[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Rules and Regulations]
[Pages 5816-5950]
[FR Doc No: 2019-01298]

Vol. 84

Friday,

No. 36

February 22, 2019

Part II

Environmental Protection Agency

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40 CFR Parts 261, 262, 264, et al.

Management Standards for Hazardous Waste Pharmaceuticals and Amendment
to the P075 Listing for Nicotine; Final Rule

Federal Register / Vol. 84 , No. 36 / Friday, February 22, 2019 /
Rules and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 261, 262, 264, 265, 266, 268, 270, and 273

[EPA-HQ-RCRA-2007-0932; FRL-9988-26-OLEM]
RIN 2050-AG39

Management Standards for Hazardous Waste Pharmaceuticals and
Amendment to the P075 Listing for Nicotine

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Some pharmaceuticals are regulated as hazardous waste under
the Resource Conservation and Recovery Act (RCRA) when discarded. This
final rule adds regulations for the management of hazardous waste
pharmaceuticals by healthcare facilities and reverse distributors.
Healthcare facilities (for both humans and animals) and reverse
distributors will manage their hazardous waste pharmaceuticals under
this new set of sector-specific standards in lieu of the existing
hazardous waste generator regulations. Among other things, these new
regulations prohibit the disposal of hazardous waste pharmaceuticals
down the drain and eliminates the dual regulation of RCRA hazardous
waste pharmaceuticals that are also Drug Enforcement Administration
(DEA) controlled substances. The new rules also maintain the household
hazardous waste exemption for pharmaceuticals collected during
pharmaceutical take-back programs and events, while ensuring their
proper disposal. The new rules codify Environmental Protection Agency
(EPA)'s prior policy on the regulatory status of nonprescription
pharmaceuticals going through reverse logistics. Additionally, EPA is
excluding certain U.S. Food and Drug Administration (FDA) approved
over-the-counter (OTC) nicotine replacement therapies (NRTs) from
regulation as hazardous waste and is establishing a policy on the
regulatory status of unsold retail items that are not pharmaceuticals
and are managed via reverse logistics, fulfilling the commitment we
made in the Retail Strategy of September 2016.

DATES: This final rule is effective on August 21, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-RCRA-2007-0932. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Kristin Fitzgerald, Materials Recovery
and Waste Management Division, Office of Resource Conservation and
Recovery (5304P), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>or Brian Knieser, Materials
Recovery and Waste Management Division, Office of Resource Conservation
and Recovery (5304P), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (703)
347-8769; email address<EMAIL_ADDRESS>Also see the EPA's
website at https://www.epa.gov/hwgenerators/management-pharmaceutical-hazardous-waste.

SUPPLEMENTARY INFORMATION:

Table of Contents

    The information presented in this preamble is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. What action is the Agency taking?
    C. What is the Agency's statutory authority for taking this
action?
    D. What are the incremental costs and benefits of this action?
II. List of Acronyms
III. Rationale for the Final Rule
IV. Background
    A. Summary of the Proposal
    B. Retail Sector Notice of Data Availability (NODA)
    C. Retail Strategy
    D. EPA Inspector General Report
V. Amendment to the Acute Hazardous Waste Listing for Nicotine and
Salts (Hazardous Waste No. P075)
    A. Background
    B. Summary of the Proposal
    C. Summary of Comments
    D. Final Rule Provisions
    E. Comments and Responses
VI. Reverse Distribution and Reverse Logistics
    A. Summary
    B. Background
    C. EPA's Proposed Regulations for Reverse Distribution of
Pharmaceuticals
    D. EPA's Final Reverse Distribution Regulation and Reverse
Logistics Policy
    E. Applicability of the Household Hazardous Waste Exemption to
Retail Items
VII. Scope of the Final Rule
    A. What facilities are subject to the final rule?
    B. What facilities are not subject to the final rule?
    C. Scope of Hazardous Wastes Addressed by This Final Rule
    D. Wastes Generated at Healthcare Facilities That Are Not
Included in the Scope of this Final Rule
VIII. What terms are defined in this final rule? (Sec.  266.500)
    A. Definition of Pharmaceutical
    B. Definition of Hazardous Waste Pharmaceutical
    C. Definition of Reverse Distributor
    D. Definition of Potentially Creditable Hazardous Waste
Pharmaceutical
    E. Definition of Non-Creditable Hazardous Waste Pharmaceutical
    F. Definition of Evaluated Hazardous Waste Pharmaceutical
    G. Definition of Household Waste Pharmaceutical
    H. Definition of Non-Hazardous Waste Pharmaceutical
    I. Definition of Non-Pharmaceutical Hazardous Waste
    J. Definition of Healthcare Facility
    K. Definition of Long-Term Care Facility
IX. Applicability (Sec.  266.501)
    A. What facilities are subject to the final rule?
    B. What facilities or pharmaceuticals are not subject to the
final rule? (Sec. Sec.  266.501(c) and 266.501(f) and 266.501(g))
    C. Do Not Count Hazardous Waste Pharmaceuticals Managed Under
Subpart P Toward Determining Generator Category (Sec. Sec.
262.13(c)(9))
X. Standards for Healthcare Facilities That Manage Non-Creditable
Hazardous Waste Pharmaceuticals (Sec.  266.502)
    A. Notification/Withdrawal Requirements for Healthcare
Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals
(Sec.  266.502(a))
    B. Personnel Training Requirements for Healthcare Facilities
Managing Non-Creditable Hazardous Waste Pharmaceuticals (Sec.
266.502(b))
    C. Healthcare Facilities Making a Hazardous Waste Determination
for Non-Creditable Pharmaceuticals (Sec.  266.502(c))
    D. No Central Accumulation Area and Satellite Accumulation Area
Requirements for Healthcare Facilities Managing Non-Creditable
Hazardous Waste Pharmaceuticals
    E. Container Standards for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(d))
    F. Labeling Standards on Containers for Healthcare Facilities
Managing Non-Creditable Hazardous Waste Pharmaceuticals (Sec.
266.502(e))
    G. Accumulation Time Limits for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(f))
    H. Land Disposal Restrictions for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(g) and
Sec.  266.502(d)(4))
    I. Procedures for Healthcare Facilities Managing Rejected
Shipments of Non-

Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(h))
    J. Reporting Requirements for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(i))
    K. Recordkeeping Requirements for Healthcare Facilities Managing
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(j))
    L. Response to Spills for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(k))
    M. Management of Non-Creditable Hazardous Waste Pharmaceuticals
by Long-Term Care Facilities That Collect Them From Individuals Who
Self-Administer
    N. Healthcare Facilities That Accept Hazardous Waste
Pharmaceuticals From Off-Site Very Small Quantity Generator
Healthcare Facilities (Sec.  266.502(l))
XI. Standards for Healthcare Facilities That Accumulate Potentially
Creditable Hazardous Waste Pharmaceuticals Prior to Shipment To
Reverse Distributors (Sec.  266.503)
    A. Healthcare Facilities Making a Hazardous Waste Determination
for Potentially Creditable Pharmaceuticals (Sec.  266.503(a))
    B. Accepting Potentially Creditable Hazardous Waste
Pharmaceuticals From an Off-Site Healthcare Facility That is a Very
Small Quantity Generator (Sec.  266.503(b))
    C. Accumulation Time, Container Management and Labeling for
Healthcare Facilities Managing Potentially Creditable Hazardous
Waste Pharmaceuticals
    D. No Biennial Reporting for Potentially Creditable Hazardous
Waste Pharmaceuticals Generated at Healthcare Facilities (Sec.
266.503(d))
    E. Recordkeeping Requirements for Healthcare Facilities Managing
Potentially Creditable Hazardous Waste Pharmaceuticals (Sec.
266.503(e))
    F. Response to Spills for Healthcare Facilities Managing
Potentially Creditable Hazardous Waste Pharmaceuticals (Sec.
266.503(f))
XII. How does this rule apply to healthcare facilities that are very
small quantity generators for both their hazardous waste
pharmaceuticals and their non-pharmaceutical hazardous waste? (Sec.
266.504)
    A. Very Small Quantity Generators Using Reverse Distributors
(Sec.  266.504(a))
    B. Off-Site Collection of Hazardous Waste Pharmaceuticals
Generated by Healthcare Facilities (Sec.  266.504(b))
    C. Long-Term Care Facilities That Are Very Small Quantity
Generators Can Dispose Hazardous Waste Pharmaceuticals in Drug
Enforcement Administration Collection Receptacles (Sec.  266.504(c))
    D. Long-Term Care Facilities With 20 Beds or Fewer Are Presumed
To Be Very Small Quantity Generators (Sec.  266.504(d))
XIII. Sewer Disposal Prohibition (Sec.  266.505)
    A. Regulatory Background on the Domestic Sewage Exclusion
    B. Summary of Proposal
    C. Summary of Comments
    D. Final Rule Provisions
    E. Comments and Responses
XIV. Conditional Exemptions for Hazardous Waste Pharmaceuticals That
Are Also Drug Enforcement Administration Controlled Substances and
Household Waste Pharmaceuticals Collected in Take-Back Programs
(Sec.  266.506)
    A. Summary of Proposal
    B. Summary of Comments
    C. Final Rule Provisions
    D. Comments and Responses
XV. Management of Residues in Pharmaceutical Containers (Sec.
266.507)
    A. Regulatory Background
    B. Stock, Dispensing and Unit-Dose Containers (Sec.  266.507(a))
    C. Syringes (Sec.  266.507(b))
    D. Other Containers, Including Delivery Devices (Sec.
266.507(c) & (d))
XVI. Shipping Standards for Hazardous Waste Pharmaceuticals
(Sec. Sec.  266.508 and 266.509)
    A. Shipping Non-Creditable Hazardous Waste Pharmaceuticals From
Healthcare Facilities to Treatment, Storage, and Disposal Facilities
(Sec.  266.508(a))
    B. Shipping Evaluated Hazardous Waste Pharmaceuticals From
Reverse Distributors to Treatment, Storage, and Disposal Facilities
(Sec.  266.508(a))
    C. Shipping Non-Creditable or Evaluated Hazardous Waste
Pharmaceuticals for Import or Export (Sec. Sec.  266.508(b) and
266.508(c))
    D. Shipping Potentially Creditable Hazardous Waste
Pharmaceuticals (Sec.  266.509)
XVII. Standards for Reverse Distributors (Sec.  266.510)
    A. Background on Reverse Distributor Operations
    B. EPA's Rationale for Finalizing New RCRA Management Standards
for Reverse Distributors
    C. Detailed Discussion of Final Reverse Distributor Standards
XVIII. Amendments to the Part 268 Prohibitions on Storage
XIX. Implementation and Enforcement
    A. Healthcare Facilities
    B. Reverse Distributors and Reverse Logistics Centers
    C. Healthcare Facilities and Reverse Distributors Managing Non-
Pharmaceutical Hazardous Waste in Accordance With 40 CFR Part 262 or
Part 273 (i.e., Complying With ``More Than One RCRA'')
    D. State Enforcement Activities and Interpretations
    E. Intersection of Part 266 Subpart P With the Hazardous Waste
Generator Improvements Rule
XX. 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
XXI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
    C. Paperwork Reduction Act
    D. Regulatory Flexibility Act
    E. Unfunded Mandates Reform Act
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation With Tribal Governments
    H. Executive Order 13045: Children's Health
    I. Executive Order 13211: Energy Supply
    J. National Technology Transfer and Advancement Act
    K. Executive Order 12898: Environmental Justice
    L. Congressional Review Act

I. General Information

A. Does this action apply to me?

    This final rule applies to healthcare facilities that generate,
accumulate, or otherwise handle hazardous waste pharmaceuticals and
reverse distributors engaged in the management of prescription
hazardous waste pharmaceuticals. The list of North American Industry
Classification System (NAICS) codes for the potentially affected
entities, other than RCRA transfer, storage, and disposal facilities
(TSDFs), are presented in Table 1. More detailed information on the
potentially affected entities is presented in sections VII and IX of
this preamble and the Regulatory Impact Analysis (RIA) which is
available in the docket for this final rule.\1\
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    \1\ EPA-HQ-RCRA-2007-0932.

