82782 Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Rules and Regulations 

Issued in Washington, DC, on November 

10, 2023. 

Thomas J. Nichols, 

Aviation Safety, Flight Standards Service, 

Manager, Standards Section, Flight 

Procedures & Airspace Group, Flight 

Technologies & Procedures Division. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, 14 CFR part 

97 is amended by amending Standard 

Instrument Approach Procedures and 

Takeoff Minimums and ODPs, effective 

at 0901 UTC on the dates specified, as 

follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 40103, 

40106, 40113, 40114, 40120, 44502, 44514, 

44701, 44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

By amending: § 97.23 VOR, VOR/ 

DME, VOR or TACAN, and VOR/DME 

or TACAN; § 97.25 LOC, LOC/DME, 

LDA, LDA/DME, SDF, SDF/DME; 

§ 97.27 NDB, NDB/DME; § 97.29 ILS, 

ILS/DME, MLS, MLS/DME, MLS/RNAV; 

§ 97.31 RADAR SIAPs; § 97.33 RNAV 

SIAPs; and § 97.35 COPTER SIAPs, 

Identified as follows: 

* * * Effective Upon Publication 

AIRAC date State City Airport name FDC No. FDC date Procedure name 

28–Dec–23 ........ CA Santa Rosa ........... Charles M Schulz—Sonoma 

County.

3/0468 10/5/23 ILS OR LOC RWY 32, Amdt 

19C. 

28–Dec–23 ........ PA Reading ................. Reading Rgnl/Carl A Spaatz 

Fld.

3/2093 10/19/23 RNAV (GPS) RWY 31, Orig. 

28–Dec–23 ........ AR Pine Bluff ............... Pinebluff Rgnl/Grider Fld ....... 3/4744 8/16/23 ILS OR LOC RWY 18, Amdt 3E. 

28–Dec–23 ........ CA Los Angeles .......... Los Angeles Intl .................... 3/6286 10/5/23 RNAV (GPS) Y RWY 25L, Amdt 

5. 

[FR Doc. 2023–25955 Filed 11–24–23; 8:45 am] 

BILLING CODE 4910–13–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0198; FRL–11435–01– 

OCSPP] 

Tolpyralate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of tolpyralate in 

or on barley, wheat and livestock 

commodities. ISK Biosciences 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 27, 2023. Objections and 

requests for hearings must be received 

on or before January 26, 2024, 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–2022–0198, 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 and for the OPP 

Docket is (202) 566–1744. Please review 

the visitor instructions and additional 

information about the docket available 

at https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Francisco Llarena-Arias, 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 Office of the Federal Register’s eCFR site at https://www.ecfr.gov/title-40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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–2022–0198 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 

January 26, 2024. 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– 

2022–0198, 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/ 


khammond on DSKJM1Z7X2PROD with RULES
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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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of May 20, 

2022 (87 FR 30855) (FRL–9410–13– 

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 petition (PP 1F8958) by 

ISK Biosciences Corporation, 7470 

Auburn Road, Suite A, Concord, Ohio, 

44077. The petition requested that 40 

CFR part 180 be amended by 

establishing tolerances for residues of 

the herbicide tolpyralate, 1-[[1-ethyl-4- 

[3-(2-methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate including 

its metabolite MT–2153, in or on barley, 

grain at 0.015 parts per million (ppm); 

barley, hay at 0.2 ppm; barley, straw at 

0.08 ppm; wheat, grain at 0.01 ppm; 

wheat, forage at 0.02 ppm; wheat, hay 

at 0.05 ppm; wheat, straw at 0.03 ppm. 

That document referenced a summary of 

the petition prepared by ISK 

Biosciences Corporation, the registrant, 

which is available in the docket, https:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. Based upon review of 

the data supporting the petition, EPA is 

establishing tolerances for residues in 

livestock commodities. The reasons for 

these changes are explained in Unit 

IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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 in 

FFDCA section 408(b)(2)(D), 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 tolpyralate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with tolpyralate follows. 

