Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides; Aluminum tris (O-ethylphosphonate), Carbon disulfide, et al.

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is finalizing 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). The tolerance actions and pesticide active ingredients addressed in this final rule are identified in Unit I.B. and discussed in detail in Unit III. of this document.

DATES:

This regulation is effective July 19, 2023. Objections and requests for hearings must be received on or before September 18, 2023 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit IV. of this document).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0128, is available online at https://www.regulations.gov or in person 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 20460–0001. Additional instructions for visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Christina Scheltema, Pesticide Re-Evaluation Division (7508M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW, Washington, DC 20460–0001; telephone number: (202) 566–2272; email address: scheltema.christina@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

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

• Pesticide manufacturing (NAICS code 32532).

B. What action is the Agency taking?

EPA is finalizing several tolerance actions that the Agency determined were necessary or appropriate during the registration review of several pesticide active ingredients. A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), residues of a pesticide chemical that are not covered by a tolerance or exemption from the requirement of a tolerance render food adulterated and may not be distributed in interstate commerce. See21 U.S.C. 331, 342, 346a(1).

This rule finalizes actions that were proposed in 2017 (82 FR 42531, September 8, 2017 (FRL–9963–03)), with a few exceptions discussed in more detail in Unit III. 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 in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., and that the pesticide's tolerances meet the safety standard of the FFDCA, 21 U.S.C. 346a. Specifically, as discussed in more detail in Unit III., EPA is finalizing the following actions:

• Revoking certain tolerances for aluminum tris ( O -ethylphosphonate), carbon disulfide, cyromazine, dichlobenil, oxydemeton-methyl, propachlor, and thiodicarb, and a tolerance exemption for d -limonene;

• Modifying certain tolerances for aluminum tris ( O -ethylphosphonate), cyromazine, and sulfentrazone;

• Establishing new tolerances for aluminum tris ( O -ethylphosphonate), cyromazine, and dichlobenil, and new tolerance exemptions for d -limonene and tartrazine;

• Revising the tolerance expressions for p -chlorophenoxyacetic acid and dichlobenil;

• Removing expired tolerances for disulfoton; and
• Correcting the listing of a tolerance for thiacloprid.

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

The tolerance actions contained in this final rule implement EPA decisions under FIFRA section 3(g), 7 U.S.C. 136a(g), which requires EPA to periodically review all registered pesticides and determine if those pesticides continue to meet the standard for registration under FIFRA. See also40 CFR 155.40(a).

Under FFDCA section 408(e), 21 U.S.C. 346a(e), EPA may establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance after providing an opportunity for public comment, which EPA has done here. FFDCA section 408(b) authorizes EPA to establish a tolerance if the Agency determines that the tolerance is safe; FFDCA section 408(c) authorizes EPA to establish an exemption from the requirement of a tolerance if the Agency determines that the exemption is safe. See21 U.S.C. 346a(b) and (c). If EPA determines that a tolerance or exemption is not safe, EPA must modify or revoke that tolerance or exemption. 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.” See21 U.S.C. 346a(b)(2)(A)(ii), (c)(2)(A)(ii). This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue[s.]” See21 U.S.C. 346a(b)(2)(C). FFDCA section 408(b)(2)(D) contains several factors EPA must consider when making determinations about establishing, modifying, or revoking tolerances. See21 U.S.C. 346a(b)(2)(D). FFDCA section 408(c)(2)(B) requires EPA, when making determinations about exemptions, to take into account, among other things, the considerations set forth in FFDCA section 408(b)(2)(C) and (D). See21 U.S.C. 346a(c)(2)(B).

Consistent with its obligations under FIFRA section 3(g) and FFDCA section 408, EPA has reviewed the available scientific data and other relevant information and determined it is appropriate to take the tolerance actions in this document.

D. When do these actions become effective?

This final rule is effective upon publication in the Federal Register . In addition, for certain tolerances being revoked or decreased, the Agency is establishing an expiration date that is six months from the date of publication 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.

