2023-19513. Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (FY23Q4)  

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    AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    EPA is proposing to implement several tolerance actions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that the Agency determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). During registration review, EPA reviews all aspects of a pesticide case, including existing tolerances, to ensure that the pesticide continues to meet the standard for registration under FIFRA. The tolerance actions and pesticide active ingredients addressed in this rulemaking are identified in Unit I.B. and discussed in detail in Unit III. of this document.

    DATES:

    Comments must be received on or before November 13, 2023.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2023–0254, through the Federal eRulemaking Portal at: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

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    FOR FURTHER INFORMATION CONTACT:

    Robert Little, Pesticide Re-Evaluation Division (7508M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 566–2234; email address: little.robert@epa.gov.

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    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. Potentially affected entities may include:

    • Crop production (NAICS code 111).
    • Animal production (NAICS code 112).
    • Food manufacturing (NAICS code 311).
    • Pesticide manufacturing (NAICS code 32532).

    B. What action is the Agency taking?

    EPA is proposing several tolerance actions that the Agency previously determined were necessary or Start Printed Page 62493 appropriate during registration review for the following pesticide active ingredients: chlorsulfuron, primisulfuron-methyl, triasulfuron, halosulfuron-methyl, sulfosulfuron, iodosulfuron-methyl-sodium, trifloxysulfuron-sodium, and mesosulfuron-methyl. The proposed tolerance actions for each pesticide active ingredient are described in Unit III. and may include but are not limited to the following types of actions:

    • Revising tolerance expressions;
    • Modifying commodity definitions;
    • Updating crop groups;
    • Removing expired tolerances;
    • Revoking tolerances that are no longer needed; and
    • Harmonizing tolerances with Codex Maximum Residue Levels (MRLs).

    Although they may not have been identified in the registration review of a particular pesticide, this rule also includes proposals to reflect the Agency's 2019 adoption of the Organization of Economic Cooperation and Development (OECD) Rounding Class Practice. Where applicable, these adjustments are proposed for specific pesticides as reflected in the proposed regulatory text section.

    C. What is EPA's authority for taking this action?

    Pursuant to its authority under the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a, EPA is proposing the tolerance actions in this rulemaking that the Agency previously determined were necessary or appropriate during the registration review conducted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.

    FFDCA section 408(b) authorizes EPA to establish a tolerance, if the Agency determines that a tolerance is safe; FFDCA section 408(c) authorizes EPA to establish an exemption from the requirement of a tolerance if the Agency determines that the exemption is safe. See21 U.S.C. 346a(b) and (c). If EPA determines that a tolerance or exemption is not safe, EPA must modify or revoke that tolerance or exemption. The 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.” 21 U.S.C. 346a(b)(2)(A)(ii), (c)(2)(A)(ii). 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 the 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[s.]” 21 U.S.C. 346a(b)(2)(C). In addition, FFDCA section 408(b)(2)(D) contains several factors EPA must consider when making determinations about establishing, modifying, or revoking tolerances. 21 U.S.C. 346a(b)(2)(D). FFDCA section 408(c)(2)(B) requires that EPA, when making determinations about exemptions, to take into account, among other things, the considerations set forth in FFDCA section 408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B).

    FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance on its own initiative. Prior to issuing the final regulation, FFDCA section 408(e)(2) requires EPA to issue a notice of proposed rulemaking for a 60-day public comment period, unless the Administrator for good cause finds that it would be in the public interest to have a shorter period and states the reasons in the rulemaking.

    Furthermore, when establishing tolerances or exemptions from the requirement of a tolerance, FFDCA sections 408(b)(3) and (c)(3) require that there be a practical method for detecting and measuring pesticide chemical residue levels in or on food, unless in the case of exemptions, EPA determines that such method is not needed and states the reasons therefor in the rulemaking. 21 U.S.C. 346a(b) and (c).

    Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to periodically review all registered pesticides and determine if those pesticides continue to meet the standard for registration under FIFRA. See also40 CFR 155.40(a). Consistent with its obligations under FIFRA section 3(g) and FFDCA section 408, EPA has reviewed the available scientific data and other relevant information and determined it is appropriate to take the tolerance actions being proposed in this rulemaking.

