62464 Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 

64300). That final rule was published 

under Regulatory Identification Number 

(RIN) 0651–AD55. As part of that final 

rule, the USPTO set a period of three 

months for responses to postregistration office actions and provided 

the option to request a single threemonth extension of the deadline, subject 

to the payment of a fee. The final rule 

stated that the post-registration changes 

would go into effect on December 1, 

2022. 

On October 13, 2022, the USPTO 

published in the Federal Register a final 

rule delaying the effective date for 

responses and extensions in the 

examination of post-registration filings 

from December 1, 2022, until October 7, 

2023. See Changes To Implement 

Provisions of the Trademark 

Modernization Act of 2020; Delay of 

Effective Date and Correction (87 FR 

62032). 

Under this final rule, the USPTO is 

further delaying the provisions that 

address post-registration responses and 

extensions. The USPTO anticipates that 

these provisions will go into effect 

sometime in the spring or early summer 

of 2024. 

The USPTO is currently upgrading its 

internal and public databases, search 

system, and internal examination 

systems. These major updates will 

provide far-reaching efficiencies for 

both customers and staff. The 

implementation of the regulatory 

changes to post-registration responses 

and extensions cannot be completed 

until the migration to the new systems 

is complete. The USPTO anticipates that 

this will occur in the spring or early 

summer of 2024. The delay will also 

provide the public with additional time 

to prepare for the new response periods. 

The USPTO will publish a final rule in 

the Federal Register providing the new 

effective date of the provisions 

addressing post-registration responses 

and extensions once it has been 

determined. 

In the final rule published at 86 FR 

64300, the cross-reference in 37 CFR 

7.40(b) to ‘‘§ 7.39(b) and (c)’’ is 

incorrect. The reference should have 

been to ‘‘§ 7.39(a) and (b).’’ When the 

USPTO publishes a final rule providing 

the new effective date of the provisions 

addressing post-registration responses 

and extensions, that section will also be 

corrected. 

Rulemaking Requirements 

A. Administrative Procedure Act: The 

changes in this rulemaking involve rules 

of agency practice and procedure, and/ 

or interpretive rules. See Perez v. Mortg. 

Bankers Ass’n, 135 S. Ct. 1199, 1204 

(2015) (Interpretive rules ‘‘advise the 

public of the agency’s construction of 

the statutes and rules which it 

administers.’’ (citation and internal 

quotation marks omitted)); Nat’l Org. of 

Veterans’ Advocates v. Sec’y of Veterans 

Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 

2001) (Rule that clarifies interpretation 

of a statute is interpretive.); Bachow 

Commc’ns Inc. v. FCC, 237 F.3d 683, 

690 (D.C. Cir. 2001) (Rules governing an 

application process are procedural 

under the Administrative Procedure 

Act.); Inova Alexandria Hosp. v. 

Shalala, 244 F.3d 342, 350 (4th Cir. 

2001) (Rules for handling appeals were 

procedural where they did not change 

the substantive standard for reviewing 

claims.). 

Accordingly, prior notice and an 

opportunity for public comment for the 

changes in this rulemaking are not 

required pursuant to 5 U.S.C. 553(b) or 

(c), or any other law. See Perez, 135 S. 

Ct. at 1206 (Notice-and-comment 

procedures are required neither when 

an agency ‘‘issue[s] an initial 

interpretive rule’’ nor ‘‘when it amends 

or repeals that interpretive rule.’’); 

Cooper Techs. Co. v. Dudas, 536 F.3d 

1330, 1336–37 (Fed. Cir. 2008) (stating 

that 5 U.S.C. 553, and thus 35 U.S.C. 

2(b)(2)(B), does not require notice-andcomment rulemaking for ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice’’ (quoting 5 U.S.C. 

553(b)(A))). 

Moreover, the Under Secretary of 

Commerce for Intellectual Property and 

Director of the USPTO, pursuant to the 

authority at 5 U.S.C. 553(b)(B), finds 

good cause to adopt the change to the 

effective date without prior notice and 

an opportunity for public comment, as 

such procedures would be impracticable 

and contrary to the public interest. The 

USPTO is currently upgrading its 

internal and public databases, search 

system, and internal examination 

systems. These major updates will 

provide far-reaching efficiencies for 

both customers and staff. The 

implementation of the regulatory 

changes to post-registration responses 

and extensions cannot be completed 

until the migration to the new systems 

is complete. The USPTO anticipates that 

this will occur in the spring or early 

summer of 2024. The delay will also 

provide the public with additional time 

to prepare for the new response periods. 

Delay of this provision to provide prior 

notice and comment procedures is also 

impracticable because it would allow 

the provisions to go into effect before 

the agency is ready to implement the 

regulatory changes regarding postregistration responses and extensions. 