In an effort to streamline its 

publications in the Federal Register, 

EPA is not reprinting sections of the 

rule that repeat what has been 

previously published in tolerance 

rulemakings for the same pesticide 

chemical. Where scientific information 

concerning a particular chemical 

remains unchanged, the content of those 

sections would not vary between 

tolerance rulemaking and republishing 

the same sections is unnecessary and 

duplicative. EPA considers referral back 

to those sections as sufficient to provide 

an explanation of the information EPA 

considered in making its safety 

determination for the new rulemaking. 

EPA has previously published a 

number of tolerance rulemakings for 

tolpyralate, in which EPA concluded, 

based on the available information, that 

there is a reasonable certainty that no 

harm would result from aggregate 

exposure to tolpyralate and established 

tolerances for residues of that chemical. 

EPA is incorporating previously 

published sections from those 

rulemakings as described further in this 

rulemaking, as they remain unchanged. 

A. Toxicological Profile 

For a discussion of the Toxicological 

Profile of tolpyralate, see Unit III.A. of 

the July 27, 2017, rulemaking (82 FR 

34877) (FRL–9964–15). 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. The PODs and 

levels of concern have not changed from 

the previous rulemaking and EPA 

incorporates the background 

information in the July 27, 2017, 

rulemaking. In addition, a summary of 

the toxicological endpoints for 

tolpyralate used for human risk 

assessment can be found in the 

document titled Tolpyralate: Human 

Health Risk Assessment for the 

Proposed Uses on Wheat and Barley and 

Addition of Aerial Application for Corn. 

(hereinafter ‘‘Tolpyralate Human Health 

Risk Assessment’’) in docket ID number 

EPA–HQ–OPP–2022–0198 in 

regulations.gov. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tolpyralate, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

tolpyralate tolerances in 40 CFR 

180.696. EPA assessed dietary 

exposures from tolpyralate in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

tolpyralate. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

under the Continuing Survey of Food 

Intake by Individuals (CSFII) and the 

Centers for Disease Control (CDC) under 

the National Health and Nutrition 

Examination Survey/What We Eat in 

America (NHANES/WEIA) 2005–2010. 

As to residue levels in food, EPA 

assumed tolerance level residues for all 

commodities and 100% crop treated. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) under the 

Continuing Survey of Food Intake by 

Individuals (CSFII) and the CDC under 

the National Health and Nutrition 

Examination Survey/What We Eat in 

America (NHANES/WEIA) 2005–2010. 

As to residue levels in food, EPA 

assumed tolerance level residues for all 

commodities and 100% crop treated. 

iii. Cancer. The Agency has 

determined that quantification of risk 

using a non-linear approach (i.e., 

reference dose or RfD), for tolpyralate 

will adequately account for all chronic 

toxicity, including carcinogenicity, that 

could result from exposure to 

tolpyralate. As a result, the chronic 

dietary exposure assessment is 

protective for potential cancer risk, and 

a separate cancer exposure assessment 

was not conducted. 


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iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for tolpyralate. Tolerance level residues 

and/or 100% CT were assumed for all 

food commodities. 

2. Dietary exposure from drinking 

water. The estimates for drinking water 

exposure have not changed since the 

previous tolerance rulemaking; the 

additional uses do not impact the 

previous calculations for drinking water 

exposure estimates. For a discussion of 

the dietary exposure of drinking water 

of tolpyralate, see Unit III.C.2. of the 

July 27, 2017, rulemaking. 

3. From non-dietary exposure. There 

are no residential (non-occupational) 

