[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Pages 58013-58092]
[FR Doc No: 2015-23167]

Vol. 80

Friday,

No. 186

September 25, 2015

Part III

Environmental Protection Agency

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

40 CFR Parts 261, 262, 266, et al.

Management Standards for Hazardous Waste Pharmaceuticals; Proposed Rule

Federal Register / Vol. 80 , No. 186 / Friday, September 25, 2015 /
Proposed Rules

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 261, 262, 266, 268, and 273

[EPA-HQ-RCRA-2007-0932; FRL-9924-08-OSWER]
RIN 2050-AG39

Management Standards for Hazardous Waste Pharmaceuticals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Some pharmaceuticals are regulated as hazardous waste under
the Resource Conservation and Recovery Act (RCRA) when discarded.
Healthcare facilities that generate hazardous waste pharmaceuticals as
well as associated facilities have reported difficulties complying with
the Subtitle C hazardous waste regulations for a number of reasons.
First, healthcare workers, whose primary focus is to provide care for
patients, are not knowledgeable about the RCRA hazardous waste
regulations, but are often involved in the implementation of the
regulations. Second, a healthcare facility can have thousands of items
in its formulary, making it difficult to ascertain which ones are
hazardous wastes when disposed. Third, some active pharmaceutical
ingredients are listed as acute hazardous wastes, which are regulated
in small amounts. To facilitate compliance and to respond to these
concerns, the U.S. Environmental Protection Agency (EPA or the Agency)
is proposing to revise the regulations to improve the management and
disposal of hazardous waste pharmaceuticals and tailor them to address
the specific issues that hospitals, pharmacies and other healthcare-
related facilities face. The revisions are also intended to clarify the
regulation of the reverse distribution mechanism used by healthcare
facilities for the management of unused and/or expired pharmaceuticals.

DATES:  Comments must be received on or before November 24, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2007-0932, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kristin Fitzgerald, Office of Resource
Conservation and Recovery (5304P), Environmental Protection Agency,
1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number:
703-308-8286; email address<EMAIL_ADDRESS>or Josh
Smeraldi, Office of Resource Conservation and Recovery (5304P),
Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

Does this action apply to me?

    This is a proposed rule. If finalized, this rule would apply to
healthcare facilities, pharmaceutical reverse distributors, and owners
or operators of treatment, storage, and disposal facilities engaged in
the management of hazardous waste pharmaceuticals. The list of NAICS
codes for the potentially affected entities, other than RCRA treatment,
storage and disposal facilities (TSDFs), are presented in Table 1. More
detailed information on the potentially affected entities is presented
in Section V.A and Section V.B.1 of this preamble.

   Table 1--NAICS Codes of Entities Potentially Affected by This Final
   Rule--Healthcare Facilities and Pharmaceutical Reverse Distributors
------------------------------------------------------------------------
            NAICS codes                   Description of NAICS code
------------------------------------------------------------------------
44611.............................  Pharmacies.
54194.............................  Veterinary Clinics.
6211..............................  Physicians' Offices.
6212..............................  Dentists' Offices.
6213..............................  Other Health Practitioners (e.g.,
                                     chiropractors).
6214..............................  Outpatient Care Centers.
6219..............................  Other Ambulatory Health Care
                                     Services.
622...............................  Hospitals.
6231..............................  Nursing Care Facilities (e.g.,
                                     assisted living facilities, nursing
                                     homes, U.S. veterans domiciliary
                                     centers).
623311............................  Continuing Care Retirement
                                     Communities (e.g., assisted living
                                     facilities with on-site nursing
                                     facilities).
Subset of 92219...................  Medical Examiners and Coroners'
                                     Offices.
Various NAICS.....................  Pharmaceutical Reverse Distributors.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities potentially impacted by this
action. This table lists examples of the types of entities of which EPA
is aware that could potentially be affected by this action. Other types
of entities not listed could also be affected. To determine whether
your entity, company, business, organization, etc. is affected by this
action, you should examine the applicability criteria in this rule. If
you have questions regarding the applicability of this action to a
particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section of this document.

Preamble Outline

I. Statutory Authority
II. List of Abbreviations and Acronyms
III. Summary of the Proposed Rule
IV. Background

    A. What is the history of hazardous waste pharmaceutical
management under RCRA?
    B. What are the rationale and goals for this proposed rule?
    C. What was the 2008 pharmaceutical universal waste proposal?
    D. EPA's Office of Inspector General Report
V. Detailed Discussion of the Proposed Rule
    A. What terms are defined in this proposed rule?
    B. What is the scope of this proposed rule?
    C. What are the proposed standards for healthcare facilities
that manage non-creditable hazardous waste pharmaceuticals?
    D. How does this proposed rule address healthcare facilities
that accumulate potentially creditable hazardous waste
pharmaceuticals prior to shipment to pharmaceutical reverse
distributors?
    E. What are the proposed novel prohibitions, exemptions and
other unique management requirements for hazardous waste
pharmaceuticals?
    F. What are the proposed standards for shipping hazardous waste
pharmaceuticals?
    G. What are the proposed standards for pharmaceutical reverse
distributors?
VI. Implementation and Enforcement
    A. Healthcare Facilities
    B. Pharmaceutical Reverse Distributors
    C. Healthcare Facilities and Pharmaceutical Reverse Distributors
Managing Non-Pharmaceutical Hazardous Waste in Accordance With 40
CFR Part 262 or Part 273
    D. State Enforcement Activities and Interpretations
VII. Request for Comment on EPA's Efforts To Identify Additional
Pharmaceuticals as Hazardous Wastes
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
    B. Basis for Original Listing
    C. Rationale for EPA's Efforts To Amend the P075 Listing
    D. Two Possible Approaches for Amending the P075 Listing
    E. Request for Comments
IX. State Authorization
    A. Applicability of Rules in Authorized States
    B. Effect on State Authorization
    C. Effect on State Authorization in States That Have Added
Pharmaceuticals to the Universal Waste Program
X. Adding and Reserving Part 266, Subpart O
XI. Summary of the Regulatory Impact Analysis
XII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Small Business Analysis
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. Statutory Authority

    These regulations are proposed under the authority of Sec. Sec.
2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of
1970, as amended by the Resource Conservation and Recovery Act (RCRA)
of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984
(HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924.

II. List of Abbreviations and Acronyms

AARP American Association of Retired Persons
AEA Atomic Energy Act
API Active Pharmaceutical Ingredient
BDAT Best Demonstrated Available Technology
CERCLA Comprehensive Environmental Response, Compensation and
Liability Act
CESQG Conditionally Exempt Small Quantity Generator
CFR Code of Federal Regulations
CSA Controlled Substances Act
CWA Clean Water Act
DEA Drug Enforcement Administration
DHHS Department of Health and Human Services
DOE Department of Energy
DOT Department of Transportation
EPA Environmental Protection Agency
EO Executive Order
FDA U.S. Food and Drug Administration
FR Federal Register
HIPAA Health Insurance Portability and Accountability Act
HSWA Hazardous and Solid Waste Amendments
LQG Large Quantity Generator
LQUWH Large Quantity Universal Waste Handler
LTCF Long-term Care Facility
LTCP Long-term Care Pharmacy
MSWLF Municipal Solid Waste Landfill
NIOSH National Institute for Occupational Safety and Health
NPRM Notice of Proposed Rulemaking
NRC Nuclear Regulatory Commission
OIG Office of Inspector General
OMB Office of Management and Budget
ONDCP Office of National Drug Control Policy
OSHA U.S. Department of Labor's Occupational Safety and Health
Administration
OSWER Office of Solid Waste and Emergency Response
OSWI Other Solid Waste Incinerators
OTC Over-the-counter
POTW Publicly Owned Treatment Works
RCRA Resource Conservation and Recovery Act
RQ Reportable Quantity
SQG Small Quantity Generator
SQUWH Small Quantity Universal Waste Handler
SWDA Solid Waste Disposal Act
TC Toxicity Characteristic
TCLP Toxicity Characteristic Leaching Procedure
TSDF Treatment, Storage and Disposal Facility

III. Summary of the Proposed Rule

    EPA is proposing to add a subpart P under 40 CFR part 266. Part 266
is entitled, ``Standards for the Management of Specific Hazardous
Wastes and Specific Types of Hazardous Waste Management Facilities.''
This new subpart P is a tailored, sector-specific regulatory framework
for managing hazardous waste pharmaceuticals at healthcare facilities
and pharmaceutical reverse distributors. If finalized, healthcare
facilities that are currently small quantity generators (SQGs) or large
quantity generators (LQGs) and all pharmaceutical reverse distributors,
regardless of their RCRA generator category, will be required to manage
their hazardous waste pharmaceuticals under subpart P of 40 CFR part
266, instead of 40 CFR part 262. That is, the proposed standards are
not an optional alternative to managing hazardous waste pharmaceuticals
under 40 CFR part 262; they are mandatory standards.
    Briefly, healthcare facilities will have different management
standards for their non-creditable and creditable hazardous waste
pharmaceuticals. Non-creditable hazardous waste pharmaceuticals (i.e.,
those that are not expected to be eligible to receive manufacturer's
credit) will be managed on-site similar to how they would have been
under a previous proposal for managing these wastes: The 2008 Universal
Waste proposal for pharmaceutical waste (73 FR 73520; December 2,
2008). When shipped off-site, they must be transported as hazardous
wastes, including the use of the hazardous waste manifest, and sent to
a RCRA interim status or permitted facility. On the other hand,
healthcare facilities will continue to be allowed to send potentially
creditable hazardous waste pharmaceuticals to pharmaceutical reverse
distributors for processing manufacturers' credit. In response to
comments received on the Universal Waste proposal, EPA is proposing
standards to ensure the safe and secure delivery of the creditable

hazardous waste pharmaceuticals to pharmaceutical reverse distributors.
    EPA is also proposing standards for the accumulation of the
creditable hazardous waste pharmaceuticals at pharmaceutical reverse
distributors. Like healthcare facilities, pharmaceutical reverse
distributors will not be regulated under 40 CFR part 262 as hazardous
waste generators, nor will they be regulated under 40 CFR parts 264,
265 and 270 as treatment, storage, and disposal facilities (TSDFs).
Rather, the proposal establishes a new category of hazardous waste
entity, called pharmaceutical reverse distributors. The proposed
standards for pharmaceutical reverse distributors are, in many
respects, similar to the LQGs standards, with supplementary standards
added to respond to commenters' concerns.
    For both healthcare facilities and reverse distributors, EPA is
proposing to prohibit facilities from disposing of hazardous waste
pharmaceuticals down the toilet or drain (i.e, flushed or sewered).
Further, EPA proposes that hazardous waste pharmaceuticals managed
under subpart P will not be counted toward calculating the site's
generator category. Additionally, EPA is proposing a conditional
exemption for hazardous waste pharmaceuticals that are also DEA
controlled substances. Finally, EPA is proposing management standards
for hazardous waste pharmaceutical residues remaining in containers.

