2026-13185: Chlormequat Chloride; Pesticide Tolerances

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- 2021-0290 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 31, 2026. 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 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, 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 ALJD 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. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA 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.'' Section 408(b)(2)(A)(ii) of FFDCA 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. Section 408(b)(2)(C) of FFDCA 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 . . . .'' 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 chlormequat chloride including exposure resulting from the tolerances modified by this action. EPA's assessment of exposures and risks associated with chlormequat chloride follows. In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections of the rule that repeat what has been previously published for tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings. 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 tolerance rulemakings for chlormequat chloride in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to chlormequat chloride and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rule, as they remain unchanged.

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 chlormequat chloride as well as the no- observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse- effect-level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document, Chlormequat Chloride. Revised Human Health Risk Assessment for the Section 3 Registration Action for a New Use on Wheat, Triticale, Barley, Oats, and Grasses Grown for Seed, in docket ID number EPA-HQ-OPP-2021-0290. This assessment incorporated a subchronic 28-day inhalation study in rats. This study showed decreases in body weight in males, increased incidence of salivation, unsteady gait, tremors, flattened posture, and decreases in white blood cells in both sexes at 0.3 mg/L. For additional discussion of the Toxicological Profile of chlormequat chloride see Unit III.A of the chlormequat chloride tolerance rulemaking published in the Federal Register of April 25, 2018 (84 FR 17925) (FRL-9974-42).

C. Toxicological Points of Departure/Levels of Concern

A summary of the toxicological endpoints used for the human health risk assessment can be found in the document, Chlormequat Chloride. Revised Human Health Risk Assessment for the Section 3 Registration Action for a New Use on Wheat, Triticale, Barley, Oats, and Grasses Grown for Seed, in docket ID number EPA-HQ-OPP-2021-0290.

D. Exposure Assessment

Much of the exposure assessment remains the same although updates have occurred to accommodate exposures from the petitioned-for tolerances. These updates are discussed in this section. For a description of the rest of the EPA approach to and assumptions for the exposure assessment, please reference Unit III.C. of the April 25, 2018, rulemaking in the Federal Register (84 FR 17925) (FRL-9974-42).

1. Dietary exposure from food and feed uses. EPA's dietary exposure

assessments have been updated to include the additional petitioned-for tolerances for residues of chlormequat chloride. In estimating acute and chronic dietary exposure, the assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID, Version 4.02, EPA) which incorporates 2005- 2010 food consumption information from the United States Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America. The acute assessment is based on tolerance-level residues and assumes 100 percent crop treated (PCT). The acute assessment is unrefined. The chronic assessment is based on average field trial values and assumes 100 PCT. The chronic assessment is partially [[Page 39491]] refined. Empirical processing factors were included where available. Otherwise, DEEM-FCID default processing factors were used. A cancer dietary assessment was not conducted because chlormequat chloride is classified as ``not likely to be carcinogenic to humans.'' EPA did not use refined PCT information in the dietary assessment for chlormequat chloride, although average field trial values were used. 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.

2. Dietary exposure from drinking water. Since the most recent

drinking water assessment was conducted, new metabolism data (aerobic soil, aerobic aquatic, anaerobic aquatic) and terrestrial field dissipation studies have been received, and refined modeling was conducted. The drinking water model and their descriptions are available at the EPA internet site: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment. The updated estimated drinking water concentrations (EDWCs) used in the dietary risk assessment are 661.7 [micro]g/L for acute risk, and 240.2 [micro]g/L for chronic risk, all based on surface water sources of drinking water.

3. From non-dietary exposure. Chlormequat chloride is not

registered for any specific use patterns that would result in residential exposure.

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, leave in effect, 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 chlormequat chloride and any other substances, and chlormequat chloride does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that chlormequat chloride has a common mechanism of toxicity with other substances.