The Director also finds good cause 

under 5 U.S.C. 553(d)(3) to waive the 

30-day delay in effectiveness of this 

rule. Immediate implementation of the 

delay in the effective date is in the 

public interest because it will provide 

the agency the ability to effectively 

manage and utilize the resources needed 

to complete all these initiatives. The 

delay will also provide the public with 

additional time to prepare for the new 

response periods. Delay of this rule to 

provide for the 30-day delay in 

effectiveness is impracticable because it 

would allow the provisions to go into 

effect before the agency is ready to 

implement the regulatory changes 

regarding post-registration responses 

and extensions. 

B. Regulatory Flexibility Act: As prior 

notice and an opportunity for public 

comment are not required pursuant to 5 

U.S.C. 553 or any other law, neither a 

Regulatory Flexibility Act analysis nor a 

certification under the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) is 

required. See 5 U.S.C. 603. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rule has 

been determined to be not significant for 

purposes of Executive Order 12866 

(Sept. 30, 1993). 

Katherine K. Vidal, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2023–19669 Filed 9–11–23; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0065; FRL–8786–01– 

OCSPP] 

Fluazaindolizine; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

fluazaindolizine in or on multiple 

commodities that are identified and 

discussed later in this document. E.I. du 

Pont de Nemours & Company 

(‘‘DuPont’’, now Corteva) requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 12, 2023. Objections and 

requests for hearings must be received 

on or before November 13, 2023, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 


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Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 62465 

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–2020–0065, is 

available online at http://

www.regulations.gov or in-person 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 the OPP 

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

status information on EPA/DC services 

and docket access, visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Charles Smith, Director, Registration 

Division (7505T), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (202) 566–1030; 

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 

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, 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–2020–0065 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 

November 13, 2023. 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– 

2020–0065, 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. 

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 April 15, 

2020 (85 FR 20910) (FRL–10006–54), 

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 9F8795) by E.I. du 

Pont de Nemours & Company 

(‘‘DuPont’’), Chestnut Run Plaza, 974 

Centre Road, Wilmington, DE 19805. 

The petition requested to establish 

tolerances in the 40 CFR part 180 for 

residues of the nematicide, 

fluazaindolizine, by measuring the sum 

of post-hydrolysis residues IN–A5760, 

IN–F4106, IN–QEK31, IN–QZY47, IN– 

TMQ01, IN–UJV12, and IN–UNS90 

(expressed in parent equivalents) in or 

on Carrots at 15 parts per million (ppm); 

Cucurbit Vegetables (Crop Group 9) at 3 

ppm; Fruiting Vegetables (Crop Group 

8–10) at 3 ppm; Sun dried tomatoes at 

30 ppm; Tomato paste at 15 ppm; 

Tomato puree at 6 ppm; Tomato wet 

pomace at 6 ppm; Tuberous and Corm 

Vegetables (Crop Subgroup 1C) at 9 

ppm; Dried potato at 30 ppm; Potato 

process waste at 40 ppm; and 

establishing tolerances for residues of 

fluazaindolizine plus its metabolites IN– 

QEK and IN–F4106 (expressed in parent 

equivalents), in the animal 

commodities: Cattle, whole milk at 0.5 

ppm; Cattle, fat at 0.09 ppm; Cattle, 

muscle at 0.02 ppm; Cattle, liver at 0.2 

ppm; Cattle, kidney at 0.5 ppm; Goat, 

whole milk at 0.5 ppm; Goat, fat at 0.09 

ppm; Goat, muscle at 0.02 ppm; Goat, 

liver at 0.2 ppm; Goat, kidney at 0.5 

ppm; Hog, whole milk at 0.5 ppm; Hog, 

fat at 0.09 ppm; Hog, muscle at 0.02 

ppm; Hog, liver at 0.2 ppm; Hog, kidney 

at 0.5 ppm; Horse, whole milk at 0.5 

ppm; Horse, fat at 0.09 ppm; Horse, 

muscle at 0.02 ppm; Horse, liver at 0.2 

ppm; Horse, kidney at 0.5 ppm; Sheep, 

whole milk at 0.5 ppm; Sheep, fat at 

0.09 ppm; Sheep, muscle at 0.02 ppm; 

