[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Rules and Regulations]
[Pages 5816-5950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01298]



[[Page 5815]]

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  

[[Page 5816]]


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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: (703) 308-8286; email 
address: [email protected], 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 protected]. 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-

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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.

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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

[[Page 5819]]

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

[[Page 5820]]

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.
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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

[[Page 5821]]

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.

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[[Page 5822]]

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-

[[Page 5823]]

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

[[Page 5824]]

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

[[Page 5825]]

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

[[Page 5826]]

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

[[Page 5827]]

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,

[[Page 5828]]

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

[[Page 5829]]

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.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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

[[Page 5830]]

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 5831]]

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 
distributor responses to EPA's questions about reverse distribution 
of pharmaceuticals, notes from Agency meetings with retail industry 
representatives, and notes from site visits to reverse distribution 
facilities.
    \74\ See comment number EPA-HQ-RCRA-2007-0932-0340 in the 
docket.
---------------------------------------------------------------------------

    In conclusion, a material is considered a solid waste if it is 
accumulated or stored before or in lieu of being disposed of, burned, 
or incinerated (Sec.  261.2(b)(3)). Even if the healthcare facility 
intends to receive credit for the prescription pharmaceutical and the 
reverse distributor intends to evaluate the prescription pharmaceutical 
for credit, the pharmaceutical is still considered a discarded material 
(Sec.  261.2(a)(2)(i)) because it is being accumulated and stored prior 
to being sent for treatment (rather than being accumulated or stored 
prior to being used/reused or reclaimed). Although the healthcare 
facility or reverse distributor intends to elicit credit from the 
prescription pharmaceutical in the interim period before it is sent for 
treatment, the pharmaceutical is still considered a discarded material. 
An intent to receive credit does not preclude the pharmaceuticals from 
being discarded; they are not mutually exclusive.
    Although EPA maintains its position that prescription 
pharmaceuticals moving through reverse distribution are solid wastes at 
the healthcare facility, this final rule establishes streamlined, 
practical standards for managing potentially creditable hazardous waste 
pharmaceuticals that will reduce regulatory burden on retailers and 
align with the existing practices of the retail sector. Thus, EPA's 
position that prescription pharmaceuticals moving

[[Page 5832]]

