57898 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 

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 14, 2023. 

Charles Smith, 

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 § 180.207, amend paragraph (a) 

by designating the table as table 1 and 

adding in alphabetical order in newly 

designated table 1 to paragraph (a) the 

entries ‘‘Tea, dried 1’’ and ‘‘Tea, 

instant 1’’ and footnote 1 following the 

table to read as follows: 

§ 180.207 Trifluralin; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Tea, dried 1 ................................. 0.05 

Tea, instant 1 ............................... 0.05 

* * * * * 

1There are no U.S. registrations as of August 24, 2023. 

* * * * * 

[FR Doc. 2023–18180 Filed 8–23–23; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0797; FRL–10971–01– 

OCSPP] 

Aspergillus flavus strain TC16F, 

TC35C, TC38B, and TC46G; 

Amendment to Temporary Exemptions 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing temporary tolerance 

exemptions for residues of Aspergillus 

flavus strains TC16F, TC35C, TC38B, 

and TC46G by establishing permanent 

tolerance exemptions for use in or on all 

food and feed commodities of field corn, 

popcorn, and sweet corn. Interregional 

Research Project Number 4 (IR–4) 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting to amend the 

existing temporary tolerance 

exemptions for Aspergillus flavus 

strains TC16F, TC35C, TC38B, and 

TC46G. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G under 

FFDCA when used in accordance with 

label directions and good agricultural 

practices. 

DATES: This regulation is effective 

August 24, 2023. Objections and 

requests for hearings must be received 

on or before October 23, 2023 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–2022–0797, 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 

20004. 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 and OPP Docket 

is (202) 566–1744. For the latest status 

information on EPA/DC services, docket 

access, visit https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Madison Le, Biopesticides and Pollution 

Prevention Division (7511M), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

main telephone number: (202) 566– 

1400; 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). 


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Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 57899 

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/title-40. 

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–2022–0797 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 23, 2023. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b), although EPA strongly 

encourages those interested in 

submitting objections or a hearing 

request to submit objections and hearing 

requests electronically. See Order 

Urging Electronic Service and Filing 

(April 10, 2020), https://www.epa.gov/ 

sites/default/files/2020-05/documents/ 

2020-04-10_-_order_urging_electronic_

service_and_filing.pdf. At this time, 

because of the COVID–19 pandemic, the 

judges and staff of the Office of 

Administrative Law Judges are working 

remotely and not able to accept filings 

or correspondence by courier, personal 

delivery, or commercial delivery, and 

the ability to receive filings or 

correspondence by U.S. Mail is 

similarly limited. When submitting 

documents to the U.S. EPA Office of 

Administrative Law Judges (OALJ), a 

person should utilize the OALJ e-filing 

system at https://yosemite.epa.gov/oa/ 

eab/eab-alj_upload.nsf. 

Although EPA’s regulations require 

submission via U.S. Mail or hand 

delivery, EPA intends to treat 

submissions filed via electronic means 

as properly filed submissions during 

this time that the Agency continues to 

maximize telework due to the 

pandemic; therefore, EPA believes the 

preference for submission via electronic 

means will not be prejudicial. If it is 

impossible for a person to submit 

documents electronically or receive 

service electronically, e.g., the person 

does not have any access to a computer, 

the person shall so advise OALJ by 

contacting the Hearing Clerk at (202) 

564–6281. If a person is without access 

to a computer and must file documents 

by U.S. Mail, the person shall notify the 

Hearing Clerk every time it files a 

document in such a manner. The 

address for mailing documents is U.S. 

Environmental Protection Agency, 

Office of Administrative Law Judges, 

Mail Code 1900R, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460. 

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– 

2022–0797, 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/where-sendcomments-epa-dockets. 

