Agency Information Collection Activities; Proposed Information Collection Request; Comment Request; Management Standards for Hazardous Waste Pharmaceuticals ICR (Renewal), EPA ICR No. 2486.04, OMB Control No. 2050-0212
Published Date: 7/30/2026
Notice
Summary
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), "Management Standards for Hazardous Waste Pharmaceuticals (Renewal)" (EPA ICR No. 2486.04, OMB Control No. 2050-0212) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described in the SUPPLEMENTARY INFORMATION section. This is a proposed extension of the ICR, which is currently approved through March 31, 2027. This document allows for 60 days for public comments.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Annual paperwork cost to private sector
EPA estimates this information collection affects about 8,163 private-sector respondents and will require a total of 40,045 hours per year and cost $3,580,140 per year. The collection is mandatory under RCRA section 3001 and would recur annually if renewed.
Mandatory labeling for pharmaceutical waste
Healthcare facilities and reverse distributors must label containers holding non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals with the words "Hazardous Waste Pharmaceuticals." This labeling requirement is part of the sector-specific standards in 40 CFR part 266, subpart P.
Manifest and exception-reporting duties
Healthcare facilities and reverse distributors must track or manage rejected shipments by sending a copy of the manifest to the facility that returned or rejected the shipment, and they must submit exception reports when a copy of a manifest is missing. These duties are part of the 40 CFR part 266, subpart P requirements.
Reverse distributors: contingency and unauthorized reports
Reverse distributors must amend their contingency plan under 40 CFR part 262, subpart M and must submit an unauthorized hazardous waste report if they receive waste they are not authorized to receive. These are mandatory requirements under the hazardous waste pharmaceuticals standards.
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