Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations 95131 

Feb. 16, 1994) directs Federal agencies 

to identify and address 

‘‘disproportionately high and adverse 

human health or environmental effects’’ 

of their actions on communities with 

environmental justice (EJ) concerns to 

the greatest extent practicable and 

permitted by law. Executive Order 

14096 (Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All, 88 FR 25251, April 26, 2023) 

builds on and supplements E.O. 12898 

and defines EJ as, among other things, 

the just treatment and meaningful 

involvement of all people, regardless of 

income, race, color, national origin, or 

Tribal affiliation, or disability in agency 

decision-making and other Federal 

activities that affect human health and 

the environment. 

The State did not evaluate EJ 

considerations as part of its SIP 

submittal; the CAA and applicable 

implementing regulations neither 

prohibit nor require such an evaluation. 

EPA performed an EJ analysis, as is 

described in the proposed action 89 FR 

56693 (July 10, 2024) in the section 

titled, ‘‘Environmental Justice.’’ 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. In 

addition, there is no information in the 

record upon which this decision is 

based inconsistent with the stated goal 

of E.O. 12898/14096 of achieving EJ for 

communities with EJ concerns. 

This action is subject to the 

Congressional Review Act, and 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 CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by January 31, 2025. 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 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Greenhouse gases, Incorporation by 

reference, Intergovernmental relations, 

Lead, Nitrogen dioxide, Ozone, 

Particulate matter, Reporting and 

recordkeeping requirements, Sulfur 

oxides, Volatile organic compounds. 

Dated: November 22, 2024. 

KC Becker, 

Regional Administrator, Region 8. 

For the reasons stated in the 

preamble, the Environmental Protection 

Agency is amending 40 CFR part 52 as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart JJ—North Dakota 

■ 2. In § 52.1820, the table in paragraph 

(e) is amended by adding an entry for 

‘‘North Dakota State Implementation 

Plan for Regional Haze (Second 

Implementation Period)’’ at the end of 

the table to read as follows: 

§ 52.1820 Identification of plan. 

* * * * * 

(e) * * * 

Rule No. Rule title 

State 

effective 

date 

EPA 

effective 

date 

Final rule 

citation/date Comments 

*******

North Dakota State Implementation Plan For Regional Haze 

*******

North Dakota State Implementation Plan for 

Regional Haze (Second 

Implementation Period).

North Dakota State Implementation Plan for 

Regional Haze 

8/10/2022 1/2/2025 [insert Federal Register citation], 12/2/ 

2024 

Excluding the sections disapproved in 

this action. EPA disapproved the 

portions of North Dakota’s 2022 SIP 

submission relating to CAA section 

169A and 40 CFR 51.308(f)(2): 

long-term strategy; 40 CFR 

51.308(f)(3): reasonable progress 

goals; and 40 CFR 51.308(i): FLM 

consultation. 

[FR Doc. 2024–27940 Filed 11–29–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2023–0368; FRL–12393–01– 

OCSPP] 

Fatty acids, C16–18 and C18-unsatd., 

esters With polyethylene glycol monoMe ether 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 fatty acids, 

C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether 

(CAS Reg. No. 518299–31–5) when used 

as an inert ingredient (surfactant and 

related adjuvant of surfactant) on 

growing crops and raw agricultural 

commodities pre- and post-harvest 

limited to 25% by weight in pesticide 

formulations. Spring Regulatory 


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95132 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations 

Sciences on behalf of Sasol Chemicals 

(USA) LLC 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 fatty acids, C16–18 and 

C18-unsatd., esters with polyethylene 

glycol mono-Me ether, when used in 

accordance with the terms of this 

exemption. 

DATES: This regulation is effective 

December 2, 2024. Objections and 

requests for hearings must be received 

on or before January 31, 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–2023–0368, 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 Federal Register Office’s eCFR site at https://www.ecfr.gov/ 

current/title-40/chapter-I/subchapter-E/ 

part-180?toc=1. 