    D. What can I do if I want the Agency to maintain a tolerance that the Agency proposes to revoke?

    This proposed rule provides a 60-day public comment period that allows any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives such a comment within the 60-day period, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f), if needed. The order would specify data needed and the timeframes for submission of the data and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

    After considering comments that are received in response to this proposed rule, EPA will issue a final rule. At the time of the final rule, you may file an objection or request a hearing on the action taken in the final rule. 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. After the filing deadline specified in the final rule, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

    E. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/​dockets/​commenting-epa-dockets#rules and clearly mark the part or all of the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.regulations.gov/​faq.

    3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies.

    II. Background

    A. What is a tolerance?

    A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on food, which includes raw agricultural commodities and processed foods and Start Printed Page 62494 feed for animals. Under the FFDCA, residues of a pesticide chemical that are not covered by a tolerance or exemption from the requirement of a tolerance are considered unsafe. See21 U.S.C. 346a(a)(1). Foods containing unsafe residues are deemed adulterated and may not be distributed in interstate commerce. See21 U.S.C. 331(a), 342(a)(2)(B). Consequently, for a food-use pesticide ( i.e., a pesticide use that is likely to result in residues in or on food) to be sold and distributed, the pesticide must not only have appropriate tolerances or exemptions under the FFDCA, but also must be registered under FIFRA, 7 U.S.C. 136 et seq. Food-use pesticides not registered in the United States must have tolerances or exemptions in order for commodities treated with those pesticides to be imported into the United States. For additional information about tolerances, go to https://www.epa.gov/​pesticide-tolerances/​about-pesticide-tolerances.

    B. Why does EPA consider international residue limits?

    When establishing a tolerance for residues of a pesticide, EPA must determine whether the Codex Alimentarius Commission (Codex) has established a Maximum Residue Limit (MRL) for that pesticide. See21 U.S.C. 346a(b)(4). As part of registration review, EPA determines whether international tolerances or MRLs exist for commodities and chemicals for which U.S. tolerances have been established. Where appropriate, EPA's intention is to harmonize U.S. tolerances with those international MRLs to facilitate trade. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of the individual human health risk assessments that support the pesticide registration review.

    C. What is pesticide registration review?

    EPA periodically reviews existing registered pesticides to ensure they can continue to be used without unreasonable adverse effects on human health or the environment. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the FIFRA registration standard of no unreasonable adverse effects. As part of the registration review of a pesticide, EPA also evaluates whether existing tolerances are safe, whether any changes to existing tolerances are necessary or appropriate, and whether any new tolerances are necessary to cover residues from registered pesticides. Where appropriate, EPA has included a safety finding under the FFDCA for the proposed tolerance action for the pesticide, which is discussed in detail in the human health risk assessments conducted to support the registration review of each specific pesticide active ingredient or registration review case. In addition, these proposed tolerance changes are summarized in both the Proposed Interim Decision (PID), and in the Interim Decision (ID) for each pesticide active ingredient or registration review case. These documents can be found in the public docket that has been opened for each pesticide, which is available online at https://www.regulations.gov, using the docket ID number listed in Unit III. for each pesticide active ingredient included in this proposed action. Additional information about pesticide registration review is available at https://www.epa.gov/​pesticide-reevaluation.

    III. Proposed Tolerance Actions

    EPA is proposing to take the specific tolerance actions identified in this unit.

    A. 40 CFR 180.405; Chlorsulfuron; Case 0631 (Docket ID No. EPA–HQ–OPP–2012–0878)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Revising the tolerance expression for chlorsulfuron to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerances cover metabolites and degradates of chlorsulfuron not specifically mentioned; and (2) compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression would not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.
    • Merging the established tolerances into a single paragraph for clarity.
    • Modifying tolerance values or tolerance levels for “Grass, forage”; “Grass, hay”; “Oat, forage”; and “Wheat, forage” to reflect current OECD rounding practices.

