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[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Pages 58013-58092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23167]

[[Page 58013]]

Vol. 80

Friday,

No. 186

September 25, 2015

Part III

Environmental Protection Agency

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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

[[Page 58014]]

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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.

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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: fitzgerald.kristin@epa.gov or Josh 
Smeraldi, Office of Resource Conservation and Recovery (5304P), 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW., 
Washington, DC 20460; telephone number: 703-308-0441; email address: 
smeraldi.josh@epa.gov.

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

[[Page 58015]]

    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

[[Page 58016]]

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

[[Page 58017]]

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).
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    \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.
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    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.
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    \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.
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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 (/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

[[Page 58018]]

pharmaceuticals, as well as state-only hazardous waste 
pharmaceuticals.\17\
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    \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 HWPharmsWiki@epa.gov.
---------------------------------------------------------------------------

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,

[[Page 58019]]

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.
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    \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.
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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.
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    \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

[[Page 58020]]

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

[[Page 58021]]

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

[[Page 58022]]

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.
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    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

[[Page 58023]]

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-

[[Page 58024]]

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.
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    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\
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    \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.
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    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

[[Page 58025]]

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.
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    \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.
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    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\
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    \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.''
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    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.
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    \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.
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    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.
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    \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.''
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    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

[[Page 58026]]

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

[[Page 58027]]

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.
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    \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.
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    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.
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    \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.
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    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

[[Page 58028]]

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.
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    \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.
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    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

[[Page 58029]]

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.
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    \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).
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    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.
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    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

[[Page 58030]]

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 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.
    \61\ NIOSH List of Antineoplastic and Other Hazardous Drugs in 
Healthcare Settings 2012. http://www.cdc.gov/niosh/docs/2012-150/.
    \62\ OSHA Technical Manual, Section VI: Chapter 2, Appendix VI: 
2-1. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.
---------------------------------------------------------------------------

    ii. Recommended best management practices for other non-hazardous 
pharmaceutical wastes (i.e., those not possessing hazardous waste like-
qualities). As far as other non-hazardous waste pharmaceuticals (i.e., 
those not possessing hazardous waste-like qualities), disposing of non-
hazardous waste pharmaceuticals at healthcare facilities via drain 
disposal is strongly discouraged and not recommended by EPA. Therefore, 
EPA endorses the Blueprint's recommendation of municipal solid waste or 
medical waste incineration for any non-hazardous waste pharmaceuticals, 
even when they do not possess hazardous waste-like qualities. The 
potential risk remains for active pharmaceutical ingredients (APIs) to 
be released into the environment if municipal solid waste landfills or 
medical waste autoclaves are used for the purposes of pharmaceutical 
waste treatment and disposal. For example, autoclaves are designed to 
kill pathogens and do not achieve the temperatures required to destroy 
most APIs during the autoclaving process. As a result, there is the 
potential for wastewater containing APIs to be generated and discharged 
into the sewer. In addition, some limited studies have shown APIs 
present in landfill leachate collected in municipal solid waste 
landfill leachate systems.63 64 Typically, the collected 
landfill leachate is subsequently sent to wastewater treatment plants 
for treatment, but their treatment technologies are not designed to 
remove all APIs from the wastewater (See Section V.E.1 for more 
information regarding sewering and APIs).
---------------------------------------------------------------------------

    \63\ Barnes, K.K., Christenson, S.C., Kolpin, D.W., Focazio, 
M.J., Furlong, E.T., Zaugg, S.D., Meyer, M.T. and Barber, L.B. 
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants 
Within a Leachate Plume Downgradient of a Municipal Landfill. 
Groundwater Monitoring & Remediation, 24: 119-126.
    \64\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., 
Zaugg, S.D., and Meyer, M.T. (June 2009), Waste-Indicator and 
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water 
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental 
Contamination and Toxicology, V82.6:635-659.
---------------------------------------------------------------------------

    b. Non-pharmaceutical hazardous wastes. These proposed regulations 
will only pertain to hazardous waste pharmaceuticals. Therefore, other 
types of hazardous wastes generated at healthcare facilities that do 
not meet the definition of a hazardous waste pharmaceutical cannot be 
managed in accordance with these proposed regulations. For example, 
hazardous wastes generated in hospital laboratories or during cleaning 
and maintenance of the facility are not considered hazardous waste 
pharmaceuticals and are not included within the scope of this proposal. 
The generation of non-pharmaceutical hazardous wastes is often more 
routine and does not trigger the same concerns that healthcare 
facilities experience when managing hazardous waste pharmaceuticals.
    After a healthcare facility determines it is subject to this 
proposed rule and manages its hazardous waste pharmaceuticals under 
part 266, subpart P, it is no longer required to count the hazardous 
waste pharmaceuticals that it generates towards its generator category. 
As a result, the healthcare facility may experience a change in RCRA 
generator category for its non-pharmaceutical hazardous waste. For 
example, a healthcare facility may shift from being an LQG to a SQG or 
even CESQG by not counting its hazardous waste pharmaceuticals toward 
its generator category, especially when acute hazardous waste 
pharmaceuticals such as warfarin (brand name: Coumadin) no longer need 
to be counted. A shift in generator category, should it occur, would 
allow a healthcare facility to manage its non-pharmaceutical hazardous 
waste, such as hazardous waste from laboratories, according to the 
reduced generator requirements. It is important to note that only when 
a healthcare facility is managing its hazardous waste pharmaceuticals 
under the new proposed subpart does it have the benefit of not counting 
them towards its generator category (see Section VI. Implementation and 
Enforcement for further discussion).

C. What are the proposed standards for healthcare facilities that 
manage non-creditable hazardous waste pharmaceuticals?

    This section discusses the proposed management standards for 
healthcare facilities (except CESQGs) that manage non-creditable 
hazardous waste pharmaceuticals, which include the following:
    (1) Notification requirements for healthcare facilities managing 
non-creditable hazardous waste pharmaceuticals;
    (2) personnel training requirements for healthcare facilities 
managing non-creditable hazardous waste pharmaceuticals;
    (3) making a hazardous waste determination for non-creditable 
hazardous waste pharmaceuticals;
    (4) elimination of central accumulation area and satellite 
accumulation area requirements for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals;
    (5) container standards for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals;
    (6) labeling standards on containers for healthcare facilities 
managing non-creditable hazardous waste pharmaceuticals;
    (7) accumulation time limits for healthcare facilities managing 
non-creditable hazardous waste pharmaceuticals;
    (8) land disposal restrictions for non-creditable hazardous waste 
pharmaceuticals;
    (9) procedures for shipping non-creditable hazardous waste 
pharmaceuticals off-site from healthcare facilities;
    (10) procedures for managing rejected shipments of non-creditable 
hazardous waste pharmaceuticals from healthcare facilities;
    (11) reporting requirements for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals;
    (12) recordkeeping requirements for healthcare facilities managing 
non-creditable hazardous waste pharmaceuticals;
    (13) procedures for responses to releases by healthcare facilities 
managing non-creditable hazardous waste pharmaceuticals;

[[Page 58031]]

    (14) special requirements for long-term care facilities managing 
non-creditable hazardous waste pharmaceuticals;
    (15) conditions for healthcare facilities that accept hazardous 
waste pharmaceuticals from off-site CESQGs; and
    (16) a prohibition of sewering hazardous waste pharmaceuticals for 
all healthcare facilities; (see section V.E.1. of the preamble, Sewer 
Disposal Prohibition).
    The proposed management standards discussed in this section only 
apply to hazardous waste pharmaceuticals that are non-creditable 
hazardous waste pharmaceuticals (i.e., they are destined for a RCRA 
permitted or interim status TSDF). They do not apply to those hazardous 
waste pharmaceuticals that meet the definition of a ``potentially 
creditable hazardous waste pharmaceutical.'' Please refer to Section 
V.D for the proposed healthcare facility management standards for 
potentially creditable hazardous waste pharmaceuticals that are 
transported to reverse distributors for the processing of 
manufacturer's credit.
1. Notification Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    In order to address commenters' concerns from the 2008 
Pharmaceutical Universal Waste proposal that regulatory agencies are 
unaware of hazardous waste pharmaceutical management activities, EPA is 
proposing to require that a healthcare facility that does not qualify 
as a CESQG to submit a one-time notification as a ``healthcare 
facility'' to the appropriate EPA Regional Administrator. Healthcare 
facilities subject to 40 CFR part 266, subpart P will have to submit 
notification even if the healthcare facility has previously obtained an 
EPA identification number. The required notification will enable EPA 
and state regulatory agencies to identify the universe of healthcare 
facilities managing hazardous waste pharmaceuticals subject to the 40 
CFR part 266, subpart P requirements. In addition, having this 
information allows EPA and state environmental regulatory agencies to 
track healthcare facilities for enforcement and inspection purposes, 
ensuring the hazardous waste pharmaceuticals are managed in accordance 
with the regulations.
    At any point a healthcare facility's hazardous waste pharmaceutical 
generation may change due to waste minimization efforts or other 
reasons, causing the facility to legitimately decrease its total 
monthly hazardous waste generation enough to qualify as a CESQG. In 
this case, if the healthcare facility plans to withdraw from the 40 CFR 
part 266, subpart P requirements due to qualifying as a CESQG, it will 
be required to re-notify EPA of its choice to withdraw.
    Alternatively, if a healthcare facility determines that it is a 
CESQG,\65\ but does not want to keep track of the amount of hazardous 
waste generated and whether it is above or below the CESQG threshold 
limit, it can choose to operate under this proposed rule. By choosing 
to operate under this proposed rule, the CESQG healthcare facility must 
comply with all of the requirements and must submit the one-time 
notification that it is operating under 40 CFR part 266, subpart P. 
Healthcare facilities that are not CESQGs, however, are required to 
operate under 40 CFR part 266, subpart P for the management of their 
hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \65\ A generator is a CESQG if it generates less than or equal 
to 100 kg of hazardous waste per calendar month, and less than or 
equal to 1 kg of acute hazardous waste per calendar month and 1 kg of acute hazardous waste or >1000 kg of 
hazardous waste.
---------------------------------------------------------------------------

    The Agency is proposing that this notification occur via the RCRA 
Subtitle C Site Identification Form (EPA Form 8700-12; or Site 
Identification Form).\66\ EPA believes that notification via the Site 
Identification Form is the preferred approach for notification purposes 
for several reasons. First, both state environmental regulatory 
agencies and hazardous waste generators are familiar with the form, as 
it is the form currently used by hazardous waste generators to notify 
regulators of their RCRA Subtitle C activities. Second, as stated 
previously, the use of the Site Identification Form will allow for EPA 
and state regulatory agencies to monitor the healthcare facilities 
utilizing the new regulatory requirements. Lastly, public comments 
received on previous EPA actions (e.g., Academic Laboratories 
Rulemaking (73 FR 72912; December 1, 2008)) have indicated that 
notification via the Site Identification Form is the notification 
approach typically preferred by the regulated community. We are 
proposing that healthcare facilities can submit their notification as 
part of the Biennial Report, if the healthcare facility will be 
required to submit a Biennial Report due to its non-pharmaceutical 
hazardous waste. Otherwise, healthcare facilities are required to 
notify within 60 days of this new subpart becoming effective, or within 
60 days of becoming subject to this new subpart.
---------------------------------------------------------------------------

    \66\ For information on the current Site Identification Form, 
please see: http://www.epa.gov/wastes/inforesources/data/form8700/8700-12.pdf.
---------------------------------------------------------------------------

    If this notification requirement is finalized, the Site 
Identification Form will be modified by EPA in a separate action.\67\ 
Specifically, the Agency intends to amend the Site Identification Form 
by adding a section to the form for a healthcare facility to indicate 
the type of entity it is (e.g., a hospital, a doctor's office, a 
veterinary clinic, a pharmacy, an assisted living facility, etc.) and 
to indicate that it generates hazardous waste pharmaceuticals. The 
healthcare facility will no longer be required to identify on the Site 
Identification Form the specific types of hazardous waste 
pharmaceuticals it generates. The Agency also intends to add a checkbox 
to the section in order to allow a healthcare facility to indicate that 
its generator category is changing to a CESQG and it is no longer 
managing its hazardous waste pharmaceuticals according to 40 CFR part 
266, subpart P.
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    \67\ The Information Collection Request (ICR) for the Site 
Identification Form (87000-12) is updated every three years and must 
be approved by the Office of Management and Budget (OMB). These 
updates and OMB approvals are published in the Federal Register and 
are subject to public comment.
---------------------------------------------------------------------------

    The Agency does not anticipate that this proposed notification 
requirement will place any undue economic burden upon healthcare 
facilities or the environmental regulatory agencies that process these 
notifications (see the Regulatory Impact Analysis for the proposed rule 
in the rulemaking docket EPA-HQ-RCRA-2007-0932). In fact, under these 
proposed regulations, healthcare facilities would no longer need to 
count the hazardous waste pharmaceuticals managed under 40 CFR part 
266, subpart P towards a healthcare facility's generator category. As a 
result, EPA anticipates that many healthcare facilities will change 
their generator category to either a SQG or CESQG for their other, non-
pharmaceutical hazardous wastes. So while the notification requirement 
ensures that the environmental regulatory agencies are informed of all 
hazardous waste pharmaceutical management activities subject to the 40 
CFR part 266, subpart P requirements in their jurisdictions, the fact 
that some healthcare facilities will no longer qualify as LQGs will 
reduce the number of healthcare facilities in the LQG universe. Because 
LQGs are inspected more frequently than SQGs or CESQGs, EPA expects 
this could result in an overall decrease in burden for both

[[Page 58032]]

the healthcare facilities and the environmental regulatory agencies.
    The Agency is soliciting comment on the notification requirement 
for healthcare facilities, the method of notification via the Site 
Identification Form, and whether this notification requirement will 
result in any undue burden to either healthcare facilities or state 
environmental regulatory agencies.
2. Personnel Training Requirements for Healthcare Facilities Managing 
Non-Creditable Hazardous Waste Pharmaceuticals
    Under the current RCRA Subtitle C regulations, an LQG healthcare 
facility must provide RCRA training to its healthcare workers involved 
in the generation and/or management of hazardous waste. Under Sec.  
262.34(a)(4), LQGs are required to comply with the personnel training 
requirements for interim status TSDFs (which are found in Sec.  
265.16). These personnel training requirements include either classroom 
instruction or on-the-job training in RCRA and state that the facility 
must maintain training documents and records for each trained staff 
person. On the other hand, under current regulation, healthcare 
facilities that are SQGs must meet a performance-based standard when 
training their healthcare workers. This entails ensuring ``that all 
employees are thoroughly familiar with proper waste handling and 
emergency procedures relevant to their responsibilities during normal 
facility operations and emergencies'' (Sec.  262.34(d)(5)(iii)). For 
comparative purposes, healthcare facilities that are considered CESQGs 
do not have any personnel training requirements under the current 
federal regulations. Similarly, generators, including healthcare 
facilities, are not required to provide RCRA training to personnel that 
only work in satellite accumulation areas regulated under Sec.  
262.34(c). However, healthcare personnel that are involved in the 
generation of pharmaceutical waste must be familiar enough with the 
pharmaceuticals with which they are working to know when they have 
generated a hazardous waste so that it will be managed in accordance 
with the RCRA regulations.
    EPA believes that the LQG RCRA training requirement is excessive 
for healthcare workers who sporadically generate hazardous waste 
pharmaceuticals at healthcare facilities, but believe it is necessary 
to have some familiarity with the dangers that hazardous waste 
pharmaceuticals can pose. Therefore, the Agency is proposing healthcare 
facility-specific personnel training requirements that are akin to the 
training requirements for SQGs and small quantity universal waste 
handlers. Specifically, healthcare facilities managing their hazardous 
waste pharmaceuticals in accordance with the proposed healthcare 
facility standards must inform all employees that handle or have 
responsibility for generating and/or managing hazardous waste 
pharmaceuticals of the proper handling and emergency procedures 
appropriate to their responsibilities during normal facility operations 
and emergencies. This training information can be disseminated through 
verbal communication or through distribution of pamphlets or other 
documentation. However, a healthcare facility that is an LQG due to its 
non-pharmaceutical hazardous wastes may choose to continue to use its 
existing training program as an LQG so as not to have different 
training programs and that would be acceptable, as well.
    The Agency solicits comments on the personnel training requirements 
proposed in this document for healthcare facilities managing hazardous 
waste pharmaceuticals. Specifically, the Agency is seeking comment 
regarding the appropriateness of these personnel training requirements 
and if these requirements will be sufficient for communicating key 
procedures to healthcare workers that generate and/or manage hazardous 
waste pharmaceuticals.
    EPA is seeking comment on whether documentation of training is 
necessary in order to verify compliance with the training requirement. 
Based on the comments received, we may include a requirement in the 
final rule for documenting and retaining records of healthcare 
personnel training. Finally, the Agency wants to reiterate that these 
proposed personnel training requirements only apply to staff generating 
and/or managing hazardous waste pharmaceuticals. The training 
requirements of 40 CFR part 262 will continue to apply to staff 
generating and/or managing other types of hazardous wastes at the 
healthcare facility.
3. Making a Hazardous Waste Determination for Non-Creditable Hazardous 
Waste Pharmaceuticals
    Similar to the current RCRA Subtitle C generator requirements, 
healthcare facilities will still be required to make a hazardous waste 
determination on pharmaceutical wastes prior to managing them under the 
proposed cradle-to-grave standards. Therefore, when a healthcare 
facility generates a solid waste pharmaceutical, the healthcare 
facility must determine if the pharmaceutical waste is listed in 40 CFR 
part 261, subpart D and if it exhibits one or more of the four 
characteristics of hazardous waste identified in 40 CFR part 261, 
subpart C. However, unlike the existing generator requirements, the 
healthcare facility does not need to identify the specific waste codes 
applying to the pharmaceutical wastes. If the pharmaceutical waste is 
determined to be a hazardous waste, then the healthcare facility must 
manage the hazardous waste pharmaceuticals in accordance with these 
proposed requirements instead of 40 CFR part 262. Pharmaceutical wastes 
not meeting the definition of a hazardous waste (i.e., non-hazardous 
waste pharmaceuticals) must be managed in compliance with applicable 
federal, state and local regulations.
    EPA understands that healthcare facilities utilize various 
approaches when making hazardous waste determinations. For example, 
healthcare facilities may hire contractors to review their formularies 
and identify those pharmaceuticals that are hazardous wastes when 
discarded. These facilities may then identify hazardous waste 
pharmaceuticals at the pharmacy level, marking these pharmaceuticals 
with a special label so that healthcare personnel know how to properly 
dispose of the pharmaceutical when it becomes a waste. Other healthcare 
facilities may instruct personnel to dispose of all pharmaceutical 
wastes into one RCRA hazardous waste collection container. These 
facilities may then choose to manage all of the contents of the 
container as hazardous waste or they may choose to sort the hazardous 
waste portion from the non-hazardous waste pharmaceutical portion in 
the central accumulation area. Due to the various ways that healthcare 
facilities make the hazardous waste determination, the Agency is not 
proposing that a specific approach be utilized when making the 
determination, only that the facility performs the waste determination. 
However, healthcare facilities may choose to manage all of their 
pharmaceutical wastes as hazardous, and thus, if a healthcare facility 
chooses this approach, they would not need to make individual hazardous 
waste determinations, but would have made a generic decision that all 
of their waste pharmaceuticals are hazardous and manage them as 
hazardous waste pharmaceuticals in accordance with the proposed 
requirements in 40 CFR part 266, subpart P.

[[Page 58033]]

4. No Central Accumulation Area and Satellite Accumulation Area 
Requirements for Healthcare Facilities Managing Non-Creditable 
Hazardous Waste Pharmaceuticals
    Hazardous waste pharmaceuticals are generated at numerous locations 
across a healthcare facility. Under the current RCRA Subtitle C 
requirements, each location at the healthcare facility with a RCRA 
hazardous waste receptacle for the disposal of hazardous waste 
pharmaceuticals is considered a satellite accumulation area and is 
subject to volume accumulation limits and other requirements.\68\ Of 
particular concern regarding the satellite accumulation requirements 
for healthcare facilities is the one quart accumulation limit for acute 
hazardous wastes (i.e., P-listed wastes). Under the December 2008 
Pharmaceutical Universal Waste proposal, no accumulation areas, central 
or satellite, were proposed to be established for hazardous waste 
pharmaceuticals. This proposed approach was consistent with the current 
federal universal waste program, since facilities are not required to 
designate a special centralized area for the accumulation of universal 
wastes nor are they required to have satellite accumulation areas for 
universal wastes. Nevertheless, EPA understands that facilities that 
handle universal wastes will often accumulate their universal wastes 
within their 90- or 180-day hazardous waste accumulation areas.
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    \68\ See Sec.  262.34(c) for the satellite accumulation 
requirements. For additional information on satellite accumulation 
areas, please see the memorandum from Robert Springer to the EPA 
Regional RCRA Directors, ``Frequently Asked Questions about 
Satellite Accumulation Areas'' (RCRA Online #14703) http://
yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/
0AC9E15424B2897D8525770600609793/$file/14703.pdf.
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    For the reasons articulated in the Pharmaceutical Universal Waste 
proposal, the Agency has decided that a healthcare facility 
accumulating hazardous waste pharmaceuticals will not be subject to the 
satellite accumulation area regulations or the central accumulation 
area regulations (also sometimes called less than 90- or 180-day 
areas), but rather to the proposed accumulation time limits and 
container standards.
    A healthcare facility may choose to accumulate hazardous waste 
pharmaceuticals within its 90- or 180-day central accumulation area if 
it has one established for its other hazardous wastes as long as it 
maintains compliance with the proposed accumulation time limit and 
container requirements of 40 CFR part 266, subpart P. The Agency notes 
that even if the hazardous waste pharmaceuticals are accumulated in a 
90- or 180-day central accumulation area, these hazardous waste 
pharmaceuticals are not subject to the 90- or 180-day requirements. EPA 
solicits public comment on its decision to not require hazardous waste 
pharmaceutical-specific central and satellite accumulation area 
requirements.
5. Container Standards for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    The container standards discussed in this section apply to those 
containers used by healthcare facilities to accumulate, store and 
transport non-creditable hazardous waste pharmaceuticals.\69\ First, we 
would note that due to the relatively small quantities of hazardous 
waste pharmaceuticals that are typically accumulated and stored at a 
healthcare facility, the Agency understands that other types of waste 
management units, such as tanks, are not used for the management of 
waste pharmaceuticals. Therefore, we are only proposing standards for 
containers. However, the Agency solicits comment as to whether other 
types of waste management units are also used by healthcare facilities 
to accumulate and store hazardous waste pharmaceuticals and whether EPA 
should establish technical standards for other types of waste 
management units.
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    \69\ The container standards proposed do not apply to the 
various packaging, blister packs, bottles, vials, IV bags, etc., in 
which pharmaceuticals are stored prior to being dispensed or 
administered.
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    The Agency is proposing to require that healthcare facilities pack 
hazardous waste pharmaceuticals into containers that are structurally 
sound and that are compatible with the hazardous waste pharmaceuticals 
that will be contained within them. EPA intends this requirement to 
mean that containers used for holding hazardous waste pharmaceuticals 
must be in good condition, with no severe rusting, apparent structural 
defects, or deterioration. Containers also must not have any evidence 
of leakage, spillage or damage that could result in the release of 
waste under reasonably foreseeable circumstances. Furthermore, the 
Agency is proposing to require that incompatible wastes not be placed 
in the same container, unless the co-mingling of incompatible hazardous 
wastes is conducted in such a way that it does not have the potential 
to (1) generate extreme heat or pressure, fire or explosion, or violent 
reaction; (2) produce uncontrolled toxic mists, fumes, dusts, or gases 
in sufficient quantities to threaten human health; (3) produce 
uncontrollable flammable fumes or gases in sufficient quantities to 
pose a risk of fire or explosions; (4) damage the structural integrity 
of the facility or container containing the hazardous waste 
pharmaceuticals; or (5) through other like means threaten human health 
or environment. For example, the majority of a healthcare facility's 
non-creditable hazardous waste pharmaceuticals are likely organic in 
nature, and thus, compatible with each other and can be accumulated 
together, especially since they will most likely be incinerated once 
they are transported to a TSDF. However, some non-creditable hazardous 
waste pharmaceuticals, such as metal bearing wastes not containing 
sufficient organics, are prohibited from being incinerated (e.g., P012, 
arsenic trioxide). The hazardous waste pharmaceuticals that cannot be 
incinerated must be accumulated separately from organic wastes destined 
for incineration.
    The Agency believes that these technical standards, like similar 
technical standards that EPA has promulgated in Sec.  265.17 for 
interim status TSDFs, would ensure that hazardous waste pharmaceuticals 
are properly managed and would not be released into the environment, 
while at the same time providing flexibility to the healthcare facility 
in selecting those containers that are most appropriate for their 
situation.
    In addition to the proposed container standards, the Agency is also 
proposing that accumulation containers for hazardous waste 
pharmaceuticals be secured in a manner that prevents unauthorized 
access to the contents in order to prevent the pilfering of hazardous 
waste pharmaceuticals or inadvertent exposures to them. As we have 
noted previously, hazardous waste pharmaceuticals still retain 
considerable value and can easily be diverted for illicit purposes. To 
ensure this does not occur, we believe it is important to propose a 
requirement that would prevent the unauthorized access to the contents 
of these containers. EPA intends this requirement to be performance-
based and does not intend to propose prescriptive regulatory 
requirements for this standard. The Agency believes that healthcare 
facilities can choose to utilize containers that have built-in 
mechanisms to prevent access to their contents or can choose to store 
containers in locked storage lockers, closets or rooms where the public 
does not have access to the containers or their contents.

