distributor responses to EPA's questions about reverse distribution
of pharmaceuticals, notes from Agency meetings with retail industry
representatives, and notes from site visits to reverse distribution
facilities.
    \74\ See comment number EPA-HQ-RCRA-2007-0932-0340 in the
docket.
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    In conclusion, a material is considered a solid waste if it is
accumulated or stored before or in lieu of being disposed of, burned,
or incinerated (Sec.  261.2(b)(3)). Even if the healthcare facility
intends to receive credit for the prescription pharmaceutical and the
reverse distributor intends to evaluate the prescription pharmaceutical
for credit, the pharmaceutical is still considered a discarded material
(Sec.  261.2(a)(2)(i)) because it is being accumulated and stored prior
to being sent for treatment (rather than being accumulated or stored
prior to being used/reused or reclaimed). Although the healthcare
facility or reverse distributor intends to elicit credit from the
prescription pharmaceutical in the interim period before it is sent for
treatment, the pharmaceutical is still considered a discarded material.
An intent to receive credit does not preclude the pharmaceuticals from
being discarded; they are not mutually exclusive.
    Although EPA maintains its position that prescription
pharmaceuticals moving through reverse distribution are solid wastes at
the healthcare facility, this final rule establishes streamlined,
practical standards for managing potentially creditable hazardous waste
pharmaceuticals that will reduce regulatory burden on retailers and
align with the existing practices of the retail sector. Thus, EPA's
position that prescription pharmaceuticals moving

through reverse distribution are solid wastes at the healthcare
facility only subjects these hazardous waste pharmaceuticals to the
streamlined part 266 subpart P standards versus the full RCRA Subtitle
C regulations. For example, EPA does not require healthcare facilities
to use a hazardous waste manifest or a hazardous waste transporter when
shipping potentially creditable hazardous waste pharmaceutical to a
reverse distributor. See section XVI.D for a discussion of the shipping
standards for potentially creditable hazardous waste pharmaceuticals.
    Because the point of generation of potentially creditable hazardous
waste pharmaceuticals is at the healthcare facility, EPA can impose the
RCRA Subtitle C cradle-to-grave management of hazardous wastes.
Specifically, it allows us to impose consistent and enforceable
tracking of hazardous waste pharmaceuticals from healthcare facilities
en route to reverse distributors. Lack of tracking was identified as a
regulatory gap by many commenters on our 2008 proposal to add
pharmaceuticals to the Universal Waste program. The tracking provides
the benefit of reducing the risk of diversion of these unused hazardous
waste pharmaceuticals onto the black market, thus fulfilling our
statutory mandate of protecting human health.
5. Nonprescription Pharmaceuticals and Other Retail Items Going Through
Reverse Logistics Are Not Wastes if They Have a Reasonable Expectation
of Being Legitimately Used/Reused or Reclaimed
    Although EPA includes nonprescription pharmaceuticals in the
definition of ``pharmaceutical'' under the final rule, the Agency makes
it clear in the definition of ``hazardous waste pharmaceutical'' that
nonprescription pharmaceuticals are not solid wastes, and therefore not
hazardous waste pharmaceuticals, if they have a reasonable expectation
of being legitimately used/reused (e.g., lawfully redistributed for its
intended purpose) or reclaimed. The applicability of the final rule
also has a new provision in Sec.  266.501(g)(2) making it clear that a
nonprescription pharmaceutical that is not a solid waste because it has
a reasonable expectation of being legitimately used/reused or reclaimed
is not subject to parts 260-273. Additionally, the final definition of
reverse distributor has been revised so that it applies only to the
reverse distribution of prescription pharmaceuticals.
    In the final rule, EPA is reaffirming the Agency's previous
policies on redistribution expressed in memos in 1981 and 1991 with
respect to nonprescription pharmaceuticals and other retail items that
have become unsalable at the retail store and are being managed by a
reverse logistics center through the reverse logistics process. That
is, EPA is maintaining a policy that nonprescription pharmaceuticals
and other retail items that are sent through reverse logistics are not
solid wastes at the retail store if they have a reasonable expectation
of being legitimately used/reused (e.g., lawfully redistributed for its
intended purpose) or reclaimed. EPA recognizes that reverse logistics
centers are designed to evaluate unsold retail items, analyze secondary
markets, and assess the suitability of the unsold retail items for
reuse in those secondary markets. These services promote the donation,
liquidation, and reuse of unsold retail items and reduce overall waste.
Importantly, these activities are distinct from the activities of
reverse distributors of prescription pharmaceuticals. Reverse
distributors of prescription pharmaceuticals are not designed to
evaluate unsold prescription pharmaceuticals and assess the suitability
of the prescription pharmaceuticals for reuse in secondary markets. As
mentioned previously, commenters pointed out that the purpose of
reverse distribution of prescription pharmaceuticals is to determinate
creditworthiness while the primary purpose of reverse logistics of
nonprescription pharmaceuticals is to aggregate and redirect viable
products into another supply chain.
    Although EPA is reaffirming this policy, EPA remains concerned
about the potential for overuse of reverse logistics centers, a concern
we originally raised in a 1991 memo related to reverse distribution:
``a reverse distribution system cannot be used as a waste management
service to customers/generators without the applicable regulatory
controls on waste management being in place . . . to the extent that
the materials involved are unused commercial chemical products with a
reasonable expectation of being recycled in some way when returned, the
materials are not considered as wastes until a determination has been
made to discard them.'' \75\ To reiterate, in order to avoid being
considered solid waste, items, including nonprescription
pharmaceuticals, sent through reverse logistics, must have some
reasonable expectation of being legitimately used/reused or reclaimed.
The 199l guidance allowing pharmaceuticals to go through reverse
distribution without being considered solid waste was based on the
notion that they had the potential for recycling by use/reuse. Over the
years, however, many have come to disregard the intent behind this
guidance and erroneously believed that it was a blanket statement that
pharmaceuticals going through reverse distribution were not solid
wastes, even if they did not have a reasonable expectation of being
redistributed or recycled. We strongly encourage the use of reverse
logistics centers to facilitate redistribution and legitimate recycling
to the fullest extent possible, and thus, reduce the amount of waste
being generated. But we also caution reverse logistic centers not to
become de facto waste management facilities for their customers. If
this were to occur, it could be the case that the decision to discard
for nonprescription pharmaceuticals and other retail items would have
occurred at the retail store or healthcare facility.
---------------------------------------------------------------------------

    \75\ See memo dated May 16, 1991, From Lowrance to Schulz, RCRA
Online #11606.
---------------------------------------------------------------------------

    Of course, once a reverse logistics center makes a decision to
discard an item, it becomes a solid waste and, if it is listed or
exhibits a characteristic, a hazardous waste. The reverse logistics
center is subject to the applicable RCRA regulations, such as part 262,
for the generation and accumulation of hazardous waste, including
hazardous waste pharmaceuticals, but not part 266 subpart P.
    EPA notes that although nonprescription pharmaceuticals and other
retail items that are sent through reverse logistics are not solid
wastes at the retail store if they have a reasonable expectation of
being legitimately used/reused or reclaimed, the items must be shipped
in accordance will all applicable Department of Transportation (DOT)
regulations. For example, DOT promulgated a final rule in March 2016 on
the reverse logistics of hazardous materials. This rule includes
provisions to help ensure that items, including consumer grade
fireworks, are in original packaging when shipped from a retail store
to a manufacturer, supplier, or distribution facility.\76\
---------------------------------------------------------------------------

    \76\ See 81 FR 18527; March 31, 2016.
---------------------------------------------------------------------------

    There are six issues that came to EPA's attention when shaping this
final reverse logistics policy. The first issue regards the ultimate
disposition of unsold retail items moving through reverse logistics.
The second issue regards unsold retail items that have expired. The
third issue involves instances when retail items cannot be

legitimately used/reused (e.g., lawfully redistributed for their
intended purpose) because the items are subject to a ``destroy
disposition.'' The fourth issue regards the crediting process for
unsold retail items. The fifth issue involves instances when
nonprescription pharmaceuticals and other unsold retail items become
subject to a voluntary, federally mandated, or state mandated recall.
The final issue involves instances when nonprescription pharmaceuticals
and other unsold retail items cannot be sent through reverse logistics
because they are broken, damaged, or leaking.
    a. Unsold retail items returned to the manufacturer or vendor. The
first issue regards the ultimate disposition of unsold retail items
moving through reverse logistics. As noted previously, data from
commenters suggests a majority of unsold retail items moving through
reverse logistics are returned to the manufacturer or vendor.\77\ EPA
did not receive data on the ultimate disposition of retail items that
are returned to a manufacturer or vendor from a reverse logistics
center. For this final action, EPA assumes the items are not wastes if
they have a reasonable expectation of being legitimately used/reused
(e.g., lawfully redistributed for its intended purpose) or reclaimed.
However, if nonprescription pharmaceuticals or other retail items do
not have a reasonable expectation of being legitimately used/reused
(e.g., lawfully redistributed for their intended purpose) or reclaimed
after they are returned to a manufacturer or vendor, then the
nonprescription pharmaceutical or other unsold retail item would be a
solid and potentially hazardous waste at the reverse logistics center.
---------------------------------------------------------------------------

    \77\ See comment number EPA-HQ-RCRA-2007-0932-0340 in the
docket.
---------------------------------------------------------------------------

    b. Unsold retail items that have expired. The second issue regards
unsold retail items that have expired.\78\ As mentioned previously,
commenters noted that when an item is sent to a reverse logistics
center because an expiration date has been exceeded, disposal is most
often the required disposition, however the items may be returned to
the manufacturer for further evaluation for potential liquidation.\79\
Furthermore, nonprescription pharmaceuticals with ``best by'' dates (as
opposed to expiration dates) often can still be donated or liquidated
after the date has passed. In addition to information received from
commenters suggesting that expired products might be considered
eligible for redistribution, FDA occasionally allows the donation of
drugs that are past the expiration date shown on the label when
provided sufficient information to show the expired pharmaceuticals are
safe and effective and other specific criteria have been met.\80\ Thus,
for this final action, EPA assumes that nonprescription pharmaceuticals
and other unsold retail items that have expired are not wastes if they
have a reasonable expectation of being legitimately used/reused (e.g.,
lawfully redistributed for its intended purpose) or reclaimed. These
items are in their original, intact packaging and do not pose a high
risk of release to the environment. Further, this position is
consistent with the goal of the RCRA statute to reduce waste, as EPA is
concerned that considering unsold retail items that have expired to be
wastes at the retail store could introduce an unintended incentive for
retailers to remove those items from shelves in advance of expiration
dates, resulting in an unnecessary increase in overall waste
generation.
---------------------------------------------------------------------------

    \78\ EPA uses the term ``expired'' consistent with Food and Drug
Administration regulations. See 21 CFR part 201.66, part 201.17, and
211.137.
    \79\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket.
    \80\ See U.S. Food and Drug Administration ``Question and
Answers for the Public: Donating Drugs to International Humanitarian
Relief Efforts'' available at: https://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM249617.pdf.
---------------------------------------------------------------------------

    c. Unsold retail items subject to a destroy disposition. The third
issue involves instances when retail items cannot be legitimately used/
reused (e.g., lawfully redistributed for their intended purpose)
because the items are subject to a ``destroy disposition.'' A destroy
disposition is when a manufacturer has established ``business rules''
that prohibit unsold retail items from being redistributed for their
intended purpose (i.e., liquidated or donated). The term ``business
rules'' (i.e., manufacturer return policies) refers to the rules that
govern the disposition of retail items agreed to by the manufacturer,
retailer, and reverse distributor or reverse logistics center.\81\ The
Agency's understanding is that manufacturers adopt destroy dispositions
over concerns related to liability and brand protection and that
assigning a destroy disposition is not a common practice because it
precludes income from potential redistribution and results in disposal
costs.\82\ For this final action, if a manufacturer has established
business rules that prohibit unsold retail items from being
legitimately used/reused (e.g., lawfully redistributed for their
intended purpose) because the items are subject to a ``destroy
disposition,'' and that prohibit the unsold retail items from being
reclaimed, the items are considered solid waste at the retail store or
healthcare facility. However, if a manufacturer has established
business rules that do not imply that disposal is the ultimate
disposition for unsold retail items, and there is a reasonable
expectation the items will be reclaimed, these items would not be solid
wastes at the retail store when they are sent through reverse
logistics. Thus, a manufacturer can adopt business rules that prohibit
the lawful redistribution of retail items for their intended purpose
(i.e., liquidation or donation), but allow for the items to be sent
through reverse logistics for reclamation. These items would not be
wastes at the retail store if there is a reasonable expectation the
items will be reclaimed.
---------------------------------------------------------------------------