   Table 1--NAICS Codes of Entities Potentially Affected by This Final
          Rule: Healthcare Facilities and Reverse Distributors
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               NAICS codes                   Description of NAICS code
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4242....................................  Drug Wholesalers.
44511...................................  Supermarkets and Other Grocery
                                           (except convenience) Stores.
44611...................................  Pharmacies and Drug Stores.
452311..................................  Warehouse Clubs and
                                           Supercenters.
54194...................................  Veterinary Services.
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).
623311..................................  Continuing Care Retirement
                                           Communities (e.g., assisted
                                           living facilities with on-
                                           site nursing facilities).
Various NAICS...........................  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 EPA knows
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.

B. What action is the Agency taking?

    On September 25, 2015, EPA proposed new regulations under part 266
subpart P for the management of hazardous waste pharmaceuticals by
healthcare facilities and reverse distributors.\2\ This final rule
promulgates part 266 subpart P. However, in response to public
comments, we have made a number of changes to the proposed rulemaking.
The comments and the changes are discussed in detail below. When this
final rule becomes effective in their states, a process that is
explained in section XX of this preamble, healthcare facilities and
reverse distributors must manage their hazardous waste pharmaceuticals
under this new set of regulations in part 266 subpart P in lieu of
operating under part 262 as they have been. These operating standards
include a prohibition on the sewering of hazardous waste
pharmaceuticals. Part 266 subpart P also includes a conditional
exemption for hazardous waste pharmaceuticals that are also identified
as controlled substances by the Drug Enforcement Administration (DEA).
Further, subpart P redefines when containers that held hazardous waste
pharmaceuticals are considered ``RCRA empty.'' Healthcare facilities
that are very small quantity generators (VSQGs) must comply with the
sewer prohibition for their hazardous waste pharmaceuticals under part
266 subpart P and have the option of complying with the entire subpart
in lieu of operating under the conditional exemption of Sec.  262.14.
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    \2\ September 25, 2015; 80 FR 58014.
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    EPA is also taking two actions in addition to promulgating part 266
subpart P. First, this final rule amends the P075 acute hazardous waste
listing for nicotine and salts to indicate that U.S. Food and Drug
Administration (FDA)-approved over-the counter (OTC) nicotine
replacement therapies (NRTs) are not included in the listing. Second,
the preamble to this final rule also establishes EPA's policy on the
regulatory status of unsold retail items, including nonprescription
pharmaceuticals, managed at reverse logistics centers, fulfilling the
commitment we made in the Retail Strategy of September 2016.
    Although the proposed rulemaking sought comment on ideas for how to
expand the universe of pharmaceuticals that are hazardous waste, this
final rule does not add pharmaceuticals to the hazardous waste listings
or expand the hazardous waste characteristics to include additional
pharmaceuticals. At the time of proposal, we indicated that any action
to expand the universe of hazardous waste pharmaceuticals would be part
of a separate, future action.
    Note that throughout the preamble and the RIA for this final rule,
the terms ``EPA,'' ``Agency'' and ``we'' are used interchangeably.

C. What is the Agency's statutory authority for taking this action?

    These regulations are promulgated under the authority of Sec. Sec.
2002, 3001, 3002, 3004, and 3018 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. 6912, 6921, 6922, 6924, and 6939.

D. What are the incremental costs and benefits of this action?

    As discussed in section XXI, the Regulatory Impact Analysis (RIA)
for this rule estimates the annualized cost to industry to comply with
the requirements is between $6.59 and $7.99 million (at a 7 percent
discount rate).\3\ The streamlined management standards for healthcare
facilities and the regulatory relief in regard to FDA-approved OTC NRT
products (i.e., patches, gums and lozenges) is estimated to result in
an annualized cost-savings of between $19.58 and $22.95 million (at a 7
percent discount rate). This results in a net annualized cost savings
for the rule of $12.99 to $14.96 million at a 7 percent discount rate.
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    \3\ See the Regulatory Impact Analysis for the final rule in the
rulemaking docket EPA-HQ-RCRA-2007-0932.
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    The provisions of the final rule are expected to improve regulatory
clarity and reduce regulatory burden. As an example of the increased
regulatory clarity and certainty provided in the rule, EPA eliminated
the dual regulation of RCRA hazardous waste pharmaceuticals that are
also DEA controlled substances by finalizing a conditional exemption.
Additionally, to the extent that the rule reduces concentrations of
hazardous waste pharmaceuticals in surface and drinking waters, this
rule may result in improved ecosystems and human health outcomes.
Ideally, the Agency would prefer to quantify and monetize the rule's
human health benefits. However, only some categories of cost savings
are quantifiable; sufficient data are not available to support a
detailed quantitative analysis for many benefit categories. In these
cases, the benefits are described qualitatively.

II. List of Acronyms

3PL Third Party Logistics Provider
AARP American Association of Retired Persons
AEA Atomic Energy Act
API Active Pharmaceutical Ingredient
ASHP American Society of Hospital Pharmacists
BDAT Best Demonstrated Available Technology
BR Biennial Report
CAA Central Accumulation Area
CCP Commercial Chemical Product
CERCLA Comprehensive Environmental Response, Compensation and
Liability Act
CFR Code of Federal Regulations
CISWI Commercial, Industrial Solid Waste Incinerator
CMS Centers for Medicare and Medicaid Services
CPSC Consumer Product Safety Commission
CWA Clean Water Act
DEA Drug Enforcement Administration
DOE Department of Energy
DOT Department of Transportation
DSCSA Drug Supply Chain Security Act
DQSA Drug Quality and Security Act
EPA Environmental Protection Agency
E.O. Executive Order
FDA Food and Drug Administration

FD&C Act Federal Food, Drug, and Cosmetic Act
FR Federal Register
HIPAA Health Insurance Portability and Accountability Act
HMIWI Hospital, Medical, Infectious Waste Incinerator
HSWA Hazardous and Solid Waste Amendments
LQG Large Quantity Generator
LTCF Long-term Care Facility
LTCP Long-term Care Pharmacy
MSWLF Municipal Solid Waste Landfill
MWC Municipal Waste Combustor
NAICS North American Industry Classification System
NIOSH National Institute for Occupational Safety and Health
NODA Notice of Data Availability
NPRM Notice of Proposed Rulemaking
NRC Nuclear Regulatory Commission
NRT Nicotine Replacement Therapy
OIG Office of Inspector General
OLEM Office of Land and Emergency Management
OMB Office of Management and Budget
ONDCP Office of National Drug Control Policy
OSHA 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
SAA Satellite Accumulation Area
SQG Small Quantity Generator
SWDA Solid Waste Disposal Act
TC Toxicity Characteristic
TCLP Toxicity Characteristic Leaching Procedure
TSDF Treatment, Storage and Disposal Facility
VSQG Very Small Quantity Generator

III. Rationale for the Final Rule

    The impetus behind this final rule is to address the various
concerns raised by stakeholders regarding the difficulty in
implementing the RCRA 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 has received input from stakeholders through
more formal mechanisms. For instance, when EPA solicited stakeholder
input in a notice of data availability (NODA) and request for comment,
``Hazardous Waste Management and the Retail Sector: Providing and
Seeking Information on Practices to Enhance Effectiveness to the
Resource Conservation and Recovery Act Program'' (``Retail NODA''),
retailers submitted comments detailing compliance challenges with
hazardous waste pharmaceuticals in their stores.\4\ 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 the Retail NODA and the OIG report, see section VI of
this preamble).\5\ The Retail NODA and the OIG Report, along with input
from healthcare facilities and retailers, 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 to the generation
and management of hazardous waste pharmaceuticals.
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    \4\ See 79 FR 8926; February 14, 2014 for the Retail NODA. Also
see the associated docket EPA-HQ-RCRA-2012-0426 for public comments.
    \5\ EPA Inaction in Identifying Hazardous Waste Pharmaceuticals
May Result in Unsafe Disposal, Report No. 12-P-0508, dated May 25,
2012). For a copy of the report, please see: https://www.epa.gov/sites/production/files/2015-10/documents/20120525-12-p-0508.pdf or
see the docket for this final rule: EPA-HQ-RCRA-2007-0932-0177.
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    First, under the current hazardous waste regulatory scheme,
healthcare personnel, 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 personnel, such as nurses and
doctors, do not typically have the expertise to make hazardous waste
determinations. In general, healthcare personnel are not prepared to
assume hazardous waste management responsibilities, nor is it EPA's
expectation that they assume primary hazardous waste management
responsibilities. EPA recognizes this challenge and provides a
framework through this final rule that allows healthcare personnel to
focus on healthcare while still ensuring that hazardous waste is
directed to proper management.
    Second, in the healthcare setting, a wide variety of hazardous
waste pharmaceuticals are generated in relatively small quantities by a
number of different employees across the facility. This situation
differs from a typical manufacturing facility where fewer employees in
a few locations generate comparatively much larger volumes of a smaller
range of hazardous wastes. Data from the Biennial Report (BR) show that
in 2013, approximately 46 percent of large quantity generators (LQGs)
generated between one and five waste streams.\6\ Further, a typical
manufacturing facility generates a more predictable set of hazardous
waste streams. In contrast, a healthcare facility can have thousands of
items in its inventory at any one time and these may vary over time,
based on the needs of the patients. In addition, pharmaceutical wastes
come in many different forms, such as tablets (pills), transdermal
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 personnel to make
appropriate hazardous waste determinations when pharmaceuticals are
disposed.
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    \6\ 81 FR 85735; November 28, 2016, Hazardous Waste Generator
Improvements Final Rule.
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    Third, 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 with more stringent
requirements at much smaller amounts. If a facility generates more than
1 kg of acute hazardous waste per calendar month, it is regulated more
rigorously as an LQG. Aside from the pharmaceuticals themselves,
residues within pharmaceutical containers that contained P-listed
commercial chemical products (CCPs) must be managed as acute hazardous
waste even if the pharmaceutical was fully administered, unless the
container is RCRA-empty (e.g., by triple-rinsing the container).\7\
Triple rinsing can be impractical with certain medical devices, such as
syringes and paper cups, so healthcare facilities often manage these
containers as hazardous waste, which can result in being subject to the
most stringently regulated generator category (i.e., LQG).\8\
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    \7\ 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)).
    \8\ 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).
As discussed in section XV of this preamble, this final rule
supersedes this memo.
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    To facilitate compliance among healthcare facilities and to respond
to these concerns, EPA is finalizing a new set of sector-specific
regulations to improve the management and disposal of hazardous waste
pharmaceuticals at healthcare facilities.
    In addition to improving compliance and responding to stakeholder
concerns, the Agency has three additional goals for this final rule.
The first is to reduce

the amount of pharmaceuticals that are disposed of down the drain.
Studies have found that many healthcare facilities, particularly long
term-care facilities, are using drain disposal (e.g., flushing) as a
routine disposal method for pharmaceutical wastes, including those that
are hazardous waste. Until this final rule, drain disposal has been an
allowable disposal method for hazardous waste pharmaceuticals under
RCRA (however, since 1990, the Clean Water Act regulations have
prohibited the drain disposal of ignitable wastes and those wastes that
result in toxic gases, vapors of fumes within the publicly owned
treatment works.) \9\ Although pharmaceuticals are thought to be
primarily entering the environment through excretion, reducing
intentional sewer disposal is one mechanism to help reduce the
environmental loading of pharmaceuticals into our Nation's waters.\10\
See section XIII for more information about how this final rule reduces
sewer disposal and pharmaceuticals in water.
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    \9\ See the Clean Water Act regulations of 40 CFR 403.5(b)(1)
and (7).
    \10\ C.G. Daughton, I.S. Ruhoy, Environmental footprint of
pharmaceuticals: The significance of factors beyond direct excretion
to sewers, Environ. Toxicol. Chem., 28 (2009), pp. 2495-2521,
10.1897/08-382.1.
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    The second goal is to address the overlap between EPA's RCRA
hazardous waste regulations and the DEA regulations for controlled
substances. Some stakeholders have indicated that hazardous waste
pharmaceuticals that are also controlled substances are stringently
regulated and therefore are expensive to manage and dispose of in
accordance with both sets of regulations. In addition, stakeholders
have indicated that the RCRA hazardous waste pharmaceuticals that are
also DEA controlled substances are most likely to be sewer disposed to
avoid the costs of compliant incineration. EPA eliminates this
regulatory overlap in this final rule, as it has been an unnecessary
burden for healthcare facilities. Additionally, we expect that
eliminating the overlap will help reduce intentional sewer disposal of
pharmaceuticals.
    The third goal is to clarify the regulatory status of a major
practice used by healthcare facilities, including retailers in
particular, for the management of unused and/or expired
pharmaceuticals, known as reverse distribution (see section VI for a
detailed discussion of reverse distribution). A number of states have
taken enforcement actions against retailers that have raised awareness
about the reverse distribution of pharmaceuticals. In particular,
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),
Rite-Aid (2013), and Safeway (2015). 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
non-dispensable pharmaceuticals, including OTC medications, through
`reverse distribution.' '' \11\ 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.
---------------------------------------------------------------------------

