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EPA/SWER

RIN: 2050-AG39

Publication ID: Spring 2009

Title: Amendment to the Universal Waste Rule: Addition of Pharmaceuticals
Abstract: EPA proposed adding hazardous pharmaceutical wastes to the universal waste system. This incorporation is appropriate because, among other reasons, these wastes are produced by a various and vast community of generators, and it has been reported that these wastes are often mismanaged due to generators' unfamiliarity with the Resource Conservation and Recovery Act regulations. EPA expects that the expansion of the universal waste system to include hazardous pharmaceutical wastes will improve protection of public health and the environment by providing a more streamlined but effective waste management system. Due to the simplified requirements, this action may provide regulatory relief for those entities that generate hazardous pharmaceutical wastes able to "opt in" to this alternative management regime. Entities that could opt-in include those in authorized states that have adopted the universal waste rule and amended their programs to include hazardous pharmaceutical wastes. EPA expects the inclusion of hazardous pharmaceutical wastes in the universal waste rule will provide relief in the management of P-listed hazardous pharmaceutical wastes by simplifying current requirements. Also, we expect that the rule will encourage health care personnel to manage other pharmaceutical wastes as universal wastes, particularly wastes that are not regulated as hazardous but which nonetheless may pose hazards. Finally, EPA expects that the addition of hazardous pharmaceutical wastes to the rule may facilitate the collection of household pharmaceutical wastes via pharmaceutical take-back programs.
Agency: Environmental Protection Agency(EPA)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: No	Unfunded Mandates: No
CFR Citation: 40 CFR 260 and 261 40 CFR 264 and 265 40 CFR 268 40 CFR 270 40 CFR 273
Legal Authority: 42 USC 6912(a) 42 USC 6921 to 6924 42 USC 6926 and 6927 42 USC 6930 42 USC 6937

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	12/02/2008	73 FR 73520
NPRM Comment Period Extended	01/30/2009	74 FR 5633
Final Action	To Be Determined

Additional Information: SAN No. 5127; EPA publication information: NPRM - http://edocket.access.gpo.gov/2008/E8-28161.htm; http://www.epa.gov/fedrgstr/EPA-WASTE/2009/January/Day-30/f2033.pdf; EPA Docket information: EPA-HQ-RCRA-2007-0932
Regulatory Flexibility Analysis Required: No	Government Levels Affected: Local, State
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Information URL: http://www.epa.gov/wastes/hazard/wastetypes/universal/pharm.htm
RIN Data Printed in the FR: No
Agency Contact: Lisa Lauer Environmental Protection Agency Solid Waste and Emergency Response 5304P, Washington, DC 20460 Phone:703 308-7418 Fax:703 308-0514 Email: Lauer.Lisa@epa.gov Mark Seltzer Environmental Protection Agency Solid Waste and Emergency Response 5304P, Washington, DC 20460 Phone:703 347-8955 Fax:703 308-0514 Email: seltzer.mark@epa.gov