and typically do not use air pollution control devices to limit toxic
air pollutants such as mercury and dioxins and furans. We believe that
crematoriums would not provide adequate public health and environmental
protection when burning non-hazardous waste pharmaceuticals. If solid
or hazardous wastes are burned in a crematorium, it would make the
crematorium subject to the Clean Air Act.

D. Comments and Responses

    In its comment, Cardinal Health included a list of pharmaceuticals
that it manages as both RCRA hazardous waste and DEA controlled
substances.\314\ In most cases, their comments reinforced the list that
we included in the proposed rulemaking. In two cases, Cardinal Health
identified additional forms of drugs that were included in the table of
DEA controlled substances and hazardous wastes in the preamble to the
proposed rulemaking. First, Cardinal Health identified Axiron as the
brand name of an additional form of testosterone that is a solution
applied to the underarms that is also ignitable. Second, Cardinal
Health identified Diastat as the brand name of an additional form of
valium that is a gel intended for rectal administration that is also
ignitable. We have amended our list of DEA controlled substances and
RCRA hazardous wastes by including Axiron and Diastat in Table 6 below
to be more

complete and accurate. However, there is no corresponding regulatory
change being made. The regulations conditionally exempt all RCRA
hazardous wastes that are also DEA controlled substances; the table
identifying which drugs are both is included in the preamble for
informational purposes:
---------------------------------------------------------------------------

    \314\ See comment number EPA-HQ-RCRA-2007-0932-0250.

                      Table 6--Pharmaceuticals Still Used in Healthcare That Are DEA Controlled Substances & RCRA Hazardous Wastes
                                                         [Amendments in bold based on comments]
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloral; chloral hydrate...........  Acetaldehyde, trichloro-;   Sedative.............  U034 toxic...........  IV                  Used in hospital
                                      Aquachloral, Noctec,                                                                          pediatric units;
                                      Somnote, Supprettes.                                                                          common ingredient in
                                                                                vet anesthetics.
Fentanyl sublingual spray..........  Subsys....................  Analgesic............  D001 ignitable.......  II                  Ignitable due to
                                                                                alcohol content.
Phenobarbital......................  Bellergal-S, Donnatal,      Anticonvulsant.......  D001 ignitable.......  IV                  Ignitable due to
                                      Luminal,.                                                                                alcohol content.
Testosterone gels/solutions........  Androgel, Axiron,           Hormone..............  D001 ignitable.......  III                 Ignitable due to
                                      Fortesta, Testim.                                                                             alcohol content.
Valium injectable/gel..............  Diazepam, Diastat.........  Anti-anxiety.........  D001 ignitable.......  IV                  Ignitable due to
                                                                                alcohol content.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Cardinal Health's comment also indicated that the company manages
Somatropin (brand names Humatrope and Genotropin) as a DEA controlled
substance and a RCRA hazardous waste. M-cresol, which is a contaminant
identified on the toxicity characteristic list in Sec.  261.24 (D024),
is used as a preservative in Somatropin. Per legislations, all anabolic
steroids are considered controlled substances; \315\ however,
Somatropin is considered a human growth hormone, not an anabolic
steroid.\316\ Therefore, although Somatropin may be a RCRA hazardous
waste for its m-Cresol content, it is not a DEA controlled substance.
---------------------------------------------------------------------------

    \315\ The Anabolic Steroids Control Act of 1990 placed anabolic
steroids into Schedule III of the Controlled Substances Act (CSA) as
of February 27, 1991.
    \316\ https://www.fda.gov/Drugs/DrugSafety/ucm237839.htm;
accessed 8/24/2017.
---------------------------------------------------------------------------

    The two conditional exemptions we are finalizing in this rule are
intended to eliminate any duplicative regulations for pharmaceuticals
that are RCRA hazardous wastes and DEA controlled substances.
Nevertheless, there are several remaining areas where DEA and EPA
regulations intersect, even if they are not duplicative. The Agency
would like to address these intersecting areas in effort to reduce
confusion and aid compliance.
1. Only Household (Ultimate User) Waste May Be Collected in DEA
Authorized Collection Receptacles
    It is important to note that in order to qualify for the
conditional exemption, a retail pharmacy (or other DEA authorized
collector pharmacy) can use the DEA authorized collection receptacle to
collect waste generated only at households (DEA refers to this as waste
from ``ultimate users'') and brought to the store for collection. The
hazardous waste generated by the retail pharmacy and store, including
hazardous waste pharmaceuticals, are not excluded household wastes
under RCRA and may not be placed in the DEA authorized receptacle.\317\
Depending on the amount generated, the hazardous waste pharmaceuticals
generated by the retail pharmacy and store must be managed under either
Sec.  262.14 (as a VSQG) or under part 266 subpart P. Furthermore,
states generally regulate non-hazardous waste and it is possible that
they may have licensing or permitting requirements for the collection
of solid waste. Because EPA would like to see the use of DEA authorized
collection receptacles become widespread, we encourage states to
streamline any requirements that may create a barrier to the use of the
DEA authorized collection receptacles.
---------------------------------------------------------------------------

    \317\ DEA also prohibits retail pharmacy stock/inventory from
being placed in the collection receptacle or mail-back envelopes
(see 21 CFR 1317.05(a)).
---------------------------------------------------------------------------

2. Sewer Prohibition, Conditional Exemption and Pharmaceutical Wastage
    In response to comments, EPA has decided against making any
exceptions to the sewer prohibition. Some commenters suggested that EPA
should allow RCRA hazardous wastes that are also DEA controlled
substances to be sewered. On the other hand, many commenters suggested,
and EPA agrees, that it would be inappropriate to make exceptions to
the sewer prohibition, even for the handful of hazardous wastes that
are also controlled substances. In part, commenters thought it was bad
environmental policy to allow sewering of any hazardous waste
pharmaceuticals. Commenters were also concerned that it would send a
mixed message to the regulated community about our goals and lead to
confusion about which hazardous waste pharmaceuticals could and could
not be sewered. As a result, all hazardous waste pharmaceuticals are
prohibited from being sewered, including the handful that are also DEA
controlled substances.
    Under the DEA regulations, a registrant's inventory of controlled
substances is already prohibited from being sewered as a means of
meeting the non-retrievable standard.\318\ Likewise, under the CWA
regulations, RCRA ignitable hazardous wastes (D001) are prohibited from
being discharged to the sewer.\319\ As noted in Table 6, four out of
the five RCRA hazardous wastes that are also DEA controlled substances
are hazardous waste due to being ignitable and hence are already
prohibited from being sewered by the CWA regulations. In effect, this
new RCRA regulation only prohibits the sewering of one additional DEA
controlled substance that is also a RCRA hazardous waste: Chloral
hydrate, which is listed for toxicity. In summary, a RCRA hazardous
waste that is also DEA controlled substance that is part of a DEA
registrant's inventory may not be sewered.
---------------------------------------------------------------------------

    \318\ See the preamble to DEA's final rule 79 FR 53548;
September 9, 2014 and the preamble to DEA's proposed rule 77 FR
75803; December 21, 2012.
    \319\ See the Clean Water Act regulations at 40 CFR 403.5(b)(1).

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

    DEA does allow controlled substance ``pharmaceutical wastage'' to
be disposed of in accordance with applicable federal, state, and local
laws, regulations, and healthcare facility policies, including sewering
or putting down the drain.\320\ DEA uses the term ``pharmaceutical
wastage'' to refer to leftover, unadministered pharmaceuticals (``e.g.,
some of the substance remains in a vial, tube, transdermal patch, or
syringe after administration but cannot or may not be further
utilized'' \321\). While DEA allows pharmaceutical wastage of
controlled substances to be sewered, the CWA regulations already
prohibit the discharge of any RCRA ignitable hazardous waste and, under
this RCRA rule, EPA is not creating any exceptions to the sewer
prohibition. As a result, neither inventory nor pharmaceutical wastage
of DEA controlled substances that are also RCRA hazardous wastes may be
sewered.
---------------------------------------------------------------------------

    \320\ See DEA letter to registrants re: Clarifying disposal of
pharmaceutical wastage dated Oct 17, 2014; http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf.
    \321\ Ibid.
---------------------------------------------------------------------------

    Even though inventory and pharmaceutical wastage are prohibited
from being sewered, both inventory and pharmaceutical wastage would be
eligible for the conditional exemption being finalized in this rule in
Sec.  266.506 for RCRA hazardous wastes that are also DEA controlled
substances. As discussed previously, EPA is finalizing the conditional
exemption that the few RCRA hazardous waste pharmaceuticals that are
also DEA controlled substances would be exempt from RCRA regulation, on
the condition that they are (1) managed in accordance with DEA
regulations and (2) incinerated by one of five types of permitted
combustors or destroyed by another method that has been publicly
approved by DEA, and (3) are not sewered.
    Therefore, if inventory or pharmaceutical wastage is both a RCRA
hazardous waste and a DEA controlled substance it would not be allowed
to be sewered, it would have to be incinerated (or destroyed by another
method publicly approved by DEA). Prior to incineration, however, the
inventory and pharmaceutical wastage, both of which are conditionally
exempt under RCRA, are regulated differently by DEA. The leftover
inventory of DEA controlled substances remains fully subject to DEA
regulations, which includes tracking and witnessed destruction. On the
other hand, controlled substance pharmaceutical wastage is no longer
regulated by DEA. Therefore, only pharmaceutical wastage could be
collected in a container at the healthcare facility prior to
incineration. If this container were used to collect only conditionally
exempt pharmaceutical wastage prior to incineration, it would not be
subject to the subpart P container standards. It is more likely,
however, that a container used to collect the conditionally exempt
pharmaceutical wastage would also be used to collect regulated
hazardous waste, in which case the container would be subject to
subpart P container standards. In either case, as DEA states in its
guidance, ``Although Part 1317 does not apply to pharmaceutical
wastage, the DEA strongly encourages all practitioners to continue to
adhere to security controls and procedures that ensure pharmaceutical
wastage is not diverted. For example, most institutional practitioners
have implemented policies that require two persons to witness and
record destruction of pharmaceutical wastage.'' \322\ In support of
DEA's guidance, EPA strongly recommends that any container that is used
to collect pharmaceutical wastage that will include DEA controlled
substances contain some sort of absorbent or chemical reactant in order
to bind or chemically alter the contents and thus deter the diversion
of the collection container for controlled substance recovery.
---------------------------------------------------------------------------

    \322\ Ibid.
---------------------------------------------------------------------------

3. Long-Term Care Facilities and the DEA Regulations
    This section will discuss the intersection of the DEA regulations
and the RCRA hazardous waste regulations that pertain to LTCFs.
    Under the DEA regulations, most LTCFs are not registrants and until
recently have had few options for properly and securely disposing of
the controlled substances from its patients (ultimate users). DEA's
2014 final regulations to implement the Secure and Responsible Drug
Disposal Act of 2010 are designed to help alleviate the problem that
LTCFs face when discarding their patients' controlled substances. DEA's
2014 final rule allows, but does not require, retail pharmacies and
hospital/clinics with an on-site pharmacy that are DEA registrants to
modify their registrations to become ``collectors'' and to place
collection receptacles at LTCFs (or at the retail pharmacy or hospital/
clinic with an on-site pharmacy) for the collection of controlled
substances from ultimate users. Per the DEA regulations, if a DEA
authorized collection receptacle is placed in a LTCF, only the ultimate
users' controlled substances may be placed in the DEA collection
receptacle. If an LTCF is a DEA registrant and discards DEA controlled
substances from its inventory, they may not be placed in the DEA
authorized collection receptacle and must be otherwise destroyed to
meet the non-retrievable standard.
    Under the 2014 DEA final rule, LTCFs now have three options for
managing their patients' controlled substances. First, if a DEA
registered retail pharmacy or hospital/clinic with an on-site pharmacy
places a collection container at an LTCF, the staff from the LTCF may
place the patients' controlled substances in the collection
receptacles. Second, although LTCFs are not allowed to conduct a
facility-wide collection event for their patients' controlled
substances for mail-back programs, they are allowed to assist patients
who choose to use a mail-back program for their own controlled
substances, on an individual-by-individual basis. And third, law
enforcement can pick up patients' controlled substances for disposal.
With these changes to DEA's regulation, LTCFs can now dispose of
patients' controlled substances in a more environmentally protective
way and EPA strongly encourages the use of any of these three
collection methods. It should be noted that the 2014 DEA regulations do
not mandate the placement of collection receptacles at long-term care
facilities or patient participation in mail-back programs or take-back
events.
    As for the RCRA regulations, this rule finalizes the provision that
hazardous waste from LTCFs will no longer be considered exempt as
household hazardous waste. Instead, it will need to be managed as
regulated hazardous waste. This interpretation will apply to all the
hazardous waste generated by a LTCF, not just its hazardous waste
pharmaceuticals (although the Agency expects that much of the hazardous
waste generated by LTCFs consists of hazardous waste pharmaceuticals).
Notwithstanding this revised interpretation, there are four other
regulatory provisions that might affect how a LTCF will actually have
to manage its hazardous waste pharmaceuticals under this final rule
    First, we have added to the final rule a presumption that LTCFs
with 20 beds or fewer will be VSQGs.\323\ And those LTCFs that have
more than 20 beds may still qualify as VSQGs (for all of their
hazardous waste) if they generate less than 100 kg of hazardous waste
and less

than 1 kg of acute hazardous waste per calendar month. In fact, based
on the RIA for the final rule, EPA estimates that 98-99 percent of
LTCFs that generate hazardous waste are VSQGs.\324\ As VSQGs, the long-
term care facilities will be subject to the reduced regulatory
provisions of 40 CFR 262.14 for all of their hazardous waste (including
those that are controlled substances), and only the sewer prohibition
provision of this new subpart for their hazardous waste
pharmaceuticals. Only the other 1-2 percent of LTCFs that generate
hazardous waste will be subject to part 266 subpart P.
---------------------------------------------------------------------------

