\61\ NIOSH List of Antineoplastic and Other Hazardous Drugs in
Healthcare Settings 2012. http://www.cdc.gov/niosh/docs/2012-150/.
    \62\ OSHA Technical Manual, Section VI: Chapter 2, Appendix VI:
2-1. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
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    ii. Recommended best management practices for other non-hazardous
pharmaceutical wastes (i.e., those not possessing hazardous waste like-
qualities). As far as other non-hazardous waste pharmaceuticals (i.e.,
those not possessing hazardous waste-like qualities), disposing of non-
hazardous waste pharmaceuticals at healthcare facilities via drain
disposal is strongly discouraged and not recommended by EPA. Therefore,
EPA endorses the Blueprint's recommendation of municipal solid waste or
medical waste incineration for any non-hazardous waste pharmaceuticals,
even when they do not possess hazardous waste-like qualities. The
potential risk remains for active pharmaceutical ingredients (APIs) to
be released into the environment if municipal solid waste landfills or
medical waste autoclaves are used for the purposes of pharmaceutical
waste treatment and disposal. For example, autoclaves are designed to
kill pathogens and do not achieve the temperatures required to destroy
most APIs during the autoclaving process. As a result, there is the
potential for wastewater containing APIs to be generated and discharged
into the sewer. In addition, some limited studies have shown APIs
present in landfill leachate collected in municipal solid waste
landfill leachate systems.63 64 Typically, the collected
landfill leachate is subsequently sent to wastewater treatment plants
for treatment, but their treatment technologies are not designed to
remove all APIs from the wastewater (See Section V.E.1 for more
information regarding sewering and APIs).
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    \63\ Barnes, K.K., Christenson, S.C., Kolpin, D.W., Focazio,
M.J., Furlong, E.T., Zaugg, S.D., Meyer, M.T. and Barber, L.B.
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants
Within a Leachate Plume Downgradient of a Municipal Landfill.
Groundwater Monitoring & Remediation, 24: 119-126.
    \64\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T.,
Zaugg, S.D., and Meyer, M.T. (June 2009), Waste-Indicator and
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental
Contamination and Toxicology, V82.6:635-659.
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    b. Non-pharmaceutical hazardous wastes. These proposed regulations
will only pertain to hazardous waste pharmaceuticals. Therefore, other
types of hazardous wastes generated at healthcare facilities that do
not meet the definition of a hazardous waste pharmaceutical cannot be
managed in accordance with these proposed regulations. For example,
hazardous wastes generated in hospital laboratories or during cleaning
and maintenance of the facility are not considered hazardous waste
pharmaceuticals and are not included within the scope of this proposal.
The generation of non-pharmaceutical hazardous wastes is often more
routine and does not trigger the same concerns that healthcare
facilities experience when managing hazardous waste pharmaceuticals.
    After a healthcare facility determines it is subject to this
proposed rule and manages its hazardous waste pharmaceuticals under
part 266, subpart P, it is no longer required to count the hazardous
waste pharmaceuticals that it generates towards its generator category.
As a result, the healthcare facility may experience a change in RCRA
generator category for its non-pharmaceutical hazardous waste. For
example, a healthcare facility may shift from being an LQG to a SQG or
even CESQG by not counting its hazardous waste pharmaceuticals toward
its generator category, especially when acute hazardous waste
pharmaceuticals such as warfarin (brand name: Coumadin) no longer need
to be counted. A shift in generator category, should it occur, would
allow a healthcare facility to manage its non-pharmaceutical hazardous
waste, such as hazardous waste from laboratories, according to the
reduced generator requirements. It is important to note that only when
a healthcare facility is managing its hazardous waste pharmaceuticals
under the new proposed subpart does it have the benefit of not counting
them towards its generator category (see Section VI. Implementation and
Enforcement for further discussion).

C. What are the proposed standards for healthcare facilities that
manage non-creditable hazardous waste pharmaceuticals?

    This section discusses the proposed management standards for
healthcare facilities (except CESQGs) that manage non-creditable
hazardous waste pharmaceuticals, which include the following:
    (1) Notification requirements for healthcare facilities managing
non-creditable hazardous waste pharmaceuticals;
    (2) personnel training requirements for healthcare facilities
managing non-creditable hazardous waste pharmaceuticals;
    (3) making a hazardous waste determination for non-creditable
hazardous waste pharmaceuticals;
    (4) elimination of central accumulation area and satellite
accumulation area requirements for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals;
    (5) container standards for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals;
    (6) labeling standards on containers for healthcare facilities
managing non-creditable hazardous waste pharmaceuticals;
    (7) accumulation time limits for healthcare facilities managing
non-creditable hazardous waste pharmaceuticals;
    (8) land disposal restrictions for non-creditable hazardous waste
pharmaceuticals;
    (9) procedures for shipping non-creditable hazardous waste
pharmaceuticals off-site from healthcare facilities;
    (10) procedures for managing rejected shipments of non-creditable
hazardous waste pharmaceuticals from healthcare facilities;
    (11) reporting requirements for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals;
    (12) recordkeeping requirements for healthcare facilities managing
non-creditable hazardous waste pharmaceuticals;
    (13) procedures for responses to releases by healthcare facilities
managing non-creditable hazardous waste pharmaceuticals;

    (14) special requirements for long-term care facilities managing
non-creditable hazardous waste pharmaceuticals;
    (15) conditions for healthcare facilities that accept hazardous
waste pharmaceuticals from off-site CESQGs; and
    (16) a prohibition of sewering hazardous waste pharmaceuticals for
all healthcare facilities; (see section V.E.1. of the preamble, Sewer
Disposal Prohibition).
    The proposed management standards discussed in this section only
apply to hazardous waste pharmaceuticals that are non-creditable
hazardous waste pharmaceuticals (i.e., they are destined for a RCRA
permitted or interim status TSDF). They do not apply to those hazardous
waste pharmaceuticals that meet the definition of a ``potentially
creditable hazardous waste pharmaceutical.'' Please refer to Section
V.D for the proposed healthcare facility management standards for
potentially creditable hazardous waste pharmaceuticals that are
transported to reverse distributors for the processing of
manufacturer's credit.
1. Notification Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    In order to address commenters' concerns from the 2008
Pharmaceutical Universal Waste proposal that regulatory agencies are
unaware of hazardous waste pharmaceutical management activities, EPA is
proposing to require that a healthcare facility that does not qualify
as a CESQG to submit a one-time notification as a ``healthcare
facility'' to the appropriate EPA Regional Administrator. Healthcare
facilities subject to 40 CFR part 266, subpart P will have to submit
notification even if the healthcare facility has previously obtained an
EPA identification number. The required notification will enable EPA
and state regulatory agencies to identify the universe of healthcare
facilities managing hazardous waste pharmaceuticals subject to the 40
CFR part 266, subpart P requirements. In addition, having this
information allows EPA and state environmental regulatory agencies to
track healthcare facilities for enforcement and inspection purposes,
ensuring the hazardous waste pharmaceuticals are managed in accordance
with the regulations.
    At any point a healthcare facility's hazardous waste pharmaceutical
generation may change due to waste minimization efforts or other
reasons, causing the facility to legitimately decrease its total
monthly hazardous waste generation enough to qualify as a CESQG. In
this case, if the healthcare facility plans to withdraw from the 40 CFR
part 266, subpart P requirements due to qualifying as a CESQG, it will
be required to re-notify EPA of its choice to withdraw.
    Alternatively, if a healthcare facility determines that it is a
CESQG,\65\ but does not want to keep track of the amount of hazardous
waste generated and whether it is above or below the CESQG threshold
limit, it can choose to operate under this proposed rule. By choosing
to operate under this proposed rule, the CESQG healthcare facility must
comply with all of the requirements and must submit the one-time
notification that it is operating under 40 CFR part 266, subpart P.
Healthcare facilities that are not CESQGs, however, are required to
operate under 40 CFR part 266, subpart P for the management of their
hazardous waste pharmaceuticals.
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    \65\ A generator is a CESQG if it generates less than or equal
to 100 kg of hazardous waste per calendar month, and less than or
equal to 1 kg of acute hazardous waste per calendar month and <100
kg of any residue or contaminated soil, waste or other debris
resulting from the clean-up of a spill, into or on any land or
water, of any acute hazardous waste listed in Sec.  261.31 or Sec.
261.33(e) per calendar month, provided it does not accumulate on-
site at any time >1 kg of acute hazardous waste or >1000 kg of
hazardous waste.
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    The Agency is proposing that this notification occur via the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12; or Site
Identification Form).\66\ EPA believes that notification via the Site
Identification Form is the preferred approach for notification purposes
for several reasons. First, both state environmental regulatory
agencies and hazardous waste generators are familiar with the form, as
it is the form currently used by hazardous waste generators to notify
regulators of their RCRA Subtitle C activities. Second, as stated
previously, the use of the Site Identification Form will allow for EPA
and state regulatory agencies to monitor the healthcare facilities
utilizing the new regulatory requirements. Lastly, public comments
received on previous EPA actions (e.g., Academic Laboratories
Rulemaking (73 FR 72912; December 1, 2008)) have indicated that
notification via the Site Identification Form is the notification
approach typically preferred by the regulated community. We are
proposing that healthcare facilities can submit their notification as
part of the Biennial Report, if the healthcare facility will be
required to submit a Biennial Report due to its non-pharmaceutical
hazardous waste. Otherwise, healthcare facilities are required to
notify within 60 days of this new subpart becoming effective, or within
60 days of becoming subject to this new subpart.
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    \66\ For information on the current Site Identification Form,
please see: http://www.epa.gov/wastes/inforesources/data/form8700/8700-12.pdf.
---------------------------------------------------------------------------

    If this notification requirement is finalized, the Site
Identification Form will be modified by EPA in a separate action.\67\
Specifically, the Agency intends to amend the Site Identification Form
by adding a section to the form for a healthcare facility to indicate
the type of entity it is (e.g., a hospital, a doctor's office, a
veterinary clinic, a pharmacy, an assisted living facility, etc.) and
to indicate that it generates hazardous waste pharmaceuticals. The
healthcare facility will no longer be required to identify on the Site
Identification Form the specific types of hazardous waste
pharmaceuticals it generates. The Agency also intends to add a checkbox
to the section in order to allow a healthcare facility to indicate that
its generator category is changing to a CESQG and it is no longer
managing its hazardous waste pharmaceuticals according to 40 CFR part
266, subpart P.
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    \67\ The Information Collection Request (ICR) for the Site
Identification Form (87000-12) is updated every three years and must
be approved by the Office of Management and Budget (OMB). These
updates and OMB approvals are published in the Federal Register and
are subject to public comment.
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    The Agency does not anticipate that this proposed notification
requirement will place any undue economic burden upon healthcare
facilities or the environmental regulatory agencies that process these
notifications (see the Regulatory Impact Analysis for the proposed rule
in the rulemaking docket EPA-HQ-RCRA-2007-0932). In fact, under these
proposed regulations, healthcare facilities would no longer need to
count the hazardous waste pharmaceuticals managed under 40 CFR part
266, subpart P towards a healthcare facility's generator category. As a
result, EPA anticipates that many healthcare facilities will change
their generator category to either a SQG or CESQG for their other, non-
pharmaceutical hazardous wastes. So while the notification requirement
ensures that the environmental regulatory agencies are informed of all
hazardous waste pharmaceutical management activities subject to the 40
CFR part 266, subpart P requirements in their jurisdictions, the fact
that some healthcare facilities will no longer qualify as LQGs will
reduce the number of healthcare facilities in the LQG universe. Because
LQGs are inspected more frequently than SQGs or CESQGs, EPA expects
this could result in an overall decrease in burden for both

