[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Rules and Regulations]
[Pages 40391-40396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10182]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0613 and EPA-HQ-OPP-2023-0347; FRL-11898-01-OCSPP]


1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco 
acyl derivatives, inner salts; and 1-Propanaminium, 3-amino-N-
(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, hydroxides, 
inner salts in Pesticide Formulations; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of 1-propanaminium, 3-amino-N-(2-
carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts (CAS 
Reg. No. 499781-63-4) when used as an inert ingredient (adjuvant or 
surfactant) on growing crops and raw agricultural commodities pre- and 
post-harvest. This regulation also establishes an exemption from the 
requirement of a tolerance for residues of 1-propanaminium, 3-amino-N-
(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, hydroxides, 
inner salts (CAS Reg. No. 61789-40-0), also known as cocamidopropyl 
betaine, when used as an inert ingredient (surfactant) on growing crops 
pre-harvest. Oxiteno USA, LLC and Bi-PA NV, respectively, each 
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 for each of these substances. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of 1-propanaminium, 3-

[[Page 40392]]

amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner 
salts; and cocamidopropyl betaine when used in accordance with the 
terms of these exemptions.

DATES: This regulation is effective May 10, 2024. Objections and 
requests for hearings must be received on or before July 9, 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 dockets for these actions, identified by docket 
identification (ID) numbers EPA-HQ-OPP-2021-0613 and EPA-HQ-OPP-2023-
0347, are 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, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[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 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-2021-0613 or EPA-HQ-OPP-2023-0347 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 July 9, 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-2021-0613 or EPA-HQ-
OPP-2023-0347, 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 October 21, 2021 (86 FR 58239) (FRL-
8792-04-OSCPP), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11550) by Spring Regulatory Sciences, on behalf of Oxiteno USA, LLC, 
3200 Southwest Freeway, Suite 1200, Houston, TX 77027. The petition 
requested that 40 CFR 180.910 be amended by establishing an exemption 
from the requirement of a tolerance for residues of 1-propanaminium, 3-
amino-N-(2-carboxyethyl)- N,N-dimethyl-, N-coco acyl derivatives, inner 
salts (CAS Reg. No. 499781-63-4) when used as an inert ingredient 
(adjuvant or surfactant) in pesticide formulations applied to growing 
crops or raw agricultural commodities pre- and post-harvest. This 
document referenced a summary of the petition prepared by Oxiteno USA, 
LLC, which is available in the docket at https://www.regulations.gov. 
There were no comments received in response to the notice of filing.
    In the Federal Register of Wednesday, July 26, 2023 (88 FR 48179) 
(FRL-10579-06-OSCPP), EPA issued a document pursuant to FFDCA section 
408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 
IN-11782) by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 
on behalf of Bi-PA NV. The petition requested that 40 CFR 180.920 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of cocamidopropyl betaine (CAS Reg. No. 61789-
40-0) when used as an inert ingredient (surfactant) in pesticide 
formulations pre-harvest at levels up to 10% w/w in pesticide 
formulations. This document referenced a summary of the petition 
prepared by Bi-PA NV, which is available in the docket at https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petitions and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is establishing an exemption for residues of 1-propanaminium, 3-amino-
N-(2-carboxyethyl)- N,N-dimethyl-, N-coco acyl derivatives, inner salts 
that includes a limitation of 25% w/w in pesticide formulations to 
account for potential aquatic toxicity. A revised petition was 
submitted by Oxiteno USA, LLC, to support this change to the 
petitioned-for exemption.

