2026-12913: Cinnamaldehyde in Pesticide Formulations; Exemption From the Requirement for a Tolerance

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. 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 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 [[Page 38536]] 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-2025-0816 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 25, 2026. EPA's Administrative Law Judges Division (ALJD), 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 ALJD electronically, a person should utilize the 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.

A. 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 cinnamaldehyde 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 cinnamaldehyde is supported by data regarding trans-cinnamaldehyde. Based on the available human health toxicity data of the two substances, EPA has determined that it is appropriate to bridge trans-cinnamaldehyde data to assess cinnamaldehyde due to [[Page 38537]] similarities in the structure and physical/chemical properties. Cinnamaldehyde exhibits low levels of acute toxicity via the oral, dermal, and inhalation routes of exposure. It is a moderate dermal and eye irritant, and a strong dermal sensitizer. Decreased body weight in female rats was observed at 4100 ppm (200 mg/kg/day) in a 2-year chronic/carcinogenicity study. No increased offspring susceptibility was observed in the available studies as offspring effects (reduced fetal body weights) were only observed in the presence of parental toxicity (increased incidence of clinical signs of toxicity, reduced pregnancy rate, and pathological changes in the stomach) at 500 mg/kg/ day. The established chronic reference dose (1.0 mg/kg/day) will be protective of offspring effects. No evidence of neurotoxicity or immunotoxicity was observed in the available studies. Concern for carcinogenicity is low, based on the absence of treatment-related neoplastic lesions or tumors in chronic/carcinogenicity studies in rats and mice, and negative results in mutagenicity studies.

B. 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 NOAEL and 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, 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/overview-risk-assessment-pesticide-program. An acute dietary endpoint was not selected because no effect attributable to a single dose was identified in the database. The 2- year chronic/carcinogenicity study in rats was selected for the chronic dietary exposure scenario as well as short- and intermediate-term incidental oral, dermal and inhalation exposure scenarios. The NOAEL of 2100 ppm (100 mg/kg/day) and LOAEL of 4100 ppm (200 mg/kg/day), based on decreased body weight in female rats, were selected for risk assessment. The study is appropriate for the duration of exposure and is protective of all chronic effects, including for the general population and the most sensitive lifestage (children). The standard inter- and intra-species uncertainty factors of 10x are applied (total uncertainty factor = 100x). The default factor of 100% is applied for the dermal and inhalation absorption rates.

1. Dietary Exposure from Food and Feed Uses. In evaluating dietary

exposure to cinnamaldehyde, EPA considered exposure under the existing and proposed exemptions from the requirement of a tolerance. EPA assessed dietary exposures from cinnamaldehyde in food as follows. Dietary exposure (food and drinking water) may occur from the existing and proposed pesticidal uses of cinnamaldehyde (e.g., eating foods treated with pesticide formulations containing cinnamaldehyde, and drinking water exposures). Dietary exposure may also occur from non-pesticidal uses (e.g., household, personal care, cosmetics, and food additive), but no reliable information is available for non- pesticidal exposures. Therefore, EPA assessed dietary exposures from pesticidal uses of cinnamaldehyde only. In conducting the dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software using the Food Commodity Intake Database, Version 4.02, which uses food consumption information from the U.S. Department of Agriculture's 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America. As to residue levels in food, no residue data were submitted for cinnamaldehyde. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the December 21, 2021, memorandum ``Update to D361707: Dietary Exposure and Risk Assessments for the Inerts,'' which can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2018-0090. In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient. The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. When used as an active ingredient, the concentrations of cinnamaldehyde in agricultural products are generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather, there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient. In the case of cinnamaldehyde, EPA made a specific adjustment to the dietary exposure assessment to account for the limit on the amount of cinnamaldehyde that can be used in pesticide formulations (100 ppm), rather than assuming that cinnamaldehyde will be present at equal quantities with the active ingredient. For the purpose of the screening level dietary risk assessment, a conservative drinking water concentration value of 100 parts per billion based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for cinnamaldehyde.