    2. Safety Finding

    During registration review, EPA assessed the risks from exposure to chlorsulfuron, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to chlorsulfuron residues. Thus, EPA has determined that the tolerances for residues of chlorsulfuron are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further detail, see Chlorsulfuron. Draft Human Health Risk Assessment in Support of Registration Review, which can be found in the docket ID number listed in the heading of this unit.

    B. 40 CFR 180.452; Primisulfuron-methyl; Case 7220 (Docket ID No. EPA–HQ–OPP–2011–0844)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Revising the tolerance expression for primisulfuron-methyl to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of primisulfuron-methyl not specifically mentioned; and (2) compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression would not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.

    2. Safety finding

    EPA has determined that the proposed change to the tolerance expression would not impact EPA's previous safety findings for the established tolerances for primisulfuron-methyl, because the change has no substantive effect on the tolerances or supporting risk assessments, but rather is merely intended to clarify the existing tolerance expression. For further detail, see Primisulfuron-Methyl. Human Health Draft Risk Assessment for Registration Review, which can be found in the Start Printed Page 62495 docket ID number listed in the heading of this unit.

    C. 40 CFR 180.459; Triasulfuron; Case 7221 (Docket ID No. EPA–HQ–OPP–2012–0115)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Revising the tolerance expression for triasulfuron to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of triasulfuron not specifically mentioned; and (2) compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression would not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.

    2. Safety Finding

    EPA has determined that the proposed change to the tolerance expression would not impact EPA's previous safety findings for the established tolerances for triasulfuron, because the change has no substantive effect on the tolerances or supporting risk assessments, but rather is merely intended to clarify the existing tolerance expression. For further detail, see Triasulfuron. Draft Human Health Risk Assessment in Support of Registration Review, which can be found in the docket ID number listed in the heading of this unit.

    D. 40 CFR 180.479; Halosulfuron-methyl; Case 7233 (Docket ID No. EPA–HQ–OPP–2011–0745)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Modifying the tolerance level for residues of halosulfuron-methyl in or on asparagus from 0.8 ppm to 1 ppm to harmonize with the Canadian MRL. There are no Codex MRLs for this pesticide chemical.

    • Converting the existing crop group tolerances for “vegetable, fruiting, group 8” and “nut, tree, crop group 14” to the updated crop group tolerances for “vegetable, fruiting, group 8–10” and “nut, tree, crop group 14–12,” respectively. The tolerance levels would remain the same. 40 CFR 180.40(j) states that “[a]t appropriate times, EPA will amend tolerances for crop groups that have been superseded by revised crop groups to conform the pre-existing crop group to the revised crop group.” EPA has indicated in updates to its crop group rulemakings that registration review is one of those appropriate times. See, e.g., Tolerance Crop Grouping Program V (85 FR 70976) (November 6, 2020).

    • Removing tolerances for residues of halosulfuron-methyl in or on certain commodities. Specifically, EPA is proposing to remove the tolerance for “pea and bean, succulent shelled, subgroup 6” because it is an incorrect entry; no such crop subgroup exists. Instead, these commodities are covered under the established tolerance for “pea and bean, succulent shelled, subgroup 6B” at the same tolerance level. In addition, EPA proposes to remove tolerances for okra and pistachio as unnecessary, because they would be covered by the updated crop group tolerances for “vegetable, fruiting, group 8–10” and “nut, tree, crop group 14–12,” respectively, at the same tolerance levels.

    2. Safety Finding

    During registration review, EPA assessed the risks from exposure to halosulfuron-methyl, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to halosulfuron-methyl residues. Thus, EPA has determined that the tolerances for residues of halosulfuron-methyl are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further detail, see Halosulfuron-Methyl. Draft Human Health Risk Assessment for Registration Review, which can be found in the docket ID number listed in the heading of this unit.