the healthcare facilities and the environmental regulatory agencies.
    The Agency is soliciting comment on the notification requirement
for healthcare facilities, the method of notification via the Site
Identification Form, and whether this notification requirement will
result in any undue burden to either healthcare facilities or state
environmental regulatory agencies.
2. Personnel Training Requirements for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals
    Under the current RCRA Subtitle C regulations, an LQG healthcare
facility must provide RCRA training to its healthcare workers involved
in the generation and/or management of hazardous waste. Under Sec.
262.34(a)(4), LQGs are required to comply with the personnel training
requirements for interim status TSDFs (which are found in Sec.
265.16). These personnel training requirements include either classroom
instruction or on-the-job training in RCRA and state that the facility
must maintain training documents and records for each trained staff
person. On the other hand, under current regulation, healthcare
facilities that are SQGs must meet a performance-based standard when
training their healthcare workers. This entails ensuring ``that all
employees are thoroughly familiar with proper waste handling and
emergency procedures relevant to their responsibilities during normal
facility operations and emergencies'' (Sec.  262.34(d)(5)(iii)). For
comparative purposes, healthcare facilities that are considered CESQGs
do not have any personnel training requirements under the current
federal regulations. Similarly, generators, including healthcare
facilities, are not required to provide RCRA training to personnel that
only work in satellite accumulation areas regulated under Sec.
262.34(c). However, healthcare personnel that are involved in the
generation of pharmaceutical waste must be familiar enough with the
pharmaceuticals with which they are working to know when they have
generated a hazardous waste so that it will be managed in accordance
with the RCRA regulations.
    EPA believes that the LQG RCRA training requirement is excessive
for healthcare workers who sporadically generate hazardous waste
pharmaceuticals at healthcare facilities, but believe it is necessary
to have some familiarity with the dangers that hazardous waste
pharmaceuticals can pose. Therefore, the Agency is proposing healthcare
facility-specific personnel training requirements that are akin to the
training requirements for SQGs and small quantity universal waste
handlers. Specifically, healthcare facilities managing their hazardous
waste pharmaceuticals in accordance with the proposed healthcare
facility standards must inform all employees that handle or have
responsibility for generating and/or managing hazardous waste
pharmaceuticals of the proper handling and emergency procedures
appropriate to their responsibilities during normal facility operations
and emergencies. This training information can be disseminated through
verbal communication or through distribution of pamphlets or other
documentation. However, a healthcare facility that is an LQG due to its
non-pharmaceutical hazardous wastes may choose to continue to use its
existing training program as an LQG so as not to have different
training programs and that would be acceptable, as well.
    The Agency solicits comments on the personnel training requirements
proposed in this document for healthcare facilities managing hazardous
waste pharmaceuticals. Specifically, the Agency is seeking comment
regarding the appropriateness of these personnel training requirements
and if these requirements will be sufficient for communicating key
procedures to healthcare workers that generate and/or manage hazardous
waste pharmaceuticals.
    EPA is seeking comment on whether documentation of training is
necessary in order to verify compliance with the training requirement.
Based on the comments received, we may include a requirement in the
final rule for documenting and retaining records of healthcare
personnel training. Finally, the Agency wants to reiterate that these
proposed personnel training requirements only apply to staff generating
and/or managing hazardous waste pharmaceuticals. The training
requirements of 40 CFR part 262 will continue to apply to staff
generating and/or managing other types of hazardous wastes at the
healthcare facility.
3. Making a Hazardous Waste Determination for Non-Creditable Hazardous
Waste Pharmaceuticals
    Similar to the current RCRA Subtitle C generator requirements,
healthcare facilities will still be required to make a hazardous waste
determination on pharmaceutical wastes prior to managing them under the
proposed cradle-to-grave standards. Therefore, when a healthcare
facility generates a solid waste pharmaceutical, the healthcare
facility must determine if the pharmaceutical waste is listed in 40 CFR
part 261, subpart D and if it exhibits one or more of the four
characteristics of hazardous waste identified in 40 CFR part 261,
subpart C. However, unlike the existing generator requirements, the
healthcare facility does not need to identify the specific waste codes
applying to the pharmaceutical wastes. If the pharmaceutical waste is
determined to be a hazardous waste, then the healthcare facility must
manage the hazardous waste pharmaceuticals in accordance with these
proposed requirements instead of 40 CFR part 262. Pharmaceutical wastes
not meeting the definition of a hazardous waste (i.e., non-hazardous
waste pharmaceuticals) must be managed in compliance with applicable
federal, state and local regulations.
    EPA understands that healthcare facilities utilize various
approaches when making hazardous waste determinations. For example,
healthcare facilities may hire contractors to review their formularies
and identify those pharmaceuticals that are hazardous wastes when
discarded. These facilities may then identify hazardous waste
pharmaceuticals at the pharmacy level, marking these pharmaceuticals
with a special label so that healthcare personnel know how to properly
dispose of the pharmaceutical when it becomes a waste. Other healthcare
facilities may instruct personnel to dispose of all pharmaceutical
wastes into one RCRA hazardous waste collection container. These
facilities may then choose to manage all of the contents of the
container as hazardous waste or they may choose to sort the hazardous
waste portion from the non-hazardous waste pharmaceutical portion in
the central accumulation area. Due to the various ways that healthcare
facilities make the hazardous waste determination, the Agency is not
proposing that a specific approach be utilized when making the
determination, only that the facility performs the waste determination.
However, healthcare facilities may choose to manage all of their
pharmaceutical wastes as hazardous, and thus, if a healthcare facility
chooses this approach, they would not need to make individual hazardous
waste determinations, but would have made a generic decision that all
of their waste pharmaceuticals are hazardous and manage them as
hazardous waste pharmaceuticals in accordance with the proposed
requirements in 40 CFR part 266, subpart P.

4. No Central Accumulation Area and Satellite Accumulation Area
Requirements for Healthcare Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
    Hazardous waste pharmaceuticals are generated at numerous locations
across a healthcare facility. Under the current RCRA Subtitle C
requirements, each location at the healthcare facility with a RCRA
hazardous waste receptacle for the disposal of hazardous waste
pharmaceuticals is considered a satellite accumulation area and is
subject to volume accumulation limits and other requirements.\68\ Of
particular concern regarding the satellite accumulation requirements
for healthcare facilities is the one quart accumulation limit for acute
hazardous wastes (i.e., P-listed wastes). Under the December 2008
Pharmaceutical Universal Waste proposal, no accumulation areas, central
or satellite, were proposed to be established for hazardous waste
pharmaceuticals. This proposed approach was consistent with the current
federal universal waste program, since facilities are not required to
designate a special centralized area for the accumulation of universal
wastes nor are they required to have satellite accumulation areas for
universal wastes. Nevertheless, EPA understands that facilities that
handle universal wastes will often accumulate their universal wastes
within their 90- or 180-day hazardous waste accumulation areas.
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    \68\ See Sec.  262.34(c) for the satellite accumulation
requirements. For additional information on satellite accumulation
areas, please see the memorandum from Robert Springer to the EPA
Regional RCRA Directors, ``Frequently Asked Questions about
Satellite Accumulation Areas'' (RCRA Online #14703) http://
yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/
0AC9E15424B2897D8525770600609793/$file/14703.pdf.
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    For the reasons articulated in the Pharmaceutical Universal Waste
proposal, the Agency has decided that a healthcare facility
accumulating hazardous waste pharmaceuticals will not be subject to the
satellite accumulation area regulations or the central accumulation
area regulations (also sometimes called less than 90- or 180-day
areas), but rather to the proposed accumulation time limits and
container standards.
    A healthcare facility may choose to accumulate hazardous waste
pharmaceuticals within its 90- or 180-day central accumulation area if
it has one established for its other hazardous wastes as long as it
maintains compliance with the proposed accumulation time limit and
container requirements of 40 CFR part 266, subpart P. The Agency notes
that even if the hazardous waste pharmaceuticals are accumulated in a
90- or 180-day central accumulation area, these hazardous waste
pharmaceuticals are not subject to the 90- or 180-day requirements. EPA
solicits public comment on its decision to not require hazardous waste
pharmaceutical-specific central and satellite accumulation area
requirements.
5. Container Standards for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    The container standards discussed in this section apply to those
containers used by healthcare facilities to accumulate, store and
transport non-creditable hazardous waste pharmaceuticals.\69\ First, we
would note that due to the relatively small quantities of hazardous
waste pharmaceuticals that are typically accumulated and stored at a
healthcare facility, the Agency understands that other types of waste
management units, such as tanks, are not used for the management of
waste pharmaceuticals. Therefore, we are only proposing standards for
containers. However, the Agency solicits comment as to whether other
types of waste management units are also used by healthcare facilities
to accumulate and store hazardous waste pharmaceuticals and whether EPA
should establish technical standards for other types of waste
management units.
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    \69\ The container standards proposed do not apply to the
various packaging, blister packs, bottles, vials, IV bags, etc., in
which pharmaceuticals are stored prior to being dispensed or
administered.
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    The Agency is proposing to require that healthcare facilities pack
hazardous waste pharmaceuticals into containers that are structurally
sound and that are compatible with the hazardous waste pharmaceuticals
that will be contained within them. EPA intends this requirement to
mean that containers used for holding hazardous waste pharmaceuticals
must be in good condition, with no severe rusting, apparent structural
defects, or deterioration. Containers also must not have any evidence
of leakage, spillage or damage that could result in the release of
waste under reasonably foreseeable circumstances. Furthermore, the
Agency is proposing to require that incompatible wastes not be placed
in the same container, unless the co-mingling of incompatible hazardous
wastes is conducted in such a way that it does not have the potential
to (1) generate extreme heat or pressure, fire or explosion, or violent
reaction; (2) produce uncontrolled toxic mists, fumes, dusts, or gases
in sufficient quantities to threaten human health; (3) produce
uncontrollable flammable fumes or gases in sufficient quantities to
pose a risk of fire or explosions; (4) damage the structural integrity
of the facility or container containing the hazardous waste
pharmaceuticals; or (5) through other like means threaten human health
or environment. For example, the majority of a healthcare facility's
non-creditable hazardous waste pharmaceuticals are likely organic in
nature, and thus, compatible with each other and can be accumulated
together, especially since they will most likely be incinerated once
they are transported to a TSDF. However, some non-creditable hazardous
waste pharmaceuticals, such as metal bearing wastes not containing
sufficient organics, are prohibited from being incinerated (e.g., P012,
arsenic trioxide). The hazardous waste pharmaceuticals that cannot be
incinerated must be accumulated separately from organic wastes destined
for incineration.
    The Agency believes that these technical standards, like similar
technical standards that EPA has promulgated in Sec.  265.17 for
interim status TSDFs, would ensure that hazardous waste pharmaceuticals
are properly managed and would not be released into the environment,
while at the same time providing flexibility to the healthcare facility
in selecting those containers that are most appropriate for their
situation.
    In addition to the proposed container standards, the Agency is also
proposing that accumulation containers for hazardous waste
pharmaceuticals be secured in a manner that prevents unauthorized
access to the contents in order to prevent the pilfering of hazardous
waste pharmaceuticals or inadvertent exposures to them. As we have
noted previously, hazardous waste pharmaceuticals still retain
considerable value and can easily be diverted for illicit purposes. To
ensure this does not occur, we believe it is important to propose a
requirement that would prevent the unauthorized access to the contents
of these containers. EPA intends this requirement to be performance-
based and does not intend to propose prescriptive regulatory
requirements for this standard. The Agency believes that healthcare
facilities can choose to utilize containers that have built-in
mechanisms to prevent access to their contents or can choose to store
containers in locked storage lockers, closets or rooms where the public
does not have access to the containers or their contents.

