category, especially when acute hazardous waste pharmaceuticals such as
warfarin (brand name: Coumadin) no longer need to be counted. A shift
in generator category, should it occur, would allow a healthcare
facility to manage its non-pharmaceutical hazardous waste, such as
hazardous waste from laboratories, according to the reduced part 262
generator regulations for a smaller category.
    For reverse distributors, it works somewhat differently than with
healthcare facilities, because all reverse distributors are subject to
part 266 subpart P for the management of their hazardous waste
pharmaceuticals, including reverse distributors that are

VSQGs. In other respects, the regulations work the same, because
reverse distributors also are not required to count their hazardous
waste pharmaceuticals when determining their part 262 generator
category for their non-pharmaceutical hazardous waste.
    Again, we emphasize, such dropping down in generator category only
pertains to non-pharmaceutical hazardous waste and is only possible
when the hazardous waste pharmaceuticals are being managed under
subpart P. Further, EPA points out that universal wastes also are not
counted toward a facility's generator category and what we are
finalizing for hazardous waste pharmaceuticals has been implemented
successfully for years within the universal waste program for
facilities that generate both universal waste and other hazardous
waste.
    Below are a diagram and a table to help summarize the preceding
sections of the preamble related to the applicability of the final rule
and the provision that allows a healthcare facility or a reverse
distributor to not count hazardous waste pharmaceuticals when
determining the facility's generator category for its non-
pharmaceutical hazardous waste.
BILLING CODE 6560-50-P

[GRAPHIC] [TIFF OMITTED] TR22FE19.000

[GRAPHIC] [TIFF OMITTED] TR22FE19.001

BILLING CODE 6560-50-C

X. Standards for Healthcare Facilities That Manage Non-Creditable
Hazardous Waste Pharmaceuticals (Sec.  266.502)

A. Notification/Withdrawal Requirements for Healthcare Facilities
Managing Non-Creditable Hazardous Waste Pharmaceuticals (Sec.
266.502(a))

1. Summary of Proposal
    To address commenters' concerns from the 2008 Pharmaceutical
Universal Waste proposal that regulatory agencies are unaware of
hazardous waste pharmaceutical management activities, EPA proposed to
require that a healthcare facility that does not qualify as a VSQG to
submit a one-time notification as a ``healthcare facility'' to the
appropriate EPA Regional Administrator. EPA proposed that healthcare
facilities subject to 40 CFR part 266 subpart P will have to submit a
notification even if the healthcare facility has previously obtained an
EPA identification number. The required notification was meant to
enable EPA and state regulatory agencies to identify the universe of
healthcare facilities managing hazardous waste pharmaceuticals subject
to the 40 CFR part 266 subpart P requirements.
    At any point, a healthcare facility's hazardous waste
pharmaceutical generation may change due to waste minimization efforts
or other reasons, causing the facility to legitimately decrease its
total monthly hazardous waste generation enough to qualify as a VSQG.
In this case, if the healthcare facility withdraws from the 40 CFR part
266 subpart P requirements due to qualifying as a VSQG, EPA proposed
that the healthcare facility must re-notify EPA of its choice to
withdraw.
    Alternatively, if a healthcare facility determines that it is a
VSQG, but does not want to keep track of the amount of hazardous waste
pharmaceuticals it generates and whether it is above or below the VSQG
threshold, we proposed that it can choose to operate under subpart P.
By choosing to operate under subpart P, the VSQG healthcare facility
must comply with all of the requirements, including the one-time
notification that it is operating under 40 CFR part 266 subpart P. We
proposed that healthcare facilities that are not VSQGs, however, are
required to operate under 40 CFR part 266 subpart P for the management
of their hazardous waste pharmaceuticals.
    The Agency proposed that this notification occur using the RCRA
Subtitle C Site Identification Form (EPA Form 8700-12; or Site
Identification Form). EPA believes that notification via the Site
Identification Form is the preferred approach for notification purposes
for several reasons. First, both state environmental regulatory
agencies and hazardous waste generators are familiar with the form, as
it is the form currently used by hazardous waste generators to notify
regulators of their RCRA Subtitle C activities. Second, as stated
previously, the use of the Site Identification Form will allow for EPA
and state regulatory agencies to monitor the healthcare facilities
utilizing the new regulatory requirements. Lastly, public comments
received on previous EPA actions (e.g., Academic Laboratories
Rulemaking (73 FR 72912; December 1, 2008)) have indicated that
notification via the Site Identification Form is the notification
approach typically preferred by the regulated community. We proposed
that healthcare facilities can submit their notification as part of the
Biennial Report, if the healthcare facility will be required to submit
a Biennial Report due to its non-pharmaceutical hazardous waste. This
was intended to take advantage of an existing reporting mechanism for
LQGs or other generators already required to submit the Biennial Report
and avoid duplicative notification requirements. Otherwise, healthcare
facilities are required to notify within 60 days of this new subpart
becoming effective, or within 60 days of becoming subject to this new
subpart. We also proposed that a healthcare facility would have to keep
a record of its notification as long as it is subject to this subpart.
    The Agency did not anticipate that the proposed notification
requirement would place any undue economic burden upon healthcare
facilities or the environmental regulatory agencies that process these
notifications (see the Regulatory Impact Analysis for the proposed
rulemaking in the rulemaking docket EPA-HQ-RCRA-2007-0932). In fact,
under the proposed regulations, healthcare facilities would no longer
need to count the hazardous waste pharmaceuticals managed under 40 CFR
part 266 subpart P towards a healthcare facility's generator category.
As a result, EPA anticipates that many healthcare facilities will
reduce their generator category to either an SQG or VSQG for their
other non-pharmaceutical hazardous wastes. So, while the notification
requirement ensures that the environmental regulatory agencies are
informed of all hazardous waste pharmaceutical management activities
subject to the 40 CFR part 266 subpart P requirements, the fact that
some healthcare facilities will no longer qualify as LQGs will reduce
the number of healthcare facilities in the LQG universe.
    The Agency solicited comment on the notification requirement for
healthcare facilities, the method of notification via the Site
Identification Form, and whether this notification requirement will
result in any undue burden to either healthcare facilities or state
environmental regulatory agencies.
2. Summary of Comments
    While there was general support for requiring healthcare facilities
to notify the EPA Regional Administrator that they are operating under
this subpart, a number of states and industry commenters provided
opposition to the proposed 60-day time frame. States supported
notification but were concerned that they would not be able to process
all of the notifications in a timely manner given that all VSQG and SQG
facilities operating under subpart P would have to notify within 60
days of the effective date of this rule. One suggestion was to instead
require notification on a rolling or staggered basis to give resource-
limited states enough time to process the notices within a timely
manner.
    States also voiced concern about the provision allowing healthcare
facilities that are LQGs because of their non-pharmaceutical waste to
notify as part of their normal Biennial Reporting schedule.\197\
Depending on the timing of the Final Rule, states were concerned about
the possibility that LQGs would not have to notify that they are
operating under this subpart for up to two years, during the course of
which they could be generating large amounts of pharmaceutical waste
and managing it under the reduced restrictions of this subpart
unbeknownst to the state or EPA. Meanwhile VSQGs and SQGs would have to
notify within 60 days.\198\ Another state recommended that healthcare
facilities be required to list on the notification what their generator
category would be if they were to count their pharmaceutical waste. The
state was concerned that a healthcare facility could be generating LQG
amounts of pharmaceutical waste but because they are now VSQGs, would
be a much lower inspection priority.\199\
---------------------------------------------------------------------------

    \197\ Sec.  262.18(d)(2) requires LQGs to renotify EPA by March
1 of each even-numbered year thereafter using EPA Form 8700-12. An
LQG may submit this renotification as part of its Biennial Report
required under Sec.  262.41.
    \198\ EPA-HQ-RCRA-2007-0932-0341.
    \199\ EPA-HQ-RCRA-2007-0932-0235.
---------------------------------------------------------------------------

    There was, however, no opposition to the provision that a
healthcare facility

be required to maintain a copy of its notification on file as long as
it is subject to this subpart.
3. Final Rule Provisions
    EPA is finalizing the notification provisions for healthcare
facilities managing non-creditable hazardous waste pharmaceuticals as
proposed, with no changes.
    All healthcare facilities as defined in Sec.  266.500 that are
subject to the requirements of this subpart (all healthcare facilities
that generate above the VSQG thresholds and healthcare facilities that
are VSQGs choosing to operate under this subpart) will have to submit a
notification to the EPA Regional Administrator using the Site ID Form
(EPA Form 8700-12) stating that they are a healthcare facility and will
be operating under this subpart. A healthcare facility that already has
an EPA Identification Number must re-notify the EPA Regional
Administrator that it will be operating under this subpart within 60
days of becoming subject to subpart P. Healthcare facilities that do
not have an EPA Identification Number will be required to obtain one by
submitting the Site Identification Form (EPA Form 8700-12) within 60
days from the effective date of this rule if they are not otherwise
required to submit Biennial Reports. A healthcare facility that
undergoes a change in generator category causing them to become subject
to the requirements of this subpart must notify the EPA Regional
Administrator within 60 days of the event that triggered the change in
generator category.
    Healthcare facilities that are LQGs for their non-pharmaceutical
hazardous waste, and therefore must submit a Biennial Report, may
notify the EPA Regional Administrator according to their normal
reporting cycle. SQGs that are required by their state to submit a
Biennial Report may also notify EPA that they are operating under
subpart P on their normal reporting cycle. Healthcare facilities that
are required to submit a Biennial Report are not, however, required to
wait to notify EPA that they are operating under subpart P on their
Biennial Report, and may notify EPA at any point prior to submitting
the Biennial Report. The Agency notes that any healthcare facility that
is required to operate under subpart P must begin complying with its
requirements as soon as the final rule becomes effective. VSQGs that
opt into subpart P may notify the EPA whenever they choose, but they
become subject to the requirements of this subpart on the date they
submit the notification. All healthcare facilities must retain a copy
of the notification as long as they are operating under this subpart.
4. Comments and Responses
    Some states were concerned about their ability to process
notifications in a timely manner given the 60-day time frame after the
effective date of this rule within which all non-LQG healthcare
facilities must notify EPA that they are operating under this subpart.
The Agency reasserts, however, that the added burden is reasonable and
necessary for the Agency and implementing states to gain a timely
understanding of the facilities within the universe of this rule.
    The Agency also notes that this final rule goes into effect six
months from the date it is published in the Federal Register in EPA
Territories and states that do not have an authorized RCRA program.
That time frame could be even longer in authorized states which must
first adopt this rule for it to become effective. Therefore, healthcare
facilities in all states have a minimum of six months from the day this
rule is published in the Federal Register, plus the 60 days in this
requirement, to notify their state that they are operating under this
subpart.
    One commenter suggested that the agency implement a staggered roll-
out of this notification provision to prevent them from becoming
inundated with incoming notifications, preventing them from processing
notifications in a timely manner. The Agency would note, however, that
there is no provision requiring a healthcare facility to receive
approval before it can operate under this subpart and states and
regions can process the notifications by whatever time frames and
methods they choose. All healthcare facilities must operate under this
subpart immediately upon becoming subject to this rule. Therefore, as
long as a healthcare facility that does not submit a BR notifies its
state within 60 days that it is operating under this subpart, it will
be in compliance. In addition, we did not propose and are not
finalizing any time frames within which regional or state offices must
process notifications, therefore, we defer to those agencies to develop
their own best practices.
    Another state suggested that EPA develop a ``smart-form'' tool for
RCRAInfo--EPA's database of RCRA-related information from required
reporting-- that would allow healthcare facilities to notify the state
electronically that they are operating under subpart P, directly input
their own information, and update their information on a regular basis.
EPA notes that it has developed an online tool called myRCRAid which
allows generators to complete and submit the Site Identification Form
electronically, which the Agency expects will reduce states'
administrative burden by reducing the number of notifications that have
to be manually input, while simultaneously reducing the potential for
error while transferring data.
    In addition, the Site Identification Form will be modified by EPA
in a separate action to add a section for a healthcare facility to
indicate that it generates hazardous waste pharmaceuticals. The
healthcare facility will no longer be required to identify on the Site
Identification Form the specific types of hazardous waste
pharmaceuticals it generates. The Agency also intends to add a checkbox
to the new section which will allow a healthcare facility to indicate
that its generator category is changing to a VSQG and it is no longer
managing its hazardous waste pharmaceuticals according to 40 CFR part
266 subpart P.
    Some states disagreed with the provision that allows healthcare
facilities that file a BR to notify EPA that they are operating under
subpart P on their normal reporting schedule, as opposed to notifying
within 60 days of this rule becoming effective, or becoming subject to
subpart P. This means that healthcare facilities that file a BR could
potentially operate under this subpart for up to two years without
having to notifying the Agency, depending on when their normal BR date
falls in relation to the effective date of this rule. They recommended
that all facilities, regardless of generator category, be required to
notify within 60 days. While the Agency agrees that the possibility for
a healthcare facility to operate for up to two years under this subpart
without notifying EPA does, in fact, exist, we do not wish to impose
duplicative notification requirements.
    One state requested that a healthcare facility be required to list
on the notification what its generator category would be if it were
required to count its hazardous waste pharmaceuticals. They were
concerned that some facilities that are LQGs because of their hazardous
waste pharmaceuticals would reduce their generator category as a result
of this rule, making them a low priority for inspections, even though
they could still be generating LQG quantities of pharmaceutical waste.
We understand the state's concern, however, making a change like this
would not be in line with the goals of this rule to provide streamlined
standards. However, options available to the states with similar
concerns are adopting more stringent requirements or using

historical notifications and Biennial Report data.