Any commodities listed in this final rule treated with the pesticides subject to this final rule, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(l)(5), which specifies that any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the U.S. Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and

2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.

E. Were international residue limits considered?

When establishing a tolerance for residues of a pesticide, EPA must determine whether the Codex Alimentarius Commission has established a Maximum Residue Limit (MRL) for that pesticide. See21 U.S.C. 346a(b)(4). Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. As part of registration review, EPA has considered Codex MRLs for each of the pesticides in this rulemaking and is harmonizing U.S. tolerances with those MRLs where appropriate. EPA may establish a tolerance that differs from a Codex MRL, provided that it explains the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of the individual human health risk assessments that support the pesticide registration review cases for the tolerance actions identified in this final rule, and EPA's reasons for departing from the Codex level is discussed in Unit III. where applicable.

II. Background

A. Summary of the Proposed Rule

In 2017, EPA proposed to take several tolerance actions that the Agency determined were necessary or appropriate during the registration review of several pesticide active ingredients (82 FR 42531, September 8, 2017 (FRL–9963–03)). In that proposed rule, EPA proposed an effective date 6 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 WTO's SPS Measures Agreement to adapt to the requirements of a final rule. EPA also proposed expiration dates for certain tolerances being revoked. At the time, the Agency believed that existing stocks of pesticide products labeled for the uses associated with the tolerances identified for revocation had been or would soon be completely exhausted and that treated commodities had cleared or would soon clear the channels of trade. As noted in Unit II.B., EPA did not receive any comments regarding existing stocks or whether the effective date or proposed expiration dates allow sufficient time for treated commodities to clear the channels of trade.

B. Summary of Comments Received and EPA Responses

EPA received two comments on the proposed rule. This unit summarizes the comments and provides EPA's response.

1. Comment. Bayer CropScience (BCS) questioned whether the tolerance level for aluminum tris ( O -ethylphosphonate) in or on caneberry subgroup 13–07A, proposed to be established at 0.05 parts per million (ppm), should be 0.1 ppm because the Canadian MRL is currently 0.1 ppm.

EPA response. EPA's proposal to establish the caneberry subgroup 13–07A tolerance for aluminum tris ( O -ethylphosphonate) at 0.05 ppm to harmonize with Canada's MRL of 0.05 ppm, preceded the increase of the aforementioned Canadian MRL to 0.1 ppm by Health Canada's Pest Management Regulatory Agency (PMRA). EPA has determined that a 0.1 ppm level for the caneberry subgroup 13–07A tolerance for aluminum tris ( O -ethylphosphonate) is safe in a risk assessment memorandum dated September 27, 2021. Consequently, EPA is establishing a tolerance in 40 CFR 180.415(a) for aluminum tris ( O -ethylphosphonate) residues in or on caneberry subgroup 13–07A at 0.1 ppm to harmonize with the Canadian MRL.

2. Comment. An anonymous commentor mentioned support for the proposed rule if it tightened regulations on pesticides and opposition if it did not.

EPA response. Section 408 of the FFDCA authorizes EPA to establish tolerances for pesticide chemical residues if those tolerances are safe and to revoke tolerances if they are not. This commentor has provided no information to support a conclusion that tolerances are either safe or not safe.

III. Tolerance Actions

In this final rule, the Agency is finalizing the tolerance actions as described in this unit.

A. 40 CFR 180.183; Disulfoton

EPA is finalizing its proposal to remove the tolerances for disulfoton, which have all expired.

B. 40 CFR 180.202; p-Chlorophenoxyacetic Acid (p-CPA or 4-CPA)

EPA is finalizing its proposal to revise the tolerance expression for p -chlorophenoxyacetic acid to remove the p -chlorophenol metabolite and to describe more clearly the scope or coverage of the tolerance and the method for measuring compliance.

