Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic) Acid, and Pelargonic (Nonanoic) Acid), 72775-72780 [2024-20078]

Download as PDF Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Proposed Rules lotter on DSK11XQN23PROD with PROPOSALS1 County Area will remain designated nonattainment for the 2010 1-hour SO2 NAAQS until such time as Maryland submits to the EPA a redesignation request and accompanying 10-year maintenance plan, and the EPA determines that the area meets the CAA requirements for redesignation to attainment and takes action to redesignate the area. If finalized, this action will address the EPA’s obligation under CAA section 179(c) to determine if the Anne Arundel-Baltimore County Area attained the 2010 1-hour SO2 NAAQS by the September 12, 2021 attainment date. The EPA is soliciting public comments on this proposed rulemaking. These comments will be considered before taking final action. IV. Statutory and Executive Order Reviews This action proposes to determine an area has attained the NAAQS by the relevant attainment date and does not impose additional or modify existing requirements. For that reason, this action: • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and • Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and VerDate Sep<11>2014 16:03 Sep 05, 2024 Jkt 262001 72775 Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address ‘‘disproportionately high and adverse human health or environmental effects’’ of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as ‘‘the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.’’ The EPA further defines the term fair treatment to mean that ‘‘no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.’’ The EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, which finds that a nonattainment area had attained the 2010 SO2 NAAQS by the applicable attainment date, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples. In addition, this proposed rulemaking, the determination of attainment by attainment date for the Anne ArundelBaltimore County SO2 nonattainment area, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because this action is not approved to apply in Indian country located in the State, and the EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. ENVIRONMENTAL PROTECTION AGENCY List of Subjects in 40 CFR Part 52 Anita Pease, Antimicrobials Division (7510M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 566–0736; email address: pease.anita@ epa.gov. Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides. Adam Ortiz, Regional Administrator, Region III. [FR Doc. 2024–19436 Filed 9–5–24; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 40 CFR Part 180 [EPA–HQ–OPP–2023–0454; FRL–12177–01– OCSPP] RIN 2070–ZA16 Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic) Acid, and Pelargonic (Nonanoic) Acid) Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA or Agency) 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 pesticide tolerances and active ingredients addressed in this rulemaking are identified and discussed in detail in Unit III. of this document. DATES: Comments must be received on or before November 5, 2024. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2023–0454, through 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. SUMMARY: FOR FURTHER INFORMATION CONTACT: 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 E:\FR\FM\06SEP1.SGM 06SEP1 72776 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Proposed Rules producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document might apply to them: • Restaurant kitchen cleaning service (NAICS code 561720); • Milk production, dairy cattle (NAICS code 112120); • Food manufacturing (NAICS code 311); • Pesticide manufacturing (NAICS code 32532); and • Food processing machinery and equipment merchant wholesalers (NAICS code 423830). If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. What action is the Agency taking? EPA is proposing several tolerance actions that the Agency previously determined were necessary or appropriate during registration review for the pesticide active ingredients identified in Unit III. The 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 groupings; • Removing expired tolerances; • Revoking tolerances that are no longer needed; and • Harmonizing tolerances with the Codex Alimentarius Commission (Codex) Maximum Residue Levels (MRLs). Although it may not have been identified in the registration review of a particular pesticide, this rule may include 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. lotter on DSK11XQN23PROD with PROPOSALS1 C. What is EPA’s authority for taking this action? Pursuant to section 408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), EPA is proposing the tolerance actions in this rulemaking that the Agency previously determined were necessary or appropriate during the registration review conducted under FIFRA, 7 U.S.C. 136 et seq. FFDCA section 408(e) VerDate Sep<11>2014 16:03 Sep 05, 2024 Jkt 262001 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. D. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit CBI to EPA through email or https:// www.regulations.gov. 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 information that you claim to be CBI. 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.epa.gov/dockets/ commenting-epa-dockets. 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. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population. E. 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 PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 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. II. Background A. What is a tolerance? A ‘‘tolerance’’ represents the maximum level for residues of a pesticide chemical legally allowed in or on food, which includes raw agricultural commodities and processed foods and 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. See 21 U.S.C. 346a(a)(1). Foods containing unsafe residues are deemed adulterated and may not be distributed in interstate commerce. See 21 U.S.C. 331(a) and 342(a)(2)(B). Consequently, for a fooduse 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. 