exposures associated with the new 

proposed uses and tolpyralate is not 

registered for any use patterns that 

would result in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

The Agency is required to consider the 

cumulative risks of pesticides sharing a 

common mechanism of toxicity. The 

Agency has determined that the HPPD 

inhibitors, which include tolpyralate, 

share a common mechanism of toxicity 

as discussed in the HPPD Inhibiting 

Herbicides: State of the Science paper 

(K. Yozzo and M. Perron, 09/18/2020, 

TXR No. 0058084, D439367). As 

explained in that document, the 

members of this group share the ability 

to bind to and inhibit the HPPD enzyme, 

resulting in elevated systemic tyrosine 

levels and common apical outcomes 

that are mediated by tyrosine, including 

ocular and developmental effects. In 

2021, after establishing a common 

mechanism grouping for the HPPD 

inhibitors, the Agency conducted the PHydroxyphenyl-Pyruvate Dioxygenase 

(HPPD) Inhibitors Cumulative Risk 

Assessment: Benzobicyclon, 

Bicyclopyrone, Isoxaflutole, Mesotrione, 

Pyrasulfotole, Tembotrione, Tolpyralate, 

and Topramezone (J. Godshall, 06/30/ 

2021, D462487) and concluded that 

cumulative exposures to HPPD 

inhibitors (based on proposed and 

registered pesticidal uses at the time the 

assessment was conducted) did not 

present risks of concern. 

An updated cumulative risk 

assessment (CRA) was not performed for 

the proposed new uses of tolpyralate on 

barley and wheat. The tolerances for 

tolpyralate being established in this 

rulemaking for barley, wheat and 

livestock commoditiest, do not impact 

the screening-level CRA based on low 

recommended tolerance levels relative 

to other HPPD inhibitors in the 

Cumulative Assessment Group (CAG). 

Therefore, an updated CRA is not 

necessary for tolpyralate. 

D. Safety Factor for Infants and 

Children 

EPA continues to conclude that there 

are reliable data to support the 

reduction of the Food Quality Protection 

Act (FQPA) safety factor from 10X to 

1X. See Unit III.D of July 27, 2017, 

rulemaking (82 FR 34877) (FRL–9964– 

15) for a discussion of the Agency’s 

rationale for that determination. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute population 

adjusted dose (aPAD) and chronic PAD 

(cPAD). For linear cancer risks, EPA 

calculates the lifetime probability of 

acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate margin 

of exposure (MOE) exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

tolpyralate will occupy 1.0% of the 

aPAD for females 13 to 49 years old, the 

only population relevant for assessing 

acute exposure to tolpyralate. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to tolpyralate 

from food and water will utilize 2.7% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. There are no 

residential uses for tolpyralate. 

3. Short-term risk. A short-term 

adverse effect was identified; however, 

tolpyralate is not registered for any use 

patterns that would result in short-term 

residential exposure. Short-term risk is 

assessed based on short-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess short-term risk), 

no further assessment of short-term risk 

is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for 

tolpyralate. 

4. Intermediate-term risk. An 

intermediate-term adverse effect was 

identified; however, tolpyralate is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

tolpyralate. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A., the chronic dietary exposure 

assessment is protective for potential 

cancer risk. Therefore, EPA does not 

expect exposure to tolpyralate to pose 

aggregate cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to tolpyralate 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(ISK Biosciences Method JSM0433) for 

plant commodities is a LC–MS/MS 

method that can be used to analyze for 

parent tolpyralate. It has been 

developed and independently validated 

and is adequate to enforce the 

established and proposed tolerances. 

For all matrices and analytes, the level 

of quantification (LOQ), defined as the 

lowest level of method validation 

(LLMV) or lowest spiking level where 

acceptable precision and accuracy data 

were obtained, was determined to be 

0.01 ppm. The limit of detection (LOD) 

was 0.004 ppm. 

Adequate enforcement methodology 

(ISK Biosciences Method D96518) for 

livestock commodities is a LC–MS/MS 

method that can be used to analyze for 

parent tolpyralate and the metabolite 

MT–2153 concurrently. It has been 

developed and independently validated 

and is adequate to enforce the 

established and proposed tolerances. 

For all matrices and analytes, the level 

of quantification (LOQ), defined as the 

lowest level of method validation 

(LLMV) or lowest spiking level where 

acceptable precision and accuracy data 

were obtained, was determined to be 

0.01 ppm. The limit of detection (LOD) 

was 0.003 ppm. 


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The methods 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). 

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 a MRL 

for tolpyralate. 