    \11\ See the docket for this rulemaking EPA-HQ-RCRA-2007-0932-
0169.
---------------------------------------------------------------------------

    Additionally, the California legislature directed the DTSC to
convene a Retail Waste Working Group with the aim of developing
recommendations to the legislature for how to address many retail waste
issues, including reverse distribution/logistics.\12\ The Retail Waste
Working Group, which consisted of large retailers, small retailers,
district attorneys, certified unified program agencies, non-government
organizations, local governments, other relevant state agencies as
determined by DTSC (such as the California Department of Public Health,
and the California Department of Resources Recycling and Recovery),
manufacturers, reverse distributors, and other interested stakeholders,
produced their final report in August 2017.\13\ Although the group was
convened by and reported to the California legislature, its membership
was drawn from across the country. EPA participated in an observer
role, but neither contributed to developing recommendations nor to
writing the group's report. The group's work has highlighted the need
for a national policy in this area.
---------------------------------------------------------------------------

    \12\ California SB-423. http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201520160SB423.
    \13\ https://www.dtsc.ca.gov/HazardousWaste/Retail_Industry/upload/SB423_Final-Rpt.pdf.
---------------------------------------------------------------------------

IV. Background

A. Summary of the Proposal

    On September 25, 2015, EPA proposed to add subpart P under 40 CFR
part 266 (see 80 FR 58014). Part 266 is entitled ``Standards for the
Management of Specific Hazardous Wastes and Specific Types of Hazardous
Waste Management Facilities.'' In this new subpart P, we proposed a
tailored, sector-specific regulatory framework for managing hazardous
waste pharmaceuticals at healthcare facilities and reverse
distributors. We proposed that healthcare facilities that are small
quantity generators (SQGs) or LQGs and all reverse distributors,
regardless of their RCRA generator category, would be required to
manage their hazardous waste pharmaceuticals under subpart P of 40 CFR
part 266, instead of the generator regulations in 40 CFR part 262. The
standards were not proposed as a voluntary or optional alternative to
managing hazardous waste pharmaceuticals under 40 CFR part 262; they
were proposed as mandatory standards.
    We discuss the proposed provisions in greater detail in subsequent
sections of the preamble, but offer a brief summary of the proposal
here. For healthcare facilities, we proposed different management
standards for non-creditable and potentially creditable hazardous waste
pharmaceuticals. We proposed that non-creditable hazardous waste
pharmaceuticals (i.e., those that are not expected to be eligible to
receive manufacturer credit) would be managed on site at the healthcare
facility similar to how they would have been under a previous proposal
for managing these wastes: The 2008 Universal Waste proposal for
pharmaceutical waste.\14\ We proposed that when shipped off site, the
non-creditable hazardous waste pharmaceuticals must be transported as
hazardous wastes, including the use of the hazardous waste manifest,
and sent to a RCRA-designated facility, such as an interim status or
permitted TSDF. Additionally, we proposed to revise our policy
regarding pharmaceuticals going through reverse distribution (i.e.,
those which are ``potentially creditable'') such that they would be
considered hazardous wastes at the healthcare facility. However, given
the value associated with these potentially

creditable hazardous waste pharmaceuticals, EPA proposed flexibilities
for some of the regulatory requirements. For instance, we proposed that
healthcare facilities would continue to be allowed to send potentially
creditable hazardous waste pharmaceuticals to reverse distributors for
them to be evaluated for manufacturer credit. After considering
comments received on the prior Universal Waste proposal regarding the
lack of tracking of shipments, EPA's 2015 proposed standards included
provisions to ensure the safe, secure and documented delivery of the
potentially creditable hazardous waste pharmaceuticals to reverse
distributors.
---------------------------------------------------------------------------

    \14\ 73 FR 73520; December 2, 2008.
---------------------------------------------------------------------------

    Under the proposal, reverse distributors would no longer be
regulated under 40 CFR part 262 as hazardous waste generators, nor
would they be regulated under 40 CFR parts 264, 265, and 270 as TSDFs.
Rather, the proposal established a new category of hazardous waste
entity, called pharmaceutical reverse distributors. EPA also proposed
that reverse distributors would have different standards for those
hazardous waste pharmaceuticals destined for another reverse
distributor (and still considered potentially creditable hazardous
waste pharmaceuticals) versus those that are destined for a TSDF
(considered to be evaluated hazardous waste pharmaceuticals.) \15\ The
proposed standards for pharmaceutical reverse distributors were, in
many respects, similar to the LQG standards, but with additional
standards to respond to concerns expressed by commenters to the
proposal to add pharmaceuticals to the Universal Waste program.
---------------------------------------------------------------------------

    \15\ The final rule defines an ``evaluated hazardous waste
pharmaceutical'' as a prescription hazardous waste pharmaceutical
that has been evaluated by a reverse distributed in accordance with
Sec.  266.510(a)(3) and will not be sent to another reverse
distributor for further evaluation or verification of manufacturer
credit.
---------------------------------------------------------------------------

    EPA proposed several additional standards that apply to both
healthcare facilities and reverse distributors. First, EPA proposed to
prohibit healthcare facilities and reverse distributors from disposing
of hazardous waste pharmaceuticals down a toilet or drain (i.e.,
flushed or sewered). Second, EPA proposed that hazardous waste
pharmaceuticals managed under subpart P would not be counted toward
calculating the site's generator category. Third, EPA proposed a
conditional exemption for hazardous waste pharmaceuticals that are also
DEA controlled substances. Fourth, EPA proposed management standards
for determining when a container with hazardous waste pharmaceutical
residues is considered RCRA empty.

B. Retail Sector Notice of Data Availability (NODA)

    In 2014, EPA published a NODA for the Retail Sector, 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 face in complying with RCRA regulations.\16\ Many retail
commenters to the NODA mentioned that because nicotine is an acute
hazardous waste (P075), retailers 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 some regulatory relief with regard
to nicotine-containing products. See section V of this preamble for a
discussion of EPA's amendment of the acute hazardous waste listing for
nicotine and salts (P075).
---------------------------------------------------------------------------

    \16\ February 14, 2014; 79 FR 8926.
---------------------------------------------------------------------------

C. Retail Strategy

    On September 12, 2016, as a follow-up to the comments we received
on the Retail NODA, EPA released its Retail Strategy. In the strategy,
EPA committed to two sets of activities. First, we committed to
completing rulemakings that were already underway, that, although were
not specifically developed with retail in mind, contained provisions
that might be helpful in resolving some issues that retailers faced in
complying with RCRA regulations. This included completing the 2016
Hazardous Waste Generator Improvements final rule and the Hazardous
Waste Pharmaceuticals final rule. Second, we committed to three new
activities that specifically address concerns identified by commenters.
First, EPA committed to developing guidance on aerosol cans. Second,
EPA committed to exploring the potential for adding certain retail
items, such as aerosol cans, pesticides, and/or electronics, to the
federal universal waste regulations. A proposed rulemaking for adding
aerosol cans to the federal universal waste regulations was published
in Federal Register on March 16, 2018.\17\ Third, EPA committed to
developing a policy that addresses the reverse distribution process for
the retail sector as a whole. This policy is articulated in detail in
section VI of the preamble of this final rule.
---------------------------------------------------------------------------

    \17\ See 83 FR 11654; March 16, 2018.
---------------------------------------------------------------------------

D. EPA 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.'' \18\ 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): \19\
---------------------------------------------------------------------------

    \18\ EPA Inaction in Identifying Hazardous Waste Pharmaceuticals
May Result in Unsafe Disposal, Report No. 12-P-0508, dated May 25,
2012). For a copy of the report, please see: https://www.epa.gov/sites/production/files/2015-10/documents/20120525-12-p-0508.pdf or
see the docket for this final rule: EPA-HQ-RCRA-2007-0932-0177.
    \19\ OSWER has since been renamed the Office of Land and
Emergency Management (OLEM).

    (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 hazardous waste pharmaceuticals.

    As detailed in OSWER's response to OIG, this final rule fulfills
our obligation for addressing the third recommendation.\20\ In the
preamble to the proposed rulemaking we solicited comment as part of our
ongoing efforts to identify additional pharmaceuticals as hazardous
wastes. EPA does not address the OIG's first two recommendations as
part of this final rulemaking directly. That said, the Agency believes
that provisions in the final rule, such as the streamlined standards
for healthcare facilities and the elimination of LQG status for the
management of hazardous waste pharmaceuticals, address the first two
recommendations indirectly by encouraging healthcare facilities to
manage their non-hazardous waste pharmaceuticals as hazardous waste
pharmaceuticals.
---------------------------------------------------------------------------

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

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

V. Amendment to the Acute Hazardous Waste Listing for Nicotine and
Salts (Hazardous Waste No. P075)

A. Background

    In 1980, EPA promulgated the P- and U-lists of CCPs or
manufacturing chemical intermediates that are hazardous wastes if they
are discarded or intended to be discarded (40 CFR 261.33(e) and (f)).
Several hundred CCPs were listed on the P- and U-lists, including
nicotine and salts.\21\ 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)).
---------------------------------------------------------------------------

    \21\ See 45 FR 33124, May 19, 1980.
---------------------------------------------------------------------------

    The P-listed chemicals are identified as acute hazardous wastes and
U-listed chemicals are identified as non-acute hazardous wastes when
discarded in unused form. EPA listed nicotine and salts (referred to
commonly as just nicotine) as acute hazardous waste P075 in 261.33(e).
A chemical substance is listed in 40 CFR 261.33(e) as an acute
hazardous waste if it meets any of the criteria in 40 CFR 261.11(a)(2),
which, as described below, are based on human toxicity data, or dose of
a chemical given orally or dermally that is lethal to 50 percent of the
test animals (LD50), or the concentration of a chemical in the air that
is lethal to 50 percent of the test animals (LC50). That is, when 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 LD50 toxicity (rat) of less than 50 milligrams per
kilogram, an inhalation LC50 toxicity (rat) of less than 2 milligrams
per liter, or a dermal LD50 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.''
    EPA listed nicotine as an acute hazardous waste based on an
estimated oral LD50 toxicity to humans of 1 mg/kg and a dermal LD50
toxicity to rabbits of 50 mg/kg. The acute toxicity criterion for
humans, as discussed above, is ``fatal to humans in low doses'' (see
Sec.  261.11(a)(2)).
    EPA's Background Document from April 1981 prepared in support of
the commercial chemical product hazardous waste listings in Sec.
261.33 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''.\22\ This Background
Document cites an estimated oral LD50 toxicity to humans for nicotine
and salts as 1 mg/kg, which corresponds to 50-60 mg of nicotine as a
lethal dose for an adult weighing 50-60 kg, and this estimated LD50
value falls within the criterion for ``fatal to humans in low doses.''
However, the Background Document does not provide any information
regarding the nicotine product or concentration of nicotine that was
used to establish this estimated oral LD50 toxicity in humans for
nicotine. According to comments submitted to EPA on the proposal by the
retailers, tobacco companies, and trade associations, the only nicotine
products being marketed at the time when EPA listed nicotine were
pesticides containing up to 40 percent nicotine sulfate. These
commenters note that the low-concentration nicotine-containing products
(specifically smoking cessation or NRT products) had not yet been
developed and, therefore, were not considered when EPA listed nicotine
as an acute hazardous waste.
---------------------------------------------------------------------------

    \22\ See pp. 21-22 and 33 in Background Document dated April
1981 in the docket for this rulemaking EPA-HQ-RCRA-2007-0932-0171.
---------------------------------------------------------------------------

