Rule2025-10307
Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic) Acid, and Pelargonic (Nonanoic) Acid)
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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
June 10, 2025
Effective
June 10, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is finalizing several tolerance actions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that the Agency previously determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During registration review, EPA reviews all aspects of a pesticide case, including existing tolerances, to ensure that the pesticide continues to meet the standard for registration under FIFRA.
Full Text
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<title>Federal Register, Volume 90 Issue 110 (Tuesday, June 10, 2025)</title>
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[Federal Register Volume 90, Number 110 (Tuesday, June 10, 2025)]
[Rules and Regulations]
[Pages 24348-24351]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10307]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0454; FRL-12177-02-OCSPP]
RIN 2070-ZA16
Pesticide Tolerances; Implementing Registration Review Decisions
for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic)
Acid, and Pelargonic (Nonanoic) Acid)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
finalizing several tolerance actions under the Federal Food, Drug, and
Cosmetic Act (FFDCA) that the Agency previously determined were
necessary or appropriate during the registration review conducted under
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During
registration review, EPA reviews all aspects of a pesticide case,
including existing tolerances, to ensure that the pesticide continues
to meet the standard for registration under FIFRA.
DATES: This rule is effective on June 10, 2025. For actions in this
final rule that lower or revoke existing tolerances, the expiration
date for the existing tolerance is December 10, 2025. Objections and
requests for hearings must be received on or before August 11, 2025,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.D. of this document).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2023-0454, is available through
<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: Anita Pease, Antimicrobials Division
(7510M), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-0736; email address: <a href="/cdn-cgi/l/email-protection#7202171301175c131c1b0613321702135c151d04"><span class="__cf_email__" data-cfemail="e09085819385ce818e899481a0859081ce878f96">[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
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. What action is the Agency taking?
EPA is finalizing several tolerance actions that the Agency
proposed in the Federal Register of September 6, 2024 (89 FR 72775
(FRL-12177-01-OCSPP)), because EPA previously determined these
tolerance actions were necessary or appropriate during registration
review of the pesticide active ingredients identified in Unit III. of
this final rule. The tolerance actions for each pesticide active
ingredient are described in Unit III. of the proposed rule and may
include but are not limited to the following types of actions:
<bullet> Revising tolerance expressions;
<bullet> Modifying commodity definitions;
<bullet> Updating crop groupings;
<bullet> Removing expired tolerances;
<bullet> Revoking tolerances that are no longer needed; and
<bullet> Harmonizing tolerances with the Codex Alimentarius
Commission (Codex) Maximum
Residue Levels (MRLs).
As indicated in the proposed rule, this final rule may reflect the
Agency's 2019 adoption of the Organization of Economic Cooperation and
Development (OECD) Rounding Class Practice. More information on the
OECD Rounding Class Practice can be found at <a href="https://one.oecd.org/document/ENV/JM/MONO">https://one.oecd.org/document/ENV/JM/MONO</a>(2011)2/en/pdf. Where applicable, these adjustments
for specific pesticides are reflected in the final regulatory text.
C. What is EPA's authority for taking this action?
FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to
establish, modify, or revoke tolerances or exemptions from the
requirement of a tolerance on its own initiative. After providing a 60-
day public comment period, EPA may finalize the rule. EPA provided a
60-day comment period and is now finalizing the rule.
FFDCA section 408(b)(2)(A)(i) allows EPA to establish a tolerance
(the legal limit for a pesticide chemical residue in or on a food) only
if EPA determines that the tolerance is ``safe.'' FFDCA section
408(b)(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. FFDCA section 408(b)(2)(C)
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 . . . .''
Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to
periodically review all registered pesticides and determine if those
pesticides continue to meet the standard for registration under FIFRA.
To learn more about the registration review, please see Unit II.C. of
the proposed rule ``Pesticide Tolerances; Implementing Registration
Review Decisions for Certain Pesticides (Capric (Decanoic) Acid,
Caprylic (Octanoic) Acid, and Pelargonic (Nonanoic) Acid)'' (89 FR
72775, September 6, 2024 (FRL-12177-01-OCSPP)).
D. 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 chemical specific docket
ID number as provided in Unit III. in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing
[[Page 24349]]
and must be received by the Hearing Clerk on or before August 11, 2025.
The 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 the EPA's regulations require submission via U.S. Mail or hand
delivery, the EPA intends to treat submissions filed via electronic
means as properly filed submissions; therefore, the 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>.