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

[[Page 40393]]

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 determines that 
the exemption 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 EPA makes a safety determination for an 
exemption from the requirement of a tolerance, FFDCA section 
408(c)(2)(B) directs the Agency to take into account 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 or 
exemption 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's 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 these 
actions. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 1-propanaminium, 3-amino-N-(2-
carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts and 
cocamidopropyl betaine, including exposure resulting from the 
exemptions established by this action. EPA's assessment of exposures 
and risks associated with 1-propanaminium, 3-amino-N-(2-carboxyethyl)-
N,N-dimethyl-, N-coco acyl derivatives, inner salts and cocamidopropyl 
betaine 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-propanaminium, 3-amino-N-(2-
carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts and 
cocamidopropyl betaine 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 1-propanaminium, 3-amino-N-(2-
carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts is 
supported by data regarding cocamidopropyl betaine and to a lesser 
extent, two other alkylamidopropyl betaines. EPA has determined that it 
is appropriate to bridge alkylamidopropyl betaine data to assess 1-
propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl 
derivatives, inner salts due to similarities in the manufacturing 
processes, functional groups/structure, composition, and physical/
chemical properties, and among the available human health toxicity and 
ecological toxicity data of these substances.
    1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco 
acyl derivatives, inner salts and cocamidopropyl betaine exhibit 
moderate acute toxicity via the oral and dermal routes. No inhalation 
studies were available but, based on their physical-chemical 
properties, they are not expected to volatilize and therefore are not 
expected to be an inhalation toxicant.
    They were shown to be a moderate dermal irritant in some studies 
and a non-irritant in others. They are severe eye irritants. Although 
some skin sensitization effects were seen in the acute studies, these 
chemicals contain byproducts that are known to cause sensitization. 
Therefore, it is possible the effects are from chemical byproducts and 
with proper manufacturing controls, these irritating components can be 
decreased.
    The repeated-dose toxicity studies showed no concern for systemic 
effects. Local irritation was seen in the forestomach of dams in 
subchronic studies and in one developmental toxicity study following 
gavage administration. This forestomach irritation likely resulted in 
the decreased maternal body weight gain and food consumption and the 
associated developmental effects observed at the highest dose tested 
(i.e., post-implantation loss and decreased mean fetal body weight). 
Due to the bolus administration of the compound (which may increase the 
irritation potential of a chemical), the lack of a forestomach in 
humans, and the developmental effects occurring at very high doses 
only, the effects observed are not considered relevant for human health 
risk assessment.
    Although no specific neurotoxicity studies were conducted, there 
was no evidence of neurotoxicity following repeated dosing. The 
neurotoxicity observed following acute dosing occurred at doses not 
relevant for risk assessment purposes (i.e., doses >1,000 mg/kg). 
Furthermore, concern for carcinogenicity is low, based on negative 
results in mutagenicity studies, and the lack of structural alerts for 
carcinogenicity.

[[Page 40394]]

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 (LOC) 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.
    The hazard profiles of 1-propanaminium, 3-amino-N-(2-carboxyethyl)-
N,N-dimethyl-, N-coco acyl derivatives, inner salts and cocamidopropyl 
betaine are adequately defined. Overall, these chemicals are of low to 
moderate acute toxicity, and low subchronic and developmental toxicity. 
No toxicity relevant for risk assessment was observed up to 1,000 mg/
kg/day. Therefore, no toxicological endpoints of concern or PODs were 
identified and a qualitative risk assessment for 1-propanaminium, 3-
amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner 
salts and cocamidopropyl betaine was performed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, 
N-coco acyl derivatives, inner salts and cocamidopropyl betaine, EPA 
considered exposure under the proposed exemptions from the requirement 
of a tolerance. EPA assessed dietary exposures from 1-propanaminium, 3-
amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner 
salts and cocamidopropyl betaine in food as follows.
    Dietary exposure (food and drinking water) to 1-propanaminium, 3-
amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner 
salts and cocamidopropyl betaine may occur following ingestion of foods 
with residues from their use in accordance with these exemptions. 
However, a quantitative dietary exposure assessment was not conducted 
since a toxicological endpoint for risk assessment was not identified.
    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).
    1-Propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco 
acyl derivatives, inner salts and cocamidopropyl betaine may be present 
in pesticide and non-pesticide products that may be used in and around 
the home. However, a quantitative residential exposure assessment was 
not conducted since a toxicological endpoint for risk assessment was 
not identified.
    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 or 
exemption, 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.''
    Based on the lack of systemic toxicity in the available database, 
EPA has not found 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-
dimethyl-, N-coco acyl derivatives, inner salts and cocamidopropyl 
betaine to share a common mechanism of toxicity with any other 
substances, and 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-
dimethyl-, N-coco acyl derivatives, inner salts and cocamidopropyl 
betaine do not appear to produce a toxic metabolite produced by other 
substances. For the purposes of these tolerance exemptions, therefore, 
EPA has assumed that 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-
dimethyl-, N-coco acyl derivatives, inner salts and cocamidopropyl 
betaine do 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 an assessment of 1-propanaminium, 3-amino-N-(2-
carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts and 
cocamidopropyl betaine, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children. Because there are no threshold effects associated 
with 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, N-coco 
acyl derivatives, inner salts or cocamidopropyl betaine, EPA conducted 
a qualitative assessment. As part of that assessment, the Agency did 
not use safety factors for assessing risk, and no additional safety 
factor is needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to 1-propanaminium, 3-amino-N-(2-carboxyethyl)-N,N-dimethyl-, 
N-coco acyl derivatives, inner salts or cocamidopropyl betaine 
residues.

