the point of generation at the healthcare facility and therefore must
be counted when determining whether the healthcare facility is a CESQG
regulated under Sec.  261.5, or whether it is regulated under 40 CFR
part 266, subpart P. This differs from current practice where, although
a healthcare facility must count the non-creditable hazardous waste
pharmaceuticals it generates each calendar month toward its hazardous
waste generator category, it does not count the potentially creditable
hazardous waste pharmaceuticals it sends to a pharmaceutical reverse
distributor. Therefore, although a healthcare facility currently may be
considered a CESQG, when it begins counting its potentially creditable
hazardous waste pharmaceuticals, it may no longer be a CESQG. In that
case, the healthcare facility would be subject to the 40 CFR part 266,
subpart P requirements.
2. Healthcare Facilities Managing Hazardous Waste Pharmaceuticals Under
Part 266, Subpart P
    EPA is proposing that all healthcare facilities, with the exception
of CESQGs, will be subject to the same regulations for the management
of their hazardous waste pharmaceuticals, regardless of the quantity of
hazardous waste pharmaceuticals generated. A healthcare facility that
generates both pharmaceutical and non-pharmaceutical hazardous waste
must manage the non-pharmaceutical hazardous waste pursuant to part
262, but need not count its hazardous waste pharmaceuticals toward the
facility's monthly hazardous waste generator category. In addition, if
a healthcare facility does not want to keep track of the amount of
hazardous waste it generates to ensure it does not exceed the CESQG
quantity limits, it could choose to operate under this proposed rule.
If it chooses to operate under this proposed rule, however, a
healthcare facility must comply with all the requirements of this
subpart for the management of its hazardous waste pharmaceuticals.

B. Pharmaceutical Reverse Distributors

1. Pharmaceuticals Sent to Pharmaceutical Reverse Distributors Are
Solid Wastes
    One difference between this proposal and the 2008 Pharmaceutical
Universal Waste proposal is how RCRA would apply to pharmaceuticals
returned to pharmaceutical reverse distributors to obtain
manufacturer's credit. EPA is proposing to change its existing position
on this issue. If this rule is finalized, this change would mean that
the decision by a healthcare facility to send a pharmaceutical to a
pharmaceutical reverse distributor is the decision to discard the
pharmaceutical. Therefore, under this proposed rule, once the
healthcare facility makes the decision to send a pharmaceutical to a
pharmaceutical reverse distributor for credit, it is a solid waste at
the healthcare facility. It is likely that a portion of the potentially
creditable solid waste pharmaceuticals at healthcare facilities that
are destined for a pharmaceutical reverse distributor will also meet
the definition of hazardous waste and as a result, these potentially
creditable hazardous waste pharmaceuticals would need to be managed in
accordance with the standards proposed in this document. However, until
this rule is final and effective, EPA's current position will remain in
effect.
    In addition, the Agency notes that the proposed change in EPA's
position concerning reverse distribution and the management standards
discussed in this document pertain only to the reverse distribution of
hazardous waste pharmaceuticals and does not apply to reverse
distribution or reverse logistics systems that may exist for other
consumer products. This limitation is because EPA has studied and
collected data for reverse distribution systems for hazardous waste
pharmaceuticals, and not all consumer products.\148\
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    \148\ EPA is examining the reverse logistics of non-
pharmaceutical hazardous wastes as part of its analysis of comments
received on the Retail Notice of Data Availability that was
published on February 14, 2014 (79 FR 8926).
---------------------------------------------------------------------------

2. Pharmaceutical Reverse Distributors Managing Hazardous Waste
Pharmaceuticals Under Part 266, Subpart P
    Under this proposal, all pharmaceutical reverse distributors are
subject to 40 CFR part 266, subpart P and will be subject to the same
standards with respect to their hazardous waste pharmaceuticals,
regardless of the amount of hazardous waste pharmaceuticals they
manage. Even pharmaceutical reverse distributors that are currently
CESQGs will be regulated under 40 CFR part 266, subpart P for the
management of their hazardous waste pharmaceuticals. Therefore, as with
healthcare facilities, a pharmaceutical reverse distributor subject to
40 CFR part 266, subpart P will no longer have to keep track of the
amount of hazardous waste pharmaceuticals that it generates on a
monthly basis.

C. Healthcare Facilities and Pharmaceutical Reverse Distributors
Managing Non-Pharmaceutical Hazardous Waste in Accordance With 40 CFR
Part 262 or Part 273

    Most, if not all, healthcare facilities and pharmaceutical reverse
distributors generate hazardous wastes other than pharmaceuticals.
These, non-pharmaceutical hazardous wastes will continue to be
regulated under 40 CFR part 262 (and other applicable Subtitle C
regulations). However, because a healthcare facility or pharmaceutical
reverse distributor operating under 40 CFR part 266, subpart P no
longer has to count its hazardous waste pharmaceuticals, including
acute hazardous waste pharmaceuticals such as warfarin, it could result
in a change in the facility's overall generator category and thus
change how its non-pharmaceutical hazardous waste must be managed. For
example, the generator category for a healthcare facility or
pharmaceutical reverse distributor may be reduced from an LQG to an SQG
or even a CESQG, when it stops counting its hazardous waste
pharmaceuticals, especially acute hazardous waste pharmaceuticals,
toward its generator category.
    If finalized, the standards established by this rulemaking apply
only to the management of hazardous waste

pharmaceuticals at healthcare facilities and pharmaceutical reverse
distributors. Healthcare facilities and pharmaceutical reverse
distributors likely generate or manage other types of wastes. For
example, hospitals may generate non-pharmaceutical hazardous wastes,
such as solvents in their diagnostic laboratories; those hazardous
wastes must still be managed in accordance with the RCRA Subtitle C
requirements (such as the RCRA satellite accumulation regulations
(Sec.  262.34(c)), or if it is a teaching hospital, the Academic
Laboratories Rule (if it has opted into part 262, subpart K). Retail
pharmacies in retail stores and grocery stores may have non-
pharmaceutical hazardous wastes on-site as well, which must be managed
in accordance with the 40 CFR part 262 requirements and all other
applicable RCRA Subtitle C regulations. For example, fluorescent bulbs
may be managed under the universal waste program (40 CFR part 273). For
pharmaceutical reverse distributors, this proposed rule only applies to
the management of potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals. Some
pharmaceutical reverse distributors may generate other non-
pharmaceutical hazardous wastes from activities, such as cleaning and
maintenance; other RCRA requirements will apply to those non-
pharmaceutical hazardous wastes.

D. State Enforcement Activities and Interpretations

    States have taken a variety of approaches regarding pharmaceutical
hazardous wastes. One major goal of this proposed rule is to provide
clarity on this topic, and thereby promote national consistency, which,
in turn, should promote better compliance among healthcare facilities,
including pharmacies.
    California has taken numerous enforcement actions against national
retail chains with pharmacies for not complying with the RCRA hazardous
waste regulations. In recent years, the state took enforcement actions
and imposed fines on the following chains: Kmart (2009), Walmart
(2010), Target (2011), CVS (2012), Costco (2012), Walgreens (2012) and
Rite-Aid (2013). In at least two settlement agreements, California
directed the defendants (CVS and Costco) to ``initiate work with
appropriate stakeholders from business and government, including the
U.S. Environmental Protection Agency, the U.S. Food and Drug
Administration, and the DTSC [Department of Toxic Substances Control],
and thereafter either directly or through trade associations or
informal coalitions of interested parties, undertake to promote federal
regulatory reform regarding the proper management of nondispensable
pharmaceuticals, including over-the-counter medications, through
``reverse distribution.'' \149\ Through these settlement agreements,
California is seeking clarity from EPA about its longstanding
interpretation about the regulatory status of pharmaceuticals that are
routed through pharmaceutical reverse distribution systems.
---------------------------------------------------------------------------

    \149\ http://www.calepa.ca.gov/enforcement/orders/2012/CVSStipFinal.pdf and http://www.calepa.ca.gov/enforcement/orders/2012/CostcoFinal.pdf or see the docket for this rulemaking EPA-HQ-
RCRA-2007-0932.
---------------------------------------------------------------------------

    In 2012, Connecticut's Department of Energy and Environmental
Protection (DEEP) took enforcement actions at seven CVS stores for
violations of the RCRA hazardous waste regulations. Consent orders from
Connecticut DEEP direct CVS stores in the state to follow a set of best
management practices.\150\ A number of the practices developed in these
consent orders mirror some of the practices we are proposing in this
rule, particularly with regard to pharmaceuticals destined for a
pharmaceutical reverse distributor. Connecticut DEEP asserts RCRA
jurisdiction over the pharmaceuticals destined for pharmaceutical
reverse distributors by applying specific practices to their
management. For example, CVS must maintain records of each shipment of
non-dispensable pharmaceuticals to a pharmaceutical reverse
distributor, including confirmation of receipt of the non-dispensable
pharmaceuticals from the pharmaceutical reverse distributor receiving
them. The best practices also include procedures for addressing
situations when CVS does not receive delivery confirmation of shipment
to a pharmaceutical reverse distributor. Further, the consent order
sets out separate, more comprehensive practices for the non-dispensable
pharmaceuticals that are not suitable for pharmaceutical reverse
distribution.
---------------------------------------------------------------------------

    \150\ http://www.ct.gov/deep/lib/deep/enforcement/consentorder/COWSWDH13005.pdf. or see the docket for this rulemaking EPA-HQ-RCRA-
2007-0932.
---------------------------------------------------------------------------

    Aside from best management practices developed by Connecticut as
part of a consent order, at least two other states have developed
guidance documents that apply conditions to the management of hazardous
wastes pharmaceuticals in exchange for enforcement discretion. In
particular, in 2008, the Washington State Department of Ecology issued
guidance titled, Interim Enforcement Policy: Pharmaceutical Waste in
Healthcare.\151\ Like Connecticut's consent orders with CVS, this
enforcement discretion policy has some elements in common with this
proposed rule for hazardous waste pharmaceuticals. For instance, a
healthcare facility must notify the Department of Ecology that it is
operating under the policy and must train its staff involved in
pharmaceutical waste management. Only a time limit, rather than a
quantity limit, applies to the accumulation of the hazardous waste
pharmaceuticals on-site. Of particular note is that Washington State
prohibits disposing of most hazardous waste pharmaceuticals down the
toilet or drain.
---------------------------------------------------------------------------

    \151\ See the interim enforcement policy in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932) or see it online at https://fortress.wa.gov/ecy/publications/documents/0704024.pdf.
---------------------------------------------------------------------------

    In 2011, Minnesota's Pollution Control Agency (MPCA) issued a fact
sheet titled Reverse Distribution of Pharmaceuticals: Guidance for
Minnesota Healthcare Providers.\152\ In this guidance, Minnesota
states, ``Whether a pharmaceutical is eligible for return credit does
not affect its product or waste status. In Minnesota, if a
pharmaceutical is not used or reused for its intended purpose, it is a
waste. The MPCA considers health care practitioners and pharmacies to
be generators of these pharmaceutical wastes. Nevertheless, the MPCA
believes that the established reverse distribution system provides an
environmentally protective method for handling waste pharmaceuticals.
Therefore, it will allow Minnesota health care practitioners and
pharmacies to manage certain pharmaceuticals through reverse
distribution, subject to additional requirements discussed in this fact
sheet.'' This is similar to the approach that EPA is proposing for
potentially creditable hazardous waste pharmaceuticals. For example,
like EPA's proposed rule, MPCA does not require hazardous waste
pharmaceuticals destined for a pharmaceutical reverse distributor to be
counted toward determining a healthcare facility's generator category,
and MPCA does not require hazardous waste pharmaceuticals to be
accompanied by a hazardous waste manifest when shipped to a
pharmaceutical reverse distributor. By adopting a rule that is
consistent with state approaches, EPA is bringing national consistency
to the management

of hazardous waste pharmaceuticals, while avoiding disruption to
practices already in place.
---------------------------------------------------------------------------

    \152\ See the guidance document in the docket for this
rulemaking (EPA-HQ-RCRA-2007-0932) or see it online at http://www.pca.state.mn.us/index.php/view-document.html?gid=4004.
---------------------------------------------------------------------------

