5-
<
.sfe.
*viv °
"U PR
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
EPA Inaction in Identifying
Hazardous Waste
Pharmaceuticals May
Result in Unsafe Disposal
Report No. 12-P-0508
May 25, 2012
Scan this mobile code
to learn more about
the EPA OIG.

-------
Report Contributors:	Carolyn Copper
Steve Hanna
Roopa Batni
Tapati Bhattacharyya
Brooke Shull
Abbreviations
BMP	Best Management Practice
EPA	U.S. Environmental Protection Agency
GAO	U.S. Government Accountability Office
HWPs	Hazardous waste pharmaceuticals
NIOSH	National Institute for Occupational Safety and Health
OIG	Office of Inspector General
ORCR	Office of Resource Conservation and Recovery
OSHA	Occupational Safety and Health Administration
OSWER	Office of Solid Waste and Emergency Response
RCRA	Resource Conservation and Recovery Act
UWR	Universal Waste Rule
Cover photo: Examples of pharmaceuticals. (EPA photo)
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
e-mail:	OIG Hotline@epa.gov	write: EPA Inspector General Hotline
phone:	1-888-546-8740	1200 Pennsylvania Avenue NW
fax:	202-566-2599	Mailcode 2431T
online:	http://www.epa.gov/oiq/hotline.htm	Washington, DC 20460

-------
^£Dsrx
• A v
lSi
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.

-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
May 25, 2012
MEMORANDUM
SUBJECT: EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in
Unsafe Disposal
Report No. 12-P-0508
This is our report on the subject evaluation conducted by the Office of Inspector General (OIG)
of the U.S. Environmental Protection Agency (EPA). This report contains findings that describe
the problems the OIG has identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and does not necessarily represent the final EPA position.
Final determinations on matters in this report will be made by EPA managers in accordance with
established resolution procedures.
Action Required
In accordance with EPA Manual 2750, you are required to provide a written response to this
report within 90 calendar days. The recommendations are listed as unresolved because planned
completion dates were not provided. Your response should include a corrective action plan for
agreed-upon actions, including actual or estimated milestone completion dates. Your response
will be posted on the OIG's public website, along with our comments on your response. Your
response should be provided in an Adobe PDF file that complies with the accessibility
requirements of Section 508 of the Rehabilitation Act of 1973, as amended. Please e-mail your
response to Carolyn Copper at copper.carolyn@epa.gov. If your response contains data that you
do not want to be released to the public, you should identify the data for redaction. We have no
objections to the further release of this report to the public.
If you or your staff have any questions regarding this report, please contact Carolyn Copper at
(202) 566-0829 or copper.carolyn@epa.gov, or Steve Hanna at (415) 947-4527 or
hanna. steve@epa. gov.
FROM:
Arthur A. Elkins, Jr.
TO:
Mathy Stanislaus
Assistant Administrator for Solid Waste and Emergency Response

-------
EPA Inaction in Identifying Hazardous Waste
Pharmaceuticals May Result in Unsafe Disposal
12-P-0508
Table of C
Chapters
1	Introduction		1
Purpose		1
Background		1
Scope and Methodology		5
Prior Evaluation Coverage		6
2	EPA Has Not Used Its Authority to Assess and Manage
Potential Hazards of Pharmaceutical Waste		7
EPA Has Not Used Its Hazardous Waste Management Authority		7
Health Care Facilities May be Unaware of Their RCRA Obligations		9
EPA Is Developing a New Pharmaceutical Rulemaking		10
Conclusion		11
Recommendations		11
Agency Response and OIG Evaluation		11
Status of Recommendations and Potential Monetary Benefits		13
Appendices
A Pharmaceuticals Meeting Acute Hazardous Waste Criteria	 14
B Agency Response to Draft Report and OIG Comment	 15
C Distribution	 30

-------
Chapter 1
Introduction
Purpose
The purpose of this review was 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. We addressed the following
questions:
1.	Do EPA's hazardous waste codes appropriately classify pharmaceuticals
as hazardous waste?
2.	What process has EPA established to identify and list new
pharmaceuticals as hazardous waste?
3.	What steps have states taken to identify and regulate additional
pharmaceuticals as hazardous waste?
4.	How will the Universal Waste Rule (UWR) impact the management of
hazardous waste pharmaceuticals (HWPs)? What is the current status of
the rule?
Background
The discovery of a variety of pharmaceuticals in surface, ground, and drinking
waters around the country has raised concerns about the potentially adverse
environmental consequences of these contaminants. Although the effects on
humans are unknown, the U.S. Government Accountability Office (GAO) reports
that some research has demonstrated the potential impact to human health from
exposure to pharmaceuticals found in drinking water, such as antibiotics and those
that interfere with human hormone development. In addition, minute
concentrations of some pharmaceuticals can have detrimental effects on aquatic
species, such as hormonal imbalances leading to feminization and reproductive
problems in fish populations. Studies have suggested the detection of
pharmaceutical compounds in treated wastewater effluent, streams, lakes,
seawater, and groundwater, as well as in sediments and fish tissue. For example,
during 1999 and 2000, the United States Geological Survey conducted a study of
139 streams across the country and detected pharmaceutical compounds in
80 percent of the streams sampled.
In the 2008 proposed universal waste rule, EPA defines a pharmaceutical as any
chemical product, vaccine, or allergenic, not containing a radioactive component,
that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention
of disease or injury in humans or animals. This definition also refers to any
product with the primary purpose of dispensing or delivering a pharmaceutical.
12-P-0508
1

-------
Pharmaceutical waste1 includes expired drugs, personal medications, waste
materials containing excess drugs (syringes, IV bags, tubing, vials, etc.), and
drugs that are intended to be discarded. Generators of hazardous waste
pharmaceuticals (HWPs) include: pharmacies, physicians' and dentists' offices,
outpatient care centers, ambulatory health care services, residential care facilities,
veterinary clinics, and reverse distributors.2 Health care facilities may dispose of
unused pharmaceuticals, especially residues, down the drain (e.g., intravenous
(IV) bags emptied into the sink). According to EPA, for many years, a standard
disposal practice at many health care facilities was to flush unused
pharmaceuticals down the toilet or drain. Although the domestic sewage
exclusion generally allows facilities to flush pharmaceuticals down the drain,
EPA believes that facilities should not dispose of their pharmaceuticals down the
drain.
EPA Definition of Hazardous Waste
Under the Resource Conservation and Recovery Act (RCRA), EPA has the
authority to regulate the generation, storage, transportation, treatment, and
disposal of hazardous waste. Most states have been delegated the primary
responsibility for regulating RCRA hazardous waste. Any facility, such as
hospitals and other health facilities that generate more than 100 kg (220 lbs.) of
hazardous waste per month, or greater than 1 kg (2.2 lbs.) of acute hazardous
waste per month, are subject to RCRA hazardous waste regulations. RCRA
requires that hazardous wastes be transported in approved containers to permitted
hazardous waste disposal facilities by a hazardous waste transporter. RCRA
prohibits disposal of hazardous waste in municipal waste landfills, municipal
incinerators, or medical waste plants.3
EPA's RCRA regulations establish two ways of identifying hazardous waste:
1. Characteristic hazardous waste - A waste may be considered hazardous if
it exhibits one of the four defined characteristics of hazardous waste:
a.	Ignitability - wastes that can readily catch fire and maintain
combustion.
b.	Corrosivity - wastes that are acidic or alkaline (basic).
c.	Reactivity - wastes that readily explode or undergo violent
reactions or react by releasing toxic gases or fumes.
d.	Toxicity - wastes likely to leach dangerous concentrations of toxic
chemicals into groundwater.
1	Under RCRA, EPA does not regulate pharmaceuticals until they are discarded as waste.
2	Reverse distributors are private companies that provide a service to the health care industry by keeping track of
manufacturer unused pharmaceutical reimbursement policies, and thus get health care facilities credit for the
pharmaceuticals prior to sending them off-site for disposal.
3	RCRA excludes hazardous waste generated by households from the definition of hazardous waste.
12-P-0508
2