    Once the Agency lists chemicals on either the P- or U-lists, these
chemicals are P- or U-listed hazardous wastes when discarded or
intended to be discarded regardless of chemical concentrations, with
two exceptions: Warfarin and salts (which are listed as waste number
P001 when present at concentrations greater than 0.3% and U248 when
present at concentrations of 0.3% or less) and zinc phosphide (which is
listed as Waste Code P122 when present at concentrations greater than
10% and Waste Code U249 when present at concentrations of 10% or less).
Therefore, the P075 hazardous waste listing is applicable to the
commercial chemical product nicotine or a commercial chemical product
containing nicotine as the sole active ingredient when disposed
regardless of the concentration of nicotine. The Agency has previously
stated that unused dermal patches containing nicotine, nicotine gum,
and nicotine lozenges are listed hazardous waste P075 when
discarded.\23\ The Agency stated this because nicotine is a listed
hazardous waste P075 when discarded, and nicotine is the sole active
ingredient in patches containing nicotine, nicotine gum, and nicotine
lozenges. However, once the nicotine patches, gums, and lozenges have
been used for their intended purpose, regardless of the length of use,
they are no longer commercial chemical products and would not be listed
hazardous waste P075 when discarded.
---------------------------------------------------------------------------

    \23\ See letter from Robert Dellinger, USEPA to Charlotte Smith,
WM Healthcare Solutions, Inc., dated August 23, 2010, RCRA Online
#14817.
---------------------------------------------------------------------------

B. Summary of Proposal

    In the preamble to the proposed rulemaking, EPA provided a
rationale for why it is considering the possibility of amending the
P075 acute hazardous waste listing for nicotine and salts. Primarily,
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 P075 hazardous waste listing
under RCRA. This is because the retailers did not believe their low-
concentration nicotine products meet RCRA's requirements for acute
hazardous waste, when discarded. Thus, according to the retailers, the
acute hazardous waste classification for their discarded low-
concentration nicotine products is inappropriately making them subject
to RCRA's LQG requirements. (for more information, see 80 FR 58071;
September 25, 2015). Consequently, EPA, in the preamble to the proposed
rulemaking, presented and sought comment on two possible approaches for
amending the acute hazardous waste listing for nicotine and salts and
stated that, depending on the information received during the comment
period, EPA could finalize one of them. Under the first approach, EPA
would exempt FDA-approved OTC nicotine-containing smoking cessation
products (nicotine patches, gums, and lozenges) from the P075 hazardous
waste listing if toxicity information received or collected for these
products supported a finding that these products, when disposed, do not
warrant regulation as acute hazardous wastes under RCRA Subtitle C. We
note that this preamble will collectively refer to nicotine patches,
gums, and lozenges as FDA-approved OTC NRTs. EPA also stated in the
preamble to the proposed rulemaking that e-cigarettes would not be
exempted under this approach, because they have not been approved by
FDA and the concentration of nicotine in e-cigarettes is not limited by
regulation (for more information, see discussion under Comments and
Responses included later in this section). Under the second approach,
EPA would establish a concentration-based exemption from the P075
listing for low-concentration nicotine-

containing products (including e-cigarettes); in other words, a maximum
concentration of nicotine in these products below which the P075
listing would not apply. This approach would require submission to EPA
of supporting human toxicological data or animal LD50 data for these
products at the maximum concentration of nicotine found in these
products.

C. Summary of Comments

    The comments received were mainly from retailers, tobacco
companies, individual states, trade and government associations. The
retailers, tobacco companies, and trade associations supported an
exemption from the P075 hazardous waste listing for FDA-approved OTC
NRTs. In addition, these commenters also generally favored an exemption
from the P075 listing for all other nicotine-containing products which
they considered to have low nicotine concentrations, including e-
cigarettes and e-liquids. Alternatively, if the EPA decided not to
exempt all low-concentration nicotine-containing products from the P075
listing, the commenters indicated they would support the
reclassification of such products as non-acute (i.e., U-listed)
hazardous wastes or otherwise require these products to be managed as
hazardous waste pharmaceuticals under 40 CFR part 266 subpart P. These
commenters stated that classification of low-concentration nicotine-
containing products as acute hazardous waste is unjustified. The
commenters also expressed a concern that, because of this inappropriate
classification, anyone generating more than 1 kg per month of this
acute hazardous waste becomes subject to RCRA's LQG regulations, which
result in increased economic burdens and reporting requirements. The
commenters asserted that the original P075 listing was likely based on
a concentration of nicotine that is orders of magnitude greater than
today's low-concentration NRTs, and the human toxicity data that EPA
relied upon to support the original P075 listing have been recently
reassessed and could not be substantiated. They stated further that a
U.S. Surgeon General's Report issued in 2014 could not find support for
the 1 mg/kg median lethal dose for humans used to support the original
listing.
    Additionally, the retailers, tobacco companies, and the trade
associations commented that EPA listed nicotine and salts as P075
acutely toxic hazardous wastes long before NRT products were in use and
thus EPA did not consider if they presented a risk that should be
covered by the P075 listing. According to these commenters, because the
OTC NRTs (nicotine patches, gums, and lozenges) contain very low
concentrations of nicotine, they clearly do not meet EPA's listing
criteria for acute toxicity and in addition have been approved by FDA
to be sold to the public over-the-counter (meaning these products can
be purchased without a prescription). In summary, these commenters
urged EPA to amend the P075 listing to exempt the low-concentration
nicotine-containing products based on either (1) type of product and/or
(2) a specified concentration of nicotine in these products below which
the product would be exempt, because there are no credible toxicity
data that would support keeping low-concentration nicotine-containing
products listed as acute hazardous wastes.
    All of the states and one government association (Northeast Waste
Management Officials' Association or NEWMOA) that submitted comments on
the proposal generally supported exempting FDA-approved OTC NRTs from
the P075 listing, if EPA obtained the necessary toxicity data to show
that these products are not acutely toxic. These same commenters,
except for one (Oklahoma), did not support exempting e-cigarettes or
nicotine-containing e-liquids from the P075 listing. Almost all of the
states and NEWMOA wanted continued regulation of e-cigarettes and
nicotine-containing e-liquids because the safety of these products is
less widely accepted.
    In summary, the Agency did not receive any comments that disagreed
with the proposed approach to exempt FDA-approved OTC NRTs from the
P075 listing, provided this approach is supported by sufficient
toxicity information to conclude that concentrations of nicotine
contained in these products are not acutely toxic.

D. Final Rule Provisions

    The Agency is finalizing the first approach for amending the P075
listing discussed in preamble of the proposal. That is, EPA is amending
the hazardous waste listing for hazardous waste number (commonly called
``hazardous waste code'') P075 in Sec.  261.33(e) to exempt FDA-
approved OTC NRTs. Specifically, the P075 listing for nicotine is being
amended with a parenthetical phrase stating that the listing does not
include patches, gums, and lozenges that are FDA-approved over-the-
counter nicotine replacement therapies.
    The Agency has concluded that FDA-approved OTC NRTs do not meet the
acute listing criteria under 40 CFR 261.11(a)(2), based on review of
available toxicity information for nicotine and nicotine-containing
FDA-approved OTC NRTs (see discussion under Comments and Responses
below).

E. Comments and Responses

1. Nicotine Toxicity Data
    Some commenters stated that human toxicity data that EPA originally
relied upon to list nicotine as P075 acutely toxic hazardous wastes are
not credible and do not support classifying low-concentration nicotine-
containing products as acutely toxic hazardous wastes. In addition,
they also stated that available animal toxicity data do not support
classifying low-concentration nicotine-containing products as acutely
toxic hazardous wastes. The commenters provided references to several
recent reports and an article (see discussion of these references in
the following paragraphs) to support their assertions. The commenters
stated that these recent reports and article provide evidence that
nicotine is not as toxic as originally thought.
    Commenters argued that the validity of an estimated oral LD50
toxicity to humans of 1 mg/kg (corresponding to 50-60 mg of nicotine as
a lethal dose for an adult weighing 50-60 kg) for nicotine used by EPA
to support the acute hazardous waste listing for nicotine has been
questioned by government entities and researchers, most recently by the
U.S. Surgeon General's Report, ``The Health Consequences of Smoking--50
Years of Progress'' (2014) \24\ and in an article published in Archives
of Toxicology, ``How much nicotine kills a human? Tracing back the
generally accepted lethal dose to dubious self-experiments in the
nineteenth century'' (Mayer, 2014).\25\ The U.S. Surgeon General's
Report cited by commenters states that the toxicity of nicotine is
dependent on dose, dose duration and frequency, route of exposure,
formulation of the nicotine product, and interpersonal variability.
This report also states that numerous poisonings have been documented
in the literature since the use of nicotine as a pesticide became
widespread in the early part of twentieth century; however, there has
not been a systematic assessment of the literature to characterize the
dose-response relationship. Furthermore, based on an extensive
literature search, the report states that no study was located as a
source for the 50-60 mg estimated dose that is commonly

reported to be fatal to humans. Finally, according to the report, the
literature has also shown that in one case a relatively large dose of
240 mg nicotine administered to a patient accidently did not prove to
be fatal.
---------------------------------------------------------------------------

    \24\ https://www.surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf.
    \25\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880486/.
---------------------------------------------------------------------------

    The Mayer article cited by commenters also points out that fatal
nicotine intoxications are relatively rare and that there are countless
records of subjects who have survived consumption of nicotine in
amounts far higher than 60 mg. One example referenced by Mayer in his
article was a person surviving following a suicide attempt with 4 grams
(4000 milligrams) of pure nicotine. Mayer asserts that this example and
many other literature reports on nonfatal nicotine poisonings show that
the oral LD50 toxicity of nicotine to humans of 1 mg/kg does not appear
to be reliable. Although Mayer did not conduct any lab testing on
nicotine, he uses previously reported nonfatal poisonings to develop an
estimate of the oral LD50 toxicity of nicotine to humans in the range
of 6.5-13 mg/kg (based on an adult weight of 50-60 kg, this would
correspond to an estimated range of 325-780 mg of nicotine as the
lethal dose for adults). Mayer concludes that nicotine is less toxic
than originally thought. That said, his new estimate of the oral LD50
toxicity of nicotine to humans still falls well within the range of <=
100 mg/kg, which was one of the reasons for listing nicotine and salts
as P075 acute hazardous waste.
    EPA regulations in Sec.  261.11(a)(2) state that, in the absence of
adequate human toxicity data, the criteria for identifying acute
toxicity should be based on the toxicity of the materials to laboratory
animals. Commenters directed us to a recently-issued report summarizing
available toxicity information on nicotine by the Committee for Risk
Assessment of the European Chemicals Agency (ECHA).\26\ The acute
toxicity of nicotine to laboratory animals presented in the report
issued by the Committee for Risk Assessment in comparison to the
regulatory criteria for these animals presented in 40 CFR 261.11(a)(2)
are as follows: The acute oral LD50 for rat is in the range of 52.5-70
mg/kg (ECHA) compared to the acute oral LD50 regulatory criterion for
rat of < 50 mg/kg (Sec.  261.11(a)(2)). The acute oral LD50 values for
rats reported by ECHA fall just outside the acute toxicity criterion in
EPA's regulations. The acute dermal LD50 for rabbit is 70.4 mg/kg
(ECHA) compared to acute dermal LD50 regulatory criterion for rabbit of
< 200 mg/kg (Sec.  261.11(a)(2)). The acute dermal LD50 for rabbit
falls well below the acute toxicity criterion in our regulations. There
were no comparable data available for the acute inhalation LC50 for
rat.
---------------------------------------------------------------------------

    \26\ See ECHA's Committee for Risk Assessment Opinion Proposing
Harmonized Classification and Labeling at EU Level of Nicotine,
adopted 10 September 2015 (https://echa.europa.eu/documents/10162/23665416/clh_opinion_nicotine_5579_en.pdf/0103fadb-e945-4839-c4f4-17d20854adf0).
---------------------------------------------------------------------------

