Trichoderma Atroviride Strain AT10; Exemption From the Requirement of a Tolerance, 59645-59648 [2024-16074]

Download as PDF ddrumheller on DSK120RN23PROD with RULES1 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations Division. https://hero.epa.gov/hero/ index.cfm/reference/details/reference_ id/10494329. USEPA. 2016. Six-Year Review 3—Health Effects Assessment for Existing Chemical and Radionuclide National Primary Drinking Water Regulations—Summary Report. EPA 822–R–16–008. USEPA. 2017a. National Primary Drinking Water Regulations; Announcement of the Results of EPA’s Review of Existing Drinking Water Standards and Request for Public Comment and/or Information on Related Issues. 82 FR 3518. January 11, 2017. USEPA. 2017b. Oxamyl Draft Human Health Risk Assessment in Support of Registration Review. Washington, DC: U.S. Environmental Protection Agency (USEPA), Office of Chemical Safety and Pollution Prevention, Health Effects Division. https://hero.epa.gov/hero/ index.cfm/reference/details/reference_ id/10532947. USEPA. 2017c. 2,4–D Revised Human Health Risk Assessment for Registration Review. Washington, DC: U.S. Environmental Protection Agency (USEPA), Office of Chemical Safety and Pollution Prevention, Health Effects Division. https://hero.epa.gov/hero/index.cfm/ reference/details/reference_id/10532862. USEPA. 2017d. Glyphosate: Draft Human Health Risk Assessment in Support of Registration Review. EPA–HQ–OPP– 2009–0361–0068. Washington, DC: U.S. Environmental Protection Agency (USEPA), Office of Chemical Safety and Pollution Prevention. https://hero.epa. gov/hero/index.cfm/reference/details/ reference_id/10532909. USEPA. 2018a. Draft Atrazine Human Health Risk Assessment for Registration Review. EPA–HQ–OPP–2013–0266–1256. Washington, DC: U.S. Environmental Protection Agency (USEPA). https:// hero.epa.gov/hero/index.cfm/reference/ details/reference_id/10533087. USEPA. 2018b. Simazine: Human Health Risk Assessment for Registration Review and to Support the Registration of Proposed Uses on Citrus Fruit (Crop Group 10–10), Pome Fruit (Crop Group 11–10), Stone Fruit (Crop Group 12–12), Tree Nuts (Crop Group 14–12), and Tolerance Amendment for Almond Hulls. Washington, DC: U.S. Environmental Protection Agency (USEPA), Office of Chemical Safety and Pollution Prevention. https://hero.epa. gov/hero/index.cfm/reference/details/ reference_id/10533123. USEPA. 2019. Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Contaminant Occurrence Data in Support of the EPA’s Fourth Six-Year Review of National Primary Drinking Water Regulations. 84 FR 58381. October 31, 2019. USEPA. 2020a. Microbial Disinfection Byproducts Rules: Public Meeting to Inform Potential Rule Revisions. Notice. 85 FR 61680. September 30, 2020. USEPA. 2020b. Diquat. Human Health Risk Assessment for the Establishment Of A VerDate Sep<11>2014 17:25 Jul 22, 2024 Jkt 262001 Tolerance Without U.S. Registration For Residues in/on Crop Subgroup 6C Dried Shelled Pea and Bean (Except Soybean). EPA–HQ–OPP–2017–0291–0009. Washington, DC: U.S. Environmental Protection Agency (USEPA), Office of Chemical Safety and Pollution Prevention. https://hero.epa.gov/hero/ index.cfm/reference/details/reference_ id/10533339. USEPA. 2020c. Picloram Draft Human Health Risk Assessment in Support of Registration Review. Washington, DC: U.S. Environmental Protection Agency (USEPA), Office of Chemical Safety and Pollution Prevention, Health Effects Division. https://hero.epa.gov/hero/ index.cfm/reference/details/reference_ id/10533340. USEPA. 2020d. ‘‘The Standardized Monitoring Framework: A Quick Reference Guide.’’ EPA 816–F–20–002. May 2020. https://www.epa.gov/ dwreginfo/standardized-monitoringframework-quick-reference-guide. USEPA. 2020e. Use of Total Nitrate and Nitrite Analysis for Compliance Determinations with the Nitrate Maximum Contaminant Level (WSG 213). November 30, 2020. https:// www.epa.gov/sites/default/files/2021-01/ documents/wsg_213_nitrate_wsg_11-302020_signed_508-compliantfinal.pdf. USEPA. 2020f. Clarification of Free and Total Cyanide Analysis for Safe Drinking Water Act (SDWA) Compliance Revision 1.0. EPA 815–B–20–004. June 2020. USEPA. 2022a. Request for Nominations for the Science Advisory Board Radionuclide Cancer Risk Coefficients Review Panel. 87 FR 15988. March 21, 2022. USEPA. 2022b. Availability of the Draft IRIS Toxicological Review of Hexavalent Chromium. 87 FR 63774. October 10, 2022. USEPA. 2023a. National Primary Drinking Water Regulations for Lead and Copper: Improvements (LCRI). 88 FR 84878. December 6, 2023. USEPA. 2023b. Availability of the Protocol for the Nitrate and Nitrite IRIS Assessment (Oral). 88 FR 77310. November 9, 2023. USEPA. 2024a. PFAS National Primary Drinking Water Regulation. 89 FR 32532. April 26, 2024. USEPA. 2024b. National Primary Drinking Water Regulations: Consumer Confidence Report Rule Revisions. 89 FR 45980. May 24, 2024. USEPA. 2024c. EPA Protocol for the Fourth Review of Existing National Primary Drinking Water Regulations. EPA 815–R– 24–018. USEPA. 