Rule2025-14889
Ethyl Formate; Exemption From the Requirement of a Tolerance
Primary source
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Published
August 6, 2025
Effective
August 6, 2025
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of ethyl formate in or on citrus (10-10), kiwifruit (fuzzy and hardy), and table grapes when used as a fumigant in accordance with label directions and good agricultural practices. VPTox LLC, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) on behalf of Draslovka Services Pty Ltd, requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethyl formate in or on citrus, crop group 10-10; kiwifruit, fuzzy; kiwifruit, hardy, and grape, table in accordance with the terms of the exemption.
Full Text
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<title>Federal Register, Volume 90 Issue 149 (Wednesday, August 6, 2025)</title>
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[Federal Register Volume 90, Number 149 (Wednesday, August 6, 2025)]
[Rules and Regulations]
[Pages 37800-37804]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14889]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2024-0426; FRL-12782-01-OCSPP]
Ethyl Formate; Exemption From the Requirement of 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 ethyl formate in or on citrus (10-10),
kiwifruit (fuzzy and hardy), and table grapes when used as a fumigant
in accordance with label directions and good agricultural practices.
VPTox LLC, submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA) on behalf of Draslovka Services Pty Ltd,
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of ethyl formate in or on citrus, crop group 10-10;
kiwifruit, fuzzy; kiwifruit, hardy, and grape, table in accordance with
the terms of the exemption.
DATES: This regulation is effective August 6, 2025. Objections and
requests for hearings must be received on or before October 6, 2025 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-2024-0426, is available 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>.
[[Page 37801]]
FOR FURTHER INFORMATION CONTACT: Sydnie Vergara, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number: (202) 566-1606; email address:
<a href="/cdn-cgi/l/email-protection#a3e1f3f3e7e5f1edccd7cac0c6d0e3c6d3c28dc4ccd5"><span class="__cf_email__" data-cfemail="662436362220342809120f0503152603160748010910">[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.
<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 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, 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-2024-0426 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
October 6, 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>.
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 Exemption
In the Federal Register of November 12, 2024 (89 FR 88948) (FRL-
11682-09-OCSPP), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 0F8850) by VPTox LLC, on behalf of Draslovka
Services Pty Ltd., 21320 Sweet Clover Place, Ashburn, VA 20147. The
petitioner requested that 40 CFR part 180 be amended by establishing an
exemption from the requirement of a tolerance for residues of ethyl
formate. The petition did not specify any limit on the food commodities
for the tolerance exemption, and EPA's notice indicated that the
petition requested the exemption for all food commodities. The document
referenced a summary of the petition prepared by the petitioner,
Draslovka Services, which is available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Comments were received on the notice of filing.
One comment was in support of this regulation and was submitted by the
California Citrus Quality Council (CCQC). Three comments were not
substantive, and one comment was for a different chemical (submitted to
this docket in error).
III. Final Tolerance Actions
A. EPA's Safety Determination
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 to ethyl formate, including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with ethyl formate are
summarized in this Unit.
B. Toxicological Profile
Ethyl formate is of low acute and subchronic toxicity. All acute
toxicity data demonstrate that ethyl formate has low to negligible
toxicity. For most routes of exposure (acute dermal, acute inhalation,
primary eye irritation, and
[[Page 37802]]
primary dermal irritation), ethyl formate is classified as Toxicity
Category IV. For acute oral toxicity, it is classified as Toxicity
Category III. It is not a dermal sensitizer.
All data and information submitted to address the subchronic data
requirements (90-day oral, 90-day dermal, 90-day inhalation,
genotoxicity, prenatal developmental, and maternal toxicity) are
acceptable. For the 90-day oral toxicity, the study indicated the no-
observable-adverse-effect-level (NOAEL) is 1,000 mg/kg/day (limit
dose), and a lowest-observable-adverse-effect-level (LOAEL) is
therefore not established. The 90-day dermal toxicity was addressed by
scientific rationales since dermal exposure to ethyl formate is not
expected. For the 90-day inhalation toxicity, the study indicated the
NOAEL is equal or greater than the recommended limit dose of 1.0 mg/L
(330 ppm) and no endpoints were identified at this level. For
genotoxicity, the Ames test determined there was no concern for
genotoxic potential. The maternal toxicity, LOAEL for ethyl formate was
not determined and the maternal NOAEL is greater than or equal to 1,000
mg/kg/day (limit dose).
For the developmental toxicity, the study indicated the NOAEL is
300 mg/kg/day and the LOAEL is 1,000 mg/kg/day. The adverse effect
identified in the database is a 9% fetal body weight reduction
(combined sexes) at the extremely high dose (limit dose: 1000 mg/kg/
day). Ethyl formate is not stable, and it quickly breaks down once in
contact with water. Ethyl formate has a high volatility (vapor pressure
= 200 mmHg), and it is readily vaporized. Because both the NOAEL and
LOAEL dose levels are far from achievable in real life, they are not
considered relevant to human risk assessment.