VII. Request for Comment on EPA's Efforts To Identify Additional
Pharmaceutical Hazardous Wastes

    Some of the comments EPA received in response to the 2008 Universal
Waste proposal recommended that EPA add additional pharmaceutical
wastes to the P and U hazardous waste lists (see Sec.  261.33). Some
commenters suggested that EPA assess the hazards from all discarded
pharmaceuticals (especially chemotherapy drugs) that have come into the
market since the promulgation of the original P and U hazardous waste
lists \153\ and that EPA update these lists to include discarded
pharmaceuticals that are hazardous. In response to these comments, the
Agency began gathering and reviewing information related to
pharmaceuticals that may exhibit hazardous properties. EPA identified
204 drugs, which include 172 drugs that the National Institute for
Occupational Safety and Health (NIOSH) and the Occupational Safety and
Health Administration (OSHA) identified as hazardous, and 32 drugs that
NIOSH proposed for addition to its hazardous drug list.\154\ EPA also
collected toxicity data and other information for these 204 drugs.
These findings, along with additional information regarding the
management of pharmaceutical wastes, are presented in the final report
entitled Data Collection on the Toxicity, Use, and Disposal of
Hazardous Drugs Report (September 2011) placed in the docket for this
proposed rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    \153\ May 19, 1980 Federal Register (45 FR 33084) and November
25, 1980 Federal Register (45 FR 78525).
    \154\ See NIOSH's Preventing Occupational Exposures to
Antineoplastic and Other Hazardous Drugs in Healthcare Settings
(http://www.cdc.gov/niosh/docs/2004-165/) and OSHA Technical Manual
Section VI: Chapter 2--Controlling Occupational Exposure to
Hazardous Drugs (https://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html). Note that the ``hazardous'' classification used by
NIOSH and OSHA is not the same as the definition of hazardous under
the RCRA subtitle C regulations.
---------------------------------------------------------------------------

    Commenters specifically referred to EPA's P and U hazardous waste
lists under the RCRA subtitle C regulations. Generally, in its
hazardous waste determinations, EPA has evaluated both ``production
wastes'' (from specific or non-specific sources; see Sec. Sec.  261.31
and 261.32) and ``commercial chemical products'' that, when discarded,
become wastes (Sec.  261.33). This latter category (commercial chemical
products that are discarded) is the most relevant of the listed
hazardous wastes to the pharmaceuticals wastes discussed elsewhere in
this preamble, and to which commenters referred in the 2008 Universal
Waste proposal. As discussed in Section IV.A.of this preamble,
commercial chemical products listed in Sec.  261.33 are (when
discarded) defined as either P-listed ``acute'' hazardous wastes, or U-
listed (non-acute) hazardous wastes. The criteria for listing a solid
waste as hazardous under RCRA Subtitle C are described in Sec.  261.11.
A waste may be identified as a P-listed waste if it is shown to be
fatal to humans or animals at low doses (see Sec.  261.11(a)(2)). Thus,
lethality data for any chemical is the principal factor for making a
determination that a discarded commercial chemical product is a P-
listed hazardous waste.\155\
---------------------------------------------------------------------------

    \155\ Sec.  261.11(a)(2) states ``The Administrator shall list a
solid waste as a hazardous waste only upon determining that the
solid waste . . . has been found to be fatal to humans in low doses
or, in the absence of data on human toxicity, it has been shown in
studies to have an oral LD 50 toxicity (rat) of less than 50
milligrams per kilogram, an inhalation LC 50 toxicity (rat) of less
than 2 milligrams per liter, or a dermal LD 50 toxicity (rabbit) of
less than 200 milligrams per kilogram or is otherwise capable of
causing or significantly contributing to an increase in serious
irreversible, or incapacitating reversible, illness. (Waste listed
in accordance with these criteria will be designated Acute Hazardous
Waste.)''
---------------------------------------------------------------------------

    In contrast, a waste may be identified as a U-listed waste if it
contains any of the toxic constituents listed in Appendix VIII of 40
CFR part 261, and if, after examining each of 10 factors in Sec.
261.11(a)(3), it is determined that the waste is capable of posing a
``substantial present or potential hazard to human health or the
environment when improperly treated, stored, transported, or disposed
of, or otherwise managed.'' \156\ Examples of these 10 factors include
the toxicity and concentration of the hazardous constituent in the
waste, the plausible types of improper management to which the waste
could be subjected, the quantities of the waste generated at individual
generation sites or on a regional or national basis, the nature and
severity of the human health and environmental damage that has occurred
as a result of the improper management of wastes, and action taken by
other governmental agencies or regulatory programs based on the health
or environmental hazard posed by the waste or waste constituent. EPA
may only revise either of these lists of commercial chemical products
through notice-and-comment rulemaking.
---------------------------------------------------------------------------

    \156\ The Agency cannot list hazardous wastes under section
Sec.  261.11(a)(3) based on inherent toxicity alone without
considering exposure factors, particularly the likelihood of
mismanagement. That is, EPA needs to examine each of the 10 factors
and, to the extent it does not use one or more of them, must explain
why they are irrelevant or unimportant. See Dithiocarbamate Task
Force v. EPA (No. 95-1249).
---------------------------------------------------------------------------

    In its September 2011 report, EPA found that 11 drugs on the NIOSH
or OSHA lists of hazardous drugs meet the specific criteria for acute
toxicity in Sec.  261.11(a)(2) (identified as ``Tier 1'' drugs in the
report). An additional 114 drugs on the NIOSH or OSHA lists did not
meet the specific criteria in Sec.  261.11(a)(2) for acute toxicity,
but did have lethal doses for other animals or humans (``Tier 2''
drugs). The remaining 79 drugs had limited human or animal toxicity
data, and no lethality data, and were designated ``Tier 3'' in the
report. Thus, the vast majority of the NIOSH/OSHA hazardous drugs
evaluated in the EPA 2011 report do not meet the criteria for listing
as acute hazardous waste under RCRA subtitle C.\157\ As discussed
previously, to include a drug on the U-list, the Agency must
demonstrate that a discarded drug would be ``capable of posing a
substantial present or potential hazard to human health or the
environment when improperly treated, stored, transported, or disposed
of, or otherwise managed.'' Therefore, for the NIOSH/OSHA drugs that do
not meet the listing criteria for inclusion on the P-list, the Agency
would have to examine the 10 factors in Sec.  261.11(a)(3) to determine
whether a drug meets the criteria to be included on the U-list. In
addition to toxicity data (which is lacking in particular for the drugs
identified as Tier 3), the types of information that would be relevant
include waste volumes, plausible management scenarios, exposure
potential, damage cases, and actions taken by other governmental
agencies or regulatory programs. To obtain this information for this
class of materials poses a challenge. While EPA has some information--
the September 2011 report includes summaries of drug management
practices and references to others--there remain significant gaps.
---------------------------------------------------------------------------

    \157\ EPA emphasizes that this finding reflects the manner in
which EPA defines acute hazardous waste under the RCRA subtitle C
program; the NIOSH/OSHA lists are based upon different criteria
related to preventing occupational exposure to these drugs.
---------------------------------------------------------------------------

    In addition, as discussed in Section IV.D. of this preamble, the
EPA's OIG has recommended that EPA identify and review existing
pharmaceuticals to determine whether they qualify for regulation as
hazardous waste, and establish a process to review new pharmaceuticals
to determine whether they qualify for regulation as hazardous waste.
While EPA has an existing process generally for defining whether or not
a solid waste is a listed hazardous

waste (i.e., EPA has regulatory criteria for defining listed hazardous
waste described previously; EPA has established policies for evaluating
risk and other factors in making listing determinations; \158\ and EPA
must use the notice-and-comment rulemaking process when proposing
listing determinations), the OIG observed that EPA's hazardous waste
program has not kept pace with the large number of pharmaceuticals that
have been developed since 1980. EPA plans to regularly review the
NIOSH/OSHA lists of hazardous drugs, as they represent a source of
valuable information on pharmaceuticals that have already been
identified as having the possibility of posing risks that might warrant
regulation as hazardous waste.
---------------------------------------------------------------------------

    \158\ EPA's policy statement on hazardous waste listing
determinations is contained in the Federal Register preamble to the
first proposed Dyes and Pigments Listing Determination (59 FR 66072,
December 22, 1994).
---------------------------------------------------------------------------

    EPA is also exploring ways to identify new sources of information,
along with alternative approaches that can most efficiently address
these concerns. EPA is using the opportunity in this preamble to seek
stakeholders' input on the best course of action concerning regulation
of additional pharmaceuticals as hazardous wastes. It is also an
opportunity for stakeholders to provide additional information that
they may have about potentially hazardous pharmaceuticals. Thus, before
deciding on a possible proposal to list additional pharmaceuticals as
hazardous wastes, we request comment on the September 2011 final
report, and solicit information regarding additional potentially
hazardous pharmaceuticals. We request information on the sources and
identity of additional potentially hazardous pharmaceuticals along with
annual product generation data, annual waste generation data, use
information, toxicity data, waste storage and handling information, and
disposal information.
    In addition, we request stakeholder input for alternative
approaches to making hazardous waste listing determinations for
pharmaceuticals that do not meet the acute hazardous criteria. Based on
the existing listing determination process described previously for
non-acute wastes, there is no single toxicity effect (e.g.,
LD50) to readily determine whether or not the waste is
hazardous under RCRA subtitle C. As such, we are seeking ideas on
alternative approaches to more efficiently evaluate potentially
hazardous non-acute discarded pharmaceuticals. For example, should EPA
develop and promulgate new criteria specific to discarded
pharmaceuticals that would allow it to establish a single hazardous
waste listing for all discarded pharmaceuticals that meet the new
criteria? Such approaches could also include consideration of whether
discarded pharmaceuticals are already managed under a regulatory scheme
that prevents mismanagement that a hazardous waste designation would
otherwise address (similar to the hazardous waste listing factor that
takes into account ``actions taken by other governmental agencies or
regulatory programs''). We also are seeking information on any
innovative processes or programs that states may have for identifying,
reviewing, and making a hazardous waste determination for discarded
pharmaceuticals.
    The Agency emphasizes that no regulatory action is being proposed
with respect to expanding the number of pharmaceuticals that are
considered hazardous waste. We will use the comments we receive to help
inform how to proceed with evaluating discarded pharmaceuticals as
listed or characteristic hazardous wastes. Any action taken would be
part of a separate, proposed rulemaking in the future.

VIII. Request for Comment on EPA's Efforts To Amend the Acute Hazardous
Waste Listing for Nicotine and Salts (Hazardous Waste No. P075)

A. Background

    In 1980, as part of its final and interim final regulations
implementing Section 3001 of RCRA, EPA promulgated the list of
commercial chemical products or manufacturing chemical intermediates
(40 CFR 261.33) that are hazardous wastes if they are discarded or
intended to be discarded, which included nicotine and salts (45 FR
33124; May 19, 1980). The phrase ``commercial chemical product or
manufacturing chemical intermediate'' refers to a ``chemical substance
which is manufactured or formulated for commercial or manufacturing use
which consists of the commercially pure grade of the chemical, any
technical grades of the chemical that are produced or marketed, and all
formulations in which the chemical is the sole active ingredient'' (see
the Comment following 40 CFR 261.33(d)). A chemical substance is listed
in 40 CFR 261.33(e) as an acutely hazardous waste if it meets any of
the criteria in 40 CFR 261.11(a)(2), which states that the waste ``has
been found to be fatal to humans in low doses or, in the absence of
data on human toxicity, it has been shown in studies to have an oral LD
50 toxicity (rat) of less than 50 milligrams per kilogram, an
inhalation LC 50 toxicity (rat) of less than 2 milligrams per liter, or
a dermal LD 50 toxicity (rabbit) of less than 200 milligrams per
kilogram or is otherwise capable of causing or significantly
contributing to an increase in serious irreversible, or incapacitating
reversible, illness.''

B. Basis for Original Listing

    EPA listed nicotine and salts (referred to commonly as just
nicotine) as acutely hazardous waste (P075) in Sec.  261.33(e) based on
an estimated oral LD50 toxicity to humans of 1 mg/kg and a dermal LD50
toxicity to rabbits of 50 mg/kg.\159\ As discussed previously, for
humans, the standard in the regulations for acute toxicity is ``fatal
to humans in low doses'' (see Sec.  261.11(a)(2)). EPA's Background
Document for Section 261.33 from 1981 provides a basis for what is
meant by ``fatal to humans in low doses'' for chemicals that have been
given through the oral route (``fatal to humans upon ingestion of <=100
mg/kg''). The estimated oral LD50 to humans of 1 mg/kg falls within the
criteria for ``fatal to humans in low doses.'' However, the background
listing document and its references do not provide sufficient detail to
determine the concentration of nicotine that was used to establish the
estimated oral LD50 in humans.
---------------------------------------------------------------------------

    \159\ See EPA's listing Background Document for Section 261.33,
April 1981, in the docket for this proposed rule (EPA-HQ-RCRA-2007-
0932).
---------------------------------------------------------------------------

C. Rationale for EPA's Efforts To Amend the P075 Listing

    On February 14, 2014, EPA published a Notice of Data Availability
(NODA) and Request for Comment (79 FR 8926) entitled ``Hazardous Waste
Management and the Retail Sector: Providing and Seeking Information on
Practices to Enhance Effectiveness to the RCRA Program.'' EPA received
44 comments in response to this NODA, many of which included comments
related to pharmaceuticals, in particular comments concerning expired
or returned low-concentration nicotine-containing smoking cessation
products and e-cigarettes. The most detailed comments concerning the
unsold low-concentration nicotine products were jointly submitted by
the Retail Industry Leaders Association (RILA), the Food Marketing
Institute (FMI), the National Association of Chain Drug Stores (NACDS),
the National Retail Federation, and their members (referred to as the
retail associations, retailers, or

commenters).\160\ In their comments, the retail associations,
representing a broad range of retailers within the retail industry,
asked EPA to undertake a rulemaking to remove low-concentration
nicotine products from the acute hazardous waste P075 classification
under RCRA. The retailers believe these products do not meet RCRA's
requirements for acute hazardous waste. Thus, according to the
retailers, the acute hazardous classification is inappropriately making
them subject to RCRA's LQG requirements, which become applicable when
someone generates more than 1 kg/month of acute hazardous waste. The
retailers also expressed concern that they are subject to increased
economic burdens and reporting requirements because they are subject to
RCRA's LQG requirements.
---------------------------------------------------------------------------