E. Safety Factor for Infants and Children

EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act safety factor from 10X to 1X. See Unit III.D. of the rulemaking published in the Federal Register of April 25, 2018 (84 FR 17925) (FRL-9974-42), for a discussion of 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 population adjusted dose (aPAD) and chronic population adjusted dose (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 points of departure (PODs) to ensure that an adequate margin of exposure (MOE) exists. Acute dietary risks are below the Agency's level of concern of 100% of the aPAD; they are 22% of the aPAD for infants (<1 year old), the population subgroup with the highest exposure. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 76% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure. Short- and intermediate-term aggregate risks take into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Short- and intermediate-term adverse effects were identified; however, chlormequat chloride is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- or intermediate-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for chlormequat chloride. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, chlormequat chloride is not expected to pose a cancer risk to humans. Therefore, based on the 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 chlormequat chloride residues. More detailed information on this action can be found in the document, Chlormequat Chloride. Revised Human Health Risk Assessment for the Section 3 Registration Action for a New Use on Wheat, Triticale, Barley, Oats, and Grasses Grown for Seed in docket ID number EPA-HQ-OPP-2021-0290.

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method, see Unit IV.A. of the April 25, 2018, rulemaking in the Federal Register (84 FR 17925) (FRL-9974-42).

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). 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. The Codex has established MRLs for chlormequat chloride in or on: Barley, grain at 2 ppm; Barley, hay at 50 ppm; Barley, straw at 50 ppm; Hog, meat byproducts at 1 ppm; Hog, meat at 0.2 ppm; Milk at 0.3 ppm; Oat, grain at 4 ppm; Oat, straw at 7 ppm; Wheat, bran at 7 ppm; Wheat, grain at 2 ppm; Wheat, hay at 80 ppm; and Wheat, straw at 80 ppm. These MRLs are different than the tolerances established for chlormequat chloride in the U.S. as a result of the use pattern proposed. EPA is harmonizing with Codex-established MRLs for chlormequat chloride in or on: Cattle, meat byproducts at 1 ppm; Cattle, meat [[Page 39492]] at 0.2 ppm; Egg at 0.1 ppm; Goat, meat byproducts at 1 ppm; Goat, meat at 0.2 ppm; Poultry, meat byproducts at 0.1 ppm; Sheep, meat byproducts at 1 ppm; and Sheep, meat at 0.2 ppm. EPA is harmonizing with Canada- established MRLs for chlormequat chloride in or on: Barley, bran at 20 ppm; Barley, grain at 8 ppm; Oat, grain at 40 ppm; Oat, bran at 80 ppm, Poultry, meat at 0.05 ppm; Wheat, bran at 15 ppm; Wheat, germ at 20 ppm; Wheat, grain at 5 ppm; and Wheat, straw at 80 ppm. Mexico adopts U.S. tolerances and/or Codex MRLs for its export purposes.

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.

