2026-14114: Bacteriophage Active Against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage Active Against Pseudomonas syringae pv. tomato_EcoPhage; Exemptions from the Requirement of a Pesticide Tolerance

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 might apply to them: Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(c)(2)(A)(i) allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ``safe.'' FFDCA section 408(c)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings but does not include occupational exposure. 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 [[Page 43043]] 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 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 the Agency consider, among other things, ``available information concerning the cumulative effects of a particular pesticide's residues'' and ``other substances that have a common mechanism of toxicity.''

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify the docket ID number EPA-HQ- OPP-2024-0329 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 14, 2026. 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 December 3, 2025, which can be found at https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf. Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, 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 at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

A. EPA's Safety Determination

EPA evaluated the available toxicological and exposure data on Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage 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 titled, ``Human Health Risk Assessment of Bacteriophages Active Against Xanthomonas campestris pv. vesicatoria_ECOPHAGE and Pseudomonas syringae pv. tomato_ECOPHAGE, New Active Ingredients in the End-use Product 102839-R Golden-Eco 1000 Proposed for Registration and an Associated Petition Requesting a Tolerance Exemption'' or the Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage 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 available data and information demonstrated that, with regard to humans, Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage are not anticipated to be toxic, pathogenic, or infective via any route of exposure. Furthermore, humans, including infants and children, have been exposed to bacteriophage through food and water, where they are commonly found, with no known adverse effects. Significant dietary and non-occupational exposures to residues of Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage are not expected due to the inability of bacteriophage to persist when the specific bacterial hosts are not present and the sensitivity of bacteriophage to environmental conditions (e.g., ultraviolet light and heat). Even if dietary and non- occupational exposures to residues of Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage were to occur, there is not a concern due the lack of potential for adverse effects. Because there are no threshold levels of concern with the toxicity, pathogenicity, or infectivity of Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage, EPA determined that the additional margin of safety referred to as the Food Quality Protection Act Safety Factor is not necessary to protect infants and children as part of the qualitative assessment conducted. Based upon its evaluation in the Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage Human Health Risk Assessment, which concludes that [[Page 43044]] there are no potential risks of concern from aggregate exposure to Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage, EPA determines 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 Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage. Therefore, exemptions from the requirement of a tolerance are established for residues of Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage in or on all food or feed commodities when used in accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

An analytical method is not required because EPA is establishing exemptions from the requirement of a tolerance without any numerical limitation.

C. Conclusion

Therefore, exemptions from the requirement of a tolerance are established for residues of Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage and Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage in or on all food or feed commodities when used in accordance with label directions and good agricultural practices.

A. Executive Order 12866: Regulatory Planning and Review

This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866.

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because actions that establish a tolerance or tolerance exemption under FFDCA section 408 are exempted from review under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

This action does not impose an information collection burden under the PRA 44 U.S.C. 3501 et seq., because it does not contain any information collection activities.

D. Regulatory Flexibility Act (RFA)

This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to the APA but is subject to FFDCA section 408(d), which does not require notice and comment rulemaking to take this action in response to a petition.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any State, local, or Tribal governments or the private sector.

F. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian

Tribal Governments This action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.

H. Executive Order 13045: Protection of Children From Environmental

Health Risks and Safety Risks This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's 2026 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance 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 . . .'' (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in the pesticide-specific review documents, located in the applicable docket at https://www.regulations.gov.

I. Executive Order 13211: Actions Concerning Regulations That

Significantly Affect Energy Supply, Distribution or Use This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer Advancement Act (NTTAA)

This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

K. Congressional Review Act (CRA)

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. [[Page 43045]] Dated: July 7, 2026. Edward Messina, Director, Office of Pesticide Programs. For the reasons set forth 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. Sec. 180.1426 and 180.1427 to subpart D to read as

follows: Sec. 180.1426 Bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of bacteriophage active against Xanthomonas campestris pv. vesicatoria_EcoPhage in or on all food or feed commodities when used in accordance with label directions and good agricultural practices. Sec. 180.1427 Bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of bacteriophage active against Pseudomonas syringae pv. tomato_EcoPhage in or on all food or feed commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2026-14114 Filed 7-13-26; 8:45 am] BILLING CODE 6560-50-P