    \160\ See comments by the retail associations in response to
EPA's Retail NODA in the docket for the Retail NODA (EPA-HQ-RCRA-
2012-0426-0019).
---------------------------------------------------------------------------

    The commenters, to support their request to EPA, state that EPA's
listing for nicotine and salts warrants a reevaluation, because in more
recent literature concerning nicotine toxicity, doubts have been
expressed about the estimated oral LD50 toxicity to humans of 1 mg/kg,
used as a key basis for the listing. According to information provided
by commenters, the estimated oral LD50 toxicity to humans of 1 mg/kg
was based on extrapolations from toxicological effects observed as
result of ``self-experiments'' performed with nonfatal doses of
nicotine. However, according to the commenters, there are doubts about
the 1 mg/kg estimate because people have survived after ingesting much
larger amounts of nicotine.
    The commenters also state that in 1980, when EPA listed nicotine
and salts as acute hazardous wastes, the nicotine products in the
market contained a high concentration of the chemical (e.g., pesticides
which contained 40 percent nicotine sulfate), but that these products
are no longer on the market. The commenters stressed that the current
nicotine products on the market are low-concentration nicotine products
that do not meet the regulatory criteria for acutely hazardous wastes.
The low-concentration nicotine-containing products that are currently
on the market were identified by commenters as nicotine replacement
therapy products (e.g., gums, lozenges, patches, inhalers, and nasal
sprays) and e-cigarettes. These products, according to the commenters,
generally contain less than 3 percent nicotine.
    While it may be reasonable for the commenters to conclude that
toxicity is higher at higher concentrations of a chemical and lower at
lower concentrations of a chemical, EPA currently lacks sufficient
information to conclude that low-concentration nicotine-containing
products are not acutely toxic as defined under 40 CFR 261.11(a)(2). In
addition, except for warfarin and zinc phosphide, the listings for
commercial chemical products under 40 CFR 261.33(e) are not
concentration-based listings. The warfarin and zinc phosphide listings
were changed to concentration-based listings because companies using
products containing lower concentration formulations of warfarin and
zinc phosphide petitioned EPA to amend the listings and provided LD50
data for animals for the lower concentration products to support their
petition (see 49 FR 19922; May 10, 1984). The Agency does not think
that linear extrapolations from toxicity levels determined using
higher-concentration nicotine products can be used to characterize the
acute toxicity of low-concentration nicotine-containing products.
Furthermore, although nicotine pesticides are no longer available, high
concentration nicotine products still exist. For example, manufacturers
of nicotine-containing products, such as e-cigarettes, buy concentrated
nicotine solutions and dilute them for consumer use.
    In summary, nicotine and salts are P075 listed acute hazardous
wastes if the waste arises from the discard of an unused commercial
chemical product, manufacturing chemical intermediate, or off-
specification material. Additionally, the P075 waste code applies only
if the nicotine is present in pure or technical grade form, or is the
sole active ingredient in the chemical formulation when discarded. As
such, unused (unsold, expired, or returned) nicotine-containing
products, including patches, gums, lozenges,\161\ inhalers, nasal
sprays and e-cigarettes,\162\ are classified as P075 listed acute
hazardous wastes when discarded. When discarded, these unsold products
are causing many retailers to notify and operate as LQGs, which has
resulted in increased economic burdens and reporting requirements for
retailers. EPA is aware that this is an issue of great concern to the
retail associations and their members and would like to address the
issue, if possible, by amending the P075 listing to conditionally
exempt certain low-concentration nicotine-containing products. The
Agency is considering two possible approaches, described below, for
amending the P075 listing.
---------------------------------------------------------------------------

    \161\ See memo from Dellinger to Smith, dated August 23, 2010,
RCRA Online # 14817 regarding unused patches, gums and lozenges
http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/209444BADDA4ECDC852577ED00624E8F/
$file/14817.pdf.
    \162\ See memo from Johnson to DeWitt, May 8, 2015, regarding e-
cigarettes, RCRA Online # 17850.
---------------------------------------------------------------------------

D. Two Possible Approaches for Amending the P075 Listing

1. Exemption from P075 Listing for FDA-Approved Over-the-Counter
Nicotine-Containing Smoking Cessation Products
    The over-the-counter (OTC) nicotine-containing smoking cessation
products, referred to also as nicotine replacement therapy (NRT)
products (i.e., nicotine patches, gums, and lozenges) are approved by
the Food and Drug Administration (FDA), which ensures that the risk to
the public using these products have been evaluated. EPA is currently
trying to obtain the risk evaluation data for these products from FDA,
which may provide data on the exact concentration of nicotine in the
NRT products and any animal and/or human toxicity data associated with
use of these products. The Agency is also trying to gather any publicly
available animal and/or human toxicity data for these products, in
particular toxicity data that could be compared to EPA's acute toxicity
criteria under Sec.  261.11(a)(2). If the Agency is successful in
obtaining the toxicity data to support the conclusion that FDA-approved
over-the-counter nicotine-containing smoking cessation products do not
meet the criteria for listing as an acutely hazardous waste, then the
Agency will propose to exempt these products from the P075 listing.
    Since e-cigarettes have not been approved by the FDA as smoking
cessation products, we do not anticipate being able to obtain animal or
human toxicity data from the FDA on nicotine concentrations in e-
cigarettes. To complicate matters, the concentration of nicotine in e-
cigarettes is not limited by any regulation or approval process and is
therefore unpredictable. As a result, this option would likely be
limited to excluding FDA-approved over-the-counter nicotine-containing
smoking cessation products from the P075 listing and would not include
e-cigarettes.
2. Concentration-Based Exemption From P075 Listing for Low-
Concentration Nicotine-Containing Products
    The comments from the retail associations have stressed that the
low

concentration nicotine products currently in the market (generally
containing less than 3 percent nicotine) should not be classified as
acutely hazardous wastes under RCRA. However, they did not submit any
human toxicological data or animal LD50 data for these products to
demonstrate that these products are not acutely toxic as defined under
Sec.  261.11(a)(2). Without these data, it is difficult for the Agency
to justify exempting these products from the P075 listing. Furthermore,
in order for the Agency to consider a concentration-based exemption for
low-concentration nicotine-containing products from the P075 listing,
the Agency needs human toxicological data and animal LD50 data for
nicotine-containing products at maximum concentrations of nicotine in
these products (e.g., 3 percent nicotine). If the toxicological data
for nicotine-containing products at maximum concentrations of nicotine
in these products show that these products are not acutely toxic as
defined under Sec.  261.11(a)(2), then the Agency could propose a
concentration-based exemption for these products (including e-
cigarettes) from the P075 listing. However, depending on the toxicity
data, the Agency may also propose to list the P075 exempt nicotine-
containing products as non-acute hazardous wastes (U-listed wastes)
under 40 CFR 261.33(f). In that case, the concentration-based exemption
for nicotine-containing products from the P075 listing would be similar
to what the Agency proposed for warfarin and zinc phosphide listings
(see 48 FR 7714; February 23, 1983).

E. Request for Comments

    EPA invites comments on all possible approaches to amend the acute
hazardous waste listing for nicotine and salts, including the two
approaches discussed above in Section VIII.D. We also request toxicity
information for low-concentration nicotine-containing products that
could help determine whether or not these products meet the criteria
for acute hazardous wastes under Sec.  261.11(a)(2). The Agency
emphasizes that no regulatory language is currently being proposed with
respect to amending the P075 listing to exempt the low-concentration
nicotine-containing products. However, depending on the information
received during the comment period, EPA could finalize one of the
approaches discussed previously without a separate proposed rulemaking
in the future.
    In addition, we request comments on whether we should exempt other
low-concentration nicotine-containing smoking cessation products, such
as inhalers and nasal sprays, from the P075 listing under approach 1,
described in the Section VIII.D, above. These products are also FDA-
approved, but require a prescription to purchase. The nicotine-
containing patches, gums, and lozenges are sold over-the-counter, so
they do not require a prescription for purchase. We are interested in
finding out what the differences are between nicotine-containing
smoking cessation products requiring a prescription and those products
that do not require a prescription (e.g., in concentrations of
nicotine, amount of nicotine delivered over time, health effects).
    Finally, we request comment on whether we should include e-
cigarettes and nicotine-containing e-liquids for the e-cigarettes
within the scope of the definition of pharmaceutical. As described in
this proposal, pharmaceutical hazardous wastes do not count toward
generator category. Therefore, since e-cigarettes and nicotine-
containing e-cigarette refill liquids (sometimes referred to as e-
liquids or e-juice) are P075, if they are considered pharmaceuticals,
they would not impact the hazardous waste generator category of the
retailers. The retailers, however, would have to manage e-cigarettes
and nicotine-containing liquids as hazardous waste pharmaceuticals
under part 266, subpart P. We will use the comments we receive to help
us decide whether and how to proceed with amending the scope of the
definition of pharmaceutical to include e-cigarettes and nicotine-
containing e-liquids.

IX. State Authorization

A. Applicability of Rules in Authorized States

    Under Section 3006 of RCRA, EPA may authorize a qualified State to
administer its own hazardous waste program within the State in lieu of
the Federal program. Following authorization, EPA retains enforcement
authority under Sections 3008, 3013, and 7003 of RCRA, although
authorized States have primary enforcement responsibility. The
standards and requirements for State authorization are found at 40 CFR
part 271.
    Prior to enactment of the Hazardous and Solid Waste Amendments of
1984 (HSWA), a State with final RCRA authorization administered its
hazardous waste program entirely in lieu of EPA administering the
Federal program in that State. The federal requirements no longer
applied in the authorized State, and EPA could not issue permits for
any facilities in that State, since only the State was authorized to
issue RCRA permits. When new, more stringent federal requirements were
promulgated, the State was obligated to enact equivalent authorities
within specified time frames. However, the new federal requirements did
not take effect in an authorized State until the State adopted the
federal requirement as State law.
    In contrast, under RCRA Section 3006(g) (42 U.S.C. 6926(g)), which
was added by HSWA, new requirements and prohibitions imposed under HSWA
authority take effect in authorized States at the same time that they
take effect in unauthorized States. The statute directs EPA to
implement these requirements and prohibitions in authorized States,
including the issuance of permits, until the State is granted
authorization to do so. While the State must still adopt HSWA related
provisions as State law in order to retain final authorization, EPA
implements the HSWA provisions in authorized States until the States do
so.
    Authorized States are required to modify their program only when
EPA enacts federal requirements that are more stringent or broader in
scope than the existing federal requirements. RCRA Section 3009 allows
the States to impose standards more stringent than those in the federal
program (see also Sec.  271.1).\163\ Therefore, authorized States may,
but are not required to, adopt federal regulations, both HSWA and non-
HSWA, that are considered less stringent than previous federal
regulations.
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    \163\ EPA notes that decisions regarding whether a state rule is
more stringent or broader in scope than the federal program are made
when the Agency authorizes state programs.
---------------------------------------------------------------------------

B. Effect on State Authorization

    This action proposes to add a new subpart P to 40 CFR part 266, and
it is being proposed in part under the authority of HSWA and in part
under non-HSWA authority. The bulk of 40 CFR part 266, subpart P is
being proposed under non-HSWA authority. Thus, when finalized, the
amendments promulgated under non-HSWA authority would be applicable on
the effective date only in those states that do not have final
authorization of their base RCRA programs. However, the prohibition of
sewering pharmaceutical hazardous wastes (Sec.  266.504) is being
proposed under HSWA authority in section 3018 of RCRA. Thus, when
finalized, the amendments promulgated under the authority of HSWA would
be applicable on the effective date of the final rule in all states.
Moreover, authorized states are required to modify

their programs only when EPA promulgates federal regulations that are
more stringent or broader in scope than the authorized state
regulations. This proposed rule is considered, on the whole, to be more
stringent than the current federal standards. Therefore, authorized
states will be required to modify their programs to adopt the
amendments, when finalized. When a state adopts this new subpart, if
elements of the state program are more stringent than this new subpart,
the state has the option of retaining those more stringent elements.
Likewise, when a state adopts this new subpart, the state has the
option of adding elements that are more stringent or broader in scope
than this new subpart.

