Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of Solid Waste Rule; Technical Corrections

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Parts 261, 262, and 266</CFR> <DEPDOC>[EPA-HQ-OLEM-2023-0081; FRL 8687-04-OLEM]</DEPDOC> <RIN>RIN 2050-AH23</RIN> <SUBJECT>Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of Solid Waste Rule; Technical Corrections</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or the Agency) is finalizing five amendments that were withdrawn in its December 6, 2023, partial withdrawal of direct final rule. Due to receipt of adverse comments, the EPA withdrew eight amendments from the August 9, 2023, direct final rule that included revisions to the 2016 Hazardous Waste Generator Improvements Rule, the 2019 Hazardous Waste Pharmaceuticals Rule and the 2018 Vacatur of the Definition of Solid Waste Rule (88 FR 54086). The EPA is responding to the relevant adverse comments in this action. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> This final rule is effective on February 10, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The EPA has established a docket for this action under Docket ID No. EPA-HQ-OLEM-2023-0081. All documents in the docket are listed on the <E T="03">http://www.regulations.gov</E> website. Although listed in the index, some information is not publicly available, <E T="03">e.g.,</E> CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through <E T="03">http://www.regulations.gov.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Kathy Lett, U.S. Environmental Protection Agency, Office of Resource Conservation and Recovery (MC: 5304T), 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-0517, ( <E T="03">lett.kathy@epa.gov</E> ) or Kristin Fitzgerald, U.S. Environmental Protection Agency, Office of Resource Conservation and Recovery (MC: 5304T), 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-0512 ( <E T="03">fitzgerald.kristin@epa.gov</E> ). </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. General Information</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> Entities potentially affected by this action include hazardous waste generators, treatment, storage, and disposal facilities, healthcare facilities, reverse distributors, importers/exporters of hazardous waste, and users of the transfer-based exclusion to the definition of solid waste. Also affected are States and EPA Regions implementing these RCRA hazardous waste regulations. This discussion is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This discussion includes the types of entities that the EPA is now aware could potentially be regulated by this action. Other types of entities not included could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria found in Section IV of the preamble. If you have questions regarding the applicability of this action to a particular entity, consult the persons listed in the <E T="02">FOR FURTHER INFORMATION CONTACT</E> section. <HD SOURCE="HD2">B. What action is the agency taking?</HD> This action finalizes five amendments that were included in its August 9, 2023, direct final rule that made technical corrections to three rulemakings related to the generation of hazardous waste: the 2016 Hazardous Waste Generator Improvements Rule, the 2019 Hazardous Waste Pharmaceuticals Rule, and the 2018 Vacatur of the Definition of Solid Waste Rule (88 FR 54086). Due to receipt of adverse comments, eight amendments were withdrawn in the EPA's December 6, 2023, partial withdrawal of direct final rule (88 FR 84710). EPA has evaluated the comments received on the amendments and is finalizing five of these amendments, found in §§ 261.4(e)(1), 262.16(b)(1), 262.17(a)(8)(i) introductory text, 262.17(a)(8)(i)(A) and 266.508(a)(2)(ii). These five provisions relate to the 2016 Hazardous Waste Generator Improvements Rule and the 2019 Hazardous Waste Pharmaceuticals Rule. Finalizing these technical corrections will correct or clarify the regulations for generators and handlers of hazardous waste. The EPA is also responding in this preamble to the adverse comments on the items that we are finalizing in this action. The three provisions we are not finalizing will not go into effect with this action and the EPA is not responding to the adverse comments on these three provisions. <HD SOURCE="HD2">C. What is the agency's authority for taking this action?</HD> This rule is authorized under sections 1004, 2002, 3001, 3002, 3003, 3004, 3005, 3006, and 3010, of the Resource Conservation and Recovery Act of 1976, as amended, 42 U.S.C. 6903, 6912, 6921, 6922, 6923, 6924, 6925, 6926, and 6930. <HD SOURCE="HD1">III. Background</HD> In the EPA's August 9, 2023, direct final rule (88 FR 54086), EPA explained that the Agency views the minor fixes and clarifications included in the action as noncontroversial. However, EPA published a parallel proposed rule the same day that could serve as the proposed rule to adopt the provisions in the direct final rule if adverse comments were received. EPA stated that in this case, there would not be a second comment period on this action. The direct final rule preamble also stated that if the Agency were to receive adverse comment on any individual correction, we would publish a timely withdrawal in the <E T="04">Federal Register</E> informing the public about the specific regulatory paragraph or amendment that will not take effect. The EPA received adverse comments on eight amendments from the direct final rule and withdrew them on December 6, 2023 (88 FR 84710). All corrections that were not withdrawn became effective on December 7, 2023. <HD SOURCE="HD1">IV. Provisions Being Finalized and Response to Comment</HD> <HD SOURCE="HD2">A. Section 261.4(e)(1)</HD> The August 9, 2023, direct final rule identified a number of regulatory citations that were incorrect and outdated in the regulations for generators of hazardous waste and updated those citations. Section 261.4(e) provides requirements for management of samples used in treatability studies and included citations that needed to be updated. The list of corrections included revising § 261.4(e)(1) to replace the references to quantity determinations in §§ 261.5 and 262.34(d) with a reference to the counting requirements in § 262.13 and the accumulation limits in § 262.16(b)(1). EPA received an adverse comment to this revision. The commenter stated that it appears that the revised citation in this location, which identifies which categories of generators do not need to count treatability sample weight towards generator accumulation limits was incomplete. The comment stated that the revised citation should point to the accumulation limits for very small quantity generators (VSQGs), large quantity generators (LQGs), and satellite accumulation areas (SAAs), not just SQGs. EPA partially agrees with the commenter and is revising this citation to include references to §§ 262.14(a)(3) and (4), the accumulation limits for VSQGs accumulating acute and non-acute hazardous waste. The original language in this section referred to accumulation limits for VSQGs and SQGs and this revision reestablishes those two references. Generators accumulating waste at SAAs must include that waste in their monthly quantities for determining generator status, but the original regulatory language did not refer to the SAA requirements and LQGs do not have an accumulation limit. For these reasons, EPA is not amending the language to add any references to SAA or LQG requirements. <HD SOURCE="HD2">B. Section 262.16(b)(1)</HD> The 2016 Generator Improvements rule established definitions for very small, small, and large quantity generators, reorganized the regulations for these categories of generators, and clearly distinguished the generator categories—determined by how much hazardous waste is generated per calendar month at a site—from the conditions for exemption that specify limits for how much hazardous waste small and very small quantity generators can accumulate on site at any one time. However, the small quantity generator conditions for exemption include an on-site accumulation limit of 6,000 kilograms for non-acute hazardous waste but do not specify an on-site accumulation limit for acute hazardous waste. In the original 1980 hazardous waste generator regulations, there were only two categories of hazardous waste generator: small (generating less than 1,000 kilograms of hazardous waste per month) and large (generating more than 1,000 kilograms of hazardous waste per month). These pre-1986 small quantity generators had a total on-site hazardous waste accumulation limit of 6,000 kilograms of non-acute hazardous waste and one kilogram of acute hazardous waste. The 1986 rule that established the category and specific requirements for those generating between 100 kilograms and 1,000 kilograms per month (small quantity generators) (51 FR 10146; March 24, 1986) implemented the changes to the hazardous waste program required by the Hazardous and Solid Waste Amendments of 1984 (HSWA) and established a new category of “conditionally exempt small quantity generator” for those generating less than 100 kilograms of non-acute hazardous waste per month. The scope of HSWA and the new regulations for conditionally exempt small quantity generators did not include acute h ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 33k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━