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.

• 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-2025-0148 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 January 12, 2027.

The 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 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, 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 ALJD electronically, a person should utilize the OALJ e-filing system at 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 www.regulations.gov. Follow the online instructions for submitting ( printed page 73169) 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 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 December 16, 2025 (90 FR 58181) (FRL-12474-10-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 5E9168) by Interregional Research Project No. 4 (IR-4), North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 2100, Raleigh, NC 27606. The petition requested that 40 CFR 180.300 be amended by establishing tolerances for residues of the fungicide ethephon, in or on fig at 0.02 parts per million (ppm). That document referenced a summary of the petition prepared by IR-4, the petitioner, which is available in the docket, at www.regulations.gov. The U.S. Department of Agriculture (USDA) submitted a comment supporting the use of ethephon as a plant growth regulator for figs.

III. Final Tolerance Action

A. Aggregate Risk Assessment and Determination of Safety

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

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical or is otherwise publicly available. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking and/or registration review decisions, EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published several tolerance rulemakings for ethephon and the more recent “Ethephon Interim Registration Review Decision Case Number 0382” (EPA-HQ-OPP-2010-0098-0034) in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to ethephon and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings, human health risk assessments, and registration review decisions as described further in this rulemaking, as they remain unchanged. These sections include toxicological profile, toxicological points of departure/levels of concern, exposure assessment, cancer, dietary exposure of drinking water, safety factor for infants and children, aggregate risk and determination of safety, chronic risk, and analytical enforcement methodology. The risk assessment published in support of this rulemaking is “Ethephon. Human Health Risk Assessment for New Section 3 Use on Fig” which is available in docket EPA-HQ-OPP-2025-0148 at www.regulations.gov.

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. Specific information on the studies received and the nature of the adverse effects caused by ethephon as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies for ethephon are summarized in the “Ethephon: Human Health Risk Assessment for a New Section 3 Use on Fig”, located in docket EPA-HQ-OPP-2025-0148, which can be found at www.regulations.gov.

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, 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 www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​human-health-risk-pesticides.

A summary of the toxicological endpoints for ethephon used for human risk assessment is discussed in the document “Ethephon: Human Health Risk Assessment for a New Section 3 Use on Fig”, pages 14-15, available in docket EPA-HQ-OPP-2025-0148.

D. Exposure Assessment

1. Dietary Exposure From Food and Feed Uses

In evaluating dietary exposure to ethephon, EPA considered exposure under the petitioned-for tolerances as well as all existing ethephon tolerances in 40 CFR 180.300. EPA assessed dietary exposures from ethephon 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.

The acute dietary (food and drinking water) assessment for ethephon was conducted using a refined, probabilistic assessment, incorporating the entire distribution of residues from the USDA Pesticide Data Program (PDP) for apples and grapes and residues from field trials for most other commodities. Default processing factors were used for most commodities for which they were available. Adequate processing studies are available for apples, barley, coffee, cottonseed, grapes, pineapple, tomato, ( printed page 73170) sugarcane, and wheat. Empirical processing factors obtained from those studies were used in the acute analyses. The maximum theoretical dietary burdens (MTDB) in beef and dairy cattle, poultry, and swine were previously determined at the time of the Tolerance Reassessment Eligibility Document using the established uses of ethephon. The proposed new use on fig does not include new feedstuff items and does not impact previously calculated MTDBs. MTDBs were calculated based on average or highest average anticipated residues (ARs) from field trial data and a diet comprised of cotton, wheat, and soybean.

ii. Chronic Exposure. In conducting the chronic dietary exposure assessment, a refined assessment used average field trial residues, average PDP residues along with tolerance level residues, and average percent crop treated (PCT) estimates where available. Default processing factors were used for most commodities. Adequate processing studies are available for apples, barley, coffee, cottonseed, grapes, pineapple, tomato, sugarcane, and wheat. As a result, empirical processing factors obtained from those studies were used in the chronic analyses. The same ARs were used for livestock commodities as in the acute analyses. As with the acute assessment, where no PCT data were available, the chronic assessment assumed 100 PCT for those commodities.

iii. Cancer. Based on the data summarized in “Ethephon: Human Health Risk Assessment for a New Section 3 Use on Fig”, available in docket EPA-HQ-OPP-2025-0148, EPA has concluded that ethephon should be classified as “Not Likely to be Carcinogenic to Humans”. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated Residue and PCT Information. Section 408(b)(2)(E) of FFDCA 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. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the following conditions are met.

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The following maximum PCT estimates were used in the acute dietary risk assessment for the following crops that are currently registered for ethephon: apples: 25%; barley: 5%; blackberry: 2.5%; blueberry: 5%; cantaloupe: 5%; sweet cherry: 5%; tart cherry: 75%; cotton: 65%; grapes (table): 35%; grape (raisin): 15%; grape juice: 2.5%; grape (/wine): 2.5%; peppers: 5%; tomato: 40%, walnut: 35%, and wheat: 5%. The PCT for cotton was used to refine the anticipated residues for ruminant commodities: 65% for the acute analysis.

The following average PCT estimates were used in the chronic dietary risk assessment for the following crops that are currently registered for ethephon: apples: 15%; barley 5%; cantaloupe: 5%; sweet cherry: 2.5%; tart cherry: 65%; cotton: 50%; grapes (table): 25%; grape (raisin): 5%; grape juice: 2.5%; grape (/wine): <1%; peppers: 5%; tomato: 20%; walnut: 25%.; and wheat 5%. The PCT for cotton was used to refine the anticipated residues for ruminant commodities: 50% for chronic analysis.

In most cases, EPA uses available data from USDA/National Agricultural Statistics Service, proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in Unit III.D.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which ethephon may be applied in a particular area.