D. Revisions to Petitioned-For Tolerances

The tolerance expression for chlormequat chloride stated measuring only chlormequat (2-chloro-N,N,N-trimethylammonium) and should be updated as follows: ``The sum of chlormequat and its salts expressed as chlormequat cation'', as the residue definition for both tolerance enforcement and risk assessment for plants and livestock commodities in order to harmonize with Codex and Canada. The registrant petitioned for a tolerance of 90 ppm for Barley, hay and 50 ppm for Barley, straw. EPA is establishing the tolerances for Barley, hay at 150 ppm and Barley, straw at 60 ppm due to these residues being increased when converted to chlormequat chloride equivalents using a molecular weight conversion factor (MWCF) of 1.29 and calculated with the Organisation for Economic Cooperation and Development (OECD) MRL calculation procedures. EPA is establishing tolerances for Cattle, meat byproducts; Goat, meat byproducts; and Sheep, meat byproducts at levels higher than requested in order to harmonize with Codex MRLs. There are established tolerances for Cattle, meat at 0.20 ppm; Egg at 0.10 ppm; Goat, meat at 0.20 ppm, Milk at 0.50 ppm; Poultry, meat byproducts at 0.10 ppm; and Sheep, meat at 0.20 ppm. EPA is establishing the tolerance for Cattle, meat at 0.2 ppm; Egg at 0.1 ppm; Goat, meat at 0.2 ppm; Milk at 0.5 ppm; Poultry, meat byproducts at 0.1 ppm; and Sheep, meat at 0.2 ppm based on rounding class practices. The registrant petitioned for a tolerance of 0.5 ppm for Hog, meat byproducts and 0.2 ppm for Hog, meat. However, EPA is not establishing those tolerances because the available residue and metabolism data indicate that there is no reasonable expectation of finite residues in swine/hog commodities. In such situations, EPA's regulations state that EPA does not set tolerances for the residues in the hog or swine livestock commodities. See 40 CFR 180.6(b). The registrant did not petition for Horse, meat byproducts, or Horse, meat. EPA is establishing tolerance levels for Horse, meat byproducts at 1 ppm for harmonization with Codex, and Horse, meat at 0.2 ppm. The registrant petitioned for a tolerance of 100 ppm for Oat, hay. EPA is establishing the tolerances for Oat, hay at 150 ppm due to these residues being increased when converted to chlormequat chloride equivalents using a MWCF of 1.29 and calculated with the OECD MRL calculation procedures. The registrant did not petition for Barley, bran. The tolerance on Barley, bran is significantly higher than raw agricultural commodity, Barley, grain; therefore, a tolerance is needed for the processed commodity Barley, bran. EPA is establishing tolerance levels for Barley, bran at 20 ppm for harmonization with Health Canada Pest Management Regulatory Agency (PMRA) EPA is establishing tolerance levels for Wheat, bran at 15 ppm for harmonization with Health Canada PMRA. The registrant petitioned for a tolerance of 90 ppm for Wheat, hay. EPA is establishing the tolerances for wheat, hay at 150 ppm due to these residues being increased when converted to chlormequat chloride equivalents using a MWCF of 1.29 and calculated with the OECD MRL calculation procedures.

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 [[Page 39493]] 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 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). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements. Dated: June 26, 2026. Leo Gueriguian, Acting Director, Office of Pesticide Programs. For the reasons set forth in the preamble, 40 CFR chapter I is amended as follows: --------------------------------------------------------------------------- \1\ This tolerance expires December 30, 2026. --------------------------------------------------------------------------- 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. 180.698, revise the table in paragraph (a) to read as

follows: Sec. 180.698 Chlormequat chloride; tolerances for residues. (a) * * * Table 1 to Paragraph (a) ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Barley, bran............................................ 20 Barley, grain........................................... 8 Barley, hay............................................. 150 Barley, straw........................................... 60 Cattle, meat byproducts................................. 1 Cattle, meat............................................ 0.2 Egg..................................................... 0.1 Goat, meat byproducts................................... 1 Goat, meat.............................................. 0.2 Hog, meat byproducts\1\................................. 0.5 Hog, meat\1\............................................ 0.2 Horse, meat byproducts.................................. 1 Horse, meat............................................. 0.2 Milk.................................................... 0.5 Oat, grain.............................................. 40 Oat, forage............................................. 15 Oat, hay................................................ 150 Oat, straw.............................................. 50 Poultry, meat byproducts................................ 0.1 Poultry, meat........................................... 0.05 Sheep, meat byproducts.................................. 1 Sheep, meat............................................. 0.2 Wheat, bran............................................. 15 Wheat, germ............................................. 20 Wheat, grain............................................ 5 Wheat, forage........................................... 30 Wheat, hay.............................................. 150 Wheat, straw............................................ 70 ------------------------------------------------------------------------ * * * * * [FR Doc. 2026-13185 Filed 6-29-26; 8:45 am] BILLING CODE 6560-50-P