pharmaceuticals. This addition allows healthcare facilities that are
VSGQs two options for where to send their potentially creditable
hazardous waste pharmaceuticals. The first option is to send them
directly to a reverse distributor.\232\ The second option is to send
them to a healthcare facility operating under part 266 subpart P,
provided the receiving facility meets the conditions of 266.503(b)(1)-
(4).
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    \232\ As allowed by 40 CFR 266.504(a).
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    The third change related to off-site consolidation of hazardous
waste pharmaceuticals is to add paragraph Sec.  262.14(a)(5)(x).
Section 262.14(a)(5) of the VSQG regulations consists of a list of
types of facilities to which VSQGs can send their hazardous waste.
Section 262.14(a)(5)(viii) allows VSQGs to send their hazardous waste
to large quantity generators under the control of the same person as
the VSQG, provided certain conditions are met. This provision is
similar to the provision we are finalizing in this rule for healthcare
facilities that are VSQGs. Therefore, for consistency, we have added
paragraph (x) to the list of facilities in Sec.  262.14(a)(5) such that
a healthcare facility that is a VSQG can send its non-creditable
hazardous waste pharmaceuticals and potentially creditable hazardous
waste pharmaceuticals to an off-site healthcare facility (as defined in
Sec.  266.500) that meets the conditions in Sec.  266.502(l) and Sec.
266.503(b), as applicable.
4. Comments and Responses
    Some states and pharmacists noted that language in the first
condition may have the unintended consequence of prohibiting healthcare
facilities from consolidating their hazardous waste pharmaceuticals due
to their relationship with the consolidating facility. The first
condition that a receiving healthcare facility must be under the
control of the same person or contracted to supply pharmaceutical
products to the VSQG's LTCF might prevent some long-term care
facilities from taking advantage of this provision. Long-term care
facilities that would otherwise be eligible to take advantage of this
exclusion might not use it since CMS does not prevent long-term care
facilities and/or their residents from using more than one long-term
care pharmacy. This allows the long-term care facilities and the
residents to shop for the ``best and most competitive'' pricing for
medications and to change as needed.\233\ Commenters believed that
adding ``business relationship'' in addition to a contractual
relationship for the healthcare facility and receiving facility to both
be under the control of the same person would relieve this concern.
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    \233\ https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html.
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    Furthermore, pharmacists raised the concern that a long-term care
pharmacy would not want to take responsibility for returned
pharmaceuticals under this condition as proposed unless they could
confirm that they were the ones that distributed the pharmaceuticals in
the first place (a receipt of purchase or similar documentation), since
the management of these wastes is costly and may not be covered by the
various healthcare programs. According to the CMS website, the managing
of returned pharmaceuticals at long-term care pharmacies varies from
state to state and is not a specific requirement of the Medicare/
Medicaid program.\234\ This consolidation provision was created so that
VSQGs could consolidate their hazardous waste pharmaceuticals for
proper management. If the provision as written is preventing long-term
care facilities from potentially consolidating their hazardous waste,
then it is thwarting the intended outcome of this provision and that is
why EPA decided to add ``business relationship'' to the first condition
for VSQG consolidation.
---------------------------------------------------------------------------

    \234\ https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html.
---------------------------------------------------------------------------

    One state commenter recommended that the receiving healthcare
facilities must either be an LQG or comply with the LQG requirements
under part 262, since LQGs have more protective management standards
during accumulation. First, under part 266 subpart P, healthcare
facilities do not

have a generator category for their hazardous waste pharmaceuticals;
all healthcare facilities are regulated the same under part 266 subpart
P. Second, if EPA limited this consolidation provision to LQGs, then
there would be a very small subset of receiving healthcare facilities
that would be able to take advantage of this provision. Since subpart P
allows healthcare facilities operating under this subpart to not count
their hazardous waste pharmaceuticals towards their generator category,
some healthcare facilities may no longer be LQGs for their other
hazardous waste. It is highly unlikely that a long-term care pharmacy
would remain an LQG under this rule since the majority of the hazardous
waste that would be handled at these pharmacies would be
pharmaceuticals. If we were to limit this provision to only LQG
receiving facilities, then we would be preventing LTCFs from
consolidating at long-term care pharmacies. Therefore, we determined
that requiring the receiving facilities to be LQGs or to comply with
LQG standards as a condition of the consolidation provision would
severely limit the value of this provision.
    In addition, the Agency is not finalizing a requirement for
healthcare facilities that receive hazardous waste pharmaceuticals from
VSQG healthcare facilities to manage the received pharmaceutical waste
under the part 262 LQG standards. The Agency does not see the necessity
in having more stringent management standards for healthcare facilities
that receive pharmaceutical waste, because subpart P management
standards are the same for all non-VSQG healthcare facilities,
regardless of the amount of hazardous waste pharmaceuticals they
generate. The Agency has determined that the subpart P standards are
sufficiently protective of human health and the environment since all
pharmaceuticals at a receiving healthcare facility must be managed
under the same subpart P standards, regardless of whether they were
generated on site or received from off site. If a state determines that
the standards being finalized for healthcare facilities that receive
hazardous waste pharmaceuticals from off-site are not adequate, that
state may implement its own standards, provided they are more
stringent.
    The waste management industry, as well as some states, recommended
that EPA require a notification when a facility was receiving hazardous
waste pharmaceuticals and at least some minimal requirements for
labeling, recordkeeping, and documentation of shipments. One state also
recommended that we issue licenses to facilities that were receiving
hazardous waste pharmaceuticals in order to track who was taking
advantage of this provision. Consistent with our rationale for the
limited shipping requirements for ``potentially creditable hazardous
waste pharmaceuticals'' in this rule, the Agency believes that the
shipping of hazardous waste pharmaceuticals poses a relatively low risk
of release to the environment but a high risk for diversion of the
pharmaceuticals when labeled ``pharmaceuticals.'' The hazardous waste
that are being shipped often are in pill form or blister packs and not
fifty-gallon drums of liquids that can be easily spilled. They are not
likely to pose the same risks that typical hazardous waste could cause
during shipping and transport, but there is a real risk to them being
stolen if attention is brought to the contents of the containers. If
the four conditions are met, the Agency believes this ensures the
proper management of hazardous waste pharmaceuticals and adding new
labeling and shipping requirements is unnecessary to accomplish that
goal. Furthermore, the part 262 VSQG regulations do not require
labeling or recordkeeping, and VSQGs might not take advantage of this
consolidation provision if the requirements are too onerous, thus
continuing to put their hazardous waste pharmaceuticals in municipal
solid waste landfills.
    The waste management industry asked for clarification on hazardous
waste pharmaceuticals consolidation across state lines that have
different requirements for VSQGs. There is nothing in this section that
prevents a healthcare facility from sending their hazardous waste
pharmaceuticals to a healthcare facility in another state provided both
states have adopted this provision. Each state has their own
requirements, so it would be prudent for VSQG healthcare facilities to
make sure that the state in which they are consolidating has adopted
this provision and does not impose any additional requirements on the
receiving healthcare facility that accepts this waste.
    EPA also received comments on what types of facilities could take
advantage of this provision, specifically whether this provision will
include wholesale drug distribution centers. In the final rule, EPA has
defined wholesale distributors as a type of healthcare facility under
Sec.  266.500. Wholesale distributors were not an example that was
given to us at proposal for this consolidation provision, but if all
four conditions were met and there was a contractual or business
relationship between the VSQG healthcare facility and the wholesale
distributor, they would not be precluded from using this provision.
However, we would note that when a wholesale distributor receives
hazardous waste pharmaceutical return from a healthcare facility, the
pharmaceuticals are usually restocked, which means they are
pharmaceutical products and not hazardous waste pharmaceuticals.
    Lastly, a non-profit organization asked us to clarify if these
consolidated hazardous waste pharmaceuticals would be eligible for
redistribution or evaluation for donation once consolidated to the
receiving facility. In regard to redistribution or evaluation for
donation, if the receiving healthcare facility can lawfully donate or
redistribute the consolidated hazardous waste pharmaceuticals, there is
nothing in this provision that prevents that from occurring, but those
shipments would not fall under the consolidation provision in subpart
P. If a VSQG is sending products to another facility, then the
receiving facility should evaluate the received pharmaceuticals as they
would any other products they receive for continued use, redistribution
to secondary markets, donation and/or any other lawful possibilities.
At this point, they are not a solid or hazardous waste and not subject
to the requirements in Sec.  266.502(l) or Sec.  266.503(b).
    EPA would also note that this provision is optional and it is not
meant to impose undue burden on healthcare facilities. This section
does not require a VSQG healthcare facility to ship their hazardous
waste pharmaceuticals to a receiving healthcare facility. VSQG
healthcare facilities continue to have the option, unless the state
regulations are more stringent, of sending their hazardous waste
pharmaceuticals to any of the types of facilities specified in Sec.
262.14, including a municipal solid waste landfill.

XI. Standards for Healthcare Facilities That Accumulate Potentially
Creditable Hazardous Waste Pharmaceuticals Prior to Shipment to Reverse
Distributors (Sec.  266.503)

A. Healthcare Facilities Making a Hazardous Waste Determination for
Potentially Creditable Pharmaceuticals (Sec.  266.503(a))

