Health Care Alert
December 2008
Authors:
Raymond P. Pepe
+1.717.231.5988
raymond.pepe@klgates.com
Patricia Shea
+1.717.231.5870
patricia.shea@klgates.com
Jessica Leigh Wray
+1.717.231.4815
leigh.wray@klgates.com
K&L Gates comprises approximately
1,700 lawyers in 28 offices located in
North America, Europe and Asia, and
represents capital markets participants,
entrepreneurs, growth and middle market
companies, leading FORTUNE 100 and
FTSE 100 global corporations and public
sector entities. For more information, visit
www.klgates.com.
www.klgates.com
Disposing of Hazardous Pharmaceutical Wastes: It’s
Not Just for Hospitals Anymore
The Problem
The EPA is stepping up its inspections of healthcare facilities to ensure that they are
complying with regulations governing the disposal of hazardous pharmaceutical
wastes. Indeed, recent EPA inspections of hospitals in Regions 1, 2 and 4 have
produced compliance orders and fines ranging from $40,000 to more than $250,000
for violations of hazardous waste management requirements. The EPA has also
notified many other hospitals that they are targets of future EPA inspections, and
given the breadth of the federal regulations, other types of healthcare facilities are
left to wonder who is going to be next.
The EPA, however, wants to make it “easier” for hospitals and other healthcare facilities
to comply with regulations governing hazardous pharmaceutical waste disposal. The
EPA’s “solution” is a proposal published in the December 2, 2008, Federal Register
for healthcare facilities, and others, to optionally classify hazardous pharmaceutical
waste as “universal wastes.” This proposal would apply not only to hospitals, but also
to most other types of healthcare facilities, including retail pharmacies, nursing homes,
assisted living facilities, and physician, dentist and veterinary offices.
Healthcare facilities should regard EPA’s proposal as a clear indication that the EPA and
state environmental regulators will be expanding current efforts to ensure compliance
with pharmaceutical waste management requirements beyond hospitals to other types
of healthcare facilities. Owners and operators of all types of healthcare facilities
therefore have a stake in the EPA’s proposal and should review it and submit comments
as warranted. Perhaps more importantly, healthcare facilities should also carefully
evaluate whether their current operations comply with existing waste management
regulations so that they do not become the next recipients of the EPA’s fines.
This Alert describes generally how hazardous pharmaceutical wastes are currently
regulated and how the EPA’s proposal would modify that regulatory structure. The
Alert discusses whether the EPA’s proposal makes sense for healthcare facilities and
explains how healthcare facilities can, and perhaps should, submit comments to the
EPA’s proposal.
Current Regulation of Hazardous Pharmaceutical Wastes
How Is Hazardous Pharmaceutical Waste Generated?
All healthcare facilities – not just hospitals – have the potential to become
generators of hazardous pharmaceutical waste if they collect or receive returns of
unused prescription or over-the-counter medications, generate residues through the
compounding of prescriptions, dispose of medications that are spilled or otherwise
contaminated, or dispose of out-of-date medications other than through their
return to reverse distributors or manufacturers for credit. In these circumstances,
Health Care Alert
the healthcare facilities must evaluate whether
the pharmaceutical products contain as their
sole active ingredient chemical products which
(1) could potentially be lethal if administered
in oral doses of 50 mg/kg or less (i.e., “acutely
hazardous” “P” class waste), (2) have been
specifically designated by the EPA as “toxic” (i.e.,
“U” class wastes); or (3) display characteristics
of ignitability, corrosivity, reactivity or toxicity as
determined by testing or other analysis.
Hazardous waste generators are classified into one of
three categories depending on the total amounts of
all types of hazardous waste generated at a particular
site in any month, as follows:
Large Quantity
Generators (“LQGs”)
Small Quantity
Generators (SQGs”)
Conditionally
Exempt Small
Quantity Generators
(“CESQGs”)
produce 1000 kg or
more of hazardous
waste per month
(approximately
2,200 lbs), or greater
than 1 kg of acutely
hazardous waste per
month (approximately
2.2 lbs)
produce between 100
kg (approximately 220
lbs) and 1,000 kg of
hazardous waste per
month and 1 kg or less
of acutely hazardous
waste per month
produce 100 kg or
less per month of
hazardous waste, or 1
kg or less per month
of acutely hazardous
waste
In applying these quantity limits, generators
must include not only pharmaceutical wastes,
but also containers used for storage of hazardous
pharmaceutical wastes, personal protective clothing
contaminated with such wastes, or other materials
with which hazardous waste are mixed, including
debris contaminated by spills, when making their
calculations.
Most facilities that generate hazardous
pharmaceutical wastes are classified as SQGs or
CESQGs. However, classifications may change
from month-to-month, especially based upon the
production of more than one kilogram of any acute
hazardous wastes.
What must generators do to dispose of the
hazardous pharmaceutical wastes?