During registration review, EPA assessed the risks from exposure to p -chlorophenoxyacetic acid, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to p -chlorophenoxyacetic acid residues. Thus, EPA has determined that the tolerances for residues of p -chlorophenoxyacetic acid are safe. Adequate enforcement methodology as described in the Food and Drug Administration's Pesticide Analytical Manual, Volume 2, is available to enforce the tolerance expression. For further details, see 4-Chlorophenoxyacetic acid. Human Health Risk Assessment in Support of Registration Review, which can be accessed using docket ID number EPA–HQ–OPP–2014–0544.

C. 40 CFR 180.211; Propachlor

EPA is finalizing its proposal to revoke all tolerances for residues of propachlor. Because there are no U.S. registrations for propachlor and because the Agency received no comments requesting the tolerances be retained for imported commodities, these tolerances are no longer needed. These tolerances will expire on January 19, 2024.

D. 40 CFR 180.231; Dichlobenil

EPA is finalizing its proposal to revise the tolerance expression for dichlobenil to describe more clearly the measurement and scope or coverage of tolerances. EPA is also finalizing its proposal to establish a new tolerance for dichlobenil residues in or on cherry at 0.15 ppm, concomitant with the revocation of the tolerance for fruit, stone, group 12 that is no longer needed. The 0.15 ppm tolerance for fruit, stone, group 12 will expire on January 19, 2024. Codex has not established any MRLs for dichlobenil in or on cherry.

This final rule does not include EPA's proposal to change the listing of significant figures for existing tolerances for dichlobenil because the Agency changed its rounding class practice effective March 27, 2019. On that date, EPA adopted the rounding class practice of the Organization for Economic Cooperation and Development (OECD), which eliminates any perceived trade barriers and helps harmonize U.S. tolerances with international MRLs.

During registration review, EPA assessed the risks from exposure to dichlobenil, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to dichlobenil residues. Thus, EPA has determined that the tolerances for residues of dichlobenil are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further details, see Dichlobenil—Draft Human Health Risk Assessment for Registration Review, which can be accessed using docket ID number EPA–HQ–OPP–2012–0395.

E. 40 CFR 180.330; Oxydemeton-methyl (S-(2-Ethylsulfinyl)ethyl)O,O)-dimethylphosphorothioate)

EPA is finalizing its proposal to revoke all tolerances for residues of oxydemeton-methyl. Since the proposed expiration date of December 31, 2017, has already passed, EPA is setting the expiration date for these tolerances as January 19, 2024.

EPA is not making any changes to tolerances with regard to significant figures or harmonization as discussed in the September 2017, proposal since the tolerances are being revoked when they expire.

F. 40 CFR 180.407; Thiodicarb

EPA is finalizing its proposal to revoke the tolerances for broccoli; cabbage; cauliflower; corn, sweet, kernel plus cob with husks removed; and vegetable, leafy, except brassica, group 4. EPA is establishing an expiration date of January 19, 2024, for these tolerances. These tolerances are no longer needed because there are no thiodicarb products registered in the United States labeled for use on these commodities and no comments were received indicating the need to retain these tolerances for imported commodities.

G. 40 CFR 180.414; Cyromazine

EPA is finalizing its proposal to increase the tolerances for cyromazine residues in or on mango from 0.3 to 0.5 ppm, milk from 0.05 to 0.1 ppm, and mushroom from 1.0 to 8 ppm to harmonize with Canadian MRLs. This final rule does not include EPA's proposal to increase tolerances for pepper to 3 ppm; tomato to 1 ppm; Brassica, leafy greens to 35 ppm; leafy vegetables, except Brassica to 10 ppm; and onion, bulb, subgroup 3–07A to 0.3 ppm because these actions were finalized on October 7, 2019 (84 FR 53316) (FRL–9999–57). As a housekeeping measure, EPA is modifying tolerances for bean, dry, except cowpeas; Bean, lima; Bean, succulent; and Broccoli to remove trailing zeroes, in accordance with the 2019 change in the Agency's rounding class practice.