-------
2. Listed hazardous waste - EPA may also explicitly identify hazardous
wastes through a listing process. Lists of hazardous waste developed by
EPA are:
a.	F-list (wastes from non-specific sources) - hazardous wastes from
certain common industrial and manufacturing processes.
b.	K-list (wastes from specific industries).
c.	P- and U- lists of chemicals - hazardous wastes including specific
unused chemicals. Chemicals are included on the U-list based on
toxicity or other characteristics. Chemicals are included on the
P-list if they are acutely toxic. P-list chemicals are regulated when
generated in lower quantities than U-list chemicals.
P-listed wastes are identified as acute hazardous waste because the waste has been
found to be fatal to humans or animals above certain thresholds/doses. EPA can
regulate a waste as acutely hazardous if it has been shown in studies to have:
•	an oral Lethal Dose 504 toxicity for rats of less than 50 milligrams per
kilogram,
•	an inhalation Lethal Concentration 50 toxicity for rats of less than
2 milligrams per liter, or
•	a dermal Lethal Dose 50 toxicity for rabbits of less than 200 milligrams
per kilogram
EPA also can regulate a waste as acutely hazardous if it is capable of causing or
significantly contributing to an increase in serious irreversible or incapacitating
reversible illness.
Pharmaceuticals can be included on the U-list if they exhibit any of the four
hazardous characteristics described above, or if they contain a toxic constituent
and are capable of posing a "substantial present or potential hazard to human
health or the environment when improperly treated, stored, transported, or
disposed of, or otherwise managed." Toxic constituents identified by RCRA are
chemical compounds or elements which scientific studies show to have toxic,
carcinogenic (i.e., cancer-causing), mutagenic (i.e., causing genetic mutation
which can lead to cancer), or teratogenic (i.e., causing birth defects) effects on
humans or other life forms.
Volume of Hazardous Waste Pharmaceuticals
According to EPA, pharmaceuticals are commonly used for diagnosing, treating,
or preventing an extremely broad range of medical problems and for cosmetic and
lifestyle purposes. HWPs are generated by a large number of facilities from
different sectors across the country. However, estimates of the volume of HWPs
4 The LD50 and LC50 value is a measure of acute toxicity, and indicates the ability of a toxic or poisonous
substance to kill half the population in animal studies after a specified test duration.
12-P-0508
3

-------
may be understated because of EPA's failure to identify any new HWPs since
1980. In addition, volumes may be understated because EPA believes that many
health care facilities, such as hospitals, are unaware of their RCRA reporting
obligations5 for hazardous waste. Further, federal regulations require only large
quantity generators to report their hazardous waste generation types and volumes
to EPA. EPA estimates that hospitals and reverse distributors generate about
15,000 tons of HWPs each year. We note that, by itself, volume is not the only
meaningful measure of the potential HWP problem, as many pharmaceuticals are
toxic at very low concentrations.
EPA's Best Management Practices Guidance for Pharmaceuticals
EPA has taken some action to address concerns about possible effects on human
health and the environment from the release of pharmaceuticals into the
environment. In August 2010, EPA's Office of Water issued a draft guidance
document, Best Management Practices for Unused Pharmaceuticals at Health
Care Facilities. As defined in this guidance, EPA's goal is to keep
pharmaceuticals out of U.S. waters. The guidance recommends best management
practices (BMPs) to be used by health care facilities (e.g., hospitals) to minimize
the release of pharmaceuticals to the environment. EPA identified these BMPs
after:
•	site visits at 12 health care facilities;
•	consulting with over 700 stakeholders, including health care
professionals, government entities, health care industry associations, and
companies that manage unused pharmaceuticals;
•	review of disposal data from 20 hospitals and long-term care facilities
(e.g., nursing homes, assisted living facilities); and
•	review of literature data, reports, and state recommendations.
The guidance describes BMPs that EPA recommends to health care facilities,
long-term care facilities, medical clinics, and doctors' offices, when managing
and disposing of unused pharmaceuticals.
EPA's 2008 Universal Waste Rule Amendment to Address Hazardous
Waste Pharmaceuticals
In December 2008, EPA proposed to add HWPs to the UWR6. The UWR,
originally issued on May 11, 1995, modified RCRA hazardous waste regulations
by establishing a set of streamlined requirements for the collection of certain
widely dispersed hazardous wastes, called "universal wastes." According to
5	Hazardous waste generators producing more than 2,200 pounds of hazardous waste, or more than 2.2 pounds of
acute hazardous waste, in a calendar month must report the waste type and volume to EPA every 2 years. The total
volume of hazardous waste reported in 2009 was approximately 35 million tons.
6	Federal Register: December 2, 2008 (Volume 73, Number 232), Page 73519-73544, at
http://www.epa. gov/fedrgstr/EPA-WASTE/2008/December/Dav-02/f28161 .htm.
12-P-0508
4

-------
EPA, the proposed 2008 rule would facilitate better and environmentally sound
management of pharmaceutical wastes by streamlining the generator requirements
and encouraging generators of HWPs to manage them under the provisions of the
UWR. EPA believed this would ensure that HWPs are properly disposed of and
treated as hazardous wastes. In 2009, EPA summarized comments on the
proposed rule. According to EPA, there was substantial negative comment on the
proposed rule such that the Agency decided that it could not address the
comments without re-proposing a new rule. EPA has recently stated that the
Agency has decided to develop another proposal for health care facility-specific
regulations for the management of hazardous waste pharmaceuticals.
Other Federal Agency Hazardous Drug Lists
The National Institute for Occupational Safety and Health (NIOSH) is the federal
agency responsible for conducting research and making recommendations for the
prevention of work-related injury and illness. NIOSH publishes a List of
Antineoplastic (e.g., chemotherapy) and Other Hazardous Drugs in Health Care
Settings, also referred to as the NIOSH Drug Alert list, listing what it believes
should be handled as hazardous materials. The Occupational Safety and Health
Administration (OSHA) hazard communication standard requires facilities to
identify hazardous drugs that must be handled using special precautions. OSHA
developed a hazardous drug list in the early 1990s and it remains a primary
reference for identifying drugs that should be handled as hazardous waste. OSHA
lists 61 pharmaceuticals on its hazardous drug list and the latest version of the
NIOSH list published in 2010 includes 157 drugs.
Scope and Methodology
We conducted our work from August 2011 to February 2012 in accordance with
generally accepted government auditing standards. Those standards require that
we plan and perform the evaluation to obtain sufficient, appropriate evidence to
provide a reasonable basis for our findings and conclusions based on our
objectives. We assessed whether EPA has a systematic process to identify and
appropriately classify pharmaceuticals as hazardous waste and to ensure their safe
disposal. We believe the evidence obtained provides a reasonable basis for our
findings and conclusions based upon our objectives.
We interviewed program and information technology staff of the EPA Office of
Resource Conservation and Recovery (ORCR), scientists and program staff of the
EPA Office of Research and Development, and staff of the EPA Region 9
Waste Management Division Enforcement. We interviewed state environmental
protection program staff from Minnesota, Washington, and California.
In addition, we interviewed staff from the U.S. Drug Enforcement Agency's
Office of Diversion Control in Washington, DC; and the Director of
PharmEcology, a Waste Management company.
12-P-0508
5

-------
We reviewed EPA and state programs, regulations, and guidance documents
related to HWPs, including EPA's Proposed UWR and BMP guidance. We also
reviewed the following documents to identify potential HWPs and toxicity data:
•	EPA P- and U-lists of hazardous waste.
•	EPA Endocrine Disruptors list.
•	NIOSH Drug Alert list of hazardous pharmaceuticals.
•	OSHA Chemical list and Carcinogen list.
Prior Evaluation Coverage
The following Office of Inspector General (OIG) and GAO reports addressed
issues related to the scope of our review:
•	OIG Report No. 11 -P-0215, EPA 's Endocrine Disruptor Screening
Program Should Establish Management Controls to Ensure More Timely
Results, May 3, 2011.
•	GAO Report No. GAO-11 -346, Environmental Health: Action Needed to
Sustain Agencies' Collaboration on Pharmaceuticals in Drinking Water,
August 8, 2011.
12-P-0508
6