C. Effect on State Authorization in States That Have Added
Pharmaceuticals to the Universal Waste Program

    The Universal Waste program allows states to add wastestreams to
their own state program, even when the waste stream has not been added
to the federal Universal Waste program, provided the state has adopted
and been authorized for the petition process in Sec. Sec.  260.20 and
260.23. Two states have added hazardous waste pharmaceuticals to their
Universal Waste programs: Florida and Michigan. Because this proposed
rule is considered more stringent than either the ``traditional RCRA''
standards or the Universal Waste program, both Florida and Michigan
will be required to modify their programs to adopt an approach at least
as stringent as the amendments, if this rule is finalized. Furthermore,
because the Agency has determined that it is not appropriate to add
hazardous waste pharmaceuticals to the Universal Waste program, both
Florida and Michigan must remove hazardous waste pharmaceuticals from
their Universal Waste program when they adopt this new subpart,
although they may continue to regulate non-hazardous waste
pharmaceuticals under the Universal Waste program, to the extent
allowed under state law. In addition, states may not add hazardous
waste pharmaceuticals to their Universal Waste program in the future.

X. Adding and Reserving Part 266, Subpart O

    In addition to proposing new standards for the management of
hazardous waste pharmaceuticals at healthcare facilities and
pharmaceutical reverse distributors, EPA is proposing to add and
reserve 40 CFR part 266, subpart O. Specifically, on May 22, 2001, EPA
finalized a Project XL rule in 40 CFR part 266, subpart O (66 FR 28066)
for US Filter Recovery Services. However, on July 2, 2008, EPA
published a rule that withdrew 40 CFR part 266, subpart O (73 FR
37858). Generally, in order to avoid the potential for confusion that
might be caused by reusing a subpart, EPA reserves a subpart that has
already been used and removed. In 2008, when we removed 40 CFR part
266, subpart O, we neglected to reserve it. Consequently, we are
proposing to add and reserve 40 CFR part 266, subpart O.

XI. Summary of Regulatory Impact Analysis

    In order to meet the Office of Management and Budget (OMB) Circular
A-4 requirement that EPA analyze the costs and benefits of regulations,
we conducted an economic analysis of the proposed rule. The economic
analysis follows OMB guidelines and estimates the costs and benefits of
the rule. The economic analysis is titled ``Regulatory Impact Analysis
for EPA's Proposed Healthcare Facility-Specific Regulations for the
Management of Hazardous Waste Pharmaceuticals'' and is hereafter
referred to as the Regulatory Impact Analysis (RIA). The RIA is
summarized here while the full RIA can be found at regulations.gov
under docket number EPA-HQ-RCRA-2007-0932.
    This proposed rule may affect several different types of healthcare
facilities, including hospitals, physicians' offices, dentists'
offices, outpatient care centers, pharmacies, veterinary clinics,
nursing care facilities, coroners' offices, other health practitioners,
other ambulatory care services, and pharmaceutical reverse
distributors. Based on data from the 2007 Economic Census and a limited
number of states, the RIA estimates that the rule will affect
approximately 174,000 facilities. Table 12 lists the number of
facilities (by NAICS code) expected to be affected by the proposed
rule. The vast majority of these (83.6%) are CESQGs, followed by SQGs
(13.4%), and LQGs (3.0%).

[GRAPHIC] [TIFF OMITTED] TP25SE15.008

    We estimate that there is a total of approximately 139,000 tons of
RCRA hazardous waste generated by healthcare facilities annually.
Approximately 36,200 tons (26%) of this total are hazardous waste
pharmaceuticals.

A. Costs of the Proposed Rule

    The estimated costs of the proposed rule are the incremental costs
over and above the ``baseline'' (i.e., assumptions about the way in
which healthcare facilities currently dispose of their hazardous waste
pharmaceuticals). The base case set of baseline assumptions reflects
``full compliance'' with the current RCRA hazardous waste requirements
for the management of hazardous waste pharmaceuticals. A sensitivity
analysis of baseline assumptions was also conducted that reflects only
``partial compliance'' with current regulations. To see the results for
the partial compliance baseline sensitivity analysis, please see the
RIA.
    The estimated cost of the proposed rule, including the proposed
prohibition on sewering of hazardous waste pharmaceuticals is estimated
at $37 million annually under the full compliance baseline. However,
there are also significant cost savings under the proposed rule: $24.3
million annually under the full compliance baseline. Therefore the net
cost of the rule is $13 million annually ($37million cost minus $24.3
million cost savings = $13 million net costs). Please see the RIA for
more detailed analysis and results regarding the cost of the rule and
the regulatory options analyzed.

B. Benefits of the Proposed Rule

    The proposed rule for the management of hazardous waste
pharmaceuticals is expected to yield a range of environmental benefits
as hospitals, medical clinics, and other healthcare facilities divert
hazardous waste pharmaceuticals currently disposed in sewers, municipal
solid waste landfills (MSWLFs), municipal waste combustors (MWCs), and
medical waste autoclaves and incinerators, to hazardous waste
incinerators. The rule reduces the amount of hazardous waste
pharmaceuticals sewered into waterways, provides regulatory clarity for
industry and provides healthcare facilities and pharmaceutical reverse
distributors with cost savings.
    The largest quantified benefit is from avoided sewering of
hazardous waste pharmaceuticals. Disposal of hazardous waste
pharmaceuticals through sewering is believed to be a widespread
practice of disposal. Sewering is believed to be one of the most
deleterious disposal methods because active pharmaceutical ingredients
(APIs) entering surface waters, often untreated by municipal wastewater
treatment plants, pose the potential for adverse human health and
environmental effects since they may be absorbed by humans and other
organisms. Under the proposed rule, the Agency anticipates preventing
approximately 6,400 tons of hazardous waste pharmaceuticals annually
into waterways via a sewering ban. While the Agency was not able to
quantify the human health and environmental benefits of reducing or
eliminating the sewering of hazardous waste pharmaceuticals, EPA did
estimate the cost savings of eliminating the wastewater treatment costs
associated with sewering such pharmaceuticals. The estimated cost
savings of eliminated wastewater treatment related to the prevented
sewering of hazardous waste pharmaceuticals is estimated to be $4.3
million annually.
    The proposed rule will yield other benefits beyond the reduction in
sewering of hazardous waste pharmaceuticals. For example, under the
proposed rule, healthcare facilities will no longer be required to
count hazardous waste pharmaceuticals toward their RCRA generator
category. This, in turn, will lead to changes in a healthcare
facility's generator category,

enabling them to realize an additional cost savings. The extent to
which such changes in generator category will occur under the proposed
rule is uncertain, but these changes would be most likely for those
healthcare facilities for which hazardous waste pharmaceuticals make up
a large portion of their overall hazardous waste generation. Please see
the RIA for a breakout of cost savings by regulatory requirement.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735; October 4, 1993), this
action is a ``significant regulatory action'' because it is likely to
raise novel legal or policy issues under section 3(f)(4). Accordingly,
EPA submitted this action to the Office of Management and Budget (OMB)
for review under Executive Orders 12866 and 13563 (76 FR 3821; January
21, 2011) and any changes made in response to OMB recommendations have
been documented in the docket for this action (EPA-HQ-RCRA-2007-0932).
    Findings for the RIA indicate that the rule, as proposed, is
projected to result in an aggregate annual cost of approximately $37
million based on a discount rate of 7%. However, the proposed rule will
also achieve an annual cost savings, which is estimated to be $24.3
million. Therefore, the net cost of the rule is estimated at $13
million annually. The costs, which represents annualized incremental
costs relative to the full compliance baseline, is below the $100
million threshold established under part 3(f)(1) of the Order.
    In addition to calling for an assessment of regulatory costs,
Executive Order 12866 also requires Federal agencies to assess benefits
and, ``recognizing that some costs and benefits are difficult to
quantify, propose or adopt a regulation only upon a reasoned
determination that the benefits of the intended regulation justify its
costs.'' As discussed previously, the cost savings for the rule are
estimated to be $24.3 million annually. These cost savings are
considered benefits of the rule. Also, EPA estimates that the proposed
rule will lead to the diversion of approximately 6,440 tons annually of
hazardous waste pharmaceuticals from sewer disposal to alternate forms
of disposal. This reduction in sewering will likely reduce the
concentration of active pharmaceutical ingredients in the nation's
waterways, potentially benefiting both ecosystems and human
populations. Please see the RIA for more details on the benefits of the
proposed rule.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the PRA. The Information Collection Request (ICR) document
that the EPA prepared has been assigned EPA ICR number 2486.01. You can
find a copy of the ICR in the docket for this rule, and it is briefly
summarized here.
    EPA is proposing in this rule, under a new subpart P to 40 CFR part
266, new and revised reporting and recordkeeping requirements for
healthcare facilities and pharmaceutical reverse distributors managing
hazardous waste pharmaceuticals. These proposed requirements, which are
also identified in the ICR supporting this action, will enable EPA and
state regulatory agencies to identify the universe of healthcare
facilities managing hazardous waste pharmaceuticals. The healthcare
facilities must keep records of any test results, waste analyses or
other determinations made on hazardous waste pharmaceuticals for three
years from the date of analyses. In addition, the proposed requirements
include provisions for improved tracking of hazardous waste
pharmaceuticals that are routed through pharmaceutical reverse
distributors.
    EPA will use the collected information to ensure that hazardous
waste pharmaceuticals are being managed in a protective manner. The
tracking requirements ensure that these wastes arrive at their intended
destinations rather than diverted for illicit purposes or managed at
facilities not equipped to manage these wastes. These tracking
requirements will also help facilities identify shipments that do not
arrive at their destination as planned, allowing generators to take
corrective action that will ensure that future shipments are
transported to the appropriate location. In addition, during a facility
inspection, information kept in facility records will help EPA and
state environmental regulatory agencies determine whether or not
regulatory requirements are being followed. Information marked on
containers of hazardous waste pharmaceuticals will assist handlers and
transporters in ensuring proper management during storage and shipment.
    EPA has carefully considered the burden imposed upon the regulated
community by the proposed regulations. EPA is confident that those
activities required of respondents are necessary and, to the extent
possible, has attempted to minimize the burden imposed. EPA believes
strongly that if the minimum requirements specified under the proposed
regulations are not met, neither the facilities nor EPA can ensure that
hazardous waste pharmaceuticals are managed in a manner protective of
human health and the environment.
    EPA estimates that the total annual respondent burden for the new
paperwork requirements in the proposed rule is approximately 54,857
hours, and the annual respondent cost for the new paperwork
requirements in the rule is approximately $3,457,478. The estimated
annual hourly burden ranges from 0.1 to 3.5 hours per response for the
28,637 respondents. However, in addition to estimating the annual
respondent burden associated with new paperwork requirements in the
proposed rule, the Agency also estimated the annual benefits (hours and
cost savings) to respondents from the new paperwork requirements in
comparison to complying with the existing RCRA hazardous waste
information collection requirements for hazardous waste pharmaceuticals
(e.g., preparation of biennial reports, recordkeeping, etc.). Taking
both the new proposed and existing RCRA requirements into account, EPA
expects the proposed rule would result in a net annual paperwork burden
to the 28,637 respondents of approximately 28,660 hours or $2,301,873.
The net cost to EPA of administering the rule is expected to be
negligible, since the Agency is not required to review and approve any
information submitted by respondents. Burden is defined at 5 CFR
1320.3(b).
    Respondents/affected entities: Private entities.
    Respondent's obligation to respond: Mandatory per 40 CFR part 266,
subpart P.
    Estimated number of respondents: 28,637.
    Frequency of response: Once.
    Total estimated burden: 54,857 hours.
    Total estimated cost: $3,457,478, includes $1,038,856 annualized
capital or operation & maintenance costs.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. Submit your
comments on the Agency's need for this information, the accuracy of the

provided burden estimates and any suggested methods for minimizing
respondent burden to the EPA using the docket identified at the
beginning of this rule. You may also send your ICR-related comments to
OMB's Office of Information and Regulatory Affairs via email to
<EMAIL_ADDRESS>Attention: Desk Officer for the EPA.
Since OMB is required to make a decision concerning the ICR between 30
and 60 days after receipt, OMB must receive comments no later than
October 26, 2015. The EPA will respond to any ICR-related comments in
the final rule.