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–2023–0368 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 31, 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– 

2023–0368, 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 September 

19, 2023 (88 FR 64398, FRL–10579–08), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–11755) by Spring 

Regulatory Sciences (6620 Cypresswood 

Dr., Suite 250, Spring, TX 77379) on 

behalf of Sasol Chemicals (USA) LLC 

(12120 Wickchester Lane, Houston, TX 

77224). The petition requested that 40 

CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of fatty acids, C16–18 and C18-unsatd., 

esters with polyethylene glycol monoMe ether (CAS Reg. No. 518299–31–5) 

when used as an inert ingredient 

(surfactant and related adjuvant of 

surfactant) in pesticide formulations 

applied to growing crops or raw 

agricultural commodities pre- and postharvest limited to 25% by weight in 

pesticide formulations. That document 

referenced a summary of the petition 

prepared by Spring Regulatory Sciences 

on behalf of Sasol Chemicals (USA) 

LLC, the petitioner, which is available 

in the docket at https://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 

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 


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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations 95133 

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. FFDCA section 

408(c)(2)(B) directs EPA to take into 

account the considerations in section 

408(b)(2)(C) and (D) when making a 

safety determination for an exemption 

from the requirement of a tolerance. 

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 when making 

safety determinations, including 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. 

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 fatty acids, C16–18

and C18-unsatd., esters with 

polyethylene glycol mono-Me ether, 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with fatty acids, C16–18 and 

C18-unsatd., esters with polyethylene 

glycol mono-Me ether 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 fatty acids, C16–18 and C18-unsatd., 

esters with polyethylene glycol monoMe ether as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

The toxicological database of fatty 

acids, C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether is 

supported by data regarding methyl 

laurate and alcohol ethoxylates (C12AE7, 

C13AE3, C14AE3, C14AE7, C14AE12, 

C15AE3 and C15AE7). EPA has 

determined that it is appropriate to 

bridge methyl laurate and the 

aforementioned alcohol ethoxylates data 

to assess fatty acids, C16–18 and C18- 

unsatd., esters with polyethylene glycol 

mono-Me ether based on similarities in 

the functional groups/structure, 

composition, and physical/chemical 

properties. 

Fatty acids, C16–18 and C18-unsatd., 

esters with polyethylene glycol monoMe exhibits low levels of acute toxicity 

via the oral, dermal, and inhalation 

routes of exposure. It is not a skin 

irritant or a skin sensitizer, but it is 

minimally irritating to the eyes. 

Reduced body weight starting at 250 

mg/kg/day was observed in the 

combined reproduction and 

developmental toxicity test, 2- 

generation reproduction toxicity, and 

chronic/carcinogenicity studies. 

Increased offspring susceptibility was 

observed in the two-generation 

reproduction toxicity study in rats. 

Reduced body weight in pups was 

observed at 250 mg/kg/day in the 

absence of maternal toxicity. However, 

the concern for offspring susceptibility 

is low because the established chronic 

reference dose (cRfD, 1.6 mg/kg/day) 

will be protective of offspring effects 

observed at 250 mg/kg/day. No effects 

on reproductive parameters, 

neurotoxicity or immunotoxicity were 

observed in the available studies. 

Concern for carcinogenicity is low, 

based on no evidence of tumors or 

cancer in chronic/carcinogenicity 

studies and negative results in 

mutagenicity 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 

database. Co-critical chronic/ 

carcinogenicity studies in rats were 

selected for the chronic dietary 

exposure scenario as well as short- and 

intermediate-term incidental oral, 

dermal and inhalation exposure 

scenarios. The NOAEL of 160 mg/kg/ 

day and LOAEL of 250 mg/kg/day, 

based on decreased body weight, are 

selected for risk assessment. The studies 

are appropriate for the duration of 

exposure, protective of all subchronic 

effects, protective of the general 

population, and are protective of the 

most sensitive lifestage (children). The 

standard inter- and intra-species 


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uncertainty factors of 10x are applied 

(total uncertainty factor = 100x). A 

dermal absorption factor of 20% is 

applied. The default factor of 100% is 

applied for the inhalation absorption 

rate. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fatty acids, C16–18 and C18- 

unsatd., esters with polyethylene glycol 

mono-Me ether, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

There are no known non-pesticidal 

dietary exposures for fatty acids, C16–18

and C18-unsatd., esters with 

polyethylene glycol mono-Me ether. 

