Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt; Exemption From the Requirement of a Tolerance, 24731-24735 [2021-09911]

Download as PDF khammond on DSKJM1Z7X2PROD with RULES Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 2021. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) VerDate Sep<11>2014 16:22 May 07, 2021 Jkt 253001 List of Subjects in 40 CFR Part 62 Environmental protection, Air pollution control, Administrative practice and procedure, Intergovernmental relations, Large municipal waste combustors, Reporting and recordkeeping requirements. Dated: May 4, 2021. Cheryl Newton, Acting Regional Administrator, Region 5. For the reasons stated in the preamble, EPA amends 40 CFR part 62 as follows: PART 62—APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS 1. The authority citation for part 62 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. 2. Section 62.12360 is revised to read as follows: ■ § 62.12360 Identification of plan. On September 25, 2020, the Wisconsin Department of Natural Resources submitted a withdrawal letter to EPA certifying that there is only one Large Municipal Waste Combustor unit in the State of Wisconsin subject to the emissions guidelines at 40 CFR part 60, subpart Eb, and requested that the Federal Plan at subpart FFF of this part, apply. [FR Doc. 2021–09808 Filed 5–7–21; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2019–0607; FRL–10022–79] Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of Poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% SUMMARY: PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 24731 weight/weight (wt/wt). Milliken Chemical submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt. DATES: This regulation is effective May 10, 2021. Objections and requests for hearings must be received on or before July 9, 2021, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2019–0607, 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 is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; 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 E:\FR\FM\10MYR1.SGM 10MYR1 24732 Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations 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 Government Publishing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. khammond on DSKJM1Z7X2PROD with RULES 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–2019–0607 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 July 9, 2021. 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– 2019–0607, 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. VerDate Sep<11>2014 16:22 May 07, 2021 Jkt 253001 • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/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–11359) by Milliken Chemical, 920 Milliken Rd., M–209 Spartanburg, SC 29303. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt (CAS Reg. No. N/A) when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities not to exceed 20% (wt/wt). That document referenced a summary of the petition prepared by Milliken Chemical, the petitioner, 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 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) and (c)(2)(B) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or exemption and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ 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 appreciable risks 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 Poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with Poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1- E:\FR\FM\10MYR1.SGM 10MYR1 Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations ethanediyl}bis[w-hydroxy-, monosodium salt follows. khammond on DSKJM1Z7X2PROD with RULES 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 Poly(oxy-1,2-ethanediyl), a, a′-{[[4[(3-sulfophenyl)azo]phenyl]imino]di2,1-ethanediyl}bis[w-hydroxy-, monosodium salt as well as the noobserved-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies are discussed in this unit. In acute studies, exposure to Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt resulted in no observable or minimal toxicity. The acute oral median lethal dose (LD50) in rats is >2,000 mg/kg. Minimal dermal irritation was observed in an acute dermal study with rabbits. No indications of sensitization have been observed in local lymph node assay. Two reverse mutation assays (OECD 471), a mouse lymphoma assay (OECD 476) and an in vitro micronucleus test (OECD 487) found Poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt to not be mutagenic. In a combined repeat dose developmental/reproduction study (OECD 422), there were no adverse effects from oral administration of Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt up to 1000 mg/kg/day on any parameter measured, including gonadal function, mating performance, conception, development of the conceptus or parturition. The NOAEL for these parameters was 1000 mg/kg/ day for males and females. The NOAEL for reproductive performance and fetal/ developmental toxicity was also considered to be 1,000 mg/kg/day. B. Toxicological Points of Departure/ Levels of Concern Based on available studies provided for Poly(oxy-1,2-ethanediyl), a, a′-{[[4[(3-sulfophenyl)azo]phenyl]imino]di2,1-ethanediyl}bis[w-hydroxy-, monosodium salt, no toxicological VerDate Sep<11>2014 16:22 May 07, 2021 Jkt 253001 endpoint of concern was identified, and a quantitative risk assessment is not required for this compound. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt in food as follows: Dietary exposure (food and drinking water) to Poly(oxy-1,2-ethanediyl), a, a′{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt is not expected to occur due to its intended use as a colorant for seed treatment. Seed treatment formulas containing Poly(oxy1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt will be applied directly to seeds and if released into the environment, the colorant would not be taken up by the germinating seedling and translocated within the plant vascular system to result in crop residues and dietary exposures. 2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Poly(oxy-1,2-ethanediyl), a, a′-{[[4[(3-sulfophenyl)azo]phenyl]imino]di2,1-ethanediyl}bis[w-hydroxy-, monosodium salt may be used in pesticide products and non-pesticide products used in and around the home that would have residential exposures. However, because no toxicological endpoint of concern was identified, a quantitative residential exposure assessment for Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt was not conducted. PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 24733 4. 