C. Regulatory Flexibility Small Business Analysis

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. The
small entities subject to the requirements of this action are indicated
in Table 13. The Agency has determined that costs of the regulation for
a facility are less than 1 percent of annual revenue.
    To assess the number of small entities in the regulated universe,
EPA consulted NAICS-level data from the 2007 Economic Census and
tallied the number of facilities, by NAICS code, owned by entities with
revenues below SBA's threshold for consideration as small. Entities in
revenue categories above the SBA threshold are not considered small.
See Table 12 for the SBA thresholds and revenues.
[GRAPHIC] [TIFF OMITTED] TP25SE15.009

    The percentage of facilities that qualify as small under SBA's
thresholds were estimated for each industry affected by the proposed
rule. These percentages were applied to the number of facilities in the
regulatory universe, as presented in the RIA. After estimating the
number of small entities by NAICS code, the average cost per small
entity was estimated based on the model facility costs presented in the
RIA. Next, the EPA determined whether the per

facility costs incurred by small entities represent more than 1% of
annual revenues, which required estimating small entities' average
annual revenues. For each NAICS code, the average per facility revenue
of entities considered small under the SBA standard was estimated based
on data from the 2007 Economic Census.
    The proposed rule is expected to impact a total of 144,228 small
entities (1,634 hospitals, 142,566 other healthcare facilities (i.e.,
healthcare facilities that are not hospitals) and 28 pharmaceutical
reverse distributors). The highest cost impact to small entities is
estimated to be 0.013% of revenues at other healthcare facilities and
0.002% of revenues at hospitals. Because pharmaceutical reverse
distributers are in various NAICS codes, the Agency was not able to
obtain revenue data for pharmaceutical reverse distributors. However
the estimated cost impact to small entity pharmaceutical reverse
distributors is estimated at $5,300 annually, which the Agency does not
anticipate will cause significant hardship on pharmaceutical reverse
distributors that are small entities. However, the Agency requests
comment on the cost impacts on small entity pharmaceutical reverse
distributors that process creditable hazardous waste pharmaceuticals.
    In the RIA, small entity impacts are presented incremental to the
full compliance baseline. The annual per facility costs incremental to
both baselines are estimated to be much less than 1% of average annual
revenues. Since the incremental impact to the smallest healthcare
facilities in terms of revenue is less than 1% of average annual
revenues, the proposed rule is not expected to cause a significant
impact to a substantial number of small businesses. Please see the RIA
for a detailed analysis of cost impacts on small entities.
    Although this proposed rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. We continue
to be interested in the potential impacts of the proposed rule on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

    This rule does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. As indicated
previously, the annual net cost is estimated to be $13 million annually
after cost savings ($37 million cost minus $24.3 million in cost
savings). Thus, this proposed rule is not subject to the requirements
of sections 202 or 205 of UMRA.
    This proposed rule is also not subject to the requirements of
section 203 of UMRA because it contains no regulatory requirements that
might significantly or uniquely affect small governments. While some
hospitals and coroners' offices are publicly owned, the requirements
affecting those facilities are not unique in that they are the same as
those affecting all facilities in the proposed rule. Also, using data
on revenues of hospitals owned by state and local governments, EPA
estimated that the costs of the rule borne by state and local
governments represent less than 0.001% of their revenues. Therefore,
the costs incurred by small governments are not expected to be
significant.

 E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action may have tribal implications. However, it will neither
impose substantial direct compliance costs on tribal governments, nor
preempt tribal law.
    To assess the potential tribal implications of the proposed rule,
EPA compiled data on the number of tribally run healthcare facilities
in the U.S. and estimated the costs of the proposed rule for these
facilities. Estimates of tribally run healthcare facilities were
obtained from the U.S. Department of Health and Human Services' Indian
Health Service (IHS), as summarized in Table 14.\164\ Data were not
readily available on the size or hazardous waste generation amounts for
the tribally run healthcare facilities identified by the IHS. To
estimate the potential costs of each regulatory option, per facility
costs derived in the RIA were applied to the IHS facility counts. Based
on these values, Table 14 summarizes the costs that tribally run
healthcare facilities are expected to incur under the proposed rule.
OMB has not issued guidance on what constitutes a substantial burden on
tribal governments under this executive order. The relatively low costs
estimated for tribally run healthcare facilities in Table14, however,
suggest that the proposed rule will not impose a substantial burden on
tribal governments. EPA welcomes comments on the proposed rule's impact
on tribal governments. EPA specifically solicits additional comment on
this proposed action from tribal officials.
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    \164\ Indian Health Service (IHS), U.S. Department of Health and
Human Services, IHS Year 2013 Profile, available at http://www.ihs.gov/PublicAffairs/IHSBrochure/Profile.asp, accessed December
20, 2012.

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[GRAPHIC] [TIFF OMITTED] TP25SE15.010

    The EPA consulted with tribal officials under the EPA Policy on
Consultation and Coordination with Indian Tribes early in the process
of developing this regulation to permit them to have meaningful and
timely input into its development. A summary of that consultation is
provided in the docket for this proposed rule (see EPA-HQ-RCRA-2007-
0932).
    As required by section 7(a), the EPA's Tribal Consultation Official
has certified that the requirements of the executive order have been
met in a meaningful and timely manner. A copy of the certification is
included in the docket for this proposed rule (see EPA-HQ-RCRA-2007-
0932).

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This proposed rule is not subject to Executive Order 13045 because
it is not economically significant as defined in Executive Order 12866,
and because the Agency does not believe the environmental health or
safety risks addressed by this action present a disproportionate risk
to children.
    To examine whether the proposed rule has a disproportionate impact
on children, the RIA uses a geographic analysis of demographics near
wastewater treatment plants and hazardous waste combustion facilities.
Table 15 summarizes the results of this analysis. As indicated in the
table, this analysis finds that children (i.e., individuals under the
age of 18) account for a slightly larger share of the population
(28.5%) in the one-mile radius around wastewater treatment plants than
they account for nationally (25.3%). Among the catchment zones of
wastewater treatment plants, however, children make up a much smaller
portion of the population (9.8%). Within both the one- and three-mile
buffers around hazardous waste combustion facilities, children's share
of the population slightly exceeds their share nationally.
    These data suggest that the proposed rule will not result in a
disproportionate adverse impact on children. Because the children's
share of the population near hazardous waste combustion facilities is
near the national average, any increase in the combustion of hazardous
waste combustion that occurs as a result of the proposed rule is
unlikely to have a significant disproportionate impact on children's
health. The data in Table 15 also show that the number of children
living in close proximity to wastewater treatment plants, in areas
likely to benefit from the rule, far exceeds the number of children who
live near hazardous waste combustion facilities. This suggests that the
diversion of hazardous waste pharmaceuticals from wastewater treatment
plants to combustion facilities will benefit a much greater number of
children than it may put at greater risk of adverse health effects. See
Table 15 for the demographics of children surrounding wastewater
treatment plants and hazardous waste combustion facilities. Please see
the RIA for a detailed methodology of the children's health analysis.

[GRAPHIC] [TIFF OMITTED] TP25SE15.011

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211, (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.
    The proposed rule does not directly regulate energy production or
consumption. Changes in the management of hazardous waste
pharmaceuticals stipulated in the proposed rule are not expected to
impact energy production or distribution. Similarly, the management
requirements outlined in the proposed rule will have minimal impact on
energy consumption (e.g., from transporting hazardous waste
pharmaceuticals that otherwise would have been sewered). Because the
changes in energy production and consumption under the proposed rule
are likely to be minimal, the proposed rule is not expected to have a
significant adverse effect on energy supply, distribution, or use. In
addition, no measurable adverse impacts are expected on energy prices
or foreign supplies.

I. National Technology Transfer and Advancement Act (NTTAA)

    This proposed rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects

on minority, low-income or indigenous populations. The results of this
evaluation are summarized in the following paragraphs. The evaluation
is contained in the Regulatory Impact Analysis (RIA), which can be
found at regulations.gov under docket number EPA-HQ-RCRA-2007-0932.
    To meet the requirements of Executive Order 12898, EPA analyzed
potential environmental justice impacts associated with the diversion
of hazardous waste pharmaceuticals from sewer disposal to hazardous
waste combustion facilities. Populations living near and downstream
from wastewater treatment plants may also benefit from the elimination
of sewering of hazardous waste pharmaceuticals. To the extent that
minority and/or low-income populations near or downstream from
wastewater treatment plants make up a disproportionately high portion
of the overall population, the proposed rule may result in positive
environmental justice impacts. See Table 16 for the results of the
Environmental Justice analysis.
    Overall, EPA expects that the proposed rule may positively affect
U.S. environmental justice populations, although the size of the impact
will vary by wastewater treatment plant. As suggested by Table 16, the
reduction in sewering expected under the proposed rule may benefit
relatively large minority and low-income populations in close proximity
to or downstream from wastewater treatment plants. The diversion of
hazardous waste pharmaceuticals to combustion facilities, however, may
increase the environmental burden borne by environmental justice
populations near these combustion facilities. Although these effects
offset each other to a certain degree, the number of minority and low-
income individuals near wastewater treatment facilities greatly exceeds
the number near hazardous waste combustion facilities. This suggests
that, on the whole, the proposed rule may benefit environmental justice
populations.

[GRAPHIC] [TIFF OMITTED] TP25SE15.012

List of Subjects

40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.

40 CFR Part 262

    Environmental protection, Exports, Hazardous materials
transportation, Hazardous waste, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.

40 CFR Part 266

    Environmental protection, Energy, Hazardous Waste, Recycling,
Reporting and recordkeeping requirements.

40 CFR Part 268

    Environmental protection, Hazardous waste, Reporting and
recordkeeping requirements.

40 CFR Part 273

    Environmental protection, Hazardous materials transportation,
Hazardous waste.

    Dated: August 31, 2015.
Gina McCarthy,
Administrator.

    For the reasons stated in the preamble, Title 40, chapter I, of the
Code of Federal Regulations is proposed to be amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
1. The authority citation for part 261 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and
6938.

0
2. Amend Sec.  261.5 by adding paragraph (c)(8) to read as follows:

Sec.  261.5  Special requirements for hazardous waste generated by
conditionally exempt small quantity generators.

* * * * *
    (c) * * *
    (8) Is a hazardous waste pharmaceutical managed under 40 CFR part
266, subpart P.
* * * * *
0
3. Amend Sec.  261.7 by adding paragraph (c) to read as follows:

Sec.  261.7  Residues of hazardous waste in empty containers.

* * * * *
    (c) Healthcare facilities and pharmaceutical reverse distributors
operating under 40 CFR part 266, subpart P are subject to Sec.  266.507
for the management of hazardous waste pharmaceutical residues in
containers, in lieu of this section.

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE

0
4. The authority citation for part 262 continues to read as follows:

    Authority: 42 U.S.C 6906, 6912, 6922-6925, 6937, and 6938.

0
5. Amend Sec.  262.10 by adding paragraphs (m) and (n) to read as
follows:

Sec.  262.10  Purpose, scope and applicability.

* * * * *
    (m) All pharmaceutical reverse distributors (as defined in Sec.
266.500) are subject to 40 CFR part 266, subpart P for the management
of hazardous waste pharmaceuticals in lieu of this part.
    (n) Each healthcare facility (as defined in Sec.  266.500) must
determine whether it is subject to 40 CFR part 266, subpart P for the
management of hazardous waste pharmaceuticals, based on the total
hazardous waste it generates per calendar month (including
pharmaceutical hazardous waste and non-pharmaceutical hazardous waste).
Healthcare facilities that generate (or accumulate) more than 100 kg
(220 pounds) of hazardous waste per calendar month, or more than 1 kg
(2.2 pounds) of acute hazardous waste per calendar month, or more than
100 kg (220 pounds) per calendar month of any residue or contaminated
soil, waste, or other debris, resulting from the clean-up of a spill,
into or on any land or water, of any acute hazardous wastes listed in
Sec.  261.31 or Sec.  261.33(e), are subject to 40 CFR part 266,
subpart P for the management of hazardous waste pharmaceuticals in lieu
of this part.

PART 266--STANDARDS FOR THE MANAGEMENT OF SPECIFIC HAZARDOUS WASTES
AND SPECIFIC TYPES OF HAZARDOUS WASTE MANAGEMENT FACILITIES

0
6. The authority citation for part 266 continues to read as follows:

    Authority: 42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905,
6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.

Subpart O--[Reserved]

0
7. Add reserved subpart O:
0
8. Add subpart P to read as follows:
Subpart P -- Hazardous Waste Pharmaceuticals
Sec.
266.500 Definitions for this subpart.
266.501 Applicability.
266.502 Standards for healthcare facilities managing non-creditable
hazardous waste pharmaceuticals.
266.503 Standards for healthcare facilities managing potentially
creditable hazardous waste pharmaceuticals.
266.504 Healthcare facilities that are conditionally exempt small
quantity generators (CESQGs).
266.505 Prohibition of sewering hazardous waste pharmaceuticals.
266.506 Conditional exemption for hazardous waste pharmaceuticals
that are also controlled substances.
266.507 Management of hazardous waste pharmaceutical residues in
containers.
266.508 Shipping non-creditable hazardous waste pharmaceuticals from
a healthcare facility or evaluated hazardous waste pharmaceuticals
from a pharmaceutical reverse distributor.
266.509 Shipping potentially creditable hazardous waste
pharmaceuticals from a healthcare facility or a pharmaceutical
reverse distributor to a pharmaceutical reverse distributor.
266.510 Standards for the management of potentially creditable
hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals at pharmaceutical reverse distributors.

Subpart P--Hazardous Waste Pharmaceuticals

Sec.  266.500  Definitions for this subpart.