1. Summary of Proposal
    EPA proposed standards for healthcare facilities managing
potentially creditable hazardous waste pharmaceuticals in Sec.  266.503
of subpart P. As with non-creditable hazardous waste pharmaceuticals, 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.
    Accordingly, we proposed that a healthcare facility that generates
a solid waste that is a potentially creditable pharmaceutical must
determine whether the potentially creditable solid waste pharmaceutical
is a potentially creditable hazardous waste pharmaceutical (i.e., is
listed in 40 CFR part 261 subpart D or exhibits a characteristic
identified in 40 CFR part 261 subpart C).
    We also proposed that a healthcare facility may choose to manage
all of its potentially creditable waste pharmaceuticals (both hazardous
and non-hazardous) together as potentially creditable hazardous waste
pharmaceuticals while accumulating on site and when shipping off site
under Sec.  266.509. If a healthcare facility chooses this approach of
commingling its hazardous and non-hazardous potentially creditable
waste pharmaceuticals, it would not need to make individual hazardous
waste determinations, but would have made a generic decision that all
of its potentially creditable waste pharmaceuticals are hazardous and
would manage them as potentially creditable hazardous waste
pharmaceuticals in accordance with the requirements in 40 CFR part 266
subpart P.
    We proposed that healthcare facilities may choose to manage
potentially creditable non-hazardous waste pharmaceuticals as
potentially creditable hazardous waste pharmaceuticals under the
shipping standards of Sec.  266.509. Additionally, EPA proposed that
healthcare facilities would be prohibited from sending hazardous waste
other than potentially creditable hazardous waste pharmaceuticals to a
reverse distributor. This was in keeping with our position that a
reverse distributor's function in managing hazardous waste should be
limited to managing hazardous waste pharmaceuticals that have a
reasonable expectation of receiving manufacturer credit and not non-
creditable hazardous waste pharmaceuticals or other non-pharmaceutical
hazardous waste.
2. Summary of Comments
    Pharmacists, some wholesalers, and manufacturers expressed concern
that making hazardous waste determinations at their facilities would
require additional staff, additional training on making hazardous waste
determination, as well as more storage space in which to hold the
hazardous waste as the determinations are being made.
    We received mixed comments on commingling potentially creditable
non-hazardous and hazardous waste pharmaceuticals. Healthcare
facilities and pharmacists were in favor of EPA allowing commingling
potentially creditable non-hazardous and hazardous waste
pharmaceuticals, and the benefit it offers in handling their
pharmaceutical waste or continuing the common practice of commingling
potentially creditable non-hazardous and hazardous waste
pharmaceuticals when sent to reverse distributors. On the other hand,
waste management and states raised concerns that commingling
potentially creditable non-hazardous and hazardous waste
pharmaceuticals may prevent healthcare facilities from sending their
waste across state lines or to certain reverse distributors, due to
state regulations and/or reverse distributors' policies.
3. Final Rule Provisions
    EPA is finalizing the standards as proposed, with some minor
changes. Under this section, a healthcare facility has two choices: (1)
Make a hazardous waste determination on each potentially creditable
waste pharmaceutical and determine individually which are hazardous
waste and thus subject to regulation under this subpart or, (2)
commingle all potentially creditable pharmaceutical waste whether or
not it is hazardous waste and manage the commingled pharmaceuticals
under this subpart and thereby not have to make individual hazardous
waste determinations.
    EPA removed ``even if the solid waste pharmaceuticals do not
exhibit a characteristic identified in 40 CFR part 261 subpart C and
are not listed in 40 CFR part 261 subpart D'' from the non-hazardous
waste provision of this section since it was redundant with
determinations of solid waste pharmaceuticals and whether they are
potentially creditable or not.
    EPA has also modified the regulatory language in the final rule to
make clear that when a healthcare facility commingles potentially
creditable non-hazardous and hazardous waste pharmaceuticals, the
healthcare facility is choosing to subject the potentially creditable
non-hazardous waste pharmaceuticals to all of subpart P while being
managed at a healthcare facility and in preparation for shipping off-
site. Once potentially creditable non-hazardous and hazardous waste
pharmaceuticals are commingled they are subject to all applicable
subpart P management standards while they remain commingled. As a
practical matter, however, we expect that the primary impact to
healthcare facilities will be that potentially creditable non-hazardous
waste pharmaceuticals are subject to the shipping standards of Sec.
266.509. Once potentially creditable non-hazardous waste
pharmaceuticals are shipped off site to a reverse distributor, a
reverse distributor may choose to segregate the non-hazardous waste
pharmaceuticals from the hazardous waste pharmaceuticals. This process
of segregation by the reverse distributor would require the reverse
distributor to make new hazardous waste determinations on the
commingled pharmaceuticals.
4. Comments and Responses
    We received many comments on making hazardous waste determinations
and commingling potentially creditable non-hazardous and hazardous
waste pharmaceuticals. While the commenters raised valid concerns on
why making hazardous waste determinations can be burdensome on a
healthcare facility, or why commingling potentially creditable non-
hazardous and hazardous waste pharmaceuticals may not work for all
facilities, EPA made only minor editorial changes to this section of
the final rule. The Agency determined that more substantive changes
were unnecessary because this provision contains sufficient flexibility
by providing healthcare facilities with two options.
    a. Making hazardous waste determinations. Pharmacists, some
wholesalers, and manufacturers expressed concern that being required to
make hazardous waste determinations at their facilities would impose
undue burden because they would have to hire additional staff and train
them to make accurate waste determination. They argue that they would
also need to allocate more space in which to store waste as the
determinations are being made. Some commenters stated that making
hazardous waste determinations may prevent healthcare facilities from
sending their hazardous waste pharmaceuticals to reverse distributors
at all. In support of the comments above, manufacturers and wholesalers
argued that reverse distributors have the appropriate RCRA expertise to
make accurate waste determinations, that they have served as a
consolidation point for unused and hazardous waste pharmaceuticals for
many years, and that the process has been effective and successful. The
Agency notes, however, that allowing potentially creditable

pharmaceuticals to be sent to a reverse distributor without a hazardous
waste determination being made at the point of generation violates a
basic tenet of RCRA, because the decision to send them to a reverse
distributor is effectively a decision to discard. In addition, the
burden mentioned by commenters associated with making individual waste
determinations would likely be significantly mitigated by exercising
the option to manage all potentially creditable waste pharmaceuticals
as potentially creditable hazardous waste pharmaceuticals.
    b. Commingled waste stream. As previously noted, we received mixed
comments on commingling potentially creditable non-hazardous hazardous
waste pharmaceuticals.
    EPA proposed the option of commingling potentially creditable non-
hazardous and hazardous waste pharmaceuticals to mitigate the burden of
complying with the management standards, particularly for healthcare
personnel making hazardous waste determinations. Given that many
healthcare facilities currently commingle their potentially creditable
non-hazardous and hazardous waste pharmaceuticals, we expect the
practice to continue. However, if commingling causes undue burden on a
facility due to state regulations, reverse distributor policies, or
other reasons, then the healthcare facility does not have to utilize
this option and can make individual hazardous waste determinations in
accordance with Sec.  266.503(a). This is an individual decision for
each healthcare facility and each healthcare facility may choose what
works best for managing its potentially creditable pharmaceutical
waste.
    Retailers and reverse distributors recommended that healthcare
facilities should be allowed to make a determination about whether the
item will be managed as hazardous when it becomes a waste at the time
of arrival at the retail store or healthcare facility. They believe
this practice would be impeded if all pharmaceuticals must be managed
as potentially creditable hazardous waste pharmaceuticals when they
become waste. If this is common practice among healthcare facilities,
then the need to commingle their waste may not be something that is
important. Allowing the commingling of all solid waste pharmaceuticals
is meant to ease the burden on healthcare facilities that are not
currently making hazardous waste determinations, or do not wish to make
them, by allowing them to manage and ship all of their potentially
creditable waste pharmaceuticals together.

B. Accepting Potentially Creditable Hazardous Waste Pharmaceuticals
From an Off-Site Healthcare Facility That Is a Very Small Quantity
Generator (Sec.  266.503(b))

1. Summary of Proposal
    EPA proposed to allow healthcare facilities operating under subpart
P to accept potentially creditable and non-creditable hazardous waste
pharmaceuticals from an off-site VSQG healthcare facility without a
hazardous waste manifest, provided four conditions are met. We proposed
this provision in Sec.  266.502(m) under the standards for managing
non-creditable hazardous waste pharmaceuticals.\235\ We proposed that
healthcare facilities operating under subpart P could accept both
potentially creditable and non-creditable hazardous waste
pharmaceuticals from an off-site healthcare facility that is a VSQG.
Previously, the part 262 VSQG regulations did not allow a healthcare
facility to send its hazardous waste off-site to another healthcare
facility, unless the receiving healthcare facility is one of the eight
types of facilities listed in Sec.  262.14(a)(5)(i-viii). For more
detailed information on our proposal, please refer to section X.N.
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    \235\ This provision is now found at Sec.  266.502(l).
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2. Summary of Comments
    EPA only received one comment in this section concerning changes to
the generator category of the receiving facility. A trade association
of pharmacists was concerned that allowing VSQG consolidation would
affect the generator category of the receiving healthcare facility, and
that it would need to report as an LQG.
3. Final Rule Provision
    In the proposed rulemaking, EPA intended to allow healthcare
facilities to accept both potentially creditable and non-creditable
(including commingled) hazardous waste pharmaceuticals from an off-site
VSQG healthcare facility, provided the receiving healthcare facility
complies with the four conditions of Sec.  266.502(m) (now in Sec.
266.502(l)). In the final rule, we clarified our intention to allow
healthcare facilities to accept both potentially creditable and non-
creditable (including commingled) hazardous waste pharmaceuticals from
an off-site VSQG healthcare facility by placing similar standards in
Sec.  266.503(b) under the standards for managing potentially
creditable hazardous waste pharmaceuticals. This does not reflect a
change from what was proposed, only that the consolidation standards
apply to healthcare facilities receiving both non-creditable and
potentially creditable hazardous waste pharmaceuticals.
    Under the final rule, a healthcare facility that is a VSQG can send
both its potentially creditable hazardous waste pharmaceuticals and
non-creditable (including commingled) hazardous waste pharmaceuticals
to an off-site healthcare facility operating under subpart P, provided
the receiving healthcare facility complies with the four requirements
of the respective sections. Regulations for the receiving healthcare
facilities now appear in Sec.  266.502(l) for non-creditable hazardous
waste pharmaceuticals and in Sec.  266.503(b) for potentially
creditable hazardous waste pharmaceuticals. VSQG healthcare facilities
that send their hazardous waste pharmaceuticals to an off-site
healthcare facility are subject to the regulations in Sec.  266.504(b),
with further discussion in section XII.B of the preamble.
    Under Sec.  266.503(b) of the final rule, a healthcare facility may
accept potentially creditable hazardous waste pharmaceuticals from an
off-site healthcare facility that is a VSQG under Sec.  262.14, without
a permit or without having interim status, provided the receiving
healthcare facility:
    (1) Is under the control of the same person, as defined in Sec.
260.10, as the VSQG healthcare facility that is sending potentially
creditable hazardous waste pharmaceuticals off site, or has a
contractual or other documented business relationship whereby the
receiving healthcare facility supplies pharmaceuticals to the VSQG
healthcare facility;
    (2) Is operating under subpart P for the management of its
potentially creditable hazardous waste pharmaceuticals;
    (3) Manages the potentially creditable hazardous waste
pharmaceuticals that it receives from off site in compliance with
subpart P; and
    (4) Keeps records of the potentially creditable hazardous waste
pharmaceuticals shipments it receives from off site for three years
from the date that the shipment is received.
    It is important to note that a VSQG healthcare facility that
chooses to consolidate its hazardous waste pharmaceuticals at an off-
site healthcare facility is not considered to be operating under
subpart P, and does not need to notify as a VSQG operating under
subpart P.

4. Comments and Responses
    A pharmacists' association was concerned that allowing for VSQG
consolidation would change the generator category of the receiving
healthcare facilities and that the consolidating facility would need to
report as an LQG. All healthcare facilities operating under part 266
subpart P are regulated the same, regardless of the amount of hazardous
waste pharmaceuticals they generate. Further, healthcare facilities
managing their hazardous waste pharmaceuticals under this subpart do
not count their hazardous waste pharmaceuticals toward their generator
category so consolidation of this additional hazardous waste
pharmaceuticals at their facilities would not change the generator
category of the receiving healthcare facility.

C. Accumulation Time, Container Management and Labeling for Healthcare
Facilities Managing Potentially Creditable Hazardous Waste
Pharmaceuticals