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). Cinnamaldehyde can be used as an inert ingredient in pesticide products that are registered for specific uses that [[Page 38538]] may result in residential exposure, such as pesticides used in and around the home. Therefore, screening level residential handler and post-application risk assessments have been performed for common residential exposure scenarios, using assumptions detailed in the 2012 Residential Standard Operating Procedures, which is available at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 cinnamaldehyde to share a common mechanism of toxicity with any other substances, and cinnamaldehyde does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that cinnamaldehyde does not have a common mechanism of toxicity with other substances. Information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals is available at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. 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. Based on the evaluation of available toxicity studies, there is low concern for pre- and postnatal susceptibility from exposure to cinnamaldehyde. The FQPA safety factor has been reduced to 1X because: (1) the toxicity database is adequate to characterize potential pre- and postnatal risk; (2) the established POD of 2100 ppm (100 mg/kg/day) will be protective of reduced fetal body weight seen at 4100 ppm (500 mg/kg/day) in the developmental toxicity study in rats; (3) no evidence of neurotoxicity was observed in the database; and (4) the assumptions for the exposure assessment are conservative and unlikely to underestimate risk.

E. 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. An acute aggregate risk assessment takes into

account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified, and no acute dietary endpoint was selected. Therefore, cinnamaldehyde is not expected to pose an acute risk.

2. Chronic Risk. Using the exposure assumptions described in this

unit for chronic exposure, EPA has concluded that chronic exposure to cinnamaldehyde from food and water will utilize approximately 1% and 2% of the cPAD for the U.S. population and children 1-2 years old (the most highly exposed populations). Therefore, cinnamaldehyde is not expected to pose a chronic risk.

3. Short- and Intermediate-Term Risks. Short- and intermediate-term

aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposures to food and water (considered to be a background exposure level). Cinnamaldehyde can be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to cinnamaldehyde. Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in an aggregate MOE of 12658 for adults. Adult residential exposure combines high-end dermal and inhalation residential handler exposure from aerosol spray/trigger pump application with high-end post- application dermal exposure from contact with treated lawns. The combined short- and intermediate-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 3154 for children. Children's residential exposure is based on total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's level of concern for cinnamaldehyde is an MOE of 100 or below, these MOEs are not of concern.

4. Cancer Risk. EPA has not identified any concerns for

carcinogenicity relating to cinnamaldehyde. Therefore, cinnamaldehyde is not expected to pose a cancer risk.

F. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of cinnamaldehyde in or on any food commodities. EPA is establishing a limitation on the amount of cinnamaldehyde that may be used in pesticide formulations. 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 for food use that exceeds 100 ppm cinnamaldehyde in the final pesticide formulation to be applied pre- or post-harvest.

G. Conclusions

Therefore, an exemption from the requirement of a tolerance is established for residues of cinnamaldehyde (CAS Reg. No. 104-55-2) when used as an inert ingredient (preservative/stabilizer) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910, limited to no more than 100 ppm in the end-use pesticide formulation.

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 (See Unit VI.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's 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 Unit IV and the pesticide-specific review documents, located in the applicable docket 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 9, 2026. Charles Smith, Director, Registration Division, Office of Pesticide Programs. For the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 0

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371. 0

2. In Sec. 180.910, amend Table 1 to Sec. 180.910 by adding, in

alphabetical order, an entry for ``cinnamaldehyde'' to 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 ------------------------------------------------------------------------ * * * * * * * Cinnamaldehyde (CAS Reg. No. 104- Not more than 100 Preservative/ 55-2). ppm in the end- Stabilizer. use pesticide formulation. * * * * * * * ------------------------------------------------------------------------ [[Page 38540]] [FR Doc. 2026-12913 Filed 6-25-26; 8:45 am] BILLING CODE 6560-50-P