[[Page 58034]]

    The Agency is seeking comment on the appropriateness of the 
proposed container management standards. In addition, the EPA is 
soliciting comment on the proposed requirement for ensuring that the 
hazardous waste pharmaceuticals contained in collection containers 
remain secure.
6. Labeling Standards on Containers for Healthcare Facilities Managing 
Non-Creditable Hazardous Waste Pharmaceuticals
    During the period of accumulation and storage, the Agency is 
proposing that containers of hazardous waste pharmaceuticals be marked 
with the words ``Hazardous Waste Pharmaceuticals.'' The Agency is not 
proposing to require that the hazardous waste numbers (often referred 
to as hazardous waste codes) of the container's contents be listed on 
the label. The personnel at healthcare facilities that typically 
generate the hazardous waste pharmaceuticals will be healthcare workers 
(e.g., nurses). Healthcare workers are not usually intimately familiar 
with RCRA and its regulations and are primarily focused on patients and 
their health. In addition, while a healthcare facility may have an 
environmental compliance manager or environmental consultant that is 
knowledgeable about RCRA and its regulations and can make hazardous 
waste determinations, this individual cannot be present to assign a 
hazardous waste code and label the collection receptacle each time a 
pharmaceutical waste is generated. For these reasons, EPA does not 
believe it is necessary to require individual waste codes on the 
hazardous waste pharmaceutical collection container at the healthcare 
facility. The Agency is soliciting comment on the appropriateness of 
the proposed general labeling requirement. The Agency also requests 
comment on security concerns regarding having the word 
``pharmaceutical'' marked on the containers.
7. Accumulation Time Limits for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    Several hazardous waste pharmaceuticals are P-listed, acute 
hazardous wastes (e.g., nicotine, warfarin, etc.). Under current 
regulations, if a generator generates more than 1 kg of acute hazardous 
waste per calendar month or accumulates more than1 kg of acute 
hazardous waste at any time, the generator is regulated as an LQG. Due 
to this low generation/accumulation threshold associated with P-listed 
wastes, healthcare facilities are often LQGs. However, while healthcare 
facilities can generate enough P-listed waste to become LQGs, they 
often do not generate sufficient amounts of hazardous waste 
pharmaceuticals within the allowed accumulation period of 90 days to 
make off-site shipments using a hazardous waste transporter cost-
effective.
    Under the 2008 Pharmaceutical Universal Waste proposal, universal 
waste handlers would have had one year for accumulation of its 
hazardous waste pharmaceuticals in order to facilitate proper treatment 
and disposal. Commenters on the 2008 Universal Waste proposed rule 
indicated support for the one-year accumulation time limit. Thus, the 
Agency is proposing to allow healthcare facilities to accumulate 
hazardous waste pharmaceuticals for up to one year, without having 
interim status or a RCRA permit. As with Universal Waste, one year is 
an appropriate timeframe because it strikes a balance between allowing 
healthcare facilities enough time to accumulate amounts of hazardous 
waste pharmaceuticals to make it economically viable for transporting 
their hazardous waste pharmaceuticals off-site while ensuring that the 
hazardous wastes are not accumulated beyond the one year storage limit 
under the land disposal restrictions programs (see Sec.  268.50).\70\
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    \70\ See the preamble to the Universal Waste final rule: May 11, 
1995; 60 FR 25492 (page 25526).
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    Healthcare facilities will have various approaches to demonstrate 
the length of time that hazardous waste pharmaceuticals are accumulated 
on-site. For example, a healthcare facility can choose to mark the 
container label with the date that accumulation first began, maintain 
an inventory system that identifies dates when the hazardous waste 
pharmaceuticals were first accumulated, identify in the central 
accumulation area \71\ the earliest date that a hazardous waste 
pharmaceutical became a waste, or any other method that clearly 
demonstrates the length of time that the hazardous waste pharmaceutical 
has been accumulated from the date it became a hazardous waste. The 
Agency assumes that any accumulation for up to one year is for the 
purpose of facilitating proper treatment and disposal. EPA proposes to 
require that any healthcare facility needing a longer accumulation time 
for any unforeseen circumstances beyond the control of the healthcare 
facility (e.g., a recall or litigation) request an extension from the 
appropriate EPA Regional Administrator. This request must be sent in 
writing (electronic or paper) explaining the need for the extension, 
the approximate amount of hazardous waste pharmaceuticals accumulated 
beyond the one year, and the amount of extra time requested. An 
extension period will be granted at the discretion of the Regional 
Administrator on a case-by-case basis.
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    \71\ While the proposed rules do not require healthcare 
facilities to comply with the central accumulation requirements 
under 262.34, a healthcare facility may have a central accumulation 
area for the other hazardous wastes that it generates.
---------------------------------------------------------------------------

    Finally, the Agency reiterates that the one-year accumulation time 
limit only applies to a healthcare facility's non-creditable hazardous 
waste pharmaceuticals and does not apply to any other types of 
hazardous waste generated on-site or to potentially creditable 
hazardous waste pharmaceuticals. EPA solicits comment on the proposed 
accumulation time limit of one year in order to allow healthcare 
facilities to generate enough non-creditable hazardous waste 
pharmaceuticals for cost-effective shipment, and solicits comment on 
the proposed mechanism to request a time extension.
8. Land Disposal Restrictions for Non-Creditable Hazardous Waste 
Pharmaceuticals
    Similar to the current RCRA Subtitle C generator requirements, 
healthcare facilities must comply with the land disposal restrictions 
(LDR) prior to land disposal of the hazardous waste pharmaceuticals 
they generate. Since healthcare facilities are generators, even though 
they are not subject to the 40 CFR part 262 requirements for the 
management of hazardous waste pharmaceuticals, they must comply with 
the land disposal restrictions found at 40 CFR part 268. The land 
disposal restrictions are in place to ensure that toxic constituents 
present in hazardous waste are properly treated to reduce their 
mobility or toxicity before hazardous waste is placed into or onto the 
land (i.e., land disposed). With limited exceptions, hazardous waste 
must be treated by a RCRA permitted or interim status TSDF. Again, EPA 
notes that autoclaving is not an acceptable method of treating 
hazardous waste.
    In general, generators of hazardous waste assign the appropriate 
hazardous waste numbers codes to allow TSDFs to determine the specific 
treatment standard(s) for each prohibited waste. The Agency is 
proposing that healthcare facilities generating non-creditable 
hazardous waste pharmaceuticals do not have to assign hazardous waste 
codes to these wastes, but rather label them as ``hazardous waste 
pharmaceuticals''. They do, however, need to be aware that

[[Page 58035]]

while most of the hazardous waste pharmaceuticals are likely organic in 
nature and will be incinerated, some of their hazardous waste 
pharmaceuticals may not be suitable for incineration and therefore must 
be segregated from the organic wastes. The pharmaceutical hazardous 
wastes not suitable for incineration include characteristic metal 
wastes prohibited from being combusted because of the dilution 
prohibition of Sec.  268.3(c), as well as the listed wastes U151 
(mercury), U205 (selenium sulfide), and P012 (arsenic trioxide), unless 
they contain greater than 1% total organic carbon. In order to comply 
with the LDRs, healthcare facilities will need to segregate these 
wastes from the organic pharmaceutical hazardous wastes so that they 
can be properly treated by the TSDF. The Agency seeks comment on 
whether it is necessary to incorporate into the regulations a 
requirement to segregate these wastes and whether additional labeling 
requirements are necessary to identify the hazardous waste 
pharmaceuticals that are not suitable for incineration.
    Tables 2 through 4 list the hazardous waste pharmaceuticals with 
their hazardous waste codes and their LDR treatment standards.

[[Page 58036]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.000

[[Page 58037]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.001

[[Page 58038]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.002

    The organic hazardous waste pharmaceuticals (other than arsenic 
trioxide) may all be incinerated at RCRA permitted or interim status 
hazardous waste combustors. As noted in Tables 2-4, most of the organic 
wastes have a specified treatment standard of combustion (CMBST). The 
remaining seven organics (lindane, chloroform, m-cresol, 
dichlorodifluoro methane, trichloromonofluoromethane, phenacetin and 
phenol) have numerical treatment standards, such that no particular 
treatment technology is specified or required in order to achieve the 
numerical treatment standards. While these wastes may be incinerated, 
the incinerator residue (ash) must be analyzed for these seven organic 
constituents to demonstrate compliance with the LDR treatment standards 
before that ash can be disposed.
    As mentioned earlier, because this proposed rule does not require 
that healthcare facilities label their waste with the hazardous waste 
codes, the TSDF must always analyze the incinerator ash for these seven 
constituents--lindane, chloroform, m-cresol, dichlorodifluoro methane, 
trichloromonofluoromethane, phenacetin, and phenol--according to their 
waste analysis plan, as they could possibly be present in any shipment 
of organic hazardous waste pharmaceuticals.
    a. Alternative treatment standards considered. In their comments to 
the 2008 Universal Waste proposal, Environmental Technology Council 
(ETC) suggested revising the treatment standards for the organic 
hazardous waste pharmaceuticals that have numerical treatment standards 
to the specified treatment standard of

[[Page 58039]]

combustion.\72\ Specifying combustion would relieve the TSDFs from 
demonstrating compliance with the numerical treatment standards. EPA 
explored the feasibility of making combustion an alternative treatment 
standard for the seven organic hazardous waste pharmaceuticals that 
currently have numeric treatment standards. In fact, EPA notes that the 
numerical treatment standards were developed based on levels achieved 
through combustion. However, in order to allow maximum flexibility, EPA 
has indicated a preference for numerical treatment standards over 
specifying treatment standards whenever possible. Furthermore, it is 
not clear that pharmaceuticals would be the sole source of the seven 
organic constituents in question. Therefore, even if we proposed an 
alternative treatment standard of combustion for the seven organic 
pharmaceuticals, hazardous waste incinerators would still be required 
to test their ash for these constituents to demonstrate compliance with 
numeric treatment standards if they received the organics from another, 
non-pharmaceutical source.
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    \72\ See comment number 0125 in the docket for this rulemaking. 
EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    b. Incineration of mercury-containing hazardous waste 
pharmaceuticals. It is rare, but some pharmaceuticals contain mercury 
(e.g., thimerosal, a mercury-containing preservative). When discarded, 
a mercury-containing pharmaceutical would be a D009 hazardous waste if 
the leachate generated by the toxicity characteristic leaching 
procedure (TCLP), or if the pharmaceutical itself (when the waste 
contains = 0.2 mg/L mercury (see 
Sec.  261.24).\73\ As indicated in Table 2, a D009 hazardous waste with 
mercury content >= 260 mg/kg of total mercury and that also contains 
organics, must be treated by IMERC (incineration) or RMERC (mercury 
retorting). However, hazardous waste pharmaceuticals that are D009 are 
expected to have mercury content kg, in which case the 
treatment standards are numeric and treatment by RMERC or IMERC is not 
required. With numeric treatment standards, the generator has 
flexibility regarding which hazardous waste treatment method to use to 
meet the treatment standard. As explained previously, incineration of 
mercury-bearing hazardous waste with >1% total organic carbon is not 
considered impermissible dilution (see Sec.  268.3(c)) and therefore is 
an allowable form of treatment.
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    \73\ The Agency is not aware of any hazardous waste 
pharmaceuticals that would be considered U151 because mercury would 
have to be the sole active ingredient.
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    Emissions from combustion units that burn hazardous waste \74\ are 
regulated under RCRA and the Clean Air Act (CAA). The implementing 
regulations under these statutory authorities include emission limits 
for new and existing combustion units for mercury, semi-volatile metals 
(cadmium and lead), low volatility metals (arsenic, beryllium, and 
chromium), particulate matter, chlorinated dioxins and furans, other 
toxic organic compounds, hydrogen chloride and chlorine. The 
regulations also (1) specify when and how combustion sources must 
comply with the emission standards and operating requirements, (2) 
prescribe detailed monitoring requirements to show continuous 
compliance with the emission standards, and (3) prescribe performance 
testing requirements to demonstrate compliance with the emission 
standards (see 40 CFR part 63, subpart EEE).
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    \74\ Combustors that burn hazardous waste include the following 
types of combustion units: Incinerators, cement kilns, lightweight 
aggregate kilns, industrial boilers and process heaters, and 
hydrochloric acid production furnaces.
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    To ensure continuous compliance with the emission limits, hazardous 
waste combustors are required to establish limits on (1) the feedrate 
of metals (including mercury), chlorine, and (for some types of 
hazardous waste combustors) ash; (2) combustor operating parameters 
such as minimum combustion chamber temperature; and (3) operating 
parameters of the air pollution control device. For mercury, continuous 
compliance requirements would generally include a limit on the total 
feedrate of mercury in all feedstreams to the combustion unit, limits 
on the operation of a wet scrubber (depending on the species of mercury 
in the combustion gases, wet scrubbers can be efficient at removing 
mercury), and operating limits on the activated carbon injection or 
carbon bed system, if such systems are used.
    In addition, RCRA directs permitting authorities to impose 
additional terms and conditions on a site-specific basis as may be 
necessary to protect human health and the environment (see Sec.  
270.32(b)). Thus, if the mercury emission limits specified previously 
are not protective in an individual instance, the permit writer will 
establish permit limits that are protective.
    Nevertheless, EPA is aware that some stakeholders are concerned 
about the risks associated with incinerating mercury-bearing hazardous 
wastes and we encourage healthcare facilities and pharmaceutical 
reverse distributors to consider the use of treatment technologies 
other than incineration for meeting the numeric treatment standards for 
mercury-bearing hazardous waste pharmaceuticals. Thimerosal-containing 
pharmaceuticals are expected to be non-wastewaters as defined by Sec.  
268.2, because they have more than 1% total organic carbon. For low 
mercury non-wastewaters, the numeric treatment standard can be achieved 
by stabilization/solidification, either with or without subsequent 
encapsulation.\75\
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    \75\ EPA is not aware of any testing done to demonstrate the 
effectiveness of this treatment method specifically for thimerosal-
containing hazardous wastes, so vendors performing such treatment 
may need to do treatability studies to identify optimal use of 
stabilization/solidification treatment technologies.
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9. Shipments of Non-Creditable Hazardous Waste Pharmaceuticals Off-site 
From Healthcare Facilities
    The Agency is proposing to maintain the current RCRA Subtitle C 
tracking requirement by requiring that a hazardous waste manifest be 
prepared for each off-site shipment of non-creditable hazardous waste 
pharmaceuticals from healthcare facilities. Accordingly, each off-site 
shipment of hazardous waste pharmaceuticals must be transported to an 
interim status or permitted TSDF via a hazardous waste transporter. 
However, the Agency is proposing that for hazardous waste 
pharmaceuticals shipped by healthcare facilities, the RCRA hazardous 
waste codes do not need to be listed on the manifest. This is intended 
to accommodate the fact that healthcare providers generating the 
hazardous waste pharmaceuticals are generally unfamiliar with RCRA and 
are focused on providing healthcare to patients. One function of the 
hazardous waste codes is to determine the appropriate hazardous waste 
treatment standards under the land disposal restrictions (part 268). 
However, virtually all hazardous waste pharmaceuticals sent for off-
site treatment are sent to hazardous waste incinerators, even when the 
treatment standard does not require incineration. The fact that EPA is 
proposing to not require hazardous waste codes for shipping hazardous 
waste pharmaceuticals is not intended to alter or impact any Department 
of Transportation (DOT) requirements for the shipment of these 
hazardous wastes. For a more detailed discussion of these proposed 
requirements, as well as the basis for these requirements, please see 
Section V.F.1 of this document.

[[Page 58040]]

10. Rejected Shipment From Healthcare Facilities of Non-creditable 
Hazardous Waste Pharmaceuticals
    In rare circumstances, a healthcare facility may send its non-
creditable hazardous waste pharmaceuticals to a designated facility 
that is unable to manage the hazardous waste. For such situations, we 
are proposing that healthcare facilities follow the same procedures 
listed in 40 CFR part 262 (see Sec.  262.23(f)). Specifically, if a 
designated facility is unable to accept the hazardous waste 
pharmaceuticals, and it returns the hazardous waste pharmaceuticals to 
the healthcare facility, the healthcare facility must sign the manifest 
that was used to return the shipment, provide the transporter a copy of 
the manifest, send a copy of the manifest within thirty days to the 
designated facility that returned the shipment and retain a copy of the 
manifest for three years from the date of delivery of the returned 
shipment. EPA believes that it is appropriate to continue current 
practices for rejected shipments that are part of the generator 
regulations of 40 CFR part 262 because rejected shipments are 
relatively rare and the procedures currently used for rejected 
shipments is relatively straightforward. In addition, healthcare 
facilities should be familiar with these procedures already.
11. Reporting Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    The Agency is proposing that healthcare facilities managing non-
creditable hazardous waste pharmaceuticals have reporting requirements 
similar to SQGs s regulated under 40 CFR part 262--that is, the 
exception reporting requirement under Sec.  262.44(b) and the 
additional reporting requirement under Sec.  262.44(c). In addition, we 
are proposing that healthcare facilities that are LQGs would no longer 
be required to include their hazardous waste pharmaceuticals on their 
biennial report (BR). Each of these reporting requirements for 
healthcare facilities is discussed below.
    First, as part of the current RCRA Subtitle C generator 
requirements, healthcare facilities that are LQGs must submit a BR to 
the Regional Administrator by March 1st of every even numbered year 
(see Sec.  262.41). Among other requirements, the BR must include a 
description (EPA hazardous waste number and DOT hazard class) and 
quantity of each hazardous waste shipped off-site to a TSDF during each 
odd numbered year. If a healthcare facility is an LQG due to its non-
pharmaceutical hazardous waste, it will continue to be required to 
submit a BR. However, it need not include its hazardous waste 
pharmaceuticals in its BR. As discussed previously, the Agency is no 
longer requiring healthcare facilities to count hazardous waste 
pharmaceuticals when determining their generator category. Instead, all 
healthcare facilities, with the exception of CESQGs, will be subject to 
this proposed rule. The Agency has determined that it does not need the 
information to be included in the BR because this proposed rule will 
bring a consistent approach to managing pharmaceutical hazardous 
wastes. Nevertheless, the Agency is soliciting public comment on 
whether the Agency should require healthcare facilities--that is, all 
healthcare facilities subject to the 40 CFR part 266, subpart P 
requirements--to submit a BR, and if so, the type of information that 
should be included.
    Second, the Agency is proposing that healthcare facilities follow 
the same reporting procedures for exception reporting that generators 
operating under the 40 CFR part 262 must follow. We are proposing to 
incorporate the generator exception reporting procedures in this new 
subpart. Specifically, if a healthcare facility does not receive a copy 
of the hazardous waste manifest from the designated facility within 60 
days, the healthcare facility must submit to the EPA Regional 
Administrator a copy of the manifest with a statement that the 
healthcare facility did not receive confirmation of the hazardous waste 
pharmaceuticals' delivery along with an explanation of the efforts 
taken to locate the hazardous waste pharmaceuticals and the results of 
those efforts. Likewise, if a shipment of hazardous waste 
pharmaceuticals from a healthcare facility is rejected by the 
designated facility and it is shipped to an alternate facility and if 
the healthcare facility does not receive a signed copy of the hazardous 
waste manifest from the alternate facility within 60 days, it must 
submit to the EPA Regional Administrator a copy of the hazardous waste 
manifest with a statement that the healthcare facility did not receive 
confirmation of the hazardous waste pharmaceuticals' delivery along 
with an explanation of the efforts taken to locate the hazardous waste 
pharmaceuticals and the results of those efforts. Again, the Agency 
believes it is advantageous to use established procedures that should 
be familiar to healthcare facilities, especially given that rejected 
shipments are relatively rare.
    Finally, the Agency proposes that the Administrator may require 
healthcare facilities to furnish additional reports concerning the 
quantities and disposition of hazardous waste pharmaceuticals. This is 
already the case for generators operating under the 40 CFR part 262 
requirements. As with 40 CFR part 262, it is a codification of 
statutory authority under Sec. Sec.  2002(a) and 3002(a)(6) that 
provides the Agency some flexibility in what reports may be required. 
The Agency solicits public comment on the proposed reporting 
requirements for healthcare facilities managing their hazardous waste 
pharmaceuticals in accordance with the standards proposed in this 
document.
12. Recordkeeping Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    The Agency is proposing that healthcare facilities managing non-
creditable hazardous waste pharmaceuticals maintain records similar to 
the records that must be kept by generators regulated under 40 CFR part 
262 (see Sec.  262.40). Specifically, healthcare facilities must keep a 
signed copy of each hazardous waste manifest as a record for three 
years from the date that the non-creditable hazardous waste 
pharmaceutical was accepted by the initial hazardous waste transporter. 
If the healthcare facility is required to file an exception report 
because it does not receive a signed copy of the manifest from the 
designated facility within 60 days of the date that the hazardous waste 
pharmaceutical was accepted by the initial transporter, then the 
healthcare facility must keep a copy of the each exception report for a 
period of at least three years from the due date of the report.\76\ In 
addition, EPA is proposing that a healthcare facility must keep records 
of any test results, waste analyses or other determinations made on 
hazardous waste pharmaceuticals regarding which pharmaceuticals are 
hazardous wastes for three years from the date of the test, analysis, 
or other determination.
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    \76\ Sec.  262.40 requires that generators keep a copy of each 
BR for a period of at least three years from the due date of the 
report. However, since we are not requiring a healthcare facility to 
include its hazardous waste pharmaceuticals on its a BR, the Agency 
is also not including in subpart P a requirement that a BR be kept 
at the healthcare facility. If healthcare facility must submit a BR 
due to its non-pharmaceutical hazardous waste, the Sec.  262.40 
recordkeeping requirements will apply (see the discussion under 
Reporting Requirement for Healthcare Facilities Managing Non-
creditable Hazardous Waste Pharmaceuticals for the Agency's basis of 
not requiring healthcare facilities to include hazardous waste 
pharmaceuticals on the BR.