B. Personnel Training Requirements for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(b))

1. Summary of Proposal
    a. Performance-based training standards. EPA believes that the part
262 LQG training regulations are excessive for healthcare personnel who
sporadically generate hazardous waste pharmaceuticals at healthcare
facilities, but believes it is necessary to have some familiarity with
the dangers that hazardous waste pharmaceuticals can pose, making the
VSQG training standards insufficient. Therefore, the Agency proposed
healthcare facility-specific personnel training requirements that are
akin to the training requirements for SQGs and small quantity universal
waste handlers, for all healthcare facilities subject to subpart P.
Specifically, we proposed that healthcare facilities managing hazardous
waste pharmaceuticals in accordance with subpart P must inform all
employees that handle or have responsibility for generating and/or
managing hazardous waste pharmaceuticals of the proper handling and
emergency procedures appropriate to their responsibilities during
normal facility operations and emergencies. We indicated in the
preamble to the proposed rulemaking that this training information can
be disseminated through verbal communication or through distribution of
pamphlets or other documentation. However, a healthcare facility that
is an LQG due to its non-pharmaceutical hazardous wastes may choose to
continue to use its existing training program as an LQG so as not to
have different training programs.
    Under part 262 regulations, an LQG healthcare facility had to
provide full RCRA training to its personnel involved in the generation
and/or management of hazardous waste according to the standards in
Sec.  262.17(a)(7). These personnel training requirements include
either classroom instruction, on-line training, or on-the-job training
in RCRA and require the facility to maintain documentation of that
training. On the other hand, before this rule was finalized, under the
part 262 regulations, an SQG healthcare facility had to meet a
performance-based standard when training personnel involved in the
generation and/or management of hazardous waste pharmaceuticals.
Specifically, this entailed ensuring ``that all employees are
thoroughly familiar with proper waste handling and emergency procedures
relevant to their responsibilities during normal facility operations
and emergencies. '' \200\ For comparative purposes, healthcare
facilities that are considered VSQGs did not have any personnel
training requirements under the part 262 regulations. Similarly, SQGs
and LQGs, including healthcare facilities, were not required to provide
RCRA training to personnel that only work in SAAs regulated under Sec.
262.15. That said, healthcare personnel that are involved in the
generation of hazardous waste pharmaceuticals must be familiar enough
with the pharmaceuticals with which they work to know when they have
generated a hazardous waste so that it will be managed in accordance
with the RCRA regulations.
---------------------------------------------------------------------------

    \200\ Sec.  262.16(b)(9)(iii)
---------------------------------------------------------------------------

    b. Documentation of training. Although no regulations were
proposed, EPA also sought comment in the preamble to the proposed
rulemaking on whether documentation of training is necessary in order
to verify compliance with the training requirement.
2. Summary of Comments
    a. Performance-based training standards. There were a variety of
comments on the proposed training standards, both in support and
opposition. Although most states agreed with the assessment that
standard LQG regulations would be excessive if applied to healthcare
facilities, some wanted EPA to provide more stringent and prescriptive
language. Commenters from the waste management industry were also
opposed to the proposed performance-based standards for similar
reasons.
    Pharmacy trade groups generally agreed with the proposed standards,
citing the same rationale provided in the preamble of the proposed
rulemaking, which states that the variability in waste generated and
turnover in employees warrants a performance-based standard, and any
subsequent training should be left up the healthcare facility. They
stated that most pharmacy staff are trained on proper handling and
management of radiation and other pharmaceuticals that can pose
significant risks as required by other accreditation and standard-
setting agencies and any prescriptive training standards under subpart
P would be duplicative.
    b. Documentation of training. There were mixed comments on whether
to require that a healthcare facility document that its personnel have
been trained according to the standards set forth in 40 CFR 266.502(b).
All of the states that commented on this issue were supportive of the
requirement to document training. These states were mostly concerned
with their ability to cite specific violations of the training
provisions during inspections. Another state mentioned that many
facilities already maintain documentation of training as a best
management practice.
    Waste management companies also wanted EPA to require healthcare
facilities to document that employees have been trained. They argued
that the training standards will not have their intended effect if
there is no requirement for documentation because healthcare facilities
will not feel compelled to comply with them.
    Pharmacy trade groups were concerned that requiring documentation
of training would result in added burden and generally opposed this
provision. They argued that there are a number of standard-setting and
accreditation agencies that already require documentation that
employees have been trained, and as such, this requirement would be
redundant and overly burdensome.
3. Final Rule Provisions
    a. Performance-based training standards. EPA is finalizing the
performance-based training standards as proposed. A healthcare facility
must train employees to the extent that they are thoroughly familiar
with the proper handling and emergency procedures relevant to their
responsibilities during normal operations and emergencies. The
information can be disseminated verbally, via printed materials, or
other means. These standards are similar to the training standards for
SQGs and small quantity handlers of universal waste.201 202
The agency feels that these standards provide consistency across
generator types and do not impose any added burden on inspection and
enforcement actions beyond what is already in place within the
Universal Waste program.
---------------------------------------------------------------------------

    \201\ 40 CFR part 262.16 (a)(9)(iii).
    \202\ 40 CFR part 273.16.
---------------------------------------------------------------------------

    b. Documentation of training. EPA has decided not to finalize a
standard that would have required healthcare facilities to document
that the performance-based training standards have been met. The Agency
thinks this requirement would have resulted in an undue increase in the
regulatory burden for healthcare facilities. Also, there is no such
requirement in the part 262 SQG training requirements or for small
quantity handlers of universal waste.

The agency feels this approach is consistent with other RCRA
regulations and would improve consistency with the Universal Waste
program, especially since the requirements for healthcare facilities
managing hazardous waste pharmaceuticals were purposefully modeled
after the requirements for small quantity handlers of universal waste.
The Agency ultimately concluded that, because this approach is
sufficient for universal waste, it is also acceptable for hazardous
waste pharmaceuticals.
4. Comments and Responses
    a. Performance-based training standard. There were a number of
commenters from states and the waste management industry that
recommended more rigorous and prescriptive training standards such as
more specific minimum requirements, recurring training, and that the
Agency specify the job titles subject to the training requirements. The
Agency is not finalizing any of these recommendations, however, because
we believe that the proposed performance-based standards are protective
of human health and the environment without imposing undue burden
either on states or industry. These standards strike an appropriate
balance between ensuring proper management of hazardous waste
pharmaceuticals and reducing the regulatory burden on healthcare
facilities and healthcare personnel in a manner that also encourages
compliance with these new regulations.
    One commenter mentioned that prescriptive RCRA training
requirements would be duplicative given the training requirements of
the various accreditation entities. The Agency responds that any waste
management training for healthcare personnel would not be duplicative
because accreditation training typically focusses on managing
pharmaceuticals prior to becoming a waste, whereas the training
required in subpart P is targeted specifically at management practices
after the pharmaceuticals have become waste. As mentioned previously,
the Agency is not finalizing prescriptive training standards in an
effort to minimize regulatory burden and allow healthcare facilities to
tailor their training programs in a way that best fits their
circumstances.
    These training standards apply only to healthcare personnel.
Healthcare personnel includes any person that manages hazardous waste
pharmaceuticals at a healthcare facility (e.g., employees, volunteers,
students). Environmental health and safety personnel are likely to
manage hazardous wastes other than just hazardous waste pharmaceuticals
at a healthcare facility, in which case, they would be subject to other
RCRA Subtitle C training requirements.
    The Agency acknowledges that there are many pharmaceuticals that
pose significant risk to human health and the environment, yet are not
RCRA hazardous when they become waste. We in no way intend to imply
that these items pose any less of a risk by virtue of being considered
non-hazardous under RCRA and encourage healthcare facilities to provide
all relevant training to healthcare personnel and observe industry best
management practices.
    b. Documentation of training. After requesting comment on
documentation of training, the Agency decided not to finalize any
requirements for healthcare facilities to document and maintain records
verifying that healthcare personnel have met the training requirements.
We considered the many adverse comments and ultimately agreed that such
requirements would be overly burdensome and more stringent than the
training requirements in the Universal Waste rule, which were largely
emulated in this rule. Many comments that advocated for a requirement
to document training were from states. Although such a 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 documentation of training, that would be considered more
stringent and permissible under RCRA.

C. Healthcare Facilities Making a Hazardous Waste Determination for
Non-Creditable Pharmaceuticals (Sec.  266.502(c))

1. Summary of Proposal
    EPA proposed that, similar to the current part 262 generator
requirements, healthcare facilities operating under subpart P would be
required to make hazardous waste determinations on pharmaceutical
wastes in order to determine the applicable management standards.
Specifically, we proposed that when a healthcare facility generates a
solid waste pharmaceutical, the healthcare facility must determine if
the discarded pharmaceutical is listed in 40 CFR part 261 subpart D
and/or if it exhibits one or more of the four characteristics of
hazardous waste identified in 40 CFR part 261 subpart C. We proposed
that, if the non-creditable pharmaceutical waste is determined to be a
hazardous waste, then the healthcare facility must manage the non-
creditable hazardous waste pharmaceuticals in accordance with part 266
subpart P instead of 40 CFR part 262. Pharmaceutical wastes--both
potentially creditable and non-creditable--not meeting the definition
of a hazardous waste (i.e., non-hazardous waste pharmaceuticals) must
be managed in compliance with applicable federal, state and local
regulations.
    EPA understands that healthcare facilities utilize various
approaches when making hazardous waste determinations. For example,
healthcare facilities may hire consultants to review their formularies
and identify those pharmaceuticals that are hazardous wastes when
discarded. These facilities may then identify hazardous waste
pharmaceuticals at the pharmacy level, marking these pharmaceuticals
with a special label so that healthcare personnel know how to properly
dispose of the pharmaceutical when it becomes a waste. Other healthcare
facilities may instruct personnel to dispose of all pharmaceutical
wastes into one RCRA hazardous waste collection container. These
healthcare facilities may then choose to manage all of the contents of
the container as hazardous waste or they may choose to sort the
hazardous waste portion from the non-hazardous waste pharmaceutical
portion in an on-site hazardous waste accumulation area, also known as
a CAA. Due to the various ways that healthcare facilities make the
hazardous waste determination, the Agency did not propose that a
specific approach be utilized when making the hazardous waste
determination, only that the facility performs the hazardous waste
determination.
    We also proposed that healthcare facilities have the option to
manage all of their pharmaceutical wastes as hazardous, and thus, if a
healthcare facility chooses this approach, they would not need to make
individual hazardous waste determinations. Instead, they would have
made a generic decision that all of their discarded pharmaceuticals are
hazardous and manage them as hazardous waste pharmaceuticals in
accordance with the requirements in 40 CFR part 266 subpart P.
Accumulating all non-creditable waste pharmaceuticals in one container
(except for those that are incompatible or cannot be incinerated
according to the dilution prohibition) \203\ and

managing them under subpart P would relieve healthcare facilities from
the burden associated with making individual hazardous waste
determinations.
---------------------------------------------------------------------------

    \203\ Sec.  268.3(c) Dilution prohibited as a substitute for
treatment. See appendix XI of part 268 for a full list of hazardous
wastes that are prohibited from being combusted.
---------------------------------------------------------------------------

