Rule2025-19915
Castor Oil, Polymer With 2-Ethylhexanol, Maleic Anhydride and Soybean Oil, Sodium Salt in Pesticide Formulations: Tolerance Exemption
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 castor oil, polymer with 2-ethylhexanol, maleic anhydride and soybean oil, sodium salt (CAS No. 3057850-65-1) minimum number average molecular weight 4571; when used as an inert ingredient in a pesticide chemical formulation under 40 CFR 180.960. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Spring Regulatory Sciences on behalf of Ashland Specialty Ingredients G.P. submitted a petition to EPA requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of castor oil, polymer with 2-ethylhexanol, maleic anhydride and soybean oil, sodium salt on food or feed commodities when used in accordance with these exemptions.
Full Text
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<title>Federal Register, Volume 90 Issue 219 (Monday, November 17, 2025)</title>
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[Federal Register Volume 90, Number 219 (Monday, November 17, 2025)]
[Rules and Regulations]
[Pages 51123-51127]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19915]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2025-0079; FRL-12955-01-OCSPP]
Castor Oil, Polymer With 2-Ethylhexanol, Maleic Anhydride and
Soybean Oil, Sodium Salt in Pesticide Formulations: Tolerance Exemption
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 castor oil, polymer with 2-ethylhexanol,
maleic anhydride and soybean oil, sodium salt (CAS No. 3057850-65-1)
minimum number average molecular weight 4571; when used as an inert
ingredient in a pesticide chemical formulation under 40 CFR 180.960.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Spring
Regulatory Sciences on behalf of Ashland Specialty Ingredients G.P.
submitted a petition to EPA requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of castor oil,
polymer with 2-ethylhexanol, maleic anhydride and soybean oil, sodium
salt on food or feed commodities when used in accordance with these
exemptions.
DATES: This regulation is effective November 17, 2025. Objections and
requests for hearings must be received
[[Page 51124]]
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 the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2025-0079 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 center 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#36647270647859425f5553457653465718515940"><span class="__cf_email__" data-cfemail="df8d9b998d91b0abb6bcbaac9fbaafbef1b8b0a9">[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. Can I file an objection or hearing request?
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-2025-0079 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 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. Petitioned for Tolerance
In the Federal Register of July 3, 2025 (90 FR [29516]) (FRL-12474-
05), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PPIN-11998) filed
by Spring Regulatory Sciences, 6620 Cypresswood Dr., Suite 250, Spring,
TX 77379 on behalf of Ashland Specialty Ingredients G.P. (8145 Blazer
Drive, Wilmington, DE 19808). The petition requested that 40 CFR
180.960 be amended by establishing an exemption from the requirement of
a tolerance for residues of castor oil, polymer with 2-ethylhexanol,
maleic anhydride and soybean oil, sodium salt (CAS No. 3057850-65-1)
minimum number average molecular weight 4571. That document included a
summary of the petition prepared by the petitioner and solicited
comments on the petitioner's request. The Agency did not receive any
comments.
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
[[Page 51125]]
use in residential settings but does not include occupational exposure.
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 an exemption from the requirement of 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 . . .'' and specifies factors EPA is to
consider in establishing an exemption.
III. Final Tolerance Action
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks 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(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information 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. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Castor oil, polymer with 2-
ethylhexanol, maleic anhydride and soybean oil, sodium salt conforms to
the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize. An
available biodegradation study supports that castor oil, polymer with
2-ethylhexanol, maleic anhydride and soybean oil, sodium salt is not
readily biodegradable (MRID 52499102).
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 Daltons.
7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6).
Additionally, the polymer also meets as required the following
exemption criteria: specified in 40 CFR 723.250(e).
The polymer's number average MW of 4571 Daltons is greater than
1,000 and less than 10,000 Daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
Thus, castor oil, polymer with 2-ethylhexanol, maleic anhydride and
soybean oil, sodium salt meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to castor oil, polymer with 2-
ethylhexanol, maleic anhydride and soybean oil, sodium salt.
A. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that castor oil, polymer with 2-ethylhexanol,
maleic anhydride and soybean oil, sodium salt could be present in all
raw and processed agricultural commodities and drinking water, and that
non-occupational non-dietary exposure was possible. The number average
MW of castor oil, polymer with 2-ethylhexanol, maleic anhydride and
soybean oil, sodium salt is 4571 Daltons. Generally, a polymer of this
size would be poorly absorbed through the intact gastrointestinal tract
or through intact human skin. Since castor oil, polymer with 2-
ethylhexanol, maleic anhydride and soybean oil, sodium salt conform to
the criteria that identify a low-risk polymer, there are no concerns
for risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.
B. 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 castor oil, polymer with 2-ethylhexanol, maleic
anhydride and soybean oil, sodium salt to share a common mechanism of
toxicity with any other substances, and castor oil, polymer with 2-
ethylhexanol, maleic anhydride and soybean oil, sodium salt does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance exemption, therefore, EPA has assumed
that castor oil, polymer with 2-ethylhexanol, maleic anhydride and
soybean oil, sodium salt does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
<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>.
C. 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. Due to the expected low
toxicity of castor oil, polymer with 2-ethylhexanol, maleic anhydride
and soybean oil, sodium salt, EPA has not used a safety factor analysis
to assess
[[Page 51126]]
the risk. For the same reasons no additional safety factor is needed
for assessing risk to infants and children.
D. Determination of Safety
Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of castor oil, polymer with 2-
ethylhexanol, maleic anhydride and soybean oil, sodium salt.
E. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
F. Conclusion
Accordingly, EPA finds that exempting residues of castor oil,
polymer with 2-ethylhexanol, maleic anhydride and soybean oil, sodium
salt from the requirement of a tolerance will be safe.
VI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-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.
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 each chemical docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended 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. Amend Sec. 180.960, in table 1, by adding in alphabetical order an
entry for ``Castor oil, polymer with 2-ethylhexanol, maleic anhydride
and soybean oil, sodium salt'' to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
[[Page 51127]]
Table 1 to Sec. 180.960
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Polymer CAS No.
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* * * * * * *
Castor oil, polymer with 2-ethylhexanol, maleic 3057850-65-1
anhydride and soybean oil, sodium salt, minimum
number average molecular weight 4571(in amu).........
* * * * * * *
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[FR Doc. 2025-19915 Filed 11-14-25; 8:45 am]
BILLING CODE 6560-50-P
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