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[[Page 58041]]

    The Agency is also proposing that any of the retention periods be 
extended during the course of enforcement actions against any activity 
associated with hazardous waste pharmaceutical management or as 
requested by the Administrator to ensure that the appropriate records 
are available and can be reviewed as part of any enforcement action. 
The Agency solicits public comment on the proposed recordkeeping 
requirements for healthcare facilities managing their non-creditable 
hazardous waste pharmaceuticals in accordance with the standards 
proposed in this document.
13. Response to Releases by Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals
    For hazardous waste pharmaceuticals generated and managed by 
healthcare facilities under the proposed standards, the Agency is 
proposing basic release responses, including the requirement that 
healthcare facilities immediately contain all releases of, and other 
residues from, hazardous waste pharmaceuticals. In addition, this 
proposal would require healthcare facilities to determine whether any 
material, residue, or debris resulting from the release is or contains 
a hazardous waste pharmaceutical and, if so, to manage it under the 
management standards for hazardous waste pharmaceuticals proposed in 
this document. These proposed release response procedures are the same 
as those under the Universal Waste program (see Sec.  273.17 for small 
quantity universal waste handlers, and Sec.  273.37 for large quantity 
universal waste handlers). Commenters to the 1993 proposed rule that 
established the Universal Waste program overwhelmingly supported the 
release response measures (60 FR 25528; May 11, 1995). Thus, we believe 
it is appropriate to include it again in this proposal.
    Any releases of hazardous waste pharmaceuticals not cleaned up 
immediately would generally constitute illegal disposal, which may 
result in further action by EPA or an authorized state under RCRA. In 
addition, hazardous wastes under RCRA are included in the definition of 
hazardous substances for purposes of the Comprehensive Environmental 
Response Compensation, and Liability Act (CERCLA) (see CERCLA Section 
101(14) \77\). Thus, any releases into the environment of hazardous 
substances above the reportable quantity (RQ) thresholds must be 
reported under CERCLA (see CERCLA Section 103). That is, since 
hazardous waste pharmaceuticals are hazardous wastes and, hazardous 
substances under CERCLA, reporting for hazardous waste pharmaceutical 
releases is required when RQs are exceeded (see 40 CFR 302.4 for a list 
of RQs and hazardous substances). Such reports provide notification to 
the Agency (through the National Response Center) concerning releases 
into the environment and help inform whether EPA should take action, if 
necessary, under either RCRA or CERCLA.
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    \77\ http://www.epw.senate.gov/cercla.pdf.
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    The Agency solicits comment regarding the proposed standard for the 
response to releases of hazardous waste pharmaceuticals at healthcare 
facilities.
14. Long-Term Care Facilities Managing Non-Creditable Hazardous Waste 
Pharmaceuticals
    Long-term care facilities differ in one respect from other types of 
healthcare facilities subject to these proposed standards. Unlike 
hospitals, who own the pharmaceuticals they dispense to patients, many 
of the hazardous waste pharmaceuticals generated at long-term care 
facilities belong to the residents of the facility. That is, the 
pharmaceuticals are dispensed under the patient's name. However, as 
previously discussed in this preamble, EPA is proposing to no longer 
allow hazardous waste pharmaceuticals generated at long-term care 
facilities (as defined under this proposed regulation) to be eligible 
for the household hazardous waste exemption. As a result, long-term 
care facilities must manage all hazardous waste pharmaceuticals 
generated on-site, regardless of ownership, in accordance with these 
same proposed management standards for healthcare facilities. EPA 
understands that while long-term care facilities often maintain each 
individual's pharmaceuticals in a centralized location, such as a 
pharmaceutical cart, there are instances where some individuals may 
keep and self-administer their own pharmaceuticals. EPA is proposing 
that the long-term care facilities collect and manage all hazardous 
waste pharmaceuticals generated at their facilities in accordance with 
these proposed requirements. This requirement means that in addition to 
the hazardous waste pharmaceuticals kept in the centralized location, 
long-term care facilities will need to collect all other hazardous 
waste pharmaceuticals from individuals that self-administer these 
pharmaceuticals and manage them in accordance with these proposed 
standards, which, among other things, prohibits the sewering of 
hazardous waste pharmaceuticals. The Agency solicits comment on the 
extent to which long-term care facilities keep an inventory of the 
pharmaceuticals that individuals self-administer, as this would 
facilitate the collection of the hazardous waste pharmaceuticals for 
proper disposal.
    Although long-term care facilities would not be required under this 
rule to collect non-hazardous waste pharmaceuticals, or hazardous waste 
pharmaceuticals from the independent living portion of a continuing 
care facility, EPA recommends that long-term care facilities collect 
all waste pharmaceuticals to ensure proper management, avoid flushing, 
and minimize the potential for accidental poisonings, misuse or abuse. 
As discussed later in this preamble, DEA regulations govern the 
management of controlled substances (see Section V.E.2.a of the 
preamble for a discussion of DEA's 2014 final rule for the disposal of 
controlled substances and the implications of that rule and this 
proposed rule for long-term care facilities.\78\) Also discussed later 
in more detail, EPA is proposing to exempt from RCRA those hazardous 
waste pharmaceuticals that are also controlled substances, provided 
they are combusted at a permitted or interim status hazardous waste 
incinerator or permitted municipal solid waste incinerator and managed 
in compliance with applicable DEA regulations (see Section V.E.2 of the 
preamble for a detailed discussion of the exemption).
---------------------------------------------------------------------------

    \78\ DEA's final rule for disposal of controlled substances: 79 
FR 53520; September 9, 2104.
---------------------------------------------------------------------------

    The Agency solicits comment regarding this requirement, and 
specifically requests comment on the various approaches that long-term 
care facilities use, or could use in collecting hazardous waste 
pharmaceuticals from individuals that self-administer their 
pharmaceuticals.
15. Healthcare Facilities That Accept Hazardous Waste Pharmaceuticals 
From Off-Site Conditionally Exempt Small Quantity Generators (CESQGs) 
\79\
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    \79\ Unlike other sub-sections of Section V.C., which discusses 
the proposed standards for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals, this sub-section 
addresses both non-creditable and creditable hazardous waste 
pharmaceuticals.
---------------------------------------------------------------------------

    Typically, hazardous waste pharmaceuticals from healthcare 
facilities are transported either to a reverse distributor, if it is 
potentially creditable,\80\ or to a permitted or interim

[[Page 58042]]

status hazardous waste TSDF. However, stakeholders have informed EPA 
that in some cases, hazardous waste pharmaceuticals are transported to 
another healthcare facility. We are aware of at least two situations in 
which this is occurring. First, patients at long-term care facilities 
who receive their pharmaceuticals from an off-site long-term care 
pharmacy sometimes return their unused pharmaceuticals to the long-term 
care pharmacy.\81\ Upon return, the long-term care pharmacy sorts 
through the returned pharmaceuticals to determine whether they will be 
disposed or restocked for reuse. Due to many factors, such as Medicare 
regulations and the cost of the pharmaceutical as compared to the cost 
of repackaging and restocking, only a small fraction of the returned 
pharmaceuticals are restocked for potential reuse. One long-term care 
pharmacy estimated that approximately 10 percent of the pharmaceuticals 
it sends to long-term care facilities come back as returns.\82\ Some 
portion of the returns would be considered hazardous waste 
pharmaceuticals when discarded.\83\ In the second situation, the Army 
has established off-post health clinics to provide easier access to 
healthcare for military personnel, including veterans. The pharmacies 
at the off-post clinics receive their pharmaceutical products via 
couriers that deliver the pharmaceuticals from the on-post, main 
pharmacy. The off-post pharmacies also return their unused 
pharmaceuticals to the on-post, main pharmacy via courier.
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    \80\ Potentially creditable hazardous waste pharmaceuticals 
include pharmaceuticals that are: (1) Unused or un-administered, (2) 
unexpired or less than one year past the expiration date; or (3) in 
unopened or opened packaging or containers.
    \81\ DEA controlled substances can be returned to a long-term 
care pharmacy only if they are subject to a recall (see 21 CFR 
1317.85(a)).
    \82\ See notes from 11-15-12 site visit to Omnicare, Inc. in the 
docket for this proposed rule (EPA-HQ-RCRA-2007-0932).
    \83\ Due to the DEA regulations, a DEA registered long term care 
pharmacy may not accept returns of a controlled substances. DEA 
regulations define ``reverse distribute'' and reverse distributor'' 
in 21 CFR 1300.01. A pharmacy is not authorized to accept returns of 
controlled substances from patients or reverse distribute (see 21 
CFR 1301.13(e)(1)(iv)).
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    EPA data indicates that the majority of long-term care facilities 
are CESQGs \84\ and the Army has informed EPA that their off-post 
clinics are generally CESQGs, as well.\85\ The existing CESQG 
regulations do not allow a generator to send its hazardous waste off-
site to another hazardous waste generator, unless the receiving 
generator is also one of the seven types of facilities listed in Sec.  
261.5(f)(3) for acute hazardous waste or Sec.  261.5(g)(3) for 
hazardous waste, including municipal and non-municipal non-hazardous 
solid waste landfills. The Agency does not think that disposal in 
landfills is the best option for hazardous waste pharmaceuticals. 
Limited studies have shown active pharmaceutical ingredients are 
present in landfill leachate that is collected in municipal solid waste 
landfill leachate collection systems.86 87 Landfill leachate 
is then typically transported to a wastewater treatment plant for 
treatment; however, active pharmaceutical ingredients can pass through 
the treatment system and into our Nation's waters.
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    \84\ Under these proposed requirements, hazardous waste 
pharmaceuticals will not count towards a facility's generator 
category. Therefore, EPA expects that long-term care facilities will 
remain CESQGs, even though the Agency is proposing that all 
hazardous waste pharmaceuticals generated on the premises must be 
managed in accordance with these proposed requirements.
    \85\ See notes from 11-28-12 meeting with U.S. Army Institute of 
Public Health in the docket for this proposed rule (EPA-HQ-RCRA-
2007-0932).
    \86\ Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio, 
M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and Barber, L. B. 
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants 
Within a Leachate Plume Downgradient of a Municipal Landfill. 
Groundwater Monitoring & Remediation, 24: 119-126.
    \87\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., 
Zaugg, S.D., and Meyer, M.T. (June 2009), Waste-Indicator and 
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water 
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental 
Contamination and Toxicology, V82.6:635-659.
---------------------------------------------------------------------------

    EPA thinks it would be preferable to allow healthcare facilities 
that are CESQGs to send their hazardous waste pharmaceuticals to 
another healthcare facility rather than send it to a municipal or non-
municipal non-hazardous solid waste landfill. Therefore, EPA is 
proposing to allow healthcare facilities that are CESQGs operating 
under this subpart to send their hazardous waste pharmaceuticals to an 
off-site healthcare facility, without a hazardous waste manifest, 
provided four conditions are met. First, the receiving healthcare 
facility must be contracted to supply pharmaceutical products to the 
CESQG long-term care facility, or the CESQG healthcare facility and the 
receiving healthcare facility must both be under the control \88\ of 
the same person, as defined by Sec.  260.10 (e.g., the Army). Second, 
the receiving healthcare facility must be managing its hazardous waste 
pharmaceuticals in accordance with the regulations of this proposed 
rule.\89\ Third, the hazardous waste pharmaceuticals from the CEQSG 
must be managed by the receiving healthcare facility as hazardous waste 
pharmaceuticals in accordance with the regulations of this proposed 
rule once it arrives at the receiving healthcare facility. Fourth, the 
receiving healthcare facility must keep and maintain records of the 
hazardous waste pharmaceuticals received from the off-site CESQG 
healthcare facilities for three years from receipt of shipment. These 
conditions should ensure the proper management of the hazardous waste 
pharmaceuticals, in that once they are received by the healthcare 
facility, they are subject to the same management standards EPA is 
proposing for hazardous waste pharmaceuticals managed by healthcare 
facilities, while at the same time would not impose an undue burden on 
healthcare facilities that are CESQGs, especially since these 
healthcare facilities always have the option of sending their hazardous 
waste pharmaceuticals to a municipal or non-municipal solid waste 
landfill.
---------------------------------------------------------------------------

    \88\ For purposes of this provision, ``control'' means the power 
to direct the policies of the healthcare facility, whether by the 
ownership of stock, voting rights, or otherwise, except that 
contractors who operate facilities on behalf of a different person 
shall not be deemed to control such healthcare facility.
    \89\ This condition is only applicable if the receiving 
healthcare facility is also a CESQG, since healthcare facilities 
that are SQGs and LQGs must comply with the requirements proposed in 
40 CFR part 266 subpart P.
---------------------------------------------------------------------------

    The Agency solicits comment on this new provision under this 
subpart, including whether any additional conditions should be imposed. 
In recommending any additional conditions, the Agency requests that 
commenters provide their rationale for the additional condition(s), as 
well as why such additional condition(s) would not pose an undue burden 
on healthcare facilities that are CESQGs. In addition, the Agency 
solicits comment on whether it might be appropriate to allow 
facilities, other than those meeting the proposed definition of a 
healthcare facility, to accept hazardous waste pharmaceuticals from an 
off-site CESQG (e.g., a military medical logistics facility).

D. How does this proposed rule address healthcare facilities that 
accumulate potentially creditable hazardous waste pharmaceuticals prior 
to shipment to pharmaceutical reverse distributors?

1. Potentially Creditable Hazardous Waste Pharmaceuticals Are Not 
Products
    One difference between this proposal and the 2008 Pharmaceutical 
Universal Waste proposal is the proposed interpretation of how RCRA 
applies to pharmaceuticals that are returned to reverse distributors to 
obtain manufacturers' credit. Two previous agency policy memos set out 
EPA's existing understanding of the status of these ``creditable'' 
pharmaceuticals. The

[[Page 58043]]

first, a letter to Merck Sharp & Dohme in 1981, explained that 
pharmaceuticals sent for credit may be reclaimed and are not wastes 
since the decision to discard a particular material does not occur 
until after the product has been returned to the manufacturing 
plant.\90\ The second, a letter to BFI Pharmaceutical Services, Inc. in 
1991 states, ``to the extent that the materials involved are unused 
commercial chemical products with a reasonable expectation of being 
recycled in some way when returned, the materials are not considered as 
wastes until a determination has been made to discard them.'' \91\ In 
addition to these letters, EPA's 2008 Pharmaceutical Universal Waste 
proposal stated, ``Because unused or expired pharmaceuticals are 
returned (via the reverse distributor) for possible manufacturer's 
credit, they still have potential value to the pharmacy or hospital and 
are thus not considered wastes.'' \92\
---------------------------------------------------------------------------

    \90\ Alan Corson to Steven Wittner on May 13, 1981 (RCRA Online 
#11012) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/B630CD51DC85EDC58525670F006BCE84/
$file/11012.pdf.
    \91\ Sylvia Lowrance to Mark J. Schulz on May 16, 1991 (RCRA 
Online #11606) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/A3A7A7A8F297438B8525670F006BE5D8/
$file/11606.pdf.
    \92\ 73 FR 73525; December 2, 2008.
---------------------------------------------------------------------------

    In this action, we are proposing to modify EPA's position regarding 
the waste status of creditable pharmaceuticals. Because we understand 
that many participants in this sector have relied on the 
interpretations in the two letters and the 2008 Pharmaceutical 
Universal Waste preamble, we are providing notice of a change in EPA's 
position and providing an opportunity for public comment. Until this 
rule is final and effective, however, EPA's previous interpretations 
will continue to be in effect.
    In terms of the concept that returned pharmaceuticals have value 
and are not waste, EPA confirms the general rule under RCRA that 
materials that are discarded are solid wastes, regardless of the 
economics of the system in which those discarded materials are handled. 
Therefore, the fact that a material may have monetary value (e.g., 
through a manufacturer's credit) does not determine whether that 
material is a solid waste. Rather, the ``decision point'' on whether a 
pharmaceutical is a solid waste is when it has been discarded, or the 
decision has been made to discard the material. That is, a discarded 
pharmaceutical may retain value in the reverse distribution system, but 
still be considered a solid waste. Additionally, the economic value of 
hazardous waste can be one important consideration in determining 
whether a hazardous waste is legitimately recycled (see, for example, 
the discussion of Useful Economic Information in the 2008 Definition of 
Solid Waste final rule, 73 FR 84706-07, October 30, 2008) and therefore 
excluded from being a solid waste. The definition of legitimate 
recycling is codified at 40 CFR 260.43 and is discussed in the 2015 
Definition of Solid Waste final rule (80 FR 1694, January 13, 2015).
    Commenters to the 2008 Pharmaceutical Universal Waste proposal, the 
2014 Retail Notice of Data Availability (NODA), stakeholders, and 
pharmaceutical reverse distributors themselves have informed EPA that 
pharmaceuticals transported to reverse distributors to receive credit 
are rarely, if ever, repurposed, recycled, or reused. One commenter 
wrote, ``. . . EPA's belief that reverse distributors first arrange to 
transport and receive the drugs, and then determine whether the drugs 
are useful products or wastes, is pure fiction.'' \93\ Another 
commenter wrote, ``. . . the vast majority of the returned 
pharmaceuticals are to be collected for disposal or destruction once 
credit has been given.'' \94\ A third commenter wrote, ``. . . drugs 
sent through reverse distribution are not reused or recycled due to 
economic and safety reasons.'' \95\ Regulations pertaining to the 
repurposing of pharmaceuticals vary by state, as they are established 
by each state's Board of Pharmacy. However, stakeholders have 
overwhelmingly declared that state Boards of Pharmacy only allow 
pharmaceuticals to be repurposed under very narrow circumstances--that 
is, when a specific set of conditions are followed to ensure the 
viability and integrity of the pharmaceutical. The set of conditions 
vary by state; however, states have some restrictions in common when it 
comes to repurposing drugs. According to the National Conference of 
State Legislatures (NCSL), ``Virtually all [state] laws include some 
restrictions designed to assure purity, safety and freshness of the 
products. Unless otherwise noted, all programs require:
---------------------------------------------------------------------------

    \93\ Comment EPA-HQ-RCRA-2007-0932-0125.
    \94\ Comment EPA-HQ-RCRA-2007-0932-0068.
    \95\ Comment EPA-HQ-RCRA-2012-0426-0025.
---------------------------------------------------------------------------

    [ssquf] All donated drugs must not be expired and must have a 
verified future expiration date.
    [ssquf] Controlled substances, defined by the federal Drug 
Enforcement Administration (DEA) usually be excluded and prohibited.
    [ssquf] A state-licensed pharmacist or pharmacy to be part of the 
verification and distribution process.
    [ssquf] Each patient who is to receive a drug must have a valid 
prescription form in his/her own name.'' \96\
---------------------------------------------------------------------------

    \96\ Content is copied from http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx (accessed 
May 13, 2015).
---------------------------------------------------------------------------

    Thus, in most, if not all cases, pharmaceuticals that are 
transported back to a reverse distributor for credit are discarded by 
the reverse distributor.\97\ For that reason, the decision to send a 
pharmaceutical to a reverse distributor is essentially a decision to 
discard the pharmaceutical.
---------------------------------------------------------------------------

    \97\ Any facility, including a pharmaceutical manufacturer 
engaged in processing pharmaceutical hazardous waste for 
facilitation or verification of manufacturer's credit would be 
considered a pharmaceutical reverse distributor under the proposed 
rule with respect to those operations, and would be subject to the 
proposed regulations for pharmaceutical reverse distributors.
---------------------------------------------------------------------------

    Therefore, EPA is proposing to reinterpret its position such that 
the decision to send a pharmaceutical to a reverse distributor is the 
point at which a decision has been made to discard the pharmaceutical. 
As a result, once the decision is made to send a hazardous waste 
pharmaceutical to a reverse distributor, it is a solid waste at the 
healthcare facility. In this document, EPA is proposing to define the 
term ``potentially creditable hazardous waste pharmaceutical.'' A 
portion of the potentially creditable pharmaceuticals at healthcare 
facilities that are transported to reverse distributors will likely 
meet the definition of hazardous waste. Of the set of pharmaceuticals 
that are hazardous wastes, only ``potentially creditable'' hazardous 
waste pharmaceuticals may be transported to a reverse distributor for 
manufacturer's credit (see definition Section V.A.3).
    The Agency notes that the management standards discussed below 
pertain only to potentially creditable hazardous waste pharmaceuticals 
that are managed via reverse distribution and do not apply to the 
reverse distribution or reverse logistics systems that may exist for 
other consumer products. In addition to the standards discussed in this 
section, EPA is proposing standards for shipping potentially creditable 
hazardous waste pharmaceuticals to pharmaceutical reverse distributors 
as well as associated recordkeeping (see Section V.F.2. of the 
preamble).
2. Hazardous Waste Determination for Potentially Creditable Hazardous 
Waste Pharmaceuticals
    As with non-creditable hazardous waste pharmaceuticals discussed