Sheep, liver at 0.2 ppm; Sheep, kidney 

at 0.5 ppm. In addition, DuPont 

proposed pursuant to section 408(d) of 

the Federal Food, Drug and Cosmetic 

Act, 21 U.S.C. 346a(d), to amend 40 CFR 

part 180 to establish indirect or 

inadvertent tolerances for residues of 

fluazaindolizine, by measuring the sum 

of post-hydrolysis residues IN–A5760, 

IN–F4106, IN–QEK31, IN–QZY47, IN– 

TMQ01, IN–UJV12, and IN–UNS90 

(expressed in parent equivalents) in or 

on the following commodities: Brassica 

Head and Stem Vegetables (Crop Group 

5–16) at 0.5 ppm; Bulb Vegetables (Crop 

Group 3–07) at 3 ppm; Cereal Grains 

(Crop Group 15) at 3 ppm; Corn milled 

by-products at 6 ppm; Foliage of 

Legume Vegetables (Crop Group 7), 

Vines at 8 ppm; Foliage of Legume 

Vegetables (Crop Group 7), Forage and 

Straw at 5 ppm; Foliage of Legume 

Vegetables (Crop Group 7), Hay at 40 

ppm; Forage, Fodder and Straw of 

Cereal Grains (Crop Group 16), Fodder 

at 4 ppm; Forage, Fodder and Straw of 

Cereal Grains (Crop Group 16), Forage at 

8 ppm; Forage, Fodder and Straw of 

Cereal Grains (Crop Group 16), Hay at 

15 ppm; Forage, Fodder and Straw of 

Cereal Grains (Crop Group 16), Straw at 

10 ppm; Fruiting Vegetables (Crop 

Group 8–10) at 1 ppm; Grain, Aspirated 

Fractions at 0.5 ppm; Grass, Forage, 

Fodder and Hay (Crop Group 17), 

Forage at 8 ppm; Grass, Forage, Fodder 

and Hay (Crop Group 17), Hay at 15 


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62466 Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 

ppm; Leafy Vegetables (Crop Group 4– 

16) at 9 ppm; Leaves of Root and Tuber 

(Crop Group 2) at 15 ppm; Legume 

Vegetables (Crop Group 6), Mature Seed 

at 9 ppm; Legume Vegetables (Crop 

Group 6), Immature Seed and Pod at 3 

ppm; Low Growing Berry (Crop 

Subgroup 13–07G) at 0.6 ppm; Nongrass 

Animal Feeds (Forage, Fodder, Straw 

and Hay) (Crop Group 18), Fodder at 5 

ppm; Nongrass Animal Feeds (Forage, 

Fodder, Straw and Hay) (Crop Group 

18), Forage at 8 ppm; Nongrass Animal 

Feeds (Forage, Fodder, Straw and Hay) 

(Crop Group 18), Hay at 15 ppm; 

Nongrass Animal Feeds (Forage, Fodder, 

Straw and Hay) (Crop Group 18), Straw 

at 10 ppm; Oilseed (Crop Group 20) at 

9 ppm; Oilseed Crop Group 20), Forage 

and Straw at 5 ppm; Root Vegetables 

(Crop Subgroup 1A) at 7 ppm; Root 

Vegetables Except Sugar Beet (Crop 

Subgroup 1B) at 7 ppm; Soybean Hulls 

at 20 ppm; Soybean Meal at 20 ppm; 

Stalk, Stem and Leaf Petiole Vegetables 

(Crop Group 22) at 3 ppm; Strawberry, 

Dehydrated at 3 ppm; and Wheat Milled 

By-Products at 6 ppm. That document 

referenced a summary of the petition 

prepared by DuPont (now Corteva), the 

registrant, which is available in the 

docket, http://www.regulations.gov. A 

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

In the Federal Register of June 28, 

2021 (86 FR 33922) (FRL–10025–08), 

EPA issued a document pursuant to 

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

346a(d)(3), amending the previous NOF 

dated April 15, 2020 by announcing 

commodities that were not included in 

the previous NOF. E.I. du Pont de 

Nemours & Company (‘‘DuPont’’), 

Chestnut Run Plaza, 974 Centre Road, 

Wilmington, DE 19805, requests to 

establish a tolerance in 40 CFR part 180 

for residues of the nematicide, 

fluazaindolizine in or on Poultry, fat at 

0.01 ppm; Poultry, meat at 0.01 ppm; 

Poultry, meat byproducts at 0.01 ppm; 

and Eggs at 0.01 ppm. In addition, 

DuPont is proposing pursuant to section 

408(d) of the Federal Food, Drug and 

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

amend 40 CFR part 180 to establish 

indirect or inadvertent tolerances for 

residues of fluazaindolizine, including 

its metabolites and their conjugates, 

expressed as the stoichiometric 

equivalent of fluazaindolizine, in or on 

the following commodity: Grass, forage, 

fodder and hay, group 17, straw at 0.15 

ppm. 

Based upon review of the data 

supporting the petition, EPA is 

establishing tolerances at different 

levels than petitioned-for and has 

determined that tolerances for certain 

petitioned-for commodities are not 

necessary. The Agency has also 

modified all of the commodity 

definitions used and updated certain 

crop groups. The reasons for these 

changes are explained in Unit IV.D. 

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 fluazaindolizine 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluazaindolizine 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The main target organs of 

fluazaindolizine are the urinary tract 

(rat and mouse), liver and/or gallbladder 

(mouse and dog), and hematopoietic 

system (dog). In the mouse 

carcinogenicity study, the incidence and 

severity of amyloidosis in specific 

tissues was increased in both sexes. 

