Butoxypolypropylene glycol, et al.; Exemption From the Requirement of a Tolerance, 17013-17018 [2022-06327]

Download as PDF Federal Register / Vol. 87, No. 58 / Friday, March 25, 2022 / Rules and Regulations Name of non-regulatory SIP revision Applicable geographic area * * Philadelphia Area Base Year Inventory for the 2015 Ozone National Ambient Air Quality Standards. * * Delaware’s portion of the Philadelphia-Wilmington-Atlantic City, PA–NJ–MD–DE 2015 ozone NAAQS nonattainment area (i.e., New Castle County). BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2018–0156; FRL–9574–01– OCSPP] Butoxypolypropylene glycol, et al.; 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 butoxypolypropylene glycol (BPG; abutyl-w¬-hydroxy-poly-oxy(methyl-1,2ethanediyl) (CAS Reg. No. 9003–13–8)), oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1-yl ether (CAS Reg. No. 9041–33–2; polyether 1), poly(oxy-1,2-ethanediyl), a-acetyl-w¬-(2propen-1-yloxy)- (CAS Reg. No. 27252– 87–5; polyether 2) and poly(oxy-1,2ethanediyl), a-methyl-w¬-(2-propen-1yloxy)- (CAS Reg. No. 27252–80–8; polyether 3) when used as an inert ingredient in/on growing crops and raw agricultural commodities pre- and postharvest and applied to animals. Spring Trading Company, on behalf of Evonik Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of BPG and polyethers 1, 2, and 3 when used in accordance with these exemptions. DATES: This regulation is effective March 25, 2022. Objections and requests for hearings must be received on or before May 24, 2022, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). lotter on DSK11XQN23PROD with RULES1 VerDate Sep<11>2014 16:48 Mar 24, 2022 Jkt 256001 EPA approval date * 10/09/20 * 3/25/2022, [insert Federal Register citation]. The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2018–0156, 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 open to visitors by appointment only. For the latest status information on EPA/DC services and access, visit https://www.epa.gov/dockets. ADDRESSES: [FR Doc. 2022–06276 Filed 3–24–22; 8:45 am] SUMMARY: State submittal date 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: 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). PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 17013 Additional explanation * Delaware’s portion of the Philadelphia Area consists of New Castle County. B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register’s e-CFR site at https:// www.ecfr.gov/current/title-40. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, 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–2018–0156 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 May 24, 2022. 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– 2018–0156, 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 E:\FR\FM\25MRR1.SGM 25MRR1 17014 Federal Register / Vol. 87, No. 58 / Friday, March 25, 2022 / Rules and Regulations 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 May 18, 2018 (83 FR 23249) (FRL–9976–87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–11104) by Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354), on behalf of Evonik Corporation (P.O. Box 34628, Richmond, VA 23234). The petition requested that 40 CFR 180.910 and 180.930 be amended by establishing exemptions from the requirement of a tolerance for residues of BPG and polyethers 1, 2, and 3 when used as an inert ingredient in pesticide formulations applied in/on growing crops pre- and post-harvest and applied to animals. That document referenced a summary of the petition prepared by Spring Trading Company on behalf of Evonik Corporation, the petitioner, which is available in the docket, https:// www.regulations.gov. There were no relevant comments received in response to the notice of filing. lotter on DSK11XQN23PROD with RULES1 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.’’ VerDate Sep<11>2014 15:53 Mar 24, 2022 Jkt 256001 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 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 BPG and polyethers 1, 2 and 3 including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with BPG and polyethers 1, 2 and 3 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 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by BPG and polyethers 1, 2 and 3 as well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit. Toxicity information is available for BPG but not for polyethers 1, 2 or 3. Therefore, information from BPG and the related compound polyoxyethylene polyoxypropylene monobutyl ether (PPME; CAS Reg. No. 9038–95–3) and several related alcohol ethoxylates are