LQGs and SQGs are required to manage, store and
arrange for the processing or disposal of hazardous
pharmaceutical wastes pursuant to federal and
state hazardous wastes management requirements
that obligate them to (1) register with the EPA as
hazardous waste generators; (2) either limit the
amounts of hazardous waste stored on-site and the
length of time waste is accumulated prior to offsite management and disposal, or obtain hazardous
waste storage permits; (3) either arrange for the
transportation of waste for processing or disposal
at facilities permitted to process or dispose of
hazardous waste, or obtain permits for the on-site
processing or disposal; (4) comply with hazardous
waste transportation requirements pertaining to
packaging and manifesting requirements; (5)
comply with detailed requirements regarding
containers and tanks used for the on-site storage
of hazardous waste; (6) comply with hazardous
waste preparedness and prevention plan and
emergency management requirements; (7) certify
the completion of best efforts to minimize the
production of hazardous wastes; and (8) maintain
detailed records regarding the generation and
management of hazardous wastes.
CESQGs have more flexibility in managing
hazardous wastes. For example, CESQGs are not
required to register with the EPA and do not have to
comply with manifesting requirements. CESQGs
may also use certain types of qualified municipal or
non-hazardous industrial waste disposal facilities
and sewage systems connected to publicly-owned
wastewater treatment facilities. Like LQGs and
SQGs, however, CESQGs must determine whether
wastes are hazardous. CESQGs are also subject
to more stringent limitations than other generators
regarding the amounts of hazardous waste that
may be stored prior to processing or disposal and
the period of time that it may be stored, unless a
December 2008 | 2
Health Care Alert
CESQG applies for and obtains a hazardous waste
storage permit.
Do the states also regulate this waste?
The federal hazardous waste management program
establishes minimum standards that apply in all
states, but states are free to impose additional,
more stringent requirements. For example, in
some jurisidictions, including Pennsylvania,
CESQGs are prohibited from disposing of any
hazardous wastes in municipal or residual waste
management facilities. States are also not required
to adopt the EPA’s more flexible universal waste
management standards, and to date only a limited
number of states have done so.
The EPA’s compliance program and proposed
expansion of the universal waste rule may spur
many states into re-evaluating their requirements
for the management of pharmaceutical wastes. As a
result, while more states may adopt EPA’s universal
waste rule, there is also a potential for each state to
adopt more stringent requirements, such as bans on
landfill or sewage disposal of pharmaceutical wastes,
supplemental manifesting requirements, sourceseparation mandates, and additional requirements
for waste reduction, minimization, recordkeeping,
and emergency management procedures. State
professional licensing boards, in particular pharmacy
and medical boards, may also elect to enhance
inspection and facility management requirements
in response to EPA’s regulatory initiatives.
EPA’s Proposed Changes for Disposing
of Hazardous Pharmaceutical Wastes
The EPA has proposed expanding the “universal
waste rule” to include the disposal of hazardous
pharmaceutical wastes. The EPA adopted the
universal waste rule in 1995 to provide an optional
streamlined and simplified set of requirements
for managing certain types of hazardous waste
typically generated in small quantities by a
very large number of generators. Currently the
universal waste rule applies to batteries, pesticides,
mercury-containing equipment, and fluorescent,
high intensity, neon, mercury vapor, high pressure
sodium, metal halide or other types of lamps
(called “universal wastes”).
Generally, disposing of universal wastes may be
a little less complicated than complying with the
disposal requirements for hazardous pharmaceutical
waste even though universal waste disposal is
restricted to facilities permitted for the processing
or disposal of hazardous wastes. In fact, generators
who accumulate less than 5,000 kilograms (or
approximately 11,000 pounds) of universal waste are
not required to register with the EPA as hazardous
waste generators. These generators may also arrange
for the transportation of universal waste without
compliance with hazardous waste manifesting
requirements, and are not required to consider the
volumes of materials handled as universal wastes
in the SQGs or CESQG calculations when a facility
also generates other types of hazardous wastes. In
addition, if all wastes that fall within a category of
materials classified as universal wastes are managed
in compliance with universal waste standards,
generators are not required to conduct assessments
to determine whether particular materials constitute
hazardous versus non-hazardous wastes. Small
quantity “handlers” of universal waste, however,
must generally limit the period of time universal
wastes are stored on-site to not more than one year;
comply with employee safety, labeling and record
keeping requirements for the storage of universal
wastes; and establish procedures to ensure that
universal wastes are only processed and disposed of
by other universal or hazardous waste management
facilities.
In its proposal, the EPA has suggested designating
pharmaceutical wastes as an additional category
of universal waste without any significant
modifications of the existing requirements for the
management of universal wastes. For purposes of
the proposed expansion to the universal waste rule,
“pharmaceuticals” consist of chemical products,
vaccines or allergenics, or products primarily used
to dispense or deliver chemical products, vaccines
or allergenics, that do not contain a radioactive
component, and are intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease
or injury in man or other animals, or that affect the
structure or function of the body in man or other
animals. This definition includes products such
as transdermal patches and oral delivery devices
such as gums or lozenges, but excludes sharps,
infectious or biohazardous waste, dental amalgams,
December 2008 | 3
Health Care Alert
medical devices not used for delivery or dispensing
purposes.