There was no evidence of increased in 

utero susceptibility in the rat or rabbit 

developmental studies; however, 

increased quantitative susceptibility 

was observed in the rat reproductive 

toxicity study, based on urinary tract 

histopathological lesions in F2

generation weanlings at a lower dose 

than doses resulting in toxicity in 

parental animals. Fluazaindolizine is 

classified as ‘‘Not likely to be 

carcinogenic to humans’’ based on lack 

of evidence of treatment-related 

increases in tumors in adequately 

conducted carcinogenicity studies in 

rats and mice. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluazaindolizine as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Fluazaindolizine: Human Health 

Risk Assessment for the New Active 

Ingredient’’ (hereinafter 

‘‘Fluazaindolizine Human Health Risk 

Assessment’’) on pages 54–82 in docket 

ID number EPA–HQ–OPP–2020–0065. 

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. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticide-science-andassessing-pesticide-risks. 

A summary of the toxicological 

endpoints for fluazaindolizine used for 


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human risk assessment can be found in 

the Fluazaindolizine Human Health 

Risk Assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluazaindolizine, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from fluazaindolizine 

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. 

No such effects were identified in the 

toxicological studies for 

fluazaindolizine; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the 2003–2008 

food consumption data from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA used field-trial based 

anticipated residue calculations for all 

crops and assumed 100 percent crop 

treated (PCT) for all crops. 

iii. Cancer. Based on the data 

summarized in the Fluazaindolizine 

Human Health Risk Assessment, EPA 

has concluded that fluazaindolizine 

does not pose a cancer risk to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluazaindolizine in drinking water. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/modelspesticide-risk-assessment. 

Separate estimated drinking water 

concentrations (EDWCs) were calculated 

for the metabolite IN–VM862 and a 

combination of fluazaindolizine and the 

other metabolites IN–QEK31, IN– 

REG72, IN–F4106, and IN–A5760, due 

to greater toxicological potency of IN– 

VM862. This combination is referred to 

as the Fluazaindolizine Drinking Water 

Total Residue Fraction (FDWTRF). 

Based on the Pesticide Water Calculator 

(PWC), EPA used an EDWC of 990 ppb 

for FDWTRF and 1,300 ppb for IN– 

VM862 in the chronic dietary risk 

assessment. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fluazaindolizine is not registered for 

any specific use patterns that would 

result in residential exposure. 

4. 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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fluazaindolizine and any other 

substances and fluazaindolizine does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

fluazaindolizine has 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/pesticide-scienceand-assessing-pesticide-risks/ 

cumulative-assessment-risk-pesticides. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

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 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. 

2. Prenatal and postnatal sensitivity. 

Increased quantitative susceptibility 

was observed for fluazaindolizine in the 

rat 2-generation reproductive study. An 

increased incidence and severity of 

urinary tract histopathology was 

observed in male and female F2

weanlings at a lower dose than in P and 

F1 adult animals. No susceptibility was 

observed in the rat or rabbit 

developmental toxicity studies. The 

metabolite IN–F4106 showed increased 

prenatal susceptibility (decreased fetal 

body weight) in the rat developmental 

toxicity study. However, concern for 

prenatal susceptibility is low for both 

parent and metabolite because clear 

NOAELs and LOAELs were identified 

for fetal toxicity and endpoints selected 

for risk assessment are protective of 

these findings. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

fluazaindolizine is complete. 

ii. There is no indication that 

fluazaindolizine is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors to account 

for neurotoxicity. 

iii. Increased quantitative 

susceptibility was observed for 

fluazaindolizine in the rat twogeneration reproductive study. 

However, as noted above, concern for 

prenatal susceptibility is low for both 

parent and metabolite because clear 

NOAELs and LOAELs were identified 

for fetal toxicity and endpoints selected 

for risk assessment are protective of 

these findings. 

iv. There are no residual uncertainties 

with regard to the exposure assessment 


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62468 Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 

for fluazaindolizine. An acute dietary 

endpoint was not identified for any 

population and therefore an assessment 

of acute dietary risk was not performed. 

For chronic dietary exposure, risk 

estimates were partially refined by using 

average field trial residues and 

empirical processing factors. 

Conservative, upper bound estimates 

were used to assess exposure to 

fluazaindolizine and its residues of 

concern through drinking water. Based 

on these considerations, exposure from 

food and drinking water will not be 

underestimated. No residential use 

patterns are proposed at this time. 

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 PAD (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 MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, fluazaindolizine is 

not expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to 

fluazaindolizine from food and water 

will utilize 82% of the cPAD for all 

infants less than one year old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for fluazaindolizine. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

risk takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, fluazaindolizine is 

not registered for any use patterns that 

would result in either short- or 

intermediate-term residential exposure. 