used to assess the toxicity of the petitioned-for polymers. Based on the available read-across information, BPG and polyethers 1, 2, and 3, are considered to have low acute toxicity via the oral, dermal, and inhalation routes. They are minor eye irritants, but not dermal irritants or skin sensitizers. In repeated-dose toxicity studies, the kidneys, liver, hematological system and lungs were the major target organs. However, the effects observed in these oral and dermal studies occurred at doses at or above the limit dose and thus, are not considered relevant for risk assessment purposes. Based on their expected volatility and results from a repeated-dose inhalation study, inhalation is the route of toxicological concern for BPG and polyethers 1, 2, and 3. There is no evidence of susceptibility in the available developmental toxicity study and no effects on reproductive organs were observed throughout the database. Concern for carcinogenicity is low based on negative results in mutagenicity and genotoxicity studies and lack of effects in the available chronic studies. 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. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as E:\FR\FM\25MRR1.SGM 25MRR1 Federal Register / Vol. 87, No. 58 / Friday, March 25, 2022 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 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/pesticides/factsheets/ riskassess.htm. An acute dietary endpoint was not selected because no effect attributable to a single dose was identified in the database. No chronic dietary endpoint was selected because the effects observed in the oral studies occurred at doses above the limit dose, which are not relevant for risk assessment purposes. No short- and intermediateterm incidental oral endpoints were selected because the effects observed in the oral studies occurred at doses above the limit dose, which are not relevant for risk assessment purposes. No dermal endpoints were selected. There were also no adverse systemic effects reported in the 90-day dermal toxicity study in rats, and there was no evidence of increased susceptibility in the young. The short-term and intermediate-term inhalation endpoints were derived from the 2-week inhalation toxicity study in rats, with a NOAEL of 100 mg/m3 and a LOAEL of 500 mg/m3, based on rapid respiration in females, hematology, clinical chemistry and urinalysis findings and microscopic findings in the lung in both sexes. This represents the lowest NOAEL in the database in the most sensitive species. The standard uncertainty factors (UFs) were applied to account for interspecies (10x) and intraspecies (10x) variations. The default value of 100% was used for the dermal and inhalation absorption factors. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Although dietary exposure via food is anticipated, no acute or chronic dietary endpoints of concern were identified; therefore, a quantitative dietary exposure assessment was not conducted. 2. Dietary exposure from drinking water. Although dietary exposure via drinking water is anticipated, no acute or chronic dietary endpoints of concern were identified; therefore, a quantitative dietary exposure assessment was not conducted. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in VerDate Sep<11>2014 15:53 Mar 24, 2022 Jkt 256001 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). BPG and polyethers 1, 2 and 3 may be used as an inert ingredient in products that are registered for specific uses that may result in residential exposure. A screening level residential exposure and risk assessment was completed for products containing BPG and polyethers 1, 2 and 3 as inert ingredients. The Agency selected representative scenarios, based on end-use product application methods and labeled application rates. The Agency conducted an assessment to represent worst-case residential exposure by assessing BPG and polyethers 1, 2 and 3 in pesticide formulations (outdoor scenarios) and BPG and polyethers 1, 2 and 3 in disinfectant-type uses (indoor scenarios). The Agency assessed the disinfectant-type products containing BPG and polyethers 1, 2 and 3 using exposure scenarios used by OPP’s Antimicrobials Division to represent worst-case indoor residential handler exposure to possible non-food use applications. Further details of the residential exposure and risk analysis can be found at https:// www.regulations.gov in the memorandum entitled ‘‘JITF Inert Ingredients. Residential and Occupational Exposure Assessment Algorithms and Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations’’ (D364751, 5/7/09, Lloyd/ LaMay) in docket ID number EPA–HQ– OPP–2008–0710. 