IV. Background

A. What is the history of hazardous waste pharmaceutical management
under RCRA?

1. What Is the Resource Conservation and Recovery Act?
    The Resource Conservation and Recovery Act governs the management
and disposal of hazardous wastes.\1\ Under Subtitle C of RCRA, EPA has
established a comprehensive set of regulations for hazardous waste
management, generation, transportation, treatment, storage, and
disposal. EPA can authorize an individual state hazardous waste program
to operate in lieu of the federal program provided the authorized
state's program is at least as stringent as, and consistent with, the
federal program.\2\ However, EPA maintains oversight of the authorized
state's hazardous waste program and the authority to take independent
enforcement actions. RCRA regulates pharmaceutical wastes that meet a
listing of hazardous waste or exhibit one or more characteristics of
hazardous waste. Accordingly, hospitals, pharmacies, reverse
distributors and other healthcare-related establishments that generate
hazardous wastes, including hazardous waste pharmaceuticals, are
required to manage and dispose of their hazardous wastes in accordance
with applicable federal, state, and/or local environmental regulations.
---------------------------------------------------------------------------

    \1\ RCRA also governs the disposal of non-hazardous solid
wastes; however, state and/or local environmental regulatory
agencies predominantly administer the regulations pertaining to the
management of non-hazardous wastes.
    \2\ For more information on RCRA State Authorization, see:
http://www.epa.gov/osw/laws-regs/state/index.htm.
---------------------------------------------------------------------------

2. What are the current standards for generators of hazardous waste?
    Currently, there are no RCRA Subtitle C regulations that focus
specifically on the management of hazardous wastes from hospitals,
pharmacies, reverse distributors and other healthcare-related
facilities. Rather, healthcare facilities are currently required to
comply with the same RCRA hazardous waste regulations as many other
industries that generate hazardous waste. While the RCRA Subtitle C
program has requirements for all aspects of hazardous waste management,
including those generating (referred to as ``generators'' by RCRA),
transporting, storing, treating, and disposing of hazardous wastes, it
is the generator requirements found under 40 CFR part 262 that will
typically be most pertinent to healthcare-related facilities.
    Under the federal RCRA regulations, the standards for hazardous
waste generators are divided into three categories--LQGs, SQGs, and
Conditionally Exempt Small Quantity Generators (CESQGs) depending upon
the total amount of hazardous waste a facility generates per calendar
month. It is the facility's generator category that determines the
applicable RCRA hazardous waste management requirements with which the
generator must comply.\3\
---------------------------------------------------------------------------

    \3\ For more information on hazardous waste generators, please
see: http://www.epa.gov/waste/hazard/generation/index.htm.
---------------------------------------------------------------------------

    A generator that generates a solid waste \4\ is required by Sec.
262.11 to determine whether such waste meets the definition of RCRA
hazardous waste.\5\ If the waste meets the RCRA definition of a
hazardous waste, then the generator must manage the waste in accordance
with the regulations that apply to its hazardous waste generator
category (see Sec.  261.5 and 40 CFR part 262 for the generator
regulations). In particular:
---------------------------------------------------------------------------

    \4\ See 40 CFR 261.2 for the definition of solid waste.
    \5\ The waste determination process includes determining if the
waste is specifically excluded or exempted from the RCRA hazardous
waste regulations. If not, then the entity must determine if the
waste is listed by EPA under the F-, K-, P- or U-lists of hazardous
wastes (Sec. Sec.  261.31-33). If the waste is not listed, then it
must be determined if the waste exhibits a characteristic of a
hazardous waste: Ignitability, corrosivity, reactivity, or toxicity
(Sec. Sec.  261.21-24).
---------------------------------------------------------------------------

     Facilities qualify as LQGs if in a calendar month they
generate 1,000 kg or more of hazardous waste or more than 1 kg of acute
hazardous waste (i.e., P-listed waste), or more than 100 kg of any
residue or contaminated soil, waste, or other debris resulting from the
clean-up of a spill, into or on any land or water, of any acute
hazardous wastes listed in Sec. Sec.  261.31 or 261.33(e). Federal
regulations for LQGs include, but are not limited to the following:
Obtaining an EPA Identification number; a 90-day limit for accumulating
hazardous waste on-site (with relevant standards for the accumulation
of hazardous waste) without having to obtain a RCRA permit or comply
with the interim status standards, provided that they comply with the
conditions for exemption set forth in Sec.  262.34(a) such as
management and labeling standards specific to the type of accumulation
unit (e.g., container, tank); RCRA training of personnel; contingency
planning; manifesting and recordkeeping and reporting (biennial
report).
     Facilities qualify as SQGs if in a calendar month they
generate more than 100 kg but less than 1,000 kg of hazardous waste.
SQGs are subject to fewer requirements than LQGs and are given
additional flexibility. For example, SQGs have a longer on-site
accumulation time limit (180 or 270 days vs. 90 days for LQGs), with
fewer standards for the accumulation of hazardous waste, without having
to obtain a RCRA permit or comply with the interim status standards,
provided that they comply with the conditions set forth in Sec.
262.34(d) (which have fewer personnel training and contingency planning
obligations than in the conditions for exemption for LQGs); and do not
need to complete a biennial report (BR).
     Facilities qualify as CESQGs if in a calendar month they
generate less than or equal to 100 kg of hazardous waste, and less than
or equal to 1 kg of acutely hazardous waste (i.e., P-listed), and less
than or equal to 100 kg of any residue or contaminated soil, waste, or
other debris resulting from the clean-up of a spill, into or on any
land or water, of any acute hazardous wastes listed in

Sec. Sec.  261.31, or 261.33(e).\6\ CESQGs are subject to very few of
the RCRA Subtitle C hazardous waste regulations, provided that they
comply with the conditions set forth in Sec.  261.5(f)(3) and (g)(3).
---------------------------------------------------------------------------

    \6\ EPA recommends that facilities that qualify as CESQGs under
the federal regulations contact their state and/or local
environmental regulatory agencies, as authorized states can be more
stringent than the federal regulations. As a result, not all
authorized states recognize the CESQG category or they may have more
stringent regulatory requirements for CESQGs.
---------------------------------------------------------------------------

    Finally, under the household hazardous waste exemption in Sec.
261.4(b)(1), hazardous wastes generated by households are not subject
to the RCRA hazardous waste regulations. This exemption from the
Subtitle C requirements extends to any household wastes collected
during community-oriented take-back programs or events, as long as
these collected household hazardous wastes are managed separately from
regulated hazardous wastes.\7\ However, while collected household
hazardous wastes are not regulated under the federal standards, more
stringent state standards may apply.
---------------------------------------------------------------------------

    \7\ For clarification on household hazardous waste collection
issues, please see the November 1, 1988 memo from Win Porter to the
Regional Waste Management Division Directors (RCRA Online # 11377)
at: http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/2FD51915214EF63C8525670F006BDC88/
$file/11377.pdf.
---------------------------------------------------------------------------

3. Are pharmaceuticals considered hazardous wastes under RCRA?
    A portion of the pharmaceuticals currently on the market meets
RCRA's definition of hazardous waste when discarded. As previously
explained, it is the responsibility of the generator of a solid waste
to determine if the waste is hazardous; this includes solid wastes that
are pharmaceuticals. If the pharmaceutical waste meets RCRA's
definition of hazardous waste, then the generator must manage it in
accordance with all applicable federal, state, and/or local
environmental regulations. A pharmaceutical is considered a hazardous
waste under RCRA in one of two ways. First, a discarded pharmaceutical
can be a listed hazardous waste if it is a commercial chemical product
\8\ that is listed under RCRA's P- or U-list, and the pharmaceutical
has not been used for its intended purpose (Sec.  261.33 (e) and (f),
respectively).\9\ A few examples of pharmaceuticals that are considered
P-listed wastes when discarded are arsenic trioxide (P012), smoking
cessation products with nicotine as the sole active ingredient (P075),
and pharmaceuticals with greater than 0.3% warfarin (and salts) as the
sole active ingredient, such as Coumadin (P001). Some examples of
pharmaceuticals that are considered U-listed wastes are:
Cyclophosphamide (U058), mitomycin C (U010), streptozotocin (U206) and
warfarin and salts (<=0.3%) as the sole active ingredient (U248).
---------------------------------------------------------------------------

    \8\ Commercial chemical product 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 (Sec.  261.33(d)).
    \9\ The P- and U-lists deem as hazardous certain commercial
chemical products when they are discarded or intended to be
discarded. These listings consist of commercial chemical products
having the generic names listed, off-specification species,
container residues, and spill residues. Chemicals on the P-list are
identified as acute hazardous wastes and are regulated at lower
amounts than those on the U-list.
---------------------------------------------------------------------------

    Second, if the discarded pharmaceutical is not on the P- or U-list,
then the pharmaceutical may be a hazardous waste if it exhibits one or
more of the hazardous waste characteristics. Under the federal
requirements (Sec.  261.21-24), a waste is a characteristic hazardous
waste if it is ignitable (D001), corrosive (D002), reactive (D003) or
toxic (D004-D043).\10\ A number of pharmaceuticals are prepared in
alcohol, which may cause the waste to be hazardous due to ignitability
(D001), even if the active pharmaceutical ingredient itself is not
considered hazardous waste. The Regulatory Impact Analysis for this
proposed rule includes a list of pharmaceuticals that, to our
knowledge, are hazardous waste when disposed, although this list should
not be considered exhaustive (see the docket for this proposed rule
EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    \10\ The toxicity characteristic (TC) indicates that the waste
is likely to leach concentrations of contaminants that may be
harmful, and TC waste is identified using the Toxicity
Characteristic Leaching Procedure (see Sec.  261.24). Examples of TC
constituents that may be present in pharmaceuticals include, but are
not limited to: Arsenic, barium, cadmium, selenium, silver,
chloroform, lindane and m-cresol.
---------------------------------------------------------------------------

    Since the hazardous waste rules were initially promulgated, EPA has
issued several clarifications regarding the regulatory status of
certain commercial chemical products on the P- and U-lists, and these
clarifications have affected the regulatory status of some active
pharmaceutical ingredients.\11\ For example, EPA recently clarified
that phentermine hydrochloride and other phentermine salts are not
included within the scope of the P046 (phentermine) listing.\12\
Similarly, EPA has also clarified that epinephrine salts are not
included in the epinephrine listing (P042).\13\ In addition, medicinal
nitroglycerin typically is not considered P081 since the medicinal form
of this compound generally does not exhibit the characteristic of
reactivity for which nitroglycerin was originally listed.\14\
Furthermore, in a 1998 memo, EPA clarified that the U034 listing
includes both anhydrous chloral and chloral hydrate.\15\ And in a 2010
memo, EPA stated that unused nicotine patches, gums and lozenges are
finished dosage forms of nicotine and therefore are regulated as P075
when discarded.\16\
---------------------------------------------------------------------------

    \11\ In addition, in December 2008, the Agency proposed to
regulate hazardous waste pharmaceuticals under the Universal Waste
rule. However, based on the comments received, the Agency decided
not to finalize that proposal and to proceed with a sector-based
approach. (See section IV.C. of the preamble for further discussion
of the Universal Waste proposal.)
    \12\ Memo from Devlin to RCRA Division Directors, February 17,
2012 (RCRA Online #14831) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/A5C07D01188ECA59852579EA0067CDB1/
$file/14831.pdf.
    \13\ Memo December 1, 1994 (RCRA Online #13718) http://
yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/
1C1DEB3648A62A868525670F006BCCD2/$file/13718.pdf.
    \14\ Memo from Dellinger to Smith, March 18, 2003 (RCRA Online
#14654) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/7ACFEC572DE8897F85256D1600748BCB/
$file/14654.pdf.
    \15\ Memo from Brandes to Knauss, April 6, 1998 (RCRA Online
#14175) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/7417D2556AD322FA852568E300468198/
$file/14175.pdf.
    \16\ Memo from Dellinger to Smith, August 23, 2010 (RCRA Online
#14817) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/209444BADDA4ECDC852577ED00624E8F/
$file/14817.pdf.
---------------------------------------------------------------------------

    Finally, EPA has developed a ``Hazardous Waste Pharmaceuticals
Wiki'' as a platform to facilitate the sharing of expertise among the
healthcare industry and other stakeholders in order to help make
accurate hazardous waste determinations for waste pharmaceuticals and
increase compliance with the hazardous waste regulations. The Hazardous
Waste Pharmaceuticals Wiki will also help users find guidance
documents, state-specific information, and manufacturers' information.
The Hazardous Waste Pharmaceuticals Wiki can be viewed at: http://hwpharms.wikispaces.com. EPA encourages healthcare stakeholders to use
the Wiki to share information regarding federal hazardous waste

pharmaceuticals, as well as state-only hazardous waste
pharmaceuticals.\17\
---------------------------------------------------------------------------

    \17\ Anyone may view the Wiki. Those in the healthcare community
who wish to contribute content or edit the Wiki can register by
sending an email request to<EMAIL_ADDRESS>---------------------------------------------------------------------------

B. What are the rationale and goals for this proposed rule?

1. Sector-Based Approach
    The impetus behind this proposal is to address the various concerns
raised by stakeholders regarding the difficulty in implementing the
Subtitle C hazardous waste regulations for the management of hazardous
waste pharmaceuticals generated at healthcare facilities. EPA has met
with various stakeholders to learn about compliance challenges, and it
has received input from stakeholders through more formal mechanisms.
For instance, when EPA solicited stakeholder input in response to
Executive Order 13563 (Improving Regulation and Regulatory Review),
retailers submitted comments detailing compliance challenges with
hazardous waste pharmaceuticals in their stores.\18\ Further, EPA's
Office of Inspector General (OIG) published a report citing the need to
clarify how hazardous waste pharmaceuticals are regulated (for more
information on both of these reports, see the next section). These two
reports and input from healthcare (and associated) facilities
identified a number of ways in which a healthcare facility differs from
a manufacturing facility when it comes to applying the RCRA Subtitle C
program for generating and managing hazardous waste.
---------------------------------------------------------------------------

    \18\ Executive Order 13563 was signed by President Obama on
January 18, 2011 and published in the Federal Register on January
21, 2011 (76 FR 3821). In response to the Executive Order, EPA
solicited comments on ``Improving EPA Regulations,'' in a Federal
Register notice published on February 23, 2011 (76 FR 9988). See
docket number EPA-HQ-OA-2011-0160 for public comments related to
waste.
---------------------------------------------------------------------------