    The Agency is seeking comment on the appropriateness of the
proposed container management standards. In addition, the EPA is
soliciting comment on the proposed requirement for ensuring that the
hazardous waste pharmaceuticals contained in collection containers
remain secure.
6. Labeling Standards on Containers for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals
    During the period of accumulation and storage, the Agency is
proposing that containers of hazardous waste pharmaceuticals be marked
with the words ``Hazardous Waste Pharmaceuticals.'' The Agency is not
proposing to require that the hazardous waste numbers (often referred
to as hazardous waste codes) of the container's contents be listed on
the label. The personnel at healthcare facilities that typically
generate the hazardous waste pharmaceuticals will be healthcare workers
(e.g., nurses). Healthcare workers are not usually intimately familiar
with RCRA and its regulations and are primarily focused on patients and
their health. In addition, while a healthcare facility may have an
environmental compliance manager or environmental consultant that is
knowledgeable about RCRA and its regulations and can make hazardous
waste determinations, this individual cannot be present to assign a
hazardous waste code and label the collection receptacle each time a
pharmaceutical waste is generated. For these reasons, EPA does not
believe it is necessary to require individual waste codes on the
hazardous waste pharmaceutical collection container at the healthcare
facility. The Agency is soliciting comment on the appropriateness of
the proposed general labeling requirement. The Agency also requests
comment on security concerns regarding having the word
``pharmaceutical'' marked on the containers.
7. Accumulation Time Limits for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    Several hazardous waste pharmaceuticals are P-listed, acute
hazardous wastes (e.g., nicotine, warfarin, etc.). Under current
regulations, if a generator generates more than 1 kg of acute hazardous
waste per calendar month or accumulates more than1 kg of acute
hazardous waste at any time, the generator is regulated as an LQG. Due
to this low generation/accumulation threshold associated with P-listed
wastes, healthcare facilities are often LQGs. However, while healthcare
facilities can generate enough P-listed waste to become LQGs, they
often do not generate sufficient amounts of hazardous waste
pharmaceuticals within the allowed accumulation period of 90 days to
make off-site shipments using a hazardous waste transporter cost-
effective.
    Under the 2008 Pharmaceutical Universal Waste proposal, universal
waste handlers would have had one year for accumulation of its
hazardous waste pharmaceuticals in order to facilitate proper treatment
and disposal. Commenters on the 2008 Universal Waste proposed rule
indicated support for the one-year accumulation time limit. Thus, the
Agency is proposing to allow healthcare facilities to accumulate
hazardous waste pharmaceuticals for up to one year, without having
interim status or a RCRA permit. As with Universal Waste, one year is
an appropriate timeframe because it strikes a balance between allowing
healthcare facilities enough time to accumulate amounts of hazardous
waste pharmaceuticals to make it economically viable for transporting
their hazardous waste pharmaceuticals off-site while ensuring that the
hazardous wastes are not accumulated beyond the one year storage limit
under the land disposal restrictions programs (see Sec.  268.50).\70\
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    \70\ See the preamble to the Universal Waste final rule: May 11,
1995; 60 FR 25492 (page 25526).
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    Healthcare facilities will have various approaches to demonstrate
the length of time that hazardous waste pharmaceuticals are accumulated
on-site. For example, a healthcare facility can choose to mark the
container label with the date that accumulation first began, maintain
an inventory system that identifies dates when the hazardous waste
pharmaceuticals were first accumulated, identify in the central
accumulation area \71\ the earliest date that a hazardous waste
pharmaceutical became a waste, or any other method that clearly
demonstrates the length of time that the hazardous waste pharmaceutical
has been accumulated from the date it became a hazardous waste. The
Agency assumes that any accumulation for up to one year is for the
purpose of facilitating proper treatment and disposal. EPA proposes to
require that any healthcare facility needing a longer accumulation time
for any unforeseen circumstances beyond the control of the healthcare
facility (e.g., a recall or litigation) request an extension from the
appropriate EPA Regional Administrator. This request must be sent in
writing (electronic or paper) explaining the need for the extension,
the approximate amount of hazardous waste pharmaceuticals accumulated
beyond the one year, and the amount of extra time requested. An
extension period will be granted at the discretion of the Regional
Administrator on a case-by-case basis.
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    \71\ While the proposed rules do not require healthcare
facilities to comply with the central accumulation requirements
under 262.34, a healthcare facility may have a central accumulation
area for the other hazardous wastes that it generates.
---------------------------------------------------------------------------

    Finally, the Agency reiterates that the one-year accumulation time
limit only applies to a healthcare facility's non-creditable hazardous
waste pharmaceuticals and does not apply to any other types of
hazardous waste generated on-site or to potentially creditable
hazardous waste pharmaceuticals. EPA solicits comment on the proposed
accumulation time limit of one year in order to allow healthcare
facilities to generate enough non-creditable hazardous waste
pharmaceuticals for cost-effective shipment, and solicits comment on
the proposed mechanism to request a time extension.
8. Land Disposal Restrictions for Non-Creditable Hazardous Waste
Pharmaceuticals
    Similar to the current RCRA Subtitle C generator requirements,
healthcare facilities must comply with the land disposal restrictions
(LDR) prior to land disposal of the hazardous waste pharmaceuticals
they generate. Since healthcare facilities are generators, even though
they are not subject to the 40 CFR part 262 requirements for the
management of hazardous waste pharmaceuticals, they must comply with
the land disposal restrictions found at 40 CFR part 268. The land
disposal restrictions are in place to ensure that toxic constituents
present in hazardous waste are properly treated to reduce their
mobility or toxicity before hazardous waste is placed into or onto the
land (i.e., land disposed). With limited exceptions, hazardous waste
must be treated by a RCRA permitted or interim status TSDF. Again, EPA
notes that autoclaving is not an acceptable method of treating
hazardous waste.
    In general, generators of hazardous waste assign the appropriate
hazardous waste numbers codes to allow TSDFs to determine the specific
treatment standard(s) for each prohibited waste. The Agency is
proposing that healthcare facilities generating non-creditable
hazardous waste pharmaceuticals do not have to assign hazardous waste
codes to these wastes, but rather label them as ``hazardous waste
pharmaceuticals''. They do, however, need to be aware that

while most of the hazardous waste pharmaceuticals are likely organic in
nature and will be incinerated, some of their hazardous waste
pharmaceuticals may not be suitable for incineration and therefore must
be segregated from the organic wastes. The pharmaceutical hazardous
wastes not suitable for incineration include characteristic metal
wastes prohibited from being combusted because of the dilution
prohibition of Sec.  268.3(c), as well as the listed wastes U151
(mercury), U205 (selenium sulfide), and P012 (arsenic trioxide), unless
they contain greater than 1% total organic carbon. In order to comply
with the LDRs, healthcare facilities will need to segregate these
wastes from the organic pharmaceutical hazardous wastes so that they
can be properly treated by the TSDF. The Agency seeks comment on
whether it is necessary to incorporate into the regulations a
requirement to segregate these wastes and whether additional labeling
requirements are necessary to identify the hazardous waste
pharmaceuticals that are not suitable for incineration.
    Tables 2 through 4 list the hazardous waste pharmaceuticals with
their hazardous waste codes and their LDR treatment standards.

[GRAPHIC] [TIFF OMITTED] TP25SE15.000

[GRAPHIC] [TIFF OMITTED] TP25SE15.001

[GRAPHIC] [TIFF OMITTED] TP25SE15.002

    The organic hazardous waste pharmaceuticals (other than arsenic
trioxide) may all be incinerated at RCRA permitted or interim status
hazardous waste combustors. As noted in Tables 2-4, most of the organic
wastes have a specified treatment standard of combustion (CMBST). The
remaining seven organics (lindane, chloroform, m-cresol,
dichlorodifluoro methane, trichloromonofluoromethane, phenacetin and
phenol) have numerical treatment standards, such that no particular
treatment technology is specified or required in order to achieve the
numerical treatment standards. While these wastes may be incinerated,
the incinerator residue (ash) must be analyzed for these seven organic
constituents to demonstrate compliance with the LDR treatment standards
before that ash can be disposed.
    As mentioned earlier, because this proposed rule does not require
that healthcare facilities label their waste with the hazardous waste
codes, the TSDF must always analyze the incinerator ash for these seven
constituents--lindane, chloroform, m-cresol, dichlorodifluoro methane,
trichloromonofluoromethane, phenacetin, and phenol--according to their
waste analysis plan, as they could possibly be present in any shipment
of organic hazardous waste pharmaceuticals.
    a. Alternative treatment standards considered. In their comments to
the 2008 Universal Waste proposal, Environmental Technology Council
(ETC) suggested revising the treatment standards for the organic
hazardous waste pharmaceuticals that have numerical treatment standards
to the specified treatment standard of

combustion.\72\ Specifying combustion would relieve the TSDFs from
demonstrating compliance with the numerical treatment standards. EPA
explored the feasibility of making combustion an alternative treatment
standard for the seven organic hazardous waste pharmaceuticals that
currently have numeric treatment standards. In fact, EPA notes that the
numerical treatment standards were developed based on levels achieved
through combustion. However, in order to allow maximum flexibility, EPA
has indicated a preference for numerical treatment standards over
specifying treatment standards whenever possible. Furthermore, it is
not clear that pharmaceuticals would be the sole source of the seven
organic constituents in question. Therefore, even if we proposed an
alternative treatment standard of combustion for the seven organic
pharmaceuticals, hazardous waste incinerators would still be required
to test their ash for these constituents to demonstrate compliance with
numeric treatment standards if they received the organics from another,
non-pharmaceutical source.
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    \72\ See comment number 0125 in the docket for this rulemaking.
EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    b. Incineration of mercury-containing hazardous waste
pharmaceuticals. It is rare, but some pharmaceuticals contain mercury
(e.g., thimerosal, a mercury-containing preservative). When discarded,
a mercury-containing pharmaceutical would be a D009 hazardous waste if
the leachate generated by the toxicity characteristic leaching
procedure (TCLP), or if the pharmaceutical itself (when the waste
contains < 0.5% filterable solids), contains >= 0.2 mg/L mercury (see
Sec.  261.24).\73\ As indicated in Table 2, a D009 hazardous waste with
mercury content >= 260 mg/kg of total mercury and that also contains
organics, must be treated by IMERC (incineration) or RMERC (mercury
retorting). However, hazardous waste pharmaceuticals that are D009 are
expected to have mercury content <260 mg/kg, in which case the
treatment standards are numeric and treatment by RMERC or IMERC is not
required. With numeric treatment standards, the generator has
flexibility regarding which hazardous waste treatment method to use to
meet the treatment standard. As explained previously, incineration of
mercury-bearing hazardous waste with >1% total organic carbon is not
considered impermissible dilution (see Sec.  268.3(c)) and therefore is
an allowable form of treatment.
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    \73\ The Agency is not aware of any hazardous waste
pharmaceuticals that would be considered U151 because mercury would
have to be the sole active ingredient.
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    Emissions from combustion units that burn hazardous waste \74\ are
regulated under RCRA and the Clean Air Act (CAA). The implementing
regulations under these statutory authorities include emission limits
for new and existing combustion units for mercury, semi-volatile metals
(cadmium and lead), low volatility metals (arsenic, beryllium, and
chromium), particulate matter, chlorinated dioxins and furans, other
toxic organic compounds, hydrogen chloride and chlorine. The
regulations also (1) specify when and how combustion sources must
comply with the emission standards and operating requirements, (2)
prescribe detailed monitoring requirements to show continuous
compliance with the emission standards, and (3) prescribe performance
testing requirements to demonstrate compliance with the emission
standards (see 40 CFR part 63, subpart EEE).
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    \74\ Combustors that burn hazardous waste include the following
types of combustion units: Incinerators, cement kilns, lightweight
aggregate kilns, industrial boilers and process heaters, and
hydrochloric acid production furnaces.
---------------------------------------------------------------------------

    To ensure continuous compliance with the emission limits, hazardous
waste combustors are required to establish limits on (1) the feedrate
of metals (including mercury), chlorine, and (for some types of
hazardous waste combustors) ash; (2) combustor operating parameters
such as minimum combustion chamber temperature; and (3) operating
parameters of the air pollution control device. For mercury, continuous
compliance requirements would generally include a limit on the total
feedrate of mercury in all feedstreams to the combustion unit, limits
on the operation of a wet scrubber (depending on the species of mercury
in the combustion gases, wet scrubbers can be efficient at removing
mercury), and operating limits on the activated carbon injection or
carbon bed system, if such systems are used.
    In addition, RCRA directs permitting authorities to impose
additional terms and conditions on a site-specific basis as may be
necessary to protect human health and the environment (see Sec.
270.32(b)). Thus, if the mercury emission limits specified previously
are not protective in an individual instance, the permit writer will
establish permit limits that are protective.
    Nevertheless, EPA is aware that some stakeholders are concerned
about the risks associated with incinerating mercury-bearing hazardous
wastes and we encourage healthcare facilities and pharmaceutical
reverse distributors to consider the use of treatment technologies
other than incineration for meeting the numeric treatment standards for
mercury-bearing hazardous waste pharmaceuticals. Thimerosal-containing
pharmaceuticals are expected to be non-wastewaters as defined by Sec.
268.2, because they have more than 1% total organic carbon. For low
mercury non-wastewaters, the numeric treatment standard can be achieved
by stabilization/solidification, either with or without subsequent
encapsulation.\75\
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    \75\ EPA is not aware of any testing done to demonstrate the
effectiveness of this treatment method specifically for thimerosal-
containing hazardous wastes, so vendors performing such treatment
may need to do treatability studies to identify optimal use of
stabilization/solidification treatment technologies.
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9. Shipments of Non-Creditable Hazardous Waste Pharmaceuticals Off-site
From Healthcare Facilities
    The Agency is proposing to maintain the current RCRA Subtitle C
tracking requirement by requiring that a hazardous waste manifest be
prepared for each off-site shipment of non-creditable hazardous waste
pharmaceuticals from healthcare facilities. Accordingly, each off-site
shipment of hazardous waste pharmaceuticals must be transported to an
interim status or permitted TSDF via a hazardous waste transporter.
However, the Agency is proposing that for hazardous waste
pharmaceuticals shipped by healthcare facilities, the RCRA hazardous
waste codes do not need to be listed on the manifest. This is intended
to accommodate the fact that healthcare providers generating the
hazardous waste pharmaceuticals are generally unfamiliar with RCRA and
are focused on providing healthcare to patients. One function of the
hazardous waste codes is to determine the appropriate hazardous waste
treatment standards under the land disposal restrictions (part 268).
However, virtually all hazardous waste pharmaceuticals sent for off-
site treatment are sent to hazardous waste incinerators, even when the
treatment standard does not require incineration. The fact that EPA is
proposing to not require hazardous waste codes for shipping hazardous
waste pharmaceuticals is not intended to alter or impact any Department
of Transportation (DOT) requirements for the shipment of these
hazardous wastes. For a more detailed discussion of these proposed
requirements, as well as the basis for these requirements, please see
Section V.F.1 of this document.