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 or exemption, 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 found Poly(oxy-1,2-ethanediyl), a, a′{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt to share a common mechanism of toxicity with any other substances, and Poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has assumed that poly(oxy-1,2-ethanediyl), a, a′-{[[4[(3-sulfophenyl)azo]phenyl]imino]di2,1-ethanediyl}bis[w-hydroxy-, monosodium salt does not have 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/pesticides/cumulative. D. Safety Factor for Infants and Children Based on the lack of threshold effects, EPA has not identified any toxicological endpoints of concern and is conducting a qualitative assessment of poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt. That qualitative assessment does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on an assessment of poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children. E. Aggregate Risks and Determination of Safety Taking into consideration all available information on poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt when used as an inert E:\FR\FM\10MYR1.SGM 10MYR1 24734 Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% (wt/wt), EPA has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% (wt/wt), is safe under FFDCA section 408. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. khammond on DSKJM1Z7X2PROD with RULES B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex is a joint United Nation 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. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for poly(oxy-1,2-ethanediyl), a, a′-{[[4[(3-sulfophenyl)azo]phenyl]imino]di2,1-ethanediyl}bis[w-hydroxy-, monosodium salt. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established VerDate Sep<11>2014 16:22 May 07, 2021 Jkt 253001 under 40 CFR 180.920 for poly(oxy-1,2ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt (CAS Reg. No. N/A) when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% (wt/wt). VII. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of 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 exemption 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 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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 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: May 4, 2021. Marietta Echeverria, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.920, amend the table by adding in alphabetical order the inert ingredient ‘‘Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt’’ to read as follows: ■ § 180.920 Inert ingredients used preharvest; exemptions from the requirement of a tolerance. * E:\FR\FM\10MYR1.SGM * * 10MYR1 * * 24735 Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations Inert ingredients Limits * * * * Poly(oxy-1,2-ethanediyl), a, a′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1ethanediyl}bis[w-hydroxy-, monosodium salt. * * * BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 412 [CMS–1762–IFC] RIN 0938–AU56 Medicare Program; Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (MGCRB) Centers for Medicare & Medicaid Services (CMS), Health and Human Services, (HHS). ACTION: Interim final rule with comment period. AGENCY: This interim final rule with comment period (IFC) amends our current regulations to allow hospitals with a rural redesignation under the Social Security Act (the Act) to reclassify through the Medicare Geographic Classification Review Board (MGCRB) using the rural reclassified area as the geographic area in which the hospital is located. These regulatory changes align our policy with the decision in Bates County Memorial Hospital v. Azar, effective with reclassifications beginning with fiscal year (FY) 2023. We would also apply the policy in this IFC when deciding timely appeals before the Administrator of applications for reclassifications beginning with FY 2022 that were denied by the MGCRB due to the current policy, which does not permit hospitals with rural redesignations to use the rural area’s wage data for purposes of reclassifying under the MGCRB. khammond on DSKJM1Z7X2PROD with RULES SUMMARY: DATES: Effective date: These regulations are effective on May 10, 2021. Comment date: To be assured consideration, comments must be received at one of the addresses provided below by June 28, 2021. VerDate Sep<11>2014 16:22 May 07, 2021 Jkt 253001 * * Not to exceed 20% by weight of pesticide formulation. * * In commenting, please refer to file code CMS–1762–IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may (and we encourage you to) submit electronic comments on this regulation to https:// www.regulations.gov. Follow the instructions under the ‘‘submit a comment’’ tab. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1762–IFC, P.O. Box 8013, Baltimore, MD 21244–1850. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments via express or overnight mail to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1762–IFC, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. For information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Tehila Lipschutz, (410) 786–1344 or Dan Schroder, (410) 786–7452. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: https:// regulations.gov. Follow the search instructions on that website to view public comments. Comments received timely will be also available for public inspection as they are received, generally beginning ADDRESSES: [FR Doc. 2021–09911 Filed 5–7–21; 8:45 am] PO 00000 Frm 00037 Fmt 4700 Uses Sfmt 4700 * * Colorant. * approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1–800–743–3951. I. Background A. Wage Index for Acute Care Hospitals Paid Under the Hospital Inpatient Prospective Payment System (IPPS) Under section 1886(d) of the Social Security Act (the Act), hospitals are paid based on prospectively set rates. To account for geographic area wage level differences, section 1886(d)(3)(E) of the Act requires that the Secretary of the Department of Health and Human Services (the Secretary) adjust the standardized amounts by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital, as compared to the national average hospital wage level. We currently define hospital labor market areas based on the delineations of statistical areas established by the Office of Management and Budget (OMB). The current statistical areas (which were implemented beginning with FY 2015) are based on revised OMB delineations issued on February 28, 2013, in OMB Bulletin No. 13–01, with updates as reflected in OMB Bulletins Nos. 15–01, 17–01, and 18–04. We refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963) for a full discussion of our implementation of the new OMB labor market area delineations beginning with the FY 2015 wage index, and to the FY 2021 IPPS/LTCH PPS final rule (85 FR 58743 through 58755) for a discussion of the latest updates to these delineations. Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index of hospitals annually, and to base the update on a survey of wages and wage-related costs of short-term, acute care hospitals. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amounts so as to ensure that aggregate payments under the IPPS, after E:\FR\FM\10MYR1.SGM 10MYR1