    First, in the healthcare setting, many hazardous waste
pharmaceuticals are generated unpredictably and in relatively small
quantities by a number of different employees across the facility. This
situation differs from a manufacturing facility where fewer employees
in a few locations generate comparatively much larger volumes of a
smaller range of hazardous wastes.
    Second, under the current hazardous waste regulatory scheme,
healthcare workers, whose primary focus is to provide care for
patients, are typically responsible for making hazardous waste
determinations since they are at the point of generation (e.g., a
patient's bedside). Yet, healthcare workers, such as nurses and
doctors, do not typically have the expertise to make hazardous waste
determinations.
    Third, a healthcare facility can have thousands of items in its
formulary at any one time and these may vary over time. In addition,
pharmaceutical wastes come in many different forms, such as pills,
patches, lozenges, gums, creams, and liquids, and are delivered by a
variety of devices, such as nebulizers, intravenous (IV) tubing,
syringes, etc. The combination of having thousands of different
pharmaceutical products and little expertise in hazardous waste
regulations makes it difficult for healthcare workers to make
appropriate hazardous waste determinations when pharmaceuticals are
disposed. This situation differs from manufacturing, where fewer, more
predictable waste streams are generated.
    Fourth, several of the hazardous waste pharmaceuticals that are
generated by healthcare facilities are P-listed acute hazardous wastes
(see Sec.  261.33(e)), which are regulated at much smaller amounts. If
a facility generates more than 1 kg of acute hazardous waste per
calendar month or accumulates that amount at any time, it is regulated
as an LQG. In addition to the pharmaceuticals, residues within
pharmaceutical containers that contained P-listed commercial chemical
products must be managed as acute hazardous waste even if the
pharmaceutical was fully dispensed,\19\ unless the container is RCRA-
empty (e.g., by triple-rinsing the container). Triple rinsing can be
impractical with certain medical devices, such as syringes and paper
cups, so healthcare facilities often end up managing these containers
as hazardous waste, which can result in the facilities being subject to
the most stringently regulated generator category (i.e., LQG).\20\
---------------------------------------------------------------------------

    \19\ P-listed hazardous waste residues in containers are
themselves considered P-listed hazardous wastes (see Sec.
261.33(c)), unless the container is considered ``RCRA empty'' either
by undergoing triple-rinsing with an appropriate solvent; or
cleaning with a method that has been proven in scientific literature
or tests conducted by the generator to achieve equivalent removal
(see Sec.  261.7(b)(3)).
    \20\ On November 4, 2011, ORCR issued a memo to the Regional
RCRA Division Directors highlighting three acceptable approaches,
beyond triple-rinsing containers, that healthcare facilities can
employ when managing P-listed container residues. Please see: Memo
from Suzanne Rudzinski to RCRA Division Directors (RCRA Online
#14827) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/57B21F2FE33735128525795F00610F0F/
$file/14827.pdf.
---------------------------------------------------------------------------

    To facilitate compliance among healthcare facilities and to respond
to these concerns, EPA is proposing a new set of sector-specific
regulations to improve the management and disposal of hazardous waste
pharmaceuticals at healthcare facilities. This proposed rule also
intends to clarify the regulatory status of a major practice used by
healthcare facilities for management of unused and/or expired
pharmaceuticals, known as reverse distribution (see Sections V.D.1 and
V.G).
    In addition to improving compliance and responding to stakeholder
concerns, the Agency has two additional goals for this proposal. The
first is to reduce the amount of pharmaceuticals that are disposed of
``down the drain.'' This is presently an allowable and common disposal
practice among healthcare facilities (as long as the pharmaceutical
waste is not ignitable (see the Clean Water Act regulations of 40 CFR
403.5(b)(1)) and provided certain conditions are met (see the Clean
Water Act regulations of 40 CFR 403.12(p)). Studies have found that
many healthcare facilities, particularly long term-care facilities, are
using drain disposal as a routine disposal method for pharmaceutical
wastes. Although pharmaceuticals are also entering the environment
through excretion, reducing sewer disposal is one mechanism to help
reduce the environmental loading of pharmaceuticals into our Nation's
waters. For more information about sewer disposal and pharmaceuticals
in water, see Section V.E.1.
    The second goal is to address the overlap between EPA's RCRA
hazardous waste regulations and the controlled substances regulations
of the Drug Enforcement Administration (DEA). Stakeholders have
indicated that hazardous waste pharmaceuticals that are also controlled
substances are stringently regulated and expensive to dispose of in
accordance with both sets of requirements when sent for incineration.
In addition, stakeholders have indicated that those regulated hazardous
waste pharmaceuticals that are also controlled substances are most
likely to be sewer disposed to avoid the costs of compliant
incineration. EPA plans to address this overlap in this proposed rule,
as this is an unnecessary burden for healthcare facilities and revised
requirements will help to reduce sewer disposal.
2. Executive Order 13563 for the Retrospective Review of Existing
Regulations
    On January 18, 2011, President Obama issued Executive Order 13563,
which directed all federal agencies to perform periodic retrospective
reviews of existing regulations to determine whether any should be
modified,

streamlined, expanded, or repealed.\21\ EPA made its preliminary plan
available for public review and comment during the spring of 2011 and
released the final version of the plan in August 2011.\22\ During the
public comment process, EPA received requests to clarify and make more
effective the hazardous waste regulations as they pertain to discarded
retail products, including pharmaceutical wastes. In response to this
specific issue, EPA agreed to review data and information currently in
its possession as part of the development for a rulemaking to address
pharmaceutical waste management issues.\23\ This Notice of Proposed
Rulemaking provides notice that EPA has completed its review and has
satisfied this part of its obligation for retail hazardous waste
pharmaceutical management issues.
---------------------------------------------------------------------------

    \21\ For a copy of Executive Order 13563, please see: http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf.
    \22\ US EPA. Improving Our Regulations: Final Plan for Periodic
Retrospective Reviews of Existing Regulations. http://www.epa.gov/regdarrt/retrospective/documents/eparetroreviewplan-aug2011.pdf.
    \23\ See page 45, item 2.2.17 of EPA's ``Improving Our
Regulations: Final Plan for Periodic Retrospective Reviews of
Existing Regulations'' at http://www.epa.gov/regdarrt/retrospective/documents/eparetroreviewplan-aug2011.pdf.
---------------------------------------------------------------------------

3. Retail Notice of Data Availability
    EPA published a Notice of Data Availability (NODA) for the Retail
Sector on February 14, 2014 (79 FR 8926), in which the Agency
requested, among other things, comment on a series of topics related to
retail operations in order to better understand the issues retail
stores/establishments face in complying with RCRA regulations. Many
retail commenters mentioned that because nicotine is an acute hazardous
waste (P075), they are considered LQGs when they discard more than 1 kg
per month of unused nicotine-containing products (e.g., e-cigarettes
and smoking cessation products such as gums, patches and lozenges).
Retailers discard these products mainly because they are either expired
or they are returned by customers and the retailer does not restock
them due to safety concerns. In comments to the NODA, retailers urged
the EPA to provide them some regulatory relief with regard to nicotine-
containing products. See Section VIII of this preamble for a discussion
of EPA's potential future efforts to amend the acute hazardous waste
listing for nicotine and salts (P075).

C. What was the 2008 Pharmaceutical Universal Waste proposal?

1. The 2008 Proposal To Add Hazardous Waste Pharmaceuticals to the
Federal Universal Waste Program
    On December 2, 2008, EPA proposed to add hazardous waste
pharmaceuticals to the existing federal universal waste program, which
would have provided a streamlined approach to facilitate the proper
management and disposal of hazardous waste pharmaceuticals generated at
pharmacies, hospitals, reverse distributors, and other healthcare-
related facilities. Specifically, under the universal waste program,
handlers and transporters who generate or manage items designated as a
universal waste \24\ are subject to the management standards under part
273, rather than the full RCRA subtitle C hazardous waste regulations.
Universal waste handlers include universal waste generators and
collection facilities. The regulations distinguish between ``large
quantity handlers of universal waste'' (or those who handle more than
5,000 kilograms of total universal waste at any one time) and ``small
quantity handlers of universal waste'' (or those who handle 5,000
kilograms or less of universal waste at any one time).\25\ The
streamlined requirements for all types of universal waste include
modified requirements for storage, labeling and marking, preparing the
waste for shipment off-site, employee training, response to releases
and notification.
---------------------------------------------------------------------------

    \24\ The current federal universal wastes include hazardous
waste batteries, certain hazardous waste pesticides, mercury-
containing equipment, and hazardous waste lamps.
    \25\ The 5,000 kilogram accumulation criterion applies to the
quantity of all universal wastes accumulated.
---------------------------------------------------------------------------

    Transporters of universal waste are also subject to less stringent
requirements than the full RCRA subtitle C hazardous waste
transportation regulations. However, the primary difference between the
universal waste transportation requirements and full RCRA subtitle C
requirements is that no hazardous waste manifest is required for the
transport of universal waste.
    Destination facilities under the universal waste program are those
facilities that treat, store, dispose of, or recycle universal wastes.
Universal waste destination facilities are subject to all currently
applicable requirements for hazardous waste treatment, storage, and
disposal facilities (TSDFs), including the requirement to obtain a RCRA
permit for such activities. (See 73 FR 73520, December 2, 2008, for a
more detailed discussion of the proposed universal waste program for
pharmaceutical wastes.)
2. What were the public comments to the 2008 Pharmaceutical Universal
Waste proposal?
    EPA received approximately 100 public comments on the 2008 proposal
to add hazardous waste pharmaceuticals to the universal waste
program.\26\ Generally, public commenters supported the Agency's desire
to address the issue of hazardous waste pharmaceutical management.
However, although there were several aspects of the proposal that were
well supported (e.g., training requirements, accumulation times, and
hazardous waste pharmaceuticals not being counted towards the generator
category), public commenters expressed concern over the lack of
notification and tracking requirements for small quantity handlers of
universal waste and the reduced notification and tracking requirements
for large quantity handlers. As a result, commenters, including state
environmental regulatory agencies, expressed concern that they would
not be informed of hazardous waste pharmaceutical generation,
management, and transportation in their regulatory jurisdictions.
Furthermore, public commenters expressed concern that because the
universal waste program does not require a hazardous waste manifest or
another tracking mechanism, the hazardous waste pharmaceuticals could
be vulnerable to diversion. Public commenters argued that hazardous
waste pharmaceuticals are different from the other federal universal
wastes (batteries, mercury-containing equipment, lamps, and pesticides)
in that the pharmaceuticals, as well as their containers, still retain
considerable value upon disposal and can be easily diverted for illicit
purposes. Therefore, tracking requirements beyond the requirements
included in the current universal waste program were considered
necessary by the majority of the public commenters.
---------------------------------------------------------------------------

    \26\ See docket EPA-HQ-RCRA-2007-0932 at www.regulations.gov for
public comments: http://www.regulations.gov/#!docketDetail;D=EPA-HQ-
RCRA-2007-0932;dct=FR%252BPR%252BN%252BO%252BSR.
---------------------------------------------------------------------------