    \81\ This definition is derived from the definition of
``business rules'' in the ``Surplus Household Consumer Products and
Wastes: Report to the Legislature.'' Available at: http://www.dtsc.ca.gov/HazardousWaste/Retail_Industry/upload/SB423_Final-Rpt.pdf.
    \82\ See discussion of ``destroy dispositions'' in the ``Surplus
Household Consumer Products and Wastes: Report to the Legislature.''
Available at: http://www.dtsc.ca.gov/HazardousWaste/Retail_Industry/upload/SB423_Final-Rpt.pdf.
---------------------------------------------------------------------------

    d. Crediting process for unsold retail items. The fourth issue
regards the crediting process for unsold retail items. It is the
Agency's understanding that there are two primary credit models. The
first is the ``traditional approach'' whereby credit is awarded after
unsold retail items are returned to a reverse logistics center for
processing. The second is the adjustable rate policy, which is also
commonly referred to as a ``swell allowance,'' whereby credit is
awarded up-front based on an assumption that a certain percentage of
items will become unsalable for various reasons at the primary
retailer.\83\ EPA's understanding is that one of the goals of the
adjustable rate policy is to reduce the amount of unsold items sent
through to reverse logistics centers and to encourage sale at the
primary retailer--even if this means discounting those items. EPA's
understanding is that under such an approach, retailers are responsible
for managing unsold retail items and determining the ultimate
disposition since the manufacturer is not involved in the disposition
decision. That being said, retailers can utilize reverse logistics to
assist in the management and disposition of unsold retail items sold
under an adjustable rate policy. More importantly, under EPA's final
policy, although the

potential exists for a manufacturer to issue credit for an unsold
retail item, the ``decision point'' on whether a retail item is a solid
waste is when the decision has been made to discard the material. In
other words, a pharmaceutical is a solid waste when the decision has
been made to discard regardless of whether the pharmaceutical has
value. Thus, for this final action, the credit model is not relevant to
the waste status of unsold retail items. EPA assumes that
nonprescription pharmaceuticals and other unsold retail items that
receive credit up-front through an adjustable rate policy are not
wastes if they have a reasonable expectation of being legitimately
used/reused (e.g., lawfully redistributed for their intended purpose)
or reclaimed.
---------------------------------------------------------------------------

    \83\ Additional information on the Adjustable Rate Policy and
other reimbursement policies for unsalable items can be found in the
publication entitled, 2008 Joint Industry Unsaleables Management
Study: The Real Causes and Actionable Solutions. This publication is
available at http://www.gmaonline.org/downloads/research-and-reports/UnsaleablesFINAL091108.pdf.
---------------------------------------------------------------------------

    e. Unsold retail items subject to a recall. The fifth issue
involves instances when nonprescription pharmaceuticals and other
unsold retail items become subject to a voluntary, federally mandated,
or state mandated recall. Almost all pharmaceutical recalls are
overseen by FDA. However, under the Poison Prevention Packaging Act,
the U.S. Consumer Product Safety Commission (CPSC) has authority
regarding special packaging (sometimes called child resistant
packaging) of certain household products, including drugs (as that term
is defined in the Federal Food, Drug, and Cosmetic Act).\84\ Similarly,
under the child Nicotine Poisoning Prevention Act of 2015, CPSC has
authority for administering special packaging requirements for liquid
nicotine containers.\85\ Thus, CPSC oversees a recall if there is a
problem with a pharmaceutical's special packaging or containers for
liquid nicotine. Additionally, CPSC has jurisdiction over recalls of
many other consumer products sold at retail stores.\86\ EPA is choosing
not to apply RCRA regulations to nonprescription pharmaceuticals and
other unsold retail items while they are subject to a recall, provided
the recall is regulated and overseen by FDA or CPSC. This is true
whether they become subject to a recall at a reverse logistics center,
healthcare facility, or retail store. It is possible that recalled
nonprescription pharmaceuticals and other unsold retail items are not a
solid waste if they are legitimately used/reused or reclaimed. For
example, if CPSC oversees a recall if there is a problem with a
pharmaceutical's packaging (e.g., an item's packaging poses a threat
because it is not sufficiently child resistant), it is possible the
pharmaceutical could still be sent for reclamation. Although it is
difficult for EPA to make a blanket determination on whether all
recalled nonprescription pharmaceuticals and other unsold retail items
are or are not solid wastes, EPA is choosing not to apply RCRA
regulations to recalled nonprescription pharmaceuticals and other
unsold retail items provided the recall is overseen by FDA or CPSC.
When FDA directs the destruction of some or all of the recalled retail
items, or CPSC grants permission to dispose or destroy some or all of
the recalled items, the materials that are hazardous waste must be
managed in accordance with RCRA, including the hazardous waste
generator regulations standards in 40 CFR part 262.
---------------------------------------------------------------------------

    \84\ See 15 U.S.C. 1471-1477 for the Poison Prevention Packaging
Act.
    \85\ Public Law 114-116 (January 28, 2016).
    \86\ The CPSC has jurisdiction over more than 15,000 kinds of
consumer products used in and around the home, in sports, recreation
and schools. See https://www.recalls.gov/cpsc.html for more
information.
---------------------------------------------------------------------------

    Although FDA and CPSC are the federal agencies that primarily
regulate recalled nonprescription pharmaceuticals and other unsold
retail items, other federal agencies regulate some recalled retail
items. For example, the National Highway Traffic Safety Administration
oversees motor vehicle defects and safety recalls. Although other
federal agencies may occasionally regulate recalled retail items, EPA
is only choosing not to apply RCRA regulations to recalled
nonprescription pharmaceuticals and other unsold retail items when the
recall is overseen by FDA or CPSC. CPSC requires manufacturers to
develop a recall strategy that outlines all of the actions to be taken
on behalf of the manufacturer from start to finish. FDA requires firms
that initiate a recall to develop a recall strategy and recommends that
firms that initiate a FDA-requested recall develop a recall
strategy.\87\ Included as a required component of a comprehensive
recall strategy is a requirement that FDA or CPSC approves a
manufacturer's decision to take the action to discard some or all of
the recalled items. Thus, EPA believes it is reasonable not to apply
RCRA regulations to recalled nonprescription pharmaceuticals and other
unsold retail items when the recall is overseen by FDA or CPSC.
However, the Agency will continue to evaluate recalled nonprescription
pharmaceuticals and other unsold retail items managed by other federal
agencies on a case-by-case basis. As an example, see the memo that EPA
released in 2017 that describes how RCRA regulations apply to recalled
Takata airbag inflators while they are being held under the 2015 DOT
preservation order.\88\ EPA's policy does not apply to unused
pesticides that are suspended or canceled under the Federal
Insecticide, Fungicide, and Rodenticide Act and recalled, as these can
be managed as universal waste under 40 CFR part 273. Finally, while EPA
is not applying RCRA regulations in these situations, we note that if
recalled nonprescription pharmaceuticals and other unsold retail items
are not managed and stored in a manner that prevents release to the
environment, they may be considered a solid waste and a hazardous waste
under sections 3007, 3013, and 7003 of RCRA.
---------------------------------------------------------------------------

    \87\ See 21 CFR 7.46(a)(8) and 21 CFR 7.45(b), respectively.
    \88\ See RCRA Online #14893 for the June 23, 2017 memo titled
``Recalled Takata Airbag Inflators.''
---------------------------------------------------------------------------

    f. Unsold retail items that are broken, damaged, or leaking. The
sixth issue involves instances when nonprescription pharmaceuticals and
other unsold retail items cannot be sent through reverse logistics
because they are broken, damaged, or leaking. In recent years, EPA took
multiple enforcement actions against national retailers for sending
hazardous waste, in the form of broken and/or leaking items with
hazardous contents, to unpermitted TSDFs (in the form of reverse
distributors and reverse logistics centers), among other RCRA
violations.\89\ The resulting settlements specify that unsold retail
items with broken and/or leaking packaging are waste at the retailer
and, if they are hazardous, cannot be sent to a reverse distributor or
reverse logistics center. CVS commented on the proposed rulemaking and
asked that EPA clarify that when pharmaceutical packaging is in
sufficiently poor condition that it is broken, leaking, or otherwise
unable to be used for its intended purpose, that those pharmaceuticals
become solid waste at the healthcare facility.\90\ CVS noted that this
is consistent with their current practice, whereby broken and leaking
items are managed as waste at their facilities and are not sent through
reverse distribution or reverse logistics.
---------------------------------------------------------------------------

    \89\ Walmart Consent Agreement and Final Order, Docket Nos.
RCRA-HQ-2013-4001 and FIFRA-HQ-2013-5056.
    \90\ See comment number EPA-HQ-RCRA-2007-0932-0312 in the
docket.
---------------------------------------------------------------------------

    Although EPA affirms the resulting settlements and agrees that
nonprescription pharmaceuticals and other retail items cannot be sent
through reverse logistics when they are broken, damaged, or leaking,
the Agency is aware that there is inherent uncertainty

surrounding when these items are considered broken, damaged, or
leaking. For example, a nonprescription pharmaceutical could experience
damage to the outer packaging while the inner container remains intact.
For this final action, unsold retail items, including nonprescription
pharmaceuticals, are not considered waste at the retail store if their
packaging is in good condition, with no leaks or other continuing or
intermittent unpermitted releases of the materials to the
environment,\91\ and they are contained to prevent releases to the
environment,\92\ and they have a reasonable expectation of being
legitimately used/reused (e.g., lawfully redistributed for its intended
purpose) or reclaimed. Thus, the Agency intends that nonprescription
pharmaceuticals and other unsold retail items can be sent to a reverse
logistics center and are not considered wastes at the retail store if
they meet this standard. For example, if an outer cardboard box
containing vials of nonprescription pharmaceuticals is damaged, but the
vials are intact and not damaged or leaking, EPA does not consider the
item to be damaged such that it cannot go through reverse logistics.
---------------------------------------------------------------------------

    \91\ As defined in Sec.  260.10, unpermitted releases are
releases that are not covered by a permit (such as a permit to
discharge to water or air) and may include, but are not limited to,
releases through surface transport by precipitation runoff, releases
to soil and groundwater, wind-blown dust, fugitive air emissions,
and catastrophic unit failures.
    \92\ These conditions are derived from the definition of
contained as defined in Sec.  260.10.
---------------------------------------------------------------------------

    In order to prevent exposures to personnel, the public, and the
environment, if items are not in good condition, or are leaking or
releasing to the environment, these items must be managed as wastes at
the stores in accordance with the applicable hazardous waste
regulations. Specifically, if the broken, damaged, or leaking item is a
hazardous waste pharmaceutical, the retail store must manage it under
the streamlined standards of part 266 subpart P (unless it is a VSQG
for all its hazardous waste). Otherwise, the retail store would manage
hazardous wastes under the applicable RCRA regulations, including part
262 generator regulations.

E. Applicability of the Household Hazardous Waste Exemption to Retail
Items

    One commenter suggested that the ``household hazardous waste''
exclusion at 40 CFR 261.4(b)(1) apply to retail items purchased by a
customer and subsequently returned to the retailer.\93\ The Agency has
already addressed the issue of retail wastes as part of a previous
rulemaking that responded to a petition from the American Retail
Federation. As explained in a November 13, 1984, final rule \94\, EPA
excluded household hazardous waste because the legislative history of
RCRA indicated an intent to exclude such wastes and not because these
wastes can never pose the risks associated with hazardous wastes.
Additionally, consistent with legislative history, when evaluating the
American Retail Federation's petition, EPA determined that it was
necessary to establish two criteria that must be met to qualify for
this exclusion. First, the waste must be generated by individuals on
the premises of a temporary or permanent residence and, second, the
waste stream must be composed primarily of materials found in wastes
generated by consumers in their homes. In this final rule, EPA denied
the American Retail Federation's petition to exempt consumer household
hazardous waste generated by retail sources because these wastes fail
to meet both criteria. The Agency reaffirmed this position in the
Retail Strategy, arguing that retail goods, including those that could
become wastes when discarded, do not satisfy the criteria for this
exclusion.
---------------------------------------------------------------------------

    \93\ See comment number EPA-HQ-RCRA-2007-0932-0277 in the docket
for this rulemaking.
    \94\ See 49 FR 44978; November 13, 1984.
---------------------------------------------------------------------------

    The Agency believes that this interpretation extends to retail
items purchased by a customer and subsequently returned to a retail
store. Hazardous waste generated at retail stores, including retail
items purchased by a customer that are subsequently returned, does not
meet the first criterion for the household hazardous waste exemption.
Specifically, the decision to discard does not occur at the residence,
it occurs at the retail store. In fact, many retail items that are
returned are restocked and sold at the store (e.g. lawfully
redistributed for their intended purpose) and are not solid wastes.
    On the other hand, the Agency notes that a household pharmaceutical
that is collected from individuals by a healthcare facility (e.g.,
retail store) as part of a DEA pharmaceutical take-back program
maintains the household hazardous waste exemption as long as it is not
sewered, and is destroyed by a method that DEA has publicly deemed in
writing to meet their non-retrievable standard of destruction or
combusted at one of the types of combustors identified in Sec.
266.506(b). For more discussion on DEA take-backs of household
pharmaceuticals, please see section XIV of this preamble.