Because there is no short- or 

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 short- or intermediate-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for 

fluazaindolizine. 

4. Aggregate cancer risk for U.S. 

population. Fluazaindolizine is not 

expected to pose a cancer risk to 

humans. 

5. 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 

fluazaindolizine residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Crops: The petitioner submitted 

method validation, supplemental 

method validation, and radiovalidation 

data for Method No. DuPont-33861 (Rev. 

3). This method successfully quantitates 

two ion transitions for fluazaindolizine 

via liquid chromatography with tandem 

mass spectrometry (LC–MS/MS). 

Method No. DuPont-33861 (Rev. 3) 

meets HED’s criteria for enforcement 

analytical methods. 

Livestock: The petitioner submitted 

method validation and an independent 

laboratory validation (ILV) for Method 

No. DuPont-39226 (Rev. 1). This method 

successfully quantitates two ion 

transitions for fluazaindolizine via LC– 

MS/MS. Method No. DuPont-39226 

(Rev. 1) meets HED’s criteria for 

enforcement analytical methods. 

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 has not established any 

MRLs for fluazaindolizine. 

C. Response to Comments 

One comment was received on the 

April 15, 2020, notice of filing that 

stated in part ‘‘this application should 

be denied. stop using this chemical.’’ 

Although the Agency recognizes that 

some individuals believe that pesticides 

should be banned on agricultural crops, 

the existing legal framework provided 

by section 408 of the FFDCA authorizes 

EPA to establish tolerances when it 

determines that the tolerance is safe. 

Upon consideration of the validity, 

completeness, and reliability of the 

available data as well as other factors 

the FFDCA requires EPA to consider, 

EPA has determined that the 

fluazaindolizine tolerances are safe. The 

commenter has provided no information 

indicating that a safety determination 

cannot be supported. 

D. Revisions to Petitioned-For 

Tolerances 

All tolerance values being established 

in this rulemaking vary slightly from 

what the petitioner requested. This is 

primarily because the petitioner 

proposed various metabolites as 

residues of concern for crop and 

livestock commodities, whereas EPA 

has concluded that the only residue 

needed to measure compliance with the 

tolerance is fluazaindolizine. All raw 

agricultural commodity (RAC) crop 

tolerances were calculated according to 

the Organization for Economic 

Cooperation and Development (OECD) 

tolerance calculation procedure. 

Tolerances in/on processed 

commodities were calculated by 

multiplying average processing factors 

by the mean or highest average field 

trial (HAFT) value for blended and nonblended commodities, respectively. 

Commodity definitions are used in 

accordance with EPA’s correct 

commodity definition guideline. 

EPA is not establishing the requested 

primary crop tolerances for dried potato, 

potato process waste, tomato paste, and 

tomato puree, or the requested 

rotational crop tolerances for aspirated 

grain fractions (AGF), corn milled 

byproducts, soybean hulls, soybean 

meal, dehydrated strawberries, and 

wheat milled byproducts. Residues of 

parent fluazaindolizine in these 

processed commodities are not expected 

to concentrate to levels above the 

associated tolerances for the raw 

agricultural commodities, so processed 

commodity tolerances are not necessary. 

The Agency is not establishing the 

requested primary crop tolerance on 

tomato wet pomace, as this processed 

fraction is not considered a significant 

feed item and a tolerance is not 

necessary. 

The Agency is not establishing the 

requested rotational crop tolerance for 

fruiting vegetable crop group 8–10, as 

residues of parent fluazaindolizine are 


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Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 62469 

expected to be below the limit of 

quantitation (LOQ) in fruiting vegetables 

planted as rotational crops and therefore 

the primary crop tolerance is adequate. 

The Agency is not establishing the 

requested rotational crop tolerances for 

the straw of commodities in crop groups 

7 and 20, as these are not identified as 

significant feed items and tolerances are 

not needed. Similarly, EPA is not 

establishing the requested rotational 

crop tolerance for the fodder of crop 

group 18, as this is not a recognized 

commodity for the crop group. 

Finally, EPA is establishing rotational 

crop tolerances for crop groups 6–22, 7– 

22, 15–22 and 16–22 rather than the 

requested rotational crop tolerances on 

crop groups 6, 7, 15 and 16. EPA 

proposed changes to these four crop 

groups on January 10, 2022 (87 FR 1091) 

(FRL–5031–12–OCSPP) and finalized 

the revised crop groups as 6–22, 7–22, 

15–22 and 16–22 on September 21, 2022 

(87 FR 57627) (FRL–5031–13–OCSPP). 