2024d. Data Management and Quality Assurance/Quality Control Process for the Fourth Six-Year Review Information Collection Request Dataset. EPA 815–R–24–017. USEPA. 2024e. Chemical Contaminant Summaries for the Fourth Six-Year Review of Existing National Primary Drinking Water Regulations. EPA 815–S– 24–002. USEPA. 2024f. Results of the Health Effects Assessment for the Fourth Six-Year PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 59645 Review of Existing Chemical and Radionuclide National Primary Drinking Water Standards. EPA 815–R–24–020. USEPA. 2024g. Analytical Feasibility Support Document for the Fourth SixYear Review of National Primary Drinking Water Regulations. EPA 815–R– 24–015. USEPA. 2024h. Analysis of Regulated Contaminant Occurrence Data from Public Water Systems in Support of the Fourth Six-Year Review of National Primary Drinking Water Regulations: Chemical Phase and Radionuclides Rules. EPA 815–R–24–014. USEPA. 2024i. Review of Fluoride Occurrence for the Fourth Six-Year Review. EPA 815–R–24–021. USEPA. 2024j. Occurrence Analysis for Potential Source Waters for the Fourth Six-Year Review of National Primary Drinking Water Regulations. EPA 815–R– 24–019. USEPA. 2024k. Support Document for the Fourth Six-Year Review of Drinking Water Regulations for Acrylamide and Epichlorohydrin. EPA 815–R–24–023. USEPA. 2024l. Consideration of Other Regulatory Revisions in Support of the Fourth Six-Year Review of the National Primary Drinking Water Regulations: Chemical Phase Rules and Radionuclides Rule. EPA 815–R–24–016. USEPA. 2024m. Six-Year Review 4 Technical Support Document for Microbial Contaminant Regulations. EPA 815–R– 24–022. Wallender, E.K., E.C. Ailes, J.S. Yoder, V.A. Roberts, and J.M. Brunkard. 2014. Contributing factors to disease outbreaks associated with untreated groundwater. Ground Water. 52(6): 886–97. World Health Organization (WHO). 2004. Guidelines for Drinking-Water Quality, Third Edition. Volume 1: Recommendations. https://www.who.int/ publications/i/item/9789241547611. WHO. 2009. Guide to hygiene and sanitation in aviation, 3rd edition. https://www. who.int/publications/i/item/97892415 47772. Michael S. Regan, Administrator. [FR Doc. 2024–15807 Filed 7–22–24; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2023–0221; FRL–11818–01– OCSPP] Trichoderma Atroviride Strain AT10; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a SUMMARY: E:\FR\FM\23JYR1.SGM 23JYR1 59646 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations tolerance for residues of Trichoderma atroviride strain AT10 in or on all food commodities when used in accordance with label directions and good agricultural practices. Agrotecnologı́as Naturales S.L., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Trichoderma atroviride strain AT10 under FFDCA when used in accordance with this exemption. DATES: This regulation is effective July 23, 2024. Objections and requests for hearings must be received on or before September 23, 2024 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2023–0221, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20004. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and OPP Docket is (202) 566–1744. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Madison H. Le, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–1400; email address: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information ddrumheller on DSK120RN23PROD with RULES1 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). VerDate Sep<11>2014 17:25 Jul 22, 2024 Jkt 262001 • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180; through the Office of the Federal Register’s e-CFR site at https://www.ecfr. gov/current/title-40. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2023–0221 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before September 23, 2024. The EPA’s Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See ‘‘Revised Order Urging Electronic Filing and Service,’’ dated June 22, 2023, which can be found at https://www.epa.gov/system/files/ documents/2023-06/2023-06-22%20%20revised%20order%20urging%20 electronic%20filing%20and%20 service.pdf. Although the EPA’s regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https:// yosemite.epa.gov/OA/EAB/EAB-ALJ_ upload.nsf. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2023–0221, by one of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/where-sendcomments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Background In the Federal Register of July 5, 2023 (88 FR 42936) (FRL–10579–05–OCSPP), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 3F9053) by Agrotecnologı́as Naturales S.L., Ctra. T–214, s/n Km 4,125; 43762 Riera de Gaià La; Tarragona; Spain (c/ o SciReg, Inc., 12733 Director’s Loop, Woodbridge, VA 22192). The petition requested that 40 CFR part 180; be amended by establishing an exemption from the requirement of a tolerance for residues of Trichoderma atroviride AT10 in or on all food commodities. That notice referenced a summary of the petition prepared by the petitioner, Agrotecnologı́as Naturales S.L. and available in the docket via https:// www.regulations.gov. EPA received a comment on the notice of filing. EPA’s response to this comment is discussed in Unit III.C. In addition, EPA modified the name of the active ingredient proposed in the notice of filing to conform with microbial active ingredient naming conventions from Trichoderma atroviride AT10 to Trichoderma atroviride strain AT10. III. Final Rule A. EPA’s Safety Determination Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ E:\FR\FM\23JYR1.SGM 23JYR1 ddrumheller on DSK120RN23PROD with RULES1 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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. . . .’’ Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.’’ EPA evaluated the available toxicological and exposure data on Trichoderma atroviride strain AT10 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled ‘‘Human Health Risk Assessment of Trichoderma atroviride AT10, a New Active Ingredient, in the End Use Product (EP) TRICOTEN WP, Proposed for Registration and an Associated Petition Requesting a Tolerance Exemption’’ (Trichoderma atroviride strain AT10 EP Human Health Risk Assessment). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. The toxicological profile of Trichoderma atroviride strain AT10 was previously described in the ‘‘Human Health Risk Assessment of Trichoderma atroviride AT10, a New Active Ingredient, in the End Use Product (EP) TRICOTEN WP, Proposed for Registration and an Associated Petition Requesting a Tolerance Exemption’’. Based upon its evaluation, EPA concludes that, with regard to humans, Trichoderma atroviride strain AT10 is not anticipated to be toxic, pathogenic, irritating, or infective. Significant dietary and non-occupational exposure VerDate Sep<11>2014 17:25 Jul 22, 2024 Jkt 262001 to residues of Trichoderma atroviride strain AT10 are not expected as the products will be applied in agricultural settings, other non-occupational exposures through drift or other measures are considered very unlikely. Even if dietary and non-occupational exposures to residues of Trichoderma atroviride strain AT10 were to occur, there is not concern due to the lack of adverse effects from toxicity and pathogenicity studies. Because there are no thresholds of concern with the toxicity, pathogenicity, or infectivity of Trichoderma atroviride strain AT10, EPA determined that no additional margin of safety is necessary to protect infants and children as part of the qualitative assessment conducted. Based upon its evaluation in the Trichoderma atroviride strain AT10, human health risk assessment, which concludes that there are no risks of concern from aggregate exposure to Trichoderma atroviride strain AT10, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Trichoderma atroviride strain AT10. B. Analytical Enforcement Methodology An analytical method is not required for Trichoderma atroviride strain AT10 because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. Response to Comments One comment was received in response to the notice of filing. EPA reviewed the comment and determined that it was irrelevant to the tolerance exemption in this action. D. Conclusion Therefore, an exemption from the requirement of a tolerance is established for residues of Trichoderma atroviride strain AT10 in or on all food commodities when used in accordance with label directions and good agricultural practices. IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 59647 not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, EPA has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under title II of the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require EPA’s consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 272 note). V. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and E:\FR\FM\23JYR1.SGM 23JYR1 59648 Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 24, 2024. Edward Messina, Director, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 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. Add § 180.1409 to subpart D to read as follows: ■ § 180.1409 Trichoderma atroviride strain AT10; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Trichoderma atroviride strain AT10 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2024–16074 Filed 7–22–24; 8:45 am] BILLING CODE 6560–50–P FEDERAL MARITIME COMMISSION 46 CFR Part 542 [Docket No. FMC–2023–0010] RIN 3072–AC92 Definition of Unreasonable Refusal To Deal or Negotiate With Respect to Vessel Space Accommodations Provided by an Ocean Common Carrier Federal Maritime Commission. Final rule. AGENCY: The Federal Maritime Commission (FMC or Commission) is issuing regulations to implement the Ocean Shipping Reform Act of 2022’s prohibition against unreasonable refusals of cargo space accommodations when available and unreasonable refusals to deal or negotiate with respect to vessel space accommodations by ddrumheller on DSK120RN23PROD with RULES1 SUMMARY: VerDate Sep<11>2014 17:25 Jul 22, 2024 Jkt 262001 To view background documents or comments received, you may use the Federal eRulemaking Portal at www.regulations.gov under Docket No. FMC–2023–0010. FOR FURTHER INFORMATION CONTACT: David Eng, Secretary; Phone: (202) 523– 5725; Email: secretary@fmc.