C. Revisions to Petitioned-For 

Tolerances 

The tolerances being established for 

the proposed new uses of tolpyralate are 

based on values obtained using the 

OECD MRL calculator and submitted 

residue data. The tolerances being 

established are consistent with the 

values in the petition, with the 

exception of barley, grain, which is 

established at 0.01 ppm instead of 0.015 

ppm to correct a typo that was 

published in the Federal Register of 

May 20, 2022 (87 FR 30855) (FRL–9410– 

13–OCSPP). EPA is establishing 

tolerances for residues in livestock 

commodities due to an update in the 

dietary burden calculation. 

As part of the review of the petition, 

a revised Maximum Reasonable Dietary 

Burden (MRDB), including the potential 

contributions of barley and wheat were 

evaluated. As indicated in EPA’s 

regulation, 40 CFR 180.6, when finite 

pesticide chemical residues will be 

found in livestock commodities as a 

result of the use of a pesticide in or on 

animal feedstuffs, EPA will establish 

tolerances in livestock commodities to 

accommodate those residues. The 

additional uses of tolpyralate on barley 

and wheat will result in an increase in 

the MRDB for beef and dairy cattle and 

consequently necessitate increasing 

tolerances for tolpyralate residues in 

ruminant commodities. New tolerance 

levels in ruminant commodities were 

determined using the Langmuir model, 

and based on that analysis, EPA is 

establishing tolerances for residues in or 

on cattle, byproducts at 0.02 ppm; goat, 

byproducts at 0.02 ppm; horse, 

byproducts at 0.02 ppm and sheep, 

byproducts at 0.02 ppm. 

V. Conclusion 

Therefore, tolerances for plant 

commodities are established for 

residues of tolpyralate, 1-[[1-ethyl-4-[3- 

(2-methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate in or on 

barley, grain at 0.01 ppm; barley, hay at 

0.2 ppm; barley, straw at 0.08 ppm 

wheat, grain at 0.01 ppm; wheat, forage 

at 0.02 ppm; wheat, hay at 0.05 ppm 

and; wheat, straw at 0.03 ppm. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only tolpyralate, 1-[[1-ethyl4-[3-(2-methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate, in or on 

the commodity. 

In addition, tolerances for livestock 

commodities are established for 

residues of tolpyralate, 1-[[1-ethyl-4-[3- 

(2-methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate and 

metabolite MT–2153 [1-ethyl-5- 

hydroxy-1H-pyrazol-4-yl-3-(2- 

methoxyethoxy)-4-mesyl-2- 

methylphenyl ketone], in or on cattle, 

byproducts at 0.02 ppm; goat, 

byproducts at 0.02 ppm; horse, 

byproducts at 0.02 ppm and sheep, 

byproducts at 0.02 ppm. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

tolpyralate, 1-[[1-ethyl-4-[3-(2- 

methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate and 

metabolite MT–2153 [1-ethyl-5- 

hydroxy-1H-pyrazol-4-yl-3-(2- 

methoxyethoxy)-4-mesyl-2- 

methylphenyl ketone], in or on the 

commodity. 

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 


khammond on DSKJM1Z7X2PROD with RULES
82786 Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Rules and Regulations 

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: November 16, 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. Amend § 180.696 by: 

■ a. Designating the introductory text of 

paragraph (a) as paragraph (a)(1) and the 

table in newly designated paragraph 

(a)(1) as table 1 to paragraph (a)(1). 

■ b. Adding, in alphabetical order, in 

newly designated table 1 to paragraph 

(a)(1), the entries ‘‘Barley, grain’’; 

‘‘Barley, hay’’; ‘‘Barley, straw’’; ‘‘Wheat, 

forage’’; ‘‘Wheat, grain’’; ‘‘Wheat, hay’’; 

and ‘‘Wheat, straw’’. 

■ c. Add paragraph (a)(2). 

The additions read as follows: 

§ 180.696 Tolpyralate; tolerances for 

residues. 