EPA regulations state ‘‘Once a revised 

crop group is established, EPA will no 

longer establish tolerances under the 

pre-existing crop group.’’ 40 CFR 

180.40(j)(4). EPA has determined that 

the residue data support rotational crop 

tolerances for crop groups 6–22, 7–22, 

15–22 and 16–22 based on EPA’s 

practice for evaluating residue data for 

rotational crop tolerances and because 

there were no changes to major crops in 

groups 6–22, 7–22, 15–22 and 16–22. No 

food commodities are included in the 

revised crop groups that were not 

already accounted for in the initial 

dietary exposure assessment. Therefore, 

an updated dietary assessment is not 

needed, and the exposure and risk 

assessments do not change as a result of 

the crop group updates. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluazaindolizine, 

including its metabolites and degradates 

in or on carrot at 0.05 ppm; cattle, fat 

at 0.01 ppm; cattle, meat at 0.01 ppm; 

cattle, meat byproducts at 0.01 ppm; egg 

at 0.01 ppm; goat, fat at 0.01 ppm; goat, 

meat at 0.01 ppm; goat, meat byproducts 

at 0.01 ppm; hog, fat at 0.01 ppm; hog, 

meat at 0.01 ppm; hog, meat byproducts 

at 0.01 ppm; horse, fat at 0.01 ppm; 

horse, meat at 0.01 ppm; horse, meat 

byproducts at 0.01 ppm; milk at 0.01 

ppm; poultry, fat at 0.01 ppm; poultry 

meat at 0.01 ppm; poultry, meat 

byproducts at 0.01 ppm; sheep, fat at 

0.01 ppm; sheep, meat at 0.01 ppm; 

sheep, meat byproducts at 0.01 ppm; 

tomato, dried at 0.4 ppm; vegetable, 

cucurbit, group 9 at 0.15 ppm; 

vegetable, fruiting, group 8–10 at 0.07 

ppm; and vegetable, tuberous and corm, 

subgroup 1C at 0.2 ppm. 

Additionally, tolerances are 

established for inadvertent residues of 

fluazaindolizine, including its 

metabolites and degradates in or on 

animal feed, nongrass, group 18, forage 

at 0.01 ppm; animal feed, nongrass, 

group 18, hay at 0.015 ppm; animal 

feed, nongrass, group 18, straw at 0.15 

ppm; berry, low growing, subgroup 13– 

07G at 0.01 ppm; grain, cereal, forage, 

hay, stover, and straw group 16–22, 

forage at 0.01 ppm; grain, cereal, forage, 

hay, stover, and straw group 16–22, hay 

at 0.015 ppm; grain, cereal, forage, hay, 

stover, and straw group 16–22, stover at 

0.15 ppm; grain, cereal, forage, hay, 

stover, and straw group 16–22, straw at 

0.15 ppm; grain, cereal, group 15–22 at 

0.01 ppm; grass, forage, fodder and hay, 

group 17, forage at 0.01 ppm; grass, 

forage, fodder, and hay, group 17, hay 

at 0.015 ppm; grass, forage, fodder and 

hay, group 17, straw at 0.15 ppm; 

oilseed group 20 at 0.8 ppm; rapeseed, 

forage at 0.09 ppm; stalk, stem, and leaf 

petiole vegetable group 22 at 0.03 ppm; 

vegetable, Brassica, head and stem, 

group 5–16 at 0.015 ppm; vegetable, 

bulb, group 3–07 at 0.03 ppm; vegetable, 

legume, forage and hay, group 7–22, 

forage at 0.09 ppm; vegetable, legume, 

forage and hay, group 7–22, hay at 0.4 

ppm; vegetable, leafy, group 4–16 at 

0.015 ppm; vegetable, leaves of root and 

tuber, group 2 at 0.015 ppm; vegetable, 

legume, group 6–22 at 0.8 ppm; and 

vegetable, root, subgroup 1B at 0.02 

ppm. 

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 tolerances 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 


lotter on DSK11XQN23PROD with RULES1
62470 Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 5, 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. Add § 180.720 to subpart C to read 

as follows: 

§ 180.720 Fluazaindolizine; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

nematicide fluazaindolizine, including 

its metabolites and degradates, in or on 

the commodities to Table 1 of this 

section. Compliance with the tolerance 

levels specified in Table 1 is to be 

determined by measuring only 

fluazaindolizine, 8-chloro-N-[(2-chloro5-methoxyphenyl)sulfonyl]-6- 

(trifluoromethyl)imidazo[1,2-a]pyridine2-carboxamide, in or on the commodity. 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

Carrot ................................................................................................................................................................................................... 0.05 

Cattle, fat ............................................................................................................................................................................................. 0.01 

Cattle, meat ......................................................................................................................................................................................... 0.01 

Cattle, meat byproducts ....................................................................................................................................................................... 0.01 

Egg ....................................................................................................................................................................................................... 0.01 

Goat, fat ............................................................................................................................................................................................... 0.01 

Goat, meat ........................................................................................................................................................................................... 0.01 

Goat, meat byproducts ........................................................................................................................................................................ 0.01 

