Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 44623 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for pyrrolo[3,4- 

c]pyrrole-1,4-dione, 3,6-bis(4- 

chlorophenyl)-2,5-dihydro- (CAS Reg. 

No. 84632–65–5) when used as an inert 

ingredient (dye, coloring agent) in 

pesticide formulations applied pre- and 

post-harvest. 

VII. Statutory and Executive Order 

Reviews 

This action establishes 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 exemption 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. 

Dated: July 23, 2021. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, 40 CFR chapter I is amended 

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. In § 180.910, amend the table by 

adding in alphabetical order the inert 

ingredient ‘‘Pyrrolo[3,4-c]pyrrole-1,4- 

dione, 3,6-bis(4-chlorophenyl)-2,5- 

dihydro- (CAS Reg. No. 84632–65–5)’’ to 

the table to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

TABLE 1 TO 180.910 

Inert ingredients Limits Uses 

*******

Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis(4-chlorophenyl)-2,5-dihydro- (CAS Reg. No. 84632–65–5) ..... ........................ Dye, coloring agent. 

*******

[FR Doc. 2021–17192 Filed 8–12–21; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0050; FRL–8560–01– 

OCSPP] 

Boscalid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of boscalid in or 

on tea, dried; tea, instant. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 13, 2021. Objections and 

requests for hearings must be received 


jbell on DSKJLSW7X2PROD with RULES
44624 Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 

on or before October 12, 2021, 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–2020–0050, is 

available at http://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: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/ 

Title40/40tab_02.tpl. 

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–2020–0050 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 

October 12, 2021. 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– 

2020–0050, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

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 http://

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

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of September 

30, 2020 (85 FR 61681) (FRL–10014–74), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E8819) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.589 be amended by 

establishing tolerances for residues of 

the fungicide boscalid in or on tea at 80 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by BASF Corporation, the 

registrant, which is available in the 

docket, http://www.regulations.gov. No 

comments were received in response to 

the notice of filing. 

FFDCA section 408(d)(4)(A)(i) permits 

the Agency to finalize a tolerance that 

varies from that sought by the petition. 

Based upon review of the data 

supporting the petition, EPA has 

modified the tolerance level being 

established and corrected the 

commodity definition of ‘‘tea’’ to ‘‘tea, 

dried’’ and ‘‘tea, instant.’’ The reason for 

these changes is explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

A. Statutory Background 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires 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 . . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D) and the factors specified 

therein, 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 boscalid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with boscalid follows. 

B. Aggregate Risk Assessment 

In an effort to streamline Federal 

Register publications, EPA is not 


jbell on DSKJLSW7X2PROD with RULES
Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 44625 

reprinting sections that have not 

changed from previous rulemakings for 

the same pesticide. On October 19, 

2018, EPA published in the Federal 

Register a final rule establishing 

tolerances for residues of boscalid in or 

on multiple commodities based on the 

Agency’s conclusion that aggregate 

exposure to boscalid is safe for the 

general population, including infants 

and children. See 83 FR 52991 (EPA– 

HQ–OPP–2017–0310). Refer to the 

following sections from the previous 

tolerance rulemaking for boscalid that 

have remained the same under the 

current risk assessment: Units III.A 

(Toxicological Profile); III.B 

(Toxicological Points of Departure/ 

Levels of Concern); III.C. (Exposure 

Assessment), except as explained below; 

and III.D. (Safety Factor for Infants and 

Children). EPA has conducted an 

updated human health risk assessment 

to evaluate the safety of the requested 

tolerances, which is limited to an 

updated dietary exposure and risk 

assessment, and subsequent updates to 

the aggregate exposure and risk 

assessment. See ‘‘Boscalid. Human 

Health Risk Assessment for the 

Establishment of a Permanent Tolerance 

Without a U.S. Registration on Tea.’’ 

(D456100, 04/01/2021), which is 

available in the docket established by 

this action, EPA–HQ–OPP–2020–0050. 

Updates to exposure assessment. 

EPA’s dietary (food and drinking water) 

exposure assessments have been 

updated to include the potential 

additional exposure from the tolerance 

for boscalid residues in or on tea, dried 

and tea, instant. The exposure 

assessments relied on tolerance-level 

residues for all crops and an assumption 

of 100 percent crop treated (PCT) as the 

October 19, 2018, final rule. Exposure in 

drinking water and from residential 

sources are not impacted by the 

increased tolerance on tea, dried and 

tea, instant because the tolerances are 

without U.S. registration. 

Assessment of aggregate risks. An 

acute dietary exposure assessment was 

not conducted because there were no 

observed effects attributable to a single 

dose. Chronic dietary risks are below 

the Agency’s level of concern of 100% 

of the chronic population adjusted dose 

(cPAD): 60% of the cPAD for children 

1 to 2 years old, the most highly 

exposed population subgroup. 

For the aggregate risk assessment, 

exposures to boscalid in food and 

drinking water are combined with 

residential exposures for the relevant 

exposure duration period. There is 

potential for short-term aggregate 

exposure to boscalid via dietary (which 

is considered background exposure) and 

residential (which is considered 

primary) exposure pathways. The shortterm aggregate margins of exposure 

(MOEs) are 160 for children 6 to 11 

years old, 360 for youth 11 to 16 years 

old, and 130 for adults (LOC = 100), 

which are not of concern because they 

exceed EPA’s level of concern (MOEs 

less than or equal to 100). 

A separate cancer dietary assessment 

was not conducted since boscalid was 

classified by the Cancer Assessment 

Review Committee (CARC) as 

‘‘suggestive evidence of 

carcinogenicity’’; and the chronic 

exposure assessment is protective of any 

cancer risks. Therefore, based on the 

chronic exposure assessment, which 

accounts for potential carcinogenicity, 

EPA does not expect boscalid to pose a 

cancer risk. 