    \323\ See 40 CFR 266.504(d).
    \324\ See the Regulatory Impact Analysis for this final rule in
the docket EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    Second, this final rule allows an LTCF that is a VSQG (for all of
its hazardous waste) to send its hazardous waste pharmaceuticals to an
off-site healthcare facility that either supplies the LTCF with its
pharmaceuticals (e.g., a long-term care pharmacy) or is under the
control of the same person and that is operating under subpart P.\325\
Note that this provision is limited to hazardous waste pharmaceuticals
and not to those that are also controlled substances because the DEA
allows controlled substances to be returned to a long-term care
pharmacy only when they are subject to a recall.
---------------------------------------------------------------------------

    \325\ See 40 CFR 266.502(l) and 266.503(b) for non-creditable
and creditable hazardous waste pharmaceuticals, respectively.
---------------------------------------------------------------------------

    Third, this final rule also allows a healthcare facility, including
a LTCF that is a VSQG, to use an on-site DEA authorized collection
receptacle to dispose of its hazardous waste pharmaceuticals (see Sec.
266.504(c)). It could be argued that VSQGs would already be allowed to
use DEA authorized collection receptacles for their hazardous waste
pharmaceuticals even without this new provision, provided the waste
from the DEA authorized collection receptacles is treated or disposed
at one of the types of facilities identified in Sec.  262.14(a)(5)
(e.g., facilities that are permitted or have interim status to manage
hazardous waste and facilities that are permitted, licensed or
registered by a state to manage hazardous waste, municipal waste or
non-municipal waste). Nevertheless, we did propose, and are finalizing
the provision in Sec.  266.504(c) making it clear that healthcare
facilities that are VSQGs can place their hazardous waste
pharmaceuticals in an on-site DEA collection receptacle. DEA already
allows controlled substances to be commingled with non-controlled
substances. Therefore, EPA believes it is consistent to allow VSQG
hazardous waste pharmaceuticals that are not controlled substances to
be placed in DEA collection receptacles with controlled substances. EPA
believes that management of VSQGs' hazardous waste pharmaceuticals as
DEA controlled substances is preferable because it provides greater
protection to patients, visitors, and workers at healthcare facilities
to have the hazardous waste pharmaceuticals accumulating in DEA-
authorized collection receptacles rather than in the regular trash.
However, it is important to note that the DEA regulations for
controlled substances are much narrower in what may be placed in a
collection receptacle; DEA only allows controlled substances from
patients to be placed in collection receptacles that are at LTCFs. To
reiterate, under the DEA regulations, if a LTCF, or any other
healthcare facility, is a DEA registrant it may not place its own
inventory of controlled substances in a collection receptacle, even if
it is a VSQG under RCRA.
    Fourth, for the LTCFs that are not VSQGs, the handful of RCRA
hazardous waste pharmaceuticals that are also DEA controlled substances
will not be subject to RCRA, provided they meet three conditions: (1)
They are combusted at a small or large MWC, a HMIWI, a CISWI or a
hazardous waste combustor (or destroyed by another method publicly
approved by DEA), (2) they are managed and disposed of in compliance
with all applicable DEA regulations for controlled substances, and (3)
they are not sewered. DEA allows LTCFs to put their patients'
controlled substances into an on-site collection receptacle; therefore,
an LTCF could also place its patients' controlled substances that are
also RCRA hazardous waste into a DEA authorized collection receptacle
(alternatively, patients could use another allowable take-back method,
such as mail-back envelopes) in order to meet the conditional
exemption. However, we must stress that only LTCFs would be able to use
collection receptacles (or another allowable take-back method) to meet
the conditional exemption for RCRA hazardous wastes that are also DEA
controlled substances, because they are the only type of facility that
DEA allows to place their patients' wastes into an on-site collection
container. Other healthcare facilities, such as hospitals, could not
meet the conditional exemption by placing their DEA controlled
substances that are also RCRA hazardous wastes in a collection
receptacle because DEA does not allow patients at hospitals to use on-
site collection receptacles. No registrant healthcare facility,
including an LTCF, would be able to use the collection receptacle to
meet the terms of the conditional exemption for any of its own
inventory of DEA controlled substances that are also RCRA hazardous
wastes because DEA does not allow registrants to use collection
receptacles for their own inventory.
    For those LTCFs that are not VSQGs, the hazardous waste
pharmaceuticals that are not controlled substances (and therefore not
conditionally exempt) will be subject to part 266 subpart P, while the
other hazardous wastes will be subject to the SQG or LQG regulations,
as applicable, in part 262.
    See Table 7 for a summary of the intersection of RCRA and DEA
regulations for the disposal of hazardous waste pharmaceuticals at
LTCFs:

                  Table 7--Intersection of RCRA & DEA Regulations at Long-Term Care Facilities
----------------------------------------------------------------------------------------------------------------
                                                             RCRA regulatory requirements
                                     ---------------------------------------------------------------------------
  Types of pharmaceutical waste at                                  DEA authorized        Can be returned to an
      long-term care facilities                                   collection methods      off-site HCF owned by
                                          How RCRA applies          allowed for HW        the same person or LTC
                                                                   pharmaceuticals?             pharmacy?
----------------------------------------------------------------------------------------------------------------
Hazardous Waste Pharmaceuticals that
 are NOT Controlled Substances:
    if LTCF is a VSQG...............  Sec.   262.14 and sewer  Yes. Sec.   266.504(c)..  Yes.
                                       prohibition.
    if LTCF is not a VSQG...........  part 266 subpart P.....  No......................  No.
Hazardous Waste Pharmaceuticals that
 are also Controlled Substances:

    if LTCF is a VSQG...............  Sec.   262.14 and sewer  Yes. Only from patients.  Only if subject to a
                                       prohibition.                                       recall.
    if LTCF is not a VSQG...........  Conditionally exempt     Yes. Only from patients   Only if subject to a
                                       from RCRA (Sec.          (DEA collection methods   recall.
                                       266.506) if:             meet the terms of the
                                       Combusted (or    RCRA conditional
                                       other DEA approved       exemption).
                                       destruction method)..
                                       Comply with
                                       DEA regulations.
----------------------------------------------------------------------------------------------------------------

XV. Management of Residues in Pharmaceutical Containers (Sec.  266.507)

A. Regulatory Background

    Over the years, EPA has received numerous inquiries regarding the
regulatory status of residues in various types of containers that once
held pharmaceuticals that are considered hazardous waste when
discarded. Stakeholders have been particularly concerned about residues
in containers that once held pharmaceuticals that are on the ``P-list''
of acutely hazardous commercial chemical products in Sec.  261.33(e)
because a generator becomes an LQG if it generates more than 1 kg of
acute hazardous waste per calendar month.\326\ The regulatory status of
acute and non-acute commercial chemical product residues remaining in a
container are specifically addressed in Sec.  261.33:
---------------------------------------------------------------------------

    \326\ Additionally, acute hazardous wastes are included on the
F-list of Sec.  261.31; however, none of those acute hazardous
wastes are pharmaceuticals.
---------------------------------------------------------------------------

    ``The following materials or items are hazardous wastes if and when
they are discarded or intended to be discarded . . . (c) Any residue
remaining in a container or in an inner liner removed from a container
that has held any commercial chemical product or manufacturing chemical
intermediate having the generic name listed in paragraphs (e) or (f) of
this section, unless the container is empty as defined in Sec.
261.7(b).''
    In Sec.  261.7(b)(1), there are two ways a container that held a
non-acute hazardous waste can be considered ``empty.'' The container is
considered empty if all wastes have been removed that can be removed
using the practices commonly employed to remove materials from that
type of container, e.g., pouring, pumping, aspirating, and (1) no more
than 2.5 centimeters (one inch) of residue remain on the bottom of the
container or inner liner, or (2) No more than 3 percent by weight of
the total capacity of the container remains in the container or inner
liner if the container is less than or equal to 119 gallons in size; or
no more than 0.3 percent by weight of the total capacity of the
container remains in the container or inner liner if the container is
greater than 119 gallons in size.
    Therefore, it is important to note that if the container that held
the non-acute hazardous waste pharmaceutical does not have its contents
removed by a commonly employed practice even though it has one inch or
less of residue remaining or has 3 percent or less by weight of the
total capacity of the container remaining,\327\ the container is still
not considered ``RCRA empty.'' If the container is not ``RCRA empty,''
then the residues are regulated as hazardous waste (since the residues
are within the container, the container must be managed as hazardous
waste, as well, even if it is not itself hazardous waste).
---------------------------------------------------------------------------

    \327\ We are assuming that containers that hold pharmaceuticals
are in containers less than 119 gallons in size.
---------------------------------------------------------------------------

    According to Sec.  261.7(b)(3), there are three ways that a
container that held an acute hazardous waste can be considered empty:
    (1) The container or inner liner has been triple rinsed using a
solvent capable of removing the commercial chemical product or
manufacturing chemical intermediate;
    (2) The container or inner liner has been cleaned by another method
that has been shown in the scientific literature, or by tests conducted
by the generator, to achieve equivalent removal; or
    (3) In the case of a container, the inner liner that prevented
contact of the commercial chemical product or manufacturing chemical
intermediate with the container, has been removed.
    According to these requirements, if the container that held the P-
listed pharmaceutical is not triple rinsed, or cleaned by another
method that has been demonstrated to achieve equivalent removal, or had
the inner liner removed, the container is not considered ``RCRA
empty,'' even though the pharmaceutical may have been fully removed. If
the container is not ``RCRA empty,'' then the residues are regulated as
acute hazardous waste.
    In November 2011, EPA issued guidance about containers that once
held P-listed pharmaceuticals \328\ that provides three possible
regulatory approaches for generators:
---------------------------------------------------------------------------

    \328\ Rudzinski to RCRA Division Directors, November 11, 2011,
RCRA Online #14827.
---------------------------------------------------------------------------

    (1) Count only the weight of the hazardous waste residues toward
generator category
    (2) Demonstrate an equivalent removal method to render containers
RCRA empty
    (3) In the case of warfarin, show that the concentration in the
residue is below the P-listed concentration
    This guidance was intended as a short-term solution that worked
within the confines of the existing RCRA hazardous waste regulations.
In 2015, we proposed to amend the regulations that pertain to residues
in containers that once held pharmaceuticals that are RCRA hazardous
wastes. EPA proposed different regulatory solutions for different types
of containers found in healthcare settings. Specifically, the proposal
addressed the following three categories of containers: (1) Unit-dose
containers (e.g., packets, cups, wrappers, blister packs, and delivery
devices) and dispensing bottles and vials; (2) dispensed syringes; and
(3) other containers, including delivery devices. Generally, commenters
were supportive of the need for these new empty container standards
specifically developed for the types of small containers used in the
healthcare setting, although they did have suggestions for changes.
Each category

of container is discussed separately below. Today's new ``empty
container'' regulations in Sec.  266.507 will replace the November 2011
guidance as it pertained to residues of hazardous waste pharmaceuticals
in containers, although the memo will remain in effect for non-
pharmaceutical hazardous wastes.