    Under the hazardous waste generator regulations in part 262, EPA
requires specific management standards for containers that hold
hazardous waste. However, potentially creditable hazardous waste
pharmaceuticals pose a lower risk of release into the environment than
traditional industrial hazardous waste. The risk of release is lower
for several reasons.
    First, potentially creditable hazardous waste pharmaceuticals must
be in original manufacturers' packaging by definition and are often in
their outer packaging as well, providing two layers of protection from
leaks or spills.\236\ 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 waste 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.
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    \236\ See 73 FR 73529; December 2, 2008.
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    For the reasons listed above, EPA did not propose specific
standards for managing and labeling containers of potentially
creditable hazardous waste pharmaceuticals at healthcare facilities.
For the same reasons, we also did not propose a limit on how long
healthcare facilities may accumulate containers of potentially
creditable hazardous waste pharmaceuticals.
    This is not to say that all potentially creditable hazardous waste
pharmaceuticals waste pharmaceuticals are safe and pose no risk of
spill or release into the environment. 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
due to possible spills or leaks than solid pills. However, EPA believes
that the small quantities in which liquid and aerosol potentially
creditable hazardous waste pharmaceuticals are generated, along with
the DOT packaging requirements (49 CFR parts 173, 178, and 180),
significantly reduces the risks of spills or releases to the
environment.
    In addition, to further mitigate the potential for spills or leaks,
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 (e.g.,
sealed storage bag) before placing them in the accumulation container.
1. Accumulation Time and Container Management of Potentially Creditable
Hazardous Waste Pharmaceuticals
    a. Summary of proposal. EPA did not propose a limit on how long
healthcare facilities may accumulate containers of potentially
creditable hazardous waste pharmaceuticals or specific standards for
how the containers must be managed during accumulation.
    b. Summary of comments. Most commenters were in favor of adding
some guidelines for accumulation time and container management. Some
states commented that the proposed standards for non-creditable
hazardous waste pharmaceuticals should be applied to both non-
creditable and potentially creditable hazardous waste pharmaceuticals
to prevent confusion from having multiple accumulation standards, and
to provide extra protection of human health and the environment.
    c. Final rule provisions. EPA is not finalizing a time limit for
accumulating containers of potentially creditable hazardous waste
pharmaceuticals. EPA is also not finalizing specific container
management standards for healthcare facilities that accumulate
containers of potentially creditable hazardous waste pharmaceuticals
    d. Comments and responses. Several states expressed concern about
the security of potentially creditable hazardous waste pharmaceuticals
during accumulation. These commenters agreed that potentially
creditable hazardous waste pharmaceuticals should be accumulated in a
designated area that is labeled and kept locked or sealed according to
best management practices for that facility as an additional deterrent
to illicit diversion. Commenters also expressed concerned that not
having designated accumulation areas could lead to situations where
healthcare facility personnel may misplace or forget the locations of
accumulation containers. States were concerned that the potential for
healthcare facilities to receive manufacturer credit does not
sufficiently encourage proper management.
    As previously discussed, potentially creditable hazardous waste
pharmaceuticals do not pose the same risks as other hazardous wastes.
We received many comments, especially from the retail industry, about
the condition of packages being important for being eligible and
receiving manufacturer credit. For example, broken and/or leaking
containers cannot be sent to a reverse distributor per the definition
of ``potentially creditable hazardous waste pharmaceuticals,'' so there
is an incentive to manage these items carefully. There is also an
incentive to not overaccumulate wastes in healthcare facilities since
manufacturer credit is only issued by reverse distributors and in many
cases, cannot be collected by a healthcare facility until the reverse
distributor receives them.
    It is also important to note that many of these potentially
creditable hazardous waste pharmaceuticals are already being generated
and stored in secure areas, such as pharmacies, and being handled by
personnel that have pharmaceutical expertise. EPA is also recommending
that liquids and aerosols be put in sealed plastic bags, containers, or
other management practices during accumulation to reduce the risk of
spills and releases.
    As for labeling the accumulation area with the words pharmaceutical
waste, the concern still remains for increasing the potential for
illicit diversion of these potentially creditable hazardous waste
pharmaceuticals by bringing attention to the fact that it contains
pharmaceuticals. Therefore, the Agency is not finalizing a requirement
for healthcare facilities to label accumulation areas for potentially
creditable hazardous waste pharmaceuticals.
    Finally, if a state is uncomfortable with our approach to the
accumulation of potentially creditable hazardous waste pharmaceuticals,
it may choose to be more stringent in this regard when it adopts the
rule.

2. Labeling Requirements for Containers of Potentially Creditable
Hazardous Waste Pharmaceuticals
    a. Summary of proposal. EPA did not propose specific labeling
standards for containers holding potentially creditable hazardous waste
pharmaceuticals while they are accumulated on-site at a healthcare
facility because they are in original manufacturer packaging, they are
already labeled, and any additional labeling would be duplicative or
apply to secondary containers, such as boxes used to ship to reverse
distributors.
    In addition, due to concerns regarding illicit diversion of
pharmaceuticals, EPA believes that it is safer not to call attention to
the fact that these containers hold pharmaceuticals. Unlike floor or
patient care pharmaceutical waste, the potentially creditable hazardous
waste pharmaceuticals returned to a reverse distributor often have high
black-market value that makes them susceptible to diversion. Thus, EPA
did not propose to require a label for containers used to accumulate
potentially creditable hazardous waste pharmaceuticals.
    b. Summary of comments. Many states believe that labeling should be
required for all containers of hazardous waste to ensure proper
management and disposal. Proper management, according to comments,
includes accumulation in designated locations with individual
containers labeled for inspection.
    Other commenters expressed concerns that containers that are not
labeled are subject to inaccurate waste determinations and will be
mishandled and treated as non-creditable hazardous waste
pharmaceuticals and sent to a TSDF rather than as potentially
creditable which could ultimately be destined for a reverse
distributor.
    c. Final rule provision. EPA is not finalizing labeling standards
for containers of potentially creditable hazardous waste
pharmaceuticals accumulated by healthcare facilities.
    d. Comments and responses. While the commenter's concerns apply to
hazardous waste in general and for hazardous waste going to a TSDF, we
do not believe they are equally applicable to containers of potentially
creditable hazardous waste pharmaceuticals. First, containers of
potentially creditable hazardous waste pharmaceuticals are in original
manufacturer's packaging (or have been repackaged for use in a LTCF)
and thus the contents are easily identifiable. Second, if a healthcare
facility does not label an accumulation container on site and then
forgets about it or misidentifies where it needs to go, then no
manufacturer credit will be issued for those potentially creditable
hazardous waste pharmaceuticals. Likewise, if a healthcare facility
does label the containers on site and the contents are illicitly
diverted, then the healthcare facility will not receive the
manufacturer credit for those items. Healthcare facilities have a
monetary incentive to keep track of what is in these containers,
regardless of whether they are labeled, and to make sure they arrive
unmolested at the reverse distributor.
    Additionally, by imposing labeling requirements, EPA does not want
to deter the practice of commingling potentially creditable hazardous
waste pharmaceuticals with potentially creditable non-hazardous waste
pharmaceuticals since both are typically transported together to a
reverse distributor.
    Therefore, EPA concludes that it is not necessary to require any
labeling standards for potentially creditable hazardous waste
pharmaceuticals.

D. No Biennial Reporting for Potentially Creditable Hazardous Waste
Pharmaceuticals Generated at Healthcare Facilities (Sec.  266.503(d))

1. Summary of Proposal
    The Agency proposed that healthcare facilities are not subject to
biennial reporting requirements under Sec.  262.41 with respect to
potentially creditable hazardous waste pharmaceuticals managed under
this subpart.
2. Summary of Comments
    One state commented that it would prefer to be notified about who
is handling this waste to ensure that healthcare facilities are
adhering to the prohibition on sewering, since they will not know who
is handling this waste.
3. Final Rule Provision
    The Agency is finalizing as proposed that healthcare facilities are
not subject to biennial reporting requirements under Sec.  262.41 with
respect to potentially creditable hazardous waste pharmaceuticals
managed under this subpart. Potentially creditable hazardous waste
pharmaceutical quantities will be captured by the reverse distributors'
required biennial reports,\237\ therefore, a requirement for healthcare
facilities to report quantities of potentially creditable hazardous
waste pharmaceuticals generated would be duplicative.
---------------------------------------------------------------------------

    \237\ This provision is found at Sec.  266.510(c)(9)(i)
---------------------------------------------------------------------------

4. Comments and Responses
    One state was concerned that they would not know which healthcare
facilities are generating potentially creditable hazardous waste
pharmaceuticals. All healthcare facilities operating under this subpart
will be required to submit a one-time notification that they are
subject to subpart P (Sec.  266.502(a)(1)). States will, therefore, be
informed of what healthcare facilities are operating under subpart P
and can inspect accordingly.

E. Recordkeeping Requirements for Healthcare Facilities Managing
Potentially Creditable Hazardous Waste Pharmaceuticals (Sec.
266.503(e))

1. Summary of Proposal
    EPA proposed to require healthcare facilities to keep records of
the shipments of potentially creditable hazardous waste pharmaceuticals
to reverse distributors.
    Specifically, we proposed that healthcare facilities that initiate
a shipment of potentially creditable hazardous waste pharmaceuticals to
a reverse distributor keep (1) records of advance notification, (2)
shipping papers or bills of lading, and (3) records of delivery
confirmation. We proposed that a healthcare facility must retain these
records for three years after the shipment was initiated. These records
document that shipments of potentially creditable hazardous waste
pharmaceuticals have been taken into the control and custody of the
receiving reverse distributor and have not been diverted. In most
cases, retaining records for three years should be sufficient for
inspection purposes; however, we proposed that the periods of retention
are automatically extended during unresolved enforcement activity, or
at the request of the EPA Regional Administrator.
2. Summary of Comments
    One state agreed that three years was a sufficient retention period
to enable inspectors to identify issues upon inspection. State and
local governments requested clarification about what types of
documentation (e.g., shipping papers/bills of lading) satisfies the
requirement. One commenter argued that the receiving facility should
document efforts made to locate shipments that did not arrive.
3. Final Rule Provision
    EPA is finalizing the proposed recordkeeping provision for
potentially creditable hazardous waste pharmaceuticals for healthcare
facilities and reverse distributors that initiate a

shipment to another reverse distributor with two changes. First, as we
discuss later in the shipping standards, we have eliminated the
requirement for healthcare facilities to provide advance notification
of shipments of potentially creditable hazardous waste pharmaceuticals
to reverse distributors. Thus, we have removed the requirement to keep
a record of the advance notification. Second, EPA removed the reference
to bills of lading from the recordkeeping requirement while keeping
shipping papers since bills of lading are a type of shipping papers
under DOT regulations. This is also responsive to comments asking for
clarification. Healthcare facilities initiating shipments of
potentially creditable hazardous waste pharmaceuticals must keep, (1)
delivery confirmation for each shipment and (2) shipping papers
prepared in accordance with 49 CFR part 172 subpart C, if applicable.
EPA is finalizing that these records must be retained for three years
unless there is an unresolved enforcement activity or a request by the
EPA Regional Administrator to keep them longer. In that case, the
period of retention is automatically extended. EPA is finalizing this
requirement as proposed despite input from commenters, as this is
standard practice with enforcement activity. At the request of
commenters, we have added a requirement that all records must be
readily available upon request by an inspector.

F. Response to Spills for Healthcare Facilities Managing Potentially
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.503(f))

1. Summary of Proposal
    EPA proposed response requirements for spills of non-creditable
hazardous waste pharmaceuticals but did not propose similar response
requirements for releases of potentially creditable hazardous waste
pharmaceuticals.
2. Summary of Comments
    A commenter suggested that spills of potentially creditable
hazardous waste pharmaceuticals should also be subject to the same
containment and cleanup requirements as non-creditable hazardous waste
pharmaceuticals. The commenter also asked whether EPA intended that all
spills of potentially creditable hazardous waste pharmaceuticals render
them non-creditable.
3. Final Rule Provision
    EPA agrees with comments that all spills of hazardous waste
pharmaceuticals, both potentially creditable and non-creditable, must
be contained, and that all spills of potentially creditable hazardous
waste pharmaceuticals renders them non-creditable. Therefore, in
response to this comment, we have added a similar provision to the
healthcare facility standards of Sec.  266.503(f) for responding to
releases of potentially creditable hazardous waste pharmaceuticals.
    The standards in this section are based upon what is being
finalized in the standards for response to spills of non-creditable
hazardous waste pharmaceuticals at healthcare facilities in Sec.
266.502(k). The final rule requires that a healthcare facility must
immediately contain all spills of potentially creditable hazardous
waste pharmaceuticals and manage the spill clean-up materials as non-
creditable hazardous waste pharmaceuticals in accordance with subpart
P.
    It is EPA's understanding that unused/undispensed pharmaceuticals
that remain in original manufacturer's packaging often receive
manufacturer credit even if the packaging has been opened. In the event
of a spill, a healthcare facility should reevaluate whether any
pharmaceuticals that remain in their containers (not spilled) are still
eligible to receive manufacturer credit per the definition of
potentially creditable hazardous waste pharmaceutical in Sec.  266.500.
The healthcare facility must determine whether the pharmaceuticals that
remain in the containers are potentially creditable and manage them
according to subpart P. Even if a healthcare facility determines that
the remaining pharmaceuticals are potentially creditable, it must also
ensure that the decision is consistent with the manufacturer's
policies. It is important to note that this only applies to whatever
might be left in the container and was not spilled.