VII. Scope of the Final Rule

A. What facilities are subject to the final rule?

    This final rule is a sector-based rule that applies to the
management of hazardous waste pharmaceuticals that are generated and
managed by healthcare facilities and reverse distributors. Subsequent
sections of the preamble will discuss in detail the definitions of
these terms, as well as what provisions of the rule apply to each type
of facility (see section VIII for a discussion of each definition and
section IX for Applicability). Healthcare facilities and reverse
distributors will use the regulations finalized under 40 CFR part 266
subpart P in lieu of the RCRA generator regulations in 40 CFR part 262
to which they were previously subject.

B. What facilities are not subject to the final rule?

1. Pharmaceutical Manufacturers
    Part 266 subpart P does not apply to the management of hazardous
waste pharmaceuticals that are generated by pharmaceutical
manufacturers. A pharmaceutical manufacturer remains subject to part
262 and all applicable RCRA subtitle C regulations for the management
of its hazardous waste, including its hazardous waste pharmaceuticals.
Pharmaceutical manufacturers do not face the same challenges that
healthcare facilities experience when managing hazardous waste
pharmaceuticals in accordance with the federal RCRA subtitle C
regulations (for an explanation of the challenges healthcare facilities
face, see discussion in section III of the preamble). The types of
hazardous waste pharmaceuticals generated by manufacturers are less
variable and therefore more predictable, and the staff have the
necessary expertise to determine which pharmaceutical waste is
hazardous waste. However, when any facility, including a pharmaceutical
manufacturer, meets the definition found in this proposal for a reverse
distributor, it would be subject to the final regulations for reverse
distributors with respect to those operations.
2. Households
    The Agency emphasizes that the regulatory requirements in this
final rule do not apply to households that discard pharmaceuticals.
Pharmaceuticals that are discarded by households are not regulated as
hazardous waste and are generally considered municipal solid waste.
While a small percentage of these

household waste pharmaceuticals meet the definition of hazardous waste
under RCRA, the federal RCRA hazardous waste regulations include an
exclusion for all hazardous wastes generated by households.\95\ Thus
household hazardous waste pharmaceuticals--like other household
hazardous wastes--are not subject to the federal RCRA hazardous waste
regulations.
---------------------------------------------------------------------------

    \95\ See the household waste exclusion at Sec.  261.4(b)(1),
which is often referred to as the household hazardous waste or HHW
exclusion.
---------------------------------------------------------------------------

    Despite the fact that household hazardous wastes are not regulated
as hazardous wastes, it is important to note that ``EPA excluded
household wastes because the legislative history of RCRA indicated an
intent to exclude such wastes, though not because they necessarily pose
no hazard.'' \96\ Some household products, including pharmaceuticals,
contain ignitable, corrosive, reactive, or toxic ingredients. As a
result, for household hazardous waste collected at a household
hazardous waste collection program, the Agency has historically
recommended that communities operating the collection programs manage
the collected household hazardous waste as hazardous waste, even though
it is not required by RCRA.\97\
---------------------------------------------------------------------------

    \96\ See 49 FR 44978; November 13, 1984.
    \97\ See memo November 1, 1988, from Porter to Regions (RCRA
Online #11377).
---------------------------------------------------------------------------

    Similarly, the Agency recommends that, whenever possible,
households utilize pharmaceutical collection events as the preferred
disposal option for their unwanted pharmaceuticals.\98\ For consumers
without access to a pharmaceutical take-back event, FDA provides
information on the disposal of unused pharmaceuticals and step-by-step
guidance for disposing of pharmaceuticals in the household trash.\99\
---------------------------------------------------------------------------

    \98\ For pharmaceuticals, these collection events are often
referred to as pharmaceutical take-back events. As used in this
preamble, a take-back event refers to one-day collection events,
such as the DEA bi-annual pharmaceutical take back days, while a
take-back program refers to an ongoing collection program, such as a
DEA-approved collection receptacle at a retail store.
    \99\ For more information on the safe disposal of household
waste pharmaceuticals, please see: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm.
---------------------------------------------------------------------------

    In a 2012 memo, the Agency recommended 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.\100\ 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). The Agency included this recommendation as a requirement for
household waste pharmaceuticals that have been collected (see Sec.
266.506).\101\ See section XIV of this preamble for a detailed
discussion of this provision.
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    \100\ See memo September 26, 2012, Rudzinski to the Regional
RCRA Division Directors (RCRA Online# 14833).
    \101\ 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.
---------------------------------------------------------------------------

3. Farmers, Ranchers and Fisheries
    This final rule is a sector-specific rulemaking that applies to
healthcare facilities and reverse distributors. As such, this final
rule does not apply other generators of hazardous waste pharmaceuticals
such as farmers, ranchers, and fisheries. Although these businesses
might administer pharmaceuticals to their animals in the regular course
of their business, they would not fall within the definition of a
healthcare facility or a reverse distributor. The Agency designed this
final rule to address the unique needs of the healthcare sector and
concluded that it would not be appropriate to apply it to all sectors
that generate hazardous waste pharmaceuticals. Other generators of
hazardous waste pharmaceuticals, such as farmers, ranchers and
fisheries, remain subject to the part 262 generator regulations. As
discussed in detail in section VIII of this preamble, the definition of
healthcare facility does include veterinary clinics and veterinary
hospitals.
4. RCRA-Permitted or Interim Status Treatment, Storage and Disposal
Facilities
    This final rule does not affect how RCRA-permitted or interim
status TSDFs manage hazardous waste pharmaceuticals at their
facilities, except indirectly when they treat hazardous waste
pharmaceuticals to meet the land disposal restrictions (LDRs). See
section X.H. of this preamble for additional detail.

C. Scope of Hazardous Wastes Addressed by This Final Rule

1. Hazardous Waste Pharmaceuticals
    These final regulations pertain only to those pharmaceutical wastes
that are RCRA hazardous wastes that are generated by healthcare
facilities or managed by reverse distributors. Under this rulemaking,
EPA has not added additional pharmaceuticals to the hazardous waste
listings or expanded the hazardous waste characteristics to include
additional pharmaceuticals. Although we solicited ideas from commenters
for possible methods or approaches for regulating additional
pharmaceuticals as hazardous waste, any action taken to address the
comments we received in response to this request would be a separate
action taken by the Agency in the future and is not part of this final
rulemaking.
2. Related Federal or State Regulations
    The generation, accumulation, transportation, treatment, storage,
and disposal of hazardous waste pharmaceuticals are regulated under
RCRA Subtitle C. However, hazardous waste pharmaceuticals may also be
subject to a number of other statutes and implementing regulations
administered by state or other federal agencies. Examples include
pharmaceuticals that are subject to the Controlled Substances Act and
DEA regulations; infectious pharmaceutical wastes that are subject to
state and local medical waste regulations; pharmaceuticals with a
radioactive component that are subject to the Atomic Energy Act (AEA)
and pharmaceuticals that are hazardous waste as defined in 40 CFR 261.3
that are subject to OSHA's Hazardous Waste Operations and Emergency
Response standard. These potentially overlapping requirements make the
appropriate management of pharmaceutical wastes a complex matter. The
following discusses the impact of this final rule on various dually
regulated hazardous waste pharmaceuticals.
    a. Controlled substances. Under prior regulations, any healthcare
facility generating or managing a RCRA hazardous waste pharmaceutical
that is also a DEA controlled substance listed in Schedule II-V\102\
had to comply with the RCRA hazardous waste requirements, as well as
the requirements of the Controlled Substances Act and DEA regulations.
DEA regulations from 2014 to implement the Secure and Responsible Drug
Disposal Act of 2010 require that

controlled substances be destroyed so that they are ``non-
retrievable.'' \103\ In the preamble to both the proposed and final DEA
rules, DEA stated that flushing alone will not meet DEA's new non-
retrievable standard.\104\ Due to difficulties associated with managing
these hazardous waste pharmaceuticals that are also controlled
substances, the Agency is finalizing a conditional exemption from the
RCRA regulatory requirements for the handful of pharmaceuticals that
are both a RCRA hazardous waste and a DEA controlled substance. That
is, this final rule eliminates the dual regulation for RCRA hazardous
waste pharmaceuticals that are also DEA controlled substances. A more
detailed discussion of this conditional exemption is found in section
XIV of this final rule.
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    \102\ See 21 CFR part 1308 for a complete list of controlled
substances.
    \103\ Final rule: September 9, 2014; 79 FR 53520.
    \104\ Proposed rule: December 21, 2012; 77 FR 75784, see page
75803; and final rule: September 9, 2014; 79 FR 53520, see page
53548).
---------------------------------------------------------------------------

    b. Medical wastes. There are instances when a hazardous waste
pharmaceutical will also pose a biological hazard. The healthcare
industry often refers to pharmaceutical wastes that are both RCRA
hazardous and a biological hazard as ``dual wastes,'' and such wastes
must be managed in accordance with RCRA and state and/or local medical
waste regulations. As a result, the healthcare facility must send these
dual wastes to a hazardous waste TSDF that is also permitted by their
state to accept medical wastes. Some examples of dual wastes include
partially administered syringes containing hazardous waste
pharmaceuticals (e.g., physostigmine) or intravenous (IV) bags
containing residues of a hazardous waste pharmaceutical that are
attached to the tubing and needles used to administer the
pharmaceutical. The RCRA hazardous waste pharmaceutical component of
these dual wastes are included within these final subpart P management
standards so that healthcare facilities can obtain the benefits of this
new subpart, while ensuring the hazardous waste component of the waste
is managed appropriately and ultimately delivered to RCRA-permitted
TSDFs. Healthcare facilities must still manage the biological hazard in
accordance with state and/or local medical waste requirements. EPA
notes that autoclaving alone is not an acceptable method of treating
hazardous wastes (pharmaceutical or non-pharmaceutical) that are also
medical waste. In addition, as discussed in section XV of this
preamble, EPA is exempting from RCRA regulation the residues of
hazardous waste pharmaceuticals remaining in empty (i.e., fully
administered) syringes.
    c. Hazardous waste pharmaceuticals with a radioactive component.
Hazardous waste pharmaceuticals that also contain a radioactive
component subject to the Atomic Energy Act of 1954 (AEA) (which are
often referred to as ``mixed waste'') are also regulated by multiple
agencies. The hazardous waste component is regulated under EPA or the
authorized state RCRA Subtitle C programs, while either the Nuclear
Regulatory Commission (NRC) or the Department of Energy (DOE) regulates
the radioactive component of the waste under the AEA.\105\ Healthcare
facilities can use this final rule to meet the obligation of complying
with the RCRA Subtitle C hazardous waste regulations for hazardous
waste pharmaceuticals while also complying with the appropriate AEA
regulations. Although we do not believe that anything in this subpart
is inconsistent with the AEA, Sec.  1006(a) of RCRA states that if the
RCRA requirements are inconsistent with the AEA requirements, then the
RCRA requirements do not apply. Therefore, if a healthcare facility
that manages hazardous waste pharmaceuticals encounters specific RCRA
requirements that are inconsistent with specific AEA requirements, only
the AEA requirements would apply.
---------------------------------------------------------------------------

    \105\ The NRC regulates radioactive wastes generated by
commercial or non-DOE facilities, whereas DOE regulates radioactive
wastes generated by DOE facilities.
---------------------------------------------------------------------------

    As is discussed in the Joint NRC/EPA Guidance on Testing
Requirements for Mixed Radioactive and Hazardous Waste an inconsistency
occurs when compliance with one statute or set of regulations would
necessarily cause non-compliance with the other statute or set of
regulations.\106\ Relief from the regulatory inconsistency would be
provided by the AEA requirement overriding the specific RCRA
requirement. It is important to note, however, that the determination
of an inconsistency would relieve the healthcare facility only from
compliance with the specific RCRA requirement(s) that is deemed
inconsistent with the AEA requirement(s); the healthcare facility would
still be required to comply with all of the other hazardous waste
pharmaceutical management standards.
---------------------------------------------------------------------------

