```

[Federal Register Volume 89, Number 231 (Monday, December 2, 2024)]
[Rules and Regulations]
[Pages 95131-95136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28080]

-----------------------------------------------------------------------

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 mono-Me 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

[[Page 95132]]

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: [email protected].

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 e-CFR 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-send-comments-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 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 or raw agricultural commodities 
pre- and post-harvest 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

[[Page 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 mono-Me ether 
as well as the no-observed-adverse-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 mono-Me 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-and-assessing-pesticide-risks/overview-risk-assessment-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

[[Page 95134]]

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 non-occupational, 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 mono-Me 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-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide).
    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-and-assessing-pesticide-risks/cumulative-assessment-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

[[Page 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 mono-Me 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 high-end 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-to-mouth 
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 mono-Me ether that may be used in pesticide formulations applied 
pre- and post-harvest. 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

[[Page 95136]]

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

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  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:

Sec.  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-          25% by weight  Surfactant and
 unsatd., esters with                                 related adjuvant
 polyethylene glycol mono-Me                          of surfactant.
 ether (CAS Reg. No. 518299-31-
 5).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2024-28080 Filed 11-29-24; 8:45 am]
BILLING CODE 6560-50-P
```