II. Background
In the Federal Register of September 6, 2024 (89 FR 72775 (FRL-
12177-01-OCSPP)), EPA proposed several tolerance actions to amend
established tolerance exemptions for capric (decanoic) acid, caprylic
(octanoic) acid, and pelargonic (nonanoic) acid. The Agency previously
determined in a March 2022 Combined Preliminary Work Plan/Proposed
Interim Decision that these amendments were necessary or appropriate
during registration review of these pesticide active ingredients. For
additional background information, see Unit II. of the proposed rule.
EPA received six comments in response to the proposed rule. Two
comments were in support of the Agency action (see <a href="https://www.regulations.gov">https://www.regulations.gov</a> for public comments identified as Document ID Nos.
EPA-HQ-OPP-2023-0454-0003 and EPA-HQ-OPP-2023-0454-0007). Four comments
suggested EPA eliminate redundancies but maintain tolerances on capric
acid, caprylic acid, and pelargonic acid, either at the existing level
or consistent with global tolerance levels (see public comments
identified as Document ID Nos. EPA-HQ-OPP-2023-0454-0002, EPA-HQ-OPP-
2023-0454-0004, EPA-HQ-OPP-2023-0454-0005, and EPA-HQ-OPP-2023-0454-
0006). These commenters noted general concerns that consumers may
assume foods are free of pesticides, that there is a potential for
consumption in large quantities, and that there may be unknown long-
term effects. The existing legal framework provided by section 408 of
the FFDCA authorizes EPA to establish tolerances when it determines
that the tolerance is safe. Upon consideration of the validity,
completeness, and reliability of the available data as well as other
factors that the FFDCA requires EPA to consider, EPA has determined
that these exemptions from the requirement of a tolerance are safe. The
commenters provided no information supporting a conclusion that the
exemptions for pelargonic acid, capric acid, and caprylic acid are not
safe. As stated in the ``Pelargonic Acid, Salts and Esters; Fatty Acid
Monoesters; Capric Acid; and Caprylic Acid Combined Preliminary Work
Plan and Proposed Interim Decision'' (March 2022), due to low systemic
toxicity and low probability of dietary (human) exposure when used
according to label directions, no dietary endpoints were selected and
therefore, no quantitative risk assessment was deemed necessary at the
time. While there is the potential for dietary exposure, it is likely
low due to the approved use patterns, and EPA has not identified any
risks of concern due to the low toxicity. Therefore, the Agency's
conclusions from the most recent qualitative risk assessment still
apply; there are no dietary risks of concern for registered uses. The
comments received on the proposal did not change the Agency's tolerance
assessment and final decision.
III. Final Tolerance Actions
A. EPA's Safety Determination
As noted in the proposed rule, EPA has assessed the individual
risks from exposure to capric (decanoic) acid, caprylic (octanoic)
acid, and pelargonic (nonanoic) acid, as discussed in Unit III. of the
proposed rule, taking into consideration all reliable data on toxicity
and exposure, including for infants and children, and has included a
safety finding under FFDCA section 408(b) for the tolerance actions in
the proposed rule. After fully considering comments on the proposed
rule, EPA is confirming the safety findings contained in Unit III. of
the proposed rule.
Based on the supporting risk assessments and registration review
documents, which demonstrate that the aggregate exposure for each
individual chemical is below the Agency's level of concern, EPA
concludes there is a reasonable certainty that no harm will result to
the general population, or specifically to infants and children, from
aggregate exposure to residues of capric (decanoic) acid, caprylic
(octanoic) acid, and pelargonic (nonanoic) acid (Docket ID No. EPA-HQ-
OPP-2021-0336). For further detail about pesticide-specific
registration review findings, see the public docket that has been
opened for each pesticide, which is available online at <a href="https://www.regulations.gov">https://www.regulations.gov</a> using the docket ID number listed in Unit III. of
the proposed rule.
B. Analytical Enforcement Methodology
Adequate enforcement methodology as described in the supporting
documents is available to enforce the tolerance expressions.