    \106\ 62 FR 62079, 62085; November 20, 1997.
---------------------------------------------------------------------------

    d. Clean Air Act. The combustion of hazardous waste pharmaceuticals
is subject to both RCRA and to Sec.  112 of the Clean Air Act. In
general, the Clean Air Act protects human health and the environment
from the harmful effects of air pollution by requiring reductions in
the emissions of air pollutants. These pollutants, which are known or
suspected to cause serious health problems, such as cancer or birth
defects, are referred to as hazardous air pollutants (HAPs) and include
several metals that are found in pharmaceuticals, such as selenium,
mercury, and chromium compounds. Under Sec.  112 of the Clean Air Act,
EPA is required to list categories of major and area sources of HAPs;
EPA has listed Hazardous Waste Combustors as one of these categories.
    EPA is also required to establish National Emission Standards for
Hazardous Air Pollutants (NESHAPs) for the control of HAP emissions
from listed sources. The NESHAPs are to reflect the maximum degree of
reduction in emissions of HAPs that is achievable. This is known as
``maximum achievable control technology'' (MACT) and is based on
emission levels that are achieved by the best-performing sources within
a source category. On October 12, 2005, EPA promulgated NESHAP for
Hazardous Waste Combustors that set MACT standards for HAPs from this
source category.\107\ The owner or operator of a hazardous waste
combustor is required to comply with specific emission standards that
control HAPs to levels that reflect MACT. These standards vary based on
the type of hazardous waste combustion source (e.g., incinerator,
cement kiln, boiler), and in some instances based on the amount of HAPs
that are emitted by the facility (e.g., boilers that are area sources
can elect to comply with fewer HAP emission standards). Generally
speaking; however, hazardous waste combustors are required to comply
with emission standards for chlorinated dioxins and furans, mercury,
lead, cadmium, arsenic, beryllium, chromium, hydrochloric acid/chlorine
gas, as well as particulate matter as a surrogate to control five
additional metals, and carbon monoxide, hydrocarbon, and destruction
removal efficiency as surrogates to control nondioxin/furan organic
HAPs.
---------------------------------------------------------------------------

    \107\ 70 FR 59402; October 12, 2005.
---------------------------------------------------------------------------

    Hazardous waste combustors may be subject to more stringent
emission limitations issued under the RCRA omnibus authority provisions
(Sec.  3005(c)(3)). This is usually where site-specific circumstances
indicate that a MACT standard is not protective of health and the
environment. In other words, some hazardous waste combustors also have
a RCRA permit

limit that further reduces emissions of certain HAPs (e.g., mercury)
beyond that which is required by the Clean Air Act MACT standard.
    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 and implementing regulations. These regulations
established emission limits for nine substances or mixtures (i.e.,
particulate matter, carbon monoxide, dioxins/furans, sulfur dioxide,
nitrogen oxides, hydrogen chloride, lead, mercury, and cadmium, as well
as opacity where appropriate) from several categories incineration
units, including: municipal waste combustors (MWCs); hospital, medical
and infectious waste incinerators (HMIWIs); commercial and industrial
solid waste incinerators (CISWIs); and other solid waste incinerators
(OSWIs). The emission limits are based on the application of MACT and
reflect the emission levels achieved by the best performers in each
category.
3. Drug Supply Chain Security Act
    On November 27, 2013, the Drug Quality and Security Act was signed
into law, amending the Federal Food, Drug and Cosmetic Act (FD&C
Act).\108\ The Drug Quality and Security Act consists of two titles:
Title I is known as the Compounding Quality Act and Title II is known
as the Drug Supply Chain Security Act (DSCSA). The FDA was given the
responsibility of developing the implementing regulations for both
titles of the Drug Quality and Security Act. In a summary of the DSCSA
written by the Congressional Research Service, a nonpartisan division
of the Library of Congress, it states that the Act ``Establishes
requirements to facilitate the tracing of prescription drug products
through the pharmaceutical supply distribution chain.'' \109\ Prior to
enactment of this federal law, several states had passed similar laws
to ensure the pedigree of the drug supply chain. Because each state law
was slightly different, it made compliance difficult for companies
operating in multiple states. As a result, Congress amended the FD&C
Act to add Sec.  585, entitled Uniform National Policy, which moots the
pedigree laws already in effect (to the extent they are inconsistent
with the DSCSA) and prevents states (and others) from enacting
inconsistent pedigree laws in the future. This section, which was added
by the DSCSA, includes sub-sections that are sometimes referred to as
``preemption clauses.'' \110\
---------------------------------------------------------------------------

    \108\ Public Law 113-54.
    \109\ https://www.congress.gov/bill/113th-congress/house-bill/3204/summary/49; accessed September 13, 2017.
    \110\ See sections 585(a) and 585(b)(1) of the FD&C Act, as
amended by the DSCSA.
---------------------------------------------------------------------------

    Since the DSCSA was signed into law, some have argued to EPA and
RCRA-authorized states that Sec.  585 of the FD&C Act (as amended by
the DSCSA) preempts all state hazardous waste regulatory authority as
it may relate to the documentation of the disposition of hazardous
waste pharmaceuticals. EPA disagrees with this interpretation of the
DSCSA. Section 585 specifically avoids preempting state requirements,
such as RCRA hazardous waste laws, that are unrelated to the tracing of
products within the prescription drug distribution supply chain and
other issues expressly addressed by the DSCSA. As stated in Sec.
585(c), ``Nothing in this section shall be construed to preempt State
Requirements related to the distribution of prescription drugs if such
requirements are not related to product tracing as described in
subsection (a) or wholesale distributor and third-party logistics
provider licensure as described in subsection (b) applicable under
Sec.  503(e) (as amended by the Drug Supply Chain Security Act) or this
subchapter (or regulations issued thereunder)'' (emphasis added).
    This provision makes clear that Sec.  585 applies only to state
requirements related to distribution of prescription drugs and only to
the extent that these requirements are related to product tracing or
other issues specifically addressed by the DSCSA, such as licensure.
Thus, as EPA interprets Sec.  585, it would not apply to state
requirements related to documentation of RCRA hazardous waste
management activities, including disposal, because those activities are
distinct and unrelated to the product tracing and other requirements of
the DSCSA.
    And indeed, in EPA's consultation with FDA on this issue, FDA
agreed with EPA's conclusion that Sec.  585 does not preempt state
hazardous waste regulations related to the documentation of the
management of hazardous waste pharmaceuticals. EPA's position is based
upon our review of both the direct language and intent of the
statute.\111\
---------------------------------------------------------------------------

    \111\ For a more thorough legal analysis of this issue, see
EPA's letter to the Minnesota Pollution Control Agency, dated April
9, 2015, in the docket for this rulemaking EPA-HQ-RCRA-2007-0932.
EPA consulted with FDA in the development of this letter and FDA
agrees with the analysis and conclusions set forth in the letter.
---------------------------------------------------------------------------

    To understand the connection between state hazardous waste
regulations and the DSCSA, it is important to understand the
relationship between the federal and state hazardous waste regulations.
The federal RCRA program is implemented by state RCRA programs that are
authorized by EPA under RCRA section 3006, 42 U.S.C. 6926. Authorized
state hazardous waste regulations must, at a minimum, be equivalent to
federal RCRA hazardous waste regulations. Under RCRA, EPA authorizes
state hazardous waste programs to operate in lieu of the federal
hazardous waste program.\112\ Authorized state requirements are
federally enforceable as requirements under RCRA Subtitle C.
---------------------------------------------------------------------------

    \112\ RCRA section 3006(b), 42 U.S.C. 6926(b).
---------------------------------------------------------------------------

    Nothing in the DSCSA indicates that Congress intended to impliedly
repeal federal RCRA requirements. Such an implied repeal would leave
gaps in RCRA coverage and result in no hazardous waste regulations of
any kind--federal or state--applying to the documentation of the
management of hazardous waste pharmaceuticals. Given that (i) there is
no indication of Congressional intent to repeal hazardous waste
documentation regulations via the DSCSA (indeed, there is no mention of
hazardous waste in the DSCSA at all), and (ii) Sec.  585(c) of the FD&C
Act, as added by the DSCSA, expressly notes the limits of the statute's
preemptive effect, we believe it is clear that Congress did not intend
to impliedly repeal RCRA authorized state hazardous waste requirements
as they apply to the documentation of the management, including
disposal, of hazardous waste pharmaceuticals. The general rule
enunciated by the U.S. Supreme Court is that ``when two [federal]
statutes are capable of co-existence, it is the duty of the courts,
absent a clearly expressed congressional intention to the contrary, to
regard each as effective.'' \113\ Here, both RCRA and the DSCSA coexist
easily, because neither the language nor the purpose of the DSCSA is in
conflict with RCRA.
---------------------------------------------------------------------------

    \113\ Morton v. Macari, 417 U.S. 535, 551(1974).
---------------------------------------------------------------------------

    In addition, some commenters have argued that, in the case of
nonsaleable pharmaceutical products, DSCSA requirements preempt RCRA
requirements and that nonsaleable pharmaceutical products are regulated
exclusively by the FDA pursuant to the provisions of the DSCSA.\114\
Commenters have also argued that under the DSCSA, nonsaleable
pharmaceutical products that are sent from wholesale distributors,
dispensers, and repackagers as nonsaleable may be sent to a returns
processor reverse

logistics provider for handling as products. These commenters believed
that, at a minimum, the mere fact that a pharmaceutical product becomes
nonsaleable does not mean that such pharmaceutical product is now a
solid waste under the RCRA hazardous waste regulations.
---------------------------------------------------------------------------

    \114\ The DSCSA uses the term ``drug product.''
---------------------------------------------------------------------------

    EPA does not agree with these comments. The preemption provisions
added to the FD&C Act by the DSCSA--both Sec.  585(a) and Sec.
585(b)--only apply to the protection of the drug supply chain and do
not apply to waste management requirements under RCRA.\115\ Under RCRA,
EPA regulates pharmaceuticals differently than FDA does under the DSCSA
since the goals of the statutes serve different purposes. The purpose
of the DSCSA is to protect the security, pedigree, and quality of
pharmaceutical products in the drug supply chain. One of the many
purposes of RCRA is to ensure that any waste that is generated is
``treated, stored or disposed of so as to minimize the present and
future threat to human health and the environment.'' \116\ In addition,
we note that the DSCSA applies only to prescription drug products (not
to OTC drug products), so there can be no conflict between DSCSA and
RCRA for nonsaleable OTC drug products.
---------------------------------------------------------------------------

    \115\ Section 585(a) of the DSCSA contains a preemption
provision for state requirements for tracing drug products through
the distribution system. Section 585(b) of the DSCSA contains a
preemption provision for state requirements for wholesale
prescription drug distributors and third-party logistics providers.
    \116\ See 42 U.S.C. 6902(b).
---------------------------------------------------------------------------

    As explained in further detail throughout this preamble, whether a
pharmaceutical has monetary value (such as when it receives
manufacturer credit) is not determinative of whether it is a waste
under RCRA. Under RCRA, one considers whether a material is discarded--
and not whether it receives credit, or holds value or no value--to
determine whether it is waste. Thus, prescription pharmaceuticals that
are sent by healthcare facilities to reverse distributors and that will
be discarded (even if these pharmaceuticals receive credit) will first
be considered wastes at the healthcare facility when the decision is
made by the healthcare facility to send them to a reverse distributor.
    Furthermore, EPA disagrees with commenters that a nonsaleable
pharmaceutical product sent to reverse distributors should not be
considered a waste. Nonsaleable pharmaceutical products sent to reverse
distributors are not sent for reuse or donation, but are sent for
disposal, and thus would be considered wastes at the healthcare
facility. In its comments to the FDA on the Draft Guidance for
Industry, Identifying Trading Partners Under the Drug Supply Chain
Security Act,\117\ an industry trade association appears to confirm
this point when it says, ``Most fundamentally, returns processors are
unlike the trading partners described in the DSCSA. Trading partners
are dedicated to moving products forward for dispensing and
administration to patients. Returns processors' activities come at the
end, when the product is no longer retained for distribution or
dispensing and is safely removed from the supply chain.''\118\ The
commenter goes on to say that ``the assumptions that product is being
distributed for further use, rather than only for credit assessment
and/or disposition'' do not appear to apply to returns processors
(known as reverse distributors in this final rule.\119\ Similarly, a
reverse distributor also submitted comments to the FDA on the same
draft guidance, stating that ``once these products reach the returns
processors for creditability assessment and final disposition
management, they are forever removed from commerce.'' \120\
Furthermore, during a site visit to a large reverse distributor, EPA
was told that none of the pharmaceuticals on site would be donated or
redistributed or otherwise returned to commerce.\121\ After they are
evaluated for manufacturer credit, the pharmaceuticals are sent for
incineration. Under Sec.  261.2(b)(3) of the RCRA regulations,
``Materials are solid waste if they are abandoned by being . . .
Accumulated, stored, or treated (but not recycled) before or in lieu of
being abandoned by being disposed of, burned, or incinerated.'' The
pharmaceuticals at reverse distributors are being accumulated prior to
being incinerated and therefore are solid wastes. Additionally, in a
2013 memo EPA includes a series of questions to help determine whether
a commercial chemical product is a solid and hazardous waste. One set
of questions relates to whether the facility appears to be selling into
commerce the material being evaluated. If the facility has no customers
or market for the material, it can be an indication that the material
is a solid waste.\122\
---------------------------------------------------------------------------