2. Dietary Exposure From Drinking Water

The new use on fig does not result in an increase in the estimated residue levels in drinking water, so EPA used the same estimated drinking water concentrations identified in the 2015 human health risk assessment for registration review of ethephon. All registered uses of ethephon were evaluated with the Surface Water Concentration Calculator and Pesticide Root Zone Model Ground Water to determine the Estimated Drinking Water Concentrations (EDWCs). These models were running using the maximum use patterns to produce drinking water value in surface and groundwater. The surface water EDWCs were higher than the groundwater; as a result, the groundwater EDWCs are not being presented. The surface water EDWC for ethephon is not expected to exceed 25.7 parts per billion for 1-in-10-year acute, ( printed page 73171) and 0.46 for the 1-in-10-year annual average. For the chronic assessment, the EDWC point estimate was incorporated. For acute assessment, the Agency generated daily time series outputs that simulate 30 years of residue of ethephon in surface drinking water using the scenario with the highest 1-in-10-year daily average.

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).

Ethephon is currently registered for the following uses that could result in residential exposures: ornamentals, home gardens/trees, and golf course use. All registered ethephon product labels with residential use sites ( e.g., ornamentals and home gardens/trees) require that handlers wear specific clothing ( e.g., long sleeve shirt/long pants) and/or use PPE. Therefore, EPA has made the assumption that these products are not for homeowner use and has not conducted a quantitative residential handler assessment. There is the potential for post-application exposure for individuals exposed as a result of being in an environment that has been previously treated with ethephon ( i.e., ornamentals and home gardens/trees, and golf courses). However, in the absence of a dermal point of departure, dermal post-application exposure assessments were not conducted. The prior post-application incidental oral assessment for children (1 to <2 years old) playing on treated turf is no longer necessary since residential turf was removed from all ethephon product labels. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​standard-operating-procedures-residential-pesticide.

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 ethephon and any other substances. For the purposes of this action, therefore, EPA has not assumed that ethephon has a common mechanism of toxicity with other substances.

In 2016, EPA's Office of Pesticide Programs released a guidance document, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis. This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach beginning with the evaluation of available toxicological information and if necessary, followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups and conducting cumulative risk assessments.

Ethephon is an organophosphonate ethylene releaser, as opposed to an organophosphate. It is structurally different from and demonstrates different physical and chemical properties than traditional organophosphate compounds, and its toxicological profile also differs from those of the organophosphate compounds. EPA determined that ethephon does not share a common mechanism with the organophosphate compounds, and it was not included in the organophosphate cumulative risk assessment. At this time, EPA does not expect any exposures from other organophosphonate ethylene releaser pesticides or substances since there are no other organophosphonate ethylene releaser pesticides registered for use in the United States, nor has EPA established any tolerances for residues of any organophosphonate ethylene releaser pesticides. As a result, EPA concludes that ethephon does not have a common mechanism of toxicity with other substances that contribute to the risk assessment. If other organophosphonate ethylene releaser pesticides are registered, EPA will use the framework to examine the potential for a common mechanism of toxicity and the potential for cumulative risk as part of the ongoing registration review process. 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 www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​pesticide-cumulative-risk-assessment-framework.

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 (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 reliable data to support the reduction of the FQPA SF from 10X to 1X. See “Ethephon: Human Health Risk Assessment for a New Section 3 Use on Fig.”, available at docket ID EPA-HQ-OPP-2025-0148 for a discussion on the Agency's rationale for that determination.

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

An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. The acute dietary risk estimates serve as the aggregate risk estimates. There are no acute dietary risks of concern for the general U.S. population or for any population subgroups; therefore, there are no acute aggregate risks of concern. Risk estimates are 26% of the aPAD for the general population and 73% for the most highly exposure population subgroup of children 1 to 2 years of age at the 99.9th percentile of exposure.

2. Chronic Risk

There are no chronic dietary risks of concern to the general U.S. population or any population subgroups. Therefore, there are no chronic aggregate risks of concern. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded ( printed page 73172) that chronic exposure to ethephon from food and water will utilize <1% of the cPAD for the general population and 1.8% cPAD for the most highly exposure population subgroup of children 1 to 2 years of age.

3. Short-Term 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). 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). There are no residential exposures that contribute to aggregate risk. As a result, short-term and intermediate-term aggregate risk assessments were not conducted.

4. Aggregate Cancer Risk for U.S. Population

Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, ethephon is not expected to pose a cancer risk to humans.

5. 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 ethephon residues. More detailed information about the Agency's analysis can be found at www.regulations.gov in the document titled “Ethephon: Human Health Risk Assessment for a New Section 3 Use on Fig”, available at docket ID EPA-HQ-OPP-2025-0148.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (Amchem-Plant Method (PAM, VOL. II, Method I) is available to enforce the tolerance expression.

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 (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The 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 MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for ethephon in or on fig at 3 ppm. These MRLs are different than the tolerances established for ethephon in the United States. The difference is due to the MRLs being based on uses with significantly different good agricultural practices. The Codex MRL is based on a pre-harvest (PHI) of five days, whereas the petitioned-for tolerance is based on a PHI of 120 days.

The tolerance expression for ethephon currently established under 40 CFR 180.300 does not comply with Final Guidance on Tolerance Expressions. EPA is revising 40 CFR 180.300 to state that compliance with the ethephon tolerance levels is to be determined by measuring only ethephon ((P)-(2-chloroethyl)phosphonic acid).

V. Conclusion

Therefore, tolerances are established for residues of ethephon, in or on fig at 0.02 ppm.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and Executive orders can be found at 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 tolerance 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 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 ( printed page 73173) 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, 40 CFR chapter I is amended as follows:

91 FR 73168