Amendment to the Universal Waste Rule: Addition of Pharmaceuticals (Proposed Rule)

Forms and Documents

Document Name	Status
2324ss01.doc Supporting Statement A	2008-11-24

IC Document Collections

IC ID	Document Title	Status
187392	Addition of Pharmaceuticals - Private Sector	New

ICR Details

OMB Control No: 2050-0200	ICR Reference No: 200812-2050-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: EPA/OLEM	Agency Tracking No: 2324.01
Title: Amendment to the Universal Waste Rule: Addition of Pharmaceuticals (Proposed 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: Comment filed on proposed rule	Conclusion Date: 05/01/2009
	Date Received in OIRA: 12/02/2008
Terms of Clearance: This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is withholding approval for this request at this time. Prior to the publication of the final rule, the agency should provide a summary of all comments related to the information collection and anychanges made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: EPA is proposing to add hazardous pharmaceutical wastes to the existing Universal Waste Rule (UWR) at 40 CFR Part 273. This proposed rule would facilitate better management of pharmaceutical wastes by streamlining the generator requirements and encouraging generators of hazardous pharmaceutical wastes to manage them under the provisions of the UWR, which ensures that these hazardous pharmaceutical wastes are properly disposed of and treated as hazardous wastes. In addition, this proposed rule would facilitate the implementation of pharmaceutical take-back programs, and thus would redirect hazardous and non-hazardous pharmaceutical wastes from municipal solid waste landfills and sewer systems to hazardous waste landfills and incinerators.

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Authorizing Statute(s): US Code: 42 USC 912(a), 6921, 6922, 6924, 6926 Name of Law: Hazardous and Solid Waste Amendments of 1984 (HSWA)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2050-AG39	Proposed rulemaking	73 FR 73520	12/02/2008

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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
Addition of Pharmaceuticals - Private Sector

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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: EPA is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule (UWR). This is expected to improve management of hazardous and non-hazardous pharmaceutical wastes, as well as decreased regulatory burden for many hazardous pharmaceutical waste generators. The increase in burden would result from the need for universal pharmaceutical waste handlers to read the rule that adds hazardous pharmaceutical wastes to the existing UWR. In addition, the large quantity handlers would also be required to maintain records of all universal pharmaceutical waste shipments. The total increase in new annual paperwork requirements in the proposed rule is approximately 960 hours. However, in addition to the new paperwork requirements for respondents, the proposed rule would result in annual respondent burden savings under the existing paperwork requirements (associated with four existing EPA ICRs) of approximately 1,900 hours. Taking both the new proposed and existing RCRA requirements into account, the proposed rule would result in a net reduction in annual paperwork burden of approximately 935 hours.

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Annual Cost to Federal Government: $0

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/02/2008

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