through reverse distribution are solid wastes at the healthcare 
facility only subjects these hazardous waste pharmaceuticals to the 
streamlined part 266 subpart P standards versus the full RCRA Subtitle 
C regulations. For example, EPA does not require healthcare facilities 
to use a hazardous waste manifest or a hazardous waste transporter when 
shipping potentially creditable hazardous waste pharmaceutical to a 
reverse distributor. See section XVI.D for a discussion of the shipping 
standards for potentially creditable hazardous waste pharmaceuticals.
    Because the point of generation of potentially creditable hazardous 
waste pharmaceuticals is at the healthcare facility, EPA can impose the 
RCRA Subtitle C cradle-to-grave management of hazardous wastes. 
Specifically, it allows us to impose consistent and enforceable 
tracking of hazardous waste pharmaceuticals from healthcare facilities 
en route to reverse distributors. Lack of tracking was identified as a 
regulatory gap by many commenters on our 2008 proposal to add 
pharmaceuticals to the Universal Waste program. The tracking provides 
the benefit of reducing the risk of diversion of these unused hazardous 
waste pharmaceuticals onto the black market, thus fulfilling our 
statutory mandate of protecting human health.
5. Nonprescription Pharmaceuticals and Other Retail Items Going Through 
Reverse Logistics Are Not Wastes if They Have a Reasonable Expectation 
of Being Legitimately Used/Reused or Reclaimed
    Although EPA includes nonprescription pharmaceuticals in the 
definition of ``pharmaceutical'' under the final rule, the Agency makes 
it clear in the definition of ``hazardous waste pharmaceutical'' that 
nonprescription pharmaceuticals are not solid wastes, and therefore not 
hazardous waste pharmaceuticals, if they have a reasonable expectation 
of being legitimately used/reused (e.g., lawfully redistributed for its 
intended purpose) or reclaimed. The applicability of the final rule 
also has a new provision in Sec.  266.501(g)(2) making it clear that a 
nonprescription pharmaceutical that is not a solid waste because it has 
a reasonable expectation of being legitimately used/reused or reclaimed 
is not subject to parts 260-273. Additionally, the final definition of 
reverse distributor has been revised so that it applies only to the 
reverse distribution of prescription pharmaceuticals.
    In the final rule, EPA is reaffirming the Agency's previous 
policies on redistribution expressed in memos in 1981 and 1991 with 
respect to nonprescription pharmaceuticals and other retail items that 
have become unsalable at the retail store and are being managed by a 
reverse logistics center through the reverse logistics process. That 
is, EPA is maintaining a policy that nonprescription pharmaceuticals 
and other retail items that are sent through reverse logistics are not 
solid wastes at the retail store if they have a reasonable expectation 
of being legitimately used/reused (e.g., lawfully redistributed for its 
intended purpose) or reclaimed. EPA recognizes that reverse logistics 
centers are designed to evaluate unsold retail items, analyze secondary 
markets, and assess the suitability of the unsold retail items for 
reuse in those secondary markets. These services promote the donation, 
liquidation, and reuse of unsold retail items and reduce overall waste. 
Importantly, these activities are distinct from the activities of 
reverse distributors of prescription pharmaceuticals. Reverse 
distributors of prescription pharmaceuticals are not designed to 
evaluate unsold prescription pharmaceuticals and assess the suitability 
of the prescription pharmaceuticals for reuse in secondary markets. As 
mentioned previously, commenters pointed out 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.
    Although EPA is reaffirming this policy, EPA remains concerned 
about the potential for overuse of reverse logistics centers, a concern 
we originally raised in a 1991 memo related to reverse distribution: 
``a reverse distribution system cannot be used as a waste management 
service to customers/generators without the applicable regulatory 
controls on waste management being in place . . . to the extent that 
the materials involved are unused commercial chemical products with a 
reasonable expectation of being recycled in some way when returned, the 
materials are not considered as wastes until a determination has been 
made to discard them.'' \75\ To reiterate, in order to avoid being 
considered solid waste, items, including nonprescription 
pharmaceuticals, sent through reverse logistics, must have some 
reasonable expectation of being legitimately used/reused or reclaimed. 
The 199l guidance allowing pharmaceuticals to go through reverse 
distribution without being considered solid waste was based on the 
notion that they had the potential for recycling by use/reuse. Over the 
years, however, many have come to disregard the intent behind this 
guidance and erroneously believed that it was a blanket statement that 
pharmaceuticals going through reverse distribution were not solid 
wastes, even if they did not have a reasonable expectation of being 
redistributed or recycled. We strongly encourage the use of reverse 
logistics centers to facilitate redistribution and legitimate recycling 
to the fullest extent possible, and thus, reduce the amount of waste 
being generated. But we also caution reverse logistic centers not to 
become de facto waste management facilities for their customers. If 
this were to occur, it could be the case that the decision to discard 
for nonprescription pharmaceuticals and other retail items would have 
occurred at the retail store or healthcare facility.
---------------------------------------------------------------------------

    \75\ See memo dated May 16, 1991, From Lowrance to Schulz, RCRA 
Online #11606.
---------------------------------------------------------------------------

    Of course, once a reverse logistics center makes a decision to 
discard an item, it becomes a solid waste and, if it is listed or 
exhibits a characteristic, a hazardous waste. The reverse logistics 
center is subject to the applicable RCRA regulations, such as part 262, 
for the generation and accumulation of hazardous waste, including 
hazardous waste pharmaceuticals, but not part 266 subpart P.
    EPA notes that although nonprescription pharmaceuticals and other 
retail items that are sent through reverse logistics are not solid 
wastes at the retail store if they have a reasonable expectation of 
being legitimately used/reused or reclaimed, the items must be shipped 
in accordance will all applicable Department of Transportation (DOT) 
regulations. For example, DOT promulgated a final rule in March 2016 on 
the reverse logistics of hazardous materials. This rule includes 
provisions to help ensure that items, including consumer grade 
fireworks, are in original packaging when shipped from a retail store 
to a manufacturer, supplier, or distribution facility.\76\
---------------------------------------------------------------------------

    \76\ See 81 FR 18527; March 31, 2016.
---------------------------------------------------------------------------