    Based on the toxicity information discussed above, and the listing
criteria in 40 CFR 262.11(a)(2), the evidence is clear that nicotine is
still acutely toxic to both humans and animals under the RCRA hazardous
waste regulations and must continue to be listed as acute hazardous
waste number P075 under Sec.  261.33(e). As already noted, under the
hazardous waste regulations the Agency generally lists commercial
chemical products, if they are discarded or intended to be discarded,
regardless of chemical concentrations. However, EPA is not precluded
from amending (through rulemaking) an existing listing, for example, if
a particular subset of wastes within that listing can be identified as
not posing the risk for which the original listing was established.
2. Food and Drug Administration-Approved Nicotine Replacement Therapies
    A number of commenters urged EPA to exempt low-concentration
nicotine-containing products (specifically OTC NRTs) from the P075
listing. The commenters stated that millions of people use OTC NRTs
daily without showing any signs of acute toxicity, and these products
have been approved by FDA to be sold over the counter without a
prescription. Therefore, they believe this is the best evidence that
these products are not acutely toxic and safe for people to use.
    As noted above, the Agency stated in the proposal that if it
obtained toxicity data to support the conclusion that FDA-approved OTC
NRTs do not meet the criteria for listing as an acutely hazardous
waste, then it will exempt these products from the P075 listing. The
FDA-approved OTC NRTs are designed to help people quit smoking by
delivering controlled amounts of nicotine to ease symptoms of
withdrawal and craving. The Consumer Health Products Association stated
in its comments that nicotine gums and lozenges contain 2-4 mg nicotine
(approximately 0.2-2 percent by weight depending on lozenge size) and
nicotine patches contain 7 mg, 14 mg, or 21 mg of nicotine
(approximately 2-7 percent by weight). Comments from Reynolds American
Inc. Services Company (RAI Services or RAI) provided similar
information on the amount of nicotine in these FDA-approved OTC
NRTs.\27\ According to information on FDA's website, FDA regulations
ensure that OTC drug products are safe and effective for people to
use.\28\ In most cases, OTC drug products are regulated by FDA through
OTC drug monographs. OTC drug monographs state the active ingredients
and other conditions of use (including dose, dosage form, and route of
administration) that are generally recognized as safe and effective to
treat certain diseases or conditions without a prescription. OTC drug
products that conform to a final monograph and other relevant
requirements are not required to be reviewed by FDA before marketing.
Products that do not conform to a final monograph must be reviewed
under the new drug application process. The new drug application
process is how manufacturers provide evidence to FDA to demonstrate
that the new drug product is safe and effective for use as recommended
in the product's labeling. Sometimes, an OTC drug product begins as an
approved prescription drug and then a drug company will submit an
application to FDA to switch the drug product from prescription status
to OTC status. FDA reviews the information in the application, along
with information about adverse events associated with the use of the
drug, and determines whether the prescription drug can be used safely
and effectively as an OTC drug. FDA allowed nicotine patches and gums,
which were initially available by prescription only, to be switched to
OTC status between 1996 and 2002. The nicotine lozenge and mini-lozenge
were approved by FDA directly for OTC use in 2002 and 2009 via new drug
applications.29 30
---------------------------------------------------------------------------

    \27\ See P.9 of RAI's comments dated December 23, 2015 in the
docket for this rulemaking EPA-HQ-RCRA-2007-0932-0329.
    \28\ https://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm342560.htm.
    \29\ See 78 FR 19718; April 2, 2013.
    \30\ See FDA materials for New Drug Application Numbers 21-330
and 22-360 in the docket for this rulemaking EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    FDA has determined that OTC NRTs can be used safely and effectively
by people without a healthcare professional's supervision when used in
accordance with their label instructions. Since FDA first approved NRTs
for OTC use, FDA has reviewed a number of studies that examined use of
OTC NRTs, including use of OTC NRTs in combination with other nicotine-
containing products, use of OTC NRTs at higher than standard-dose, and
use of OTC NRTs over periods longer than recommended, and it has not
identified

any significant safety concerns.\31\ It is useful to recognize one
characteristic of FDA-approved OTC NRTs when considering the toxicity
of nicotine contained in these products, which is that they are
designed for controlled release of nicotine to approximate the nicotine
amounts obtained from smoking. This characteristic of FDA-approved OTC
NRTs means that nicotine enters the body over a period of time and
there is a gradual increase in the level of nicotine in the blood when
used in accordance with the accompanying label. According to EPA's
review of FDA information and RAI's comments, FDA's Center for Drug
Evaluation and Research reviewed pharmacology and toxicology data for
nicotine polacrilex lozenges and made a number of observations
concerning nicotine's toxicology. FDA stated that ``oral doses of
nicotine that have been reported to be lethal in animals are
approximately 8- to 150-fold greater than nicotine exposures that would
result from use of Nicotine Polacrilex Lozenges.'' In addition, the FDA
noted that ``the toxicological profile of nicotine in animals has been
largely superseded by the extensive human experience with this agent.
Based on the established clinical experience with similar nicotine
replacement therapy products, acute toxic reactions would not be
anticipated from use of Nicotine Polacrilex Lozenges at the recommended
dosage.'' \32\
---------------------------------------------------------------------------

    \31\ See 78 FR 19718; April 2, 2013.
    \32\ See pages 5 and 6 of the Pharmacology Review for the New
Drug Application Number 21-330 in the docket for this rulemaking
EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    In summary, the most common dosage of nicotine from OTC nicotine
gums and lozenges (2-4 mg) and OTC nicotine patches (7-21 mg) is
absorbed slowly and results in significantly lower concentrations of
nicotine in blood levels compared to the amount of nicotine that has
been determined or estimated to be lethal to animals and humans. The
OTC nicotine patch, the strongest of which contains 114 mg of nicotine,
delivers 21 mg of nicotine at a relatively steady rate over a 24-hour
period when the patch is applied to the skin. The most frequently
reported side effects from use of patches are local skin reactions,
which can be reduced by moving the site of the patch application daily
as instructed.\33\ In addition, FDA has reviewed and approved these
products as being safe and effective for people to use without a
prescription. Furthermore, the FDA-approved OTC NRTs have been in the
market for over two decades and although some serious adverse events
have been reported, based on the available information, EPA has
concluded that the serious adverse events do not meet EPA's criteria
for acute toxicity under 40 CFR 261.11(a)(2) (i.e., fatal to humans in
low doses or capable of causing or significantly contributing to an
increase in serious irreversible, or incapacitating reversible,
illness).\34\ Finally, the serious adverse events that have been
reported have not caused FDA to reverse its decision to allow the NRTs
to be sold as OTCs. Therefore, the Agency finds that FDA-approved OTC
NRTs are not acutely toxic and is exempting them from the P075 listing.
---------------------------------------------------------------------------

    \33\ International Journal of Health Sciences (Qassim).
``Nicotine Replacement Therapy: An Overview'' (July, 2016) 10(3):
pp. 425-435.
    \34\ See the following four FDA documents included in the docket
for this rulemaking EPA-HQ-RCRA-2007-0932: (1) Letter from Janet
Woodcock responding to a citizen petition, dated June 4, 2015; (2)
Memo from Kellie Taylor et al. on citizen petition response, dated
May 8, 2015; (3) Memo from Joslyn Swann providing a review of Abuse,
Misuse, and Overdose associated with Nicotine Replacement Therapy
products, dated October 1, 2010; and (4) Nicoderm OTC Switch Medical
Officer Review (NDA 20-165), dated August 7, 1995.
---------------------------------------------------------------------------

    The FDA-approved OTC NRTs, prior to the effective date of this
rule, were listed hazardous waste P075 when discarded. Therefore, these
wastes have been required to be managed under RCRA Subtitle C hazardous
waste regulations. Following exemption from the P075 listing, these OTC
NRT wastes will be considered non-hazardous wastes and can be managed
under applicable non-hazardous solid waste regulations. The Agency does
not have any information at this time to suggest that these wastes will
be improperly managed as non-hazardous wastes or have the potential to
cause human or environmental exposures. The Agency believes, because of
the low concentrations of nicotine in these wastes and their design to
slowly release the nicotine, any risk from plausible mismanagement
scenarios would not be sufficient to cause a substantial present or
potential hazard to human health or the environment. Nevertheless, the
Agency encourages healthcare facilities to first consider if their
unused nicotine-containing products, which are to be discarded, can be
legitimately recycled to recover the nicotine. The Agency has recently
stated to one recycler that legitimately recycled nicotine-containing
products would not be considered solid waste and thus would not be
subject to RCRA hazardous waste regulation.\35\ In addition, the Agency
reminds healthcare facilities, especially retail-sector pharmacies, who
may decide to discard expired FDA-approved OTC NRTs in their dumpsters
or regular trash, that products' labels direct them to ensure that
these products are kept out of the reach of children and pets.
Therefore, the Agency recommends that healthcare facilities, including
retailers, take the necessary security measures to discard unused,
unwanted, or expired OTC NRTs where they are not freely accessible to
the public. The recommended security measures could be simple as having
locks on the dumpsters and trash cans that are used for discarding OTC
NRTs or placing the dumpsters and trash cans in locked areas.
---------------------------------------------------------------------------

    \35\ See letter from Barnes Johnson, USEPA to Scott DeMuth, g\2\
Revolution, LLC., dated May 8, 2015, RCRAOnline #14851.
---------------------------------------------------------------------------

3. E-Cigarettes, E-Liquids, and Prescription Nicotine Replacement
Therapies
    There were mixed comments on exempting e-cigarettes, nicotine
containing e-liquids, and NRTs requiring a prescription from the P075
hazardous waste listing when discarded (for more information, see
Summary of Comments included previously in this section). The comments
from retailers, tobacco companies, and trade associations generally
favored exempting these categories of products from the P075 listing
when discarded, whereas comments from four of five states and NEWMOA
did not support exempting these products from the P075 listing when
discarded.
    The e-cigarettes and nicotine-containing e-liquids (or just e-
liquids) are currently not regulated by FDA in the same manner as NRTs.
NRTs are regulated as drugs by FDA while e-cigarettes and e-liquids are
regulated as tobacco products by FDA. Consequently, the FDA has not
been able to evaluate the health risks to the public from e-cigarettes
and e-liquids to the same extent as it has been able to for drugs.
Moreover, the concentrations of nicotine in e-cigarettes and e-liquids
are not limited by any FDA regulation or approval process and are
therefore unpredictable. The supplemental comments on the proposal
submitted to EPA by the Retail Associations (June 29, 2016) \36\ stated
that a recent promulgation of a final rule by FDA referred to as the
``Deeming Rule'' (81 FR 28973; May 10, 2016) will ensure against
``unpredictable'' nicotine concentrations in e-cigarette products and,
therefore, strengthens the case for reclassification or exemption of
these

products from the P075 listing. The Deeming Rule extended FDA's
regulatory authority to all tobacco products, including electronic
nicotine delivery systems (or e-cigarettes). This rule allows FDA to
evaluate factors such as ingredients (e.g., nicotine and its
concentration), product design, and health risks to both users and non-
users. The Deeming Rule ensures that newly regulated tobacco products,
before they are introduced into the market, meet certain requirements,
including warning labels, prohibiting sales to minors, registering with
FDA, and obtaining marketing authorization from FDA. It is, however,
important to note that FDA's review and approval process for
introducing new tobacco products to the market is not as rigorous in
assessing their safe use as review and approval of drug products.
Furthermore, in August 2017, the FDA extended the compliance deadline
for the newly regulated noncombustible tobacco products in the Deeming
Rule, such as e-cigarettes, from November 8, 2017 to August 8, 2022.
Therefore, without controls on the concentration of nicotine in e-
cigarettes and e-liquids or FDA's approval of these products as being
safe and effective for people to use, the Agency lacks adequate
information and certainty to conclude that these nicotine-containing
products will not pose the risks similar to those for which the P075
listing was established. For all of the above reasons, at this time the
Agency cannot support exempting e-cigarettes and nicotine-containing e-
liquids from the P075 listing.
---------------------------------------------------------------------------

    \36\ See the docket for this rulemaking EPA-HQ-RCRA-2007-0932-
0392.
---------------------------------------------------------------------------

    Furthermore, in the short time that e-cigarettes have been in the
U. S. marketplace (since about 2007), the calls to poison control
centers related to exposures to this product, mostly among young
children, have increased substantially. This significant increase can
be attributed largely to the rapid rise in the use of e-cigarettes by
the public. According to an article published in the Journal
Pediatrics, ``Pediatric Exposure to E-Cigarettes, Nicotine, and Tobacco
Products in the United States'' (May 2016), the monthly number of
exposures among young children (younger than six years old) associated
with e-cigarettes increased by almost 1500 percent from January 1, 2012
(14 exposures) to April 30, 2015 (223 exposures).\37\ During the same
period, children under two years old accounted for 44.1 percent of the
exposures associated with e-cigarettes. Exposures of children to
unregulated nicotine concentrations in e-cigarette cartridges and
refill solutions (e-liquids) have the potential to cause much more
severe toxic effects compared to exposures of children to FDA-approved
OTC NRTs. This is because e-liquid refill containers are available in
concentrations up to 100 mg/mL that are then diluted before use. The
liquid nicotine, ingested or absorbed through skin, is likely to result
in more severe toxic effects because it is available in higher
concentrations and absorbed rapidly by the body. In December 2014, a 1-
year old child died from liquid nicotine poisoning, the first such
death in the U.S.\38\
---------------------------------------------------------------------------