[[Page 58044]]

previously, a healthcare facility must determine which potentially 
creditable pharmaceuticals are listed or characteristic hazardous 
wastes, in order to determine which potentially creditable 
pharmaceuticals are subject to regulation under this subpart. 
Potentially creditable hazardous waste pharmaceuticals must be managed 
under this subpart, while pharmaceuticals that do not meet the 
definition of hazardous waste but are potentially creditable, do not 
have to be managed under this subpart. However, a healthcare facility 
may choose to manage all of its potentially creditable pharmaceuticals 
(both hazardous and non-hazardous) as potentially creditable hazardous 
waste pharmaceuticals while accumulating on-site and when shipping off-
site. If a healthcare facility chooses this approach, it would not need 
to make individual hazardous waste determinations, but would have made 
a generic decision that all of their potentially creditable waste 
pharmaceuticals are hazardous and manage them as potentially creditable 
hazardous waste pharmaceuticals in accordance with the proposed 
requirements in 40 CFR part 266, subpart P.
3. Accumulation Time, Container Management, and Labeling for 
Potentially Creditable Hazardous Waste Pharmaceuticals at Healthcare 
Facilities
    Typically, EPA requires specific management standards for 
containers that hold hazardous waste. However, potentially creditable 
hazardous waste pharmaceuticals appear to pose lower environmental risk 
of release than patient care hazardous waste pharmaceuticals or 
traditional industrial hazardous waste. The risk of release is lower 
for several reasons. First, potentially creditable hazardous waste 
pharmaceuticals that are prepared for shipment to a reverse distributor 
are usually in their original containers as well as outer packaging, 
providing two layers of protection from leaks or spills.\98\ Second, 
potentially creditable hazardous waste pharmaceuticals are typically 
generated in the pharmacy area of a healthcare facility where there is 
restricted access, creating a layer of security for these 
pharmaceuticals. Third, EPA has been informed that it is common 
practice at healthcare facilities for potentially creditable 
pharmaceuticals that are destined for a reverse distributor to be taken 
from the shelves of the pharmacy periodically and promptly boxed for 
off-site shipment. EPA anticipates that this relatively quick timing is 
largely driven by the economic value of the manufacturer's credit for 
the returned pharmaceuticals. Therefore, because of the lower risk 
these pharmaceuticals pose, EPA is not proposing specific management 
standards for healthcare facilities that accumulate containers of 
potentially creditable hazardous waste pharmaceuticals. For the same 
reasons, we also are not proposing a limit on how long healthcare 
facilities may accumulate containers of potentially creditable 
hazardous waste pharmaceuticals. EPA requests comment on the assumption 
that healthcare facilities promptly remove potentially creditable 
hazardous waste pharmaceuticals from pharmacy shelves and send them to 
reverse distributors. EPA asks for comment on whether the expectation 
of credit provides sufficient incentive to ensure that the hazardous 
waste pharmaceuticals will be managed appropriately or whether it is 
necessary to establish management standards and/or a maximum time limit 
for the accumulation of potentially creditable hazardous waste 
pharmaceuticals prior to off-site shipment.
---------------------------------------------------------------------------

    \98\ See 73 FR 73529; December 2, 2008.
---------------------------------------------------------------------------

    In the 2008 Pharmaceutical Universal Waste proposal, EPA 
specifically solicited comment on whether stakeholders have knowledge 
of problems with mixing incompatible pharmaceuticals during 
accumulation. In response, one commenter indicated that there were no 
issues encountered with the compatibility of pharmaceuticals during 
storage.\99\ Since then, a 2011 article by Charlotte Smith states, 
``oxidizers, acids, and bases also are incompatible, but they occur 
infrequently as finished dosage forms.'' \100\ It is important to note 
that the accumulation of some potentially creditable hazardous waste 
pharmaceuticals, such as liquids and aerosols, may pose more of a risk 
than solid pills due to possible spillage or leakage. However, EPA 
believes that the small quantities in which the liquid and aerosol 
potentially creditable hazardous waste pharmaceuticals are generated, 
along with the DOT packaging requirements (49 CFR parts 173, 178, and 
180), would likely obviate these risks. In addition, to further 
mitigate the potential for spillage or leakages, as a best management 
practice, EPA encourages healthcare facilities to place the original 
containers and packaging containing liquids and aerosols 
pharmaceuticals in separate individual containers, such as a sealed 
storage bag before placing them in the container that will be shipped.
---------------------------------------------------------------------------

    \99\ Commenter #EPA-HQ-RCRA-2007-0932-0091.
    \100\ Charlotte Smith, RPH, MS; Managing Pharmaceutical Waste: A 
New Implementation Blueprint; Pharmacy Practice News, Special 
Edition, 2011.
---------------------------------------------------------------------------

    EPA also is proposing not to require specific labeling standards 
for containers holding potentially creditable hazardous waste 
pharmaceuticals, while they accumulate on-site. EPA does not want to 
deter the practice of co-mingling potentially creditable hazardous 
waste pharmaceuticals with potentially creditable non-hazardous waste 
pharmaceuticals since both are typically transported to a reverse 
distributor together.
    In addition, due to concerns regarding diversion of 
pharmaceuticals, EPA believes that it is safer not to call attention to 
the fact that these containers hold pharmaceuticals. Unlike floor waste 
or patient care pharmaceutical waste, or most hazardous waste, the 
hazardous waste pharmaceuticals returned to a reverse distributor often 
have high street value that makes them susceptible to diversion. Thus, 
EPA is not proposing to require a label for potentially creditable 
hazardous waste pharmaceuticals during accumulation at a healthcare 
facility. The Agency seeks comment on its proposal not to require 
specific accumulation, container management or labeling standards for 
potentially creditable hazardous waste pharmaceuticals that will be 
transported to a reverse distributor, including no specific labeling 
standards for containers holding potentially creditable hazardous waste 
pharmaceuticals on-site prior to shipment off-site.

E. What are the proposed novel prohibitions, exemptions and other 
unique management requirements for hazardous waste pharmaceuticals?

1. Sewer Disposal Prohibition
    a. Regulatory background on the domestic sewage exclusion. Under 
RCRA and the Subtitle C hazardous wastes regulations, if a material is 
not a solid waste, then it cannot be considered a hazardous waste. 
Under Sec.  261.4(a)(1)(ii) of the RCRA regulations, ``Any mixture of 
domestic sewage and other wastes that passes through a sewer system to 
a publicly-owned treatment works for treatment'' is not a solid waste 
for purposes of Subtitle C regulation. This exclusion was finalized by 
EPA on May 19, 1980, based on the reasoning that ``Mixed waste streams 
that pass through sewer systems to publicly-owned treatment works 
(POTW's) will be subject to controls under the Clean

[[Page 58045]]

Water Act. The Agency's construction grants program provides financial 
assistance for the proper treatment of these wastes. In addition, the 
Agency's pretreatment program provides a basis for EPA and the local 
communities to ensure that users of sewer and treatment systems do not 
dump wastes in the system that will present environmental problems'' 
(45 FR 33097).
    In 1984, Congress enacted the Hazardous and Solid Waste Amendments 
(HSWA) to the Solid Waste Disposal Act (SWDA), as amended by RCRA. HSWA 
included a new Section 3018, entitled Domestic Sewage. This section 
directed EPA to do two things with respect to the 261.4(a)(1)(ii) 
exclusion for mixtures of domestic sewage and other wastes: (1) Submit 
a Report to Congress (RTC) that describes the types, size and number of 
generators which dispose of such wastes in this manner, the types and 
quantities of wastes disposed of in this manner, and identify 
significant generators, wastes and waste constituents not regulated 
under existing Federal law or regulated in a manner sufficient to 
protect human health and the environment; and (2) based on the report, 
revise the existing regulations that are necessary to ``ensure that 
substances . . . which pass through a sewer system to a publicly owned 
treatment works are adequately controlled to protect human health and 
the environment.''
    EPA submitted its Report to Congress on February 7, 1986 (Domestic 
Sewage Study). Subsequent to the Report to Congress, EPA issued an 
advance notice of proposed rulemaking (ANPR) on August 22, 1986 (51 FR 
30166); a response to comments on the ANPR on June 22, 1987 (52 FR 
23477); a notice of proposed rulemaking (NPR) on November 23, 1988 (53 
FR 47632); and a final rule on July 24, 1990 (55 FR 30082). That final 
rule prohibits the discharge of pollutants which create a fire or 
explosion hazard in the POTW, which includes, but is not limited to, 
wastestreams with a closed cup flashpoint of less than 140 degrees 
Fahrenheit or 60 degrees Celsius using the test methods specified in 40 
CFR 261.21'' (55 FR 30087). Although the exclusion for mixtures of 
domestic sewage and other wastes is found under the RCRA regulations in 
Sec.  261.4(a)(1)(ii), the sewer ban of liquid ignitable hazardous 
wastes (i.e., with the hazardous waste code D001) was established under 
40 CFR 403.5(b)(1), which is under the Clean Water Act (CWA) 
regulations. The Agency seeks comment on whether it would be helpful to 
incorporate in 40 CFR 261.4(a)(1)(ii), a cross-reference to the CWA 
regulations prohibiting the sewering of liquid ignitable hazardous 
wastes.
    b. Prevalence of flushing in lieu of hazardous waste management. In 
the preamble to the July 1990 final rule, EPA stated its intent ``to 
carefully review the effect of this rule and promulgate in the future 
any additional regulations that experience reveals are necessary to 
improve control over hazardous waste and other industrial user 
discharges to POTWs'' (55 FR 30084). Since then, studies have found 
that many healthcare facilities, particularly long term-care 
facilities, use drain disposal as a routine disposal method for 
pharmaceutical wastes in lieu of collection and shipment off-site for 
management. For example,
     A 2008 study of 59 long-term care facilities showed that 
46 percent of the long-term care facilities dispose of their 
pharmaceuticals by dumping them down the drain.\101\
---------------------------------------------------------------------------

    \101\ Kansas State University. January 31, 2008. Nancy J. 
Larson. Pharmaceutical Waste Outreach Project.
---------------------------------------------------------------------------

     A 2003 King County, Washington survey of healthcare 
facilities showed that the vast majority of liquids, and nearly half of 
the pills, were disposed of down the drain.\102\
---------------------------------------------------------------------------

    \102\ King County Pharmaceutical Waste Survey Final Report. King 
County, Washington. April 2003.
---------------------------------------------------------------------------

     In a study by The Albany Medical Center, funded by an EPA 
Pollution Prevention Grant, the author states, ``up to now, toilet 
wasting has been the common practice for drug wasting by patient care 
staff.'' \103\
---------------------------------------------------------------------------

    \103\ The Albany Medical Center, October 29, 2009, Russell F. 
Mankes, Progress Report on the Source Reduction Demonstration 
Project, EPA Grant #X9-97256506-0.
---------------------------------------------------------------------------

     In a detailed study about the waste management practices 
within the healthcare industry, EPA's Office of Water also found that 
sewering of waste pharmaceuticals was common practice.\104\
---------------------------------------------------------------------------

    \104\ Health Services Industry Study: Management and Disposal of 
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
---------------------------------------------------------------------------

     EPA staff from the Office of Research and Development 
(ORD) have published numerous articles on the subject of active 
pharmaceutical ingredients (APIs) in the environment. One such paper 
states that ``unit-packaged pills are probably not frequently disposed 
via toilets, whereas liquids are probably routinely poured down 
drains,'' although the authors acknowledge that ``gaining an 
understanding of the types and quantities of APIs introduced directly 
and purposefully to the environment by the disposal of unwanted, 
leftover drugs has been more problematic because of a dearth of 
comprehensive or reliable data.'' \105\
---------------------------------------------------------------------------

    \105\ Ruhoy and Daughton; Beyond the medicine cabinet: An 
analysis of where and why medications accumulate; Environment 
International 34(2008) 1157-1169.
---------------------------------------------------------------------------

    c. Inadequacy of POTW treatment to remove pharmaceuticals. Under 
the Clean Water Act (CWA), EPA establishes national regulations (called 
effluent limitations guidelines and pretreatment standards) to reduce 
discharges of pollutants from industries to surface waters and POTWs. 
However, there are currently no national effluent limitations or 
pretreatment standards that apply to discharges of pharmaceuticals by 
healthcare facilities to POTWs. Furthermore, traditional wastewater 
treatment operations implemented in the 1970s and 1980s at POTWs are 
designed to remove conventional pollutants, such as suspended solids 
and biodegradable organic compounds. They are not designed to remove 
pharmaceuticals that are present in discharges from medical and 
veterinary facilities. While some POTWs may have implemented advanced 
treatment technologies at their facilities, these technologies are also 
not designed to remove pharmaceuticals. EPA released a study in 2009 in 
which over 100 chemicals (including some pharmaceuticals) were analyzed 
in the influent and effluent at nine POTWs.\106\ Although it was a 
limited study and difficult to generalize the results to all POTWs, it 
does indicate that the capabilities of treatment technologies currently 
employed by POTWs does not include treatment to remove APIs.\107\ In 
addition, as stated in the Health Services Industry study, ``synthetic 
compounds, such as pharmaceuticals, are often manufactured to be 
resistant to metabolic transformation. As a result, some pharmaceutical 
compounds that are present in the influent to POTWs may pass through 
treatment systems at conventional POTWs and discharge to receiving 
waters.'' \108\
---------------------------------------------------------------------------

    \106\ EPA, Occurrence of Contaminants of Emerging Concern in 
Wastewater from Nine Publicly Owned Treatment Works, August 2009; 
EPA-821-R-09-009.
    \107\ Eggen RI, Hollender J, Joss A, Sch[auml]rer M, Stamm C, 
``Reducing the Discharge of Micropollutants in the Aquatic 
Environment: The Benefits of Upgrading Wastewater Treatment Plant.'' 
Environmental Science and Technology 2014, 48(14) 7683-7689.
    \108\ Health Services Industry Study: Management and Disposal of 
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
---------------------------------------------------------------------------

    d. Adverse impacts to human health and the environment due to 
pharmaceuticals in the environment.

[[Page 58046]]

The pharmaceuticals entering the environment, through flushing or other 
means, are having a negative effect on aquatic ecosystems and on fish 
and animal populations. The Regulatory Impact Analysis for this 
proposed rulemaking summarizes the scientific literature with regard to 
ecological effects (see the Regulatory Impact Analysis in the docket 
for this proposed rule EPA-HQ-RCRA-2007-0932). The scientific research 
with regard to human health effects due to pharmaceuticals in the 
environment is still ongoing. Nevertheless, the important features and 
risks of the problem can be summarized as follows: \109\
---------------------------------------------------------------------------

    \109\ A. Ginebreda et al, Environmental risk assessment of 
pharmaceuticals in rivers: Relationships between hazard indexes and 
aquatic macroinvertebrate diversity indexes in the Llobregat River 
(NE Sapin). Environ Int. (2009), doi:10.1016/j.envint.2009.10.003.
---------------------------------------------------------------------------

    (1) Pharmaceuticals are intrinsically bioactive compounds; 
therefore, they are potentially able to impact living systems.
    (2) There is a continuous and worldwide increase in their use and, 
thus, on their subsequent input into the environment.
    (3) Many of the hundreds of frequently prescribed pharmaceuticals 
are known for targeted effects and adverse off-target side effects, a 
problem that can be exacerbated by interactive effects during therapy 
involving co-administration.
    e. Banning sewering of hazardous waste pharmaceuticals. Given the 
demonstrated negative ecological effects and the potential for negative 
human health effects, EPA is proposing to impose a sewer ban on all 
hazardous waste pharmaceuticals managed by healthcare facilities and 
pharmaceutical reverse distributors that are subject to this proposed 
rule--that is, they are prohibited from disposing of pharmaceuticals 
that are listed hazardous waste and/or exhibit one or more of the four 
hazardous waste characteristics (i.e., ignitability, corrosivity, 
reactivity, or toxicity) by putting them down a drain (e.g., sink, 
toilet, or floor drain).
    In addition, while healthcare facilities that are CESQGs are 
generally not subject to this proposed rule, EPA is proposing that the 
sewer ban of hazardous waste pharmaceuticals also apply to healthcare 
facilities that are CESQGs. The vast majority of healthcare facilities 
are CESQGs (84 percent). Some particular types of healthcare facilities 
have an even larger proportion of CESQGs: Over 94 percent of dental 
offices are CESQGs, and 94 percent of continuing care retirement 
communities are CESQGs (see the Regulatory Impact Analysis in the 
docket for this proposed rule EPA-HQ-RCRA-2007-0932.
    EPA is concerned that these smaller healthcare facilities are more 
likely to dispose of their hazardous waste pharmaceuticals via the 
sewer. EPA estimates that there are more than 145,000 healthcare 
facilities that are CESQGs. Given this large number, the combined 
impact of sewer disposal by healthcare facilities that are CESQGs has 
an even greater potential to provide a substantial impact on the 
environment, as well as human health.
    EPA solicits comment on EPA's proposal to ban the sewer disposal of 
hazardous waste pharmaceuticals at all healthcare facilities, including 
healthcare facilities that are CESQGs that generate such wastes. As 
part of its solicitation of comments, the Agency especially requests 
comment on the risk-risk tradeoffs inherent in prohibiting sewer 
disposal, which extends the life cycle of pharmaceutical waste, 
resulting in additional opportunities for diversion and increasing the 
possibility of inadvertent exposures for certain workers (and possibly 
even patients or visitors) as a tradeoff for a reduction in aquatic 
risks. EPA also solicits comment on whether the ban on sewer disposal 
should be limited to those healthcare facilities that are currently 
LQGs and SQGs, and not extended to CESQGs.
    Under 40 CFR 403.12(p) of the CWA regulations, industrial users 
that discharge a substance to a POTW that, if otherwise disposed of, 
would be a hazardous waste, must notify in writing the POTW, the EPA 
Regional Waste Management Division Director and State hazardous waste 
authorities. POTWs should be made aware that under this proposal, if 
made final, the notifications they receive from healthcare facilities 
will no longer include hazardous waste pharmaceuticals since the 
healthcare facilities will be prohibited from sewering their hazardous 
waste pharmaceuticals.
    We note that EPA's proposed ban on sewering hazardous waste 
pharmaceuticals is consistent with other federal and state actions. For 
example, the Drug Enforcement Administration (DEA) has finalized new 
regulations to implement the Secure and Responsible Drug Disposal Act 
of 2010 (September 9, 2014; 79 FR 53520). DEA's new regulations require 
a ``non-retrievable'' method of destruction of controlled substances. 
The preambles to DEA's proposed and final rules state that flushing 
does not meet the non-retrievable standard for destruction.\110\ 
According to the preamble of the DEA final rule, DEA received 20 
comments supporting their position against flushing controlled 
substances.\111\ The comments supporting the prohibition against 
sewering came from states, regional and local hazardous waste 
management programs, recycling associations, non-governmental 
organizations (NGOs), trade associations and environmental 
organizations. Many of these commenters noted that wastewater treatment 
systems do not eliminate many of the drugs that are flushed into the 
sewers and requested that DEA clearly state in the regulatory language, 
not just preamble, that sewering is not allowable as a means of 
destruction.
---------------------------------------------------------------------------

    \110\ Proposed rule: December 21, 2012; 77 FR 75784 (see page 
75803) and Final rule: September 9, 2014; 79 FR 53520 (see page 
53548).
    \111\ September 9, 2014; 79 FR 53520 (see page 53548).
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    In addition, three states and the District of Columbia have taken 
action to limit the sewering of pharmaceuticals and a third has 
introduced a bill. In 2009, Illinois passed the Safe Pharmaceutical 
Disposal Act, which prohibits healthcare facilities from flushing any 
unused medication into public sewers or septic systems.\112\ In 2012, 
New Jersey passed a similar law that prohibits healthcare facilities 
from discharging prescription medications into public sewers or septic 
systems.\113\ In 2002, California banned the use of lindane in 
pharmaceuticals after it found that lindane was adversely impacting 
wastewater quality. The authors of the paper ``Outcomes of the 
California Ban on Pharmaceutical Lindane: Clinical and Ecologic Impacts 
state that ``This is the first time that a pharmaceutical has been 
outlawed to protect water quality.'' \114\ After researching and 
documenting environmental benefits of the ban, the authors conclude, 
``This ban serves as a model for governing bodies considering limits on 
the use of lindane or other pharmaceuticals.'' And the District of 
Columbia has promulgated municipal regulations, effective January 1, 
2011, that prohibits healthcare facilities from flushing pharmaceutical 
products.\115\ The Connecticut legislature has also considered a bill 
to ban the discharge of medication into public or private waste water 
collection systems or septic

[[Page 58047]]

systems, although it has not yet become law.\116\
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    \112\ Illinois Public Act 096-0221.
    \113\ Nicknamed Bateman's Law, after Senator Christopher ``Kip'' 
Bateman (R-Somerset) that sponsored the legislation.
    \114\ Humphreys, et al. Environmental Health Perspectives. 2008 
March; 116(3) 297-302.
    \115\ Title 22-B Chapter 5 Safe Disposal of Unused 
Pharmaceuticals in Health Care Facilities.
    \116\ State of Connecticut General Assembly, January Session 
2013, Raised Bill No. 6439. An Act Concerning the Disposal and 
Collection of Unused Medication.
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    Finally, we would note that although the sewer ban is limited to 
pharmaceuticals that are RCRA hazardous wastes, EPA strongly recommends 
as a best management practice to not sewer any waste pharmaceutical 
(i.e., hazardous or non-hazardous), except when sewering is 
specifically directed by FDA guidance (as noted on pharmaceutical 
packaging).\117\
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    \117\ http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf.
---------------------------------------------------------------------------

    For household pharmaceutical waste, we refer the public to the 
guidelines developed by the U.S. Office of National Drug Control Policy 
(ONDCP), the FDA, and EPA for the disposal of unwanted household 
pharmaceuticals. In summary, these guidelines are as follows:
    (1) Use a drug take-back event or program, when available;
    (2) Dispose in household trash, after mixing the unwanted medicines 
with an undesirable substance such as kitty litter or coffee grounds 
and placing in a sealed container; and
    (3) Only if the drug label specifically instructs you to, flush the 
unwanted medicine down the toilet.\118\
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    \118\ http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf.
---------------------------------------------------------------------------

2. Conditional Exemption for Hazardous Waste Pharmaceuticals That Are 
Also Controlled Substances
    When a pharmaceutical that is discarded is both a hazardous waste 
and a controlled substance, its management and disposal is regulated 
under both the RCRA Subtitle C hazardous waste regulations, which is 
under EPA's or the authorized state's purview, and the Controlled 
Substances Act (CSA) and its implementing regulations, which is under 
DEA's purview. EPA understands that only a handful of pharmaceuticals 
are in common usage that are both hazardous waste and controlled 
substances and therefore subject to dual regulation by both EPA and the 
DEA. These are identified in Table 5:
[GRAPHIC] [TIFF OMITTED] TP25SE15.003

    Chloral hydrate, U034, is the only dually regulated hazardous 
waste/controlled substance that is a listed hazardous waste. It is 
listed for toxicity (note that EPA's U034 listing includes chloral 
hydrate, see memo dated April 6, 1998; Brandes to Knauss, RCRA Online 
#14175). On the other hand, the remaining four dually regulated 
hazardous wastes/controlled substances in common use are considered 
hazardous because they exhibit the characteristic of ignitibility 
(D001). However, the active ingredient is not ignitable, but these 
particular forms of the pharmaceuticals are ignitable because they are 
prepared in ignitable solutions, such as alcohol.
    EPA is aware of three additional hazardous waste pharmaceuticals 
that are DEA controlled substances, but it is our understanding that 
they are no longer in common usage, although there may be legacy 
supplies remaining in healthcare facilities. See Table 6.

