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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
0
0
0
0
0
0
0
0
0
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.
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.
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:
(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;
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.
2324ss01.doc
Addition of Pharmaceuticals - Private Sector