-------
Chapter 2
EPA Has Not Used Its Authority to Assess and
Manage Potential Hazards of Pharmaceutical Waste
Although EPA has the authority under RCRA, it has not added to its regulations
pharmaceuticals that may qualify as hazardous waste since 1980. EPA also has
not established a process for the regular identification and review of
pharmaceuticals that may qualify for regulation. EPA believes many health care
facilities flush HWPs down drains, a potentially harmful disposal method. In
2008, EPA proposed an amendment to the UWR, in part to address health care
facilities' unfamiliarity or confusion with RCRA requirements. However, the rule
has been stalled since 2009 and EPA just recently decided it would develop
another proposal for healthcare facility-specific regulations for the management
of HWPs. Given the proliferation of pharmaceutical development since RCRA
was enacted, EPA inaction on adding to its regulations pharmaceuticals that
qualify as hazardous waste may result in unsafe disposal and releases of
dangerous pharmaceuticals into the environment.
EPA Has Not Used Its Hazardous Waste Management Authority
In 1980, EPA identified approximately 31 chemicals used as pharmaceuticals that
met the RCRA hazardous waste criteria but EPA has not updated its list since that
time. Moreover, EPA has not established a process for the regular identification
and review of pharmaceuticals that may qualify for regulation as HWPs. The
Food and Drug Administration has approved an average of 30 new drugs each
year since 1996. Consequently, RCRA hazardous waste regulations are not
keeping up with drug development and the potential hazards they may pose if
mismanaged and disposed without the necessary protections to human health and
the environment. Without an established process to review pharmaceuticals, EPA
cannot ensure that it has identified pharmaceutical contaminants that may pose a
hazardous risk to human health and the environment.
Many More Drugs Than EPA Has Identified May Be Hazardous
There are more than 100 drugs that NIOSH and OSHA have identified as
hazardous but may not have been reviewed by EPA to determine if they qualify
for hazardous waste regulation. We reviewed both lists and identified eight
chemicals from the NIOSH list of hazardous pharmaceuticals that meet EPA
criteria for regulation as acute hazardous waste, but are not regulated.7 We also
identified three U-list pharmaceuticals that meet P-list criteria based on rat oral
LD50 values.7 Further, we identified at least 21 additional pharmaceuticals with
7 See appendix A for additional details.
12-P-0508
7

-------
LD50 values between 50 and 500 mg/kg, which are within the range of values
found for existing U-list pharmaceuticals.8
According to EPA's 2010 draft guidance, Best Management Practices for Unused
Pharmaceuticals at Health Care Facilities, many health care facilities, such as
hospitals, use the NIOSH list of hazardous materials to identify unused
pharmaceuticals that should be handled similarly to hazardous waste as defined
under RCRA. The draft guidance further states that, although RCRA does not
require facilities to manage NIOSH-listed hazardous materials the same as RCRA
hazardous waste, EPA recommends RCRA guidelines as a BMP for managing
NIOSH-listed hazardous materials. Drugs considered hazardous by the NIOSH
definition include those that exhibit characteristics in humans or animals, such as
carcinogenicity (cancer-causing), reproductive toxicity, organ toxicity at low
doses; and structure and toxicity profiles of new drugs that mimic existing drugs
determined hazardous by the above criteria. There are 157 drugs identified on the
NIOSH Drug Alert list that NIOSH recommends handling as hazardous materials
to avoid occupational exposure. These include chemotherapy drugs, hormones
(e.g., estrogens), and antibiotics.
In comments to EPA on EPA's August 2010 guidance document, Best
Management Practices for Unused Pharmaceuticals at Health Care Facilities, the
state of Minnesota noted that because EPA has not reviewed any pharmaceuticals
for regulation as hazardous waste since the promulgation of RCRA regulations
(i.e., 1980), some dangerous pharmaceuticals are not subject to more rigorous
regulation as hazardous or acute hazardous waste. Specifically, the state said:
The proliferation of pharmaceutical development since the
promulgation of RCRA regulations, coupled with the absence of
any updates to the U- or P-lists, results in some extremely
dangerous pharmaceutical waste (e.g., chemotherapeutic drugs) not
being listed or characteristic once fully evaluated, while other
pharmaceutical waste (e.g., warfarin and nicotine) that is much less
hazardous in finished drug form is regulated as acutely toxic waste.
The fact that there is still no federal mandatory waste management
regulation for most chemotherapy drugs is alarming. Encouraging
health care facilities to manage NIOSH hazardous drugs as
hazardous waste does not adequately address the danger.
In addition, in its comments on EPA's 2008 UWR amendment, the state of
Minnesota also reflects the problem with not having a regular process to evaluate
pharmaceuticals for hazardous waste regulation. Specifically, the state said:
The P-List of hazardous waste is out-of-date to the extent that it is
largely irrelevant with regard to currently used pharmaceuticals
8 This potentially defines possible candidate U-list pharmaceuticals. U-listing requires additional justification
beyond an LD50 value.
12-P-0508
8

-------
and hence currently generated pharmaceutical waste. Many of the
hazardous pharmaceuticals that are listed on either the P-List or
U-List are no longer in common use. At the same time, a plethora
of new, more toxic pharmaceuticals are not listed at all, despite the
fact that they are being generated in a wide variety of health care
facilities.
Health Care Facilities May be Unaware of Their RCRA Obligations
EPA has learned, from its communication with stakeholders, and stated in its cost-
benefit analysis of the 2008 Universal Waste proposed rule, that "many healthcare
facilities have been unable to comply with the RCRA hazardous waste regulations
as they relate to hazardous pharmaceutical wastes and often manage these wastes
improperly."9 According to EPA, health care workers, retail pharmacy employees,
and other pharmaceutical generators are often unfamiliar with or confused by
RCRA hazardous waste management requirements, prompting them to
improperly dispose of hazardous pharmaceuticals as municipal or bulk wastes.
Outreach and enforcement efforts undertaken in Minnesota and Washington have
indicated that confusion and a lack of awareness exist among health care
facilities, such as hospitals, regarding the applicability of RCRA regulations to
their pharmaceutical wastes. EPA also acknowledges that many health care-
related facilities are unaware of their RCRA obligations, or, even if there is
knowledge of RCRA, they have problems training workers to properly manage
hazardous wastes. ORCR staff informed us that they could implement outreach
activities to assist with education and compliance. However, at this time, EPA
does not have a comprehensive outreach and compliance assistance plan for
HWPs that states can use to improve RCRA compliance.
Improper Management of Pharmaceuticals in Health Care Facilities
State environmental agencies in Minnesota and Washington have conducted
outreach and enforcement activities in response to confusion and unfamiliarity
among the health care industry about RCRA rules for HWPs. For example, the
Minnesota Pollution Control Agency developed a Health Care Initiative in 2002
to address widespread noncompliance with RCRA regulations. They began with
an outreach program that provided training to the health care industry, followed
by inspections and enforcement. From 2004 to 2007, they identified 2 million
pounds of pharmaceuticals that had been properly managed as a result of
compliance and enforcement activities. The Washington Department of Ecology
created enforcement guidance and conducted outreach activities to educate
hospitals about proper disposal of pharmaceutical wastes. These outreach efforts
were in response to hospitals' requests for clarification on how to identify and
manage HWPs, particularly controlled substances.
9 Assessment of the Potential Costs, Benefits, and Other Impacts of Adding Pharmaceuticals to the Universal Waste
Rule, as Proposed. EPA-HQ-RCRA-2007-0932-0010, October 2008, page 1.
12-P-0508
9