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, 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 BPG or polyether 1, 2 or 3 to share a common mechanism of toxicity with any other substances, and BPG and polyether 1, 2 and 3 do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that BPG and polyether 1, 2 and 3 do not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 17015 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 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply 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. 2. Prenatal and postnatal sensitivity. Based on the evaluation of available toxicity studies with BPG and related compounds, there is low concern for pre- and postnatal susceptibility for infants and children from exposure to BPG, and polyethers 1, 2, and 3. 3. Conclusion. The FQPA safety factor has been reduced to 1X because: (1) The toxicity database is adequate to characterize potential pre- and postnatal risk for infants and children; (2) no effects on reproductive organs or reproductive parameters were observed in the available studies; (3) no developmental effects were observed in the available dermal developmental study in rats; (4) no evidence of neurotoxicity was observed in the database; and (5) the exposure assessment is unlikely to underestimate risk. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure 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. Shortand intermediate-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 dietary risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and E:\FR\FM\25MRR1.SGM 25MRR1 lotter on DSK11XQN23PROD with RULES1 17016 Federal Register / Vol. 87, No. 58 / Friday, March 25, 2022 / Rules and Regulations drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, BPG and polyethers 1, 2 and 3 are not expected to pose an acute dietary risk. 2. Chronic dietary risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from repeated oral exposure was identified and no chronic dietary endpoint was selected. Therefore, BPG and polyether 1, 2 and 3 are not expected to pose a chronic dietary risk. 3. Short-term 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). BPG and polyethers 1, 2 and 3 are 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 to BPG and polyethers 1, 2 and 3. 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 ranging from 22,000 to 280,000 for adults (handler only; no dietary exposure). Because EPA’s level of concern for BPG and polyethers 1, 2 and 3 is an MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term 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). BPG and polyethers 1, 2 and 3 are currently used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to BPG and polyethers 1, 2 and 3. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs ranging from 22,000 to 280,000 for adults (handler only; no dietary exposure). Because EPA’s level of concern for BPG and polyethers 1, 2 and 3 is a MOE of 100 or below, these MOEs are not of concern. VerDate Sep<11>2014 15:53 Mar 24, 2022 Jkt 256001 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in the provided studies, BPG and polyethers 1, 2 and 3 are not expected to pose a cancer risk to humans. 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 BPG and polyethers 1, 2 and 3 residues. 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). The Codex Alimentarius 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 BPG and polyether 1, 2 and 3. VI. Conclusions Therefore, exemptions from the requirement of a tolerance are established under 40 CFR 180.910 and 180.930 for butoxypolypropylene glycol (BPG; a-butyl-w¬-hydroxy-polyoxy(methyl-1,2-ethanediyl) (CAS Reg. No. 9003–13–8), oxirane, 2-methyl-, polymer with oxirane, mono-2-propen1-yl ether (CAS Reg. No. 9041–33–2; polyether 1), poly(oxy-1,2-ethanediyl), a-acetyl-w¬-(2-propen-1-yloxy)- (CAS Reg. No. 27252–87–5; polyether 2) and poly(oxy-1,2-ethanediyl), a-methyl-w¬-(2propen-1-yloxy)- (CAS Reg. No. 27252– 80–8; polyether 3) when used as an inert ingredient in pesticide formulations applied in/on growing crops and raw PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 agricultural commodities pre- and postharvest under and applied to animals. 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 Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In E:\FR\FM\25MRR1.SGM 25MRR1 17017 Federal Register / Vol. 87, No. 58 / Friday, March 25, 2022 / Rules and Regulations 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 Authority: 21 U.S.C. 321(q), 346a and 371. Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). 2. In § 180.910, amend Table 1 to 180.910 by adding, in alphabetical order, the inert ingredients ‘‘Butoxypolypropylene glycol (CAS Reg. No. 9003–13–8)’’; ‘‘Oxirane, 2-methyl-, polymer with oxirane, mono-2-propen1-yl ether (CAS Reg. No. 9041–33–2)’’; ‘‘Poly(oxy-1,2-ethanediyl), a-acetyl-w¬(2-propen-1-yloxy)- (CAS Reg. No. 27252–87–5)’’; and ‘‘Poly(oxy-1,2ethanediyl), a-methyl-w¬-(2-propen-1yloxy)- (CAS Reg. No. 27252–80–8)’’ to read as follows: ■ List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 21, 2022. 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 § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * * 1. The authority citation for part 180 continues to read as follows: ■ TABLE 1 TO 180.910 Inert ingredients Limits Uses * * * * * Butoxypolypropylene glycol (CAS Reg. No. 9003–13–8) ........................................................................................ * ........................ * ........................ * * * * * Oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1-yl ether (CAS Reg. No. 9041–33–2). * * * * * * Poly(oxy-1,2-ethanediyl), a-acetyl-w¬-(2-propen-1-yloxy)- (CAS Reg. No. 27252–87–5). * * * * * * * Poly(oxy-1,2-ethanediyl), a-methyl-w¬-(2-propen-1-yloxy)- (CAS Reg. No. 27252–80–8). * * * * * * * * * 3. In § 180.930, amend Table 1 to 180.930 by adding, in alphabetical order, the inert ingredients ‘‘Butoxypolypropylene glycol (CAS Reg. No. 9003–13–8)’’; ‘‘Oxirane, 2-methyl-, polymer with oxirane, mono-2-propen- ■ * 1-yl ether (CAS Reg. No. 9041–33–2)’’; ‘‘Poly(oxy-1,2-ethanediyl), a-acetyl-w¬(2-propen-1-yloxy)- (CAS Reg. No. 27252–87–5)’’; and ‘‘Poly(oxy-1,2ethanediyl), a-methyl-w¬-(2-propen-1- yloxy)- (CAS Reg. No. 27252–80–8)’’ to read as follows: § 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance. * * * * * TABLE 1 TO 180.930 Inert ingredients lotter on DSK11XQN23PROD with RULES1 * * * Butoxypolypropylene glycol (CAS Reg. No. 9003–13–8). Limits * * * * * * * Oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1-yl ether (CAS Reg. No. 9041–33–2). * * * * * * Poly(oxy-1,2-ethanediyl), a-acetyl-w¬-(2-propen-1-yloxy)- (CAS Reg. No. 27252–87–5). Poly(oxy-1,2-ethanediyl), a-methyl-w¬-(2-propen-1-yloxy)- (CAS Reg. No. 27252–80–8). * * * * * * * VerDate Sep<11>2014 * 15:53 Mar 24, 2022 * Jkt 256001 PO 00000 * * Uses * Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\25MRR1.SGM 25MRR1 17018 Federal Register / Vol. 87, No. 58 / Friday, March 25, 2022 / Rules and Regulations [FR Doc. 2022–06327 Filed 3–24–22; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 216 and 300 [Docket No. 220322–0076] RIN 0648–BK88 International Fisheries; Pacific Tuna Fisheries; Purse Seine Observer Exemptions in the Eastern Pacific Ocean National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. AGENCY: NMFS issues regulations under the authority of the Marine Mammal Protection Act (MMPA) and the Tuna Conventions Act (TCA) of 1950, as amended, to allow NMFS to issue temporary exemptions from purse seine observer requirements in the eastern Pacific Ocean (EPO) in accordance with procedures adopted by Parties to the Agreement on the International Dolphin Conservation Program (AIDCP) and members of the Inter-American Tropical Tuna Commission (IATTC). This final rule is necessary for the continuity of fishing activities for large U.S. purse seine vessels and for the United States to satisfy its obligations as a member of the IATTC. DATES: Effective March 25, 2022. ADDRESSES: Copies of supporting documents that were prepared for this final rule, including the Regulatory Impact Review, are available via the Federal e-Rulemaking Portal: www.regulations.gov, docket NOAA– NMFS–2021–0111, or contact William Stahnke, NMFS WCR, Long Beach Office, 501 W Ocean Blvd., Suite 4200, Long Beach, CA 90802, or WCR.HMS@ noaa.gov. FOR FURTHER INFORMATION CONTACT: William Stahnke, NMFS WCR, at (562) 980–4088. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with RULES1 SUMMARY: Background On February 4, 2022, NMFS published a proposed rule in the Federal Register (87 FR 6474) to revise regulations at 50 CFR part 216, subpart C and 50 CFR part 300, subpart C, to allow NMFS to issue temporary VerDate Sep<11>2014 15:53 Mar 24, 2022 Jkt 256001 exemptions from purse seine observer requirements in the eastern Pacific Ocean (EPO) in accordance with procedures adopted by Parties to the Agreement on the International Dolphin Conservation Program (AIDCP) and members of the Inter-American Tropical Tuna Commission (IATTC). The 30-day public comment period for the proposed rule closed on March 7, 2022. The final rule is implemented under the authority of the Marine Mammal Protection Act (16 U.S.C. 1361 et seq.), and the Tuna Conventions Act (16 U.S.C. 951 et seq.). This final rule applies to U.S. large purse seine vessels (i.e., those greater than 400 short ton carrying capacity) fishing for tuna in the IATTC Convention Area. The IATTC Convention Area is defined as waters of the eastern Pacific Ocean (EPO) within the area bounded by the west coast of the Americas and by 50° N. latitude, 150° W. longitude, and 50° S. latitude. Background on the AIDCP and IATTC The AIDCP has been ratified or acceded by 14 countries, including the United States, and is applied provisionally by another two. Among the objectives of the AIDCP are to reduce dolphin mortalities and ensure the long-term sustainability of the tuna stocks within the AIDCP Agreement Area.1 The full text of the AIDCP is available online at: https:// www.iattc.org/PDFFiles/AIDCP/_ English/AIDCP.pdf. The United States is a member of the IATTC, which was established under the 1949 Convention for the Establishment of an Inter-American Tropical Tuna Commission (1949 Convention). The 1949 Convention was updated by the Convention for the Strengthening of the IATTC Established by the 1949 Convention between the United States of America and the Republic of Costa Rica (Antigua Convention). The full text of the Antigua Convention is available online at: https://www.iattc.org/PDFFiles/ IATTC-Instruments/_English/IATTC_ Antigua_Convention%20Jun%202003. pdf. The IATTC consists of 21 member nations and five cooperating nonmember nations. The IATTC facilitates scientific research, as well as the conservation and management, of tuna and tuna-like species in the IATTC Convention Area.2 The IATTC maintains a scientific research and 1 Defined as waters of the EPO within the area bounded by the west coast of the Americas and by 50° N latitude, 150° W longitude, and 50° S latitude. 2 Defined as waters of the EPO within the area bounded by the west coast of the Americas and by 50° N latitude, 150° W longitude, and 50° S latitude. PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 fishery monitoring program and regularly assesses the status of tuna, sharks, and billfish stocks in the IATTC Convention Area to determine appropriate catch limits and other measures deemed necessary to promote sustainable fisheries and prevent the overexploitation of these stocks. International Obligations of the United States Under the Antigua Convention and AIDCP As a Party to the Antigua Convention and AIDCP and a Member of the IATTC, the United States is legally bound to implement decisions of the IATTC under the Tuna Conventions Act (16 U.S.C. 951 et seq.) and decisions of the Parties to the AIDCP under the Marine Mammal Protection Act (16 U.S.C. 1361 et seq.). The Tuna Conventions Act directs the Secretary of Commerce, in consultation with the Secretary of State and, with respect to enforcement measures, the U.S. Coast Guard, to promulgate such regulations as may be necessary to carry out the United States’ obligations under the Antigua Convention, including recommendations and decisions adopted by the IATTC. The authority of the Secretary of Commerce to promulgate such regulations has been delegated to NMFS. The MMPA directs the Secretary of Commerce to issue regulations, and revise those regulations as may be appropriate, to implement the International Dolphin Conservation Program. As with the TCA, the authority of the Secretary of Commerce to promulgate such regulations has been delegated to NMFS. AIDCP and IATTC Observer Program and U.S. Observer Requirements U.S. large purse seine vessels (i.e., those greater than 400 short ton carrying capacity) fishing for tuna in the EPO are subject to 100 percent observer coverage obligations under Annex II, paragraph 2 of the AIDCP and IATTC Resolution C– 09–04, Resolution on the International Dolphin Conservation Program. The United States implemented this requirement for 100 percent observer coverage into domestic regulation at 50 CFR 216.24(e)(1), which requires vessel permit holders to allow an authorized observer to accompany the vessel on all fishing trips in the eastern tropical Pacific Ocean (ETP) for the purpose of collecting information pertaining to research and observing operations and prohibits vessels that fail to carry an observer in accordance with these requirements from engaging in fishing operations. The United States does not have its own national observer program for the large tuna purse seine fishery E:\FR\FM\25MRR1.SGM 25MRR1