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/pesticidetolerances/about-pesticide-tolerances. B. Why does EPA consider international residue limits? When establishing a tolerance for residues of a pesticide, EPA must determine whether Codex has established a MRL for that pesticide. See 21 U.S.C. 346a(b)(4). Additionally, as part of the registration review of a pesticide (see Unit II.C.), EPA determines whether international MRLs exist for commodities and chemicals for which U.S. tolerances have been established. Where appropriate, EPA’s E:\FR\FM\06SEP1.SGM 06SEP1 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Proposed Rules intention is to harmonize U.S. tolerances with those international MRLs to facilitate trade. EPA’s effort to harmonize with international MRLs is summarized in the tolerance reassessment section of the individual Human Health Draft Risk Assessments that support the pesticide registration review. lotter on DSK11XQN23PROD with PROPOSALS1 C. What is registration review? 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 also 40 CFR 155.40(a). 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 can continue to be used without causing unreasonable adverse effects on human health and the environment. 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. In addition, any tolerance changes identified as necessary or appropriate during registration review of a pesticide are summarized in the registration review decision documents for each pesticide active ingredient or registration review case (e.g., in the Proposed Interim Decision (PID), Proposed Final Decision (PFD), Interim Decision (ID) and Final Decision (FD)). 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/pesticidereevaluation. D. What are ‘‘Safety Findings’’? EPA has assessed the individual risks from exposure to the pesticide active ingredients identified and discussed in Unit III., taking into consideration all reliable data on toxicity and exposure, including for infants and children, and has included a safety finding under FFDCA section 408(b) for the proposed tolerance actions. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure for each individual chemical is below the Agency’s level of concern, EPA VerDate Sep<11>2014 16:03 Sep 05, 2024 Jkt 262001 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 residues of the pesticide active ingredients identified and discussed in Unit III. Thus, EPA has determined that the proposed tolerances for residues of the pesticide active ingredients identified and discussed in Unit III. are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expressions. Chemical specific safety findings are 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. The human health risk assessments 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. E. How does EPA’s policy on children’s health apply to tolerance actions? EPA’s Policy on Children’s Health (October 5, 2021) requires EPA to protect children from environmental exposures by consistently and explicitly considering early life exposures (from conception, infancy, early childhood and through adolescence until 21 years of age) and lifelong health in all human health decisions through identifying and integrating children’s health data and information when conducting risk assessments. https://www.epa.gov/ system/files/documents/2021-10/2021policy-on-childrens-health.pdf. 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 . . .’’ (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 the chemical specific registration review documents that are available in the pesticide specific docket as identified in Unit III. PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 72777 III. Proposed Tolerance Actions EPA is proposing to take the specific tolerance actions identified in this unit and as described in the March 2022 Combined PWP/PID. Capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic (nonanoic) acid are registered for antimicrobial use as a sanitizer on food processing and dairy equipment. As a result of those uses, residues of these chemicals may be found in food that come into contact with treated surfaces; thus, that use is categorized as an ‘‘indirect food use’’ that requires a tolerance or exemption. Absent information supporting a conclusion that no residues would be available for transfer to food, a tolerance or tolerance exemption is required for capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic (nonanoic) acid. However, the Agency is now proposing to amend these established tolerance exemptions because they include outdated application rate limits. Because the latest evaluations of these pesticides determined that there are no dietary risks of concern, the application rate limits on the tolerance exemptions are no longer necessary. Additionally, the Agency is proposing to remove several duplicative tolerance exemptions that were not initially identified in the combined PWP/PID but are justified by the same science rationale as described in the combined PWP/PID. A. 40 CFR 180.940; Capric (Decanoic) Acid As noted in the March 2022 PWP/PID, there are exemptions from the requirement of a tolerance under 40 CFR 180.940 (b) and (c) for residues of capric (decanoic) acid when applied to dairyprocessing equipment and food processing equipment and utensils, with the limitation that the end-use concentration of capric (decanoic) acid does not exceed 90 ppm (section b), and 234 ppm (section c). After the issuance of the PWP/PID, it was found that an exemption from the requirement of a tolerance for capric (decanoic acid) exists in section (a) as well with the limitation that the end-use concentration of caprylic (octanoic) acid is not to exceed 100 ppm. EPA, on its own initiative is therefore proposing to remove the redundant exemptions and limits for capric (decanoic) acid under 40 CFR 180.940 (b) and (c) entirely, and to remove the 100 ppm limit for capric (decanoic) acid from 180.940(a). As discussed in Unit II.D., EPA concludes there is a reasonable certainty that no harm will result to the general E:\FR\FM\06SEP1.SGM 06SEP1 72778 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Proposed Rules population, or specifically to infants and children, from aggregate exposure to capric (decanoic