    \117\ August 2017, docket number FDA-2017-D-1956.
    \118\ See page 6 of comment FDA-2017-D-1956-0013.
    \119\ See page 7 of comment FDA-2017-D-1956-0013.
    \120\ See page 14 of comment FDA-2017-D-1956-0011.
    \121\ See notes from site visit to Med-Turn, October 10, 2017 in
the docket for this rulemaking EPA-HQ-RCRA-2007-0932. Med-Turn is a
subsidiary of Inmar.
    \122\ See Section 3 of Attachment A of memo entitled Checklist
to Assist in Evaluating Whether Commercial Chemical Products or
Solid and Hazardous Waste Under the Resource Conservation and
Recovery Act, May 14, 2013, Devlin to RCRA Division Directors, RCRA
Online #14837.
---------------------------------------------------------------------------

    As explained elsewhere in the preamble, EPA distinguishes between
reverse distributors (as defined in this rule) and reverse logistics
centers. Reverse distributors do not reuse or donate, but in fact,
dispose of the pharmaceuticals they receive. In sum, what DSCSA would
consider to be a nonsaleable product is still considered to be a solid
waste under RCRA when it is discarded according to the RCRA
regulations, and the DSCSA does not preclude pharmaceuticals from being
waste under RCRA.
    EPA notes that many of the implementing regulations for the DSCSA
are still under development by the FDA and the FDA has announced that
it is delaying enforcement of certain requirements.\123\ Section 584(d)
of the FD&C Act, as added by the DSCSA, directs the FDA to issue
licensing regulations for third party logistics providers (3PLs) within
two years of the date of enactment of the DSCSA.\124\ Draft FDA
guidance issued in August 2017 indicates that FDA plans to consider a
returns processor or reverse logistics provider to be a type of
3PL.\125\ However, FDA has not yet finalized this guidance or issued
proposed or final regulations for licensing 3PLs. The listing for the
relevant regulation in the most recent version of the public list of
planned federal rulemaking (the Unified Agenda of Regulatory and
Deregulatory Actions, or ``Unified Agenda'') indicates that FDA plans
to issue a proposed DSCSA licensing regulation within the next
year.\126\
---------------------------------------------------------------------------

    \123\ On June 30, 2017, FDA issued a draft guidance, Product
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM565272.pdf.
    \124\ The DSCSA was enacted on November 27, 2013; therefore, the
3PL licensing regulations were scheduled to be issued by FDA by
November 27, 2015.
    \125\ August 2017, Identifying Trading Partners Under the Drug
Supply Chain Security Act--Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM572252.pdf.
    \126\ See the Spring 2018 Unified Agenda, available at https://www.reginfo.gov/public/do/eAgendaMain.
---------------------------------------------------------------------------

    Furthermore, since 3PLs, such as reverse logistics providers, do
not take ownership of the drugs that they manage at their facilities,
the DSCSA requirements related to tracing drugs

through the supply chain, including transaction information (TI),
transaction history (TH), and transaction statements (TS), do not apply
to them. In the absence of relevant FDA regulations, it is difficult
for EPA to consider the possibility of deferring to FDA for the
regulation of reverse distributors, who we consider to be managing
hazardous wastes. In the future, if there are duplicative regulations,
EPA may need to revisit the regulation of reverse distributors after
the FDA issues proposed and final licensing regulations for 3PLs in
accordance with the DSCSA.

D. Wastes Generated at Healthcare Facilities That Are Not Included in
the Scope of This Final Rule

    Wastes that are not included in the scope of this proposed
rulemaking include non-hazardous wastes and non-pharmaceutical
hazardous wastes. Pharmaceutical wastes that are not listed or
characteristic hazardous wastes under RCRA Subtitle C may nonetheless
pose some risks to public health and the environment. These wastes are
discussed further below.
1. How should non-hazardous waste pharmaceuticals be disposed?
    A large portion of the pharmaceutical wastes generated at
healthcare facilities will not meet the definition of a RCRA hazardous
waste under RCRA Subtitle C. This final rule, therefore, does not
require that healthcare facilities manage these waste pharmaceuticals
under the RCRA Subtitle C hazardous waste regulations, including this
final rule. However, a healthcare facility may choose to manage its
non-hazardous and hazardous waste pharmaceuticals together (as
hazardous waste pharmaceuticals) under the new subpart P regulations.
Because all healthcare facilities operating under this subpart are
regulated in the same way regardless of quantity of hazardous waste
pharmaceuticals generated, managing non-hazardous waste pharmaceuticals
as hazardous waste under this subpart would not affect the facility's
hazardous waste generator category. While not regulated by the federal
RCRA hazardous waste requirements, non-hazardous waste pharmaceuticals
that are not managed under subpart P are still considered solid wastes
under the federal regulations and must be managed in accordance with
applicable federal, state, and/or local regulatory requirements.
Moreover, some waste pharmaceuticals that do not qualify as ``hazardous
wastes'' under RCRA can nonetheless be extraordinarily hazardous thus,
extreme care may be warranted.\127\ These are discussed below in
section VII.D.1.a.
---------------------------------------------------------------------------

    \127\ See, for example, https://www.cdc.gov/niosh/review/peer/isi/hazdrug2018-pr.html or NIOSH [2016]. NIOSH list of
antineoplastic and other hazardous drugs in healthcare settings,
2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan
JP. Cincinnati, OH: U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication Number
2016-161 (Supersedes 2014-138). https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf.
---------------------------------------------------------------------------

    If a healthcare facility decides to segregate its hazardous and
non-hazardous waste pharmaceuticals, EPA recommends that healthcare
facilities follow the best management practices (BMPs) outlined in
``Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare
Facilities in the United States,'' (Blueprint) \128\ an EPA guidance
document for the management, treatment, storage and disposal of non-
hazardous waste pharmaceuticals. The following summarizes the
recommended BMPs found in the Blueprint for various categories of
pharmaceutical wastes, including those wastes that possess hazardous
waste-like qualities yet are not regulated as hazardous waste under
RCRA Subtitle C.
---------------------------------------------------------------------------

    \128\ Practice Greenhealth, Revised August 2008. Published in
2006, the development of the original Blueprint was funded by the
Office of Solid Waste and Emergency Response and managed by EPA
Region 1. The 2008 revision of the Blueprint was funded by the
Healthcare Environmental Resource Center. http://practicegreenhealth.org/sites/default/files/upload-files/pharmwasteblueprint.pdf.
---------------------------------------------------------------------------

    a. Recommended best management practices for healthcare facilities
managing non-hazardous waste pharmaceuticals possessing hazardous
waste-like qualities. Currently, most pharmaceuticals are not regulated
as RCRA hazardous wastes when discarded by healthcare facilities. These
``non-RCRA-hazardous'' pharmaceuticals can be divided into two
categories: Those that possess hazardous waste-like qualities and those
that do not. As outlined in the Blueprint, there are pharmaceuticals
that possess hazardous waste-like qualities, but for various reasons,
are not regulated by the RCRA Subtitle C hazardous waste regulations.
The Agency supports the Blueprint's recommendation of hazardous waste
incineration as the BMP for healthcare facilities and reverse
distributors discarding pharmaceuticals that may possess hazardous
waste-like qualities, but are not regulated as RCRA hazardous waste.
This recommendation would apply to pharmaceuticals with more than one
active ingredient listed on the P- or U-lists,\129\ chemotherapeutic
agents characterized as bulk wastes,\130\ pharmaceuticals which meet
the hazardous drug criteria set by the National Institute for
Occupational Safety and Health (NIOSH),\131\ pharmaceuticals with LD50s
<= 50 mg/kg, pharmaceuticals that are carcinogenic or endocrine
disrupting compounds, and vitamin/mineral preparations containing heavy
metals.
---------------------------------------------------------------------------

    \129\ As noted in the comment after Sec.  261.33(d), the phrase
``commercial chemical product'' includes formulations in which the
P- or U-listed chemical is the sole active ingredient. Therefore,
formulations with more than one active ingredient do not meet the
specifications of the P- and U-listings even if one, two or all of
the active ingredients are listed on the P- and/or U-lists.
    \130\ The descriptions ``bulk'' and ``trace'' when applied to
chemotherapeutic wastes are industry terms and are not defined by
the federal RCRA regulations.
    \131\ See NIOSH list of antineoplastic and other hazardous drugs
in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG,
Trout DB, O'Callaghan JP. Cincinnati, OH: U.S. Department of Health
and Human Services, Centers for Disease Control and Prevention,
National Institute for Occupational Safety and Health, DHHS (NIOSH)
Publication Number 2016-161 (Supersedes 2014-138). https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf.
---------------------------------------------------------------------------

    b. Recommended best management practices for other non-hazardous
waste pharmaceuticals (not possessing hazardous waste-like qualities).
As far as other non-hazardous waste pharmaceuticals (i.e., those not
possessing hazardous waste-like qualities), disposing of non-hazardous
waste pharmaceuticals at healthcare facilities via drain disposal is
strongly discouraged and not recommended by EPA. Therefore, EPA
endorses the Blueprint's recommendation of municipal solid waste
incineration or medical waste incineration for any non-hazardous waste
pharmaceuticals, even when they do not possess hazardous waste-like
qualities. The potential risk remains for active pharmaceutical
ingredients (APIs) to be released into the environment if medical waste
autoclaves or municipal solid waste landfills are used for the purposes
of pharmaceutical waste treatment and disposal. For example, autoclaves
are designed to kill pathogens and do not achieve the temperatures
required to destroy most APIs during the autoclaving process. As a
result, when wastewater is generated either by cleaning an autoclave,
or during automatic blow down from autoclaves equipped with steam
generators, there is the potential for wastewater containing APIs to be
generated and discharged into the sewer. In addition, some limited
studies have shown APIs present in landfill leachate collected in
municipal solid waste landfill leachate

systems.132 133 Typically, the collected landfill leachate
is subsequently sent to wastewater treatment plants for treatment, but
their treatment technologies are not designed to remove all APIs from
the wastewater (See section XIII for more information regarding the
prohibition on sewering hazardous waste pharmaceuticals).
---------------------------------------------------------------------------

    \132\ Barnes, K.K., Christenson, S.C., Kolpin, D.W., Focazio,
M.J., Furlong, E.T., Zaugg, S.D., Meyer, M.T. and Barber, L.B.
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants
Within a Leachate Plume Downgradient of a Municipal Landfill.
Groundwater Monitoring & Remediation, 24: 119-126
    \133\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T.,
Zaugg, S.D., and Meyer, M.T. (June 2009), Waste-Indicator and
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental
Contamination and Toxicology, V82.6:635-659.
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2. How should non-pharmaceutical hazardous waste be disposed?
    These newly promulgated subpart P regulations will pertain only to
hazardous waste pharmaceuticals. Therefore, other types of hazardous
wastes generated at healthcare facilities and reverse distributors that
do not meet the definition of a hazardous waste pharmaceutical cannot
be managed in accordance with this new subpart (as previously
discussed, non-hazardous waste pharmaceuticals may be managed under
this new subpart). For example, hazardous wastes generated in hospital
laboratories or during cleaning and maintenance of the facility are not
considered hazardous waste pharmaceuticals and are not included within
the scope of this final rule. The generation of non-pharmaceutical
hazardous wastes is often more routine and does not trigger the same
concerns that healthcare facilities experience when managing hazardous
waste pharmaceuticals. Also note that the 2016 Hazardous Waste
Generator Improvements final rule added new flexibility for episodic
generators of non-pharmaceutical hazardous waste under part 262 subpart
L.