    E. 40 CFR 180.552; Sulfosulfuron; Case 7247 (Docket ID No. EPA–HQ–OPP–2011–0434)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Revising the tolerance expression for sulfosulfuron to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of sulfosulfuron not specifically mentioned; and (2) compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression do not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.
    • Removing the tolerances for residues of sulfosulfuron in or on hog, meat (0.005 ppm); hog, fat (0.005 ppm); and hog, meat byproducts (0.05 ppm). EPA has determined that there is no reasonable expectation of finite residues of concern in swine. See 40 CFR 180.6(a)(3). Moreover, a re-evaluation of tolerance enforcement methods determined that the limits of quantitation for these methods is 0.01 ppm.

    2. Safety Finding

    During registration review, EPA assessed the risks from exposure to sulfosulfuron, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to sulfosulfuron residues. Thus, EPA has determined that the tolerances for residues of sulfosulfuron are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further detail, see Sulfosulfuron. Draft Human Health Risk Assessment in Support of Registration Review, which can be found in the docket ID number listed in the heading of this unit.

    F. 40 CFR 180.580; Iodosulfuron-methyl-sodium; Case 7253 (Docket ID No. EPA–HQ–OPP–2012–0717)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by: Start Printed Page 62496

    • Revising the tolerance expression for iodosulfuron-methyl-sodium to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of iodosulfuron-methyl-sodium not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression do not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.

    2. Safety Finding

    EPA has determined that the proposed change to the tolerance expression would not impact EPA's previous safety findings for the established tolerances for iodosulfuron-methyl-sodium, because the change has no substantive effect on the tolerances or supporting risk assessments, but rather is merely intended to clarify the existing tolerance expression. For further detail, see Iodosulfuron-Methyl-Sodium. Draft Human Health Risk Assessment in Support of Registration Review, which can be found in the docket ID number listed in the heading of this unit.

    G. 40 CFR 180.591; Trifloxysulfuron; Case 7028 (Docket ID No. EPA–HQ–OPP–2013–0409)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Revising the tolerance expression for trifloxysulfuron, resulting from the application of its sodium salt, to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of trifloxysulfuron not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression do not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.

    • Revoking tolerances for residues of trifloxysulfuron in or on almond (0.02 ppm) and almond hulls (0.01 ppm). Almonds are no longer included as a use site on any trifloxysulfuron-sodium product labels; therefore, the Agency is proposing to revoke the established tolerances. In addition, 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 these requirements in the final rule, EPA is proposing to amend the existing tolerances to include an expiration date that would be six months after the date of publication of the final rule in the Federal Register .

    2. Safety Finding

    During registration review, EPA assessed the risks from exposure to trifloxysulfuron-sodium, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to trifloxysulfuron-sodium. Thus, EPA has determined that the tolerances for residues of trifloxysulfuron, resulting from the application of its sodium salt, are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further detail, see Trifloxysulfuron-Sodium. Draft Human Health Risk Assessment in Support of Registration Review, which can be found in the docket ID number listed in the heading of this unit

    H. 40 CFR 180.597; Mesosulfuron-Methyl; Case 7277 (Docket ID No. EPA–HQ–OPP–2012–0833)

    1. Proposed Changes to the Current Tolerances

    EPA is proposing to amend the current tolerances by:

    • Revising the tolerance expression for mesosulfuron-methyl to describe more clearly the scope or coverage of the tolerances and the method for measuring compliance. Consistent with EPA policy, the revised tolerance expression would clarify that (1) as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of mesosulfuron-methyl not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring the specific compounds mentioned in the tolerance expression. The revisions to the tolerance expression do not substantively change the tolerances or, in any way, modify the permissible level of residues permitted by the tolerances.

    2. Safety Finding

    EPA has determined that the proposed change to the tolerance expression would not impact EPA's previous safety findings for the established tolerances for mesosulfuron-methyl, because the change has no substantive effect on the tolerances or supporting risk assessments, but rather is merely intended to clarify the existing tolerance expression. For further detail, see Mesosulfuron-Methyl. Human Health Draft Risk Assessment for Registration Review, which can be found in the docket ID number listed in heading of this unit.