acid) residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available. lotter on DSK11XQN23PROD with PROPOSALS1 B. 40 CFR 180.940; Caprylic (Octanoic) Acid As noted in the March 2022 PWP/PID, there are exemptions from the requirement of a tolerance under 40 CFR 180.940 (b), and (c) for residues of caprylic (octanoic) acid when applied to dairy-processing equipment and food processing equipment and utensils, with the limitation that the end-use concentration of caprylic (octanoic) acid does not exceed 176 ppm (section b), and 234 ppm (section c). After the issuance of the PWP/PID, it was found that two exemptions from the requirement of a tolerance for caprylic (octanoic acid) exist in section (a) as well with limitations that the end-use concentration of caprylic (octanoic) acid is not to exceed 52 ppm and 100 ppm. EPA, on its own initiative is therefore proposing to remove the redundant exemptions and limits for caprylic (octanoic) acid from 40 CFR 180.940 (b) and (c) entirely, and to remove the 100 ppm limits for caprylic (octanoic) acid from 180.940(a). As discussed in Unit II.D., 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 caprylic (octanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available. C. 40 CFR 180.940; Pelargonic (Nonanoic) Acid As noted in the March 2022 PWP/PID, there are exemptions from the requirement of a tolerance under 40 CFR 180.940(a), (b), and (c) for residues of pelargonic (nonanoic) acid when applied to dairy-processing equipment and food processing equipment and utensils, with the limitation that the end-use concentration of pelargonic (nonanoic) acid does not exceed 100 ppm (section a) and 90 ppm (sections b and c). EPA, on its own initiative is therefore proposing to remove the redundant exemptions and limits for pelargonic (nonanoic) acid from 40 CFR 180.940 (b) and (c) entirely, and to remove the 100 ppm limit for pelargonic (nonanoic) acid from 180.940(a). As discussed in Unit II.D., 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 VerDate Sep<11>2014 16:03 Sep 05, 2024 Jkt 262001 to pelargonic (nonanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available. D. 40 CFR 180.1159(c); Pelargonic (Nonanoic Acid) Also outlined in the March 2022 PWP/PID, there is an exemption from the requirement of a tolerance for residues of pelargonic (nonanoic) acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of pelargonic (nonanoic) acid as an antimicrobial treatment in solutions containing a diluted end-use concentration of pelargonic (nonanoic) acid on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants, with a limitation of 170 ppm. EPA, on its own initiative, is therefore proposing to remove the limit of 170 ppm under 40 CFR 180.1159(c) for pelargonic (nonanoic) acid. As discussed in Unit II.D., 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 pelargonic (nonanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available. E. 40 CFR 180.1225; Capric (Decanoic) Acid As outlined in the March 2022 PWP/ PID, there is an exemption from the requirement of a tolerance for residues of capric (decanoic) acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of capric (decanoic) acid as an antimicrobial treatment in solutions containing a diluted end-use concentration of capric (decanoic) acid on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers, and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants, with the limitation of 170 ppm. EPA, on its own initiative, is therefore proposing to remove the limit of 170 ppm under 40 CFR 180.1225 for capric (decanoic) acid. As discussed in Unit II.D., 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 capric (decanoic) acid residues. The proposed tolerance changes are considered safe PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 and adequate enforcement methodology is available. IV. Proposed Effective and Expiration Date(s) 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 for the existing tolerance 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/ regulations/and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 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 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 action is any significant adverse economic impact on small entities and that the Agency is certifying that this action will not have a significant economic impact on a substantial E:\FR\FM\06SEP1.SGM 06SEP1 72779 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Proposed Rules number of small entities because the action has no net burden on small entities subject to this rulemaking. 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 docket ID No. EPA–HQ–OPP–2005–0322 at https://www.regulations.gov. For the pesticides named in this rulemaking, EPA concludes that there is no reasonable expectation that residues of the pesticides for tolerances listed in this rulemaking for revocation will be found on the commodities discussed in this rulemaking, 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 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. lotter on DSK11XQN23PROD with PROPOSALS1 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. VerDate Sep<11>2014 16:03 Sep 05, 2024 Jkt 262001 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 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 (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 2021 Policy on Children’s Health applies to this action as discussed in Unit II.D. generally, and in Unit III. in the context of the individual chemicals addressed in this action. 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 that would require Agency consideration under 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 and Executive Order 14096: Revitalizing Our Nation’s Commitment to Environmental Justice for All EPA believes that the human health and environmental conditions that exist prior to this action do not result in disproportionate and adverse effects on communities with EJ concerns as described in Executive Orders 12898 (59 FR 7629, February 16, 1994), and 14096 (88 FR 25251, April 26, 2023). Furthermore, EPA believes that this action is not likely to result in new disproportionate and adverse effects on PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 communities with environmental justice concerns. As discussed in more detail in the pesticide specific risk assessments conducted as part of the registration review for each pesticide 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. See also Unit I.D.3. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 28, 2024. Edward Messina, Director, Office of Pesticide Programs. Therefore, the EPA proposes to amend 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Amend § 180.940 by: a. In table 1 in paragraph (a): i. Removing the entries for ‘‘Decanoic acid’’; Nonanoic acid’’; and ‘‘Octanoic acid’’; ■ ii. Adding in alphabetical order the entries ‘‘Capric (decanoic) acid’’; ‘‘Caprylic (octanoic) acid’’; and ‘‘Pelargonic (nonanoic) acid’’; ■ b. In the table in paragraph (b) removing the entries for ‘‘Decanoic acid’’; ‘‘Nonanoic acid’’; and ‘‘Octanoic acid’’; and ■ c. In the table in paragraph (c) removing the entries in paragraph (c) for ‘‘Decanoic acid’’; ‘‘Nonanoic acid’’; and ‘‘Octanoic acid’’. The additions read as follows: ■ ■ ■ § 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). * * * (a) * * * * * TABLE 1 TO PARAGRAPH (a) Pesticide chemical CAS Reg. No. * * * Capric (decanoic) acid ............ Caprylic (octanoic) acid ........... * 334–48–5 124–07–2 * None. None. * * * Pelargonic (nonanoic) acid ..... * 112–05–0 * None. E:\FR\FM\06SEP1.SGM * * 06SEP1 * * Limits * 72780 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Proposed Rules * * * * * 3. Amend § 180.1159 by revising the section heading and revising and republishing paragraph (c) to read as follows: ■ § 180.1159 Pelargonic (nonanoic) acid; exemption from the requirement of tolerances. * * * * * (c) An exemption from the requirement of a tolerance is established for residues of pelargonic (nonanoic) acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of pelargonic (nonanoic) acid as an antimicrobial treatment for application on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants. ■ 4. Revise and republish § 180.1225 to read as follows: § 180.1225 Capric (decanoic) acid; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of capric (decanoic) acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of capric (decanoic) acid as an antimicrobial treatment in solutions containing a diluted end-use concentration of capric (decanoic) acid on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants. [FR Doc. 2024–20078 Filed 9–5–24; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 90 and 96 [GN Docket No. 17–258; FCC 24–86; FR ID 240738] lotter on DSK11XQN23PROD with PROPOSALS1 Promoting Investment in the 3550– 3700 MHz Band Federal Communications Commission. ACTION: Notice of proposed rulemaking. AGENCY: In this document the Federal Communications Commission (FCC or Commission) continues to shape development of the Citizens Broadband SUMMARY: VerDate Sep<11>2014 16:03 Sep 05, 2024 Jkt 262001 Radio Service operations in the 3.55–3.7 GHz band (3.5 GHz band). This Notice of Proposed Rulemaking (NPRM) provides an overview of the federal protection regime implemented by the National Telecommunications and Information Administration (NTIA), Department of Defense (DoD), and Commission staff and solicits input on proposals to update the technical and service rules. It also seeks commenters’ ideas for further innovations and improvements to the 3.5 GHz band. DATES: Interested parties may file comments on or before October 7, 2024; and reply comments on or before November 5, 2024. ADDRESSES: You may submit comments, identified by GN Docket No. 17–258, by any of the following methods: • Federal Communications Commission’s Website: https:// apps.fcc.gov/ecfs/. Follow the instructions for submitting comments. • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: FCC504@fcc.gov or phone: 202–418–0530 or TTY: 202– 418–0432. For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: For additional information on this proceeding, contact Paul Powell of the Wireless Telecommunications Bureau, Mobility Division, at (202) 418–1613 Paul.Powell@fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Notice of Proposed Rulemaking in GN Docket No. 17–258, FCC 24–86, adopted on August 5, 2024, and released on August 16, 2024. The full text of this document is available for public inspection online at https://www.fcc.gov/document/fcclooks-modernize-35-ghz-citizensbroadband-radio-service-rules. Providing Accountability Through Transparency Act: The Providing Accountability Through Transparency Act, Public Law 118–9, requires each agency, in providing notice of a rulemaking, to post online a brief plain language summary of the proposed rule. The required summary of this Notice of Proposed Rulemaking is available at https://www.fcc.gov/proposedrulemakings. Pursuant to sections 1.415 and 1.419 of the Commission’s rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 page of this document. Comments may be filed using the Commission’s Electronic Comment Filing System (ECFS). • Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: https:// www.fcc.gov/ecfs/. • Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. • Filings can be sent by hand or messenger delivery, by commercial courier, or by the U.S. Postal Service. All filings must be addressed to the Secretary, Federal Communications Commission. • Hand-delivered or messengerdelivered paper filings for the Commission’s Secretary are accepted between 8:00 a.m. and 4:00 p.m. by the FCC’s mailing contractor at 9050 Junction Drive, Annapolis Junction, MD 20701. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building. • Commercial courier deliveries (any deliveries not by the U.S. Postal Service) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. • Filings sent by U.S. Postal Service First-Class Mail, Priority Mail, and Priority Mail Express must be sent to 45 L Street NE, Washington, DC 20554. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202–418–0530 (voice), 202– 418–0432 (TTY). Ex Parte Status: The proceeding this NPRM initiates shall be treated as a ‘‘permit-but-disclose’’ proceeding in accordance with the Commission’s ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter’s written comments, memoranda or other filings in the proceeding, the presenter E:\FR\FM\06SEP1.SGM 06SEP1