-------
In addition, EPA Regions 1 and 2 have increased enforcement activities related to
improper disposal of hazardous pharmaceuticals. In 2004, Region 1 notified
250 hospitals in New England of its intention to enforce hazardous waste laws for
health care facilities. In 2003 and 2004, Region 2 identified violations at health
care facilities, leading to fines ranging from $40,000 to $280,000. In 2010, five
hospitals and nursing homes were cited by the New York Attorney General for
failure to properly identify, track, and dispose of pharmaceuticals and other
wastes defined as hazardous waste under RCRA.
EPA Is Developing a New Pharmaceutical Rulemaking
In 2008, EPA proposed an amendment to its 1995 UWR to provide a system for
disposing HWPs that is protective of public health and the environment. The
proposed rule was aimed at streamlining the current regulations governing HWPs
to ensure that larger quantities of these wastes are managed properly. By March
2009, EPA staff stated they had received approximately 100 stakeholder
comments on the rule. Stakeholders commenting on the proposal expressed
concerns over the lack of notification and tracking requirements for facilities that
handle and transport universal pharmaceutical wastes. According to EPA,
generators of HWPs also have expressed concerns related to making hazardous
waste determinations, changes in generator status resulting from generation of
acutely hazardous waste, regulation of additional pharmaceuticals as RCRA
hazardous waste, and accumulation time limits.
Shortly after receiving and reviewing public comments in 2009, EPA determined
that the 2008 UW proposal could not be used as a basis for a final rule that would
address commenters' concerns. In the response to the draft report (see Appendix
B) ORCR staff said that in the fall of 2010, they began developing a new proposal
for the health care industry for managing hazardous waste pharmaceuticals.
ORCR staff further stated that in September of 2011 the Agency completed Early
Guidance, the first of three major milestones in its rule development process, and
completed Option Selection, the second milestone, in April of 2012. They
acknowledged that there are issues not properly addressed within the current
version of the proposed rule and are working to identify areas that need to be
addressed in the future version of the rule. Until a rule is finalized, concerns
raised by pharmaceutical waste generators related to identification and
management of hazardous pharmaceuticals, generator status, and accumulation
time limits remain unresolved. EPA has recently stated on its UWR website that
"the Agency has decided to develop another proposal for health care facility-
specific regulations for the management of hazardous pharmaceutical wastes in
order to provide a regulatory scheme that addresses the unique issues that
hospitals, pharmacies and other health care-related facilities face. It is anticipated
that the proposal will be available for public comment in Spring 2013." EPA has
also included updated information on the UWR status in the EPA Fall 2011
Regulatory Agenda.
12-P-0508
10

-------
Conclusion
For more than 30 years, EPA has not used its RCRA authority to determine
whether pharmaceuticals may qualify as hazardous waste. This may mean some
drugs are disposed and managed in ways that are not safe for humans and the
environment. EPA's belief that there is widespread noncompliance in the health
care industry with RCRA hazardous waste regulations further compounds the
potential risks to human health and the environment from unregulated HWPs. In
addition, the idle status of EPA's rule to improve management of HWPs, coupled
with its primary reliance on "best management practices" to ensure human health
and environmental protection, represent small steps in an environment where
hundreds of pharmaceutical products are widely used throughout the nation.
EPA has recently published its intent to develop another proposal to address the
management of pharmaceutical wastes at health care facilities. Over 100 drugs
have been identified by other federal agencies as hazardous pharmaceuticals,
whereas EPA has identified 31 hazardous pharmaceutical compounds. If EPA's
hazardous waste rules do not keep up with new drug development or ensure that
regulated entities understand and comply with their obligations, uncertainties
about human health and environmental risks from hazardous pharmaceuticals are
likely to grow.
Recommendations
We recommend the Assistant Administrator for Solid Waste and Emergency
Response:
1.	Identify and review existing pharmaceuticals to determine
whether they qualify for regulation as hazardous waste.
2.	Establish a process to review new pharmaceuticals to
determine whether they qualify for regulation as hazardous
waste.
3.	Develop a nationally consistent outreach and compliance
assistance plan to help states address challenges that health
care facilities, and others as needed, have in complying with
RCRA regulations for managing HWPs.
Agency Response and OIG Evaluation
We reviewed the Office of Solid Waste and Emergency Response's (OSWER's)
comments and made changes to the report as appropriate. Appendix B provides
the full text of OSWER's response and the OIG's comments.
12-P-0508
11

-------
OSWER does not clearly agree or disagree with recommendations 1 and 2, and
agrees with recommendation 3. In its response to recommendation 1, OSWER
agrees that pharmaceuticals are a category of chemicals that need attention and
stated that it has recently completed a research effort to identify and evaluate new
and existing pharmaceuticals for potential addition to the lists of regulated
hazardous wastes. In its response to recommendation 2, OSWER states that it will
consider the next steps it can take when it completes actions on recommendation 1.
OSWER acknowledges that the next steps could include activities consistent with
OIG recommendation 2. We will continue to recommend that EPA adopt a process
to review new pharmaceuticals to determine whether they qualify for regulation as
hazardous waste, because listing of hazardous waste is integral to the RCRA
program.
All recommendations are listed as unresolved. In its 90-day response to this
report, EPA should indicate agreement or disagreement with recommendations 1
and 2 and include a detailed corrective action plan with estimated milestone dates
for all recommendations.
12-P-0508
12

-------
Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Planned
Completion
Action Official	Date
Identify and review existing pharmaceuticals to
determine whether they qualify for regulation as
hazardous waste.
Establish a process to review new pharmaceuticals
to determine whether they qualify for regulation as
hazardous waste.
Develop a nationally consistent outreach and
compliance assistance plan to help states address
challenges that health care facilities, and others as
needed, have in complying with RCRA regulations
for managing HWPs.
Claimed
Amount
Ag reed-To
Amount
Assistant Administrator
for Solid Waste and
Emergency Response
Assistant Administrator
for Solid Waste and
Emergency Response
Assistant Administrator
for Solid Waste and
Emergency Response
1 0 = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is unresolved with resolution efforts in progress
12-P-0508
13

-------
Appendix A
Pharmaceuticals Meeting
Acute Hazardous Waste Criteria
Pharmaceutical
P/U code
Rat Oral LD50 (mg/kg)
NIOSH-listed hazardous pharmaceuticals not listed as EPA hazardous waste
Carmustine
None
20
Cisplatin
None
25.8
Colchicine
None
26
Dactinomycin
None
7.2
Mechlorethamine
None
10
Oxytocin
None
20.52
Thiotepa
None
23
Vinorelbine tartrate
None
26
P-listed RCRA hazardous waste pharmaceuticals
Arsenic trioxide
P012
14.6
Epinephrine
P042
30
Nicotine
P075
50
Nitroglycerin
P081
105
Phentermine
P046
Rat oral LD50 not found
Physostigmine
P204
4.5
Physostigmine
salicylate
P188
Rat oral LD50 Not found
Warfarin >0.3%
P001
1.6
U-listed RCRA hazardous waste pharmaceuticals with P-level LD50 values
Melphalan
U150
11.2
Mitomycin C
U010
30
Uracil mustard
U237
3.55
Source: OIG analysis. Rat oral LD50 values were obtained from toxicity data at the National Library
of Medicine ChemlDPIus Advanced website. The value for Vinorelbine tartrate was obtained from
an Internet Material Safety Data Sheet, and Colchicine was obtained from a Food and Drug
Administration abstract. The NIOSH chemicals listed are those we could identify that meet EPA's
criteria for regulation as acute hazardous waste but are not regulated.
12-P-0508
14

