Management Standards for Hazardous Waste Pharmaceuticals (Renewal)

Forms and Documents

Document Name	Status
2486ss03.docx Supporting Statement A	2022-03-18

IC Document Collections

IC ID	Document Title	Status
217986	Management Standards for Hazardous Waste Pharmaceuticals	Modified

ICR Details

OMB Control No: 2050-0212	ICR Reference No: 202203-2050-004
Status: Received in OIRA	Previous ICR Reference No: 201902-2050-001
Agency/Subagency: EPA/OLEM	Agency Tracking No: 2486.03
Title: Management Standards for Hazardous Waste Pharmaceuticals (Renewal)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/25/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2022
Responses	8,163	13,373
Time Burden (Hours)	40,045	43,577
Cost Burden (Dollars)	0	0

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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 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 262 Subpart M. A reverse distributor must submit an unauthorized hazardous waste report if it receives waste it is not authorized to receive.

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Authorizing Statute(s): US Code: 42 USC 6901 Name of Law: Resource Conservation and Recovery Act (RCRA)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 56704	10/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 15421	03/18/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Management Standards for Hazardous Waste Pharmaceuticals

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	8,163	13,373	0	0	-5,210	0
Annual Time Burden (Hours)	40,045	43,577	0	0	-3,532	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There is a decrease of 3,532 hours compared to the currently approved ICR due to a decrease in the universe. The universe estimates are based on real data for this renewal.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 03/25/2022

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