Agencies

[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Proposed Rules]
[Pages 72775-72780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20078]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0454; FRL-12177-01-OCSPP]
RIN 2070-ZA16


Pesticide Tolerances; Implementing Registration Review Decisions 
for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic) 
Acid, and Pelargonic (Nonanoic) Acid)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA or Agency) 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 pesticide 
tolerances and active ingredients addressed in this rulemaking are 
identified and discussed in detail in Unit III. of this document.

DATES: Comments must be received on or before November 5, 2024.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2023-0454, through 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.

FOR FURTHER INFORMATION CONTACT: Anita Pease, Antimicrobials Division 
(7510M), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-0736; email address: [email protected].

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

[[Page 72776]]

producer, food manufacturer, or pesticide manufacturer. The following 
list of North American Industrial Classification System (NAICS) codes 
is not intended to be exhaustive, but rather provides a guide to help 
readers determine whether this document might apply to them:
     Restaurant kitchen cleaning service (NAICS code 561720);
     Milk production, dairy cattle (NAICS code 112120);
     Food manufacturing (NAICS code 311);
     Pesticide manufacturing (NAICS code 32532); and
     Food processing machinery and equipment merchant 
wholesalers (NAICS code 423830).
    If you have any questions regarding the applicability of this 
proposed action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

B. What action is the Agency taking?

    EPA is proposing several tolerance actions that the Agency 
previously determined were necessary or appropriate during registration 
review for the pesticide active ingredients identified in Unit III. The 
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 groupings;
     Removing expired tolerances;
     Revoking tolerances that are no longer needed; and
     Harmonizing tolerances with the Codex Alimentarius 
Commission (Codex) Maximum Residue Levels (MRLs).
    Although it may not have been identified in the registration review 
of a particular pesticide, this rule may include 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.

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

    Pursuant to section 408(e) of the Federal Food, Drug and Cosmetic 
Act (FFDCA), 21 U.S.C. 346a(e), EPA is proposing the tolerance actions 
in this rulemaking that the Agency previously determined were necessary 
or appropriate during the registration review conducted under FIFRA, 7 
U.S.C. 136 et seq. FFDCA section 408(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.

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

    1. Submitting CBI. Do not submit CBI to EPA through email or 
https://www.regulations.gov. 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 
information that you claim to be CBI. 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.epa.gov/dockets/commenting-epa-dockets.
    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. To help address potential environmental justice issues, the 
Agency seeks information on any groups or segments of the population 
who, as a result of their location, cultural practices, or other 
factors, may have atypical or disproportionately high and adverse human 
health impacts or environmental effects from exposure to the pesticides 
discussed in this document, compared to the general population.