XII. How does this rule apply to healthcare facilities that are very
small quantity generators for both their hazardous waste
pharmaceuticals and their non-pharmaceutical hazardous waste? (Sec.
266.504)

A. Very Small Quantity Generators Using Reverse Distributors (Sec.
266.504(a))

1. Summary of Proposal
    VSQGs are subject to a limited set of federal RCRA Subtitle C
hazardous waste regulations, provided that they comply with the
conditions set forth in Sec.  262.14.\238\ Under Sec.  262.14, VSQGs
are limited in where they may send their hazardous waste for treatment
and disposal.\239\ In Sec.  266.504(a), we proposed to allow VSQG
healthcare facilities to send their potentially creditable hazardous
waste pharmaceuticals to a reverse distributor. Without this change,
VSQGs would have been required to send all their hazardous waste
pharmaceuticals, including those that are potentially creditable, to
one of the types of facilities in Sec.  262.14, which does not include
a reverse distributor. Although we proposed to make this change within
part 266 subpart P, we requested comment on whether stakeholders would
prefer this change to be made within the VSQG regulations in Sec.
262.14 (formerly the CESQG regulations in Sec.  261.5) instead. VSQGs
are still required to send their non-pharmaceutical hazardous waste and
their non-creditable hazardous waste pharmaceuticals to one of the
types of facilities listed in Sec.  262.14.\240\
---------------------------------------------------------------------------

    \238\ Since the hazardous waste pharmaceutical rule was
proposed, Sec.  261.5 has been renumbered to Sec.  262.14 as part of
the reorganization of the generator regulations in the Generator
Improvements final rule and this will be referenced later in this
section.
    \239\ Since the Pharmaceutical rule was proposedSec.
261.5(f)(3)(i)-(vii) for acute hazardous waste and Sec.
261.5(g)(3)(i)-(vii) for non-acute hazardous waste has been combined
and renumbered to Sec.  262.14(a)(5)(i)-(vii) for acute and non-
acute hazardous waste in the Hazardous Waste Generator Improvements
final rule.
    \240\ A VSQG healthcare facility may be able to send its
hazardous waste pharmaceuticals for consolidation at another
healthcare facility operating under subpart P as allowed by Sec.
266.504(b), or a large quantity generator and 262.14(a)(5)(viii),
see section X of the preamble for further discussion.
---------------------------------------------------------------------------

2. Summary of Comments
    States, waste management and reverse distributors supported
allowing VSQG healthcare facilities to send their potentially
creditable hazardous waste to reverse distributors. These same
commenters were also in favor of including their change in both this
rule and Sec.  262.14 to ensure that all healthcare facilities that
might have potentially creditable hazardous waste pharmaceuticals would
be aware of this provision and be able to take advantage of it.
3. Final Rule Provision
    We are finalizing this provision as proposed, with minor edits. In
general, this final rulemaking will preserve the current regulatory
scheme for VSQGs: healthcare facilities that qualify as VSQGs for their
total count of hazardous waste pharmaceuticals and non-pharmaceutical
hazardous waste will maintain their conditional exemption under Sec.
262.14 and will not be subject

to most aspects of this proposal. Healthcare facilities that are VSQGs
are subject to three provisions of part 266 subpart P: The sewer ban in
Sec.  266.505, the empty container standards in Sec.  266.507, and the
optional provisions in Sec.  266.504.
    In response to commenter's request for clarity, the final rule
makes it clear that Sec.  266.504 applies to VSQG healthcare facilities
that are VSQGs when counting both its hazardous waste pharmaceuticals
and non-pharmaceutical hazardous waste. Section 266.504 does not apply
to healthcare facilities that become VSQGs under this rule as a result
of not having to count their hazardous waste pharmaceuticals. Such
healthcare facilities are VSQGs with respect to their non-
pharmaceutical hazardous waste only and must operate under subpart P
for their hazardous waste pharmaceuticals.
    Under the final rule, a healthcare facility that is a VSQG when
counting both its hazardous waste pharmaceuticals and non-
pharmaceutical hazardous waste may choose to send its potentially
creditable hazardous waste pharmaceuticals to a reverse distributor. In
response to comments, EPA has added a conforming change to the VQSG
generator provision in Sec.  262.14(a)(5)(ix) for added clarity on this
point. It is a restatement of Sec.  266.504(a) which allows VSQG
healthcare facilities to send their potentially creditable hazardous
waste pharmaceuticals to a reverse distributor.
    A healthcare facility that is a VSQG for both their hazardous waste
pharmaceuticals and non-pharmaceutical hazardous waste is given a
choice. The healthcare facility may

     Operate as a standard VSQG under part 262 rules, and
can use the optional provisions in Sec.  266.504, or
     Operate under as a healthcare facility under part 266
subpart P.
4. Comments and Responses
    The waste management industry requested that EPA regulate all
healthcare facilities under the proposed subpart P requirements
regardless of generator category. While this rule's requirements are
meant to create uniformity for healthcare facilities managing hazardous
waste pharmaceuticals, we want to avoid creating undue burden on VSQGs
and have declined to make them subject to part 266 subpart P except for
the sewer prohibition in Sec.  266.505, the empty container provisions
in Sec.  266.507 and the optional provisions in Sec.  266.504..

B. Off-Site Collection of Hazardous Waste Pharmaceuticals Generated by
Healthcare Facilities (Sec.  266.504(b))

1. Summary of Proposal
    EPA proposed that a healthcare facility that is a VSQG may send its
hazardous waste pharmaceuticals to another healthcare facility provided
the receiving healthcare facility meets certain conditions. These
conditions were proposed in Sec.  266.502(m) of this subpart.
2. Summary of Comments
    One state was concerned about how consolidation might affect the
generator category of the receiving facility. The commenter also raised
concerns about the receiving facility performing some functions of a
reverse distributor.
3. Final Rule Provision
    EPA is finalizing the proposed provision with conforming changes
that correspond with other sections within this rule and one additional
change. The first conforming change added the words ``hazardous waste
pharmaceuticals and non-pharmaceutical hazardous waste'' to clarify
that only healthcare facilities that are VSQGs for both their hazardous
waste pharmaceuticals and their non-pharmaceutical hazardous waste may
take advantage of this provision. The second conforming change
converted the term CESQG to VSQG according to the 2016 Hazardous Waste
Generator Improvements final rule. EPA notes that the consolidation
provisions for healthcare facilities that receive both non-creditable
hazardous waste pharmaceuticals and potentially creditable hazardous
waste pharmaceuticals from off-site were added to the regulations in
Sec. Sec.  266.502(l) and 266.503(b) (sections X.N and XI.B of the
preamble), respectively. The final change added flexibility for VSQGs
to meet the consolidation provisions that were added as part of the
2016 Hazardous Waste Generator Improvements final rule in lieu of the
subpart P off-site consolidation provisions. In this case, the
receiving LQG would have to meet the conditions in Sec.  262.17(f)
while the VSQG healthcare facility would have to meet the conditions in
Sec.  262.14(a)(5)(viii).
    The final rule provision allows a healthcare facility that is a
VSQG for both hazardous waste pharmaceuticals and non-pharmaceutical
hazardous waste to send its hazardous waste pharmaceuticals off-site
provided either of the following is met: (1) The receiving healthcare
facility meets the conditions in Sec.  266.502(1) and Sec.  266.503(b)
of this subpart, as applicable, or (2) the VSQG healthcare facility
meets the conditions in Sec.  262.14(a)(5)(viii), and the receiving
large quantity generator meets the conditions in Sec.  262.17(f).
4. Comments and Responses
    One commenter asked for clarification about whether EPA will allow
consolidation of a healthcare facility's potentially creditable or non-
creditable hazardous waste pharmaceuticals at a reverse distributor. In
response, the Agency is clarifying that subpart P does not allow
healthcare facilities to consolidate any pharmaceutical waste at a
reverse distributor. Healthcare facilities may only consolidate their
waste at another facility that meets the definition of a healthcare
facility as defined in Sec.  266.500. See sections X.N and XI.B,
respectively, for further discussion about healthcare facilities that
receive non-creditable and potentially creditable hazardous waste
pharmaceuticals from off-site healthcare facilities.

C. Long-Term Care Facilities That Are Very Small Quantity Generators
Can Dispose Hazardous Waste Pharmaceuticals in Drug Enforcement
Administration Collection Receptacles (Sec.  266.504(c))

1. Summary of Proposal
    We proposed that a LTCF that is a VSQG that has an on-site DEA
collection receptacle could use the collection receptacle for its
hazardous waste pharmaceuticals, even if they are not controlled
substances. We reasoned that since DEA already allows controlled
substances to be commingled with non-controlled substances, it was
consistent to allow VSQG hazardous waste pharmaceuticals that are not
controlled substances to be placed in DEA authorized collection
receptacles along with controlled substances. Further, we reasoned that
the management of VSQG hazardous waste pharmaceuticals as DEA
controlled substances is preferable to management as municipal solid
waste because it provides greater protection to patients, visitors, and
workers at LTCFs to have the hazardous waste pharmaceuticals in DEA
authorized collection receptacles than down the sewer or in the
facility's regular trash.
2. Summary of Comments
    The few comments we received on this specific provision of the
proposed rulemaking were mostly supportive.
3. Final Rule Provisions
    We are finalizing the provision that allows an LTCF that is a VSQG
to use

a DEA authorized collection receptacle to dispose of its hazardous
waste pharmaceuticals with three minor changes. The first change is to
clarify again that this provision only applies to LTCFs that are VSQGs
for both hazardous waste pharmaceuticals and non-pharmaceutical
hazardous waste and are therefore not subject to subpart P (except the
sewer prohibition of Sec.  266.505, the empty container standards of
Sec.  266.507, and the optional provisions of Sec.  266.504). The
second change is to clarify that the DEA authorized collection
receptacle that the VSQG LTCF uses to dispose of its hazardous waste
pharmaceuticals must be on-site. The third change is to exclude items
such as contaminated personal protective equipment or clean-up residues
from being placed into the DEA authorized collection receptacle.
Although these items meet our new definition of pharmaceutical, a DEA
authorized collection receptacle is designed for the collection of the
pharmaceuticals themselves and not larger items that might be
contaminated by the pharmaceuticals, such as contaminated PPE or clean-
up residues. For instance, they are required to have small openings and
limited volumes, making their use for contaminated PPE and clean-up
residues impractical.
4. Comments and Responses
    One commenter thought that this proposed provision was ``not
feasible'' because ``take-back kiosks for controlled substances are
intended to be used by end users and not the DEA registrant.'' \241\ In
many, if not most, cases at an LTCF, the hazardous waste
pharmaceuticals will be from an ultimate user and the DEA regulations
permit the collection receptacles to be used for collecting both
controlled and non-controlled substances from ultimate users. There are
more limited cases where an LTCF may have its own inventory of non-
controlled hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \241\ See comment number EPA-HQ-RCRA-2007-0932-0280.
---------------------------------------------------------------------------

    Although EPA concurs with the commenters that the DEA authorized
collection receptacles are only for controlled substances from ultimate
users, EPA does not believe that the same limitation needs to be placed
on the pharmaceuticals from VSQGs that are hazardous waste but not
controlled substances. In fact, it could be argued that long-term care
facilities that are VSQGs would be allowed to use DEA authorized
collection receptacles for their hazardous waste pharmaceuticals even
without this new provision, provided the waste from the DEA authorized
collection receptacles is treated or disposed at one of the types of
facilities identified in Sec.  262.14(a)(5) (e.g., facilities that are
permitted or have interim status to manage hazardous waste and
facilities that are permitted, licensed or registered by a state to
manage hazardous waste, municipal waste or non-municipal waste).
Nevertheless, we did propose, and are finalizing the provision in Sec.
266.504(c) making it clear that an LTCF that is a VSQG can place its
hazardous waste pharmaceuticals in an on-site DEA collection
receptacle.
    However, as the commenter pointed out, it is important to note that
the DEA regulations for controlled substances are much narrower in what
may be placed in a collection receptacle; DEA only allows controlled
substances from ultimate users (patients) to be placed in collection
receptacles that are at long-term care facilities. As a result, if a
LTCF (or any other healthcare facility) is a DEA registrant, it may not
place its inventory of controlled substances in a collection
receptacle, even if it is a VSQG.