2. Summary of Comments
    There were a wide variety of comments on this provision. Many in
the regulated community requested some sort of a reference or
compendium containing a comprehensive and up-to-date list of the waste
pharmaceuticals that would be considered RCRA hazardous.
    Commenters from states were generally supportive of the provision
allowing all waste pharmaceuticals to be managed as hazardous waste
pharmaceuticals. They believe the provision will encourage healthcare
facilities to manage all of their waste pharmaceuticals in an
environmentally protective manner. One commenter did suggest that
healthcare facilities be required to choose whether they will make
individual hazardous waste determinations for their waste
pharmaceuticals or manage all of them as hazardous waste
pharmaceuticals under this subpart and maintain documentation
reflecting their decision.
    Retail industry commenters were opposed to what they believe are
contrary requirements, specifically, allowing a healthcare facility to
manage all of its waste pharmaceuticals as hazardous but still require
them to segregate incompatible hazardous waste and those prohibited
from combustion as required by Sec.  266.502(d)(4). They believe having
to segregate incompatible and non-combustible waste significantly
diminishes the intended relief.
3. Final Rule Provisions
    EPA has finalized the provisions of this section with minor edits
that further clarify that this section applies only to non-creditable
pharmaceuticals. A healthcare facility that generates solid waste that
is a non-creditable pharmaceutical has two options for hazardous waste
determination. It may choose to either; (1) determine if each non-
creditable pharmaceutical is a listed or characteristic hazardous waste
to determine whether it is subject to the subpart P requirements, or
(2) manage all of its non-creditable waste pharmaceuticals under the
subpart P requirements as non-creditable hazardous waste
pharmaceuticals. A healthcare facility that chooses the latter option,
instead of making individual hazardous waste determinations at the
point of generation, would have made a generic decision that all of
their non-creditable pharmaceutical waste is hazardous and place it
into a container or containers that are managed under part 266 subpart
P.
    The Agency wanted to provide maximum flexibility to healthcare
facilities managing non-creditable waste pharmaceuticals while ensuring
protection of human health and the environment, which is why we are
finalizing the provision to allow healthcare facilities the option of
managing all of their waste pharmaceuticals under subpart P. If a
healthcare facility chooses to manage all of its non-creditable waste
pharmaceuticals under the subpart P requirements, healthcare personnel
are relieved from having to make individual hazardous waste
determinations which might otherwise distract from their efforts in
providing patient care.
4. Comments and Responses
    A number of commenters asked if a third party can come on site and
make individual hazardous waste determinations for commingled non-
creditable waste pharmaceuticals. If a healthcare facility chooses to
use a third party, typically a hazardous waste transport company, to
come on site and make hazardous waste determinations at any time
(typically in preparation for transport off site), that would also be
permissible under this subpart.
    Many comments were focused on the lack of an EPA-provided reference
guide of which pharmaceuticals are hazardous waste when discarded. The
RCRA generator regulations have always placed the onus on the generator
of a waste to determine whether it is solid and hazardous waste.
Nevertheless, EPA has made efforts to aid healthcare facilities in
making hazardous waste determinations by developing the Hazardous Waste
Pharmaceuticals wiki.\204\ The website has served as a central location
where users (e.g., healthcare facilities, states) can share their
knowledge about which pharmaceuticals are listed or characteristic
hazardous waste, and other related information. EPA has also funded a
compliance assistance center for healthcare facilities, which provides
information on which pharmaceuticals are hazardous waste as well as
other hazardous wastes found in a healthcare setting.205 206
---------------------------------------------------------------------------

    \204\ Hazardous Waste Pharmaceuticals Wiki. http://hwpharms.wikispaces.com. Wiki spaces is phasing out its business of
hosting wiki pages. The Agency plans to preserve the information
that has been contributed to the wiki on EPA's website, but the
content will be static.
    \205\ Healthcare Environmental Resource Center. http://www.hercenter.org.
    \206\ EPA makes no claims, promises, or guarantees about the
accuracy, completeness, or adequacy of the contents of these sites.
---------------------------------------------------------------------------

D. No Central Accumulation Area and Satellite Accumulation Area
Requirements for Healthcare Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals

1. Summary of Proposal
    Hazardous waste pharmaceuticals are generated at numerous locations
across a healthcare facility. Under the part 262 generator regulations,
each location at the healthcare facility with a RCRA hazardous waste
receptacle for the disposal of hazardous waste pharmaceuticals is
considered an SAA and is subject to volume accumulation limits and
other provisions. Of particular concern regarding the SAA regulations
for healthcare facilities is the one-quart accumulation limit for acute
hazardous wastes (i.e., P-listed wastes) and the requirement that
hazardous waste must be accumulated at or near the point of generation.
In particular, hospitals have noted that their difficulties are with
having an SAA in each hospital room. As a result, the proposed December
2008 Pharmaceutical Universal Waste rule did not require the
establishment of any accumulation areas (neither central nor satellite)
for hazardous waste pharmaceuticals. This proposed approach was
consistent with the current federal universal waste program, since
facilities are not required to designate a special centralized area for
the accumulation of universal wastes, nor are they required to have
SAAs for universal wastes. Nevertheless, EPA understands that
healthcare facilities will often accumulate their universal wastes
within their 90- or 180-day hazardous waste accumulation areas. The
part 262 generator regulations, including the SAA and CAA regulations,
were designed more for industrial and manufacturing operations. Part
266 subpart P is a sector-based regulatory approach designed to work
better with how the healthcare sector operates. Therefore, consistent
with the approach initially taken in the Universal Waste proposed
rulemaking, the Agency designed the proposed standards for healthcare
facilities accumulating hazardous waste pharmaceuticals under subpart P
to operate in lieu of the SAA regulations or the CAA regulations (also
sometimes called `` less than 90- or 180-day are as'').

2. Summary of Comments
    The majority of commenters on this provision were states. All but
one state and all other commenters agreed with the proposal to
eliminate requirements for SAAs and CAAs for healthcare facilities
managing non-creditable hazardous waste pharmaceuticals. The lone
dissenting state agreed with eliminating requirements for SAAs but
expressed concern about not requiring CAAs. They recommended that
hazardous waste pharmaceuticals be accumulated in or near a 90-day or
180-day accumulation area for LQGs and SQGs respectively.
3. Final Rule Provisions
    The agency is finalizing the approach for part 266 subpart P to
operate in lieu of requiring CAAs and SAAs for healthcare facilities
managing non-creditable hazardous waste pharmaceuticals. The SAA
regulations, in particular, were not a good fit for how healthcare
facilities operate. Additionally, there was near-unanimous agreement
among commenters that SAAs and CAAs are not necessary to accumulate
hazardous waste pharmaceuticals, further supporting the agency's
decision.
    Although there is no requirement that a healthcare facility
accumulate its hazardous waste pharmaceuticals in a CAA, doing so is,
nonetheless, acceptable. A healthcare facility may choose to accumulate
hazardous waste pharmaceuticals within its 90-day or 180-day CAA if it
has one established for its other hazardous wastes, as long as it
maintains compliance with the accumulation time limit and container
requirements of 40 CFR part 266 subpart P. If a healthcare facility
chooses to accumulate its hazardous waste pharmaceuticals in a CAA,
those hazardous waste pharmaceuticals will only be subject to the
requirements of part 266 subpart P and not the part 262 hazardous waste
generator standards.

E. Container Standards for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(d))

1. Summary of Proposal
    The container standards discussed in this section apply to those
containers used by healthcare facilities to accumulate non-creditable
hazardous waste pharmaceuticals. First, we would note that due to the
relatively small quantities of hazardous waste pharmaceuticals that are
typically accumulated and stored at a healthcare facility, the Agency
understands that other types of waste management units, such as tanks,
are not used for the management of waste pharmaceuticals. Therefore, we
only proposed standards for containers as defined in 40 CFR 260.10.
However, the Agency solicited comment as to whether other types of
waste management units are also used by healthcare facilities to
accumulate and store hazardous waste pharmaceuticals and whether EPA
should establish technical standards for other types of waste
management units.
    The Agency proposed to require that healthcare facilities place
hazardous waste pharmaceuticals into containers that are structurally
sound and that are compatible with the hazardous waste pharmaceuticals
that will be contained within them. EPA intends this requirement to
mean that containers used for holding non-creditable hazardous waste
pharmaceuticals must be in good condition, with no severe rusting,
apparent structural defects, nor deterioration. EPA also proposed that
containers also must not have any evidence of leakage, spillage, or
damage that could result in the release of waste under reasonably
foreseeable circumstances. Furthermore, the Agency proposed to require
that incompatible wastes not be placed in the same container, unless
the commingling of incompatible hazardous wastes is conducted in such a
way that it does not have the potential to (1) generate extreme heat or
pressure, fire or explosion, or violent reaction; (2) produce
uncontrolled toxic mists, fumes, dusts, or gases in sufficient
quantities to threaten human health; (3) produce uncontrollable
flammable fumes or gases in sufficient quantities to pose a risk of
fire or explosions; (4) damage the structural integrity of the facility
or container containing the hazardous waste pharmaceuticals; or (5)
through other like means threaten human health or the environment. For
example, the majority of a healthcare facility's non-creditable
hazardous waste pharmaceuticals are likely organic in nature, and thus,
compatible with each other and can be accumulated together, especially
since they will most likely be incinerated once they are transported to
a TSDF.
    The Agency believes that these technical standards, like similar
technical standards that EPA has promulgated in Sec.  265.17(b) for
interim status TSDFs,\207\ would ensure that hazardous waste
pharmaceuticals are properly managed and would not be released into the
environment, while at the same time providing flexibility to the
healthcare facility in selecting those containers that are most
appropriate for their situation.
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    \207\ Sec.  265.17 General requirements for ignitable, reactive,
or incompatible wastes is available. https://www.gpo.gov/fdsys/pkg/CFR-2017-title40-vol28/pdf/CFR-2017-title40-vol28-part265.pdf.
---------------------------------------------------------------------------

    In addition to the proposed container standards, the Agency also
proposed that accumulation containers for hazardous waste
pharmaceuticals be secured in a manner that prevents unauthorized
access to the contents in order to prevent the diversion of hazardous
waste pharmaceuticals or inadvertent exposures to them. Unlike most
other hazardous wastes, some hazardous waste pharmaceuticals might
still retain considerable value to individuals or on the black market,
which can increase the likelihood of diversion for illicit purposes.
    Some non-creditable hazardous waste pharmaceuticals, such as metal-
bearing wastes not containing sufficient organics (e.g., P012, arsenic
trioxide), are prohibited from being incinerated under the dilution
prohibition.\208\ Dilution is not a substitute for treatment of certain
restricted wastes because the hazardous constituents are not destroyed,
removed, or immobilized before being disposed of on the land.\209\ EPA
proposed that the hazardous waste pharmaceuticals that cannot be
incinerated must be accumulated separately from organic wastes destined
for incineration.
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    \208\ Sec.  268.3(c) Dilution prohibited as a substitute for
treatment. See appendix XI of part 268 for a full list of hazardous
wastes that are prohibited from being combusted.
    \209\ See RCRA Policy Statement: Clarification of the Land
Disposal Restrictions' Dilution Prohibition and the Combustion of
Inorganic Metal-Bearing Hazardous Waste. https://www.epa.gov/hw/policy-statement-clarification-dilution-prohibition-and-combustion-inorganic-metal-bearing.
---------------------------------------------------------------------------

2. Summary of Comments
    There was considerable interest in this section with a broad range
of comments in support, in opposition, and suggesting modifications.
While some states were in support of the proposed standards, others
were concerned that they would not be easily understood by healthcare
facility workers, and that we should provide more detail about what
constitutes a closed container. There was also a comment that
recommended we clarify that hazardous waste pharmaceuticals can only be
accumulated in containers, and not tanks or other accumulation units,
and also what would constitute an acceptable container. For example,
the commenter asked if re-sealable plastic storage bags or plastic pill
bottles are considered a container under this subpart.