E. 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.

II. Background

A. What is a tolerance?

    A ``tolerance'' represents the maximum level for residues of a 
pesticide chemical legally allowed in or on food, which includes raw 
agricultural commodities and processed foods and 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. See 21 U.S.C. 346a(a)(1). Foods containing unsafe 
residues are deemed adulterated and may not be distributed in 
interstate commerce. See 21 U.S.C. 331(a) and 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. 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 Codex has established a MRL for that pesticide. See 
21 U.S.C. 346a(b)(4). Additionally, as part of the registration review 
of a pesticide (see Unit II.C.), EPA determines whether international 
MRLs exist for commodities and chemicals for which U.S. tolerances have 
been established. Where appropriate, EPA's

[[Page 72777]]

intention is to harmonize U.S. tolerances with those international MRLs 
to facilitate trade. EPA's effort to harmonize with international MRLs 
is summarized in the tolerance reassessment section of the individual 
Human Health Draft Risk Assessments that support the pesticide 
registration review.

C. What is registration review?

    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 also 40 CFR 155.40(a). 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 can continue 
to be used without causing unreasonable adverse effects on human health 
and the environment. 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. In addition, any tolerance changes identified as 
necessary or appropriate during registration review of a pesticide are 
summarized in the registration review decision documents for each 
pesticide active ingredient or registration review case (e.g., in the 
Proposed Interim Decision (PID), Proposed Final Decision (PFD), Interim 
Decision (ID) and Final Decision (FD)). 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.

D. What are ``Safety Findings''?

    EPA has assessed the individual risks from exposure to the 
pesticide active ingredients identified and discussed in Unit III., 
taking into consideration all reliable data on toxicity and exposure, 
including for infants and children, and has included a safety finding 
under FFDCA section 408(b) for the proposed tolerance actions. Based on 
the supporting risk assessments and registration review documents, 
which demonstrate that the aggregate exposure for each individual 
chemical 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 residues of the pesticide active ingredients identified and 
discussed in Unit III. Thus, EPA has determined that the proposed 
tolerances for residues of the pesticide active ingredients identified 
and discussed in Unit III. are safe.
    Adequate enforcement methodology as described in the supporting 
documents is available to enforce the tolerance expressions. Chemical 
specific safety findings are 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. The 
human health risk assessments 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.

E. How does EPA's policy on children's health apply to tolerance 
actions?

    EPA's Policy on Children's Health (October 5, 2021) requires EPA to 
protect children from environmental exposures by consistently and 
explicitly considering early life exposures (from conception, infancy, 
early childhood and through adolescence until 21 years of age) and 
lifelong health in all human health decisions through identifying and 
integrating children's health data and information when conducting risk 
assessments. https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.
    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 . . 
.'' (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 the chemical specific 
registration review documents that are available in the pesticide 
specific docket as identified in Unit III.

III. Proposed Tolerance Actions

    EPA is proposing to take the specific tolerance actions identified 
in this unit and as described in the March 2022 Combined PWP/PID. 
Capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic 
(nonanoic) acid are registered for antimicrobial use as a sanitizer on 
food processing and dairy equipment. As a result of those uses, 
residues of these chemicals may be found in food that come into contact 
with treated surfaces; thus, that use is categorized as an ``indirect 
food use'' that requires a tolerance or exemption. Absent information 
supporting a conclusion that no residues would be available for 
transfer to food, a tolerance or tolerance exemption is required for 
capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic 
(nonanoic) acid.
    However, the Agency is now proposing to amend these established 
tolerance exemptions because they include outdated application rate 
limits. Because the latest evaluations of these pesticides determined 
that there are no dietary risks of concern, the application rate limits 
on the tolerance exemptions are no longer necessary. Additionally, the 
Agency is proposing to remove several duplicative tolerance exemptions 
that were not initially identified in the combined PWP/PID but are 
justified by the same science rationale as described in the combined 
PWP/PID.

A. 40 CFR 180.940; Capric (Decanoic) Acid

    As noted in the March 2022 PWP/PID, there are exemptions from the 
requirement of a tolerance under 40 CFR 180.940 (b) and (c) for 
residues of capric (decanoic) acid when applied to dairy-processing 
equipment and food processing equipment and utensils, with the 
limitation that the end-use concentration of capric (decanoic) acid 
does not exceed 90 ppm (section b), and 234 ppm (section c). After the 
issuance of the PWP/PID, it was found that an exemption from the 
requirement of a tolerance for capric (decanoic acid) exists in section 
(a) as well with the limitation that the end-use concentration of 
caprylic (octanoic) acid is not to exceed 100 ppm. EPA, on its own 
initiative is therefore proposing to remove the redundant exemptions 
and limits for capric (decanoic) acid under 40 CFR 180.940 (b) and (c) 
entirely, and to remove the 100 ppm limit for capric (decanoic) acid 
from 180.940(a). As discussed in Unit II.D., EPA concludes there is a 
reasonable certainty that no harm will result to the general

[[Page 72778]]

population, or specifically to infants and children, from aggregate 
exposure to capric (decanoic acid) residues. The proposed tolerance 
changes are considered safe and adequate enforcement methodology is 
available.