    In addition to the public comments about the strengths and
weaknesses of using the universal waste program to address the disposal
of hazardous waste pharmaceuticals, EPA received other comments
expressing concern with the proposal, including the following: The
point of generation of hazardous waste pharmaceuticals as it pertains
to reverse distribution; the management of

containers that contain hazardous waste pharmaceutical residues; the
variability in the land disposal restriction (LDR) treatment standards
for hazardous waste pharmaceuticals; the overlap of EPA and DEA
regulations for the management of hazardous waste pharmaceuticals that
are also controlled substances; and the lack of activity to add
pharmaceutical wastes to the hazardous waste listings. The Agency
provides additional discussion on these specific comments within this
preamble.
3. Why is EPA not finalizing the 2008 Pharmaceutical Universal Waste
proposal?
    Based on the adverse comments received on the 2008 Pharmaceutical
Universal Waste proposal regarding the lack of notification and
tracking requirements for small quantity universal waste handlers, the
reduced notification and tracking requirements for large quantity
universal waste handlers, as well as the other issues raised in public
comments, the Agency has decided to not finalize the proposal to add
hazardous waste pharmaceuticals to the Universal Waste program. In
fact, EPA has concluded that the universal waste program is not
appropriate for managing hazardous waste pharmaceuticals because, among
other things, we are unable to adequately address the notification and
tracking concerns raised by the public comments within the Universal
Waste program.
    Under the Universal Waste regulations, there are eight factors to
consider when determining whether it is appropriate to add a new
hazardous waste or category of hazardous waste to the Universal Waste
program (Sec.  273.81). A hazardous waste does not need to meet every
factor in order to be added to the Universal Waste program. Rather, the
Agency's decision is ``based on the weight of evidence showing that
regulation under part 273 is appropriate for the waste or category of
waste, will improve management practices for the waste or category of
waste, and will improve implementation of the hazardous waste program''
(Sec.  273.80(c)).
    The Agency has concluded based on the comments received that the
weight of evidence does not show that regulation under the Universal
Waste program is appropriate for hazardous waste pharmaceuticals.
Specifically, we find the Universal Waste program to be lacking with
regard to the factor in Sec.  273.81(e), which states that the risk
posed by the waste being considered for universal waste be relatively
low compared to other hazardous wastes and that the management
standards would be protective of human health and the environment
during accumulation and transport. Although we continue to believe that
potentially creditable pharmaceuticals en route to reverse distributors
pose a low risk for leaks and other releases to the environment,
commenters urged us to consider the unique risk posed by the
accumulation and transport of hazardous waste pharmaceuticals: the risk
of diversion. Although it is rare that a hazardous waste is so valuable
that it is sought for abuse or sale on the black market, EPA believes
that the diversion of hazardous waste pharmaceuticals for illicit use
is a risk to human health.
    The Universal Waste program does not include sufficient tracking
requirements to address the potential for diversion. Under part 273,
tracking is not required for shipments by small quantity handlers of
universal waste; certain tracking of shipments is required only for
large quantity handlers of universal waste and destination facilities.
More importantly, these basic tracking requirements consist only of
recordkeeping of shipments sent and received and no tracking is
required to ensure delivery. Commenters noted that these tracking
requirements are not sufficient given the high value of many of the
unused pharmaceuticals en route to reverse distribution and the
potential for diversion.
    Accordingly, the Agency is proposing to amend Sec.  273.80 to state
that hazardous waste pharmaceuticals may not be added as a category of
hazardous waste for management under the Universal Waste program. See
Section IX State Authorization of the preamble for a discussion on the
effect on the two states that have adopted pharmaceuticals under the
Universal Waste program (Michigan and Florida).
    By proposing a new set of management standards outside the confines
of the Universal Waste program, it allows us greater flexibility in
addressing the tracking of such shipments, as well as additional
pharmaceutical waste management issues raised by stakeholders, such as
drain disposal, container residues, pharmaceutical reverse
distribution, and the overlap with DEA regulation. This new action will
address the original stakeholder concerns that resulted in the 2008
Pharmaceutical Universal Waste proposal, as well as the comments
received on that proposal.
    To reiterate, EPA is not adding hazardous waste pharmaceuticals to
the federal Universal Waste program. Rather, we are proposing sector-
specific regulations for the management of hazardous waste
pharmaceuticals by healthcare facilities and pharmaceutical reverse
distributors. If finalized, these regulations will be codified in 40
CFR part 266, separate from both the generator regulations (40 CFR part
262) and the Universal Waste program (40 CFR part 273). This new
proposed rulemaking will pertain to those waste pharmaceuticals that
meet the current definition of a RCRA hazardous waste and are generated
by healthcare-related facilities and managed by pharmaceutical reverse
distributors, as defined by this proposal. Finally, as this current
proposal is a direct result of the comments received on the December 2,
2008, Pharmaceutical Universal Waste proposal, the Agency considers the
2008 Pharmaceutical Universal Waste proposal obsolete. Therefore, EPA
is withdrawing the Universal Waste proposal for pharmaceutical waste,
and does not seek comment on any provisions of the 2008 Pharmaceutical
Universal Waste proposal or the current Universal Waste program. The
Agency will only be accepting comments from the public on the
provisions of this new proposed rulemaking.

D. EPA's Office of Inspector General Report

    On May 25, 2012, the EPA's Office of Inspector General (OIG) issued
the report, ``EPA Inaction in Identifying Hazardous Waste
Pharmaceuticals May Result in Unsafe Disposal'' (Report No. 12-P-
0508).\27\ The OIG reviewed EPA's process for identifying and listing
pharmaceuticals as hazardous wastes. Because of this review, the OIG
provided the following recommendations to the Assistant Administrator
for the Office of Solid Waste and Emergency Response (OSWER):
---------------------------------------------------------------------------

    \27\ For a copy of the report, please see: http://www.epa.gov/oig/reports/2012/20120525-12-P-0508.pdf or see the docket for this
proposed rule: EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    (1) Identify and review existing pharmaceuticals to determine
whether they qualify for regulation as hazardous waste.
    (2) Establish a process to review new pharmaceuticals to determine
whether they qualify for regulation as hazardous waste.
    (3) Develop a nationally consistent outreach and compliance
assistance plan to help states address challenges that healthcare
facilities, and others as needed, have in complying with RCRA
regulations for managing HWPs [hazardous waste pharmaceuticals] (Report
No. 12-P-0508).
    As detailed in OSWER's response to OIG, this proposal fulfills our
obligation

for addressing the third recommendation.\28\ EPA does not address the
OIG's first two recommendations as part of this proposed rulemaking;
however, in Section VII of this preamble, we solicit comment on our
ongoing efforts to identify additional pharmaceuticals as hazardous
wastes.
---------------------------------------------------------------------------

    \28\ For a copy of OSWER's full response to OIG, please see:
http://www.epa.gov/oig/reports/2012/12-P-0508_Agency%20Response.pdf.
---------------------------------------------------------------------------

V. Detailed Discussion of the Proposed Rule

    EPA is proposing an entirely new set of regulations (40 CFR part
266, subpart P) for managing hazardous waste pharmaceuticals at both
healthcare facilities and pharmaceutical reverse distributors. This
section discusses in detail the major features of the proposal. The
Agency also presents other options that it is considering or were
considered in developing the proposed rule. EPA welcomes comments on
all aspects of this proposed rule, and on options under consideration.
Throughout this section, EPA requests comments on specific options and
on specific issues, but comments are welcome on all provisions of this
proposal.

A. What terms are defined in this proposed rule?

    All the definitions that appear in this proposal are for the
purposes of 40 CFR part 266, subpart P only. Therefore, the definitions
are relevant only to healthcare facilities and pharmaceutical reverse
distributors that are subject to these proposed standards. For the
purposes of this regulation, the Agency is proposing and soliciting
public comment on the following terms and their definitions presented
below: ``evaluated hazardous waste pharmaceutical,'' ``hazardous waste
pharmaceutical,'' ``healthcare facility,'' ``household waste
pharmaceutical,'' ``long-term care facility,'' ``non-creditable
hazardous waste pharmaceutical,'' ``non-hazardous waste
pharmaceutical,'' ``non-pharmaceutical hazardous waste,''
``pharmaceutical,'' ``pharmaceutical reverse distributor,'' and
``potentially creditable hazardous waste pharmaceutical.'' Although the
proposed definitions appear in alphabetical order in the regulations,
we have chosen to discuss the proposed definitions in a different order
in the preamble.
1. What is the proposed definition of ``pharmaceutical''?
    This proposed rule defines ``pharmaceutical'' as 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 (FD&C
Act), prescription drugs, over-the-counter drugs, residues of
pharmaceuticals remaining in containers, personal protective equipment
contaminated with residues of pharmaceuticals, and clean-up material
from the spills of pharmaceuticals.
    This proposed definition of ``pharmaceutical'' is intended to
include all dose forms, including, but not limited to tablets,
capsules, medicinal gums or lozenges, medicinal liquids, ointments and
lotions, intravenous (IV) or other compounded solutions, chemotherapy
pharmaceuticals, vaccines, allergenics, medicinal shampoos,
antiseptics, and any delivery device, including medicinal dermal
patches, with the primary purpose to deliver or dispense the
pharmaceutical. As a rule of thumb, if an over-the-counter product is
required by the FDA to include ``Drug Facts'' on the label, it would be
considered a pharmaceutical for the purposes of this rule. EPA asks for
comment to identify additional types or forms of pharmaceuticals that
are not adequately captured by the definition.
    EPA previously proposed to define the term ``pharmaceutical'' in
the December 2008 Pharmaceutical Universal Waste proposal to mean ``any
chemical product, vaccine or allergenic (including any product with the
primary purpose to dispense or deliver a chemical product, vaccine or
allergenic), not containing a radioactive component, that is intended
for use in the diagnosis, cure, mitigation, treatment or prevention of
disease or injury in man or other animals; or any chemical product,
vaccine, or allergenic (including any product with the primary purpose
to dispense or deliver a chemical product, vaccine, or allergenic), not
containing a radioactive component, that is intended to affect the
structure or function of the body in man or other animals. This
definition includes products such as transdermal patches, and oral
delivery devices such as gums or lozenges. This definition does not
include sharps or other infectious or biohazard waste, dental amalgams,
medical devices not used for delivery or dispensing purposes,
equipment, contaminated personal protective equipment or contaminated
cleaning materials.'' This definition was adapted from FD&C Act's
definition for ``drug'' 21 U.S.C. 321(g).
    Based on the comments received in response to the Pharmaceutical
Universal Waste proposal, the Agency is continuing to rely primarily on
the FD&C Act's definition for ``drug'' for the definition of
pharmaceutical in this proposal and has preserved most of the
definition proposed in the previous proposal. However, EPA is proposing
to expand on its previous proposed definition of pharmaceutical based
on stakeholder input. In particular, stakeholders requested that the
Agency take a broad view in delineating what items are included in the
definition of pharmaceutical so that the proposed standards apply
broadly. Stakeholders indicated a preference for managing more items
under the new standards than trying to determine how to apply the
existing RCRA framework to pharmaceutical related items. Thus, the
proposed definition of pharmaceutical no longer excludes
pharmaceuticals with a radioactive component and includes items not
specifically recognized by the U.S. Food and Drug Administration (FDA)
as drugs, such as dietary supplements and pharmaceutical residues in
containers (including delivery devices), personal protective equipment
contaminated with residues of pharmaceuticals, and clean-up material
from spills of pharmaceuticals.
    EPA's decision to include dietary supplements under this
rulemaking's proposed definition of hazardous waste pharmaceutical
reflects our interest in promoting a management scheme for all types of
pharmaceuticals, and is based upon our understanding that dietary
supplements are commonly found in various healthcare settings because
they are recommended or prescribed by healthcare providers to
patients.\29\ Further, retail pharmacies routinely sell vitamins and
other medicinal minerals and supplements.
---------------------------------------------------------------------------

    \29\ Including dietary supplements under the definition of
pharmaceutical for this regulation does not supersede the
requirements of the Dietary Supplement Health and Education Act of
1994, the Federal Food, Drug and Cosmetic Act, or FDA regulations.
---------------------------------------------------------------------------

    When EPA uses the term ``dietary supplements'' in our proposed
definition of ``pharmaceutical,'' EPA is referencing the definition for
dietary supplement used by the FD&C Act, as amended by the Dietary
Supplement Health and Education Act of 1994 (21 U.S.C. 321(ff)).\30\
EPA understands that

the FDA does not recognize dietary ingredients or dietary supplements
under its definition of ``drug,'' but rather categorizes such items
under the general umbrella of foods and therefore, does not review them
before being marketed.31 32 For the purposes of this
proposed rule, however, EPA recognizes that healthcare facilities may
benefit from managing dietary supplements along with other drugs under
the regulatory scheme being proposed, and thus, is including it in the
proposed definition of pharmaceutical. Although dietary supplements
would be considered pharmaceuticals under this proposed definition,
only the dietary supplements that meet the definition of hazardous
waste (e.g., exhibits the toxicity characteristic for metal content)
would be regulated under part 266, subpart P as hazardous waste
pharmaceuticals (see the definition of ``hazardous waste
pharmaceutical''). We seek public comment on the Agency's decision to
recognize dietary supplements as pharmaceuticals under this regulation.
---------------------------------------------------------------------------

    \30\ The substance of the definition is: a product (other than
tobacco) intended to supplement the diet that bears or contains one
or more of the following dietary ingredients: (A) a vitamin; (B) a
mineral; (C) an herb or other botanical; (D) an amino acid; (E) a
dietary substance for use by man to supplement the diet by
increasing the total dietary intake; or (F) a concentrate,
metabolite, constituent, extract, or combination of any ingredient
described in clause (A), (B), (C), (D), or (E); For the complete
definition for dietary supplement, please see: http://www.gpo.gov/fdsys/pkg/USCODE-2013-title21/pdf/USCODE-2013-title21-chap9-subchapII-sec321.pdf.
    \31\ For more information regarding dietary supplements, please
see: http://www.fda.gov/Food/DietarySupplements/default.htm.
    \32\ It is the responsibility of the manufacturers to ensure
their dietary supplements are safe and that all claims on labels are
true and accurate. Nevertheless, FDA has the authority to take
action against any unsafe dietary supplements, as well as to take
action against any products with false and misleading claims.
---------------------------------------------------------------------------

