2,6-Pyridinedicarboxylic Acid; Exemption From the Requirement of a Tolerance, 71523-71527 [2022-25582]

Download as PDF 71523 Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Rules and Regulations Global express guaranteed Country Price group Max. wt. (lbs.) 6 * 70 * * Turkiye, Republic of ............................................ * * * * * * Priority mail express international Price group Max. wt. (lbs.) 4 66 * * * Individual Country Listings * * * * * [Revise the country name ‘‘Turkey’’ to read as follows (reflecting the new country name):] PMEI flat rate envelopes price group 1 Priority mail international Price group * 8 * * * * Priority Mail Express International shipments to Turkiye. * * * * * Ruth Stevenson, Chief Counsel, Ethics and Legal Compliance. [FR Doc. 2022–25482 Filed 11–22–22; 8:45 am] ENVIRONMENTAL PROTECTION AGENCY * Restrictions * * * * * [Revise the entry ‘‘Food supplements’’ to read as follows (reflecting the new country name):] Food supplements and foods for athletes may be sent to Turkiye only when a medical report, prescription, or national sportsperson‘s certificate is enclosed with the item by the addressee. * * * * * [Revise the second entry to read as follows (reflecting the new country name):] 2. Each commercial shipment for Turkiye must have enclosed a combined certificate of origin and consular invoice, which must be certified by a chamber of commerce or other trade organization or by a notary public, and be legalized by a Turkish consul. * * * * * Priority Mail Express International * * * * * Customs Forms Required * * * * * lotter on DSK11XQN23PROD with RULES1 Notes: [Revise the second entry to read as follows (reflecting the new country name):] 2. Coins; banknotes; currency notes, including paper money; securities of any kind payable to bearer; traveler’s checks; platinum, gold, and silver; precious stones; jewelry; watches; and other valuable articles are prohibited in VerDate Sep<11>2014 40 CFR Part 180 [EPA–HQ–OPP–2019–0601; FRL–10400–01– OCSPP] 2,6-Pyridinedicarboxylic Acid; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes exemptions from the requirement of a tolerance for residues of 2,6pyridinedicarboxylic acid, also known as DPA (CAS Reg. No. 499–83–2), when used as an inert ingredient in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils and when used in pesticide formulations applied preand post-harvest to crops with an enduse concentration not to exceed 2 parts per million (ppm). EcoLab Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the establishment of such exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of DPA. DATES: This regulation is effective November 23, 2022. Objections and requests for hearings must be received on or before January 23, 2023 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: Observations 15:59 Nov 22, 2022 Jkt 259001 PO 00000 Frm 00017 Fmt 4700 66 * BILLING CODE P * Sfmt 4700 PMI flat rate envelopes and boxes price group 2 FCMI price group 3 FCPIS price group 4 * 4 3 * 4 Turkiye, Republic of Country Conditions for Mailing Max. wt. (lbs.) First-class mai international and first-class package international service 8 * * The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2019–0601, 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 20460–0001. 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 the OPP Docket is (202) 566–1744. For the latest status information on EPA/DC services, docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–1030; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: 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 E:\FR\FM\23NOR1.SGM 23NOR1 71524 Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Rules and Regulations Register’s e-CFR site at https:// www.ecfr.gov/current/title-40. lotter on DSK11XQN23PROD with RULES1 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–2019–0601 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 January 23, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). 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– 2019–0601, 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//send-comments-epadockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets/epa-dockets. II. Petition for Exemption In the Federal Register of February 11, 2020 (85 FR 7708) (FRL–10005–02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–11307) by EcoLab Inc., 1 Ecolab Place, St. Paul, MN 55102. The VerDate Sep<11>2014 15:59 Nov 22, 2022 Jkt 259001 petition requested to amend an exemption from the requirement of a tolerance for residues of 2,6pyridinedicarboxylic acid, also known as DPA, (CAS Reg. No. 499–83–2) by consolidating and expanding the current exemptions to 40 CFR 180.940(a) and increasing the limit to 2 parts per million (ppm) when used as a pesticide inert ingredient in pesticide formulations applied to hard, nonporous food-contact surfaces in public eating places, dairy processing equipment, and food-processing equipment and utensils. The petition also requested EPA establish an exemption from the requirement of a tolerance at 40 CFR 180.910, limited to 2 ppm when used in pesticide formulations applied to growing crops. That document referenced a summary of the petition prepared by EcoLab Inc, which is available in the docket, https:// www.regulations.gov. There were no comments received in response to the notice of filing. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety Section 408(c)(2)(A)(i) of FFDCA 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 tolerance is ‘‘safe.’’ Section 408(b)(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 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA 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 . . . .’’ EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for DPA including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with DPA follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by DPA as well as the no-observedadverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit. The Agency assessed DPA via the Threshold of Toxicological Concern E:\FR\FM\23NOR1.SGM 23NOR1 Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Rules and Regulations (TTC) approach as outlined by the European Food Safety Authority (EFSA) in their 2019 guidance document on the use of TTC in food safety assessment. This approach relies on the most recent evaluation of the literature on TTC as reviewed by EFSA and the World Health Organization (WHO) in 2016. Information regarding the database of studies and chemicals used to derive TTCs are reviewed therein. The TTC approach has been used by the Joint Expert Committee on Food Additives of the U.N.’s Food and Agriculture Organization and the World Health Organization, the former Scientific Committee on Food of the European Commission, the European Medicines Agency, and EFSA. TTC are derived from a conservative and rigorous approach developed by Munro and Kroes to establish generic threshold values for human exposure at which a very low probability of adverse effects is likely. There are three Cramer Classes that are organized by structural classes using the Cramer (1978) decision scheme. By comparing a range of compounds by Cramer Class (classes I, II, and III) and no-observed-effect-level (NOEL), fifth percentile NOELs were established for each Cramer Class as ‘‘Human Exposure Thresholds’’ assuming a 60 kg human. These values were 3, 0.91 and 0.15 mg/kg/day for classes I, II and III, respectively. lotter on DSK11XQN23PROD with RULES1 B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For nonthreshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/overview-riskassessment-pesticide-program. VerDate Sep<11>2014 15:59 Nov 22, 2022 Jkt 259001 The human exposure threshold value for threshold (i.e., non-cancer) risks for DPA is based upon Cramer structural class. DPA is categorized as Cramer class III based on the OECD QSAR toolbox analysis of the Cramer decision scheme; therefore, this assessment uses the NOEL of 0.15 mg/kg/day as the point of departure for all exposure scenarios assessed (chronic dietary, incidental oral, dermal and inhalation exposures). C. Exposure Assessment 1. Dietary exposure. In evaluating dietary exposure to DPA, EPA considered exposure under the proposed tolerance exemptions at a concentration not to exceed 2 ppm of DPA in an end-use pesticide formulation, as well as any other sources of dietary exposure. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for DPA, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. Dietary exposure (food and drinking water) may occur from the existing and proposed uses of DPA (e.g., eating foods treated with pesticide formulations containing DPA, and drinking water exposures). An acute dietary assessment was not performed due to the lack of adverse effects attributed to a single dietary exposure. 2. Residential exposure. The term ‘‘residential exposure’’ is used in this document to refer to non-occupational, non-dietary exposure (e.g., from hard surface disinfection on walls, floors, and tables). DPA may be used as an inert ingredient in products that are registered for specific uses that may result in short-term and intermediateterm residential exposure, such as pesticides used in and around the home. The Agency conducted a conservative assessment of potential residential exposure by assessing DPA in pesticides in outdoor and indoor scenarios. The Agency’s assessment of adult residential exposure combines high-end dermal and inhalation handler exposure from outdoor and indoor uses. The Agency’s assessment of children’s residential exposure includes total post-application exposures associated with total exposures to contact with both treated outdoor or indoor scenarios. 3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 71525 requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not made a common mechanism of toxicity finding as to DPA and any other substances, and DPA does not appear to produce toxic metabolites produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that DPA has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. D. Safety Factor for Infants and Children FFDCA Section 408(b)(2)(C) provides that EPA shall retain an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. The FQPA SF has been reduced to 1X for DPA because clear NOELs and LOELs were established in the studies analyzed by Munro et al 1996 (which included developmental and reproductive toxicity studies), maternal and developmental-specific 5th percentile NOELs calculated by van Ravenzwaay et al 2011 indicate low potential for offspring susceptibility, there is no known precedent for developmental or reproductive toxicity potential for DPA using the QSAR Toolbox DART Scheme, and the conservative assumptions made in the exposure assessment are unlikely underestimate to risk. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure E:\FR\FM\23NOR1.SGM 23NOR1 lotter on DSK11XQN23PROD with RULES1 71526 Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Rules and Regulations estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute aggregate risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effects resulting from a single oral exposure were identified and no acute dietary endpoint were selected for DPA. Therefore, DPA is not expected to pose an acute risk. 2. Short-term aggregate risk. Shortterm aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). DPA is currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1400 for both adult males and females. EPA has concluded the combined short-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 530 for children. Because EPA’s level of concern for DPA is a MOE of 100 or below, these MOEs are not of concern. 