B. Stock, Dispensing and Unit-Dose Containers (Sec.  266.507(a))

1. Summary of Proposal
    We proposed that a dispensing bottle, vial, or ampule (not to
exceed 1 liter or 1,000 pills) or a unit-dose container (e.g., a unit-
dose packet, cup, wrapper, blister pack or delivery device) would be
considered empty and the residues would not be regulated as hazardous
waste if the hazardous waste pharmaceuticals have been removed from the
dispensing or unit-dose container by commonly employed methods.
    This proposal applied to containers that once held acute or non-
acute hazardous waste pharmaceuticals. Under the proposal, for
containers that once held non-acute hazardous waste pharmaceuticals, it
would not be necessary to measure the remaining contents. Likewise,
under the proposal, for containers that once held acute hazardous waste
pharmaceuticals, it would not be necessary to triple rinse the
containers or demonstrate an equivalent removal method. Rather, we
proposed that a dispensing or unit-dose container would be considered
empty if all pharmaceuticals have been removed using the practices
commonly employed to remove materials from that type of container--
thus, the residues (and therefore the container as well) may be
disposed of as non-hazardous waste.
    We proposed this new ``RCRA empty'' standard for containers used
within a healthcare setting for two reasons. First, this approach will
help eliminate the sewering of pharmaceuticals. In a healthcare
setting, if containers are triple rinsed, the rinsate will likely be
poured down the drain, which is not a good environmental practice. We
think it is important that the residues be managed in a more controlled
manner--such as in municipal solid waste landfills-- rather than poured
down the drain. Second, although the ``empty container'' regulations of
Sec.  261.7 apply to all sizes of containers, they were developed with
larger, industrial-sized containers in mind. For the most part, the
containers that hold pharmaceuticals are smaller in size than a 55-
gallon drum; therefore, the amount of residue will likely be much less
in these containers. In the preamble to the proposed rulemaking, we
explained that we selected the 1,000-pill/1-liter limit because, in our
observation, EPA had rarely seen dispensing bottles larger than that.
We specifically sought comment on whether larger containers are used
for dispensing pharmaceuticals and, if so, which pharmaceuticals they
are used for and what RCRA hazardous waste codes would apply.
    In the proposal, EPA presented data from three stakeholders helping
to confirm the assumption that very little residue remains in
containers after the pharmaceuticals (e.g., pills) have been removed.
In addition, EPA's Office of Research and Development conducted similar
research.\329\ A summary of the results is in the preamble to the
proposed rulemaking, while the full results from each of the four
sources are included in the docket for the proposed rulemaking.\330
331\
---------------------------------------------------------------------------

    \329\ Tolaymat, T. and A. El Badawy. Evaluation of P-Listed
Pharmaceutical Residues in Empty Pharmaceutical Containers. U.S.
Environmental Protection Agency, Washington, DC, EPA/600/R-14/167,
2015.
    \330\ September 25, 2018; 80 FR 58052.
    \331\ EPA-HQ-RCRA-2007-0932-0153 through 0156.
---------------------------------------------------------------------------

    EPA is aware that there are certain limitations with the data from
the four sources. For instance, in one of the studies, no replicate
samples were tested. In another study, only warfarin residues were
tested. However, given the size of the containers involved and the
nominal quantities of residues involved, the Agency proposed to allow
the residues in dispensing bottles, vials and ampules, and single-unit
dose containers that once held hazardous waste pharmaceuticals to be
managed as non-hazardous waste provided the pharmaceutical product has
been removed (e.g., all pills have been removed).
    As part of the proposal, EPA raised the concern of potential
diversion of the pharmaceutical containers that may occur when the
pharmaceutical residues and containers are discarded in the municipal
waste stream. The Agency proposed that RCRA-empty pharmaceutical
containers that are original pharmaceutical packages (and therefore
susceptible to diversion) should be destroyed prior to placing them in
the trash. These types of containers would include dispensing bottles,
vials, or ampules typically used in pharmacies, but would not include
paper or plastic cups, or blister packs used for dispensing singles
doses to patients. In the preamble to the proposal, we explained that
the means of destruction could include crushing or shredding the
container.
2. Summary of Comments
    The comments for this section can be broken into two major groups.
One group of comments expressed concern with the 1,000-pill/1-liter
size limit to pharmaceutical dispensing containers and commenters asked
EPA to consider allowing the new RCRA-empty standard for pharmaceutical
dispensing containers to apply to larger pharmaceutical containers or
even to all dispensing containers, regardless of size.
    As part of its comments, CVS Health included results from an
analysis conducted on containers that held warfarin.\332\ Their tests
included brand name and generic warfarin stock bottles, testing the
largest stock bottles with the highest prescription strength warfarin
typically found in a CVS Health Pharmacy, although their comments do
not specify the size of the largest stock bottle, nor do they specify
the highest prescription strength of warfarin. That said, their results
do offer similar results as the studies used in support of the
proposal, indicating the range of total residues detected was 0.0-19.8
mg (excluding outliers).
---------------------------------------------------------------------------

    \332\ See comment number EPA-HQ-RCRA-2007-0932-0312.
---------------------------------------------------------------------------

    Another group of comments objected to the proposed requirement to
destroy the containers before disposing of them in municipal solid
waste landfills. Commenters objected to this proposed provision for
several reasons. First, the most common reason given by commenters that
objected to this provision was they disagreed with EPA that diversion
of these containers is occurring. Many states commented that this has
never been a problem in their state and that the issues with these
types of containers arise from purchase of empty vials on the internet
and counterfeit labels made on home computers, not from dumpster
diving. Second, there was concern that this would be a costly option
since many healthcare facilities would now need to hire someone or buy
equipment to destroy the containers. Many commenters thought the same
goals could be reached through more cost-effective means such as
defacing the label to render the containers unusable for illicit
purposes. Third, a few commenters were also concerned with the release
of the residues in these containers upon destruction and the effect
that could have on the workers. This set of commenters included the one
state that favored destruction of the containers. Finally, some
commenters noted that these empty containers are already being disposed
of in locked

dumpsters and there are adequate institutional controls to address any
public health risk from use of discarded containers in counterfeit drug
sales.
3. Final Rule Provisions
    In response to comments, we have made three substantive changes to
the regulations proposed in Sec.  266.507(a) that define when a
dispensing or unit-dose container is empty. First, based on comments,
we now recognize that we used the term ``dispensing'' bottle, vial, or
ampule incorrectly. Dispensing bottles are those that are provided to
patients when they get a prescription filled. Although a healthcare
facility such as a pharmacy may dispose of some dispensing bottles,
they are more likely to dispose of the stock bottles that they use to
fill the dispensing bottles provided to the patients. As a result, we
have modified the regulatory language to include stock bottles in
addition to dispensing bottles, vials or ampules, and unit-dose
containers.
    Second, after reviewing comments and asking for additional support
and clarification from commenters, including the Army Public Health
Center, CVS Health and the Department of Veterans Affairs, the Agency
has increased the size of the dispensing containers from 1,000 pills to
10,000 pills.\333\ The Army Public Health Center states that they
``routinely procure containers containing 1K, 2K, and even 5K or 10K
pill counts'' for refilling the automated dispensing machines at their
facilities.\334\ This exceeds the size of dispensing containers that we
and others tested, but given that the contents are solid pills,
capsules and tablets, and that the residues we and others detected are
very small, we determined that it is appropriate to increase the size
of the stock or dispensing container to 10,000 pills.
---------------------------------------------------------------------------

    \333\ See the email correspondence from Lisa Strutz (APHC);
Donald Dempsey (CVS Health); and Peter Carbrey (VA) in the
supporting materials of the docket for this final rulemaking (EPA-
HQ-RCRA-2007-0932).
    \334\ See the email correspondence from Lisa Strutz (APHC) to
Kristin Fitzgerald (EPA), dated February 9, 2017, in the supporting
materials of the docket for this final rulemaking (EPA-HQ-RCRA-2007-
0932).
---------------------------------------------------------------------------

    However, we have kept the maximum volume for stock and dispensing
containers at a maximum of 1 liter since this volume limit would apply
to liquids (and other non-pill formulations), which are harder to fully
remove, and commenters did not provide sufficient information to
support increasing the volume limit. Further, it is not clear from
comments or subsequent correspondence whether any containers larger
than 1 liter are in use for pharmaceuticals that would be hazardous
waste when discarded. Stock or dispensing containers that exceed 1
liter would be considered ``other containers'' under Sec.  266.507(d).
As such, under the final rule, if they held pharmaceuticals that are
non-acute hazardous waste, then they would be able to use Sec.
261.7(b)(1) to show that they are empty.
    The third substantive change is that we have removed the proposed
requirement to destroy the empty pharmaceutical containers prior to
disposal. We share commenters' concerns about possible worker exposure
during the process of crushing or shredding the containers. However,
EPA remains concerned about the diversion of the empty containers for
illicit purposes. Therefore, we strongly encourage healthcare
facilities to use best management practices, such as locked dumpsters
and defacing labels, to prevent the diversion of these containers, but
the extra step of destroying these containers will not be required.
    Thus, under the final rule, a stock bottle, dispensing bottle,
vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose
container (e.g., a unit-dose packet, cup, wrapper, blister pack, or
delivery device) is considered empty and the residues are not regulated
as hazardous waste provided the pharmaceuticals have been removed from
the stock bottle, dispensing bottle, vial, ampule, or the unit-dose
container using the practices commonly employed to remove materials
from that type of container.
    In Sec.  261.33(c), we have also added a reference to the new empty
container provisions for hazardous waste pharmaceuticals in Sec.
266.507 as a conforming change. Previously, Sec.  261.33(c) referenced
only the empty container provisions of Sec.  261.7(b).
4. Comments and Responses
    One commenter asked us to add an explicit reference to acute/P-
listed hazardous waste in this section of the regulations. We believe
this is unnecessary since Sec.  261.7(c) indicates that containers of
hazardous waste pharmaceuticals (which includes acute and non-acute
hazardous waste pharmaceuticals) are subject to Sec.  266.507 in lieu
of Sec.  261.7 for determining when they are empty. Nevertheless, we
agree with the commenter that all of the new empty container provisions
in Sec.  266.507 apply to containers that held either non-acute or
acute hazardous waste pharmaceuticals. Under the new subpart P
provisions, for containers that once held non-acute waste
pharmaceuticals to be considered empty, it will not be necessary to
measure the remaining contents, and for containers that once held acute
hazardous waste pharmaceuticals, it will not be necessary to triple-
rinse the containers or demonstrate an equivalent removal method.

C. Syringes (Sec.  266.507(b))

1. Summary of Proposal
    EPA proposed that the residues remaining in a syringe would not be
regulated as hazardous waste provided the syringe had been used to
administer a pharmaceutical to a patient, the syringe is placed in a
sharps container (if appropriate), and is managed in accordance with
all applicable federal, state, and local medical waste or regulated
waste regulations. As with all of the new empty container standards
proposed in Sec.  266.507, this proposed provision applied to syringes
used to administer pharmaceuticals that are acute or non-acute
hazardous waste when discarded.
    Prior to the proposal, EPA issued guidance regarding the regulatory
status of residues in syringes in December 1994 and April 2008.\335
336\ In the December 1994 RCRA/Superfund Hotline Q&A about whether
epinephrine residues in a discarded syringe would be P042, EPA stated,
``Drug residues often remain in a dispensing instrument after the
instrument is used to administer medication. EPA considers such
residues remaining in a dispensing instrument to have been used for
their intended purpose. The epinephrine remaining in the syringe,
therefore, is not a commercial chemical product and not a P042
hazardous waste. The epinephrine could be a RCRA hazardous waste,
however, if it exhibits a characteristic of hazardous waste.'' \337\ In
the April 2008 memo, EPA clarified that the 1994 interpretation extends
to other P- and U-listed pharmaceuticals that have been used to
administer the pharmaceutical by syringe.
---------------------------------------------------------------------------

    \335\ December 1994, RCRA Online #13718.
    \336\ Memo from Dellinger to Chilcott, April 14, 2008, RCRA
Online #14788.
    \337\ Note that since this Q&A was issued, EPA issued guidance
indicating that epinephrine salts are not included in the scope of
the P042 listing and therefore, most, if not all, medical
applications of epinephrine are not P042 (October 15, 2007; RCRA
Online #14778).
---------------------------------------------------------------------------

    EPA thinks that it is important to clarify in regulation when
syringes are considered RCRA empty as this has been a source of many
questions over the years. As part of the decision making, EPA is aware
of the need to

minimize the potential for exposures of healthcare workers to the
sharps, which may be contaminated with bloodborne pathogens, as well as
to the contents of the syringes.
    The preamble to the proposed rulemaking also noted that sharps
containers containing syringes are typically autoclaved prior to
disposal. EPA expressed concern that the residues remaining in the
syringes could be aerosolized during autoclaving and inadvertently
expose workers to the aerosolized hazardous waste residues, posing
risks via pulmonary exposure to those present during venting of the
autoclave. Research suggests that autoclaving may even increase the
toxicity of certain drugs.\338\ As a result, EPA requested comment on
whether it is necessary to place a limit on the volume of residue or
the volume of the syringe to which this new provision would apply or
whether any other conditions would be appropriate.
---------------------------------------------------------------------------