Agencies

[Federal Register Volume 87, Number 58 (Friday, March 25, 2022)]
[Rules and Regulations]
[Pages 17013-17018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06327]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0156; FRL-9574-01-OCSPP]


Butoxypolypropylene glycol, et al.; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of butoxypolypropylene glycol (BPG; [alpha]-
butyl-[omega]-hydroxy-poly-oxy(methyl-1,2-ethanediyl) (CAS Reg. No. 
9003-13-8)), oxirane, 2-methyl-, polymer with oxirane, mono-2-propen-1-
yl ether (CAS Reg. No. 9041-33-2; polyether 1), poly(oxy-1,2-
ethanediyl), [alpha]-acetyl-[omega]-(2-propen-1-yloxy)- (CAS Reg. No. 
27252-87-5; polyether 2) and poly(oxy-1,2-ethanediyl), [alpha]-methyl-
[omega]-(2-propen-1-yloxy)- (CAS Reg. No. 27252-80-8; polyether 3) when 
used as an inert ingredient in/on growing crops and raw agricultural 
commodities pre- and post-harvest and applied to animals. Spring 
Trading Company, on behalf of Evonik Corporation, submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting establishment of exemptions from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of BPG and polyethers 1, 2, and 3 when 
used in accordance with these exemptions.

DATES: This regulation is effective March 25, 2022. Objections and 
requests for hearings must be received on or before May 24, 2022, 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-2018-0156, 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 open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and 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 provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2018-0156 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 
May 24, 2022. 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-2018-0156, 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

[[Page 17014]]

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 May 18, 2018 (83 FR 23249) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11104) by 
Spring Trading Company (203 Dogwood Trail, Magnolia, TX 77354), on 
behalf of Evonik Corporation (P.O. Box 34628, Richmond, VA 23234). The 
petition requested that 40 CFR 180.910 and 180.930 be amended by 
establishing exemptions from the requirement of a tolerance for 
residues of BPG and polyethers 1, 2, and 3 when used as an inert 
ingredient in pesticide formulations applied in/on growing crops pre- 
and post-harvest and applied to animals. That document referenced a 
summary of the petition prepared by Spring Trading Company on behalf of 
Evonik Corporation, the petitioner, which is available in the docket, 
https://www.regulations.gov. There were no relevant 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 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 BPG and polyethers 1, 2 and 3 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with BPG and 
polyethers 1, 2 and 3 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 BPG and polyethers 1, 2 and 3 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.
    Toxicity information is available for BPG but not for polyethers 1, 
2 or 3. Therefore, information from BPG and the related compound 
polyoxyethylene polyoxypropylene monobutyl ether (PPME; CAS Reg. No. 
9038-95-3) and several related alcohol ethoxylates are used to assess 
the toxicity of the petitioned-for polymers. Based on the available 
read-across information, BPG and polyethers 1, 2, and 3, are considered 
to have low acute toxicity via the oral, dermal, and inhalation routes. 
They are minor eye irritants, but not dermal irritants or skin 
sensitizers.
    In repeated-dose toxicity studies, the kidneys, liver, 
hematological system and lungs were the major target organs. However, 
the effects observed in these oral and dermal studies occurred at doses 
at or above the limit dose and thus, are not considered relevant for 
risk assessment purposes. Based on their expected volatility and 
results from a repeated-dose inhalation study, inhalation is the route 
of toxicological concern for BPG and polyethers 1, 2, and 3. There is 
no evidence of susceptibility in the available developmental toxicity 
study and no effects on reproductive organs were observed throughout 
the database. Concern for carcinogenicity is low based on negative 
results in mutagenicity and genotoxicity studies and lack of effects in 
the available chronic studies.

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. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as

[[Page 17015]]