    The Agency also is clarifying that its proposed definition includes
any items containing pharmaceutical residuals, such as dispensing
bottles, IV bags and tubing, vials, unit dose packages, and delivery
devices, such as syringes and patches. In addition, EPA is proposing
that items contaminated with or containing residual pharmaceuticals,
such as personal protective equipment containing trace amounts of
pharmaceuticals or related spill clean-up materials (including loose
tablets accumulated during pharmacy floor sweepings) also meet this
proposed definition of pharmaceutical. However, this proposed
definitions does not include sharps (e.g., needles from IV bags or
syringes). Used sharps, such as needles or syringes with needles, are
not included under the proposed rule because sharps are considered
medical wastes, presently regulated at the state and local level. In
addition, sharps pose both an unreasonable physical danger and
biohazard danger so have not been included in the definition of
pharmaceutical under this proposed rule. OSHA's Technical Manual
incorporates a recommendation from the American Society of Hospital
Pharmacists that ``all syringes and needles used in the course of
preparation be placed in ``sharps'' containers for disposal without
being crushed, clipped or capped.'' \33\ Further, as discussed in
Section V.E.3.c of this preamble, EPA is proposing to conditionally
exclude the residues of hazardous waste pharmaceuticals remaining in
fully dispensed syringes from RCRA regulation. However, EPA is
concerned about the possibility that some syringes may be disposed of
in sharps containers that may contain significant amounts of
undispensed pharmaceutical. EPA seeks comment on the prevalence of this
situation.
---------------------------------------------------------------------------

    \33\ See Section VI, Chapter 2 of OSHA's Technical Manual
(paragraph V.C.1.b.) https://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
---------------------------------------------------------------------------

    The Agency solicits public comment on the proposed definition of
``pharmaceutical'' in its entirety, and particularly on EPA's decision
to incorporate dietary supplements and items containing pharmaceutical
residuals as part of the definition of pharmaceutical.
2. What is the proposed definition of a ``hazardous waste
pharmaceutical''?
    This proposed rule defines ``hazardous waste pharmaceutical'' as 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. See Section IV.A.3. of this preamble
for a discussion of pharmaceuticals that may be listed or
characteristic hazardous wastes.\34\
---------------------------------------------------------------------------

    \34\ For additional information about RCRA hazardous waste
listings and characteristics, see: http://www.epa.gov/osw/hazard/wastetypes/index.htm.
---------------------------------------------------------------------------

    The Agency is proposing to define the term ``hazardous waste
pharmaceutical'' in order to clarify its intent that only
pharmaceuticals (as defined in this proposal) that meet the definition
of hazardous waste when disposed or discarded need to be managed under
these proposed management standards. This means that any pharmaceutical
waste that meets the definition of hazardous waste is a hazardous waste
pharmaceutical for the purposes of this rule. For example, the
prescription pharmaceutical warfarin (brand name Coumadin) is a listed
hazardous waste and when discarded meets the definition of a hazardous
waste pharmaceutical. EPA requests public comment on the proposed
definition for ``hazardous waste pharmaceutical.'' The Agency also
solicits information on whether any dietary supplements currently on
the market meet or potentially could meet RCRA's definition of a
hazardous waste.
3. What is the proposed definition of a ``potentially creditable
hazardous waste pharmaceutical''?
    In order to distinguish hazardous waste pharmaceuticals that are
transported to RCRA treatment, storage and disposal facilities (TSDFs)
from those hazardous waste pharmaceuticals being returned by a
healthcare facility to a pharmaceutical reverse distributor for a
determination or verification of manufacturer's credit, the Agency is
proposing a definition for ``potentially creditable hazardous waste
pharmaceutical.''
    The proposed rule defines ``potentially creditable hazardous waste
pharmaceutical'' to mean a hazardous waste pharmaceutical that has the
potential to receive manufacturer's credit and is
    (1) unused or un-administered; and
    (2) unexpired or less than one year past expiration date.
    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.
    Whether a pharmaceutical is eligible for manufacturer's credit is
determined solely by the manufacturer's return policy. Based on
comments received for the 2008 Universal Waste proposed rule and
through discussions with various stakeholders, the Agency understands
that the return policies of manufacturers change regularly. As a
result, pharmacies are not always aware if a particular pharmaceutical
will be creditable at the time that it is pulled from the shelves.
However, the Agency also understands that there are instances where it
is well known that a pharmaceutical will not be creditable. Examples of
these instances include the following: if the pharmaceutical has been
removed from the original container and re-packaged for dispensing
purposes; if an attempt was made to administer a pharmaceutical, but
the patient refused to take it; if the hazardous waste pharmaceutical
was generated during patient care; if the pharmacy receives a return of
a dispensed pharmaceutical for which

they had already received compensation by a third-party payer; or if
the pharmaceutical is more than one year past its expiration date. In
these instances, as well as others, the healthcare facility knows that
it will not receive manufacturer's credit. It is the Agency's intent
for the proposed definition of potentially creditable hazardous waste
pharmaceuticals to allow the return of hazardous waste pharmaceuticals
to reverse distributors for the determination of credit. It is not the
Agency's intent, however, for reverse distributors to serve in the
capacity as TSDFs when it is well known that the manufacturer will not
give credit for those hazardous waste pharmaceuticals.
    Also, based on communication with stakeholders and the public
comments received on the 2008 Universal Pharmaceutical Waste proposal,
EPA understands that pharmaceutical manufacturers' policies often allow
for credit to be received on the return of `partials.' Partials is a
term used in the industry to refer to opened containers that have had
some contents removed. Under the proposed definition, the Agency would
consider partials to be potentially creditable hazardous waste
pharmaceuticals.
    The Agency is soliciting comment on the proposed definition of
``potentially creditable hazardous waste pharmaceutical'' and whether
the definition is broad enough to encompass the various types of
hazardous waste pharmaceuticals that are shipped to reverse
distributors for manufacturer's credit, while also ensuring that non-
creditable hazardous waste pharmaceuticals are not inappropriately
shipped to reverse distributors solely for waste management purposes.
Finally, the Agency is seeking comment on additional situations where
it is well known that a returned pharmaceutical will or will not
receive manufacturer's credit.
4. What is the proposed definition of ``non-creditable hazardous waste
pharmaceutical''?
    As discussed previously, there are instances when it is well known
that credit will not be received for certain hazardous waste
pharmaceuticals. In order to distinguish hazardous waste
pharmaceuticals that have the potential for credit from those that have
no expectation of receiving credit, the Agency is proposing to define
the term ``non-creditable hazardous waste pharmaceutical.'' The
proposed definition of a ``non-creditable hazardous waste
pharmaceutical'' is a hazardous waste pharmaceutical that is not
expected to be eligible for manufacturer's credit. Examples include,
but are not limited to: if the pharmaceutical has been removed from the
original container and re-packaged for dispensing purposes; if an
attempt was made to administer a pharmaceutical, but the patient
refused to take it; if the hazardous waste pharmaceutical was generated
during patient care; if the pharmacy receives a return of a dispensed
pharmaceutical for which they had already received compensation by a
third-party payer (e.g. health insurance company); or if the
pharmaceutical is more than one year past its expiration date. EPA
requests comment on the proposed definition and seeks additional
examples of hazardous waste pharmaceuticals that have no expectation of
receiving manufacturer's credit.
5. What is the proposed definition of ``evaluated hazardous waste
pharmaceutical''?
    After potentially creditable hazardous waste pharmaceuticals arrive
at a pharmaceutical reverse distributor, they are evaluated to
determine whether they are eligible for manufacturer's credit, or
whether they need to be transferred to another pharmaceutical reverse
distributor for additional verification of manufacturer's credit.
Hazardous waste pharmaceuticals that need to be transferred to another
pharmaceutical reverse distributor for additional verification of
manufacturer's credit will continue to be considered potentially
creditable hazardous waste pharmaceuticals. EPA is proposing that
hazardous waste pharmaceuticals for which manufacturer's credit has
been issued (and no further verification of credit is required), as
well as those that have been deemed non-creditable, be referred to as
``evaluated hazardous waste pharmaceuticals.'' EPA is proposing to
define ``evaluated hazardous waste pharmaceutical'' as 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. It is important to
define this term since the proposed management and shipping standards
for potentially creditable hazardous waste pharmaceuticals differ from
the proposed management and shipping standards for evaluated hazardous
waste pharmaceuticals. For a discussion of the proposed management and
shipping standards for potentially creditable hazardous waste
pharmaceuticals, see Section V.F.2. For a discussion of the proposed
management and shipping standards for evaluated hazardous waste
pharmaceuticals, see Section V.F.1.b.
6. What is the proposed definition of ``household waste
pharmaceutical''?
    We are proposing to define the term ``household waste
pharmaceutical'' as a solid waste, as defined in Sec.  261.2, that also
meets the definition of pharmaceutical, as defined in this proposed
rule, but is not a hazardous waste because it is exempt from RCRA
Subtitle C regulation by the household waste exclusion in Sec.
261.4(b)(1). We are proposing this term to distinguish this type of
waste pharmaceutical from the hazardous waste pharmaceuticals that are
proposed to be regulated under this new subpart. This proposed rule
does not apply to pharmaceutical waste that is exempt due to the
household waste exclusion.
7. What is the proposed definition of ``non-hazardous waste
pharmaceutical''?
    We are proposing to define the term ``non-hazardous waste
pharmaceutical.'' While hazardous waste pharmaceuticals are proposed to
be regulated under this new subpart, non-hazardous waste
pharmaceuticals will not be regulated under this new subpart, nor the
RCRA subtitle C hazardous waste regulations. The Agency is proposing to
include this definition since we believe it important to delineate what
is and is not regulated under this new subpart. We propose to define
the term ``non-hazardous waste pharmaceutical'' to mean a
pharmaceutical that is a solid waste, as defined in Sec.  261.2, but
that is not a listed hazardous waste and does not exhibit any
characteristics of hazardous waste (i.e., ignitable, corrosive,
reactive, toxic).
8. What is the proposed definition of ``non-pharmaceutical hazardous
waste''?
    Like the previous definition, we are proposing a definition for
non-pharmaceutical hazardous waste to help us delineate what is and
what is not regulated under this new subpart. We are proposing to
define the term ``non-pharmaceutical hazardous waste'' as a solid
waste, as defined in Sec.  261.2, that is either a listed hazardous
waste or exhibits one or more characteristics of hazardous waste, but
does not meet the definition of a pharmaceutical, as proposed under
this new subpart. The management of non-pharmaceutical hazardous wastes
is not regulated under this subpart; rather generators of non-

pharmaceutical hazardous wastes, including healthcare facilities and
reverse distributors, remain subject to the existing Subtitle C
hazardous waste regulations for the management of those hazardous
wastes. Examples of non-pharmaceutical hazardous wastes that healthcare
facilities may generate include cleaning solutions, solvents, and
laboratory wastes. Some hazardous wastes exist in pharmaceutical form
and non-pharmaceutical form. For example, warfarin, nicotine, and
lindane were all originally listed as hazardous waste because they were
pesticides, not medicines. If these products are not intended for human
or animal use, they would be considered non-pharmaceutical hazardous
wastes and remain subject to the existing RCRA hazardous waste
regulations, not part 266, subpart P.
9. What is the proposed definition of a ``healthcare facility''?
    These proposed regulations differ from those in the Pharmaceutical
Universal Waste proposal in that they apply based not only on the type
of hazardous waste generated, but also on the sector generating the
waste. Accordingly, EPA is proposing a definition for ``healthcare
facility'' so that it is clear to whom these proposed regulations
apply. This proposed definition is adapted from the definition of
``health care'' that the Department of Health and Human Services (DHHS)
promulgated as a result of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) (45 CFR part 160.103).\35\ Thus, for
the purposes of these proposed regulations, EPA is proposing that
``healthcare facility'' means any person that (1) 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 (2) sells or dispenses over-the-counter or
prescription pharmaceuticals. 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. Thus, these proposed
regulations will be applicable to any healthcare facility for human or
animal which generates hazardous waste pharmaceuticals on its premises.
---------------------------------------------------------------------------

    \35\ 45 CFR part 160 http://aspe.hhs.gov/admnsimp/final/pvctxt01.htm.
---------------------------------------------------------------------------