-------
Appendix B
Agency Response to Draft Report
and OIG Comment
MEMORANDUM
SUBJECT: Response to the Office of Inspector General Draft Audit Report, EPA
Inaction in Identifying Hazardous Pharmaceutical Waste May Result in
Unsafe Disposal
FROM: Mathy Stanislaus
Assistant Administrator
TO:	Elizabeth Grossman
Acting Assistant Inspector General for Program Evaluation
Office of Inspector General
Thank you for the opportunity to review and respond to the Office of Inspector General
(OIG) draft audit report, EPA Inaction in Identifying Hazardous Pharmaceutical Waste May
Result in Unsafe Disposal. The purpose of this memorandum is to transmit the Office of Solid
Waste and Emergency Response's (OSWER) response to the OIG draft report and its
recommendations. This memorandum addresses the report's recommendations; Attachment 1
provides detailed comments on the report.
Before responding to the recommendations, however, I would like to provide some
background on the Resource Conservation and Recovery Act (RCRA) hazardous waste
identification regulations. This serves as context for the issue that you have raised on
pharmaceuticals. The basic RCRA waste identification regulations were first established in 1980.
Major revisions were made in response to the Hazardous and Solid Waste Amendments (HSWA)
of 1984. We added additional listings of hazardous wastes required under HSWA for wastes
from specific sources; the final listing was completed in 2005. In 1990 we revised the Toxicity
Characteristic, also in response to a HSWA directive. Since that time, new technologies, such as
nanotechnology and biotechnology, and new and modified organic and inorganic chemicals are
constantly being developed, generating new wastes that may pose risks when disposed of.
Resources to evaluate new waste streams and regulate them appropriately are increasingly
limited. Within these limitations, however, we are working to address those that most need
attention.
12-P-0508
15

-------
OIG RECOMMENDATIONS AND OSWER RESPONSES
OIG Recommendation 1: Identify and review existing pharmaceuticals to determine whether
they qualify for regulation as hazardous waste.
OSWER Response 1:
OSWER agrees that pharmaceuticals are a category of chemicals that need attention and
has recently completed a research effort to identify and evaluate new and existing
pharmaceuticals for potential addition to the lists of regulated hazardous wastes.
To make the best use of our very limited resources, we have prioritized our work in a
number of ways. First, we focused on pharmaceuticals that had been identified as chemicals of
concern in processes designed to identify pharmaceuticals of high risk already conducted by
other federal agencies. We used lists developed by the National Institute for Occupational Safety
and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA).10 Second,
we gathered readily available existing toxicological information about these pharmaceuticals.
Third, we compared the existing available information to the defined regulatory standard for
identifying acutely hazardous waste. The work that we conducted and the results we found were
similar to the research recently done by your staff as part of your investigation and presented in
the Appendix to your report.
OSWER is now reviewing the results of this project and deciding on next steps that could
be completed within available resources to address identified potential risks from disposal of
pharmaceuticals. (See Attachment for further discussion regarding the listing of hazardous waste
pharmaceuticals.) Possible next steps range from taking no action to potential regulatory
considerations. We caution that, due to limited resources, the work we have conducted is narrow
in scope and has a number of limitations. As we evaluate next steps, we will consider whether
and how these limitations could be addressed with available resources.
OIG Response: OSWER does not clearly agree or disagree with this recommendation.
However, OSWER agrees that pharmaceuticals are a category of chemicals that need attention
and stated that it has recently completed a research effort to identify and evaluate new and
existing pharmaceuticals for potential addition to the lists of regulated hazardous wastes. In its
90-day response to the final report, OSWER should agree or disagree with the recommendation,
and, as appropriate, provide actual or estimated milestone completion dates for actions to
respond to this recommendation. In addition OSWER should provide a complete description of
its corrective action plan for this recommendation. This recommendation will be designated as
unresolved in the final report.
OIG Recommendation 2: Establish a process to review new pharmaceuticals to determine
whether they qualify for regulation as hazardous waste.
111 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2010 (157 drugs) and OSHA
Technical Manual, Section VI, Chapter 2, Appendix VL2-1 Some Common Drugs Considered Hazardous (61
drugs).
12-P-0508
16

-------
OSWER Response 2:
As part of OSWER's decision on next steps as discussed in Response 1, we will consider
the appropriate next steps to take given significant resource constraints and competing priorities.
The next steps to be considered could include a process to review newly developed
pharmaceuticals.
OIG Response: OSWER's response to recommendation 2 is linked to its response on
recommendation 1, which OSWER does not clearly agree or disagree with. OSWER states that it
will consider the next steps it can take when it completes actions on recommendation 1. OSWER
acknowledges that the next steps could include activities consistent with OIG recommendation 2.
We continue to recommend that EPA adopt a process to review new pharmaceuticals to
determine whether they qualify for regulation as hazardous waste, because listing of hazardous
waste is integral to the RCRA program. As stated in EPA's RCRA Orientation Manual, "Proper
hazardous waste identification is essential to the success of the RCRA program." This
recommendation will be designated as unresolved in the final report. In its 90-day response to the
report, EPA should indicate agreement or disagreement with recommendation 2, and, as
appropriate, provide estimated milestone completion dates for agreed-to corrective actions along
with a description of the corrective action plan.
OIG Recommendation 3: Develop a nationally consistent outreach and compliance assistance
plan to help states address challenges health care facilities, and others as needed, have in
complying with RCRA regulations for managing HPWs.11
OSWER Response 3:
OSWER agrees with the recommendation. Our response includes three planned phases: 1)
continue ongoing outreach and compliance assistance for the current regulations; 2) propose
revisions to RCRA regulations to more effectively address hazardous waste pharmaceuticals in
the health care sector; and 3) as we do for all new rules, develop a communications plan detailing
outreach efforts to implement the new regulations.
• Phase 1: We note that OSWER and the Office of Enforcement and Compliance
Assurance (OECA) have already done a great deal of work to assist states and the
regulated community with implementation of and compliance with the current RCRA
regulations for hazardous waste pharmaceuticals. Examples are listed below. Within
available resources, we will continue these kinds of outreach and compliance assistance
efforts for the current regulations.
1. Healthcare Environmental Resource Center (HERC) - HERC provides
compliance assistance and pollution prevention information to the healthcare
sector. It is funded by OECA's Office of Compliance, managed by the Office of
Chemical Safety and Pollution Prevention, and OSWER provides technical
expertise on RCRA. HERC offers compliance assistance to healthcare facilities
11 Hazardous pharmaceutical waste.
12-P-0508
17

-------
and veterinarians, and a center devoted to dentists is currently being developed.
(http://www.hercenter.org)
2.	"Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities
in the United States" (The Blueprint) - The Blueprint provides hospitals a step-by-
step guide for developing and implementing a comprehensive pharmaceutical
waste management program. While the most recent version (revised August 2008)
was funded by HERC, the original Blueprint (April 2006) was funded by OSWER
and managed by EPA Region 1. The Office of Resource Conservation and
Recovery Staff (ORCR) staff reviewed and provided comments on both versions.
(http://practicegreenhealth.org/sites/default/files/upload-
files/pharmwasteblueprint.pdf)
3.	Development of healthcare-specific memoranda: Through guidance memoranda,
OSWER has addressed various healthcare-specific pharmaceutical waste issues
that have been raised by the regulated community. For example, most recently, in
November 2011,ORCR issued guidance for managing containers that held P-
listed pharmaceuticals, most commonly warfarin and nicotine. The guidance
outlined several approaches generators may be able to use to address this issue. In
particular, the EPA pointed out that only the weight of the residue in the container
counts towards the generator status and that the container itself is not a hazardous
waste. This guidance has been very well received by the industry.
4.	Outreach: OSWER maintains close communication with stakeholders on these
issues and has made numerous presentations on pharmaceutical waste issues,
including updates on the pharmaceutical rulemaking, at conferences and webinars
hosted by the regulated community and by EPA.
•	Phase 2: As noted in your report, we are in the process of developing major revisions to
the hazardous waste regulations to make them more effective for the health care sector
and the hazardous waste pharmaceuticals they generate. This step will help states with
implementation and the regulated community with compliance with the RCRA
regulations for hazardous waste pharmaceuticals. Our current plans anticipate publication
of a proposed rule in March 2013.
•	Phase 3: As we do for all new rules, as we complete the revisions to the regulations,
OSWER will develop a communications plan detailing outreach steps to assist states with
adoption and implementation of the new regulations and to assist the regulated
community with learning about and coming into compliance with the new regulations.
OIG Response: OSWER agrees with recommendation 3. OSWER is taking steps to
communicate with health care facilities to assist compliance with RCRA regulations for
managing HWPs. The activities described meet the intent of the recommendation. However,
because estimated or actual milestone dates were not included, this recommendation will be
listed as unresolved in the final report. In its 90-day response to the report, EPA should provide
estimated or actual completion dates for the milestones.
12-P-0508
18

