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
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), "Management Standards for Hazardous Waste Pharmaceuticals (Renewal)" (EP...
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.
DATES:
Comments may be submitted on or before September 28, 2026.
ADDRESSES:
Submit your comments, referencing Docket ID No. EPA-HQ-OLEM-2026-5414, to EPA online using
https://www.regulations.gov
(our preferred method), or by mail to: EPA Docket Center, U.S. Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
This is a proposed extension of the ICR, which is currently approved through March 31, 2027. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
This document allows 60 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov
or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit
https://www.epa.gov/dockets.
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate forms of information technology. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another
Federal Register
document to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.
Abstract:
Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. In 2019 EPA promulgated regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors (84 FR 5816, February 22, 2019). Healthcare facilities (for both humans and animals) and reverse distributors now manage their hazardous waste pharmaceuticals under a new set of sector-specific standards in lieu of the existing hazardous waste generator regulations. These regulations are found in 40 CFR part 266, subpart P, and are mandatory. The new requirements include labeling containers holding non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals with the words “Hazardous Waste Pharmaceuticals”. Healthcare facilities and reverse distributors must also track or manage rejected shipments by sending a copy of the manifest to the designated facility that returned or rejected the shipment. Additionally, healthcare facilities and reverse distributors must submit exception reports for a missing copy of a manifest. Reverse distributors are required to amend their contingency plan under 40 CFR part 262, subpart M. A reverse distributor must submit an unauthorized hazardous waste report if it receives waste it is not authorized to receive.
Form numbers:
None.
Respondents/affected entities:
Entities potentially affected by this action are the private sector.
Respondent's obligation to respond:
Mandatory (RCRA section 3001).
Estimated number of respondents:
8,163.
Frequency of response:
Annual.
Total estimated burden:
40,045 hours per year. Burden is defined at 5 CFR 1320.03(b).
Total estimated cost:
$3,580,140 (per year), includes $0 annualized capital or operation & maintenance costs.
( printed page 48101)
Changes in the estimates:
The burden hours are likely to stay substantially the same.
Dated: July 21, 2026.
Andrew Baca,
Director, Office of Resource Conservation and Recovery.