105470 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 

477–4727; website: https://spokane

cleanair.org. 

(i) SRCAA Regulation I, Article VI, 

Section 6.17: Standards for Municipal 

Solid Waste Combustors, effective July 

7, 2022. 

(ii) [Reserved] 

§ 62.11881 Identification of sources— 

Spokane Regional Clean Air Agency. 

The plan in § 62.11880 applies to all 

existing large municipal waste 

combustors in the Spokane County, 

Washington, excluding Indian country, 

constructed on or before September 20, 

1994. 

§ 62.11882 Effective date—Spokane 

Regional Clean Air Agency. 

The effective date of the plan 

identified in § 62.11880 and submitted 

on July 18, 2022, by the Spokane 

Regional Clean Air Agency for existing 

large municipal waste combustors is 

January 27, 2025. 

[FR Doc. 2024–30535 Filed 12–26–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2023–0596; FRL–12457–01– 

OCSPP] 

Ethiprole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance (without U.S. registrations) for 

residues of ethiprole in or on sugarcane. 

Bayer CropScience LP requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 27, 2024. Objections and 

requests for hearings must be received 

on or before February 25, 2025 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–2023–0596, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room and the OPP 

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

status information on EPA/DC services, 

docket access, visit https://

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

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 Federal Register Office’s e-CFR site 

at https://www.ecfr.gov/current/title-40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2023–0596 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 

February 25, 2025. 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– 

2023–0596, 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/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, are available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of July 1, 2024 

(89 FR 54398) (FRL–11682–05–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 3F9067) by Bayer 

CropScience LP, 800 N Lindbergh Blvd., 

St. Louis, MO 63167. The petition 

requested to amend 40 CFR part 180 by 

establishing a tolerance for residues of 

ethiprole in or on the raw agricultural 

commodity sugarcane at 0.1 parts per 

million (ppm). 

That document referenced a summary 

of the petition, which is available in the 

docket, http://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 has revised the tolerance 

from 0.1 ppm to 0.07 ppm. The reason 

for this change is 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 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 105471 

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . . . ’’ 

Consistent with FFDCA section 

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

therein, EPA has reviewed the available 

scientific data and other relevant 

information in support of this action. 

EPA has sufficient data to assess the 

hazards of and to make a determination 

on aggregate exposure for ethiprole 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with ethiprole follows. 

In an effort to streamline its 

publications in the Federal Register, 

EPA is not reprinting sections that 

repeat what has been previously 

published for tolerance rulemaking of 

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 

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 

tolerance rulemakings for ethiprole, in 

which EPA concluded, based on the 

available information, that there is a 

reasonable certainty that no harm would 

result from aggregate exposure to 

ethiprole and established tolerances for 

residues of that chemical. EPA is 

incorporating previously published 

sections of those rulemakings that 

remain unchanged, as described further 

in this rulemaking. Specific information 

on the risk assessment conducted in 

support of this action, including on the 

studies received and the nature of the 

adverse effects caused by ethiprole, can 

be found in the document titled 

‘‘Ethiprole. Human Health Risk 

Assessment for Tolerance without U.S. 

Registration in/on Imported Sugarcane’’ 

which is available in the docket for this 

action at https://www.regulations.gov. 

Toxicological profile. For a discussion 

of the Toxicological Profile of ethiprole, 

see Unit III.A. of the rulemaking 

published in the Federal Register of 

June 28, 2019 (84 FR 30933) (FRL– 

9985–41). 

Toxicological points of departure/ 

Levels of concern. For a summary of the 

Toxicological Points of Departure/ 

Levels of Concern used for the safety 

assessment of ethiprole, see Unit III.B. 

of the June 28, 2019, rulemaking. 

Exposure assessment. Much of the 

exposure assessment remains 

unchanged from the rulemaking 

published in the June 28, 2019, 

rulemaking, although the new exposure 

assessment incorporates the additional 

dietary exposure from the petitioned-for 

tolerance. Other changes are described 

below. 

Acute and chronic dietary exposure 

assessments were conducted using 

DEEM–FCID Version 4.02. This software 

uses 2005–2010 food consumption data 

from the U.S. Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/ 

WWEIA). Unrefined acute and chronic 

dietary exposure and risk assessments 

were conducted using tolerance-level 

residues, empirical and default 

processing factors, and assuming 100% 

crop treated. 

Drinking water and non-occupational 

exposures. There are no registered or 

proposed U.S. uses of ethiprole. As a 

result, estimated drinking water 

concentrations (EDWCs) were not 

included in the dietary exposure and 

risk assessments because residues of 

ethiprole and its degradates are not 

anticipated to be present in U.S. 

drinking water. 

A residential handler and residential 

post-application assessment is not 

necessary since the action is to establish 

an import tolerance without a U.S. 

registration on sugarcane. 

