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 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(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 . . .”

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 docket ID number EPA-HQ-OPP-2025-0158 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 July 28, 2026.

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 “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 the 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, 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 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. ( printed page 31959)

II. Petitioned-For Tolerance

In the Federal Register of September 5, 2025 (90 FR 42896) (FRL-12474-06-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 petition (PP 5F9175) by ABERCO, Inc., a Balchem Company, 5 Paragon Drive, Suite 201, Montvale, NJ 07645. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide propylene oxide (PPO), in or on sesame, seed; turmeric, roots, dried; ginger, dried; pepper, bell, dried; and pepper, nonbell, dried at 300 parts per million (ppm) for PPO, including its metabolites and degradates, and 6,000 ppm for its reaction product propylene chlorohydrin (PCH), including its metabolites and degradates. That document referenced a summary of the petition prepared by ABERCO, Inc., a Balchem Company, the registrant, which is available in the docket, ID number EPA-HQ-OPP-2025-0158, at http://www.regulations.gov.

EPA received one comment on the notice of filing. The comment did not pertain to the PPO or PCH tolerances described in the notice of filing and provided no information indicating that a safety determination for these tolerances cannot be supported.

EPA is not establishing the petitioned-for PCH tolerances because the request was subsequently withdrawn by the petitioner. The reason for this change is explained in Unit IV.C.

III. Final Tolerance Action

A. Aggregate Risk Assessment and Determination of Safety

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, 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 PPO, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with PPO follows.

B. Toxicological Profile

EPA has evaluated the available toxicity data and considered its 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.

Systemic effects in toxicity studies via the inhalation route suggest that PPO is absorbed locally and systemically, accumulating in the mucosa of the nose, trachea, and lung, but also reaching the liver; however, data suggest that inhalation exposure produces adverse effects only at the portal of entry. Oral and dermal toxicity studies have also found mostly portal of entry effects, suggesting that PPO is minimally absorbed systemically via those routes. Hydrolysis of PPO may occur spontaneously in the acidic environment of the stomach. Under in vitro conditions similar to the stomach environment, PPO hydrolysis is fast (half-life of 1 minute) and yields propylene glycol. Conjugation of PPO to glutathione (GSH), and alkylation to DNA or proteins can also occur, especially at the portal of entry. Chronic oral gavage dosing induced forestomach lesions in rats; however, this effect is not relevant for risk assessment because humans do not have a forestomach or any similar tissues. Inhalation exposure to PPO decreased non-protein sulfhydryl (NPSH) levels in respiratory mucosa, lung, and liver, and induced nasal cavity lesions in rats (olfactory epithelium atrophy, necrosis and regeneration; respiratory epithelium regeneration; inflammation; epithelial and squamous metaplasia) and mice (inflammation). For inhalation exposure, PPO is classified as “B2; Probable Human Carcinogen” by the Integrated Risk Information System, and a cancer slope factor (Q1*) of 3.7 x 10⁻⁶ (μg/m³ )⁻¹ based on nasal cavity hemangioma in mice is used for inhalation risk assessment. There is no offspring susceptibility in the PPO database.

In animal studies via the oral route, PCH targets primarily the acinar cells of the pancreas, with lesions that progress from cytoplasmic alteration and degeneration at 14 days, to fatty change and focal metaplasia at 90 days of exposure. In prenatal developmental studies in rat and rabbit, fetuses had decreased weight at the same dose that showed increased incidence of maternal mortality and pre-term delivery. In a reproductive study, rat dams showed decreased body weight at delivery and during lactation at a higher dose than that causing decreased body weight in pups, indicating offspring susceptibility. In an acute neurotoxicity study, lower total ambulatory activity was observed. PCH is classified as “Not Likely to be Carcinogenic to Humans.” This is based on a lack of treatment-related tumors observed in male and female mice and rats. There is also low concern for mutagenicity in vivo.

Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by PPO and PCH, can be found in the document titled “Propylene Oxide. Human Health Risk Assessment for Proposed New Uses on Sesame, seed; Turmeric, roots, dried; Ginger, dried; Pepper, bell, dried; and Pepper, nonbell, dried” (hereinafter “PPO Human Health Risk Assessment”), which is available in the docket for this action.

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 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 (PAD) or a reference dose (RfD), and a safe margin of exposure (MOE). 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/​human-health-risk-pesticides.

More detailed information on the toxicological endpoints for PPO and PCH used for human health risk assessment can be found in the PPO Human Health Risk Assessment, which is available in the docket for this action.

D. Exposure Assessment

1. Dietary Exposure From Food and Feed Uses

In evaluating dietary exposure to PPO and PCH, EPA considered exposure under the petitioned-for tolerances as ( printed page 31960) well as all existing PPO tolerances in 40 CFR 180.491. A quantitative dietary exposure assessment was not conducted for PPO, because no effect of concern was identified in the database for oral exposure scenarios and no dietary PODs were selected for PPO for any population. A quantitative dietary exposure assessment was conducted for PCH only. EPA assessed dietary exposures from PCH in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for PCH. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. This model uses 2005-2010 food consumption information from the United States Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted a partially refined acute dietary (food only) exposure and risk assessment, taking into account the interval between treatment and availability of treated commodities for consumption. EPA assumed 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In estimating chronic dietary exposure, EPA used the DEEM-FCID Version 4.02 and 2005-2010 food consumption information from the NHANES/WWEIA. As to residue levels in food, EPA conducted a partially refined chronic dietary (food only) exposure and risk assessment, taking into account the interval between treatment and availability of treated commodities for consumption. EPA assumed 100 PCT for all commodities.

iii. Cancer. PCH has been classified as “Not Likely to be Carcinogenic to Humans,” and therefore a cancer dietary assessment was not conducted.

iv. Anticipated residue and PCT information. FFDCA section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require, pursuant to FFDCA section 408(f)(1), that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. EPA assumed 100 PCT for both the acute and chronic dietary assessments for this action.