    Commenters from the waste management industry were generally in
support of the proposed container standards although one commenter took
issue with the security standards in 40 CFR 266.502(d)(3), stating that
they are not adequate and recommending that we incorporate existing DEA
guidance on container security standards. The commenter also suggested
the final regulations incorporate an additional security provision
stating that hazardous waste pharmaceuticals be put into a ``product or
container that is specifically designed to render them inaccessible,
non-consumable, and/or irretrievable prior to final disposal.'' A
different waste management company echoed the concerns shared by the
previously mentioned state that the final rule should specify that
hazardous waste pharmaceuticals can only be accumulated in containers
and not in other types of waste accumulation units.\210\ No commenters
indicated that any other types of waste management units are used to
accumulate hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \210\ See comment number EPA-HQ-RCRA-2007-0932-0257.
---------------------------------------------------------------------------

    Trade associations representing a range of stakeholders also
generally supported the proposed provisions but were concerned about
the requirements to segregate hazardous waste pharmaceuticals that
cannot be incinerated. One waste treatment trade association
recommended that the regulatory language that allows the incineration
of certain mercury-bearing hazardous waste pharmaceuticals be changed
to discourage the incineration of such wastes even though it is
permissible. They believe that the proposed language may be interpreted
as advocating for their incineration. A state association was concerned
about the possible subjectivity of the language in 40 CFR
262.502(d)(2), which contains standards for facilities that manage
ignitable or hazardous waste pharmaceuticals or that mix or commingle
incompatible wastes in the same container. They recommend instead, that
the final rule employ the ``traditional prohibition'' on
incompatibility.\211\
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    \211\ See comment number EPA-HQ-RCRA-2007-0932-0216.
---------------------------------------------------------------------------

3. Final Rule Provisions
    The Agency is finalizing the container standards for non-creditable
hazardous waste pharmaceuticals as proposed. A healthcare facility must
place its non-creditable hazardous waste pharmaceuticals in containers
that are structurally sound, compatible with the contents, and that
would prevent any leaks or spills under reasonably foreseeable
conditions. If incompatible hazardous waste pharmaceuticals are
commingled in a container, the healthcare facility must manage the
container such that it does not have the potential to generate
dangerous heat and/or pressure, emit any toxic substances (e.g., mists,
fumes, dust), produce flammable fumes or gases, damage the structural
integrity of the container, or otherwise endanger human health and the
environment.
    To address the concerns of commenters, EPA would like to emphasize
that, while it is permissible for hazardous waste pharmaceuticals
containing metals such as mercury to be incinerated if the total
organic carbon is greater than 1%,\212\ we strongly recommend that they
be segregated out and treated via other acceptable methods that comply
with the land disposal restrictions.
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    \212\ Sec.  268.3 (c) Dilution prohibited as a substitute for
treatment.
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    EPA is clarifying that the container standards like the other
standards for non-creditable hazardous waste pharmaceuticals do not
apply to hazardous waste pharmaceuticals that are also DEA controlled
substances because these DEA controlled substances are conditionally
exempt from RCRA.\213\ Section XIV further discusses hazardous waste
pharmaceuticals that are also DEA controlled substances.
---------------------------------------------------------------------------

    \213\ Sec.  266.506.
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    To reduce the risk of illicit diversion, the Agency is finalizing
the requirement preventing unauthorized access to the contents of
containers used to accumulate non-creditable hazardous waste
pharmaceuticals. EPA intended this requirement to be performance-based
and did not finalize prescriptive regulatory requirements for this
standard. Healthcare facilities may choose to utilize containers that
are designed to prevent unauthorized access to their contents when
located in areas with uncontrolled access or store containers in areas
with controlled access, such as locked storage lockers, locked closets,
or locked rooms, to prevent unauthorized access to the contents of the
containers. Containers used to accumulate non-creditable hazardous
waste pharmaceuticals may also be kept behind a pharmacy counter
because of the restricted access to those areas.
    The Agency received no comments indicating that non-creditable
hazardous waste pharmaceuticals are accumulated in any waste management
units other than containers. Therefore, these standards apply only to
containers used to accumulate non-creditable hazardous waste
pharmaceuticals. Other types of hazardous waste accumulation units are
not permitted for the accumulation of non-creditable hazardous waste
pharmaceuticals.
4. Comments and Responses
    Section (d)(4) of this provision regarding the requirement to
segregate certain metal-bearing non-creditable hazardous waste
pharmaceuticals was added as a reminder that, due to existing LDR
regulations, a few hazardous waste pharmaceuticals cannot be
incinerated and therefore must be segregated. This is not a new
requirement for healthcare facilities and does not represent a change
in the regulatory burden.
    One commenter asked if plastic bags are considered a container as
defined in Sec.  260.10. If hazardous waste is placed inside a plastic
bag, it meets the definition of a RCRA container and is subject to all
applicable standards in 40 CFR 264 subpart I and 40 CFR 265 subpart I.
Specifically, to be in compliance, a plastic bag must be compatible
with the waste, able to prevent the contents from leaking, kept closed
during storage except when it is necessary to add or remove waste, and
handled or stored in a manner that prevents rupture and/or causes
leaking. EPA would also note that, even though this commenter did not
mention other types of containers, that cups, pill bottles, vials, etc.
are also considered a container under RCRA.\214\
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    \214\ See memo November 11, 2011, Rudzinski to the Regional RCRA
Division Directors (RCRA Online #14827).
---------------------------------------------------------------------------

    Regarding the state association that suggested EPA apply the
``traditional prohibition'' on mixing or commingling incompatible
wastes in the same container because they were concerned about the
possible subjectivity of the five specified conditions in 40 CFR
262.502(d)(2), that regulatory language was taken directly from the
general requirements for ignitable, reactive, or incompatible wastes,
in the General Facility Standards at 40 CFR 265.17(b). This is not a
newly designed requirement. Healthcare facilities that manage hazardous
waste pharmaceuticals are already required to comply with this
provision.

F. Labeling Standards on Containers for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(e))

1. Summary of Proposal
    During the period of accumulation, the Agency proposed that
containers of hazardous waste pharmaceuticals be marked with the words
``Hazardous Waste Pharmaceuticals.'' The Agency did not propose to
require that the hazardous waste numbers (often referred to as
hazardous waste codes) of the container's contents be listed on the
label. Healthcare personnel (e.g., nurses) typically generate the
hazardous waste pharmaceuticals. Healthcare personnel are not usually
intimately familiar with RCRA and its regulations and are primarily
focused on patients and their health. In addition, while a healthcare
facility may have an environmental compliance manager or environmental
consultant that is knowledgeable about RCRA and its regulations and can
make hazardous waste determinations, this individual cannot be present
to assign a hazardous waste code and label the collection receptacle
each time a hazardous waste pharmaceutical is generated. For these
reasons, EPA did not believe it would be practical to require
individual hazardous waste codes on the hazardous waste pharmaceutical
collection container at the healthcare facility.
    The Agency solicited comment on the appropriateness of the proposed
general labeling requirement. The Agency also requested comment on
security concerns regarding having the word ``pharmaceutical'' marked
on the containers.
2. Summary of Comments
    The issues of determining waste codes and whether they should be
required on labels and/or manifests cuts across a number of provisions
in this rule. Many commenters intertwined their opinions on container
labeling standards with manifest requirements, waste code
determinations by healthcare workers, and LDRs. While the Agency
understands the inter-relatedness of these issues, this section
pertains specifically to the proposed standards of requiring the words
``Hazardous Waste Pharmaceuticals'' on containers used to accumulate
hazardous waste pharmaceuticals, and whether having the word
``Pharmaceutical'' displayed on those containers increases the risk of
illicit diversion. Many of the comments alluded to these container
labeling requirements during on-site accumulation, but did not address
them directly, instead focusing on how the proposed labeling standards
to not require hazardous waste codes on containers will affect the
manifesting, shipping, and LDR processes. We will address those
comments in subsequent sections as appropriate.
    States had mixed views with a few voicing support for the proposed
labeling standards, while another asked that the Agency provide more
leeway in the required wording on the container label. Another state
agreed with not requiring individual waste codes, but recommended that
EPA require some sort of identification of potentially incompatible
wastes to help prevent their inadvertent mixing. Two states were
opposed to the proposed standards and recommended requiring individual
hazardous waste codes on container labels to reduce the risk of
mismanagement and incorrect treatment.
    One reverse logistics company tacitly agreed with the proposal to
not require hazardous waste codes on containers (or manifests) and
instead, write ``Hazardous Waste Pharmaceuticals'' on the container and
comply with DOT requirements. They expressed agreement with the
agency's proposal to not require hazardous waste codes on the manifest,
which leads the Agency to conclude that not requiring hazardous waste
codes on containers is acceptable to them as well.
    Comments from the waste treatment sector were mixed as well. One
commenter agreed with the proposal to not require hazardous waste codes
on container labels but wanted more flexibility in labeling. Other
commenters from the waste treatment industry were wholly opposed to the
proposed labeling requirements citing the need for waste codes by TSDFs
to meet LDR standards.\215\
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    \215\ See comment numbers EPA-HQ-RCRA-2007-0932-0333 and EPA-HQ-
RCRA-2007-0932-0297.
---------------------------------------------------------------------------

    One medical waste trade association did not explicitly agree that
hazardous waste codes should not be required on container labels, but
they did request that, at a minimum, hazardous waste codes should be
included on the manifest.
    Stericycle initially disagreed with the proposal to require the
word ``pharmaceutical'' on labels in addition to ``Hazardous Waste''
when it commented on the 2008 proposal to add pharmaceuticals to the
Universal Waste rule. It has subsequently, through first-hand
experience, determined that including the word ``pharmaceutical'' on
containers does not increase the risk for illicit diversion. Therefore,
in its comments to this proposed rulemaking, it is now in support of
labeling containers of hazardous waste pharmaceuticals with the words
``Hazardous Waste Pharmaceuticals.''
    Multiple commenters representing regional and national healthcare
systems currently label their containers with the word
``pharmaceuticals'' and feel it is appropriate.\216\ A commenter from
the healthcare waste association also agrees that including the word
``pharmaceutical'' on containers is current practice and does not
present any additional risk of diversion.\217\
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    \216\ See comment number EPA-HQ-RCRA-2007-0932-0297.
    \217\ See comment number EPA-HQ-RCRA-2007-0932-0296.
---------------------------------------------------------------------------

    3. Final Rule Provisions EPA is finalizing the container labeling
requirements as proposed. Specifically, containers of non-creditable
hazardous waste pharmaceuticals must be marked with the words
``Hazardous Waste Pharmaceuticals'' when accumulating on-site. This
final rule provision is consistent with the container labeling
requirements in the Hazardous Waste Generator Improvements rule,\218\
in that generators are not required to label containers with hazardous
waste codes during on-site accumulation. Previously, the regulations
did not specify when hazardous waste codes needed to be added to
container labels.
---------------------------------------------------------------------------

    \218\ Final rule: November 28, 2016; 81 FR 85808.
---------------------------------------------------------------------------

    The Agency was concerned about increasing the risk of diversion
resulting from displaying the word ``pharmaceutical'' on a container.
However, given the general support from commenters, in this final rule,
EPA is comfortable including the word ``pharmaceutical'' on the label
of containers used to accumulate hazardous waste pharmaceuticals. There
was no opposition from commenters representing healthcare systems and
pharmacy trade groups. In fact, many commented that this is has been
standard practice for some time and has not resulted in any increased
diversion.
4. Comments and Responses
    One state was concerned that allowing the commingling of hazardous
waste pharmaceuticals could inadvertently lead to incompatible
hazardous waste pharmaceuticals being mixed together, and suggested
that EPA add a requirement to label containers with potentially
incompatible wastes. It is the Agency's understanding that there are
only a few pharmaceuticals that are incompatible according to DOT.
Pressurized aerosols are the most common, although both DOT and EPA are
considering relaxing their

management requirements in the near future. Other DOT incompatible
wastes include oxidizers, acids, and bases, yet they occur infrequently
in dosage form.\219\ In addition, there are a limited number of cases
in which commingled incompatible pharmaceutical waste has caused a
problem. Therefore, the Agency has determined that the risk does not
rise to the level of requiring a specific provision and is not
finalizing any additional labeling requirement for incompatible
hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \219\ Smith, Charlotte A. ``Managing Pharmaceutical Waste: A New
Implementation Blueprint.'' Pharmacy Practice News, Special Edition,
2011.
---------------------------------------------------------------------------

    One commenter from the waste management industry suggested that EPA
add the flexibility to label containers of hazardous waste
pharmaceuticals with the words ``hazardous waste'' or other words that
communicate the hazards per Sec.  262.34(c)(1)(ii).\220\ The Agency is
not finalizing this suggestion. EPA recently revisited these provisions
in the 2016 Hazardous Waste Generator Improvements rule to require that
generators label containers with both the words ``hazardous waste'' and
other words that indicate the nature of the hazard partially because
the Agency felt that the previous requirements were too vague. In
addition, Sec.  262.34 applied only to containers in SAAs whereas there
are no SAAs in a subpart P healthcare facility.
---------------------------------------------------------------------------