Agencies

[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Rules and Regulations]
[Pages 24731-24735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09911]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0607; FRL-10022-79]


Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Poly(oxy-1,2-ethanediyl), [alpha], 
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt when used as an 
inert ingredient (colorant) in pesticide formulations applied to seed 
treatment slurries for raw agricultural commodities and not to exceed 
20% weight/weight (wt/wt). Milliken Chemical submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt.

DATES: This regulation is effective May 10, 2021. Objections and 
requests for hearings must be received on or before July 9, 2021, 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-2019-0607, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; 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

[[Page 24732]]

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 Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2019-0607 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 
July 9, 2021. 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-2019-0607, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/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-
11359) by Milliken Chemical, 920 Milliken Rd., M-209 Spartanburg, SC 
29303. The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt (CAS Reg. No. N/A) when used as an inert 
ingredient (colorant) in pesticide formulations applied to seed 
treatment slurries for raw agricultural commodities not to exceed 20% 
(wt/wt). That document referenced a summary of the petition prepared by 
Milliken Chemical, the petitioner, 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(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Section 408(b)(2)(C) and (c)(2)(B) of FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
or exemption and to ``ensure that there is a reasonable certainty that 
no harm will result to infants and children from aggregate exposure to 
the pesticide chemical residue. . . .''
    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 appreciable risks 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 Poly(oxy-1,2-ethanediyl), 
[alpha], [alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with Poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-

[[Page 24733]]

ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt 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 Poly(oxy-1,2-ethanediyl), [alpha], 
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt 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.
    In acute studies, exposure to Poly(oxy-1,2-ethanediyl), [alpha], 
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt resulted in no 
observable or minimal toxicity. The acute oral median lethal dose 
(LD50) in rats is >2,000 mg/kg. Minimal dermal irritation 
was observed in an acute dermal study with rabbits. No indications of 
sensitization have been observed in local lymph node assay.
    Two reverse mutation assays (OECD 471), a mouse lymphoma assay 
(OECD 476) and an in vitro micronucleus test (OECD 487) found Poly(oxy-
1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt to not be mutagenic.
    In a combined repeat dose developmental/reproduction study (OECD 
422), there were no adverse effects from oral administration of 
Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt up to 1000 mg/kg/day on any parameter 
measured, including gonadal function, mating performance, conception, 
development of the conceptus or parturition. The NOAEL for these 
parameters was 1000 mg/kg/day for males and females. The NOAEL for 
reproductive performance and fetal/developmental toxicity was also 
considered to be 1,000 mg/kg/day.