2. Dietary Exposure From Drinking Water

Based on the registered and proposed uses of PPO as an indoor fumigant, PPO and PCH residues are not expected in surface water or groundwater, so exposure to PPO and PCH in drinking water is not expected. A quantitative drinking water exposure assessment therefore was not conducted for PPO or PCH.

3. From Non-Dietary Exposure

The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). There are no residential uses of PPO registered or proposed, and no residential handler or residential post-application exposure is expected. Quantitative residential handler and residential post-application exposure assessments therefore were not conducted for PPO or PCH.

4. 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.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to PPO or PCH and any other substances and they do not appear to produce a toxic metabolite produced by other substances. Therefore, for the purposes of this action, EPA has not assumed that neither PPO nor PCH has a common mechanism of toxicity with other substances.

E. Safety Factor for 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.

Based on the analysis in section 4.1 of the PPO Human Health Risk Assessment, EPA concludes that there is reliable data to support the reduction of the FQPA safety factor for PPO and PCH to 1X. That analysis demonstrates that a FQPA safety factor of 1X will be safe for infants and children because the available information fully accounts for the potential for pre- and post-natal toxicity of PPO and PCH and the toxicological and exposure databases for PPO and PCH are adequate to characterize potential pre- and post-natal risk for infants and children.

F. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute Risk

There are no registered or proposed uses of PPO that are expected to result in drinking water exposure. Therefore, the acute aggregate risk assessment considers exposures from food only. For PPO, no adverse effect resulting from oral exposure was identified and no dietary endpoint was selected. Therefore, PPO is not expected to pose an acute risk. For PCH, using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to PCH from food will occupy 16% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure, and is not of concern.

2. Chronic Risk

There are no registered or proposed uses of PPO that are expected to result in drinking water exposure or direct residential exposure. Therefore, the chronic aggregate risk assessment considers exposures from food only. For PPO, no adverse effect resulting from oral exposure was identified and no dietary endpoint was selected. Therefore, PPO is not expected to pose a chronic risk. For PCH, using the exposure assumptions described in this unit for chronic exposure, EPA has ( printed page 31961) concluded that chronic exposure to PCH from food will utilize 8.0% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure, and is not of concern.

3. Short-Term Risk

Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no registered or proposed uses of PPO resulting in direct residential exposures, and no residues expected in drinking water, the short-term risk is equal to the chronic dietary risk described above.

4. Intermediate-Term Risk

Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no registered or proposed uses of PPO resulting in direct residential exposures, and no residues expected in drinking water, the intermediate-term risk is equal to the chronic dietary risk described above.

5. Aggregate Cancer Risk for U.S. Population

No dietary cancer risks of concern were identified for PPO or PCH. The Agency did not conduct an oral quantitative cancer risk assessment for PPO, based on the available information ( i.e., no effects relevant to humans were identified as a result of oral exposure to PPO). Similarly, no cancer risk of concern was identified for PCH. PCH is classified as “Not Likely to be Carcinogenic to Humans”.

6. Determination of Safety

Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to PPO residues, including its metabolites and degradates. More detailed information about the Agency's analysis can be found in the PPO Human Health Risk Assessment, which is available in the docket for this action.

IV. Other Considerations

A. Analytical Enforcement Methodology

The available analytical enforcement method, ABC METHOD 46306-PPO/Hydrins Rev 1.0, is able to quantitate the residues of PPO in various commodities using head space gas chromatography with flame ionization detection (GC/FID). A confirmatory method has been validated for PPO and PCH, utilizing GC with electron impact ionization mass spectrometry (EIMS) for quantitation of PPO, and either GC/EIMS or GC/ELCD (electron capture detection) for quantitation of the isomers of PCH. More detailed information about analytical enforcement methodology can be found in the PPO Human Health Risk Assessment, which is available in the docket for this action.

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRL) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

Codex has not established a MRL for PPO in or on ginger, bell or nonbell pepper, sesame seed, or turmeric, roots.

C. Revisions to Petitioned-For Tolerances

During the registration review of PPO conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA determined that PCH tolerances are not needed since PPO residues alone are adequate for detection of PPO misuse for enforcement activities, and there are no established Codex MRLs for PCH. For regulatory clarity, and to ensure residues of PPO reaction products (including PCH and propylene bromohydrin) remain covered under the PPO tolerances, the Agency proposed and finalized a rule under the FFDCA removing all PCH tolerances from 40 CFR 180.491 and revising the tolerance expression for PPO to specify the inclusion of these reaction products. See90 FR 42896, June 9, 2025 (FRL-12765-01-OCSPP), and 91 FR 21386, April 22, 2026 (FRL-12765-02-OCSPP). As a result, the petitioner withdrew its request that EPA establish the petitioned-for PCH tolerances, and EPA is not establishing these tolerances.

V. Conclusion

Therefore, tolerances are established for residues of propylene oxide in or on ginger, dried; pepper, bell, dried; pepper, nonbell, dried; sesame, seed; and turmeric, roots, dried at 300 ppm.

VI. 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 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)

Since tolerance actions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this action.

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 on the private sector.

F. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive ( printed page 31962) 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 tolerance actions like this one are exempt from review under Executive Order 12866.

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 summarized in Unit III.E.

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 set forth in the preamble, EPA is amending 40 CFR chapter I as follows:

91 FR 31958