Hog, fat ................................................................................................................................................................................................ 0.01 

Hog, meat ............................................................................................................................................................................................ 0.01 

Hog, meat byproducts ......................................................................................................................................................................... 0.01 

Horse, fat ............................................................................................................................................................................................. 0.01 

Horse, meat ......................................................................................................................................................................................... 0.01 

Horse, meat byproducts ...................................................................................................................................................................... 0.01 

Milk ....................................................................................................................................................................................................... 0.01 

Poultry, fat ............................................................................................................................................................................................ 0.01 

Poultry, meat ........................................................................................................................................................................................ 0.01 

Poultry, meat byproducts ..................................................................................................................................................................... 0.01 

Sheep, fat ............................................................................................................................................................................................ 0.01 

Sheep, meat ........................................................................................................................................................................................ 0.01 

Sheep, meat byproducts ...................................................................................................................................................................... 0.01 

Tomato, dried ....................................................................................................................................................................................... 0.4 

Vegetable, cucurbit, group 9 ............................................................................................................................................................... 0.15 

Vegetable, fruiting, group 8–10 ........................................................................................................................................................... 0.07 

Vegetable, tuberous and corm, subgroup 1C ..................................................................................................................................... 0.2 

(b)–(c) [Reserved] 

(d) Indirect or inadvertent residues. 

Tolerances are established for residues 

of the nematicide fluazaindolizine, 

including its metabolites and 

degradates, in or on the commodities to 

Table 2 of this section. Compliance with 

the tolerance levels specified in Table 2 

is to be determined by measuring only 

fluazaindolizine, 8-chloro-N-[(2-chloro5-methoxyphenyl)sulfonyl]-6- 

(trifluoromethyl)imidazo[1,2-a]pyridine2-carboxamide, in or on the commodity. 

TABLE 2 TO PARAGRAPH (d) 

Commodity Parts per 

million 

Animal feed, nongrass, group 18, forage ............................................................................................................................................ 0.01 

Animal feed, nongrass, group 18, hay ................................................................................................................................................ 0.015 

Animal feed, nongrass, group 18, straw ............................................................................................................................................. 0.15 

Berry, low growing, subgroup 13–07G ................................................................................................................................................ 0.01 

Grain, cereal, forage, hay, stover, and straw group 16–22, forage .................................................................................................... 0.01 

Grain, cereal, forage, hay, stover, and straw group 16–22, hay ........................................................................................................ 0.015 

Grain, cereal, forage, hay, stover, and straw group 16–22, stover .................................................................................................... 0.15 

Grain, cereal, forage, hay, stover, and straw group 16–22, straw ..................................................................................................... 0.15 

Grain, cereal, group 15–22 .................................................................................................................................................................. 0.01 

Grass, forage, fodder and hay, group 17, forage ............................................................................................................................... 0.01 

Grass, forage, fodder and hay, group 17, hay .................................................................................................................................... 0.015 

Grass, forage, fodder and hay, group 17, straw ................................................................................................................................. 0.15 

Oilseed group 20 ................................................................................................................................................................................. 0.8 

Rapeseed, forage ................................................................................................................................................................................ 0.09 

Stalk, stem and leaf petiole vegetable group 22 ................................................................................................................................. 0.03 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Rules and Regulations 62471 

1Update to Publication for Television Broadcast 

Station DMA Determinations for Cable and Satellite 

Carriage, Report and Order, FCC 22–89, MB Docket 

No. 22–239 (rel. Nov. 18, 2022). 

2 Id. at Appendix B, Final Rules, para. 3. 

3 47 U.S.C. 325(b)(3)(B) (‘‘The regulations 

required by subparagraph (A) shall require that 

television stations, within one year after October 5, 

1992, and every three years thereafter, make an 

election between the right to grant retransmission 

consent under this subsection and the right to 

signal carriage under section 534 of this title.’’). 

4 Id. 

5 5 U.S.C. 553(b)(3)(B) (notice and comment is not 

necessary ‘‘when the agency for good cause finds 

(and incorporates the finding and a brief statement 

of reasons therefor in the rules issued) that notice 

and public procedure thereon are impracticable, 

unnecessary, or contrary to the public interest’’). 

6The Paperwork Reduction Act of 1995, Public 

Law 104–13, 109 Stat. 163 (1995) (codified in 

Chapter 35 of title 44 U.S.C.). 

