A recent report by the Office of Inspector General has
identified significant deficiencies in U.S. Environmental
Protection Agency's (EPA) regulation of pharmaceuticals that
are hazardous wastes when discarded. In its response to these
findings, the EPA indicated that it expects to propose new
regulations for hazardous waste pharmaceuticals in 2013. The EPA
also concluded that there may be widespread noncompliance in the
health care industry with current hazardous waste regulations.
Health care facilities may consider reviewing their current
management of pharmaceutical waste in light of current laws and the
potential impact of an expanded list of hazardous waste
pharmaceuticals that may soon be expected.
On May 25, 2012, the Office of Inspector General published a
review of regulation of hazardous waste pharmaceuticals (HWP). The
review found that since 1980, EPA has not updated its list of
pharmaceuticals that are considered as hazardous waste when
discarded. Nor has EPA established a process for updating the list
of HWPs. As a consequence, the Inspector General found potentially
hundreds of pharmaceuticals that are not listed but may be HWPs, 11
of which could meet the criteria for acute hazardous waste that has
a lower threshold for regulation. In its response to these
findings, EPA indicated that in Spring 2013 it expects to propose
new regulations governing the handling and disposal of
pharmaceutical waste. There may be steps health care facilities
should consider to prepare for potential changes in HWP
regulations.
Disposal of HWPs is regulated under the Resource Conservation and
Recovery Act (RCRA). Under RCRA, EPA identified 31 pharmaceuticals
as HWPs whereas the National Institute for Occupational Safety and
Health and the Occupational Safety and Health Administration have
identified over 100 drugs as hazardous pharmaceuticals. EPA
regulates listed pharmaceuticals as hazardous waste (H-Listed) or
acutely hazardous waste (P-Listed). The regulatory thresholds for
acute hazardous waste is considerably lower than for H-listed
wastes. For example, facilities generating more than 2.2 pounds of
P-Listed waste in any single month are considered as Large Quantity
Generators, whereas the equivalent threshold for H-Listed waste is
2,200 pounds per month.
In addition to identifying EPA's inaction in identifying HWPs,
the Inspector General also found that EPA has concluded that there
may be widespread noncompliance in the health care industry with
current hazardous waste regulations. For example, a 2004 increase
in enforcement activities in EPA Regions 1 and 2 related to HWPs
led to fines ranging from $40,000 to $250,000 for multiple
facilities not complying with RCRA regulations.
In response to the Inspector General's report, EPA indicated
that it agreed that waste pharmaceuticals is an area in need of
attention and expects to propose new rules in Spring 2013. EPA also
indicated its intent to address the perceived extensive
noncompliance with increased outreach and compliance to assist the
health care industry for the current regulations.
Clearly, the Inspector General's review indicates a potential
for increased regulatory scrutiny on the way health care
organizations manage pharmaceutical waste. Health care facilities
may consider reviewing their current management of pharmaceutical
waste in light of current laws and the potential impact of an
expanded list of HWPs that may soon be expected.
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