3. Intermediate-term aggregate risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, DPA exposure values for intermediate term risks are all lower than the short-term risk. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediateterm risk), no further assessment of intermediate-term risk is necessary, and VerDate Sep<11>2014 15:59 Nov 22, 2022 Jkt 259001 EPA relies on the chronic dietary risk assessment for evaluating intermediateterm risk for DPA. 4. Chronic aggregate risk. A chronic aggregate risk assessment takes into account exposure estimates from chronic dietary consumption of food and drinking water. Using the exposure assumptions described in unit IV for chronic exposure, EPA has concluded that chronic exposure to DPA from food and water will utilize 18.1% of the cPAD for children 1 to 2 years old, the highest exposed subgroup. Therefore, chronic dietary risks are below the Agency’s level of concern of 100% of the cPAD. The chronic aggregate risk is equal to the chronic dietary risk and is not of concern for DPA. 5. Cancer aggregate risk. No structural alerts for cancer were identified for DPA. Therefore, there is low concern for genotoxicity/carcinogenicity in humans and the assessment under the TTC value for non-cancer risks is protective for all risks, including carcinogenicity. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to residues of DPA. V. Other Considerations Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for DPA in or on any food commodities. EPA is establishing a limitation on the amount of DPA that may be used in pesticide formulations. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 2 ppm of 2,6pyridinedicarboxylic acid in the final pesticide formulation. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for 2,6pyridinedicarboxylic acid, also known as DPA, (CAS Reg. No. 499–83–2) when used as an inert ingredient in antimicrobial pesticide formulations applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at an end-use concentration not to exceed 2 ppm, and under 40 CFR 180.910 when used as an inert ingredient (stabilizer) in pesticide PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 formulations applied to growing crops or to raw agricultural commodities after harvest at a concentration not to exceed 2 ppm. VII. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) 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, 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 (PRA) (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 in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (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, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 E:\FR\FM\23NOR1.SGM 23NOR1 71527 Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Rules and Regulations 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 (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VIII. 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 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). PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ List of Subjects in 40 CFR Part 180 Authority: 21 U.S.C. 321(q), 346a and 371. Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 17, 2022. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR part 180 as follows: 2. In § 180.910, amend Table 1 to 180.910, by adding in alphabetical order, an entry for ‘‘2,6pyridinedicarboxylic acid (CAS Reg. No. 449–83–2)’’ to the table to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * * TABLE 1 TO 180.910 Inert ingredients Limits * * * * 2,6-pyridinedicarboxylic acid (CAS Reg. No. 449–83–2) ....................................... * * Not to exceed 2 ppm ............................. * * * 3. Amend § 180.940, by: a. Adding in alphabetical order an entry for the pesticide chemical ‘‘2,6Pyridinedicarboxylic acid’’ in table 1 to paragraph (a); ■ ■ * Uses * * Stabilizer. * * § 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). b. Removing the entry for ‘‘2,6Pyridinedicarboxylic acid’’ from the table in paragraph (b); and ■ c. Removing the entry for ‘‘2,6Pyridinedicarboxylic acid’’ from the table in paragraph (c). The addition reads as follows: ■ * * * (a) * * * * * TABLE 1 TO PARAGRAPH (a) Pesticide chemical CAS Reg. No. * * 2,6-Pyridinedicarboxylic acid ..................... * * * * * * * 499–83–2 Limits * * * * When ready for use, the end-use concentration is not to exceed 2 ppm. * * * * * * Final rule. DEPARTMENT OF COMMERCE ACTION: National Oceanic and Atmospheric Administration SUMMARY: [FR Doc. 2022–25582 Filed 11–22–22; 8:45 am] BILLING CODE 6560–50–P 50 CFR Part 648 [Docket No. 221116–0244] lotter on DSK11XQN23PROD with RULES1 RIN 0648–BI18 Fisheries of the Northeastern United States; Amendment 20 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. AGENCY: VerDate Sep<11>2014 15:59 Nov 22, 2022 Jkt 259001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 This final rule announces approval of, and implements management measures contained in, Amendment 20 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan. The Mid-Atlantic Fishery Management Council developed these measures to limit the amount of surfclam or ocean quahog individual transferable quota share or annual allocation in the form of cage tags that an individual or their family members are permitted to hold. These changes are intended to ensure the management plan is consistent with requirements of the Magnuson-Stevens Fishery E:\FR\FM\23NOR1.SGM 23NOR1