10. Rejected Shipment From Healthcare Facilities of Non-creditable
Hazardous Waste Pharmaceuticals
    In rare circumstances, a healthcare facility may send its non-
creditable hazardous waste pharmaceuticals to a designated facility
that is unable to manage the hazardous waste. For such situations, we
are proposing that healthcare facilities follow the same procedures
listed in 40 CFR part 262 (see Sec.  262.23(f)). Specifically, if a
designated facility is unable to accept the hazardous waste
pharmaceuticals, and it returns the hazardous waste pharmaceuticals to
the healthcare facility, the healthcare facility must sign the manifest
that was used to return the shipment, provide the transporter a copy of
the manifest, send a copy of the manifest within thirty days to the
designated facility that returned the shipment and retain a copy of the
manifest for three years from the date of delivery of the returned
shipment. EPA believes that it is appropriate to continue current
practices for rejected shipments that are part of the generator
regulations of 40 CFR part 262 because rejected shipments are
relatively rare and the procedures currently used for rejected
shipments is relatively straightforward. In addition, healthcare
facilities should be familiar with these procedures already.
11. Reporting Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    The Agency is proposing that healthcare facilities managing non-
creditable hazardous waste pharmaceuticals have reporting requirements
similar to SQGs s regulated under 40 CFR part 262--that is, the
exception reporting requirement under Sec.  262.44(b) and the
additional reporting requirement under Sec.  262.44(c). In addition, we
are proposing that healthcare facilities that are LQGs would no longer
be required to include their hazardous waste pharmaceuticals on their
biennial report (BR). Each of these reporting requirements for
healthcare facilities is discussed below.
    First, as part of the current RCRA Subtitle C generator
requirements, healthcare facilities that are LQGs must submit a BR to
the Regional Administrator by March 1st of every even numbered year
(see Sec.  262.41). Among other requirements, the BR must include a
description (EPA hazardous waste number and DOT hazard class) and
quantity of each hazardous waste shipped off-site to a TSDF during each
odd numbered year. If a healthcare facility is an LQG due to its non-
pharmaceutical hazardous waste, it will continue to be required to
submit a BR. However, it need not include its hazardous waste
pharmaceuticals in its BR. As discussed previously, the Agency is no
longer requiring healthcare facilities to count hazardous waste
pharmaceuticals when determining their generator category. Instead, all
healthcare facilities, with the exception of CESQGs, will be subject to
this proposed rule. The Agency has determined that it does not need the
information to be included in the BR because this proposed rule will
bring a consistent approach to managing pharmaceutical hazardous
wastes. Nevertheless, the Agency is soliciting public comment on
whether the Agency should require healthcare facilities--that is, all
healthcare facilities subject to the 40 CFR part 266, subpart P
requirements--to submit a BR, and if so, the type of information that
should be included.
    Second, the Agency is proposing that healthcare facilities follow
the same reporting procedures for exception reporting that generators
operating under the 40 CFR part 262 must follow. We are proposing to
incorporate the generator exception reporting procedures in this new
subpart. Specifically, if a healthcare facility does not receive a copy
of the hazardous waste manifest from the designated facility within 60
days, the healthcare facility must submit to the EPA Regional
Administrator a copy of the manifest with a statement that the
healthcare facility did not receive confirmation of the hazardous waste
pharmaceuticals' delivery along with an explanation of the efforts
taken to locate the hazardous waste pharmaceuticals and the results of
those efforts. Likewise, if a shipment of hazardous waste
pharmaceuticals from a healthcare facility is rejected by the
designated facility and it is shipped to an alternate facility and if
the healthcare facility does not receive a signed copy of the hazardous
waste manifest from the alternate facility within 60 days, it must
submit to the EPA Regional Administrator a copy of the hazardous waste
manifest with a statement that the healthcare facility did not receive
confirmation of the hazardous waste pharmaceuticals' delivery along
with an explanation of the efforts taken to locate the hazardous waste
pharmaceuticals and the results of those efforts. Again, the Agency
believes it is advantageous to use established procedures that should
be familiar to healthcare facilities, especially given that rejected
shipments are relatively rare.
    Finally, the Agency proposes that the Administrator may require
healthcare facilities to furnish additional reports concerning the
quantities and disposition of hazardous waste pharmaceuticals. This is
already the case for generators operating under the 40 CFR part 262
requirements. As with 40 CFR part 262, it is a codification of
statutory authority under Sec. Sec.  2002(a) and 3002(a)(6) that
provides the Agency some flexibility in what reports may be required.
The Agency solicits public comment on the proposed reporting
requirements for healthcare facilities managing their hazardous waste
pharmaceuticals in accordance with the standards proposed in this
document.
12. Recordkeeping Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    The Agency is proposing that healthcare facilities managing non-
creditable hazardous waste pharmaceuticals maintain records similar to
the records that must be kept by generators regulated under 40 CFR part
262 (see Sec.  262.40). Specifically, healthcare facilities must keep a
signed copy of each hazardous waste manifest as a record for three
years from the date that the non-creditable hazardous waste
pharmaceutical was accepted by the initial hazardous waste transporter.
If the healthcare facility is required to file an exception report
because it does not receive a signed copy of the manifest from the
designated facility within 60 days of the date that the hazardous waste
pharmaceutical was accepted by the initial transporter, then the
healthcare facility must keep a copy of the each exception report for a
period of at least three years from the due date of the report.\76\ In
addition, EPA is proposing that a healthcare facility must keep records
of any test results, waste analyses or other determinations made on
hazardous waste pharmaceuticals regarding which pharmaceuticals are
hazardous wastes for three years from the date of the test, analysis,
or other determination.
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    \76\ Sec.  262.40 requires that generators keep a copy of each
BR for a period of at least three years from the due date of the
report. However, since we are not requiring a healthcare facility to
include its hazardous waste pharmaceuticals on its a BR, the Agency
is also not including in subpart P a requirement that a BR be kept
at the healthcare facility. If healthcare facility must submit a BR
due to its non-pharmaceutical hazardous waste, the Sec.  262.40
recordkeeping requirements will apply (see the discussion under
Reporting Requirement for Healthcare Facilities Managing Non-
creditable Hazardous Waste Pharmaceuticals for the Agency's basis of
not requiring healthcare facilities to include hazardous waste
pharmaceuticals on the BR.

---------------------------------------------------------------------------

    The Agency is also proposing that any of the retention periods be
extended during the course of enforcement actions against any activity
associated with hazardous waste pharmaceutical management or as
requested by the Administrator to ensure that the appropriate records
are available and can be reviewed as part of any enforcement action.
The Agency solicits public comment on the proposed recordkeeping
requirements for healthcare facilities managing their non-creditable
hazardous waste pharmaceuticals in accordance with the standards
proposed in this document.
13. Response to Releases by Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    For hazardous waste pharmaceuticals generated and managed by
healthcare facilities under the proposed standards, the Agency is
proposing basic release responses, including the requirement that
healthcare facilities immediately contain all releases of, and other
residues from, hazardous waste pharmaceuticals. In addition, this
proposal would require healthcare facilities to determine whether any
material, residue, or debris resulting from the release is or contains
a hazardous waste pharmaceutical and, if so, to manage it under the
management standards for hazardous waste pharmaceuticals proposed in
this document. These proposed release response procedures are the same
as those under the Universal Waste program (see Sec.  273.17 for small
quantity universal waste handlers, and Sec.  273.37 for large quantity
universal waste handlers). Commenters to the 1993 proposed rule that
established the Universal Waste program overwhelmingly supported the
release response measures (60 FR 25528; May 11, 1995). Thus, we believe
it is appropriate to include it again in this proposal.
    Any releases of hazardous waste pharmaceuticals not cleaned up
immediately would generally constitute illegal disposal, which may
result in further action by EPA or an authorized state under RCRA. In
addition, hazardous wastes under RCRA are included in the definition of
hazardous substances for purposes of the Comprehensive Environmental
Response Compensation, and Liability Act (CERCLA) (see CERCLA Section
101(14) \77\). Thus, any releases into the environment of hazardous
substances above the reportable quantity (RQ) thresholds must be
reported under CERCLA (see CERCLA Section 103). That is, since
hazardous waste pharmaceuticals are hazardous wastes and, hazardous
substances under CERCLA, reporting for hazardous waste pharmaceutical
releases is required when RQs are exceeded (see 40 CFR 302.4 for a list
of RQs and hazardous substances). Such reports provide notification to
the Agency (through the National Response Center) concerning releases
into the environment and help inform whether EPA should take action, if
necessary, under either RCRA or CERCLA.
---------------------------------------------------------------------------

    \77\ http://www.epw.senate.gov/cercla.pdf.
---------------------------------------------------------------------------

    The Agency solicits comment regarding the proposed standard for the
response to releases of hazardous waste pharmaceuticals at healthcare
facilities.
14. Long-Term Care Facilities Managing Non-Creditable Hazardous Waste
Pharmaceuticals
    Long-term care facilities differ in one respect from other types of
healthcare facilities subject to these proposed standards. Unlike
hospitals, who own the pharmaceuticals they dispense to patients, many
of the hazardous waste pharmaceuticals generated at long-term care
facilities belong to the residents of the facility. That is, the
pharmaceuticals are dispensed under the patient's name. However, as
previously discussed in this preamble, EPA is proposing to no longer
allow hazardous waste pharmaceuticals generated at long-term care
facilities (as defined under this proposed regulation) to be eligible
for the household hazardous waste exemption. As a result, long-term
care facilities must manage all hazardous waste pharmaceuticals
generated on-site, regardless of ownership, in accordance with these
same proposed management standards for healthcare facilities. EPA
understands that while long-term care facilities often maintain each
individual's pharmaceuticals in a centralized location, such as a
pharmaceutical cart, there are instances where some individuals may
keep and self-administer their own pharmaceuticals. EPA is proposing
that the long-term care facilities collect and manage all hazardous
waste pharmaceuticals generated at their facilities in accordance with
these proposed requirements. This requirement means that in addition to
the hazardous waste pharmaceuticals kept in the centralized location,
long-term care facilities will need to collect all other hazardous
waste pharmaceuticals from individuals that self-administer these
pharmaceuticals and manage them in accordance with these proposed
standards, which, among other things, prohibits the sewering of
hazardous waste pharmaceuticals. The Agency solicits comment on the
extent to which long-term care facilities keep an inventory of the
pharmaceuticals that individuals self-administer, as this would
facilitate the collection of the hazardous waste pharmaceuticals for
proper disposal.
    Although long-term care facilities would not be required under this
rule to collect non-hazardous waste pharmaceuticals, or hazardous waste
pharmaceuticals from the independent living portion of a continuing
care facility, EPA recommends that long-term care facilities collect
all waste pharmaceuticals to ensure proper management, avoid flushing,
and minimize the potential for accidental poisonings, misuse or abuse.
As discussed later in this preamble, DEA regulations govern the
management of controlled substances (see Section V.E.2.a of the
preamble for a discussion of DEA's 2014 final rule for the disposal of
controlled substances and the implications of that rule and this
proposed rule for long-term care facilities.\78\) Also discussed later
in more detail, EPA is proposing to exempt from RCRA those hazardous
waste pharmaceuticals that are also controlled substances, provided
they are combusted at a permitted or interim status hazardous waste
incinerator or permitted municipal solid waste incinerator and managed
in compliance with applicable DEA regulations (see Section V.E.2 of the
preamble for a detailed discussion of the exemption).
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    \78\ DEA's final rule for disposal of controlled substances: 79
FR 53520; September 9, 2104.
---------------------------------------------------------------------------

    The Agency solicits comment regarding this requirement, and
specifically requests comment on the various approaches that long-term
care facilities use, or could use in collecting hazardous waste
pharmaceuticals from individuals that self-administer their
pharmaceuticals.
15. Healthcare Facilities That Accept Hazardous Waste Pharmaceuticals
From Off-Site Conditionally Exempt Small Quantity Generators (CESQGs)
\79\
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    \79\ Unlike other sub-sections of Section V.C., which discusses
the proposed standards for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals, this sub-section
addresses both non-creditable and creditable hazardous waste
pharmaceuticals.
---------------------------------------------------------------------------