    \37\ http://pediatrics.aappublications.org/content/early/2016/05/05/peds.2016-0041?utm_source=TrendMD&utm_medium=TrendMD&utm_campaign=Pediatrics_TrendMD_1.
    \38\ https://www.healthychildren.org/English/safety-prevention/at-home/Pages/Liquid-Nicotine-Used-in-E-Cigarettes-Can-Kill-Children.aspx.
---------------------------------------------------------------------------

    Prescription NRTs, like OTC NRTs, must be approved for use by FDA
as drugs. However, the FDA considers OTC drug products to be safe
enough to take without the guidance of a health professional. A
prescription for a drug is written by a health professional for an
individual at a specific dose after the health professional has
diagnosed an illness. Generally, nicotine-containing prescription drugs
(e.g., nicotine inhaler and nicotine spray) contain an aqueous solution
intended for administration as a metered spray, which means, in
comparison to FDA-approved OTC NRTs, nicotine can be delivered rapidly
to the body. When a prescription pharmaceutical is transitioned to OTC
status, the key question for FDA is whether consumers can achieve the
desired medical result without the intervention of a health care
professional and without endangering their safety.\39\ For example, FDA
has to review information about adverse events and serious adverse
events resulting from use of a prescription drug before it can make a
determination on whether a prescription drug is safe to switch over to
an OTC drug. FDA has not yet made that determination for the existing
prescription NRTs and EPA also did not receive any toxicity or health
effects information on prescription NRTs. Prescription NRTs are also
expected to be used less frequently than FDA-approved OTC NRTs, and,
thus, should not exist in the same quantities at retailers as FDA-
approved OTC NRTs. Furthermore, prescription NRTs are not expected to
be returned to retailers like FDA-approved OTC NRTs, because they are
prescribed by health professionals for specific individuals and can't
be resold once dispensed. Therefore, the comments from retailers also
expressed less concern about the disposal of prescription NRTs causing
a change in their hazardous waste generator category.
---------------------------------------------------------------------------

    \39\ https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143547.htm.
---------------------------------------------------------------------------

    Based on the information discussed above and the comments from a
majority of the states and NEWMOA, the Agency is not exempting e-
cigarettes, e-liquids, or prescription NRTs from the P075 hazardous
waste listing. The Agency believes that any plausible mismanagement or
diversion of these waste products, if exempted and allowed to be
managed as non-hazardous wastes, has the ability to cause substantial
present or potential hazard to human health and the environment. This
is because prescription NRT products can contain nicotine at much
higher concentrations and in a more readily available form (i.e., in
liquid and mist), which acts faster on the body, than the nicotine
contained in FDA-approved OTC NRTs. Instead, the Agency is allowing e-
cigarettes, e-liquids, and prescription NRTs to be managed as hazardous
waste pharmaceuticals under 40 CFR part 266 subpart P when they are
discarded.
4. Concentration-Based Exemption
    Some commenters stated that the data and information they provided
to EPA should be adequate to support a concentration-based exemption
for nicotine-containing products. These commenters requested that EPA
exempt from the P075 listing all present and future nicotine-containing
products with less than a particular nicotine concentration (e.g., less
than 3% or 5%).
    The Agency stated in the proposal that it would consider a
concentration-based exemption for low-concentration nicotine-containing
products if toxicology data (e.g., animal LD50 data) for nicotine-
containing products at maximum concentration of nicotine in these
products became available. On June 9, 2017, Perrigo submitted
additional comments along with oral and dermal LD50 toxicity studies
for nicotine gums and lozenges manufactured by Perrigo.\40\ The gums
and lozenges tested contain 5% nicotine polacrilex. Nicotine polacrilex
is a nicotine-containing resin which contains 15% nicotine. With 5%
nicotine polacrilex in the gums and lozenges, the total nicotine in
these products is less than 1%. The Perrigo LD50 studies reported oral
and dermal rat LD50 toxicity values of greater than 5000 mg/kg for both
nicotine gum and lozenge products. Based on their data, Perrigo asked
the Agency to exempt

from the P075 listing nicotine at concentrations below 5%.
---------------------------------------------------------------------------

    \40\ See the docket for this rulemaking EPA-HQ-RCRA-2007-0932-
0398.
---------------------------------------------------------------------------

    EPA's review of the Perrigo LD50 studies revealed several critical
flaws in the way these studies were conducted. First, the studies were
conducted using nicotine polacrilex instead of nicotine itself. A
concentration-based listing for nicotine would require toxicity data
for nicotine itself. The amount of nicotine in gums and lozenges with
5% nicotine polacrilex, as stated above, is less than 1% and it is in a
form that is not readily available when ingested or applied (nicotine
is designed to be released slowly when it is in the form of nicotine
polacrilex). In fact, the nicotine will not release from the nicotine-
containing resin (nicotine polacrilex) until it is exposed to an
aqueous solution or proper pH, such as found in saliva. Therefore,
nicotine polacrilex would not be expected to be absorbed dermally. In
contrast, nicotine is readily absorbed dermally, as indicated by
nicotine patches. To support a concentration-based exemption of
nicotine, Perrigo should have conducted the toxicity studies for
nicotine using the percent of nicotine (not nicotine polacrilex) in the
gums and lozenges, since this would have provided data on toxicity of
nicotine (the P075 listed chemical). Second, for acute oral testing, a
single bolus dose of nicotine should have been administered to the test
animals all at once (or over a short period of time) instead of over a
period of 24 hours. Third, in EPA's listing regulations under Sec.
261.11(a)(2), the dermal LD50 toxicity value is based on studies with
rabbits, but Perrigo's studies used rats. Fourth, Perrigo did not
provide LD50 toxicity data for nicotine patches (this could be because
Perrigo does not manufacture nicotine patches). Finally, no explanation
or justification was included for using their toxicity data which was
for nicotine polacrilex with concentrations of nicotine at less than
1%, to extrapolate to exempting all nicotine with a concentration below
5%.
    EPA, for the reasons previously stated, has already determined that
FDA-approved OTC NRTs are not acutely toxic and is exempting them from
the P075 listing. The toxicological data submitted by Perrigo are for
nicotine polacrilex, instead of nicotine, and are not considered to be
adequate to support a concentration-based exemption for nicotine-
containing products. Therefore, the Agency has no other information to
conclude that a particular nicotine concentration can be exempt from
the P075 listing.

VI. Reverse Distribution and Reverse Logistics

A. Summary

    Based on information collected from outreach efforts and comments
received on the proposed rulemaking, EPA is finalizing regulations for
the reverse distribution of prescription hazardous waste
pharmaceuticals, codifying our existing interpretation for the reverse
logistics of nonprescription pharmaceuticals,\41\ and establishing a
policy for the reverse logistics of other unsold retail items.\42\ In
the case of prescription pharmaceuticals, EPA maintains its position as
stated in the proposed rulemaking preamble that prescription
pharmaceuticals moving through reverse distribution are solid wastes at
the healthcare facility (e.g., retail store).\43\ In contrast, EPA is
codifying our existing interpretation that nonprescription
pharmaceuticals that are sent through reverse logistics are not solid
wastes at the retail store \44\ if they have a reasonable expectation
of being legitimately used/reused (e.g., lawfully redistributed for
their intended purpose) \45\ or reclaimed.\46\ Additionally, EPA is
establishing a policy that other retail items that are sent through
reverse logistics are not solid waste at the retail store if they have
a reasonable expectation of being legitimately used/reused (e.g.,
lawfully redistributed for their intended purpose) or reclaimed. The
remainder of this section proceeds as follows. First, EPA provides a
brief background on the Agency's work to better understand the retail
sector and provide guidance on RCRA's applicability to the retail
sector. EPA then describes the proposal to revise the Agency's position
regarding how RCRA applies to pharmaceuticals that are returned to
reverse distributors under the pharmaceuticals proposed rulemaking.
Finally, EPA provides the rationale for finalizing distinct regulations
and policies for the reverse distribution of prescription hazardous
waste pharmaceuticals and the reverse logistics of other unsold retail
items and nonprescription pharmaceuticals and describes new information
received in comments on the proposed rulemaking.
---------------------------------------------------------------------------

    \41\ Under the final rule, the definition of pharmaceutical
includes, but is not limited to, prescription drugs, over-the-
counter drugs, dietary supplements, and homeopathic drugs. See the
definition of pharmaceutical in Sec.  266.500. For the remainder of
this section, EPA refers to over-the-counter drugs, dietary
supplements, and homeopathic drugs as nonprescription
pharmaceuticals. Prescription pharmaceuticals are defined by 21 CFR
203.3(y).
    \42\ Under the final rule, other unsold retail items can include
any non-pharmaceutical unsold retail item from a retail store that
if discarded would otherwise meet the definition of hazardous waste.
Examples include but are not limited to aerosol cans, pool
chemicals, mercury-containing lightbulbs, some pesticides, certain
cleaning products, paint thinner, ammunition, and fireworks.
    \43\ Under the final rule, the definition of healthcare facility
includes, but is not limited to, retail facilities such as
pharmacies and retailers of over-the-counter medications. See the
definition of healthcare facility in Sec.  266.500.
    \44\ Throughout this section, EPA uses the term ``retail store''
to describe facilities that send nonprescription pharmaceutical and
other unsold retail items through reverse logistics. EPA's
understanding is that the retail sector is the only industry that
sends nonprescription pharmaceuticals and other unsold items through
reverse logistics. However, EPA's final policy that nonprescription
pharmaceuticals and other unsold retail items, excluding
prescription pharmaceuticals, that are sent through reverse
logistics are not solid wastes if they have a reasonable expectation
of being legitimately used/reused or reclaimed, is not limited to
the retail sector.
    \45\ Commenters from the retail industry commonly use the terms
``liquidation'' or ``donation'' to refer to legitimate methods of
redistribution. For example, see comment numbers EPA-HQ-RCRA-2007-
0932-0312 and EPA-HQ-RCRA-2007-0932-0340 in the docket. Under RCRA's
definition of solid waste regulations in Sec.  261.2(e),
redistribution would be referred to as use/reuse.
    \46\ See Sec.  261.1(b)(4) for the definition of reclamation and
Sec.  261.1(b)(5) for the definition of use/reuse.
---------------------------------------------------------------------------

B. Background

    In 2008, EPA initiated a review of RCRA's applicability to the
retail sector in order to understand the challenges the retail sector
faces in complying with RCRA. EPA's review consisted of discussions
with various members of the retail community and states through
meetings, conferences, and site visits. In 2014, EPA published a NODA
for the Retail Sector in order to better understand the concerns from
all stakeholders regarding RCRA's applicability to that sector.\47\
---------------------------------------------------------------------------

    \47\ February 14, 2014 (79 FR 8926).
---------------------------------------------------------------------------

    Subsequent to issuance of the NODA, EPA continued conducting
outreach efforts (e.g., meetings, conferences, site visits) with
stakeholders to gather information regarding the management of unsold
retail items. EPA's outreach efforts, combined with an analysis of
comments received on the NODA, improved the Agency's understanding of
the challenges that the retail sector faces when managing items that
have become unsalable at stores for a variety of reasons. Unsold retail
items include excess inventory, such as expired or outdated items,
seasonal items,

overstock, recalled items, and returned items that cannot be returned
to stock/inventory. In the NODA, EPA used the terms ``reverse
distribution'' and ``reverse logistics'' to describe the process or
system employed by the retail sector to manage these unsold retail
items.
    Based on information gathered through outreach and comments to the
Retail NODA, EPA developed a cohesive plan to address the unique
challenges faced by the retail sector in complying with RCRA
regulations. This plan is called the ``Strategy for Addressing the
Retail Sector under the Resource Conservation and Recovery Act's
Regulatory Framework'' (Retail Strategy) and was made publicly
available on September 12, 2016.\48\
---------------------------------------------------------------------------

    \48\ EPA's Retail Strategy is available at https://www.epa.gov/hwgenerators/strategy-addressing-retail-sector-under-resource-conservation-and-recovery-acts.
---------------------------------------------------------------------------

