Sodium Nitrate in Pesticide Formulations; Exemption From the Requirement of a Tolerance
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Issuing agencies
Abstract
This regulation establishes an exemption from the requirement of a tolerance for residues of sodium nitrate (CAS Reg. No. 7631-99-4) when used as an inert ingredient (dilutant/oxidizer) in pesticide formulations applied to raw agricultural commodities post-harvest under 40 CFR 180.910, only when used in a fumigant canister that is remotely detonated and released inside a sealed warehouse. AgroFresh Inc. 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 sodium nitrate, when used in accordance with the terms of this exemption. This action also corrects a typographical error to the CAS Reg. No. of d-Alpha tocopherol. A digit was inadvertently omitted from the previously listed CAS Reg. No., resulting in a number that is not valid and does not represent any chemical.
Full Text
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<title>Federal Register, Volume 91 Issue 114 (Monday, June 15, 2026)</title>
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[Federal Register Volume 91, Number 114 (Monday, June 15, 2026)]
[Rules and Regulations]
[Pages 35892-35897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11941]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2023-0296; FRL-13292-01-OCSPP]
Sodium Nitrate in Pesticide Formulations; 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 sodium nitrate (CAS Reg. No. 7631-99-4)
when used as an inert ingredient (dilutant/oxidizer) in pesticide
formulations applied to raw agricultural commodities post-harvest under
40 CFR 180.910, only when used in a fumigant canister that is remotely
[[Page 35893]]
detonated and released inside a sealed warehouse. AgroFresh Inc.
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 sodium nitrate,
when used in accordance with the terms of this exemption. This action
also corrects a typographical error to the CAS Reg. No. of d-Alpha
tocopherol. A digit was inadvertently omitted from the previously
listed CAS Reg. No., resulting in a number that is not valid and does
not represent any chemical.
DATES: This regulation is effective June 15, 2026. Objections and
requests for hearings must be received on or before August 14, 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-2023-0296, 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#9ac8dedcc8d4f5eef3f9ffe9daffeafbb4fdf5ec"><span class="__cf_email__" data-cfemail="edbfa9abbfa38299848e889ead889d8cc38a829b">[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 applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
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 of 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 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. . . .''
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-2023-0296 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 August 14, 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 ``Order Urging Electronic Filing and Service,'' dated
December 3, 2025, which can be found at <a href="https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf">https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.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 Exemption
In the Federal Register of July 5, 2023 (88 FR 42935) (FRL-10579-
05-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11745) by AgroFresh Inc., 3 Spring House Innovation Park, Suite 100,
Lower Gwynedd, PA 19002. The petition requested that 40 CFR 180.910 be
amended by establishing an exemption from the requirement of a
tolerance for residues of sodium nitrate (CAS Reg. No. 7631-99-4) when
used as an inert ingredient (dilutant/oxidizer) in pesticide
formulations applied to growing crops or raw agricultural commodities
pre- and post-harvest. That document referenced a summary of the
petition, which is available in the docket. There were no comments
received in response to the notice of filing. Based upon review of the
data supporting the petition and in
[[Page 35894]]
accordance with its authority under FFDCA section 408(d)(4)(A)(i), and
consistent with the proposed use pattern, EPA is establishing an
exemption for residues of sodium nitrate that includes a limitation for
use only in post-harvest applications in a fumigant canister that is
remotely detonated and released inside a sealed warehouse.
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 sodium nitrate, including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with sodium nitrate
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 sodium nitrate 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 sodium nitrate is supported in some
areas by data regarding nitrate. Sodium nitrate is a naturally occuring
water-soluble inorganic salt that readily dissociates into sodium and
the nitrate anion. EPA has determined that it is appropriate to bridge
nitrate data to assess sodium nitrate due to similarities in the
manufacturing processes, structure, composition, and physical/chemical
properties of the two substances, and because the human health toxicity
and ecological toxicity data available for both substances show
similarities in their toxicological profiles. Therefore, data on
nitrate has been used to assess the safety of sodium nitrate when
chemical-specific data is not available.
Sodium nitrate has been shown to be slightly toxic in acute oral
and dermal toxicity studies. It was moderately toxic for primary eye
irritation and practically non-toxic for primary dermal irritation.