    \220\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the
docket for this rulemaking. The regulation cited by the commenter
has been since moved to 262.16(b)(6) as part of the 2016 Hazardous
Waste Generator Improvements Final Rule.
---------------------------------------------------------------------------

G. Accumulation Time Limits for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(f))

1. Summary of Proposal
    a. One-year accumulation time limit. A few hazardous waste
pharmaceuticals are P-listed acute hazardous wastes, the most common
being warfarin. Under the part 262 generator regulations, if a
generator generates more than 1 kg of acute hazardous waste per
calendar month, the generator is regulated as an LQG and subject to a
90-day limit on accumulation. Due to this low generation/accumulation
threshold associated with P-listed wastes, healthcare facilities are
often LQGs. However, while healthcare facilities can generate enough P-
listed waste to become LQGs, they often do not generate sufficient
total amounts of hazardous waste pharmaceuticals within the allowed
accumulation period of 90 days to make off-site shipments using a
hazardous waste transporter cost-effective.
    Under the 2008 proposed amendment to add pharmaceuticals to the
Universal Waste program, handlers of pharmaceutical universal waste
would have had one year to accumulate their hazardous waste
pharmaceuticals in order to facilitate proper treatment and disposal.
Commenters on the proposed 2008 Pharmaceutical Universal Waste rule
indicated support for the one-year accumulation time limit. Thus, under
part 266 subpart P, the Agency proposed to allow healthcare facilities
to accumulate non-creditable hazardous waste pharmaceuticals for up to
one year without triggering interim status or the need to obtain a RCRA
permit. EPA proposed one year as an appropriate time frame because it
strikes a balance between allowing healthcare facilities enough time to
accumulate enough non-creditable hazardous waste pharmaceuticals to
make it economically viable to transport their hazardous waste
pharmaceuticals off site while ensuring that the hazardous wastes are
not accumulated beyond the one-year storage limit under the LDR program
(see Sec.  268.50). Under the LDR storage prohibition, the Agency
assumes that any accumulation for up to one year is for the purpose of
facilitating proper treatment and disposal.
    EPA proposed that healthcare facilities could use various
approaches to demonstrate the length of time that non-creditable
hazardous waste pharmaceuticals are accumulated on site. For example,
EPA proposed that a healthcare facility can choose to mark the
container label with the date that accumulation first began, maintain
an inventory system that identifies dates when the hazardous waste
pharmaceuticals were first accumulated, identify in the accumulation
area the earliest date that a hazardous waste pharmaceutical became a
hazardous waste, or any other method that clearly demonstrates the
length of time that the hazardous waste pharmaceutical has been
accumulated from the date it became a hazardous waste.
    b. Extensions to accumulation time limits. In the proposed time
frames to accumulate non-creditable hazardous waste pharmaceuticals,
EPA included a provision that allowed any healthcare facility needing
longer than the one-year accumulation time frame to request an
extension from the appropriate EPA Regional Administrator. The Agency
provided several examples of situations when a healthcare facility
might request an extension. The reasons included litigation (now
referred to as preservation orders, investigations or judicial
proceedings),\221\ recalls, and circumstances that are beyond the
control of the healthcare facility. The proposed extension provision
required that healthcare facilities send a request in writing
(electronic or paper) to the Regional EPA Administrator explaining the
need for the extension, the approximate amount of hazardous waste
pharmaceuticals to be accumulated beyond the one year, and the amount
of extra time requested. The Agency then proposed to allow the Regional
Administrator the discretion to grant, modify, or deny the requested
extension on a case-by-case basis. Lastly, the Agency solicited comment
on the proposed mechanism to request a time extension.
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    \221\ Subsequent to the proposal, the Agency became aware that
the term ``litigation'' was not sufficiently broad to encompass all
of the legal actions that might require a hazardous waste
pharmaceutical to be preserved. To maintain consistency throughout
the final rule, all instances where the term ``litigation'' or
``litigation holds'' appeared in the proposed rule have been changed
to ``preservation order, investigation, or judicial proceeding,''
except in this section which discusses what was proposed.
---------------------------------------------------------------------------

2. Summary of Comments
    a. One-year accumulation time limit. One commenter from industry
agreed with the proposed time limits, but expressed concern about the
ability of a healthcare facility to track accumulation times of their
waste, and recommended that there be an additional requirement to
inventory container contents in a manner that will ensure that the 1-
year limit is not exceeded. Another state commenter also recommended
that Sec.  266.502(f)(2)(iv), which would have allowed containers to be
marked in ``any other method which clearly demonstrates the length of
time that the non-creditable hazardous waste pharmaceuticals have been
accumulating from the date it first became a waste,'' be eliminated
because it is too vague.
    b. Extensions to accumulation time limits. The proposed extension
provisions were opposed by a majority of commenters from both industry
and state governments. Industry commenters were concerned about the
additional burden that would likely arise from having to generate,
transmit, and maintain an additional set of records for a scenario (the
need to accumulate hazardous waste pharmaceuticals beyond the one-year
allotment) that they say occurs more often than EPA seems to have been
aware of at the time of proposal. Similarly, many state agencies were
concerned about the added burden that would be imposed by a novel

source of administrative workload in the form of written requests that
must be processed, analyzed, afforded appropriate consideration/
discretion, and responded to. In addition, many commenters mentioned
the possibility that these provisions would conflict with existing
federal regulations, those of FDA for recalls, in particular. Other
commenters brought up similar concerns about pharmaceuticals being
stored pursuant to a litigation hold because of their protracted and
unpredictable nature.
3. Final Rule Provisions
    a. One-year accumulation time limit. The Agency is finalizing a
one-year accumulation time limit for healthcare facilities accumulating
non-creditable hazardous waste pharmaceuticals. Healthcare facilities
may use one of three approaches to demonstrate the length of time that
non-creditable hazardous waste pharmaceuticals are accumulated on site.
A healthcare facility can choose to mark the container label with the
date that accumulation first began, maintain an inventory system that
identifies dates when the hazardous waste pharmaceuticals were first
accumulated, or identify in the accumulation area the earliest date
that a hazardous waste pharmaceutical became a hazardous waste.
    The Agency reiterates that the one-year accumulation time limit
only applies to a healthcare facility's non-creditable hazardous waste
pharmaceuticals and does not apply to any other types of non-
pharmaceutical hazardous waste generated on-site nor to potentially
creditable hazardous waste pharmaceuticals.
    The provision in Sec.  266.502(f)(2)(iv) has been eliminated. It
would have allowed for the accumulation start date to be labeled in any
manner that clearly indicates the length of time that it first began
accumulating non-creditable hazardous waste pharmaceuticals. One
commenter argued that the provision was overly broad and EPA agreed.
    b. Extensions to accumulation time limits. The Agency is not
finalizing any of the proposed provisions in Sec.  266.502(f)(3) that
would have allowed a healthcare facility to request an extension of the
one-year accumulation period for non-creditable hazardous waste
pharmaceuticals and has addressed commenter concerns in other areas of
the rule.
    Recalls and preservation orders, investigations, or judicial
proceedings (formerly referred to as litigation in the proposed
rulemaking) were the two specific situations that the Agency attempted
to address in the proposal as examples of unforeseen circumstances
beyond the control of the healthcare facility. Pharmaceuticals that are
subject to a voluntary or federally-mandated recall (most likely
overseen by FDA, rarely CPSC) must be managed according to the
requirements of either one or both agencies, as appropriate. Although
many of these items could likely be considered RCRA solid waste, EPA is
choosing not to apply RCRA regulations upon recalled pharmaceuticals
that are managed under a voluntary or federally-mandated recall until a
decision is made to destroy those items either in part or in whole.
Similarly, the agency also determined that pharmaceuticals being stored
pursuant to a preservation order, investigation, or judicial proceeding
are not RCRA hazardous waste. Both scenarios are addressed in the
Applicability section of the final rule in the preamble and regulations
(see Sec. Sec.  266.501(g)(4) and 266.501(g)(5)). Because
pharmaceuticals that have been recalled and/or are being stored
pursuant to a preservation order, investigation, or judicial proceeding
are not subject to this subpart, the Agency does not see the need to
include a provision for extending accumulation time. Recall managers
(likely reverse distributors) and states will not be burdened by
producing and responding to such requests.
    The proposed rulemaking also discussed other unforeseen
circumstances (other than a recall or preservation order,
investigation, or judicial proceeding) as a legitimate reason for
requesting an extension of the one-year period to accumulation of non-
creditable hazardous waste pharmaceuticals. However, the only
circumstances mentioned by commenters that would necessitate an
extension were recalls and litigation (preservation orders,
investigations, or judicial actions). Because both of those scenarios
are now addressed individually in the finalized Applicability section
of the preamble and regulations, and have no associated accumulation
time limits, the Agency saw no need to codify a provision to allow a
healthcare facility to request an extension of the accumulation time
limit for other reasons beyond their control. Therefore, the EPA is not
finalizing the proposal to allow healthcare facilities to request an
extension of the one-year accumulation time frame from the Regional
Administrator for any reason.

H. Land Disposal Restrictions for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(g) and Sec.
266.502(d)(4))

1. Summary of Proposal
    As required by HSWA and consistent with part 262 generator
requirements, EPA proposed that healthcare facilities must comply with
the LDR requirements prior to land disposal of the hazardous waste
pharmaceuticals they generate. Since healthcare facilities are
generators, even though they are not subject to the 40 CFR part 262
requirements for the management of hazardous waste pharmaceuticals, we
proposed that they must comply with the LDR requirements found at 40
CFR part 268. The LDRs required by HSWA are in place to ensure that
toxic constituents present in hazardous waste are properly treated to
reduce their mobility or toxicity before hazardous waste is placed into
or onto the land (i.e., land disposed). With limited exceptions,
hazardous waste must be treated by a RCRA-permitted or interim status
TSDF.
    In general, generators of hazardous waste assign the appropriate
hazardous waste numbers (commonly called hazardous waste codes) to
allow TSDFs to determine the specific treatment standard(s) for each
prohibited waste. The Agency proposed that healthcare facilities
generating non-creditable hazardous waste pharmaceuticals do not have
to label the containers with the words ``hazardous waste'' or the
hazardous waste codes when transporting them off site, but rather must
label the containers with the words ``hazardous waste
pharmaceuticals.'' Healthcare facilities do, however, need to make
determinations as to whether wastes must be treated to meet LDR
treatment standards. While most hazardous waste pharmaceuticals are
likely organic in nature and may be incinerated, some hazardous waste
pharmaceuticals may not be suitable for incineration and, therefore,
must be segregated from the organic wastes. The hazardous waste
pharmaceuticals not suitable for incineration include characteristic
metal wastes (i.e., D004-D043) prohibited from being combusted because
of the dilution prohibition of Sec.  268.3(c), as well as the listed
wastes U151 (mercury), U205 (selenium sulfide), and P012 (arsenic
trioxide), unless they contain greater than 1% total organic carbon.
Put another way, hazardous waste pharmaceuticals with these metals that
also contain greater than 1% total organic carbon may be incinerated.