    There are six issues that came to EPA's attention when shaping this 
final reverse logistics policy. The first issue regards the ultimate 
disposition of unsold retail items moving through reverse logistics. 
The second issue regards unsold retail items that have expired. The 
third issue involves instances when retail items cannot be

[[Page 5833]]

legitimately used/reused (e.g., lawfully redistributed for their 
intended purpose) because the items are subject to a ``destroy 
disposition.'' The fourth issue regards the crediting process for 
unsold retail items. The fifth issue involves instances when 
nonprescription pharmaceuticals and other unsold retail items become 
subject to a voluntary, federally mandated, or state mandated recall. 
The final issue involves instances when nonprescription pharmaceuticals 
and other unsold retail items cannot be sent through reverse logistics 
because they are broken, damaged, or leaking.
    a. Unsold retail items returned to the manufacturer or vendor. The 
first issue regards the ultimate disposition of unsold retail items 
moving through reverse logistics. As noted previously, data from 
commenters suggests a majority of unsold retail items moving through 
reverse logistics are returned to the manufacturer or vendor.\77\ EPA 
did not receive data on the ultimate disposition of retail items that 
are returned to a manufacturer or vendor from a reverse logistics 
center. For this final action, EPA assumes the items are not wastes if 
they have a reasonable expectation of being legitimately used/reused 
(e.g., lawfully redistributed for its intended purpose) or reclaimed. 
However, if nonprescription pharmaceuticals or other retail items do 
not have a reasonable expectation of being legitimately used/reused 
(e.g., lawfully redistributed for their intended purpose) or reclaimed 
after they are returned to a manufacturer or vendor, then the 
nonprescription pharmaceutical or other unsold retail item would be a 
solid and potentially hazardous waste at the reverse logistics center.
---------------------------------------------------------------------------

    \77\ See comment number EPA-HQ-RCRA-2007-0932-0340 in the 
docket.
---------------------------------------------------------------------------

    b. Unsold retail items that have expired. The second issue regards 
unsold retail items that have expired.\78\ As mentioned previously, 
commenters noted that when an item is sent to a reverse logistics 
center because an expiration date has been exceeded, disposal is most 
often the required disposition, however the items may be returned to 
the manufacturer for further evaluation for potential liquidation.\79\ 
Furthermore, nonprescription pharmaceuticals with ``best by'' dates (as 
opposed to expiration dates) often can still be donated or liquidated 
after the date has passed. In addition to information received from 
commenters suggesting that expired products might be considered 
eligible for redistribution, FDA occasionally allows the donation of 
drugs that are past the expiration date shown on the label when 
provided sufficient information to show the expired pharmaceuticals are 
safe and effective and other specific criteria have been met.\80\ Thus, 
for this final action, EPA assumes that nonprescription pharmaceuticals 
and other unsold retail items that have expired are not wastes if they 
have a reasonable expectation of being legitimately used/reused (e.g., 
lawfully redistributed for its intended purpose) or reclaimed. These 
items are in their original, intact packaging and do not pose a high 
risk of release to the environment. Further, this position is 
consistent with the goal of the RCRA statute to reduce waste, as EPA is 
concerned that considering unsold retail items that have expired to be 
wastes at the retail store could introduce an unintended incentive for 
retailers to remove those items from shelves in advance of expiration 
dates, resulting in an unnecessary increase in overall waste 
generation.
---------------------------------------------------------------------------

    \78\ EPA uses the term ``expired'' consistent with Food and Drug 
Administration regulations. See 21 CFR part 201.66, part 201.17, and 
211.137.
    \79\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket.
    \80\ See U.S. Food and Drug Administration ``Question and 
Answers for the Public: Donating Drugs to International Humanitarian 
Relief Efforts'' available at: https://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM249617.pdf.
---------------------------------------------------------------------------

