Rule2025-19916
Oxirane, Methyl-, Polymer With Oxirane, Monobutyl Ether and Oxirane, 2-Methyl, Polymer With Oxirane, Monomethyl Ether in Pesticide Formulations; Exemption From the Requirement for a Tolerance
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
November 17, 2025
Effective
November 17, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of oxirane, methyl-, polymer with oxirane, monobutyl ether (CAS Reg. No. 9038-95-3) minimum number average molecular weight 800 Daltons and a limitation of 10% for oxirane, 2- methyl-, polymer with oxirane, monomethyl ether (CAS Reg. No. 9063-06- 3) minimum number average molecular weight 800 Daltons as inert ingredients when used as an inert ingredient (adjuvant, carrier, diluent or solvent) on growing crops and raw agricultural commodities pre- and post-harvest under 40 CFR 180.910 and to animals under 40 CFR 180.930. Spring Regulatory Sciences on behalf of Evonik Corporation 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 oxirane, methyl-, polymer with oxirane, monobutyl ether and oxirane, 2-methyl-, polymer with oxirane, monomethyl ether, when used in accordance with the terms of those exemptions.
Full Text
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[Federal Register Volume 90, Number 219 (Monday, November 17, 2025)]
[Rules and Regulations]
[Pages 51164-51168]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19916]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0003; FRL-12980-01-OCSPP]
Oxirane, Methyl-, Polymer With Oxirane, Monobutyl Ether and
Oxirane, 2-Methyl, Polymer With Oxirane, Monomethyl Ether in Pesticide
Formulations; Exemption From the Requirement for a Tolerance
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 oxirane, methyl-, polymer with oxirane,
monobutyl ether (CAS Reg. No. 9038-95-3) minimum number average
molecular weight 800 Daltons and a limitation of 10% for oxirane, 2-
methyl-, polymer with oxirane, monomethyl ether (CAS Reg. No. 9063-06-
3) minimum number average molecular weight 800 Daltons as inert
ingredients when used as an inert ingredient (adjuvant, carrier,
diluent or solvent) on growing crops and raw agricultural commodities
pre- and post-harvest under 40 CFR 180.910 and to animals under 40 CFR
180.930. Spring Regulatory Sciences on behalf of Evonik Corporation
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 oxirane, methyl-,
polymer with oxirane, monobutyl ether and oxirane, 2-methyl-, polymer
with oxirane, monomethyl ether, when used in accordance with the terms
of those exemptions.
DATES: This regulation is effective November 17, 2025. Objections and
requests for hearings must be received on or before January 16, 2026
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2023-0003, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#feacbab8acb0918a979d9b8dbe9b8e9fd0999188"><span class="__cf_email__" data-cfemail="0c5e484a5e426378656f697f4c697c6d226b637a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
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 might apply to
them:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What is EPA's authority for taking this action?
EPA is issuing this rulemaking under section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section
408(c)(2)(A)(i) 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.'' FFDCA section 408(c)(2)(A)(ii) 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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from the requirement of a tolerance,
EPA must take into account the factors set forth in FFDCA section
408(b)(2)(C), which require 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. . . .''
Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider, among other things, ``available information concerning the
cumulative effects of a particular pesticide's residues'' and ``other
substances that have a common mechanism of toxicity.''
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. If you fail to file an objection to the
final rule within the time period specified in the final rule, you will
have waived the right to raise any issues resolved in the final rule.
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 the docket ID number EPA-HQ-
OPP-2023-0003 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 16, 2026.
EPA's Office of Administrative Law Judges (OALJ), in which the
Hearing Clerk is housed, urges parties to file and serve documents by
electronic means only, notwithstanding any other particular
requirements set forth in other procedural rules governing those
proceedings. See ``Revised Order Urging Electronic Filing and
Service,'' dated June 22, 2023, which can be found at <a href="https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf">https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf</a>.
Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions; therefore, EPA believes the preference
for submission via electronic means will not be prejudicial. When
submitting documents to the OALJ electronically, a person should
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
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 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow
the online instructions for submitting
[[Page 51165]]
comments. Do not submit electronically any information you consider to
be CBI or other information whose disclosure is restricted by statute.