In order to comply with the LDRs, healthcare facilities will need to
segregate these wastes from the organic hazardous waste pharmaceuticals
so that they can be properly treated by the TSDF. Although the Agency
did include a requirement to segregate these metal-bearing low total
organic carbon hazardous waste pharmaceuticals in proposed Sec.
266.502(d)(4), the Agency requested comment on whether it is necessary
to incorporate into the regulations at Sec.  266.502(g) a requirement
to segregate these wastes and whether additional labeling requirements
are necessary to identify the hazardous waste pharmaceuticals that are
not suitable for incineration.
    Because EPA proposed that containers of non-creditable hazardous
waste pharmaceuticals would not be required to list the hazardous waste
codes on the label, we also proposed that waste codes are not required
on the LDR notification.
2. Summary of Comments
    There were a variety of comments on this provision, primarily
regarding four issues: (1) The segregation of hazardous waste
pharmaceuticals unsuitable for incineration, (2) the incineration of
hazardous waste pharmaceuticals with numeric treatment standards, (3)
the LDR notification, and (4) the need for hazardous waste
pharmaceuticals-specific waste code and treatment standard.
    Commenters from both states and the waste management industry
requested that the agency add a requirement for healthcare facilities
to segregate any hazardous waste pharmaceuticals that are unsuitable
for incineration into separate containers and label them with the
appropriate waste codes. They argued that there would be an increased
likelihood that pharmaceuticals containing metals subject to the
dilution prohibition would be inadvertently incinerated, resulting in
noncompliance with LDR standards.
    Many waste management companies expressed concern about their
ability to meet LDR standards without knowing specific waste codes and
the added burden they would incur from having to test their ash for the
seven hazardous waste pharmaceuticals with numeric treatment
standards--lindane, chloroform, m-cresol, dichlorodifluoromethane,
trichloromonofluoromethane, phenacetin and phenol.\222\ They did,
however, agree that healthcare workers should not have to make
hazardous waste determinations. They stated that they would have to
alter or augment their testing protocols for residual ash which would
add undue burden. One commenter suggested that, at a minimum,
segregation be performed before a shipment of hazardous waste
pharmaceuticals are transported off site for disposal, but having waste
codes either on a label or the manifest would be preferable. They
generally stated that they do not feel waste management should bear all
of the added burden of LDR compliance under this rule.
---------------------------------------------------------------------------

    \222\ See 40 CFR 268.40 table ``Treatment Standards for
Hazardous Wastes,'' which identifies maximum concentration values
for all hazardous constituents in the waste/treatment residue prior
to land disposal.
---------------------------------------------------------------------------

    Another common theme among commenters, from the waste management
industry in particular, was a recommendation for a new, single
hazardous waste code for all hazardous waste pharmaceuticals with a
corresponding alternate treatment of standard of combustion (CMBST).
One commenter representing the retail industry expressed concern that
the relief provided by this rule will be negated by the requirement to
list waste codes on the LDR notice.
3. Final Rule Provisions
    The Agency is finalizing the LDRs for non-creditable hazardous
waste pharmaceuticals as proposed. The non-creditable hazardous waste
pharmaceuticals generated by a healthcare facility are subject to the
LDRs of 40 CFR part 268. A healthcare facility that generates hazardous
waste pharmaceuticals must comply with the land disposal restrictions
in accordance with Sec.  268.7(a) requirements, except that it is not
required to identify the hazardous waste numbers (i.e., hazardous waste
codes) on the LDR notification.
    To address commenters' concerns about whether hazardous waste codes
are required on the LDR notification, the Agency has added clarifying
language to specify that waste codes are, in fact, not required on the
LDR notification. The Agency would note, however, that the proposed
regulatory language did, in fact, specify in Sec.  266.502(g) that
waste codes are not required on the LDR notice. Due to the number of
commenters who were under the impression that waste codes would still
be required on the LDR notice, we added an additional clarification to
make it more obvious that waste codes are not required on the LDR
notice.
    The final rule requires healthcare facilities that generate non-
creditable hazardous waste pharmaceuticals to comply with the LDRs. In
response to comments, we have made one minor change for added clarity.
The Agency has added a requirement to Sec.  266.502(d)(4) for
healthcare facilities that generate non-creditable hazardous waste
pharmaceuticals that are unsuitable for incineration to segregate them
into separate containers from those containing commingled non-
creditable hazardous waste pharmaceuticals, and label them with the
appropriate hazardous waste codes. We would note, however, that the
dilution prohibition of Sec.  268.3 already necessitates such
segregation, therefore, this addition in Sec.  266.502 (d)(4) is for
the purposes of clarity and does not substantially change any of the
proposed LDR requirements for hazardous waste pharmaceuticals.
4. Comments and Responses
    Waste management companies opposed the provision to not require
healthcare facilities to label containers with hazardous waste codes
because of the added burden they argue would result from having to
conduct additional testing for pharmaceuticals with numeric treatment
standards. Nevertheless, the Agency is not finalizing a requirement for
healthcare facilities to label containers of non-creditable hazardous
waste pharmaceuticals with hazardous waste codes, nor is the Agency
finalizing any additional requirements for healthcare facility
personnel to segregate the seven pharmaceuticals that have numeric
treatment standards, although a vendor could include such a requirement
in its contract with a healthcare facility.
    Unlike metal-bearing hazardous waste pharmaceuticals that may not
be incinerated, the seven hazardous waste pharmaceuticals with
numerical treatment standards may be incinerated or treated using any
other treatment method to meet LDR values. Therefore, the Agency thinks
it would cause confusion and add burden to require healthcare
facilities to segregate the hazardous waste pharmaceuticals with
numeric treatment standards. Further, the Agency has determined that
several of the seven organics with numeric treatment standards also
appear in non-pharmaceutical hazardous waste, which means that
hazardous waste combustors are already required to test their ash to
ensure compliance with LDRs for those constituents.
    Because this rule does not require that healthcare facilities label
their waste with the hazardous waste codes, TSDFs will now have to
analyze their incinerator residue (ash) for the seven organics that
have numerical treatment standards according to the conditions
established in the facility waste analysis plan, as they could possibly
be present in any shipment of organic hazardous

waste pharmaceuticals or treatment residues. Organic hazardous waste
pharmaceuticals (other than arsenic trioxide) may all be incinerated at
RCRA-permitted or interim status hazardous waste combustors. Most
organic wastes have a specified treatment standard of combustion
(CMBST). The remaining seven organics have numerical treatment
standards, such that no particular treatment technology is required to
achieve the numerical LDR treatment standards. While these wastes may
be incinerated, the ash must be analyzed for these seven organic
constituents to demonstrate compliance with the LDR treatment standards
before that ash can be land disposed. The Agency is not finalizing any
standards that would affect the frequency of testing, simply that TSDFs
test their ash for these seven constituents as part of their existing
protocol.
    EPA is not finalizing recommendations from commenters that the
Agency implement a new waste code or alternative treatment standards
specifically for hazardous waste pharmaceuticals. Because the Agency
did not propose any new waste codes or treatment standards for
hazardous waste pharmaceuticals, the recommendation is outside the
scope of this rule. The Agency does agree that implementing an
alternative treatment standard of combustion for hazardous waste
pharmaceuticals that currently have numeric treatment standards would
be a viable solution to mitigate any added burden imposed on TSDFs that
will have to modify their testing protocol; however, we did not receive
the necessary data to propose such a change prior to proposal, and
therefore cannot finalize an alternative treatment standard in this
rule. The Agency is, however, open to considering alternative treatment
standards for hazardous waste pharmaceuticals in possible future
rulemakings.
    In their comments on this rule and the 2008 Universal Waste
proposal, Environmental Technology Council (ETC) suggested revising the
treatment standards for the organic hazardous waste pharmaceuticals
that have numerical treatment standards to the specified treatment
standard of combustion. Specifying combustion would relieve the TSDFs
from demonstrating compliance with the numerical treatment
standards.\223\ EPA explored the feasibility of making combustion an
alternative treatment standard for the seven organic hazardous waste
pharmaceuticals that currently have numeric LDR treatment standards. In
fact, EPA notes that the numerical treatment standards were developed
based on levels achieved through combustion. However, EPA has indicated
a preference for numerical treatment standards over specifying
treatment standards whenever possible, to allow maximum flexibility.
Furthermore, it is not clear that pharmaceuticals would be the sole
source of the seven organic constituents in question. Therefore, even
if we proposed an alternative treatment standard of combustion for the
seven organic pharmaceuticals, hazardous waste combustors would still
be required to test their ash for these constituents to demonstrate
compliance with numeric treatment standards if they received the
organics from another, non-pharmaceutical source.
---------------------------------------------------------------------------

    \223\ Prohibited waste may be land disposed if it is treated
using the technology specified in the table (e.g., CMBST:''), which
are described in detail in Sec.  268.42, Table 1--Technology Codes
and Description of Technology-Based Standards.
---------------------------------------------------------------------------

    Again, EPA notes that autoclaving is not an acceptable method of
treating hazardous waste.\224\
---------------------------------------------------------------------------

    \224\ See section VII.D.1.b for further discussion.
---------------------------------------------------------------------------

I. Procedures for Healthcare Facilities Managing Rejected Shipments of
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(h))

1. Summary of Proposal
    In rare circumstances, a healthcare facility may send its non-
creditable hazardous waste pharmaceuticals to a designated facility
that is unable to manage the hazardous waste. For such situations, we
proposed that healthcare facilities follow the same procedures listed
in 40 CFR part 262 (see Sec.  262.23(f)). EPA believes that it is
appropriate to continue current practices for rejected shipments that
are part of the generator regulations of 40 CFR part 262 because
rejected shipments are relatively rare and the procedures currently
used for rejected shipments is relatively straightforward. In addition,
healthcare facilities should be familiar with these procedures already.
2. Summary of Comments
    There were relatively few comments on this section of the proposed
rulemaking. One state and one waste management company agreed with the
standards as proposed. Another state suggested that, as written, the
regulatory language contradicts itself. Specifically, the commenter
said that proposed Sec.  266.502(h)(4) implies that a healthcare
facility that receives a rejected shipment of non-creditable hazardous
waste pharmaceuticals (a shipment that it initiated) must offer it for
shipment to a new designated facility upon receipt, as opposed to the
90-day additional accumulation period mentioned in Sec.  266.502(h).
They reason that, because there are no time frames in the requirement,
the Agency intended to mean upon receipt.
3. Final Rule Provisions
    The agency is finalizing the provisions in this section as proposed
with the added clarification that a healthcare facility that sends a
shipment of non-creditable hazardous waste pharmaceuticals to a
designated facility must have an understanding that the designated
facility can accept and manage the waste. However, if the healthcare
facility later receives the shipment back as a rejected load, the
healthcare facility must sign the manifest that was used to return the
shipment, provide the transporter a copy of the manifest, send a copy
of the manifest within 30 days to the designated facility that returned
the shipment and ship the non-creditable hazardous waste
pharmaceuticals to a new designated facility. The Agency also added
additional clarification to Sec.  266.502(h)(4), to respond to
comments, specifying that a healthcare facility has up to 90 days to
ship the rejected shipment to a new designated facility.

J. Reporting Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(i))

1. Summary of Proposal
    We proposed that healthcare facilities that are required to submit
a BR would no longer be required to include their non-creditable
hazardous waste pharmaceuticals in the report. In addition, the Agency
proposed that healthcare facilities managing non-creditable hazardous
waste pharmaceuticals have reporting requirements similar to generators
regulated under 40 CFR part 262--that is, the exception reporting
requirement under Sec.  262.44(b) and the additional reporting
requirement under Sec.  262.44(c).
    We proposed to incorporate and adapt the generator exception
reporting procedures of 262.44(b) for this new subpart. Specifically,
we proposed that if a healthcare facility does not receive a copy of
the hazardous waste manifest from the designated facility within 60
days, the healthcare facility must submit to the EPA Regional
Administrator a copy of the manifest with a statement that the
healthcare facility did not

