Management Standards for Hazardous Waste Pharmaceuticals (Final Rule)

Forms and Documents

Document Name	Status
2486ss02.docx Supporting Statement A	2019-02-22

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: 201902-2050-001
Status: Active	Previous ICR Reference No: 201508-2050-002
Agency/Subagency: EPA/OLEM	Agency Tracking No: 2486.02
Title: Management Standards for Hazardous Waste Pharmaceuticals (Final Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/22/2019
	Date Received in OIRA: 02/22/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2022	36 Months From Approved
Responses	13,373	0	0
Time Burden (Hours)	43,577	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 3001 of the Resource Conservation and Recovery Act (RCRA) of 1976, as amended, requires the Environmental Protection Agency (EPA) to identify which solid wastes are hazardous wastes and therefore must be managed as hazardous waste during treatment, storage, or disposal. Under this authority, EPA established four hazardous waste characteristics (toxicity, reactivity, ignitability, and corrosivity), and listed specific wastes that must be managed as hazardous wastes. EPA is revising the regulations to improve management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify regulation of the reverse distribution mechanism used by healthcare facilities for management of unused and/or expired pharmaceuticals. EPA is adding a new subpart P under part 266. This new subpart is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all reverse distributors, regardless of RCRA generator category, will be required to manage hazardous waste pharmaceuticals under this new subpart P of part 266, in lieu of part 262. That is, the final standards are not an optional alternative to managing hazardous waste pharmaceuticals under part 262, they are mandatory standards. Healthcare facilities will have different management standards for their non-creditable and potentially creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals will be managed on-site similar to how they would have been under the 2008 Universal Waste proposal for pharmaceutical waste. When they are shipped off-site, they must be transported as hazardous wastes and sent to a RCRA interim status or permitted hazardous waste facility. On the other hand, healthcare facilities will continue to be allowed to send potentially creditable hazardous waste pharmaceuticals to reverse distributors for verification of manufacturer credit. EPA is finalizing standards to ensure the safe and secure delivery of the potentially creditable hazardous waste pharmaceuticals to reverse distributors. EPA is also finalizing standards for the accumulation of the hazardous waste pharmaceuticals at reverse distributors. The standards regard reverse distributors as a new type of hazardous waste entity called reverse distributors. The key provisions of EPAs final rule are: 1)Hazardous waste pharmaceuticals managed under the new rule are not counted toward a facilitys RCRA generator status; 2) Reverse distributors must comply with LQG-like standards regardless of the quantity of hazardous waste pharmaceuticals that they manage; 3) FDA approved over-the-counter nicotine replacement therapies, such as patches, gums, and lozenges, will no longer by managed as hazardous waste; and 4) Sewer disposal of hazardous waste pharmaceuticals is prohibited.

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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:
2050-AG39	Final or interim final rulemaking	84 FR 5618	02/22/2019

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Federal Register Notices & Comments

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 Approved	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	13,373	0	0	13,373	0	0
Annual Time Burden (Hours)	43,577	0	0	43,577	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The requirements covered in this ICR are for the requirements that healthcare facilities (including retail facilities) and reverse distributors managing hazardous waste pharmaceuticals have under 40 CFR part 266 subpart P. The final rule is expected to result in a reduction in paperwork burden for a subset of facilities. For example, EPA expects that many facilities will be able to operate as very small quantity generators (VSQGs) rather than large quantity generators (LQGs) as a result of the exemption for FDA approved over-the-counter nicotine replacement therapies. However, rather than estimating the burden reduction for the affected facilities under this ICR, EPA estimates the total burden to reverse distributors and healthcare facilities for the paperwork requirements under subpart P. In a separate action, EPA will amend the base Hazardous Waste Generator Standards ICR to reflect the burden reduction that results from this final rule. The burden reduction from the final rule is due to the fact that many facilities will experience a change in generator category from LQG to VSQG, and therefore EPA will amend the base Hazardous Waste Generator ICR to remove the facilities from the universe that are no longer expected to comply with the standards for LQGs.

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Annual Cost to Federal Government: $2,382

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? Uncollected

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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: 02/22/2019

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