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:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• 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 https://www.epa.gov/​system/​files/​documents/​2025-12/​2025-12-03-order-urging-electronic-filing-and-service.pdf. 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 https://yosemite.epa.gov/​oa/​eab/​eab-alj_​upload.nsf.

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 https://www.regulations.gov. 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 https://www.epa.gov/​dockets/​commenting-epa-dockets#rules 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 ( printed 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 ( printed 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 https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​overview-risk-assessment-pesticide-program.

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 https://www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​cumulative-assessment-risk-pesticides.

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 ( printed 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 https://www.epa.gov/​regulations/​and-executive-orders.

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 https://www.regulations.gov.

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).

For the reasons stated in the preamble, the EPA amends 40 CFR chapter I as follows:

91 FR 35892