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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
12-P-0508
May 25, 2012
Why We Did This Review
We conducted this review to
evaluate the U.S.
Environmental Protection
Agency's (EPA's) process to
identify and appropriately
classify pharmaceuticals as
hazardous waste and to ensure
their safe disposal.
Background
The discovery of a variety of
pharmaceuticals in water has
raised concerns about
potentially adverse
environmental consequences of
these contaminants. Studies
have suggested the detection of
pharmaceutical compounds in
treated wastewater effluent,
streams, lakes, seawater,
drinking water, and
groundwater, as well as in
sediments and fish tissue. EPA
has the authority under the
Resource Conservation and
Recovery Act (RCRA) to
regulate hazardous waste
pharmaceuticals (HWPs) to
ensure safe management and
disposal practices.
For further information, contact
our Office of Congressional and
Public Affairs at (202) 566-2391.
The full report is at:
www.epa.aov/oia/reports/2012/
20120525-12-P-0508.pdf
EPA Inaction in Identifying Hazardous Waste
Pharmaceuticals May Result in Unsafe Disposal
What We Found
Since 1980, EPA has not used its RCRA authority to determine whether
pharmaceuticals may qualify as hazardous waste. EPA also has not established a
process for the regular identification and review of pharmaceuticals that may qualify
for regulation as hazardous waste. Without a regular process, EPA cannot provide
assurance that pharmaceuticals that may pose a hazardous risk to human health and
the environment have been identified. We identified eight chemicals found in
pharmaceuticals that meet EPA's criteria for regulation as acute hazardous waste, but
wastes containing these chemicals are not regulated as such. There are over 100 drugs
that federal occupational safety organizations have identified as hazardous but may
not have been reviewed by EPA to determine whether they may qualify as hazardous
waste. EPA staff stated they have started examining these drugs for listing as
hazardous waste. Further, the state of Minnesota recently noted that there has been a
proliferation of pharmaceutical development since RCRA regulations were
established. Our review has identified a risk that there are unknown but potentially
dangerous unregulated HWPs that may be unsafely disposed and released into the
environment.
An additional challenge to ensuring the safe disposal of HWPs is that some health
care facilities, such as hospitals, may be unaware of federal hazardous waste
regulations. The state of Minnesota, for example, has reported that there is a "general
lack of awareness by the health care industry of RCRA regulatory requirements."
This may result in mismanagement of hazardous waste pharmaceuticals.
In 2008, EPA proposed an amendment to the Universal Waste Rule to address
pharmaceutical wastes. However, no action on the Rule has occurred since the close
of the public comments period in 2009. During our review, EPA staff informed us
that the Agency has decided to develop another proposal for the regulation of
hazardous waste pharmaceuticals at health care facilities. EPA staff stated that "due
to substantial negative public comments received on the 2008 universal waste
proposal, the Agency is developing a revised proposal for regulation of hazardous
waste pharmaceuticals at healthcare facilities." EPA anticipates the proposal will be
available for public comment in spring 2013.
What We Recommend
We recommend that EPA establish a process to review pharmaceuticals for regulation
as hazardous waste and develop an outreach and compliance assistance plan for
health care facilities managing HWPs.

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