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 ( printed page 73165) listed under FOR FURTHER INFORMATION CONTACT .

B. What action is the Agency taking?

In accordance with the Federal Food, Drug, and Cosmetic Act (FFDCA) sections 408(e) and 408(l ) (6) of, 21 U.S.C. 346a(e) and 346a(1)(6), EPA is establishing a time-limited tolerance for residues of isocycloseram, including its metabolites and degradates, in or on sunflowers at 0.4 parts per million (ppm). This time-limited tolerance expires on December 31, 2029.

C. How can I file an objection or hearing request?

Under section 408(g) of the FFDCA, 21 U.S.C. 346a, 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-2026-5678 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 ALJD 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 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. Background and Statutory Findings

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, ( i.e., without having received any petition from an outside party).

FFDCA 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. . . .”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Isocycloseram on Sunflowers and FFDCA Tolerance

The South Dakota Department of Agriculture and Natural Resources (DANR) utilized a specific exemption under FIFRA for the use of isocycloseram to control Red Sunflower Seed Weevil (RSSW). The applicant asserts that an emergency pest situation exists due to widespread infestations of RSSW. According to DANR, there is a lack of available insecticides to control these pests that are compatible with integrated pest management in sunflowers. Lacking effective controls, South Dakota sunflower growers face significant economic yield losses from severe RSSW infestations.

After having reviewed the specific exemption request, EPA authorized the specific exemption and determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of isocycloseram in or on sunflower, seed. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although this time-limited tolerance expires on December 31, 2029, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amount specified in the tolerance remaining in or on sunflowers after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this time-limited tolerance at the time of that application. EPA will take action to revoke the time-limited tolerance earlier if any experience with scientific data or other relevant information on this pesticide indicates that the residues are not safe.

Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether isocycloseram ( printed page 73166) meets FIFRA's registration requirements for use on sunflowers or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of isocycloseram by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than South Dakota to use this pesticide on sunflowers under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for isocycloseram, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

IV. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance 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 expected as a result of the use proposed by this emergency exemption request and the time-limited tolerance for residues of isocycloseram on sunflowers at 0.4 ppm. EPA's assessment of exposures and risks associated with establishing the time-limited tolerance follows.

On November 20, 2025 (90 FR 52256), EPA published a final rule that established tolerances for residues of isocycloseram in or on multiple commodities based on the Agency's determination that aggregate exposure to isocycloseram resulting from the residues subject to those tolerances is safe for the U.S. general population, including infants and children. The toxicity profile for isocycloseram has not changed since the November 20, 2025 (90 FR 52256), rule was published, therefore EPA is relying upon the discussion of that profile (Unit III.A.), the identified toxicological endpoints (Unit III.A.), and the identified toxicological endpoints (Unit III B.), as part of this rulemaking.

EPA's most recent exposure assessment for isocycloseram appears in the comprehensive risk assessment dated June 26, 2026, and entitled, “Isocycloseram. Human Health Risk Assessment for the Proposed Section 18 Emergency Exemption Request for Use on Sunflowers in South Dakota,” as that assessment included dietary, occupational, and aggregate exposures to isocycloseram on sunflowers in South Dakota.

For aggregate risk assessment, risk estimates resulting from food, drinking water, and residential uses are combined. Acute, short-and intermediate-term, and long-term (chronic) aggregate assessments were performed for isocycloseram, and no risk estimates of concern were identified. Further information about EPA's risk assessment and determination of safety supporting these tolerances can be found at www.regulations.gov in the document entitled “Isocycloseram: Human Health Risk Assessment for the Proposed Section 18 Emergency Exemption Request for Use on Sunflowers in South Dakota,” dated June 26, 2026, identified by (docket ID EPA-HQ-OPP-2026-5678).

In the 2026 assessment, EPA conducted unrefined and slightly refined chronic dietary analyses for all current uses of isocycloseram together with the emergency use on sunflowers. The assessments incorporated tolerance-level residues, average residues for some commodities (chronic), the Agency's default and empirical processing factors, conservative drinking water estimates, and assumed that 100% of the proposed crops were treated. The results of the acute and chronic analyses do not exceed the Agency's level of concern. That is, <100% of the population adjusted dose (PAD) are not of concern for the general U.S. population and all population subgroups. There were no adverse effects seen up to the highest test doses, thus there is no risk concern from single (acute) exposures and acute risk estimates were not calculated. The chronic dietary (food and drinking water) risk estimates utilized 31% of the chronic PAD (cPAD) for the general U.S. population and utilized 67% of the cPAD for children 1-2 years old, the highest exposed population subgroup.

The short-term aggregate exposure assessment for isocycloseram is based on food and drinking water as well as residential uses. No acute or long-term (chronic) residential exposures are expected, therefore acute and chronic aggregate risks are equivalent to acute and chronic dietary exposure estimates, respectively. Since the dermal and incidental oral point of departures are the same for both short- and intermediate-term durations, the short-term aggregate risk estimates are considered protective of any potential intermediate-term exposures and risks. The short-term aggregate margin of exposure (MOE) for children 1 to <2 years old is 300; no aggregate risk estimates are of concern because EPA considers MOEs of less than 100 to be of concern for aggregate risk.

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general U.S. population, or to infants and children from aggregate exposure to isocycloseram residues. More detailed information on the subject action to establish a time-limited tolerance on sunflowers can be found at www.regulations.gov in the document entitled “Isocycloseram: Human Health Risk Assessment for the Proposed Section 18 Emergency Exemption Request for Use on Sunflowers in South Dakota.” This document can be found in docket ID number EPA-HQ-OPP-2026-5678.

V. Other Considerations

A. Analytical Enforcement Methodology

QuEChERS high-performance liquid chromatography with mass-spectrometric detection (HPLC-MS/MS) multi-residue method (EN 15662:2009) has been independently validated for tolerance enforcement of parent isocycloseram in plant commodities at a limit of quantification (LOQ) of 0.01ppm. QuEChERS HPLC-MS/MS multi-residue method (EN 15662:2008) has been independently validated for tolerance enforcement of isocycloseram in livestock commodities at an LOQ of 0.01 ppm.

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 ( printed page 73167) 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 Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. There are no Codex or Canadian MRLs established on sunflowers.

VI. Conclusion

Therefore, a time-limited tolerance is established for residues of isocycloseram, in or on sunflower, seed at 0.4 ppm. This tolerance expires on December 31, 2029.

VII. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at www.epa.gov/​laws-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)

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, 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 the pesticide-specific review documents, located in the applicable docket at 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).

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

91 FR 73164