    EPA proposes to include coroners in the definition of a healthcare
facility despite the fact that the services coroners provide occur
after life. Coroners will often inventory, and then dispose of, any
pharmaceuticals that may be found at the scene of a death. A common
method of disposal is sewering. In order to reduce the sewer disposal
practices of coroners, and to provide the same management options that
are available to other healthcare facilities, EPA has decided to
include ``coroners'' within the definition of healthcare facility,
although the Agency solicits comment on including coroners within the
definition of healthcare facility.\36\
---------------------------------------------------------------------------

    \36\ For more information on the disposal process, please see:
Ruhoy, I.S. and Daughton, C.G. ``Types and Quantities of Leftover
Drugs Entering the Environment via Disposal to Sewage--Revealed by
Coroner Records,'' Sci. Total Environ., 2007, 388(1-3):137-148.
http://www.epa.gov/nerlesd1/bios/daughton/SOTE2007.pdf.
---------------------------------------------------------------------------

    Under the proposed definition, healthcare facilities include
locations that sell pharmaceuticals over the internet, through the
mail, or through other distribution mechanisms. A pharmacy does not
necessarily have to have a ``brick and mortar'' or ``store front''
presence to be considered a healthcare facility for the purposes of
this proposed rule. The proposed definition of a ``healthcare
facility'' also applies to entities that engage in drug compounding. In
general, compounding is a practice in which a licensed pharmacist, a
licensed physician, or, in the case of an outsourcing facility, a
person under the supervision of a licensed pharmacist, combines, mixes,
or alters ingredients of a drug to create a medication tailored to the
needs of an individual patient. The proposed definition of ``healthcare
facility'' applies to state-licensed pharmacies, Federal facilities,
and licensed physicians that compound drugs in accordance with section
503A of the FD&C Act, and to outsourcing facilities that compound drugs
in accordance with section 503B of the FD&C Act. The Agency is
soliciting comment on the proposed definition of ``healthcare
facility,'' including whether it is appropriate to consider these
compounders as healthcare facilities within the scope of this proposed
rule.
    The proposed definition of ``healthcare facility'' does not apply
to pharmaceutical manufacturers and their representatives, wholesalers,
or any other entity that is involved in the manufacturing, processing
or wholesale distribution of over-the-counter or prescription
pharmaceuticals, unless they meet the definition of a ``reverse
distributor'' as discussed in this section and in Section V.G. The
purpose for these sector-based regulations is to address the various
issues that healthcare facilities and reverse distributors face when
managing hazardous waste pharmaceuticals. As noted previously, the
Agency does not anticipate that manufacturing facilities, which
predictably generate a known range of hazardous wastes, face the same
issues as healthcare facilities.
10. What is the proposed definition of a ``long-term care facility''?
    The term ``long-term care facility'' does not have a standardized,
industry definition. EPA is, therefore, proposing the following
definition for ``long-term care facility'' (LTCF): 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.
    The included facilities are licensed care facilities that are more
similar to hospitals than to standard residences. Although group homes
may be licensed care facilities, they are typically very small (under
10 beds). Independent living communities are not licensed care
facilities, but rather are residences made up of individual units such
as townhomes or apartments. Finally, private residences with visiting
nurses are not considered long-term care facilities. EPA requests
public comment on the proposed definition of long-term care facility,
and the inclusion of assisted living facilities, skilled nursing
facilities and other LTCFs that administer their residents'
pharmaceuticals as an integral part of their services within the
definition of ``healthcare facility.''
    The DEA's definition of ``long term care facility'' is ``a nursing
home, retirement care, mental care or other facility or institution
which provides extended health care to resident patients'' (21 CFR
1300.01). EPA's definition is more descriptive, and includes a list--
which is not

exhaustive--of examples of long-term care facilities. We feel this a
more flexible way to define the universe. Although the definitions
differ, they are not necessarily incompatible.
11. What is the proposed definition of a ``pharmaceutical reverse
distributor''?
    As more fully discussed in Section V.G.1 of this preamble,
pharmaceutical manufacturers often offer credit to healthcare
facilities on the return of unused and/or expired pharmaceuticals.\37\
Stakeholders have informed the Agency that manufacturers issue credit
for a variety of reasons. For example, it is a marketing incentive tool
that helps ensure against illicit diversion \38\ or improper disposal,
and it allows manufacturers to collect data on the returned items,
which then can be used to help plan for future pharmaceutical
production. Reverse distributors are contracted by both pharmaceutical
manufacturers and healthcare facilities to facilitate the crediting
process.
---------------------------------------------------------------------------

    \37\ As noted in the definition of ``potentially creditable
hazardous waste pharmaceutical,'' credit is provided for those
pharmaceuticals that are less than one year past the expiration
date.
    \38\ Through the return of pharmaceuticals by a pharmacy for
manufacturer's credit, manufacturers are able to maintain control of
the pharmaceutical up to the point of its disposal, thereby,
decreasing the risk of diversion of the pharmaceutical.
---------------------------------------------------------------------------

    Some of the pharmaceuticals returned for credit will meet RCRA's
definition of a hazardous waste. Due to the fact that the vast majority
of pharmaceuticals that are returned for manufacturer's credit are
disposed of once credit eligibility is determined, EPA is proposing new
standards for shipment of potentially creditable hazardous waste
pharmaceuticals (see Section V.F.2.) and the management of potentially
creditable hazardous waste pharmaceuticals by reverse distributors (see
Section V.G). Thus, EPA is proposing to define pharmaceutical reverse
distributor to clearly delineate which types of facilities are subject
to this proposed rule. In keeping with how the term is commonly used in
the healthcare sector, EPA is proposing to define a ``pharmaceutical
reverse distributor'' as 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.
    The Agency also needs to clarify the difference between what is
defined as a pharmaceutical reverse distributor for the purpose of
these proposed regulations and how DEA regulations define ``reverse
distribute.'' The recently amended DEA regulatory definition of
``reverse distribute'' is to ``acquire controlled substances from
another registrant or law enforcement for the purposes of: (1) Return
to the registered manufacturer or another registrant authorized by the
manufacturer to accept returns on the manufacturer's behalf; or (2)
Destruction (21 CFR 1300.01).\39\
---------------------------------------------------------------------------

    \39\ On September 9, 2014, DEA finalized new definitions for
``reverse distribute'' and ``reverse distributor.'' Please see 79 FR
53520. The term ``reverse distributor'' is defined as ``a person
registered with the Administration [DEA] as a reverse distributor.''
---------------------------------------------------------------------------

    Under DEA's definition, a reverse distributor does not necessarily
process pharmaceuticals for the purpose of determining manufacturer's
credit; rather, their main function under DEA's definition is to
destroy the controlled substances. Under EPA's proposed definition,
however, a pharmaceutical reverse distributor is defined more broadly
as a facility that can accept potentially creditable pharmaceuticals
for the purposes of determining manufacturer's credit. These
potentially creditable pharmaceuticals may or may not be identified as
controlled substances by DEA.\40\ Therefore, a DEA-registered reverse
distributor may or may not meet EPA's definition of a pharmaceutical
reverse distributor and vice versa. For example, a pharmaceutical
reverse distributor that accepts controlled substances (that are also
hazardous wastes) for the sole purpose of destruction (e.g.,
incineration) would be regulated as a DEA-registered reverse
distributor and as a RCRA TSDF, and not as a pharmaceutical reverse
distributor under the RCRA hazardous waste regulations. Conversely, a
pharmaceutical reverse distributor that processes pharmaceuticals for
manufacturer's credit, but is not a DEA registrant and therefore,
cannot accept controlled substances, would meet the RCRA pharmaceutical
reverse distributor definition, but not DEA's reverse distributor
definition. However, EPA has heard from stakeholders that many, if not
all, entities that facilitate manufacturer's credit are also DEA-
registered reverse distributors. Therefore, such pharmaceutical reverse
distributors would meet both EPA's proposed definition of
pharmaceutical reverse distributor, as well as the DEA's definition of
reverse distributor. Lastly, we would note that EPA's definition for
reverse distribution does not alter or supersede the requirements of
the Controlled Substances Act and DEA regulations.
---------------------------------------------------------------------------

    \40\ In order for a reverse distributor to be able to accept
controlled substances, the reverse distributor must be a DEA
registrant. See 21 CFR part 1308 for a complete list of controlled
substances.
---------------------------------------------------------------------------

    In addition, the Department of Transportation's Pipeline and
Hazardous Materials Safety Administration (PHMSA) has defined the
closely related term, ``reverse logistics,'' in a recent proposed
rulemaking.\41\ The EPA has been coordinating with the PHMSA to ensure
that our rules are compatible, even if the definitions differ. It is
important to note that, when finalized, the PHMSA rule will not
supersede EPA's RCRA Subtitle C regulations for when something is
considered a solid or hazardous waste or how a hazardous waste must be
managed.
---------------------------------------------------------------------------

    \41\ 79 FR 46748; August 11, 2014. The PHMSA's proposed
definition of reverse logistics ``is the process of moving goods
from their final destination for the purpose of capturing value,
recall, replacement, proper disposal, or similar reason.''
---------------------------------------------------------------------------

    The Agency solicits public comment on its proposed definition of a
``pharmaceutical reverse distributor.'' Specifically, EPA asks for
comment on whether the definition of ``pharmaceutical reverse
distributor'' captures the universe of facilities acting as reverse
distributors for pharmaceuticals. In addition, the Agency asks for
comment regarding the intersection of DEA and EPA's definitions.

B. What is the scope of this proposed rule?

1. What facilities are subject to this rulemaking?
    a. Healthcare facilities. The Agency is proposing that healthcare
facilities that are currently considered either SQGs or LQGs will be
required to manage all hazardous waste pharmaceuticals generated at
their facilities in accordance with the standards proposed in this
document. In other words, these management standards will apply to any
healthcare facility that generates (or accumulates) more than 100 kg of
hazardous waste per calendar month or more than 1 kg of acute hazardous
waste per calendar month (e.g., P-listed hazardous waste) or more than
100 kg of any residue or contaminated soil, waste, or other debris
resulting from the clean-up of a spill, into or on any land or water,
of any acute hazardous wastes listed in Sec. Sec.  261.31, or 261.33(e)
per calendar month. All healthcare facilities

that meet these applicability criteria will be subject to the same set
of standards for the management of their hazardous waste
pharmaceuticals. That is, subpart P is not optional for healthcare
facilities that generate above the CESQG monthly quantity limits (see
Section V.B.1.c. of the preamble for a discussion of what regulations
apply to CESQGs). EPA is proposing to make subpart P mandatory to
promote national consistency, a goal championed by stakeholder comments
as well as EPA. In addition, having one set of standards applicable to
pharmaceutical waste will be less confusing to the regulated community,
which should lead to better compliance. The stringency of the subpart P
management standards for hazardous waste pharmaceuticals do not change
if a healthcare facility generates more hazardous waste pharmaceuticals
from one month to another. The generator categories--that is, LQG, SQG,
and CESQG--under the part 262 RCRA requirements will only be relevant
for the healthcare facilities' non-pharmaceutical hazardous waste
because non-pharmaceutical hazardous waste remain subject to the 40 CFR
part 262 generator regulations (see Section VI. Implementation and
Enforcement for further discussion).
    b. Long-term care facilities subject to this rule. Long-term care
facilities are included within the proposed definition of healthcare
facility. Further, EPA is proposing to change its policy regarding the
management of hazardous waste and hazardous waste pharmaceuticals
generated on the premises of long-term care facilities. Under current
federal RCRA interpretation (see 73 FR 73525, December 2, 2008),
hazardous wastes (including pharmaceuticals) generated on the premises
of a long-term care facility can fall under two categories: (1) RCRA
Subtitle C hazardous waste or (2) household hazardous waste that is
exempt from RCRA Subtitle C regulation. As explained in the preamble to
the proposal to add pharmaceuticals to the Universal Waste program,
``the [long-term care] facility itself may generate hazardous wastes as
a result of its central management of pharmaceuticals in its pharmacy
or pharmacy-like area. These hazardous pharmaceutical wastes would be
subject to the RCRA hazardous waste generator regulations since the
pharmaceuticals are under the control of the facility, and thus, the
resulting wastes are generated by that facility. However, patients and
residents in long-term care facilities may generate hazardous wastes.
Those pharmaceuticals that are under the control of the patient or
resident of the long-term care facility, when discarded, would be
subject to RCRA's household hazardous waste exclusion (Sec.
261.4(b)(1)). Hazardous pharmaceutical wastes generated by the resident
are excluded from regulation because they are considered to be derived
from a household'' (see December 2, 2008; 73 FR 73525).
    The Agency is now providing notice that it intends to revise this
interpretation. Specifically, hazardous waste (including
pharmaceuticals) generated at long-term care facilities will no longer
be considered exempt as household hazardous waste. It will be regulated
as hazardous waste, subject to the appropriate RCRA Subtitle C
management standards, including the standards being proposed. The
Agency is revising its interpretation with regard to hazardous wastes
generated at long-term care facilities based on a reevaluation of how
such facilities operate. Specifically, in order for hazardous waste to
qualify for the household hazardous waste exemption of Sec.
261.4(b)(1), it must meet two criteria: (1) The hazardous waste must be
generated by individuals on the premises of a household, and (2) the
hazardous waste must be composed primarily of materials found in the
wastes generated by consumers in their homes.\42\ EPA now believes that
hazardous waste generated at long-term care facilities, even when those
pharmaceuticals are under the control of the patient or resident, does
not meet either criterion for the household hazardous waste exemption.
---------------------------------------------------------------------------