VIII. What terms are defined in this final rule? (Sec.  266.500)

A. Definition of Pharmaceutical

1. Summary of Proposal
    EPA proposed to define ``pharmaceutical'' as any chemical or
biological product that is intended for use in the diagnosis, cure,
mitigation, care, treatment, or prevention of disease or injury of a
human or other animal; or any chemical or biological product that is
intended to affect the structure or function of the body of a human or
other animal. This definition included, but was not limited to dietary
supplements as defined by the Federal Food, Drug, and Cosmetic Act
(FD&C Act), prescription drugs, OTC drugs, residues of pharmaceuticals
remaining in containers, personal protective equipment contaminated
with residues of pharmaceuticals, and clean-up material from the spills
of pharmaceuticals. This proposed definition of ``pharmaceutical'' was
intended to include all dose forms, including, but not limited to,
tablets, capsules, medicinal gums or lozenges, medicinal liquids,
ointments and lotions, IV or other compound solutions, chemotherapy
pharmaceuticals, vaccines, allergenics, medicinal shampoos,
antiseptics, and any delivery device, including medicinal dermal
patches, with the primary purpose to deliver or dispense the
pharmaceutical.
    EPA relied on the FD&C Act's definition of ``drug'' to develop the
proposed definition of ``pharmaceutical'' but expanded on the
definition based on comments to the 2008 Universal Waste proposed
rulemaking. In particular, stakeholders requested that the Agency take
a broad view in delineating what items are included in the definition
of pharmaceutical so that the proposed standards applied broadly. Thus,
the proposed definition of ``pharmaceutical'' did not exclude
pharmaceuticals with a radioactive component and included items not
specifically recognized by the FDA as drugs, such as dietary
supplements, pharmaceutical residues in non-empty containers (including
delivery devices), personal protective equipment contaminated with
residues of pharmaceuticals, and clean-up material from spills of
pharmaceuticals.
2. Summary of Comments
    The most frequent comment EPA received on the definition of
``pharmaceutical'' was on the inclusion of personal protective
equipment and clean-up material in the definition of pharmaceutical.
Many commenters argued that personal protective equipment and clean-up
material should not be included in the final definition. One commenter
suggested that loose tablets be included in the definition of
pharmaceutical but that personal protective equipment should not be
included. Waste Management National Services, Inc. suggested that only
``overtly contaminated'' personal protective equipment or clean-up
materials be included in the definition, but not personal protective
equipment and clean-up materials with trace contamination.\134\ Two
commenters asked EPA to clarify which personal protective equipment is
included in the definition of ``pharmaceutical.''
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    \134\ See comment number 0257 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    One state expressed concern that EPA proposed to take a broad view
in delineating what items are included in the definition of
``pharmaceutical.'' The New Jersey Department of Environmental
Protection pointed out that although ``sharps'' did not meet the
proposed definition of ``pharmaceutical'' that IV bags, tubing and
syringes that come in contact with blood or pathogens could fall under
the definition of ``pharmaceutical.'' They asked that EPA exclude these
items from the definition.\135\
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    \135\ See comment number 0235 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
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    EPA requested comment on the Agency's decision to include dietary
supplements in the definition of ``pharmaceutical'' under the final
rule. Four states and one industry association supported the Agency's
proposal to include dietary supplements under the definition of
``pharmaceutical.'' One state and five industry associations did not
support including dietary supplements in the definition of
``pharmaceutical.'' Multiple commenters requested that EPA only include
dietary supplements that are regulated as drugs and exclude supplements
regulated as foods.
    EPA requested comment on the possibility of including low-
concentration nicotine products, such as electronic nicotine delivery
systems (e-cigarettes), in the definition of ``pharmaceuticals'' under
the final rule. EPA received multiple comments on whether to include e-
cigarettes and liquid nicotine (e-liquids) in the final definition.
Hawaii State Department of Health and the Hematology/Oncology Pharmacy
Association did not support including e-cigarettes or e-liquids in the
final definition of ``pharmaceutical.'' \136\ RILA requested that EPA
exempt all low-concentration nicotine products from the P075 listing,
including e-cigarettes and e-liquids, but agreed that if EPA did not
exempt these products from the P075 listing, that e-cigarette products
should fall under the definition of ``pharmaceutical.'' \137\
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    \136\ See comment numbers 0238 and 0264 in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932).
    \137\ See comment number 0295 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    The American Dental Association asked that EPA specifically exclude

dental amalgam from the final definition of ``pharmaceutical.'' \138\
---------------------------------------------------------------------------

    \138\ See comment number 0294 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Multiple commenters pointed out that the same chemical may have a
pharmaceutical and non-pharmaceutical use (e.g., isopropyl alcohol is
used to clean wounds and to clean instruments and surfaces). \139\
Commenters asked EPA to clarify that they are regulated differently.
---------------------------------------------------------------------------

    \139\ See comment numbers 0246, 0280, 0296 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Stericycle, Inc. requested that investigational or research drugs
be considered pharmaceuticals because they are difficult to
characterize.\140\
---------------------------------------------------------------------------

    \140\ See comment number 0280 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

3. Final Rule Provisions
    In this final rule, ``pharmaceutical'' means any drug or dietary
supplement for use by humans or other animals; any electronic nicotine
delivery system (e.g., electronic cigarette or vaping pen), or any
liquid nicotine (e-liquid) packaged for retail for use in electronic
nicotine delivery systems (e.g., pre-filled cartridges or vials). This
definition includes, but is not limited to dietary supplements, as
defined by the Federal Food, Drug and Cosmetic Act; prescription drugs,
as defined by 21 CFR 203.3(y); OTC drugs; homeopathic drugs; compounded
drugs; investigational new drugs; pharmaceuticals remaining in non-
empty containers; personal protective equipment contaminated with
pharmaceuticals; and clean-up material from spills of pharmaceuticals.
This definition does not include dental amalgam or sharps.
    The final definition of pharmaceutical includes both prescription
drugs, as defined by 21 CFR 203.3(y) and OTC drugs. As previously
mentioned, commenters pointed out that the same chemical may have a
pharmaceutical and non-pharmaceutical use.\141\ If an OTC product is
required by the FDA to include ``Drug Facts'' on the label, it would be
considered a pharmaceutical for the purposes of this rule.\142\ In rare
cases, some items that are OTC pharmaceuticals may not be labeled
appropriately with a ``Drug Facts'' label. It is the Agency's
understanding, however, that all OTC drugs must contain a Drug Facts
label. Therefore, if an item meets the criteria to be considered a
pharmaceutical under subpart P but is not labeled with Drug Facts, it
should still be managed as a pharmaceutical. Any non-pharmaceutical
hazardous wastes must be managed pursuant to all other applicable RCRA
regulations. The final definition of ``pharmaceutical'' also includes
any pharmaceutical residuals remaining in non-empty containers, such as
the pharmaceutical residuals remaining in dispensing bottles, IV bags
and tubing, vials, unit dose packages, and delivery devises, such as
syringes and patches. However, the final definition does not include
sharps (e.g., needles from IV bags or syringes). Used sharps, such as
needles or syringes with needles, are not included under the final
definition of pharmaceutical because sharps are considered medical
wastes, presently regulated at both the state and local level. Further,
as discussed in section XV of this preamble, EPA is finalizing
regulations for when pharmaceutical containers are considered empty.
---------------------------------------------------------------------------

    \141\ See comment numbers 0246, 0280, 0296 in the docket for
this rulemaking (EPA-HQ-RCRA-2007-0932).
    \142\ See 21 CFR 201.66
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' also includes items
contaminated with or containing pharmaceuticals, such as personal
protective equipment contaminated with pharmaceuticals or related spill
clean-up materials (including loose tablets accumulated during pharmacy
floor sweepings). EPA's decision to include contaminated personal
protective equipment under the definition of ``pharmaceutical''
reflects the Agency's interest in promoting a similar management scheme
for the personal protective equipment containing pharmaceuticals and
other types of pharmaceuticals. Only personal protective equipment that
is already considered hazardous waste under the ``contained in'' policy
because it is contaminated with pharmaceuticals will fall under the
definition of pharmaceutical.\143\ These items are included in the
definition so that facilities can manage more types of hazardous waste
commonly found in healthcare settings under the same standards. For
example, the contained in policy would not apply to gloves that have
touched a warfarin pill during the course of patient care. However, if
a healthcare worker spills a hazardous waste pharmaceutical on their
personal protective equipment and it cannot be removed from the
personal protective equipment, the personal protective equipment would
be considered a hazardous waste pharmaceutical. If the personal
protective equipment only has trace amounts of contamination it would
not be considered a hazardous waste and therefore not be considered a
hazardous waste pharmaceutical.
---------------------------------------------------------------------------

    \143\ See memo from Lowrance to Fields, January 3, 1989 (RCRA
Online #11387).
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' includes dietary
supplements for the same reason--in order to promote a consistent
management scheme for similar waste streams. Dietary supplements are
commonly found in various healthcare settings because they are
recommended or prescribed by healthcare providers to patients.\144\
Further, retail pharmacies routinely sell vitamins and other medicinal
minerals and supplements. When EPA uses the term ``dietary
supplements'' in the definition of ``pharmaceutical,'' EPA is
referencing the definition for dietary supplement used by the FD&C Act,
as amended by the Dietary Supplement Health and Education Act of 1994
(21 U.S.C. 321 (ff)).\145\ If a dietary supplement is required by the
FDA to include a ``Supplement Facts'' panel on the label, it would be
considered a pharmaceutical for the purposes of this rule.\146\ The
FD&C Act categorizes dietary ingredients and dietary supplements under
the general umbrella of foods and therefore does not review them before
being marketed. In fact, several commenters suggested that because the
FD&C Act does not regulate supplements as drugs, EPA does not have the
authority to regulate them as pharmaceuticals under RCRA. EPA disagrees
with the commenters, noting that any waste that is listed or exhibits a
characteristic is regulated as a hazardous waste when discarded,
including supplements. This final rule does not newly apply RCRA to the
disposal of supplements that meet the definition of hazardous waste, as
some commenters suggest; it changes which regulations apply when
discarding supplements that are hazardous waste. EPA recognizes that
healthcare facilities may benefit from managing dietary supplements
along with drugs under the

final regulation, and thus, is including it in the final definition of
``pharmaceutical.'' Although dietary supplements are considered
pharmaceuticals under this definition, only the dietary supplements
that meet the definition of hazardous waste (e.g., exhibits the
toxicity characteristic for metal content) would be regulated under
part 266 subpart P as hazardous waste pharmaceuticals (see the
definition of ``hazardous waste pharmaceutical'').
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    \144\ Including dietary supplements under the definition of
``pharmaceutical'' does not supersede the requirements of the
Dietary Supplement Health and Education Act of 1994, the Federal
Food, Drug and Cosmetic Act, or FDA regulations.
    \145\ The substance of the definition is: A Product (other than
tobacco) intended to supplement the diet that bears or contains one
or more of the following dietary ingredients: (A): A vitamin; (B) a
mineral; (C) an herb or other botanical; (D) an amino acid; (E) a
dietary substance for use by man to supplement the diet by
increasing the total dietary intake; or (F) a concentrate,
metabolite, constituent, extract, or combination of any ingredient
described in clause (A), (B), (C), (D), or (E); For the complete
definition of dietary supplement, please see: https://www.gpo.gov/fdsys/pkg/USCODE-2011-title21/pdf/USCODE-2011-title21-chap9-subchapII.pdf.
    \146\ See 21 CFR 101.36.
---------------------------------------------------------------------------

    The final rule specifically excludes dental amalgam from the final
definition of pharmaceutical. EPA promulgated new pretreatment
standards in June 2017 to reduce discharges of mercury from dental
offices into publicly owned treatment works.\147\ If EPA included
dental amalgam in the final definition of pharmaceutical, it would
subject dentists to duplicative regulatory requirements.
---------------------------------------------------------------------------

    \147\ 82 FR 27154; June 14, 2017.
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' includes electronic
nicotine delivery systems and liquid nicotine (e-liquid) packaged for
retail for use in electronic nicotine delivery systems. These items are
included in the definition ``pharmaceutical'' so that facilities can
manage more types of hazardous waste commonly found in healthcare
settings under part 266 subpart P. The final definition of
``pharmaceutical'' applies to finished product electronic nicotine
delivery systems, including components and parts, sealed in final
packaging intended for consumer use (e.g., electronic cigarettes and
vaping pens) and e-liquid that is packaged for retail for use in the
electronic nicotine delivery systems (e.g., pre-filled cartridges and
vials that are sold separately to consumers or as part of kits). EPA
intends that e-liquid used by manufacturers of tobacco products (as
defined by the FD&C Act) not be included in the final definition of
``pharmaceutical.'' \148\ That is, a pre-filled e-liquid cartridge
sealed in final packaging that is to be sold or distributed to a
consumer for use is included in the definition, but in contrast, an e-
liquid that is sold or distributed for further manufacturing, mixing,
or packaging into a finished electronic nicotine delivery system is not
included.\149\ EPA believes that finished products sealed in packaging
intended for consumer use pose a lower risk for leaks and other
releases to the environment than e-liquid that is sold or distributed
for further manufacturing. E-liquid that is packaged for retail for use
in electronic nicotine delivery systems, such as e-liquid that is in
pre-filled cartridges and vials, is typically sold at lower
concentrations and smaller quantities than e-liquid that is sold or
distributed for further manufacturing.
---------------------------------------------------------------------------

    \148\ 26 U.S.C. 5702 (d)
    \149\ This distinction is adapted from the term ``finished
tobacco product'' used by FDA in its regulations for e-cigarettes,
cigars, and all other tobacco products. 81 FR 28973; May 10, 2016.
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' includes investigational
drugs. One commenter asked EPA to include investigational drugs in the
definition because these drugs are difficult to characterize. The
investigational drugs might have proprietary ingredients that the
manufacturer might not be willing to divulge during trials. The final
definition includes investigational drugs in order to provide clarity
on how to manage these items when discarded. See section IX.B.2.e
regarding the applicability of subpart P to discarded investigational
drugs.

