store, including hazardous waste pharmaceuticals, are not excluded
household wastes under RCRA and may not be placed in the DEA authorized
receptacle.\124\ Furthermore, states generally regulate non-hazardous
waste and 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 collection receptacles.
---------------------------------------------------------------------------

    \124\ DEA regulations also prohibits retail pharmacy stock/
inventory from being placed in the collection receptacle or mail-
back envelopes (see 21 CFR 1317.05(a)).
---------------------------------------------------------------------------

    Under this proposal, pharmaceuticals collected in DEA authorized
collection receptacles will continue to be excluded from regulation as
household hazardous waste, with some conditions. The Agency has a long-
standing recommendation that household hazardous waste collection
programs manage the collected waste as hazardous waste. We strongly
believe that if a program goes to the expense of collecting the waste,
including waste pharmaceuticals, it should manage the waste as
hazardous waste, rather than manage it as municipal solid waste, which
the household could do absent the collection program. However, the
current household waste exemption does not require an entity that hosts
a household hazardous waste collection event to manage the collected
waste as hazardous waste. Typically, the parties conducting household
hazardous waste collection events have been government entities--
municipalities and counties. It is relatively new that retail
pharmacies and others are becoming interested in performing this
function. To encourage this practice, while at the same time ensuring
that collection programs are managing the collected waste properly, we
are proposing that pharmaceuticals that are household hazardous waste
(i.e., ``household waste pharmaceuticals'') and are collected in DEA
authorized collection receptacles where they may be co-mingled \125\
with controlled substances continue to be excluded from RCRA
regulation, provided they are:
---------------------------------------------------------------------------

    \125\ DEA does not prohibit co-mingling of controlled substances
with non-controlled substances provided they are all then managed as
controlled substances.
---------------------------------------------------------------------------

    (1) Combusted at a municipal solid waste or hazardous waste
combustor, and
    (2) managed in accordance with all applicable DEA regulations (see
Sec.  266.506(a)(2)).The Agency solicits comments on all these
provisions.
    On a separate, but related matter, EPA has received a number of
inquiries about the exemption in the Clean Air Act regulations for
Other Solid Waste Incinerator (OSWI) ``units that combust contraband or
prohibited goods'' (see the exemption at 40 CFR 60.2887(p) for new
OSWIs and 40 CFR 60.2993(p) for existing OSWIs). As indicated in a
previous guidance memo, EPA does not consider pharmaceuticals,
voluntarily collected from ultimate users in a take-back program, to be
contraband or prohibited goods.\126\ Likewise, EPA will not consider
pharmaceuticals that are voluntarily dropped off at collection
receptacles to be contraband or prohibited goods. Therefore, the OSWI
exemption does not apply and law enforcement may not destroy
voluntarily collected pharmaceuticals in the same way that it is
allowed to destroy contraband or prohibited goods.
---------------------------------------------------------------------------

    \126\ Rudzinski to RCRA Division Directors, September 26, 2012,
RCRA Online #14833 http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/fcb11dd6f61d4b1685257afe005eb5ce!OpenDocument.
---------------------------------------------------------------------------

3. Management of Residues in Pharmaceutical Containers
    a. Regulatory background. Over the years, EPA has received numerous
inquiries regarding the regulatory status of various types of
containers that once held pharmaceuticals that are considered hazardous
waste when discarded because of the hazardous waste residue in the
containers. Stakeholders have been particularly concerned about
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 or accumulates more than 1 kg
of acute hazardous waste at any time.\127\ The current regulatory
status of acute and non-acute commercial chemical product residues
remaining in a container are specifically addressed in Sec.  261.33:
---------------------------------------------------------------------------

    \127\ 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). [emphasis added]
    According to Sec.  261.7(b)(1), there are two ways a container that
held a non-acute hazardous waste can be considered ``empty'':
    A container or an inner liner removed from a container that has
held any hazardous waste, except a waste that is a compressed gas or
that is identified as an acute hazardous waste listed in Sec.  261.31
or Sec.  261.33(e) of this chapter is empty if:
    (i) 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
    (ii) No more than 2.5 centimeters (one inch) of residue remain on
the bottom of the container or inner liner, or
    (iii)
    (A) 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
    (B) 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, if the container that held the non-acute hazardous waste
pharmaceutical does not have its contents removed by a commonly
employed practice and either has one inch or less of residue remaining
or has 3 percent or less by weight of the total capacity of the
container remaining,\128\ then the container is not considered ``RCRA
empty,'' even though the pharmaceutical may have been fully dispensed.
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). On the other hand, if the contents of the
container have been removed by a commonly employed

practice and either have one inch or less of residue remaining, or 3
percent or less of weight of the total capacity of the container
remaining, then the container is considered ``RCRA empty,'' and may be
managed as non-hazardous waste.
---------------------------------------------------------------------------

    \128\ We are assuming that containers that hold pharmaceuticals
are in containers less than 119 gallons in size.
---------------------------------------------------------------------------

    Likewise, according to Sec.  261.7(b)(3), there are three ways that
a container that held an acute hazardous waste can be considered
``empty'':
    A container or an inner liner removed from a container that has
held an acute hazardous waste listed in Sec. Sec.  261.31 or 261.33(e)
is ``empty'' if:
    (i) The container or inner liner has been triple rinsed using a
solvent capable of removing the commercial chemical product or
manufacturing chemical intermediate;
    (ii) 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
    (iii) 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.
    Therefore, 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 dispensed. 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 \129\ that provides three possible
regulatory approaches for generators:
---------------------------------------------------------------------------

    \129\ Rudzinski to RCRA Division Directors, November 11, 2011,
RCRA Online #14827 http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/57B21F2FE33735128525795F00610F0F/
$file/14827.pdf.
---------------------------------------------------------------------------

    (1) Count only the weight of the residue 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
and EPA indicated at the time that a more comprehensive solution would
require notice and public comment that occurs during a rulemaking. We
are proposing to amend the regulations that pertain to containers that
once held pharmaceuticals that are RCRA hazardous wastes. We are
proposing different regulatory solutions for different types of
containers found in healthcare settings. Specifically, we address the
following three types 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. If finalized, these new
regulations for pharmaceutical containers would replace the November
2011 guidance; however, in the meantime, the guidance remains in
effect.
    b. Unit-dose containers. First, with regard to unit-dose containers
and dispensing bottles and vials up to 1 liter or 1000 pills, we are
proposing a conditional exemption from the empty container regulations
of Sec.  261.7 for containers from which the pharmaceuticals have been
fully dispensed. Specifically, we are proposing that the removal of the
pharmaceuticals from the unit-dose containers, and dispensing bottles
and vials (up to 1 liter or 1000 pills), is equivalent to rendering the
container ``RCRA empty.'' Therefore, for containers that once held non-
acute hazardous wastes, it will not be necessary to measure the
remaining contents, and for containers that once held acute hazardous
wastes, it will not be necessary to triple-rinse the containers or
demonstrate an equivalent removal method. Rather, if the contents of
the container have been fully dispensed by removing all pharmaceuticals
that can be removed using the practices commonly employed to remove
materials from that type of container, the residues (and therefore the
container) may be disposed of as non-hazardous waste.
    We are proposing this conditional exemption for two reasons. First,
we want to eliminate the sewering of pharmaceuticals. We are
particularly concerned that in a healthcare setting, when containers
are triple rinsed, the rinsate will 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 municipal
solid waste management--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 range in size from a few milliliters (e.g., packaging
for nicotine gum, paper cups used to dispense pharmaceuticals to in-
patients) to a liter (e.g., bottles that hold bulk quantities of
pills). In rare circumstances, containers with pharmaceuticals are as
large as two or three liters (e.g., powders that are reconstituted with
water). This differs significantly from the 55-gallon drums that are
typically used in other sectors that generate hazardous waste.
Consequently, the amount of residues in the containers was anticipated
to be much more substantial than is the case for containers typically
used for pharmaceuticals.
    EPA has received data from three stakeholders demonstrating that
there is very little residue remaining in fully dispensed containers of
pharmaceuticals. In addition, EPA's ORD conducted similar research. The
results from each of the four sources are summarized below; the full
results are included in the docket for this proposed rulemaking (EPA-
HQ-RCRA-2007-0932).
    i. Consulting Firm. One stakeholder, with a hazardous medical
materials consulting firm, provided some laboratory testing. They had
the residues from single-unit dose packaging of four different P-listed
pharmaceuticals tested using gas chromatography/mass spectrometry (GC/
MS) and high performance liquid chromatography/ultraviolet detector
(HPLC/UV). The amount of active pharmaceutical ingredient in the
residues remaining in containers was quantified and the results from
containers that had been triple rinsed were compared with containers
that had not been triple rinsed. For the containers that were triple
rinsed, the active ingredient in the residues was non-detect in all
cases. For the containers that were not triple rinsed, the highest
level detected was 35.8 [mu]g (or 0.0358 mg). The laboratory results
submitted to EPA are summarized in Table 9; the full laboratory results
are included in the docket for this rulemaking (EPA-HQ-RCRA-2007-0932).

[GRAPHIC] [TIFF OMITTED] TP25SE15.006

    ii. Large Retailer. The second stakeholder that submitted data to
EPA was a large retailer. Their data provide the weight of active
pharmaceutical ingredient residues remaining in bulk containers (i.e.,
100-count) of various dosage strengths of warfarin. The residues were
quantified using HPLC-UV/Vis (high performance liquid chromatography/
ultraviolet/visible light detector). The data are summarized in Table
10; the full results submitted to EPA are included in the docket for
this proposed rulemaking (EPA-HQ-RCRA-2007-0932).
[GRAPHIC] [TIFF OMITTED] TP25SE15.007

    The results from each of the first two stakeholders reflect only
the weight of the active pharmaceutical ingredient, not the full weight
of the hazardous waste residues. Since it is the Agency's position that
it is the full weight of the hazardous waste residues and not just the
weight of the active pharmaceutical ingredients that must be counted in
determining generator status, we have used the results to calculate the
weight of the total residues. In the retailer's case, they have
informed EPA that a typical pill with a 10 mg dose of Coumadin (brand
name of warfarin) weighs 200 mg. The active ingredient represents 10
mg, or 5% of the weight of the pill, while 190 mg, or 95% of the weight
of the pill, consists of ingredients other than the active ingredient.
As indicated in Table 10, the average weight of warfarin residue
remaining in a fully dispensed bottle of the high dose of warfarin (10
mg) is 1.196 mg. If we assume that the residue in the container has the
same proportions of ingredients (i.e., 5% of the residue is warfarin
and 95% of the residue are other ingredients), then there would be an
average of 23.92 mg of total hazardous waste residue remaining in a
100-count bottle of 10 mg pills of warfarin. The amount of hazardous
waste residue remaining in a 100-count bottle of pills is very small
compared with the residue that would remain in a 55-gallon drum, which
is what the regulations for container residues envisaged.
    iii. Riverside County. The third stakeholder that provided data to
EPA was the Riverside County Department of Environmental Health,
Hazardous Materials Management Branch. The county received a grant from
the California Certified Unified Program Agency (CUPA) Forum Board to
conduct a study of residues remaining in pharmaceutical containers.
Researchers at the University of California, Riverside (UCR) conducted
the study and provided their results in a report to Riverside County
entitled, Residue Analysis of P-Listed Pharmaceutical Containers for
Warfarin and Nicotine. The results are summarized below, but UCR's full
results are in the docket for this proposed rulemaking (EPA-HQ-RCRA-
2007-0932).\130\
---------------------------------------------------------------------------

    \130\ See Exhibit 2 of the CUPA Forum Board Trust Fund Grant
Report submitted by the Riverside County Department of Environmental
Health at the conclusion of the grant.
---------------------------------------------------------------------------