If adopted, the proposed expansion of the universal
waste rule will give healthcare facilities and other
facilities handling pharmaceutical waste, including
reverse distributors, the option of managing
pharmaceutical wastes through LQG, SWG or
CESQG standards, or as universal wastes. In
particular, the proposed rule would require healthcare
facilities electing to handle pharmaceutical waste
as a type of universal waste to comply with the
following requirements:
Waste management. Handlers of universal
wastes must manage these wastes in a manner
that prevents release of the materials into the
environment. Wastes must be packed into
containers that are structurally sound and pose
minimal risks of release through spills or leakage.
The containers are not required to be closed
because most pharmaceutical wastes would be
unused and in the original package. Handlers
must not store incompatible pharmaceutical
wastes in the same container without evaluating
whether the mixture of the materials will threaten
human health or the environment. For example,
handlers must determine whether the mixture will
create an explosion or omit toxic mists, fumes,
dusts or gases. Wastes may be sorted in a manner
that complies with applicable OSHA regulations,
but sorting is not required.
Accumulation Limit. Pharmaceutical universal
wastes handlers will be most likely classified
as a small quantity universal waste handler,
which allows the handler to accumulate 5,000
kg (11,000 lbs.) or less of any type of universal
waste at any time.
Accumulation Time Limits. There is a one year
accumulation limit. For any accumulation
beyond one year, the handler must demonstrate
that accumulation is solely to facilitate proper
recovery, treatment or disposal.
Labeling. Pharmaceutical waste items or
containers must be labeled either “Universal
Waste – Pharmaceuticals,” or “Waste
Pharmaceuticals.”
Employee training. Employees must be familiar
with proper waste handling and emergency
procedures. Training that is provided under other
programs that meet any or all of the requirements
under the universal waste rule may be used to
satisfy the requirements.
Off-site shipments. Pharmaceutical universal
wastes must be taken or sent to a place that is
another universal waste handler, a destination
facility or a foreign destination.
Tracking universal waste shipments. Manifests
are not required for shipments of universal wastes.
Large quantity handlers of universal wastes must
comply with basic tracking requirements under
the universal waste rule.
Comparison of the Current Disposal
Requirements to the EPA’s Proposal
The EPA’s proposed expansion of the universal
waste rule to include pharmaceutical wastes may
present an attractive alternative to complying with
the current LQG and SQG standards. Notably,
however, the question of whether the proposal
offers practical benefit to CESQGs is less clear
because of the costs associated with shipping
pharmaceutical waste off-site for processing
or disposal in compliance with universal waste
standards. Such compliance will in most cases
substantially exceed the costs of municipal waste
disposal or commingling of pharmaceutical wastes
with community sewage. On the other hand,
the option to treat all pharmaceutical wastes as
universal wastes without testing or evaluation may
wholly or in part offset these costs for facilities
otherwise subject to CESQG requirements because
of the costs, difficulty and complexity of assessing
whether particular streams of pharmaceutical
waste are hazardous.
EPA’s Rulemaking Process
Regardless of the type of healthcare facility, the
EPA’s proposal signals two very important things
for all healthcare facilities – not just hospitals.
First, healthcare facilities need to review the
proposal to determine whether the expanded
universal waste rule may be beneficial to them
December 2008 | 4
Health Care Alert
or whether more information is needed before
they can make that determination. The EPA has
also raised a number of questions regarding the
proposal for which it has expressly requested
comment. Given the influence the proposal, if
adopted, might have on state regulation, healthcare
facilities may want to provide such commentary.
Questions and comments regarding the proposed
expansion of the universal waste rule can be
submitted to the EPA until February 9, 2009.
Probably more important, however, is the clear
message that the EPA is sending to all healthcare
facilities that generate pharmaceutical waste –
namely, complying with disposal requirements is
simply not optional, and healthcare facilities that
choose to ignore those requirements will pay a
price.
K&L Gates comprises multiple affiliated partnerships: a limited liability partnership with the full name K&L Gates LLP qualified in Delaware and
maintaining offices throughout the U.S., in Berlin, in Beijing (K&L Gates LLP Beijing Representative Office), and in Shanghai (K&L Gates LLP
Shanghai Representative Office); a limited liability partnership (also named K&L Gates LLP) incorporated in England and maintaining our
London and Paris offices; a Taiwan general partnership (K&L Gates) which practices from our Taipei office; and a Hong Kong general
partnership (K&L Gates, Solicitors) which practices from our Hong Kong office. K&L Gates maintains appropriate registrations in the
jurisdictions in which its offices are located. A list of the partners in each entity is available for inspection at any K&L Gates office.
This publication is for informational purposes and does not contain or convey legal advice. The information herein should not be used or
relied upon in regard to any particular facts or circumstances without first consulting a lawyer.
©1996-2008 K&L Gates LLP. All Rights Reserved.
December 2008 | 5