V. 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-
propanaminium, 3-amino-N-(2-

[[Page 40395]]

carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts or 
cocamidopropyl betaine in or on any food commodities. EPA is 
establishing a limitation on the amount of 1-propanaminium, 3-amino-N-
(2-carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts 
and cocamidopropyl betaine that may be used in pesticide formulations. 
This limitation is based on the potential for aquatic toxicity and 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% 1-propanaminium, 3-amino-N-(2-carboxyethyl)-
N,N-dimethyl-, N-coco acyl derivatives, inner salts and/or 10% 
cocamidopropyl betaine in the final pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of 1-propanaminium, 3-amino-N-(2-
carboxyethyl)- N,N-dimethyl-, N-coco acyl derivatives, inner salts (CAS 
Reg. No. 499781-63-4) when used as an inert ingredient (adjuvant or 
surfactant) up to 25% w/w in pesticide formulations applied to growing 
crops or raw agricultural commodities pre- and post-harvest under 40 
CFR 180.910.
    An exemption from the requirement of a tolerance is also 
established for residues of 1-propanaminium, 3-amino-N-(carboxymethyl)-
N,N-dimethyl-, N-coco acyl derivatives, hydroxides, inner salts (CAS 
Reg. No. 61789-40-0), also known as cocamidopropyl betaine, when used 
as an inert ingredient (surfactant) up to 10% w/w in pesticide 
formulations applied to growing crops pre-harvest under 40 CFR 180.920.

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: May 2, 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

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, an entry for ``1-Propanaminium, 3-amino-N-(2-
carboxyethyl)-N,N-dimethyl-, N-coco acyl derivatives, inner salts (CAS 
Reg. No. 499781-63-4)'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
1-Propanaminium, 3-amino-N-(2-    25% w/w in          Adjuvant or
 carboxyethyl)-N,N-dimethyl-, N-   pesticide           surfactant.
 coco acyl derivatives, inner      formulation.
 salts (CAS Reg. No. 499781-63-
 4).
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 40396]]


0
3. In Sec.  180.920, amend table 1 to 180.920 by adding, in 
alphabetical order, an entry for ``1-Propanaminium, 3-amino-N-
(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivatives, hydroxides, 
inner salts (CAS Reg. No. 61789-40-0)'' to read as follows:


Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

                           Table 1 to 180.920
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
1-Propanaminium, 3-amino-N-       10% w/w in          Surfactant.
 (carboxymethyl)-N,N-dimethyl-,    pesticide
 N-coco acyl derivatives,          formulation.
 hydroxides, inner salts (CAS
 Reg. No. 61789-40-0).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2024-10182 Filed 5-9-24; 8:45 am]
BILLING CODE 6560-50-P