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: ■ ACTION: ocean common carriers. This final rule adopts with changes the supplemental notice of proposed rulemaking published on June 14, 2023. This rule establishes the necessary elements for the FMC to apply Federal law with respect to refusals of cargo space accommodations when available. It also establishes the necessary elements for the FMC to apply Federal law with respect to refusals of vessel space accommodations. This rule applies to complaints brought before the FMC by a private party, as well as enforcement cases brought by the Commission. DATES: This final rule is effective on September 23, 2024, except for instruction 2 adding § 542.1(j), and instruction 3 adding § 542.99, which are delayed. The Commission will publish a document in the Federal Register announcing the effective date of those amendments. I. Background A. Procedural History The Ocean Shipping Reform Act of 2022 (OSRA 2022), Public Law 117–146, was enacted on June 16, 2022. OSRA 2022 amended various statutory provisions contained in part A of subtitle IV of title 46, United States Code. OSRA 2022 made clear that the categorical refusal by an ocean common carrier, alone or in conjunction with another person, directly or indirectly, to accommodate U.S. exports, without demonstrating that the refusal is reasonable, is a violation of the Shipping Act. By definition, not all refusals will necessarily be a violation. Whether a refusal to deal or a refusal to negotiate falls within the scope of section 41104(a)(10), or a refusal of cargo space accommodations falls within the scope of section 41104(a)(3), depends upon the particular circumstances of a given case. Section 7(d) of OSRA 2022 requires the Commission, in consultation with the United States Coast Guard, to initiate and complete a rulemaking to define the phrase ‘‘unreasonable refusal to deal or negotiate with respect to vessel space accommodations’’ provided by an ocean common carrier to work in conjunction with 46 U.S.C. 41104(a)(10). In response to this PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 requirement, on September 21, 2022, the FMC issued a notice of proposed rulemaking (NPRM) that proposed adding a new part 542 under title 46 of the Code of Federal Regulations (CFR), which would work in conjunction with 46 U.S.C. 41104(a)(10).1 The proposal considered the common carriage roots of 46 U.S.C. 41104(a)(10), as well as the overall competition basis of the Commission’s authority.2 On June 14, 2023, after reviewing the comments received in response to the NPRM, the Commission issued a revised and expanded supplemental notice of proposed rulemaking (SNPRM). In addition to addressing OSRA 2022’s amendment to 46 U.S.C. 41104(a)(10), the SNPRM also addressed OSRA 2022’s amendment to 46 U.S.C. 41104(a)(3), which prohibits a common carrier from unreasonably refusing cargo space accommodations when available. The restrictions that 46 U.S.C. 41104 (a)(3) and (a)(10) impose on ocean common carriers are distinct but closely related. Both provisions address refusals by ocean common carriers to accommodate shippers’ attempts to secure overseas transportation for their cargo. The distinction between the conduct covered by these two provisions is timing, more specifically whether the refusal occurred while the parties were still negotiating and attempting to reach a deal on service terms and conditions (negotiation stage), or after a deal was reached (execution stage). If the refusal occurred at the execution stage, after the parties reached a deal or mutually agreed on service terms and conditions, then 46 U.S.C. 41104(a)(3) applies. If the refusal occurred at the negotiation stage, before the parties reached a deal or mutually agreed on service terms and conditions, then 46 U.S.C. 41104(a)(10) applies. Interpreting these related provisions in a single rulemaking allows the Commission to delineate the types of refusal conduct covered by 46 U.S.C. 41104 (a)(3) and (a)(10) and highlight the differences between them. As discussed in the SNPRM, restricting the rulemaking to refusals to deal or negotiate under 46 U.S.C. 41104(a)(10) would not address the reliability issues that commenters on the NPRM identified as a critical and a driving factor impeding their ability to ship cargo overseas. Shippers impacted by unlawful refusals to accommodate their requests for vessel space accommodations have been able to bring a cause of action against ocean common carriers since the OSRA 2022 amendments took effect immediately in 1 87 2 87 E:\FR\FM\23JYR1.SGM FR 57674. FR 57674, 57676. 23JYR1