    IV. Proposed Effective Date

    EPA is proposing that these tolerance actions would be effective on the date of publication of the final rule in the Federal Register . However, for actions in the final rule that lower or revoke existing tolerances, EPA is proposing an expiration date of six months after the date of publication of the final rule in the Federal Register , 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. 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 Orders 12866: Regulatory Planning and Review and 14094: Modernizing Regulatory Review

    This action is exempt from review under Executive Order 12866 (58 FR 51735) (October 4, 1993), as amended by Executive Order 14094 (88 FR 21879) (April 11, 2023), because it proposes to establish or modify a pesticide tolerance or a tolerance exemption under FFDCA section 408. This exemption also applies to tolerance revocations for which extraordinary circumstances do not exist. As such, this exemption applies to the tolerance revocations in this proposed rule because the Agency knows of no extraordinary Start Printed Page 62497 circumstances that warrant reconsideration of this exemption for those proposed tolerance revocations.

    B. 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.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the Agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule has no net burden on small entities subject to the rule. This determination takes into account an EPA analysis for tolerance establishments and modifications that published in the Federal Register of May 4, 1981 (46 FR 24950) (FRL–1809–5) and for tolerance revocations on December 17, 1997 (62 FR 66020) (FRL–5753–1).

    Additionally, in a 2001 memorandum, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. See Memorandum from Denise Keehner, Division Director, Biological and Economic Analysis Division, Office of Pesticide Programs, entitled “RFA/SBREFA Certification for Import Tolerance Revocation” and dated May 25, 2001, which is available in the docket.

    For the pesticides named in this proposed rule, EPA concludes that there is no reasonable expectation that residues of the pesticides for tolerances listed in this proposed rule for revocation will be found on the commodities discussed in this proposed rule, and the Agency knows of no extraordinary circumstances that exist as to the present proposed rule that would change EPA's previous analyses.

    Any comments about the Agency's determination for this rulemaking should be submitted to EPA along with comments on the proposed rule and will be addressed in the final rule.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate 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.

    E. 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.

    F. 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.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885) (April 23, 1997) directs federal agencies to include an evaluation of the health and safety effects of the planned regulation on children in federal health and safety standards and explain why the regulation is preferable to potentially effective and reasonably feasible alternatives. This action is not subject to Executive Order 13045 because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866 (See Unit V.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's Policy on Children's Health applies to this action.

    This rule proposes 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)). 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 these proposed tolerance actions. The Agency's consideration is documented in the pesticide specific registration review decision documents. See the pesticide specific discussions in Unit III. and access the chemical specific registration review documents in each chemical docket at https://www.regulations.gov.

    H. 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.

    I. National Technology Transfer Advancement Act (NTTAA)

    This action does not involve technical standards under the NTTAA section 12(d), 15 U.S.C. 272.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629) (February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or indigenous peoples) and low-income populations. As discussed in more detail in the pesticide specific risk assessments conducted as part of the registration review for each pesticide as identified in Unit III., EPA has considered the safety risks for the pesticides subject to this rulemaking and in the context of the tolerance actions set out in this rulemaking. EPA believes that the human health and environmental conditions that exist prior to this action do not result in disproportionate and adverse effects on people of color, low-income populations, and/or indigenous peoples. Furthermore, EPA believes that this action is not likely to result in new disproportionate and adverse effects on people of color, low-income populations and/or indigenous peoples.

    Start List of Subjects Start Printed Page 62498

    List of Subjects in 40 CFR Part 180

    • Environmental protection
    • Administrative practice and procedure
    • Agricultural commodities
    • Pesticides and pests
    • Reporting and recordkeeping requirements
    End List of Subjects Start Signature

    Dated: August 31, 2023.

    Edward Messina,

    Director, Office of Pesticide Programs.

    End Signature

    Therefore, for the reasons stated in the preamble, it is proposed that 40 CFR chapter I be amended as follows:

    Start Part

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

    End Part Start Amendment Part

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

    End Amendment Part Start Authority

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

    End Authority Start Amendment Part

    2. Amend § 180.405 by revising paragraph (a)(1) to read as follows:

    End Amendment Part
    Chlorsulfuron; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of chlorsulfuron, including its metabolites and degradates, in or on the commodities in table 1 to this paragraph (a)(1). Compliance with the tolerance levels specified in table 1 is to be determined by measuring only chlorsulfuron (2-chloro-N-[[(4-methoxy-6-methyl-1,3,5-triazin-2- yl)amino]carbonyl]benzenesulfonamide) in or on the commodity.