B. 40 CFR 180.940; Caprylic (Octanoic) Acid

    As noted in the March 2022 PWP/PID, there are exemptions from the 
requirement of a tolerance under 40 CFR 180.940 (b), and (c) for 
residues of caprylic (octanoic) acid when applied to dairy-processing 
equipment and food processing equipment and utensils, with the 
limitation that the end-use concentration of caprylic (octanoic) acid 
does not exceed 176 ppm (section b), and 234 ppm (section c). After the 
issuance of the PWP/PID, it was found that two exemptions from the 
requirement of a tolerance for caprylic (octanoic acid) exist in 
section (a) as well with limitations that the end-use concentration of 
caprylic (octanoic) acid is not to exceed 52 ppm and 100 ppm. EPA, on 
its own initiative is therefore proposing to remove the redundant 
exemptions and limits for caprylic (octanoic) acid from 40 CFR 180.940 
(b) and (c) entirely, and to remove the 100 ppm limits for caprylic 
(octanoic) acid from 180.940(a). As discussed in Unit II.D., 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 caprylic (octanoic) acid residues. The proposed 
tolerance changes are considered safe and adequate enforcement 
methodology is available.

C. 40 CFR 180.940; Pelargonic (Nonanoic) Acid

    As noted in the March 2022 PWP/PID, there are exemptions from the 
requirement of a tolerance under 40 CFR 180.940(a), (b), and (c) for 
residues of pelargonic (nonanoic) acid when applied to dairy-processing 
equipment and food processing equipment and utensils, with the 
limitation that the end-use concentration of pelargonic (nonanoic) acid 
does not exceed 100 ppm (section a) and 90 ppm (sections b and c). EPA, 
on its own initiative is therefore proposing to remove the redundant 
exemptions and limits for pelargonic (nonanoic) acid from 40 CFR 
180.940 (b) and (c) entirely, and to remove the 100 ppm limit for 
pelargonic (nonanoic) acid from 180.940(a). As discussed in Unit II.D., 
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 pelargonic (nonanoic) acid residues. The 
proposed tolerance changes are considered safe and adequate enforcement 
methodology is available.

D. 40 CFR 180.1159(c); Pelargonic (Nonanoic Acid)

    Also outlined in the March 2022 PWP/PID, there is an exemption from 
the requirement of a tolerance for residues of pelargonic (nonanoic) 
acid in or on all raw agricultural commodities and in processed 
commodities, when such residues result from the use of pelargonic 
(nonanoic) acid as an antimicrobial treatment in solutions containing a 
diluted end-use concentration of pelargonic (nonanoic) acid on food 
contact surfaces such as equipment, pipelines, tanks, vats, fillers, 
evaporators, pasteurizers and aseptic equipment in restaurants, food 
service operations, dairies, breweries, wineries, beverage and food 
processing plants, with a limitation of 170 ppm. EPA, on its own 
initiative, is therefore proposing to remove the limit of 170 ppm under 
40 CFR 180.1159(c) for pelargonic (nonanoic) acid. As discussed in Unit 
II.D., 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 pelargonic (nonanoic) acid 
residues. The proposed tolerance changes are considered safe and 
adequate enforcement methodology is available.

E. 40 CFR 180.1225; Capric (Decanoic) Acid

    As outlined in the March 2022 PWP/PID, there is an exemption from 
the requirement of a tolerance for residues of capric (decanoic) acid 
in or on all raw agricultural commodities and in processed commodities, 
when such residues result from the use of capric (decanoic) acid as an 
antimicrobial treatment in solutions containing a diluted end-use 
concentration of capric (decanoic) acid on food contact surfaces such 
as equipment, pipelines, tanks, vats, fillers, evaporators, 
pasteurizers, and aseptic equipment in restaurants, food service 
operations, dairies, breweries, wineries, beverage and food processing 
plants, with the limitation of 170 ppm. EPA, on its own initiative, is 
therefore proposing to remove the limit of 170 ppm under 40 CFR 
180.1225 for capric (decanoic) acid. As discussed in Unit II.D., 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 capric (decanoic) acid residues. The proposed 
tolerance changes are considered safe and adequate enforcement 
methodology is available.