Acute inhalation toxicity studies were not available; however, the
proposed use pattern (i.e., sodium nitrate is contained in a fumigant
canister that is remotely detonated and released inside a sealed
warehouse) will not lead to inhalation exposure.
Several repeated dose studies are available, including a six-week
oral toxicity study in rats, various chronic and carcinogenicity
studies, and multiple reproduction and developmental toxicity studies.
In addition, there were several human epidemiological studies available
for review. Neurotoxicity and immunotoxicity studies are not available.
However, no evidence of neurotoxicity or immunotoxicity was seen in
available studies.
In the six-week oral (diet) toxicity study in rats, the only
effects observed (i.e., decreased body weight gain and bluish staining
observed at necropsy), occurred at high doses (i.e., >=5000 milligrams/
kilogram/day (mg/kg/day)). Although sodium nitrate has been reported as
carcinogenic in epidemiological studies, no evidence of carcinogenic
activity or increased incidence of tumors was observed when sodium
nitrate alone was administered in chronic and carcinogenicity
laboratory studies. Thus, sodium nitrate is not expected to be
carcinogenic. However, nitrate toxicity is primarily based on its
conversion to nitrite, which occurs naturally in the environment and
the human body under certain conditions. Nitrite can potentially
combine with amines in the environment and the body to form
nitrosamines, and there is sufficient evidence for the carcinogenicity
of some nitrosamines.
While some epidemiological studies suggest a correlation between
exposure to nitrate and adverse reproductive and developmental effects,
causation has not been established. Furthermore, laboratory studies
showed no treatment-related maternal, reproductive, or developmental
effects in multiple reproduction and developmental toxicity studies in
various species up to the highest doses tested (66 mg/kg/day in rats
and rabbits). Therefore, EPA has low concern for reproductive and
developmental toxicity under the proposed use pattern.
Epidemiological studies have identified methemoglobinemia in
children as the most sensitive endpoint. Following conversion of
nitrate to nitrate, nitrite can oxidize the iron in hemoglobin to form
methemoglobin, which is not capable of carrying oxygen. In human blood,
a trace amount of methemoglobin (<2%) is naturally present; however, if
too much hemoglobin is converted to methemoglobin, it can lead to
methemoglobinemia.
C. 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. PODs are developed
based on a careful
[[Page 35895]]
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 or a reference dose, and a safe margin of exposure. For
non-threshold risks, the Agency assumes that any amount of exposure
will lead to some degree of risk. Thus, the Agency estimates risk in
terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
Because acute toxicity is expected to be low, no acute endpoint of
concern was identified for sodium nitrate, and a quantitative acute
dietary exposure assessment is unnecessary. Methemoglobinemia is the
primary adverse human health effect associated with exposure to nitrate
or nitrite in epidemiological studies. Therefore, the endpoint used by
EPA for risk assessment for chronic oral, dermal, and inhalation routes
of exposure is 1.6 mg/kg/day nitrate-nitrogen, which is based on
methemoglobinemia observed in children.
D. Exposure Assessment
The proposed pesticide product is a fumigant canister containing
sodium nitrate, which would be remotely detonated and released inside a
sealed warehouse. Used as the oxidizing agent, sodium nitrate is not
expected to be present after combustion and will leave the canister as
the components sodium carbonate, carbon dioxide, water, and nitrogen.
An exemption from the requirement of a tolerance has been established
for sodium carbonate residues under 40 CFR 180.1234 and carbon dioxide
residues under 40 CFR 180.910. Water and nitrogen released are
anticipated to be indistinguishable from background.
Because sodium nitrate is expected to be fully consumed in the
reaction and used inside sealed warehouse, it is not expected to enter
the environment or drinking water from the proposed use pattern. Sodium
nitrate is currently approved for use as an active ingredient (used in
pyrotechnic fumigants in animal burrows) and as an inert ingredient
(used pre-harvest under 40 CFR 180.920 as a ``solid diluent''). There
is no dietary exposure from the use as an active ingredient. EPA
previously determined that aggregate exposure from the pre-harvest use
as an inert ingredient is safe in the January 31, 2005, document
``Inert Ingredient Tolerance Reassessment--Ammonium Nitrate (CAS Reg.
No. 6484-52-2), Magnesium Nitrate (CAS Reg. No. 10377-60-3), Sodium
Nitrate (CAS Reg. No. 7631-99-4), and Sodium Nitrite (CAS Reg. No.