B. Definition of Hazardous Waste Pharmaceutical

1. Summary of Proposal
    EPA proposed to define ``hazardous waste pharmaceutical'' as a
pharmaceutical that is a solid waste, as defined in Sec.  261.2, and is
listed in part 261 subpart D, or exhibits one or more characteristics
identified in part 261 subpart C. The Agency proposed to define the
term ``hazardous waste pharmaceutical'' in order to clarify its intent
that only pharmaceuticals that meet the definition of hazardous waste
when disposed or discarded need to be managed under the new subpart P
management standards.
2. Summary of Comments
    EPA requested comment on the proposed definition of ``hazardous
waste pharmaceutical'' and specifically on whether any dietary
supplements currently on the market meet or could potentially meet
RCRA's definition of hazardous waste.
    The New Mexico Environment Department requested that EPA broaden
the definition of ``hazardous waste pharmaceutical'' to include
antineoplastic agents. The New Mexico Environment Department argued
that EPA has not updated the P- and U-hazardous waste lists even though
new pharmaceuticals have been developed that should be considered
hazardous waste.\150\ Public Employees for Environmental Responsibility
also argued that the definition of ``hazardous waste pharmaceutical''
is too narrow because not enough pharmaceuticals meet the
definition.\151\ American Pharmacists Association expressed concern
that the definition is difficult to understand because the P- and U-
hazardous waste lists are not comprehensive.\152\
---------------------------------------------------------------------------

    \150\ See comment number 0211 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
    \151\ See comment number 0247 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
    \152\ See comment number 0321 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Waste Management National Services Inc., supported the proposed
definition of ``hazardous waste pharmaceutical'' and pointed out that
there are dietary supplements on the market that meet the RCRA
definition of hazardous waste because the supplements contain selenium
or chromium.\153\
---------------------------------------------------------------------------

    \153\ See comment number 0257 in the docket for this rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

3. Final Rule Provisions and Response to Comments
    In this final rule, ``hazardous waste pharmaceutical'' means a
pharmaceutical that is a solid waste, as defined in Sec.  261.2, and
exhibits one or more characteristics identified in part 261 subpart C,
or is listed in part 261 subpart D. A pharmaceutical is not a solid
waste, as defined in Sec.  261.2, and therefore not a hazardous waste
pharmaceutical, if it is legitimately used/reused (e.g., lawfully
donated for its intended purpose) or reclaimed. An OTC pharmaceutical,
dietary supplement, or homeopathic drug is not a solid waste, as
defined in Sec.  261.2, and therefore not a hazardous waste
pharmaceutical, if it has a reasonable expectation of being
legitimately used/reused (e.g., lawfully redistributed for its intended
purpose) or reclaimed.
    The Agency is including in the final definition of ``hazardous
waste pharmaceutical'' that a pharmaceutical is not a solid waste, as
defined in Sec.  261.2, and therefore not a hazardous waste
pharmaceutical if it is lawfully donated. The Agency included this
language to clarify that pharmaceuticals are not solid waste if they
are donated for use (see section IX.B for more discussion).
    The Agency is defining the term ``hazardous waste pharmaceutical''
in order to clarify its intent that only pharmaceuticals (as defined in
this final rule) that are hazardous waste when disposed or discarded
need to be managed under the final subpart P management standards. For
example, warfarin (brand name Coumadin) is a listed hazardous waste and
when discarded meets the definition of hazardous waste pharmaceutical.
The Agency notes that hazardous waste pharmaceuticals are hazardous
wastes; more specifically, they are a subset of

hazardous waste. The term hazardous waste is defined in Sec.  260.10 as
``a hazardous waste as defined in Sec.  261.3.'' Therefore, even though
we do not reference Sec.  261.3 in the definition of hazardous waste
pharmaceutical, a hazardous waste pharmaceutical is also hazardous
waste as defined in Sec.  261.3. This is relevant to the OSHA Hazardous
Waste Operations and Emergency Response standard (29 CFR 1910.120),
which apply to hazardous wastes, as defined by Sec.  261.3. This final
rule does not impact the applicability of the OSHA Hazardous Waste
Operations and Emergency Response standards.
    Multiple commenters suggested that the proposed definition of
``hazardous waste pharmaceutical'' was too narrow because the P- and U-
hazardous waste lists have not been updated even though new
pharmaceuticals have been developed. Although we solicited ideas from
commenters for possible methods or approaches for regulating additional
pharmaceuticals as hazardous waste, any action taken to address the
comments we received in response to this request would have to be a
separate action taken by the Agency in the future and is not part of
this final rulemaking. Therefore, these comments are considered to be
out of the scope of this final action and we do not plan to address
them at this time. That said, we do anticipate that because subpart P
lowers regulatory barriers to over-managing non-hazardous waste
pharmaceuticals, some healthcare facilities will choose to over-manage
non-hazardous waste pharmaceuticals as hazardous waste pharmaceuticals
even if they do not meet a current listing or exhibit a hazardous waste
characteristic.

C. Definition of Reverse Distributor 154
---------------------------------------------------------------------------

    \154\ The proposed rule used the term ``pharmaceutical reverse
distributor'' but the final rule uses the term ``reverse
distributor.'' To avoid confusion, we use the term ``reverse
distributor'' in this preamble, even when discussing the proposed
rulemaking.
---------------------------------------------------------------------------

1. Summary of Proposal
    EPA proposed to define reverse distributor as any person that
receives and accumulates potentially creditable hazardous waste
pharmaceuticals for the purpose of facilitating or verifying
manufacturer credit. EPA proposed that any person, including forward
distributors and pharmaceutical manufacturers, that processes
pharmaceuticals for the facilitation or verification of manufacturer
credit would be considered a reverse distributor. Pharmaceutical
manufacturers often offer credit to healthcare facilities for unused
and/or expired pharmaceuticals.\155\ Manufacturers issue credit for a
variety of reasons: it can be a marketing incentive tool, it helps
protect against illicit diversion \156\ or improper disposal, and it
allows manufacturers to collect data on the returned items, which then
can be used to help plan for future pharmaceutical production. Reverse
distributors contract with both manufacturers and healthcare facilities
to act as an intermediary to facilitate the crediting process.
---------------------------------------------------------------------------

    \155\ As noted in the definition of ``potentially creditable
hazardous waste pharmaceutical,'' manufacturers provide credit for
those pharmaceuticals that are less than one year past the
expiration date.
    \156\ Through the return of pharmaceuticals by a pharmacy for
manufacturer credit, manufacturers are able to maintain control of
the pharmaceutical up to the point of its disposal, thereby,
decreasing the risk of diversion of the pharmaceutical.
---------------------------------------------------------------------------

    EPA proposed new standards for shipping potentially creditable
hazardous waste pharmaceuticals to reverse distributors and management
standards of potentially creditable hazardous waste pharmaceuticals by
reverse distributors. Thus, EPA proposed to define ``reverse
distributor'' to clearly delineate which types of facilities were
subject to the proposed rulemaking. The agency solicited public comment
on its proposed definition of ``reverse distributor.'' Specifically,
EPA asked for comment on whether the definition of ``reverse
distributor'' captures the universe of facilities acting as reverse
distributors for pharmaceuticals.
2. Summary of Comments
    Commenters requested that EPA clarify who would be considered a
reverse distributor and what the functions of a reverse distributor
are. States and industry, including manufacturers, wholesalers, and
waste management companies, wanted to know if any facility that
performed reverse distribution functions would be encompassed in this
definition. Reverse distributors asked for clarification in how 3PLs
fit into the definition of reverse distributor and whether all
functions performed by their business would fall under the definition.
3. Final Rule Provision
    Under the final rule, reverse distributor means any person that
receives and accumulates prescription pharmaceuticals that are
potentially creditable hazardous waste pharmaceuticals for the purpose
of facilitating or verifying manufacturer credit. Any person, including
forward distributors, third-party logistics providers, and
pharmaceutical manufacturers, that processes prescription
pharmaceuticals for the facilitation or verification of manufacturer
credit is considered a reverse distributor.
    In response to comments, EPA made two changes to the definition of
``reverse distributor'' for the final rule. First, EPA proposed to use
the term ``pharmaceutical reverse distributor'' but the final rule uses
the term ``reverse distributor.'' EPA dropped the word
``pharmaceutical'' from reverse distributor because the definition of
pharmaceutical is overly broad given that it refers to both
prescription and nonprescription pharmaceuticals. EPA received comments
from stakeholders pointing out that in the terminology of the industry,
reverse distributors receive prescription pharmaceuticals, while
reverse logistics centers receive nonprescription pharmaceuticals and
other unsold retail items. This distinction is useful to EPA in making
the same distinction in these regulations and EPA has adopted it.
    The second change EPA made was to add the word prescription to the
definition to further clarify that the definition does not include
reverse logistics centers that receive nonprescription pharmaceuticals
or other unsold retail items that are evaluated for legitimate use/
reuse or reclamation. EPA's definition of ``reverse distributor'' only
includes prescription hazardous waste pharmaceuticals that are
evaluated for credit and then disposed. EPA made this clarification to
be consistent with the policy for the reverse logistics of
nonprescription pharmaceuticals and other unsold retail items. See
section VI of this preamble for discussion of the regulations for the
reverse distribution of prescription hazardous waste pharmaceuticals
and the policy for the reverse logistics of other unsold retail items,
including nonprescription pharmaceuticals.
    EPA incorporated the changes to the final definition of ``reverse
distributor'' in response to the comments summarized below.
4. Comments and Responses
    EPA received comments from states and industry, including
manufacturers, wholesalers and waste management companies, asking for
clarification on who would be considered a reverse distributor. For
example, commenters asked whether wholesalers, forward distributors and
3PLs meet the definition of ``reverse distributor'' even if reverse
distribution is only a part of their business. For example, a facility

might act as a sorting and shipping facility or a pharmacy might act as
a consolidation center but not evaluate for manufacturer credit. The
definition of ``reverse distributor'' specifically states that any
person, including forward distributors (e.g., wholesalers), 3PLs, or
pharmaceutical manufacturers, that processes prescription
pharmaceuticals for the facilitation or verification of manufacturer
credit is considered a reverse distributor. Any person that is
performing the function of a reverse distributor, even if it is a small
part of their business, would need to operate under the reverse
distributor standards. If a facility is not processing any hazardous
waste prescription pharmaceuticals for facilitating or verifying
manufacturer credit, then it would not meet the definition of ``reverse
distributor.''
    The retail industry was especially concerned with need to
differentiate between reverse distributors and reverse logistics
centers. Reverse logistics centers that receive nonprescription
pharmaceuticals (such as OTC pharmaceuticals) would not fall under this
definition. Likewise, wholesale distributors receiving returns from
their customers would not be considered reverse distributors. This is
because wholesale distributors do not facilitate manufacturer credit.
Further, according to comments received from Healthcare Distribution
Management Association, in 2013, approximately 94% of the returns to
wholesale distributors, were saleable.157 158 As saleable
products, the pharmaceuticals returned to wholesale distributors would
remain subject to the track and trace requirements of the DSCSA.
Reverse logistics centers, which evaluate nonprescription
pharmaceuticals for legitimate use/reuse and reclamation do not fit
this definition.
---------------------------------------------------------------------------

    \157\ Healthcare Distribution Management Association has since
been renamed Healthcare Distribution Alliance.
    \158\ See comment #EPA-HQ-RCRA-2007-0932-0276.
---------------------------------------------------------------------------