D. Long-Term Care Facilities With 20 Beds or Fewer Are Presumed To Be
Very Small Quantity Generators (Sec.  266.504(d))

1. Summary of Proposal
    EPA took comment on whether we should provide a rebuttable
presumption that LTCFs with fewer than 10 beds are assumed to be VSQGs
and thus would not be required to keep track of the amount of hazardous
waste generated each month. The Agency did not propose regulatory
language for this provision. EPA asked commenters to submit data to
support a 10-bed cutoff to show that LTCFs with fewer than 10 beds are
generally VSQGs. Alternatively, if commenters supported a different
cutoff for the rebuttable assumption, EPA asked that the commenters
submit information to support their suggested cutoff.
2. Summary of Comments
    Comments on the rebuttable presumption for LTCFs with fewer than 10
beds varied. One state did not support providing a rebuttable
presumption for LTCFs with fewer than 10 beds and argued that all
generators should be required to count the hazardous waste they
generate.\242\ One state expressed support for providing a rebuttable
presumption and requested that EPA keep the cutoff at 10 beds.\243\ One
state did not support providing the rebuttable presumption because most
healthcare facilities in their state, including LTCFs, have more than
10 beds but generate only VSQG quantities of hazardous waste.\244\
---------------------------------------------------------------------------

    \242\ See comment number EPA-HQ-RCRA-2007-0932-0238 in the
docket for this rulemaking.
    \243\ See comment number EPA-HQ-RCRA-2007-0932-0242 in the
docket for this rulemaking.
    \244\ See comment number EPA-HQ-RCRA-2007-0932-0332 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Two healthcare industry commenters that supported the rebuttable
presumption asked that EPA increase the cutoff from 10 beds to 20
beds.\245\ One healthcare industry commenter supported the rebuttable
presumption and asked that EPA increase the bed cutoff from 10 beds to
15 beds.\246\
---------------------------------------------------------------------------

    \245\ See comment numbers EPA-HQ-RCRA-2007-0932-0239 and EPA-HQ-
RCRA-2007-0932-0282 in the docket for this rulemaking.
    \246\ See comment number EPA-HQ-RCRA-2007-0932-0328 in the
docket for this rulemaking.
---------------------------------------------------------------------------

3. Final Rule Provisions
    Under the final rule, EPA is finalizing a rebuttable presumption in
Sec.  266.504(d) that LTCFs with 20 beds or fewer are assumed to be
VSQGs and thus are not required to demonstrate the amount of hazardous
waste generated each month. Under this presumption, LTCFs are only
subject to the requirements for VSQG healthcare facilities as described
elsewhere in this proposal, including the requirement not to sewer
hazardous waste pharmaceuticals (Sec.  266.505), the empty container
standards (Sec.  266.507), and the optional provisions of Sec.
266.504. Under the final rule, the EPA Regional Administrator has the
responsibility to demonstrate that a LTCF with 20 beds or fewer
generates quantities of hazardous waste that are in excess of the VSQG
limits as defined in Sec.  260.10 if the EPA Regional Administrator
wishes to mandate that the LTCF operate under subpart P. A LTCF with
more than 20 beds that operates as a VSQG under Sec.  262.14 must
demonstrate that it generates quantities of hazardous waste that are
within the VSQG limits as defined by Sec.  260.10.
    Based on available data, EPA believes it is reasonable to be
responsive to the healthcare industry commenters who supported the
rebuttable presumption and to increase the cutoff to 20 beds. The
available information on hazardous waste generation at LTCFs suggests
that LTCFs with 20 beds or fewer are generally VSQGs. Although EPA did
not receive any data from the healthcare industry commenters, one state
commented that most healthcare facilities in their state, including
LTCFs, have many more than 10 beds but generate only VSQG quantities of

hazardous waste.\247\ Additionally, EPA estimates that there are
between 2,875 and 4,770 long-term care facilities that generate
hazardous waste and that 98 to 99 percent of the facilities are
VSQGs.\248\ Although EPA estimates that there are few LTCF hazardous
waste generators that are SQGs or LQGs, EPA does not have data on the
number of beds at each facility, making it difficult to estimate a
facility size threshold at which a LTCF becomes an SQG or an LQG. EPA
conducted additional analysis using data on the average size of LTCFs
in the United States and data on the average volume of hazardous waste
generated annually at LTCFs that submitted a biennial hazardous waste
report between 2001 and 2015 in order to estimate the average size at
which a LTCFs become SQGs or LQGs.\249\ The estimates suggest that
LTCFs with fewer than 20 beds will generally be VSQGs. Therefore, EPA
concludes that it is reasonable to provide a rebuttable presumption
that LTCFs with 20 beds or fewer are assumed to be VSQGs and thus are
not required to demonstrate the amount of hazardous waste generated
each month.
---------------------------------------------------------------------------

    \247\ See comment number EPA-HQ-RCRA-2007-0932-0332 in the
docket for this rulemaking.
    \248\ Regulatory Impact Analysis in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932).
    \249\ See memorandum ``Long-Term Care Facility Summary Data and
Hazardous Waste Generation Data'' in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

XIII. Sewer Disposal Prohibition (Sec.  266.505)

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 (POTWs) will be subject to controls under the Clean
Water Act (CWA). 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.'' \250\
---------------------------------------------------------------------------

    \250\ May 19, 1980; 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 Sec.  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 appropriate existing regulations 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 on August 22, 1986; \251\ a
response to comments on the advanced notice of proposed rulemaking on
June 22, 1987; \252\ a notice of proposed rulemaking (NPR) on November
23, 1988; \253\ and a final rule on July 24, 1990.\254\ That final rule
expanded an existing prohibition on the discharge of pollutants which
create a fire or explosion hazard in the POTW, so that it included, but
was not limited to, ``waste streams with a closed cup flashpoint of
less than 140 degrees Fahrenheit or 60 degrees Centigrade using the
test methods specified in 40 CFR 261.21.'' \255\ Although the RCRA
characteristic of reactivity (D003) was not specifically mentioned in
the CWA regulations, discharges of some D003 reactive hazardous wastes
are also prohibited by this section of the CWA regulations: (1)
Chemicals that react violently with water \256\ and (2) chemicals that
form potentially explosive mixtures with water.\257\
---------------------------------------------------------------------------

    \251\ See the advance notice of proposed rulemaking in August
22, 1986; 51 FR 30166.
    \252\ See the response to comments in June 22, 1987; 52 FR
23477.
    \253\ See the proposed rule November 23, 1988; 53 FR 47632.
    \254\ See the final rule in July 24, 1990; 55 FR 30082.
    \255\ See the prohibition in 40 CFR 403.5(b)(1).
    \256\ See 40 CFR 261.23(a)(2).
    \257\ See 40 CFR 261.23(a)(3).
---------------------------------------------------------------------------

    The 1990 CWA final rule added a new prohibition such that no
discharge shall ``result in the presence of toxic gases, vapors or
fumes within the POTW in a quantity that may cause acute worker health
and safety problems.'' \258\ Similarly, although the RCRA
characteristic of reactivity (D003) was not specifically mentioned in
this section of the CWA regulations, discharges of some D003 reactive
hazardous wastes are also prohibited by this section: (1) Chemicals
that, when mixed with water, generate toxic gases, vapors or fumes in
quantity sufficient to present a danger to human health or the
environment \259\ or (2) cyanide or sulfide bearing waste which, when
exposed to pH conditions between 2 and 12.5, can generate toxic gases,
vapors or fumes in a quantity sufficient to present a danger to human
health or the environment.\260\
---------------------------------------------------------------------------

    \258\ See 40 CFR 403.5(b)(7).
    \259\ See 40 CFR 261.23(a)(4).
    \260\ See 40 CFR 261.23(a)(5).
---------------------------------------------------------------------------

    In addition, some D002 corrosive hazardous wastes were prohibited
prior to the 1990 CWA final rule and remain prohibited. Under RCRA, a
waste is considered D002 for corrosivity if it has a pH of less than or
equal to 2 (strongly acidic) or greater than or equal to 12.5 (strongly
basic). Section 403.5(b)(2) of the CWA regulations prohibits discharges
with a pH of less than 5.0, except under limited circumstances.
Therefore, acidic D002 hazardous waste is prohibited from being
discharged under the CWA regulations.
    Note that although the exclusion for mixtures of domestic sewage
and other wastes is found under the RCRA regulations in Sec.
261.4(a)(1)(ii), and it was HSWA, which is an amendment to RCRA, that
directed the review of and amendments to that exclusion, the sewer ban
of liquid ignitable D001 hazardous wastes and some D002 and D003
hazardous wastes was established under 40 CFR 403.5(b), which is under
the CWA regulations. Also note that EPA left open the possibility of
additional future action when it stated in the preamble to the July 24,
1990, final rule, 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.'' \261\
---------------------------------------------------------------------------

    \261\ July 24, 1990 Federal Register; 55 FR 30084.

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

B. Summary of Proposal

    In 2015, EPA proposed to impose a sewer ban on all hazardous waste
pharmaceuticals managed by healthcare facilities and reverse
distributors. That is, healthcare facilities and reverse distributors
subject to part 266 subpart P would not be able to use the RCRA
domestic sewage exclusion in Sec.  261.4(a)(1)(ii) any longer for their
hazardous waste pharmaceuticals. They would be 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).
    EPA proposed this sewer prohibition of hazardous waste
pharmaceuticals for several reasons. First, as described in detail in
the preamble to the proposed rulemaking, a number of studies had shown
that flushing of leftover medications had become a prevalent practice
used in lieu of proper hazardous waste management and that experience
had, indeed, revealed that additional regulations were ``necessary to
improve control over hazardous waste and other industrial user
discharges to POTWs.'' \262\
---------------------------------------------------------------------------

    \262\ July 24, 1990 Federal Register; 55 FR 30084.
---------------------------------------------------------------------------

    Second, although EPA establishes national regulations under the CWA
(called effluent limitations guidelines and pretreatment standards) to
reduce discharges of pollutants from industries to surface waters and
POTWs, currently there are no national effluent limitations or
pretreatment standards that apply to healthcare facilities discharging
pharmaceuticals to POTWs. Furthermore, traditional wastewater treatment
operations implemented 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, these
technologies are 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.\263\ 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 active pharmaceutical ingredients (APIs).\264\ In a
more recent study, EPA measured concentrations of 56 APIs in effluent
samples from 50 large POTWs across the country and discovered at least
one API in each sample.\265\ In addition, as stated in EPA's 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.'' \266\
---------------------------------------------------------------------------

    \263\ EPA, Occurrence of Contaminants of Emerging Concern in
Wastewater from Nine Publicly Owned Treatment Works, August 2009;
EPA-821-R-09-009.
    \264\ 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.
    \265\ Kostich MS, Batt AL, Lazorchak JM, ``Concentrations of
prioritized pharmaceuticals in effluents from 50 large wastewater
treatment plants in the US and implications for risk estimation.''
Environmental Pollution 2014, 184:354-9.
    \266\ Health Services Industry Study: Management and Disposal of
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
---------------------------------------------------------------------------

    Third, the pharmaceuticals entering the environment, through
flushing or other means, are having a negative effect on aquatic
ecosystems and on fish and animal populations. A recent article
highlighted the scientific literature that examines the effect of
pharmaceuticals on freshwater ecosystems, particularly the effect of
pharmaceuticals on key ecological processes.\267\ The RIA for the
proposed rulemaking more fully summarized the scientific literature
with regard to ecological effects.\268\ 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: \269\
---------------------------------------------------------------------------