C. Conclusion
Therefore, EPA is finalizing the tolerance action proposed in the
September 6, 2024 proposed rule. Specifically, EPA is removing the
redundant exemptions and limits for capric (decanoic) acid under 40 CFR
180.940(b) and (c) entirely, removing the 100 ppm limit for capric
(decanoic) acid from 40 CFR 180.940(a), and removing the limit of 170
ppm under 40 CFR 180.1225 for capric (decanoic) acid. EPA is removing
the redundant exemptions and limits for caprylic (octanoic) acid from
40 CFR 180.940(a) (limit of 52 ppm), (b), and (c) entirely, and
removing the 100 ppm limits for caprylic (octanoic) acid from 40 CFR
180.940(a). EPA is also removing the redundant exemptions and limits
for pelargonic (nonanoic) acid from 40 CFR 180.940(b) and (c) entirely,
removing the 100 ppm limit for pelargonic (nonanoic) acid from 40 CFR
180.940(a), and removing the limit of 170 ppm under 40 CFR 180.1159(c)
for pelargonic (nonanoic) acid.
IV. Effective and Expiration Date(s)
These tolerance actions are effective on the date of publication of
the final rule in the Federal Register. For actions in the final rule
that lower or revoke existing tolerances, EPA has set an expiration
date for the existing tolerance of December 10, 2025, six months after
the date of publication of the final rule in the Federal Register, to
allow a reasonable interval for producers in exporting members of the
World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS)
Measures Agreement to adapt to the requirements.
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>.
[[Page 24350]]
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.
This exemption also applies to tolerance revocations for which
extraordinary circumstances do not exist. As such, this exemption
applies to the tolerance revocations in this final rule because the
Agency knows of no extraordinary circumstances that warrant
reconsideration of this exemption for those tolerance revocations.
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)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this action is any significant adverse economic
impact on small entities and that the Agency is certifying that this
action will not have a significant economic impact on a substantial
number of small entities because the action has no net burden on small
entities subject to this rulemaking. As discussed in the proposed rule,
this determination takes into account the EPA analysis for the
establishment and modification of tolerances. EPA did not receive any
comments on these conclusions as presented in the proposed rule.
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 V.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: May 23, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons set forth 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. Amend Sec. 180.940 by:
0
a. In table 1 to paragraph (a):
0
i. Adding in alphabetical order the entries for ``Capric (decanoic)
acid'' and ``Caprylic (octanoic) acid'';
0
ii. Removing the entries for ``Decanoic acid'' and ``Nonanoic acid''
and the two entries for ``Octanoic acid''; and
0
iii. Adding in alphabetical order the entry for ``Pelargonic (nonanoic)
acid'';
0
b. In the table in paragraph (b):
0
i. Adding a table heading; and
0
ii. Removing the entries for ``Decanoic acid'', ``Nonanoic acid'', and
``Octanoic acid''; and
0
c. In the table in paragraph (c):
0
i. Adding a table heading; and
0
ii. Removing the entries for ``Decanoic acid'', ``Nonanoic acid'', and
``Octanoic acid''.
The additions read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
[[Page 24351]]
Table 1 to Paragraph (a)
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Pesticide chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
Capric (decanoic) acid.......... 334-48-5......... None.
Caprylic (octanoic) acid........ 124-07-2......... None.
* * * * * * *
Pelargonic (nonanoic) acid...... 112-05-0......... None.
* * * * * * *
------------------------------------------------------------------------
* * * * *
(b) * * *
Table 2 to Paragraph (b)
* * * * *
(c) * * *
Table 3 to Paragraph (c)
* * * * *
0
3. Amend Sec. 180.1159 by revising the section heading and revising
and republishing paragraph (c) to read as follows:
Sec. 180.1159 Pelargonic (nonanoic) acid; exemption from the
requirement of tolerances.
* * * * *
(c) An exemption from the requirement of a tolerance is established
for residues of pelargonic (nonanoic) acid in or on all raw
agricultural commodities and in processed commodities, when such
residues result from the use of pelargonic (nonanoic) acid as an
antimicrobial treatment for application on food contact surfaces such
as equipment, pipelines, tanks, vats, fillers, evaporators,
pasteurizers and aseptic equipment in restaurants, food service
operations, dairies, breweries, wineries, beverage and food processing
plants.
0
4. Revise and republish Sec. 180.1225 to read as follows:
Sec. 180.1225 Capric (decanoic) acid; exemption from the requirement
of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of capric (decanoic) acid in or on all raw agricultural
commodities and in processed commodities, when such residues result
from the use of capric (decanoic) acid as an antimicrobial treatment in
solutions containing a diluted end-use concentration of capric
(decanoic) acid on food contact surfaces such as equipment, pipelines,
tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment
in restaurants, food service operations, dairies, breweries, wineries,
beverage and food processing plants.
[FR Doc. 2025-10307 Filed 6-9-25; 8:45 am]
BILLING CODE 6560-50-P
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