Agencies

[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Rules and Regulations]
[Pages 71523-71527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25582]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0601; FRL-10400-01-OCSPP]


2,6-Pyridinedicarboxylic Acid; Exemption From the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of 2,6-pyridinedicarboxylic acid, also known 
as DPA (CAS Reg. No. 499-83-2), when used as an inert ingredient in 
antimicrobial pesticide formulations for use on food contact surfaces 
in public eating places, dairy processing equipment, and food 
processing equipment and utensils and when used in pesticide 
formulations applied pre- and post-harvest to crops with an end-use 
concentration not to exceed 2 parts per million (ppm). EcoLab Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting the establishment of such exemptions from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of DPA.

DATES: This regulation is effective November 23, 2022. Objections and 
requests for hearings must be received on or before January 23, 2023 
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-2019-0601, 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 20460-0001. 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 the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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

[[Page 71524]]

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-2019-0601 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 
January 23, 2023. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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-2019-0601, 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//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/epa-dockets.

II. Petition for Exemption

    In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-
10005-02), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11307) by EcoLab Inc., 1 Ecolab Place, St. Paul, MN 55102. The petition 
requested to amend an exemption from the requirement of a tolerance for 
residues of 2,6-pyridinedicarboxylic acid, also known as DPA, (CAS Reg. 
No. 499-83-2) by consolidating and expanding the current exemptions to 
40 CFR 180.940(a) and increasing the limit to 2 parts per million (ppm) 
when used as a pesticide inert ingredient in pesticide formulations 
applied to hard, non-porous food-contact surfaces in public eating 
places, dairy processing equipment, and food-processing equipment and 
utensils. The petition also requested EPA establish an exemption from 
the requirement of a tolerance at 40 CFR 180.910, limited to 2 ppm when 
used in pesticide formulations applied to growing crops. That document 
referenced a summary of the petition prepared by EcoLab Inc, which is 
available in the docket, https://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA 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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA 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 . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no harm to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for DPA including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with DPA follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by DPA as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
    The Agency assessed DPA via the Threshold of Toxicological Concern

[[Page 71525]]