receive confirmation of the non-creditable hazardous waste
pharmaceuticals' delivery, along with an explanation of the efforts
taken to locate the non-creditable hazardous waste pharmaceuticals and
the results of those efforts. Likewise, we proposed that if a shipment
of non-creditable hazardous waste pharmaceuticals from a healthcare
facility is rejected by the designated facility and it is shipped to an
alternate facility and if the healthcare facility does not receive a
signed copy of the hazardous waste manifest from the alternate facility
within 60 days, it must submit to the EPA Regional Administrator a copy
of the hazardous waste manifest with a statement that the healthcare
facility did not receive confirmation of the non-creditable hazardous
waste pharmaceuticals' delivery along with an explanation of the
efforts taken to locate the non-creditable hazardous waste
pharmaceuticals and the results of those efforts.
    Finally, the Agency proposed that the Administrator may require
healthcare facilities to furnish additional reports concerning the
quantities and disposition of hazardous waste pharmaceuticals. This is
already the case for generators operating under the 40 CFR part 262. As
with 40 CFR part 262, it is a codification of statutory authority under
Sec. Sec.  2002(a) and 3002(a)(6) that provides the Agency some
flexibility in what reports may be required.
2. Summary of Comments
    The Agency received few comments on this subsection. Comments
primarily addressed there being no requirement to include hazardous
waste pharmaceuticals on the BR, and opinions were mixed. All pharmacy
trade groups that commented were in favor of the proposal to not
require hazardous waste pharmaceuticals managed under part 266 to be
reported on the BR. States that commented were split. One state opposed
the proposal and argued it would hinder the state's ability to
reconcile what is treated at a TSDF with what is generated at a
healthcare facility. Another state disagreed with the proposed
provision and argued states will be forced to establish their own
reporting requirements at the state level, leading to inconsistency in
the way states determine their reporting fees. Another state was in
agreement with the proposed provision, stating that information
regarding amounts of non-creditable hazardous waste pharmaceuticals
generated and treated can be captured from reverse distributor and TSDF
reporting. One other state pointed out that the lack of a requirement
for healthcare facilities to determine waste codes would make reporting
in the BR difficult, if not impossible.
    Regarding the exception reporting requirements, one state suggested
that Sec.  266.502(i)(2)(ii)(A) and (B) are unnecessary because the
requirements in Sec.  266.502 (i)(2)(i)(A) and (B) for a healthcare
facility that does not receive a signed copy of the manifest within 60
days of being accepted by the initial transporter are the same, whether
the shipment is lost or rejected and transferred to a new designated
facility. The state suggested that Sec.  266.502(i)(2) should be
rewritten to simply state that an exception report is only necessary if
the healthcare facility has not received the signed manifest from the
TSDF within 60 days. One healthcare provider suggested that the
proposed 60-day period for a healthcare facility to receive the
manifest from the TSDF should be shortened to 45 days because shipments
of other non-pharmaceutical hazardous waste require receipt of the
manifest from the TSDF within 45 days.
3. Final Rule Provisions
    The reporting requirements for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals are being finalized as
proposed. That is, non-creditable hazardous waste pharmaceuticals
managed under this subpart at a healthcare facility are not required to
be reported on the BR, healthcare facilities must submit an exception
report to the Regional Administrator if they have not received a signed
copy of the manifest within 60 days of the initial transporter
accepting the shipment, and the Agency may require a healthcare
facility to furnish additional reports regarding the quantity and
disposition of non-creditable hazardous waste pharmaceuticals. When
managing rejected shipments, the Agency believes it is advantageous to
use established procedures that should be familiar to healthcare
facilities, especially given that rejected shipments are relatively
rare.
    To clarify, the exception reporting regulations for healthcare
facilities differ from the exception reporting regulations for reverse
distributors because they were based on the differing Sec.  262.42
exception reporting for LQGs and SQGs. The exception reporting
regulations for healthcare facilities were based on the corresponding
Sec.  262.42(b) SQG regulations, whereas the reverse distributor
exception reporting regulations were based on the Sec.  262.42(a) LQG
regulations.
    Although commenters voiced some concern about not knowing the
volume of non-creditable hazardous waste pharmaceuticals being
generated at healthcare facilities, the Agency believes it is
unnecessary to require healthcare facilities generating non-creditable
hazardous waste pharmaceuticals to report this information. If a state
or region wants to obtain such information, it can examine hazardous
waste received forms in the BR submission from TSDFs. Further, one of
the goals of this final rule is to reduce burden on healthcare
facilities so that they will be encouraged to manage all of their waste
pharmaceuticals under part 266 subpart P. Requiring a healthcare
facility to report hazardous waste pharmaceuticals on its BR would
discourage them from managing non-hazardous waste pharmaceuticals as
hazardous. Finally, we would note that this approach is consistent with
the Universal Waste program upon which the healthcare facility
standards are based. Universal wastes managed under part 273 are not
reported on the BR.
4. Comments and Responses
    As part of the part 262 generator regulations, healthcare
facilities that are LQGs must submit a BR to the Regional Administrator
by March 1st of every even numbered year (see Sec.  262.41). Among
other requirements, the BR must include a description (EPA hazardous
waste number and DOT hazard class) and quantity of each hazardous waste
shipped off-site to a TSDF during each odd numbered year. If a
healthcare facility is an LQG due to its non-pharmaceutical hazardous
waste, it will continue to be required to submit a BR under part 262.
However, it need not include in its BR hazardous waste pharmaceuticals
managed under part 266. As discussed previously, the Agency is no
longer requiring healthcare facilities to count hazardous waste
pharmaceuticals managed under part 266 when determining their generator
category under part 262. Instead, all healthcare facilities, with the
exception of VSQGs, will be subject to this final rule for the
management of hazardous waste pharmaceuticals. The Agency has
determined that it does not need the information to be included in the
BR because this final rule will bring a consistent approach to managing
hazardous waste pharmaceuticals.
    One commenter suggested that the time frame within which a
healthcare facility must receive a signed manifest be shortened from 60
days to 45. The Agency did not finalize that request

because many standards in this final rule were based upon SQG and
universal waste standards. Since no manifest is required for transport
and there is no exception reporting standard in the Universal Waste
program, the Agency used the 60-day time frame in the part 262 SQG
standards. LQGs have a 45-day time frame to receive a signed manifest
from a designated facility. Therefore, shortening the exception
reporting time frame from 60 days to 45 would not be consistent with
the goals of this rule to relieve the burden of LQG standards on
healthcare facilities managing non-creditable hazardous waste
pharmaceuticals.
    The Agency is not finalizing the suggestion to unify the language
in Sec.  266.502(i)(2) to cover both missing and rejected shipments.
The proposed language was taken from the generator requirements in
Sec.  262.42, which addresses both situations separately. The Agency is
not aware of the existing approach creating any problems for generators
and is finalizing the regulatory language as proposed.

K. Recordkeeping Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(j))

1. Summary of Proposal
    The Agency proposed that healthcare facilities managing non-
creditable hazardous waste pharmaceuticals maintain records similar to
the records that must be kept by generators regulated under 40 CFR part
262 (see Sec.  262.40). Specifically, we proposed that healthcare
facilities must keep a signed copy of each hazardous waste manifest as
a record for three years from the date that the non-creditable
hazardous waste pharmaceutical was accepted by the initial hazardous
waste transporter. If the healthcare facility is required to file an
exception report because it does not receive a signed copy of the
manifest from the designated facility within 60 days of the date that
the hazardous waste pharmaceutical was accepted by the initial
transporter, then the healthcare facility must keep a copy of each
exception report for a period of at least three years from the date of
the report. In addition, EPA proposed that a healthcare facility must
keep records of any test results, waste analyses or other
determinations made on hazardous waste pharmaceuticals regarding which
pharmaceuticals are hazardous wastes for three years from the date of
the test, analysis, or other determination. The Agency also proposed
that any of the retention periods be automatically extended during the
course of ongoing enforcement actions against any activity associated
with hazardous waste pharmaceutical management or as requested by the
Regional Administrator to ensure that the appropriate records are
available and can be reviewed as part of any enforcement action.
2. Summary of Comments
    There were very few comments on this proposed provision. All but
one of the commenters were states, all of which agreed with the
proposed standard. One commenter suggested that we specify that all
three types of records (manifest, exception reports, and test results/
analysis/waste determinations) be kept on site.
3. Final Rule Provisions
    The recordkeeping requirement is being finalized as proposed, with
two changes. First, the Agency added a fifth provision in Sec.
266.502(j)(5) to address comments requesting that all records be kept
on site. The added provision also requires that all records must be
readily available upon request by an inspector. The Agency understands
that some records may be kept at off-site locations (e.g.,
headquarters), which is acceptable as long as those records are able to
be produced in a timely manner upon the request of an inspector.
    The second change was an addition to Sec.  266.502(j)(3) that
relieves a healthcare facility from the requirement to retain
documentation of hazardous waste determinations in Sec.  266.502(c) if
it chooses to manage all of its non-creditable waste pharmaceuticals as
hazardous waste under subpart P. As discussed elsewhere, a goal of this
rule is to encourage healthcare facilities to manage all of their waste
pharmaceuticals under subpart P to reduce the amount of pharmaceuticals
entering surface and groundwater via sewering and landfill leachate.
The relief provided in Sec.  266.502(j)(3) provides additional
incentive for healthcare facilities to manage their non-creditable non-
hazardous pharmaceutical waste under subpart P.
    A healthcare facility must keep a copy of the signed manifest for a
period of at least three years from the date the shipment was accepted
by the initial transporter. A healthcare facility must also keep a copy
of any exception report for a period of at least three years from the
date of the report. To make the recordkeeping consistent with the 2016
Generator Improvements final rule, a healthcare facility must keep any
information used to support its hazardous waste determination for at
least three years from the date the waste was last sent to on-site or
off-site treatment, storage or disposal, unless it chooses to manage
all of its non-creditable pharmaceutical waste as hazardous waste under
subpart P. The periods of retention will be automatically extended in
the event of any enforcement activity or as requested by the Regional
Administrator.

L. Response to Spills for Healthcare Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals (Sec.  266.502(k))

1. Summary of Proposal
    For non-creditable hazardous waste pharmaceuticals generated and
managed by healthcare facilities under this subpart, the Agency
proposed basic spill response requirements, including the requirement
that healthcare facilities immediately contain all spills of, and other
residues from, hazardous waste pharmaceuticals. In addition, we
proposed that healthcare facilities determine whether any material
(e.g., residue, contaminated clean-up materials, or debris resulting
from the spill) is or contains a hazardous waste pharmaceutical and, if
so, that the healthcare facility manage it under the management
standards for non-creditable hazardous waste pharmaceuticals.
Commenters to the original 1993 proposed rulemaking for establishing
the Universal Waste program overwhelmingly supported these release
response measures (60 FR 25528; May 11, 1995). Thus, we believe it was
appropriate to include them again in this proposal for healthcare
facilities managing non-creditable hazardous waste pharmaceuticals
since it was based on the Universal Waste program.
2. Summary of Comments
    One waste management company was in support of the proposed
standards while another voiced its concern with the proposed preamble
language discussing the requirement to report releases into the
environment greater than the reportable quantity without knowing the
waste codes of the wastes that had been spilled. They recommended that
the Agency establish a reportable quantity for hazardous waste
pharmaceuticals so large releases are appropriately reported to EPA.
Similarly, one pharmacist trade association recommended that the Agency
define what constitutes a release because the proposed regulatory
language and preamble are unclear, and therefore it is also unclear
when a release needs to be reported to the Agency.

    One state commenter pointed out that these standards should also
apply to healthcare facilities that accumulate potentially creditable
hazardous waste pharmaceuticals. They recommend that this standard
apply to all hazardous waste pharmaceuticals and that after a spill is
cleaned up, the determination of credit potential must be made again.
All other states agreed with the proposed standards for responding to
spills.
3. Final Rule Provisions
    The standards in this subsection are being substantially finalized
as proposed with two changes.
    First, we changed the word ``release'' to ``spill'' in the
regulations in response to a commenter that expressed concern about
having to comply with CERCLA requirements for spills of non-creditable
hazardous waste pharmaceuticals. It was not the Agency's intent to
imply that spills occurring inside a healthcare facility are
automatically subject to CERCLA. The proposed preamble language was
intended to differentiate between three scenarios: Spills that are
cleaned up immediately, spills that are not cleaned up immediately, and
releases to the environment. Spills that are cleaned up immediately
must be managed under this subpart. Spills that are not cleaned up
immediately would generally constitute illegal disposal, which may
result in further action by EPA or an authorized state. The proposal
also mentioned that hazardous waste is included in the definition of
hazardous substance under CERCLA, and any release to the environment
would trigger CERCLA authority in addition to RCRA. In many cases, a
spill of a hazardous waste pharmaceuticals that occurs inside a
healthcare facility does not constitute a release to the environment
under CERCLA.\225\ Therefore, this standard applies to spills that do
not constitute a release to the environment, and there are no reporting
requirements for spills unless they result in a release to the
environment. This requirement makes no assertions about when or how
CERCLA applies to spills of both non-creditable hazardous waste
pharmaceuticals and potentially creditable hazardous waste
pharmaceuticals. The new terminology is also consistent with the term
used in the definition of non-creditable hazardous waste
pharmaceuticals in Sec.  266.500, which refers to spills as opposed to
releases.
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    \225\ Spills are likely to occur upon impermeable surfaces both
inside of and outside of a healthcare facility which limits the
potential for release into the environment. Under CERCLA, a release
to the environment also includes releases into the atmosphere. Since
many pharmaceuticals are in pill form, spilled pharmaceuticals would
rarely, constitute a release to the environment under CERCLA.
---------------------------------------------------------------------------

    Second, we addressed the comment from the state that requested a
clarification regarding whether the spill response requirements apply
to potentially creditable hazardous waste pharmaceuticals and non-
creditable hazardous waste pharmaceuticals. The Agency agrees that the
applicability of this proposed provision--whether it applies only to
non-creditable hazardous waste pharmaceuticals or to both potentially
creditable hazardous waste pharmaceuticals and non-creditable hazardous
waste pharmaceuticals--was unclear. The regulatory language has been
changed to reflect that the standards in this subsection apply only to
spilled non-creditable hazardous waste pharmaceuticals. Further, the
proposed regulations required that a healthcare facility determine
whether, after being cleaned up, spilled non-creditable hazardous waste
pharmaceuticals are potentially creditable or non-creditable, implying
that non-creditable hazardous waste pharmaceuticals could become
potentially creditable. The Agency did not intend to imply that spilled
non-creditable hazardous waste pharmaceuticals could become potentially
creditable. The regulatory language has been modified to simply require
that spilled non-creditable hazardous waste pharmaceuticals and clean-
up material be contained and managed as non-creditable hazardous waste
pharmaceuticals. To address this regulatory gap that commenters
identified regarding spilled potentially creditable hazardous waste
pharmaceuticals, the Agency has added a corresponding subsection
containing standards for response to spills of potentially creditable
hazardous waste pharmaceuticals at a healthcare facility to the
regulatory language at Sec.  266.503(f).