7632-00-0),'' which is available in the docket for this action. No
increased exposure to sodium nitrate is expected from the proposed use
pattern, as described below.
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sodium nitrate, EPA considered exposure under the proposed
exemption from the requirement of a tolerance and from existing uses.
EPA assessed dietary exposures from sodium nitrate in food as follows.
Dietary exposure (food and drinking water) to sodium nitrate can
occur following ingestion of foods treated with pesticide formulations
containing this inert ingredient, through FDA-approved dietary
applications as direct and indirect food additives, or through
naturally occuring endogenous levels found in food and water. The
proposed post-harvest use in a sealed warehouse is not expected to
result in increased concentrations of sodium nitrate in or on food or
drinking water. Therefore, increased dietary exposure as a result of
the post-harvest application is not expected.
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).
The pre-harvest use of sodium nitrate as an inert ingredient under
40 CFR 180.920 can result in residential exposures. Because the
proposed post-harvest use will be limited to use in a sealed warehouse,
it will not result in any increased residential exposure.
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 sodium nitrate to share a common mechanism of
toxicity with any other substances, and sodium nitrate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance exemption, therefore, EPA has assumed that
sodium nitrate 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>.
E. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the Food Quality Protection Act
(FQPA) safety factor. In applying this provision, EPA either retains
the default value of 10X, or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor.
The concern for fetal susceptibility is low because the endpoint
(i.e., NOAEL of 1.6 mg/kg/day) was based on the most sensitive effect
(methemoglobinemia) in the most sensitive subpopulation (infants)
selected from human epidemiological studies. This POD was established
by EPA based on the concentration of nitrate where methemoglobinemia
was not observed in infants. It is therefore protective of any effects
observed above the endpoint, including any potential offspring effects
that may occur at doses higher than those tested in the available
animal studies. Therefore, the FQPA safety factor can be reduced to 1x
for sodium nitrate for all exposure scenarios.
F. Aggregate Risks and Determination of Safety
The pre-harvest use of sodium nitrate as an inert ingredient has
been previously assessed by EPA as safe and an exemption from the
requirement of a tolerance has been established under 40 CFR 180.920
without limitation. Because no additional dietary or residential
exposure is expected from
[[Page 35896]]
the proposed post-harvest use of sodium nitrate as an inert ingredient
in a sealed warehouse, EPA concludes that there is a reasonable
certainty that no harm will result to the general population, including
infants and children, from aggregate exposure to sodium nitrate
residues.
G. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
sodium nitrate in or on any food commodities. EPA is establishing a
limitation on the way sodium nitrate may be used in pesticide
formulations applied post-harvest. This limitation will be enforced
through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. EPA
will not register any pesticide formulation containing sodium nitrate
for food use post-harvest unless it is in a fumigant canister that will
be remotely detonated and released inside a sealed warehouse.
H. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established for residues of sodium nitrate (CAS Reg. No. 7631-99-4)
when used as an inert ingredient (dilutant/oxidizer) in pesticide
formulations applied to raw agricultural commodities after harvest
under 40 CFR 180.910, only when used in a fumigant canister that is
remotely detonated and released inside a sealed warehouse.
Additionally, EPA is correcting a typographical error to the CAS
Reg. No. of d-Alpha tocopherol under 40 CFR 180.910. The correct CAS
Reg. No. is 59-02-9.
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 or a tolerance exemption
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 2026 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 human health risk assessment
supporting this action, which is available in the docket for this
action 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.
[[Page 35897]]
Dated: June 9, 2026.
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. Amend Sec. 180.910 by:
0
a. In Table 1 to Sec. 180.910:
0
i. Adding, in alphabetical order, an entry for ``Sodium nitrate (CAS
Reg. No. 7631-99-4)''; and
0
ii. Revising the entry for ``d-Alpha tocopherol (CAS Reg. No. 9-02-
9)''.
The revision and addition 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
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
d-Alpha tocopherol (CAS Reg. No. 59-02- None............................ Safener.
9).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Sodium nitrate (CAS Reg. No. 7631-99-4). For use only in post-harvest Dilutant/oxidizer.
applications in a fumigant
canister that is remotely
detonated and released inside a
sealed warehouse..
* * * * * * *
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[FR Doc. 2026-11941 Filed 6-12-26; 8:45 am]
BILLING CODE 6560-50-P
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</html>This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.