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 

In the Federal Register of February 

23, 2023 (88 FR 11401) (FRL–10579–01), 

EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance exemption petition (PP 

1E8975) by IR–4, North Carolina State 

University, 1730 Varsity Drive, Suite 

210, Venture IV, Raleigh, NC 27606, on 

behalf of the Texas Corn Producers 

Board, 4205 N Interstate 27, Lubbock, 

Texas 79403. The petition requested 

that 40 CFR 180.1338 be amended to 

establish an amendment of the existing 

temporary tolerance exemptions for the 

microbial pesticides Aspergillus flavus 

strains TC16F, TC35C, TC38B, and 

TC46G in or on all food and feed 

commodities of field corn, popcorn, and 

sweet corn. That notice referenced a 

summary of the petition prepared by the 

petitioner IR–4 and available in the 

docket via https://www.regulations.gov. 

EPA received no comments in response 

to the notice of filing. 

EPA modified language from the 

requested tolerance exemption and 

changed ‘‘exemption’’ to ‘‘exemptions’’ 

in the amended tolerance exemption 

expression. The reason for this change 

is explained in Unit III.C. 

III. Final Rule 

A. EPA’s Safety Determination 

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

allows EPA to establish an exemption 

from the requirement of 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 or tolerance exemption 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 EPA 

consider ‘‘available information 

concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and 

other substances that have a common 

mechanism of toxicity.’’ 

EPA evaluated the available 

toxicological and exposure data on 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G and 

considered their validity, completeness, 

and reliability, as well as the 

relationship of this information to 

human risk. A full explanation of the 

data upon which EPA relied and its risk 

assessment based on those data can be 

found within the document entitled 

‘‘Human Health Risk Assessment of 

Aspergillus flavus strain TC16F, 

Aspergillus flavus strain TC35C, 

Aspergillus flavus strain TC38B, and 

Aspergillus flavus strain TC46G, New 

Active Ingredients, in FourSure 


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57900 Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 

Proposed for Registration and an 

Associated Petition Requesting a 

Tolerance Exemption’’ (Human Health 

Risk Assessment of Aspergillus flavus 

strains TC16F, TC35C, TC38B, and 

TC46G). This document, as well as other 

relevant information, is available in the 

docket for this action as described under 

ADDRESSES. 

The toxicological profiles of 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G were 

previously described in the ‘‘Review of 

Product Identity, Human Health Data, 

and Petition for a Temporary Tolerance 

Exemption for the IR–4 and Texas Corn 

Producers Board FourSure Experimental 

Use Permit 5E8397,’’ available in docket 

EPA–HQ–OPP–2015–0742 and remain 

unchanged at this time. Based upon its 

evaluation, EPA concludes that, with 

regard to humans, Aspergillus flavus 

strains TC16F, TC35C, TC38B, and 

TC46G are not anticipated to be toxic, 

pathogenic, or infective via any 

reasonably foreseeable route of 

exposure. Although there is potential for 

dietary and non-occupational exposure 

to residues of Aspergillus flavus strains 

TC16F, TC35C, TC38B, and TC46G, 

there is not a concern due to the lack of 

potential for adverse effects. Because 

there are no threshold levels of concern 

with the toxicity, pathogenicity, or 

infectivity of Aspergillus flavus strains 

TC16F, TC35C, TC38B, and TC46G, EPA 

determined that no additional margin of 

safety is necessary to protect infants and 

children as part of the qualitative 

assessment conducted. 

Based upon its evaluation in the 

Human Health Risk Assessment of 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G, which 

concludes that there are no risks of 

concern from aggregate exposure to 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G, EPA 

concludes that there is a reasonable 

certainty that no harm will result to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of Aspergillus flavus strains 

TC16F, TC35C, TC38B, and TC46G. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G because EPA 

is amending temporary exemptions from 

the requirement of a tolerance without 

any numerical limitations. 

C. Revisions to the Requested 

Amendment to a Tolerance Exemption 

One modification was made to the 

requested tolerance exemption. EPA 

changed ‘‘exemption’’ to ‘‘exemptions’’ 

as four different active ingredients are 

covered with this action. 