-------
OSWER welcomes the opportunity to continue working with OIG to implement these
recommendations and to strengthen its hazardous waste identification program. If you have any
questions, please contact Suzanne Rudzinski, in the Office of Resource Conservation and
Recovery, at (703) 308-8895.
Attachment
12-P-0508
19

-------
ATTACHMENT
EPA Comments on OIG February 29,2012 Draft Report EPA Inaction in Identifying
Hazardous Pharmaceutical Waste May Result in Unsafe Disposal
GENERAL COMMENT REGARDING HAZARDOUS WASTE IDENTIFICATION
The report does not appear to fully appreciate the complexities of listing a chemical as a commercial
chemical product. The report says (page 3):
P and U lists of chemicals - hazardous wastes including specific unused chemicals. Chemicals are
included on the U list based on toxicity and characteristics. Chemicals are included on the P list if
they are acutely toxic. P list chemicals are managed more stringently than U list chemicals.
The report correctly cites the criteria for listing chemicals as P-listed waste. However, the description for U-
listed chemicals is much too simplified and does not fully delineate the process for listing a chemical on the
U-list. The report states (pages 3 and 7 - 8):
Pharmaceuticals can be included on the U list if they exhibit any of the hazardous characteristics
described above, or if they contain a toxic constituent and are capable of posing a "substantial
present or potential hazard to human health or the environment when improperly treated, stored,
transported, or disposed of, or otherwise managed."
Further, we identified at least 21 additional pharmaceuticals with LD50 values between 50 and 500
mg/kg, which are within the range of values found for existing U-list pharmaceuticals.8
8 This potentially defines possible candidate U-list pharmaceuticals. U-listing requires additional
justification beyond an LD50 value.
In fact, the process for listing chemicals on the U-list is not a matter of simply comparing LD50 values.
Therefore, the results provided in the report using such a comparison are not meaningful. As the report
itself noted (page 3), unless a pharmaceutical exhibits any of the hazardous characteristics, listing a
chemical on the U-list requires that the Agency demonstrate that the chemical poses a "substantial present
or potential hazard to human health or the environment" when improperly managed. The regulations for this
listing approach are set out in 40 CFR 261.11 (a)(3). These regulations specify a number of factors that
must be considered, including:
•	the toxicity and concentrations of the hazardous constituents in the waste,
•	the quantity of the waste generated,
•	the potential for the constituents to migrate, persist, and bioaccumulate in the environment,
•	any cases of environmental damage from improper management, and
•	plausible types of management of the waste.
For all recent listings, EPA has used risk assessment tools to assess potential risks from waste
management to encompass most of these factors. Furthermore, whether a waste is listed or not depends to
a great degree on how the waste is being managed. That is, the waste must present a "substantial" hazard
12-P-0508
20

-------
based on "plausible" management practices. Therefore, while the inherent toxicity of a chemical in a waste
is important, the other factors in 261.11(a)(3) must be considered in evaluating a chemical for listing as a
U-list hazardous waste. This type of assessment requires a large amount of information about a waste, and
listing a waste using these criteria requires a significant effort and resources.
OIG Response: The OIG acknowledges the potential complexity beyond LD50 values for
U-listed waste. The report specifically states criteria for U-listing in EPA Definition of
Hazardous Waste Chapter 1 pages 2-3, and also states in Chapter 2 footnote 8 page 8 that Tr-
usting requires additional justification.
SPECIFIC COMMENTS
Entire report:
1. When referring to wastes that are currently identified by RCRA regulation as hazardous waste,
recommend using the term "Hazardous Waste Pharmaceutical" (HWP) instead of "Hazardous
Pharmaceutical Waste" (HPW). Because "hazardous waste" is a specific regulatory phrase, it is
clearer to use it directly in the term. Also recommend using another term, such as "non-regulated
pharmaceutical waste" for discarded pharmaceuticals that may be of concern, but are not currently
regulated under RCRA. This would clarify whether the text is referring to RCRA-regulated or non-
regulated pharmaceutical wastes.
OIG Response: The term "Hazardous Pharmaceutical Waste (HPW)" has been changed in the
report to "Hazardous Waste Pharmaceutical (HWP)" as requested by OSWER. We note that this
represents a recent change, as HPW was used in prior EPA publications such as the 2008
proposed universal waste rule and the 2010 draft Guidance Document: Best Management
Practices for Unused Pharmaceuticals at Health Care Facilities. HWP was most recently used
in OSWER's Management Standards for Hazardous Waste Pharmaceuticals published in the
Fall 2011 Regulatory Agenda. However, we note that OSWER continues to use the term
"hazardous pharmaceutical wastes" in recent updates to its UWR website. We suggest that
OSWER consistently use "hazardous waste pharmaceuticals" in all future publications. The
report uses "unregulated HWP" to refer to pharmaceutical wastes not currently regulated by
RCRA, instead of "non-regulated pharmaceutical waste."
2. Recommend using the term "active pharmaceutical ingredients (APIs)" when discussing chemicals
in the environment since environmental analysis tests for individual APIs.
OIG Response: This change will not be incorporated, as it would add unneeded complexity to
the terminology of the report.
12-P-0508
21

-------
At a Glance:
3. Background, left-hand column, 2nd sentence: Add drinking water to the list of types of water where
APIs are found.
OIG Response: "Drinking water" added as suggested.
4. Background, left-hand column: When discussing APIs in water it is important to note that: 1) While
improper disposal of drugs contributes to the presence of APIs in our nation's waters, other
contributions include excretion and pass-through from POTWs; and 2) Available studies identify
very few APIs in water that are regulated hazardous wastes.
OIG Response: This point will not be added to the Background in the At a Glance section. The
additional level of detail is not appropriate for this section, which is intended to provide a
snapshot of what the report is about.
5. "What We Found," 1st paragraph, 5th sentence: For accuracy, revise to read "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, unless they exhibit a
characteristic."
OIG Response: The important point in this statement is that these pharmaceuticals have not
been specifically identified by EPA for regulation as acute hazardous waste even though they
meet the toxicity criteria. "As such" added to the end of the sentence for clarification.
6.	"What We Found," 1st paragraph, 6th sentence: For accuracy, revise to read 'There are over 100
drugs that federal occupational safety organizations have identified as hazardous but have only
recently been reviewed by EPA to determine whether they may qualify as hazardous waste. As a
result of comments received on the proposed rule for pharmaceutical wastes, EPA started an
examination of the lists from OSHA and NIOSH for potential candidates for listing as commercial
chemical products. EPA found that relatively few of them would meet the criteria for listing as acute
hazardous waste under the commercial chemical product listings (40 CFR 261.33(e)), similar
results to those found by the OIG in its work for this study."
OIG Response: No change was made because the referenced sentence is accurate as written.
A new sentence was added to acknowledge EPA's stated efforts: "EPA staff stated they have
started examining these drugs for listing as hazardous waste."
7.	"What We Found," 2nd paragraph, 3rd sentence: Delete and replace with "This may result in
mismanagement of hazardous waste pharmaceuticals." Note: RCRA regulations generally allow
drain disposal of HW. The domestic sewage exclusion of 40 CFR 261.4(a)(1)(ii) is designed to
avoid duplicative regulation under the Clean Water Act and RCRA and thus defers coverage of
domestic sewage to the Clean Water Act regulations.
12-P-0508
22