If you wish to include CBI in your request, please follow the
applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the information that you claim to be
CBI. Information not marked confidential pursuant to 40 CFR part 2 may
be disclosed publicly by EPA without prior notice.
II. Petition for Exemption
In the Federal Register of February 23, 2023 (88 FR 11401, FRL-
10579-01-OCSPP), EPA issued a document pursuant to FFDCA section 408,
21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11716) by Spring Regulatory Sciences (6620 Cypresswood Dr., Suite 250,
Spring, TX 77379) on behalf of Evonik Corporation (P.O. Box 34628,
Richmond, Virginia 23234). The petition requested that 40 CFR be
amended by establishing an exemption from the requirement of a
tolerance for residues of oxirane, methyl-, polymer with oxirane,
monobutyl ether (CAS Reg. No. 9038-95-3) minimum number average
molecular weight 800 Da and oxirane, 2-methyl-, polymer with oxirane,
monomethyl ether (CAS Reg. No. 9063-06-3) minimum number average
molecular weight 800 Da when used as an inert ingredient (adjuvant,
carrier, diluent or solvent) in pesticide formulations applied to
growing crops or raw agricultural commodities pre- and post-harvest
under 40 CFR 180.910 and in/on animals under 40 CFR 180.930. That
document referenced a summary of the petition prepared by Spring
Regulatory Sciences on behalf of Evonik Corporation, the petitioner,
which is available in the docket. 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. Final Tolerance Action
A. EPA's Safety Determination
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 oxirane, methyl-, polymer with
oxirane, monobutyl ether and oxirane, 2-methyl-, polymer with oxirane,
monomethyl ether including exposure resulting from the exemption
established by this action. EPA's assessment of exposures and risks
associated with oxirane, methyl-, polymer with oxirane, monobutyl ether
and oxirane, 2-methyl-, polymer with oxirane, monomethyl ether follows.
B. 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 oxirane, methyl-, polymer with
oxirane, monobutyl ether and oxirane, 2-methyl-, polymer with oxirane,
monomethyl 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 oxirane, methyl-, polymer with
oxirane, monobutyl ether and oxirane, 2-methyl-, polymer with oxirane,
monomethyl ether is supported by data regarding butoxypolypropylene
glycol, dipropylene glycol monobutyl ether, and poly(oxy-1,2-
ethanediyl), [alpha]-hydro-[omega]-hydroxy- ethane-1,2-diol,
ethoxylated. EPA has determined that it is appropriate to bridge the
aforementioned surrogate chemicals data to assess oxirane, methyl-,
polymer with oxirane, monobutyl ether and oxirane, 2-methyl-, polymer
with oxirane, monomethyl ether due to similarities in the structures,
composition, and physical/chemical properties.
Based on the available read-across data, oxirane, methyl-, polymer
with oxirane, monobutyl ether and oxirane, 2-methyl-, polymer with
oxirane, monomethyl ether exhibit low levels of acute toxicity via the
oral, dermal, and inhalation routes of exposure. They are expected to
be slightly irritating to the skin and moderately irritating to the
eyes, but not skin sensitizers. In repeated-dose toxicity studies, the
kidneys and liver are the major target organs. However, the effects
observed in oral toxicity studies occurred at doses at or above the
limit dose and thus, are not considered relevant for risk assessment
purposes. Based on the results from a repeated-dose inhalation study,
inhalation is the route of toxicological concern for oxirane, methyl-,
polymer with oxirane, monobutyl ether and oxirane, 2-methyl-, polymer
with oxirane, monomethyl ether, with portal-of-entry effects observed.
There is no evidence of susceptibility in the available developmental
toxicity study. Concern for carcinogenicity is low, based on negative
results in mutagenicity and genotoxicity studies and lack of effects in
the available chronic study.
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.
[[Page 51166]]
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, EPA 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>.