EPA is finalizing its proposal to consolidate the tolerances for meat byproducts of cattle, goat, hog, horse, and sheep to include kidney and to increase the tolerances from 0.2 to 0.3 ppm. EPA is also finalizing its proposal to revoke the tolerances for kidney of cattle, goat, hog, horse, and sheep; and meat byproducts, except kidney, of cattle, goat, hog, horse, and sheep because they are no longer needed. In addition, EPA is finalizing its proposal to increase tolerances for cyromazine residues in or on egg from 0.25 to 0.3 ppm; meat of cattle, goat, hog, horse, and sheep from 0.05 to 0.3 ppm; poultry, meat (from chicken layer hens and chicken breeder hens only) from 0.05 to 0.1 ppm; poultry, meat byproducts (from chicken layer hens and chicken breeder hens only) from 0.05 to 0.2 ppm; and vegetable, cucurbit, group 9 from 1.0 to 2 ppm. As a housekeeping measure, EPA is removing the tolerance for onion, potato, which has expired.

To address inadvertent residues of cyromazine used as a feed-through fly control agent for chicken manure used as a fertilizer, EPA is finalizing its proposal to establish tolerances for indirect and inadvertent residues of cyromazine resulting from crops grown in soil amended with cyromazine-treated fertilizer, to redesignate 40 CFR 180.414(d) as 180.414(d)(1), and to establish a new paragraph and table in 40 CFR 180.414(d)(2). EPA is establishing tolerances at 0.6 ppm for grain, cereal, forage, fodder and straw, group 16; grain, cereal, group 15; herbs and spices, group 19; oilseed, group 20; onion, bulb, subgroup 3–07A; strawberry; vegetable, foliage of legume, group 7; vegetable, fruiting, group 8–10; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6; and vegetable, root and tuber, group 1.

This final rule does not include EPA's proposal to change the listing of significant figures for tolerances of cyromazine because the Agency changed its rounding class practice in 2019. Nor does it include EPA's proposal to establish tolerances for indirect or inadvertent residues for cotton, undelinted seed at 0.10 ppm; corn, sweet kernel plus cob with husks removed; corn sweet forage; corn, sweet stover; radish roots; and radish, tops, all at 50 ppm because these actions were finalized on October 7, 2019 (84 FR 53316) (FRL–9999–57).

During registration review, EPA assessed the risks from exposure to cyromazine, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to cyromazine residues. Thus, EPA has determined that the tolerances for residues of cyromazine are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further details, see Cyromazine: Human Health Risk Assessment for Registration Review, which can be accessed using docket ID number EPA–HQ–OPP–2006–0108 and the October 7, 2019, final rule, Pesticide Tolerances: Cyromazine.

H. 40 CFR 180.415; Aluminum Tris (O-ethylphosphonate) (or fosetyl-al)

EPA is finalizing its proposal to establish tolerances for aluminum tris ( O -ethylphosphonate), also known as fosetyl-al, residues in or on bushberry subgroup 13–07B at 40 ppm and fruit, pome, group 11–10 at 10 ppm concomitant with the revocation of the tolerances on bushberry subgroup 13B at 40 ppm and fruit, pome, group 11 at 10 ppm.

The Agency is also finalizing its proposal to decrease the tolerance on ginseng from 0.1 to 0.05 ppm to harmonize with the Canadian MRL. The 0.1 ppm tolerance on ginseng will expire on January 19, 2024.

EPA is also finalizing its proposal to establish a new tolerance on caneberry subgroup 13–07A concomitant with the revocation of the tolerance on caneberry subgroup 13A. However, EPA is modifying its proposal to establish the caneberry subgroup 13–07A tolerance at 0.05 ppm. In response to a comment from Bayer CropScience, described in detail in Unit II.B, EPA is establishing this tolerance at 0.1 ppm.