-------
OIG Response: Sentence changed as suggested.
8.	"What We Found," 3rd paragraph: Delete 2nd sentence.
OIG Response: No change was made. The sentence states that no action has occurred on the
2008 UWR since 2009. EPA states in the Fall 2011 Regulatory Agenda, ".. EPA is considering
re-proposing healthcare facility-specific regulations for the management of hazardous
pharmaceutical wastes..but no specific action has yet been taken.
9.	"What We Found," 3rd paragraph, 3rd sentence: For accuracy, revise to read "EPA staff informed us
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."
OIG Response: Sentence modified to incorporate this comment.
Table of Contents:
10.	Suggest including the word "findings" in the title of Chapter 2 for clarity.
OIG Response: No change was made. This is an editorial comment and it is our opinion that the
title is an appropriate description of the contents of the chapter.
Chapter 1:
11.	Page 1, Background, 2nd sentence: Add a clarifying footnote at the end of the sentence to read
"Note: very few, if any antibiotics and endocrine disrupters are HWP. In addition, they do not meet
the current hazardous waste listing/characteristic criteria."
OIG Response: No change was made. This statement in the report is an accurate summary of
statements in the GAO report, Environmental Health: Action Needed to Sustain Agencies'
Collaboration on Pharmaceuticals in Drinking Water, August 2011. Further, EPA provides no
evidence for the statement that "few, if any antibiotics and endocrine disrupters are HWP."
12.	Page 1, Background, 3rd and 4th sentences: Recommend providing references to sources for
information presented about detrimental effects of pharmaceuticals on aquatic species, etc.
OIG Response: These statements are based on information in the EPA Health Services Industry
Study Management and Disposal of Unused Pharmaceuticals (Interim Technical Report) August
2008; and the GAO report, Action Needed to Sustain Agencies' Collaboration on
Pharmaceuticals in Drinking Water, August 2011.
13.	Page 1, Background, 2nd paragraph, 1st sentence: Replace definition of pharmaceutical, or explain
the source of this definition. At this time, EPA does not have a formal definition of pharmaceutical.
EPA proposed a regulatory definition of pharmaceutical in the 2008 proposal, but since the rule
12-P-0508
23

-------
was not finalized, that definition is not in place. FDA may have a definition that would serve the
purpose.
OIG Response: This definition is from the 2008 proposal. "In the 2008 proposed universal
waste rule," added for clarity.
14. Page 1-2, Background, last sentence: For clarity, revise to read "A Pharmaceutical becomes a
waste when a decision is made to dispose of it. This can include unused but expired drugs (e.g.,
personal medications) and waste materials containing excess drugs, such as syringes, IV bags,
tubing, vials, etc."
OIG Response: No change was made. Footnote 1 specifies that EPA does not regulate
pharmaceuticals until they are discarded as waste, which is when a decision is made to dispose of
them.
15. Page 1, Footnote 1: Revise to read "Under RCRA, EPA can not regulate pharmaceuticals until a
decision is made to dispose of it."
OIG Response: No change was made. Footnote 1 specifies that EPA does not regulate
pharmaceuticals until they are discarded as waste, which is when a decision is made to dispose of
them.
16. Page 2, Footnote 2: To incorporate information provided by public commenters on the 2008
proposed rule, revise to read "Reverse distributors are private companies that provide a service to
the health care industry by determining credit eligibility on returned pharmaceuticals and by
facilitating the receipt of proper credit."
OIG Response: The definition of distributors was taken directly from the 2010 EPA draft
Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care
Facilities.
17. Page 2, Background, Last sentence: For accuracy, revise to read "The domestic sewage exclusion
at 40 CFR 261.4(a)(1)(ii) generally allows facilities to flush pharmaceuticals down the drain.
However, due to the detection of active pharmaceutical ingredients in the environment, EPA
recommends that facilities not dispose of their pharmaceuticals down the drain."
OIG Response: The sentence is accurate as written, and was used by EPA in its 2010 draft
Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care
Facilities. At the beginning of the sentence, we added the words "Although the domestic sewage
exclusion generally allows facilities to flush pharmaceuticals down the drain," to address this
comment.
18. Page 2, EPA Definition of Hazardous Waste, 3rd and 4th sentences: For accuracy, revise to read
"Federally, any facility, such as a hospital or other health facility, that generates more than 100 kg
12-P-0508
24

-------
(220 lbs.) and less than 1000 kg (2200 lbs) of hazardous waste per month, is a small quantity
generator (SQG) under RCRA. A facility that generates greater than 1 kg (2.2 lbs.) of acute
hazardous waste per month and/or 1000 kg (2200 lbs.) or more of hazardous waste per month is a
large quantity generator (LQG) under RCRA. Facilities that generate less than SQGs and LQGs
per month have minimal RCRA requirements. Both SQGs and LQGs are subject to full RCRA
hazardous waste regulation. Full RCRA regulations generally include management standards for
waste accumulation and required transportation by a hazardous waste transporter to a permitted
hazardous waste treatment, storage and disposal facility." DOT regulations require certain
container packaging for transport, and RCRA defers to DOT on this.
OIG Response: The sentences are accurate as written, and the suggested revisions provide a
level of detail not necessary for this report and, in our opinion, will impede readability of the
report.
19. Page 2, "corrosivity": For accuracy, revise to read "wastes that are extremely acidic or alkaline
(basic)."
OIG Response: OIG's definition is accurate. It is identical with the definitions in the EPA's
RCRA Orientation Manual 2011.
20.	Page 3, c: For accuracy, revise to read "Chemicals are included on the U-list based on toxicity or
other characteristics. Chemicals are included on the P-list if they are acutely toxic. P-list chemicals
are regulated when generated in lower quantities than U-list chemicals."
OIG Response: Sentences changed as suggested.
21.	Page 3,1st full sentence: For accuracy, revise to read "P-listed wastes are identified as acute
hazardous waste because the waste has been found to be fatal to humans or animals above
certain thresholds/doses."
OIG Response: Sentence changed as suggested.
22.	Page 3, Footnote 4: For accuracy, revise to read "The LD50 and LC50 value is a measure of acute
toxicity and indicates the ability of a toxic or poisonous substance to kill half the population in
animal studies within the study's timeframe."
OIG Response: Footnote wording changed to "The LD50 and LC50 value is a measure of acute
toxicity, and indicates the ability of a toxic or poisonous substance to kill half the population in
animal studies after a specified test duration."
23.	Page 3, EPA Definition of Hazardous Waste, last paragraph, first sentence: For clarity, revise to
read "Pharmaceuticals can be included on the U-list if they exhibit any of the four hazardous
characteristics..."
OIG Response: "Four" added to the sentence as suggested.
12-P-0508
25

-------
24. Page 3, Volume of Hazardous Pharmaceutical Waste, 3rd and 4th sentences: For accuracy, revise
to read "However, estimates of the volume of HWP may be understated because under federal
regulations, only large quantity generators are required to report their hazardous waste types and
volumes."
OIG Response: A new sentence was added after the fourth sentence: "Further, federal
regulations require only large quantity generators to report their hazardous waste types and
volumes to EPA."
25.	Page 3, Footnote 5: For clarity, revise to read "Hazardous waste generators producing more than
2,200 pounds of hazardous waste, or more than 2.2 pounds of acute hazardous waste, in a
calendar month must report the waste type and volume to EPA every 2 years."
OIG Response: Sentence changed as suggested.
26.	Page 3-4, sentence beginning "EPA estimates...": Recommend additional context such as how
much total hazardous waste is generated per year.
OIG Response: We added to footnote 5: "The total volume of hazardous waste reported in 2009
was approximately 35 million tons."
27.	Page 4, EPA's Best Management Practices Guidance for Pharmaceuticals, last sentence: For
accuracy revise to read "The draft guidance describes BMPs that EPA recommends to health care
facilities, long-term care facilities, medical clinics, and doctors' offices, when managing and
disposing of unused pharmaceuticals. Numerous comments were received on the draft BMPs."
OIG Response: No change was made. The statement is accurate as written and adding the
suggested additional text is not necessary for purposes of the OIG's report.
28.	Page 4, last 2 sentences: For accuracy, revise to read: "In 2009, EPA summarized comments on
the proposed rule. There was substantial negative comment on the proposed rule such that the
Agency decided that it could not address the comments without re-proposing a new rule. Since the
fall of 2010, the Agency has been actively developing a new proposed rule that addresses the
comments received on the Universal Waste proposal."
OIG Response: We added the following new sentences to reflect EPA's current position on the
rulemaking: "According to EPA, there was substantial negative comment on the proposed rule
such that the Agency decided that it could not address the comments without re-proposing a new
rule. EPA has recently stated that the Agency has decided to develop another proposal for
healthcare facility-specific regulations for the management of hazardous waste pharmaceuticals."
29.	Page 5, Other Federal Agency Hazardous Drug Lists, 2nd to last sentence: For accuracy, revise to
read: "OSHA developed a hazardous drug list in the early 1990s and it remains a primary
12-P-0508
26