Cumulative exposure. 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 

ethiprole and any other substances and 

ethiprole does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

action, therefore, EPA has not assumed 

that ethiprole has a common mechanism 

of toxicity with other substances. 

In 2016, EPA’s Office of Pesticide 

Programs released a guidance document 

titled, Pesticide Cumulative Risk 

Assessment: Framework for Screening 

Analysis (https://www.epa.gov/ 

pesticide-science-and-assessingpesticide-risks/pesticide-cumulativerisk-assessment-framework). This 

document provides guidance on how to 

screen groups of pesticides for 

cumulative evaluation using a two-step 

approach beginning with the evaluation 

of available toxicological information 

and if necessary, followed by a riskbased screening approach. This 

framework supplements the existing 

guidance documents for establishing 

common mechanism groups (CMGs) and 

conducting cumulative risk assessments 

(CRAs). 

Ethiprole is a phenyl-pyrazole 

insecticide. As part of the ongoing 

process to review registered pesticides, 

the Agency intends to apply this 

framework to determine if the available 

toxicological data for ethiprole suggests 

a candidate CMG may be established 

with other pesticides. If a CMG is 

established, a screening-level toxicology 

and exposure analysis may be 

conducted to provide an initial screen 

for multiple pesticide exposure. 

Safety Factor for Infants and 

Children. EPA continues to conclude 

that there is reliable data showing that 

the safety of infants and children would 

be adequately protected if the Food 

Quality Protection Act (FQPA) safety 

factor were reduced from 10X to 1X. 

The reasons for that decision are 

articulated in Unit III.D. of the June 28, 

2019, rulemaking. 

Aggregate risks and determination of 

safety. EPA determines whether acute 

and chronic dietary pesticide exposures 

are safe by comparing dietary exposure 

estimates to the acute populationadjusted dose (aPAD) and chronic 

population-adjusted dose (cPAD). Short- 

, intermediate-, and chronic-term 

aggregate risks are evaluated by 

comparing the estimated total food, 

water, and residential exposure to the 

appropriate points of departure to 

ensure that an adequate margin of 

exposure (MOE) exists. 

Acute dietary (food only) risks are 

below the Agency’s level of concern of 

100% of the aPAD; they are 2.4% of the 

aPAD for all infants (less than 1 year 

old), which is the population subgroup 

with the highest exposure estimate. 

Chronic dietary (food only) risks are 

below the Agency’s level of concern of 

100% of the cPAD; they are 6% of the 

cPAD for all infants less than one year 


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105472 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Rules and Regulations 

old, which is the population subgroup 

with the highest exposure estimate. 

The short- and intermediate-term 

aggregate risks combine chronic dietary 

(food and drinking water) and shortand intermediate-term residential 

exposures. Since there are no U.S. 

registrations, aggregate risk is the same 

as the chronic dietary risk, which is 

below the Agency’s level of concern. 

Because ethiprole is classified as 

‘‘Suggestive Evidence of 

Carcinogenicity, but Not Sufficient to 

Assess Human Carcinogenicity 

Potential,’’ EPA has concluded that a 

cancer aggregate assessment was not 

required. 

Therefore, based on the risk 

assessments and information described 

above, EPA concludes there is a 

reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to ethiprole residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

For a discussion of the available 

analytical enforcement method, see Unit 

IV.A. of the June 28, 2019, rulemaking. 

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). 

Codex, Canada, and Mexico have not 

established MRLs for residues of 

ethiprole on sugarcane commodities; 

therefore, there are no harmonization 

issues at this time. 

C. Revisions to Petitioned-For 

Tolerances 

Review of the field trial data 

determined one of the nine independent 

sugarcane field trials was to be a 

replicate; therefore, the residues were 

averaged, and the pair of sites was taken 

to be one independent trial. The 

Organization for Economic Cooperation 

and Development (OECD) MRL 

calculator recommended a tolerance of 

0.07 ppm for residues of ethiprole in 

sugarcane. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of ethiprole in or on 

sugarcane at 0.07 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, titled ‘‘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, 

titled ‘‘Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001), or to Executive Order 13045, 

titled ‘‘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, titled ‘‘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, 

titled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, titled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

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

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

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

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides, 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 16, 2024. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter 1 as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.652, amend the table in 

paragraph (a) by adding a table heading 

and adding in alphabetical order the 

commodity ‘‘Sugarcane’’ to read as 

follows: 

§ 180.652 Ethiprole; tolerances for 

residues. 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Commodity Parts per 

million 

* * * * * 

Sugarcane 1 .......................... 0.07 

* * * * * 

1There are no U.S. registrations for this 

commodity as of December 27, 2024. 

* * * * * 

[FR Doc. 2024–30581 Filed 12–26–24; 8:45 am] 

BILLING CODE 6560–50–P 


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