    Table 1 to Paragraph ( a )(1)

    CommodityParts per million
    Barley, grain0.1
    Barley, straw0.5
    Cattle, fat0.3
    Cattle, meat0.3
    Cattle, meat byproducts0.3
    Goat, fat0.3
    Goat, meat0.3
    Goat, meat byproducts0.3
    Grass, forage11
    Grass, hay19
    Hog, fat0.3
    Hog, meat0.3
    Hog, meat byproducts0.3
    Horse, fat0.3
    Horse, meat0.3
    Horse, meat byproducts0.3
    Milk0.1
    Oat, forage20
    Oat, grain0.1
    Oat, straw0.5
    Sheep, fat0.3
    Sheep, meat0.3
    Sheep, meat byproducts0.3
    Wheat, forage20
    Wheat, grain0.1
    Wheat, straw0.5
    * * * * *
    Start Amendment Part

    3. Amend § 180.452 by:

    End Amendment Part Start Amendment Part

    a. Revising paragraph (a) introductory text, and

    End Amendment Part Start Amendment Part

    b. Adding table heading “Table 1 to Paragraph (a)”.

    End Amendment Part

    The revision reads as follows:

    Primisulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of primisulfuron-methyl, including its metabolites and degradates, in or on the commodities in table 1 to this paragraph (a). Compliance with the tolerance levels specified in table 1 is to be determined by measuring only primisulfuron-methyl (methyl 2-[[[[[4,6-bis(difluoromethoxy)-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]benzoate) in or on the commodity.

    * * * * *
    Start Amendment Part

    4. Amend § 180.459 by:

    End Amendment Part Start Amendment Part

    a. Revising paragraph (a) introductory text; and

    End Amendment Part Start Amendment Part

    b. Adding table heading “Table 1 to Paragraph (a)”.

    End Amendment Part

    The revision reads as follows:

    Triasulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of triasulfuron, including its metabolites and degradates, in or on the commodities in table 1 to this paragraph (a). Compliance with the tolerance levels specified in table 1 is to be determined by measuring only triasulfuron (2-(2-chloroethoxy)-N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]benzenesulfonamide) in or on the commodity.

    * * * * *
    Start Amendment Part

    5. Amend § 180.479, paragraph (a) by:

    End Amendment Part Start Amendment Part

    a. Adding table heading “Table 1 to Paragraph (a)” in paragraph (a)(1);

    End Amendment Part Start Amendment Part

    b. In the Table in paragraph (a)(2):

    End Amendment Part Start Amendment Part

    i. Adding table heading “Table 2 to Paragraph (a)”;

    End Amendment Part Start Amendment Part

    ii. Revising the entry “Asparagus”;

    End Amendment Part Start Amendment Part

    iii. Adding in alphabetical order the entry “Nut, tree, group 14–12”;

    End Amendment Part Start Amendment Part

    iv. Removing the entries “Okra”; “Pea and bean, succulent shelled, subgroup 6”, “Pistachio”, and “Vegetable, fruiting, group 8”; and

    End Amendment Part Start Amendment Part

    v. Adding in alphabetical order the entry “Vegetable, fruiting, group 8–10”.

    End Amendment Part

    The revisions and additions read as follows:

    Halosulfuron-methyl; tolerances for residues.

    (2) * * *

    Table 2 to Paragraph ( a )

    CommodityParts per million
    *    *    *    *    *
    Asparagus1
    *    *    *    *    *
    Nut, tree, group 14–120.05
    *    *    *    *    *
    Vegetable, fruiting, group 8–100.05
    * * * * *
    Start Amendment Part

    6. Amend § 180.552 by:

    End Amendment Part Start Amendment Part

    a. Revising paragraph (a) introductory text;

    End Amendment Part Start Amendment Part

    b. Adding the table heading “Table 1 to Paragraph (a)” in paragraph (a)(1); and

    End Amendment Part Start Amendment Part

    c. Removing in Table 1 the entries “Hog, fat”; “Hog, meat”; and “Hog, meat byproducts”.

    End Amendment Part

    The revision reads as follows:

    Sulfosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of sulfosulfuron (N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-2-(ethylsulfonyl)imidazo[1,2-a]pyridine-3-sulfonamide), including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only those sulfosulfuron residues convertible to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine, expressed as the stoichiometric equivalent of sulfosulfuron.

    * * * * *
    Start Amendment Part

    7. Amend § 180.580 by:

    End Amendment Part Start Amendment Part

    a. Revising paragraph (a) introductory text; and

    End Amendment Part Start Amendment Part

    b. Adding table heading “Table 1 to Paragraph (a)” in paragraph (a)(1).

    End Amendment Part

    The revision reads as follows:

    Iodosulfuron-Methyl-sodium; tolerances for residues.

    (a) General. Tolerances are established for residues of the herbicide iodosulfuron-methyl-sodium, including its metabolites and degradates, in or on the commodities listed in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only iodosulfuron-methyl-sodium (methyl 4-iodo-2-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2- yl)amino] carbonyl]amino]sulfonyl] benzoate, sodium salt), calculated as the stoichiometric equivalent of Start Printed Page 62499 iodosulfuron-methyl-sodium, in or on the commodity.

    * * * * *
    Start Amendment Part

    8. Amend § 180.591 by:

    End Amendment Part Start Amendment Part

    a. Revising paragraph (a) introductory text;

    End Amendment Part Start Amendment Part

    b. Adding table heading “Table 1 to Paragraph (a)” in paragraph (a)(1);

    End Amendment Part Start Amendment Part

    c. Revising in Table 1 the entries “Almond” and “Almond, hulls”; and

    End Amendment Part Start Amendment Part

    d. Adding footnote 1 to Table 1.

    End Amendment Part

    The revisions and additions read as follows:

    Trifloxysulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of trifloxysulfuron, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only trifloxysulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(2,2,2-trifluoroethoxy)-2-pyridinesulfonamide.

    Table 1 to Paragraph ( a )

    CommodityParts per million
    Almond 10.02
    Almond, hulls10.01
    *    *    *    *    *
    1  These tolerances expire on [DATE 6 MONTHS AFTER DATE OF PUBLICATION IN THE Federal Register ].
    * * * * *
    Start Amendment Part

    9. Amend § 180.597 by:

    End Amendment Part Start Amendment Part

    a. Revising paragraph (a) introductory text; and

    End Amendment Part Start Amendment Part

    b. Adding table heading “Table 1 to Paragraph (a)” in paragraph (a)(1).

    End Amendment Part

    The revision reads as follows:

    Mesosulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of mesosulfuron-methyl, including its metabolites and degradates, in or on the commodities in the table in this paragraph. Compliance with the tolerance levels specified in this paragraph is to be determined by measuring only mesosulfuron-methyl, methyl 2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]-4-[[(methylsulfonyl)amino]methyl]benzoate.

    * * * * *
    End Supplemental Information

    [FR Doc. 2023–19513 Filed 9–11–23; 8:45 am]

    BILLING CODE 6560–50–P

Document Information

Published:
09/12/2023
Department:
Environmental Protection Agency
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
2023-19513
Dates:
Comments must be received on or before November 13, 2023.
Pages:
62492-62499 (8 pages)
Docket Numbers:
EPA-HQ-OPP-2023-0254, FRL-11283-01-OCSPP
RINs:
2070-ZA16
Topics:
Administrative practice and procedure, Agricultural commodities, Environmental protection, Pesticides and pests, Reporting and recordkeeping requirements
PDF File:
2023-19513.pdf
CFR: (8)
40 CFR 180.405
40 CFR 180.452
40 CFR 180.459
40 CFR 180.479
40 CFR 180.552
More ...