    \42\ See November 13, 1984; 49 FR 44978.
---------------------------------------------------------------------------

    First, a long-term care facility is more akin to a hospital than it
is a typical residence and EPA does not consider hospitals to be
households. Long-term care facilities are licensed, residential care
settings that offer their residents a wide range of services, many of
which are centered on administering medications and providing
healthcare by various professional healthcare providers, such as
medical technicians, nurse's aides, nurses, and doctors. Other services
provided involve assistance in performing activities of daily living,
such as bathing, and eating. A 2012 American Association of Retired
Person (AARP) Public Policy Institute report indicates that there is an
average of 24 beds per licensed residential care facilities (excluding
nursing homes).\43\ Based on another report prepared as a collaborative
project of the American Association of Homes and Services for the Aging
(AAHSA), American Seniors Housing Association (ASHA), Assisted Living
Federation of America (ALFA), National Center for Assisted Living
(NCAL) and National Investment Center for the Seniors Housing and Care
Industry (NIC), there is an average of 54 units (e.g., rooms) for all
types of assisted living/dementia care properties.\44\ Unlike other
multiple dwellings, approximately 81 percent of these facilities store
medications in a central location and 89 percent administer medications
to their residents.\45\ Given that long-term care facilities are
licensed settings for the care of their residents and routinely provide
healthcare services, we believe that long-term care facilities more
closely resemble hospitals than typical residences.
---------------------------------------------------------------------------

    \43\ AARP Public Policy Institute, INSIGHT on the Issues 58,
Assisted Living and Residential Care in the States in 2010, April
2012. http://www.aarp.org/content/dam/aarp/research/public_policy_institute/ltc/2012/residential-care-insight-on-the-issues-july-2012-AARP-ppi-ltc.pdf or see the docket for this
proposed rulemaking (EPA-HQ-RCRA-2007-0932).
    \44\ 2009 Overview of Assisted Living; a collaborative research
project of AAHSA, ASHA, ALFA, NCAL & NIC.
    \45\ Ibid.
---------------------------------------------------------------------------

    Second, the hazardous wastes generated by long-term care facilities
do not meet the second criteria for the waste to be considered
household hazardous waste. This is primarily due to the quantity of
pharmaceutical wastes that are often generated on the premises of long-
term care facilities when compared to a typical residence. For example,
the Colorado Department of Public Health and Environment estimates that
a 100-bed nursing home might expect to generate approximately 120 to
336 pounds of pharmaceutical waste per year.\46\ In addition, long-term
care facilities, such as assisted living facilities and nursing homes,
generate a greater variety of hazardous waste pharmaceuticals and a
greater quantity of hazardous waste than a typical household generates.
The AARP Public Policy Institute report indicates that ``residents take
an average of seven or eight different prescriptions and two OTC [over-
the-counter] medications daily.'' This number is larger than what we
would expect a typical household to generate. This distinction about
volume of waste is analogous to the distinction that EPA has made in
the past about contractor or do-it-yourself waste from

households: waste from ``routine residential maintenance'' is exempt as
household hazardous waste, while waste from ``building construction,
renovation, demolition'' is not exempt.\47\ Therefore, EPA is providing
notice that if this rule is finalized, long-term care facilities may no
longer use the household hazardous waste exemption. If this rule is
finalized, long-term care facilities would need to manage their
hazardous waste pharmaceuticals in accordance with the healthcare
facility specific management standards in this proposal and their non-
pharmaceutical hazardous wastes in accordance with the applicable RCRA
hazardous waste generator requirements in Sec.  261.5 (for CESQGs) or
part 262 (for SQGS and LQGs). However, even though long-term care
facilities will no longer be considered eligible to use the household
hazardous waste exemption, our data show that only 28% of long-term
care facilities generate hazardous waste pharmaceuticals, and of those,
85% are small enough to be considered CESQGs of hazardous waste
(regulated under Sec.  261.5) and therefore not subject to part 266,
subpart P (except the sewer ban).\48\ The Agency seeks comment on
whether this proposed change to consider long-term care facilities to
be healthcare facilities instead of households is appropriate. We also
seeking comment on the extent to which long-term care facilities will
pass the cost of compliance onto its customers. Until this rule is
finalized, the current interpretation from the Universal Waste preamble
will stand regarding hazardous waste from long-term care facilities.
---------------------------------------------------------------------------

    \46\ Net weight (without packaging) of types of pharmaceuticals
wastes, including those that are RCRA hazardous, non-RCRA hazardous,
DEA controlled, prescription and over-the-counter. Memo from Lillian
Gonzalez, Colorado Department of Public Health and Environment to
Kristin Fitzgerald, EPA; January 9, 2013, see the docket for this
proposed rulemaking (EPA-HQ-RCRA-2007-0932).
    \47\ Memo from Petruska to McNally, February 28, 1995; RCRA
Online #11897 that discusses the distinction about what renovation
waste is household hazardous waste and what is not.
    \48\ See the docket for this rulemaking for data about long-term
care facilities which was developed using data in the economic
analysis: EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    c. Conditionally exempt small quantity generators (CESQGs). As
discussed in the Background Section (Section IV.A.2), CESQGs are
subject to a limited set of federal RCRA Subtitle C hazardous waste
regulations, provided that they comply with the conditions set forth in
Sec.  261.5.\49\ This proposed rulemaking will preserve this current
regulatory structure for the most part; therefore, healthcare
facilities that generate hazardous waste pharmaceuticals and qualify as
CESQGs, will maintain their conditional exemption under Sec.  261.5 and
will not be subject to most aspects of this proposal. However, as part
of this rulemaking, EPA is proposing a ban on sewer disposal of
hazardous waste pharmaceuticals by all healthcare facilities and
reverse distributors. EPA is proposing that the sewer ban would apply
to all healthcare facilities, including CESQG healthcare facilities.
Please see Section V.E.1 of this preamble for a more detailed
discussion on this proposed sewer prohibition. EPA asks for comment on
whether the proposed healthcare facility standards, in addition to the
sewer ban, should apply to CESQG healthcare facilities.
---------------------------------------------------------------------------

    \49\ Not all authorized states recognize the CESQG category and
may have more stringent regulatory requirements for CESQGs.
Therefore, as noted previously, EPA recommends that facilities that
qualify as CESQGs under the federal regulations contact their state
and/or local environmental regulatory agencies to determine whether
more stringent regulatory requirements apply to CESQGs in their
state.
---------------------------------------------------------------------------

    EPA is proposing one additional change for CESQGs in order to allow
them to continue to send their potentially creditable hazardous waste
pharmaceuticals to a pharmaceutical reverse distributor. Currently,
under Sec.  261.5, CESQGs are limited in where they may send their
hazardous waste for treatment and disposal (see Sec.  261.5(f)(3)(i)-
(vii) for acute hazardous waste and Sec.  261.5(g)(3)(i)-(vii) for
hazardous waste). However, in Sec.  266.504(a) we are proposing to
allow CESQGs to send their potentially creditable hazardous waste
pharmaceuticals to a pharmaceutical reverse distributor. Without this
change, CESQGs would be required to send all their hazardous waste
pharmaceuticals, including those that are potentially creditable, to
one of the types of facilities in Sec.  261.5, which does not include a
pharmaceutical reverse distributor. Although we are proposing to make
this change within part 266, subpart P, we request comment on whether
stakeholders would prefer this change to be made within Sec.  261.5
instead. CESQGs will still be required to send their non-pharmaceutical
hazardous waste and their non-creditable hazardous waste
pharmaceuticals to one of the types of facilities listed in Sec.
261.5.
    In addition, it has been suggested that EPA seek comment on
providing a rebuttable presumption that LTCFs with fewer than 10-beds
are assumed to be CESQGs and thus would not be required to count the
amount of hazardous waste generated each month. Under this presumption,
they would be subject to all the requirements for CESQGs as described
elsewhere in this proposal, including the requirement not to sewer
hazardous waste pharmaceuticals. Therefore, EPA asks for comment on
this rebuttable presumption and specifically whether the 10-bed cut off
is appropriate or whether there are other criteria EPA should take into
account. Further, EPA asks for commenters to submit data to support a
10-bed cut off to show that LTCFs with fewer than 10-beds are generally
CESQGs. Alternatively, if comments wish to support a different cut-off
for the rebuttable assumption, EPA also asks that the commenters submit
information/data to support their suggested cut-off.
    d. Pharmaceutical reverse distributors. EPA is proposing that
pharmaceutical reverse distributors, including pharmaceutical
manufacturers, which accumulate potentially creditable hazardous waste
pharmaceuticals or evaluated hazardous waste pharmaceuticals are
subject to this rule. Pharmaceutical reverse distributors are only
subject to this proposed rule for the accumulation of potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous
waste pharmaceuticals; if a reverse distributor also treats and/or
disposes of hazardous waste pharmaceuticals, it is subject to the
applicable RCRA Subtitle C TSDF regulations, including the requirement
to have a permit or interim status. Stakeholders have indicated a
strong preference for EPA to clarify how pharmaceutical reverse
distributors are regulated under RCRA, as states have applied varied
hazardous waste regulatory approaches to pharmaceutical reverse
distributors. EPA is proposing specific standards in 40 CFR part 266,
subpart P for pharmaceutical reverse distributors (as defined in this
proposed rule) that incorporate various generator standards, as well as
some TSDF standards. See Section V.G for more information.
2. To what facilities does this rule not apply?
    a. Pharmaceutical manufacturers. EPA does not intend for these
proposed regulations to apply to hazardous waste pharmaceuticals that
are generated by pharmaceutical manufacturers or wholesalers.
Pharmaceutical manufacturers and wholesalers do not face the same
challenges that healthcare facilities experience when managing
hazardous waste pharmaceuticals and potentially creditable hazardous
waste pharmaceuticals in accordance with the federal RCRA subtitle C
requirements (for an explanation of the challenges healthcare
facilities face, see discussion in section IV.B.1 of the preamble).
These entities (i.e., manufacturers and wholesalers) generate hazardous
waste pharmaceuticals that are more predictable and the staff have the

necessary expertise to determine which pharmaceutical waste is
hazardous waste. However, as mentioned previously, when any facility,
including a pharmaceutical manufacturer, meets the definition found in
this proposal for a ``pharmaceutical reverse distributor,'' it would be
subject to the proposed regulations for pharmaceutical reverse
distributors with respect to those operations.
    b. Households. The Agency would like to emphasize that the
regulatory requirements in this proposed rule do not apply to
households or to household pharmaceutical collection and take-back
events and programs. (For information regarding collection programs,
see Section V.E.2.) Pharmaceuticals that are unwanted by consumers
(households) are not regulated as hazardous waste and are generally
considered municipal solid wastes. While a small percentage of these
household waste pharmaceuticals meet the definition of hazardous waste
under RCRA, the federal RCRA hazardous waste regulations include an
exclusion for all hazardous wastes generated by households (see the
``household hazardous waste'' exclusion at Sec.  261.4(b)(1)). Thus
household waste pharmaceuticals--like other household hazardous
wastes--are not subject to the federal RCRA hazardous waste
regulations.
    ``EPA excluded household wastes because the legislative history of
RCRA indicated an intent to exclude such wastes, though not because
they necessarily pose no hazard.'' \50\ Some household products,
including pharmaceuticals, contain ignitable, corrosive, reactive, or
toxic ingredients. As a result, for household hazardous waste collected
at a take-back event or program, the Agency has historically
recommended that communities operating the collection programs manage
the collected household hazardous wastes as hazardous waste, even
though it is not required by RCRA.\51\ Furthermore, the Agency has
recently recommended that collected household waste pharmaceuticals be
incinerated--preferably at a permitted hazardous waste incinerator, but
when that is not feasible, at a large or small municipal waste
combustor.\52\ The Agency believes that this practice is already common
among collection programs since one goal of many collection programs is
to divert pharmaceuticals from municipal landfills. Nevertheless, the
Agency is proposing to make this recommendation a requirement for
collected household waste pharmaceuticals in Sec.  266.506.\53\ The
Agency seeks comment on changing this recommendation to a requirement
for pharmaceutical collection programs.
---------------------------------------------------------------------------