    \267\ Richmond EK, Grace MR, Kelly JJ, Reisinger AJ, Rosi EJ,
Walters, DM. ``Pharmaceuticals and personal care products (PPCPs)
are ecological disrupting compounds (EcoDC).'' Elem Sci Anth 2017,
5:66.
    \268\ See page 147 of the Regulatory Impact Analysis for the
proposed rule in the docket EPA-HQ-RCRA-2007-0932-0151.
    \269\ 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 can potentially 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 and disposal.
    While healthcare facilities that are VSQGs were generally not
subject to the proposed rulemaking, EPA proposed that the sewer ban of
hazardous waste pharmaceuticals also apply to healthcare facilities
that are VSQGs. The RIA for the rule projects that the vast majority of
healthcare facilities are VSQGs (81-86 percent).\270\ Some particular
types of healthcare facilities have an even larger proportion of VSQGs:
For example, the RIA estimates that of the LTCFs that generate
hazardous waste, 98-99 percent of LTCFs are VSQGs.\271\ EPA was and
remains concerned that these smaller healthcare facilities are more
likely to dispose of their hazardous waste pharmaceuticals via the
sewer. EPA estimates that there are between 50,900 and 84,800
healthcare facilities that are VSQGs.\272\ Given this large number, the
combined impact of sewer disposal by healthcare facilities that are
VSQGs has an even greater potential to provide a substantial impact on
the environment, as well as human health. EPA solicited comment on
whether it was appropriate to apply the proposed ban on the sewer
disposal of hazardous waste pharmaceuticals to all healthcare
facilities, including healthcare facilities that are VSQGs. Comments
submitted to the Agency in response to this request are discussed in
the next section.
---------------------------------------------------------------------------

    \270\ See the Regulatory Impact Analysis for the final rule in
the docket EPA-HQ-RCRA-2007-0932.
    \271\ Ibid.
    \272\ Ibid.
---------------------------------------------------------------------------

    We note that EPA's proposed ban on sewering hazardous waste
pharmaceuticals is consistent with other federal state, and local
actions. For example, the DEA has finalized regulations to implement
the Secure and Responsible Drug Disposal Act of 2010.\273\ DEA's
regulations require a ``non-retrievable'' method of destruction of
controlled substances. The preamble to DEA's proposed and final rules
state that flushing does not meet the non-retrievable standard for
destruction.\274\ According to the preamble of the DEA final rule, DEA
received 20 comments supporting their position against

flushing controlled substances.\275\ 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.
---------------------------------------------------------------------------

    \273\ September 9, 2014; 79 FR 53520.
    \274\ Proposed rule: December 21, 2012; 77 FR 75784 (see page
75803); and Final rule: September 9, 2014; 79 FR 53520 (see page
53548).
    \275\ September 9, 2014; 79 FR 53520 (see page 53548).
---------------------------------------------------------------------------

    In addition, four states, the District of Columbia, and local
California jurisdictions have taken action to limit the sewering of
pharmaceuticals and another state has introduced a bill. ``Colorado has
prohibited the discharging of solid/hazardous waste down the drain
since the adoption of RCRA in the 1980s.'' \276\ In 2009, Illinois
passed the Safe Pharmaceutical Disposal Act, which prohibits healthcare
facilities from flushing any solid dosage form other than DEA schedule
II drugs into public sewers or septic systems.\277\ In 2012, New Jersey
passed a similar law that prohibits healthcare facilities from
discharging prescription medications into public sewers or septic
systems.\278\ 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.'' \279\ 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.'' Also in California, some
county departments, such as Sacramento County and Contra Costa County,
prohibit sewering of hazardous waste pharmaceuticals.\280\ And the
District of Columbia has promulgated municipal regulations, effective
January 1, 2011, that prohibits healthcare facilities from flushing
pharmaceutical products.\281\ The Connecticut legislature has also
considered a bill to ban the discharge of medication into public or
private wastewater collection systems or septic systems, although it
has not yet become law.\282\ Nevertheless, the Connecticut Department
of Energy and Environmental Protection's (CT DEEP) ``current hazardous
waste management regulations essentially ban sewer disposal of RCRA
waste by requiring all generators in Connecticut, including [VSQGs], to
ensure delivery by a licensed waste transporter with an EPA ID Number
to a facility authorized to receive the waste.'' \283\
---------------------------------------------------------------------------

    \276\ See comment number: EPA-HQ-RCRA-2007-0932-0242.
    \277\ Illinois Public Act 096-0221.
    \278\ Nicknamed Bateman's Law, after Senator Christopher ``Kip''
Bateman (R-Somerset) that sponsored the legislation.
    \279\ Humphreys, et al. Environmental Health Perspectives. 2008
March; 116(3) 297-302.
    \280\ See comment number: EPA-HQ-RCRA-2007-0932-0378.
    \281\ DCMR Title 22-B Chapter 5 Safe Disposal of Unused
Pharmaceuticals in Health Care Facilities
    \282\ State of Connecticut General Assembly, January Session
2013, Raised Bill No. 6439. An Act Concerning the Disposal and
Collection of Unused Medication.
    \283\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    The Agency sought comment on several areas related to the
prohibition on sewering hazardous waste pharmaceuticals. First, the
Agency requested comment on whether the sewer ban should apply to
healthcare facilities that are VSQGs. Second, we requested comment on
the trade-offs inherent in prohibiting sewer disposal; that is, would
the benefit of the reduction in aquatic risk be outweighed by
additional opportunities for diversion and the possibility of
inadvertent exposures for certain workers? Third, we sought comment on
whether it would be appropriate to allow any exceptions to the sewer
ban, such as for leftover portions of hazardous wastes that are also
controlled substances.\284\ Finally, the Agency sought comment on
whether it would be helpful to incorporate in 40 CFR 261.4(a)(1)(ii), a
cross-reference to the CWA regulations that prohibit the sewering of
certain hazardous wastes.
---------------------------------------------------------------------------

    \284\ In a DEA letter dated October 17, 2014, DEA refers to
leftover, partially administered drugs as ``pharmaceutical
wastage.'' https://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf
---------------------------------------------------------------------------

C. Summary of Comments

    Nearly a third of the commenters to the proposed rulemaking
commented on the proposed prohibition of sewering hazardous waste
pharmaceuticals. Commenters were nearly unanimous in their support for
the prohibition on sewering of hazardous waste pharmaceuticals. Support
was expressed by a broad and diverse set of commenters, including state
and local governments, sewer districts, environmental groups, and waste
management companies. Although some commenters had suggestions for
minor exceptions, few commenters expressed complete opposition to the
prohibition on sewering. Furthermore, there was widespread support from
commenters for applying the prohibition on sewering hazardous waste
pharmaceuticals to healthcare facilities that are VSQGs. As one
commenter noted, ``given the large number of small generators . . . If
each of these small generators were allowed to discharge even a small
amount of pharmaceuticals, the overall volume would be significant.
''\285\
---------------------------------------------------------------------------

    \285\ See comment number EPA-HQ-RCRA-2007-0932-0337.
---------------------------------------------------------------------------

D. Final Rule Provisions

    Given the environmental concerns described above combined with the
overwhelming support that we received from commenters, we are
finalizing the prohibition of sewering hazardous waste pharmaceuticals.
The prohibition on sewering hazardous waste pharmaceuticals applies to
all reverse distributors and all healthcare facilities, including
healthcare facilities that are VSQGs. Furthermore, EPA is not providing
any exceptions to the prohibition on sewering. Therefore, the
prohibition on sewering hazardous waste pharmaceuticals applies to all
hazardous waste pharmaceuticals that are generated by any healthcare
facilities and reverse distributors, including hazardous waste
pharmaceuticals that are also controlled substances and any
pharmaceutical wastage from partial administration of hazardous waste
pharmaceuticals. How the sewer prohibition intersects with the disposal
of pharmaceutical wastage will be discussed in greater detail in
section XIV.D.2. rather than this section.
    In response to commenters' suggestions, we are making some minor
editorial changes, including adding two cross references to the CWA
prohibitions on sewering hazardous wastes in Sec.  403.5(b). One cross
reference will be added to Sec.  261.4(a)(1)(ii) and the other cross
reference will be added to Sec.  266.505. We also eliminated the second
sentence of the proposed prohibition, which read: The exclusion in
Sec.  261.4(a)(1)(ii) for mixtures of domestic sewage and other wastes
that pass through a sewer system to a publicly owned treatment works
does not apply to hazardous waste pharmaceuticals.

    Oklahoma Department of Environmental Quality (OK DEQ) expressed
concern that this ``second sentence could be interpreted that EPA is
exerting RCRA authority over domestic sewage if it contains [hazardous
waste pharmaceuticals]--an area that has been exclusively under Clean
Water Act jurisdiction since the first regulations were promulgated in
1980.'' \286\ EPA had proposed the second sentence in an attempt to be
abundantly clear that the proposed prohibition on sewering hazardous
waste pharmaceuticals supersedes the exclusion in Sec.
261.4(a)(1)(ii). We did not intend to assert RCRA jurisdiction over
domestic sewage; therefore, we have concluded that it is better to
remove the sentence in order to avoid the concern expressed by OK DEQ.
Nevertheless, we wish to emphasize that the prohibition on sewering
hazardous waste pharmaceuticals being finalized in Sec.  266.505 does,
in fact, supersede the exclusion in Sec.  261.4(a)(1)(ii). To make that
point clear, we are amending Sec.  261.4(a)(1)(ii) to state that any
mixture of domestic sewage and other wastes that passes through a sewer
system to a publicly-owned treatment works for treatment, except as
prohibited by Sec. Sec.  266.505 and Clean Water Act requirements at 40
CFR 403.5(b), is not a solid waste.
---------------------------------------------------------------------------

    \286\ See commenter number EPA-HQ-RCRA-2007-0932-0231.
---------------------------------------------------------------------------

E. Comments and Responses

    Many comments suggested various ways in which we should broaden the
applicability of the prohibition on sewering hazardous waste
pharmaceuticals. In some cases, commenters urged us to apply the
prohibition to all pharmaceuticals, not just hazardous waste
pharmaceuticals. Subtitle D of RCRA, which governs the management of
non-hazardous (solid) waste, does not provide EPA the statutory
authority to apply the prohibition to non-hazardous waste
pharmaceuticals. Nevertheless, EPA strongly recommends against sewering
any pharmaceuticals. The American Water Works Association asked us to
extend the prohibition to prevent the sewering of pharmaceuticals that
are radioactive and patient waste containing radioactive
pharmaceuticals. As discussed previously, hazardous waste
pharmaceuticals that also contain a radioactive component subject to
the Atomic Energy Act of 1954 (i.e., ``mixed waste'') are regulated by
multiple agencies. The hazardous waste component is regulated under EPA
or the authorized state RCRA programs, while either the NRC or the
Department of Energy regulates the radioactive component of the waste
under the Atomic Energy Act.\287\ Therefore, a ``mixed waste''
pharmaceutical that is both radioactive and RCRA hazardous waste is
prohibited from being discharged to the sewer. We strongly recommend
against sewering other radioactive pharmaceuticals and patient waste
containing radioactive pharmaceuticals.
---------------------------------------------------------------------------

    \287\ The NRC regulates radioactive wastes generated by
commercial or non-DOE facilities, whereas DOE regulates radioactive
wastes generated by DOE facilities.
---------------------------------------------------------------------------