D. Conclusion 

Therefore, the existing Aspergillus 

flavus strains TC16F, TC35C, TC38B, 

and TC46G temporary tolerance 

exemptions are amended by establishing 

permanent tolerance exemptions for 

residues of Aspergillus flavus strains 

TC16F, TC35C, TC38B, and TC46G in or 

on all food and feed commodities of 

corn, field; corn, pop; and corn, sweet 

when used in accordance with label 

directions and good agricultural 

practices. 

IV. Statutory and Executive Order 

Reviews 

This action amends temporary 

tolerance exemptions under FFDCA 

section 408(d) in response to a petition 

submitted to EPA. 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, 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 amended on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance exemptions in this action, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (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. As a 

result, this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

EPA 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, EPA 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 (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

EPA’s consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act (15 

U.S.C. 272 note). 

V. 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 16, 2023. 

Edward Messina, 

Director, 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 § 180.1338 to read as 

follows: 

§ 180.1338 Aspergillus flavus strains 

TC16F, TC35C, TC38B, and TC46G; 

exemptions from the requirement of a 

tolerance. 

Exemptions from the requirement of a 

tolerance are established for residues of 


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Federal Register / Vol. 88, No. 163 / Thursday, August 24, 2023 / Rules and Regulations 57901 

Aspergillus flavus strains TC16F, 

TC35C, TC38B, and TC46G in or on all 

food and feed commodities of corn, 

field; corn, pop; and corn, sweet when 

used in accordance with label directions 

and good agricultural practices. 

[FR Doc. 2023–18182 Filed 8–23–23; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 405, 410, 411, 412, 413, 

416, 419, 424, 485, and 489 

[CMS–1772–FC; CMS–1744–F; CMS–3419– 

F; CMS–5531–F; CMS–9912–F] 

RIN 0938–AU82 

Medicare Program: Hospital Outpatient 

Prospective Payment and Ambulatory 

Surgical Center Payment Systems and 

Quality Reporting Programs; Organ 

Acquisition; Rural Emergency 

Hospitals: Payment Policies, 

Conditions of Participation, Provider 

Enrollment, Physician Self-Referral; 

New Service Category for Hospital 

Outpatient Department Prior 

Authorization Process; Overall 

Hospital Quality Star Rating; COVID–19 

Correction 

In rule document 2023–23918 

beginning on page 71748 in the issue of 

November 23, 2022, make the following 

correction: 

§ 413.404 Corrected 

On page 72288, in the first column, in 

amendatory instruction 23, in the 

seventh line ‘‘(b)(3)(ii)(C)(1) through 

(3)’’ should read ‘‘(b)(3)(ii)(C)(1) through 

(3)’’. 

On page 72288, in the second column, 

in paragraph (b)(3)(i)(C)(1)(ii), in the 

second line ‘‘(b)(3)(i)(C)(1)(i)’’ should 

read ‘‘(b)(3)(i)(C)(1)(i)’’. 

On the same page, in the same 

column, in paragraph (b)(3)(i)(C)(2)(ii), 

in the first line ‘‘(b)(3)(i)(C)(2)(i)’’ should 

read ‘‘(b)(3)(i)(C)(2)(i)’’. 

On the same page, in the third 

column, in paragraph (b)(3)(i)(C)(1)(ii), 

‘‘(b)(3)(i)(C)(1)(i)’’ should read 

‘‘(b)(3)(i)(C)(1)(i)’’. 

On the same page, in the same 

column, in paragraph (b)(3)(i)(C)(2)(ii), 

in the second line ‘‘(b)(3)(ii)(B)(2)(i)’’ 

should read ‘‘(b)(3)(ii)(B)(2)(i)’’. 

[FR Doc. C1–2022–23918 Filed 8–23–23; 8:45 am] 

BILLING CODE 1505–01–D 


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