Agencies

[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Rules and Regulations]
[Pages 59645-59648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16074]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0221; FRL-11818-01-OCSPP]


Trichoderma Atroviride Strain AT10; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a

[[Page 59646]]

tolerance for residues of Trichoderma atroviride strain AT10 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices. Agrotecnolog[iacute]as Naturales S.L., 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Trichoderma atroviride strain AT10 
under FFDCA when used in accordance with this exemption.

DATES: This regulation is effective July 23, 2024. Objections and 
requests for hearings must be received on or before September 23, 2024 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0221, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20004. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and OPP Docket is (202) 566-1744. Please review the 
visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Madison H. Le, Biopesticides and 
Pollution Prevention Division (7511M), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-1400; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

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. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180; through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2023-0221 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
September 23, 2024.
    The EPA's Office of Administrative Law Judges (OALJ), in which the 
Hearing Clerk is housed, urges parties to file and serve documents by 
electronic means only, notwithstanding any other particular 
requirements set forth in other procedural rules governing those 
proceedings. See ``Revised Order Urging Electronic Filing and 
Service,'' dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. 
Although the EPA's regulations require submission via U.S. Mail or hand 
delivery, the EPA intends to treat submissions filed via electronic 
means as properly filed submissions; therefore, the EPA believes the 
preference for submission via electronic means will not be prejudicial. 
When submitting documents to the OALJ electronically, a person should 
utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2023-0221, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of July 5, 2023 (88 FR 42936) (FRL-10579-
05-OCSPP), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
exemption petition (PP 3F9053) by Agrotecnolog[iacute]as Naturales 
S.L., Ctra. T-214, s/n Km 4,125; 43762 Riera de Gai[agrave] La; 
Tarragona; Spain (c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, 
VA 22192). The petition requested that 40 CFR part 180; be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Trichoderma atroviride AT10 in or on all food commodities. 
That notice referenced a summary of the petition prepared by the 
petitioner, Agrotecnolog[iacute]as Naturales S.L. and available in the 
docket via https://www.regulations.gov. EPA received a comment on the 
notice of filing. EPA's response to this comment is discussed in Unit 
III.C. In addition, EPA modified the name of the active ingredient 
proposed in the notice of filing to conform with microbial active 
ingredient naming conventions from Trichoderma atroviride AT10 to 
Trichoderma atroviride strain AT10.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.''