    Throughout the Retail Strategy, EPA used the term ``reverse
distribution'' to describe the system through which unsold retail items
flow and the term ``reverse logistic center'' to describe the
facilities managing the reverse flow of these items. In crafting the
Retail Strategy, EPA recognized that the reverse distribution process
that retail stores employ to send unsold retail items to reverse
logistics centers is a well-established business practice in the retail
sector and retail stores sometimes rely upon arrangements with
manufacturers \49\ to determine the ultimate disposition of these
goods. EPA also noted that a number of questions have been raised by
both retailers and regulators regarding how the reverse distribution
process is regulated, or should be regulated, under RCRA. In addition,
this issue becomes more complicated for national retailers with store
locations in multiple states, as states have taken various positions on
how RCRA regulations apply. The Agency's understanding when crafting
the Retail Strategy was that ``reverse distribution'' is the term most
commonly used for the return of all pharmaceuticals (both prescription
and nonprescription) that have the potential to receive manufacturer
credit, whereas ``reverse logistics'' is the term used for the reverse
flow of retail items other than pharmaceuticals.\50\
---------------------------------------------------------------------------

    \49\ EPA has not distinguished among the terms ``supplier'' and
``vendor'' (the latter more commonly used in the retail industry)
versus ``manufacturer'' and these terms are used interchangeably in
this preamble, although the Agency realizes that the flow of goods/
products more commonly occurs between retailers and suppliers/
vendors (or agents thereof) and that suppliers themselves may also
be manufacturers or product formulators.
    \50\ As discussed subsequently in this preamble, the distinction
between ``reverse distribution'' and ``reverse logistics'' has
become important in light of the Agency's response to comments
received on the proposed rule.
---------------------------------------------------------------------------

    Because of the challenges facing the retail sector in complying
with RCRA, EPA stated in the Retail Strategy its intent to develop a
policy addressing the reverse distribution process for the retail
sector as a whole. In the Retail Strategy, EPA agreed to develop a
comprehensive policy that applied to all unsold retail items, not just
pharmaceuticals. In order to fulfill EPA's intent to address the
reverse distribution process for the retail sector as a whole, EPA is
establishing a policy for the reverse logistics of other unsold retail
items in addition to finalizing regulations for the reverse
distribution of prescription hazardous waste pharmaceuticals and
codifying our existing interpretation for the reverse logistics of
nonprescription pharmaceuticals.

C. EPA's Proposed Regulations for Reverse Distribution of
Pharmaceuticals

    In the proposed Management Standards for Hazardous Waste
Pharmaceuticals, EPA proposed to revise the Agency's position regarding
how RCRA applies to pharmaceuticals that are returned to reverse
distributors to obtain manufacturer credit. EPA's original position was
outlined in two RCRA policy memos released in 1981 and 1991.\51\ In the
first memo, EPA agreed that pharmaceuticals did not become wastes until
the decision to discard was made at a manufacturing plant. EPA's
interpretation was based on the understanding that the decision to
either return goods for reclamation or dispose of them took place only
at the manufacturing plant. In the second memo, EPA agreed that
pharmaceuticals returned to a manufacturer, wholesaler, or third-party
service company would not be considered wastes until a decision to
discard has been made. In this 1991 memo, EPA specifically noted that,
``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 waste until a
determination to discard them is made.'' Although EPA made a statement
in the preamble to the 2008 Pharmaceutical Universal Waste proposal
that linked the value of these pharmaceuticals, in the form of
manufacturers credit, to the idea that these pharmaceuticals would not
be considered waste, EPA never finalized this universal waste rule or
that interpretation. Thus, the 1991 memo describes EPA's interpretation
regarding how RCRA applies to pharmaceuticals that are returned to
reverse distributors prior to this final rulemaking.
---------------------------------------------------------------------------

    \51\ Refer to the preamble of the proposed rule (pages 58042 and
58043), which includes discussion of the two EPA policy memos, dated
May 13, 1981 (RCRA Online #11012) and May 16, 1991 (RCRA Online
#11606).
---------------------------------------------------------------------------

    In the preamble to the proposed rulemaking, EPA indicated the
Agency's intent to modify its position regarding the point of
generation in circumstances where a pharmaceutical is sent to a reverse
distributor. EPA proposed 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. That is, EPA proposed that, once the
decision is made to send a potentially creditable hazardous waste
pharmaceutical \52\ from a healthcare facility to a reverse
distributor, a decision to discard has been made and the pharmaceutical
is considered a solid waste. This proposed change of policy was based
on the EPA's understanding that in almost all cases, pharmaceuticals
returned to a reverse distributor for manufacturer credit are
ultimately discarded.\53\ Under the proposed rulemaking, the definition
of ``pharmaceutical reverse distributor'' included any person that
receives and accumulates potentially creditable hazardous waste
pharmaceuticals for the purpose of facilitating or verifying
manufacturer credit. Additionally, under the proposed rulemaking, the
definition of ``pharmaceutical'' included not just prescription
pharmaceuticals but also nonprescription pharmaceuticals. Therefore,
under the proposal, potentially creditable prescription pharmaceuticals
and nonprescription pharmaceuticals transported to a facility that
facilitates or verifies manufacturer credit, even in cases where a
credit determination is yet to be made, would be considered discarded
and, therefore, solid wastes at the healthcare facility.
---------------------------------------------------------------------------

    \52\ Potentially creditable hazardous waste pharmaceutical in
the proposal was generally defined as a hazardous waste
pharmaceutical that has the potential to receive manufacturer credit
and is (1) unused or un-administered; and (2) unexpired or less than
one year past expiration date. See 80 FR 58014.
    \53\ See further discussion in the proposed rule preamble at 80
FR 58043.
---------------------------------------------------------------------------

    In proposing this shift, EPA specifically stated that, although a
pharmaceutical may retain monetary value within the reverse
distribution system (i.e., potential exists for a manufacturer to issue
credit), the

pharmaceutical would still be considered a solid waste. The ``decision
point'' on whether a pharmaceutical is a solid waste is when it has
been discarded or when the decision has been made to discard the
material. That is, when a pharmaceutical is discarded determines
whether it is a solid waste, not whether the pharmaceutical has value.
This interpretation is consistent with EPA's approach under RCRA that
materials that are discarded are solid wastes, regardless of their
monetary value or the economics of the system in which those discarded
materials are handled. EPA has long maintained, and continues to
maintain, the interpretation that value is not determinative of solid
waste status.
    In 1986, EPA released a memo on the regulation of hazardous wastes
that are recycled, and wrote that ``persons transporting and storing
hazardous wastes before recycling are similar to persons transporting
and storing hazardous waste before disposal: There is nothing about the
waste that makes it so valuable that safe handling is assured absent
regulation.'' \54\ EPA reaffirmed this interpretation in a 1989 memo on
the regulatory status of solder skimmings (tin/lead alloy) purchased
for reclamation, writing that even though the skimmings have value,
they are still considered a solid waste.\55\
---------------------------------------------------------------------------

    \54\ See RCRA Online #12762 for the October 8, 1986 letter from
EPA to Senator John Glenn titled ``Hazardous Wastes that are
Recycled, Handling.''
    \55\ See RCRA Online #11446 for the July 20, 1989 memo from EPA
to Electrum Recovery Works, Inc.
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    In a more recent application of this interpretation, EPA outlined
its position on chlorofluorocarbons (CFCs) that are processed back into
the refrigerant market or sent for destruction, but receive carbon
offset credits and thus have value, in two memos signed in 2017.\56\
Irrespective of whether facilities pay for hazardous CFCs or receive
carbon offsets for the destruction of CFCs, the material is considered
a solid waste. As another example of a material that is discarded as
solid waste but has monetary value, EPA maintains that spent lead acid
batteries being reclaimed are regulated as hazardous waste under part
266 subpart G or under universal waste irrespective of the fact that
the batteries may have value and that reclamation facilities sometimes
buy batteries due to the monetary value of the lead.\57\ This finding
was upheld in United States v. Ilco Inc., 996 F. 2d 1126, where the
court found that the fact that the batteries were discarded ``does not
change just because a reclaimer has purchased or finds value in the
components.'' EPA also maintains that recyclable materials that are
reclaimed to recover economically significant amounts of gold, silver,
and other various precious metals are still regulated as hazardous
waste under part 266 subpart F despite the fact that the precious
metals have monetary value. Additionally, the holdings of multiple
court decisions is that simply because a hazardous waste has, or may
have, monetary value does not mean the material loses its status as a
solid waste. See American Petroleum Institute v. EPA, 906 F.2d 741 n.16
(D.C. Cir. 1990); United States v. ILCO Inc., 996 F.2d 1126 1131-32
(11th Cir. 1993); Owen Steel v. Browner, 37 F.3d 146, 150 (4th Cir.
1994).
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    \56\ See docket number EPA-HQ-RCRA-2007-0932 for the January 30,
2017 letter from EPA Region 5 to Tradewater, LLC and the July 14,
2017 letter from EPA to A-Gas U.S. Holdings, Inc.
    \57\ See docket number EPA-HQ-RCRA-2007-0932 for notes from a
November 19, 2013 site visit to a lead acid battery recycler.
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D. EPA's Final Reverse Distribution Regulation and Reverse Logistics
Policy

1. Introduction
    In light of comments received on the proposed rulemaking, along
with EPA's understanding of current business practices, the Agency is
making a clear distinction in the final rule between the reverse
distribution of prescription pharmaceuticals and the reverse logistics
of other unsold retail items, including nonprescription
pharmaceuticals. In addition to receiving information from comments on
the proposed rulemaking, EPA gathered information from site visits and
by participating as an observer in the Retail Waste Working Group.\58\
In the case of prescription pharmaceuticals, EPA is finalizing, as
proposed, that prescription pharmaceuticals moving through reverse
distribution are solid wastes at the healthcare facility. However, EPA
notes that these tailored RCRA regulations for prescription
pharmaceuticals going through reverse distribution are designed with
existing business practices in mind. For more explanation, see section
4 below and section XVII of this preamble. EPA is also codifying our
existing interpretation for the reverse logistics of nonprescription
pharmaceuticals. EPA makes it clear in Sec.  266.501(g)(2) that
nonprescription pharmaceuticals are not solid wastes because they have
a reasonable expectation of being legitimately used/reused (e.g.,
lawfully redistributed for their intended purpose) or reclaimed (also
see section IX of this preamble). Also in this preamble, EPA is
establishing a policy that other unsold retail items that are sent
through reverse logistics are not solid wastes at the retail store
because they have a reasonable expectation of being legitimately used/
reused (e.g., lawfully redistributed for its intended purpose) or
reclaimed.
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    \58\ See the report prepared by the Retail Waste Working Group,
``Surplus Household Consumer Products and Wastes: Report to the
Legislature.'' Available at: http://www.dtsc.ca.gov/HazardousWaste/Retail_Industry/upload/SB423_Final-Rpt.pdf.
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2. Comments on EPA's Proposed Reverse Distribution Regulation
    EPA received numerous comments on the proposed position that the
decision to send potentially creditable pharmaceuticals through reverse
distribution is a decision to discard. States were generally supportive
of the proposed change in position, while many comments from the retail
industry objected to the Agency's proposed change in position.
    EPA received many broad comments on EPAs proposed position
regarding the waste status of pharmaceuticals going through reverse
distribution and reverse logistics, which are discussed in further
detail in section XVII. EPA also received many comments describing the
potential burden that the revised interpretation would place on the
retail industry, which are also discussed in further detail in section
XVII. The remainder of this section focuses on comments received on the
distinction between the reverse distribution of prescription
pharmaceuticals and the reverse logistics of nonprescription
pharmaceuticals and other unsold retail items.
    EPA received numerous comments that described the key distinctions
between reverse distribution and reverse logistics as they pertain to
the waste status of pharmaceuticals and other unsold retail items going
through these two processes. Multiple commenters argued that EPA
mistakenly concluded that pharmaceuticals, including nonprescription
pharmaceuticals, transported to facilities that facilitate or verify
manufacturer credit are in most, if not all cases, discarded.\59\
Commenters argued that the Agency failed to take into account the
ability to donate, liquidate, or reclaim nonprescription
pharmaceuticals that are sent through reverse logistics. However,
commenters did confirm that prescription pharmaceuticals are in