C. Toxicological Points of Departure/Levels of Concern
No toxicological endpoints have been identified for ethyl formate
since it is of low toxicity, and significant exposure is not expected
based on the low application rates and rapid degradation in the
environment.
D. Exposure Assessment
1. Dietary exposure from food, feed uses and drinking water. As
part of its qualitative risk assessment for ethyl formate, the Agency
considered the potential for dietary exposure to residues of the
chemical. EPA concludes that dietary (food and drinking water)
exposures are expected to be negligible. The end-use products (EPs) are
used as fumigants in enclosed spaces and drinking water exposure is not
expected. Ethyl formate is rapidly hydrolyzed in the fruits, and its
residues are not anticipated to be found at levels beyond those occur
naturally in the fumigated commodities (citrus crop group 10-10;
kiwifruit, fuzzy; kiwifruit, hardy; and grape, table).
2. 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). The proposed ethyl
formate end-use products are classified as Restricted Use Pesticides,
(RUP) based upon the presence of inert ingredients that warrant
specific worker protections. These end-use products must be applied by
certified applicators. Residential handler exposures are not expected.
Because the proposed use pattern only allows for fumigation uses on
specific commodities, the product is not expected to be applied in
residential areas, so no post-application non-occupational exposure is
expected.
3. Cumulative Effects from Substances with a Common Mechanism of
Toxicity. FFDCA section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
considers ``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 ethyl formate to
share a common mechanism of toxicity with any other substances, and
ethyl formate does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that ethyl formate 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/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
E. Safety Factor for Infants and Children
FFDCA Section 408(b)(2)(C) provides that EPA shall retain 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. An FQPA safety factor is not required at this time for ethyl
formate because a qualitative dietary assessment has been conducted
based on negligible dietary exposure concerns.
F. Aggregate Risk
In accordance with the FFDCA, EPA must consider and aggregate (add)
pesticide exposures and risks from three major sources: food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources that have the same toxicological endpoints are
added together and compared to quantitative estimates of hazard, or the
risks themselves can be aggregated. When aggregating exposures and
risks from various sources, EPA considers both the route and duration
of exposure. A quantitative aggregate exposure and risk assessment was
not conducted in this review because dietary exposure to pesticidal
ethyl formate is considered negligible, there are no residential uses,
bystander inhalation exposure is low, and ethyl formate is of low
toxicity. No risks of concern have been identified.
A full explanation of the data upon which EPA relied and its risk
assessment based on those data can be found within the May 14, 2024,
document entitled ``Product Chemistry Review and Human Health Risk
Assessment for FIFRA Section 3 Registrations of eFUME Fumigant and
eFUME Onsite Fumigant, containing 99.76% Ethyl Formate as the Active
Ingredient, and eFUME Pre-mixed Fumigant, Containing 16.7% Ethyl
Formate as the Active Ingredient'' This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
G. Analytical Enforcement Methodology
An analytical method is not required because EPA is establishing an
exemption from the requirement of a tolerance without any numerical
limitation.
IV. Determination of Safety for U.S. Population, Infants and Children
Based on the Agency's assessment, EPA concludes that there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
ethyl formate.
[[Page 37803]]
V. Revisions to Petitioned-For Tolerances
The petitioner requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of ethyl formate on all food commodities. After submitting its
petition, the petitioner limited its corresponding pesticide
registration application to propose use only on citrus, kiwifruit, and
table grapes. Consequently, EPA is limiting this exemption from the
requirement of a tolerance for residues of ethyl formate in or on
citrus commodities in crop group 10-10; kiwifruit, fuzzy; kiwifruit,
hardy; and grape, table when used as a fumigant in accordance with
label directions and good agricultural practices.
VI. Conclusion
EPA is establishing an exemption from the requirement of a
tolerance for residues of the fumigant ethyl formate in or on the
commodities in citrus, crop group 10-10; kiwifruit, fuzzy; kiwifruit,
hardy, and grape, table when used in accordance with label directions
and good agricultural practice.
VII. 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/and-executive-orders">https://www.epa.gov/laws-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, 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 review documents,
located in the applicable 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 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: July 28, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
For the reasons stated in the preamble, EPA is amending 50 CFR
chapter I as follows:
PART 180--[AMENDED]
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. Add Sec. 180.1419 to subpart D to read as follows:
Sec. 180.1419 Ethyl formate; Exemption from the Requirement of a
Tolerance.
An exemption from the requirement of a tolerance is established for
residues of the fumigant ethyl formate in or on the commodities in the
citrus crop group 10-10; kiwifruit, fuzzy; kiwifruit, hardy; and grape,
table when used in
[[Page 37804]]
accordance with label directions and good agricultural practices.
[FR Doc. 2025-14889 Filed 8-5-25; 8:45 am]
BILLING CODE P
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