    \338\ Daughton CG, Drugs and the Environment: Stewardship &
Sustainability, National Exposure Research Laboratory, Environmental
Sciences Division, US EPA, Las Vegas, NV; NERL-LV-ES 10/081, EPA/
600/R-10/106; September 2010 (https://cfpub.epa.gov/si/si_public_record_report.cfm?dirEntryID=228503).
---------------------------------------------------------------------------

2. Summary of Comments
    As noted above, commenters generally supported EPA's goal of
codifying new standards for defining when containers are considered
empty, including syringes. EPA received many comments requesting that
the Agency clarify what it means when it uses the term ``dispensed.''
Further, they noted that although the proposed regulations used the
term ``dispensed,'' in several cases in the preamble, we used the term
``fully dispensed'' and they requested clarification about which was
correct. Commenters also noted that EPA used the term ``dispensed''
inappropriately and stated that the term ``administered'' was more
appropriate. The Agency received mixed comments on whether any residues
or contents should be left in the syringes when disposing of the
syringe. In the case of autoclaving residues in syringes, almost all
commenters agreed that the hazardous waste pharmaceutical residues
should not be autoclaved. Some commenters believed that the contents
should be disposed of in a gauze pad or equivalent while others argued
that this was in contradiction to NIOSH recommendations for minimizing
exposure to hazardous drugs. Some commenters were comfortable with
leaving contents in the syringes, suggesting that would be in
compliance with OSHA \339\ and DOT.\340\
---------------------------------------------------------------------------

    \339\ OSHA Title 29 CFR 1910.1030 Bloodborne Pathogens.
    \340\ DOT Title 49 CFR 172.343 subpart D--Marking; 172 subpart
E--Labeling Standards; 172.432 Subpart E.
---------------------------------------------------------------------------

3. Final Rule Provisions
    We have made two substantive changes to this section of the
regulations that define when syringes are considered empty for the sake
of RCRA regulation. First, EPA agrees with commenters that we used the
term ``dispensed'' inappropriately in the proposed rulemaking. FDA
defines ``dispense to patients to mean the act of delivering a
prescription drug product to a patient or an agent of the patient.''
\341\ Dispensed pharmaceuticals are then administered directly to the
patient. EPA has revised the regulations to address commenters'
concerns. In the final rule, to avoid confusion, when discussing
syringes we do not use the term dispensed, fully dispensed, or
administered. Instead, under the final rule, a syringe is considered
empty and the residues are not regulated as hazardous waste provided
the contents have been removed by fully depressing the plunger of the
syringe. Thus, the final regulations convey an intent that is more
similar to the proposed preamble use of the term ``fully dispensed.''
This reflects commenters' and EPA's desire to avoid the possibility of
autoclaving syringes that may have a large portion of their hazardous
waste pharmaceutical contents remaining.
---------------------------------------------------------------------------

    \341\ See 21 CFR 208.3.
---------------------------------------------------------------------------

    Commenters affirmed EPA's concerns about aerosolizing the
autoclaved hazardous waste in sharps containers and we have concluded
that hazardous waste incineration of hazardous waste pharmaceuticals
remaining in non-empty syringes is more appropriate. A recent
literature search also supports this position. The NIOSH and the
American Society of Hospital Pharmacists (ASHP) have both published
articles regarding autoclaving of sharps. The 2004 NIOSH alert states,
``Do not place hazardous drug-contaminated sharps in red sharps
containers that are used for infectious wastes, since these are often
autoclaved or microwaved.'' \342\ The ASHP article states, ``Sharps
used in the preparation of hazardous drugs should not be placed in red
sharps containers or needle boxes, since these are most frequently
disinfected by autoclaving or microwaving, not by incineration, and
pose a risk of aerosolization to waste-handling employees.'' \343\
---------------------------------------------------------------------------

    \342\ NIOSH. ``Preventing Occupational Exposures to
Antineoplastic and Other Hazardous Drugs in Health Care Settings.''
Publication Number 2004-165, Department of Health and Human
Services, Centers for Disease Control and Prevention (CDC), National
Institute for Occupational Safety and Health (NIOSH), Cincinnati,
OH, 2004. 58 pp; http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf.
    \343\ ASHP. ``ASHP guidelines on handling hazardous drugs.''
American Journal of Health-System Pharmacy 2006, 63:1172-1193;
http://dx.doi.org/10.2146/ajhp050529.
---------------------------------------------------------------------------

    A syringe with a fully depressed plunger will have a minute amount
of residue and the syringe can be considered empty under the final
rule. Thus the residue in the empty syringe (as well as the syringe)
will not be regulated as hazardous waste. A syringe that does not have
a fully depressed plunger could have anything from a small amount to
99% of hazardous waste pharmaceutical contents still left in it.
Therefore, we have concluded that it is impracticable to impose an
alternate bright line for determining whether a partially administered
syringe is empty. Further, we concur with ASHP and NIOSH regarding
concerns about the safety of autoclave operators and believe the
standard in this final rule will help prevent exposing workers to
volatilized hazardous waste pharmaceutical residues during the
autoclaving process.
    The second substantive change we made in the final rule is to
clarify that if a syringe contains a pharmaceutical that is a hazardous
waste and it is not empty because the plunger is not fully depressed,
the syringe must be placed with its remaining hazardous waste
pharmaceuticals into a container that is managed and disposed of as a
non-creditable hazardous waste pharmaceutical under this subpart as
well as any applicable federal, state, and local requirements for
sharps containers and medical or regulated waste. We note that the new
empty syringe provisions being finalized today supersedes the previous
EPA interpretations expressed in guidance memos in December 1994 and
April 2008.\344 345\
---------------------------------------------------------------------------

    \344\ December 1994, RCRA Online #13718.
    \345\ Memo from Dellinger to Chilcott, April 14, 2008, RCRA
Online #14788.
---------------------------------------------------------------------------

    We note that a syringe can become empty in three ways: (1) Fully
depressing the plunger of the syringe by administering the contents of
the syringes to a patient, or (2) fully depressing the plunger by
injecting the contents of the syringe into another delivery device such
as an IV bag, or (3) fully depressing the plunger of the syringe by
emptying the remaining contents into a hazardous waste collection
container.

4. Consultation With OSHA
    As part of the final rule process, EPA consulted with OSHA to gain
a better understanding of its Bloodborne Pathogens standard and how it
interacts with other regulations for the disposal of sharps and the
contents within the syringes. The Bloodborne Pathogens standard states
that ``[u]niversal precautions shall be observed to prevent contact
with blood or other potentially infectious materials. Under
circumstances in which differentiation between body fluid types is
difficult or impossible, all body fluids shall be considered
potentially infectious materials.'' \346\ It also states that disposal
of a sharp shall be done ``immediately or as soon as feasible.'' \347\
Further, OSHA requires that containers for contaminated sharps shall be
``easily accessible to personnel and located as close as is feasible to
the immediate area where sharps are used or can reasonably anticipated
to be found.'' \348\ When workers travel to a remote location to
discard a sharp, it increases the possibility of an accidental
needlestick, increases the chances that needles and other sharps will
be improperly discarded, and creates potential hazards for other staff
members. The determination of whether or not a sharps disposal
container is as close as feasible should be made on a case-by-case
basis by OSHA.\349\
---------------------------------------------------------------------------

    \346\ See 29 CFR 1910.1030(d)(1).
    \347\ See 29 CFR 1910.1030(d)(4)(iii)(A)(1).
    \348\ See 29 CFR 1910.1030(d)(4)(iii)(A)(2)(i).
    \349\ OSHA Compliance Directive CPL 02-02-069 Enforcement
Procedures for the Occupational Exposure to Bloodborne Pathogens
https://www.osha.gov/OshDoc/Directive_pdf/CPL_02-02-069.pdf.
---------------------------------------------------------------------------

    Therefore, the practice of emptying the contents of the syringe
would not violate the OSHA standard if the containers are as close as
feasible. Any related work practices must also be such that they do not
create additional hazards to workers (e.g., containers are located in
close proximity to the work area to avoid employees travelling with
used sharps to disposal receptacles located outside the point of use).
Furthermore, nothing in this new subpart requires workers to recap
needles or other sharps, or otherwise manually manipulate the sharp or
needle during emptying, such as unscrewing the needle from the syringe.
    As part of this consultation, OSHA addressed the issue of waste
disposal. OSHA's Bloodborne Pathogens compliance directive states:
``[W]hile OSHA specifies certain features of the regulated waste
containers, including appropriate tagging, the ultimate disposal method
(landfilling, incinerating, and so forth) for medical waste falls under
the purview of the EPA and possibly State and local regulations''
(``Disposal of all regulated waste shall be in accordance with
applicable regulations of the United States, States and Territories,
and political subdivisions of States and Territories''
(1910.1030(d)(4)(iii)(C))).\350\
---------------------------------------------------------------------------

    \350\ Ibid.
---------------------------------------------------------------------------

    The Agency also received comment that we should recommend the extra
protective step that all syringes/sharps be incinerated. Any sharps
container that contains hazardous waste must be treated to meet the LDR
requirements in part 268. In most cases, the LDR treatment standard for
hazardous waste pharmaceuticals is incineration. On the other hand, if
a sharps container does not contain hazardous waste pharmaceuticals
because all the syringes have been emptied by fully depressing the
plunger, then the RCRA hazardous waste regulations would not apply to
these sharps containers (although these sharps containers are still
solid wastes).
    Regardless of whether sharps containers have regulated hazardous
waste pharmaceutical residues, they could contain bloodborne pathogens
or other infectious materials. Thus, OSHA's Bloodborne Pathogens
standard requires that ``disposal of all regulated waste shall be in
accordance with applicable regulations of the United States, States and
Territories, and political subdivisions of States and Territories.''
\351\ Many states have medical waste regulations that require the
treatment of regulated medical waste, including sharps containers, to
render it non-infectious, which is often achieved by autoclaving, prior
to disposal as solid waste.
---------------------------------------------------------------------------

    \351\ See 29 CFR 1910.1030(d)(4)(iii)(C).
---------------------------------------------------------------------------

D. Other Containers, Including Delivery Devices (Sec.  266.507(c) &
(d))

1. Summary of Proposal
    EPA proposed that the residues remaining in other types of unused
or used containers, including delivery devices, such as IV bags and
tubing, inhalers, aerosols, nebulizers, tubes of ointments, gels, or
creams, would be regulated as hazardous waste if the residues are acute
or non-acute hazardous waste. In some cases, such as with IV bags, the
volume of hazardous waste being disposed is much larger than with
residues contained in syringes or unit-dose containers. It is extremely
difficult to determine how much residue remains in tubes of ointments,
gel, or cream. In the case of aerosols, it would be inadvisable to
remove the contents of the container. Since EPA proposed that hazardous
waste pharmaceuticals managed under subpart P would not be counted
towards a facility's generator category, we argued that managing these
residues and containers as hazardous waste under the proposed
provisions should not pose the same burden that generators had been
facing in with keeping track of the monthly amount of residues in
containers that are not ``RCRA empty.''
2. Summary of Comments
    Comments were mixed in this section. Some commenters agreed with
EPA that it is difficult to determine if containers such as inhalers,
aerosol cans, tubes of ointments, gels, or creams meet the RCRA empty
standards within Sec.  261.7 and, therefore, managing them under the
streamlined requirements of subpart P would be protective. Other
commenters wanted EPA to allow these other containers to continue to
meet the definition of empty within Sec.  261.7 or develop specific
empty container standards for them within subpart P. One commenter
recommended that EPA revise the regulations to state that IV bags and
their tubing, inhalers, aerosols, nebulizers, tubes of ointments, and
gels or creams are RCRA empty and not subject to hazardous waste
regulations if they contain non-acute hazardous waste and their
contents are fully administered.
3. Final Rule Provision
    In response to comments, the final rule contains an empty container
standard for IV bags separate from other containers, including delivery
devices. The Agency stated in the proposal that it is very hard to
determine if aerosols, tubes of ointments, gels and creams, inhalers,
and nebulizers are empty due to their containers and contents. As
commenters pointed out, this is not the case for IV bags and tubing
since they are transparent and the liquids inside can be easily
observed.
    Taking approaches suggested from commenters, EPA is finalizing in
Sec.  266.507(c) that an IV bag is considered empty and the residues
are not regulated as hazardous waste provided the pharmaceuticals in
the IV bag have been fully administered to a patient. In cases where
the IV bag has not been fully administered and the IV bag held non-
acute hazardous waste pharmaceuticals, then IV bag can be shown to be
empty and the remaining residues not regulated as hazardous waste per
Sec.  261.7(b)(1). If an IV bag is not empty through either of these
means because it either has not been fully