    c. Unsold retail items subject to a destroy disposition. The third 
issue involves instances when retail items cannot be legitimately used/
reused (e.g., lawfully redistributed for their intended purpose) 
because the items are subject to a ``destroy disposition.'' A destroy 
disposition is when a manufacturer has established ``business rules'' 
that prohibit unsold retail items from being redistributed for their 
intended purpose (i.e., liquidated or donated). The term ``business 
rules'' (i.e., manufacturer return policies) refers to the rules that 
govern the disposition of retail items agreed to by the manufacturer, 
retailer, and reverse distributor or reverse logistics center.\81\ The 
Agency's understanding is that manufacturers adopt destroy dispositions 
over concerns related to liability and brand protection and that 
assigning a destroy disposition is not a common practice because it 
precludes income from potential redistribution and results in disposal 
costs.\82\ For this final action, if a manufacturer has established 
business rules that prohibit unsold retail items from being 
legitimately used/reused (e.g., lawfully redistributed for their 
intended purpose) because the items are subject to a ``destroy 
disposition,'' and that prohibit the unsold retail items from being 
reclaimed, the items are considered solid waste at the retail store or 
healthcare facility. However, if a manufacturer has established 
business rules that do not imply that disposal is the ultimate 
disposition for unsold retail items, and there is a reasonable 
expectation the items will be reclaimed, these items would not be solid 
wastes at the retail store when they are sent through reverse 
logistics. Thus, a manufacturer can adopt business rules that prohibit 
the lawful redistribution of retail items for their intended purpose 
(i.e., liquidation or donation), but allow for the items to be sent 
through reverse logistics for reclamation. These items would not be 
wastes at the retail store if there is a reasonable expectation the 
items will be reclaimed.
---------------------------------------------------------------------------

    \81\ This definition is derived from the definition of 
``business rules'' in the ``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.
    \82\ See discussion of ``destroy dispositions'' in the ``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.
---------------------------------------------------------------------------

    d. Crediting process for unsold retail items. The fourth issue 
regards the crediting process for unsold retail items. It is the 
Agency's understanding that there are two primary credit models. The 
first is the ``traditional approach'' whereby credit is awarded after 
unsold retail items are returned to a reverse logistics center for 
processing. The second is the adjustable rate policy, which is also 
commonly referred to as a ``swell allowance,'' whereby credit is 
awarded up-front based on an assumption that a certain percentage of 
items will become unsalable for various reasons at the primary 
retailer.\83\ EPA's understanding is that one of the goals of the 
adjustable rate policy is to reduce the amount of unsold items sent 
through to reverse logistics centers and to encourage sale at the 
primary retailer--even if this means discounting those items. EPA's 
understanding is that under such an approach, retailers are responsible 
for managing unsold retail items and determining the ultimate 
disposition since the manufacturer is not involved in the disposition 
decision. That being said, retailers can utilize reverse logistics to 
assist in the management and disposition of unsold retail items sold 
under an adjustable rate policy. More importantly, under EPA's final 
policy, although the

[[Page 5834]]

potential exists for a manufacturer to issue credit for an unsold 
retail item, the ``decision point'' on whether a retail item is a solid 
waste is when the decision has been made to discard the material. In 
other words, a pharmaceutical is a solid waste when the decision has 
been made to discard regardless of whether the pharmaceutical has 
value. Thus, for this final action, the credit model is not relevant to 
the waste status of unsold retail items. EPA assumes that 
nonprescription pharmaceuticals and other unsold retail items that 
receive credit up-front through an adjustable rate policy are not 
wastes if they have a reasonable expectation of being legitimately 
used/reused (e.g., lawfully redistributed for their intended purpose) 
or reclaimed.
---------------------------------------------------------------------------

    \83\ Additional information on the Adjustable Rate Policy and 
other reimbursement policies for unsalable items can be found in the 
publication entitled, 2008 Joint Industry Unsaleables Management 
Study: The Real Causes and Actionable Solutions. This publication is 
available at http://www.gmaonline.org/downloads/research-and-reports/UnsaleablesFINAL091108.pdf.
---------------------------------------------------------------------------