    EPA is also finalizing the definitions for potentially creditable
and non-creditable hazardous waste pharmaceuticals (in parts D and E of
this section) to differentiate between reverse distributors' function
in evaluation of credit versus the traditional TSDF role in waste
disposal. It is the Agency's intent that potentially creditable
hazardous waste pharmaceuticals can be sent to reverse distributors for
the determination of credit under subpart P. It is not the Agency's
intent, however, for reverse distributors to serve in the capacity as
storage facilities or TSDFs for other hazardous waste.
    Multiple state commenters asked EPA to clarify what is meant by
``facilitate.'' The facilitation of credit encompasses the role that
reverse distributors serve between healthcare facilities and
manufacturers. A reverse distributor receives potentially creditable
hazardous waste pharmaceuticals for evaluation of manufacturer credit.
Once the evaluation is complete and it is determined that credit can be
given, reverse distributors will issue the manufacturer credit on
behalf of the manufacturer to the healthcare facility.
    Reverse distributors wanted to add all the other functions
performed by reverse distributors to the regulatory definition to more
fully define their role. EPA did not add reverse distributors' other
functions to the definition of ``reverse distributor'' in the final
rule. While a reverse distributor may continue to perform other lawful
activities, they are not relevant for the purpose of defining a reverse
distributor under this final rule. EPA's definition of reverse
distribution focuses on issuing of manufacturer credit because although
the pharmaceuticals are hazardous waste, they have value to the
healthcare facility and the reverse distributor. Since these hazardous
waste pharmaceuticals have value, there is a greater economic incentive
to manage them with more care than typical hazardous waste. The final
definition captures the handling of prescription hazardous waste
pharmaceuticals that fall under RCRA and the rest of the functions can
be regulated, as needed, under local, state and other federal
regulations.
    The waste management industry requested clarification on the
intersection of DEA reverse distributors and RCRA reverse distributors
and how a reverse distributor that receives a DEA controlled substance
as a waste would determine if they are also subject to subpart P. A
hazardous waste pharmaceutical that is also a DEA controlled substance
is not subject to subpart P, provided they meet the terms of the
conditional exemption in Sec.  266.506. The conditional exemption for
DEA controlled substances that are also RCRA hazardous waste is covered
in section XIV of the preamble.
    The Agency also wants to clarify the difference between what is
defined as a reverse distributor under this final rule and how DEA
regulations define ``reverse distribute.'' The recently amended DEA
regulatory definition of ``reverse distribute'' is to ``acquire
controlled substances from another registrant or law enforcement for
the purposes of: (1) Return to the registered manufacturer or another
registrant authorized by the manufacturer to accept returns on the
manufacturer's behalf; or (2) Destruction.'' \159\
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    \159\ See 21 CFR 1300.01. On September 9, 2014, DEA finalized
new definitions for ``reverse distribute'' and ``reverse
distributor.'' Please see 79 FR 53520. The term ``reverse
distributor'' is defined as ``a person registered with the
Administration [DEA] as a reverse distributor.''
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    Under DEA's definition, a reverse distributor does not necessarily
process pharmaceuticals for the purpose of determining manufacturer
credit: Often a reverse distributor's main function under DEA's
definition is to destroy the controlled substances. Under EPA's
definition, however, a reverse distributor is defined as a facility
that accepts potentially creditable pharmaceuticals for the purposes of
evaluating manufacturer credit. These potentially creditable hazardous
waste pharmaceuticals may or may not be identified as controlled
substances by DEA.\160\ Therefore, a DEA-registered reverse distributor
may or may not meet EPA's definition of a reverse distributor and vice
versa. For example, a reverse distributor that accepts DEA controlled
substances that are also hazardous waste pharmaceuticals for the
purpose of destruction (e.g., incineration) would be regulated as a
DEA-registered reverse distributor and as a RCRA TSDF (or other
regulated incinerator, depending on what other wastes it combusts), but
not as a reverse distributor under part 266 subpart P. Conversely, a
reverse distributor that processes pharmaceuticals for manufacturer
credit, but is not a DEA registrant and therefore, cannot accept
controlled substances, would meet the subpart P reverse distributor
definition, but not DEA's reverse distributor definition. However, EPA
has heard from stakeholders that most, if not all, entities that
facilitate manufacturer credit are also DEA-registered reverse
distributors. Therefore, such reverse distributors would meet both
EPA's definition of reverse distributor and the DEA's definition of
reverse distributor. Lastly, EPA's definition for reverse distribution
does not alter or supersede the requirements of the Controlled
Substances Act and DEA regulations.
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    \160\ In order for a reverse distributor to be able to accept
controlled substances, the reverse distributor must be a DEA
registrant. See 21 CFR part 1308 for a complete list of controlled
substances.
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    In addition, the DOT's Pipeline and Hazardous Materials Safety
Administration has defined the closely related term, ``reverse
logistics,'' in a

recent rulemaking.\161\ EPA coordinated with the Pipeline and Hazardous
Materials Safety Administration to ensure that our rules are
compatible, even if the definitions differ. It is important to note
that their final rule does not supersede EPA's RCRA Subtitle C
regulations for solid or hazardous waste determinations or hazardous
waste management.
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    \161\ 79 FR 46748; August 11, 2014. The Pipeline and Hazardous
Material Safety Administration's definition of reverse logistics
``is the process of moving goods from their final destination for
the purpose of capturing value, recall, replacement, proper
disposal, or similar reason.''
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D. Definition of Potentially Creditable Hazardous Waste Pharmaceutical

1. Summary of Proposal
    In order to distinguish hazardous waste pharmaceuticals that are
sent by a healthcare facility to RCRA TSDFs from those hazardous waste
pharmaceuticals that are sent by a healthcare facility to a reverse
distributor for a determination or verification of manufacturer credit,
the Agency proposed a definition for ``potentially creditable hazardous
waste pharmaceutical.''
    EPA proposed to define ``potentially creditable hazardous waste
pharmaceutical'' to mean a hazardous waste pharmaceutical that has the
potential to receive manufacturer credit and is
    (1) unused or un-administered; and
    (2) unexpired or less than one year past expiration date.
    The proposed term did not include evaluated hazardous waste
pharmaceuticals, residues of pharmaceuticals remaining in containers,
contaminated personal protective equipment, and clean-up material from
the spills of pharmaceuticals. These pharmaceuticals are typically
unopened and in their original packaging and include both generic and
name brand pharmaceuticals.
    Whether a pharmaceutical is eligible for manufacturer credit is
determined solely by the manufacturer's return policy. Based on
comments received for the 2008 Universal Waste proposed rulemaking and
through discussions with various stakeholders, the Agency understands
that the return policies of manufacturers change regularly. As a
result, healthcare facilities are not always aware if a particular
pharmaceutical will be creditable at the time that it is pulled from
the shelves. However, the Agency also understands that there are
instances where it is well known that a pharmaceutical will not be
creditable. Examples of these instances include the following: If the
pharmaceutical has been removed from the original container and
repackaged for dispensing purposes; if an attempt was made to
administer a pharmaceutical, but the patient refused to take it; if the
hazardous waste pharmaceutical was generated during patient care; if
the pharmacy receives a return of a dispensed pharmaceutical for which
they had already received compensation by a third-party payer; or if
the pharmaceutical is more than one year past its expiration date. In
these instances, as well as others, the healthcare facility knows that
it will not receive manufacturer credit. It is the Agency's intent for
the proposed definition of ``potentially creditable hazardous waste
pharmaceutical'' to allow the return of hazardous waste pharmaceuticals
to reverse distributors for the determination of credit. It is not the
Agency's intent, however, for reverse distributors to serve in the
capacity as TSDFs when it is well known that the manufacturer will not
give credit for those hazardous waste pharmaceuticals.
    Also, based on communication with stakeholders and the public
comments received on the 2008 Universal Pharmaceutical Waste proposal,
EPA understands that pharmaceutical manufacturers' policies often allow
for credit to be issued on the return of ``partials.'' ``Partials'' is
a term used in the industry to refer to opened containers that have had
some contents removed. Under the proposed definition, the Agency
considered partials to be potentially creditable hazardous waste
pharmaceuticals.
2. Summary of Comments
    States, manufacturers and waste management companies commented that
word changes to this definition would clarify which hazardous waste
pharmaceuticals could or could not be returned to reverse distributors.
Manufacturers, some states and healthcare facilities argued that all
pharmaceuticals should go to reverse distributors to relieve the burden
on healthcare facilities to make these individual determinations.
Pharmacists and reverse distributors wanted further clarification on
what distinguishes a potentially creditable hazardous waste
pharmaceutical and how it relates to credit.
3. Final Rule Provision
    In response to comments, EPA has made five changes to the
definition of ``potentially creditable hazardous waste pharmaceutical''
from the proposal. First, the final definition specifically includes
prescription pharmaceuticals only. Second, we added the phrase
``reasonable expectation'' to clarify that the healthcare facility does
not have to definitively know whether something will receive
manufacturer credit but rather indicates that they should have a
reasonable expectation that it will. We also note that EPA could have
proposed to use the term ``creditable hazardous waste
pharmaceuticals,'' but chose to use the term ``potentially creditable
hazardous waste pharmaceutical'' to convey the same concept (i.e., that
a healthcare facility does not have to definitively know whether a
specific item will receive manufacturer credit.) Third, we replaced
``unadministered'' with the term ``undispensed'' to make clear that it
is not just that a patient refused to take a prescription
pharmaceutical, but rather that it was never dispensed to a patient at
all. Fourth, we removed the word ``unused'' from the definition since
the use of this term could introduce some confusion given that
``partials'' can get manufacturer credit. Fifth, we specified that the
pharmaceuticals be in the ``original manufacturer's packaging'' since
repackaged prescription pharmaceuticals are not typically eligible for
credit.\162\
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    \162\ See email correspondence from Nicole Wilkinson of CVS
dated February 21, 2018 and Erica Burwell of Inmar dated February
22, 2018, both in the docket for this rulemaking EPA-HQ-RCRA-2007-
0932.
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    For the final rule, a potentially creditable hazardous waste
pharmaceutical means a prescription hazardous waste pharmaceutical that
has a reasonable expectation to receive manufacturer credit and is (1)
in original manufacturer's packaging (except pharmaceuticals that were
subject to recall); (2) undispensed; and (3) unexpired or less than one
year past expiration date. The term does not include evaluated
hazardous waste pharmaceuticals or nonprescription pharmaceuticals
including, but not limited to, OTC drugs, homeopathic drugs, and
dietary supplements.
4. Comments and Responses
    a. Definitional Wording. EPA received many comments from states and
industry on revising the definition to clarify which hazardous waste
pharmaceuticals could and could not be returned to reverse
distributors. States especially stressed that ``potentially
creditable'' should be changed to ``reasonable expectation of credit''
or that EPA should define potentially creditable hazardous waste
pharmaceuticals as those that are

accepted by reverse distributors for evaluation, as compared to those
that are not. Manufacturers and states asked us to clarify whether we
mean ``unadministered'' or ``undispensed'' or whether the term
``unopened'' should be added to the definition. The waste management
industry had some concern that adding expiration dates to the
definition might prevent potentially creditable hazardous waste
pharmaceuticals from being returned to the reverse distributor.
    In the final definition of potentially creditable hazardous waste
pharmaceuticals, EPA has added some new phrases such as ``reasonable
expectation of credit'' to the definition to be clear that not all
hazardous waste pharmaceuticals should be going back to reverse
distributors. We have also changed words like ``unadministered'' to
``undispensed'' since the expectation of credit ends once a
pharmaceutical has been dispensed to a patient regardless of whether
the patient takes the pharmaceutical and deleted ``unused'' since that
could imply it has been dispensed but not used and/or that it was never
opened.
    We are specifically not adding the word ``unopened'' to the
definition as some commenters had suggested, since it is EPA's
understanding that ``partials'' can be given credit under certain
circumstances and some pharmaceuticals may be repackaged. Although the
definition does not include the word ``intact'' when describing
original manufacturer's packaging, the definition of ``potentially
creditable hazardous waste pharmaceutical'' does not include anything
that is leaking or damaged.
    Some commenters also argued that EPA was limiting manufacturers
from changing policies by defining potentially creditable hazardous
waste pharmaceuticals and giving examples of what those are. EPA
recognizes that special circumstances may arise where a prescription
hazardous waste pharmaceutical may be given credit but not fit squarely
within this definition. We have added an example of this in our
definition by noting that a recalled pharmaceutical may be given credit
although it is not in original packaging. This definition is meant to
give examples of what is commonly done and to aid healthcare facilities
in being able to more easily identify a potentially creditable from a
non-creditable hazardous waste pharmaceutical. It is not intended to
prevent a manufacturer from changing its credit policies.
    b. Evaluation of Hazardous Waste Pharmaceuticals and Credit. In
their comments regarding potentially creditable hazardous waste
pharmaceuticals received by reverse distributors, manufacturers and
reverse distributors expressed concern about the burden being added to
healthcare facilities by not allowing them to send all the hazardous
waste pharmaceuticals together and putting the onus on them to
determine if something is ``potentially creditable''. Healthcare
facilities were concerned that credit policies are frequently updated
by manufacturers and that a healthcare facility would not know if
credit would be issued for any given pharmaceutical or not.
    Commenters also addressed the question of a bright line as to what
is and what is not potentially creditable hazardous waste