C. Determination of Safety 

Therefore, based on the risk 

assessments and information described 

above, EPA concludes there is a 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to boscalid residues. More 

detailed information about the Agency’s 

analysis can be found in the document 

entitled, ‘‘Boscalid. Human Health Risk 

Assessment for the Establishment of a 

Permanent Tolerance Without a U.S. 

Registration on Tea.’’ (D456100, 04/01/ 

2021) by going to http://

www.regulations.gov. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate methods exist for both 

plants and livestock. In plants, the 

parent residue is extracted using an 

aqueous organic solvent mixture 

followed by liquid/liquid partitioning 

and a column clean up. Quantitation is 

by gas chromatography using mass 

spectrometry (GC/MS) or liquid 

chromatography in tandem with mass 

spectrometric detection (LC/MS/MS). In 

livestock, the residues are extracted 

with methanol. The extract is treated 

with enzymes in order to release the 

conjugated glucuronic acid metabolite. 

The residues are then isolated by liquid/ 

liquid partition followed by column 

chromatography. The hydroxylated 

metabolite is acetylated followed by a 

column clean-up. The parent and 

acetylated metabolite are quantitated by 

gas chromatography with electron 

capture detection. 

Adequate enforcement methodology, 

extraction using an aqueous organic 

solvent mixture followed by liquid/ 

liquid partitioning and a column clean 

up with quantitation by gas 

chromatography using mass 

spectrometry (GC/MS) or liquid 

chromatography in tandem with mass 

spectrometric detection (LC/MS/MS), is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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). 

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 a MRL for boscalid. Taiwan 

has an MRL for residues of boscalid in/ 

on dried tea leaves at 10 ppm, and Japan 

has an MRL of residues of boscalid in/ 

on dried tea leaves at 60 ppm. The 

tolerance expression for Taiwan and 

Japan are harmonized with the US 

tolerance definition in crops as parent 

boscalid only but do not metabolites 

and degradates. All international MRLs 

fall below the calculated tolerance value 

of 70 ppm. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioned-for tolerance for 

residues on the commodity tea at 80 

ppm is revised so that there will be two 

separate tolerances for residues on tea, 

dried and tea, instant each at 70 ppm 

and corrected commodity definitions. 

The tolerance is also revised pursuant to 

a difference in how the tolerances are 

calculated. The registrant calculated a 

processing factor for dried black tea as 

4.1x and used the field trial values from 

the fresh leaves at 7-days. EPA 

determined the processing factor to be 

no greater than 2.54x and extrapolated 

the 7-day residues for black tea based on 

the combination of the processing factor 

and the decline trend for fresh leaves. 

V. Conclusion 

Therefore, tolerances are established 

for residues of boscalid, in or on Tea, 

dried; and Tea, instant at 70 ppm. 


jbell on DSKJLSW7X2PROD with RULES
44626 Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations 

2There are no U.S. registrations for these 

commodities as of August 13, 2021. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

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). 

VII. 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. 

Dated: August 2, 2021. 

Marietta Echeverria, 

Acting Director, Registration 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. In § 180.589 amend the table in 

paragraph (a)(1) by adding in 

alphabetical order entries for ‘‘Tea, 

dried2’’ and ‘‘Tea, instant 2’’ to read as 

follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Tea, dried 2 ................................. 70 

Tea, instant 2 ............................... 70 

* * * * * 

* * * * * 

[FR Doc. 2021–16973 Filed 8–12–21; 8:45 am] 

BILLING CODE 6560–50–P 

NATIONAL FOUNDATION ON THE 

ARTS AND HUMANITIES 

National Endowment for the 

Humanities 

45 CFR Part 1174 

RIN 3136–AA36 

Implementation of the Program Fraud 

Civil Remedies Act of 1986 

AGENCY: National Endowment for the 

Humanities; National Foundation on the 

Arts and the Humanities. 

ACTION: Final rule. 

SUMMARY: The National Endowment for 

the Humanities (NEH) is adopting as 

final its proposed regulations to 

implement the Program Fraud Civil 

Remedies Act of 1986 (PFCRA). The 

PFCRA authorizes certain Federal 

agencies, including NEH, to impose 

civil penalties and assessments through 

administrative adjudication against any 

person who makes, submits, or presents 

a false, fictitious, or fraudulent claim or 

written statement to NEH. The rule 

establishes the procedures that NEH 

will follow in implementing the PFCRA, 

and specifies the hearing and appeal 

rights of persons subject to penalties 

and assessments under the PFCRA. 

DATES: This final rule is effective on 

August 13, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Voyatzis, Deputy General 

Counsel, Office of the General Counsel, 

National Endowment for the 

Humanities, 400 7th Street SW, Room 

4060, Washington, DC 20506; (202) 606– 

8322; gencounsel@neh.gov. 

SUPPLEMENTARY INFORMATION: 

1. Background 

On June 25, 2021, NEH published in 

the Federal Register a notice of 

proposed rulemaking (86 FR 33603), 

requesting public comment on a 

proposed rule to implement to 

implement the PFCRA. The agency 

received no comments. Accordingly, 

NEH is adopting the rule as proposed, 

subject to certain minor corrections to 

the rule’s organization and formatting. 

In October 1986, Congress enacted the 

PFCRA, 31 U.S.C. 3801–3812. The 

PFCRA established an administrative 

remedy against any person who makes, 

or causes to be made, a false claim or 

written statement to certain Federal 

agencies. The PFCRA requires these 


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