    Typically, hazardous waste pharmaceuticals from healthcare
facilities are transported either to a reverse distributor, if it is
potentially creditable,\80\ or to a permitted or interim

status hazardous waste TSDF. However, stakeholders have informed EPA
that in some cases, hazardous waste pharmaceuticals are transported to
another healthcare facility. We are aware of at least two situations in
which this is occurring. First, patients at long-term care facilities
who receive their pharmaceuticals from an off-site long-term care
pharmacy sometimes return their unused pharmaceuticals to the long-term
care pharmacy.\81\ Upon return, the long-term care pharmacy sorts
through the returned pharmaceuticals to determine whether they will be
disposed or restocked for reuse. Due to many factors, such as Medicare
regulations and the cost of the pharmaceutical as compared to the cost
of repackaging and restocking, only a small fraction of the returned
pharmaceuticals are restocked for potential reuse. One long-term care
pharmacy estimated that approximately 10 percent of the pharmaceuticals
it sends to long-term care facilities come back as returns.\82\ Some
portion of the returns would be considered hazardous waste
pharmaceuticals when discarded.\83\ In the second situation, the Army
has established off-post health clinics to provide easier access to
healthcare for military personnel, including veterans. The pharmacies
at the off-post clinics receive their pharmaceutical products via
couriers that deliver the pharmaceuticals from the on-post, main
pharmacy. The off-post pharmacies also return their unused
pharmaceuticals to the on-post, main pharmacy via courier.
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    \80\ Potentially creditable hazardous waste pharmaceuticals
include pharmaceuticals that are: (1) Unused or un-administered, (2)
unexpired or less than one year past the expiration date; or (3) in
unopened or opened packaging or containers.
    \81\ DEA controlled substances can be returned to a long-term
care pharmacy only if they are subject to a recall (see 21 CFR
1317.85(a)).
    \82\ See notes from 11-15-12 site visit to Omnicare, Inc. in the
docket for this proposed rule (EPA-HQ-RCRA-2007-0932).
    \83\ Due to the DEA regulations, a DEA registered long term care
pharmacy may not accept returns of a controlled substances. DEA
regulations define ``reverse distribute'' and reverse distributor''
in 21 CFR 1300.01. A pharmacy is not authorized to accept returns of
controlled substances from patients or reverse distribute (see 21
CFR 1301.13(e)(1)(iv)).
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    EPA data indicates that the majority of long-term care facilities
are CESQGs \84\ and the Army has informed EPA that their off-post
clinics are generally CESQGs, as well.\85\ The existing CESQG
regulations do not allow a generator to send its hazardous waste off-
site to another hazardous waste generator, unless the receiving
generator is also one of the seven types of facilities listed in Sec.
261.5(f)(3) for acute hazardous waste or Sec.  261.5(g)(3) for
hazardous waste, including municipal and non-municipal non-hazardous
solid waste landfills. The Agency does not think that disposal in
landfills is the best option for hazardous waste pharmaceuticals.
Limited studies have shown active pharmaceutical ingredients are
present in landfill leachate that is collected in municipal solid waste
landfill leachate collection systems.86 87 Landfill leachate
is then typically transported to a wastewater treatment plant for
treatment; however, active pharmaceutical ingredients can pass through
the treatment system and into our Nation's waters.
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    \84\ Under these proposed requirements, hazardous waste
pharmaceuticals will not count towards a facility's generator
category. Therefore, EPA expects that long-term care facilities will
remain CESQGs, even though the Agency is proposing that all
hazardous waste pharmaceuticals generated on the premises must be
managed in accordance with these proposed requirements.
    \85\ See notes from 11-28-12 meeting with U.S. Army Institute of
Public Health in the docket for this proposed rule (EPA-HQ-RCRA-
2007-0932).
    \86\ Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio,
M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and Barber, L. B.
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants
Within a Leachate Plume Downgradient of a Municipal Landfill.
Groundwater Monitoring & Remediation, 24: 119-126.
    \87\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T.,
Zaugg, S.D., and Meyer, M.T. (June 2009), Waste-Indicator and
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental
Contamination and Toxicology, V82.6:635-659.
---------------------------------------------------------------------------

    EPA thinks it would be preferable to allow healthcare facilities
that are CESQGs to send their hazardous waste pharmaceuticals to
another healthcare facility rather than send it to a municipal or non-
municipal non-hazardous solid waste landfill. Therefore, EPA is
proposing to allow healthcare facilities that are CESQGs operating
under this subpart to send their hazardous waste pharmaceuticals to an
off-site healthcare facility, without a hazardous waste manifest,
provided four conditions are met. First, the receiving healthcare
facility must be contracted to supply pharmaceutical products to the
CESQG long-term care facility, or the CESQG healthcare facility and the
receiving healthcare facility must both be under the control \88\ of
the same person, as defined by Sec.  260.10 (e.g., the Army). Second,
the receiving healthcare facility must be managing its hazardous waste
pharmaceuticals in accordance with the regulations of this proposed
rule.\89\ Third, the hazardous waste pharmaceuticals from the CEQSG
must be managed by the receiving healthcare facility as hazardous waste
pharmaceuticals in accordance with the regulations of this proposed
rule once it arrives at the receiving healthcare facility. Fourth, the
receiving healthcare facility must keep and maintain records of the
hazardous waste pharmaceuticals received from the off-site CESQG
healthcare facilities for three years from receipt of shipment. These
conditions should ensure the proper management of the hazardous waste
pharmaceuticals, in that once they are received by the healthcare
facility, they are subject to the same management standards EPA is
proposing for hazardous waste pharmaceuticals managed by healthcare
facilities, while at the same time would not impose an undue burden on
healthcare facilities that are CESQGs, especially since these
healthcare facilities always have the option of sending their hazardous
waste pharmaceuticals to a municipal or non-municipal solid waste
landfill.
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    \88\ For purposes of this provision, ``control'' means the power
to direct the policies of the healthcare facility, whether by the
ownership of stock, voting rights, or otherwise, except that
contractors who operate facilities on behalf of a different person
shall not be deemed to control such healthcare facility.
    \89\ This condition is only applicable if the receiving
healthcare facility is also a CESQG, since healthcare facilities
that are SQGs and LQGs must comply with the requirements proposed in
40 CFR part 266 subpart P.
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    The Agency solicits comment on this new provision under this
subpart, including whether any additional conditions should be imposed.
In recommending any additional conditions, the Agency requests that
commenters provide their rationale for the additional condition(s), as
well as why such additional condition(s) would not pose an undue burden
on healthcare facilities that are CESQGs. In addition, the Agency
solicits comment on whether it might be appropriate to allow
facilities, other than those meeting the proposed definition of a
healthcare facility, to accept hazardous waste pharmaceuticals from an
off-site CESQG (e.g., a military medical logistics facility).

D. How does this proposed rule address healthcare facilities that
accumulate potentially creditable hazardous waste pharmaceuticals prior
to shipment to pharmaceutical reverse distributors?

1. Potentially Creditable Hazardous Waste Pharmaceuticals Are Not
Products
    One difference between this proposal and the 2008 Pharmaceutical
Universal Waste proposal is the proposed interpretation of how RCRA
applies to pharmaceuticals that are returned to reverse distributors to
obtain manufacturers' credit. Two previous agency policy memos set out
EPA's existing understanding of the status of these ``creditable''
pharmaceuticals. The

first, a letter to Merck Sharp & Dohme in 1981, explained that
pharmaceuticals sent for credit may be reclaimed and are not wastes
since the decision to discard a particular material does not occur
until after the product has been returned to the manufacturing
plant.\90\ The second, a letter to BFI Pharmaceutical Services, Inc. in
1991 states, ``to the extent that the materials involved are unused
commercial chemical products with a reasonable expectation of being
recycled in some way when returned, the materials are not considered as
wastes until a determination has been made to discard them.'' \91\ In
addition to these letters, EPA's 2008 Pharmaceutical Universal Waste
proposal stated, ``Because unused or expired pharmaceuticals are
returned (via the reverse distributor) for possible manufacturer's
credit, they still have potential value to the pharmacy or hospital and
are thus not considered wastes.'' \92\
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    \90\ Alan Corson to Steven Wittner on May 13, 1981 (RCRA Online
#11012) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/B630CD51DC85EDC58525670F006BCE84/
$file/11012.pdf.
    \91\ Sylvia Lowrance to Mark J. Schulz on May 16, 1991 (RCRA
Online #11606) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/A3A7A7A8F297438B8525670F006BE5D8/
$file/11606.pdf.
    \92\ 73 FR 73525; December 2, 2008.
---------------------------------------------------------------------------

    In this action, we are proposing to modify EPA's position regarding
the waste status of creditable pharmaceuticals. Because we understand
that many participants in this sector have relied on the
interpretations in the two letters and the 2008 Pharmaceutical
Universal Waste preamble, we are providing notice of a change in EPA's
position and providing an opportunity for public comment. Until this
rule is final and effective, however, EPA's previous interpretations
will continue to be in effect.
    In terms of the concept that returned pharmaceuticals have value
and are not waste, EPA confirms the general rule under RCRA that
materials that are discarded are solid wastes, regardless of the
economics of the system in which those discarded materials are handled.
Therefore, the fact that a material may have monetary value (e.g.,
through a manufacturer's credit) does not determine whether that
material is a solid waste. Rather, the ``decision point'' on whether a
pharmaceutical is a solid waste is when it has been discarded, or the
decision has been made to discard the material. That is, a discarded
pharmaceutical may retain value in the reverse distribution system, but
still be considered a solid waste. Additionally, the economic value of
hazardous waste can be one important consideration in determining
whether a hazardous waste is legitimately recycled (see, for example,
the discussion of Useful Economic Information in the 2008 Definition of
Solid Waste final rule, 73 FR 84706-07, October 30, 2008) and therefore
excluded from being a solid waste. The definition of legitimate
recycling is codified at 40 CFR 260.43 and is discussed in the 2015
Definition of Solid Waste final rule (80 FR 1694, January 13, 2015).
    Commenters to the 2008 Pharmaceutical Universal Waste proposal, the
2014 Retail Notice of Data Availability (NODA), stakeholders, and
pharmaceutical reverse distributors themselves have informed EPA that
pharmaceuticals transported to reverse distributors to receive credit
are rarely, if ever, repurposed, recycled, or reused. One commenter
wrote, ``. . . EPA's belief that reverse distributors first arrange to
transport and receive the drugs, and then determine whether the drugs
are useful products or wastes, is pure fiction.'' \93\ Another
commenter wrote, ``. . . the vast majority of the returned
pharmaceuticals are to be collected for disposal or destruction once
credit has been given.'' \94\ A third commenter wrote, ``. . . drugs
sent through reverse distribution are not reused or recycled due to
economic and safety reasons.'' \95\ Regulations pertaining to the
repurposing of pharmaceuticals vary by state, as they are established
by each state's Board of Pharmacy. However, stakeholders have
overwhelmingly declared that state Boards of Pharmacy only allow
pharmaceuticals to be repurposed under very narrow circumstances--that
is, when a specific set of conditions are followed to ensure the
viability and integrity of the pharmaceutical. The set of conditions
vary by state; however, states have some restrictions in common when it
comes to repurposing drugs. According to the National Conference of
State Legislatures (NCSL), ``Virtually all [state] laws include some
restrictions designed to assure purity, safety and freshness of the
products. Unless otherwise noted, all programs require:
---------------------------------------------------------------------------

    \93\ Comment EPA-HQ-RCRA-2007-0932-0125.
    \94\ Comment EPA-HQ-RCRA-2007-0932-0068.
    \95\ Comment EPA-HQ-RCRA-2012-0426-0025.
---------------------------------------------------------------------------

    [ssquf] All donated drugs must not be expired and must have a
verified future expiration date.
    [ssquf] Controlled substances, defined by the federal Drug
Enforcement Administration (DEA) usually be excluded and prohibited.
    [ssquf] A state-licensed pharmacist or pharmacy to be part of the
verification and distribution process.
    [ssquf] Each patient who is to receive a drug must have a valid
prescription form in his/her own name.'' \96\
---------------------------------------------------------------------------

    \96\ Content is copied from http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx (accessed
May 13, 2015).
---------------------------------------------------------------------------

    Thus, in most, if not all cases, pharmaceuticals that are
transported back to a reverse distributor for credit are discarded by
the reverse distributor.\97\ For that reason, the decision to send a
pharmaceutical to a reverse distributor is essentially a decision to
discard the pharmaceutical.
---------------------------------------------------------------------------

    \97\ Any facility, including a pharmaceutical manufacturer
engaged in processing pharmaceutical hazardous waste for
facilitation or verification of manufacturer's credit would be
considered a pharmaceutical reverse distributor under the proposed
rule with respect to those operations, and would be subject to the
proposed regulations for pharmaceutical reverse distributors.
---------------------------------------------------------------------------