B. Toxicological Points of Departure/Levels of Concern

    Based on available studies provided for Poly(oxy-1,2-ethanediyl), 
[alpha], [alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt, no 
toxicological endpoint of concern was identified, and a quantitative 
risk assessment is not required for this compound.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt in food as follows:
    Dietary exposure (food and drinking water) to Poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt is not expected to occur due to its intended 
use as a colorant for seed treatment. Seed treatment formulas 
containing Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt will be applied directly to seeds and if 
released into the environment, the colorant would not be taken up by 
the germinating seedling and translocated within the plant vascular 
system to result in crop residues and dietary exposures.
    2. Dietary exposure from drinking water. Since a hazard endpoint of 
concern was not identified for the acute and chronic dietary 
assessment, a quantitative dietary exposure risk assessment for 
drinking water was not conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt may be used in pesticide products and non-
pesticide products used in and around the home that would have 
residential exposures. However, because no toxicological endpoint of 
concern was identified, a quantitative residential exposure assessment 
for Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt was not conducted.
    4. 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 or 
exemption, 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 
found Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt to share a common mechanism of toxicity with 
any other substances, and Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-
{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this action, therefore, EPA has assumed that poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt does not have 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/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Based on the lack of threshold effects, EPA has not identified any 
toxicological endpoints of concern and is conducting a qualitative 
assessment of poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt. That qualitative assessment does not use 
safety factors for assessing risk, and no additional safety factor is 
needed for assessing risk to infants and children. Based on an 
assessment of poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on poly(oxy-
1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt when used as an inert

[[Page 24734]]

ingredient (colorant) in pesticide formulations applied to seed 
treatment slurries for raw agricultural commodities and not to exceed 
20% (wt/wt), EPA has determined that there is a reasonable certainty 
that no harm to the general population or any population subgroup, 
including infants and children, will result from aggregate exposure to 
poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt. Therefore, the establishment of an exemption 
from tolerance under 40 CFR 180.920 for residues of poly(oxy-1,2-
ethanediyl), [alpha], [alpha]'-{[[4-[(3-
sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl{time} bis[[omega]-
hydroxy-, monosodium salt when used as an inert ingredient (colorant) 
in pesticide formulations applied to seed treatment slurries for raw 
agricultural commodities and not to exceed 20% (wt/wt), is safe under 
FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). Codex is a joint United Nation 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. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    The Codex has not established a MRL for poly(oxy-1,2-ethanediyl), 
[alpha], [alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for poly(oxy-1,2-ethanediyl), [alpha], 
[alpha]'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt (CAS Reg. No. N/
A) when used as an inert ingredient (colorant) in pesticide 
formulations applied to seed treatment slurries for raw agricultural 
commodities and not to exceed 20% (wt/wt).

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 exemption 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 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: May 4, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.920, amend the table by adding in alphabetical order 
the inert ingredient ``Poly(oxy-1,2-ethanediyl), [alpha], [alpha]'-
{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
ethanediyl{time} bis[[omega]-hydroxy-, monosodium salt'' to read as 
follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

[[Page 24735]]



------------------------------------------------------------------------
       Inert ingredients               Limits                Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Poly(oxy-1,2-ethanediyl),        Not to exceed 20%   Colorant.
 [alpha], [alpha]'-{[[4-[(3-      by weight of
 sulfophenyl)azo]phenyl]imino]d   pesticide
 i-2,1-ethanediyl{time}           formulation.
 bis[[omega]-hydroxy-,
 monosodium salt.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2021-09911 Filed 5-7-21; 8:45 am]
BILLING CODE 6560-50-P
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