15040 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Rules and Regulations 

commercial operations or programs and 

policies.’’ 

The air agency did not evaluate 

environmental justice considerations as 

part of its submittal; the CAA and 

applicable implementing regulations 

neither prohibit nor require such an 

evaluation. The EPA performed an 

environmental justice analysis, as 

described in the section titled 

‘‘Environmental Justice Considerations’’ 

in the proposed rule associated with 

this action (88 FR 72723, October 23, 

2023). The analysis was done for the 

purpose of providing additional context 

and information about this rulemaking 

to the public, not as a basis of the 

action. Due to the nature of the action 

being taken here, this action is expected 

to have a neutral impact on the air 

quality of the affected area. In addition, 

there is no information in the record 

upon which this action is based 

inconsistent with the stated goal of E.O. 

12898 of achieving environmental 

justice for people of color, low-income 

populations, and Indigenous peoples. 

This action is subject to the 

Congressional Review Act, and the EPA 

will submit a rule report to each House 

of the Congress and to the Comptroller 

General of the United States. This action 

is not a ‘‘major rule’’ as defined by 5 

U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by April 30, 2024. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. This action may 

not be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 62 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Reporting and recordkeeping 

requirements. 

Dated: February 22, 2024. 

Earthea Nance, 

Regional Administrator, Region 6. 

For the reasons stated in the 

preamble, the Environmental Protection 

Agency amends 40 CFR part 62 as 

follows: 

PART 62—APPROVAL AND 

PROMULGATION OF STATE PLANS 

FOR DESIGNATED FACILITIES AND 

POLLUTANTS 

■ 1. The authority citation for part 62 

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq. 

Subpart E—Arkansas 

■ 2. Amend § 62.850 by revising 

paragraphs (c)(1) and (2) and removing

and reserving paragraph (c)(3) to read as

follows:

§ 62.850 Identification of plan.

* * * * * 

(c) * * *

(1) Kraft pulp mills.

(2) Municipal solid waste landfills.

(3) [Reserved]

■ 3. Revise § 62.855 to read as follows: 

§ 62.855 Identification of plan—negative

declaration.

Submittal from the Arkansas 

Department of Energy and Environment, 

Division of Environmental Quality 

(ADEQ) dated June 20, 2022, and 

supplemented on August 24, 2022, and 

August 31, 2022, certifying that there 

are no known existing sulfuric acid 

plants subject to the Sulfuric Acid 

Plants Emission Guidelines and 40 CFR 

part 60, subpart Cd, within its 

jurisdiction. 

■ 4. Revise § 62.865 to read as follows: 

§ 62.865 Identification of plan.

(a) Identification of plan. Control of

air emissions from existing kraft pulp 

mills, as adopted by the State of 

Arkansas on January 28, 2022, and 

submitted on June 20, 2022, by the 

Governor in a letter dated May 12, 2022. 

The plan includes the regulatory 

provisions cited in paragraph (d) of this 

section, which EPA incorporates by 

reference. 

(b) Identification of sources. The plan,

as adopted by the State of Arkansas on 

January 28, 2022, and submitted on June 

20, 2022, applies to existing kraft pulp 

mills subject to the Kraft Pulp Mills 

Emission Guidelines (i.e., kraft pulp 

mills, as defined in 40 CFR 60.281(a), 

that commenced construction, 

reconstruction, or modification on or 

before September 24, 1976) within its 

jurisdiction in the State of Arkansas. 

(c) Effective date. The effective date of

the plan is April 1, 2024. 

(d) Incorporation by reference. The

material listed in this paragraph (d) is 

incorporated by reference into this 

section with the approval of the Director 

of the Federal Register under 5 U.S.C. 

552(a) and 1 CFR part 51. All approved 

incorporation by reference (IBR) 

material is available for inspection at 

the EPA and at the National Archives 

and Records Administration (NARA). 

Contact the EPA Region 6 office at 1201 

Elm Street, Suite 500, Dallas, Texas 

75270; phone 214–665–2200. For 

information on the availability of this 

material at NARA, visit 

www.archives.gov/federal-register/cfr/ 

ibr-locations or email fr.inspection@

nara.gov. The material may be obtained 

from the State of Arkansas, Office of the 

Secretary of State, Arkansas Register, 

State Capitol, Room 026, Little Rock, AR 

72201, arkansasregister@

sos.arkansas.gov, https://

www.sos.arkansas.gov/rulesregulations/arkansas-register/. 

(1) Arkansas Pollution Control and

Ecology Commission (APC&EC) Rule 

No. 19, Rules of the Arkansas Plan of 

Implementation for Air Pollution 

Control, Chapter 8, 111(d) Designated 

Facilities, approved January 28, 2022. 

(2) [Reserved]

[FR Doc. 2024–04102 Filed 2–29–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2022–0595; FRL–11726–01– 

OCSPP] 

1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione in Pesticide 

Formulations; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, when used as an 

inert ingredient (colorant/dye) on 

growing crops and raw agricultural 

commodities pre- and post-harvest in/ 

on animals, limited to a maximum 

concentration of 0.5% in a pesticide 

formulation, and in antimicrobial 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils not 

to exceed 300 ppm in the end-use 

concentration. Spring Regulatory 

Sciences on behalf of Colorants 

Solutions (new name Heubach 

Colorants USA LLC) submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 


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exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 1,4- 

bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, when used in 

accordance with the terms of those 

exemptions. 

DATES: This regulation is effective 

March 1, 2024. Objections and requests 

for hearings must be received on or 

before April 30, 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–2022–0595, 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 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: 

Charles Smith, 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 40 CFR part 180 

through the Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2022–0595 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 April 

30, 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– 

2022–0595, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be CBI 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at https://

www.epa.gov/dockets/where-sendcomments-epa-dockets#express. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of August 30, 

2022 (87 FR 52868, FRL–9410–04), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP IN– 

11698) by Spring Regulatory Sciences, 

6620 Cypresswood Dr., Suite 250, 

Spring, TX 77379 on behalf of Heubach 

Colorants USA LLC, 4000 Monroe Road, 

Charlotte, NC 28205. The petition 

requested that 40 CFR be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione (CAS Reg. No. 

123944–63–8) when used as an inert 

ingredient (colorant/dye) in pesticide 

formulations applied to growing crops 

or raw agricultural commodities preand post-harvest under 40 CFR 180.910, 

in/on animals under 40 CFR 180.930, 

and in food contact sanitizing solutions 

under 40 CFR 180.940(a). That 

document referenced a summary of the 

petition prepared by Spring Regulatory 

Sciences on behalf of Heubach 

Colorants USA LLC, the petitioner, 

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 and in 

accordance with its authority under 

FFDCA section 408(d)(4)(A)(i), EPA is 

modifying the petitioner’s request to 

limit the maximum concentration to no 

more than 0.5% of 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione under 40 CFR 

180.910, and 40 CFR 180.930, and not 

to exceed 300 ppm in the end-use 

concentration under 40 CFR 180.940(a). 

This limitation is based on the Agency’s 

risk assessment which can be found at 

https://www.regulations.gov in 

document IN–11698; 1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione. Human Health 

Risk Assessment and Ecological Effects 

Assessment to Support Inert Ingredient 

Approval for use in Pesticide 

Formulations in docket ID number 

EPA–HQ–OPP–2022–0595. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 


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dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and

Determination of Safety

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

allows EPA to establish an exemption 

from the requirement for 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(c)(2)(A)(ii) of FFDCA 

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings but does not include 

occupational exposure. When making a 

safety determination for an exemption 

for the requirement of a tolerance 

FFDCA section 408(c)(2)(B) directs EPA 

to consider the considerations in section 

408(b)(2)(C) and (D). 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. . . .’’ Section 

408(b)(2)(D) lists other factors for EPA 

consideration making safety 

determinations, e.g., the validity, 

completeness, and reliability of 

available data, nature of toxic effects, 

available information concerning the 

cumulative effects of the pesticide 

chemical and other substances with a 

common mechanism of toxicity, and 

available information concerning 

aggregate exposure levels to the 

pesticide chemical and other related 

substances, among others. 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

harm to human health. In order to 

determine the risks from aggregate 

exposure to pesticide inert ingredients, 

the Agency considers the toxicity of the 

inert in conjunction with possible 

exposure to residues of the inert 

ingredient through food, drinking water, 

and through other exposures that occur 

as a result of pesticide use in residential 

settings. If EPA is able to determine that 

a finite tolerance is not necessary to 

ensure that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to the inert 

ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione follows. 

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered their 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione exhibits low 

levels of acute toxicity via the oral and 

dermal routes of exposure. In the rat, the 

oral and dermal LD50s are greater than 

2,000 milligrams/kilogram (mg/kg). 

Acute inhalation toxicity is not 

expected due to the very low vapor 

pressure. It is not irritating to the rabbit 

eye. It is not expected to be irritating to 

the skin based on the absence of skin 

irritation in the acute dermal toxicity 

study and low exposure. It is not a 

dermal sensitizer. 

The most sensitive effects were 

observed in a 28-day oral toxicity study 

with 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione. Increased levels 

of methemoglobin, total bilirubin and 

bile acids and decreased blood urea 

nitrogen were observed in female rats at 

the lowest observed adverse level 

(LOAEL) of 330 mg/kg/day. The no 

observed adverse effect level (NOAEL) 

is 110 mg/kg/day. Fetal susceptibility 

was not observed in the reproduction/ 

developmental toxicity screening study 

in rats. Maternal (decreased thyroid 

hormone levels) and offspring 

(decreased bodyweights) toxicity was 

observed at the same dose, the LOAEL 

of 1,000 mg/kg/day. The NOAEL is 300 

mg/kg/day. No reproduction toxicity 

effects are seen in the available studies. 

The concern for carcinogenicity is low, 

based on QSAR metabolism data 

showing the absence of metabolites 

associated with carcinogenicity and 

negative results in in vitro mutagenicity 

studies. 

Neurotoxicity and immunotoxicity 

toxicity studies are not available for 

review. However, no evidence of 

neurotoxicity or immunotoxicity was 

observed in the submitted studies. 

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 https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-pesticide-program. 

An acute dietary endpoint was not 

selected because no effect attributable to 

a single dose was identified in the 


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database. The 28-day oral toxicity study 

in rats is selected for the chronic dietary 

exposure scenario as well as short- and 

intermediate-term incidental oral, 

dermal and inhalation exposure 

scenarios. The NOAEL is 110 mg/kg/ 

day, and the LOAEL is 330 mg/kg/day 

based on increased levels of 

methemoglobin, total bilirubin and bile 

acids and decreased blood urea nitrogen 

in females. This study is appropriate for 

the duration of exposure, it is protective 

of the general population, and it is 

protective of the most sensitive lifestage 

(children). The standard inter- and 

intra-species uncertainty factors of 10× 

are applied. An additional 10× 

uncertainty factor was applied to 

account for the use of a short-term study 

for chronic dietary exposure. The 

default factor of 100% is applied for the 

dermal absorption rate and the 

inhalation absorption rate. 

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. In evaluating dietary 

exposure to 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione in food as follows: 

In conducting the dietary exposure 

assessment using the Dietary Exposure 

Evaluation Model DEEM–FCIDTM, 

Version 4.02, EPA used food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

2005–2010 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, no residue data 

were submitted for 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione. In the absence of 

specific residue data, EPA has 

developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Update to 

D361707: Dietary Exposure and Risk 

Assessments for the Inerts.’’ (12/21/ 

2021) and can be found at https://

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2018–0090. In 

the dietary exposure assessments, the 

Agency assumed that the residue level 

of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest levels of tolerances would 

be no higher than the concentration of 

the active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. Further, pesticide 

products rarely have a single inert 

ingredient; rather there is generally a 

combination of different inert 

ingredients used which additionally 

reduces the concentration of any single 

inert ingredient in the pesticide product 

in relation to that of the active 

ingredient. In the case of 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, EPA made a 

specific adjustment to the dietary 

exposure assessment to account for the 

use limitations of the amount of 1,4- 

bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione that may be in 

pesticide formulations (limited to no 

more than 0.5%) present at the 

maximum limitation rather than at 

equal quantities with the active 

ingredient. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for 1,4-bis[[3- 

[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, a conservative 

drinking water concentration value of 

100 parts per billion (ppb) based on 

screening level modeling was used to 

assess the contribution to drinking 

water for chronic dietary risk 

assessments for 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione. 

To assess dietary exposure due to its 

use in antimicrobial products, the EPA 

calculated the Estimated Daily Intake 

(EDI) and Daily Dietary Dose (DDD) as 

described in the Food Drug 

Administration (FDA) model, based on 

a maximum concentration of 300 ppm 

in the pesticide formulation. The 

assessment considered: application 

rates, residual solution or quantity of 

solution remaining on the treated 

surface without rinsing with potable 

water, surface area of the treated surface 

which comes into contact with food, 

pesticide migration fraction, and body 

weight. These assumptions are based on 

FDA guidelines (2003). 

2. 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). 

Although there are non-pesticidal 

uses for 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, no reliable 

exposure information is available to 

EPA on those uses. 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione may be used as an 

inert ingredient in pesticide products 

that are registered for specific uses that 

may result in residential exposure, such 

as pesticides used in and around the 

home. Therefore, screening level 

residential handler and post-application 

risk assessments have been performed 

for common residential exposure 

scenarios, using assumptions detailed in 

the 2012 Residential SOPs (available at 

https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide). 

3. 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.’’ 

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.’’ 

EPA has not found 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione to share a 

common mechanism of toxicity with 

any other substances, and 1,4-bis[[3-[2- 

(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance exemption, therefore, EPA 

has assumed that 1,4-bis[[3-[2-(2- 


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hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione does not have 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-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

D. Additional Safety Factor for the

Protection of Infants and Children

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10×) 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 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10×, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

Based on the evaluation of available 

toxicity studies, there is low concern for 

pre- and postnatal susceptibility from 

exposure to chemical name. The FQPA 

safety factor has been reduced to 1× 

because: (1) the toxicity database is 

adequate to characterize potential preand postnatal risk; (2) the established 

PoD (110 mg/kg/day) will be protective 

of the body weight decreases in 

offspring seen at 1,000 mg/kg/day in the 

combined reproduction/developmental 

toxicity screening study in rats; (3) no 

evidence of neurotoxicity was observed 

in the database; and (4) the assumptions 

for the exposure assessment are 

conservative and unlikely to 

underestimate risk. 

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, 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione 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 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione from food and 

water will utilize ∼20.4% and 53.3% of 

the cPAD for the U.S. population and 

children 1 to 2 years old and nonnursing infants (the most highly 

exposed populations). 

3. Short- and intermediate term risks.

Short- and intermediate term aggregate 

exposures takes into account short- and 

intermediate-term residential exposures 

plus chronic exposures to food and 

water (considered to be a background 

exposure level). 

1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione is currently used 

as an inert ingredient in non-pesticidal 

products and pesticidal products that 

are registered for uses that could result 

in short- and intermediate-term 

residential exposures, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposures through 

food and water with short- and 

intermediate-term residential exposures 

to 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione. Although, there 

are non-pesticide exposures (i.e. 

colorant for fabric and home care 

products including laundry) to 1,4- 

bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione, aggregate 

exposures consider exposure due to 

pesticide uses only since no reliable 

exposure information is available for 

non-pesticidal uses. 

Using the exposure assumptions 

described in this unit for short- and 

intermediate-term exposures, EPA has 

concluded the combined short- and 

intermediate-term food, water, and 

residential exposures result in an 

aggregate risk index (ARI) of 4.3 for 

adults. Adult residential exposure 

combines high end dermal and 

inhalation handler exposure from 

aerosol spray/trigger pump with a highend post application dermal exposure 

from contact with treated lawns. The 

combined short- and intermediate-term 

aggregated food, water, and residential 

pesticide exposures result in an 

aggregate ARI of 1.69 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth exposures). Because EPA’s level 

of concern for 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione is an ARI of 1 or 

below, these ARIs are not of concern. 

V. Other Considerations

A. Analytical Enforcement Methodology

An analytical method is not required

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione in or on any food 

commodities. EPA is establishing a 

limitation on the amount of 1,4-bis[[3- 

[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione that may be used 

in pesticide formulations applied preand post-harvest, in/on animals; and in 

food contact sanitizing solutions. This 

limitation will be enforced through the 

pesticide registration process under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (‘‘FIFRA’’), 7 U.S.C. 

136 et seq. EPA will not register any 

pesticide formulation for food use that 

exceeds 0.5% 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione in the final 

pesticide formulations to be applied 

pre- and post-harvest, in/on animals; 

and not to exceed 300 ppm in the enduse concentration when ready for use 

antimicrobial formulations (food-contact 

surface sanitizing solutions). 

B. Revisions to Petitioned-For

Tolerances

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

the Agency to finalize a tolerance that 

varies from that sought by the petition. 

EPA is establishing a tolerance 

exemption for residues of 1,4-bis[[3-[2- 

(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione (CAS Reg. No. 

123944–63–8) with concentration limits 

not sought by the petition based on the 

Agency’s risk assessment. 

VI. Conclusions

Therefore, an exemption from the

requirement of a tolerance is established 

for residues of 1,4-bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione (CAS Reg. No. 

123944–63–8) when used as an inert 

ingredient (colorant/dye) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest under 40 CFR 180.910 and in/ 


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on animals under 40 CFR 180.930, 

limited to a maximum concentration of 

0.5% in a pesticide formulation and in 

antimicrobial formulations applied to 

food-contact surfaces in public eating 

places, dairy-processing equipment, and 

food-processing equipment and utensils 

under 40 CFR 180.940(a) not to exceed 

300 ppm in the end-use concentration. 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001), or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemptions in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal governments, on the 

relationship between the National 

Government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999), and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

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

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

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

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 26, 2024. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.910, amend table 1 to 

180.910 by adding in alphabetical order 

an entry for ‘‘1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione (CAS Reg. No. 

123944–63–8)’’ to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

TABLE 1 TO 180.910 

Inert ingredients Limits Uses 

*******

1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]-9,10- 

anthracenedione (CAS Reg. No. 123944– 

63–8).

0.5% by weight ................................................. Dye, coloring agent. 

* * * * * * * 

■ 3. In § 180.930, amend table 1 to 

180.930 by adding in alphabetical order 

an entry for ‘‘1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione (CAS Reg. No. 

123944–63–8)’’ to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 


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15046 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Rules and Regulations 

TABLE 1 TO 180.930 

Inert ingredients Limits Uses 

*******

1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]-9,10- 

anthracenedione (CAS Reg. No. 123944– 

63–8).

0.5% by weight ................................................. Dye, coloring agent. 

* * * * * * * 

■ 4. In § 180.940, amend table 1 to 

paragraph (a) by adding in alphabetical 

order an entry for ‘‘1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]- 

9,10-anthracenedione’’ to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

TABLE 1 TO PARAGRAPH (a) 

Pesticide chemical CAS Reg. No. Limits 

*******

1,4-Bis[[3-[2-(2- 

hydroxyethoxy)ethoxy]propyl]amino]-9,10- 

anthracenedione.

123944–63–8 .................................................... When ready for use, the end-use concentration is not to exceed 300 ppm. 

* * * * * * * 

* * * * * 

[FR Doc. 2024–04355 Filed 2–29–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2020–0295; FRL–11719–01– 

OCSPP] 

Various Fragrance Components in 

Pesticide Formulations; Tolerance 

Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of various 

fragrance components listed in Unit II of 

this document when they are used as 

inert ingredients in antimicrobial 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils 

when the end-use concentration does 

not exceed 100 parts per million (ppm). 

Innovative Reform Group, on behalf of 

The Clorox Company, submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of various 

fragrance components, when used in 

accordance with the terms of those 

exemptions. 

DATES: This regulation is effective 

March 1, 2024. Objections and requests 

for hearings must be received on or 

before April 30, 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–2020–0295, 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 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, 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 40 CFR part 180 

through the Office of the Federal 


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