of each CMP was most recently 

established or modified. In the 

December 15, 2021, Office of 

Management and Budget (OMB) 

Memorandum for the Heads of 

Executive Agencies and Departments, 

M–22–07, ‘‘Implementation of Penalty 

Inflation Adjustments for 2022, 

Pursuant to the Federal Civil Penalties 

Inflation Adjustment Act Improvements 

Act of 2015,’’ OMB published the 

multiplier for the required annual 

adjustment. The cost-of-living 

adjustment multiplier for 2022, based 

on the CPI–U for the month of October 

2021, not seasonally adjusted, is 

1.06222. The multiplier is applied to 

each applicable penalty amount that 

was updated and published for fiscal 

year (FY) 2021 and is rounded to the 

nearest dollar. 

III. Other Revisions 

In addition to the inflation 

adjustments for 2022, this final rule 

updates the table in 45 CFR 102.3 to add 

references to new, applicable civil 

money penalty authorities that were 

established or implemented since the 

publication of the November 15, 2021 

update and that are being updated in 

this rule. The rule also corrects several 

technical errors to regulatory citations 

in the table and updates descriptions for 

clarification and accuracy. The 

following technical errors were 

identified and are corrected in the table 

at 45 CFR 102.3: 

• The citation to, and description of, 

42 U.S.C. 299c–3(d) are revised for 

accuracy. 

• The regulatory reference of 42 CFR 

1003.210(a)(5) implementing 42 U.S.C. 

1395cc(g) which was inadvertently 

omitted from the regulation and is 

added. 

• The description of the CMP at 42 

U.S.C. 1320a–7a(o) is revised for 

accuracy. 

• The regulatory reference to 45 CFR 

155.206(i) 1 implementing 42 U.S.C. 

18041(c)(2) 2 which was inadvertently 

omitted from the regulation is added. 

Additionally, the amount for this CMP 

was not included in the 2021 inflation 

adjustment rule. 86 FR 62928, 62943 

(Nov. 15, 2021). Thus, we are updating 

the inflation amount at this time. 

• The first description tied to 42 

U.S.C. 1395mm(i)(6)(B)(i) is revised 

from ‘‘is such plan’’ to ‘‘if such plan’’. 

• The regulatory reference to 85 FR 

71142 (Nov. 6, 2020) implementing 

CARES Act, Pub. L. 116–136, section 

3202(b)(2), is revised to read 45 CFR 

182.70. 

++ The 2022 adjusted amount is 

calculated by applying the 2021 

multiplier to 1.06222 percent and this 

adjusted amount is reflected in the table 

of the regulation at 45 CFR 102.3. 


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