(a) * * * 

(1) * * * 

TABLE 1 TO PARAGRAPH (a)(1) 

Commodity Parts per 

million 

Barley, grain ............................... 0.01 

Barley, hay .................................. 0.2 

Barley, straw ............................... 0.08 

* * * * * 

Wheat, forage ............................. 0.02 

Wheat, grain ............................... 0.01 

Wheat, hay ................................. 0.05 

Wheat, straw ............................... 0.03 

(2) Tolerances are established for 

residues of tolpyralate, 1-[[1-ethyl-4-[3- 

(2-methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate and 

metabolite MT–2153 [1-ethyl-5- 

hydroxy-1H-pyrazol-4-yl-3-(2- 

methoxyethoxy)-4-mesyl-2- 

methylphenyl ketone], in or on the 

livestock commodities in table 2 to this 

paragraph (a)(2). Compliance with the 

tolerance levels specified in table 2 to 

this paragraph (a)(2) is to be determined 

by measuring tolpyralate, 1-[[1-ethyl-4- 

[3-(2-methoxyethoxy)-2-methyl-4- 

(methylsulfonyl)benzoyl]-1H-pyrazol-5- 

yl]oxy]ethyl methyl carbonate and 

metabolite MT–2153 [1-ethyl-5- 

hydroxy-1H-pyrazol-4-yl-3-(2- 

methoxyethoxy)-4-mesyl-2- 

methylphenyl ketone], in or on the 

commodity. 

TABLE 2 TO PARAGRAPH (a)(2) 

Commodity Parts per 

million 

Cattle, byproducts ....................... 0.02 

Goat, byproducts ........................ 0.02 

Horse, byproducts ...................... 0.02 

Sheep, byproducts ...................... 0.02 

* * * * * 

[FR Doc. 2023–25871 Filed 11–24–23; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 402 

Office of the Secretary 

45 CFR Part 102 

[CMS–6061–CN] 

RIN 0938–AT86 

Medicare Program; Medicare 

Secondary Payer and Certain Civil 

Money Penalties; Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Final rule; correction. 

SUMMARY: This document corrects 

technical errors in the final rule that 

appeared in the October 11, 2023 

Federal Register titled ‘‘Medicare 

Program; Medicare Secondary Payer and 

Certain Civil Money Penalties’’. 

DATES: Effective date: This correcting 

document is effective December 11, 

2023. 

FOR FURTHER INFORMATION CONTACT: 

Brian Broznowicz, (410) 786–3349. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This correcting document identifies 

and corrects errors in FR Doc. 2023– 

22282 of October 11, 2023 (88 FR 

70363). The provisions in this 

correction document are effective as if 

they had been included in the document 

published October 11, 2023. 

Accordingly, the corrections are 

effective December 11, 2023. 

II. Summary of Errors 

On page 70363, we inadvertently 

omitted a part of the header. 

On page 70372, we made an error in 

the Words of Issuance. 

On page 70373, we made technical 

errors in the amendatory instructions as 

well as the headings, entries, and table 

notes in the civil monetary penalty 

adjustment table at 45 CFR 102.3. 

III. Waiver of Proposed Rulemaking 

and Delay in Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule in accordance with 5 

U.S.C. 553(b) of the Administrative 

Procedure Act (APA). The notice of 

proposed rulemaking includes a 

reference to the legal authority under 

which the rule is proposed, and the 

terms and substances of the proposed 

rule or a description of the subjects and 

issues involved. This procedure can be 

waived, however, if an agency finds 

good cause that a notice-and-comment 

procedure is impracticable, 

unnecessary, or contrary to the public 

interest and incorporates a statement of 

the finding and its reasons in the rule 

issued. 

We believe that this final rule 

correcting document does not constitute 

a rule that would be subject to the 

notice and comment or delayed effective 

date requirements. This document 

merely corrects typographical and 

technical errors in the final rule, and it 

does not make substantive changes to 

the policies or the implementing 

regulations that were adopted in the 

final rule. As a result, this final rule 

correcting document is intended to 

ensure that the information in the final 

rule accurately reflects the policies and 

regulatory amendments adopted in that 

document. 

In addition, even if this were a rule to 

which the notice and comment 

procedures and delayed effective date 

requirements applied, we find that there 

is good cause to waive such 

requirements. Undertaking further 

notice and comment procedures to 

incorporate the minor corrections in this 

document into the final rule or delaying 


khammond on DSKJM1Z7X2PROD with RULES