administered or cannot meet the requirements of Sec.  261.7(b)(1) or
because it contained an acute hazardous waste pharmaceutical, the IV
bag must be placed with its remaining hazardous waste pharmaceuticals
into a container that managed and disposed of as a non-creditable
hazardous waste pharmaceutical under this subpart.
    In the final rule, EPA has also altered the requirements for other
types of containers including delivery devices. Commenters pointed out
that a healthcare facility should not be precluded from proving that
these containers meet the RCRA-empty standards in Sec.  261.7 simply
due to the type of container or contents. EPA agrees with the
commenters that these types of containers which held non-acute
hazardous waste pharmaceuticals should be able to use the RCRA empty
container standards under Sec.  261.7 and has changed the final rule to
allow this. If the containers meet the RCRA empty standard under Sec.
261.7 then the non-acute hazardous waste pharmaceutical residues (and
the container) are not regulated as hazardous waste and can be managed
as solid waste.
    If these other containers, a category that includes but is not
limited to inhalers, aerosols, nebulizers, tubes of ointments, gels or
creams, once held an acute hazardous waste pharmaceutical or if they
held a non-acute hazardous waste pharmaceutical but cannot meet the
RCRA empty container standard of Sec.  261.7, then the residues of
these hazardous waste pharmaceuticals (and their containers) must be
managed as non-creditable hazardous waste pharmaceuticals under this
subpart.
4. Comments and Responses
    One commenter was concerned that managing all other containers that
held hazardous waste pharmaceuticals as non-empty could cause a VSQG
healthcare facility to bump up in generator category to an LQG. This
will no longer be a concern since a healthcare facility now has the
option to prove that their other containers that held non-acute
hazardous waste pharmaceuticals meet the RCRA empty container standards
in Sec.  261.7 and they can manage the residues (and containers) as
non-hazardous waste. Otherwise, if these other containers are not
considered empty, then the residues (and containers) must be managed as
non-creditable hazardous waste pharmaceuticals under subpart P and
hazardous waste pharmaceuticals managed under subpart P do not count
towards determining the generator category. Further, we note that a
healthcare facility can use the new empty container provisions in Sec.
266.507 when determining whether they generate enough hazardous waste
to become subject to part 266 subpart P.

XVI. Shipping Standards for Hazardous Waste Pharmaceuticals (Sec. Sec.
266.508 and 266.509)

A. Shipping Non-Creditable Hazardous Waste Pharmaceuticals From
Healthcare Facilities to Treatment, Storage, and Disposal Facilities
(Sec.  266.508(a))

1. Summary of Proposal
    Under part 266 subpart P, hazardous waste pharmaceuticals generated
in a healthcare facility fall into two categories: (1) Non-creditable
hazardous waste pharmaceuticals (e.g., partially administered for
patient care), and (2) potentially creditable hazardous waste
pharmaceuticals (e.g., unused, unadministered). This section discusses
the proposed requirements for shipping non-creditable hazardous waste
pharmaceuticals. For information regarding the shipment of potentially
creditable hazardous waste pharmaceuticals from healthcare facilities
and reverse distributors, see section XVI.D. of this preamble.
    Generally, non-creditable hazardous waste pharmaceuticals differ
from potentially creditable hazardous waste pharmaceuticals in that
they have been partially administered and often are not in their
original packaging. In addition, since there is not a reasonable
expectation that prescription non-creditable hazardous waste
pharmaceuticals are eligible to receive manufacturer credit, they are
shipped off site to a TSDF rather than a reverse distributor. Due to
concerns that a healthcare facility might send all of its hazardous
waste pharmaceuticals to a reverse distributor even if there is not a
reasonable expectation of receiving manufacturer credit--essentially
using the reverse distributor as a TSDF--EPA proposed that non-
creditable hazardous waste pharmaceuticals generated at healthcare
facilities, when shipped off site, must be shipped to a designated
facility (e.g., an interim status or permitted hazardous waste TSDF),
as was required under part 262 (unless the healthcare facility has
interim status or a RCRA permit to store or treat hazardous waste and
chooses to store or treat the non-creditable hazardous waste
pharmaceuticals on site instead of shipping them to a designated
facility).
    Specifically, EPA proposed that healthcare facilities shipping non-
creditable hazardous waste pharmaceuticals to a designated facility for
treatment or disposal must continue to comply with the existing
Department of Transportation (DOT) pre-transport requirements for
packaging, labeling and marking, and that the non-creditable hazardous
waste pharmaceuticals must continue to be shipped using a hazardous
waste transporter and be tracked with a hazardous waste manifest.
However, to avoid unnecessarily burdening the healthcare facility
staff, who the Agency assumes are typically unfamiliar with RCRA, EPA
proposed that the hazardous waste numbers (often called hazardous waste
codes) are not required to be entered into the hazardous waste manifest
for non-creditable hazardous waste pharmaceuticals. In lieu of
hazardous waste codes, EPA proposed that the words, ``hazardous waste
pharmaceuticals'' must be entered in the ``special handling and
additional information'' box on the manifest (this box was called Item
14 at the time of the proposal).
    We also proposed that all existing RCRA recordkeeping requirements
regarding hazardous waste manifesting as well as all applicable DOT
shipping requirements continue to apply to healthcare facilities
shipping non-creditable hazardous waste pharmaceuticals to a TSDF for
treatment or disposal (see section X.K).
2. Summary of Comments
    Comments on this section of the proposed rulemaking were mixed.
Commenters generally agreed with the proposed standards for packaging,
labeling, marking, placarding, and shipping papers. Adverse comments
were mostly in regard to the decision to not require individual waste
codes on the manifest for a healthcare facility sending non-creditable
hazardous waste pharmaceuticals to a TSDF for disposal. In fact,
commenters were generally concerned about the proposal to not require
individual waste codes anywhere in the management standards for
healthcare facilities managing non-creditable hazardous waste
pharmaceuticals. Whether the comments were regarding waste code
determinations, labeling containers with waste codes, or including
waste codes on the manifest, the overarching concern was that TSDFs
would not know the specific contents of shipments received, resulting
in an increase to their burden, and possibly would be detrimental to
human health and the environment. Therefore, the adverse comments
regarding the lack of a proposed requirement to input individual waste
codes on the manifest are applicable more broadly to the subject of
whether or not the

information that individual waste codes convey should somehow be
provided to a TSDF by the healthcare facility shipping non-creditable
hazardous waste pharmaceuticals.
    Some states agreed with the proposal to not require individual
waste codes on the manifest, while others commented that it is
important to have waste codes at all steps where they would otherwise
be required under previous RCRA regulations. Comments from waste
management companies were also mixed, with some supporting the proposal
to not require individual hazardous waste codes on the manifest, while
others agreed with the proposal but suggested including a profile of
likely constituents to alert TSDFs of potential waste contents to aid
in LDR compliance.
    Those waste management companies that disagreed with the proposed
standards cited the added burden imposed by not knowing the specific
waste constituents included in a shipment, which would make compliance
with LDR standards more difficult. They were primarily concerned about
the added burden of having to either begin testing their ash for wastes
that have a numeric treatment standard, or modify existing testing
protocols. One commenter from the healthcare industry disagreed with
the elimination of individual hazardous waste codes on manifests from
healthcare facilities shipping non-creditable hazardous waste
pharmaceuticals, arguing that healthcare workers are capable of making
accurate hazardous waste determinations. They also stated that
hazardous waste codes are integral to properly managing hazardous
waste. One waste management commenter stated that continuing to require
waste codes on LDR notices altogether negates any actual relief because
healthcare facilities will have to determine appropriate waste codes
before sending hazardous waste pharmaceuticals off site to a TSDF
whether or not they are required on the container label or manifest.
    One reverse distributor also agreed with the proposed standards
under the condition that the Agency agree that pharmaceuticals being
sent to a reverse distributor are not waste.
3. Final Rule Provisions
    The agency is finalizing the majority of the proposed requirements
in this section. Before being shipped off site, all shipments of non-
creditable hazardous waste pharmaceuticals must comply with applicable
DOT pre-transport requirements for packaging (49 CFR parts 173, 178,
and 180), labeling (49 CFR part 172 subpart E), and marking (49 CFR
part 172 subpart D). There are, however, three notable changes being
finalized.
    First, Sec.  266.508(a)(1)(v) has been removed and a healthcare
facility shipping hazardous waste pharmaceuticals to a TSDF for
disposal must instead comply with Sec.  266.508(a)(2)'s manifest
requirement to meet DOT's shipping papers requirement.
    Second, the agency has decided to modify the proposal to not
require any hazardous waste codes in Item 13 (Waste Codes) of the
hazardous waste manifest for shipments of non-creditable hazardous
waste pharmaceuticals being sent to a TSDF, and write the words
``Hazardous Waste Pharmaceuticals'' in Item 14 (Special Handling
Instructions and Additional Information). The Agency is instead
finalizing a requirement to write only one waste code-- ``PHARMS''--in
Item 13, and not impose any requirements for what must be written in
Item 14. After further consideration of the impacts this proposed
requirement would impose on implementation and data collection, the
Agency decided it had to be modified. During the development of this
rule, the Agency has also been developing the electronic manifest
system (e-Manifest) which requires that some code be written in Item
13. We chose the PHARMS code because it both meets the required number
of characters and communicates the nature of the waste. Since the waste
will now be sufficiently characterized in Item 13, the Agency feels
there is no longer the need to require the words ``hazardous waste
pharmaceuticals'' in Item 14.
    This new PHARMS code is for manifesting and reporting purposes only
and is not an official EPA hazardous waste code. Because it will be
written in the same place as other official EPA hazardous waste codes,
it may also be referred to colloquially as a ``hazardous waste code.''
However, it does not modify any existing LDR treatment standards, nor
does it enact any new or alternate LDR treatment standards for
hazardous waste pharmaceuticals. Many commenters throughout the
proposed rulemaking suggested that EPA promulgate an alternative
treatment standard of the ``CMBST'' code specifically for hazardous
waste pharmaceuticals with numeric treatment standards. The agency
considered incorporating these suggestions into the proposed
rulemaking, but did not receive the necessary data to support such an
action. The Agency does, however, generally agree that implementing a
new alternative treatment standard for hazardous waste pharmaceuticals
might help mitigate burden on the regulated community while remaining
protective of human health and the environment. The Agency remains open
to considering the addition of an alternative treatment standard for
hazardous waste pharmaceuticals in future rulemakings.
    Although the Agency is now requiring the PHARMS code in Item 13 for
shipments of non-creditable hazardous waste pharmaceuticals from a
healthcare facility to a TSDF, hazardous waste codes are not required
on the manifest, which was preferred by some commenters. As a result,
TSDFs treating hazardous waste pharmaceuticals will have to assume that
shipments of hazardous waste pharmaceuticals contain the few that have
numeric treatment standards in order to demonstrate compliance with
LDRs.
    The third change made to the regulations was to modify the
regulatory language in Sec.  266.508(a) slightly to clarify that
shipments of non-creditable hazardous waste pharmaceuticals being sent
from a healthcare facility for disposal must be sent to a designated
facility and accompanied by a hazardous waste manifest. As part of the
manifest requirements in 40 CFR part 262 subpart B, shipments of non-
creditable and evaluated hazardous waste pharmaceuticals must be sent
to a designated facility via a hazardous waste transporter. One
commenter noted that the proposed language could have been interpreted
to mean that such shipments are also allowed to go elsewhere, which was
not the Agency's intent.
    Another substantive change to the regulatory language that resulted
from incorporating commenters' concerns was to remove the requirements
for shipping papers in Sec.  266.508(a)(1)(v). A commenter pointed out
that the requirement is unnecessary given the requirements in Sec.
266.508(a)(2) and the Agency agreed. Section 266.508(a)(1)(v) would
have required a healthcare facility shipping non-creditable hazardous
waste pharmaceuticals to a TSDF to prepare shipping papers in
accordance with 49 CFR 172 subpart C; however, the subsequent paragraph
(Sec.  266.508(a)(2)) outlines the requirements for manifesting a
shipment of non-creditable hazardous waste pharmaceuticals. Requiring
both shipping papers and a manifest is redundant and could have
possibly resulted in confusion and contradictory requirements. The
hazardous waste manifest requirements, if complied

with, duly satisfy DOT's shipping paper requirements.
    The wording in Sec.  266.508(a) was modified slightly to clarify
that healthcare facilities and reverse distributors that ship non-
creditable and evaluated hazardous waste pharmaceuticals off site,
respectively, are required to send them to a designated facility.
    Finally, to be consistent with the Hazardous Waste Generator
Improvements final rule, we have added paragraph 266.508(a)(1)(iii)(C)
to mirror Sec.  262.32(d), which addresses marking for lab packs.
Specifically, lab packs of hazardous waste pharmaceuticals that will be
treated using the alternative treatment standard of incineration, as
allowed by Sec.  268.42(c), do not have to marked or labeled with EPA
hazardous waste numbers. However, lab packs that contain D004
(arsenic), D005 (barium), D006 (cadmium), D007 (chromium), D008 (lead),
D010 (selenium) or D011 (silver), the EPA hazardous waste number must
be marked or labeled with the EPA hazardous waste numbers (or
electronic means may be used). These specific metals must be identified
because Sec.  268.42(c)(4) requires any incinerator residues from lab
packs that contain any of these specific metals to undergo further
treatment prior to land disposal.