    Therefore, EPA is proposing to reinterpret its position such that
the decision to send a pharmaceutical to a reverse distributor is the
point at which a decision has been made to discard the pharmaceutical.
As a result, once the decision is made to send a hazardous waste
pharmaceutical to a reverse distributor, it is a solid waste at the
healthcare facility. In this document, EPA is proposing to define the
term ``potentially creditable hazardous waste pharmaceutical.'' A
portion of the potentially creditable pharmaceuticals at healthcare
facilities that are transported to reverse distributors will likely
meet the definition of hazardous waste. Of the set of pharmaceuticals
that are hazardous wastes, only ``potentially creditable'' hazardous
waste pharmaceuticals may be transported to a reverse distributor for
manufacturer's credit (see definition Section V.A.3).
    The Agency notes that the management standards discussed below
pertain only to potentially creditable hazardous waste pharmaceuticals
that are managed via reverse distribution and do not apply to the
reverse distribution or reverse logistics systems that may exist for
other consumer products. In addition to the standards discussed in this
section, EPA is proposing standards for shipping potentially creditable
hazardous waste pharmaceuticals to pharmaceutical reverse distributors
as well as associated recordkeeping (see Section V.F.2. of the
preamble).
2. Hazardous Waste Determination for Potentially Creditable Hazardous
Waste Pharmaceuticals
    As with non-creditable hazardous waste pharmaceuticals discussed

previously, a healthcare facility must determine which potentially
creditable pharmaceuticals are listed or characteristic hazardous
wastes, in order to determine which potentially creditable
pharmaceuticals are subject to regulation under this subpart.
Potentially creditable hazardous waste pharmaceuticals must be managed
under this subpart, while pharmaceuticals that do not meet the
definition of hazardous waste but are potentially creditable, do not
have to be managed under this subpart. However, a healthcare facility
may choose to manage all of its potentially creditable pharmaceuticals
(both hazardous and non-hazardous) as potentially creditable hazardous
waste pharmaceuticals while accumulating on-site and when shipping off-
site. If a healthcare facility chooses this approach, it would not need
to make individual hazardous waste determinations, but would have made
a generic decision that all of their potentially creditable waste
pharmaceuticals are hazardous and manage them as potentially creditable
hazardous waste pharmaceuticals in accordance with the proposed
requirements in 40 CFR part 266, subpart P.
3. Accumulation Time, Container Management, and Labeling for
Potentially Creditable Hazardous Waste Pharmaceuticals at Healthcare
Facilities
    Typically, EPA requires specific management standards for
containers that hold hazardous waste. However, potentially creditable
hazardous waste pharmaceuticals appear to pose lower environmental risk
of release than patient care hazardous waste pharmaceuticals or
traditional industrial hazardous waste. The risk of release is lower
for several reasons. First, potentially creditable hazardous waste
pharmaceuticals that are prepared for shipment to a reverse distributor
are usually in their original containers as well as outer packaging,
providing two layers of protection from leaks or spills.\98\ Second,
potentially creditable hazardous waste pharmaceuticals are typically
generated in the pharmacy area of a healthcare facility where there is
restricted access, creating a layer of security for these
pharmaceuticals. Third, EPA has been informed that it is common
practice at healthcare facilities for potentially creditable
pharmaceuticals that are destined for a reverse distributor to be taken
from the shelves of the pharmacy periodically and promptly boxed for
off-site shipment. EPA anticipates that this relatively quick timing is
largely driven by the economic value of the manufacturer's credit for
the returned pharmaceuticals. Therefore, because of the lower risk
these pharmaceuticals pose, EPA is not proposing specific management
standards for healthcare facilities that accumulate containers of
potentially creditable hazardous waste pharmaceuticals. For the same
reasons, we also are not proposing a limit on how long healthcare
facilities may accumulate containers of potentially creditable
hazardous waste pharmaceuticals. EPA requests comment on the assumption
that healthcare facilities promptly remove potentially creditable
hazardous waste pharmaceuticals from pharmacy shelves and send them to
reverse distributors. EPA asks for comment on whether the expectation
of credit provides sufficient incentive to ensure that the hazardous
waste pharmaceuticals will be managed appropriately or whether it is
necessary to establish management standards and/or a maximum time limit
for the accumulation of potentially creditable hazardous waste
pharmaceuticals prior to off-site shipment.
---------------------------------------------------------------------------

    \98\ See 73 FR 73529; December 2, 2008.
---------------------------------------------------------------------------

    In the 2008 Pharmaceutical Universal Waste proposal, EPA
specifically solicited comment on whether stakeholders have knowledge
of problems with mixing incompatible pharmaceuticals during
accumulation. In response, one commenter indicated that there were no
issues encountered with the compatibility of pharmaceuticals during
storage.\99\ Since then, a 2011 article by Charlotte Smith states,
``oxidizers, acids, and bases also are incompatible, but they occur
infrequently as finished dosage forms.'' \100\ It is important to note
that the accumulation of some potentially creditable hazardous waste
pharmaceuticals, such as liquids and aerosols, may pose more of a risk
than solid pills due to possible spillage or leakage. However, EPA
believes that the small quantities in which the liquid and aerosol
potentially creditable hazardous waste pharmaceuticals are generated,
along with the DOT packaging requirements (49 CFR parts 173, 178, and
180), would likely obviate these risks. In addition, to further
mitigate the potential for spillage or leakages, as a best management
practice, EPA encourages healthcare facilities to place the original
containers and packaging containing liquids and aerosols
pharmaceuticals in separate individual containers, such as a sealed
storage bag before placing them in the container that will be shipped.
---------------------------------------------------------------------------

    \99\ Commenter #EPA-HQ-RCRA-2007-0932-0091.
    \100\ Charlotte Smith, RPH, MS; Managing Pharmaceutical Waste: A
New Implementation Blueprint; Pharmacy Practice News, Special
Edition, 2011.
---------------------------------------------------------------------------

    EPA also is proposing not to require specific labeling standards
for containers holding potentially creditable hazardous waste
pharmaceuticals, while they accumulate on-site. EPA does not want to
deter the practice of co-mingling potentially creditable hazardous
waste pharmaceuticals with potentially creditable non-hazardous waste
pharmaceuticals since both are typically transported to a reverse
distributor together.
    In addition, due to concerns regarding diversion of
pharmaceuticals, EPA believes that it is safer not to call attention to
the fact that these containers hold pharmaceuticals. Unlike floor waste
or patient care pharmaceutical waste, or most hazardous waste, the
hazardous waste pharmaceuticals returned to a reverse distributor often
have high street value that makes them susceptible to diversion. Thus,
EPA is not proposing to require a label for potentially creditable
hazardous waste pharmaceuticals during accumulation at a healthcare
facility. The Agency seeks comment on its proposal not to require
specific accumulation, container management or labeling standards for
potentially creditable hazardous waste pharmaceuticals that will be
transported to a reverse distributor, including no specific labeling
standards for containers holding potentially creditable hazardous waste
pharmaceuticals on-site prior to shipment off-site.

E. What are the proposed novel prohibitions, exemptions and other
unique management requirements for hazardous waste pharmaceuticals?

1. Sewer Disposal Prohibition
    a. Regulatory background on the domestic sewage exclusion. Under
RCRA and the Subtitle C hazardous wastes regulations, if a material is
not a solid waste, then it cannot be considered a hazardous waste.
Under Sec.  261.4(a)(1)(ii) of the RCRA regulations, ``Any mixture of
domestic sewage and other wastes that passes through a sewer system to
a publicly-owned treatment works for treatment'' is not a solid waste
for purposes of Subtitle C regulation. This exclusion was finalized by
EPA on May 19, 1980, based on the reasoning that ``Mixed waste streams
that pass through sewer systems to publicly-owned treatment works
(POTW's) will be subject to controls under the Clean

Water Act. The Agency's construction grants program provides financial
assistance for the proper treatment of these wastes. In addition, the
Agency's pretreatment program provides a basis for EPA and the local
communities to ensure that users of sewer and treatment systems do not
dump wastes in the system that will present environmental problems''
(45 FR 33097).
    In 1984, Congress enacted the Hazardous and Solid Waste Amendments
(HSWA) to the Solid Waste Disposal Act (SWDA), as amended by RCRA. HSWA
included a new Section 3018, entitled Domestic Sewage. This section
directed EPA to do two things with respect to the 261.4(a)(1)(ii)
exclusion for mixtures of domestic sewage and other wastes: (1) Submit
a Report to Congress (RTC) that describes the types, size and number of
generators which dispose of such wastes in this manner, the types and
quantities of wastes disposed of in this manner, and identify
significant generators, wastes and waste constituents not regulated
under existing Federal law or regulated in a manner sufficient to
protect human health and the environment; and (2) based on the report,
revise the existing regulations that are necessary to ``ensure that
substances . . . which pass through a sewer system to a publicly owned
treatment works are adequately controlled to protect human health and
the environment.''
    EPA submitted its Report to Congress on February 7, 1986 (Domestic
Sewage Study). Subsequent to the Report to Congress, EPA issued an
advance notice of proposed rulemaking (ANPR) on August 22, 1986 (51 FR
30166); a response to comments on the ANPR on June 22, 1987 (52 FR
23477); a notice of proposed rulemaking (NPR) on November 23, 1988 (53
FR 47632); and a final rule on July 24, 1990 (55 FR 30082). That final
rule prohibits the discharge of pollutants which create a fire or
explosion hazard in the POTW, which includes, but is not limited to,
wastestreams with a closed cup flashpoint of less than 140 degrees
Fahrenheit or 60 degrees Celsius using the test methods specified in 40
CFR 261.21'' (55 FR 30087). Although the exclusion for mixtures of
domestic sewage and other wastes is found under the RCRA regulations in
Sec.  261.4(a)(1)(ii), the sewer ban of liquid ignitable hazardous
wastes (i.e., with the hazardous waste code D001) was established under
40 CFR 403.5(b)(1), which is under the Clean Water Act (CWA)
regulations. The Agency seeks comment on whether it would be helpful to
incorporate in 40 CFR 261.4(a)(1)(ii), a cross-reference to the CWA
regulations prohibiting the sewering of liquid ignitable hazardous
wastes.
    b. Prevalence of flushing in lieu of hazardous waste management. In
the preamble to the July 1990 final rule, EPA stated its intent ``to
carefully review the effect of this rule and promulgate in the future
any additional regulations that experience reveals are necessary to
improve control over hazardous waste and other industrial user
discharges to POTWs'' (55 FR 30084). Since then, studies have found
that many healthcare facilities, particularly long term-care
facilities, use drain disposal as a routine disposal method for
pharmaceutical wastes in lieu of collection and shipment off-site for
management. For example,
     A 2008 study of 59 long-term care facilities showed that
46 percent of the long-term care facilities dispose of their
pharmaceuticals by dumping them down the drain.\101\
---------------------------------------------------------------------------

    \101\ Kansas State University. January 31, 2008. Nancy J.
Larson. Pharmaceutical Waste Outreach Project.
---------------------------------------------------------------------------

     A 2003 King County, Washington survey of healthcare
facilities showed that the vast majority of liquids, and nearly half of
the pills, were disposed of down the drain.\102\
---------------------------------------------------------------------------

    \102\ King County Pharmaceutical Waste Survey Final Report. King
County, Washington. April 2003.
---------------------------------------------------------------------------

     In a study by The Albany Medical Center, funded by an EPA
Pollution Prevention Grant, the author states, ``up to now, toilet
wasting has been the common practice for drug wasting by patient care
staff.'' \103\
---------------------------------------------------------------------------

    \103\ The Albany Medical Center, October 29, 2009, Russell F.
Mankes, Progress Report on the Source Reduction Demonstration
Project, EPA Grant #X9-97256506-0.
---------------------------------------------------------------------------

     In a detailed study about the waste management practices
within the healthcare industry, EPA's Office of Water also found that
sewering of waste pharmaceuticals was common practice.\104\
---------------------------------------------------------------------------

    \104\ Health Services Industry Study: Management and Disposal of
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
---------------------------------------------------------------------------

     EPA staff from the Office of Research and Development
(ORD) have published numerous articles on the subject of active
pharmaceutical ingredients (APIs) in the environment. One such paper
states that ``unit-packaged pills are probably not frequently disposed
via toilets, whereas liquids are probably routinely poured down
drains,'' although the authors acknowledge that ``gaining an
understanding of the types and quantities of APIs introduced directly
and purposefully to the environment by the disposal of unwanted,
leftover drugs has been more problematic because of a dearth of
comprehensive or reliable data.'' \105\
---------------------------------------------------------------------------