    \50\ See 49 FR 44978; November 13, 1984.
    \51\ See memo November 1, 1988, from Porter to Regions (RCRA
Online #11377). http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/2FD51915214EF63C8525670F006BDC88/
$file/11377.pdf.
    \52\ See memo September 26, 2012, Rudzinski to the Regional RCRA
Division Directors (RCRA Online# 14833). http://yosemite.epa.gov/
osw/rcra.nsf/0c994248c239947e85256d090071175f/
FCB11DD6F61D4B1685257AFE005EB5CE/$file/14833.pdf.
    \53\ Since pharmaceutical collection programs typically co-
mingle DEA controlled substances with non-controlled substances,
this requirement is included in a section of the regulations that
pertains to controlled substances.
---------------------------------------------------------------------------

    The Agency recommends that, whenever possible, households utilize
pharmaceutical collection and take-back events as the disposal option
for their unwanted pharmaceuticals. For consumers without access to a
pharmaceutical take-back event, FDA provides information on the
disposal of unused pharmaceuticals and step-by-step guidance for
disposing of pharmaceuticals in the household trash. For more
information on the safe disposal of household pharmaceuticals, please
see: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm.
3. Which hazardous wastes are addressed by this proposed rule?
    a. Hazardous waste pharmaceuticals. If finalized, these regulations
will only pertain to those pharmaceutical wastes that are RCRA
hazardous wastes generated by healthcare facilities or managed by
pharmaceutical reverse distributors. Under this rulemaking, EPA is not
proposing to add additional pharmaceuticals to the hazardous waste
listings or to expand the hazardous waste characteristics to include
additional pharmaceuticals. See Section VII of the preamble, Request
for Comment on EPA's Efforts to Identify Additional Pharmaceuticals as
Hazardous Waste, for a discussion of possible future actions by EPA to
regulate additional pharmaceuticals as hazardous waste.
    b. How does this proposal affect hazardous waste pharmaceuticals
that are also regulated by other federal or state regulations? The
management, transportation, treatment, storage and disposal of
hazardous waste pharmaceuticals are regulated under RCRA Subtitle C.
However, hazardous waste pharmaceuticals may also be subject to a
number of other statutes and implementing regulations administered by
state or other federal agencies. Examples include pharmaceuticals that
are subject to the Controlled Substances Act and DEA regulations;
infectious pharmaceutical wastes that are subject to state and local
medical waste regulations; and pharmaceuticals with a radioactive
component that are subject to the Atomic Energy Act (AEA). These
potentially overlapping requirements make the appropriate management of
pharmaceutical wastes a complex matter. The following discusses the
impact of this proposed rule on various dually regulated hazardous
waste pharmaceuticals.
    i. Hazardous waste pharmaceuticals that are also controlled
substances. Under current regulations, any healthcare facility
generating or managing a RCRA hazardous waste pharmaceutical that is
also a controlled substance listed in Schedule II-V \54\ must comply
with the RCRA hazardous waste requirements, as well as the requirements
of the Controlled Substances Act and DEA regulations. Recently revised
DEA regulations to implement the Secure and Responsible Drug Disposal
Act of 2010 require that controlled substances be destroyed so that
they are ``non-retrievable.'' \55\ In the preamble to both the proposed
and final rules, DEA has stated that flushing alone will not meet DEA's
new non-retrievable standard.\56\ Stakeholders have told EPA that it is
expensive and difficult to incinerate controlled substances that are
also hazardous wastes under both DEA and EPA regulatory schemes. As a
result, healthcare facilities with hazardous waste pharmaceuticals that
are also controlled substances have often sewered on-site in order to
avoid the expense of complying with dual regulation that would apply if
they were incinerated. Due to difficulties associated with managing
these hazardous waste pharmaceuticals that are also controlled
substances, the Agency is proposing to conditionally exempt from RCRA
regulatory requirements those pharmaceuticals that are both a RCRA
hazardous waste and a DEA controlled substance, provided the hazardous
waste pharmaceuticals that are also DEA controlled substances are
combusted at a permitted or interim

status hazardous waste incinerator, or a permitted municipal solid
waste incinerator. A more detailed discussion of this exemption is
found in Section V.E.2 of this proposal, Conditional Exemption for
Hazardous Waste Pharmaceuticals that are also Controlled Substances.
---------------------------------------------------------------------------

    \54\ See 21 CFR 1308 for a complete list of controlled
substances.
    \55\ Final rule: September 9, 2014; 79 FR 53520.
    \56\ Proposed rule: December 21, 2012; 77 FR 75784, see page
75803; and final rule: September 9, 2014; 79 FR 53520, see page
53548).
---------------------------------------------------------------------------

    ii. Hazardous waste pharmaceuticals that are also medical wastes.
There are instances when a hazardous waste pharmaceutical will also
exhibit a biological hazard. The healthcare industry often refers to
pharmaceutical wastes that are both RCRA hazardous and a biological
hazard as ``dual wastes,'' and such wastes must be managed in
accordance with RCRA and state and/or local medical waste regulations.
As a result, the healthcare facility must send these dual wastes to a
hazardous waste treatment, storage and disposal facility that is also
permitted to accept medical wastes. Some examples of dual wastes
include un-administered syringes containing hazardous waste
pharmaceuticals (e.g., physostigmine) or IV bags containing residues of
a hazardous waste pharmaceutical that are attached to the tubing and
needles used to administer the pharmaceutical. The RCRA hazardous waste
pharmaceutical portion of these ``dual'' wastes are included within
these proposed management standards so that healthcare facilities can
obtain the benefits of this proposal, while ensuring the hazardous
waste portion of the waste is managed appropriately and ultimately
delivered to RCRA-permitted TSDFs. In addition, healthcare facilities
must still manage the biological hazard in accordance with state and/or
local medical waste requirements. EPA notes that autoclaving is not an
acceptable method of treating hazardous wastes that are also medical
waste. In addition, as discussed in Section V.E.3.c of this preamble,
EPA is proposing to conditionally exclude the residues of hazardous
waste pharmaceuticals remaining in fully dispensed syringes from RCRA
regulation.
    iii. Hazardous waste pharmaceuticals that contain a radioactive
component. Hazardous waste pharmaceuticals that also contain a
radioactive component subject to the Atomic Energy Act of 1954 (AEA)
(i.e., ``mixed waste'') are regulated by multiple agencies. The
hazardous waste component is regulated under EPA or the authorized
state RCRA programs, while either the Nuclear Regulatory Commission
(NRC) or the Department of Energy (DOE) regulates the radioactive
component of the waste under the AEA.\57\ Healthcare facilities would
be able to use this rule (if finalized) to comply with the hazardous
waste component for hazardous waste pharmaceuticals. Although we do not
believe that anything in this proposal is inconsistent with the AEA,
Sec.  1006(a) of RCRA states that if the RCRA requirements are
inconsistent with the AEA requirements, then the RCRA requirements do
not apply. Therefore, if a healthcare facility that manages hazardous
waste pharmaceuticals encounters specific RCRA requirements that are
inconsistent with specific AEA requirements, only the AEA requirements
would apply.
---------------------------------------------------------------------------

    \57\ The NRC regulates radioactive wastes generated by
commercial or non-DOE facilities, whereas DOE regulates radioactive
wastes generated by DOE facilities.
---------------------------------------------------------------------------

    As is discussed in the Joint NRC/EPA Guidance on Testing
Requirements for Mixed Radioactive and Hazardous Waste (62 FR 62079,
62085; November 20, 1997), an inconsistency occurs when compliance with
one statute or set of regulations would necessarily cause non-
compliance with the other statute or set of regulations. Relief from
the regulatory inconsistency would be provided by the AEA requirement
overriding the specific RCRA requirement. It is important to note,
however, that the determination of an inconsistency would relieve the
healthcare facility only from compliance with the specific RCRA
requirement(s) that is deemed inconsistent with the AEA requirement(s);
it would still be required to comply with all of the other hazardous
waste pharmaceutical management standards.
4. Management of Wastes Generated at Healthcare Facilities That Are Not
Included in the Scope of this Proposed Rule
    Wastes that are not included in the scope of this proposed rule
include non-hazardous wastes or non-pharmaceutical hazardous wastes.
Pharmaceutical wastes that are not listed or characteristic hazardous
wastes under RCRA Subtitle C may nonetheless pose some risks to public
health and the environment. These wastes are discussed further below.
    a. How should non-hazardous waste pharmaceutical be disposed? A
large portion of the pharmaceutical wastes generated at healthcare
facilities will not meet the definition of a RCRA hazardous waste under
RCRA Subtitle C. This proposal, therefore, does not require that
healthcare facilities manage these waste pharmaceuticals under the RCRA
subtitle C hazardous waste regulations, including this proposed rule.
However, a healthcare facility may choose to manage its solid and
hazardous waste pharmaceuticals together (as hazardous waste
pharmaceuticals) under these new proposed regulations. Because all
healthcare facilities operating under this subpart are regulated in the
same way regardless of quantity of pharmaceutical hazardous waste
generated, managing non-hazardous waste pharmaceuticals as hazardous
waste under this subpart would not affect the facility's hazardous
waste generator category. While not regulated by the federal RCRA
hazardous waste requirements, non-hazardous waste pharmaceuticals are
still considered solid wastes under the federal regulations and must be
managed in accordance with applicable federal, state and/or local
regulatory requirements.
    If a healthcare facility decides to segregate its hazardous and
non-hazardous pharmaceuticals, EPA recommends that healthcare
facilities follow the best management practices (BMPs) outlined in the
``Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare
Facilities in the United States'' (Practice Greenhealth, Revised August
2008) \58\ for the management, treatment, storage and disposal of non-
hazardous waste pharmaceuticals. The following summarizes the
recommended BMPs found in the Blueprint for various categories of
pharmaceutical wastes, including those wastes that possess hazardous
waste-like qualities yet are not regulated as hazardous waste under
RCRA Subtitle C.
---------------------------------------------------------------------------

    \58\ Published in 2006, the development of the original
Blueprint was funded by the Office of Solid Waste and Emergency
Response and managed by EPA Region 1. The 2008 revision of the
Blueprint was funded by the Healthcare Environmental Resource
Center. http://practicegreenhealth.org/sites/default/files/upload-files/pharmwasteblueprint.pdf
---------------------------------------------------------------------------

    i. Recommended BMPs for healthcare facilities managing non-
hazardous waste pharmaceuticals possessing hazardous waste-like
qualities. Currently, most pharmaceuticals are not regulated as RCRA
hazardous wastes when discarded by healthcare facilities. These ``non-
RCRA-hazardous'' pharmaceuticals can be divided into two categories:
those that possess hazardous waste-like qualities and those that do
not. As outlined in the Blueprint, there are pharmaceuticals that
possess hazardous waste-like qualities, but for various reasons, are
not regulated by the RCRA Subtitle C hazardous waste regulations. The
Agency supports the Blueprint's

recommendation of hazardous waste incineration as the BMP for
healthcare facilities and pharmaceutical reverse distributors
discarding pharmaceuticals that may possess hazardous waste-like
qualities, but are not regulated as RCRA hazardous waste. This
recommendation would apply to pharmaceuticals with more than one active
ingredient listed on the P- or U-lists,\59\ chemotherapeutic agents
characterized as bulk wastes,\60\ pharmaceuticals which meet the NIOSH
Hazardous Drug Criteria,\61\ pharmaceuticals listed in Appendix VI of
the OSHA Technical Manual,\62\ pharmaceuticals with LD50s <=50 mg/kg,
pharmaceuticals that are carcinogenic or endocrine disrupting
compounds, and vitamin/mineral preparations containing heavy metals.
---------------------------------------------------------------------------

    \59\ As noted in the comment after Sec.  261.33(d), the phrase
``commercial chemical product'' includes formulations in which the
P- or U-listed chemical is the sole active ingredient. Therefore,
formulations with more than one active ingredient do not meet the
specifications of the P- and U-listings even if one, two or all of
the active ingredients are listed on the P- and/or U-lists.
    \60\ The descriptions ``bulk'' and ``trace'' when applied to
chemotherapeutic wastes are industry terms and are not defined by
the federal RCRA regulations.