B. Shipping Evaluated Hazardous Waste Pharmaceuticals From Reverse
Distributors to Treatment, Storage, and Disposal Facilities (Sec.
266.508(a))

1. Summary of Proposal
    For reverse distributors, once a potentially creditable hazardous
waste pharmaceutical has been evaluated and it has been determined that
it is not destined for another reverse distributor for further
evaluation or verification of credit, EPA proposed that the hazardous
waste pharmaceuticals be referred to as ``evaluated hazardous waste
pharmaceuticals.'' As with shipping non-creditable hazardous waste
pharmaceuticals, when evaluated hazardous waste pharmaceuticals are
shipped off-site, EPA proposed that they must be shipped in accordance
with the existing DOT pre-transport requirements under 49 CFR parts
172-80 for packaging, labeling, marking, placarding, and shipping
papers. We also proposed that they must be shipped in accordance with
the existing RCRA manifest requirements of 40 CFR part 262 subpart B,
which requires all relevant waste codes be listed in Item 13 and that
they be shipped via a hazardous waste transporter to a designated
facility. This continues current practices under existing regulations
for this type of hazardous waste pharmaceutical and does not represent
an increase in burden. EPA argued that the use of a hazardous waste
manifest and a hazardous waste transporter are appropriate at this
point for two reasons. First, once credit for the hazardous waste
pharmaceuticals has been verified, the potential for mismanagement is
greater because evaluated pharmaceuticals no longer retain any value
and will cost the reverse distributor money to dispose. Second, TSDFs
are accustomed to receiving hazardous waste via a hazardous waste
transporter with a hazardous waste manifest and it would place
administrative and compliance burdens on the receiving TSDF to accept
shipments of hazardous waste with alternative tracking.
    EPA proposed that a reverse distributor must list all appropriate
hazardous waste codes on the manifest when shipping evaluated hazardous
waste pharmaceuticals to a TSDF. This differs from the requirements for
a healthcare facility shipping non-creditable hazardous waste
pharmaceuticals to a TSDF. Unlike non-creditable hazardous waste
pharmaceuticals generated at a healthcare facility, hazardous waste
pharmaceuticals received by reverse distributors are typically in the
manufacturer's original, intact, and labeled packaging (if not, they
are likely non-creditable hazardous waste pharmaceuticals and should be
sent to a TSDF), so the information needed to determine the appropriate
hazardous waste codes once evaluated should be readily available to the
reverse distributor. Also, reverse distributors are currently required
to include hazardous waste codes on the manifest and it is expected
that they have the necessary expertise in the management of these
hazardous wastes that healthcare personnel lack. Under the reverse
distributor standards in Sec.  266.510(c)(10)(ii), EPA also proposed
that reverse distributors must keep copies of hazardous waste manifests
for three years from the date evaluated hazardous waste pharmaceuticals
are shipped to a TSDF.
2. Summary of Comments
    Comments in this section were mixed. Many commenters addressed the
standards for healthcare facilities sending shipments of non-creditable
hazardous waste pharmaceuticals to a TSDF but did not specifically
mention the standards for shipping evaluated hazardous waste
pharmaceuticals to a TSDF. Nevertheless, many of the concerns expressed
by commenters with the standards for healthcare facilities shipping
non-creditable hazardous waste pharmaceuticals to a TSDF are relevant
because the standards in Sec.  266.508 are the same for healthcare
facilities shipping non-creditable hazardous waste pharmaceuticals as
they are for reverse distributors shipping evaluated hazardous waste
pharmaceuticals, with the exception of Sec.  266.508(a)(2)(i) and (ii).
The few that commented directly on the proposed shipping standards for
evaluated hazardous waste pharmaceuticals being shipped from a reverse
distributor to a TSDF agreed with the standards as proposed.
    Reverse distributor and waste management industry commenters were
in agreement with the proposed standards for shipping evaluated
hazardous waste pharmaceuticals to a TSDF, but to reiterate, did not
agree with the standards for shipping non-creditable hazardous waste
pharmaceuticals from a healthcare facility to a TSDF (no waste codes on
the manifest). Many commenters on this section simply stated that waste
codes should be included on a manifest, referring to the requirements
in Sec.  266.508(a)(2)(i) and (ii) which do not require waste codes on
the manifest for healthcare facilities shipping non-creditable
hazardous waste pharmaceuticals to a TSDF. Since those standards only
apply to healthcare facilities shipping non-creditable hazardous waste
pharmaceuticals to a TSDF and not reverse distributors sending
evaluated hazardous waste pharmaceuticals to a TSDF, the agency assumes
that those same commenters are generally in agreement with the
requirement for reverse distributors shipping evaluated hazardous waste
pharmaceuticals to a TSDF to comply with all of the manifest standards
in 40 CFR part 262 subpart B, which includes a requirement to list all
applicable EPA hazardous waste codes on the manifest.
3. Final Rule Provisions
    The Agency is finalizing the standards for shipping evaluated
hazardous waste pharmaceuticals from a reverse distributor to a TSDF
with minor changes. First, Sec.  266.508(a)(1)(v) has been removed. The
standards for shipping papers for reverse distributors sending
evaluated hazardous waste pharmaceuticals to a TSDF are contained
instead in subparagraph Sec.  266.508(a)(2) (i.e., the manifest).
    Second, the clarification to the regulatory language mentioned
previously, which specifies that non-creditable hazardous waste

pharmaceuticals must go only to a TSDF, also applies to evaluated
hazardous waste pharmaceuticals. As mentioned above, commenters were
concerned that the proposed regulatory language appeared to make it
optional for a reverse distributor to ship evaluated hazardous waste
pharmaceuticals to a TSDF for disposal, although it was not intended to
read that way. The finalized regulatory language was modified to
clarify that a reverse distributor shipping evaluated hazardous waste
pharmaceuticals must send them to a TSDF for treatment and disposal.
This change pertains to both evaluated pharmaceuticals being shipped
from a reverse distributor as well as non-creditable hazardous waste
pharmaceuticals being shipped from a healthcare facility.
    To summarize, reverse distributors sending evaluated hazardous
waste pharmaceuticals to a TSDF for disposal are required to comply
with all standards in Sec.  266.508(a), which includes a requirement to
list all applicable waste codes in Item 13 of the manifest, even though
healthcare facilities sending non-creditable hazardous waste
pharmaceuticals to a TSDF do not. They are not, however, required to
write the word PHARMS in Item 13 or on the container label in addition
to all other applicable waste codes.

C. Shipping Non-Creditable or Evaluated Hazardous Waste Pharmaceuticals
for Import or Export (Sec. Sec.  266.508(b) and 266.508(c))

1. Summary of Proposal
    Under part 262, a healthcare facility or reverse distributor may
not import hazardous waste pharmaceuticals unless it has a RCRA permit
or interim status that allows it to accept hazardous waste from off
site and complies with the requirements for importing hazardous waste
in 40 CFR part 262 subpart H. Under part 266, EPA did not propose to
change the regulations as they apply to the import of non-creditable or
evaluated hazardous waste pharmaceuticals. Likewise, under part 262, a
healthcare facility or reverse distributor may not export (non-
creditable nor evaluated) hazardous waste pharmaceuticals unless it
complies with requirements for exporting hazardous waste in 40 CFR part
262 subpart H. Under part 266, EPA did not propose to change the
regulations as they apply to the export of (non-creditable or
evaluated) hazardous waste pharmaceuticals.\352\
---------------------------------------------------------------------------

    \352\ In the proposed rule we referenced part 262 subparts E and
F when discussing this provision. Part 262 subparts E and F have
since been replaced by part 262 subpart H; see the Hazardous Waste
Export-Import Revisions final rule, 81 FR 85696; December 31, 2016.
---------------------------------------------------------------------------

    EPA requested comment on the likelihood that non-creditable
hazardous waste pharmaceuticals that are shipped from a healthcare
facility to a domestic TSDF, would then be exported to a TSDF in a
foreign country. In addition, EPA did not anticipate that hazardous
waste pharmaceuticals would be destined for transboundary shipments for
purposes of recovery operations and therefore potentially subject to 40
CFR part 262 subpart H; however, we also requested comment on whether
this is the case.
2. Summary of Comments
    We received no comments on the proposed standards for importing and
exporting non-creditable or evaluated hazardous waste pharmaceuticals.
3. Final Rule Provisions
    Since part 266 subpart P was proposed, the hazardous waste import
and export regulations under part 262 have been revised.\353\ The
export regulations which had been in part 262 subpart E are now in part
262 subpart H. Likewise, the import regulations which had been in part
262 subpart F are also now in part 262 subpart H. The requirements for
both importing and exporting non-creditable hazardous waste
pharmaceuticals are being substantially finalized as proposed. The only
change being made from the proposed requirements is to update the
reference to the revised part 262 regulations, in order to conform to
the changes implemented in the Hazardous Waste Imports and Exports
Improvement Rule. Whereas the proposed Sec.  266.508(b) and (c) refer
to the standards in 40 CFR part 262 subpart E and F, they now refer to
40 CFR part 262 subpart H.
---------------------------------------------------------------------------

    \353\ See the final Hazardous Waste Export-Import Revisions
rule, 81 FR 85696; December 31, 2016.
---------------------------------------------------------------------------

D. Shipping Potentially Creditable Hazardous Waste Pharmaceuticals
(Sec.  266.509).

1. Summary of Proposal
    This section discusses the proposed requirements for shipping
potentially creditable hazardous waste pharmaceuticals from a
healthcare facility to a reverse distributor and between reverse
distributors. The return of potentially creditable waste
pharmaceuticals (hazardous and non-hazardous) to a reverse distributor
can involve multiple shipping steps before the pharmaceuticals are
transported for ultimate treatment and disposal. In comments on the
2008 Pharmaceutical Universal Waste proposal and in response to EPA's
request for information,\354\ reverse distributors described various
scenarios. For example, a healthcare facility typically sends waste
pharmaceuticals to the reverse distributor with which it has a
contract. However, some manufacturers will only provide manufacturer
credit after the pharmaceuticals have been returned to the reverse
distributor with which the manufacturer has a contract. Thus, if the
reverse distributor with which the healthcare facility has a contract
differs from the reverse distributor with which the manufacturer has a
contract, then the healthcare facility's reverse distributor must send
the pharmaceuticals on to the manufacturer's reverse distributor for
the manufacturer credit to be given to the healthcare facility. In some
cases, a pharmaceutical manufacturer may require the reverse
distributor to ship the pharmaceuticals back to them so they can
perform the verification and issue credit themselves. The estimated
amount of pharmaceuticals transported from reverse distributors to
manufacturers for verification varies. Based on our request for
information, reverse distributors indicated that the percent of
potentially creditable hazardous waste pharmaceuticals transported to
manufacturers ranged from an estimated 25 percent to 93 percent of
total volume, depending on the contractual agreement between the
reverse distributor and the manufacturer. The scenarios described
previously occur routinely and are an integral part of the process by
which manufacturers issue credit.
---------------------------------------------------------------------------