    \105\ Ruhoy and Daughton; Beyond the medicine cabinet: An
analysis of where and why medications accumulate; Environment
International 34(2008) 1157-1169.
---------------------------------------------------------------------------

    c. Inadequacy of POTW treatment to remove pharmaceuticals. Under
the Clean Water Act (CWA), EPA establishes national regulations (called
effluent limitations guidelines and pretreatment standards) to reduce
discharges of pollutants from industries to surface waters and POTWs.
However, there are currently no national effluent limitations or
pretreatment standards that apply to discharges of pharmaceuticals by
healthcare facilities to POTWs. Furthermore, traditional wastewater
treatment operations implemented in the 1970s and 1980s at POTWs are
designed to remove conventional pollutants, such as suspended solids
and biodegradable organic compounds. They are not designed to remove
pharmaceuticals that are present in discharges from medical and
veterinary facilities. While some POTWs may have implemented advanced
treatment technologies at their facilities, these technologies are also
not designed to remove pharmaceuticals. EPA released a study in 2009 in
which over 100 chemicals (including some pharmaceuticals) were analyzed
in the influent and effluent at nine POTWs.\106\ Although it was a
limited study and difficult to generalize the results to all POTWs, it
does indicate that the capabilities of treatment technologies currently
employed by POTWs does not include treatment to remove APIs.\107\ In
addition, as stated in the Health Services Industry study, ``synthetic
compounds, such as pharmaceuticals, are often manufactured to be
resistant to metabolic transformation. As a result, some pharmaceutical
compounds that are present in the influent to POTWs may pass through
treatment systems at conventional POTWs and discharge to receiving
waters.'' \108\
---------------------------------------------------------------------------

    \106\ EPA, Occurrence of Contaminants of Emerging Concern in
Wastewater from Nine Publicly Owned Treatment Works, August 2009;
EPA-821-R-09-009.
    \107\ Eggen RI, Hollender J, Joss A, Sch[auml]rer M, Stamm C,
``Reducing the Discharge of Micropollutants in the Aquatic
Environment: The Benefits of Upgrading Wastewater Treatment Plant.''
Environmental Science and Technology 2014, 48(14) 7683-7689.
    \108\ Health Services Industry Study: Management and Disposal of
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
---------------------------------------------------------------------------

    d. Adverse impacts to human health and the environment due to
pharmaceuticals in the environment.

The pharmaceuticals entering the environment, through flushing or other
means, are having a negative effect on aquatic ecosystems and on fish
and animal populations. The Regulatory Impact Analysis for this
proposed rulemaking summarizes the scientific literature with regard to
ecological effects (see the Regulatory Impact Analysis in the docket
for this proposed rule EPA-HQ-RCRA-2007-0932). The scientific research
with regard to human health effects due to pharmaceuticals in the
environment is still ongoing. Nevertheless, the important features and
risks of the problem can be summarized as follows: \109\
---------------------------------------------------------------------------

    \109\ A. Ginebreda et al, Environmental risk assessment of
pharmaceuticals in rivers: Relationships between hazard indexes and
aquatic macroinvertebrate diversity indexes in the Llobregat River
(NE Sapin). Environ Int. (2009), doi:10.1016/j.envint.2009.10.003.
---------------------------------------------------------------------------

    (1) Pharmaceuticals are intrinsically bioactive compounds;
therefore, they are potentially able to impact living systems.
    (2) There is a continuous and worldwide increase in their use and,
thus, on their subsequent input into the environment.
    (3) Many of the hundreds of frequently prescribed pharmaceuticals
are known for targeted effects and adverse off-target side effects, a
problem that can be exacerbated by interactive effects during therapy
involving co-administration.
    e. Banning sewering of hazardous waste pharmaceuticals. Given the
demonstrated negative ecological effects and the potential for negative
human health effects, EPA is proposing to impose a sewer ban on all
hazardous waste pharmaceuticals managed by healthcare facilities and
pharmaceutical reverse distributors that are subject to this proposed
rule--that is, they are prohibited from disposing of pharmaceuticals
that are listed hazardous waste and/or exhibit one or more of the four
hazardous waste characteristics (i.e., ignitability, corrosivity,
reactivity, or toxicity) by putting them down a drain (e.g., sink,
toilet, or floor drain).
    In addition, while healthcare facilities that are CESQGs are
generally not subject to this proposed rule, EPA is proposing that the
sewer ban of hazardous waste pharmaceuticals also apply to healthcare
facilities that are CESQGs. The vast majority of healthcare facilities
are CESQGs (84 percent). Some particular types of healthcare facilities
have an even larger proportion of CESQGs: Over 94 percent of dental
offices are CESQGs, and 94 percent of continuing care retirement
communities are CESQGs (see the Regulatory Impact Analysis in the
docket for this proposed rule EPA-HQ-RCRA-2007-0932.
    EPA is concerned that these smaller healthcare facilities are more
likely to dispose of their hazardous waste pharmaceuticals via the
sewer. EPA estimates that there are more than 145,000 healthcare
facilities that are CESQGs. Given this large number, the combined
impact of sewer disposal by healthcare facilities that are CESQGs has
an even greater potential to provide a substantial impact on the
environment, as well as human health.
    EPA solicits comment on EPA's proposal to ban the sewer disposal of
hazardous waste pharmaceuticals at all healthcare facilities, including
healthcare facilities that are CESQGs that generate such wastes. As
part of its solicitation of comments, the Agency especially requests
comment on the risk-risk tradeoffs inherent in prohibiting sewer
disposal, which extends the life cycle of pharmaceutical waste,
resulting in additional opportunities for diversion and increasing the
possibility of inadvertent exposures for certain workers (and possibly
even patients or visitors) as a tradeoff for a reduction in aquatic
risks. EPA also solicits comment on whether the ban on sewer disposal
should be limited to those healthcare facilities that are currently
LQGs and SQGs, and not extended to CESQGs.
    Under 40 CFR 403.12(p) of the CWA regulations, industrial users
that discharge a substance to a POTW that, if otherwise disposed of,
would be a hazardous waste, must notify in writing the POTW, the EPA
Regional Waste Management Division Director and State hazardous waste
authorities. POTWs should be made aware that under this proposal, if
made final, the notifications they receive from healthcare facilities
will no longer include hazardous waste pharmaceuticals since the
healthcare facilities will be prohibited from sewering their hazardous
waste pharmaceuticals.
    We note that EPA's proposed ban on sewering hazardous waste
pharmaceuticals is consistent with other federal and state actions. For
example, the Drug Enforcement Administration (DEA) has finalized new
regulations to implement the Secure and Responsible Drug Disposal Act
of 2010 (September 9, 2014; 79 FR 53520). DEA's new regulations require
a ``non-retrievable'' method of destruction of controlled substances.
The preambles to DEA's proposed and final rules state that flushing
does not meet the non-retrievable standard for destruction.\110\
According to the preamble of the DEA final rule, DEA received 20
comments supporting their position against flushing controlled
substances.\111\ The comments supporting the prohibition against
sewering came from states, regional and local hazardous waste
management programs, recycling associations, non-governmental
organizations (NGOs), trade associations and environmental
organizations. Many of these commenters noted that wastewater treatment
systems do not eliminate many of the drugs that are flushed into the
sewers and requested that DEA clearly state in the regulatory language,
not just preamble, that sewering is not allowable as a means of
destruction.
---------------------------------------------------------------------------

    \110\ Proposed rule: December 21, 2012; 77 FR 75784 (see page
75803) and Final rule: September 9, 2014; 79 FR 53520 (see page
53548).
    \111\ September 9, 2014; 79 FR 53520 (see page 53548).
---------------------------------------------------------------------------

    In addition, three states and the District of Columbia have taken
action to limit the sewering of pharmaceuticals and a third has
introduced a bill. In 2009, Illinois passed the Safe Pharmaceutical
Disposal Act, which prohibits healthcare facilities from flushing any
unused medication into public sewers or septic systems.\112\ In 2012,
New Jersey passed a similar law that prohibits healthcare facilities
from discharging prescription medications into public sewers or septic
systems.\113\ In 2002, California banned the use of lindane in
pharmaceuticals after it found that lindane was adversely impacting
wastewater quality. The authors of the paper ``Outcomes of the
California Ban on Pharmaceutical Lindane: Clinical and Ecologic Impacts
state that ``This is the first time that a pharmaceutical has been
outlawed to protect water quality.'' \114\ After researching and
documenting environmental benefits of the ban, the authors conclude,
``This ban serves as a model for governing bodies considering limits on
the use of lindane or other pharmaceuticals.'' And the District of
Columbia has promulgated municipal regulations, effective January 1,
2011, that prohibits healthcare facilities from flushing pharmaceutical
products.\115\ The Connecticut legislature has also considered a bill
to ban the discharge of medication into public or private waste water
collection systems or septic

systems, although it has not yet become law.\116\
---------------------------------------------------------------------------

    \112\ Illinois Public Act 096-0221.
    \113\ Nicknamed Bateman's Law, after Senator Christopher ``Kip''
Bateman (R-Somerset) that sponsored the legislation.
    \114\ Humphreys, et al. Environmental Health Perspectives. 2008
March; 116(3) 297-302.
    \115\ Title 22-B Chapter 5 Safe Disposal of Unused
Pharmaceuticals in Health Care Facilities.
    \116\ State of Connecticut General Assembly, January Session
2013, Raised Bill No. 6439. An Act Concerning the Disposal and
Collection of Unused Medication.
---------------------------------------------------------------------------

    Finally, we would note that although the sewer ban is limited to
pharmaceuticals that are RCRA hazardous wastes, EPA strongly recommends
as a best management practice to not sewer any waste pharmaceutical
(i.e., hazardous or non-hazardous), except when sewering is
specifically directed by FDA guidance (as noted on pharmaceutical
packaging).\117\
---------------------------------------------------------------------------

    \117\ http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf.
---------------------------------------------------------------------------

    For household pharmaceutical waste, we refer the public to the
guidelines developed by the U.S. Office of National Drug Control Policy
(ONDCP), the FDA, and EPA for the disposal of unwanted household
pharmaceuticals. In summary, these guidelines are as follows:
    (1) Use a drug take-back event or program, when available;
    (2) Dispose in household trash, after mixing the unwanted medicines
with an undesirable substance such as kitty litter or coffee grounds
and placing in a sealed container; and
    (3) Only if the drug label specifically instructs you to, flush the
unwanted medicine down the toilet.\118\
---------------------------------------------------------------------------

    \118\ http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf.
---------------------------------------------------------------------------

2. Conditional Exemption for Hazardous Waste Pharmaceuticals That Are
Also Controlled Substances
    When a pharmaceutical that is discarded is both a hazardous waste
and a controlled substance, its management and disposal is regulated
under both the RCRA Subtitle C hazardous waste regulations, which is
under EPA's or the authorized state's purview, and the Controlled
Substances Act (CSA) and its implementing regulations, which is under
DEA's purview. EPA understands that only a handful of pharmaceuticals
are in common usage that are both hazardous waste and controlled
substances and therefore subject to dual regulation by both EPA and the
DEA. These are identified in Table 5:
[GRAPHIC] [TIFF OMITTED] TP25SE15.003

    Chloral hydrate, U034, is the only dually regulated hazardous
waste/controlled substance that is a listed hazardous waste. It is
listed for toxicity (note that EPA's U034 listing includes chloral
hydrate, see memo dated April 6, 1998; Brandes to Knauss, RCRA Online
#14175). On the other hand, the remaining four dually regulated
hazardous wastes/controlled substances in common use are considered
hazardous because they exhibit the characteristic of ignitibility
(D001). However, the active ingredient is not ignitable, but these
particular forms of the pharmaceuticals are ignitable because they are
prepared in ignitable solutions, such as alcohol.
    EPA is aware of three additional hazardous waste pharmaceuticals
that are DEA controlled substances, but it is our understanding that
they are no longer in common usage, although there may be legacy
supplies remaining in healthcare facilities. See Table 6.