[[Page 58048]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.004

    Similarly, as noted in Table 7, phentermine is a controlled 
substance, but the medical form is a phentermine salt, and the salts 
are no longer considered to be within the scope of the P046 listing 
(see memo dated February 17, 2012; from Devlin to RCRA Division 
Directors, RCRA Online #14831).
[GRAPHIC] [TIFF OMITTED] TP25SE15.005

    EPA requests comment on whether these are, indeed, the only 
pharmaceuticals in common usage that are regulated both as DEA 
controlled substances, and when discarded, RCRA hazardous waste.
    Common practices that healthcare facilities have used in the past 
in order to comply with the DEA regulations for destroying controlled 
substances include sewering and incineration. However, DEA's new 
regulation requires that controlled substances must be destroyed, such 
that they are ``non-retrievable.'' As discussed previously, the 
preambles for DEA's proposed and final rules state that flushing will 
not meet their new non-retrievable standard, a position which EPA fully 
supports. However, EPA is concerned that flushing will continue to be 
used by healthcare facilities for eliminating their controlled 
substances. In part, this concern is due to a 2009 EPA report which 
concluded, ``controlled substances are the pharmaceuticals most 
commonly poured down the drain, especially the partially-used IVs 
containing controlled substances.'' \119\ In addition, stakeholders 
have informed EPA that it is expensive and difficult to manage 
controlled substances that are also hazardous wastes under both DEA and 
EPA regulatory schemes and therefore the unintended consequence is that 
they are often sewered on-site in order to avoid the expense of 
complying with dual regulation en route to incineration.
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    \119\ Pathways for Environmental Releases of Unused 
Pharmaceuticals, October 12, 2009, Memo from ERG to EPA, EPA-HQ-OW-
2008-0517-0518.

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

[[Page 58049]]

    EPA wants to eliminate the flushing of pharmaceuticals in order to 
reduce potential environmental contamination. Sewering hazardous wastes 
that are ignitable (D001) is already banned and EPA is now proposing to 
eliminate the sewering of all other hazardous waste 
pharmaceuticals.\120\ To eliminate duplicative regulation and thereby 
further reduce the incidence of flushing, EPA is proposing to 
conditionally exempt from RCRA Subtitle C regulation those hazardous 
wastes that are also DEA controlled substances. Specifically, EPA is 
proposing that hazardous wastes that are also controlled substances 
will be exempt from all RCRA Subtitle C requirements, including 40 CFR 
part 266, subpart P, provided they meet two conditions: (1) They are 
combusted at a permitted large or small municipal waste combustor or a 
permitted or interim status hazardous waste combustor (incinerator or 
cement kiln), and (2) they are managed and disposed of in compliance 
with all applicable DEA regulations for controlled substances.
---------------------------------------------------------------------------

    \120\ See 40 CFR 403.5 for specific pretreatment prohibitions.
---------------------------------------------------------------------------

    The first condition is to ensure that the controlled substances are 
destroyed in an environmentally protective manner by a high-temperature 
combustor, such as a large or small municipal waste combustor or a 
permitted or interim status hazardous waste combustor (incinerator or 
cement kiln). The majority of the hazardous wastes that are also 
controlled substances are hazardous because they exhibit the 
characteristic of ignitability. The best demonstrated available 
technology (BDAT) developed for ignitable hazardous waste under the 
LDRs includes combustion (see Sec.  268.40). In addition, although 
chloral hydrate (U034) is listed because of its toxicity, its BDAT is 
also combustion. Therefore, in an effort to eliminate the sewering of 
these dually regulated hazardous wastes/controlled substances, and 
because combustion of these pharmaceuticals is a suitable technology 
for destruction, EPA is proposing to allow the few hazardous wastes 
pharmaceuticals that are also controlled substances to be combusted at 
municipal solid waste combustors, although as noted previously, a 
hazardous waste incinerator (permitted or interim status) would also be 
allowed.
    We realize that DEA may allow a technology other than combustion to 
be used to destroy controlled substances. However, if the RCRA 
hazardous waste pharmaceuticals that are DEA controlled substances are 
exempt from RCRA, the other destruction technologies may lack 
environmental controls and permits. Therefore, combustion of the 
hazardous wastes/controlled substances, which requires permitting, 
operating and monitoring standards, is a condition of the exemption. 
EPA requests comment on whether there are additional technologies that 
would be appropriate to include for the destruction of hazardous waste 
pharmaceuticals that are also controlled substances. Under this 
proposal, if DEA allows a technology other than incineration for the 
destruction of controlled substances, it would be allowed only for DEA 
controlled substances, but not for those that are also RCRA hazardous 
wastes.
    The second condition is to ensure that dually regulated hazardous 
wastes/controlled substances are managed under another rigorous 
regulatory program since they will not be managed in accordance with 
the RCRA Subtitle C regulations. Although developed for different 
reasons, both EPA's hazardous waste and DEA's controlled substance 
regulatory programs are designed to track the regulated material from 
cradle to grave. DEA regulations have requirements similar to EPA's 
hazardous waste manifest. In particular, in order to ship a schedule II 
controlled substance, a DEA registrant must submit a DEA Form 222 to 
the supplier of the schedule II controlled substance. The DEA Form 222 
is a numerically controlled form issued by the DEA to authorized 
registrants, containing certain pre-printed information. The supplier 
must indicate on the DEA Form 222, the quantity of packages shipped and 
the date the packages were shipped. Like a hazardous waste manifest, a 
copy of Form 222 must accompany the shipment and it must be kept by 
both the supplier and purchaser for at least two years (copies of 
manifests must be kept for three years). Suppliers and distributors may 
utilize the electronic version of the DEA Form 222, which requires the 
same information and retention period. Similarly, DEA Schedule III, IV 
and V controlled substances must be accompanied by an invoice, which 
also must include a detailed inventory of the contents shipped. A copy 
of the invoice must also be retained by the supplier and purchaser of 
the controlled substances for a period of two years. EPA believes that 
the DEA tracking and shipping requirements are sufficient to act in 
lieu of the RCRA hazardous waste manifest and hazardous waste 
transporter requirements. EPA requests comment on this assessment.
    DEA has previously stated that controlled substance 
``pharmaceutical wastage'' may be disposed of in accordance with 
applicable federal, state, and local laws, regulations, and healthcare 
facility policies, to include sewering or putting down the drain.\121\ 
The term ``pharmaceutical wastage'' refers to leftover, unadministered 
pharmaceuticals (``e.g., some of the substance remains in a vial, tube, 
transdermal patch, or syringe after administration but cannot or may 
not be further utilized'' \122\). EPA is proposing that the few 
hazardous waste pharmaceuticals that are also controlled substances 
would be exempt from RCRA, but only on the condition that they are 
incinerated at a permitted hazardous waste or municipal solid waste 
incinerator and managed in accordance with DEA regulations. As a 
result, if pharmaceutical wastage is both hazardous waste and 
controlled substance it would not be allowed to be sewered; it would 
have to be incinerated. Prior to incineration, the pharmaceutical 
wastage would be exempt from RCRA and could be collected in a container 
at the healthcare facility. As an alternative, we request comment on 
whether to allow the sewering of the pharmaceutical wastage for the 
five hazardous wastes that are also controlled substances. We are 
concerned, however, that this alternative approach will lead to the 
sewering of all pharmaceutical wastage as healthcare providers are 
unlikely to keep track of which hazardous waste pharmaceuticals are 
allowed to be sewered and which are not. We request comment on these 
approaches for pharmaceutical wastage and request data on the impact on 
healthcare facilities of not allowing pharmaceutical wastage to be 
sewered.
---------------------------------------------------------------------------

    \121\ See DEA letter to registrants re: clarifying disposal of 
pharmaceutical wastage dated Oct 17, 2014; http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf.
    \122\ Ibid.
---------------------------------------------------------------------------

    a. Long-term care facilities and the DEA final rule. As discussed 
previously, EPA is proposing that hazardous waste from long-term care 
facilities will no longer be considered exempt as household hazardous 
waste. Instead it will need to be managed as regulated hazardous waste. 
This interpretation will apply to all the hazardous waste generated by 
a long-term care facility, not just its hazardous waste 
pharmaceuticals, although the Agency expects that much of the hazardous 
waste generated by long-term care facilities consists of hazardous 
waste pharmaceuticals. However, there are

[[Page 58050]]

two exceptions. First, hazardous waste pharmaceuticals that are also 
controlled substances will not be subject to RCRA, provided they meet 
two conditions: (1) They are combusted at a permitted large or small 
municipal waste combustor or a permitted or interim status hazardous 
waste combustor (incinerator or cement kiln), and (2) they are managed 
and disposed of in compliance with all applicable DEA regulations for 
controlled substances. Second, as discussed previously, EPA estimates 
that only 28% of long-term care facilities generate hazardous waste 
pharmaceuticals and of those, 85% generate small enough quantities of 
hazardous waste that they will qualify as CESQGs and will be subject to 
the reduced regulatory requirements of 40 CFR 261.5, and only the sewer 
ban provision of this new subpart.\123\
---------------------------------------------------------------------------

    \123\ 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.
---------------------------------------------------------------------------

    DEA's new regulations to implement the Secure and Responsible Drug 
Disposal Act of 2010 are expected to help alleviate the problem that 
long-term care facilities face when discarding controlled substances. 
DEA's new regulations allow retail pharmacies and hospital/clinics with 
an on-site pharmacy that are DEA registrants to modify their 
registrations and become ``collectors'' to place collection receptacles 
at long-term care facilities (or at the retail pharmacy or hospital/
clinic with an on-site pharmacy) for the collection of controlled 
substances from ultimate users (i.e., consumers).
    Under the new DEA regulations, long-term care facilities have three 
options, two of which are new, for managing their patients' controlled 
substances. First, if a DEA registered retail pharmacy or hospital/
clinic with an on-site pharmacy places a collection container at a 
long-term care facility, the staff from the long-term care facility may 
place the patients' controlled substances in the collection 
receptacles. Second, although long-term care facilities will not be 
able to conduct collection events for their patients' controlled 
substances for mail-back programs, they will be allowed to assist 
patients who choose to use a mail-back program for their own controlled 
substances, on an individual-by-individual basis. And third, law 
enforcement will continue to be allowed to pick up patients' controlled 
substances for disposal. With these changes to DEA's regulation, long-
term care facilities can now dispose of patients' controlled substances 
in a more environmentally protective way. Because we are proposing that 
hazardous waste pharmaceuticals that are also controlled substances are 
conditionally exempt from RCRA, these wastestreams may also be managed 
in any of these three ways allowed by DEA, provided the waste is 
managed to meet the conditions of the RCRA conditional exemption.
    The new DEA regulations do not mandate the placement of collection 
receptacles or patient participation in mail-back programs or take-back 
events. However, if long-term care facilities are prohibited from 
disposing of pharmaceuticals down the toilet or drain under RCRA (and 
as a method of destruction under DEA regulations), then the only way 
for patients at long-term care facilities to lawfully dispose of DEA 
controlled substances that are also RCRA hazardous wastes would be 
through participation in one of DEA's collection methods. Long-term 
care facilities are allowed to place patients' hazardous waste 
pharmaceuticals that are controlled substances in the DEA collection 
receptacles; the other hazardous waste pharmaceuticals generated by 
long-term care facilities must be managed under the proposed RCRA 
management standards for healthcare facilities. However, we note that 
if the long-term care facility is a CESQG, we are proposing as an 
acceptable method of disposal of the long-term care facility's 
hazardous waste pharmaceuticals would be to place them in a DEA 
collection receptacle, even if they are not controlled substances (see 
Sec.  266.504(b)). DEA already allows controlled substances to be co-
mingled with non-controlled substances. Therefore, EPA believes it is 
consistent to allow CESQG hazardous waste pharmaceuticals that are not 
controlled substances to be placed in DEA collection receptacles with 
controlled substances. EPA believes that management of CESQGs' 
hazardous wastes as DEA controlled substances is preferable to 
management as municipal solid waste because it provides greater 
protection to patients, visitors and workers at long-term care 
facilities to have the hazardous waste pharmaceuticals in DEA 
collection receptacles rather than in the regular trash. See Table 8 
for a summary of the intersection of RCRA and DEA regulations for the 
disposal of hazardous waste pharmaceuticals at long-term care 
facilities:

                          Table 8--RCRA & DEA Regulations at Long-Term Care Facilities
----------------------------------------------------------------------------------------------------------------
                                                                 Regulatory requirements
Types of pharmaceutical waste at long- -------------------------------------------------------------------------
         term care facilities                                      DEA Authorized collection methods allowed for
                                                   RCRA                      patients' pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Hazardous Waste Pharmaceuticals that    Conditionally exempt from  Yes.
 are also Controlled Substances.         RCRA.
Hazardous Waste Pharmaceuticals that    .........................  .............................................
 are not Controlled Substances.
if LTCF is a CESQG....................  261.5 and sewer ban......  Yes.
if LTCF is not a CESQG................  Part 266, subpart P......  No.
----------------------------------------------------------------------------------------------------------------

    b. Household hazardous waste collected in DEA authorized collection 
receptacles. In response to questions that EPA has received since the 
DEA rule was published, we are taking this opportunity to clarify the 
current RCRA regulatory status of the pharmaceuticals collected in DEA 
authorized collection receptacles. DEA's regulations allow the co-
mingling of controlled substances and non-controlled substances in its 
collection receptacles. In some instances, the pharmaceuticals that are 
collected by retail pharmacies and law enforcement in DEA authorized 
collection receptacles may contain pharmaceuticals that are RCRA 
hazardous waste. However, as household wastes, these hazardous waste 
pharmaceuticals would be excluded from regulation by

[[Page 58051]]

Sec.  261.4(b)(1) because the exclusion applies even when the household 
hazardous wastes are collected. It is important to note that in order 
to maintain the exclusion, a retail pharmacy (or other DEA authorized 
collector pharmacy) can use the DEA authorized collection receptacle to 
collect waste generated only at households and brought to the store for 
collection. The hazardous waste generated by the retail pharmacy and 
store, including hazardous waste pharmaceuticals, are not excluded 
household wastes under RCRA and may not be placed in the DEA authorized 
receptacle.\124\ Furthermore, states generally regulate non-hazardous 
waste and they may have licensing or permitting requirements for the 
collection of solid waste. Because EPA would like to see the use of DEA 
authorized collection receptacles become widespread, we encourage 
states to streamline any requirements that may create a barrier to the 
use of the collection receptacles.
---------------------------------------------------------------------------

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

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

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

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

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

3. Management of Residues in Pharmaceutical Containers
    a. Regulatory background. Over the years, EPA has received numerous 
inquiries regarding the regulatory status of various types of 
containers that once held pharmaceuticals that are considered hazardous 
waste when discarded because of the hazardous waste residue in the 
containers. Stakeholders have been particularly concerned about 
containers that once held pharmaceuticals that are on the ``P-list'' of 
acutely hazardous commercial chemical products in Sec.  261.33(e) 
because a generator becomes an LQG if it generates more than 1 kg of 
acute hazardous waste per calendar month or accumulates more than 1 kg 
of acute hazardous waste at any time.\127\ The current regulatory 
status of acute and non-acute commercial chemical product residues 
remaining in a container are specifically addressed in Sec.  261.33:
---------------------------------------------------------------------------

    \127\ Additionally, acute hazardous wastes are included on the 
F-list of Sec.  261.31; however none of those acute hazardous wastes 
are pharmaceuticals.
---------------------------------------------------------------------------

    The following materials or items are hazardous wastes if and when 
they are discarded or intended to be discarded . . .
    (c) Any residue remaining in a container or in an inner liner 
removed from a container that has held any commercial chemical product 
or manufacturing chemical intermediate having the generic name listed 
in paragraphs (e) or (f) of this section, unless the container is empty 
as defined in Sec.  261.7(b). [emphasis added]
    According to Sec.  261.7(b)(1), there are two ways a container that 
held a non-acute hazardous waste can be considered ``empty'':
    A container or an inner liner removed from a container that has 
held any hazardous waste, except a waste that is a compressed gas or 
that is identified as an acute hazardous waste listed in Sec.  261.31 
or Sec.  261.33(e) of this chapter is empty if:
    (i) All wastes have been removed that can be removed using the 
practices commonly employed to remove materials from that type of 
container, e.g., pouring, pumping, aspirating, and
    (ii) No more than 2.5 centimeters (one inch) of residue remain on 
the bottom of the container or inner liner, or
    (iii)
    (A) No more than 3 percent by weight of the total capacity of the 
container remains in the container or inner liner if the container is 
less than or equal to 119 gallons in size; or
    (B) No more than 0.3 percent by weight of the total capacity of the 
container remains in the container or inner liner if the container is 
greater than 119 gallons in size.
    Therefore, if the container that held the non-acute hazardous waste 
pharmaceutical does not have its contents removed by a commonly 
employed practice and either has one inch or less of residue remaining 
or has 3 percent or less by weight of the total capacity of the 
container remaining,\128\ then the container is not considered ``RCRA 
empty,'' even though the pharmaceutical may have been fully dispensed. 
If the container is not ``RCRA empty,'' then the residues are regulated 
as hazardous waste (since the residues are within the container, the 
container must be managed as hazardous waste, as well, even if it is 
not itself hazardous waste). On the other hand, if the contents of the 
container have been removed by a commonly employed

[[Page 58052]]

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

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

    Likewise, according to Sec.  261.7(b)(3), there are three ways that 
a container that held an acute hazardous waste can be considered 
``empty'':
    A container or an inner liner removed from a container that has 
held an acute hazardous waste listed in Sec. Sec.  261.31 or 261.33(e) 
is ``empty'' if:
    (i) The container or inner liner has been triple rinsed using a 
solvent capable of removing the commercial chemical product or 
manufacturing chemical intermediate;
    (ii) The container or inner liner has been cleaned by another 
method that has been shown in the scientific literature, or by tests 
conducted by the generator, to achieve equivalent removal; or
    (iii) In the case of a container, the inner liner that prevented 
contact of the commercial chemical product or manufacturing chemical 
intermediate with the container, has been removed.
    Therefore, if the container that held the P-listed pharmaceutical 
is not triple rinsed, or cleaned by another method that has been 
demonstrated to achieve equivalent removal, or had the inner liner 
removed, the container is not considered ``RCRA empty,'' even though 
the pharmaceutical may have been fully dispensed. If the container is 
not ``RCRA empty,'' then the residues are regulated as acute hazardous 
waste.
    In November 2011, EPA issued guidance about containers that once 
held P-listed pharmaceuticals \129\ that provides three possible 
regulatory approaches for generators:
---------------------------------------------------------------------------

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

    (1) Count only the weight of the residue toward generator category
    (2) Demonstrate an equivalent removal method to render containers 
RCRA empty
    (3) In the case of warfarin, show that the concentration in the 
residue is below the P-listed concentration.
    This guidance was intended as a short-term solution that worked 
within the confines of the existing RCRA hazardous waste regulations 
and EPA indicated at the time that a more comprehensive solution would 
require notice and public comment that occurs during a rulemaking. We 
are proposing to amend the regulations that pertain to containers that 
once held pharmaceuticals that are RCRA hazardous wastes. We are 
proposing different regulatory solutions for different types of 
containers found in healthcare settings. Specifically, we address the 
following three types of containers: (1) Unit-dose containers (e.g., 
packets, cups, wrappers, blister packs, and delivery devices) and 
dispensing bottles and vials; (2) dispensed syringes; and (3) other 
containers, including delivery devices. If finalized, these new 
regulations for pharmaceutical containers would replace the November 
2011 guidance; however, in the meantime, the guidance remains in 
effect.
    b. Unit-dose containers. First, with regard to unit-dose containers 
and dispensing bottles and vials up to 1 liter or 1000 pills, we are 
proposing a conditional exemption from the empty container regulations 
of Sec.  261.7 for containers from which the pharmaceuticals have been 
fully dispensed. Specifically, we are proposing that the removal of the 
pharmaceuticals from the unit-dose containers, and dispensing bottles 
and vials (up to 1 liter or 1000 pills), is equivalent to rendering the 
container ``RCRA empty.'' Therefore, for containers that once held non-
acute hazardous wastes, it will not be necessary to measure the 
remaining contents, and for containers that once held acute hazardous 
wastes, it will not be necessary to triple-rinse the containers or 
demonstrate an equivalent removal method. Rather, if the contents of 
the container have been fully dispensed by removing all pharmaceuticals 
that can be removed using the practices commonly employed to remove 
materials from that type of container, the residues (and therefore the 
container) may be disposed of as non-hazardous waste.
    We are proposing this conditional exemption for two reasons. First, 
we want to eliminate the sewering of pharmaceuticals. We are 
particularly concerned that in a healthcare setting, when containers 
are triple rinsed, the rinsate will be poured down the drain which is 
not a good environmental practice. We think it is important that the 
residues be managed in a more controlled manner--such as municipal 
solid waste management--rather than poured down the drain. Second, 
although the ``empty container'' regulations of Sec.  261.7 apply to 
all sizes of containers, they were developed with larger, industrial-
sized containers in mind. For the most part, the containers that hold 
pharmaceuticals range in size from a few milliliters (e.g., packaging 
for nicotine gum, paper cups used to dispense pharmaceuticals to in-
patients) to a liter (e.g., bottles that hold bulk quantities of 
pills). In rare circumstances, containers with pharmaceuticals are as 
large as two or three liters (e.g., powders that are reconstituted with 
water). This differs significantly from the 55-gallon drums that are 
typically used in other sectors that generate hazardous waste. 
Consequently, the amount of residues in the containers was anticipated 
to be much more substantial than is the case for containers typically 
used for pharmaceuticals.
    EPA has received data from three stakeholders demonstrating that 
there is very little residue remaining in fully dispensed containers of 
pharmaceuticals. In addition, EPA's ORD conducted similar research. The 
results from each of the four sources are summarized below; the full 
results are included in the docket for this proposed rulemaking (EPA-
HQ-RCRA-2007-0932).
    i. Consulting Firm. One stakeholder, with a hazardous medical 
materials consulting firm, provided some laboratory testing. They had 
the residues from single-unit dose packaging of four different P-listed 
pharmaceuticals tested using gas chromatography/mass spectrometry (GC/
MS) and high performance liquid chromatography/ultraviolet detector 
(HPLC/UV). The amount of active pharmaceutical ingredient in the 
residues remaining in containers was quantified and the results from 
containers that had been triple rinsed were compared with containers 
that had not been triple rinsed. For the containers that were triple 
rinsed, the active ingredient in the residues was non-detect in all 
cases. For the containers that were not triple rinsed, the highest 
level detected was 35.8 [mu]g (or 0.0358 mg). The laboratory results 
submitted to EPA are summarized in Table 9; the full laboratory results 
are included in the docket for this rulemaking (EPA-HQ-RCRA-2007-0932).