    \354\ See the survey of reverse distributors in docket number:
EPA-HQ-RCRA-2007-0932-0158 through 0160.
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    As explained in section IV.A, EPA proposed that all pharmaceuticals
transported to reverse distributors for manufacturer credit are solid
wastes, some of which would also be considered hazardous wastes. The
finalized regulations have been modified, however, such that only
prescription pharmaceuticals going through reverse distribution for
manufacturer credit are solid wastes, while OTC pharmaceuticals going
through reverse logistics are outside of this rule. Under the part 262
regulations, hazardous waste, including hazardous waste
pharmaceuticals, must be manifested to a permitted or interim

status TSDF and shipped using a hazardous waste transporter to ensure
the cradle-to-grave system of RCRA is maintained. However, compared to
other hazardous wastes, EPA believes that the risk of environmental
release posed by most potentially creditable hazardous waste
pharmaceuticals during accumulation and transport is relatively low.
The risk is low because of the form and packaging of most potentially
creditable hazardous waste pharmaceuticals, which is typically in
small, individually packaged doses (such as with many tablets and
capsules) or small vials. These small volumes of individually wrapped
or packaged pharmaceuticals, when aggregated in a larger container, are
unlikely to spill or be released into the environment since they are
essentially double-packed when transported to a reverse distributor.
Potentially creditable hazardous waste pharmaceuticals that are in
liquid and aerosol forms may pose more of a risk during accumulation
and transport due to possible spillage or leakage, but the small
quantities in which they are generated, along with the DOT packaging
requirements of 49 CFR parts 173, 178, and 180, would likely mitigate
this risk (see EPA's recommendation regarding liquids and aerosols in
section XI.C.1). Further, the 2008 Pharmaceutical Universal Waste
proposal specifically sought comment regarding the risks of
transportation of hazardous waste pharmaceuticals and no commenters
identified environmental risks.
    Due to the low risk to human health and release to the environment,
EPA proposed to allow potentially creditable hazardous waste
pharmaceuticals to be shipped without a hazardous waste manifest and
without the use of hazardous waste transporters when the healthcare
facility is sending potentially creditable hazardous waste
pharmaceuticals to a reverse distributor or when a reverse distributor
is sending potentially creditable hazardous waste pharmaceuticals to
another reverse distributor. The same DOT shipping requirements would
continue to apply to shipments of potentially creditable hazardous
waste pharmaceuticals (provided they are classified as DOT hazardous
materials) that applied prior to this final rule. Nothing in this final
rule changes how DOT shipping requirements apply to shipments of
prescription pharmaceuticals to reverse distributors.
    EPA proposed an alternate tracking method for potentially
creditable hazardous waste pharmaceuticals--with two requirements in
lieu of requiring a hazardous waste manifest and the use of hazardous
waste transporters. First, EPA proposed that for each shipment,
healthcare facilities and reverse distributors must provide in writing
(via letter or electronic communication), advance notice of the intent
to send a shipment to the receiving reverse distributor. We also
proposed that the receiving reverse distributor must provide
acknowledgement to the shipper that they received the advance notice.
This requirement was intended to function like a manifest, tracking the
potentially creditable hazardous waste pharmaceuticals en route to the
reverse distributor. Second, EPA proposed that for each shipment, the
receiving reverse distributor must provide confirmation to the
healthcare facility or reverse distributor that initiated the shipment,
that the shipment of potentially creditable hazardous waste
pharmaceuticals has been received. The Agency proposed this requirement
in direct response to concerns expressed by commenters over the lack of
tracking of pharmaceutical waste in the 2008 Pharmaceutical Universal
Waste proposal.
    The Agency proposed that, if a healthcare facility or reverse
distributor initiates a shipment of potentially creditable hazardous
waste pharmaceuticals to a reverse distributor and does not receive
delivery confirmation within seven calendar days, that the healthcare
facility or reverse distributor that initiated the shipment must
contact the shipper and the intended recipient promptly to (1) report
that the confirmation was not received, and (2) to determine the status
and whereabouts of the potentially creditable hazardous waste
pharmaceuticals that were shipped.
    The Agency proposed that if a healthcare facility or reverse
distributor exports potentially creditable hazardous waste
pharmaceuticals, it must generally comply with 40 CFR part 262 subpart
E, except that it is not required to manifest the potentially
creditable hazardous waste pharmaceuticals. The Agency also proposed
that any person that imports potentially creditable hazardous waste
pharmaceuticals, must comply with the proposed requirements for the
shipment of potentially creditable hazardous waste pharmaceuticals, in
lieu of the requirements for hazardous waste imports found at 40 CFR
part 262 subpart F.\355\
---------------------------------------------------------------------------

    \355\ Part 262 subparts E and F have since been replaced by part
262 subpart H; see the Hazardous Waste Export-Import Revisions final
rule, 81 FR 85696; December 31, 2016.
---------------------------------------------------------------------------

    EPA proposed to require healthcare facilities (Sec.  266.503(d))
and reverse distributors (Sec.  266.510(b)(4)) to keep records of the
shipments of potentially creditable hazardous waste pharmaceuticals to
reverse distributors. Specifically, we proposed that healthcare
facilities and reverse distributors that initiate a shipment to a
reverse distributor must keep (1) records of advance notification
regarding shipments of potentially creditable hazardous waste
pharmaceuticals, (2) delivery confirmation for three years after the
shipment was initiated, and (3) shipping papers or bills of lading. The
Agency argued that these records are necessary to ensure that
potentially creditable hazardous waste pharmaceuticals reach their
intended destination and are not diverted.
    In most cases, retaining records for three years should be
sufficient for inspection purposes; however, we proposed that the
periods of retention would be automatically extended during unresolved
enforcement activity, or at the request of the EPA Regional
Administrator. The Agency sought comment on whether additional
recordkeeping is necessary to document the cases when the reverse
distributor does not receive a shipment of potentially creditable
pharmaceuticals within seven calendar days and the steps must be taken
to locate the shipment.
2. Summary of Comments
    The majority of comments focused on the provision to allow
shipments of potentially creditable hazardous waste pharmaceuticals to
be sent via carrier (i.e., not by hazardous waste transporter), the
requirements for advance notice of shipment and delivery confirmation,
and the time frame within which delivery confirmation is received
before the shipper must take action to locate a missing shipment.
    Comments on whether the Agency should allow shipments of
potentially creditable hazardous waste pharmaceuticals to be sent via
carriers such as USPS, UPS, and FedEx without a manifest were mixed.
Only a few states commented on this provision specifically. The
majority of states agreed that shipping via carriers provides
sufficiently low risk of release or illicit diversion. However, one
state was concerned that we did not propose a requirement to reconcile
the contents of what was shipped with what was received. That same
commenter, as well as a handful of others, also voiced concern about
whether DOT regulations would permit hazardous waste

pharmaceuticals to be lawfully shipped via carrier in the first place.
Manufacturers, waste management companies, healthcare industry groups,
and pharmacy trade associations were all generally in agreement with
the proposed shipping standards for potentially creditable hazardous
waste pharmaceuticals.
    One of the primary points of contention in this subsection was the
proposed standard that would require a shipper to provide advance
notice of its intent to ship potentially creditable hazardous waste
pharmaceuticals to a reverse distributor. Reverse distributors
objected, arguing it would impart undue financial and administrative
burden, which would require them to hire additional staff to adequately
process advance notices, track, and confirm the delivery of thousands
of shipments per year. A national trade association of retailers
expressed similar concerns. They did not support the proposed advance
notice and delivery confirmation requirements and argued the
requirements would add undue burden due to the high volume of shipments
large retailers send per year. The commenters suggested that the
proposed notification and delivery standards either be removed or
modified to match current inventory and accounting practices.\356\ One
pharmaceutical manufacturer also disagreed with the proposed standard,
but gave no reasoning as to why, other than they thought it was
unnecessary. States generally agreed with the proposed standard and a
few suggested the Agency finalize additional requirements like
reconciling what was in the notice with the contents of the package
after delivery which would also require an inventory of each container.
One state was concerned about its ability to confirm that a shipment
has reached its final destination (TSDF) in scenarios where a shipment
is sent to an out-of-state reverse distributor or a second reverse
distributor. Healthcare facilities and pharmacist trade groups either
agreed with the proposed standards or did not mention these standards
specifically. One pharmacist trade group said they want some
clarification about what constitutes advance notice.\357\
---------------------------------------------------------------------------

    \356\ See comment number EPA-HQ-RCRA-2007-0932-0295.
    \357\ See comment number EPA-HQ-RCRA-2007-0932-0284.
---------------------------------------------------------------------------

    There were numerous comments both in agreement with and opposition
to the proposed requirement to take action to locate a shipment of
potentially creditable hazardous waste pharmaceuticals if no delivery
confirmation is received within seven days from the day the shipment
leaves the shipper's facility. Most comments were related to the time
frame within which the shipper must receive delivery confirmation, but
a few commenters from the retail and reverse distribution industries
opposed the requirement altogether because of the added financial,
procedural, and administrative burden they argue it would impose. Many
commenters were concerned that the proposed time frame was too short
and would result in frequent situations in which the shipper would be
required to undertake efforts to locate a shipment that eventually
arrives without intervention sometime after the seven days. Some
commenters noted that seven days is the minimum transit time for a
standard cross-country shipment under ideal conditions, which provides
no buffer for unforeseen circumstances that may cause delays such as
inclement weather or some other service disruption. One state suggested
a 35-day time frame as an alternative because it would be the same as
the time frame specified for delivery confirmation of universal waste
shipped via carrier per the universal waste rule.\358\
---------------------------------------------------------------------------

    \358\ See comment number EPA-HQ-RCRA-2007-0932-0238.
---------------------------------------------------------------------------

    There were limited comments regarding the proposed standards for
healthcare facilities and reverse distributors importing and/or
exporting potentially creditable hazardous waste pharmaceuticals. The
only concern raised was whether shipments sent to or received from U.S.
territories (e.g., Puerto Rico, Guam) are considered exports/imports,
and if so, they recommended that the Agency confer with other
appropriate federal agencies and their reverse distributor contractors.
3. Final Rule Provisions
    In response to comments, the Agency has made several changes to the
proposed standards for shipping potentially creditable hazardous waste
pharmaceuticals. First, we have made a minor change to make our
regulatory language more consistent with DOT's terminology and clarify
to whom the regulations refer. Specifically, in Sec.  266.509(c), we
changed the word shipper to carrier. As originally proposed, the word
shipper could have been interpreted to refer to the party that prepares
and offers a shipment of potentially creditable hazardous waste
pharmaceuticals, whereas the regulations apply to the company providing
transportation of a shipment of potentially creditable hazardous waste
pharmaceuticals. To clarify, a shipper is the party that prepares and
offers a shipment to be transported by a carrier.
    Second, we have eliminated the requirement in Sec.  266.509(a)(1)
for a healthcare facility or reverse distributor that ships potentially
creditable hazardous waste pharmaceuticals to provide advance notice of
the shipment. The Agency believes that the proposed advance notice
requirement goes beyond the manifest requirements and would have
resulted in undue burden on both the shippers and the receiving reverse
distributors while only nominally more protective of human health and
the environment. We would, however, recommend that, as a best practice,
shippers of potentially creditable hazardous waste pharmaceuticals
provide advance notice to the recipients to the extent practicable.
Conforming changes have been made throughout the regulations that
reflect the elimination of the requirement to provide advance notice of
shipments of potentially creditable hazardous waste pharmaceuticals.
    Third, the proposed requirement that a reverse distributor that
receives a shipment of potentially creditable hazardous waste
pharmaceuticals must provide delivery confirmation to the facility that
initiated the shipment is being finalized as proposed, with the added
clarification that the shipment is not considered delivered until it is
under the custody and control of the receiving reverse distributor.
Requiring delivery confirmation provides assurance that the shipment
was actively received by the reverse distributor and the chain of
custody maintained. Without this confirmation from the receiving
reverse distributor personnel, it is possible for a shipment to be
delivered to the destination location but not necessarily taken into
their custody and control (e.g., left unattended outside the building).
    Under this final rule, healthcare facilities and reverse
distributors may use carriers, such as USPS, UPS, and FedEx for
shipments of potentially creditable hazardous waste pharmaceuticals to
and between reverse distributors, as long as personnel are present to
receive and take control of the shipments upon arrival. EPA believes
that carriers are able to provide safe shipment since these potentially
creditable hazardous waste pharmaceuticals present low risk of release
during transport.
    In addition, all of the carriers EPA is aware of offer services
that meet the delivery confirmation requirement.