This final rule does not include EPA's proposal to establish a tolerance for fruit, citrus group 10–10 at 9.0 ppm and to revoke the tolerance for fruit, citrus, group 10 at 5.0 ppm because these actions were finalized in 2018, March 21, 2018 (83 FR 12260) (FRL–9974–63). This final rule also does not include the proposed changes to the listing of significant figures for existing tolerances for aluminum tris ( O -ethylphosphonate) for pineapple; pea, succulent; onion, bulb; tomato; and onion, green to reflect a change to the Agency's rounding class practice in 2019.

Although Codex had not established any MRLs for aluminum tris ( O -ethylphosphonate) (also known as fosetyl-al) when this rule was proposed in 2017, EPA notes that Codex established several MRLs in 2018. Therefore, EPA expects to issue a new proposal at a future date to harmonize the tolerances in 40 CFR 180.415 with the Codex MRLs, where appropriate.

During registration review, EPA assessed the risks from exposure to aluminum tris ( O -ethylphosphonate), taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to aluminum tris ( O -ethylphosphonate) residues. Thus, EPA has determined that the tolerances for residues of aluminum tris ( O -ethylphosphonate) are safe. Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expression. For further details, see Fosetyl-Aluminum: Registration Review Preliminary Risk Assessment, which can be accessed using docket ID number EPA–HQ–OPP–2007–0379, and the September 27, 2021, document, Fosetyl-Al Memo to Support AlCarChlCyDi Final Rule, which is in the docket for this final rule.

I. 40 CFR 180.467; Carbon Disulfide From the Application of Sodium Tetrathiocarbonate

EPA is finalizing its proposal to revoke the tolerances for residues of carbon disulfide from the application of sodium tetrathiocarbonate in or on almond; almond, hulls; grape; grapefruit; lemon; orange, sweet; peach; and plum, prune, fresh. These tolerances will expire on January 19, 2024.

J. 40 CFR 180.498; Sulfentrazone

EPA is finalizing its proposal to modify the tolerance for flax to change the commodity definition from flax to flax, seed, to be consistent with the Agency's commodity vocabulary. This final rule does not include EPA's proposal to change the listing of significant figures for existing tolerances due to the 2019 change to the Agency's rounding class practice. Nor does this final rule include EPA's proposal to establish a tolerance for residues of sulfentrazone in or on nut, tree, group 14–2 at 0.15 ppm and to revoke the existing tolerances for residues of sulfentrazone in or on nut, tree, group 14 at 0.15 ppm and pistachio at 0.15 ppm because these actions were finalized on April 13, 2018 (83 FR 15977) (FRL–9975–77).

K. 40 CFR 180.539 and 40 CFR 180.1342; d-Limonene

As proposed, the Agency is revoking a tolerance exemption for insecticidal uses of d -limonene at 40 CFR 180.539, and concomitantly establishing two tolerance exemptions in 40 CFR 180.1342 to cover both its existing insecticidal and herbicidal uses.

During registration review, EPA assessed the risks from exposure to d -limonene, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to d -limonene residues. Thus, EPA has determined that the exemptions from the requirement of a tolerance for residues of d -limonene are safe and that an enforcement method is not necessary to enforce the tolerance exemption. For further details, see d-Limonene. Revised Human Health Risk Assessment in Support of Registration Review, which can be accessed using docket ID number EPA–HQ–OPP–2010–0673.

Because revocation of the exemption in 40 CFR 180.539 will not impact import of food commodities treated with d -limonene, this revocation is not considered a trade restrictive measure necessitating a six-month implementation delay under the WTO SPS Agreement.

L. 40 CFR 180.594; Thiacloprid

EPA is finalizing its proposal to modify the tolerance for thiacloprid to correct the listing for the 0.05 ppm stone fruit tolerance from Peach subgroup 12–12C to Plum subgroup 12–12C. This corrects an inadvertent mistake promulgated in a final rule published on June 1, 2016 (81 FR 34902) (FRL–9943–73), which determined that the tolerance is safe. Codex has established an MRL for thiacloprid on stone fruit at 0.5 ppm. U.S. tolerances for Cherry subgroup 12–12A and Peach subgroup 12–12B are harmonized with Codex. EPA is not harmonizing the Plum subgroup 12–12C tolerance as part of this action because that increase was not proposed, and EPA has not yet evaluated its safety.

