[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Pages 58014-58092]
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: [email protected] 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:
[email protected].
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
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NAICS codes Description of NAICS code
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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.
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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).
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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 (<=0.3%) as the sole active ingredient (U248).
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\8\ Commercial chemical product refers to a chemical substance
which is manufactured or formulated for commercial or manufacturing
use which consists of the commercially pure grade of the chemical,
any technical grades of the chemical that are produced or marketed
and all formulations in which the chemical is the sole active
ingredient (Sec. 261.33(d)).
\9\ The P- and U-lists deem as hazardous certain commercial
chemical products when they are discarded or intended to be
discarded. These listings consist of commercial chemical products
having the generic names listed, off-specification species,
container residues, and spill residues. Chemicals on the P-list are
identified as acute hazardous wastes and are regulated at lower
amounts than those on the U-list.
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Second, if the discarded pharmaceutical is not on the P- or U-list,
then the pharmaceutical may be a hazardous waste if it exhibits one or
more of the hazardous waste characteristics. Under the federal
requirements (Sec. 261.21-24), a waste is a characteristic hazardous
waste if it is ignitable (D001), corrosive (D002), reactive (D003) or
toxic (D004-D043).\10\ A number of pharmaceuticals are prepared in
alcohol, which may cause the waste to be hazardous due to ignitability
(D001), even if the active pharmaceutical ingredient itself is not
considered hazardous waste. The Regulatory Impact Analysis for this
proposed rule includes a list of pharmaceuticals that, to our
knowledge, are hazardous waste when disposed, although this list should
not be considered exhaustive (see the docket for this proposed rule
EPA-HQ-RCRA-2007-0932).
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\10\ The toxicity characteristic (TC) indicates that the waste
is likely to leach concentrations of contaminants that may be
harmful, and TC waste is identified using the Toxicity
Characteristic Leaching Procedure (see Sec. 261.24). Examples of TC
constituents that may be present in pharmaceuticals include, but are
not limited to: Arsenic, barium, cadmium, selenium, silver,
chloroform, lindane and m-cresol.
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Since the hazardous waste rules were initially promulgated, EPA has
issued several clarifications regarding the regulatory status of
certain commercial chemical products on the P- and U-lists, and these
clarifications have affected the regulatory status of some active
pharmaceutical ingredients.\11\ For example, EPA recently clarified
that phentermine hydrochloride and other phentermine salts are not
included within the scope of the P046 (phentermine) listing.\12\
Similarly, EPA has also clarified that epinephrine salts are not
included in the epinephrine listing (P042).\13\ In addition, medicinal
nitroglycerin typically is not considered P081 since the medicinal form
of this compound generally does not exhibit the characteristic of
reactivity for which nitroglycerin was originally listed.\14\
Furthermore, in a 1998 memo, EPA clarified that the U034 listing
includes both anhydrous chloral and chloral hydrate.\15\ And in a 2010
memo, EPA stated that unused nicotine patches, gums and lozenges are
finished dosage forms of nicotine and therefore are regulated as P075
when discarded.\16\
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\11\ In addition, in December 2008, the Agency proposed to
regulate hazardous waste pharmaceuticals under the Universal Waste
rule. However, based on the comments received, the Agency decided
not to finalize that proposal and to proceed with a sector-based
approach. (See section IV.C. of the preamble for further discussion
of the Universal Waste proposal.)
\12\ Memo from Devlin to RCRA Division Directors, February 17,
2012 (RCRA Online #14831) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/A5C07D01188ECA59852579EA0067CDB1/
$file/14831.pdf.
\13\ Memo December 1, 1994 (RCRA Online #13718) http://
yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/
1C1DEB3648A62A868525670F006BCCD2/$file/13718.pdf.
\14\ Memo from Dellinger to Smith, March 18, 2003 (RCRA Online
#14654) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/7ACFEC572DE8897F85256D1600748BCB/
$file/14654.pdf.
\15\ Memo from Brandes to Knauss, April 6, 1998 (RCRA Online
#14175) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/7417D2556AD322FA852568E300468198/
$file/14175.pdf.
\16\ Memo from Dellinger to Smith, August 23, 2010 (RCRA Online
#14817) http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/209444BADDA4ECDC852577ED00624E8F/
$file/14817.pdf.
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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 [email protected].
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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.
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\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.
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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\
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\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.
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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.
---------------------------------------------------------------------------
\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.
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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):
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\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.
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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.
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\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.
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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.
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\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.
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\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\
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\34\ For additional information about RCRA hazardous waste
listings and characteristics, see: http://www.epa.gov/osw/hazard/wastetypes/index.htm.
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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.
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\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.
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\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.
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\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
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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 <=50 mg/kg,
pharmaceuticals that are carcinogenic or endocrine disrupting
compounds, and vitamin/mineral preparations containing heavy metals.
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\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.
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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).
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\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.
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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.
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\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 <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 waste listed in Sec. 261.31 or Sec.
261.33(e) per calendar month, provided it does not accumulate on-
site at any time >1 kg of acute hazardous waste or >1000 kg of
hazardous waste.
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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.
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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.
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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.
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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.
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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 < 0.5% filterable solids), 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 <260 mg/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).
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\78\ DEA's final rule for disposal of controlled substances: 79
FR 53520; September 9, 2104.
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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.
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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.
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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.
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\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.
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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\
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\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.
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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:
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\93\ Comment EPA-HQ-RCRA-2007-0932-0125.
\94\ Comment EPA-HQ-RCRA-2007-0932-0068.
\95\ Comment EPA-HQ-RCRA-2012-0426-0025.
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[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\
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\96\ Content is copied from http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx (accessed
May 13, 2015).
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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.
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\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.
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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.
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\98\ See 73 FR 73529; December 2, 2008.
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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.
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\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.
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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\
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\101\ Kansas State University. January 31, 2008. Nancy J.
Larson. Pharmaceutical Waste Outreach Project.
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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\
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\102\ King County Pharmaceutical Waste Survey Final Report. King
County, Washington. April 2003.
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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\
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\103\ The Albany Medical Center, October 29, 2009, Russell F.
Mankes, Progress Report on the Source Reduction Demonstration
Project, EPA Grant #X9-97256506-0.
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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\
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\104\ Health Services Industry Study: Management and Disposal of
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
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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\
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\105\ Ruhoy and Daughton; Beyond the medicine cabinet: An
analysis of where and why medications accumulate; Environment
International 34(2008) 1157-1169.
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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.
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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.
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\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.
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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.
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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.
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[[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.
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\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.
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\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.
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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\
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\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.
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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.
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\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)).
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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.
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\126\ Rudzinski to RCRA Division Directors, September 26, 2012,
RCRA Online #14833 http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/fcb11dd6f61d4b1685257afe005eb5ce!OpenDocument.
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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:
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\127\ Additionally, acute hazardous wastes are included on the
F-list of Sec. 261.31; however none of those acute hazardous wastes
are pharmaceuticals.
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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.
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\128\ We are assuming that containers that hold pharmaceuticals
are in containers less than 119 gallons in size.
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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:
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\129\ Rudzinski to RCRA Division Directors, November 11, 2011,
RCRA Online #14827 http://yosemite.epa.gov/osw/rcra.nsf/
0c994248c239947e85256d090071175f/57B21F2FE33735128525795F00610F0F/
$file/14827.pdf.
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(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\
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\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.
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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\
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\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#)
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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\
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\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)
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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.
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\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.)
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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\
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\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.
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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).
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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.
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\138\ Pharmaceutical Universal Waste proposal, 73 FR 73529;
December 2, 2008.
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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.
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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\
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\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.
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\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.
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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.
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\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.
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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.
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\144\ Meeting with representatives from CVS/Caremark (November
8, 2012); see the docket for meeting notes (EPA-HQ-RCRA-2007-0932).
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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.
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\145\ See all the responses EPA received from pharmaceutical
reverse distributors in the docket for this proposed rulemaking
(EPA-HQ-RCRA-2007-0932).
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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\
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\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).
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\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.
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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.
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\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.
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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.
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\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).
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EPA is also exploring ways to identify new sources of information,
along with alternative approaches that can most efficiently address
these concerns. EPA is using the opportunity in this preamble to seek
stakeholders' input on the best course of action concerning regulation
of additional pharmaceuticals as hazardous wastes. It is also an
opportunity for stakeholders to provide additional information that
they may have about potentially hazardous pharmaceuticals. Thus, before
deciding on a possible proposal to list additional pharmaceuticals as
hazardous wastes, we request comment on the September 2011 final
report, and solicit information regarding additional potentially
hazardous pharmaceuticals. We request information on the sources and
identity of additional potentially hazardous pharmaceuticals along with
annual product generation data, annual waste generation data, use
information, toxicity data, waste storage and handling information, and
disposal information.
In addition, we request stakeholder input for alternative
approaches to making hazardous waste listing determinations for
pharmaceuticals that do not meet the acute hazardous criteria. Based on
the existing listing determination process described previously for
non-acute wastes, there is no single toxicity effect (e.g.,
LD50) to readily determine whether or not the waste is
hazardous under RCRA subtitle C. As such, we are seeking ideas on
alternative approaches to more efficiently evaluate potentially
hazardous non-acute discarded pharmaceuticals. For example, should EPA
develop and promulgate new criteria specific to discarded
pharmaceuticals that would allow it to establish a single hazardous
waste listing for all discarded pharmaceuticals that meet the new
criteria? Such approaches could also include consideration of whether
discarded pharmaceuticals are already managed under a regulatory scheme
that prevents mismanagement that a hazardous waste designation would
otherwise address (similar to the hazardous waste listing factor that
takes into account ``actions taken by other governmental agencies or
regulatory programs''). We also are seeking information on any
innovative processes or programs that states may have for identifying,
reviewing, and making a hazardous waste determination for discarded
pharmaceuticals.
The Agency emphasizes that no regulatory action is being proposed
with respect to expanding the number of pharmaceuticals that are
considered hazardous waste. We will use the comments we receive to help
inform how to proceed with evaluating discarded pharmaceuticals as
listed or characteristic hazardous wastes. Any action taken would be
part of a separate, proposed rulemaking in the future.
VIII. Request for Comment on EPA's Efforts To Amend the Acute Hazardous
Waste Listing for Nicotine and Salts (Hazardous Waste No. P075)
A. Background
In 1980, as part of its final and interim final regulations
implementing Section 3001 of RCRA, EPA promulgated the list of
commercial chemical products or manufacturing chemical intermediates
(40 CFR 261.33) that are hazardous wastes if they are discarded or
intended to be discarded, which included nicotine and salts (45 FR
33124; May 19, 1980). The phrase ``commercial chemical product or
manufacturing chemical intermediate'' refers to a ``chemical substance
which is manufactured or formulated for commercial or manufacturing use
which consists of the commercially pure grade of the chemical, any
technical grades of the chemical that are produced or marketed, and all
formulations in which the chemical is the sole active ingredient'' (see
the Comment following 40 CFR 261.33(d)). A chemical substance is listed
in 40 CFR 261.33(e) as an acutely hazardous waste if it meets any of
the criteria in 40 CFR 261.11(a)(2), which states that the waste ``has
been found to be fatal to humans in low doses or, in the absence of
data on human toxicity, it has been shown in studies to have an oral LD
50 toxicity (rat) of less than 50 milligrams per kilogram, an
inhalation LC 50 toxicity (rat) of less than 2 milligrams per liter, or
a dermal LD 50 toxicity (rabbit) of less than 200 milligrams per
kilogram or is otherwise capable of causing or significantly
contributing to an increase in serious irreversible, or incapacitating
reversible, illness.''
B. Basis for Original Listing
EPA listed nicotine and salts (referred to commonly as just
nicotine) as acutely hazardous waste (P075) in Sec. 261.33(e) based on
an estimated oral LD50 toxicity to humans of 1 mg/kg and a dermal LD50
toxicity to rabbits of 50 mg/kg.\159\ As discussed previously, for
humans, the standard in the regulations for acute toxicity is ``fatal
to humans in low doses'' (see Sec. 261.11(a)(2)). EPA's Background
Document for Section 261.33 from 1981 provides a basis for what is
meant by ``fatal to humans in low doses'' for chemicals that have been
given through the oral route (``fatal to humans upon ingestion of <=100
mg/kg''). The estimated oral LD50 to humans of 1 mg/kg falls within the
criteria for ``fatal to humans in low doses.'' However, the background
listing document and its references do not provide sufficient detail to
determine the concentration of nicotine that was used to establish the
estimated oral LD50 in humans.
---------------------------------------------------------------------------
\159\ See EPA's listing Background Document for Section 261.33,
April 1981, in the docket for this proposed rule (EPA-HQ-RCRA-2007-
0932).
---------------------------------------------------------------------------
C. Rationale for EPA's Efforts To Amend the P075 Listing
On February 14, 2014, EPA published a Notice of Data Availability
(NODA) and Request for Comment (79 FR 8926) entitled ``Hazardous Waste
Management and the Retail Sector: Providing and Seeking Information on
Practices to Enhance Effectiveness to the RCRA Program.'' EPA received
44 comments in response to this NODA, many of which included comments
related to pharmaceuticals, in particular comments concerning expired
or returned low-concentration nicotine-containing smoking cessation
products and e-cigarettes. The most detailed comments concerning the
unsold low-concentration nicotine products were jointly submitted by
the Retail Industry Leaders Association (RILA), the Food Marketing
Institute (FMI), the National Association of Chain Drug Stores (NACDS),
the National Retail Federation, and their members (referred to as the
retail associations, retailers, or
[[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.
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\163\ EPA notes that decisions regarding whether a state rule is
more stringent or broader in scope than the federal program are made
when the Agency authorizes state programs.
---------------------------------------------------------------------------
B. Effect on State Authorization
This action proposes to add a new subpart P to 40 CFR part 266, and
it is being proposed in part under the authority of HSWA and in part
under non-HSWA authority. The bulk of 40 CFR part 266, subpart P is
being proposed under non-HSWA authority. Thus, when finalized, the
amendments promulgated under non-HSWA authority would be applicable on
the effective date only in those states that do not have final
authorization of their base RCRA programs. However, the prohibition of
sewering pharmaceutical hazardous wastes (Sec. 266.504) is being
proposed under HSWA authority in section 3018 of RCRA. Thus, when
finalized, the amendments promulgated under the authority of HSWA would
be applicable on the effective date of the final rule in all states.
Moreover, authorized states are required to modify
[[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
[email protected], 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