M. Management of Non-Creditable Hazardous Waste Pharmaceuticals by
Long-Term Care Facilities That Collect Them From Individuals Who Self-
Administer

1. Summary of Proposal
    The Agency proposed that a LTCF must collect hazardous waste
pharmaceuticals from its residents that self-administer their
medication and manage them under this subpart. This provision was
proposed in order to require the proper management of all hazardous
waste pharmaceuticals at LTCFs. LTCFs are similar to hospitals in that
they are both healthcare providers, but they differ with respect to who
owns the pharmaceuticals dispensed to patients. While hospitals own the
pharmaceuticals they dispense, the pharmaceuticals dispensed at long-
term care facilities belong to the residents of the facility. EPA
understands that, while long-term care facilities often maintain each
individual's pharmaceuticals in a centralized location, such as a
pharmaceutical cart, there are instances where some individuals at some
types of LTCFs may keep and self-administer their own pharmaceuticals.
Under the proposal, long-term care facilities would have had to collect
and manage all hazardous waste pharmaceuticals generated on site,
regardless of ownership, in accordance with these same proposed subpart
P management standards for healthcare facilities. EPA believed this
approach would prohibit and prevent sewering of hazardous waste
pharmaceuticals at these locations.
2. Summary of Comments
    There was very little agreement with the proposed requirement for
LTCFs to collect hazardous waste pharmaceuticals from patients that
self-administer their medication. Most commenters argued that hazardous
waste pharmaceuticals generated by residents who self-administer are
household hazardous waste and that LTCFs are not allowed by law to
perform any mandatory collection actions and have no authority to
compel residents to surrender their unused medications. In addition,
they commented that medication prescribed under Medicare Subpart D is
considered the property of the resident. One commenter also pointed out
that this provision would be unlawful and even dangerous to enforce
because it would entail inspectors having to enter private residences,
which is prohibited by many state statutes, and search through garbage
bags and dumpsters to ensure that hazardous waste pharmaceuticals have
not been illegally disposed.
    Also, one commenter mentioned that this provision would add
significant cost to the residents because waste management expenses are
not covered under Medicare and pharmacies are not allowed to offer
waste collection services for less than cost and would therefore be
required to pass the full cost onto the residents.
3. Final Rule Provisions
    The Agency is not finalizing the proposed provisions in this
subsection. As discussed previously, after consideration of the
comments, the Agency modified the definition of LTCF

to specifically exclude assisted living facilities, group homes,
independent living communities, and the independent/assisted living
portions of continuing care retirement communities. The Agency agrees
that the hazardous waste pharmaceuticals generated at these types of
facilities meet the criteria for the household hazardous waste
exclusion in Sec.  261.4(b)(1) and are therefore not under the purview
of RCRA regulations. Accordingly, we have also deleted proposed Sec.
266.502(l) and the final rule does not require LTCFs to collect
hazardous waste pharmaceuticals for their residents that have custody
of and self-administer their medication. The Agency does, however,
reiterate that this definition of LTCFs classified them as a type of
healthcare facility. As such, LTCFs are subject to all the provisions
being finalized for hazardous waste pharmaceuticals that are present in
an LTCF's central pharmacy, because the hazardous waste being generated
is not the property of the residents. Additionally, hazardous waste
pharmaceuticals that are in the custody of the LTCF on behalf of the
resident must be managed under this subpart. That said, the Agency
expects that most LTCFs will be VSQGs and therefore only subject to a
limited subset of the regulations in this rule, including the sewer
prohibition of Sec.  266.505, the empty container standards of Sec.
266.507, and the optional provisions of Sec.  266.504. In fact, Sec.
266.504(d) of the final rule includes a presumption that an LTCF with
fewer than 20 beds is a VSQG.
    Although not regulated under this subpart, the Agency recommends
that assisted living facilities, group homes, independent living
communities, and the independent and assisted living portions of
continuing care retirement communities develop voluntary pharmaceutical
collection programs for both hazardous and non-hazardous waste
pharmaceuticals as a best management practice, as allowed by DEA
regulations, to ensure proper management, avoid flushing, and minimize
the potential for accidental poisonings, misuse or abuse.

N. Healthcare Facilities That Accept Hazardous Waste Pharmaceuticals
From Off-Site Very Small Quantity Generator Healthcare Facilities
(Sec.  266.502(l))

1. Summary of Proposal
    Typically, hazardous waste pharmaceuticals from healthcare
facilities are transported either to a reverse distributor, if it is
potentially creditable, or to a permitted or interim status hazardous
waste TSDF, if it is not. However, stakeholders have informed EPA that
in some cases, hazardous waste pharmaceuticals are transported to
another healthcare facility.
    Until EPA finalized the Hazardous Waste Generator Improvements rule
on November 28, 2016, CESQG regulations of Sec.  261.5 did not allow a
generator to send its hazardous waste off site to another generator,
unless the receiving generator was one of the seven types of facilities
listed in Sec.  261.5(f)(3)(i)-(vii) or Sec.  261.5(g)(i)-(vii), which
included landfills permitted by state law.\226\ The 2016 Hazardous
Waste Generator Improvements final rule added a new provision for the
consolidation of hazardous waste from VSQGs to LQGs under the control
of the same person.\227\ Person is defined under RCRA in Sec.  260.10
and control is defined as ``the power to direct policies at the
facility under RCRA in Sec.  260.10.'' 228 229 This
provision now allows the same company to consolidate its VSQG hazardous
waste at its LQG sites.
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    \226\ The Hazardous Waste Generator Improvements final rule
renamed CESGGs as VSQGs, moved the regulations from Sec.  261.5 to
Sec.  262.14 and added an eighth type of facility.
    \227\ 40 CFR 262.14(a)(5)(viii).
    \228\ Person means an individual, trust, firm, joint stock
company, Federal Agency, corporation (including a government
corporation), partnership, association, State, municipality,
commission, political subdivision of a State, or any interstate
body.
    \229\ For purposes of this provision, ``control'' means the
power to direct the policies of the healthcare facility, whether by
the ownership of stock, voting rights, or otherwise, except that
contractors who operate facilities on behalf of a different person
shall not be deemed to control such healthcare facility.
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    Specific to healthcare facilities, EPA is aware of two situations
in which VSQGs would like to consolidate their hazardous waste
pharmaceuticals at other healthcare facilities. The first situation is
LTCFs that are VSQGs that return their hazardous waste pharmaceuticals
to long-term care pharmacies that they contract with. The second
situation involves military bases, where the off-post clinics that are
generally VSQGs would like to send their hazardous waste
pharmaceuticals back to the base clinics or pharmacies on the nearby
base.\230\
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    \230\ See notes from 11-28-12 meeting with U.S. Army Institute
of Public Health in the docket for this rule (EPA-HQ-RCRA-2007-0932-
0209).
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    Since long-term care pharmacies are not generally under the control
of the same person as the LTCF, the proposed healthcare facility
consolidation provision was broader than what was finalized in the 2016
Hazardous Waste Generator Improvements rule to accommodate the
contractual relationship between long-term care facilities and long-
term care pharmacies. The Agency proposed this consolidation provision
to allow healthcare facilities that are VSQGs to send their hazardous
waste pharmaceuticals to another healthcare facility rather than send
it to a municipal solid waste landfill.
    Specifically, EPA proposed to allow VSQG healthcare facilities to
send their hazardous waste pharmaceuticals to an off-site healthcare
facility without a hazardous waste manifest, provided the receiving
healthcare facility meets four conditions. First, the receiving
healthcare facility must be contracted to supply pharmaceutical
products to the VSQG LTCF, or the VSQG healthcare facility and the
receiving healthcare facility must both be under the control of the
same person, as defined by Sec.  260.10.\231\ Second, the receiving
healthcare facility must be managing its hazardous waste
pharmaceuticals in accordance with subpart P. Third, the hazardous
waste pharmaceuticals from the VSQG must be managed by the receiving
healthcare facility as hazardous waste pharmaceuticals in accordance
with subpart P once it arrives at the receiving healthcare facility.
Fourth, the receiving healthcare facility must keep and maintain
records of the hazardous waste pharmaceuticals received from the off-
site VSQG healthcare facilities for three years from receipt of
shipment.
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    \231\ For purposes of this provision, ``control'' means the
power to direct the policies of the healthcare facility, whether by
the ownership of stock, voting rights, or otherwise, except that
contractors who operate facilities on behalf of a different person
shall not be deemed to control such healthcare facility.
---------------------------------------------------------------------------

    As proposed, these conditions would ensure the proper management of
the hazardous waste pharmaceuticals: Once they are received by the
healthcare facility, they are subject to the same management standards
EPA proposed for hazardous waste pharmaceuticals managed by healthcare
facilities.
    EPA took comment on two aspects of this exclusion: (1) Whether any
additional conditions should be imposed in this provision and (2)
whether to expand the scope of the provision to facilities that do not
meet the proposed definition of a healthcare facility in this rule.
2. Summary of Comments
    Overall, states, waste management and the healthcare industry were
supportive of the proposal to allow VSQG healthcare facilities to
consolidate their hazardous waste

pharmaceuticals at another healthcare facility, provided the four
conditions outlined above are met. One state, however, did oppose this
provision unless the receiving healthcare facility is subject to all of
the LQG requirements under part 262. They recommended that hazardous
waste pharmaceuticals from VSQGs be consolidated at larger healthcare
facilities under the 2016 Hazardous Waste Generator Improvements final
rule to ensure more stringent standards are met by the receiving
facility. Some states and pharmacists raised concerns that some of the
language within the conditions was too narrow to serve the purpose that
the language was trying to achieve.
3. Final Rule Provision
    EPA is finalizing the provision to allow healthcare facilities that
are operating under subpart P to receive hazardous waste
pharmaceuticals from VSQGs with minor changes. Healthcare facilities
that are VSQGs for their pharmaceutical and non-pharmaceutical waste
may send their potentially creditable and non-creditable hazardous
waste pharmaceuticals to an off-site healthcare facility operating
under subpart P, without a hazardous waste manifest, provided the
receiving healthcare facility meets the four conditions in Sec.
266.502(l)(1)-(4) or Sec.  266.503(b)(1)-(4), as applicable.
    Several conforming changes were made to reflect the change in
terminology from CESQG to VSQG and to reflect the reorganization of the
VSQG regulations from Sec.  261.5 to Sec.  262.14. There are three more
substantive changes from the proposal. First, under Sec.  266.502(l)(1)
where we proposed that one way a healthcare facility could receive
hazardous waste pharmaceuticals from an off-site VSQG healthcare
facility was to have a contractual relationship to provide the
pharmaceutical products to the LTCF, we broadened the language to allow
cases in which a ``business relationship'' between the LTCF and long-
term care pharmacy exists.
    Under the final rule, a healthcare facility under subpart P may
accept non-creditable hazardous waste pharmaceuticals from an off-site
healthcare facility that is a VSQG under Sec.  262.14, without a permit
or without having interim status, provided the receiving healthcare
facility:
    (1) Is under the control of the same person, as defined in Sec.
260.10, as the VSQG healthcare facility that is sending the non-
creditable hazardous waste pharmaceuticals off site, or has a
contractual or other documented business relationship whereby the
receiving healthcare facility supplies pharmaceuticals to the VSQG
healthcare facility;
    (2) Is operating under subpart P for the management of its non-
creditable hazardous waste pharmaceuticals;
    (3) Manages the non-creditable hazardous waste pharmaceuticals that
it receives from off site in compliance with subpart P; and
    (4) Keeps records of the non-creditable hazardous waste
pharmaceuticals shipments it receives from off site for three years
from the date that the shipment is received.
    It is important to note that a VSQG healthcare facility that
chooses to send their waste for consolidation to an off-site healthcare
facility is not considered to be operating under subpart P and does not
need to notify as a VSQG operating under subpart P.
    The second substantive change was to include a parallel provision
in Sec.  266.503 for potentially creditable hazardous waste