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/pesticides/factsheets/riskassess.htm.
    An acute dietary endpoint was not selected because no effect 
attributable to a single dose was identified in the database. No 
chronic dietary endpoint was selected because the effects observed in 
the oral studies occurred at doses above the limit dose, which are not 
relevant for risk assessment purposes. No short- and intermediate-term 
incidental oral endpoints were selected because the effects observed in 
the oral studies occurred at doses above the limit dose, which are not 
relevant for risk assessment purposes. No dermal endpoints were 
selected. There were also no adverse systemic effects reported in the 
90-day dermal toxicity study in rats, and there was no evidence of 
increased susceptibility in the young.
    The short-term and intermediate-term inhalation endpoints were 
derived from the 2-week inhalation toxicity study in rats, with a NOAEL 
of 100 mg/m\3\ and a LOAEL of 500 mg/m\3\, based on rapid respiration 
in females, hematology, clinical chemistry and urinalysis findings and 
microscopic findings in the lung in both sexes. This represents the 
lowest NOAEL in the database in the most sensitive species. The 
standard uncertainty factors (UFs) were applied to account for 
interspecies (10x) and intraspecies (10x) variations. The default value 
of 100% was used for the dermal and inhalation absorption factors.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Although dietary 
exposure via food is anticipated, no acute or chronic dietary endpoints 
of concern were identified; therefore, a quantitative dietary exposure 
assessment was not conducted.
    2. Dietary exposure from drinking water. Although dietary exposure 
via drinking water is anticipated, no acute or chronic dietary 
endpoints of concern were identified; therefore, a quantitative dietary 
exposure assessment 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).
    BPG and polyethers 1, 2 and 3 may be used as an inert ingredient in 
products that are registered for specific uses that may result in 
residential exposure. A screening level residential exposure and risk 
assessment was completed for products containing BPG and polyethers 1, 
2 and 3 as inert ingredients. The Agency selected representative 
scenarios, based on end-use product application methods and labeled 
application rates. The Agency conducted an assessment to represent 
worst-case residential exposure by assessing BPG and polyethers 1, 2 
and 3 in pesticide formulations (outdoor scenarios) and BPG and 
polyethers 1, 2 and 3 in disinfectant-type uses (indoor scenarios). The 
Agency assessed the disinfectant-type products containing BPG and 
polyethers 1, 2 and 3 using exposure scenarios used by OPP's 
Antimicrobials Division to represent worst-case indoor residential 
handler exposure to possible non-food use applications. Further details 
of the residential exposure and risk analysis can be found at https://www.regulations.gov in the memorandum entitled ``JITF Inert 
Ingredients. Residential and Occupational Exposure Assessment 
Algorithms and Assumptions Appendix for the Human Health Risk 
Assessments to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as Inert Ingredients in Pesticide Formulations'' 
(D364751, 5/7/09, Lloyd/LaMay) in docket ID number EPA-HQ-OPP-2008-
0710.
    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, 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 BPG or polyether 1, 2 or 3 to share a common 
mechanism of toxicity with any other substances, and BPG and polyether 
1, 2 and 3 do not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that BPG and polyether 1, 2 and 3 do 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

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply 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.
    2. Prenatal and postnatal sensitivity. Based on the evaluation of 
available toxicity studies with BPG and related compounds, there is low 
concern for pre- and postnatal susceptibility for infants and children 
from exposure to BPG, and polyethers 1, 2, and 3.
    3. Conclusion. The FQPA safety factor has been reduced to 1X 
because: (1) The toxicity database is adequate to characterize 
potential pre- and postnatal risk for infants and children; (2) no 
effects on reproductive organs or reproductive parameters were observed 
in the available studies; (3) no developmental effects were observed in 
the available dermal developmental study in rats; (4) no evidence of 
neurotoxicity was observed in the database; and (5) the exposure 
assessment is unlikely to underestimate risk.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure 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- and intermediate-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 dietary risk. An acute aggregate risk assessment takes 
into account acute exposure estimates from dietary consumption of food 
and

[[Page 17016]]

drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
BPG and polyethers 1, 2 and 3 are not expected to pose an acute dietary 
risk.
    2. Chronic dietary risk. A chronic aggregate risk assessment takes 
into account chronic exposure estimates from dietary consumption of 
food and drinking water. No adverse effect resulting from repeated oral 
exposure was identified and no chronic dietary endpoint was selected. 
Therefore, BPG and polyether 1, 2 and 3 are not expected to pose a 
chronic dietary risk.
    3. Short-term 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). BPG and 
polyethers 1, 2 and 3 are 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 to BPG and polyethers 1, 2 and 3.
    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 ranging from 22,000 
to 280,000 for adults (handler only; no dietary exposure). Because 
EPA's level of concern for BPG and polyethers 1, 2 and 3 is an MOE of 
100 or below, these MOEs are not of concern.
    4. Intermediate-term 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). BPG and polyethers 1, 2 and 3 are currently used as an inert 
ingredient in pesticide products that are registered for uses that 
could result in intermediate-term residential exposure, and the Agency 
has determined that it is appropriate to aggregate chronic exposure 
through food and water with intermediate-term residential exposures to 
BPG and polyethers 1, 2 and 3.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs ranging from 22,000 to 280,000 for adults (handler only; 
no dietary exposure). Because EPA's level of concern for BPG and 
polyethers 1, 2 and 3 is a MOE of 100 or below, these MOEs are not of 
concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in the provided studies, BPG and polyethers 
1, 2 and 3 are not expected to pose a cancer risk to humans.
    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 BPG and polyethers 1, 2 and 3 residues.