    The intent of the study was to investigate the third regulatory
approach suggested in the November 2011 memo discussed previously. That

is, the study investigated whether the concentration of warfarin in the
residues of warfarin pill bottles was greater than 0.3% and therefore
met the listing criteria for P001 or whether the residues were at or
below 0.3% and therefore met the listing criteria for U248. Although
nicotine is not a concentration-based P-listing, packaging from
nicotine-containing products were also investigated to determine total
remaining residues.
    The researchers collected a total of 59 samples containers,
including 44 sample containers that had held warfarin pills but had
been fully dispensed and another 15 sample containers from nicotine-
containing products. The samples included warfarin and nicotine from
several manufacturers, in a range of dose strengths and in various
container types. The residues were solvent-extracted and then dried by
rotary evaporation to determine the total weight of residues.
Subsequently, the residues were re-dissolved in methanol and analyzed
using HPLC to determine the concentration of the active pharmaceutical
within the residues.
    The majority of warfarin containers were plastic bottles, but some
containers were blister packs and three samples were 30-pill blister
packs, sometimes referred to as a ``bingo card.'' The results indicate
that the concentration of the active pharmaceutical ingredient warfarin
in the residues in plastic bottles was usually over the 0.3%
concentration. However, the concentration of warfarin in the residues
on blister packs, including the 30-pack blister pack, was consistently
below 0.3%. Overall, in the majority of cases, the warfarin within the
residues was present at a high enough concentration to be considered
P001 (33 of 44 samples, 75 percent of the samples).
    However, the results also confirm the results from the first two
stakeholders. That is, the total weight of residues remaining in the
containers after they were emptied of the warfarin pills is negligible.
For the plastic bottles, the total weight of residue ranged from 4.3-
82.3 mg. For the single-dose blister packs, the total weight of residue
ranged from 3.5-7.6 mg. And for the 30-pack blister pack, the total
weight ranged from 134.8-273 mg. Taking the smallest amount of residue
of 3.5 mg, it would take close to 300,000 containers per month to
exceed the 1 kg threshold to be an LQG. Even on the conservative side,
taking the largest amount of residue of 273 mg, it would take close to
4000 containers per month to exceed the 1 kg threshold to be an LQG.
    The results for nicotine residues were similar. For containers of
gum and patches, the weight of total residues ranged from 9-111.2 mg,
although the two containers of liquid nicotine solution contained more
residues--1301 and 1616 mg. Although nicotine is not a concentration-
based listing, it is worth noting that the active pharmaceutical
ingredient of nicotine in the residues was below the quantifiable limit
of 1.5 [mu]g/ml in 8 of the 15 samples and for the other 7 samples, the
concentration of nicotine ranged from 0.01-0.09%.
    iv. EPA's Office of Research and Development. Finally, EPA's ORD
conducted an analysis to evaluate whether simply removing a drug from
the container is equivalent to triple rinsing the container. ORD's
results are summarized in Table 11, but the Final Project Report
containing the full results is in the docket for this proposed
rulemaking (EPA-HQ-RCRA-2007-0932). ORD analyzed three different P-
listed pharmaceuticals: Warfarin, nicotine and physostigmine
salicylate. Table 11 lists the 18 different combinations of active
pharmaceutical ingredients, form, dosage strengths and packaging
combinations that ORD analyzed.

                            Table 11--Pharmaceutical Combinations Tested by EPA's ORD
----------------------------------------------------------------------------------------------------------------
     Active pharmaceutical        Manufacturer/Brand
          ingredient                     name                Form             Dosage           Packaging type
----------------------------------------------------------------------------------------------------------------
Warfarin......................  Taro Pharmaceutical    Tablet..........  1 mg............  Plastic bottle.
                                 Industries, Ltd..     Tablet..........  5 mg............  Plastic bottle.
                                                       Tablet..........  10 mg...........  Plastic bottle.
                                                       Tablet..........  2 mg............  Single-dose blister
                                                                                pack.
                                Upsher-Smith/Jantoven  Tablet..........  1 mg............  Single-dose blister
                                                       Tablet..........  10 mg...........   pack
                                                                                Single-dose blister
                                                                                pack.
Nicotine......................  GlaxoSmithKline/       Gum.............  2 mg............  Single-dose blister
                                 Nicorette.            Gum.............  4 mg............   pack.
                                                                                Single-dose blister
                                                                                pack.
                                Rugby Laboratories...  Gum.............  2 mg............  Single-dose blister
                                                       Gum.............  4 mg............   pack.
                                                                                Single-dose blister
                                                                                pack.
                                GlaxoSmithKline/       Lozenge.........  2 mg............  Plastic vial
                                 Nicorette.            Lozenge.........  4 mg............  Plastic vial.
                                Rugby Laboratories...  Patch...........  7 mg............  Peel-off plastic.
                                Habitrol.............  Patch...........  14 mg...........  Peel-off plastic.
                                Rugby Laboratories...  Patch...........  21 mg...........  Peel-off plastic.
                                Pfizer/Nicotrol......  Spray...........  10 mg/ml........  Glass vial.
                                                       Inhaler.........  10 mg...........  Plastic container.
Physostigmine Salicylate......  Akron Inc............  Liquid..........  1 mg/ml.........  Glass ampoule.
----------------------------------------------------------------------------------------------------------------

    All combinations in Table 11 were analyzed in triplicate using the
following three-step approach:
    (1) After removing the tablets, gum, lozenges, etc from the
containers, the amount of total residuals remaining in the container
was determined using a sensitive balance to weigh the container before
and after triple rinsing,
    (2) The ``maximum possible weight of residual drug/total residual/
container'' was calculated for each compound and packaging combination.
This calculated result was used to infer a theoretical upper limit for
the amount of active pharmaceutical compound in the total residue
remaining in the container, and
    (3) Thermal gravimetric analysis (TGA) was used to qualitatively
evaluate the presence of active pharmaceutical ingredient in the
residuals removed from the containers before and after triple-rinsing.
    With respect to the weight of the remaining residuals in the
containers, ORD's results are similar to the results

from the first three sources. That is, the weight of the total
residuals remaining in the packaging of P-listed pharmaceuticals is
minimal. For single-dose blister packs, lozenge vials and the peel-off
plastic from nicotine patches the weight of the residuals was
negligible and within the range of error of the balance, but all
results were below 0.0002 grams. For plastic containers that held
tablets, the weight of residuals were higher, but still very low,
ranging from 0.0152-0.0157 grams. For containers that held liquids, the
weight of residuals was the highest, but still very low, ranging from
0.0472 grams for glass vials of nicotine spray, to 0.0651 grams for
glass ampoules that held liquid physostigmine salicylate. The residuals
in the nicotine inhaler were not experimentally determined; rather, the
manufacturer (Pfizer) states on the packaging that the 10 mg cartridge
delivers a 4 mg dose, so the residuals are assumed to be 6 mg (or 0.006
grams).\131\
---------------------------------------------------------------------------

    \131\ Optimizing drug dose is a major factor in improving the
sustainability of healthcare. The prescriber needs to be cognizant
that prescribed treatments can have unanticipated, collateral
impacts that reach far beyond the healthcare setting. See: Daughton
and Ruhoy, Lower-dose prescribing: Minimizing ``side effects'' of
pharmaceuticals on society and the environment; Sci Total Environ,
443(2013), pp. 324-336, which presents a critical examination of the
multi-faceted potential role of drug dose in reducing the ambient
levels of APIs in the environment and in reducing the incidence of
drug wastage, which ultimately necessitates disposal of leftovers.
(http://sciencedirect.com/science/article/pii/S004896712013927#)
---------------------------------------------------------------------------

    Unlike the quantitative results from the HPLC analyses from outside
stakeholders, the results from the TGA are qualitative only. That is,
the TGA was only intended to evaluate the presence of the API and
compare the results from containers that had been triple rinsed with
those that had not been triple rinsed. Using TGA, the API was not
detected in the residuals, with one exception: The liquid nasal spray
(note that TGA was not used on the nicotine inhaler residuals). In most
cases, the TGA detected other, unspecified ingredients in the
residuals, but not the active pharmaceutical ingredient on the P-list.
The total weight of the residues was well under a gram and the active
pharmaceutical ingredient is a small proportion of the total weight of
the tablet, gum, etc. As a result, with the exception of the nicotine
nasal spray, the TGA was not sensitive enough to detect the presence of
the active pharmaceutical ingredient, regardless of whether the
container had been triple rinsed or not.
    EPA is aware that there are certain limitations with the data from
the four sources. For instance, in the case of the consulting firm, no
replicate samples were tested. In the case of the retailer, only
warfarin residues were tested. However, given the size of the
containers involved and the nominal quantities of residues involved,
the Agency is proposing to allow the residues in single-unit dose
containers/packaging and dispensing bottles, vials and ampules that
once held pharmaceuticals to be managed as non-hazardous waste
pharmaceuticals provided the pharmaceutical product has been fully
dispensed (e.g., all pills have been removed). EPA is soliciting
comment on whether these studies are representative of the spectrum of
formulations and containers that might be encountered.
    Finally, we note that the Agency is concerned about the potential
for diversion of the pharmaceutical containers that may occur when the
pharmaceutical residues and containers are discarded in the municipal
waste stream. In such instances, we are concerned that the containers
could be diverted from the municipal waste stream and used for illicit
purposes, such as packaging counterfeit pharmaceuticals. Therefore, EPA
is proposing that ``RCRA empty'' pharmaceutical containers that are
original pharmaceutical packages (and therefore are 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. The means of destruction could include crushing or shredding
the container. We do not believe that simply defacing the label would
be sufficient to avoid diversion, since labels could be replaced if the
container is intact.
    We request comment on these proposed provisions, including whether
it is necessary to limit the size of the dispensing bottle to which
this provision would apply. In our observation, EPA has rarely seen
pharmaceutical dispensing bottles that are larger than 1000-count,
which are approximately 1 liter in size. EPA requests 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 apply. We also seek comment as to whether ``RCRA empty''
pharmaceutical containers that are the original pharmaceutical packages
should be destroyed prior to placing them in the trash.
    c. Dispensed syringes. With regard to dispensed syringes, EPA is
proposing a conditional exemption for syringes that have been used to
administer pharmaceuticals that are listed or characteristic hazardous
waste when discarded. The residues remaining in a dispensed syringe
would not be regulated as hazardous waste provided the syringe has been
used to administer a pharmaceutical to a patient and the syringe is
placed in a sharps container (if appropriate) and is managed in
accordance with all applicable state and federal medical waste
regulations. This would apply to syringes used to administer
pharmaceuticals that are P- or U-listed, or exhibit a hazardous waste
characteristic.
    EPA issued guidance regarding the regulatory status of residues in
syringes in December 1994 \132\ and April 2008.\133\ In the December
1994 RCRA/Superfund Hotline Q&A about whether epinephrine 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.'' \134\
---------------------------------------------------------------------------

    \132\ December 1994, RCRA Online #13718 http://yosemite.epa.gov/
osw/rcra.nsf/0c994248c239947e85256d090071175f/
1C1DEB3648A62A868525670F006BCCD2/$file/13718.pdf.
    \133\ Memo from Dellinger to Chilcott, April 14, 2008, RCRA
Online #14788 http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/6A5DEDF2FBA24FE68525744B0045B4AF/
$file/14788.pdf.
    \134\ 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)
---------------------------------------------------------------------------

    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. This proposed conditional
exemption for syringes, in large part, would maintain the existing
interpretation. The primary difference is that under the proposed
conditional exemption, healthcare facilities would not be required to
determine if the residues in the syringes meet a listing description or
exhibit a hazardous waste characteristic.