    Other commenters suggested that the prohibition should not be
limited to discharges to POTWs; rather, it should also apply to
discharges to septic tanks, privately owned treatment works and
federally owned treatment works. Section 261.4(a)(1)(ii) allows the
discharge of what would otherwise be a hazardous waste to POTWs,
without being considered a solid or hazardous waste. The prohibition on
discharges of hazardous waste pharmaceuticals being finalized today is
intended to reduce the scope of that exclusion in the existing
regulations. Discharges of hazardous waste to other types of sewage
systems, such as septic tanks, privately owned treatment works and
federally owned treatment works are not allowed by exclusion in Sec.
261.4(a)(1)(ii). Therefore, the discharge of hazardous wastes to septic
tanks, privately owned treatment works and federally owned treatment
works is already prohibited, even though it is not explicitly stated.
    We note that although our RCRA statutory authority limits us to
apply the prohibition on sewering narrowly 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) from any source or location. This recommendation against
sewering pharmaceuticals includes households and assisted living
facilities, except in the relatively rare situation when households and
assisted living facilities are specifically directed by FDA guidance to
flush certain potentially dangerous drugs down the toilet (as noted on
pharmaceutical packaging), when a drug take-back option is not readily
available, to help ensure that they are not misused or accidentally
ingested or touched.\288\ In lieu of sewering, we recommend that
households, including residents of assisted living facilities, follow
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, the guidelines for households disposing of
pharmaceuticals are as follows (in order of preference):
---------------------------------------------------------------------------

    \288\ https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf.
---------------------------------------------------------------------------

    (1) Use a drug take-back event or program, when available;
    (2) Dispose in household trash, after mixing the unwanted medicines
with an unpalatable substance such as dirt, cat litter, or used 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.\289\
---------------------------------------------------------------------------

    \289\ https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm.
---------------------------------------------------------------------------

    We also note that the CWA prohibitions on discharges of hazardous
waste in Sec.  403.5(b) are broader than just pharmaceuticals and apply
beyond healthcare facilities and reverse distributors. Like all of the
prohibited discharges under the CWA regulations, the prohibitions of
hazardous waste discharges apply to any industrial user. Additionally,
the CWA prohibitions on hazardous waste discharges apply to all D001
ignitable liquids, acidic D002 hazardous wastes, and D003 reactive
hazardous wastes that (1) react violently with water,\290\ (2) form
potentially explosive mixtures with water,\291\ or (3) result in the
presence of toxic gases, vapors or fumes within the POTW in a quantity
that may cause acute worker health and safety problems,\292\ not just
pharmaceuticals that exhibit those characteristics.
---------------------------------------------------------------------------

    \290\ See 40 CFR 261.23(a)(2).
    \291\ See 40 CFR 261.23(a)(3).
    \292\ See 40 CFR 403.5(b)(7).
---------------------------------------------------------------------------

    Some commenters asked us to include some exceptions to the
prohibition on discharges of hazardous waste pharmaceuticals.
Specifically, one commenter who supported our proposed ban on sewering
of hazardous waste pharmaceuticals, and even supported extending it to
non-hazardous waste pharmaceuticals, suggested that we allow exceptions
``for those that do not contain active pharmaceutical ingredients, such
as sterile water and 0.9% sodium chloride for injection and
irrigation.'' \293\ First, as a point of clarification, because sterile
water and 0.9% sodium chloride are not hazardous waste, they would not
be subject to the prohibition of discharging hazardous waste
pharmaceuticals to the

sewer. And even though, as a general rule, we strongly recommend
against sewering any pharmaceutical, regardless of whether it meets our
definition of hazardous waste, we agree with the commenter that it
seems unnecessary to prohibit the sewering of sterile water and 0.9%
sodium chloride.
---------------------------------------------------------------------------

    \293\ See comment number EPA-HQ-RCRA-2007-0932-0230.
---------------------------------------------------------------------------

    Other commenters asked us to make other exceptions to the
prohibition on discharging hazardous waste pharmaceuticals. For
example, the Healthcare Waste Institute suggested that we allow the
discharge of hazardous waste pharmaceuticals that are specifically
allowed by the local wastewater treatment agency or POTW.\294\ CT DEEP
made a similar suggestion, saying that we should allow discharges if
they are ``explicitly authorized by a National Pollutant Discharge
Elimination System (NPDES) or State pretreatment permit.'' \295\ We
have concluded that such an allowance is unnecessary because no known
pretreatment standards or local limits have been established that
specifically allow for the discharge of any pharmaceuticals. Note that
40 CFR part 439 separately regulates discharges from pharmaceutical
manufacturers to POTWs and waters of the U.S. Furthermore, in the
absence of water quality standards for specific drugs, we would like to
avoid a situation where local wastewater treatment agencies might feel
pressured to make judgments on which discharges would be acceptable
without knowing the effects on aquatic life or the synergistic effects
of multiple drugs.
---------------------------------------------------------------------------

    \294\ See comment number EPA-HQ-RCRA-2007-0932-0296.
    \295\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    We received few comments related to our inquiry about trade-offs
inherent in prohibiting sewer disposal. Sharps Compliance did note that
as ``our experience as a DEA authorized collector has shown,
regulations that ban the sewering in conjunction with a proactive
collection and destruction program offer the best protection against
both environmental harm and the risk of diversion.'' \296\ In addition,
CT DEEP commented they do ``not believe there is an unfavorable risk
trade-off inherent in prohibiting sewer disposal,'' indicating both
risks are manageable.\297\
---------------------------------------------------------------------------

    \296\ See comment number EPA-HQ-RCRA-2007-0932-0248.
    \297\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    Eli Lilly was one of the few commenters that opposed the
prohibition on sewering hazardous waste pharmaceuticals, even though,
as a manufacturer, they are not subject to the prohibition.\298\ They
expressed two reasons for their opposition: (1) They do not believe
that a total prohibition is based on sound risk management decisions
and should be more flexible to exclude pharmaceuticals which FDA says
should be disposed of down the drain, and (2) they believe that an
effluent guideline under the CWA regulations is more appropriate and
that EPA's Office of Water has decided not to promulgate an effluent
guideline for the healthcare industry. As discussed previously, the
prohibition on sewering hazardous waste pharmaceuticals and the FDA
flush list do not conflict with one another. The prohibition applies to
healthcare facilities (which does not include assisted living
facilities) and reverse distributors, while the FDA flush list is
directed to households and assisted living facilities and includes the
caveat that flushing takes place only when a drug take-back option is
not readily available. As to the commenter's second point, while it is
true that the Office of Water has not yet promulgated an effluent
guideline for the healthcare industry, this should not be taken as a
sign that a decision has been made affirmatively that an effluent
guideline is not appropriate at some time in the future. Rather, the
Office of Water has preferred that the Office of Resource Conservation
and Recovery (ORCR) first focus on preventing intentional discharges of
hazardous waste pharmaceuticals. We firmly believe that the prohibition
of sewering hazardous waste pharmaceuticals would complement any future
action taken by the Office of Water to issue effluent guidelines for
the healthcare industry.
---------------------------------------------------------------------------

    \298\ See comment number EPA-HQ-RCRA-2007-0932-0249.
---------------------------------------------------------------------------

XIV. Conditional Exemptions for Hazardous Waste Pharmaceuticals That
Are Also Drug Enforcement Administration Controlled Substances and
Household Waste Pharmaceuticals Collected in Take-Back Programs (Sec.
266.506)

A. Summary of Proposal

    Prior to this final rulemaking, the management and disposal of a
pharmaceutical that was both a RCRA hazardous waste and a DEA
controlled substance was 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 and its implementing
regulations, which is under DEA's purview. At the time of the proposal,
EPA was aware of only a handful of pharmaceuticals in common usage that
are both hazardous waste and controlled substances and therefore
subject to regulation by both EPA and the DEA. These are identified in
Table 3:

                     Table 3--Pharmaceuticals Still Used in Healthcare That Are DEA Controlled Substances and RCRA Hazardous Wastes
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloral; chloral hydrate...........  Acetaldehyde, trichloro-;   Sedative.............  U034, toxic..........  IV                  Used in hospital
                                      Aquachloral, Noctec,                                                                          pediatric units;
                                      Somnote, Supprettes.                                                                          common ingredient in
                                                                                vet anesthetics.
Fentanyl sublingual spray..........  Subsys....................  Analgesic............  D001, ignitable......  II                  Ignitable due to
                                                                                alcohol content.
Phenobarbital......................  Bellergal-S, Donnatal,      Anticonvulsant.......  D001, ignitable......  IV                  Ignitable due to
                                      Luminal,.                                                                                alcohol content.
Testosterone gels..................  Androgel, Fortesta, Testim  Hormone..............  D001, ignitable......  III                 Ignitable due to gel
                                                                                base.
Valium injectable..................  Diazepam..................  Anti-anxiety.........  D001, ignitable......  IV                  Ignitable due to
                                                                                alcohol content.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Chloral hydrate (U034), which is listed for toxicity, is the only
dually regulated hazardous waste/controlled substance that is a listed
hazardous waste.\299\ The other four dually regulated hazardous wastes/
controlled substances in common use are considered hazardous because
they exhibit the characteristic of ignitibility (D001). While the
active ingredient is not ignitable, these particular forms of the
pharmaceuticals are ignitable because they are prepared in ignitable
solutions, such as alcohol.
---------------------------------------------------------------------------

    \299\ Note that EPA's U034 listing includes chloral hydrate, see
memo dated April 6, 1998; Brandes to Knauss, RCRA Online #14175
---------------------------------------------------------------------------

    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 4.

                         Table 4--DEA Controlled Substances and RCRA Hazardous Wastes Pharmaceuticals That Are Not in Common Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Paraldehyde........................  1,3,5-Trioxane, 2,4,6-      Anticonvulsant.......  U182 toxic...........  IV                  No longer in common
                                      trimethyl-; Paral.                                                                            use.
Paregoric..........................  camphorated tincture of     Analgesic,             D001 ignitable.......  III                 No longer in common
                                      opium.                      expectorant,                                                      use.
                                                                  antidiarrheal.
Opium Tincture.....................  Laudanam..................  Analgesic,...........  D001 ignitable.......  II                  No longer in common
                                                                 antidiarrheal........                                              use.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Similarly, as noted in Table 5, 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.\300\
---------------------------------------------------------------------------

    \300\ See memo dated February 17, 2012; from Devlin to RCRA
Division Directors, RCRA Online #14831.