EPA assessed dietary exposures from 

fatty acids, C16–18 and C18-unsatd., esters 

with polyethylene glycol mono-Me 

ether 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 fatty acids, C16–18

and C18-unsatd., esters with 

polyethylene glycol mono-Me ether. 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 titled ‘‘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 fatty acids, 

C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether, 

EPA made a specific adjustment to the 

dietary exposure assessment to account 

for the use limitations of the amount of 

fatty acids, C16–18 and C18-unsatd., esters 

with polyethylene glycol mono-Me 

ether that may be in pesticide 

formulations (limited to no more than 

25%) present at the maximum 

limitation rather than at equal quantities 

with the active ingredient. 

For the purpose of the screening level 

dietary risk assessment, 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 the chronic dietary risk 

assessments for fatty acids, C16–18 and 

C18-unsatd., esters with polyethylene 

glycol mono-Me ether. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Fatty acids, C16–18 and C18-unsatd., 

esters with polyethylene glycol monoMe ether 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-science-andassessing-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.’’ 

EPA has not found fatty acids, C16–18

and C18-unsatd., esters with 

polyethylene glycol mono-Me ether to 

share a common mechanism of toxicity 

with any other substances, and fatty 

acids, C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance exemption, therefore, EPA has 

assumed that fatty acids, C16–18 and C18- 

unsatd., esters with polyethylene glycol 

mono-Me ether 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 (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 

Food Quality Protection Act (FQPA) 

safety factor. 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. 

Based on the evaluation of available 

toxicity studies, there is low concern for 

pre- and postnatal susceptibility from 

exposure to fatty acids, C16–18 and C18- 

unsatd., esters with polyethylene glycol 

mono-Me ether. The FQPA safety factor 

has been reduced to 1X because: (1) the 

toxicity database is adequate to 

characterize potential pre- and postnatal 

risk; (2) the established PoD (160 mg/kg/ 

day) will be protective of the body 

weight decrease in offspring seen at 250 

mg/kg/day in the 2-generation 

reproduction toxicity study in rats; (3) 

no evidence of neurotoxicity was 


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Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations 95135 

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, fatty acids, C16–18

and C18-unsatd., esters with 

polyethylene glycol mono-Me ether 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 fatty acids, 

C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether 

from food and water will utilize 

approximately 8.9% and 32.3% of the 

cPAD for the U.S. population and 

children 1–2 years old (the most highly 

exposed populations). 

3. Short- and intermediate term risks. 

Short- and intermediate term aggregate 

exposures take into account short- and 

intermediate-term residential exposures 

plus chronic exposures to food and 

water (considered to be a background 

exposure level). 

Fatty acids, C16–18 and C18-unsatd., 

esters with polyethylene glycol monoMe ether may be used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to fatty 

acids, C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether. 

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 margin of exposure (MOE) of 

268 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 MOE of 127 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 fatty acids, C16–18 and C18- 

unsatd., esters with polyethylene glycol 

mono-Me ether is an MOE of 100 or 

below, these MOEs are not of concern. 

V. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of fatty acids, 

C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether in 

or on any food commodities. EPA is 

establishing a limitation on the amount 

of fatty acids, C16–18 and C18-unsatd., 

esters with polyethylene glycol monoMe ether that may be used in pesticide 

formulations applied pre- and postharvest. 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 25% fatty 

acids, C16–18 and C18-unsatd., esters with 

polyethylene glycol mono-Me ether in 

the final pesticide formulations to be 

applied pre- and post-harvest. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of fatty acids, C16–18 and 

C18-unsatd., esters with polyethylene 

glycol mono-Me ether (CAS Reg. No. 