    e. Unsold retail items subject to a recall. The fifth issue 
involves instances when nonprescription pharmaceuticals and other 
unsold retail items become subject to a voluntary, federally mandated, 
or state mandated recall. Almost all pharmaceutical recalls are 
overseen by FDA. However, under the Poison Prevention Packaging Act, 
the U.S. Consumer Product Safety Commission (CPSC) has authority 
regarding special packaging (sometimes called child resistant 
packaging) of certain household products, including drugs (as that term 
is defined in the Federal Food, Drug, and Cosmetic Act).\84\ Similarly, 
under the child Nicotine Poisoning Prevention Act of 2015, CPSC has 
authority for administering special packaging requirements for liquid 
nicotine containers.\85\ Thus, CPSC oversees a recall if there is a 
problem with a pharmaceutical's special packaging or containers for 
liquid nicotine. Additionally, CPSC has jurisdiction over recalls of 
many other consumer products sold at retail stores.\86\ EPA is choosing 
not to apply RCRA regulations to nonprescription pharmaceuticals and 
other unsold retail items while they are subject to a recall, provided 
the recall is regulated and overseen by FDA or CPSC. This is true 
whether they become subject to a recall at a reverse logistics center, 
healthcare facility, or retail store. It is possible that recalled 
nonprescription pharmaceuticals and other unsold retail items are not a 
solid waste if they are legitimately used/reused or reclaimed. For 
example, if CPSC oversees a recall if there is a problem with a 
pharmaceutical's packaging (e.g., an item's packaging poses a threat 
because it is not sufficiently child resistant), it is possible the 
pharmaceutical could still be sent for reclamation. Although it is 
difficult for EPA to make a blanket determination on whether all 
recalled nonprescription pharmaceuticals and other unsold retail items 
are or are not solid wastes, EPA is choosing not to apply RCRA 
regulations to recalled nonprescription pharmaceuticals and other 
unsold retail items provided the recall is overseen by FDA or CPSC. 
When FDA directs the destruction of some or all of the recalled retail 
items, or CPSC grants permission to dispose or destroy some or all of 
the recalled items, the materials that are hazardous waste must be 
managed in accordance with RCRA, including the hazardous waste 
generator regulations standards in 40 CFR part 262.
---------------------------------------------------------------------------

    \84\ See 15 U.S.C. 1471-1477 for the Poison Prevention Packaging 
Act.
    \85\ Public Law 114-116 (January 28, 2016).
    \86\ The CPSC has jurisdiction over more than 15,000 kinds of 
consumer products used in and around the home, in sports, recreation 
and schools. See https://www.recalls.gov/cpsc.html for more 
information.
---------------------------------------------------------------------------

    Although FDA and CPSC are the federal agencies that primarily 
regulate recalled nonprescription pharmaceuticals and other unsold 
retail items, other federal agencies regulate some recalled retail 
items. For example, the National Highway Traffic Safety Administration 
oversees motor vehicle defects and safety recalls. Although other 
federal agencies may occasionally regulate recalled retail items, EPA 
is only choosing not to apply RCRA regulations to recalled 
nonprescription pharmaceuticals and other unsold retail items when the 
recall is overseen by FDA or CPSC. CPSC requires manufacturers to 
develop a recall strategy that outlines all of the actions to be taken 
on behalf of the manufacturer from start to finish. FDA requires firms 
that initiate a recall to develop a recall strategy and recommends that 
firms that initiate a FDA-requested recall develop a recall 
strategy.\87\ Included as a required component of a comprehensive 
recall strategy is a requirement that FDA or CPSC approves a 
manufacturer's decision to take the action to discard some or all of 
the recalled items. Thus, EPA believes it is reasonable not to apply 
RCRA regulations to recalled nonprescription pharmaceuticals and other 
unsold retail items when the recall is overseen by FDA or CPSC. 
However, the Agency will continue to evaluate recalled nonprescription 
pharmaceuticals and other unsold retail items managed by other federal 
agencies on a case-by-case basis. As an example, see the memo that EPA 
released in 2017 that describes how RCRA regulations apply to recalled 
Takata airbag inflators while they are being held under the 2015 DOT 
preservation order.\88\ EPA's policy does not apply to unused 
pesticides that are suspended or canceled under the Federal 
Insecticide, Fungicide, and Rodenticide Act and recalled, as these can 
be managed as universal waste under 40 CFR part 273. Finally, while EPA 
is not applying RCRA regulations in these situations, we note that if 
recalled nonprescription pharmaceuticals and other unsold retail items 
are not managed and stored in a manner that prevents release to the 
environment, they may be considered a solid waste and a hazardous waste 
under sections 3007, 3013, and 7003 of RCRA.
---------------------------------------------------------------------------