    EPA believes this conditional exemption is important to minimize
the potential for exposures to healthcare workers, which can happen if
they are accidentally stuck with a needle. Typically, sharps containers
are more readily available to a medical practitioner than a hazardous
waste container. Therefore, the used syringe will be discarded more
quickly into a sharps container and there will be less opportunity for
accidental sticks to occur en route to disposing the sharp.
    However, we also note that syringes in sharps containers are
typically autoclaved prior to disposal. EPA is concerned 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.\135\ EPA
seeks comment on the extent of risks associated with autoclaving
hazardous waste residues leftover in syringes and whether it is
necessary to place a limit on the volume of residue or the volume of
the syringe to which this conditional exemption would apply or whether
any other conditions would be appropriate. For instance, stakeholders
have informed us that they will squirt the residues remaining in a
syringe onto a gauze pad prior to placing the syringe in the sharps
container. Then, if the residues on the gauze pad are hazardous waste,
the gauze pad is managed as hazardous waste, while allowing the syringe
to be fully dispensed before placing it in the sharps container. In
EPA's view, this method of managing excess residues is preferred over
another practice that is commonly used: The disposal of excess residues
down the drain.
---------------------------------------------------------------------------

    \135\ Daughton CG, Drugs and the Environment: Stewardship &
Sustainability, National Exposure Research Laboratory, Environmental
Sciences Division, U.S. EPA, Las Vegas, NV; NERL-LV-ES 10/081, EPA/
600/R-10/106; September 2010 (http://www.epa.gov/nerlesd1/bios/daughton/APM200-2010.pdf.)
---------------------------------------------------------------------------

    d. Other containers, including delivery devices. With regard to
other containers, including delivery devices, EPA is proposing that the
residues remaining in unused or used containers (such as IV bags and
tubing, inhalers, aerosols, nebulizers, tubes of ointment, gels, or
creams) would be regulated as hazardous waste if the residues are a P-
or U-listed hazardous waste or exhibit a hazardous waste
characteristic. In some cases, such as with IV bags, the volume of
hazardous waste is much larger than with residues contained in syringes
or unit-dose containers. Stakeholders have stated that it is common
practice for the leftover contents of IV bags and tubing to be emptied
into a sink, which is a practice we are striving to eliminate. It is
extremely difficult to determine how much residue remains in tubes of
ointment, gel or cream. In the case of aerosols, it would be
inadvisable to remove the contents of the container. Since hazardous
waste pharmaceuticals managed under this proposed rule would not be
counted towards a facility's generator category, managing these
residues and containers as hazardous waste under proposed 40 CFR part
266, subpart P should not pose the same burden that generators
currently face with keeping track of the monthly amount of residues in
containers that are not ``RCRA empty.'' Further, comments on the 2008
Pharmaceutical Universal Waste proposal indicated that stakeholders
prefer clear distinctions in regulating the hazardous waste from
healthcare facilities and this proposed standard for container residues
responds to that comment. EPA seeks comment on whether these proposed
provisions address stakeholder concerns, while protecting human health
and the environment.

F. What are the proposed standards for shipping hazardous waste
pharmaceuticals?

1. Shipping Standards for Non-Creditable Hazardous Waste
Pharmaceuticals and Evaluated Hazardous Waste Pharmaceuticals to
Treatment, Storage, and Disposal Facilities
a. Shipping Standards for Non-Creditable Hazardous Waste
Pharmaceuticals From Healthcare Facilities to TSDFs
    Typically, hazardous waste pharmaceuticals generated in a
healthcare facility fall into two categories: (1) Non-creditable (e.g.,
patient care) hazardous waste pharmaceuticals and (2) potentially
creditable hazardous waste pharmaceuticals. This section discusses the
proposed requirements for shipping of non-creditable, patient care/
floor hazardous waste pharmaceuticals. For information regarding the
shipment of potentially creditable hazardous waste pharmaceuticals from
healthcare facilities and pharmaceutical reverse distributors, see
Section V.F.2 of the preamble.
    Generally, patient care/floor 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, patient care/floor hazardous waste
pharmaceuticals cannot receive manufacturer's credit and therefore may
not be shipped to a reverse distributor. EPA is proposing that patient
care/floor hazardous waste pharmaceuticals generated at healthcare
facilities, when shipped off-site, must be shipped to a designated
facility (i.e., an interim status or permitted hazardous waste TSDF),
as currently required (unless the healthcare facility has interim
status or a RCRA permit to store or treat hazardous waste).
Specifically, EPA proposes that non-creditable hazardous waste
pharmaceuticals must continue to comply with the existing 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 tracked with a hazardous waste
manifest. However, to avoid unnecessarily burdening the healthcare
facility staff, who are unfamiliar with RCRA, EPA proposes 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 is proposing that the words, ``hazardous waste
pharmaceuticals'' must be entered in the ``special handling and
additional information'' box on the manifest (box # 14). All existing
RCRA recordkeeping requirements regarding hazardous waste manifesting
continue to apply, (see Section V.C.12), as well as all applicable DOT
shipping requirements. EPA requests comment on this proposed approach
for manifesting non-creditable hazardous waste pharmaceuticals from a
healthcare facility.
b. Shipping Standards for Evaluated Hazardous Waste Pharmaceuticals
From Pharmaceutical Reverse Distributors to TSDFs
    For pharmaceutical reverse distributors, once potentially
creditable hazardous waste pharmaceuticals have been deemed non-
creditable or credit has been issued and they do not require any
additional verification of credit, EPA is proposing 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 is proposing that they must be shipped in
accordance

with the existing pre-transport requirements for packaging, labeling
and marking, and that evaluated hazardous waste pharmaceuticals must be
shipped via a hazardous waste transporter using a hazardous waste
manifest 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
believes that 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 issued and
verified, the potential for mismanagement is greater. This is because
the pharmaceuticals have lost their 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 is proposing that the pharmaceutical reverse distributor list
the appropriate hazardous waste codes on the manifest (even though the
healthcare facility is not required to provide such information to the
reverse distributor). Hazardous waste pharmaceuticals received by
pharmaceutical reverse distributors are in their original packaging
with their label, so the information to determine the appropriate
hazardous waste codes should be readily available. 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 workers
lack. As described in Section V.G.3 (pharmaceutical reverse distributor
management standards), reverse distributors must keep copies of
hazardous waste manifests for three years from the date of shipment.
    EPA requests comment regarding the proposed manifest and
transportation requirements for non-creditable hazardous waste
pharmaceuticals from healthcare facilities and evaluated hazardous
waste pharmaceuticals from pharmaceutical reverse distributors.
c. Importing/Exporting Non-Creditable or Evaluated Hazardous Waste
Pharmaceuticals
    Under the existing regulations, a healthcare facility or
pharmaceutical 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
F. This proposal does not change the regulations as they apply to the
import of non-creditable or evaluated hazardous waste pharmaceuticals.
Likewise, under existing regulations, a healthcare facility or
pharmaceutical reverse distributor may not export (non-creditable or
evaluated) hazardous waste pharmaceuticals unless it complies with
requirements for exporting hazardous waste in 40 CFR part 262, subpart
E. This proposal also does not change the regulations as they apply to
the export of (non-creditable or evaluated) hazardous waste
pharmaceuticals.\136\
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    \136\ The Controlled Substances Import and Export Act prohibits
controlled substances from being imported or exported unless
permitted by DEA, even when the controlled substances are wastes.
See 21 U.S.C. 952 and 953.
---------------------------------------------------------------------------

    EPA requests 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 does 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 request comment on whether
this is the case.
2. Shipping Standards for Potentially Creditable Hazardous Waste
Pharmaceuticals
    This section discusses the proposed requirements for shipping
potentially creditable hazardous waste pharmaceuticals from healthcare
facilities to pharmaceutical reverse distributors and between
pharmaceutical reverse distributors. The return of potentially
creditable pharmaceuticals (hazardous and non-hazardous) to reverse
distributors 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,\137\ pharmaceutical reverse
distributors explained various scenarios that require extra shipping
steps. For example, a healthcare facility typically sends
pharmaceuticals to the reverse distributor with which it has a
contract. However, some manufacturers will only provide manufacturer's
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's credit to be given to the healthcare facility. In
some cases, a pharmaceutical manufacturer may require the reverse
distributor to ship the returned pharmaceuticals to the manufacturer so
that the manufacturer itself can verify pharmaceutical amounts and
credits. The estimate of the amount of pharmaceuticals transported from
reverse distributors to manufacturers for verification varies. Based on
our request for information, reverse distributors have indicated that
the percent of potentially creditable pharmaceuticals transported to
manufacturers ranged from an estimated 25 percent to 93 percent,
depending on the contractual agreement between the reverse distributor
and the manufacturer. Both of the scenarios described previously happen
routinely and are part of the business of returning pharmaceuticals to
reverse distributors (including manufacturers) for manufacturer's
credit.
---------------------------------------------------------------------------

    \137\ EPA sent nine pharmaceutical reverse distributors a letter
asking for more information about their business practices in an
effort to more fully understand reverse distribution of
pharmaceuticals. The seven responses representing the views of eight
reverse distributors can be found in the docket of this proposed
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    As explained in Section V.D.1, EPA is proposing that
pharmaceuticals transported to pharmaceutical reverse distributors for
credit are solid wastes, some of which will also be considered
hazardous wastes. Under the current RCRA Subtitle C 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 wastes pharmaceuticals during
accumulation and transport are 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.\138\
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 V.D.2.). 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.
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    \138\ Pharmaceutical Universal Waste proposal, 73 FR 73529;
December 2, 2008.
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    Due to the low risk of release to the environment described
previously, EPA is proposing to allow potentially creditable hazardous
waste pharmaceuticals to be shipped without a hazardous waste manifest
and without the use of hazardous waste transporters. However, this
exemption from manifesting and use of hazardous wastes transporters
only applies if the healthcare facility is sending potentially
creditable hazardous waste pharmaceuticals to a pharmaceutical reverse
distributor, or if a pharmaceutical reverse distributor is sending
potentially creditable hazardous waste pharmaceuticals to another
pharmaceutical reverse distributor. Further, DOT shipping requirements
continue to apply to shipments of potentially creditable hazardous
waste pharmaceuticals.
    In lieu of requiring a hazardous waste manifest and the use of
hazardous waste transporters, EPA is proposing an alternate type of
tracking for potentially creditable hazardous waste pharmaceuticals--
with two requirements. First, for each shipment, healthcare facilities
and pharmaceutical reverse distributors must provide in writing (via
letter or electronic communication), advance notice of the shipment to
the pharmaceutical reverse distributor. Second, for each shipment, the
receiving pharmaceutical reverse distributors must provide confirmation
to the healthcare facility or pharmaceutical reverse distributor that
initiated the shipment that the shipment of potentially creditable
hazardous waste pharmaceuticals has arrived. One way to comply with
this requirement would be for the receiving reverse distributor to
require the healthcare facility or pharmaceutical reverse distributor
that initiates the shipment of potentially creditable hazardous waste
pharmaceuticals to utilize some form of ``delivery confirmation''
mechanism that is provided by the shipper that confirms that a shipment
to a reverse distributor has reached its destination and is under the
custody and control of the recipient (e.g. delivery confirmation
tracking with return receipt). This ``delivery confirmation'' notice
can be paper-based or electronic. As part of the delivery confirmation
system, a signature (paper or electronic) or other confirmation from a
representative of the receiving pharmaceutical reverse distributor
would be required. The signature by the pharmaceutical reverse
distributor would provide assurance that the shipment was received by
the reverse distributor. Without the signature or other confirmation of
a representative of the pharmaceutical reverse distributor, it is
possible for the shipper to state that delivery to the location has
occurred, but it would not necessarily indicate that the recipient was
there to receive the shipment. This proposed requirement is in direct
response to concerns expressed by commenters over the lack of tracking
of pharmaceuticals in the 2008 Pharmaceutical Universal Waste proposal.
    Alternatively, EPA has learned that some stakeholders use bar-
coding on the pharmaceuticals or on the boxes to track shipments. The
barcodes contain detailed information, including the exact quantities
and types of pharmaceuticals included in the shipment. Typically, when
a reverse distributor receives a barcoded shipment, it will scan in the
shipment and the sender will receive electronic notification that the
shipment has arrived. This type of bar-code tracking would meet the
delivery confirmation requirement of this proposed rule, but other
mechanisms of ``delivery confirmation'' that are offered by common
carriers, such as the U.S. Postal Service, FedEx or United Parcel
Service (UPS), would also be acceptable.
    Under this proposal, healthcare facilities and reverse distributors
may use common carriers, such as the U.S. Postal Service, United Parcel
Service, or FedEx \139\ for shipments of potentially creditable
hazardous waste pharmaceuticals to and between pharmaceutical reverse
distributors. EPA believes that common carriers are able to provide
safe shipment since these potentially creditable hazardous waste
pharmaceuticals present low transportation risk. We note that
healthcare facilities and pharmaceutical reverse distributors must meet
the applicable Pipeline and Hazardous Materials Safety Administration
(PHMSA) Hazardous Materials Regulation (HMR; 49 CFR parts 171-180)
shipping requirements, including preparing proper shipping papers when
shipping potentially creditable hazardous waste pharmaceuticals. A RCRA
hazardous waste that does not meet DOT hazard classes 1-8 in the HMR,
are only Class 9 hazardous materials when defined as a RCRA hazardous
wastes that requires a manifest. As a result, the DOT shipping
requirements will apply when potentially creditable hazardous waste
pharmaceuticals are shipped to pharmaceutical reverse distributors only
when the hazardous wastes are DOT class 1-8 hazardous materials.
---------------------------------------------------------------------------

    \139\ Note EPA is not endorsing the use of any of the shipping
companies cited.
---------------------------------------------------------------------------

    EPA notes that a pharmaceutical reverse distributor is not required
to sort 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 sorted, the
pharmaceutical reverse distributor must follow the tracking procedures
in this proposal for the entire shipment. On the other hand, if a
pharmaceutical reverse distributor chooses to sort the potentially
creditable hazardous waste pharmaceuticals from the creditable 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
proposed standards. EPA asks for comment on whether the proposed
tracking system and controls are sufficient to protect human health and
the environment.
a. What Happens if a Healthcare Facility or Pharmaceutical Reverse
Distributor Initiates a Shipment and Does Not Get Confirmation of
Delivery?
    If a healthcare facility or pharmaceutical reverse distributor
initiates a shipment of potentially creditable hazardous waste
pharmaceuticals to a reverse distributor and does not receive delivery
confirmation from the intended recipient within seven calendar days,
EPA is proposing that the healthcare facility or pharmaceutical 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 requests comment on whether any additional
requirements, such as reporting to the implementing agency, are
necessary in such cases.
b. Importing/Exporting Potentially Creditable Hazardous Waste
Pharmaceuticals
    If a healthcare facility or pharmaceutical reverse distributor
imports potentially creditable hazardous waste pharmaceuticals, then it
must comply with the proposed requirements for the shipment of
potentially creditable hazardous waste pharmaceuticals. The proposed
requirements would be in lieu of those for manifested hazardous waste
imports found at 40 CFR part 262, subpart F. EPA requests comment on
whether potentially creditable hazardous waste pharmaceuticals are
imported into the U.S. and, if so, how they are currently declared to
customs when imported.
    If a healthcare facility or pharmaceutical reverse distributor
exports potentially creditable hazardous waste pharmaceuticals then 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.\140\
---------------------------------------------------------------------------

    \140\ The Controlled Substances Import and Export Act prohibits
controlled substances from being imported or exported unless
permitted by DEA, even when the controlled substances are wastes.
See 21 U.S.C. 952 and 953.
---------------------------------------------------------------------------

c. Recordkeeping for Shipments of Potentially Creditable Hazardous
Waste Pharmaceuticals
    EPA is proposing to require healthcare facilities and reverse
distributors to keep records of the shipments of potentially creditable
hazardous waste pharmaceuticals to reverse distributors. Specifically,
we are proposing that healthcare facilities and reverse distributors
that initiate a shipment to another pharmaceutical reverse distributor
keep (1) records of advance notification regarding shipments of
potentially creditable hazardous waste pharmaceuticals, (2) shipping
papers, and (3) confirmation of receipt of shipment for three years
after the shipment was initiated. These records are necessary to ensure
that potentially creditable hazardous waste pharmaceuticals are
reaching their intended destination and not diverted. In most cases,
retaining records for 3 years should be sufficient for inspection
purposes; however, we are proposing that the periods of retention are
automatically extended during unresolved enforcement activity, or at
the request of the EPA Regional Administrator. The Agency seeks comment
on whether additional recordkeeping is necessary to document the cases
when the pharmaceutical reverse distributor does not receive a shipment
of potentially creditable pharmaceuticals within 7 calendar days and
the steps must be taken to locate the shipment.

G. What are the proposed standards for pharmaceutical reverse
distributors?

1. Background on Pharmaceutical Reverse Distributor Operations
    Pharmaceutical 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 and EPA site visits, EPA's
understanding is that when a pharmaceutical 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' return goods policies, the pharmaceutical reverse
distributors determine which potentially creditable hazardous waste
pharmaceuticals can be credited, as well as which must be sent on to
another reverse distributor for completion of the crediting process.
    In many cases, there is more than one reverse distributor involved
in establishing and verifying manufacturer's 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 pharmaceutical 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 pharmaceutical reverse distributor
sends the returned pharmaceutical on to the reverse distributor that
has a contract with the pharmaceutical manufacturer in order to
facilitate the credit process.
    Because manufacturers' return goods policies change over time,
sometimes a pharmaceutical reverse distributor receives a potentially
creditable hazardous waste pharmaceutical that is not eligible for
credit immediately, and the pharmaceutical reverse distributor retains
the potentially creditable hazardous waste pharmaceutical on-site until
it is credit eligible. EPA requests comment on how often this happens
and how long the potentially creditable hazardous waste pharmaceuticals
are kept on-site at reverse distributors to await changes in
manufacturers' return goods policies.
    In some cases, even after the pharmaceutical reverse distributor
has awarded credit, a pharmaceutical manufacturer may request that the
hazardous waste pharmaceuticals be transported back to the manufacturer
to inventory and verify the amount of pharmaceuticals and credit. In
developing this proposed rule, EPA considered all of the previous
scenarios as part of the crediting process.
    On the other hand, if the potentially creditable hazardous waste
pharmaceuticals are not sent onward to another pharmaceutical reverse
distributor, the pharmaceutical reverse distributor awards the
manufacturer's credit to the healthcare facility and then manages the
hazardous waste pharmaceuticals on-site until they are sent off-site
for treatment and disposal. As discussed previously in this proposal,
after a potentially creditable hazardous waste pharmaceutical has been
evaluated and either credited or deemed non-creditable and no
additional pharmaceutical reverse distributors will be involved in the
crediting process, EPA proposes to use 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 credited and non-
creditable hazardous waste pharmaceuticals that have been through the
reverse distributor process and are destined to be managed by a
permitted or interim status TSDF. Both are considered hazardous waste
pharmaceuticals, but they are managed differently under the proposed
regulations.
    EPA is not aware of any pharmaceutical reverse distributors that
facilitate manufacturer's credit that also has interim status or a
permit to treat or dispose of hazardous waste on-site. Therefore, EPA
anticipates that pharmaceutical reverse distributors eventually send
all evaluated hazardous waste pharmaceuticals off-site for

treatment and disposal. EPA requests comment on whether the processes
described previously are representative of the pharmaceutical reverse
distribution process.
2. EPA's Rationale for Proposing New RCRA Management Standards for
Pharmaceutical Reverse Distributors
    This proposed rule is establishing standards for the management of
both potentially creditable hazardous waste pharmaceuticals and
evaluated hazardous waste pharmaceuticals that pharmaceutical reverse
distributors receive and manage. The Agency notes that the management
standards discussed in this section apply only to reverse distributors
of potentially creditable hazardous waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals and do not apply to reverse
distribution or reverse logistics systems that may exist for other
consumer products.
    The current federal RCRA hazardous waste regulations at 40 CFR part
262 provide that only RCRA- permitted and interim status TSDFs may
receive hazardous waste from off-site for treatment, storage, or
disposal. However, the Agency does not believe it is necessary for
pharmaceutical reverse distributors to obtain permits or have interim
status to store hazardous waste pharmaceuticals in order to protect
human health and the environment. Thus, EPA proposes a new category
under RCRA called a ``pharmaceutical reverse distributor,'' which we
proposed to define as any person that receives and accumulates
potentially creditable hazardous waste pharmaceuticals for the purpose
of facilitating or verifying manufacturer's credit. The definition
specifies that any person, including forward distributors and
pharmaceutical manufacturers, which processes pharmaceuticals for the
facilitation or verification of manufacturer's credit is considered a
pharmaceutical reverse distributor. EPA is proposing that
pharmaceutical reverse distributors are not required to have interim
status or a RCRA permit to accumulate hazardous waste pharmaceuticals
and they may only accept potentially creditable hazardous waste
pharmaceuticals from off-site provided they comply with the proposed
standards in this rule. Pharmaceutical reverse distributors may not
treat or dispose of hazardous waste on-site unless authorized to do so
as a RCRA-permitted or interim status TSDF.
    As discussed previously, EPA's existing interpretation allows
pharmaceutical reverse distributors to be generators of hazardous waste
pharmaceuticals after a decision is made about whether the
pharmaceuticals will be repurposed. As a generator, a pharmaceutical
reverse distributor currently must comply with the LQG, SQG, or CESQG
generator requirements, depending on the total volume of hazardous
waste generated in a calendar month. Some smaller pharmaceutical
reverse distributors might stay under the hazardous waste quantity
limits for CESQGs, which would mean that under the federal RCRA
requirements, these CESQG pharmaceutical reverse distributors would not
have to notify EPA as a generator and their hazardous waste
pharmaceuticals could be disposed of with municipal and non-municipal
solid waste (see Sec.  261.5). However, the Agency has concerns with
CESQG pharmaceutical reverse distributors not notifying EPA that they
are managing hazardous waste. EPA is even more concerned about
pharmaceutical reverse distributors that currently qualify as CESQGs
placing the hazardous waste pharmaceuticals into the municipal and non-
municipal solid waste stream and sending them to non-hazardous waste
landfills. Some limited studies have shown active pharmaceutical
ingredients present in landfill leachate that is collected in municipal
solid waste landfill leachate systems.141 142 Landfill
leachate is generally transported to a wastewater treatment plant to be
treated before discharge; however, some pharmaceutical compounds pass
through treatment and are discharged, becoming a potential contributor
of the pharmaceutical compounds detected in our nation's waters.
---------------------------------------------------------------------------

    \141\ Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio,
M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and Barber, L. B.
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants
Within a Leachate Plume Downgradient of a Municipal Landfill.
Groundwater Monitoring & Remediation, 24: 119-126.
    \142\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T.,
Zaugg, S.D., and Meyer, M.T. (2009), Waste-Indicator and
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental
Contamination and Toxicology, 82.6:635-659.
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    EPA is proposing to revise its position regarding potentially
creditable hazardous waste pharmaceuticals, such that they will be
first considered discarded at the healthcare facilities, not at the
reverse distributors. This revision is based on new information
demonstrating to EPA that pharmaceuticals returned to a reverse
distributor are rarely, if ever, recycled or reused, and therefore the
decision to send a potentially creditable hazardous waste
pharmaceutical to a pharmaceutical reverse distributor is a decision to
discard the pharmaceutical (as discussed previously in Section V.D.1).
Other comments on the December 2008 Pharmaceutical Universal Waste
proposal indicated that notification to EPA by pharmaceutical reverse
distributors and tracking of shipments of potentially creditable
hazardous waste pharmaceuticals are critical and must be included in
any regulatory scheme to ensure the safe management of potentially
creditable hazardous waste pharmaceuticals.
    As previously discussed, only between 2-6 percent of the
potentially creditable hazardous wastes that are received by
pharmaceutical reverse distributors are listed or characteristic
hazardous wastes.\143\ Therefore, the vast majority of the potentially
creditable pharmaceutical waste that a pharmaceutical reverse
distributor receives is not considered a characteristic or listed
hazardous waste pharmaceutical under the existing definition of
hazardous waste. This stands in contrast to a typical TSDF, which
primarily manages hazardous waste. As a result, a pharmaceutical
reverse distributor generally manages a smaller volume of hazardous
waste than a typical permitted TSDF.
---------------------------------------------------------------------------

    \143\ See EPA's request of information from reverse
distributors, as well as their responses to EPA in the docket for
this rulemaking: EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    In addition, because the pharmaceuticals in the reverse
distribution system are receiving credit, they are moved through the
system efficiently. In fact, one national pharmacy retail chain
informed EPA that the value of the credit they receive from
manufacturers for returned pharmaceuticals is approximately $1 billion
a year.\144\ Healthcare facilities and reverse distributors have a
vested interest in having potentially creditable hazardous waste
pharmaceuticals processed and credited quickly and managed
appropriately so money is not lost in the process.
---------------------------------------------------------------------------

    \144\ Meeting with representatives from CVS/Caremark (November
8, 2012); see the docket for meeting notes (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Furthermore, potentially creditable hazardous waste pharmaceuticals
generally present a low risk of release to the environment as they
typically are still in the manufacturer's packaging. Since there is a
low human health and environmental risk of release associated with the
low volumes of potentially creditable hazardous waste pharmaceuticals
shipped to reverse distributors for crediting purposes, and because EPA
is not aware of any incidents of mismanagement resulting

in environmental harm or releases of hazardous waste pharmaceuticals by
reverse distributors, EPA believes that is not necessary to require
reverse distributors to obtain RCRA hazardous waste storage permits
with respect to typical reverse distribution operations, such as
receiving, sorting, consolidating, and reshipping potentially
creditable hazardous waste pharmaceuticals.
    Thus, EPA is proposing to take a ``middle-of-the-road'' approach to
regulating pharmaceutical reverse distributors by regarding them as a
new type of RCRA hazardous waste entity--a pharmaceutical reverse
distributor. This proposed approach addresses comments that EPA
received on the December 2008 Pharmaceutical Universal Waste proposal
and reflects EPA's proposed revised interpretation that the point of
generation for potentially creditable hazardous waste pharmaceuticals
is at the healthcare facility, not the reverse distributor.
    EPA proposes to establish management standards for pharmaceutical
reverse distributors in 40 CFR part 266, subpart P. These entities
would not be subject to 40 CFR parts 262, 264, or 265. Generally, EPA
is proposing that pharmaceutical reverse distributors comply with
standards that are similar to the current federal LQG standards, in
combination with certain requirements that permitted or interim status
hazardous waste TSDFs must meet. We are establishing one set of
requirements for all pharmaceutical reverse distributors, regardless of
the amount of potentially creditable hazardous waste pharmaceuticals
they receive. EPA believes this uniform set of standards will make it
easier for pharmaceutical reverse distributors to comply with the new
proposal, since the burden of having to count hazardous waste
pharmaceuticals on a monthly basis, especially the 1 kg of acute
hazardous waste pharmaceuticals, will be removed.
    EPA proposes that a pharmaceutical reverse distributor will not be
required to have a hazardous waste permit or interim status for on-site
accumulation of creditable and evaluated hazardous waste
pharmaceuticals provided it follows the proposed pharmaceutical reverse
distributor standards. However, for activities such as treatment or
disposal of hazardous waste pharmaceuticals or other hazardous waste, a
pharmaceutical reverse distributor must either obtain a RCRA permit or
have interim status. This proposal requires pharmaceutical reverse
distributors to comply with standards that are similar to LQG standards
for on-site accumulation of hazardous waste that are found in Sec.
262.34(a) and (b). We are proposing these requirements because, as
discussed prevoiusly, the value of the potentially creditable
pharmaceuticals creates an incentive for proper management and the risk
of release is low. Furthermore, many pharmaceutical reverse
distributors are already LQGs and therefore this proposed rule should
not represent a large shift in current practices or increased burden.
However, once credit is provided, the value of the pharmaceuticals is
eliminated and therefore the evaluated hazardous waste pharmaceuticals
have a greater potential for mismanagement. As a result, we are
proposing that pharmaceutical reverse distributors have additional
standards for the management of evaluated hazardous waste
pharmaceuticals. Note that while the LQG accumulation standards are
found in Sec. Sec.  262.34(a) and (b), these generator regulations
reference many interim status TSDF standards in part 265. However, in
the regulatory text and preamble for this rule, we reference the
standards in part 265 directly for the applicable accumulation
standards for pharmaceutical reverse distributors (rather than Sec.
262.34(a) which would then simply refer the reader to part 265).
However, the Agency requests comment as to whether we should include
the regulatory standard directly in 40 CFR part 266, subpart P, instead
of providing a cross-reference to the standard in 40 CFR part 265 in an
effort to make the rules easier to follow and comply with.
3. Detailed Discussion of Proposed Pharmaceutical Reverse Distributor
Standards
    The proposed standards for pharmaceutical reverse distributors are
organized into three sections. The first section applies to the
pharmaceutical reverse distributor for the management of all
potentially creditable hazardous waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals. The second section includes additional
standards that would apply to the management of the potentially
creditable hazardous waste pharmaceuticals that will be sent to another
pharmaceutical reverse distributor for further evaluation or
verification of credit and therefore continue to be regulated as
potentially creditable hazardous waste pharmaceuticals. The third
section includes additional standards that apply to the management of
the evaluated hazardous waste pharmaceuticals that will not be sent to
another pharmaceutical reverse distributor, but instead will be sent to
a permitted or interim status TSDF.
a. Standards for Pharmaceutical Reverse Distributors
    This portion of the preamble discusses the proposed standards that
apply to pharmaceutical reverse distributors for the management of all
hazardous waste pharmaceuticals on-site. Unlike the following two
sections, the standards discussed in this section apply to all
pharmaceutical reverse distributors, regardless of the subsequent
destination of the hazardous waste pharmaceuticals. We note that a
pharmaceutical reverse distributor must follow the proposed standards
for the management of hazardous waste pharmaceuticals even if it
generates other, non-pharmaceutical hazardous waste that is managed
under 40 CFR part 262.
    i. Notification. The first proposed requirement is that a
pharmaceutical reverse distributor must notify EPA of its hazardous
waste pharmaceutical activities via the Site ID form (EPA form 8700-
12). Under the current RCRA Subtitle C program, both LQGs and TSDFs
must submit a Site ID form to EPA. Thus, EPA believes it is
appropriate, and in line with comments received on the 2008
Pharmaceutical Universal Waste proposal, to require pharmaceutical
reverse distributors to notify EPA. A pharmaceutical reverse
distributor that does not have an EPA ID number will be required to
submit the Site ID form to obtain one. If this proposal is finalized,
the Agency plans on revising the Site ID form to include a box to allow
notifications by pharmaceutical reverse distributors. For those
pharmaceutical reverse distributors that already have an EPA ID number,
they will need to re-notify EPA as a pharmaceutical reverse
distributor. Some pharmaceutical reverse distributors may also be
generators of other types of hazardous waste (e.g., from cleaning and
maintenance operations). Therefore, it is possible that a
pharmaceutical reverse distributor may notify on the same notification
form as both a generator of hazardous waste and as a pharmaceutical
reverse distributor.
    ii. Inventory. EPA is proposing a new provision that is specific to
pharmaceutical reverse distributors: the requirement is to keep an
inventory of the potentially creditable hazardous waste pharmaceuticals
and evaluated hazardous waste pharmaceuticals that are on-site. The
inventory must include the identity (e.g., name or national drug code
(NDC)) and quantity of each potentially creditable hazardous waste
pharmaceutical and evaluated hazardous waste pharmaceuticals. EPA

also recommends as a best management practice that pharmaceutical
reverse distributors also keep an inventory of their non-hazardous
waste pharmaceuticals as well. An inventory is a key requirement to
protect public health by helping to prevent the diversion of hazardous
waste pharmaceuticals. An inventory will allow the pharmaceutical
reverse distributor to know which pharmaceuticals they have on-site at
any time. The Agency believes that in many cases, pharmaceutical
reverse distributors already maintain inventories and this proposed
requirement is not expected to be burdensome for the pharmaceutical
reverse distributors to implement. In fact, according to responses from
pharmaceutical reverse distributors to a request for information, four
out of eight of them indicated that they already keep inventories as
best management practices or because it is required by the Board of
Pharmacy in their state.\145\ However, EPA requests comment on whether
this practice is already commonly followed.
---------------------------------------------------------------------------

    \145\ See all the responses EPA received from pharmaceutical
reverse distributors in the docket for this proposed rulemaking
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    iii. Security of the pharmaceutical reverse distributor. EPA is
proposing that pharmaceutical reverse distributors must meet a
performance-based security requirement which is based on the existing
interim status TSDF security requirements found at Sec.  265.14.
Specifically, due to increased thefts of narcotics from pharmacies
reported in recent years in major media outlets,\146\ EPA is concerned
that pharmaceutical reverse distributors could also face such thefts
since they accumulate unused pharmaceuticals or those that have
exceeded their expiration date. Further, commenters on the 2008
Pharmaceutical Universal Waste proposal suggested that pharmaceutical
universal waste handlers should meet the TSDF facility security
requirement. EPA agrees with the commenters that the requirements that
appear in the interim status TSDF security regulations would be
appropriate to adopt and apply to pharmaceutical reverse distributors
to prevent the illicit use of these pharmaceuticals and safeguard human
health and thus, has included this requirement for pharmaceutical
reverse distributors. The security of the facility requirement of Sec.
265.14(a) requires a facility to ``prevent the unknowing entry, and
minimize the possibility for the unauthorized entry, of persons or
livestock onto the active portion of his facility.'' EPA is proposing a
similar requirement for pharmaceutical reverse distributors: they must
prevent unknowing entry, and minimize the possibility for the
unauthorized entry into the portion of the facility where potentially
creditable and evaluated hazardous waste pharmaceuticals are kept
(e.g., a receiving area and accumulation area).
---------------------------------------------------------------------------

    \146\ ``Pharmacies Besieged by Addicted Thieves'' by Abby
Goodnough Published: February 6, 2011 http://www.nytimes.com/2011/02/07/us/07pharmacies.html.
---------------------------------------------------------------------------

    Based on site visits, EPA recognizes that many pharmaceutical
reverse distributors may already meet the proposed security standard
through the use of key cards that allow only authorized personnel into
specific areas of the pharmaceutical reverse distributor, camera
surveillance systems, and cages for storing pharmaceuticals. Some
pharmaceutical reverse distributors may use fences and signs. EPA is
including several examples of acceptable security measures in the
regulatory text, but pharmaceutical reverse distributors are not
limited to the examples provided. Further, if a pharmaceutical reverse
distributor already meets the performance-based security standard by
complying with other regulations, such as DEA's regulations, then the
pharmaceutical reverse distributor would not need to install additional
security.
    iv. Maximum 90 days for on-site accumulation and petition for an
extension of accumulation time.
    EPA is proposing that, like LQGs, pharmaceutical reverse
distributors may accumulate potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site
for up to 90 calendar days without having interim status or a permit.
However, because of the value of the potentially creditable hazardous
waste pharmaceuticals, and the low risk these materials present, the
Agency has decided not to propose specific container management
standards.
    The 90-day time limit begins when the potentially creditable
hazardous waste pharmaceuticals initially arrive at the pharmaceutical
reverse distributor. The 90-day time limit follows the potentially
creditable pharmaceutical, even after it becomes an evaluated hazardous
waste pharmaceutical. That is, there is a single 90-day accumulation
limit for the hazardous waste pharmaceutical at each pharmaceutical
reverse distributor. However, some potentially creditable hazardous
waste pharmaceuticals travel through more than one pharmaceutical
reverse distributor to receive manufacturer's credit. In such cases,
each pharmaceutical reverse distributor that receives the potentially
creditable hazardous waste pharmaceuticals has a new 90-day
accumulation limit. EPA requests comment on the 90-day timeframe and
whether this timeframe is sufficient, or whether an alternative
timeframe should be allowed.
    As discussed previously, EPA is proposing that a pharmaceutical
reverse distributor must inventory potentially creditable hazardous
waste pharmaceuticals upon arrival. Many pharmaceutical reverse
distributors utilize barcoding and scanners to log potentially
creditable pharmaceuticals into a database upon arrival or soon after a
shipment arrives. Current inventory systems may be adapted to provide
verification of the time limits. For example, if a pharmaceutical
reverse distributor includes the date of arrival in the inventory, then
the pharmaceutical reverse distributor will be able to use the
inventory to verify that potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals are not
accumulated on-site for more than 90 calendar days. EPA is not
proposing a specific method that pharmaceutical reverse distributors
must use to document that accumulation does not exceed 90 calendar
days. We anticipate that most pharmaceutical reverse distributors would
use the inventory system to verify the 90-calendar day timeframe rather
than using an additional requirement of labeling containers with dates
for verification, but we request comment on this issue. We also request
comment on whether EPA needs to specify a method of documenting that 90
calendar days is not exceeded.
    Pharmaceutical reverse distributors have informed EPA that there
are times when pharmaceutical returns may need to be consolidated for
longer periods because they are subject to litigation and the
pharmaceutical reverse distributor is not allowed to move them.
Pharmaceutical reverse distributors may also need to handle large
recalls of hazardous waste pharmaceuticals and might not be able to
process all of the returned items within 90 calendar days. Therefore,
EPA is proposing to allow a pharmaceutical reverse distributor to
request from EPA an extension of the 90-day accumulation time limit for
situations when the hazardous waste pharmaceuticals are involved in
litigation, a recall, or in unforeseen circumstances beyond the control
of the pharmaceutical reverse distributor. A pharmaceutical reverse
distributor

seeking an extension must submit a written request to the EPA Regional
Administrator (in writing or electronically), explaining the reason for
the extension, the approximate volume or weight of the hazardous waste
pharmaceuticals that will be stored for more than 90-days and the
amount of additional time requested. Under the existing RCRA subtitle C
regulations, the extension of time typically allowed is limited to an
extra 30 days for LQGs. However, due to the complex nature of
pharmaceutical litigation and recalls, EPA is proposing to allow the
EPA Regional Administrator to grant a time extension at their
discretion on a case-by-case basis. EPA requests comment on whether it
is necessary to place a limit on the length of time for which an
extension may be granted.
    v. Contingency plan and emergency procedures. The Agency is
proposing to require that pharmaceutical reverse distributors meet
standards that are the same as those that appear in the federal LQG
regulations for developing a contingency plan and emergency procedures
at 40 CFR part 265, subpart D. EPA believes that a pharmaceutical
reverse distributor should be prepared to respond to potential
emergencies just like LQGs and TSDFs. Since many pharmaceutical reverse
distributors are already LQGs, they should already have contingency
plans to address the hazards on-site. It may be possible that the
pharmaceutical reverse distributors will have to amend their
contingency plans to include the potentially creditable hazardous waste
pharmaceuticals, which have been considered products, not hazardous
waste, but we believe that such modifications should not impose much
burden.
    vi. Closure. Due to the generally low risk of release of the
hazardous waste pharmaceuticals that pharmaceutical reverse
distributors will accumulate on-site, as well as the value of the
hazardous waste pharmaceuticals, EPA is proposing to require a
performance-based closure standard that is based on the federal LQG
closure standard found at Sec.  265.111. Specifically, when a
pharmaceutical reverse distributor closes its operations related to
hazardous waste pharmaceuticals, it must control or minimize post-
closure releases of hazardous waste constituents into the environment.
This will entail removing the containers of hazardous waste
pharmaceuticals (both potentially creditable hazardous waste
pharmaceuticals as well as evaluated hazardous waste pharmaceuticals)
from the facility before closure.
    vii. Reporting. In some instances, a pharmaceutical reverse
distributor may receive a shipment from a healthcare facility that
includes items that are not potentially creditable pharmaceuticals.
These shipments can include wastes that are clearly not eligible to
receive credit, such as patient care waste (e.g., IV tubing),
contaminated personal protective equipment (PPE), medical waste, or
other inappropriate wastes. Pharmaceutical reverse distributors are not
the appropriate waste management facility for medical or infectious
wastes and these wastes must be managed and transported from the
healthcare facility directly to an appropriate waste disposal facility.
In some cases, these non-creditable wastes may be hazardous waste.
These non-creditable hazardous wastes are prohibited from being
transported from a healthcare facility to a pharmaceutical reverse
distributor; rather they should be manifested to a designated facility,
such as a permitted or interim status TSDF. Nevertheless, a healthcare
facility might incorrectly ship non-creditable hazardous wastes to a
pharmaceutical reverse distributor.
    EPA is proposing that if a pharmaceutical reverse distributor
receives a shipment from a healthcare facility that includes hazardous
waste that it is not authorized to receive, such as non-creditable
hazardous waste or hazardous waste that is not a pharmaceutical, the
pharmaceutical reverse distributor must submit an unauthorized waste
report to the EPA Regional Administrator within 15 days of receiving
the hazardous waste. We have adapted the existing requirement for
situations when permitted and interim status TSDFs receive unmanifested
hazardous waste (Sec.  264.76 and Sec.  265.76, respectively) to make
it appropriate for pharmaceutical reverse distributors that receive
unauthorized hazardous waste. However, we are also proposing two
additional requirements for pharmaceutical reverse distributors that
receive inappropriate hazardous waste. First, the pharmaceutical
reverse distributor must send a copy of the unauthorized hazardous
waste report to the healthcare facility that sent the unauthorized
hazardous waste. This requirement is intended to alert the healthcare
facility of its mistake in order to prevent further shipments of non-
creditable hazardous waste or non-pharmaceutical hazardous waste.
Second, the pharmaceutical reverse distributor must manage the
unauthorized hazardous waste that it receives in accordance with all
applicable regulations. The Agency expects that the pharmaceutical
reverse distributor will likely pass these additional costs (e.g.,
medical waste incineration) on to the healthcare facility for the
management of the hazardous waste and this will act as an incentive for
the healthcare facility to take measures to prevent further shipments
of unauthorized hazardous waste. We request comment on whether EPA's
understanding regarding this type of situation is representative.
    In order to prevent exposing employees to unnecessary risk, EPA
recommends as a best management practice that pharmaceutical reverse
distributors avoid sorting through shipments that contain non-
creditable waste since the shipment may include hazardous waste,
including infectious or radioactive healthcare waste. As a result, it
is possible that a pharmaceutical reverse distributor receiving a
shipment that includes non-creditable waste may be unsure whether the
shipment includes hazardous waste. In such cases, EPA recommends that
the pharmaceutical reverse distributor assume the shipment includes
hazardous waste and submit an unauthorized waste report. Further, we
recommend that pharmaceutical reverse distributors work with their
clients to reduce the occurrence of inappropriate shipments.
    viii. Recordkeeping. EPA is proposing three recordkeeping
requirements to provide transparency for the movement of potentially
creditable hazardous waste pharmaceuticals and as a means of
verification upon inspection. First, a pharmaceutical reverse
distributor must keep a copy of its notification (EPA form 8700-12) to
EPA to indicate that it is a pharmaceutical reverse distributor
operating under 40 CFR part 266, subpart P. A pharmaceutical reverse
distributor must keep the record of notification for as long as it is
subject to these requirements. Second, a pharmaceutical reverse
distributor must keep copies of the records associated with shipments
of potentially creditable hazardous waste pharmaceuticals that it
receives. This includes a copy of the advance notification from the
healthcare facility or other pharmaceutical reverse distributor, a copy
of delivery confirmation, shipping papers and any unauthorized waste
reports. We propose that these shipping records must be kept for three
years from the date the pharmaceutical reverse distributor receives the
shipment. We request comment on whether additional recordkeeping is
necessary to document cases when shipments of potentially creditable
hazardous waste pharmaceuticals do not reach their intended destination
within 7 calendar

days. Third, a pharmaceutical reverse distributor must keep a copy of
its current inventory at all times as long as the pharmaceutical
reverse distributor remains in operation. The inventory is a living
document that will constantly be updated and must be available for
inspection. Finally, we propose that periods of record retention
indicated previously for a pharmaceutical reverse distributor will be
automatically extended during an enforcement action, or as requested by
the EPA Regional Administrator to ensure that the appropriate records
are available and can be reviewed as part of any enforcement action.
    Note that additional recordkeeping requirements may also pertain to
pharmaceutical reverse distributors. For example, a pharmaceutical
reverse distributor that manifests its non-pharmaceutical hazardous
waste is subject to the manifest recordkeeping requirements of Sec.
262.40. Further, as discussed in subsequent sections, there are
additional recordkeeping requirements that apply to pharmaceutical
reverse distributors for the management of potentially creditable
hazardous waste pharmaceuticals destined for another pharmaceutical
reverse distributor and others that apply to pharmaceutical reverse
distributors for the management of evaluated hazardous waste
pharmaceuticals.
    ix. Evaluating potentially creditable hazardous waste
pharmaceuticals within 21 days. Based on stakeholder input and site
visits, EPA has learned that when a pharmaceutical 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 system. The pharmaceutical
reverse distributor then determines which potentially creditable
hazardous waste pharmaceuticals must be transported to another reverse
distributor and which ones will be credited and then sent off-site for
treatment and disposal. EPA is proposing that this evaluation process
must be completed within 21 days of arriving at the pharmaceutical
reverse distributor. Likewise, if the pharmaceutical reverse
distributor is a manufacturer, EPA is proposing that the manufacturer
must finish verifying the appropriate credit within 21 calendar days of
receiving the shipment of potentially creditable hazardous waste
pharmaceuticals.
    EPA has chosen to propose 21 calendar days to ensure that the
pharmaceutical reverse distributor has a long enough of time to make
the evaluation, yet a short enough time to ensure that potentially
creditable hazardous waste pharmaceuticals do not linger awaiting
evaluation. The Agency requests comment on this timeframe and whether
it should be shortened or lengthened. We also want to emphasize that
the 21 calendar days for evaluating the potentially creditable
hazardous pharmaceuticals counts as part of the total 90 calendar days
that the hazardous waste pharmaceuticals are allowed to accumulate on-
site.
    Once an evaluation is made on the incoming potentially creditable
hazardous waste pharmaceuticals, if they are destined for another
pharmaceutical reverse distributor, they are still considered
potentially creditable hazardous waste pharmaceuticals. There are
additional regulations in this proposal at Sec.  266.510(b) that
pertain to these potentially creditable hazardous waste pharmaceuticals
(discussed in Section V.G.3.b.). If, however, they are destined for an
interim status or permitted TSDF, they are considered ``evaluated
hazardous waste pharmaceuticals.'' There are additional regulations in
this proposal at Sec.  266.510(c) that pertain to these evaluated
hazardous waste pharmaceuticals (discussed in Section V.G.3.c.).
b. Additional Standards for Pharmaceutical Reverse Distributors
Managing Potentially Creditable Hazardous Waste Pharmaceuticals
Destined for Another Pharmaceutical Reverse Distributor
    This section discusses the additional standards that apply to a
pharmaceutical reverse distributor for the management of potentially
creditable hazardous waste pharmaceuticals that require further
evaluation or verification of manufacturer's credit at another
pharmaceutical reverse distributor. These hazardous waste
pharmaceuticals continue to be considered potentially creditable
hazardous waste pharmaceuticals. Until manufacturer's credit is
finalized, the potentially creditable hazardous waste pharmaceuticals
retain their value and there is greater incentive to manage them
carefully in order to receive full manufacturer's credit. Therefore,
EPA is proposing few regulatory standards for the management of the
potentially creditable hazardous waste pharmaceuticals that are
destined for another pharmaceutical reverse distributor.
    i. Where potentially creditable hazardous waste pharmaceuticals can
be sent. The proposed regulations for pharmaceutical reverse
distributors are structured so that there is a limit to the number of
transfers of potentially creditable hazardous waste pharmaceuticals
that may occur before they are ultimately transported to a TSDF for
treatment and disposal. Stakeholders expressed concern that the 2008
Pharmaceutical Universal Waste proposal would have allowed hazardous
waste pharmaceuticals to be shipped repeatedly and indefinitely from
one universal waste handler to another. From discussions with
pharmaceutical reverse distributors and reviewing information submitted
via EPA's request for information, the Agency believes a reasonable
limit is three transfers of potentially creditable hazardous waste
pharmaceuticals before the pharmaceutical hazardous waste is ultimately
transported to a TSDF. The three possible types of transfers are: \147\
---------------------------------------------------------------------------

    \147\ A healthcare facility or pharmaceutical reverse
distributor also has the option of sending its hazardous waste
pharmaceuticals to a RCRA permitted or interim status TSDF.
---------------------------------------------------------------------------

    (1) a healthcare facility may send potentially creditable hazardous
waste pharmaceuticals to a pharmaceutical reverse distributor, which
may or may not be a manufacturer;
    (2) the first pharmaceutical reverse distributor may send the
potentially creditable hazardous waste to another pharmaceutical
reverse distributor, which may or may not be a manufacturer
    (3) the second pharmaceutical reverse distributor can only send the
potentially creditable hazardous waste pharmaceuticals on to a
pharmaceutical reverse distributor that is a manufacturer.
    EPA anticipates that healthcare facilities that are CESQGs will
send their potentially creditable hazardous waste pharmaceuticals
directly to pharmaceutical reverse distributors, and that the
accumulation mechanism that we are proposing will be used to send only
non-creditable hazardous waste pharmaceuticals to off-site healthcare
facilities (see Section V.C.15.). However, EPA requests comment on
whether CESQG healthcare facilities would benefit from being able to
consolidate potentially creditable hazardous waste pharmaceuticals off-
site, as well. Depending on comments, EPA will consider allowing a
fourth transfer (for this limited situation) when potentially
creditable hazardous waste pharmaceuticals are sent from a CESQG
healthcare facility to an off-site healthcare facility for
accumulation, as would also be allowed by proposed Sec.  266.504(a).

    This chain of transfers ensures that the potentially creditable
hazardous waste pharmaceuticals will be accumulated for no more than
270 days in total after leaving a healthcare facility and before being
transported to a RCRA-permitted or interim status TSDF for treatment
and disposal (assuming no accumulation time extensions are granted).
EPA requests comment as to whether the three-transfer and 90-day limits
are appropriate and whether more or fewer transfers are necessary for
verification of manufacturer's credit.
    Put another way, if a pharmaceutical reverse distributor receives
potentially creditable hazardous waste pharmaceuticals from a
healthcare facility, the pharmaceutical reverse distributor must send
those potentially creditable hazardous waste pharmaceuticals to another
pharmaceutical reverse distributor (which may or may not be a
manufacturer) or must manage them as evaluated hazardous waste
pharmaceuticals under proposed Sec.  266.510(c). However, a
pharmaceutical reverse distributor that receives potentially creditable
hazardous waste pharmaceuticals from another pharmaceutical reverse
distributor is more limited in where it can send the potentially
creditable hazardous waste pharmaceuticals. It can send potentially
creditable hazardous waste pharmaceuticals to a pharmaceutical reverse
distributor that is the manufacturer or else must manage them as
evaluated hazardous waste pharmaceuticals under Sec.  266.510(c).
    Regardless of the destination, each pharmaceutical reverse
distributor must make an evaluation of the hazardous waste
pharmaceuticals within 21 calendar days and may only accumulate the
hazardous waste pharmaceuticals on-site for a maximum of 90 calendar
days, unless an extension is granted by the Regional Administrator
before it ships them off-site to another pharmaceutical reverse
distributor or a RCRA-permitted or interim status TSDF. In addition,
all shipments of evaluated hazardous waste pharmaceuticals are subject
to proposed Sec.  266.508 and shipments of all potentially creditable
hazardous waste pharmaceuticals are subject to proposed Sec.  266.509.
    ii. Recordkeeping for pharmaceutical reverse distributors shipping
of potentially creditable hazardous waste pharmaceuticals to another
pharmaceutical reverse distributor. Pharmaceutical reverse distributors
must keep records (paper or electronic) for each shipment of
potentially creditable hazardous waste pharmaceuticals that it
initiates to another pharmaceutical reverse distributor (whether it is
a manufacturer or not). This includes a copy of the advance
notification provided to the other pharmaceutical reverse distributor,
a copy of delivery confirmation, as well as shipping papers or bill of
lading. We propose that these shipping records must be kept for 3 years
from the date it initiates the shipment.
c. Additional Standards for Pharmaceutical Reverse Distributors
Managing Evaluated Hazardous Waste Pharmaceuticals
    This section discusses the additional standards that apply to a
pharmaceutical reverse distributor for the management of evaluated
hazardous waste pharmaceuticals (i.e., a hazardous waste pharmaceutical
that was a potentially creditable hazardous waste pharmaceutical but
has been evaluated by a pharmaceutical reverse distributor to establish
whether it is eligible for manufacturer's credit and will not be sent
to another pharmaceutical reverse distributor for further evaluation or
verification). Evaluated hazardous waste pharmaceuticals have been
through the entire crediting process. In order to minimize the
potential for their mismanagement, EPA believes it is necessary to have
additional standards for the evaluated hazardous waste pharmaceuticals.
    i. Accumulation area. As discussed previously, EPA is proposing
that a pharmaceutical reverse distributor must complete its evaluation
of a potentially creditable hazardous waste pharmaceuticals within 21
calendar days of arriving at the pharmaceutical reverse distributor.
Once the evaluation has been completed and the pharmaceutical reverse
distributor knows that it is destined for treatment and disposal at a
RCRA-permitted or interim status TSDF, rather than another
pharmaceutical reverse distributor, the pharmaceutical is considered an
evaluated hazardous waste pharmaceutical. Under the proposal, a
pharmaceutical reverse distributor must establish an on-site
accumulation area where it will accumulate these evaluated hazardous
waste pharmaceuticals. An on-site accumulation area is needed so that
the evaluated hazardous waste pharmaceuticals are segregated and
clearly distinguished from the potentially creditable hazardous waste
pharmaceuticals.
    ii. Weekly inspections. EPA is proposing that the accumulation area
for evaluated hazardous waste pharmaceuticals must be inspected at
least weekly to ensure containers are not leaking and that diversion of
the hazardous waste pharmaceuticals is not occurring. Under the
recordkeeping requirements for pharmaceutical reverse distributors, we
are proposing that a pharmaceutical reverse distributor must keep a log
of the weekly inspections of the on-site accumulation area and that the
log must be retained for at least three years from the date of
inspection. The log is necessary to validate the weekly inspections.
    iii. Personnel training. EPA is proposing to require that
pharmaceutical reverse distributors meet the same federal classroom or
on-the-job personnel training requirements that LQGs must meet (Sec.
265.16). However, we specify in this proposal that the personnel that
need to be trained are those persons who handle the evaluated hazardous
waste pharmaceuticals in the on-site accumulation area. EPA believes
that these personnel are the individuals handling and managing the
hazardous waste pharmaceuticals and must have appropriate hazardous
waste training. The Agency requests comment on whether the training
standards are appropriate for the specific reverse distributor
personnel.
    iv. Labeling and management of containers in on-site accumulation
area. EPA is proposing container labeling similar to what was proposed
under the 2008 pharmaceutical universal waste proposed rule. While
containers of hazardous waste pharmaceuticals are in the accumulation
area, they must be marked with the words, ``Hazardous Waste
Pharmaceuticals.'' We are proposing this term in order to distinguish
them from the non-hazardous waste pharmaceuticals and from the
hazardous waste pharmaceuticals that are still considered potentially
creditable. We are not proposing to require an accumulation start date
on the label for the containers, because the reverse distributor's
inventory will likely be used to verify the accumulation start date.
However, a pharmaceutical reverse distributor may choose an alternate
method, such as marking the date on each container as it arrives, to
ensure that the hazardous waste pharmaceuticals are not accumulated at
the pharmaceutical reverse distributor for more than 90 days, provided
an extension is not granted. As explained previously, EPA prefers to
allow a performance-based standard that allows flexibility to verify
the 90-day accumulation time rather than require dating on the
container labels, but we request comment regarding this requirement and
whether

it is necessary to specify a method for how a pharmaceutical reverse
distributor must verify that the 90-day maximum accumulation time is
not exceeded.
    In terms of container management standards, the Agency is proposing
requirements that are similar to the container management standards for
LQGs--that is, the standards in 40 CFR part 265, but the Agency is also
proposing to include some additional management requirements specific
to hazardous waste pharmaceuticals. Specifically, under 40 CFR
262.34(a)(1)(i), LQGs must comply with the container management
standards in 40 CFR part 265, subpart I, which includes a requirement
that containers of hazardous waste must be kept closed, except when
adding or removing waste. In this document, EPA is proposing to require
that only containers with hazardous waste pharmaceuticals that are
liquids or gels be kept closed during accumulation due to the low
potential for release for those hazardous waste pharmaceuticals that
are in a solid form. However, because most potentially creditable
hazardous waste pharmaceuticals are in their original packaging, if the
original packaging for gels or liquids is intact and sealed or the
pharmaceuticals have been repackaged (e.g., for unit dosing) and the
repackaged packaging for gels and liquids is intact and sealed, they
are considered to meet the closed container standard. EPA requests
comment on whether additional forms of hazardous waste pharmaceuticals
(other than liquids and gels) need to be specified in the regulations
and subject to the closed container requirement.
    EPA is also proposing that containers of hazardous waste
pharmaceuticals must be maintained in good condition to prevent leaks
and the container material must be compatible with the hazardous waste
pharmaceuticals placed in the container. In addition, we are proposing
to require that a pharmaceutical reverse distributor that manages
ignitable or reactive evaluated hazardous waste pharmaceuticals or that
mixes or comingles incompatible evaluated hazardous waste
pharmaceuticals must manage the container to prevent dangerous
situations, such as fire, explosion, or release of toxic fumes.
    Similar to healthcare facilities that accumulate non-creditable
hazardous waste pharmaceuticals, pharmaceutical reverse distributors
that accumulate evaluated hazardous waste pharmaceuticals must
segregate the pharmaceuticals that are prohibited from being combusted
because of the dilution prohibition of Sec.  268.3(c) and accumulate
them in separate containers from other evaluated hazardous waste
pharmaceuticals.
    There are also several existing LQG accumulation unit management
standards in Sec.  262.34(a) that EPA believes are not necessary to
include for the management of evaluated hazardous waste
pharmaceuticals. For instance, this proposal only sets standards for
the accumulation of evaluated hazardous waste pharmaceuticals in
containers. EPA does not think it is necessary to include accumulation
units such as tanks, containment buildings, or drip pads because
pharmaceutical reverse distributors do not currently use these types of
accumulation units. However, if EPA is mistaken in this understanding
and commenters indicate they would like to be able to use tanks,
containment buildings, or drip pads, EPA would consider including in
this proposal the LQG standards for accumulation in these units. The
Agency solicits comment on this matter.
    In addition, the Agency is not proposing to require pharmaceutical
reverse distributors to meet the air emission standards found in 40 CFR
part 265, subpart CC as required in Sec.  262.34(a)(1)(i) because we
anticipate that they will not be applicable. Specifically, Sec.
265.1083(c) exempts tanks, surface impoundments, and containers from
the organic air emission standards if the hazardous waste entering the
accumulation unit has an average volatile organic concentration of less
than 500 parts per million by weight, while Sec.  265.1080(b)(2)
exempts containers with a capacity of less than 0.1 m\3\ (26 gallons)
from the standards. EPA understands that the only evaluated hazardous
waste pharmaceuticals that have the potential for air emissions are
liquids and gels, but they generally do not contain volatile organics.
Thus, they do not release organic air emissions, which is what the 40
CFR part 265, subpart CC, air emission standards for tanks, surface
impoundments, and containers were promulgated to control. Moreover,
because hazardous waste pharmaceuticals are often in their original
packaging, and we are proposing to require that liquid and gel
hazardous waste pharmaceuticals must be in intact, sealed packaging or
otherwise in closed containers, EPA believes that the container air
emission standards are unnecessary. In addition, the Agency anticipates
that the packaging and containers for hazardous waste pharmaceuticals
will often have a capacity less than 0.1 m\3\ (26 gallons) further
limiting the applicability of the container air emission standards.
    Similarly, EPA does not anticipate that the 40 CFR part 265,
subpart AA--air emissions standards for process vents--and subpart BB--
air emission standards for equipment leaks--are applicable to the
activities of a pharmaceutical reverse distributor and its management
of hazardous waste pharmaceuticals. Therefore, like 40 CFR part 265,
subpart CC discussed previously, EPA is not proposing to require that
40 CFR part 265, subparts AA and BB apply to pharmaceutical reverse
distributors. EPA requests comments on whether its current
understanding is correct and whether the 40 CFR part 265, subparts AA,
BB, and CC RCRA air emission standards should be applied to
pharmaceutical reverse distributors.
    v. Hazardous waste numbers (codes). EPA is proposing to require
that the containers of evaluated hazardous waste pharmaceuticals be
labeled with the appropriate RCRA hazardous waste numbers. The
hazardous waste numbers may be placed on the container label at any
time during on-site accumulation, but they must be added prior to when
the evaluated hazardous waste pharmaceuticals are transported off-site.
The hazardous waste numbers must be marked on the container label in
order to ensure that it is readily visible and cannot be separated from
the hazardous waste. The hazardous waste numbers are necessary so that
transporters, transfer facilities, and TSDFs to know how to properly
transport, consolidate, treat, store and dispose of the hazardous waste
in compliance with the applicable RCRA regulations. We are not
requiring that the pharmaceutical reverse distributor be the party that
adds the hazardous waste numbers to the containers. The proposed
regulations allow a vendor to perform this duty on behalf of the
pharmaceutical reverse distributor. In practice, however, if a vendor
is responsible for assigning hazardous waste numbers, personnel from
the pharmaceutical reverse distributor may need to assist in the
process.
    vi. Shipping evaluated hazardous waste pharmaceuticals. Although it
is already stated in Sec.  266.508(a) under the section of the
regulations that pertains to shipping standards, for clarity, we
propose to repeat in Sec.  266.510 (the pharmaceutical reverse
distributor section of the regulations) the requirement that
pharmaceutical reverse distributors that ship evaluated hazardous waste
pharmaceuticals off-site must do so in accordance with the proposed
shipping requirements in

Sec.  266.508(a). This includes the applicable DOT packaging, marking
and labeling requirements, as well as the requirement to utilize the
hazardous waste manifest when shipping the evaluated hazardous waste to
a designated facility.
    vii. Rejected shipments. The Agency is proposing to require in
Sec.  266.510(c)(7) that pharmaceutical reverse distributors meet the
same procedures as LQGs must meet for rejected shipments in Sec.
262.42(c). If a designated permitted or interim status TSDF identified
on the hazardous waste manifest cannot accept a shipment of evaluated
hazardous waste pharmaceuticals from a pharmaceutical reverse
distributor and the TSDF returns the shipment to the pharmaceutical
reverse distributor, the pharmaceutical reverse distributor must sign
the applicable item on the manifest. In addition, the pharmaceutical
reverse distributor may consolidate the rejected hazardous waste
pharmaceuticals on-site for up to 90 days provided they are managed in
the on-site accumulation area and in accordance with this proposal's
pharmaceutical reverse distributor standards for evaluated hazardous
waste pharmaceuticals. The reporting requirements associated with
rejected shipments are discussed separately under the reporting
section.
    viii. Land disposal restrictions. EPA is proposing in Sec.
266.510(c)(8) that pharmaceutical reverse distributors are subject to
the same land disposal restrictions (LDRs) that apply to LQGs with
respect to their evaluated hazardous waste pharmaceuticals. In
addition, EPA is proposing to amend the testing, tracking, and
recordkeeping requirements for generators, treaters and disposal
facilities at Sec.  268.7 to add the words, ``pharmaceutical reverse
distributors'' to the title of that section to make the applicability
of the treatment standards clear.
    ix. Reporting by a pharmaceutical reverse distributor for evaluated
hazardous waste pharmaceuticals.
    (1) Biennial report. EPA is proposing that pharmaceutical reverse
distributors submit a BR for the evaluated hazardous waste
pharmaceuticals that are transported to a TSDF in order for the Agency
to have as complete a picture of the amount of hazardous waste
generated, treated, stored, or disposed of annually. However, the BR
should only include the evaluated hazardous waste pharmaceuticals, and
not the potentially creditable hazardous waste pharmaceuticals that a
pharmaceutical reverse distributor sends to another pharmaceutical
reverse distributor. Specifically, we are proposing in Sec.
266.510(c)(9)(i) that a pharmaceutical reverse distributor comply with
the LQG BR requirements in Sec.  262.41, except for Sec.  262.41(a)(7),
which includes the requirement to report changes in volume and toxicity
of waste achieved during the year in comparison to previous years. The
reason we are not requiring the pharmaceutical reverse distributor to
provide such information is that they do not have control of the volume
or toxicity of the hazardous waste pharmaceuticals it receives from the
healthcare facility, and thus have no ability to reduce the volume or
toxicity of the hazardous waste pharmaceuticals. Thus, EPA is not
requiring the pharmaceutical reverse distributor to report this
information in its BR.
    (2) Exception reporting. For the reasons that EPA requires
exception reporting generally--that is, to maintain the cradle to grave
tracking system, EPA is proposing in Sec.  266.510(c)(9)(ii)(A) that
pharmaceutical reverse distributors provide an exception report when a
TSDF does not return the hazardous waste manifest to the pharmaceutical
reverse distributor for shipments of hazardous waste pharmaceuticals to
a designated facility. Likewise, we are proposing in Sec.
266.510(c)(9)(ii)(B) that pharmaceutical reverse distributors meet LQG
exception reporting when a shipment from a pharmaceutical reverse
distributor is rejected by the designated facility and forwarded onto
an alternate facility.
    x. Recordkeeping by a pharmaceutical reverse distributor for
evaluated hazardous waste pharmaceuticals. Many of the proposed
recordkeeping requirements that pertain to evaluated hazardous waste
pharmaceuticals have been discussed in the sections previously, but for
clarity, it is useful to restate them in this recordkeeping section, so
that pharmaceutical reverse distributors can refer to one section to
determine their recordkeeping requirements related to evaluated
hazardous waste pharmaceuticals. In particular, we are proposing five
recordkeeping requirements that pertain to evaluated hazardous waste
pharmaceuticals at pharmaceutical reverse distributors. First, EPA is
proposing that a pharmaceutical reverse distributor keeps a log
(written or electronic) of its weekly inspections of the on-site
accumulation area. The other four recordkeeping requirements that we
are proposing in Sec.  266.510(c)(10) for pharmaceutical reverse
distributors are the same as the LQG recordkeeping requirements that
appear in Sec. Sec.  262.40-42 and Sec.  265.16; these include
hazardous waste manifest records, records of biennial reports,
exception reporting and training documentation. EPA believes that these
recordkeeping requirements are appropriate for pharmaceutical reverse
distributors, many of whom are currently LQGs, but requests comment on
this requirement.
    EPA asks commenters to review the standards EPA is proposing for
pharmaceutical reverse distributors and provide specific comment on
whether the standards are appropriate and sufficient to protect human
health and the environment.
d. When a Pharmaceutical Reverse Distributor Must Have a RCRA Hazardous
Waste Permit
    EPA is proposing to not require that a pharmaceutical reverse
distributor have a RCRA permit or interim status for accumulating
potentially creditable and evaluated hazardous waste pharmaceuticals,
provided that the pharmaceutical reverse distributor follows all the
conditions of the permitting exemption in Sec.  266.510. In other
words, a pharmaceutical reverse distributor would be subject to
regulation as a TSDF and require a RCRA permit (or interim status) if
it does not meet the conditions of Sec.  266.510. In addition, a
pharmaceutical reverse distributor must have a RCRA permit (or interim
status) if it treats or disposes of hazardous waste on-site or if it
accepts manifested hazardous waste from off-site. A pharmaceutical
reverse distributor is required to reject shipments of manifested
hazardous waste that it may inadvertently receive from off-site because
a pharmaceutical reverse distributor is not a designated facility and
therefore is not eligible to receive hazardous waste via a manifest.
EPA believes that this approach to regulation of pharmaceutical reverse
distributors that accumulate hazardous waste pharmaceuticals strikes an
appropriate balance because it recognizes that pharmaceutical reverse
distributors are different from typical hazardous waste TSDFs for
permitting purposes, while it still imposes certain conditions for
exemption from permitting requirements that provide the necessary
environmental protection.

VI. Implementation and Enforcement

A. Healthcare Facilities

1. Determining Whether a Healthcare Facility is Subject to Part 266,
Subpart P
    EPA is proposing that healthcare facilities that are currently
considered LQGs or SQGs are subject to the new 40 CFR part 266, subpart
P requirements for the management of hazardous waste pharmaceuticals.
Thus, a healthcare facility that generates (or accumulates)

more than 100 kg hazardous waste per calendar month, or more than 1 kg
of acute hazardous waste per calendar month, or more than 100 kg of any
residue or contaminated soil, waste, or other debris resulting from the
clean-up of a spill, into or on any land or water, of any acute
hazardous wastes listed in Sec. Sec.  261.31, or 261.33(e), must manage
its hazardous waste pharmaceuticals in compliance with the 40 CFR part
266, subpart P requirements. In addition, healthcare facilities that
are CESQGs are subject to the prohibition on sewering hazardous waste
pharmaceuticals in Sec.  266.5052.
    To determine whether a healthcare facility is a subject to 40 CFR
part 266, subpart P, or a CESQG regulated under Sec.  261.5, a
healthcare facility must count all the hazardous waste--pharmaceutical
and non-pharmaceutical--it generates in a calendar month. In counting
the amount of hazardous waste generated per calendar month, we note
that EPA is proposing to change which pharmaceuticals will be
considered hazardous wastes (i.e., potentially creditable hazardous
waste pharmaceuticals). Specifically, EPA is proposing that potentially
creditable hazardous waste pharmaceuticals transported to a
pharmaceutical reverse distributor will be considered solid waste from