    The following definitions apply to this subpart:
    Evaluated hazardous waste pharmaceutical means a hazardous waste
pharmaceutical that was a potentially creditable hazardous waste
pharmaceutical but has been evaluated by a pharmaceutical reverse
distributor to establish whether it is eligible for manufacturer's
credit and will not be sent to another pharmaceutical reverse
distributor for further evaluation or verification.
    Hazardous waste pharmaceutical means a pharmaceutical that is a
solid waste, as defined in Sec.  261.2, and is listed in part 261,
subpart D, or exhibits one or more characteristics identified in part
261, subpart C.
    Healthcare facility means:
    (1) Any person that:
    (i) Provides preventative, diagnostic, therapeutic, rehabilitative,
maintenance or palliative care, and counseling, service, assessment or
procedure with respect to the physical or mental condition, or
functional status, of a human or animal or that affects the structure
or function of the human or animal body; or
    (ii) Sells or dispenses over-the-counter or prescription
pharmaceuticals.
    (2) This definition includes, but is not limited to, hospitals,
psychiatric hospitals, ambulatory surgical centers, health clinics,
physicians' offices, optical and dental providers, chiropractors, long-
term care facilities, ambulance services, coroners and medical
examiners, pharmacies, long-term care pharmacies, mail-order
pharmacies, retailers of over-the-counter medications; and veterinary
clinics and hospitals.
    Household waste pharmaceutical means a pharmaceutical that is a
solid waste, as defined in Sec.  261.2, but is exempt from being a
hazardous waste under Sec.  261.4(b)(1).
    Long-term care facility means a licensed entity that provides
assistance with activities of daily living, including managing and
administering pharmaceuticals to one or more individuals at the
facility. This definition includes, but is not limited to, assisted
living, hospices, nursing homes, skilled nursing facilities, and the
assisted living and skilled nursing care

portions of continuing care retirement communities. Not included within
the scope of this definition are group homes, independent living
communities, and the independent living portions of continuing care
retirement communities.
    Non-creditable hazardous waste pharmaceutical means a hazardous
waste pharmaceutical that is not expected to be eligible for
manufacturer's credit.
    Non-hazardous waste pharmaceutical means a pharmaceutical that is a
solid waste, as defined in Sec.  261.2, and is not listed in 40 CFR
part 261, subpart D, and does not exhibit a characteristic identified
in 40 CFR part 261, subpart C.
    Non-pharmaceutical hazardous waste means a solid waste, as defined
in Sec.  261.2, that is listed in 40 CFR part 261, subpart D, or
exhibits one or more characteristics identified in 40 CFR part 261,
subpart C, but is not a pharmaceutical, as defined in this section.
    Pharmaceutical means any chemical or biological product that is
intended for use in the diagnosis, cure, mitigation, care, treatment,
or prevention of disease or injury of a human or other animal; or any
chemical or biological product that is intended to affect the structure
or function of the body of a human or other animal. This definition
includes, but is not limited to: dietary supplements as defined by the
Federal Food, Drug and Cosmetic Act, prescription drugs, over-the-
counter drugs, residues of pharmaceuticals remaining in containers,
personal protective equipment contaminated with pharmaceuticals, and
clean-up material from spills of pharmaceuticals.
    Pharmaceutical reverse distributor means any person that receives
and accumulates potentially creditable hazardous waste pharmaceuticals
for the purpose of facilitating or verifying manufacturer's credit. Any
person, including forward distributors and pharmaceutical
manufacturers, that processes pharmaceuticals for the facilitation or
verification of manufacturer's credit is considered a pharmaceutical
reverse distributor.
    Potentially creditable hazardous waste pharmaceutical means:
    (1) A hazardous waste pharmaceutical that has the potential to
receive manufacturer's credit and is:
    (i) Unused or un-administered; and
    (ii) Unexpired or less than one year past expiration date.
    (2) The term does not include ``evaluated hazardous waste
pharmaceuticals,'' residues of pharmaceuticals remaining in containers,
contaminated personal protective equipment, and clean-up material from
the spills of pharmaceuticals.

Sec.  266.501  Applicability.

    (a) A healthcare facility that is a conditionally exempt small
quantity generator remains subject to Sec.  261.5 and is not subject to
this subpart, except for Sec. Sec.  266.504, 266.505, and 266.507(a)
and (b).
    (b) A healthcare facility that is a conditionally exempt small
quantity generator has the option of complying with this subpart for
the management of its hazardous waste pharmaceuticals, as an
alternative to complying with the conditional exemption of Sec.  261.5.
    (c) A healthcare facility or pharmaceutical reverse distributor
remains subject to all applicable hazardous waste regulations with
respect to the management of its non-pharmaceutical hazardous waste.
    (d) With the exception of healthcare facilities identified in
subsection (a), a healthcare facility is subject to:
    (1) Sections 266.502 and 266.504 through 266.508 of this subpart
with respect to the management of:
    (i) Non-creditable hazardous waste pharmaceuticals, and
    (ii) Potentially creditable hazardous waste pharmaceuticals if they
are not destined for a pharmaceutical reverse distributor.
    (2) Sections 266.503 through 266.507 and 266.509 of this subpart
with respect to the management of potentially creditable hazardous
waste pharmaceuticals that are destined for a pharmaceutical reverse
distributor.
    (e) A pharmaceutical reverse distributor is subject to Sec. Sec.
266.505 through 266.510 of this subpart with respect to the management
of hazardous waste pharmaceuticals.
    (f) This subpart does not apply to the management of hazardous
waste pharmaceuticals that are generated or managed by entities other
than healthcare facilities and pharmaceutical reverse distributors.

Sec.  266.502  Standards for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals.

    (a) Notification and withdrawal from this subpart for healthcare
facilities managing non-creditable hazardous waste pharmaceuticals--(1)
Notification. A healthcare facility must notify the EPA Regional
Administrator, using the Site Identification Form (EPA form 8700-12),
that it is a healthcare facility operating under this subpart. A
healthcare facility is not required to fill out Box 11 (Description of
Hazardous Waste) of the Site Identification Form with respect to its
hazardous waste pharmaceuticals. A healthcare facility must submit a
separate notification (Site Identification Form) for each site or EPA
Identification Number.
    (i) A healthcare facility that already has an EPA identification
number must re-notify the EPA Regional Administrator, using the Site
Identification Form (EPA form 8700-12), that it is a healthcare
facility as part of its next Biennial Report, if it is required to
submit one; or if not required to submit a Biennial Report, within 60
days of the effective date of this subpart, or within 60 days of
becoming subject to this subpart.
    (ii) A healthcare facility that does not have an EPA identification
number must obtain one by notifying the EPA Regional Administrator,
using the Site Identification form (EPA form 8700-12), that it is a
healthcare facility as part of its next Biennial Report, if it is
required to submit one; or if not required to submit a Biennial Report,
within 60 days of the effective date of this subpart, or within 60 days
of becoming subject to this subpart.
    (iii) A healthcare facility must keep a copy of its notification on
file for as long as the healthcare facility is subject to this subpart.
    (2) Withdrawal. A healthcare facility that operated under this
subpart but is no longer subject to this subpart, because it is a
conditionally exempt small quantity generator under Sec.  261.5, and
elects to withdraw from this subpart, must notify the appropriate EPA
Regional Administrator using the Site Identification Form (EPA form
8700-12) that it is no longer operating under this subpart. A
healthcare facility is not required to fill out Box 11 (Description of
Hazardous Waste) of the Site Identification Form with respect to its
hazardous waste pharmaceuticals. A healthcare facility must submit a
separate notification (Site Identification Form) for each EPA
Identification Number.
    (i) A healthcare facility must submit the Site Identification Form
notifying that it is withdrawing from this subpart before it begins
operating under the conditional exemption of Sec.  261.5(b).
    (ii) A healthcare facility must keep a copy of its withdrawal on
file for three years from the date of signature on the notification of
its withdrawal.
    (b) Training of employees managing non-creditable hazardous waste
pharmaceuticals at healthcare facilities. A healthcare facility must
ensure that all employees that manage non-creditable hazardous waste
pharmaceuticals are thoroughly familiar

with proper waste handling and emergency procedures relevant to their
responsibilities during normal facility operations and emergencies.
    (c) Hazardous waste determination for non-creditable hazardous
waste pharmaceuticals at healthcare facilities. A healthcare facility
that generates a solid waste that is a pharmaceutical must determine
whether the solid waste pharmaceutical is a hazardous waste
pharmaceutical (i.e., it exhibits a characteristic identified in 40 CFR
part 261, subpart C or is listed in 40 CFR part 261, subpart D) in
order to determine whether the waste is subject to this subpart. A
healthcare facility may choose to manage its solid waste
pharmaceuticals as hazardous waste pharmaceuticals under this subpart
even if the solid waste pharmaceuticals do not exhibit a characteristic
identified in 40 CFR part 261, subpart C and are not listed in 40 CFR
part 261, subpart D.
    (d) Standards for containers used to accumulate non-creditable
hazardous waste pharmaceuticals at healthcare facilities. (1) A
healthcare facility must place non-creditable hazardous waste
pharmaceuticals in a container that is structurally sound, compatible
with its contents, and that lacks evidence of leakage, spillage, or
damage that could cause leakage under reasonably foreseeable
conditions.
    (2) A healthcare facility that manages ignitable or reactive
hazardous waste pharmaceuticals, or that mixes or commingles
incompatible hazardous waste pharmaceuticals must manage the container
so that it does not have the potential to:
    (i) Generate extreme heat or pressure, fire or explosion, or
violent reaction;
    (ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in
sufficient quantities to threaten human health;
    (iii) Produce uncontrolled flammable fumes or gases in sufficient
quantities to pose a risk of fire or explosions;
    (iv) Damage the structural integrity of the container of hazardous
waste pharmaceuticals; or
    (v) Through other like means threaten human health or the
environment.
    (3) A healthcare facility must keep containers of non-creditable
hazardous waste pharmaceuticals closed and secured in a manner that
prevents unauthorized access to its contents.
    (4) A healthcare facility may accumulate hazardous waste
pharmaceuticals and non-hazardous pharmaceutical waste in the same
container, except that hazardous waste pharmaceuticals prohibited from
being combusted because of the dilution prohibition of Sec.  268.3(c)
must be accumulated in separate containers.
    (e) Labeling containers used to accumulate non-creditable hazardous
waste pharmaceuticals at healthcare facilities. A healthcare facility
must label or clearly mark each container of hazardous waste
pharmaceuticals with the phrase ``Hazardous Waste Pharmaceuticals.''
    (f) Maximum accumulation time for non-creditable hazardous waste
pharmaceuticals at healthcare facilities. (1) A healthcare facility may
accumulate non-creditable hazardous waste pharmaceuticals on-site for
one year or less without a permit or having interim status. A
healthcare facility may accumulate for more than one year without a
permit or having interim status, only if the requirements of paragraph
(f)(3) of this section are met.
    (2) A healthcare facility that accumulates non-creditable hazardous
waste pharmaceuticals on-site must demonstrate the length of time that
the hazardous waste pharmaceuticals have been accumulating, starting
from the date it first becomes a waste. A healthcare facility may make
this demonstration by any of the following methods:
    (i) Marking or labeling the container of non-creditable hazardous
waste pharmaceuticals with the date that hazardous waste
pharmaceuticals became a waste;
    (ii) Maintaining an inventory system that identifies the date the
non-creditable hazardous waste pharmaceutical being accumulated first
became a waste;
    (iii) Placing the non-creditable hazardous waste pharmaceuticals in
a specific area and identifying the earliest date that any of the non-
creditable hazardous waste pharmaceuticals in the area became a waste;
or
    (iv) 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.
    (3) A healthcare facility may request from the EPA Regional
Administrator an extension beyond the one year accumulation time limit
for non-creditable hazardous waste pharmaceuticals involved in
litigation, a recall, or unforeseen circumstances beyond the control of
the healthcare facility.
    (i) A request must be sent to the EPA Regional Administrator in
writing (paper or electronic). The request for an extension must
include an explanation of the reason an extension is requested, the
approximate volume or weight of the hazardous waste pharmaceuticals
that will be accumulated more than 90 days, and the amount of
additional time requested.
    (ii) The amount of time extension granted is at the discretion of
the EPA Regional Administrator on a case-by-case basis.
    (g) Land disposal restrictions for non-creditable hazardous waste
pharmaceuticals. The hazardous waste pharmaceuticals generated by a
healthcare facility are subject to the Land Disposal Restrictions 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 (codes).
    (h) Procedures for healthcare facilities for managing rejected
shipments of non-creditable hazardous waste pharmaceuticals. A
healthcare facility that sends a shipment of non-creditable hazardous
waste pharmaceuticals to a designated facility and later receives that
shipment back as a rejected load in accordance with the manifest
discrepancy provisions of Sec.  264.72 or Sec.  265.72 of this chapter,
may accumulate the returned hazardous waste pharmaceuticals on-site for
up to an additional 90 days provided the rejected or returned shipment
is managed in accordance with paragraphs (d) and (e) of this section.
Upon receipt of the returned shipment, the healthcare facility must:
    (1) Sign either:
    (i) Item 18c of the original manifest, if the original manifest was
used for the returned shipment; or
    (ii) Item 20 of the new manifest, if a new manifest was used for
the returned shipment;
    (2) Provide the transporter a copy of the manifest;
    (3) Within 30 days of delivery of the rejected shipment, send a
copy of the manifest to the designated facility that returned the
shipment to the healthcare facility; and
    (4) Transport or offer for transport the returned shipment in
accordance with the shipping standards of Sec.  266.508(a).
    (i) Reporting by healthcare facilities for non-creditable hazardous
waste pharmaceuticals--(1) Biennial report by healthcare facilities.
Healthcare facilities are not subject to biennial reporting
requirements under Sec.  262.41, with respect to non-creditable
hazardous waste pharmaceuticals managed under this subpart.
    (2) Exception report by healthcare facilities for a missing copy of
the manifest. (i) For shipments from a