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). The Codex Alimentarius 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 BPG and polyether 1, 2 and 3.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established under 40 CFR 180.910 and 180.930 for butoxypolypropylene 
glycol (BPG; [alpha]-butyl-v-hydroxy-poly-oxy(methyl-1,2-ethanediyl) 
(CAS Reg. No. 9003-13-8), oxirane, 2-methyl-, polymer with oxirane, 
mono-2-propen-1-yl ether (CAS Reg. No. 9041-33-2; polyether 1), 
poly(oxy-1,2-ethanediyl), [alpha]-acetyl-v-(2-propen-1-yloxy)- (CAS 
Reg. No. 27252-87-5; polyether 2) and poly(oxy-1,2-ethanediyl), 
[alpha]-methyl-v-(2-propen-1-yloxy)- (CAS Reg. No. 27252-80-8; 
polyether 3) when used as an inert ingredient in pesticide formulations 
applied in/on growing crops and raw agricultural commodities pre- and 
post-harvest under and applied to animals.

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 Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In

[[Page 17017]]

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: March 21, 2022.
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.  180.910, amend Table 1 to 180.910 by adding, in 
alphabetical order, the inert ingredients ``Butoxypolypropylene glycol 
(CAS Reg. No. 9003-13-8)''; ``Oxirane, 2-methyl-, polymer with oxirane, 
mono-2-propen-1-yl ether (CAS Reg. No. 9041-33-2)''; ``Poly(oxy-1,2-
ethanediyl), [alpha]-acetyl-v-(2-propen-1-yloxy)- (CAS Reg. No. 27252-
87-5)''; and ``Poly(oxy-1,2-ethanediyl), [alpha]-methyl-v-(2-propen-1-
yloxy)- (CAS Reg. No. 27252-80-8)'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
Butoxypolypropylene glycol (CAS Reg. No.  ..............  ..............
 9003-13-8).............................
 
                              * * * * * * *
Oxirane, 2-methyl-, polymer with
 oxirane, mono-2-propen-1-yl ether (CAS
 Reg. No. 9041-33-2)....................
 
                              * * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-acetyl-
 v-(2-propen-1-yloxy)- (CAS Reg. No.
 27252-87-5)............................
 
                              * * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-methyl-
 v-(2-propen-1-yloxy)- (CAS Reg. No.
 27252-80-8)............................
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930, amend Table 1 to 180.930 by adding, in 
alphabetical order, the inert ingredients ``Butoxypolypropylene glycol 
(CAS Reg. No. 9003-13-8)''; ``Oxirane, 2-methyl-, polymer with oxirane, 
mono-2-propen-1-yl ether (CAS Reg. No. 9041-33-2)''; ``Poly(oxy-1,2-
ethanediyl), [alpha]-acetyl-v-(2-propen-1-yloxy)- (CAS Reg. No. 27252-
87-5)''; and ``Poly(oxy-1,2-ethanediyl), [alpha]-methyl-v-(2-propen-1-
yloxy)- (CAS Reg. No. 27252-80-8)'' to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

                           Table 1 to 180.930
------------------------------------------------------------------------
            Inert ingredients                 Limits           Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Butoxypolypropylene glycol (CAS Reg. No.
 9003-13-8).............................
 
                              * * * * * * *
Oxirane, 2-methyl-, polymer with
 oxirane, mono-2-propen-1-yl ether (CAS
 Reg. No. 9041-33-2)....................
 
                              * * * * * * *
Poly(oxy-1,2-ethanediyl), [alpha]-acetyl-
 v-(2-propen-1-yloxy)- (CAS Reg. No.
 27252-87-5)............................
Poly(oxy-1,2-ethanediyl), [alpha]-methyl-
 v-(2-propen-1-yloxy)- (CAS Reg. No.
 27252-80-8)............................
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 17018]]

[FR Doc. 2022-06327 Filed 3-24-22; 8:45 am]
BILLING CODE 6560-50-P
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