[[Page 58053]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.006

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

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

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

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

[[Page 58054]]

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

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

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

[[Page 58055]]

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

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

    Unlike the quantitative results from the HPLC analyses from outside 
stakeholders, the results from the TGA are qualitative only. That is, 
the TGA was only intended to evaluate the presence of the API and 
compare the results from containers that had been triple rinsed with 
those that had not been triple rinsed. Using TGA, the API was not 
detected in the residuals, with one exception: The liquid nasal spray 
(note that TGA was not used on the nicotine inhaler residuals). In most 
cases, the TGA detected other, unspecified ingredients in the 
residuals, but not the active pharmaceutical ingredient on the P-list. 
The total weight of the residues was well under a gram and the active 
pharmaceutical ingredient is a small proportion of the total weight of 
the tablet, gum, etc. As a result, with the exception of the nicotine 
nasal spray, the TGA was not sensitive enough to detect the presence of 
the active pharmaceutical ingredient, regardless of whether the 
container had been triple rinsed or not.
    EPA is aware that there are certain limitations with the data from 
the four sources. For instance, in the case of the consulting firm, no 
replicate samples were tested. In the case of the retailer, only 
warfarin residues were tested. However, given the size of the 
containers involved and the nominal quantities of residues involved, 
the Agency is proposing to allow the residues in single-unit dose 
containers/packaging and dispensing bottles, vials and ampules that 
once held pharmaceuticals to be managed as non-hazardous waste 
pharmaceuticals provided the pharmaceutical product has been fully 
dispensed (e.g., all pills have been removed). EPA is soliciting 
comment on whether these studies are representative of the spectrum of 
formulations and containers that might be encountered.
    Finally, we note that the Agency is concerned about the potential 
for diversion of the pharmaceutical containers that may occur when the 
pharmaceutical residues and containers are discarded in the municipal 
waste stream. In such instances, we are concerned that the containers 
could be diverted from the municipal waste stream and used for illicit 
purposes, such as packaging counterfeit pharmaceuticals. Therefore, EPA 
is proposing that ``RCRA empty'' pharmaceutical containers that are 
original pharmaceutical packages (and therefore are susceptible to 
diversion) should be destroyed prior to placing them in the trash. 
These types of containers would include dispensing bottles, vials or 
ampules typically used in pharmacies, but would not include paper or 
plastic cups, or blister packs used for dispensing singles doses to 
patients. The means of destruction could include crushing or shredding 
the container. We do not believe that simply defacing the label would 
be sufficient to avoid diversion, since labels could be replaced if the 
container is intact.
    We request comment on these proposed provisions, including whether 
it is necessary to limit the size of the dispensing bottle to which 
this provision would apply. In our observation, EPA has rarely seen 
pharmaceutical dispensing bottles that are larger than 1000-count, 
which are approximately 1 liter in size. EPA requests comment on 
whether larger containers are used for dispensing pharmaceuticals and, 
if so, which pharmaceuticals they are used for and what RCRA hazardous 
waste codes apply. We also seek comment as to whether ``RCRA empty'' 
pharmaceutical containers that are the original pharmaceutical packages 
should be destroyed prior to placing them in the trash.
    c. Dispensed syringes. With regard to dispensed syringes, EPA is 
proposing a conditional exemption for syringes that have been used to 
administer pharmaceuticals that are listed or characteristic hazardous 
waste when discarded. The residues remaining in a dispensed syringe 
would not be regulated as hazardous waste provided the syringe has been 
used to administer a pharmaceutical to a patient and the syringe is 
placed in a sharps container (if appropriate) and is managed in 
accordance with all applicable state and federal medical waste 
regulations. This would apply to syringes used to administer 
pharmaceuticals that are P- or U-listed, or exhibit a hazardous waste 
characteristic.
    EPA issued guidance regarding the regulatory status of residues in 
syringes in December 1994 \132\ and April 2008.\133\ In the December 
1994 RCRA/Superfund Hotline Q&A about whether epinephrine in a 
discarded syringe would be P042, EPA stated, ``Drug residues often 
remain in a dispensing instrument after the instrument is used to 
administer medication. EPA considers such residues remaining in a 
dispensing instrument to have been used for their intended purpose. The 
epinephrine remaining in the syringe, therefore, is not a commercial 
chemical product and not a P042 hazardous waste. The epinephrine could 
be a RCRA hazardous waste, however, if it exhibits a characteristic of 
hazardous waste.'' \134\
---------------------------------------------------------------------------

    \132\ December 1994, RCRA Online #13718 http://yosemite.epa.gov/
osw/rcra.nsf/0c994248c239947e85256d090071175f/
1C1DEB3648A62A868525670F006BCCD2/$file/13718.pdf.
    \133\ Memo from Dellinger to Chilcott, April 14, 2008, RCRA 
Online #14788 http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/6A5DEDF2FBA24FE68525744B0045B4AF/
$file/14788.pdf.
    \134\ Note that since this Q&A was issued, EPA issued guidance 
indicating that epinephrine salts are not included in the scope of 
the P042 listing and therefore, most, if not all, medical 
applications of epinephrine are not P042 (October 15, 2007; RCRA 
Online #14778)
---------------------------------------------------------------------------

    In the April 2008 memo, EPA clarified that the 1994 interpretation 
extends to other P- and U-listed pharmaceuticals that have been used to 
administer the pharmaceutical by syringe. This proposed conditional 
exemption for syringes, in large part, would maintain the existing 
interpretation. The primary difference is that under the proposed 
conditional exemption, healthcare facilities would not be required to 
determine if the residues in the syringes meet a listing description or 
exhibit a hazardous waste characteristic.

[[Page 58056]]

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

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

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

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

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

[[Page 58057]]

with the existing pre-transport requirements for packaging, labeling 
and marking, and that evaluated hazardous waste pharmaceuticals must be 
shipped via a hazardous waste transporter using a hazardous waste 
manifest to a designated facility. This continues current practices 
under existing regulations for this type of hazardous waste 
pharmaceutical and does not represent an increase in burden. EPA 
believes that use of a hazardous waste manifest and a hazardous waste 
transporter are appropriate at this point for two reasons. First, once 
credit for the hazardous waste pharmaceuticals has been issued and 
verified, the potential for mismanagement is greater. This is because 
the pharmaceuticals have lost their value and will cost the reverse 
distributor money to dispose. Second, TSDFs are accustomed to receiving 
hazardous waste via a hazardous waste transporter with a hazardous 
waste manifest and it would place administrative and compliance burdens 
on the receiving TSDF to accept shipments of hazardous waste with 
alternative tracking.
    EPA is proposing that the pharmaceutical reverse distributor list 
the appropriate hazardous waste codes on the manifest (even though the 
healthcare facility is not required to provide such information to the 
reverse distributor). Hazardous waste pharmaceuticals received by 
pharmaceutical reverse distributors are in their original packaging 
with their label, so the information to determine the appropriate 
hazardous waste codes should be readily available. Also, reverse 
distributors are currently required to include hazardous waste codes on 
the manifest and it is expected that they have the necessary expertise 
in the management of these hazardous wastes that healthcare workers 
lack. As described in Section V.G.3 (pharmaceutical reverse distributor 
management standards), reverse distributors must keep copies of 
hazardous waste manifests for three years from the date of shipment.
    EPA requests comment regarding the proposed manifest and 
transportation requirements for non-creditable hazardous waste 
pharmaceuticals from healthcare facilities and evaluated hazardous 
waste pharmaceuticals from pharmaceutical reverse distributors.
c. Importing/Exporting Non-Creditable or Evaluated Hazardous Waste 
Pharmaceuticals
    Under the existing regulations, a healthcare facility or 
pharmaceutical reverse distributor may not import hazardous waste 
pharmaceuticals unless it has a RCRA permit or interim status that 
allows it to accept hazardous waste from off-site and complies with the 
requirements for importing hazardous waste in 40 CFR part 262, subpart 
F. This proposal does not change the regulations as they apply to the 
import of non-creditable or evaluated hazardous waste pharmaceuticals. 
Likewise, under existing regulations, a healthcare facility or 
pharmaceutical reverse distributor may not export (non-creditable or 
evaluated) hazardous waste pharmaceuticals unless it complies with 
requirements for exporting hazardous waste in 40 CFR part 262, subpart 
E. This proposal also does not change the regulations as they apply to 
the export of (non-creditable or evaluated) hazardous waste 
pharmaceuticals.\136\
---------------------------------------------------------------------------

    \136\ The Controlled Substances Import and Export Act prohibits 
controlled substances from being imported or exported unless 
permitted by DEA, even when the controlled substances are wastes. 
See 21 U.S.C. 952 and 953.
---------------------------------------------------------------------------

    EPA requests comment on the likelihood that non-creditable 
hazardous waste pharmaceuticals that are shipped from a healthcare 
facility to a domestic TSDF, would then be exported to a TSDF in a 
foreign country. In addition, EPA does not anticipate that hazardous 
waste pharmaceuticals would be destined for transboundary shipments for 
purposes of recovery operations and therefore potentially subject to 40 
CFR part 262, subpart H; however, we also request comment on whether 
this is the case.
2. Shipping Standards for Potentially Creditable Hazardous Waste 
Pharmaceuticals
    This section discusses the proposed requirements for shipping 
potentially creditable hazardous waste pharmaceuticals from healthcare 
facilities to pharmaceutical reverse distributors and between 
pharmaceutical reverse distributors. The return of potentially 
creditable pharmaceuticals (hazardous and non-hazardous) to reverse 
distributors can involve multiple shipping steps before the 
pharmaceuticals are transported for ultimate treatment and disposal. In 
comments on the 2008 Pharmaceutical Universal Waste proposal and in 
response to EPA's request for information,\137\ pharmaceutical reverse 
distributors explained various scenarios that require extra shipping 
steps. For example, a healthcare facility typically sends 
pharmaceuticals to the reverse distributor with which it has a 
contract. However, some manufacturers will only provide manufacturer's 
credit after the pharmaceuticals have been returned to the reverse 
distributor with which the manufacturer has a contract. Thus, if the 
reverse distributor with which the healthcare facility has a contract 
differs from the reverse distributor with which the manufacturer has a 
contract, then the healthcare facility's reverse distributor must send 
the pharmaceuticals on to the manufacturer's reverse distributor for 
the manufacturer's credit to be given to the healthcare facility. In 
some cases, a pharmaceutical manufacturer may require the reverse 
distributor to ship the returned pharmaceuticals to the manufacturer so 
that the manufacturer itself can verify pharmaceutical amounts and 
credits. The estimate of the amount of pharmaceuticals transported from 
reverse distributors to manufacturers for verification varies. Based on 
our request for information, reverse distributors have indicated that 
the percent of potentially creditable pharmaceuticals transported to 
manufacturers ranged from an estimated 25 percent to 93 percent, 
depending on the contractual agreement between the reverse distributor 
and the manufacturer. Both of the scenarios described previously happen 
routinely and are part of the business of returning pharmaceuticals to 
reverse distributors (including manufacturers) for manufacturer's 
credit.
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    \137\ EPA sent nine pharmaceutical reverse distributors a letter 
asking for more information about their business practices in an 
effort to more fully understand reverse distribution of 
pharmaceuticals. The seven responses representing the views of eight 
reverse distributors can be found in the docket of this proposed 
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    As explained in Section V.D.1, EPA is proposing that 
pharmaceuticals transported to pharmaceutical reverse distributors for 
credit are solid wastes, some of which will also be considered 
hazardous wastes. Under the current RCRA Subtitle C regulations, 
hazardous waste, including hazardous waste pharmaceuticals must be 
manifested to a permitted or interim status TSDF and shipped using a 
hazardous waste transporter to ensure the cradle-to-grave system of 
RCRA is maintained. However, compared to other hazardous wastes, EPA 
believes that the risk of environmental release posed by most 
potentially creditable hazardous wastes pharmaceuticals during 
accumulation and transport are relatively low. The risk is low because 
of the form and packaging of most potentially creditable hazardous 
waste pharmaceuticals, which is typically in small, individually 
packaged doses (such as with many tablets and capsules) or small vials.

[[Page 58058]]

These small volumes of individually wrapped or packaged 
pharmaceuticals, when aggregated in a larger container, are unlikely to 
spill or be released into the environment since they are essentially 
double-packed when transported to a reverse distributor.\138\ 
Potentially creditable hazardous waste pharmaceuticals that are in 
liquid and aerosol forms may pose more of a risk during accumulation 
and transport due to possible spillage or leakage, but the small 
quantities in which they are generated, along with the DOT packaging 
requirements of 49 CFR parts 173, 178, and 180, would likely mitigate 
this risk (see EPA's recommendation regarding liquids and aerosols in 
Section V.D.2.). Further, the 2008 Pharmaceutical Universal Waste 
proposal specifically sought comment regarding the risks of 
transportation of hazardous waste pharmaceuticals and no commenters 
identified environmental risks.
---------------------------------------------------------------------------

    \138\ Pharmaceutical Universal Waste proposal, 73 FR 73529; 
December 2, 2008.
---------------------------------------------------------------------------

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

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

    EPA notes that a pharmaceutical reverse distributor is not required 
to sort the potentially creditable hazardous waste pharmaceuticals from 
the potentially creditable non-hazardous waste pharmaceuticals when 
they are destined for another reverse distributor. However, if the 
potentially creditable pharmaceuticals are not sorted, the 
pharmaceutical reverse distributor must follow the tracking procedures 
in this proposal for the entire shipment. On the other hand, if a 
pharmaceutical reverse distributor chooses to sort the potentially 
creditable hazardous waste pharmaceuticals from the creditable non-
hazardous waste pharmaceuticals prior to shipping to another reverse 
distributor, only the potentially creditable hazardous waste 
pharmaceutical portion would have to be shipped according to these 
proposed standards. EPA asks for comment on whether the proposed 
tracking system and controls are sufficient to protect human health and 
the environment.
a. What Happens if a Healthcare Facility or Pharmaceutical Reverse 
Distributor Initiates a Shipment and Does Not Get Confirmation of 
Delivery?
    If a healthcare facility or pharmaceutical reverse distributor 
initiates a shipment of potentially creditable hazardous waste 
pharmaceuticals to a reverse distributor and does not receive delivery 
confirmation from the intended recipient within seven calendar days, 
EPA is proposing that the healthcare facility or pharmaceutical reverse

[[Page 58059]]

distributor that initiated the shipment must contact the shipper and 
the intended recipient promptly to (1) report that the confirmation was 
not received and (2) to determine the status and whereabouts of the 
potentially creditable hazardous waste pharmaceuticals that were 
shipped. The Agency requests comment on whether any additional 
requirements, such as reporting to the implementing agency, are 
necessary in such cases.
b. Importing/Exporting Potentially Creditable Hazardous Waste 
Pharmaceuticals
    If a healthcare facility or pharmaceutical reverse distributor 
imports potentially creditable hazardous waste pharmaceuticals, then it 
must comply with the proposed requirements for the shipment of 
potentially creditable hazardous waste pharmaceuticals. The proposed 
requirements would be in lieu of those for manifested hazardous waste 
imports found at 40 CFR part 262, subpart F. EPA requests comment on 
whether potentially creditable hazardous waste pharmaceuticals are 
imported into the U.S. and, if so, how they are currently declared to 
customs when imported.
    If a healthcare facility or pharmaceutical reverse distributor 
exports potentially creditable hazardous waste pharmaceuticals then it 
must generally comply with 40 CFR part 262, subpart E, except that it 
is not required to manifest the potentially creditable hazardous waste 
pharmaceuticals.\140\
---------------------------------------------------------------------------

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

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

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

1. Background on Pharmaceutical Reverse Distributor Operations
    Pharmaceutical reverse distributors act as intermediaries between 
healthcare facilities and pharmaceutical manufacturers. They receive 
shipments of potentially creditable hazardous waste pharmaceuticals 
from healthcare facilities and, on behalf of manufacturers, facilitate 
the process of crediting healthcare facilities for these 
pharmaceuticals. From stakeholder input and EPA site visits, EPA's 
understanding is that when a pharmaceutical reverse distributor 
receives a shipment of potentially creditable hazardous waste 
pharmaceuticals, the reverse distributor sorts through the shipment and 
often uses barcodes to scan items into its computer system. Based on 
manufacturers' return goods policies, the pharmaceutical reverse 
distributors determine which potentially creditable hazardous waste 
pharmaceuticals can be credited, as well as which must be sent on to 
another reverse distributor for completion of the crediting process.
    In many cases, there is more than one reverse distributor involved 
in establishing and verifying manufacturer's credit for a particular 
potentially creditable hazardous waste pharmaceutical. For instance, 
reverse distributors may have contracts with specific pharmaceutical 
manufacturers such that only a specific pharmaceutical reverse 
distributor may facilitate credit for a particular manufacturer's 
pharmaceuticals. If the receiving reverse distributor has a contract 
with the healthcare facility, but not with the pharmaceutical 
manufacturer, then the receiving pharmaceutical reverse distributor 
sends the returned pharmaceutical on to the reverse distributor that 
has a contract with the pharmaceutical manufacturer in order to 
facilitate the credit process.
    Because manufacturers' return goods policies change over time, 
sometimes a pharmaceutical reverse distributor receives a potentially 
creditable hazardous waste pharmaceutical that is not eligible for 
credit immediately, and the pharmaceutical reverse distributor retains 
the potentially creditable hazardous waste pharmaceutical on-site until 
it is credit eligible. EPA requests comment on how often this happens 
and how long the potentially creditable hazardous waste pharmaceuticals 
are kept on-site at reverse distributors to await changes in 
manufacturers' return goods policies.
    In some cases, even after the pharmaceutical reverse distributor 
has awarded credit, a pharmaceutical manufacturer may request that the 
hazardous waste pharmaceuticals be transported back to the manufacturer 
to inventory and verify the amount of pharmaceuticals and credit. In 
developing this proposed rule, EPA considered all of the previous 
scenarios as part of the crediting process.
    On the other hand, if the potentially creditable hazardous waste 
pharmaceuticals are not sent onward to another pharmaceutical reverse 
distributor, the pharmaceutical reverse distributor awards the 
manufacturer's credit to the healthcare facility and then manages the 
hazardous waste pharmaceuticals on-site until they are sent off-site 
for treatment and disposal. As discussed previously in this proposal, 
after a potentially creditable hazardous waste pharmaceutical has been 
evaluated and either credited or deemed non-creditable and no 
additional pharmaceutical reverse distributors will be involved in the 
crediting process, EPA proposes to use the term ``evaluated hazardous 
waste pharmaceutical.'' This is to distinguish between the potentially 
creditable hazardous waste pharmaceuticals awaiting determination 
within the reverse distribution system versus credited and non-
creditable hazardous waste pharmaceuticals that have been through the 
reverse distributor process and are destined to be managed by a 
permitted or interim status TSDF. Both are considered hazardous waste 
pharmaceuticals, but they are managed differently under the proposed 
regulations.
    EPA is not aware of any pharmaceutical reverse distributors that 
facilitate manufacturer's credit that also has interim status or a 
permit to treat or dispose of hazardous waste on-site. Therefore, EPA 
anticipates that pharmaceutical reverse distributors eventually send 
all evaluated hazardous waste pharmaceuticals off-site for

[[Page 58060]]

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

    \141\ Barnes, K. K., Christenson, S. C., Kolpin, D. W., Focazio, 
M. J., Furlong, E. T., Zaugg, S. D., Meyer, M. T. and Barber, L. B. 
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants 
Within a Leachate Plume Downgradient of a Municipal Landfill. 
Groundwater Monitoring & Remediation, 24: 119-126.
    \142\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., 
Zaugg, S.D., and Meyer, M.T. (2009), Waste-Indicator and 
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water 
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental 
Contamination and Toxicology, 82.6:635-659.
---------------------------------------------------------------------------

    EPA is proposing to revise its position regarding potentially 
creditable hazardous waste pharmaceuticals, such that they will be 
first considered discarded at the healthcare facilities, not at the 
reverse distributors. This revision is based on new information 
demonstrating to EPA that pharmaceuticals returned to a reverse 
distributor are rarely, if ever, recycled or reused, and therefore the 
decision to send a potentially creditable hazardous waste 
pharmaceutical to a pharmaceutical reverse distributor is a decision to 
discard the pharmaceutical (as discussed previously in Section V.D.1). 
Other comments on the December 2008 Pharmaceutical Universal Waste 
proposal indicated that notification to EPA by pharmaceutical reverse 
distributors and tracking of shipments of potentially creditable 
hazardous waste pharmaceuticals are critical and must be included in 
any regulatory scheme to ensure the safe management of potentially 
creditable hazardous waste pharmaceuticals.
    As previously discussed, only between 2-6 percent of the 
potentially creditable hazardous wastes that are received by 
pharmaceutical reverse distributors are listed or characteristic 
hazardous wastes.\143\ Therefore, the vast majority of the potentially 
creditable pharmaceutical waste that a pharmaceutical reverse 
distributor receives is not considered a characteristic or listed 
hazardous waste pharmaceutical under the existing definition of 
hazardous waste. This stands in contrast to a typical TSDF, which 
primarily manages hazardous waste. As a result, a pharmaceutical 
reverse distributor generally manages a smaller volume of hazardous 
waste than a typical permitted TSDF.
---------------------------------------------------------------------------

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

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

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

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

[[Page 58061]]

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

[[Page 58062]]

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

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

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

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

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

[[Page 58063]]

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

[[Page 58064]]

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

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

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

[[Page 58065]]

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

[[Page 58066]]

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

[[Page 58067]]

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

VI. Implementation and Enforcement

A. Healthcare Facilities

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

[[Page 58068]]

more than 100 kg hazardous waste per calendar month, or more than 1 kg 
of acute hazardous waste per calendar month, or more than 100 kg of any 
residue or contaminated soil, waste, or other debris resulting from the 
clean-up of a spill, into or on any land or water, of any acute 
hazardous wastes listed in Sec. Sec.  261.31, or 261.33(e), must manage 
its hazardous waste pharmaceuticals in compliance with the 40 CFR part 
266, subpart P requirements. In addition, healthcare facilities that 
are CESQGs are subject to the prohibition on sewering hazardous waste 
pharmaceuticals in Sec.  266.5052.
    To determine whether a healthcare facility is a subject to 40 CFR 
part 266, subpart P, or a CESQG regulated under Sec.  261.5, a 
healthcare facility must count all the hazardous waste--pharmaceutical 
and non-pharmaceutical--it generates in a calendar month. In counting 
the amount of hazardous waste generated per calendar month, we note 
that EPA is proposing to change which pharmaceuticals will be 
considered hazardous wastes (i.e., potentially creditable hazardous 
waste pharmaceuticals). Specifically, EPA is proposing that potentially 
creditable hazardous waste pharmaceuticals transported to a 
pharmaceutical reverse distributor will be considered solid waste from 
the point of generation at the healthcare facility and therefore must 
be counted when determining whether the healthcare facility is a CESQG 
regulated under Sec.  261.5, or whether it is regulated under 40 CFR 
part 266, subpart P. This differs from current practice where, although 
a healthcare facility must count the non-creditable hazardous waste 
pharmaceuticals it generates each calendar month toward its hazardous 
waste generator category, it does not count the potentially creditable 
hazardous waste pharmaceuticals it sends to a pharmaceutical reverse 
distributor. Therefore, although a healthcare facility currently may be 
considered a CESQG, when it begins counting its potentially creditable 
hazardous waste pharmaceuticals, it may no longer be a CESQG. In that 
case, the healthcare facility would be subject to the 40 CFR part 266, 
subpart P requirements.
2. Healthcare Facilities Managing Hazardous Waste Pharmaceuticals Under 
Part 266, Subpart P
    EPA is proposing that all healthcare facilities, with the exception 
of CESQGs, will be subject to the same regulations for the management 
of their hazardous waste pharmaceuticals, regardless of the quantity of 
hazardous waste pharmaceuticals generated. A healthcare facility that 
generates both pharmaceutical and non-pharmaceutical hazardous waste 
must manage the non-pharmaceutical hazardous waste pursuant to part 
262, but need not count its hazardous waste pharmaceuticals toward the 
facility's monthly hazardous waste generator category. In addition, if 
a healthcare facility does not want to keep track of the amount of 
hazardous waste it generates to ensure it does not exceed the CESQG 
quantity limits, it could choose to operate under this proposed rule. 
If it chooses to operate under this proposed rule, however, a 
healthcare facility must comply with all the requirements of this 
subpart for the management of its hazardous waste pharmaceuticals.