healthcare facility to a designated facility: If a healthcare facility
does not receive a copy of the manifest with the handwritten signature
of the owner or operator of the designated facility within 60 days of
the date the non-creditable hazardous waste pharmaceuticals were
accepted by the initial transporter, the healthcare facility must
submit:
    (A) A legible copy of the original manifest, indicating that the
healthcare facility has not received confirmation of delivery, to the
EPA Regional Administrator for the Region in which the healthcare
facility is located, and
    (B) A handwritten or typed note on the manifest itself, or on an
attached sheet of paper, stating that the return copy was not received
and explaining the efforts taken to locate the non-creditable hazardous
waste pharmaceuticals and the results of those efforts.
    (ii) For shipments rejected by the designated facility and shipped
to an alternate facility: If a healthcare facility does not receive a
copy of the manifest for a rejected shipment of the non-creditable
hazardous waste pharmaceuticals that is forwarded by the designated
facility to an alternate facility (using appropriate manifest
procedures), with the handwritten signature of the owner or operator of
the alternate facility within 60 days of the date the waste was
accepted by the initial transporter forwarding the shipment of non-
creditable hazardous waste pharmaceuticals from the designated facility
to the alternate facility, the healthcare facility must submit:
    (A) A legible copy of the original manifest, indicating that the
healthcare facility has not received confirmation of delivery, to the
EPA Regional Administrator for the Region in which the healthcare
facility is located, and
    (B) A handwritten or typed note on the manifest itself, or on an
attached sheet of paper, stating that the return copy was not received
and explaining the efforts taken to locate the non-creditable hazardous
waste pharmaceuticals and the results of those efforts.
    (3) Additional reports. The EPA Regional Administrator may require
healthcare facilities to furnish additional reports concerning the
quantities and disposition of non-creditable hazardous waste
pharmaceuticals.
    (j) Recordkeeping by healthcare facilities for non-creditable
hazardous waste pharmaceuticals. (1) A healthcare facility must keep a
copy of each manifest signed in accordance with Sec.  262.23(a) for
three years or until it receives a signed copy from the designated
facility which received the non-creditable hazardous waste
pharmaceuticals. This signed copy must be retained as a record for at
least three years from the date the waste was accepted by the initial
transporter.
    (2) A healthcare facility must keep a copy of each exception report
for a period of at least three years from the date of the report.
    (3) A healthcare facility must keep records of any test results,
waste analyses, or other determinations made to support its hazardous
waste determination(s) for at least three years from the date of the
test, analysis, or other determination.
    (4) The periods of retention referred to in this section are
extended automatically during the course of any unresolved enforcement
action regarding the regulated activity, or as requested by the EPA
Regional Administrator.
    (k) Response to releases of non-creditable hazardous waste
pharmaceuticals at healthcare facilities. (1) A healthcare facility
must immediately contain all releases of non-creditable hazardous waste
pharmaceuticals and other residues from non-creditable hazardous waste
pharmaceuticals.
    (2) A healthcare facility must determine whether any material
resulting from the release is a non-creditable hazardous waste
pharmaceutical, and if so, must manage the non-creditable hazardous
waste pharmaceutical residues and spill clean-up materials in
accordance with the requirements of this subpart.
    (l) Long-term care facilities that manage non-creditable hazardous
waste pharmaceuticals. A healthcare facility that is a long-term care
facility and that has individuals that administer their own
pharmaceuticals must collect any unused non-creditable hazardous waste
pharmaceuticals from those self-administering individuals and manage
them in accordance with this subpart.
    (m) Accepting creditable and non-creditable hazardous waste
pharmaceuticals from an off-site healthcare facility that is a CESQG. A
healthcare facility may accept creditable and non-creditable hazardous
waste pharmaceuticals from an off-site healthcare facility that is a
conditionally exempt small quantity generator under Sec.  261.5,
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 conditionally exempt small quantity generator healthcare
facility that is sending the hazardous waste pharmaceuticals off-site
or has a contractual relationship whereby the receiving healthcare
facility supplies pharmaceuticals to the conditionally exempt small
quantity generator healthcare facility,
    (2) Is operating under this subpart for the management of its
hazardous waste pharmaceuticals,
    (3) Manages the non-creditable hazardous waste pharmaceuticals that
it receives from off-site in compliance with this subpart, and
    (4) Keeps records of the hazardous waste pharmaceuticals shipments
it receives from off-site for 3 years from the date that the shipment
is received.

Sec.  266.503  Standards for healthcare facilities managing potentially
creditable hazardous waste pharmaceuticals.

    (a) Hazardous waste determination for creditable hazardous waste
pharmaceuticals at the healthcare facility. A healthcare facility that
generates a solid waste that is a potentially creditable pharmaceutical
must determine whether the potentially creditable solid waste
pharmaceutical is a potentially creditable hazardous waste
pharmaceutical (i.e., it listed in 40 CFR part 261, subpart D or
exhibits a characteristic identified in 40 CFR part 261, subpart C). A
healthcare facility may choose to manage its potentially creditable
solid waste pharmaceuticals as potentially creditable hazardous waste
pharmaceuticals under Sec.  266.509 even if the solid waste
pharmaceuticals do not exhibit a characteristic identified in 40 CFR
part 261, subpart C and are not listed in 40 CFR part 261, subpart D.
    (b) Healthcare facilities are prohibited from sending hazardous
wastes other than potentially creditable hazardous waste
pharmaceuticals to a pharmaceutical reverse distributor.
    (c) Biennial Report by healthcare facilities. Healthcare facilities
are not subject to biennial reporting requirements under Sec.  262.41,
with respect to potentially creditable hazardous waste pharmaceuticals
managed under this subpart.
    (d) Recordkeeping. (1) A healthcare facility that initiates a
shipment of potentially creditable hazardous waste pharmaceuticals to a
pharmaceutical reverse distributor must keep the following records
(paper or electronic) for each shipment of potentially creditable
hazardous waste pharmaceuticals for 3 years from the date of shipment:

    (i) A copy of the advance notification provided to the
pharmaceutical reverse distributor;
    (ii) The confirmation of delivery; and
    (iii) The shipping papers or bill of lading.
    (2) The periods of retention referred to in this section are
extended automatically during the course of any unresolved enforcement
action regarding the regulated activity, or as requested by the EPA
Regional Administrator.

Sec.  266.504  Healthcare facilities that are conditionally exempt
small quantity generators (CESQGs).

    (a) Potentially creditable hazardous waste pharmaceuticals. A
healthcare facility that is a conditionally exempt small quantity
generator may send its potentially creditable hazardous waste
pharmaceuticals to a pharmaceuticals reverse distributor.
    (b) Off-site collection of hazardous waste pharmaceuticals
generated by a healthcare facility that is a CESQG. A healthcare
facility that is a conditionally exempt small quantity generator may
send its hazardous waste pharmaceuticals off-site to another healthcare
facility, provided the receiving healthcare facility meets the
conditions in Sec.  266.502(m) of this subpart.
    (c) Long-term care facilities that are CESQGs. A long-term care
facility that is a conditionally exempt small quantity generator may
dispose of its hazardous waste pharmaceuticals in a collection
receptacle of an authorized collector (as defined by the Drug
Enforcement Administration) that is registered with the Drug
Enforcement Administration provided the contents are collected, stored,
transported, destroyed and disposed of in compliance with all
applicable Drug Enforcement Administration regulations for controlled
substances.

Sec.  266.505  Prohibition of sewering hazardous waste pharmaceuticals.

    All healthcare facilities and pharmaceutical reverse distributors
are prohibited from discharging hazardous waste pharmaceuticals to a
sewer system that passes through to a publicly-owned treatment works.
The exclusion in Sec.  261.4(a)(1)(ii) for mixtures of domestic sewage
and other wastes that pass through a sewer system to a publicly-owned
treatment works does not apply to a hazardous waste pharmaceutical.

Sec.  266.506  Conditional exemption for hazardous waste
pharmaceuticals that are also controlled substances.

    (a) The following are exempt from 40 CFR parts 260 through 273,
provided the conditions of paragraph (b) of this section are met:
    (1) A hazardous waste pharmaceutical that is also listed on a
schedule of controlled substances by the Drug Enforcement
Administration in 21 CFR part 1308, and
    (2) An authorized collector (as defined by the Drug Enforcement
Administration) registered with the Drug Enforcement Administration
that collects controlled substances collected from an ultimate user (as
defined by the Drug Enforcement Administration) and co-mingles them
with hazardous waste pharmaceuticals that are exempt as a household
waste under Sec.  261.4(b)(1).
    (b) Conditions for exemption. The hazardous waste pharmaceuticals
must be collected, stored, transported, destroyed and disposed of in
compliance with all applicable Drug Enforcement Administration
regulations for controlled substances, and combusted at one of the
following:
    (1) A permitted large municipal waste combustor (LMWC), subject to
40 CFR part 62, subpart FFF for existing LMWCs, or 40 CFR part 60,
subparts Ea and Eb for new LMWCs, or
    (2) A permitted small municipal waste combustor (SMWC), subject to
40 CFR part 62, subpart JJJ for existing SMWCs, or 40 CFR part 60,
subparts AAAA and BBBB for new SMWCs, or
    (3) A unit that has a permit or interim status to burn hazardous
waste and is covered by 40 CFR part 63, subpart EEE. A unit that is
exempt from 40 CFR part 63, subpart EEE as specified in Sec.
63.1200(b) of this chapter is not covered by subpart EEE.

Sec.  266.507  Management of hazardous waste pharmaceutical residues in
containers.

    (a) Dispensing and unit-dose containers. A dispensing bottle, vial,
or ampule (not to exceed 1 liter or 1000 pills); or a unit-dose
container, (e.g., a unit-dose packet, cup, wrapper, blister pack, or
delivery device) is considered empty and the residues are not regulated
as hazardous waste provided:
    (1) All pharmaceuticals have been removed from the dispensing
bottle, vial or ampule; or the unit-dose container, (e.g., unit-dose
packet, cup, wrapper, blister pack, or delivery device) using the
practices commonly employed to remove materials from that type of
container, and
    (2) Any dispensing bottle or unit-dose container that is an
original manufacturer's product package is destroyed prior to disposal
in such a manner as would prevent further use of the container.
    (b) Dispensed syringes. The residues remaining in a syringe are not
regulated as hazardous waste provided:
    (1) The syringe has been used to administer the pharmaceutical to a
patient, and
    (2) The syringe is placed in a sharps container that is managed in
accordance with all applicable federal, state, and local medical waste
requirements.
    (c) Other containers, including delivery devices. The residues
remaining in all other types of unused or used containers that once
held pharmaceuticals must be managed as hazardous waste
pharmaceuticals, if the residues are listed in 40 CFR part 261, subpart
D or exhibit a characteristic identified in 40 CFR part 261, subpart C.
This includes, but is not limited to, the residues in intravenous (IV)
bags and tubing, inhalers, aerosols, nebulizers, tubes of ointment,
gels or creams.

Sec.  266.508  Shipping non-creditable hazardous waste pharmaceuticals
from a healthcare facility or evaluated hazardous waste pharmaceuticals
from a pharmaceutical reverse distributor.

    (a) A healthcare facility or pharmaceutical reverse distributor
that ships either non-creditable hazardous waste pharmaceuticals or
evaluated hazardous waste pharmaceuticals, respectively, off-site to a
designated facility (such as a permitted or interim status treatment,
storage, or disposal facility), must comply with:
    (1) The following pre-transport requirements, before transporting
or offering for transport off-site:
    (i) Packaging. Package the waste in accordance with the applicable
Department of Transportation regulations on hazardous materials under
49 CFR parts 173, 178, and 180.
    (ii) Labeling. Label each package in accordance with the applicable
Department of Transportation regulations on hazardous materials under
49 CFR part 172, subpart E.
    (iii) Marking. (A) Mark each package of hazardous waste
pharmaceuticals in accordance with the applicable Department of
Transportation regulations on hazardous materials under 49 CFR part
172, subpart D;
    (B) Mark each container of 119 gallons or less used in such
transportation with the following words and information in accordance
with the requirements of 49 CFR 172.304:

    HAZARDOUS WASTE--Federal Law Prohibits Improper Disposal. If
found, contact the nearest police or public safety

authority or the U.S. Environmental Protection Agency.
    Healthcare Facility's or Pharmaceutical Reverse Distributor's
Name and Address__.
    Healthcare Facility's or Pharmaceutical Reverse Distributor's
EPA Identification Number__.
    Manifest Tracking Number__.