Delivery confirmation can be paper-based or electronic and must
indicate that personnel from the receiving reverse distributor have
taken the shipment into their custody and control. One way for
healthcare facilities and reverse distributors sending shipments of
potentially creditable hazardous waste pharmaceuticals to a reverse
distributor via carrier may comply with the delivery confirmation
requirement would be to utilize the delivery confirmation service
provided by most carriers (e.g., Return Receipt from USPS, Delivery
Confirmation from UPS, or Signature Proof of Delivery from FedEx).
Typically, personnel at the receiving reverse distributor will sign for
a shipment confirming that it is now in their custody and control. That
signature will then be made available to the shipper, which satisfies
the delivery confirmation requirement.
    EPA has learned that some stakeholders use alternative electronic
tracking methods outside of those offered by carriers. One alternative
electronic tracking method is to apply barcoding on pharmaceutical
packaging or on containers containing multiple pharmaceutical packages.
A barcode is a unique identifier that links the container to a database
with detailed information about its contents and includes the exact
quantities of each item included in the shipment (inventories).
Typically, when a reverse distributor receives a barcoded shipment, it
will scan the barcodes upon receipt, and the sender will receive
electronic notification that the shipment has arrived at its
destination and is in the custody and control of the reverse
distributor. This type of barcode tracking would meet the delivery
confirmation requirement of this final rule. Another type of
alternative electronic tracking that would satisfy the delivery
confirmation requirement is radio frequency identification (RFID).
Similar to barcodes, RFID tags are placed inside a container, or
integrated into the container itself, and linked to inventories and
other detailed information. The RFID tags are read when they arrive at
the receiving facility and that information is made available to the
shipper, confirming that the shipment has been taken into the custody
and control of the receiving reverse distributor.\359\
---------------------------------------------------------------------------

    \359\ See comment number EPA-HQ-RCRA-2007-0932-0268.
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    Fourth, we have eliminated the regulatory language that was
proposed in Sec.  266.509(a)(2). We had referenced the DOT pre-
transport regulations that apply to shipments of non-creditable
hazardous waste pharmaceuticals. However, in 2016, DOT revised the
Hazardous Materials Regulations (HMR) as they apply to shipments of
items in reverse logistics.\360\ As a result, many of the DOT pre-
transport requirements we had referenced no longer apply to shipments
of hazardous materials in reverse logistics. In response, we have
eliminated the reference to the DOT pre-transport requirements and
instead modified our final regulations in Sec.  266.509(a) to refer to
the entire HMR, rather than specific provisions within the HMR.
Healthcare facilities and reverse distributors that send shipments of
potentially creditable hazardous waste pharmaceuticals to reverse
distributors need only comply with the applicable sections of DOT's HMR
for shipments in reverse logistics.
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    \360\ March 31, 2016; 62 FR 18527.
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    We note that healthcare facilities and reverse distributors must
meet the applicable DOT hazardous material shipping requirements only
when shipping potentially creditable hazardous waste pharmaceuticals
that meet the definition of DOT hazardous material. Under the DOT
regulations, a RCRA hazardous waste that requires a manifest is
considered a Class 9 hazardous material. Potentially creditable
hazardous waste pharmaceuticals do not require a manifest; therefore,
the DOT shipping requirements will apply when potentially creditable
hazardous waste pharmaceuticals are shipped to reverse distributors
only when the hazardous wastes are otherwise classified as DOT
hazardous materials (i.e., DOT hazard class 1-8). We added regulatory
language (that was adapted from the Universal Waste regulations) to
reflect this.
    Fifth, the Agency has finalized the requirement that the shipper of
potentially creditable hazardous waste pharmaceuticals must receive a
delivery confirmation from the reverse distributor, however, the Agency
has extended the time frame within which the shipper must receive the
delivery confirmation from the reverse distributor from the proposed
seven days to 35 days, after which the shipper must begin taking
actions to locate a shipment if the delivery confirmation is not
received. Many commenters suggested 14 days as an alternative to the
proposed seven-day time frame, while others suggested far longer or to
eliminate the time frame altogether. Upon reconsideration of the issue
and how it pertains more generally to other RCRA hazardous waste
programs, the Agency decided that 35 days was more appropriate, while
remaining duly protective of human health and the environment and
reducing burden on the regulated community. The time frame to receive
delivery confirmation for shipments of potentially creditable hazardous
waste pharmaceuticals is also now in line with the standard for
delivery confirmation under universal waste, which is also 35 days. In
addition, one of the overarching goals of this rule was to enact
universal waste-like standards for hazardous waste pharmaceuticals, to
which this provision conforms. Some states wanted the Agency to go
further and require that the EPA Regional Administrator be notified
whenever a shipment has not been received within the allotted time
frame. Although the Agency understands the utility of such a provision,
it is not being adopted because of the added burden it would impose on
both states and the regulated community. In addition, the Agency
prefers, in this instance, to allow states the flexibility to implement
more stringent reporting standards for missing shipments of potentially
creditable hazardous waste pharmaceuticals according to their
individual circumstances and preferences.
    After considering these comments, the Agency determined that it is
necessary to require a delivery confirmation in order to ensure
shipments of potentially creditable hazardous waste pharmaceuticals
have been received and taken into the custody and control of the
destination facility as a way to approximate the manifest system
without requiring the use of hazardous waste transporters or manifests.
In response to comments, we have reconsidered the proposed seven-day
time frame for the shipper to receive delivery confirmation; the Agency
decided that 35 days is more appropriate. It strikes a balance between
being duly protective of human health and the environment, reducing
burden, and is now in line with universal waste standards.
    Sixth, we have made several changes to the pre-transport
requirements that we proposed in Sec.  266.509(a)(1) and (2). Because
of the removal of the requirement for advance notice of shipments of
potentially creditable hazardous waste pharmaceuticals, we renumbered
the section such that it all appears in Sec.  266.509(a) now. What was
proposed in Sec.  266.509(a)(2) and is now in Sec.  266.509(a), has
been modified to reflect the removal of Sec.  266.508(a)(1)(v) which
previously contained a requirement that DOT shipping papers be
generated. The Agency believes that the shipping papers requirement--

although duplicative for shipments of non-creditable hazardous waste
pharmaceuticals from a healthcare facility or evaluated hazardous waste
pharmaceuticals from a reverse distributor--is appropriate for
shipments of potentially creditable hazardous waste pharmaceuticals
given that they are not manifested. Therefore, the requirement for DOT
shipping papers has been added to Sec.  266.509(a). Language was also
added to clarify that shipments of potentially creditable hazardous
waste pharmaceuticals from a healthcare facility or reverse distributor
to a reverse distributor do not require a manifest. This language was
taken from the universal waste standards in Sec.  273.52(a) which is
consistent with the goal of developing universal waste-like shipping
standards for potentially creditable hazardous waste pharmaceuticals.
    As with the export of non-creditable hazardous waste
pharmaceuticals, the proposed standards for healthcare facilities or
reverse distributors that export potentially creditable hazardous waste
pharmaceuticals to a foreign destination have also been modified to
reflect the changes made to the import/export rules of part 262.
Specifically, the Agency is finalizing requirements that exporters of
potentially creditable hazardous waste pharmaceuticals must comply will
all applicable sections of 40 CFR part 262 subpart H, except for the
manifest requirements of Sec.  262.83(c), in addition to the
requirements for shipping potentially creditable hazardous waste
pharmaceuticals in Sec.  266.509(a) through (c).
    Subsequent to when this rule was proposed in September 2015, the
Hazardous Waste Import-Export Revisions rule was finalized in
2016.\361\ As a result, the Agency has had to make conforming changes
to this final rule to reflect the changes made by the Import-Export
Revisions final rule. Because the regulations for importing and
exporting hazardous waste were previously located in separate
subparts--exports in subpart E and imports in subpart F--the proposed
requirements in this rule were also separated into discreet subsections
and referred to their respective subparts (exporting and importing) of
40 CFR part 262. A significant change enacted by the Import-Export
Revisions Rule was to consolidate into subpart H the multiple related
subparts in 40 CFR 262 regarding import, export, and transboundary
movements of hazardous waste that had been in subparts E and F.
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    \361\ See the Hazardous Waste Export-Import Revisions final
rule, 81 FR 85696; December 31, 2016.
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    The essence of the proposed regulations has not changed in the
finalized requirements. That is, a healthcare facility or reverse
distributor exporting potentially creditable hazardous waste
pharmaceuticals is still subject to the same or similar provisions as
were proposed, only now they must comply with 40 CFR part 262 subpart H
instead, except for the manifesting requirements, and paragraphs (a)
through (c) of Sec.  266.509.
    For healthcare facilities and reverse distributors that import
potentially creditable hazardous waste pharmaceuticals, the
requirements are being finalized as proposed, except that due to the
conforming changes necessitated by the Hazardous Waste Export-Import
Revisions Final Rule, they must now comply with the shipping standards
for potentially creditable hazardous waste pharmaceuticals in lieu of
40 CFR part 262 subpart H (instead of part 262 subpart F). One other
clarification was added to the regulatory language specifying that
potentially creditable hazardous waste pharmaceuticals are subject to
all applicable provisions in this subpart immediately after entering
the United States.
4. Comments and Responses
    The commenter that requested an official definition of advance
notice also requested an official definition for delivery
confirmation.\362\ The Agency is purposely leaving this standard
sufficiently broad as to allow the implementing agencies discretion to
determine the best implementation strategies on a case-by-case basis.
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    \362\ See comment number EPA-HQ-RCRA-2007-0932-0284.
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    EPA notes that a reverse distributor is not required to segregate
the potentially creditable hazardous waste pharmaceuticals from the
potentially creditable non-hazardous waste pharmaceuticals when they
are destined for another reverse distributor. However, if the
potentially creditable pharmaceuticals are not segregated, the reverse
distributor must follow the tracking procedures for the entire
shipment. On the other hand, if a reverse distributor chooses to
segregate the potentially creditable hazardous waste pharmaceuticals
from the non-hazardous waste pharmaceuticals prior to shipping to
another reverse distributor, only the potentially creditable hazardous
waste pharmaceutical portion would have to be shipped according to
these standards.

XVII. Standards for Reverse Distributors (Sec.  266.510)

A. Background on Reverse Distributor Operations

    Reverse distributors act as intermediaries between healthcare
facilities and pharmaceutical manufacturers. They receive shipments of
potentially creditable hazardous waste pharmaceuticals from healthcare
facilities and, on behalf of manufacturers, facilitate the process of
crediting healthcare facilities for these pharmaceuticals. From
stakeholder input, EPA site visits, and comments on the proposed
rulemaking, EPA's understanding is that when a reverse distributor
receives a shipment of potentially creditable hazardous waste
pharmaceuticals, the reverse distributor sorts through the shipment and
often uses barcodes to scan items into its computer system. Based on
manufacturers' ``business rules'' (i.e., manufacturers' return
policies), the reverse distributors determine which potentially
creditable hazardous waste pharmaceuticals can receive manufacturer
credit, as well as which must be sent on to another reverse distributor
for completion of the crediting process. ``Business rules'' (i.e.
manufacturers' 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.\363\
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    \363\ 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.
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    In many cases, there is more than one reverse distributor involved
in establishing and verifying manufacturer credit for a particular
potentially creditable hazardous waste pharmaceutical. For instance,
reverse distributors may have contracts with specific pharmaceutical
manufacturers such that only a specific reverse distributor may
facilitate credit for a particular manufacturer's pharmaceuticals. If
the receiving reverse distributor has a contract with the healthcare
facility, but not with the pharmaceutical manufacturer, then the
receiving reverse distributor sends the returned pharmaceutical on to
the reverse distributor that has a contract with the pharmaceutical
manufacturer in order to facilitate the manufacturer credit process.
    Because manufacturers' business rules change over time, sometimes a
reverse distributor receives a potentially creditable hazardous waste

pharmaceutical that is not eligible for credit immediately, and the
reverse distributor retains the potentially creditable hazardous waste
pharmaceutical on site until it is credit eligible (often called
``aging'' a pharmaceutical). For example, manufacturers only issue
credit for expired pharmaceuticals. As a result, sometimes a reverse
distributor receives an unexpired hazardous waste pharmaceutical that
is otherwise creditable but awaiting its expiration date. The reverse
distributor then retains the potentially creditable hazardous waste
pharmaceutical on site until after it has expired and thus becomes
eligible for manufacturer credit. In some cases, even after the reverse
distributor has awarded manufacturer credit, a pharmaceutical
manufacturer may request that the hazardous waste pharmaceuticals be
transported back to the manufacturer to verify the amount of
pharmaceuticals and manufacturer credit.
    On the other hand, if the potentially creditable hazardous waste
pharmaceuticals are not sent on to another reverse distributor and the
reverse distributor awards the manufacturer credit to the healthcare
facility itself, it then manages the hazardous waste pharmaceuticals on
site until they are sent off site for treatment and disposal. As
discussed previously, after a potentially creditable hazardous waste
pharmaceutical has been evaluated and no additional reverse
distributors will be involved in the manufacturer's crediting process,
EPA uses the term ``evaluated hazardous waste pharmaceutical.'' This is
to distinguish between the potentially creditable hazardous waste
pharmaceuticals awaiting determination within the reverse distribution
system versus the evaluated hazardous waste pharmaceuticals that will
not be sent to another reverse distributor for evaluation. Both are
considered hazardous waste pharmaceuticals, but they are managed
differently under this subpart.
    EPA is not aware of any reverse distributor that facilitates
manufacturer credit that also has interim status or a permit to treat
or dispose of hazardous waste on-site.\364\ Therefore, EPA anticipates
that reverse distributors eventually send all evaluated hazardous waste
pharmaceuticals off site for treatment and disposal.
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    \364\ Several DEA reverse distributors have RCRA interim status
or a permit to treat or dispose of hazardous waste, but these DEA
reverse distributors do not facilitate manufacturer credit.
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B. EPA's Rationale for Finalizing New RCRA Management Standards for
Reverse Distributors

    This final rule establishes standards for the management of both
potentially creditable hazardous waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals that reverse distributors receive and
manage. The management standards discussed in this section apply only
to reverse distributors of prescription pharmaceuticals that are