B. Pharmaceutical Reverse Distributors

1. Pharmaceuticals Sent to Pharmaceutical Reverse Distributors Are 
Solid Wastes
    One difference between this proposal and the 2008 Pharmaceutical 
Universal Waste proposal is how RCRA would apply to pharmaceuticals 
returned to pharmaceutical reverse distributors to obtain 
manufacturer's credit. EPA is proposing to change its existing position 
on this issue. If this rule is finalized, this change would mean that 
the decision by a healthcare facility to send a pharmaceutical to a 
pharmaceutical reverse distributor is the decision to discard the 
pharmaceutical. Therefore, under this proposed rule, once the 
healthcare facility makes the decision to send a pharmaceutical to a 
pharmaceutical reverse distributor for credit, it is a solid waste at 
the healthcare facility. It is likely that a portion of the potentially 
creditable solid waste pharmaceuticals at healthcare facilities that 
are destined for a pharmaceutical reverse distributor will also meet 
the definition of hazardous waste and as a result, these potentially 
creditable hazardous waste pharmaceuticals would need to be managed in 
accordance with the standards proposed in this document. However, until 
this rule is final and effective, EPA's current position will remain in 
effect.
    In addition, the Agency notes that the proposed change in EPA's 
position concerning reverse distribution and the management standards 
discussed in this document pertain only to the reverse distribution of 
hazardous waste pharmaceuticals and does not apply to reverse 
distribution or reverse logistics systems that may exist for other 
consumer products. This limitation is because EPA has studied and 
collected data for reverse distribution systems for hazardous waste 
pharmaceuticals, and not all consumer products.\148\
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    \148\ EPA is examining the reverse logistics of non-
pharmaceutical hazardous wastes as part of its analysis of comments 
received on the Retail Notice of Data Availability that was 
published on February 14, 2014 (79 FR 8926).
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2. Pharmaceutical Reverse Distributors Managing Hazardous Waste 
Pharmaceuticals Under Part 266, Subpart P
    Under this proposal, all pharmaceutical reverse distributors are 
subject to 40 CFR part 266, subpart P and will be subject to the same 
standards with respect to their hazardous waste pharmaceuticals, 
regardless of the amount of hazardous waste pharmaceuticals they 
manage. Even pharmaceutical reverse distributors that are currently 
CESQGs will be regulated under 40 CFR part 266, subpart P for the 
management of their hazardous waste pharmaceuticals. Therefore, as with 
healthcare facilities, a pharmaceutical reverse distributor subject to 
40 CFR part 266, subpart P will no longer have to keep track of the 
amount of hazardous waste pharmaceuticals that it generates on a 
monthly basis.

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

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

[[Page 58069]]

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

D. State Enforcement Activities and Interpretations

    States have taken a variety of approaches regarding pharmaceutical 
hazardous wastes. One major goal of this proposed rule is to provide 
clarity on this topic, and thereby promote national consistency, which, 
in turn, should promote better compliance among healthcare facilities, 
including pharmacies.
    California has taken numerous enforcement actions against national 
retail chains with pharmacies for not complying with the RCRA hazardous 
waste regulations. In recent years, the state took enforcement actions 
and imposed fines on the following chains: Kmart (2009), Walmart 
(2010), Target (2011), CVS (2012), Costco (2012), Walgreens (2012) and 
Rite-Aid (2013). In at least two settlement agreements, California 
directed the defendants (CVS and Costco) to ``initiate work with 
appropriate stakeholders from business and government, including the 
U.S. Environmental Protection Agency, the U.S. Food and Drug 
Administration, and the DTSC [Department of Toxic Substances Control], 
and thereafter either directly or through trade associations or 
informal coalitions of interested parties, undertake to promote federal 
regulatory reform regarding the proper management of nondispensable 
pharmaceuticals, including over-the-counter medications, through 
``reverse distribution.'' \149\ Through these settlement agreements, 
California is seeking clarity from EPA about its longstanding 
interpretation about the regulatory status of pharmaceuticals that are 
routed through pharmaceutical reverse distribution systems.
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    \149\ http://www.calepa.ca.gov/enforcement/orders/2012/CVSStipFinal.pdf and http://www.calepa.ca.gov/enforcement/orders/2012/CostcoFinal.pdf or see the docket for this rulemaking EPA-HQ-
RCRA-2007-0932.
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    In 2012, Connecticut's Department of Energy and Environmental 
Protection (DEEP) took enforcement actions at seven CVS stores for 
violations of the RCRA hazardous waste regulations. Consent orders from 
Connecticut DEEP direct CVS stores in the state to follow a set of best 
management practices.\150\ A number of the practices developed in these 
consent orders mirror some of the practices we are proposing in this 
rule, particularly with regard to pharmaceuticals destined for a 
pharmaceutical reverse distributor. Connecticut DEEP asserts RCRA 
jurisdiction over the pharmaceuticals destined for pharmaceutical 
reverse distributors by applying specific practices to their 
management. For example, CVS must maintain records of each shipment of 
non-dispensable pharmaceuticals to a pharmaceutical reverse 
distributor, including confirmation of receipt of the non-dispensable 
pharmaceuticals from the pharmaceutical reverse distributor receiving 
them. The best practices also include procedures for addressing 
situations when CVS does not receive delivery confirmation of shipment 
to a pharmaceutical reverse distributor. Further, the consent order 
sets out separate, more comprehensive practices for the non-dispensable 
pharmaceuticals that are not suitable for pharmaceutical reverse 
distribution.
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    \150\ http://www.ct.gov/deep/lib/deep/enforcement/consentorder/COWSWDH13005.pdf. or see the docket for this rulemaking EPA-HQ-RCRA-
2007-0932.
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    Aside from best management practices developed by Connecticut as 
part of a consent order, at least two other states have developed 
guidance documents that apply conditions to the management of hazardous 
wastes pharmaceuticals in exchange for enforcement discretion. In 
particular, in 2008, the Washington State Department of Ecology issued 
guidance titled, Interim Enforcement Policy: Pharmaceutical Waste in 
Healthcare.\151\ Like Connecticut's consent orders with CVS, this 
enforcement discretion policy has some elements in common with this 
proposed rule for hazardous waste pharmaceuticals. For instance, a 
healthcare facility must notify the Department of Ecology that it is 
operating under the policy and must train its staff involved in 
pharmaceutical waste management. Only a time limit, rather than a 
quantity limit, applies to the accumulation of the hazardous waste 
pharmaceuticals on-site. Of particular note is that Washington State 
prohibits disposing of most hazardous waste pharmaceuticals down the 
toilet or drain.
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    \151\ See the interim enforcement policy in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932) or see it online at https://fortress.wa.gov/ecy/publications/documents/0704024.pdf.
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    In 2011, Minnesota's Pollution Control Agency (MPCA) issued a fact 
sheet titled Reverse Distribution of Pharmaceuticals: Guidance for 
Minnesota Healthcare Providers.\152\ In this guidance, Minnesota 
states, ``Whether a pharmaceutical is eligible for return credit does 
not affect its product or waste status. In Minnesota, if a 
pharmaceutical is not used or reused for its intended purpose, it is a 
waste. The MPCA considers health care practitioners and pharmacies to 
be generators of these pharmaceutical wastes. Nevertheless, the MPCA 
believes that the established reverse distribution system provides an 
environmentally protective method for handling waste pharmaceuticals. 
Therefore, it will allow Minnesota health care practitioners and 
pharmacies to manage certain pharmaceuticals through reverse 
distribution, subject to additional requirements discussed in this fact 
sheet.'' This is similar to the approach that EPA is proposing for 
potentially creditable hazardous waste pharmaceuticals. For example, 
like EPA's proposed rule, MPCA does not require hazardous waste 
pharmaceuticals destined for a pharmaceutical reverse distributor to be 
counted toward determining a healthcare facility's generator category, 
and MPCA does not require hazardous waste pharmaceuticals to be 
accompanied by a hazardous waste manifest when shipped to a 
pharmaceutical reverse distributor. By adopting a rule that is 
consistent with state approaches, EPA is bringing national consistency 
to the management

[[Page 58070]]

of hazardous waste pharmaceuticals, while avoiding disruption to 
practices already in place.
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    \152\ See the guidance document in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932) or see it online at http://www.pca.state.mn.us/index.php/view-document.html?gid=4004.
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VII. Request for Comment on EPA's Efforts To Identify Additional 
Pharmaceutical Hazardous Wastes

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

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

    Commenters specifically referred to EPA's P and U hazardous waste 
lists under the RCRA subtitle C regulations. Generally, in its 
hazardous waste determinations, EPA has evaluated both ``production 
wastes'' (from specific or non-specific sources; see Sec. Sec.  261.31 
and 261.32) and ``commercial chemical products'' that, when discarded, 
become wastes (Sec.  261.33). This latter category (commercial chemical 
products that are discarded) is the most relevant of the listed 
hazardous wastes to the pharmaceuticals wastes discussed elsewhere in 
this preamble, and to which commenters referred in the 2008 Universal 
Waste proposal. As discussed in Section IV.A.of this preamble, 
commercial chemical products listed in Sec.  261.33 are (when 
discarded) defined as either P-listed ``acute'' hazardous wastes, or U-
listed (non-acute) hazardous wastes. The criteria for listing a solid 
waste as hazardous under RCRA Subtitle C are described in Sec.  261.11. 
A waste may be identified as a P-listed waste if it is shown to be 
fatal to humans or animals at low doses (see Sec.  261.11(a)(2)). Thus, 
lethality data for any chemical is the principal factor for making a 
determination that a discarded commercial chemical product is a P-
listed hazardous waste.\155\
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    \155\ Sec.  261.11(a)(2) states ``The Administrator shall list a 
solid waste as a hazardous waste only upon determining that the 
solid waste . . . has been found to be fatal to humans in low doses 
or, in the absence of data on human toxicity, it has been shown in 
studies to have an oral LD 50 toxicity (rat) of less than 50 
milligrams per kilogram, an inhalation LC 50 toxicity (rat) of less 
than 2 milligrams per liter, or a dermal LD 50 toxicity (rabbit) of 
less than 200 milligrams per kilogram or is otherwise capable of 
causing or significantly contributing to an increase in serious 
irreversible, or incapacitating reversible, illness. (Waste listed 
in accordance with these criteria will be designated Acute Hazardous 
Waste.)''
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    In contrast, a waste may be identified as a U-listed waste if it 
contains any of the toxic constituents listed in Appendix VIII of 40 
CFR part 261, and if, after examining each of 10 factors in Sec.  
261.11(a)(3), it is determined that the waste is capable of posing a 
``substantial present or potential hazard to human health or the 
environment when improperly treated, stored, transported, or disposed 
of, or otherwise managed.'' \156\ Examples of these 10 factors include 
the toxicity and concentration of the hazardous constituent in the 
waste, the plausible types of improper management to which the waste 
could be subjected, the quantities of the waste generated at individual 
generation sites or on a regional or national basis, the nature and 
severity of the human health and environmental damage that has occurred 
as a result of the improper management of wastes, and action taken by 
other governmental agencies or regulatory programs based on the health 
or environmental hazard posed by the waste or waste constituent. EPA 
may only revise either of these lists of commercial chemical products 
through notice-and-comment rulemaking.
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    \156\ The Agency cannot list hazardous wastes under section 
Sec.  261.11(a)(3) based on inherent toxicity alone without 
considering exposure factors, particularly the likelihood of 
mismanagement. That is, EPA needs to examine each of the 10 factors 
and, to the extent it does not use one or more of them, must explain 
why they are irrelevant or unimportant. See Dithiocarbamate Task 
Force v. EPA (No. 95-1249).
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    In its September 2011 report, EPA found that 11 drugs on the NIOSH 
or OSHA lists of hazardous drugs meet the specific criteria for acute 
toxicity in Sec.  261.11(a)(2) (identified as ``Tier 1'' drugs in the 
report). An additional 114 drugs on the NIOSH or OSHA lists did not 
meet the specific criteria in Sec.  261.11(a)(2) for acute toxicity, 
but did have lethal doses for other animals or humans (``Tier 2'' 
drugs). The remaining 79 drugs had limited human or animal toxicity 
data, and no lethality data, and were designated ``Tier 3'' in the 
report. Thus, the vast majority of the NIOSH/OSHA hazardous drugs 
evaluated in the EPA 2011 report do not meet the criteria for listing 
as acute hazardous waste under RCRA subtitle C.\157\ As discussed 
previously, to include a drug on the U-list, the Agency must 
demonstrate that a discarded drug would be ``capable of posing a 
substantial present or potential hazard to human health or the 
environment when improperly treated, stored, transported, or disposed 
of, or otherwise managed.'' Therefore, for the NIOSH/OSHA drugs that do 
not meet the listing criteria for inclusion on the P-list, the Agency 
would have to examine the 10 factors in Sec.  261.11(a)(3) to determine 
whether a drug meets the criteria to be included on the U-list. In 
addition to toxicity data (which is lacking in particular for the drugs 
identified as Tier 3), the types of information that would be relevant 
include waste volumes, plausible management scenarios, exposure 
potential, damage cases, and actions taken by other governmental 
agencies or regulatory programs. To obtain this information for this 
class of materials poses a challenge. While EPA has some information--
the September 2011 report includes summaries of drug management 
practices and references to others--there remain significant gaps.
---------------------------------------------------------------------------

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

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

[[Page 58071]]

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

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

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

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

A. Background

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

B. Basis for Original Listing

    EPA listed nicotine and salts (referred to commonly as just 
nicotine) as acutely hazardous waste (P075) in Sec.  261.33(e) based on 
an estimated oral LD50 toxicity to humans of 1 mg/kg and a dermal LD50 
toxicity to rabbits of 50 mg/kg.\159\ As discussed previously, for 
humans, the standard in the regulations for acute toxicity is ``fatal 
to humans in low doses'' (see Sec.  261.11(a)(2)). EPA's Background 
Document for Section 261.33 from 1981 provides a basis for what is 
meant by ``fatal to humans in low doses'' for chemicals that have been 
given through the oral route (``fatal to humans upon ingestion of kg''). The estimated oral LD50 to humans of 1 mg/kg falls within the 
criteria for ``fatal to humans in low doses.'' However, the background 
listing document and its references do not provide sufficient detail to 
determine the concentration of nicotine that was used to establish the 
estimated oral LD50 in humans.
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    \159\ See EPA's listing Background Document for Section 261.33, 
April 1981, in the docket for this proposed rule (EPA-HQ-RCRA-2007-
0932).
---------------------------------------------------------------------------

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

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

[[Page 58072]]

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

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

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

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

D. Two Possible Approaches for Amending the P075 Listing

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

[[Page 58073]]

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

E. Request for Comments

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

IX. State Authorization

A. Applicability of Rules in Authorized States

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

    \163\ EPA notes that decisions regarding whether a state rule is 
more stringent or broader in scope than the federal program are made 
when the Agency authorizes state programs.
---------------------------------------------------------------------------

B. Effect on State Authorization

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

[[Page 58074]]

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

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

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

X. Adding and Reserving Part 266, Subpart O

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

XI. Summary of Regulatory Impact Analysis

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

[[Page 58075]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.008

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

A. Costs of the Proposed Rule

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

B. Benefits of the Proposed Rule

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

[[Page 58076]]

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

XII. Statutory and Executive Order Reviews

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

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

B. Paperwork Reduction Act (PRA)

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

[[Page 58077]]

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

C. Regulatory Flexibility Small Business Analysis

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

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

[[Page 58078]]

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

D. Unfunded Mandates Reform Act (UMRA)

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

 E. Executive Order 13132: Federalism

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

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

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

    \164\ Indian Health Service (IHS), U.S. Department of Health and 
Human Services, IHS Year 2013 Profile, available at http://www.ihs.gov/PublicAffairs/IHSBrochure/Profile.asp, accessed December 
20, 2012.

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[[Page 58079]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.010

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

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

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

[[Page 58080]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.011

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

    This proposed rulemaking does not involve technical standards.

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

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

[[Page 58081]]

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

[[Page 58082]]

[GRAPHIC] [TIFF OMITTED] TP25SE15.012

List of Subjects

40 CFR Part 261

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

40 CFR Part 262

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

40 CFR Part 266

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

[[Page 58083]]

40 CFR Part 268

    Environmental protection, Hazardous waste, Reporting and 
recordkeeping requirements.

40 CFR Part 273

    Environmental protection, Hazardous materials transportation, 
Hazardous waste.

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

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

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

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

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

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

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

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

Sec.  261.7  Residues of hazardous waste in empty containers.

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

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE

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

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

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

Sec.  262.10  Purpose, scope and applicability.

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

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

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

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

Subpart O--[Reserved]

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

Subpart P--Hazardous Waste Pharmaceuticals

Sec.  266.500  Definitions for this subpart.

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

[[Page 58084]]

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

Sec.  266.501  Applicability.

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

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

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

[[Page 58085]]

with proper waste handling and emergency procedures relevant to their 
responsibilities during normal facility operations and emergencies.
    (c) Hazardous waste determination for non-creditable hazardous 
waste pharmaceuticals at healthcare facilities. A healthcare facility 
that generates a solid waste that is a pharmaceutical must determine 
whether the solid waste pharmaceutical is a hazardous waste 
pharmaceutical (i.e., it exhibits a characteristic identified in 40 CFR 
part 261, subpart C or is listed in 40 CFR part 261, subpart D) in 
order to determine whether the waste is subject to this subpart. A 
healthcare facility may choose to manage its solid waste 
pharmaceuticals as hazardous waste pharmaceuticals under this subpart 
even if the solid waste pharmaceuticals do not exhibit a characteristic 
identified in 40 CFR part 261, subpart C and are not listed in 40 CFR 
part 261, subpart D.
    (d) Standards for containers used to accumulate non-creditable 
hazardous waste pharmaceuticals at healthcare facilities. (1) A 
healthcare facility must place non-creditable hazardous waste 
pharmaceuticals in a container that is structurally sound, compatible 
with its contents, and that lacks evidence of leakage, spillage, or 
damage that could cause leakage under reasonably foreseeable 
conditions.
    (2) A healthcare facility that manages ignitable or reactive 
hazardous waste pharmaceuticals, or that mixes or commingles 
incompatible hazardous waste pharmaceuticals must manage the container 
so that it does not have the potential to:
    (i) Generate extreme heat or pressure, fire or explosion, or 
violent reaction;
    (ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in 
sufficient quantities to threaten human health;
    (iii) Produce uncontrolled flammable fumes or gases in sufficient 
quantities to pose a risk of fire or explosions;
    (iv) Damage the structural integrity of the container of hazardous 
waste pharmaceuticals; or
    (v) Through other like means threaten human health or the 
environment.
    (3) A healthcare facility must keep containers of non-creditable 
hazardous waste pharmaceuticals closed and secured in a manner that 
prevents unauthorized access to its contents.
    (4) A healthcare facility may accumulate hazardous waste 
pharmaceuticals and non-hazardous pharmaceutical waste in the same 
container, except that hazardous waste pharmaceuticals prohibited from 
being combusted because of the dilution prohibition of Sec.  268.3(c) 
must be accumulated in separate containers.
    (e) Labeling containers used to accumulate non-creditable hazardous 
waste pharmaceuticals at healthcare facilities. A healthcare facility 
must label or clearly mark each container of hazardous waste 
pharmaceuticals with the phrase ``Hazardous Waste Pharmaceuticals.''
    (f) Maximum accumulation time for non-creditable hazardous waste 
pharmaceuticals at healthcare facilities. (1) A healthcare facility may 
accumulate non-creditable hazardous waste pharmaceuticals on-site for 
one year or less without a permit or having interim status. A 
healthcare facility may accumulate for more than one year without a 
permit or having interim status, only if the requirements of paragraph 
(f)(3) of this section are met.
    (2) A healthcare facility that accumulates non-creditable hazardous 
waste pharmaceuticals on-site must demonstrate the length of time that 
the hazardous waste pharmaceuticals have been accumulating, starting 
from the date it first becomes a waste. A healthcare facility may make 
this demonstration by any of the following methods:
    (i) Marking or labeling the container of non-creditable hazardous 
waste pharmaceuticals with the date that hazardous waste 
pharmaceuticals became a waste;
    (ii) Maintaining an inventory system that identifies the date the 
non-creditable hazardous waste pharmaceutical being accumulated first 
became a waste;
    (iii) Placing the non-creditable hazardous waste pharmaceuticals in 
a specific area and identifying the earliest date that any of the non-
creditable hazardous waste pharmaceuticals in the area became a waste; 
or
    (iv) Any other method which clearly demonstrates the length of time 
that the non-creditable hazardous waste pharmaceuticals have been 
accumulating from the date it first became a waste.
    (3) A healthcare facility may request from the EPA Regional 
Administrator an extension beyond the one year accumulation time limit 
for non-creditable hazardous waste pharmaceuticals involved in 
litigation, a recall, or unforeseen circumstances beyond the control of 
the healthcare facility.
    (i) A request must be sent to the EPA Regional Administrator in 
writing (paper or electronic). The request for an extension must 
include an explanation of the reason an extension is requested, the 
approximate volume or weight of the hazardous waste pharmaceuticals 
that will be accumulated more than 90 days, and the amount of 
additional time requested.
    (ii) The amount of time extension granted is at the discretion of 
the EPA Regional Administrator on a case-by-case basis.
    (g) Land disposal restrictions for non-creditable hazardous waste 
pharmaceuticals. The hazardous waste pharmaceuticals generated by a 
healthcare facility are subject to the Land Disposal Restrictions of 40 
CFR part 268. A healthcare facility that generates hazardous waste 
pharmaceuticals must comply with the land disposal restrictions in 
accordance with Sec.  268.7(a) requirements, except that it is not 
required to identify the hazardous waste numbers (codes).
    (h) Procedures for healthcare facilities for managing rejected 
shipments of non-creditable hazardous waste pharmaceuticals. A 
healthcare facility that sends a shipment of non-creditable hazardous 
waste pharmaceuticals to a designated facility and later receives that 
shipment back as a rejected load in accordance with the manifest 
discrepancy provisions of Sec.  264.72 or Sec.  265.72 of this chapter, 
may accumulate the returned hazardous waste pharmaceuticals on-site for 
up to an additional 90 days provided the rejected or returned shipment 
is managed in accordance with paragraphs (d) and (e) of this section. 
Upon receipt of the returned shipment, the healthcare facility must:
    (1) Sign either:
    (i) Item 18c of the original manifest, if the original manifest was 
used for the returned shipment; or
    (ii) Item 20 of the new manifest, if a new manifest was used for 
the returned shipment;
    (2) Provide the transporter a copy of the manifest;
    (3) Within 30 days of delivery of the rejected shipment, send a 
copy of the manifest to the designated facility that returned the 
shipment to the healthcare facility; and
    (4) Transport or offer for transport the returned shipment in 
accordance with the shipping standards of Sec.  266.508(a).
    (i) Reporting by healthcare facilities for non-creditable hazardous 
waste pharmaceuticals--(1) Biennial report by healthcare facilities. 
Healthcare facilities are not subject to biennial reporting 
requirements under Sec.  262.41, with respect to non-creditable 
hazardous waste pharmaceuticals managed under this subpart.
    (2) Exception report by healthcare facilities for a missing copy of 
the manifest. (i) For shipments from a