[GRAPHIC] [TIFF OMITTED] TP25SE15.004

    Similarly, as noted in Table 7, phentermine is a controlled
substance, but the medical form is a phentermine salt, and the salts
are no longer considered to be within the scope of the P046 listing
(see memo dated February 17, 2012; from Devlin to RCRA Division
Directors, RCRA Online #14831).
[GRAPHIC] [TIFF OMITTED] TP25SE15.005

    EPA requests comment on whether these are, indeed, the only
pharmaceuticals in common usage that are regulated both as DEA
controlled substances, and when discarded, RCRA hazardous waste.
    Common practices that healthcare facilities have used in the past
in order to comply with the DEA regulations for destroying controlled
substances include sewering and incineration. However, DEA's new
regulation requires that controlled substances must be destroyed, such
that they are ``non-retrievable.'' As discussed previously, the
preambles for DEA's proposed and final rules state that flushing will
not meet their new non-retrievable standard, a position which EPA fully
supports. However, EPA is concerned that flushing will continue to be
used by healthcare facilities for eliminating their controlled
substances. In part, this concern is due to a 2009 EPA report which
concluded, ``controlled substances are the pharmaceuticals most
commonly poured down the drain, especially the partially-used IVs
containing controlled substances.'' \119\ In addition, stakeholders
have informed EPA that it is expensive and difficult to manage
controlled substances that are also hazardous wastes under both DEA and
EPA regulatory schemes and therefore the unintended consequence is that
they are often sewered on-site in order to avoid the expense of
complying with dual regulation en route to incineration.
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    \119\ Pathways for Environmental Releases of Unused
Pharmaceuticals, October 12, 2009, Memo from ERG to EPA, EPA-HQ-OW-
2008-0517-0518.

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    EPA wants to eliminate the flushing of pharmaceuticals in order to
reduce potential environmental contamination. Sewering hazardous wastes
that are ignitable (D001) is already banned and EPA is now proposing to
eliminate the sewering of all other hazardous waste
pharmaceuticals.\120\ To eliminate duplicative regulation and thereby
further reduce the incidence of flushing, EPA is proposing to
conditionally exempt from RCRA Subtitle C regulation those hazardous
wastes that are also DEA controlled substances. Specifically, EPA is
proposing that hazardous wastes that are also controlled substances
will be exempt from all RCRA Subtitle C requirements, including 40 CFR
part 266, subpart P, provided they meet two conditions: (1) They are
combusted at a permitted large or small municipal waste combustor or a
permitted or interim status hazardous waste combustor (incinerator or
cement kiln), and (2) they are managed and disposed of in compliance
with all applicable DEA regulations for controlled substances.
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    \120\ See 40 CFR 403.5 for specific pretreatment prohibitions.
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    The first condition is to ensure that the controlled substances are
destroyed in an environmentally protective manner by a high-temperature
combustor, such as a large or small municipal waste combustor or a
permitted or interim status hazardous waste combustor (incinerator or
cement kiln). The majority of the hazardous wastes that are also
controlled substances are hazardous because they exhibit the
characteristic of ignitability. The best demonstrated available
technology (BDAT) developed for ignitable hazardous waste under the
LDRs includes combustion (see Sec.  268.40). In addition, although
chloral hydrate (U034) is listed because of its toxicity, its BDAT is
also combustion. Therefore, in an effort to eliminate the sewering of
these dually regulated hazardous wastes/controlled substances, and
because combustion of these pharmaceuticals is a suitable technology
for destruction, EPA is proposing to allow the few hazardous wastes
pharmaceuticals that are also controlled substances to be combusted at
municipal solid waste combustors, although as noted previously, a
hazardous waste incinerator (permitted or interim status) would also be
allowed.
    We realize that DEA may allow a technology other than combustion to
be used to destroy controlled substances. However, if the RCRA
hazardous waste pharmaceuticals that are DEA controlled substances are
exempt from RCRA, the other destruction technologies may lack
environmental controls and permits. Therefore, combustion of the
hazardous wastes/controlled substances, which requires permitting,
operating and monitoring standards, is a condition of the exemption.
EPA requests comment on whether there are additional technologies that
would be appropriate to include for the destruction of hazardous waste
pharmaceuticals that are also controlled substances. Under this
proposal, if DEA allows a technology other than incineration for the
destruction of controlled substances, it would be allowed only for DEA
controlled substances, but not for those that are also RCRA hazardous
wastes.
    The second condition is to ensure that dually regulated hazardous
wastes/controlled substances are managed under another rigorous
regulatory program since they will not be managed in accordance with
the RCRA Subtitle C regulations. Although developed for different
reasons, both EPA's hazardous waste and DEA's controlled substance
regulatory programs are designed to track the regulated material from
cradle to grave. DEA regulations have requirements similar to EPA's
hazardous waste manifest. In particular, in order to ship a schedule II
controlled substance, a DEA registrant must submit a DEA Form 222 to
the supplier of the schedule II controlled substance. The DEA Form 222
is a numerically controlled form issued by the DEA to authorized
registrants, containing certain pre-printed information. The supplier
must indicate on the DEA Form 222, the quantity of packages shipped and
the date the packages were shipped. Like a hazardous waste manifest, a
copy of Form 222 must accompany the shipment and it must be kept by
both the supplier and purchaser for at least two years (copies of
manifests must be kept for three years). Suppliers and distributors may
utilize the electronic version of the DEA Form 222, which requires the
same information and retention period. Similarly, DEA Schedule III, IV
and V controlled substances must be accompanied by an invoice, which
also must include a detailed inventory of the contents shipped. A copy
of the invoice must also be retained by the supplier and purchaser of
the controlled substances for a period of two years. EPA believes that
the DEA tracking and shipping requirements are sufficient to act in
lieu of the RCRA hazardous waste manifest and hazardous waste
transporter requirements. EPA requests comment on this assessment.
    DEA has previously stated that controlled substance
``pharmaceutical wastage'' may be disposed of in accordance with
applicable federal, state, and local laws, regulations, and healthcare
facility policies, to include sewering or putting down the drain.\121\
The term ``pharmaceutical wastage'' refers to leftover, unadministered
pharmaceuticals (``e.g., some of the substance remains in a vial, tube,
transdermal patch, or syringe after administration but cannot or may
not be further utilized'' \122\). EPA is proposing that the few
hazardous waste pharmaceuticals that are also controlled substances
would be exempt from RCRA, but only on the condition that they are
incinerated at a permitted hazardous waste or municipal solid waste
incinerator and managed in accordance with DEA regulations. As a
result, if pharmaceutical wastage is both hazardous waste and
controlled substance it would not be allowed to be sewered; it would
have to be incinerated. Prior to incineration, the pharmaceutical
wastage would be exempt from RCRA and could be collected in a container
at the healthcare facility. As an alternative, we request comment on
whether to allow the sewering of the pharmaceutical wastage for the
five hazardous wastes that are also controlled substances. We are
concerned, however, that this alternative approach will lead to the
sewering of all pharmaceutical wastage as healthcare providers are
unlikely to keep track of which hazardous waste pharmaceuticals are
allowed to be sewered and which are not. We request comment on these
approaches for pharmaceutical wastage and request data on the impact on
healthcare facilities of not allowing pharmaceutical wastage to be
sewered.
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    \121\ See DEA letter to registrants re: clarifying disposal of
pharmaceutical wastage dated Oct 17, 2014; http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf.
    \122\ Ibid.
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    a. Long-term care facilities and the DEA final rule. As discussed
previously, EPA is proposing that hazardous waste from long-term care
facilities will no longer be considered exempt as household hazardous
waste. Instead it will need to be managed as regulated hazardous waste.
This interpretation will apply to all the hazardous waste generated by
a long-term care facility, not just its hazardous waste
pharmaceuticals, although the Agency expects that much of the hazardous
waste generated by long-term care facilities consists of hazardous
waste pharmaceuticals. However, there are

two exceptions. First, hazardous waste pharmaceuticals that are also
controlled substances will not be subject to RCRA, provided they meet
two conditions: (1) They are combusted at a permitted large or small
municipal waste combustor or a permitted or interim status hazardous
waste combustor (incinerator or cement kiln), and (2) they are managed
and disposed of in compliance with all applicable DEA regulations for
controlled substances. Second, as discussed previously, EPA estimates
that only 28% of long-term care facilities generate hazardous waste
pharmaceuticals and of those, 85% generate small enough quantities of
hazardous waste that they will qualify as CESQGs and will be subject to
the reduced regulatory requirements of 40 CFR 261.5, and only the sewer
ban provision of this new subpart.\123\
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    \123\ See the docket for this rulemaking for data about long-
term care facilities which was developed using data in the economic
analysis: EPA-HQ-RCRA-2007-0932.
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    DEA's new regulations to implement the Secure and Responsible Drug
Disposal Act of 2010 are expected to help alleviate the problem that
long-term care facilities face when discarding controlled substances.
DEA's new regulations allow retail pharmacies and hospital/clinics with
an on-site pharmacy that are DEA registrants to modify their
registrations and become ``collectors'' to place collection receptacles
at long-term care facilities (or at the retail pharmacy or hospital/
clinic with an on-site pharmacy) for the collection of controlled
substances from ultimate users (i.e., consumers).
    Under the new DEA regulations, long-term care facilities have three
options, two of which are new, for managing their patients' controlled
substances. First, if a DEA registered retail pharmacy or hospital/
clinic with an on-site pharmacy places a collection container at a
long-term care facility, the staff from the long-term care facility may
place the patients' controlled substances in the collection
receptacles. Second, although long-term care facilities will not be
able to conduct collection events for their patients' controlled
substances for mail-back programs, they will be allowed to assist
patients who choose to use a mail-back program for their own controlled
substances, on an individual-by-individual basis. And third, law
enforcement will continue to be allowed to pick up patients' controlled
substances for disposal. With these changes to DEA's regulation, long-
term care facilities can now dispose of patients' controlled substances
in a more environmentally protective way. Because we are proposing that
hazardous waste pharmaceuticals that are also controlled substances are
conditionally exempt from RCRA, these wastestreams may also be managed
in any of these three ways allowed by DEA, provided the waste is
managed to meet the conditions of the RCRA conditional exemption.
    The new DEA regulations do not mandate the placement of collection
receptacles or patient participation in mail-back programs or take-back
events. However, if long-term care facilities are prohibited from
disposing of pharmaceuticals down the toilet or drain under RCRA (and
as a method of destruction under DEA regulations), then the only way
for patients at long-term care facilities to lawfully dispose of DEA
controlled substances that are also RCRA hazardous wastes would be
through participation in one of DEA's collection methods. Long-term
care facilities are allowed to place patients' hazardous waste
pharmaceuticals that are controlled substances in the DEA collection
receptacles; the other hazardous waste pharmaceuticals generated by
long-term care facilities must be managed under the proposed RCRA
management standards for healthcare facilities. However, we note that
if the long-term care facility is a CESQG, we are proposing as an
acceptable method of disposal of the long-term care facility's
hazardous waste pharmaceuticals would be to place them in a DEA
collection receptacle, even if they are not controlled substances (see
Sec.  266.504(b)). DEA already allows controlled substances to be co-
mingled with non-controlled substances. Therefore, EPA believes it is
consistent to allow CESQG hazardous waste pharmaceuticals that are not
controlled substances to be placed in DEA collection receptacles with
controlled substances. EPA believes that management of CESQGs'
hazardous wastes as DEA controlled substances is preferable to
management as municipal solid waste because it provides greater
protection to patients, visitors and workers at long-term care
facilities to have the hazardous waste pharmaceuticals in DEA
collection receptacles rather than in the regular trash. See Table 8
for a summary of the intersection of RCRA and DEA regulations for the
disposal of hazardous waste pharmaceuticals at long-term care
facilities:

                          Table 8--RCRA & DEA Regulations at Long-Term Care Facilities
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                                                                 Regulatory requirements
Types of pharmaceutical waste at long- -------------------------------------------------------------------------
         term care facilities                                      DEA Authorized collection methods allowed for
                                                   RCRA                      patients' pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Hazardous Waste Pharmaceuticals that    Conditionally exempt from  Yes.
 are also Controlled Substances.         RCRA.
Hazardous Waste Pharmaceuticals that    .........................  .............................................
 are not Controlled Substances.
if LTCF is a CESQG....................  261.5 and sewer ban......  Yes.
if LTCF is not a CESQG................  Part 266, subpart P......  No.
----------------------------------------------------------------------------------------------------------------

    b. Household hazardous waste collected in DEA authorized collection
receptacles. In response to questions that EPA has received since the
DEA rule was published, we are taking this opportunity to clarify the
current RCRA regulatory status of the pharmaceuticals collected in DEA
authorized collection receptacles. DEA's regulations allow the co-
mingling of controlled substances and non-controlled substances in its
collection receptacles. In some instances, the pharmaceuticals that are
collected by retail pharmacies and law enforcement in DEA authorized
collection receptacles may contain pharmaceuticals that are RCRA
hazardous waste. However, as household wastes, these hazardous waste
pharmaceuticals would be excluded from regulation by

Sec.  261.4(b)(1) because the exclusion applies even when the household
hazardous wastes are collected. It is important to note that in order
to maintain the exclusion, a retail pharmacy (or other DEA authorized
collector pharmacy) can use the DEA authorized collection receptacle to
collect waste generated only at households and brought to the store for
collection. The hazardous waste generated by the retail pharmacy and