Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Imidacloprid

Imidacloprid; Pesticide Tolerance(s)

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 might apply 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 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-2024-0217 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 April 21, 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 "Revised Order Urging Electronic Filing and Service," dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. Although the EPA's regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at 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 Tolerance

In the Federal Register of July 3, 2025 (90 FR 29515 (FRL-12474-05-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 4F-9155) by the American Spice Trade Association. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide imidacloprid in or on black pepper at 0.05 ppm. That document referenced a summary of the petition that was prepared by the petitioner and is included in the docket.

One comment was received in response to that notice of filing. The comment expressed disdain for "chemicals", without reference to imidacloprid, or the current tolerance petition. While the Agency recognizes that some people do not like pesticides, it nevertheless has a statutory obligation to review pesticide applications and determine whether use of a pesticide meets the FIFRA and FFDCA/FQPA safety standards of causing no unreasonable adverse effects to people or the environment, and to ensure a reasonable certainty of no harm from potential dietary exposure (including drinking water), respectively. Here, the Agency has evaluated the aggregate risk of imidacloprid and has determined that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to imidacloprid residues. The commentor has offered no relevant information that would warrant a reconsideration of the Agency's determination.

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 imidacloprid, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with imidacloprid is summarized in this unit.

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.

The primary target system for toxicity following oral administration of imidacloprid in mammalian systems is the nervous system. The most sensitive species tested was the dog. Evidence of neurotoxicity was reported in the subchronic dog study and consisted of trembling and tremors. Evidence of neurotoxicity was also reported in the rat acute and developmental neurotoxicity studies (DNT) and consisted of decreased motor and locomotor activities, tremors, gait abnormalities, increased righting reflex impairments and body temperature, decreased number of rears and response to stimuli, and decreases in forelimb and hindlimb grip strength. These effects were seen at doses seven-fold higher than in the subchronic dog study. Only body-weight decrements were observed in mice following chronic exposure. Imidacloprid showed no signs of toxicity through the dermal and inhalation routes. There was no evidence of carcinogenic potential in either the rat chronic/carcinogenicity or mouse carcinogenicity studies, and imidacloprid was not genotoxic in a variety of assays.

There is no evidence of increased prenatal susceptibility in the developmental toxicity studies in rats or rabbits; however, there is evidence of increased quantitative susceptibility in the rat DNT. There were no maternal effects when imidacloprid was administered to pregnant/lactating dams, however, decreases in offspring motor activity measurements were observed at the highest dose tested (55 mg/kg/day). The apparent increased quantitative susceptibility in the DNT is well-characterized in the context of the entire hazard database with a clear NOAEL, and the doses and endpoints selected for regulatory purposes are protective of the pup effects noted at these higher doses in the DNT study. There was no evidence of susceptibility observed in the rat two-generation reproductive study, where decreases in pup body weights (reported in both litters of each generation) were observed at the same dose level as parental effects consisting of decreased premating and gestational absolute body weights. Therefore, the Food Quality Protection Act Safety Factor (FQPA SF) was reduced to 1X.

Imidacloprid was categorized as having high acute lethality through the oral route (Toxicity Category II), but low lethality through the dermal and inhalation routes (Toxicity Category IV). Imidacloprid was not an eye or skin irritant, or a dermal sensitizer.

All of the exposure scenarios and points of departure (POD) for imidacloprid are based upon an increased incidence of tremors/trembling occurring within one week of dosing observed in the 90-day dog study at the lowest-observed adverse-effect level (LOAEL) of 22 mg/kg/day. The no-observed adverse-effect level (NOAEL) is 8 mg/kg/day. The standard combined UF of 100X was applied to account for interspecies (10X) and intraspecies (10X) extrapolation, as well as the 1X FQPA SF to generate an acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD) of 0.08 mg/kg/day. The level of concern (LOC) for short-, intermediate- and long-term incidental oral, dermal and inhalation exposure scenarios is 100 based on interspecies (10X) and intraspecies (10X) extrapolation, and an FQPA SF (1X) when applicable. EPA has classified Imidacloprid as a Group E chemical, "Evidence of non-carcinogenicity for humans".

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 imidacloprid, can be found in the document titled "Imidacloprid. Proposed Tolerance for Residues in/on Imported Black Pepper " (hereinafter "Imidacloprid 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 PODs 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

More detailed information on the toxicological endpoints for imidacloprid used for human health risk assessment can be found in the Imidacloprid Human Health Risk Assessment, available in the docket for this action.

D. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to imidacloprid, EPA considered exposure under the petitioned-for tolerances as well as all existing imidacloprid tolerances in 40 CFR 180.472. The assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. EPA with 2005-2010 food consumption information from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The acute and chronic assessments used tolerance-level residues for most commodities, and 100 PCT for all commodities. For both the acute and chronic assessment, ARs and empirical processing factors were calculated for some commodities based on the results of previously submitted crop field trial and processing data. Default HED processing factors were used for all other relevant processed commodities. For more detail, see the "Imidacloprid. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for a New Tolerance for Residues in/on Importer Black Pepper" document available in the docket for this action. EPA assessed dietary exposures from imidacloprid 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 imidacloprid. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2005-2010 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 exposure assessment using tolerance-level residues for most commodities, with refined values based upon ARs and empirical processing factors for some commodities. EPA assumed 100 percent crop treated (PCT) for all commodities for the acute dietary assessment.

ii. Chronic exposure. In estimating chronic dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA conducted a partially refined, chronic dietary exposure assessment using tolerance-level residues for most commodities, with refined values based upon ARs and empirical processing factors for some commodities. EPA assumed 100 percent crop treated (PCT) for all commodities for the chronic dietary assessment.

iii. Cancer. Imidacloprid has been classified as a Group E chemical, "Evidence of non-carcinogenicity for 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 (AR) 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 Pesticide in Water Calculator's (PWC) version 1.52, the estimated drinking water concentrations (EDWCs) of imidacloprid in groundwater are 92 parts per billion (ppb) for acute exposures and 84.9 ppb for chronic exposures. Groundwater EDWCs were used in the dietary assessment for all sources of drinking water. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.

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 new proposed residential uses for imidacloprid at this time. However, imidacloprid is currently registered for uses that could result in residential handler and post-application exposures, which have been assessed previously, and are not of concern.

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." In 2016, EPA's Office of Pesticide Programs released a guidance document entitled "Pesticide Cumulative Risk Assessment: Framework for Screening Analysis." The Agency has utilized this framework for imidacloprid and determined that imidacloprid along with clothianidin, acetamiprid, dinotefuran, nithiazine, and thiacloprid form a candidate common mechanism group (CMG). This group of pesticides, referred to as neonicotinoids, is considered a candidate CMG because they share characteristics to support a testable hypothesis for a common mechanism of action for neonicotinoids.

Following this determination, the Agency conducted a screening-level cumulative risk assessment consistent with the 2016 guidance document. The current screening assessment indicates that cumulative risk estimates for neonicotinoids are below the Agency's levels of concern. No further cumulative evaluation is necessary for imidacloprid.

E. Safety Factor for Infants and Children

1. In general. FFDCA section 408(b)(2)(C) 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 (SF). 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.

EPA continues to conclude that there are reliable data to support the reduction of the 10X Food Quality Protection Act (FQPA) safety factor to 1X. See section 4.4 of the Imidacloprid Human Health Risk Assessment for more detail on this determination.

F. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, EPA has concluded that acute exposure to imidacloprid from food and water is 86% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to imidacloprid from food and water is 32% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short- and intermediate-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). Imidacloprid is currently 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 imidacloprid. Using the exposure assumptions described in this unit for short-term exposures, the children and adult MOEs are greater than their respective LOCs of 100. As a result, the short-term aggregate risk estimates are not of concern for the general U.S. population or any population subgroup.

Intermediate- and long-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). For imidacloprid, though there is potential for intermediate-term residential exposure from the registered pet collar and spot-on uses, an intermediate-term aggregate assessmen is not required. The short- and intermediate-term toxicological endpoints are the same, and the exposures assessed in the short-term aggregate (adults- combined dermal post-application exposures from contacting treated lawns and gardens; and children-combined dermal and hand-to-mouth from contacting treated turf) are greater than intermediate-term exposure estimates. Therefore, the estimates of risk for short-term duration exposures are protective of those for intermediate-term duration exposures.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, cancer aggregate risk assessments were not performed. Imidacloprid is classified as a Group E chemical, "Evidence of non-carcinogenicity for humans".

5. Determination of safety. Based on these risk assessments, and information described above, 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 imidacloprid residues. More detailed information on this action can be found in the, "Imidacloprid. Proposed Tolerance for Residues in/on Imported Black Pepper" Human Health Risk Assessment in the docket ID EPA-HQ-OPP-2024-0630.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expressions. Methodoloy is available to determine imidacloprid residues of concern in plant [Bayer gas chromatography/mass spectrometry (GC/MS) Method 00200] and livestock commodities (Bayer GC/MS Method 00191). These methods have undergone successful EPA petition method validations (PMV), and the registrant has fulfilled the remaining requirements for additional raw data, method validation, independent laboratory validation (ILV), and an acceptable confirmatory method [high-performance liquid chromatography/ultraviolet (HPLC/UV) Method 00357].

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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). The Codex Alimentarius 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.

Neither Codex nor Canada's Pest Management Regulatory Agency (PMRA) have established a MRL for imidacloprid in/on black pepper. Therefore, there are no harmonization issues regarding the establishment of a tolerance without a U.S. registration on black pepper.

C. Effective and Expiration Date(s)

In general, a tolerance action is effective on the date of publication of the final rule in the Federal Register . For actions in the final rule that lower or revoke existing tolerances, EPA will set an expiration date for the existing tolerance of six months after the date of publication of the final rule in the Federal Register , in order to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements.

V. Conclusion

Therefore, a tolerance is established for residues of imidacloprid (CASRN 138261-41-3), in or the food and feed commodities of black pepper at 0.05 ppm.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and executive orders can be found at https://www.epa.gov/laws-regulations/laws-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 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 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . ." (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.

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:

PART 180-TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

[FR Doc. 2026-03368 Filed 2-19-26; 8:45 am]

BILLING CODE 6560-50-P