-------
reference for health care facilities for identifying drugs that may pose occupational risks to
employees."
OIG Response: No was made change. The statement is accurate as written.
Chapter 2:
30.	Page 7,1st sentence: For accuracy, revise to read "Although EPA has the authority under RCRA, it
has not added to its regulations pharmaceuticals that may qualify as hazardous waste since 1980."
OIG Response: Sentence changed as suggested.
31.	Page 7, 5th sentence: For accuracy, revise to read "However, the rule was stalled during the last
half of 2009 and in early 2010. In the fall of 2010, EPA decided it would need to revise the
proposed UWR or create a new rule."
OIG Response: To reflect EPA's current position, we changed the sentence from "However, the
rule has been stalled since 2009 and EPA just recently decided it would determine the need to
revise the proposed UWR or create a new rule," to "However, the rule has been stalled since
2009 and EPA just recently decided it would develop another proposal for healthcare facility-
specific regulations for the management of HWPs."
32.	Page 7, 6th sentence: For accuracy, revise to read "Given the proliferation of pharmaceutical
development since RCRA was enacted, EPA inaction on adding to its regulations pharmaceuticals
that qualify as hazardous waste may result in unsafe disposal and releases of dangerous
pharmaceuticals into the environment."
OIG Response: Sentence revised as suggested.
33.	Page 7-8, end of 1st incomplete paragraph: Revise to reflect information in the General Comment
on Hazardous Waste Identification.
OIG Response: No change was made. Additional requirements for U-listing are noted in the
footnote.
34. Page 8,1st full paragraph, 2nd sentence: For accuracy, revised to read "Currently, EPA
recommends RCRA guidelines as a BMP for managing NIOSH-listed hazardous materials that are
not currently regulated as HWP." For completeness, OIG should provide a citation for this
statement.
OIG Response: The statement is accurate as written. The source is EPA's 2010 draft Guidance
Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities.
However, OIG has added text from the draft Guidance Document to clarify that RCRA does not
require facilities to manage NIOSH-listed hazardous materials the same as RCRA hazardous
waste.
12-P-0508
27

-------
35. Page 9,1st full paragraph: Add a reference to the "2008 Universal Waste proposed rule."
OIG Response: Text added to the first sentence on page 9 to clarify that the reference is to the
2008 Universal Waste proposed rule.
36.	Page 9,1st full paragraph, 2nd sentence: Explain, or delete the term "bulk waste."
OIG Response: The term is from the 2008 Universal Waste proposed rule: page 73530, Federal
Register Vol. 73, No. 232, December 2, 2008.
37.	Page 10,1st paragraph: It would be helpful to explain what regulatory requirement the New York
Attorney General used to cite hospitals for disposing of pharmaceutical wastes down sinks and
toilets. NY may have more stringent regulations regarding drain disposal of hazardous wastes than
the current federal RCRA program, which includes the domestic sewage exclusion of 40 CFR
261.4(a)(1)(ii).
OIG Response: The statement is based on public information released by the New York
Attorney General. The sentence has been modified to address only violations clearly identified as
federal RCRA violations.
38.	Page 10, Title - EPA Pharmaceutical Waste Rulemaking Has Stalled: The title appears to be a
remnant from before the section was updated to include recent rule development activity. Also see
next comment for further updates. For accuracy, revise to reflect progress the Agency has made
developing a new proposed rule to read "EPA is Making Progress On a New Pharmaceutical
Waste Rulemaking."
OIG Response: Title changed to "EPA Is Developing a New Pharmaceutical Rulemaking"
39.	Page 10: 3rd paragraph, 1st - 2nd sentences: To update and for accuracy, revise to read "Shortly
after receiving and reviewing public comments in 2009, EPA determined that the 2008 UW
proposal could not be used as a basis for a final rule that would address commenters' concerns.
ORCR staff said that in the fall of 2010, they began developing a new proposal for the health care
industry for managing hazardous waste pharmaceuticals. In September of 2011 the Agency
completed Early Guidance, the first of three major milestones in its rule development process, and
expects to complete Option Selection, the second milestone, in April of 2012."
OIG Response: Sentences added as suggested, changed to reflect Agency completion of Option
Selection.
40. Page 11, 2nd sentence: For accuracy, revise to read "EPA's belief that there is widespread
noncompliance in the health care industry with RCRA hazardous waste regulations suggests that
there may be potential risks to human health and the environment from regulated hazardous waste
pharmaceuticals."
12-P-0508
28

-------
OIG Response: No change was made. This is an editorial comment that is not materially
different than OIG's original conclusions.
41.	Page 11, 3rd - 5th sentences: For accuracy, revise to read "In addition, because EPA's rule to
improve management of HWP must be re-proposed, the current RCRA HW generator regulations
continue apply to generators of HWPs. The RCRA HW generator regulations can be challenging
for healthcare facilities, which may result in non-compliance over the short term. Also, over 100
drugs have been identified by other federal agencies as pharmaceuticals that pose potential
hazards, whereas EPA only regulates 31 pharmaceutical compounds as listed hazardous wastes
and additional pharmaceutical compounds as characteristic hazardous wastes. The Agency has
recently conducted a review of other federal agencies' lists to begin to address this issue." Note:
The Agency does not rely on best management practices or BMPs to regulate pharmaceuticals
that are hazardous waste, the current RCRA regulations are in effect for hazardous waste
pharmaceuticals.
OIG Response: No change was made. These are OIG conclusions.
Appendix A:
42.	Page 13, Table, For accuracy, revise to read "P-listed RCRA Hazardous Waste pharmaceuticals."
OIG Response: "Hazardous" added to the heading as suggested.
43.	Page 13, Table: For accuracy, for phentermine and physostigmine salicylate, add a footnote
indicating the toxicity exposure route and LD dose that was the basis for the P-listing. Without the
footnote, the chart seems to indicate that because no rat oral LD50 was found, there was no
reason to list the chemical. However, both chemicals were listed based on toxicology information
for one of three exposure routes.
OIG Response: No change was made. The statement about the lack of a rat oral LD50 does not
imply that there was no reason to list the chemical based on EPA's analysis. It simply states that
no rat oral LD50 was found.
44. Page 13, Table: For accuracy, revise column header to read: "U-listed RCRA Hazardous Waste
pharmaceuticals with P-level LD50 values."
OIG Response: "Hazardous" added to heading consistent with the suggested change.
12-P-0508
29

-------
Appendix C
Distribution
Office of the Administrator
Assistant Administrator for Solid Waste and Emergency Response
Deputy Assistant Administrator for Solid Waste and Emergency Response
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Director, Office of Resource Conservation and Recovery, Office of Solid Waste and
Emergency Response
Audit Follow-Up Coordinator, Office of Solid Waste and Emergency Response
12-P-0508
30

-------