    \87\ See 21 CFR 7.46(a)(8) and 21 CFR 7.45(b), respectively.
    \88\ See RCRA Online #14893 for the June 23, 2017 memo titled 
``Recalled Takata Airbag Inflators.''
---------------------------------------------------------------------------

    f. Unsold retail items that are broken, damaged, or leaking. The 
sixth issue involves instances when nonprescription pharmaceuticals and 
other unsold retail items cannot be sent through reverse logistics 
because they are broken, damaged, or leaking. In recent years, EPA took 
multiple enforcement actions against national retailers for sending 
hazardous waste, in the form of broken and/or leaking items with 
hazardous contents, to unpermitted TSDFs (in the form of reverse 
distributors and reverse logistics centers), among other RCRA 
violations.\89\ The resulting settlements specify that unsold retail 
items with broken and/or leaking packaging are waste at the retailer 
and, if they are hazardous, cannot be sent to a reverse distributor or 
reverse logistics center. CVS commented on the proposed rulemaking and 
asked that EPA clarify that when pharmaceutical packaging is in 
sufficiently poor condition that it is broken, leaking, or otherwise 
unable to be used for its intended purpose, that those pharmaceuticals 
become solid waste at the healthcare facility.\90\ CVS noted that this 
is consistent with their current practice, whereby broken and leaking 
items are managed as waste at their facilities and are not sent through 
reverse distribution or reverse logistics.
---------------------------------------------------------------------------

    \89\ Walmart Consent Agreement and Final Order, Docket Nos. 
RCRA-HQ-2013-4001 and FIFRA-HQ-2013-5056.
    \90\ See comment number EPA-HQ-RCRA-2007-0932-0312 in the 
docket.
---------------------------------------------------------------------------

    Although EPA affirms the resulting settlements and agrees that 
nonprescription pharmaceuticals and other retail items cannot be sent 
through reverse logistics when they are broken, damaged, or leaking, 
the Agency is aware that there is inherent uncertainty

[[Page 5835]]

surrounding when these items are considered broken, damaged, or 
leaking. For example, a nonprescription pharmaceutical could experience 
damage to the outer packaging while the inner container remains intact. 
For this final action, unsold retail items, including nonprescription 
pharmaceuticals, are not considered waste at the retail store if their 
packaging is in good condition, with no leaks or other continuing or 
intermittent unpermitted releases of the materials to the 
environment,\91\ and they are contained to prevent releases to the 
environment,\92\ and they have a reasonable expectation of being 
legitimately used/reused (e.g., lawfully redistributed for its intended 
purpose) or reclaimed. Thus, the Agency intends that nonprescription 
pharmaceuticals and other unsold retail items can be sent to a reverse 
logistics center and are not considered wastes at the retail store if 
they meet this standard. For example, if an outer cardboard box 
containing vials of nonprescription pharmaceuticals is damaged, but the 
vials are intact and not damaged or leaking, EPA does not consider the 
item to be damaged such that it cannot go through reverse logistics.
---------------------------------------------------------------------------

    \91\ As defined in Sec.  260.10, unpermitted releases are 
releases that are not covered by a permit (such as a permit to 
discharge to water or air) and may include, but are not limited to, 
releases through surface transport by precipitation runoff, releases 
to soil and groundwater, wind-blown dust, fugitive air emissions, 
and catastrophic unit failures.
    \92\ These conditions are derived from the definition of 
contained as defined in Sec.  260.10.
---------------------------------------------------------------------------

    In order to prevent exposures to personnel, the public, and the 
environment, if items are not in good condition, or are leaking or 
releasing to the environment, these items must be managed as wastes at 
the stores in accordance with the applicable hazardous waste 
regulations. Specifically, if the broken, damaged, or leaking item is a 
hazardous waste pharmaceutical, the retail store must manage it under 
the streamlined standards of part 266 subpart P (unless it is a VSQG 
for all its hazardous waste). Otherwise, the retail store would manage 
hazardous wastes under the applicable RCRA regulations, including part 
262 generator regulations.