    (iv) Placarding. Placard or offer the initial transporter the
appropriate placards according to Department of Transportation
regulations for hazardous materials under 49 CFR part 172, subpart F.
    (v) Shipping papers. Prepare shipping papers in accordance with 49
CFR part 172, subpart C.
    (2) The manifest requirements of 40 CFR part 262, subpart B, except
that:
    (i) A healthcare facility shipping non-creditable hazardous waste
pharmaceuticals is not required to list hazardous waste codes in box 13
of EPA Form 8700-22.
    (ii) A healthcare facility shipping non-creditable hazardous waste
pharmaceuticals must write the words ``hazardous waste
pharmaceuticals'' in Box 14 (the special handling instructions and
additional information) of EPA Form 8700-22.
    (b) Exporting non-creditable hazardous waste pharmaceuticals or
evaluated hazardous waste pharmaceuticals. A healthcare facility or
pharmaceutical reverse distributor that exports non-creditable
hazardous waste pharmaceuticals or evaluated hazardous waste
pharmaceuticals is subject to 40 CFR part 262, subpart E.
    (c) Importing non-creditable hazardous waste pharmaceuticals or
evaluated hazardous waste pharmaceuticals. Any person that imports non-
creditable hazardous waste pharmaceuticals or evaluated hazardous waste
pharmaceuticals is subject to 40 CFR part 262, subpart F. A healthcare
facility or pharmaceutical reverse distributor may not accept imported
non-creditable hazardous waste pharmaceuticals or evaluated hazardous
waste pharmaceuticals, unless they have a permit or interim status that
allows them to accept hazardous waste from off-site.

Sec.  266.509  Shipping potentially creditable hazardous waste
pharmaceuticals from a healthcare facility or a pharmaceutical reverse
distributor to a pharmaceutical reverse distributor.

    (a) A healthcare facility or a pharmaceutical reverse distributor
who transports or offers for transport potentially creditable hazardous
waste pharmaceuticals off-site to a pharmaceutical reverse distributor
must:
    (1) Provide advance notice (paper or electronic) to the
pharmaceutical reverse distributor of the intent to ship potentially
creditable hazardous waste pharmaceuticals to the receiving
pharmaceutical reverse distributor before each shipment of potentially
creditable hazardous waste pharmaceuticals is sent, and
    (2) Comply with the pre-transport requirements of Sec.
266.508(a)(1)(i) through (v).
    (b) Upon receipt of each shipment of potentially creditable
hazardous waste pharmaceuticals, the receiving pharmaceutical reverse
distributor must provide confirmation (paper or electronic) to the
healthcare facility or pharmaceutical reverse distributor that
initiated the shipment that the shipment of potentially creditable
hazardous waste pharmaceuticals has arrived.
    (c) If a healthcare facility or pharmaceutical reverse distributor
initiates a shipment of potentially creditable hazardous waste
pharmaceuticals to a pharmaceutical reverse distributor and does not
receive delivery confirmation within seven calendar days from the date
that the shipment of potentially creditable hazardous waste
pharmaceuticals was sent, the healthcare facility or pharmaceutical
reverse distributor that initiated the shipment must contact the
shipper and the intended recipient (i.e., the pharmaceutical reverse
distributor) promptly to report that the confirmation was not received
and to determine the status of the potentially creditable hazardous
waste pharmaceuticals.
    (d) Exporting potentially creditable hazardous waste
pharmaceuticals. (1) A healthcare facility or pharmaceutical reverse
distributor that sends potentially creditable hazardous waste
pharmaceuticals to a foreign destination must comply with the following
requirements in addition to paragraphs (a) through (c) of this section:
    (i) Comply with the requirements applicable to a primary exporter
at 40 CFR 262.53, 262.56(a)(1) through (4), (a)(6), and (b) and 262.57;
    (ii) Export such potentially creditable hazardous waste
pharmaceuticals only upon consent of the receiving country and in
conformance with the EPA Acknowledgement of Consent as defined in 40
CFR part 262, subpart E; and
    (iii) Provide a copy of the EPA Acknowledgement of Consent for the
shipment to the transporter transporting the shipment for export.
    (2) A transporter of potentially creditable hazardous waste
pharmaceuticals to a foreign destination other than those OECD
countries specified 40 CFR 262.58(a)(1) (in which case the transporter
is subject to the requirements of 40 CFR part 262, subpart H) may not
accept a shipment if the transporter knows the shipment does not
conform to the EPA Acknowledgment of Consent. In addition the
transporter must ensure that:
    (i) A copy of the EPA Acknowledgment of Consent accompanies the
shipment; and
    (ii) The shipment is delivered to the facility designated by the
person initiating the shipment.
    (e) Importing potentially creditable hazardous waste
pharmaceuticals. Any person that imports potentially creditable
hazardous waste pharmaceuticals into the United States is subject to
paragraphs (a) through (c) of this section in lieu of 40 CFR part 262,
subpart F.

Sec.  266.510  Standards for the management of potentially creditable
hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals at pharmaceutical reverse distributors.

    A pharmaceutical reverse distributor may accept potentially
creditable hazardous waste pharmaceuticals from off-site and accumulate
potentially creditable hazardous waste pharmaceuticals or evaluated
hazardous waste pharmaceuticals on-site without a permit or without
having interim status, provided that it complies with the following
conditions:
    (a) Standards for pharmaceutical reverse distributors managing
potentially creditable hazardous waste pharmaceuticals and evaluated
hazardous waste pharmaceuticals.
    (1) Notification. A pharmaceutical reverse distributor must notify
the EPA Regional Administrator, using the Site Identification Form (EPA
form 8700-12), that it is a pharmaceutical reverse distributor
operating under this subpart.
    (i) A pharmaceutical reverse distributor that already has an EPA
identification number must re-notify the EPA Regional Administrator,
using the Site Identification Form (EPA form 8700-12), that it is a
pharmaceutical reverse distributor, as defined in Sec.  266.500, within
60 days of the effective date of this subpart, or within 60 days of
becoming subject to this subpart.
    (ii) A pharmaceutical reverse distributor that does not have an EPA
identification number must obtain one by notifying the EPA Regional
Administrator, using the Site Identification Form (EPA form 8700-12),
that it is a pharmaceutical reverse distributor, as defined in Sec.
266.500, within 60 days of the effective date of this subpart, or
within 60 days of becoming subject to this subpart.

    (2) Inventory by the pharmaceutical reverse distributor. A
pharmaceutical reverse distributor must maintain an inventory of all
the potentially creditable hazardous waste pharmaceuticals and
evaluated hazardous waste pharmaceuticals that are accumulated on-site.
    (i) A pharmaceutical reverse distributor must inventory each
potentially creditable hazardous waste pharmaceutical upon arrival at
the pharmaceutical reverse distributor.
    (ii) The inventory must include the identity (e.g., name or
national drug code (NDC)) and quantity of each potentially creditable
hazardous waste pharmaceutical and evaluated hazardous waste
pharmaceutical.
    (3) Security at the pharmaceutical reverse distributor facility. A
pharmaceutical reverse distributor must prevent unknowing entry and
minimize the possibility for the unauthorized entry into the portion of
the facility where potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals are kept.
    (i) Examples of methods that may be used to prevent unknowing entry
and minimize unauthorized entry include, but are not limited to:
    (A) 24-hour continuous monitoring surveillance system;
    (B) An artificial barrier such as a fence; or
    (C) Means to control entry, such as keycard access.
    (ii) If the pharmaceutical reverse distributor already meets the
security requirements of this paragraph because of other regulatory
requirements, such as Drug Enforcement Administration regulations, the
facility is not required to provide separate security measures pursuant
to this section.
    (4) Maximum accumulation time for hazardous waste pharmaceuticals
at a pharmaceutical reverse distributor. A pharmaceutical reverse
distributor may accumulate potentially creditable hazardous waste
pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site
for 90 calendar days or less. The 90 days start when the potentially
creditable hazardous waste pharmaceutical arrives at the pharmaceutical
reverse distributor and applies to all hazardous waste pharmaceuticals
accumulated on-site, regardless of whether they are destined for
another pharmaceutical reverse distributor (i.e., potentially
creditable hazardous waste pharmaceuticals), or a permitted or interim
status treatment, storage or disposal facility (i.e., evaluated
hazardous waste pharmaceuticals).
    (5) Extension of 90-day accumulation time limit at a pharmaceutical
reverse distributor. A pharmaceutical reverse distributor may request
an extension of its 90-day accumulation time limit for hazardous waste
pharmaceuticals from the EPA Regional Administrator due to unforeseen
circumstances beyond the control of the pharmaceutical reverse
distributor, or if the potentially creditable hazardous waste
pharmaceuticals or evaluated hazardous waste pharmaceuticals are
involved in litigation or a recall.
    (i) A written request must be sent to the EPA Regional
Administrator (paper or electronic). The request for an extension must
include an explanation of the reason an extension is requested, the
approximate volume or weight of the hazardous waste pharmaceuticals
that will be accumulated more than 90 days, and the amount of
additional time requested.
    (ii) The amount of time granted for an extension is at the
discretion of the EPA Regional Administrator on a case-by-case basis.
    (6) Contingency plan and emergency procedures at a pharmaceutical
reverse distributor. A pharmaceutical reverse distributor that accepts
potentially creditable hazardous waste pharmaceuticals from off-site
must prepare a contingency plan and comply with the other requirements
of 40 CFR part 265, subpart D.
    (7) Closure of a pharmaceutical reverse distributor. When closing
an area where a pharmaceutical reverse distributor accumulates
potentially creditable hazardous waste pharmaceuticals or evaluated
hazardous waste pharmaceuticals, the pharmaceutical reverse distributor
must control, minimize, or eliminate to the extent necessary to protect
human health and the environment, post-closure escape of hazardous
waste, leachate, contaminated run-off, or hazardous waste decomposition
products to the ground or surface waters or to the atmosphere.
    (8) Reporting by a pharmaceutical reverse distributor--(i)
Unauthorized waste report. A pharmaceutical reverse distributor must
submit an unauthorized hazardous waste report if the pharmaceutical
reverse distributor receives hazardous waste from off-site that it is
not authorized to receive (e.g., non-creditable hazardous waste
pharmaceuticals, non-pharmaceutical hazardous waste). The
pharmaceutical reverse distributor must prepare and submit an
unauthorized waste report to the EPA Regional Administrator within 15
days after receiving the unauthorized hazardous waste and the
pharmaceutical reverse distributor must send a copy of the unauthorized
waste report to the healthcare facility (or other entity) that sent the
unauthorized hazardous waste. The pharmaceutical reverse distributor
must manage the unauthorized hazardous waste in accordance with all
applicable regulations for generators of non-pharmaceutical hazardous
waste. The unauthorized waste report must be signed by the owner or
operator of the pharmaceutical reverse distributor, or his authorized
representative, and contain the following information:
    (A) The EPA identification number, name and address of the
pharmaceutical reverse distributor;
    (B) The date the pharmaceutical reverse distributor received the
hazardous waste;
    (C) The EPA identification number, name and address of the
healthcare facility that shipped the hazardous waste, if available;
    (D) A description and the quantity of each unauthorized hazardous
waste the pharmaceutical reverse distributor received;
    (E) The method of treatment, storage, or disposal for each
unauthorized hazardous waste; and
    (F) A brief explanation of why the waste was unauthorized, if
known.
    (ii) Additional reports. The EPA Regional Administrator may require
pharmaceutical reverse distributors to furnish additional reports
concerning the quantities and disposition of potentially creditable
hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals.
    (9) Recordkeeping by pharmaceutical reverse distributors. A
pharmaceutical reverse distributor must keep the following records
(paper or electronic):
    (i) A copy of its notification on file for as long as the facility
is subject to this subpart;
    (ii) A copy of the advance notification, delivery confirmation, the
shipping papers or bill of lading for each shipment of potentially
creditable hazardous waste pharmaceuticals that it receives, and a copy
of each unauthorized waste report, for at least three years from the
date it receives the shipment;
    (iii) A copy of its inventory for as long as the facility is
subject to this subpart; and
    (iv) The periods of retention referred to in this section are
extended automatically during the course of any unresolved enforcement
action regarding the regulated activity, or as requested by the EPA
Regional Administrator.

    (10) A pharmaceutical reverse distributor that is not a
pharmaceutical manufacturer must evaluate a potentially creditable
hazardous waste pharmaceutical within 21 calendar days of arriving at
the pharmaceutical reverse distributor to establish whether it is
destined for another pharmaceutical reverse distributor for further
evaluation or verification of manufacturer's credit or for a permitted
or interim status treatment, storage or disposal facility. This 21
calendar days is part of the 90 calendar days allowed for on-site
accumulation.
    (i) A potentially creditable hazardous waste pharmaceutical that is
destined for another pharmaceutical reverse distributor is still
considered a ``potentially creditable hazardous waste pharmaceutical''
and must be managed in accordance with paragraph (b) of this section.
    (ii) A potentially creditable hazardous waste pharmaceuticals that
is destined for a permitted or interim status treatment, storage or