(TTC) approach as outlined by the European Food Safety Authority (EFSA) 
in their 2019 guidance document on the use of TTC in food safety 
assessment. This approach relies on the most recent evaluation of the 
literature on TTC as reviewed by EFSA and the World Health Organization 
(WHO) in 2016. Information regarding the database of studies and 
chemicals used to derive TTCs are reviewed therein. The TTC approach 
has been used by the Joint Expert Committee on Food Additives of the 
U.N.'s Food and Agriculture Organization and the World Health 
Organization, the former Scientific Committee on Food of the European 
Commission, the European Medicines Agency, and EFSA.
    TTC are derived from a conservative and rigorous approach developed 
by Munro and Kroes to establish generic threshold values for human 
exposure at which a very low probability of adverse effects is likely. 
There are three Cramer Classes that are organized by structural classes 
using the Cramer (1978) decision scheme. By comparing a range of 
compounds by Cramer Class (classes I, II, and III) and no-observed-
effect-level (NOEL), fifth percentile NOELs were established for each 
Cramer Class as ``Human Exposure Thresholds'' assuming a 60 kg human. 
These values were 3, 0.91 and 0.15 mg/kg/day for classes I, II and III, 
respectively.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. Uncertainty/safety 
factors are used in conjunction with the POD to calculate a safe 
exposure level--generally referred to as a population-adjusted dose 
(PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). 
For non-threshold risks, the Agency assumes that any amount of exposure 
will lead to some degree of risk. Thus, the Agency estimates risk in 
terms of the probability of an occurrence of the adverse effect 
expected in a lifetime. For more information on the general principles 
EPA uses in risk characterization and a complete description of the 
risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The human exposure threshold value for threshold (i.e., non-cancer) 
risks for DPA is based upon Cramer structural class. DPA is categorized 
as Cramer class III based on the OECD QSAR toolbox analysis of the 
Cramer decision scheme; therefore, this assessment uses the NOEL of 
0.15 mg/kg/day as the point of departure for all exposure scenarios 
assessed (chronic dietary, incidental oral, dermal and inhalation 
exposures).

C. Exposure Assessment

    1. Dietary exposure. In evaluating dietary exposure to DPA, EPA 
considered exposure under the proposed tolerance exemptions at a 
concentration not to exceed 2 ppm of DPA in an end-use pesticide 
formulation, as well as any other sources of dietary exposure. For the 
purpose of the screening level dietary risk assessment to support this 
request for an exemption from the requirement of a tolerance for DPA, a 
conservative drinking water concentration value of 100 ppb based on 
screening level modeling was used to assess the contribution to 
drinking water for the chronic dietary risk assessments for parent 
compound.
    Dietary exposure (food and drinking water) may occur from the 
existing and proposed uses of DPA (e.g., eating foods treated with 
pesticide formulations containing DPA, and drinking water exposures). 
An acute dietary assessment was not performed due to the lack of 
adverse effects attributed to a single dietary exposure.
    2. Residential exposure. The term ``residential exposure'' is used 
in this document to refer to non-occupational, non-dietary exposure 
(e.g., from hard surface disinfection on walls, floors, and tables).
    DPA may be used as an inert ingredient in products that are 
registered for specific uses that may result in short-term and 
intermediate-term residential exposure, such as pesticides used in and 
around the home. The Agency conducted a conservative assessment of 
potential residential exposure by assessing DPA in pesticides in 
outdoor and indoor scenarios. The Agency's assessment of adult 
residential exposure combines high-end dermal and inhalation handler 
exposure from outdoor and indoor uses. The Agency's assessment of 
children's residential exposure includes total post-application 
exposures associated with total exposures to contact with both treated 
outdoor or indoor scenarios.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not made a common mechanism of toxicity finding as to DPA 
and any other substances, and DPA does not appear to produce toxic 
metabolites produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that DPA has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    FFDCA Section 408(b)(2)(C) provides that EPA shall retain an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the Food Quality Protection Act 
(FQPA) Safety Factor (SF). In applying this provision, EPA either 
retains the default value of 10X, or uses a different additional safety 
factor when reliable data available to EPA support the choice of a 
different factor. The FQPA SF has been reduced to 1X for DPA because 
clear NOELs and LOELs were established in the studies analyzed by Munro 
et al 1996 (which included developmental and reproductive toxicity 
studies), maternal and developmental-specific 5th percentile NOELs 
calculated by van Ravenzwaay et al 2011 indicate low potential for 
offspring susceptibility, there is no known precedent for developmental 
or reproductive toxicity potential for DPA using the QSAR Toolbox DART 
Scheme, and the conservative assumptions made in the exposure 
assessment are unlikely underestimate to risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure

[[Page 71526]]

estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear 
cancer risks, EPA calculates the lifetime probability of acquiring 
cancer given the estimated aggregate exposure. Short-, intermediate-, 
and chronic-term risks are evaluated by comparing the estimated 
aggregate food, water, and residential exposure to the appropriate PODs 
to ensure that an adequate MOE exists.
    1. Acute aggregate risk. An acute aggregate risk assessment takes 
into account acute exposure estimates from dietary consumption of food 
and drinking water. No adverse effects resulting from a single oral 
exposure were identified and no acute dietary endpoint were selected 
for DPA. Therefore, DPA is not expected to pose an acute risk.
    2. Short-term aggregate risk. Short-term aggregate exposure takes 
into account short-term residential exposure plus chronic exposure to 
food and water (considered to be a background exposure level).
    DPA is currently used as an inert ingredient in pesticide products 
that are registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1400 for both 
adult males and females. EPA has concluded the combined short-term 
aggregated food, water, and residential pesticide exposures result in 
an aggregate MOE of 530 for children. Because EPA's level of concern 
for DPA is a MOE of 100 or below, these MOEs are not of concern.
    3. Intermediate-term aggregate risk. Intermediate-term aggregate 
exposure takes into account intermediate-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). An intermediate-term adverse effect was identified; 
however, DPA exposure values for intermediate term risks are all lower 
than the short-term risk. Intermediate-term risk is assessed based on 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for DPA.
    4. Chronic aggregate risk. A chronic aggregate risk assessment 
takes into account exposure estimates from chronic dietary consumption 
of food and drinking water. Using the exposure assumptions described in 
unit IV for chronic exposure, EPA has concluded that chronic exposure 
to DPA from food and water will utilize 18.1% of the cPAD for children 
1 to 2 years old, the highest exposed subgroup. Therefore, chronic 
dietary risks are below the Agency's level of concern of 100% of the 
cPAD. The chronic aggregate risk is equal to the chronic dietary risk 
and is not of concern for DPA.
    5. Cancer aggregate risk. No structural alerts for cancer were 
identified for DPA. Therefore, there is low concern for genotoxicity/
carcinogenicity in humans and the assessment under the TTC value for 
non-cancer risks is protective for all risks, including 
carcinogenicity.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to residues of DPA.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for DPA in or on 
any food commodities. EPA is establishing a limitation on the amount of 
DPA that may be used in pesticide formulations. This limitation will be 
enforced through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq. EPA will not register any pesticide formulation for food use 
that exceeds 2 ppm of 2,6-pyridinedicarboxylic acid in the final 
pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for 2,6-pyridinedicarboxylic acid, 
also known as DPA, (CAS Reg. No. 499-83-2) when used as an inert 
ingredient in antimicrobial pesticide formulations applied to food 
contact surfaces in public eating places, dairy processing equipment, 
and food processing equipment and utensils at an end-use concentration 
not to exceed 2 ppm, and under 40 CFR 180.910 when used as an inert 
ingredient (stabilizer) in pesticide formulations applied to growing 
crops or to raw agricultural commodities after harvest at a 
concentration not to exceed 2 ppm.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) 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, 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 (PRA) (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 in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (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, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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

[[Page 71527]]

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 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. 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 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: November 17, 2022.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR part 180 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. In Sec.  180.910, amend Table 1 to 180.910, by adding in 
alphabetical order, an entry for ``2,6-pyridinedicarboxylic acid (CAS 
Reg. No. 449-83-2)'' to the table to read as follows:


Sec.  180.910   Inert ingredients used pre- and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
      Inert ingredients             Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
2,6-pyridinedicarboxylic acid  Not to exceed 2  Stabilizer.
 (CAS Reg. No. 449-83-2).       ppm.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. Amend Sec.  180.940, by:
0
a. Adding in alphabetical order an entry for the pesticide chemical 
``2,6-Pyridinedicarboxylic acid'' in table 1 to paragraph (a);
0
b. Removing the entry for ``2,6-Pyridinedicarboxylic acid'' from the 
table in paragraph (b); and
0
c. Removing the entry for ``2,6-Pyridinedicarboxylic acid'' from the 
table in paragraph (c).
    The addition reads as follows:


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

* * * * *
    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------
 
                              * * * * * * *
2,6-Pyridinedicarboxylic acid..        499-83-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 2
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-25582 Filed 11-22-22; 8:45 am]
BILLING CODE 6560-50-P