518299–31–5) when used as an inert 

ingredient (surfactant and related 

adjuvant of surfactant) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest under 40 CFR 180.910, limited 

to a maximum concentration of 25% in 

a pesticide formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

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, 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 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 exemption 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 


ddrumheller on DSK120RN23PROD with RULES1
95136 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Rules and Regulations 

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: November 21, 2024. 

Charles Smith, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, the EPA amends 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, the entry ‘‘Fatty acids, C16–18 and 

C18-unsatd., esters with polyethylene 

glycol mono-Me ether’’ 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 

*******

Fatty acids, C16–18 and C18-unsatd., esters with polyethylene glycol mono-Me ether (CAS 

Reg. No. 518299–31–5).

25% by weight Surfactant and related adjuvant of surfactant. 

* * * * * * * 

[FR Doc. 2024–28080 Filed 11–29–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 93 

45 CFR Parts 46 and 73 

Final Scientific Integrity Policy; 

Withdrawal 

AGENCY: Office of the Assistant 

Secretary for Planning and Evaluation, 

Office of the Secretary, HHS. 

ACTION: Withdrawal. 

SUMMARY: The Department of Health and 

Human Services (HHS) is withdrawing 

the Federal Register document 

published at 89 FR 92830. The HHS 

Scientific Integrity Policy remains in 

effect. 

DATES: As of December 2, 2024, the 

document published at 89 FR 92830, on 

November 25, 2024, is withdrawn. 

FOR FURTHER INFORMATION CONTACT: 

Karen Wehner, Ph.D., Scientific 

Integrity Officer, Office of Science and 

Data Policy, Office of the Assistant 

Secretary for Planning and Evaluation, 

Office of the Secretary, HHS at 240– 

453–8435 or scientificintegrity@hhs.gov. 

SUPPLEMENTARY INFORMATION: Scientific 

integrity plays a vital role in the mission 

of HHS. Ensuring integrity in science 

throughout the Department allows HHS 

to foster and produce high-quality 

science, communicate effectively with 

the public, and base critical policy 

decisions on trustworthy and rigorous 

scientific findings. HHS has adopted a 

Department-wide scientific integrity 

policy to further strengthen scientific 

integrity and evidence-based 

policymaking throughout the 

Department. 

The Scientific Integrity Policy of the 

U.S. Department of Health and Human 

Services (Policy) was approved on 

September 16, 2024. The finalized 

Policy was announced to the HHS 

community and posted on the HHS 

scientific integrity website, at https://

www.hhs.gov/programs/research/ 

scientificintegrity/index.html, on 

September 30, 2024. 

The document that published on 

Monday November 25, 2024, at 89 FR 

92830 is being withdrawn. The Policy 

itself remains in effect and the public 

may continue to access the policy on the 

HHS website, at https://www.hhs.gov/ 

sites/default/files/hhs-scientificintegrity-policy.pdf. 

HHS would like to clarify that the 

Policy does not modify, implement, or 

change the Rules referenced in the CFR 

citations section, i.e., 42 CFR part 93 

and 45 CFR parts 46 and 73; and is not 

intended to be guidance about 

implementing those Rules. HHS also 

notes that the Policy is an internal HHS 

policy and only applies to HHS 

employees and other covered 

individuals as indicated in the Policy. 

The effective date of the Policy 

remains October 16, 2024. 

Dated: November 25, 2024. 

Katherine N. Bent, 

Associate Deputy Assistant Secretary, Office 

of Science and Data Policy, Office of the 

Assistant Secretary for Planning and 

Evaluation, Department of Health and 

Human Services. 

[FR Doc. 2024–28128 Filed 11–27–24; 8:45 am] 

BILLING CODE 4150–05–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[GN Docket No. 23–65, IB Docket No. 22– 

271, FCC 24–28; FR ID 264974] 

Single Network Future: Supplemental 

Coverage From Space; Space 

Innovation 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, 

information collections associated with 

certain rules adopted in the 2024 Single 

Network Future: Supplemental 

Coverage from Space; Space Innovation 

Report and Order and Further Notice of 


ddrumheller on DSK120RN23PROD with RULES1