M. 40 CFR 180.650; Isoxaben

This final rule does not include EPA's proposal to establish a tolerance for residues of isoxaben in or on nut, tree, group 14–12 at 0.02 ppm and to revoke the existing tolerances for residues of isoxaben in or on nut, tree, group 14 at 0.02 ppm and pistachio at 0.02 ppm because these actions were finalized on February 7, 2018 (83 FR 5307) (FRL–9972–75).

N. 40 CFR 180.1343; Tartrazine, F.D.&C. Yellow No. 5 or Acid Yellow 23

EPA is finalizing its proposal to establish a new tolerance exemption for tartrazine, which is a component of the aquatic plant control product Aquashade, because treated water may be used for irrigation of crops, livestock watering, and fishing.

During the registration review for Aquashade, of which tartrazine is a component, EPA assessed the risks from exposure to tartrazine, taking into consideration all reliable data on toxicity and exposure, including for infants and children. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to tartrazine residues. Thus, EPA has determined that the exemptions from the requirement of a tolerance for residues of tartrazine, as a component of Aquashade, is safe and that an enforcement method is not necessary to enforce the tolerance exemption. For further details, see Aquashade®. Scoping Document and Draft Risk Assessment for Registration Review, which can be accessed using docket ID number EPA–HQ–OPP–2015–0639.

IV. Objection or Hearing Requests

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–2017–0128 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 18, 2023. At this time, the Office of Administrative Law Judges, in which the Hearing Clerk is located, encourages people to utilize the electronic system for filing. See Order Urging Electronic Service and Filing, https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. The system for filing electronically can be found at this website, https://www.epa.gov/alj.

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 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–2017–0128, to the Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submission and do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders#influence.

A. Executive Orders 12866: Regulatory Planning and Review and 14094: Modernizing Regulatory Review

This action is exempt from review by the Office of Management and Budget (OMB) under Executive Orders 12866, October 4, 1993 (58 FR 51735), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), because it establishes or modifies 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 final rule because the Agency knows of no extraordinary circumstances that warrant reconsideration of this exemption for those revocation actions.

B. Paperwork Reduction Act (PRA)

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

C. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the Agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule has no net burden on small entities subject to the rule. As discussed in the proposed rule, this determination takes into account the EPA analyses for the establishment and modification of tolerances, and for import tolerances or tolerance revocations.

Moreover, for the pesticides listed in this final rule, EPA concludes that there is no reasonable expectation that residues of the pesticides for tolerances listed in this final rule for revocation will be found on the commodities discussed in this final rule, and the Agency knows of no extraordinary circumstances that exist as to the present final rule that would change EPA's previous analyses. Furthermore, the Agency did not receive any comments on these conclusions as presented in the proposed rules.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132, August 10, 1999 (64 FR 43255). 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, November 9, 2000 (65 FR 67249), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

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

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

This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue ...” (FFDCA 408(b)(2)(C)). 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 final tolerance actions. The Agency's consideration is documented in the pesticide specific registration review decision documents. See the pesticide specific discussions in Unit III. and access the chemical specific registration review documents in each chemical docket at https://www.regulations.gov.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

This action is not subject to Executive Order 13211, May 22, 2001 (66 FR 28355), because it is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act (NTTAA)

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

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

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

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

Therefore, for the reasons set forth in the preamble, EPA is amending 40 CFR part 180 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. Remove § 180.183.

3. Amend § 180.202 by revising the introductory text of paragraph (a) and by adding a heading to the table to read as follows:

4. Amend § 180.211 by revising the introductory text of paragraph (a) and by adding a heading “to the table to read as follows:

5. Amend § 180.231(a) by:

a. Revising the introductory text of paragraph (a);

b. Adding a heading to the table; and

c. Adding in alphabetical order to the table, the commodity “Cherry” and revising the entry for the commodity “Fruit, stone, group 12”.