IV. Proposed Effective and Expiration Date(s)

    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 for the existing 
tolerance 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/regulations/and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 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 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 action is any significant adverse economic 
impact on small entities and that the Agency is certifying that this 
action will not have a significant economic impact on a substantial

[[Page 72779]]

number of small entities because the action has no net burden on small 
entities subject to this rulemaking. 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 docket ID No. EPA-HQ-OPP-2005-0322 
at https://www.regulations.gov.
    For the pesticides named in this rulemaking, EPA concludes that 
there is no reasonable expectation that residues of the pesticides for 
tolerances listed in this rulemaking for revocation will be found on 
the commodities discussed in this rulemaking, 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 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.

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

    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 (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 2021 Policy on Children's Health applies to this action as 
discussed in Unit II.D. generally, and in Unit III. in the context of 
the individual chemicals addressed in this action.

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 that would require 
Agency consideration under 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 and 
Executive Order 14096: Revitalizing Our Nation's Commitment to 
Environmental Justice for All

    EPA believes that the human health and environmental conditions 
that exist prior to this action do not result in disproportionate and 
adverse effects on communities with EJ concerns as described in 
Executive Orders 12898 (59 FR 7629, February 16, 1994), and 14096 (88 
FR 25251, April 26, 2023). Furthermore, EPA believes that this action 
is not likely to result in new disproportionate and adverse effects on 
communities with environmental justice concerns. As discussed in more 
detail in the pesticide specific risk assessments conducted as part of 
the registration review for each pesticide 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. See also Unit I.D.3.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 28, 2024.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, the EPA proposes to amend 40 CFR chapter I as follows:

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. Amend Sec.  180.940 by:
0
a. In table 1 in paragraph (a):
0
i. Removing the entries for ``Decanoic acid''; Nonanoic acid''; and 
``Octanoic acid'';
0
ii. Adding in alphabetical order the entries ``Capric (decanoic) 
acid''; ``Caprylic (octanoic) acid''; and ``Pelargonic (nonanoic) 
acid'';
0
b. In the table in paragraph (b) removing the entries for ``Decanoic 
acid''; ``Nonanoic acid''; and ``Octanoic acid''; and
0
c. In the table in paragraph (c) removing the entries in paragraph (c) 
for ``Decanoic acid''; ``Nonanoic acid''; and ``Octanoic acid''.
    The additions read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                           CAS Reg.
           Pesticide chemical                No.            Limits
------------------------------------------------------------------------
 
                                * * * * *
Capric (decanoic) acid..................   334-48-5  None.
Caprylic (octanoic) acid................   124-07-2  None.
 
                                * * * * *
Pelargonic (nonanoic) acid..............   112-05-0  None.
 
                                * * * * *
------------------------------------------------------------------------


[[Page 72780]]

* * * * *
0
3. Amend Sec.  180.1159 by revising the section heading and revising 
and republishing paragraph (c) to read as follows:


Sec.  180.1159  Pelargonic (nonanoic) acid; exemption from the 
requirement of tolerances.

* * * * *
    (c) An exemption from the requirement of a tolerance is established 
for residues of pelargonic (nonanoic) acid in or on all raw 
agricultural commodities and in processed commodities, when such 
residues result from the use of pelargonic (nonanoic) acid as an 
antimicrobial treatment for application on food contact surfaces such 
as equipment, pipelines, tanks, vats, fillers, evaporators, 
pasteurizers and aseptic equipment in restaurants, food service 
operations, dairies, breweries, wineries, beverage and food processing 
plants.
0
4. Revise and republish Sec.  180.1225 to read as follows:


Sec.  180.1225  Capric (decanoic) acid; exemption from the requirement 
of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of capric (decanoic) acid in or on all raw agricultural 
commodities and in processed commodities, when such residues result 
from the use of capric (decanoic) acid as an antimicrobial treatment in 
solutions containing a diluted end-use concentration of capric 
(decanoic) acid on food contact surfaces such as equipment, pipelines, 
tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment 
in restaurants, food service operations, dairies, breweries, wineries, 
beverage and food processing plants.

[FR Doc. 2024-20078 Filed 9-5-24; 8:45 am]
BILLING CODE 6560-50-P
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