[[Page 58086]]

healthcare facility to a designated facility: If a healthcare facility 
does not receive a copy of the manifest with the handwritten signature 
of the owner or operator of the designated facility within 60 days of 
the date the non-creditable hazardous waste pharmaceuticals were 
accepted by the initial transporter, the healthcare facility must 
submit:
    (A) A legible copy of the original manifest, indicating that the 
healthcare facility has not received confirmation of delivery, to the 
EPA Regional Administrator for the Region in which the healthcare 
facility is located, and
    (B) A handwritten or typed note on the manifest itself, or on an 
attached sheet of paper, stating that the return copy was not received 
and explaining the efforts taken to locate the non-creditable hazardous 
waste pharmaceuticals and the results of those efforts.
    (ii) For shipments rejected by the designated facility and shipped 
to an alternate facility: If a healthcare facility does not receive a 
copy of the manifest for a rejected shipment of the non-creditable 
hazardous waste pharmaceuticals that is forwarded by the designated 
facility to an alternate facility (using appropriate manifest 
procedures), with the handwritten signature of the owner or operator of 
the alternate facility within 60 days of the date the waste was 
accepted by the initial transporter forwarding the shipment of non-
creditable hazardous waste pharmaceuticals from the designated facility 
to the alternate facility, the healthcare facility must submit:
    (A) A legible copy of the original manifest, indicating that the 
healthcare facility has not received confirmation of delivery, to the 
EPA Regional Administrator for the Region in which the healthcare 
facility is located, and
    (B) A handwritten or typed note on the manifest itself, or on an 
attached sheet of paper, stating that the return copy was not received 
and explaining the efforts taken to locate the non-creditable hazardous 
waste pharmaceuticals and the results of those efforts.
    (3) Additional reports. The EPA Regional Administrator may require 
healthcare facilities to furnish additional reports concerning the 
quantities and disposition of non-creditable hazardous waste 
pharmaceuticals.
    (j) Recordkeeping by healthcare facilities for non-creditable 
hazardous waste pharmaceuticals. (1) A healthcare facility must keep a 
copy of each manifest signed in accordance with Sec.  262.23(a) for 
three years or until it receives a signed copy from the designated 
facility which received the non-creditable hazardous waste 
pharmaceuticals. This signed copy must be retained as a record for at 
least three years from the date the waste was accepted by the initial 
transporter.
    (2) A healthcare facility must keep a copy of each exception report 
for a period of at least three years from the date of the report.
    (3) A healthcare facility must keep records of any test results, 
waste analyses, or other determinations made to support its hazardous 
waste determination(s) for at least three years from the date of the 
test, analysis, or other determination.
    (4) The periods of retention referred to in this section are 
extended automatically during the course of any unresolved enforcement 
action regarding the regulated activity, or as requested by the EPA 
Regional Administrator.
    (k) Response to releases of non-creditable hazardous waste 
pharmaceuticals at healthcare facilities. (1) A healthcare facility 
must immediately contain all releases of non-creditable hazardous waste 
pharmaceuticals and other residues from non-creditable hazardous waste 
pharmaceuticals.
    (2) A healthcare facility must determine whether any material 
resulting from the release is a non-creditable hazardous waste 
pharmaceutical, and if so, must manage the non-creditable hazardous 
waste pharmaceutical residues and spill clean-up materials in 
accordance with the requirements of this subpart.
    (l) Long-term care facilities that manage non-creditable hazardous 
waste pharmaceuticals. A healthcare facility that is a long-term care 
facility and that has individuals that administer their own 
pharmaceuticals must collect any unused non-creditable hazardous waste 
pharmaceuticals from those self-administering individuals and manage 
them in accordance with this subpart.
    (m) Accepting creditable and non-creditable hazardous waste 
pharmaceuticals from an off-site healthcare facility that is a CESQG. A 
healthcare facility may accept creditable and non-creditable hazardous 
waste pharmaceuticals from an off-site healthcare facility that is a 
conditionally exempt small quantity generator under Sec.  261.5, 
without a permit or without having interim status, provided the 
receiving healthcare facility:
    (1) Is under the control of the same person, as defined in Sec.  
260.10, as the conditionally exempt small quantity generator healthcare 
facility that is sending the hazardous waste pharmaceuticals off-site 
or has a contractual relationship whereby the receiving healthcare 
facility supplies pharmaceuticals to the conditionally exempt small 
quantity generator healthcare facility,
    (2) Is operating under this subpart for the management of its 
hazardous waste pharmaceuticals,
    (3) Manages the non-creditable hazardous waste pharmaceuticals that 
it receives from off-site in compliance with this subpart, and
    (4) Keeps records of the hazardous waste pharmaceuticals shipments 
it receives from off-site for 3 years from the date that the shipment 
is received.

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

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

[[Page 58087]]

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

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

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

Sec.  266.505  Prohibition of sewering hazardous waste pharmaceuticals.

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

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

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

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

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

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

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

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

[[Page 58088]]

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

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

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

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

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

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

[[Page 58089]]

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

[[Page 58090]]

    (10) A pharmaceutical reverse distributor that is not a 
pharmaceutical manufacturer must evaluate a potentially creditable 
hazardous waste pharmaceutical within 21 calendar days of arriving at 
the pharmaceutical reverse distributor to establish whether it is 
destined for another pharmaceutical reverse distributor for further 
evaluation or verification of manufacturer's credit or for a permitted 
or interim status treatment, storage or disposal facility. This 21 
calendar days is part of the 90 calendar days allowed for on-site 
accumulation.
    (i) A potentially creditable hazardous waste pharmaceutical that is 
destined for another pharmaceutical reverse distributor is still 
considered a ``potentially creditable hazardous waste pharmaceutical'' 
and must be managed in accordance with paragraph (b) of this section.
    (ii) A potentially creditable hazardous waste pharmaceuticals that 
is destined for a permitted or interim status treatment, storage or 
disposal facility is considered an ``evaluated hazardous waste 
pharmaceutical'' and must be managed in accordance with paragraph (c) 
of this section.
    (11) A pharmaceutical reverse distributor that is a pharmaceutical 
manufacturer must evaluate a potentially creditable hazardous waste 
pharmaceutical to verify manufacturer's credit within 21 calendar days 
of arriving at the facility and must manage the evaluated hazardous 
waste pharmaceuticals in accordance with paragraph (c) of this section. 
This 21 calendar days is part of the 90 calendar days allowed for on-
site accumulation.
    (b) Additional standards for pharmaceutical reverse distributors 
managing potentially creditable hazardous waste pharmaceuticals 
destined for another pharmaceutical reverse distributor. A 
pharmaceutical reverse distributor that does not have a permit or 
interim status must comply with the following conditions, in addition 
to the requirements in paragraph (a) of this section, for the 
management of potentially creditable hazardous waste pharmaceuticals 
that are destined for another pharmaceutical reverse distributor for 
further evaluation or verification of manufacturer's credit:
    (1) A pharmaceutical reverse distributor that receives potentially 
creditable hazardous waste pharmaceuticals from a healthcare facility 
must send those potentially creditable hazardous waste pharmaceuticals 
to another pharmaceutical reverse distributor within 90 days from when 
the potentially creditable hazardous waste pharmaceuticals arrived or 
follow paragraph (c) of this section for evaluated hazardous waste 
pharmaceuticals.
    (2) A pharmaceutical reverse distributor that receives potentially 
creditable hazardous waste pharmaceuticals from another pharmaceutical 
reverse distributor must send those potentially creditable hazardous 
waste pharmaceuticals to a pharmaceutical reverse distributor that is a 
pharmaceutical manufacturer within 90 days from when the potentially 
creditable hazardous waste pharmaceuticals arrived or follow paragraph 
(c) of this section for evaluated hazardous waste pharmaceuticals.
    (3) A pharmaceutical reverse distributor must ship potentially 
creditable hazardous waste pharmaceuticals destined for another 
pharmaceutical reverse distributor in accordance with Sec.  266.509.
    (4) Recordkeeping. A pharmaceutical reverse distributor must keep 
the following records (paper or electronic) for each shipment of 
potentially creditable hazardous waste pharmaceuticals that it 
initiates to another pharmaceutical reverse distributor, for at least 
three years from the date of shipment:
    (i) A copy of the advance notification provided to the 
pharmaceutical reverse distributor;
    (ii) The confirmation of delivery; and
    (iii) The shipping papers or bill of lading.
    (c) Additional standards for pharmaceutical reverse distributors 
managing evaluated hazardous waste pharmaceuticals. A pharmaceutical 
reverse distributor that does not have a permit or interim status must 
comply with the following conditions, in addition to the requirements 
of paragraph (a) of this section, for the management of evaluated 
hazardous waste pharmaceuticals:
    (1) Accumulation area at the pharmaceutical reverse distributor. A 
pharmaceutical reverse distributor must designate an on-site 
accumulation area where it will accumulate evaluated hazardous waste 
pharmaceuticals.
    (2) Weekly inspections of on-site accumulation area. A 
pharmaceutical reverse distributor must inspect its on-site 
accumulation area at least weekly, looking at containers for leaks and 
for deterioration caused by corrosion or other factors, as well as for 
signs of diversion.
    (3) Personnel training at a pharmaceutical reverse distributor. 
Personnel at a pharmaceutical reverse distributor that handle evaluated 
hazardous waste pharmaceuticals are subject to the training 
requirements of Sec.  265.16.
    (4) Labeling and management of containers at on-site accumulation 
area. A pharmaceutical reverse distributor accumulating evaluated 
hazardous waste pharmaceuticals in containers in an on-site 
accumulation area must:
    (i) Label the containers with the words, ``hazardous waste 
pharmaceuticals'';
    (ii) Ensure the containers are in good condition and managed to 
prevent leaks;
    (iii) Use containers that are made of or lined with materials which 
will not react with, and are otherwise compatible with, the evaluated 
hazardous waste pharmaceuticals, so that the ability of the container 
to contain the waste is not impaired;
    (iv) Keep containers closed, if holding liquid or gel evaluated 
hazardous waste pharmaceuticals. If the liquid or gel evaluated 
hazardous waste pharmaceuticals are in their original, intact, sealed 
packaging; or repackaged, intact, sealed packaging, they are considered 
to meet the closed container standard;
    (v) A pharmaceutical reverse distributor that manages ignitable or 
reactive evaluated hazardous waste pharmaceuticals, or that mixes or 
commingles incompatible evaluated hazardous waste pharmaceuticals must 
manage the container so that it does not have the potential to:
    (A) Generate extreme heat or pressure, fire or explosion, or 
violent reaction;
    (B) Produce uncontrolled toxic mists, fumes, dusts, or gases in 
sufficient quantities to threaten human health;
    (C) Produce uncontrolled flammable fumes or gases in sufficient 
quantities to pose a risk of fire or explosions;
    (D) Damage the structural integrity of the container of hazardous 
waste pharmaceuticals; or
    (E) Through other like means threaten human health or the 
environment; and
    (vi) Accumulate evaluated hazardous waste pharmaceuticals that are 
prohibited from being combusted because of the dilution prohibition of 
Sec.  268.3(c) (e.g., arsenic trioxide (P012)) in separate containers 
from other evaluated hazardous waste pharmaceuticals at the 
pharmaceutical reverse distributor.
    (5) Hazardous waste numbers. Containers of evaluated hazardous 
waste pharmaceuticals must be marked with the applicable hazardous 
waste number(s) (i.e., hazardous waste code(s)) prior to transport off-
site.
    (6) Shipments. A pharmaceutical reverse distributor must ship 
evaluated hazardous waste pharmaceuticals that

[[Page 58091]]

are destined for a permitted or interim status treatment, storage or 
disposal facility, in accordance with Sec.  266.508(a).
    (7) Procedures for a pharmaceutical reverse distributor for 
managing rejected shipments. A pharmaceutical reverse distributor who 
sends a shipment of evaluated hazardous waste pharmaceuticals to a 
designated facility with the understanding that the designated facility 
can accept and manage the waste, and later receives that shipment back 
as a rejected load in accordance with the manifest discrepancy 
provisions of Sec.  264.72 or Sec.  265.72 of this chapter, may 
accumulate the returned hazardous waste pharmaceuticals on-site for up 
to an additional 90 days in the on-site accumulation area provided the 
rejected or returned shipment is managed in accordance with paragraph 
(a) of this section. Upon receipt of the returned shipment, the 
pharmaceutical reverse distributor must:
    (i) Sign either:
    (A) Item 18c of the original manifest if the original manifest was 
used for the returned shipment; or
    (B) Item 20 of the new manifest if a new manifest was used for the 
returned shipment;
    (ii) Provide the transporter a copy of the manifest;
    (iii) Within 30 days of delivery of the rejected shipment of the 
evaluated hazardous waste pharmaceuticals, send a copy of the manifest 
to the designated facility that returned the shipment to the 
pharmaceutical reverse distributor; and
    (iv) Transport or offer for transport the returned shipment of 
evaluated hazardous waste pharmaceuticals in accordance with the 
shipping standards of Sec.  266.508(b).
    (8) Land disposal restrictions. Evaluated hazardous waste 
pharmaceuticals are subject to the Land Disposal Restrictions of 40 CFR 
part 268. A pharmaceutical reverse distributor that accepts potentially 
creditable hazardous waste pharmaceuticals from off-site must comply 
with the land disposal restrictions in accordance with Sec.  268.7(a) 
requirements.
    (9) Reporting by a pharmaceutical reverse distributor for evaluated 
hazardous waste pharmaceuticals. (i) Biennial report by a 
pharmaceutical reverse distributor. A pharmaceutical reverse 
distributor that ships evaluated hazardous waste pharmaceuticals off-
site must prepare and submit a single copy of a biennial report to the 
EPA Regional Administrator by March 1 of each even numbered year in 
accordance with Sec.  262.41, except Sec.  262.41(a)(7).
    (ii) Exception reporting by a pharmaceutical reverse distributor 
for a missing copy of the manifest. (A) For shipments from a 
pharmaceutical reverse distributor to a designated facility:
    (1) If a pharmaceutical reverse distributor does not receive a copy 
of the manifest with the handwritten signature of the owner or operator 
of the designated facility within 35 days of the date the evaluated 
hazardous waste pharmaceuticals were accepted by the initial 
transporter, the pharmaceutical reverse distributor must contact the 
transporter or the owner or operator of the designated facility to 
determine the status of the evaluated hazardous waste pharmaceuticals.
    (2) A pharmaceutical reverse distributor must submit an exception 
report to the EPA Regional Administrator for the Region in which the 
pharmaceutical reverse distributor is located if it has not received a 
copy of the manifest with the handwritten signature of the owner or 
operator of the designated facility within 45 days of the date the 
evaluated hazardous waste pharmaceutical was accepted by the initial 
transporter. The exception report must include:
    (i) A legible copy of the manifest for which the pharmaceutical 
reverse distributor does not have confirmation of delivery; and
    (ii) A cover letter signed by the pharmaceutical reverse 
distributor, or its authorized representative, explaining the efforts 
taken to locate the evaluated hazardous waste pharmaceuticals and the 
results of those efforts.
    (B) For shipments rejected by the designated facility and shipped 
to an alternate facility:
    (1) A pharmaceutical reverse distributor that does not receive a 
copy of the manifest with the handwritten signature of the owner or 
operator of the alternate facility within 35 days of the date the 
evaluated hazardous waste pharmaceutical was accepted by the initial 
transporter must contact the transporter or the owner or operator of 
the alternate facility to determine the status of the hazardous waste. 
The 35 day timeframe begins the date the waste is accepted by the 
transporter forwarding the hazardous waste shipment from the designated 
facility to the alternate facility.
    (2) A pharmaceutical reverse distributor must submit an Exception 
Report to the EPA Regional Administrator for the Region in which the 
pharmaceutical reverse distributor is located if it has not received a 
copy of the manifest with the handwritten signature of the owner or 
operator of the alternate facility within 45 days of the date the 
hazardous waste was accepted by the initial transporter. The 45-day 
timeframe begins the date the hazardous waste is accepted by the 
transporter forwarding the hazardous waste shipment from the designated 
facility to the alternate facility. The Exception Report must include:
    (i) A legible copy of the manifest for which the generator does not 
have confirmation of delivery; and
    (ii) A cover letter signed by the pharmaceutical reverse 
distributor, or its authorized representative, explaining the efforts 
taken to locate the evaluated hazardous waste pharmaceuticals and the 
results of those efforts.
    (10) Recordkeeping by a pharmaceutical reverse distributor for 
evaluated hazardous waste pharmaceuticals. (i) A pharmaceutical reverse 
distributor must keep a log (written or electronic) of the weekly 
inspections of the on-site accumulation area, required by paragraph 
(c)(2) of this section. This log must be retained as a record for at 
least three years from the date of the inspection.
    (ii) A pharmaceutical reverse distributor must keep a copy of each 
manifest signed in accordance with Sec.  262.23(a) for three years or 
until it receives a signed copy from the designated facility which 
received the evaluated hazardous waste pharmaceutical. This signed copy 
must be retained as a record for at least three years from the date the 
evaluated hazardous waste pharmaceutical was accepted by the initial 
transporter.
    (iii) A pharmaceutical reverse distributor must keep a copy of each 
biennial report for at least three years from the due date of the 
report.
    (iv) A pharmaceutical reverse distributor must keep a copy of each 
exception report for at least three years from the submission of the 
report.
    (v) A pharmaceutical reverse distributor must keep records to 
document personnel training, in accordance with Sec.  265.16.
    (d) When a pharmaceutical reverse distributor must have a permit. A 
pharmaceutical reverse distributor is an operator of a hazardous waste 
treatment, storage or disposal facility and is subject to the 
requirements of 40 CFR parts 264, 265, and 267 and the permit 
requirements of 40 CFR part 270, if the pharmaceutical reverse 
distributor:
    (1) Does not meet the conditions of this section;
    (2) Accepts manifested hazardous waste from off-site; or
    (3) Treats or disposes of hazardous waste on-site.

[[Page 58092]]

PART 268--LAND DISPOSAL RESTRICTIONS

0
9. The authority citation for part 268 continues to read as follows:

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

0
10. Amend Section 268.7 by revising the section heading and the 
paragraph (a) subject heading to read as follows:

Sec.  268.7  Testing, tracking, and recordkeeping requirements for 
generators, pharmaceutical reverse distributors, treaters, and disposal 
facilities.

    (a) Requirements for generators and pharmaceutical reverse 
distributors: * * *
* * * * *
0
11. Amend Sec.  268.50 by adding paragraphs (a)(4) and (5) to read as 
follows:

Sec.  268.50  Prohibitions on storage of restricted wastes.

    (a) * * *
    (4) A healthcare facility accumulates such wastes in containers on-
site solely for the purpose of the accumulation of such quantities of 
hazardous waste pharmaceuticals as necessary to facilitate proper 
recovery, treatment, or disposal and the healthcare facility complies 
with the requirements in Sec.  266.502 of this chapter.
    (5) A pharmaceutical reverse distributor accumulates such wastes in 
containers on-site solely for the purpose of the accumulation of such 
quantities of hazardous waste pharmaceuticals as necessary to 
facilitate proper recovery, treatment, or disposal and the 
pharmaceutical reverse distributor complies with Sec.  266.510 of this 
chapter.
* * * * *

PART 273--STANDARDS FOR UNIVERSAL WASTE MANAGEMENT

0
12. The authority citation for part 273 continues to read as follows:

    Authority: 42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.

0
13. Amend Sec.  273.80 by revising paragraph (a) and adding paragraph 
(d) to read as follows:

Sec.  273.80  General.

    (a) Except as provided in paragraph (d), any person seeking to add 
a hazardous waste or category of hazardous waste to this part may 
petition for a regulatory amendment under this subpart and 40 CFR 
260.20 and 260.23.
* * * * *
    (d) Pharmaceutical hazardous waste is regulated by 40 CFR part 266, 
subpart P and may not be added as a category of hazardous waste for 
management under this part.

[FR Doc. 2015-23167 Filed 9-24-15; 8:45 am]
 BILLING CODE 6560-50-P
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