An acute dietary endpoint was not selected because no effect
attributable to a single dose was identified in the database. No
chronic dietary, incidental oral, or dermal endpoint was selected
because the effects observed in the oral studies occurred at doses
above the limit dose, which are not relevant for risk assessment
purposes. The short-term and intermediate-term inhalation endpoints are
derived from the two-week inhalation toxicity study in rats, with a
NOAEL of 52 mg/m\3\ and a LOAEL of 512 mg/m\3\, based on minor ocular/
nasal irritation. This represents the lowest NOAEL in the database in
the most sensitive species. The standard uncertainty factors (UFs) were
applied to account for interspecies (10x) and intraspecies (10x)
variations. The default value of 100% was used for the inhalation
absorption factor.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to oxirane, methyl-, polymer with oxirane, monobutyl ether and
oxirane, 2-methyl-, polymer with oxirane, monomethyl ether, EPA
considered exposure under the proposed exemption from the requirement
of a tolerance. EPA assessed dietary exposures from oxirane, methyl-,
polymer with oxirane, monobutyl ether and oxirane, 2- methyl-, polymer
with oxirane, monomethyl ether in food as follows:
Dietary exposure (food and drinking water) to oxirane, methyl-,
polymer with oxirane, monobutyl ether and oxirane, 2-methyl-, polymer
with oxirane, monomethyl ether may occur following ingestion of foods
with residues from their use in accordance with this exemption.
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).
Oxirane, methyl-, polymer with oxirane, monobutyl ether and
oxirane, 2-methyl-, polymer with oxirane, monomethyl ether may be
present in pesticide and non-pesticide products that may be 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 Standard Operating Procedures (available at <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>.)
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 oxirane, methyl-, polymer with oxirane, monobutyl
ether and oxirane, 2-methyl-, polymer with oxirane, monomethyl ether to
share a common mechanism of toxicity with any other substances, and
oxirane, methyl-, polymer with oxirane, monobutyl ether and oxirane, 2-
methyl-, polymer with oxirane, monomethyl ether do not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance exemption, therefore, EPA has assumed that
oxirane, methyl-, polymer with oxirane, monobutyl ether and oxirane, 2-
methyl-, polymer with oxirane, monomethyl ether 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 FQPA Safety Factor (SF). 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 oxirane,
methyl-, polymer with oxirane, monobutyl ether and oxirane, 2-methyl-,
polymer with oxirane, monomethyl 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) no developmental or
reproductive effects were observed in the available developmental
study; (3) no evidence of neurotoxicity was observed in the database;
and (4) the assumptions for the exposure assessment are conservative
and unlikely to underestimate risk.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
oxirane, methyl-, polymer with oxirane, monobutyl ether and oxirane, 2-
methyl-, polymer with oxirane, monomethyl ether are not expected to
pose an acute risk.
[[Page 51167]]
2. Chronic risk. A chronic aggregate risk assessment considers
exposure estimates from chronic dietary consumption of food and
drinking water. Although dietary exposure via food and drinking water
is anticipated, no chronic dietary endpoints of concern were
identified; therefore, a quantitative dietary exposure assessment was
not conducted and oxirane, methyl-, polymer with oxirane, monobutyl
ether and oxirane, 2-methyl-, polymer with oxirane, monomethyl ether
are not expected to pose a chronic aggregate risk.
1. 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).
Oxirane, methyl-, polymer with oxirane, monobutyl ether and
oxirane, 2-methyl-, polymer with oxirane, monomethyl ether may be used
as inert ingredients in pesticide products that are registered for uses
that could result in short- and intermediate-term residential
exposures. However, no endpoints were selected for chronic dietary or
dermal exposures. Therefore, the aggregate risk assessment consists of
only the short- and intermediate-term residential inhalation handler
exposures, with MOEs ranging from 2,600 to 59,000. As the level of
concern is for MOEs that are lower than 100, these MOEs are not of
concern.
F. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
oxirane, methyl-, polymer with oxirane, monobutyl ether and oxirane, 2-
methyl-, polymer with oxirane, monomethyl ether in or on any food
commodities. EPA is establishing a limitation on the amount of oxirane,
2-methyl-, polymer with oxirane, monomethyl ether that may be used in
pesticide formulations applied pre-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 10% oxirane, 2-methyl-, polymer with oxirane, monomethyl
ether in the final pesticide formulation.
G. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of oxirane, methyl-, polymer with oxirane,
monobutyl ether (CAS Reg. No. 9038-95-3) minimum number average
molecular weight 800 Daltons and a limitation of 10% for oxirane, 2-
methyl-, polymer with oxirane, monomethyl ether (CAS Reg. No. 9063-06-
3) minimum number average molecular weight 800 Daltons when used as an
inert ingredient (adjuvant, carrier, diluent or solvent) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest under 40 CFR 180.910 and when used to animals under 40
CFR 180.930.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/regulations/and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review
This action is exempt from review under Executive Order 12866 (58
FR 51735, October 4, 1993), because it establishes or modifies a
pesticide tolerance or a tolerance exemption under FFDCA section 408 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.
B. Executive Order 14192: Unleashing Prosperity Through Deregulation
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply
because actions that establish a tolerance under FFDCA section 408 are
exempted from review under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose an information collection burden under
the PRA 44 U.S.C. 3501 et seq., because it does not contain any
information collection activities.
D. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the Administrative Procedure Act (APA), 5 U.S.C.
553, or any other statute. This rule is not subject to the APA but is
subject to FFDCA section 408(d), which does not require notice and
comment rulemaking to take this action in response to a petition.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more (in 1995 dollars and adjusted annually for inflation) as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. The action imposes no enforceable duty on any
State, local or tribal governments or the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and the Indian Tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian Tribes.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not a significant regulatory action under
section 3(f)(1) of Executive Order 12866 (See Unit VI.A.), and because
EPA does not believe the environmental health or safety risks addressed
by this action present a disproportionate risk to children. However,
EPA's 2021 Policy on Children's Health applies to this action.
This rule finalizes tolerance actions under the FFDCA, which
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 . . .'' (FFDCA 408(b)(2)(C)). The Agency's
consideration is documented in the pesticide-specific registration
review documents, located in the applicable docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[[Page 51168]]
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not subject to Executive Order 13211 (66 FR 28355)
(May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.
J. National Technology Transfer Advancement Act (NTTAA)
This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
K. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action does not meet the
criteria set forth in 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: October 10, 2025.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
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, an entry for ``oxirane, methyl-, polymer with
oxirane, monobutyl ether'' and ``oxirane, 2-methyl-, polymer with
oxirane, monomethyl 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
------------------------------------------------------------------------
* * * * * * *
Oxirane, methyl-, polymer with None.............. adjuvant, carrier,
oxirane, monobutyl ether (CAS diluent or
Reg. No. 9038-95-3) minimum solvent.
number average molecular weight
800 Daltons.
Oxirane, 2-methyl-, polymer with Not more than 10% adjuvant, carrier,
oxirane, monomethyl ether (CAS of pesticide diluent or
Reg. No. 9063-06-3) minimum formulations. solvent.
number average molecular weight
800 Daltons.
* * * * * * *
------------------------------------------------------------------------
0
3. In Sec. 180.930, amend Table 1 to 180.930 by adding, in
alphabetical order, an entry for ``oxirane, methyl-, polymer with
oxirane, monobutyl ether'' and ``oxirane, 2-methyl-, polymer with
oxirane, monomethyl ether'' to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
Table 1 to 180.930
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Oxirane, methyl-, polymer with None.............. adjuvant, carrier,
oxirane, monobutyl ether (CAS diluent or
Reg. No. 9038-95-3) minimum solvent.
number average molecular weight
800 Daltons.
Oxirane, 2-methyl-, polymer with Not more than 10% adjuvant, carrier,
oxirane, monomethyl ether (CAS of pesticide diluent or
Reg. No. 9063-06-3) minimum formulations. solvent.
number average molecular weight
800 Daltons.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2025-19916 Filed 11-14-25; 8:45 am]
BILLING CODE 6560-50-P
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