7The Small Business Paperwork Relief Act of 

2002 (SBPRA), Public Law 107–198, 116 Stat. 729 

(2002) (codified in Chapter 35 of title 44 U.S.C.); see 

44 U.S.C. 3506(c)(4). 

TABLE 2 TO PARAGRAPH (d)—Continued 

Commodity Parts per 

million 

Vegetable, Brassica, head and stem, group 5–16 .............................................................................................................................. 0.015 

Vegetable, bulb, group 3–07 ............................................................................................................................................................... 0.03 

Vegetable, legume, forage and hay, group 7–22, forage ................................................................................................................... 0.09 

Vegetable, legume, forage and hay, group 7–22, hay ........................................................................................................................ 0.4 

Vegetable, leafy, group 4–16 .............................................................................................................................................................. 0.015 

Vegetable, leaves of root and tuber, group 2 ..................................................................................................................................... 0.015 

Vegetable, legume, group 6–22 .......................................................................................................................................................... 0.8 

Vegetable, root, subgroup 1B .............................................................................................................................................................. 0.02 

[FR Doc. 2023–19607 Filed 9–11–23; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 76 

[MB Docket No. 22–239; DA 23–740; FR ID 

169282] 

Update to Publication for Television 

Broadcast Station DMA Determinations 

for Cable and Satellite Carriage 

AGENCY: Federal Communications 

Commission. 

ACTION: Technical amendment. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) conforms a section of its 

rules to the requirements of the 

Communications Act, correcting errors 

that were inadvertently introduced in 

the prior Report and Order, which 

revised Commission rules to use the 

Nielsen Company’s Local TV Station 

Information Report as the successor 

publication to the annual Station Index 

Directory and United States Television 

Household Estimates in determining a 

television station’s designated market 

area for satellite and cable carriage 

under the Commission’s regulations. 

This action makes no substantive 

changes to this regulation. 

DATES: This rule is effective October 12, 

2023. 

FOR FURTHER INFORMATION CONTACT: 

Contact Kenneth Lewis, Kenneth.lewis@

fcc.gov, of the Media Bureau, Policy 

Division, (202) 418–2622. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Media Bureau’s Order, 

in MB Docket No. 22–239; DA 23–740, 

adopted and released on August 21, 

2023. The full text of this document is 

available for download at https://

docs.fcc.gov/public/attachments/DA-23- 

740A1.pdf. To request materials in 

accessible formats (braille, large print, 

computer diskettes, or audio 

recordings), please send an email to 

FCC504@fcc.gov (mailto:FCC504@

fccc.gov) or call the Consumer and 

Government Affairs Bureau at (202) 

418–0530 (VOICE), (202) 418–0432 

(TTY). 

Synopsis 

On November 17, 2022, the 

Commission adopted the Nielsen 

Update Report and Order, MB Docket 

No. 22–239, FCC 22–89, which revised 

Commission rules to use the Nielsen 

Company’s Local TV Station 

Information Report as the successor 

publication to the annual Station Index 

Directory and United States Television 

Household Estimates in determining a 

television station’s designated market 

area for satellite and cable carriage 

under the Commission’s regulations.1

Pursuant to that change, § 76.66(e)(3) of 

the Commission’s rules was revised, and 

the time periods mentioned in that rule 

were brought up to date.2 These updates 

were intended to reflect the upcoming 

statutorily-established carriage election 

cycle periods,3 but contained errors. 

Technical Correction 

Section 47 U.S.C. 325(b)(3)(B) 

requires that television stations, within 

one year after October 5, 1992, and 

every three years thereafter, make an 

election between the right to grant 

retransmission consent under this 

subsection and the right to signal 

carriage under section 534 of this 

title.’’ 4 In this Order, we revise 

§ 76.66(e)(3) of the Commission’s rules 

in order to conform to the requirements 

of the Communications Act. 

Specifically, we correct the references to 

the upcoming carriage election cycles in 

the first and second sentences to 

confirm that the next cycle runs from 

2024–2026 (not 2024–2027), and the 

following cycle runs from 2027–2029 

(not 2028–2030). 

Regulatory Analyses 

Administrative Procedure Act 

We find that notice and comment 

procedures are unnecessary under the 

‘‘good cause’’ exception of the 

Administrative Procedure Act (APA) 

because correcting the references in 

§ 76.66(e)(3) entails no exercise of our 

administrative discretion.5 The dates of 

each carriage cycle are long-established 

as a matter of law, and the reference to 

these dates in § 76.66 is merely as an aid 

to understanding. The rule change does 

not establish additional regulatory 

obligations or burdens on regulated 

entities. Consequently, we find notice 

and comment procedures are 

unnecessary for this action. 

Paperwork Reduction Act Analysis 

This document does not contain any 

new or modified information collection 

requirements subject to the Paperwork 

Reduction Act of 1995 (PRA).6 In 

addition, therefore, it does not contain 

any new or modified information 

collection burden for small business 

concerns with fewer than 25 employees, 

pursuant to the Small Business 

Paperwork Relief Act of 2002.7

Congressional Review Act 

Because this is a technical correction, 

there is no impact under the 

Congressional Review Act, 5 U.S.C. 

804(2). Thus, the Bureau will not send 


lotter on DSK11XQN23PROD with RULES1