The additions and revisions read as follows:

6. Amend § 180.330 by adding paragraph (a) introductory text and revising paragraph (c) introductory text to read as follows:

7. Amend § 180.407(a) by adding a heading to the table and revising the entries for the commodities “Broccoli”; “Cabbage”; “Cauliflower”; “Corn, sweet, kernel plus cob with husks removed”; and “Vegetable, leafy, except brassica, group 4” to read as follows:

8. Amend § 180.414 by:

a. In the table to paragraph (a):

i. Adding a heading;

ii. Revising the entries for “Bean, dry, except cowpea”; “Bean, lima”; “Bean, succulent”; “Broccoli”;

iii. Removing the entries for “Cattle, kidney”;

iv. Revising the entry for “Cattle, meat”;

v. Removing the entry for “Cattle, meat byproducts, except kidney”;

vi. Adding in alphabetical order an entry for “Cattle, meat byproducts”;

vi. Revising the entry for “Egg”;

vii. Removing the entries for “Goat, kidney”; “Goat, meat byproducts, except kidney”;

viii. Revising the entry for “Goat, meat”;

ix. Adding in alphabetical order an entry for “Goat, meat byproducts”;

x. Removing the entries for “Hog, kidney”; “Hog, meat byproducts, except kidney”;

xi. Revising the entry for “Hog, meat”;

xii. Adding in alphabetical order an entry for “Hog, meat byproducts”;

xiii. Removing the entry for “Horse, kidney”;

xiv. Adding in alphabetical order an entry for “Horse, meat byproducts”;

xv. Revising the entry for “Horse, meat”;

xvi. Removing the entry for “Horse, meat byproducts, except kidney”;

xvii. Revising the entry for “Mango ¹ ”, Milk”; and “Mushroom”;

xviii. Removing the entry for “Onion, potato ² ”;

xix. Revising the entries for Poultry, meat (from chicken layer hens and chicken breeder hens only)”; “Poultry, meat byproducts (from chicken layer hens and chicken breeder hens only)”;

xx. Removing the entry for “Sheep, kidney”;

xxi. Revising the entry for “Sheep, meat”;

xxii. Adding an entry for “Sheep, meat byproducts”;

xxiii. Removing the entry for “Sheep, meat byproducts, except kidney”;

xxiv. Revising the entry for “Vegetable, cucurbit, group 9”; and

b. In paragraph (d):

i. Revising the introductory text;

ii. Adding a heading to the table in paragraph (d)(1); and

iii. Adding paragraph (d)(2).

The revisions and additions read as follows.

9. In § 180.415 amend the table in paragraph (a) by:

a. Adding a heading;

b. Revising the entries for “Bushberry subgroup 13B”; “Caneberry subgroup 13A”; “Fruit, pome, group 11” and “Ginseng”;

c. Adding an entry for “Ginseng ¹ ”.

The revisions and additions read as follows:

10. Amend § 180.467 by revising the introductory text to read as follows:

11. Amend § 180.498 by:

a. Adding a paragraph heading to paragraph (a) introductory text and removing the heading from paragraph (a)(1);

b. Adding a heading to the table in paragraph (a)(1);

c. Adding a heading to the table in paragraph (a)(2); and revising the entry for “flax”;

The revisions and additions read as follows:

12. Remove § 180.539.

13. In § 180.594 amend paragraph (a) by:

a. Adding a heading to the table;

b. Removing the entry for “Peach subgroup 12–12C ¹ ”; and

c. Adding in alphabetical order an entry for “Plum subgroup 12–12C ¹ ”.

The addition reads as follows:

14. Add § 180.1342 to subpart D to read as follows:

15. Add § 180.1343 to subpart D to read as follows: