potentially creditable hazardous waste pharmaceuticals or evaluated
hazardous waste pharmaceuticals. The management standards discussed in
this section do not apply to the reverse logistics systems that may
exist for other retail items. In response to comments, EPA is codifying
our existing interpretation that nonprescription pharmaceuticals that
are sent through reverse logistics are not solid wastes at the retail
store if they have a reasonable expectation of being legitimately used/
reused (e.g., lawfully redistributed for their intended purpose) or
reclaimed (see the definition of hazardous waste pharmaceutical under
section VIII and section IX, the applicability section). Additionally,
EPA is establishing a policy that other retail items that are sent
through reverse logistics are not solid waste at the retail store if
they have a reasonable expectation of being legitimately used/reused or
reclaimed (see section VI). Therefore, reverse logistics centers that
receive and manage nonprescription pharmaceuticals will not be
regulated under this subpart and will not be subject to the standards
for reverse distributors.
    The current federal RCRA hazardous waste generation regulations at
40 CFR part 262 provide that only designated facilities, such as 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 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 is
finalizing a new category of hazardous waste management facilities
under RCRA called a ``reverse distributor,'' which is defined as any
person that receives and accumulates prescription pharmaceuticals that
are potentially creditable hazardous waste pharmaceuticals for the
purpose of facilitating or verifying manufacturer credit. The
definition specifies that any person, including forward distributors,
third-party logistics providers, and pharmaceutical manufacturers, that
processes prescription hazardous waste pharmaceuticals for the
facilitation or verification of manufacturer credit is considered a
reverse distributor. EPA is finalizing that 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 standards in this final rule. 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 earlier in this document, EPA's previous
interpretation allows reverse distributors to be generators of
hazardous waste pharmaceuticals after a decision is made about whether
the pharmaceuticals will be repurposed. As a hazardous waste generator,
a reverse distributor had to comply with the LQG, SQG, or VSQG
generator regulations, depending on the total volume of hazardous waste
generated in a calendar month. Some smaller reverse distributors might
have stayed under the hazardous waste quantity limits for VSQGs, which
would mean that under the federal RCRA regulations, these VSQG reverse
distributors would not have had to notify EPA as a generator and their
hazardous waste pharmaceuticals could be disposed of with municipal and
non-municipal solid waste (see Sec.  262.14). However, the Agency has
concerns with VSQG reverse distributors not notifying EPA that they are
managing hazardous waste. EPA is even more concerned about reverse
distributors that currently qualify as VSQGs placing the hazardous
waste pharmaceuticals into the municipal and non-municipal solid waste
stream and sending them to non-hazardous waste landfills. Some studies
have shown active pharmaceutical ingredients present in landfill
leachate that is collected in municipal solid waste landfill leachate
systems.\365 366\ 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.
---------------------------------------------------------------------------

    \365\ 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.
    \366\ 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.
---------------------------------------------------------------------------

    In this final rule, EPA is revising its position regarding
prescription pharmaceuticals that are potentially creditable hazardous
waste pharmaceuticals, such that they will be considered discarded at
the healthcare facilities, not at the reverse distributors. This
revision is based on new information demonstrating to EPA that
prescription 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 reverse
distributor is a decision to discard the pharmaceutical (as discussed
previously in section VI). Comments on the December 2008 Pharmaceutical
Universal Waste proposal indicated that notification to EPA by 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.
    Although EPA maintains its position as stated in the proposed
rulemaking preamble that hazardous waste pharmaceuticals going to
reverse distributors are solid wastes at the healthcare facility, there
are important differences between reverse distributors and traditional
TSDFs. Only between 2-6 percent of the potentially creditable
pharmaceuticals that are received by reverse distributors are listed or
characteristic hazardous wastes.\367\ Therefore, the vast majority of
the potentially creditable pharmaceutical waste that a 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, whose
primary function is to manage hazardous waste. As a result, a reverse
distributor generally manages a smaller volume of hazardous waste than
a typical permitted TSDF.
---------------------------------------------------------------------------

    \367\ 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-2007-0932-0157, EPA-HQ-RCRA-2007-0932-
0158, EPA-HQ-RCRA-2007-0932-0159, EPA-HQ-RCRA-2007-0932-0160, EPA-
HQ-RCRA-2007-0932-0161, EPA-HQ-RCRA-2007-0932-0162, EPA-HQ-RCRA-
2007-0932-0163, EPA-HQ-RCRA-2007-0932-0164.
---------------------------------------------------------------------------

    In addition, because the pharmaceuticals in the reverse
distribution system are receiving manufacturer 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.\368\ 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.
---------------------------------------------------------------------------

    \368\ Meeting with representatives from CVS (August 11, 2012);
see the docket for meeting notes (EPA-HQ-RCRA-2007-0932-0188).
---------------------------------------------------------------------------

    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, which in some
cases includes inner and outer packaging (e.g., plastic bottle inside a
box). Since there is a relatively 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 it 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 taking a tailored approach to regulating reverse
distributors by regarding them as a new type of RCRA hazardous waste
entity--a reverse distributor. This approach balances EPA's revised
interpretation that the point of generation for prescription
pharmaceuticals that are potentially creditable hazardous waste
pharmaceuticals is at the healthcare facility, not the reverse
distributor, with the fact that potentially creditable hazardous waste
pharmaceuticals have value which provides an incentive for proper
management.
    EPA is establishing new management standards for reverse
distributors in 40 CFR part 266 subpart P. These entities will not be
subject to 40 CFR parts 262, 264, 265, or 270. Generally, EPA is
finalizing that 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
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 reverse
distributors to comply with the new subpart, in part because 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 is finalizing that a 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 final reverse distributor
standards. As mentioned previously, the on-site accumulation of
creditable and evaluated hazardous waste pharmaceuticals generally
presents low risk of release to the environment because they are
typically in the manufacturer's packaging. However, for activities such
as treatment or disposal of hazardous waste pharmaceuticals or other
hazardous waste, a reverse distributor must either obtain a RCRA permit
or have interim status, as these activities pose a higher risk of
release. EPA has determined that requirements similar to LQG standards
for on-site accumulation of hazardous waste that are found in Sec.
262.17 are appropriate. As discussed previously, the value of the
potentially creditable pharmaceuticals creates an incentive for proper
management and the risk of release is low. Furthermore, many reverse
distributors are already LQGs and, therefore, this final rule should
not represent a large shift in current practices or increased
burden.\369\ 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, EPA is finalizing additional standards for the management of
evaluated hazardous waste pharmaceuticals at reverse distributors.
---------------------------------------------------------------------------

    \369\ See the Regulatory Impact Analysis in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    EPA received numerous comments that expressed concern that the
standards for reverse distributors would be burdensome for reverse
logistics

centers that handle nonprescription pharmaceuticals. For example, one
commenter expressed concern that the reverse distributor inventory
requirements for both potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals would be
burdensome for facilities that receive and manage nonprescription
pharmaceuticals because these reverse logistics centers do not
currently maintain an inventory for these retail items.\370\ EPA is
codifying our existing interpretation that nonprescription
pharmaceuticals that are sent through reverse logistics are not solid
wastes at the retail store if they have a reasonable expectation of
being legitimately used/reused (e.g., lawfully redistributed for their
intended purpose) or reclaimed (see section VI for more discussion).
Therefore, reverse logistics centers will not be regulated under part
266 subpart P and will not be subject to the standards for reverse
distributors. As a result, comments received on the impact of the
reverse distributor standards on reverse logistics centers that receive
and manage nonprescription pharmaceuticals are outside the scope of the
final rule and are not discussed in this section. EPA also received
numerous general comments expressing concern that finalizing new RCRA
management standards for reverse distributors would be burdensome.
However, some specific provisions included in the proposed reverse
distributor standards received few comments.
---------------------------------------------------------------------------

    \370\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

C. Detailed Discussion of Final Reverse Distributor Standards

    The final standards for reverse distributors are organized into
three sections. The first section applies to the reverse distributor
for the management of all potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals (Sec.
266.510(a)). 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 reverse distributor
for further evaluation or verification of credit and therefore continue
to be regulated as potentially creditable hazardous waste
pharmaceuticals (Sec.  266.510(b)). The third section includes
additional standards that apply to the management of the evaluated
hazardous waste pharmaceuticals that will not be sent to another
reverse distributor, but instead will be sent to a permitted or interim
status TSDF (Sec.  266.510(c)).
1. Standards for Reverse Distributors Managing Potentially Creditable
Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste
Pharmaceuticals (Sec.  266.510(a))
    This portion of the preamble discusses the standards that apply to
reverse distributors for the management of all hazardous waste
pharmaceuticals on site, including potentially creditable hazardous
waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.
Unlike the following two sections, the standards discussed in this
section apply to all prescription hazardous waste pharmaceuticals at a
reverse distributor, regardless of the subsequent destination of the
hazardous waste pharmaceuticals. We note that a reverse distributor
must follow these 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. Note that we
have reorganized Sec.  266.510(a) since the proposal to more accurately
reflect the flow of hazardous waste pharmaceuticals at a reverse
distributor. The subsequent preamble section follows the organization
of the final regulations.
a. Notification
    Summary of Proposal. EPA proposed that a reverse distributor must
notify EPA of its hazardous waste pharmaceutical activities using the
Site ID Form (EPA Form 8700-12). Under the RCRA Subtitle C program,
SQGs, LQGs, and TSDFs must submit a Site ID Form to EPA. EPA proposed
that a reverse distributor that does not have an EPA ID number will be
required to submit the Site ID Form to obtain one and that a reverse
distributor that already has an EPA ID number will need to notify EPA
as a reverse distributor.
    Summary of Comments. EPA received two comments in support of the
proposed notification requirements. One state supported all of the
proposed notification requirements.\371\ Inmar, Inc. supported the
requirement that reverse distributors must notify EPA using EPA Form
8700-12.\372\
---------------------------------------------------------------------------

    \371\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \372\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(1)
that a reverse distributor must notify EPA of its hazardous waste
pharmaceutical activities using the Site ID Form (EPA Form 8700-12).
The Agency will revise the Site ID Form to include a box to allow
notifications by reverse distributors. EPA believes it is appropriate,
and in line with comments received on the proposal, to require reverse
distributors to notify EPA. Under the final rule, a reverse distributor
that does not have an EPA ID number will be required to submit the Site
ID Form to obtain one. A reverse distributor that already has an EPA ID
number will need to notify EPA as a reverse distributor. The time frame
in both cases is within 60 days of the effective date of this subpart
or within 60 days of becoming subject to this subpart. Some 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 reverse distributor may notify on the same notification
form as both a generator of hazardous waste and as a reverse
distributor.
b. Inventory
    Summary of Proposal. EPA proposed that reverse distributors must
keep an inventory of the potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals that are
on site. EPA proposed that the inventory must include the identity
(e.g., name or National Drug Code) and quantity of each potentially
creditable hazardous waste pharmaceutical and evaluated hazardous waste
pharmaceutical. EPA also proposed that a reverse distributor must
inventory each potentially creditable hazardous waste pharmaceutical
upon arrival at the reverse distributor.
    Summary of Comments. EPA received comments from states and industry
in support of the proposed inventory requirement.\373\ One state
suggested that EPA also require reverse distributors to include the
name of the healthcare facility that shipped the potentially creditable
hazardous waste pharmaceuticals to the reverse distributor.\374\
---------------------------------------------------------------------------

    \373\ See comment numbers EPA-HQ-RCRA-2007-0932-0235, EPA-HQ-
RCRA-2007-0932-0257, EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-RCRA-2007-
0932-0296, EPA-HQ-RCRA-2007-0932-0300, and EPA-HQ-RCRA-2007-0932-
0341 in the docket for this rulemaking.
    \374\ See comment number EPA-HQ-RCRA-2007-0932-0235 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Retail Industry Leaders Association argued that the inventory
requirements for reverse distributors should be reduced.\375\ Inmar,
Inc. did not support the inventory requirements and argued

that they are duplicative because reverse distributors must already
inventory and track prescription pharmaceuticals.\376\ Inmar, Inc.
wrote that at least four states currently require the maintenance of
drug inventories by law.\377\ Both Inmar, Inc. and RILA expressed
concern that the inventory requirements would be particularly
burdensome for their facilities that handle nonprescription
pharmaceuticals. Inmar, Inc. pointed out that their reverse logistics
centers do not maintain an inventory for nonprescription
pharmaceuticals.\378\
---------------------------------------------------------------------------

    \375\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket for this rulemaking.
    \376\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
    \377\ See the EPA correspondence with Inmar dated March 29, 2017
in the docket for this rulemaking EPA-HQ-RCRA-2007-0932.
    \378\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    EPA received multiple comments from industry that expressed concern
that the reverse distributor must inventory each potentially creditable
hazardous waste pharmaceutical upon arrival.\379\ One commenter
expressed concern that the reverse distributor must complete an
inventory upon arrival because packages of potentially creditable
hazardous waste pharmaceuticals can remain unopened for up to 5
business days.\380\ Healthcare Distribution Management Association
\381\ pointed out that reverse distributors sometimes receive tens of
thousands of products in a day and do individual product accounting
when the credit determination is made.\382\
---------------------------------------------------------------------------

    \379\ See comment numbers EPA-HQ-RCRA-2007-0932-0295, EPA-HQ-
RCRA-2007-0932-0276, EPA-HQ-RCRA-2007-0932-0352, and EPA-HQ-RCRA-
2007-0932-0340 in the docket for this rulemaking.
    \380\ See comment number EPA-HQ-RCRA-2007-0932-0278 in the
docket for this rulemaking.
    \381\ Now renamed Heathcare Distribution Alliance.
    \382\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Commenters on the proposed rulemaking also pointed out that reverse
distributors are already required to inventory and track prescription
pharmaceuticals under licensing and accreditation programs overseen by
the National Association of Boards of Pharmacy.\383\
---------------------------------------------------------------------------

    \383\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(2)
that reverse distributors must keep an inventory of the potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals that are on site. In response to comments, we
have made several changes to what was proposed but have determined that
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 reverse distributor to know which hazardous
waste pharmaceuticals they have on-site at any time. Based on
stakeholder input and site visits, the Agency believes that in many
cases, reverse distributors already maintain inventories of
pharmaceuticals and this requirement is not expected to be burdensome
for the reverse distributors to implement. According to responses from
reverse distributors to a 2011 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.\384\ The inventory must include the identity (e.g.,
name or National Drug Code) and quantity of each potentially creditable
hazardous waste pharmaceutical and evaluated hazardous waste
pharmaceuticals. In response to commenter concern that the inventory
requirement would be duplicative, EPA clarified in the regulatory
language of the final rule that if the reverse distributor already
meets the inventory requirements because of other regulatory
requirements, such as State Board of Pharmacy regulations, the facility
is not required to provide a separate inventory.
---------------------------------------------------------------------------

    \384\ 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-2007-0932-0157, EPA-HQ-RCRA-2007-0932-
0158, EPA-HQ-RCRA-2007-0932-0159, EPA-HQ-RCRA-2007-0932-0160, EPA-
HQ-RCRA-2007-0932-0161, EPA-HQ-RCRA-2007-0932-0162, EPA-HQ-RCRA-
2007-0932-0163, EPA-HQ-RCRA-2007-0932-0164.
---------------------------------------------------------------------------

    EPA proposed that a reverse distributor must inventory each
potentially creditable hazardous waste pharmaceutical upon arrival at
the reverse distributor. The final rule has been revised to state that
reverse distributors must inventory each potentially creditable
hazardous waste pharmaceutical within 30 calendar days of arriving at
the reverse distributor. EPA made this change in response to commenter
concern that the Agency did not provide enough time for reverse
distributors to inventory potentially creditable hazardous waste
pharmaceuticals. As previously mentioned, comments pointed out that
reverse distributors sometimes receive tens of thousands of products in
one day and need additional time to inventory each potentially
creditable hazardous waste pharmaceutical.\385\ EPA is also aware that
many reverse distributors inventory the potentially creditable
hazardous waste pharmaceutical at the same time that they evaluate the
potentially creditable hazardous waste pharmaceutical to determine if
it will receive manufacturer credit. When a reverse distributor
receives a shipment of potentially creditable hazardous waste
pharmaceuticals, the reverse distributor sorts through the shipment and
often uses barcodes to scan items into its system and make a credit
determination. EPA believes that 30 days is an adequate amount of time
for the reverse distributor to sort through shipments of hazardous
waste pharmaceuticals and inventory the potentially creditable
hazardous waste pharmaceuticals. The Agency has determined that because
of the value of the potentially creditable hazardous waste
pharmaceuticals, and the low risk these materials present, increasing
the amount of time reverse distributors have to complete the inventory
will not increase risk of release to the environment.
---------------------------------------------------------------------------

    \385\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the
docket for this rulemaking.
---------------------------------------------------------------------------

c. Evaluating Potentially Creditable Hazardous Waste Pharmaceuticals
Within 30 Days
    Summary of Proposal. The key role the reverse distributor plays in
managing the issuing of credit from a manufacturer to a healthcare
facility is sorting through shipments of potentially creditable
hazardous waste pharmaceuticals and evaluating them to determine which
must be transported to another reverse distributor for further
evaluation of manufacturer credit and which will be sent off site for
treatment and disposal. The reverse distributors often use barcodes to
scan items into their systems.
    EPA proposed that this evaluation process must be completed within
21 days of arriving at the reverse distributor. Likewise, EPA proposed
that if the reverse distributor is a manufacturer, the manufacturer
must finish verifying the appropriate credit within 21 calendar days of
receiving the shipment of potentially creditable hazardous waste
pharmaceuticals. The Agency proposed that the 21 calendar days for
evaluating the potentially creditable hazardous pharmaceuticals counts
as part of the total 90 calendar days that each reverse distributor is
allowed to accumulate hazardous waste pharmaceuticals on site.
    Summary of Comments. The most frequent comment EPA received on the
proposed requirement that reverse distributors complete the evaluation
process within 21 days of arriving at the reverse distributor is that
the proposed time frame was too short. Waste Management National
Services, Inc.

requested that EPA allow additional time for reverse distributors to
evaluate potentially creditable hazardous waste pharmaceuticals.\386\
One state requested that EPA allow reverse distributors to have 30 days
to complete the evaluation process.\387\ RILA and PharmaLink, Inc.
requested that EPA allow reverse distributors to have 60 days to
complete the evaluation process.\388\ GENCO, Qualanex, LLC, and
Healthcare Waste Institute of the National Waste and Recycling
Association requested that there be no time limit set for reverse
distributors to complete the evaluation process.\389\ One state
suggested that it is not critical to require the evaluation to take
place in a certain number of days if the days count toward the total
number of days that hazardous waste pharmaceuticals are allowed to
accumulate on site.\390\
---------------------------------------------------------------------------

    \386\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the
docket for this rulemaking.
    \387\ See comment number EPA-HQ-RCRA-2007-0932-0313 in the
docket for this rulemaking.
    \388\ See comment numbers EPA-HQ-RCRA-2007-0932-0295 and EPA-HQ-
RCRA-2007-0932-0349 in the docket for this rulemaking.
    \389\ See comment numbers EPA-HQ-RCRA-2007-0932-0336, EPA-HQ-
RCRA-2007-0932-0352, and EPA-HQ-RCRA-2007-0932-0296 in the docket
for this rulemaking.
    \390\ See comment number EPA-HQ-RCRA-2007-0932-0235 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    EPA also received multiple comments in support of the requirement
that reverse distributors complete the evaluation process in a short
time frame. One state supported the requirement that reverse
distributors complete the evaluation process in a short time
frame.\391\ Clean Harbors Environmental Services argued that 21 days is
more than adequate for a reverse distributor to evaluate potentially
creditable hazardous waste pharmaceuticals.\392\
---------------------------------------------------------------------------

    \391\ See comment number EPA-HQ-RCRA-2007-0932-0315 in the
docket for this rulemaking.
    \392\ See comment number EPA-HQ-RCRA-2007-0932-0333 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule, EPA is requiring in
Sec.  266.510(a)(3) that reverse distributors evaluate potentially
creditable hazardous waste pharmaceuticals within 30 calendar days of
arriving at the reverse distributor. Likewise, EPA is finalizing in
Sec.  266.510(a)(4) that if the reverse distributor is a manufacturer,
the manufacturer must finish verifying the appropriate credit within 30
calendar days of receiving the shipment of potentially creditable
hazardous waste pharmaceuticals.
    EPA is now aware that reverse distributors sometimes receive tens
of thousands of products in one day and that sometimes reverse
distributors need more than 21 days to evaluate the potentially
creditable hazardous waste pharmaceuticals.\393\ As mentioned
previously, commenters pointed out that many reverse distributors
inventory the potentially creditable hazardous waste pharmaceuticals at
the same time that they evaluate the potentially creditable hazardous
waste pharmaceuticals to determine if they will be credited.\394\
Therefore, the Agency is finalizing that both the inventory and the
evaluation process must be completed in 30 days to ensure that reverse
distributors have adequate time to sort through shipments of
potentially creditable hazardous waste pharmaceuticals.\395\ In the
case where healthcare facilities do not segregate hazardous waste
pharmaceuticals from non-hazardous waste pharmaceuticals as part of the
evaluation process, reverse distributors will effectively make a
hazardous waste determination in order to determine which
pharmaceuticals are hazardous waste pharmaceuticals and thus subject to
this subpart.
---------------------------------------------------------------------------

    \393\ See comment numbers EPA-HQ-RCRA-2007-0932-0276 and EPA-HQ-
RCRA-2007-0932-0257 in the docket for this rulemaking.
    \394\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the
docket for this rulemaking.
    \395\ Although RILA requested that EPA allow reverse
distributors to have 60 days to complete the evaluation process,
RILA was primarily concerned that it would be difficult for reverse
distributors to sort through over-the-counter pharmaceuticals and
dietary supplements within the proposed time frame (see comment
number EPA-HQ-RCRA-2007-0932-0295 in the docket for this
rulemaking). However, the Agency thinks that 30 days is a sufficient
amount of time for reverse distributors to sort through shipments of
potentially creditable hazardous waste pharmaceuticals, which does
not include over-the-counter pharmaceuticals and dietary supplements
under the final regulations (see the definition of ``potentially
creditable hazardous waste pharmaceuticals'' in 266.500).
---------------------------------------------------------------------------

    The Agency is finalizing that the 30 calendar days for evaluating
the potentially creditable hazardous pharmaceuticals do not count as
part of the total 180 calendar days that the hazardous waste
pharmaceuticals are allowed to accumulate on site at the reverse
distributor. The Agency has determined that because of the value of the
potentially creditable hazardous waste pharmaceuticals and the low risk
these materials present, increasing the amount of time reverse
distributors have to evaluate shipments of potentially creditable
hazardous waste pharmaceuticals will not increase risk of release to
the environment. Additionally, 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, and therefore EPA
has determined that having a longer accumulation time is not a hazard
to human health and the environment.\396\
---------------------------------------------------------------------------

    \396\ For more discussion of the closed container standard see
memo from Devlin to RCRA Division Directors, November 3, 2011 (RCRA
Online #14826).
---------------------------------------------------------------------------

    EPA is finalizing that once an evaluation is made on the incoming
potentially creditable hazardous waste pharmaceuticals, if they are
destined for another reverse distributor, they are still considered
potentially creditable hazardous waste pharmaceuticals. There are
additional regulations in this subpart at Sec.  266.510(b) that pertain
to these potentially creditable hazardous waste pharmaceuticals. 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 rule at Sec.  266.510(c) that
pertain to these evaluated hazardous waste pharmaceuticals.
d. Accumulation Time Limit
    Summary of Proposal. EPA proposed that, like LQGs, 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 because
they are in original manufacturer's packaging that would meet our
typical requirement for closed containers, the Agency decided not to
propose specific container management standards.
    The Agency proposed that the 90-day time limit begin when the
potentially creditable hazardous waste pharmaceuticals initially arrive
at the reverse distributor. The Agency also proposed that there is a
90-day accumulation limit for the hazardous waste pharmaceuticals at
each reverse distributor. Some potentially creditable hazardous waste
pharmaceuticals travel through more than one reverse distributor to
receive manufacturer credit. The Agency proposed that in such cases,
each reverse distributor that receives the potentially creditable
hazardous waste pharmaceuticals has a 90-day accumulation limit.
    EPA did not propose a specific method that reverse distributors
must use to document that accumulation does not exceed 90 calendar
days. EPA

anticipated that most reverse distributors would use the inventory
system to verify the 90-calendar day time frame rather than taking the
extra step of labeling containers with dates for verification. EPA also
proposed to allow a 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 reverse
distributor. Under the part 262 generator 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 proposed to allow the EPA Regional Administrator to grant
a time extension at their discretion on a case-by-case basis.
    Summary of Comments. The most frequent comment EPA received on the
proposed on-site accumulation time limit was that the 90-day
accumulation limit was too short. Waste Management National Services,
Inc. did not support the 90-day accumulation limit, arguing that there
are many reasons why a reverse distributor would experience significant
changes in the volumes of returns it receives, including recalls.\397\
Inmar, Inc. did not support the 90-day accumulation limit, arguing that
its facilities receive thousands of shipments every day and it would be
impractical to ensure a 90-day accumulation limit.\398\ Healthcare
Distribution Management Association pointed out that the 90-day
accumulation limit is too short because manufacturers frequently take
longer than 90 days to make credit determinations.\399\ Waste
Management National Services, Inc., Qualanex, LLC, and PharmaLink, Inc.
requested that EPA not require the 90-day accumulation to begin until
the potentially creditable hazardous waste pharmaceuticals become
evaluated hazardous waste pharmaceuticals.\400\ Stericycle, Inc.
requested that EPA extend the accumulation time limit from 90 days to
180 days and suggested that there should not be an accumulation time
limit for hazardous waste pharmaceuticals being held due to
recall.\401\ GENCO and Healthcare Waste Institute of the National Waste
and Recycling Association also requested that EPA extend the
accumulation time limit from 90 days to 180 days.\402\ RILA Association
requested that EPA extend the accumulation time limit from 90 days to
one year.\403\ National Pharmaceutical Returns requested that EPA place
no accumulation time limit on potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals.\404\
---------------------------------------------------------------------------

    \397\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the
docket for this rulemaking.
    \398\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
    \399\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the
docket for this rulemaking.
    \400\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0352, and EPA-HQ-RCRA-2007-0932-0349 in the docket
for this rulemaking.
    \401\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the
docket for this rulemaking.
    \402\ See comment numbers EPA-HQ-RCRA-2007-0932-0336 and EPA-HQ-
RCRA-2007-0932-0296 in the docket for this rulemaking.
    \403\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket for this rulemaking.
    \404\ See comment number EPA-HQ-RCRA-2007-0932-0310 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    EPA received multiple comments suggesting that the accumulation
time limits did not accommodate situations where reverse distributors
receive unexpired pharmaceuticals that are otherwise creditable but are
awaiting their expiration date or situations where reverse distributors
``age'' potentially creditable pharmaceuticals until they are eligible
for manufacturer credit.\405\
---------------------------------------------------------------------------

    \405\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    One state supported the 90-day accumulation limit.\406\ One state
agreed that the 90-day accumulation limit is reasonable but did not
support allowing each reverse distributor to have a 90-day accumulation
period because it increases the potential for mismanagement.\407\
---------------------------------------------------------------------------

    \406\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \407\ See comment number EPA-HQ-RCRA-2007-0932-0300 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. In response to comments, EPA is providing
additional time for reverse distributors accumulating hazardous waste
pharmaceuticals. Specifically, EPA is finalizing in Sec.  266.510(a)(5)
that reverse distributors may accumulate potentially creditable
hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals on site for up to 180 calendar days without having
interim status or a permit as long as they meet the conditions of this
subpart. The Agency is finalizing that the 180-day time limit begins
once the reverse distributor evaluates the potentially creditable
hazardous waste pharmaceutical and determines if the potentially
creditable hazardous waste pharmaceuticals must be transported to
another reverse distributor for further evaluation of manufacturer
credit or if it will be sent off site for treatment and disposal. As
mentioned in the previous section, reverse distributors are required to
inventory and evaluate potentially creditable hazardous waste
pharmaceuticals within 30 calendar days of arriving at the reverse
distributor. Therefore, the potentially creditable hazardous waste
pharmaceuticals can be accumulated at each reverse distributor for no
more than 210 days in total after arrival.
    The Agency is finalizing that there is a 180-day accumulation limit
for the hazardous waste pharmaceutical at each reverse distributor.
Some potentially creditable hazardous waste pharmaceuticals travel
through more than one reverse distributor to receive manufacturer
credit. Under the final rule, each reverse distributor that receives
the potentially creditable hazardous waste pharmaceuticals has a new
180-day accumulation limit. Under the final rule, the 180-day time
limit begins when the reverse distributor evaluates potentially
creditable hazardous waste pharmaceuticals and to determine which
potentially creditable hazardous waste pharmaceuticals must be
transported to another reverse distributor and which ones will be sent
off site for treatment and disposal.
    Under the final rule, EPA is not requiring a specific method that
reverse distributors must use to document that accumulation does not
exceed 180 calendar days. EPA anticipates that most reverse
distributors will use the inventory system to verify the 180-calendar
day time frame rather than taking an addition step of labeling
containers with dates for verification. As discussed previously, EPA is
finalizing that a reverse distributor must inventory potentially
creditable hazardous waste pharmaceuticals within 30 calendar days of
arriving at the reverse distributor. Many reverse distributors utilize
barcoding and scanners to log potentially creditable pharmaceuticals
into a database upon arrival or soon after a shipment arrives.
    Because of the value of the potentially creditable hazardous waste
pharmaceuticals, and the low risk these materials present, the Agency
is not requiring specific container management standards in the final
rule. Furthermore, potentially creditable hazardous waste
pharmaceuticals are typically still in the manufacturer's packaging,
which would meet our typical requirement for closed containers.
    Under the final rule, EPA has eliminated the proposed provision
allowing reverse distributors to request an extension of the
accumulation time limit. In order to accommodate situations where
hazardous waste

pharmaceuticals are involved in unforeseen circumstances beyond the
control of the reverse distributor, the Agency increased the
accumulation time limit from 90 days to 180 days. As discussed
previously, the Agency also increased the amount of time reverse
distributors can take to evaluate potentially creditable hazardous
waste pharmaceuticals from 21 to 30 days. Additionally, in order to
accommodate situations when hazardous waste pharmaceuticals are
involved in litigation or a recall, under the final rule, the Agency
decided that hazardous waste pharmaceuticals that are either involved
in an investigation or judicial proceeding or are subject to a
voluntary or federally-mandated recall are not required to be managed
under subpart P (see section IX for a detailed discussion). As a
result, we do not anticipate the need for reverse distributors to seek
accumulation time extensions and therefore we have deleted proposed
Sec.  266.510(a)(5).
    In order to accommodate situations when reverse distributors
receive unexpired pharmaceuticals that are otherwise creditable but are
awaiting their expiration date (i.e., aging in a holding morgue), EPA
has added a provision in Sec.  266.510(a)(5)(ii) to allow reverse
distributors to accumulate these unexpired pharmaceuticals for up to
180 days after the expiration date provided that the unexpired
pharmaceuticals are managed in accordance with the container labeling
and management standards for evaluated hazardous waste pharmaceuticals
found at Sec.  266.510(c)(4)(i)-(vi) while they are aging. This
includes labeling containers with the words ``hazardous waste
pharmaceuticals;'' ensuring the containers are in good condition,
managed to prevent leaks and compatible with the contents; and keeping
containers closed.
    Once a reverse distributor evaluates a hazardous waste
pharmaceutical and determines that it is not destined for another
reverse distributor, the reverse distributor must manage that hazardous
waste pharmaceutical according to the standards for evaluated hazardous
waste pharmaceuticals (unless, as previously mentioned, the hazardous
waste pharmaceuticals are unexpired pharmaceuticals that are otherwise
creditable but are awaiting their expiration date). The evaluated
hazardous waste pharmaceuticals can be accumulated for up to 180
calendar days without having interim status or permits and they must be
managed in accordance with the standards for evaluated hazardous waste
pharmaceuticals in Sec.  266.510(c). Although reverse distributors must
manage the hazardous waste pharmaceuticals that are not destined for
another reverse distributor in accordance with the standards for
evaluated hazardous waste pharmaceuticals, the reverse distributor can
decide at any point during the accumulation time that the evaluated
hazardous waste pharmaceuticals have become eligible for manufacturer
credit. If the evaluated hazardous waste pharmaceuticals become
eligible for manufacturer credit, the reverse distributor does not get
additional calendar days beyond the 180-day accumulation time limit to
accumulate the hazardous waste pharmaceuticals. If the evaluated
hazardous waste pharmaceutical becomes eligible for manufacturer
credit, and the hazardous waste pharmaceutical will still not be sent
to another reverse distributor for further evaluation, the reverse
distributor must continue to manage the hazardous waste pharmaceutical
in accordance with the standards for evaluated hazardous waste
pharmaceuticals.
    EPA does not anticipate a scenario where an evaluated hazardous
waste pharmaceutical becomes eligible for manufacturer credit and the
reverse distributor needs to send the hazardous waste pharmaceutical to
another reverse distributor for further evaluation. A reverse
distributor is unlikely to utilize resources to accumulate a
pharmaceutical that another reverse distributor is required to evaluate
due to contractual arrangements with pharmaceutical manufacturers.
Although EPA does not anticipate this scenario, if an evaluated
hazardous waste pharmaceutical becomes eligible for manufacturer credit
and the reverse distributor determines that it should go to another
reverse distributor to be further evaluated for manufacturer credit,
the reverse distributor can then resume managing the hazardous waste
pharmaceutical pursuant to the standards for potentially creditable
hazardous waste pharmaceuticals that are going on to another reverse
distributor (Sec.  266.510(b)). However, the reverse distributor does
not get additional time to accumulate the hazardous waste
pharmaceuticals. That is, the reverse distributor can only accumulate
the hazardous waste pharmaceuticals for a total of 180 days after the
initial evaluation process is complete. Overall, this approach balances
the requests from commenters to accommodate situations where reverse
anticipate that a manufacturer's policy might change and that evaluated
hazardous waste pharmaceuticals might become eligible for manufacturer
credit with EPA's belief that it is necessary to limit total
accumulation time to 180 days.
e. Security
    Summary of Proposal. EPA proposed that 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. Due to increased thefts of pharmaceuticals from pharmacies
reported in recent years in major media outlets, EPA was concerned that
reverse distributors could face such thefts since they accumulate
unused pharmaceuticals.\408\ Further, commenters on the 2008
Pharmaceutical Universal Waste proposal suggested that pharmaceutical
universal waste handlers should meet the TSDF facility security
requirement. EPA agreed with the commenters that the requirements in
the interim status TSDF security regulations would be appropriate to
adopt and apply to reverse distributors to prevent the illicit use of
these pharmaceuticals, thereby safeguarding human health. EPA's
proposal required that 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).
---------------------------------------------------------------------------

    \408\ ``Pharmacies Besieged by Addicted Thieves'' by Abby
Goodnough Published: February 6, 2011 http://www.nytimes.com/2011/02/07/us/07pharmacies.html.
---------------------------------------------------------------------------

    Summary of Comments. Inmar, Inc. and RILA did not support the
proposed security requirements and argued that they are duplicative
because protective security measures are already required by other
state and federal laws.\409\ One state and two industry commenters
expressed support that reverse distributors must meet a performance-
based security standard.\410\ One industry commenter pointed out that
this requirement should not be an added burden since reverse
distributors should already have significant security systems in place
and one industry commenter pointed out that the requirements are
consistent with the

way that reverse distributors operate.\411 412\
---------------------------------------------------------------------------

    \409\ See comment numbers EPA-HQ-RCRA-2007-0932-0377 and EPA-HQ-
RCRA-2007-0932-0295 in the docket for this rulemaking.
    \410\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0280, and EPA-HQ-RCRA-2007-0932-0315 in the docket
for this rulemaking.
    \411\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the
docket for this rulemaking.
    \412\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(6)
that 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. EPA believes that the requirements
that appear in the interim status TSDF security regulations are
appropriate to adopt and apply to reverse distributors to prevent the
illicit use of these pharmaceuticals thereby safeguarding human health.
The security 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 finalizing a similar requirement for 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).
    Based on site visits and comments received on the proposed
rulemaking, EPA recognizes that many 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 reverse
distributor, camera surveillance systems, and cages for storing
pharmaceuticals. Some reverse distributors may use fences and signs.
EPA is including several examples of acceptable security measures in
the regulatory text, but reverse distributors are not limited to the
examples provided. Further, EPA does not believe this requirement is
duplicative because we included a provision in the regulations that if
a reverse distributor already meets the performance-based security
standard by complying with other regulations, such as DEA's
regulations, then the reverse distributor would not need to install
additional security. Furthermore, in response to comments we added a
reference to the State Board of Pharmacy regulations as a second
example of other regulations that could be used to fulfill the
performance based security requirement.
f. Contingency Plan and Emergency Procedures
    Summary of Proposal. The Agency proposed to require that 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 noted in the
proposal that a reverse distributor should be prepared to respond to
potential emergencies just like LQGs and TSDFs. Since many reverse
distributors are already LQGs, they should already have contingency
plans to address the hazards on site. It may be possible that the
reverse distributors would have to amend their contingency plans to
include the potentially creditable hazardous waste pharmaceuticals,
which have been considered products, not hazardous waste, but the
Agency pointed out in the proposal that such modifications should not
impose much burden.
    Summary of Comments. One state and two industry commenters
supported the requirement that reverse distributors meet the same
contingency planning standards as LQGs at 40 CFR part 265 subpart
D.\413\ Inmar, Inc. supported the proposed contingency plan and
emergency procedures requirements and pointed out that most of their
facilities are LQGs and already follow these requirements.\414\ RILA
argued that the contingency planning and emergency procedures
requirements should not apply to reverse distributors that handle lower
volumes of hazardous waste than an SQG generates because the nature of
the waste does not warrant the more stringent requirements.\415\
---------------------------------------------------------------------------

    \413\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0341, and EPA-HQ-RCRA-2007-0932-0377 in the docket
for this rulemaking.
    \414\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
    \415\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(7)
that 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. Since this rule was proposed, the 2016
Hazardous Waste Generator Improvements rule has been finalized and has
placed the contingency plan and emergency procedures for LQGs in part
262 subpart M, entitled ``Preparedness, Prevention and Emergency
Procedures for Large Quantity Generators.'' As a result, this final
rule now references the LQG standards in part 262 subpart M rather than
the interim status TSDF standards part 265 subpart D. EPA believes that
a reverse distributor should be prepared to respond to potential
emergencies just like LQGs and TSDFs. Reverse distributors that are
LQGs should already have contingency plans to address the hazards on-
site. Commenters pointed out that reverse distributors that currently
operate as SQGs will face a burden under this requirement, but EPA's
data shows that most reverse distributors are already LQGs.\416\ It is
possible that the 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 EPA does not believe that such modifications will impose
much burden.
---------------------------------------------------------------------------

    \416\ See the Regulatory Impact Analysis in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Comments and Responses. One state recommended that EPA establish a
similar requirement to 40 CFR 264.31 (failure of a facility owner or
operator to maintain or operate facility to minimize possibility of
fire, explosion or releases of hazardous waste or hazardous waste
constituents) for reverse distributors.\417\ EPA included similar
language in the regulations at Sec.  266.510(c)(4)(v).
---------------------------------------------------------------------------

    \417\ See comment number EPA-HQ-RCRA-2007-0932-0235 in the
docket for this rulemaking.
---------------------------------------------------------------------------

g. Closure
    Summary of Proposal. Due to the generally low risk of release to
the environment of the hazardous waste pharmaceuticals that reverse
distributors will accumulate on site, as well as the value of the
hazardous waste pharmaceuticals, EPA proposed a performance-based
closure standard for reverse distributors that incorporated the federal
LQG closure standard found at Sec.  265.111. Specifically, when a
reverse distributor closes its operations related to hazardous waste
pharmaceuticals, EPA proposed that it must control or minimize post-
closure releases of hazardous waste into the environment. EPA expected
that this would entail removing the containers of both potentially
creditable hazardous waste pharmaceuticals as well as evaluated
hazardous waste pharmaceuticals from the facility before closure.
    Summary of Comments. Waste Management National Services, Inc., the
California Department of Toxic Substances Control, and the Connecticut
Department of Energy and Environmental Protection support the
requirement for a performance-based closure standard that is based on
the

federal LQG closure standard.\418\ Inmar, Inc. requested that EPA
clarify that the reverse distributor closure requirement only apply to
the closure of the facility and not to the closure of accumulation
areas.\419\
---------------------------------------------------------------------------

    \418\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0315, and EPA-HQ-RCRA-2007-0932-0341 in the docket
for this rulemaking.
    \419\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule at Sec.  266.510(a)(8),
EPA is requiring a performance-based closure standard that is based on
the federal LQG closure standard. Since the rule was proposed, the 2016
Hazardous Waste Generator Improvements rule has been finalized and has
incorporated the LQG closure standards into the new LQG regulations in
Sec.  262.17. As a result, this final rule now references the LQG
closure standard in Sec. Sec.  262.17(a)(8)(ii) and (iii) rather than
incorporating the regulatory language of Sec.  265.111. The LQG closure
standards are substantially the same as before. Therefore, when a
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 both potentially creditable hazardous waste
pharmaceuticals as well as evaluated hazardous waste pharmaceuticals
from the facility before closure. The closure standards apply when the
reverse distributor closes its operations related to hazardous waste
pharmaceuticals rather than when the reverse distributor closes an
accumulation area.
h. Reporting
    Summary of Proposal. In some instances, a shipment arriving at a
reverse distributor may inadvertently include 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 bags and tubing), contaminated personal protective
equipment (PPE), medical waste, or other inappropriate wastes. 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 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 reverse
distributor and should have been manifested from the healthcare
facility to a designated facility, such as a permitted or interim
status TSDF.
    EPA proposed that if a shipment including these unauthorized wastes
arrives at a reverse distributor from a healthcare facility, the
reverse distributor must submit an unauthorized waste report to the EPA
Regional Administrator within 15 days. EPA 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 situations when unauthorized
waste arrives at a reverse distributor. EPA also proposed additional
requirements for when inappropriate hazardous waste arrives at a
reverse distributor.
    First, EPA proposed that the reverse distributor must send a copy
of the unauthorized waste report to the healthcare facility that sent
the unauthorized waste. This requirement was 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, EPA proposed that the reverse distributor must manage the
unauthorized waste that it receives in accordance with all applicable
regulations. Third, the Agency proposed that the EPA Regional
Administrator may require reverse distributors to furnish additional
reports concerning the quantities and disposition of potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals.
    Summary of Comments. The most frequent comment that EPA received on
the proposed reporting requirements is that 15 days is not enough time
to submit an unauthorized waste report to the EPA Regional
Administrator. Four commenters argued that 15 days is not enough time
to submit an unauthorized waste report to the EPA Regional
Administrator.\420\ Two industry commenters pointed out that it may
take up to 30 days for shipments to be processed.\421\ Healthcare Waste
Institute of the National Waste and Recycling Association suggested
that reverse distributors be required to submit an unauthorized waste
report within 15 days of processing a shipment of hazardous waste
rather than within 15 days of receiving the hazardous waste.\422\
---------------------------------------------------------------------------

    \420\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0278, EPA-HQ-RCRA-2007-0932-0296, and EPA-HQ-RCRA-
2007-0932-0352 in the docket for this rulemaking.
    \421\ See comment numbers EPA-HQ-RCRA-2007-0932-0257 and EPA-HQ-
RCRA-2007-0932-0352 in the docket for this rulemaking.
    \422\ See comment number EPA-HQ-RCRA-2007-0932-0296 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    CT DEEP supported the reporting requirements and wrote that the
requirement might incentivize healthcare facilities not to ship
unauthorized wastes to reverse distributors.\423\ RILA did not support
the reporting requirements and wrote that reverse distributors should
not be required to submit an unauthorized waste report when shipments
of non-creditable hazardous waste pharmaceuticals arrive at the reverse
distributors because the healthcare facilities are not capable of
evaluating creditworthiness.\424\ Waste Management National Services,
Inc. requested that EPA only require reverse distributors to send a
copy of the unauthorized waste report to a specific healthcare facility
three times, arguing that it is not the reverse distributor's
responsibility to continue this reporting.\425\ National Pharmaceutical
Returns pointed out that reverse distributors receive a large amount of
unauthorized waste pharmaceuticals that healthcare facilities think are
potentially creditable and therefore the reporting requirements will be
time consuming.\426\ One state requested the EPA clarify if a reverse
distributor may refuse to take a shipment.\427\
---------------------------------------------------------------------------

    \423\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \424\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket for this rulemaking.
    \425\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the
docket for this rulemaking.
    \426\ See comment number EPA-HQ-RCRA-2007-0932-0310 in the
docket for this rulemaking.
    \427\ See comment number EPA-HQ-RCRA-2007-0932-0259 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. In response to comments, EPA is finalizing
at Sec.  266.510(a)(9) that if a shipment from a healthcare facility
arrives at a reverse distributor that includes hazardous waste that it
is not authorized to receive, the reverse distributor must submit an
unauthorized waste report to the EPA Regional Administrator within 45
days of receiving the hazardous waste rather than the proposed 15 days.
However, EPA is finalizing, as proposed, the additional requirements
for when shipments of unauthorized waste arrive at reverse
distributors. First, the reverse distributor must send a copy of the
unauthorized waste report to the healthcare facility that sent the
unauthorized waste. Second, the reverse distributor cannot reject the
shipment of non-creditable hazardous waste and must manage the
unauthorized waste in accordance with all applicable

regulations (e.g., part 262 or medical waste regulations). Healthcare
facilities are not equipped as well as reverse distributors to manage
the hazardous waste and EPA is concerned that rejecting shipments of
non-creditable hazardous waste will prolong mismanagement. Third, the
Agency is finalizing as proposed that the EPA Regional Administrator
may require reverse distributors to furnish additional reports
concerning the quantities and disposition of potentially creditable
hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals. This provides the Agency with some flexibility in what
reports may be required.
    Comments and Responses. The Agency believes that commenters
understood this provision to apply more broadly than we intended. We
are aware that healthcare facilities often do not know whether a
hazardous waste pharmaceutical will receive manufacturer credit at the
reverse distributor. EPA did not intend for a reverse distributor to
generate an unauthorized waste report each time a hazardous waste does
not receive credit. Rather, a reverse distributor must generate an
unauthorized waste report when it receives waste that it is not
authorized to receive or manage. EPA reworded the regulations to
include better examples of unauthorized waste, which includes, but is
not limited to, non-pharmaceutical hazardous waste and medical or
infectious waste.
    In order to prevent exposing employees to unnecessary risk, EPA
recommends as a best management practice that reverse distributors keep
to a minimum the sorting of shipments that contain unauthorized waste
since the shipment may include hazardous waste, including infectious or
radioactive healthcare waste. As a result, it is possible that a
reverse distributor that receives a shipment that includes non-
creditable waste may be unsure whether the shipment includes hazardous
waste. In such cases, EPA recommends that the reverse distributor
assume the shipment includes hazardous waste and submit an unauthorized
waste report. Further, we recommend that reverse distributors work with
their clients to reduce the occurrence of further inappropriate
shipments.
i. Recordkeeping
    Summary of Proposal. EPA proposed three recordkeeping requirements
to provide transparency for the movement of potentially creditable
hazardous waste pharmaceuticals and as a means of verification upon
inspection. First, EPA proposed that a reverse distributor must keep a
copy of its notification (EPA Form 8700-12) to EPA to indicate that it
is a reverse distributor operating under 40 CFR part 266 subpart P. EPA
proposed that a reverse distributor must keep the record of
notification for as long as it is subject to these requirements.
Second, EPA proposed that a reverse distributor must keep copies of the
records associated with shipments of potentially creditable hazardous
waste pharmaceuticals that it receives. This included a copy of the
proposed advance notification from the healthcare facility or other
reverse distributor, a copy of delivery confirmation, shipping papers
or bills of loading, and any unauthorized waste reports. The Agency
proposed that these shipping records must be kept for three years from
the date the reverse distributor receives the shipment. Third, EPA
proposed that a reverse distributor must keep a copy of its inventory
at all times as long as the reverse distributor remains subject to this
subpart. Finally, EPA proposed that periods of record retention
indicated previously for a 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.
    Summary of Comments. EPA received multiple comments on the
recordkeeping requirements. GENCO did not support the recordkeeping
requirements, arguing the requirements would impose burden.\428\ Inmar,
Inc. argued that reverse distributors are already required to keep
records under other regulatory requirements related to receipt,
storage, duration, and shipping of controlled and uncontrolled
substances.\429\
---------------------------------------------------------------------------

    \428\ See comment number EPA-HQ-RCRA-2007-0932-0336 in the
docket for this rulemaking.
    \429\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Stericycle, Inc., the Healthcare Waste Institute of the National
Waste and Recycling Association, and Waste Management National
Services, Inc. expressed concern about the requirement that a reverse
distributor must keep a copy of its inventory for as long as the
facility is subject to this subpart.\430\ Stericycle, Inc. argued that
it is not reasonable to require the inventory be maintained for the
life of the facility.\431\ The Illinois Council of Health-System
Pharmacists requested that EPA clarify whether reverse distributors
must maintain only a current inventory or that all inventories as they
change must be maintained.\432\
---------------------------------------------------------------------------

    \430\ See comment numbers EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-
RCRA-2007-0932-0296, and EPA-HQ-RCRA-2007-0932-0257 in the docket
for this rulemaking.
    \431\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the
docket for this rulemaking.
    \432\ See comment number EPA-HQ-RCRA-2007-0932-0228 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing the proposed recordkeeping
requirements at Sec.  266.510(a)(10) with some minor changes in order
to provide transparency for the movement of potentially creditable
hazardous waste pharmaceuticals and as a means of verification upon
inspection. First, EPA is finalizing that a reverse distributor must
keep a copy of its notification (EPA Form 8700-12) to EPA to indicate
that it is a reverse distributor operating under 40 CFR part 266
subpart P. A reverse distributor must keep the record of notification
for as long as it is subject to these requirements.
    Second, EPA is finalizing that a 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 delivery confirmation, shipping papers or bills of
lading, and any unauthorized waste reports. We have revised the
regulation language such that these shipping records must be kept for
three years from the date the shipment arrives at the reverse
distributor rather than when the reverse distributor ``receives'' the
shipment since this standard is more precise.
    Third, EPA is finalizing that a reverse distributor must keep a
copy of its current inventory at all times as long as the reverse
distributor remains subject to this subpart. The inventory is a living
document that will constantly be updated and must be available for
inspection. In order to clarify that a reverse distributor must
maintain only a current inventory rather than all inventories even if
they have changed, EPA revised the final regulatory language in Sec.
266.510(a)(2) such that a reverse distributor must keep a copy of its
current inventory. This recordkeeping change is being made to be
consistent with that change in Sec.  266.510(a)(2).
    Finally, EPA is finalizing that periods of record retention
referred to in this section are 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. The Agency recommends reverse distributors keep
electronic versions of these records rather than paper or hard copy
versions of these records.
    Note that additional recordkeeping requirements may also pertain to
reverse distributors. For example, a 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 reverse distributors for the management of potentially
creditable hazardous waste pharmaceuticals destined for another reverse
distributor (Sec.  266.510(b)) and others that apply to reverse
distributors for the management of evaluated hazardous waste
pharmaceuticals (Sec.  266.510(c)).
2. Additional Standards for Reverse Distributors Managing Potentially
Creditable Hazardous Waste Pharmaceuticals Destined for Another Reverse
Distributor (Sec.  266.510(b))
    This section discusses the additional standards that apply to a
reverse distributor for the management of potentially creditable
hazardous waste pharmaceuticals that require further evaluation or
verification of manufacturer credit at another reverse distributor.
Since these pharmaceuticals retain their value and there is greater
incentive to manage them carefully in order to receive full
manufacturer credit, EPA is requiring few regulatory standards for the
management of the potentially creditable hazardous waste
pharmaceuticals that are destined for another reverse distributor.
    a. Where potentially creditable hazardous waste pharmaceuticals can
be sent.
    Summary of Proposal. EPA proposed a limit of three transfers of
potentially creditable hazardous waste pharmaceuticals before the
hazardous waste pharmaceuticals are ultimately transported to a
permitted or interim status TSDF. The Agency proposed that the three
possible types of transfers were: \433\
---------------------------------------------------------------------------

    \433\ A healthcare facility or 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 reverse distributor, which may or may not be
a manufacturer;
    (2) the first reverse distributor may send the potentially
creditable hazardous waste pharmaceuticals to another reverse
distributor, which may or may not be a manufacturer;
    (3) the second reverse distributor can only send the potentially
creditable hazardous waste pharmaceuticals on to a reverse distributor
that is a manufacturer.
    Because EPA proposed that each reverse distributor could accumulate
hazardous waste pharmaceuticals up to 90 days after arriving at the
reverse distributor, this proposed chain of transfers ensured that the
potentially creditable hazardous waste pharmaceuticals would 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.\434\ As described
previously, this is consistent with current practice among reverse
distributors because of the contractual arrangements that reverse
distributors have with specific manufacturers.
---------------------------------------------------------------------------

    \434\ Although the proposal did allow for the possibility to
request an accumulation time limit, the final rule does not.
---------------------------------------------------------------------------

    Summary of Comments. One state did not support allowing three
transfers of potentially creditable hazardous waste pharmaceuticals
before the hazardous waste pharmaceuticals are required to be
transported to a TSDF and requested that EPA consider a maximum of two
transfers prior to transportation to a TSDF.\435\ Two industry
commenters opposed EPA's proposed limit on the number of times a
potentially creditable hazardous waste pharmaceutical may be
transferred before it must be transported to a TSDF.\436\ One of the
industry commenters argued that reverse distributors have no knowledge
about the pedigree of products prior to receipt and as such cannot be
held accountable as to how many times a product is handled before
transport to a TSDF.\437\
---------------------------------------------------------------------------

    \435\ See comment number EPA-HQ-RCRA-2007-0932-0261 in the
docket for this rulemaking.
    \436\ See comment numbers EPA-HQ-RCRA-2007-0932-0349 and EPA-HQ-
RCRA-2007-0932-0377 in the docket for this rulemaking.
    \437\ See comment number EPA-HQ-RCRA-2007-0932-0349 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. The final regulations for reverse
distributors continue to be 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 reverse distributors and reviewing comments received
on the proposed rulemaking, the Agency believes a reasonable limit is
three transfers of potentially creditable hazardous waste
pharmaceuticals before the hazardous waste pharmaceutical is ultimately
transported to a TSDF. The three possible types of transfers are: \438\
---------------------------------------------------------------------------

    \438\ A healthcare facility or 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 reverse distributor, which may or may not be
a manufacturer;
    (2) the first reverse distributor may send the potentially
creditable hazardous waste pharmaceuticals to another reverse
distributor, which may or may not be a manufacturer (Sec.
266.510(b)(1)); and
    (3) the second reverse distributor can only send the potentially
creditable hazardous waste pharmaceuticals on to a reverse distributor
that is a manufacturer (Sec.  266.510(b)(2)).
    Therefore, if a reverse distributor receives potentially creditable
hazardous waste pharmaceuticals from a healthcare facility, the reverse
distributor must send those potentially creditable hazardous waste
pharmaceuticals to another reverse distributor (which may or may not be
a manufacturer) or must manage them as evaluated hazardous waste
pharmaceuticals under Sec.  266.510(c). However, a reverse distributor
that receives potentially creditable hazardous waste pharmaceuticals
from another 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 reverse
distributor that is the manufacturer or else must manage them as
evaluated hazardous waste pharmaceuticals under Sec.  266.510(c).
    The Agency disagrees with the commenter who argued that reverse
distributors cannot be accountable for how many times a hazardous waste
pharmaceutical is transferred because reverse distributors do not have
a record of transfers of the potentially creditable hazardous waste
pharmaceuticals prior to receipt.\439\ It is not necessary for a
reverse distributor to have a record of previous transfers. It is only
necessary for a reverse distributor to know

whether a shipment of potentially creditable hazardous waste
pharmaceuticals originated from a healthcare facility or another
reverse distributor. EPA believes it is reasonable for a reverse
distributor to know the origin of a shipment that arrives at their
facility.
---------------------------------------------------------------------------

    \439\ See comment number EPA-HQ-RCRA-2007-0932-0349 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Regardless of the origin or the destination of the potentially
creditable hazardous waste pharmaceuticals, each reverse distributor
must make an evaluation of them within 30 calendar days and may only
accumulate the hazardous waste pharmaceuticals on site for no more than
180 calendar days after the evaluation before it ships them off-site to
another reverse distributor or a RCRA-permitted or interim status TSDF
(resulting in a maximum of 210 days). The 180 calendar day accumulation
time starts after the 30 calendar days to make an evaluation. In the
proposal, reverse distributors only had 90 days to accumulate hazardous
waste pharmaceuticals on-site, including the 21 calendar days to make
an evaluation. EPA made this conforming change to align with the change
in Sec.  266.510(a)(5) that allows reverse distributors to accumulate
hazardous waste pharmaceuticals on-site for up to 180 calendar days
without having interim status or a permit. In addition, all shipments
of evaluated hazardous waste pharmaceuticals are subject to Sec.
266.508 and shipments of all potentially creditable hazardous waste
pharmaceuticals are subject to Sec.  266.509.
    Although this chain of transfers will allow potentially creditable
hazardous waste pharmaceuticals to be accumulated for up to 630 days in
total after leaving a healthcare facility and before being transported
to a RCRA-permitted or interim status TSDF for treatment and disposal,
EPA does not expect that potentially creditable hazardous waste
pharmaceuticals will be accumulated for this time period in practice.
First, it is unlikely that a reverse distributor will expend resources
to accumulate potentially creditable hazardous waste pharmaceuticals on
site for the full 180 calendar days if the potentially creditable
hazardous waste pharmaceuticals are destined for another reverse
distributor. Second, the desire to receive manufacturer credit in a
timely manner will also make it unlikely that reverse distributors will
accumulate potentially creditable hazardous waste pharmaceuticals for
the full 180 days.
    EPA anticipated that some healthcare facilities that are VSQGs will
send their potentially creditable hazardous waste pharmaceuticals
directly to reverse distributors. We allow for this under Sec.
266.504(a). On the other hand, healthcare facilities that are VSQGs may
choose to consolidate all their hazardous waste pharmaceuticals (both
creditable and non-creditable) at an off site healthcare facility, as
allowed by Sec.  266.504(b). In this later case, the consolidated
potentially creditable hazardous waste pharmaceuticals at an off-site
VSQG in Sec.  266.504(b) are not counted as one of the 3 allowable
transfers of potentially creditable hazardous waste pharmaceuticals
under Sec.  266.510(b).
    Under the final rule, manufacturers cannot send hazardous waste
pharmaceuticals to a reverse distributor because the hazardous waste
pharmaceuticals are no longer considered potentially creditable
hazardous waste pharmaceuticals. Since manufacturers are unable to
issue credit to themselves, it is not possible for the hazardous waste
pharmaceuticals to be considered potentially creditable hazardous waste
pharmaceuticals.
    b. Recordkeeping for reverse distributors shipping potentially
creditable hazardous waste pharmaceuticals to another reverse
distributor.
    Summary of Proposal. EPA proposed that reverse distributors must
keep records (paper or electronic) for each shipment of potentially
creditable hazardous waste pharmaceuticals that it initiates to another
reverse distributor (whether it is a manufacturer or not). This
included a copy of the advance notification provided to the other
reverse distributor, a copy of delivery confirmation, as well as
shipping papers or bill of lading. EPA proposed that the reverse
distributor must keep these shipping records for three years from the
date it initiates the shipment.
    Summary of Comments. EPA received few comments on the recordkeeping
requirements for reverse distributors that ship potentially creditable
hazardous waste pharmaceuticals to another reverse distributor. One
state asked EPA to clarify what it means by ``shipping papers.'' \440\
---------------------------------------------------------------------------

    \440\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(b)(4)
that reverse distributors must keep records (paper or electronic)
readily available upon request by an inspector for each shipment of
potentially creditable hazardous waste pharmaceuticals that it
initiates to another reverse distributor (whether it is a manufacturer
or not). This includes a copy of delivery confirmation, as well as DOT
shipping papers. EPA has clarified in the regulations that it is the
DOT shipping papers prepared in accordance with 49 CFR part 172 subpart
C we are referring to as ``shipping papers''; EPA is not adding a
requirement for additional shipping papers. The regulations do not
specifically mention that reverse distributors keep a copy of a bill of
lading, as this is only one type of shipping paper that reverse
distributors can use to comply with 49 CFR part 172 subpart C. EPA is
finalizing that these shipping records must be kept for three years
from the date of shipment.
3. Additional Standards for Reverse Distributors Managing Evaluated
Hazardous Waste Pharmaceuticals (Sec.  266.510(c))
    This section discusses the additional standards that apply to a
reverse distributor for the management of evaluated hazardous waste
pharmaceuticals. In general, the term evaluated hazardous waste
pharmaceuticals refers to hazardous waste pharmaceuticals that were
potentially creditable hazardous waste pharmaceuticals but have been
evaluated by a reverse distributor to establish whether they are
eligible for manufacturer credit and will not be sent to another
reverse distributor for further evaluation or verification. While
potentially creditable hazardous waste pharmaceuticals have value in
the form of manufacturer credit, evaluated hazardous waste
pharmaceuticals do not. Therefore, in order to minimize the potential
for their mismanagement, EPA believes it is necessary to have
additional standards for the evaluated hazardous waste pharmaceuticals.
These standards generally resemble the standards for LQG CAAs.
    a. Accumulation area.
    Summary of Proposal. EPA proposed that once a reverse distributor
completes its evaluation of a potentially creditable hazardous waste
pharmaceutical and the reverse distributor knows that the hazardous
waste pharmaceutical is destined for treatment and disposal at a RCRA-
permitted or interim status TSDF, rather than another reverse
distributor, the pharmaceutical is considered an evaluated hazardous
waste pharmaceutical. EPA proposed that a 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.
    Summary of Comments. One state supported the requirement for
reverse distributors to establish on-site accumulation areas for
evaluated hazardous waste pharmaceuticals.\441\
---------------------------------------------------------------------------

    \441\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing as proposed that a reverse
distributor must establish an on-site accumulation area where it will
accumulate evaluated hazardous waste pharmaceuticals in Sec.
266.510(c)(1). 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 that have fewer requirements and are destined for
another reverse distributor.
    b. Weekly inspections.
    Summary of Proposal. EPA proposed 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
evaluated hazardous waste pharmaceuticals is not occurring. Under the
recordkeeping requirements for reverse distributors, the Agency
proposed that a 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.
    Summary of Comments. One state commented that weekly inspections
are not sufficient to determine whether or not diversion of evaluated
hazardous waste pharmaceuticals is occurring and requested EPA require
additional security provisions.\442\ Washington State Department of
Ecology requested that EPA clarify the intent of ``at least weekly''
and argued that they interpret ``at least weekly'' to mean once within
every seven days.\443\
---------------------------------------------------------------------------

    \442\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \443\ See comment number EPA-HQ-RCRA-2007-0932-0272 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. In response to comments, EPA is finalizing
that the accumulation area for evaluated hazardous waste
pharmaceuticals must be inspected at least once every seven days to
ensure containers are not leaking and that diversion of the hazardous
waste pharmaceuticals is not occurring. We agree with the commenter
that phrasing the standard as ``at least once every seven days'' is
more precise than ``at least weekly'' and will avoid the situation
where a reverse distributor could inspect early in one week and late
the following week and still claim it is inspecting weekly. Under the
recordkeeping requirements for reverse distributors in Sec.
266.510(c)(10), the Agency is finalizing that a 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.
    c. Personnel training.
    Summary of Proposal. EPA proposed to require that reverse
distributors meet the same federal classroom or on-the-job personnel
training regulations that LQGs must meet (Sec.  265.16). However, the
Agency specified in the 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 argues that these
personnel are the individuals handling and managing the evaluated
hazardous waste pharmaceuticals and must have appropriate hazardous
waste training.
    Summary of Comments. Two industry commenters and one state
supported the personnel training criteria for reverse
distributors.\444\ One state argued that the training requirements
should be applied to the personnel who handle potentially creditable
hazardous waste pharmaceuticals in addition to the personnel who handle
evaluated hazardous waste pharmaceuticals on site.\445\ Inmar, Inc.
pointed out that personnel at reverse distributors are already required
to receive training under other regulatory requirements.\446\
---------------------------------------------------------------------------

    \444\ See comment numbers EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-
RCRA-2007-0932-0296, and EPA-HQ-RCRA-2007-0932-0304 in the docket
for this rulemaking.
    \445\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \446\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule, reverse distributors
must meet the same classroom or on-the-job personnel training
requirements that LQGs must meet. EPA is finalizing that the personnel
that need to be trained are those persons who handle the evaluated
hazardous waste pharmaceuticals. Since these personnel are the
individuals handling and managing the hazardous waste pharmaceuticals,
they must have appropriate hazardous waste training. As mentioned
previously, EPA received multiple comments in support of the training
requirements for reverse distributors. Additionally, EPA does not
believe the training requirements will add burden because EPA believes
most reverse distributors currently operate as LQGs.\447\ Since the
proposed rulemaking, the 2016 Hazardous Waste Generator Improvement
rule was finalized. As part of its reorganization, the personnel
training regulations for LQGs are now incorporated into Sec.
262.17(a)(7) and no longer refer to Sec.  265.16. As a result, the
Sec.  266.510(c)(3) training requirements for personnel managing
evaluated hazardous waste pharmaceuticals at reverse distributors now
reference Sec.  262.17(a)(7) instead of Sec.  265.16.
---------------------------------------------------------------------------

    \447\ See the Regulatory Impact Analysis in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    d. Labeling and management of containers in on-site accumulation
area.
    Summary of Proposal. EPA proposed that while containers of
evaluated hazardous waste pharmaceuticals are in the on-site
accumulation area, they must be marked with the words, ``hazardous
waste pharmaceuticals.'' EPA proposed 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. The Agency did not propose to require an accumulation start
date on the label for the containers of evaluated hazardous waste
pharmaceuticals.
    In terms of container management standards, the Agency proposed
requirements that are similar to the container management standards for
LQGs, but the Agency proposed to include some requirements specific to
evaluated hazardous waste pharmaceuticals. For example, LQGs must keep
all containers of hazardous waste closed. However, EPA proposed 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 to the environment for those hazardous waste
pharmaceuticals that are in a solid form. The Agency did not propose to
require other containers of evaluated hazardous waste pharmaceuticals
to be closed during accumulation, although we expect that reverse
distributors would choose to do so as a best management practice.
Further, because most evaluated hazardous waste pharmaceuticals are in
their original packaging, we proposed that 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 proposed closed container standard.
    As with LQGs, EPA proposed that containers of evaluated hazardous
waste pharmaceuticals must be maintained in good condition to prevent
leaks and the container material must be compatible with the evaluated
hazardous waste pharmaceuticals placed in the container. Another
requirement that was tailored to reverse distributors was the proposal
that 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.
    The LQG regulations in part 262 include management standards for
several types of accumulation units that EPA did not propose to include
for the management of evaluated hazardous waste pharmaceuticals. For
instance, the proposal only set standards for the accumulation of
evaluated hazardous waste pharmaceuticals in containers. EPA did not
think it was necessary to include standards for accumulation units such
as tanks, containment buildings, or drip pads because reverse
distributors do not currently use these types of accumulation units. In
addition, the Agency did not propose to require 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) for LQGs because the Agency
anticipated that they will not be applicable. Additionally, 40 CFR part
265 subpart AA--air emissions standards for process vents--and subpart
BB--air emission standards for equipment leaks--are not applicable to
the activities of a reverse distributor.
    Summary of Comments. EPA received numerous comments on the proposed
requirements for labeling and management of containers of evaluated
hazardous waste pharmaceuticals in on-site accumulation areas at
reverse distributors. One state supported that containers be marked
with the words ``hazardous waste pharmaceuticals,'' but three states
and one industry commenter requested that EPA require reverse
distributors to label containers with the accumulation start date.\448\
Stericycle, Inc. agreed that there is not a need to include standards
for accumulation units such as tanks, containment buildings, or drip
pads.\449\ Clean Harbors argued that the only way to prevent diversion
of hazardous waste pharmaceuticals is for all containers to be closed
and sealed.\450\ One state requested that EPA prohibit reverse
distributors from mixing or commingling incompatible hazardous waste
pharmaceuticals in the same container rather than only requiring
reverse distributors to manage containers to prevent dangerous
situations, such as fire explosion or release of toxic fumes.\451\ One
commenter agreed that the 40 CFR part 265 subpart AA--air emissions
standards for process vents--and subpart BB--air emission standards for
equipment leaks--are not applicable to the activities of a reverse
distributor and its management of hazardous waste pharmaceuticals.\452\
---------------------------------------------------------------------------

    \448\ See comment numbers EPA-HQ-RCRA-2007-0932-0211, EPA-HQ-
RCRA-2007-0932-0235, EPA-HQ-RCRA-2007-0932-0341, and EPA-HQ-RCRA-
2007-0932-0257 in the docket for this rulemaking.
    \449\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the
docket for this rulemaking.
    \450\ See comment number EPA-HQ-RCRA-2007-0932-0333 in the
docket for this rulemaking.
    \451\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \452\ See comment number EPA-HQ-RCRA-2007-0932-0296 in the
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Final standards for labeling and management
of containers at an on-site accumulation area are found at Sec.
266.510(c)(4). EPA is finalizing that while containers of evaluated
hazardous waste pharmaceuticals are in the accumulation area, they must
be marked with the words, ``hazardous waste pharmaceuticals.'' Under
the final rule, reverse distributors are not required to mark 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 reverse distributor may choose an
alternate method, such as marking the date on each container, to ensure
that the containers of evaluated hazardous waste pharmaceuticals are
not accumulated at the reverse distributor for more than 180 days. As
explained previously, EPA prefers to allow a performance-based standard
that allows flexibility to verify the 180-day accumulation time rather
than require dating on the container labels. Most of the commenters
that requested accumulation start dates on labels were states. Although
the requirement is not being finalized at the federal level, any
authorized state has the ability to impose more stringent regulations.
If a state chooses to require the accumulation start date on the
container label, that would be considered more stringent and
permissible under RCRA.
    In terms of container management standards, the Agency is
finalizing the proposed requirements that are similar to the container
management standards for LQGs as well as the additional management
requirements specific to evaluated hazardous waste pharmaceuticals.
Specifically, only containers with evaluated hazardous waste
pharmaceuticals that are liquids or gels must be kept closed during
accumulation, although EPA expects that all containers of evaluated
hazardous waste pharmaceuticals will be closed given that evaluated
hazardous waste pharmaceuticals are in their original packaging. As
with the proposal, 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 is also finalizing that containers of evaluated 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, a reverse
distributor that manages any container of ignitable or reactive
evaluated hazardous waste pharmaceuticals or any container of
commingled incompatible evaluated hazardous waste pharmaceuticals must
manage the container to prevent dangerous situations, such as fire,
explosion, or release of toxic fumes. These regulations are consistent
with the LQG container management regulations in part 262 and already
apply to LQG reverse distributors accumulating hazardous waste on site.
The Agency is also finalizing that 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. The
dilution prohibition of Sec.  268.3(c) already prohibits the
incineration of some hazardous waste pharmaceuticals. This new
provision highlights this prohibition to the reverse distributors
accumulating the hazardous waste pharmaceuticals prior to sending off
site for treatment and disposal.
    Comments and Responses. EPA is finalizing management standards only
for containers used to accumulate evaluated hazardous waste
pharmaceuticals because commenters

confirmed that reverse distributors do not use other types of hazardous
waste accumulation units, such as tanks, containment buildings, or drip
pads.
    In addition, the Agency is not requiring reverse distributors to
meet the air emission standards found in 40 CFR part 265 subpart CC as
required for LQGs in Sec.  262.17(a)(1)(i) because the Agency
anticipates that they will not be applicable. Specifically, Sec.
265.1083(c) of subpart CC 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) of subpart CC 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 evaluated hazardous waste
pharmaceuticals are often in their original packaging, and EPA is
requiring that liquid and gel evaluated 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 have a capacity of 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 reverse distributor and
its management of evaluated hazardous waste pharmaceuticals. Therefore,
like 40 CFR part 265 subpart CC discussed previously, EPA is not
requiring that 40 CFR part 265 subparts AA and BB apply to reverse
distributors.
    e. Hazardous waste numbers (codes).
    Summary of Proposal. EPA proposed that RCRA hazardous waste numbers
(commonly called ``hazardous waste codes'') must be marked on the
container label in order to ensure that they are readily visible and
cannot be separated from the hazardous waste. In the proposal, the
Agency did not require that the reverse distributor be the party that
adds the hazardous waste codes to the containers. The proposed
regulations allowed a vendor to perform this duty on behalf of the
reverse distributor.
    Summary of Comments. Two states supported the requirement that
hazardous waste codes be placed on containers of evaluated hazardous
waste pharmaceuticals.\453\ Waste Management National Services, Inc.
argued that it is not practical to include all hazardous waste codes on
each container label and instead suggested that codes be listed on the
hazardous waste profile developed with the TSDF and on the
manifest.\454\
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    \453\ See comment numbers EPA-HQ-RCRA-2007-0932-0300 and EPA-HQ-
RCRA-2007-0932-0341 in the docket for this rulemaking.
    \454\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the
docket for this rulemaking.
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    Final Rule Provisions. Under the final rule, EPA is requiring that
the containers of evaluated hazardous waste pharmaceuticals be marked
with the applicable RCRA hazardous waste numbers (codes) at Sec.
266.510(c)(5). The hazardous waste codes must be added prior to
shipping evaluated hazardous waste pharmaceuticals off site, although
they may be placed on the container label at any time during on-site
accumulation. 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. It is necessary that the
hazardous waste numbers are on the containers so that transporters,
transfer facilities, and TSDFs know how to properly transport,
consolidate, treat, store and dispose of the hazardous waste in
compliance with the applicable RCRA regulations. In the final rule, the
Agency is not requiring that the reverse distributor be the party that
adds the hazardous waste numbers to the containers. The regulations
allow a vendor to perform this duty on behalf of the reverse
distributor. In practice, however, if a vendor is responsible for
assigning hazardous waste numbers, personnel from the reverse
distributor may need to assist in the process. To be consistent with
the Hazardous Waste Generator Improvements final rule, we have added a
sentence to Sec.  266.510(c)(5) indicating that a nationally recognized
electronic system, such as bar coding or radio frequency
identification, may be used to identify the EPA Hazardous Waste
number(s).
    f. Shipping evaluated hazardous waste pharmaceuticals.
    Summary of Proposal. Although it is already stated in Sec.
266.508(a) under the section of the regulations that pertains to
shipping standards, for clarity, EPA proposed to repeat in the Sec.
266.510 the reverse distributor regulations that 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.
    Summary of Comments. Two states generally supported the shipping
requirements for evaluated hazardous waste pharmaceuticals.\455\ One
state supported that EPA repeat in Sec.  266.510 the requirements
pertaining to shipping standards although it is already stated in Sec.
266.508(a).\456\
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    \455\ See comment numbers EPA-HQ-RCRA-2007-0932-0261 and EPA-HQ-
RCRA-2007-0932-0341 in the docket for this rulemaking.
    \456\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
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    Final Rule Provisions. For clarity, the final reverse distributor
regulations state that a reverse distributor must ship evaluated
hazardous waste pharmaceuticals that are destined for a permitted or
interim status treatment, storage or disposal facility in accordance
with the applicable shipping standards in Sec.  266.508(a) or (b). 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 permitted or
interim status TSDF.
    g. Procedures for managing rejected shipments.
    Summary of Proposal. The Agency proposed to require that reverse
distributors meet the same procedures that LQGs must meet for rejected
shipments in Sec.  262.42(c). Specifically, 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 reverse distributor and the TSDF returns the shipment to the
reverse distributor, EPA proposed that the reverse distributor must
sign either item 18c of the original manifest or item 20 of a new
manifest. In addition, the proposal allowed the reverse distributor to
consolidate the rejected hazardous waste pharmaceuticals on site for up
to 90 days provided they were managed in the on-site accumulation area
and in accordance with the reverse distributor standards for evaluated
hazardous waste pharmaceuticals. EPA also proposed that reverse
distributors send a copy of

the manifest to the designated facility that returned the shipment to
the reverse distributor within 30 days of delivery.
    Summary of Comments. One state requested the EPA clarify that a
reverse distributor that receives a rejected shipment does not have to
transport it off site upon receipt by the reverse distributor.\457\ One
state argued that a reverse distributor does not need 90 days to
accumulate rejected hazardous waste pharmaceuticals in the on-site
accumulation area and argued that 30 days is sufficient.\458\
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    \457\ See comment number EPA-HQ-RCRA-2007-0932-0231 in the
docket for this rulemaking.
    \458\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
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    Final Rule Provisions. The Agency is finalizing in Sec.
266.510(c)(7) that reverse distributors must meet the same procedures
that LQGs must meet for rejected shipments in Sec.  262.42(c). Under
part 262, these rejected shipment procedures already apply to LQG
reverse distributors. Furthermore, EPA anticipates that a rejected
shipment is a relatively infrequent occurrence and therefore should not
be a burden to reverse distributors. In addition, the final rule allows
the reverse distributor to 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 the reverse
distributor standards for evaluated hazardous waste pharmaceuticals.
Although one state requested EPA only allow accumulation for 30 days,
any authorized state has the ability to impose more stringent
regulations. If a state chooses to shorten the accumulation time, that
would be considered more stringent and permissible under RCRA.
    h. Land disposal restrictions.
    Summary of Proposal. EPA proposed that reverse distributors are
subject to the same LDRs that apply to LQGs with respect to their
evaluated hazardous waste pharmaceuticals. In addition, EPA proposed 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.
    Summary of Comments. EPA received multiple comments in support of
the requirement that reverse distributors meet the same LDRs that apply
to LQGs with respect to their evaluated hazardous waste
pharmaceuticals, including two states.\459\ The Oregon Association of
Clean Water Agencies wrote that applying the LDRs will reduce mobility
of pharmaceutical constituents in landfill leachate, which is
frequently routed to POTWs in Oregon.\460\
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    \459\ See comment numbers EPA-HQ-RCRA-2007-0932-0315 and EPA-HQ-
RCRA-2007-0932-0341 in the docket for this rulemaking.
    \460\ See comment number EPA-HQ-RCRA-2007-0932-0288 in the
docket for this rulemaking.
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    Final Rule Provisions. As required by HSWA, EPA is finalizing that
reverse distributors are subject to the same land disposal restrictions
that apply to LQGs with respect to their evaluated hazardous waste
pharmaceuticals. In addition, EPA is amending the titles at Sec. Sec.
268.7 and 268.7(a) to add the words, ``reverse distributors'' to make
the applicability of the land disposal restrictions clear. SQG and LQG
reverse distributors are already subject to LDRs for their hazardous
waste pharmaceuticals. Therefore, this provision does not impose
additional burden on reverse distributors.
    i. Reporting.
    Summary of Proposal. EPA proposed that reverse distributors submit
a biennial report (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. The Agency
proposed that the BR should only include the evaluated hazardous waste
pharmaceuticals, and not the potentially creditable hazardous waste
pharmaceuticals that a reverse distributor sends to another reverse
distributor. Specifically, EPA proposed that a reverse distributor
comply with the LQG BR requirements in Sec.  262.41, except for Sec.
262.41(a)(7), which included the requirement to report changes in
volume and toxicity of waste achieved during the year in comparison to
previous years. The Agency did not propose that a reverse distributor
provide such information because it does not have control of the volume
or toxicity of the hazardous waste pharmaceuticals it receives from
healthcare facilities, and thus has no ability to reduce the volume or
toxicity of the hazardous waste pharmaceuticals.
    EPA proposed that reverse distributors provide an exception report
when a TSDF does not return the hazardous waste manifest to the reverse
distributor for shipments of evaluated hazardous waste pharmaceuticals.
Likewise, EPA proposed that reverse distributors meet LQG exception
reporting when a shipment from a reverse distributor is rejected by the
designated facility and forwarded onto an alternate facility. These
proposed standards were adapted from the exception reporting for LQGs
in Sec.  262.42(a).
    Summary of Comments. One state supported both of the proposed
reporting requirements for reverse distributors managing evaluated
hazardous waste pharmaceuticals that are transported to a TSDF.\461\
RILA argued that the requirement that reverse distributors submit a BR
for the evaluated hazardous waste pharmaceuticals that are transported
to a TSDF is effectively more stringent than current generator
requirements that only require generators to submit a biennial report
if they generate over 1000 kg of hazardous waste in a month.\462\
---------------------------------------------------------------------------

    \461\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the
docket for this rulemaking.
    \462\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket for this rulemaking.
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    Final Rule Provisions. EPA is finalizing at Sec.  266.510(c)(9)(i)
that 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. The BR should only
include the evaluated hazardous waste pharmaceuticals, and not the
potentially creditable hazardous waste pharmaceuticals that a reverse
distributor sends to another reverse distributor. EPA does not expect
that requiring reverse distributors to submit a BR for evaluated
hazardous waste pharmaceuticals will be burdensome because most reverse
distributors currently operate as LQGs and already submit a BR.\463\
Specifically, under the final rule, reverse distributors must comply
with the LQG BR requirements in Sec.  262.41. EPA proposed that reverse
distributors had to comply with the LQG BR requirements in Sec.  262.41
except Sec.  262.41(a)(7), which included the requirement to report
changes in volume and toxicity of waste achieved during the year in
comparison to previous years. However, since the proposed rulemaking,
the 2016 Hazardous Waste Generator Improvement rule was finalized. As
part of that final rule, Sec.  262.41(a)(7) was removed from the
generator requirements. Thus, the final rule only states that reverse
distributors must

comply with the LQG BR requirements in Sec.  262.41.
---------------------------------------------------------------------------

    \463\ See the Regulatory Impact Analysis in the docket for this
rulemaking EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    Consistent with the LQG regulations in part 262, EPA is finalizing
at Sec.  266.510(c)(9)(ii) that reverse distributors must provide an
exception report when a TSDF does not return the signed hazardous waste
manifest to the reverse distributor for shipments of hazardous waste
pharmaceuticals to a designated facility within 45 days of shipment.
Likewise, EPA is finalizing that reverse distributors must provide an
exception report when a shipment from a reverse distributor is rejected
by the designated facility and forwarded onto an alternate facility and
the reverse distributor does not receive a copy of the manifest with
the signature of the owner or operator of the alternate facility within
35 days. These standards were adapted from the exception reporting for
LQGs in Sec.  262.42(a), while the standards for healthcare facilities
managing non-creditable hazardous waste pharmaceuticals were adapted
from the exception reporting for SQGs Sec.  262.42(b). EPA is
finalizing that a reverse distributor that does not receive a copy of
the manifest within 35 days of the date the evaluated hazardous waste
pharmaceuticals were accepted by the initial transporter must contact
the transporter or TSDF to determinate the status of the evaluated
hazardous waste pharmaceuticals. EPA is also finalizing that a reverse
distributor must submit a copy of an exception report if it has not
received a copy of the manifest within 45 days of the date the
evaluated hazardous waste pharmaceuticals were accepted by the initial
transporter. The exception report must include a legible copy of the