[[Page 59647]]

Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue, including all anticipated 
dietary exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining 
in effect an exemption from the requirement of a tolerance, EPA must 
take into account the factors set forth in FFDCA section 408(b)(2)(C), 
which require EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
tolerance or tolerance exemption 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. . . .'' 
Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider 
``available information concerning the cumulative effects of [a 
particular pesticide's] . . . residues and other substances that have a 
common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on 
Trichoderma atroviride strain AT10 and considered their validity, 
completeness, and reliability, as well as the relationship of this 
information to human risk. A full explanation of the data upon which 
EPA relied and its risk assessment based on those data can be found 
within the document entitled ``Human Health Risk Assessment of 
Trichoderma atroviride AT10, a New Active Ingredient, in the End Use 
Product (EP) TRICOTEN WP, Proposed for Registration and an Associated 
Petition Requesting a Tolerance Exemption'' (Trichoderma atroviride 
strain AT10 EP Human Health Risk Assessment). This document, as well as 
other relevant information, is available in the docket for this action 
as described under ADDRESSES.
    The toxicological profile of Trichoderma atroviride strain AT10 was 
previously described in the ``Human Health Risk Assessment of 
Trichoderma atroviride AT10, a New Active Ingredient, in the End Use 
Product (EP) TRICOTEN WP, Proposed for Registration and an Associated 
Petition Requesting a Tolerance Exemption''. Based upon its evaluation, 
EPA concludes that, with regard to humans, Trichoderma atroviride 
strain AT10 is not anticipated to be toxic, pathogenic, irritating, or 
infective. Significant dietary and non-occupational exposure to 
residues of Trichoderma atroviride strain AT10 are not expected as the 
products will be applied in agricultural settings, other non-
occupational exposures through drift or other measures are considered 
very unlikely. Even if dietary and non-occupational exposures to 
residues of Trichoderma atroviride strain AT10 were to occur, there is 
not concern due to the lack of adverse effects from toxicity and 
pathogenicity studies. Because there are no thresholds of concern with 
the toxicity, pathogenicity, or infectivity of Trichoderma atroviride 
strain AT10, EPA determined that no additional margin of safety is 
necessary to protect infants and children as part of the qualitative 
assessment conducted.
    Based upon its evaluation in the Trichoderma atroviride strain 
AT10, human health risk assessment, which concludes that there are no 
risks of concern from aggregate exposure to Trichoderma atroviride 
strain AT10, EPA concludes that there is a reasonable certainty that no 
harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of Trichoderma atroviride 
strain AT10.

B. Analytical Enforcement Methodology

    An analytical method is not required for Trichoderma atroviride 
strain AT10 because EPA is establishing an exemption from the 
requirement of a tolerance without any numerical limitation.

C. Response to Comments

    One comment was received in response to the notice of filing. EPA 
reviewed the comment and determined that it was irrelevant to the 
tolerance exemption in this action.

D. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of Trichoderma atroviride strain AT10 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 
exemption in this action, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 
et seq.) do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA has determined that this 
action will not have a substantial direct effect on States or Tribal 
Governments, on the relationship between the National Government and 
the States or Tribal Governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian Tribes. Thus, EPA has determined that 
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 
1999), and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this action. In addition, this action does not 
impose any enforceable duty or contain any unfunded mandate as 
described under title II of the Unfunded Mandates Reform Act (2 U.S.C. 
1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and

[[Page 59648]]

other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This action is not 
a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: June 24, 2024.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
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. Add Sec.  180.1409 to subpart D to read as follows:


Sec.  180.1409  Trichoderma atroviride strain AT10; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma atroviride strain AT10 in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2024-16074 Filed 7-22-24; 8:45 am]
BILLING CODE 6560-50-P
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