most, if not all cases, discarded. Commenters argued that this fact
contradicts EPA's rationale in proposing that all pharmaceuticals,
including nonprescription pharmaceuticals, going through reverse
distribution and reverse logistics are wastes at the healthcare
facility.
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    \59\ See the preamble to the proposed rule for a discussion of
the comments received on the 2008 Pharmaceutical Universal Waste
proposal and the 2014 Retail Notice of Data Availability that argued
that pharmaceuticals transported to reverse distributors to receive
credit are rarely, if ever, repurposed, recycled, or reused (80 FR
58043).
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    Overall, commenters encouraged EPA to adopt the terminology used by
industry where ``reverse distribution'' only refers to the process by
which prescription pharmaceuticals are sent to a reverse distributor
for the evaluation of manufacturers credit and ``reverse logistics''
refers to the process by which nonprescription pharmaceuticals and
other unsold retail items are sent to a reverse logistics center and
evaluated for legitimate use/reuse or reclamation. Commenters requested
that if EPA intends to finalize that a decision to send a
pharmaceutical to a reverse distributor is the point at which a
decision has been made to discard the pharmaceutical, that EPA also
adopt separate and distinct policies regarding how RCRA applies to
prescription pharmaceuticals going through ``reverse distribution'' and
to nonprescription pharmaceuticals and other unsold retail items going
through ``reverse logistics.'' \60\ One commenter noted that reverse
logistics is an integral component of inventory management, product
recall confirmation, sale through liquidation, donation for use, and
reclamation of commercial products--contributing billions of dollars to
the retail industry annually.\61\ Moreover, this commenter noted that
the reverse logistics operations help maximize the amount of OTC
pharmaceuticals and dietary supplements that can be reused or
reclaimed. Another commenter made a similar argument, writing that the
purpose of reverse distribution of prescription pharmaceuticals is to
determinate creditworthiness while the primary purpose of reverse
logistics of nonprescription pharmaceuticals is to aggregate and
redirect viable products into another supply chain.\62\
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    \60\ For example, see comment number EPA-HQ-RCRA-2007-0932-0377.
    \61\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket.
    \62\ See comment number EPA-HQ-RCRA-2007-0932-0312 in the
docket.
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    One commenter honed in on the argument that EPA failed to take into
account the ability to legitimately use/reuse or reclaim
nonprescription pharmaceuticals that are sent through reverse
logistics.\63\ This commenter pointed out that stringent chain-of-
custody documentation and disposal requirements under DEA regulations
and state Board of Pharmacy Requirements only apply to prescription
pharmaceuticals. In contrast, most nonprescription pharmaceuticals are
not susceptible to the same diversion risks as prescription
pharmaceuticals and do not face the same documentation and disposal
requirements. This makes it possible to use/reuse or reclaim
nonprescription pharmaceuticals.
---------------------------------------------------------------------------

    \63\ Ibid.
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    Walmart Stores Inc. commented that pharmaceuticals going through
reverse distribution that are ultimately discarded are likely
prescription pharmaceuticals.\64\ Walmart wrote that only a small
percentage of the consumer goods \65\ managed at Walmart's six Return
Centers, which will be considered reverse logistics centers under EPA's
final policy, are discarded. According to Walmart's data, only 2% of
the consumer goods managed at Walmart's Return Centers are discarded by
Walmart, while 28% are donated, recycled, or liquidated and 70% are
returned to the vendor.\66\ Further, for the consumer products that are
considered RCRA hazardous waste when discarded, only 1% are discarded,
33% are liquidated or donated, and 66% are returned to the vendor.\67\
Inmar, Inc. also argued that only a small percentage of the OTC
pharmaceuticals returned to a reverse logistics center are disposed
rather than liquidated, donated, or returned to the vendor.\68\ Inmar
does not maintain specific data on this issue, but wrote that it would
not be unusual for one of their subsidiary reverse logistics centers
handling nonprescription pharmaceuticals and other consumer goods to
send as little as 5% of the products for destruction.
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    \64\ See comment number EPA-HQ-RCRA-2007-0932-0340 in the
docket.
    \65\ EPA uses the term ``unsold retail items'' to refer to
excess inventory, such as expired or outdated items, seasonal items,
overstock, recalled products, and returned items that cannot be
returned to stock/inventory. Walmart and other commenters from the
retail industry use the term ``consumer goods'' to refer to similar
items.
    \66\ EPA has not distinguished among the terms ``supplier'' and
``vendor'' verses ``manufacturer'' and the terms are used
interchangeably throughout the preamble. The Agency more frequently
used the term ``manufacturer'' while retail industry commenters more
frequently used the term ``vendor.''
    \67\ EPA did not receive data on the ultimate disposition of
consumer products returned to the vendor. EPA further discusses our
policy on unsold retail items that are returned to the vendor in
section ``e.) Nonprescription Pharmaceuticals and Other Retail Items
Going through Reverse Logistics Are Not Wastes.''
    \68\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket.
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    Retail Industry Leaders Association (RILA) et al. pointed out that
nonprescription pharmaceuticals do not face the same restrictions that
preclude the redistribution or donation of prescription
pharmaceuticals.\69\ RILA et al. added that nonprescription
pharmaceuticals are regularly donated and liquidated and cited data
from two retailers.
---------------------------------------------------------------------------

    \69\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the
docket.
---------------------------------------------------------------------------

    Inmar Inc. also noted that when an item is returned because an
expiration date has been exceeded, disposal is more often the required
disposition, but the products may be returned to the manufacturer for
further evaluation for potential liquidation.\70\ Inmar also wrote that
nonprescription pharmaceuticals with ``best by'' dates (as opposed to
expiration dates) can still be donated or liquidated after the date has
passed.
---------------------------------------------------------------------------

    \70\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the
docket.
---------------------------------------------------------------------------

    Overall, these comments help to underscore the differences between
how prescription pharmaceuticals and other unsold retail items,
including nonprescription pharmaceuticals, are managed within the
reverse supply chain. These comments led EPA to make a clear
distinction in the final rule between the reverse distribution of
prescription pharmaceuticals and the reverse logistics of all other
unsold retail items, including nonprescription pharmaceuticals.
3. Distinction Between Reverse Distribution and Reverse Logistics
    EPA acknowledges that reverse distribution and reverse logistics
processes share common elements in terms of the role each plays in the
management of pharmaceuticals. However, based on the comments received
on the proposal, especially those summarized above, the Agency
recognizes that there is a key distinction between how prescription
pharmaceuticals and nonprescription pharmaceuticals (see definition of
pharmaceutical in Sec.  266.500) are managed in the reverse supply
chain. The key distinction is that there is not a reasonable
expectation of legitimate use/reuse (e.g., lawful redistribution for
its intended purpose) or reclamation for prescription pharmaceuticals,
except in very limited circumstances, but there is for other retail
items, including nonprescription pharmaceuticals.
    Prescription pharmaceuticals shipped from healthcare facilities to
reverse distributors for the evaluation of manufacturer credit are
almost always discarded. EPA is aware that prescription pharmaceuticals
are sometimes lawfully donated, in which case the pharmaceuticals would
not be

a solid waste.\71\ In the case of nonprescription pharmaceuticals and
other unsold retail items that are sent to a reverse logistics center,
there is often a reasonable expectation that they will be legitimately
used/reused (e.g., lawfully redistributed for their intended purpose)
or reclaimed.
---------------------------------------------------------------------------

    \71\ EPA is aware of one non-profit organization that
facilitates donations of prescription pharmaceuticals. See comment
from SIRUM in the docket (EPA-HQ-RCRA-2007-0932-0353). EPA is also
aware of multiple states, including Iowa, Wyoming, and Oklahoma,
that run prescription pharmaceutical return and reuse programs. For
more information, see ``State Prescription Drug Return, Reuse and
Recycling Laws'' at http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx.
---------------------------------------------------------------------------

    EPA recognizes that the awarding of credit for unsold
pharmaceuticals is a critical element of both the reverse distribution
and reverse logistics processes as it provides a healthcare facility
financial incentive to not only stock a particular pharmaceutical but
also to defray costs associated with transporting a pharmaceutical to a
reverse distributor or reverse logistics center. However, it is EPA's
position that the inherent monetary ``value'' conferred on any
pharmaceutical due to the potential to receive manufacturer credit is
not a proper indicator of waste status. Rather, the decision to discard
is determinative of when an unsold product becomes a solid waste. Under
EPA's final rule and preamble, if a nonprescription pharmaceutical or
other retail item becomes unsalable at a retail store it can continue
to be considered a product until a reverse logistics center or other
subsequent entity makes the decision to discard it, as long as there is
a reasonable expectation of it being legitimately used/reused (e.g.,
lawfully redistributed for its intended purpose) or reclaimed.
4. Prescription Pharmaceuticals Going Through Reverse Distribution Are
Wastes at the Healthcare Facility
    In the case of prescription pharmaceuticals, EPA maintains its
position, as stated in the proposed rulemaking preamble and reflected
in the regulatory text, that prescription pharmaceuticals moving
through reverse distribution are solid wastes starting at the
healthcare facility. This includes prescription pharmaceuticals that,
as potentially creditable hazardous waste pharmaceuticals, are sent
from a retail facility or healthcare facility to a reverse distributor
for manufacturer credit evaluation (see definition of potentially
creditable hazardous waste pharmaceutical in Sec.  266.500). Although
the potential exists for a manufacturer to issue credit for a
prescription pharmaceutical, the ``decision point'' on when a
pharmaceutical is a solid waste is when the decision has been made to
discard the item. That is, a pharmaceutical is a solid waste when the
decision has been made to discard regardless of whether the
pharmaceutical has value. Although prescription pharmaceuticals are
evaluated for, and in many cases ultimately receive, manufacturer
credit, it remains apparent to EPA that these pharmaceuticals will
seldom, if ever, be legitimately used/reused (e.g., lawfully
redistributed for their intended purpose) or reclaimed after they are
sent to a reverse distributor. Thus, a decision to send prescription
pharmaceuticals to a reverse distributor is a decision to discard the
material. None of the comments on the proposed rule alter EPA's
position regarding the likelihood of redistribution or reclamation of
prescription pharmaceuticals being managed through reverse
distribution. Rather, EPA received many comments that agreed with EPA's
proposed interpretation that the decision to send a pharmaceutical to a
reverse distributor is a decision to discard as it pertains to
prescription pharmaceuticals because there are limited opportunities to
legitimately use/reuse or reclaim prescription pharmaceuticals. In
circumstances when prescription pharmaceuticals are lawfully donated
for their intended purpose, they would not be considered a solid waste
and we have specifically noted this in the regulations (see Sec.
266.501(g)(1) and the definition of hazardous waste pharmaceutical in
Sec.  266.500).
    Many of the broad comments in support of the proposed
reinterpretation provided examples but did not distinguish between
prescription pharmaceuticals and nonprescription pharmaceuticals. For
example, multiple commenters argued that pharmaceuticals transported to
a reverse distributor are rarely redistributed or reclaimed, and are
usually destroyed, but did not explain if this applied only to
prescription pharmaceuticals. One commenter observed that many
manufacturers contract with reverse distributors to dispose of unsold
pharmaceuticals after review for credit eligibility is complete,
suggesting that use/reuse or reclamation does not generally occur. This
commenter was only aware of one instance of potential reuse of a
pharmaceutical after being sent through reverse distribution.\72\ That
being said, based on what EPA has learned from retail industry
commenters, site visits, and discussions with retailers about
prescription pharmaceuticals verses nonprescription pharmaceuticals,
EPA can infer that these comments likely refer to the reverse
distribution of prescription pharmaceuticals.\73\ EPA's inference is
supported by other comments received on the proposal. For example,
Walmart argued that the comments EPA received on the 2008
Pharmaceutical Universal Waste proposal (where pharmaceuticals were
defined only as prescription pharmaceuticals) and the 2014 Retail
Notice of Data Availability that pharmaceuticals going through reverse
distribution are ultimately discarded were likely talking about
prescription pharmaceuticals.\74\
---------------------------------------------------------------------------

    \72\ The example cited was an unconfirmed claim that a rodent
poison manufacturer could use discarded pharmaceutical warfarin
tablets as feedstock in its process. See comment number EPA-HQ-RCRA-
2007-0932-0358 in the docket.
    \73\ See docket number EPA-HQ-RCRA-2007-0932 for reverse