Rule2024-10182
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 10, 2024
Effective
May 10, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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- 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.
Full Text
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<title>Federal Register, Volume 89 Issue 92 (Friday, May 10, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#26746260746849524f4543556643564708414950"><span class="__cf_email__" data-cfemail="0f5d4b495d41607b666c6a7c4f6a7f6e21686079">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets#express">https://www.epa.gov/dockets/where-send-comments-epa-dockets#express</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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
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