           Table 5--Pharmaceuticals That Are DEA Controlled Substances and RCRA Hazardous Wastes Salt(s) No Longer Considered Hazardous Waste
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phentermine........................  alpha, alpha-               Appetite suppressant.  P046, Acutely toxic..  IV                  If in salt form, it
                                      Dimethylphenethyl amine;                                                                      does not meet the
                                      Benzeneethanamine,                                                                            P046 listing and
                                      alpha,alpha-dimethyl-;                                                                        medical dosage forms
                                      Adipex-P, Atti Plex P,                                                                        are salts.
                                      Fastin, Ionamin,
                                      Kraftobese, Panshape M,
                                      Obe-Nix, Pentercot,
                                      Phentride, Pro-Fast,
                                      Raphtre, Supramine, Tara-
                                      8, Termene, Termine,
                                      Zantryl.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    EPA requested comment on whether these are, indeed, the only
pharmaceuticals in common usage that are regulated both as DEA
controlled substances, and when discarded, as RCRA hazardous waste.
    To eliminate duplicative regulation for these handful of hazardous
wastes that are also controlled substances, EPA proposed to
conditionally exempt from RCRA Subtitle C regulation those hazardous
wastes that are also DEA controlled substances. Specifically, EPA
proposed 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.
    The first condition we proposed was 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). At the time of proposal, DEA had not
specified or endorsed a method by which the controlled substances
should be destroyed to meet the non-retrievable standard. Although many
hazardous wastes/controlled substances were being destroyed by
incineration, it was not required by DEA. At the time, EPA was
concerned that in the future DEA might allow a technology that lacks
environmental controls and permits. Therefore, combustion of the
hazardous wastes/controlled substances, which requires permitting,
operating and monitoring standards, was proposed as a condition of the
exemption. However, EPA requested 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.
    The second condition we proposed was 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. EPA requested comment on whether the
tracking that DEA requires for controlled substances is sufficient to
act in lieu of the RCRA manifest.
    We considered proposing a third condition that the hazardous waste
pharmaceuticals that are also DEA controlled substances would be
subject

to the sewer prohibition of Sec.  266.505. At the time of proposal,
however, we concluded that because combustion in specific units was a
condition of the exemption, that it was unnecessary to state that the
hazardous waste/controlled substances may not be sewered.
    EPA also proposed a related conditional exemption for household
pharmaceuticals, including those that are collected in DEA authorized
collection receptacles and commingled with DEA controlled substances.
Specifically, we proposed that collected household pharmaceuticals will
continue to be excluded from RCRA regulation as household hazardous
waste, provided they comply with the same two conditions. The Agency
has a long-standing recommendation that household hazardous waste
collection programs manage the collected waste as hazardous waste.\301\
As such, the Agency recommends that collected household waste
pharmaceuticals be incinerated--preferably at a permitted hazardous
waste incinerator, but when that is not feasible, at a large or small
municipal waste combustor.\302\ The Agency believes that this practice
is already common among collection programs since one goal of many
collection programs is to divert pharmaceuticals from municipal
landfills. Additionally, incineration is commonly used to meet the
``non-retrievable'' standard of destruction required by DEA for
controlled substances collected from consumers (ultimate users, as DEA
refers to them). Nevertheless, the Agency proposed to make this
recommendation a requirement for collected household waste
pharmaceuticals in Sec.  266.506.\303\ We strongly believe that if a
program goes to the expense of collecting the waste, including waste
pharmaceuticals, it should manage the waste as hazardous waste, rather
than manage it as municipal solid waste, which the household could do
absent the collection program. However, the current household waste
exemption does not require an entity that hosts a household hazardous
waste collection event to manage the collected waste as hazardous
waste. Typically, the parties conducting household hazardous waste
collection events have been government entities--municipalities and
counties. It is relatively new that retail pharmacies and others are
becoming interested in performing this function. To encourage this
practice, while at the same time ensuring that collection programs are
managing the collected waste properly, we proposed to codify our policy
that pharmaceuticals that are household hazardous waste (i.e.,
``household waste pharmaceuticals'') and are collected in DEA
authorized collection receptacles where they may be commingled \304\
with controlled substances continue to be excluded from RCRA
regulation, provided they are (1) combusted at a municipal solid waste
or hazardous waste combustor, and (2) managed in accordance with all
applicable DEA regulations.\305\
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    \301\ See memo from J. Winston Porter to Regions, dated November
1, 1988; RCRA Online #11377.
    \302\ See memo September 26, 2012, Rudzinski to the Regional
RCRA Division Directors (RCRA Online#14833) and memo October 2,
2015, Johnson to RCRA Division Directors (RCRA Online #14853).
    \303\ Since pharmaceutical collection programs typically
commingle DEA controlled substances with non-controlled substances,
this requirement is included in a section of the regulations that
pertains to controlled substances.
    \304\ DEA does not prohibit co-mingling of controlled substances
with non-controlled substances provided they are all then managed as
controlled substances.
    \305\ See 40 CFR 26.506(a)(2).
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B. Summary of Comments

    Many of the commenters, including states, healthcare facilities,
and waste management companies, supported both conditional exemptions
as a way to eliminate the duplicative regulation by DEA and EPA and
commenters thought that the DEA tracking, shipping and recordkeeping
are sufficient to operate in lieu of RCRA. Several commenters suggested
that we expand the types of treatment that are allowed to destroy the
hazardous waste pharmaceuticals that are also controlled substances. In
some cases, commenters suggested that we allow additional combustion
units such as hospital, medical, infectious waste incinerators
(HMIWIs); commercial, industrial solid waste incinerators (CISWIs); and
other solid waste incinerators (OSWIs) to combust hazardous waste
pharmaceuticals that are also controlled substances. Other commenters
suggested that we allow forms of destruction beyond combustion, such as
oxidation treatment\306\ or chemical digestion,\307\ or any technology
that achieves DEA's standard of non-retrievable.\308\
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    \306\ See Comment number EPA-HQ-RCRA-2007-0932-0287.
    \307\ See Comment number EPA-HQ-RCRA-2007-0932-0375.
    \308\ See Comment number EPA-HQ-RCRA-2007-0932-0333.
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C. Final Rule Provisions

    We are finalizing both conditional exemptions for hazardous wastes
that are also controlled substances, with some changes. First, we have
amended the regulatory language in Sec.  266.506(a)(2) to be more
consistent with the preamble to the proposed rulemaking and to be more
consistent with how the conditional exemption in Sec.  266.506(a)(1)
was crafted. In the preamble to the proposed rulemaking, we discussed
the conditional exemption in terms of the waste pharmaceuticals from
take-back events and programs, while in the proposed regulatory
language, the conditional exemption was focused on the collector of the
waste pharmaceuticals. We revised the regulatory language in Sec.
266.506(a)(2) to conditionally exempt the collected household waste
pharmaceuticals, as opposed to the collector of the household waste
pharmaceuticals. Additionally, one commenter pointed out that the
proposed regulatory language could be read to mean that if the
household waste pharmaceuticals were not commingled with DEA controlled
substances, then the requirement to combust them would not apply.\309\
EPA did not intend to make this distinction. Although we understand
that most, if not all, take-back events and programs do, in fact,
commingle controlled substances with non-controlled substances, EPA
proposed to place conditions on collectors of household waste
pharmaceuticals with the understanding that this proposed regulatory
language would capture all pharmaceuticals collected at take-back
events and programs. The revised regulatory language in this final rule
makes it clearer that the household waste pharmaceuticals collected
during a take-back event or program must be destroyed by combustion or
other DEA-approved method, whether or not the household waste
pharmaceuticals are commingled with DEA controlled substances.
---------------------------------------------------------------------------

    \309\ See comment number EPA-HQ-RCRA-2007-0932-0261.
---------------------------------------------------------------------------

    Also in response to comments, we are expanding the types of
combustors that are allowed to destroy the conditionally exempt
hazardous waste pharmaceuticals. Under the final rule, five types of
combustors will be allowed to destroy hazardous waste pharmaceuticals
that are also DEA controlled substances and the pharmaceuticals from
take-back events and programs: (1) Permitted large municipal waste
combustors (MWCs), (2) permitted small MWCs, (3) permitted HMIWIs, (4)
permitted CISWIs and (5) permitted hazardous waste combustors (either
an incinerator or other combustor, such as a cement kiln).
    In addition to the five types of permitted combustors allowed to
destroy the conditionally exempt

pharmaceuticals, EPA is building in flexibility to the final regulation
to allow for the possibility that future technologies might be
developed that meet the DEA non-retrievable standard. Specifically, we
are allowing any method of destruction for the conditional exemption
that DEA has publicly approved in writing as able to meet its non-
retrievable standard. While it is reasonable to defer to the DEA's
judgement in this matter to approve methods of destruction that are
environmentally protective, we feel it is necessary to limit future
allowable destruction technologies for the conditionally exempt
pharmaceuticals to those that are publicly approved by the DEA as
meeting the non-retrievable standard. This is intended to avoid a
situation where parties might make unsubstantiated claims that their
product is capable of meeting the DEA non-retrievable standard in order
to qualify for the conditional exemption. Furthermore, any method that
DEA might specify must not conflict with federal environmental laws or
regulations. Also, because combustion is no longer specified as the
only allowable method of destruction, we have concluded that an
additional change to the regulations is needed to make it clear that
the hazardous waste pharmaceuticals that are also DEA controlled
substances are subject to Sec.  266.505, and therefore, may not be
sewered.
    Both types of conditionally exempt hazardous waste pharmaceuticals
(i.e., those that are DEA controlled substances and those that are
collected household waste pharmaceuticals) will be able to take
advantage of the expanded list of allowable types of combustors. For
healthcare facilities and reverse distributors that generate and manage
the handful of hazardous waste pharmaceuticals that are also controlled
substances, we think it will be helpful to have additional destruction
methods for these previously dually regulated wastes. Also, the
expanded list of allowable types of combustors will be helpful for
those operating take-back programs and events. The Agency is a strong
supporter of take-back programs and events for household
pharmaceuticals as an alternative to disposing of leftover, unwanted
medications in the trash or in the toilet or down the sink (except in
cases where the FDA-approved labeling instructs patients to immediately
flush the unneeded medication down the toilet if a take-back option is
not readily available). In expanding the types of combustors that are
allowed to burn the pharmaceuticals from take-back events, we strive to
strike a balance between maximizing flexibility while still being
protective of human health and the environment. Under the revised list
in the final rule, the universe of allowable combustors will
substantially increase in number. There are 77 municipal solid waste
combustion facilities (also referred to as waste-to-energy facilities)
in 22 states,\310\ and 21 commercial hazardous waste combustion
facilities (i.e., those that accept waste from off-site) in 12
states.\311\ There are currently 33 HMIWIs units in the U.S.: 11 of the
33 are commercial HMIWIs, while the other 22 HMIWI units only combust
their own waste.\312\ There are approximately 75 CISWIs facilities in
the U.S.\313\ We note that the types of combustors we are allowing to
accept the conditionally exempt pharmaceuticals are not obligated to
accept the conditionally exempt pharmaceuticals. Of course, we strongly
encourage all the various types of allowable combustors to work with
their communities and regulators in developing viable options for
destroying the pharmaceuticals from take-back events. In particular, we
encourage the ``captive'' combustors that currently only combust their
own waste to consider amending their permits to allow them to accept
pharmaceuticals from take-back events and programs.
---------------------------------------------------------------------------

    \310\ Energy Recovery Council, 2016 Directory of Waste-to-Energy
Facilities; http://energyrecoverycouncil.org/wp-content/uploads/2016/06/ERC-2016-directory.pdf.
    \311\ Memo from Rudzinski to Regions, dated September 26, 2012;
RCRA Online #14833.
    \312\ See comment number EPA-HQ-RCRA-2007-0932-0280.
    \313\ See CISWI inventory EPA-HQ-OAR-2016-0664-0002.
---------------------------------------------------------------------------

    We have concluded that it is reasonable to expand the list of
allowable combustors able to accept the conditionally exempt
pharmaceuticals because the combustion of pharmaceuticals that meet the
definition of a RCRA solid waste but do not meet the definition of RCRA
hazardous waste (i.e., non-hazardous waste pharmaceuticals) is
regulated by Sec.  129 of the Clean Air Act. The statute requires EPA
to establish emission limits for nine air pollutants (i.e., particulate
matter, carbon monoxide, dioxins/furans, sulfur dioxide, nitrogen
oxides, hydrogen chloride, lead, mercury, and cadmium) from several
categories of solid waste incineration units, including MWCs; HMIWIs;
and CISWIs. EPA has established emission limits for each of the
categories based on the application of maximum available control
technology (MACT) which reflect the emission levels achieved by the
best performers in each category.
    In addition to complying with emission limitations, solid waste
incineration units are also subject to comprehensive operating,
monitoring and reporting requirements. In light of the common framework
used to develop emission limits and requirements for MWC, CISWI, and
HMIWI units, we believe that it is appropriate to include HMIWIs and
CISWIs as types of combustors that are allowed to burn the
pharmaceuticals from take-back events.
    While the Agency has expanded the list of allowable combustors to
include HMIWIs and CISWIs, we have not expanded the list to include
other solid waste incinerators (OSWIs). OSWIs are small units that have
fewer emission controls than other types of combustors. Further, there
are only a handful of new OSWIs in operation and the legal status of
existing OSWIs is uncertain due to litigation. EPA is also not
expanding the list of allowable combustors to include human and pet
crematoriums. Crematoriums are not regulated under the Clean Air Act