E. Applicability of the Household Hazardous Waste Exemption to Retail 
Items

    One commenter suggested that the ``household hazardous waste'' 
exclusion at 40 CFR 261.4(b)(1) apply to retail items purchased by a 
customer and subsequently returned to the retailer.\93\ The Agency has 
already addressed the issue of retail wastes as part of a previous 
rulemaking that responded to a petition from the American Retail 
Federation. As explained in a November 13, 1984, final rule \94\, EPA 
excluded household hazardous waste because the legislative history of 
RCRA indicated an intent to exclude such wastes and not because these 
wastes can never pose the risks associated with hazardous wastes. 
Additionally, consistent with legislative history, when evaluating the 
American Retail Federation's petition, EPA determined that it was 
necessary to establish two criteria that must be met to qualify for 
this exclusion. First, the waste must be generated by individuals on 
the premises of a temporary or permanent residence and, second, the 
waste stream must be composed primarily of materials found in wastes 
generated by consumers in their homes. In this final rule, EPA denied 
the American Retail Federation's petition to exempt consumer household 
hazardous waste generated by retail sources because these wastes fail 
to meet both criteria. The Agency reaffirmed this position in the 
Retail Strategy, arguing that retail goods, including those that could 
become wastes when discarded, do not satisfy the criteria for this 
exclusion.
---------------------------------------------------------------------------

    \93\ See comment number EPA-HQ-RCRA-2007-0932-0277 in the docket 
for this rulemaking.
    \94\ See 49 FR 44978; November 13, 1984.
---------------------------------------------------------------------------

    The Agency believes that this interpretation extends to retail 
items purchased by a customer and subsequently returned to a retail 
store. Hazardous waste generated at retail stores, including retail 
items purchased by a customer that are subsequently returned, does not 
meet the first criterion for the household hazardous waste exemption. 
Specifically, the decision to discard does not occur at the residence, 
it occurs at the retail store. In fact, many retail items that are 
returned are restocked and sold at the store (e.g. lawfully 
redistributed for their intended purpose) and are not solid wastes.
    On the other hand, the Agency notes that a household pharmaceutical 
that is collected from individuals by a healthcare facility (e.g., 
retail store) as part of a DEA pharmaceutical take-back program 
maintains the household hazardous waste exemption as long as it is not 
sewered, and is destroyed by a method that DEA has publicly deemed in 
writing to meet their non-retrievable standard of destruction or 
combusted at one of the types of combustors identified in Sec.  
266.506(b). For more discussion on DEA take-backs of household 
pharmaceuticals, please see section XIV of this preamble.

VII. Scope of the Final Rule

A. What facilities are subject to the final rule?

    This final rule is a sector-based rule that applies to the 
management of hazardous waste pharmaceuticals that are generated and 
managed by healthcare facilities and reverse distributors. Subsequent 
sections of the preamble will discuss in detail the definitions of 
these terms, as well as what provisions of the rule apply to each type 
of facility (see section VIII for a discussion of each definition and 
section IX for Applicability). Healthcare facilities and reverse 
distributors will use the regulations finalized under 40 CFR part 266 
subpart P in lieu of the RCRA generator regulations in 40 CFR part 262 
to which they were previously subject.

B. What facilities are not subject to the final rule?

1. Pharmaceutical Manufacturers
    Part 266 subpart P does not apply to the management of hazardous 
waste pharmaceuticals that are generated by pharmaceutical 
manufacturers. A pharmaceutical manufacturer remains subject to part 
262 and all applicable RCRA subtitle C regulations for the management 
of its hazardous waste, including its hazardous waste pharmaceuticals. 
Pharmaceutical manufacturers do not face the same challenges that 
healthcare facilities experience when managing hazardous waste 
pharmaceuticals in accordance with the federal RCRA subtitle C 
regulations (for an explanation of the challenges healthcare facilities 
face, see discussion in section III of the preamble). The types of 
hazardous waste pharmaceuticals generated by manufacturers are less 
variable and therefore more predictable, and the staff have the 
necessary expertise to determine which pharmaceutical waste is 
hazardous waste. However, when any facility, including a pharmaceutical 
manufacturer, meets the definition found in this proposal for a reverse 
distributor, it would be subject to the final regulations for reverse 
distributors with respect to those operations.
2. Households
    The Agency emphasizes that the regulatory requirements in this 
final rule do not apply to households that discard pharmaceuticals. 
Pharmaceuticals that are discarded by households are not regulated as 
hazardous waste and are generally considered municipal solid waste. 
While a small percentage of these

[[Page 5836]]

household waste pharmaceuticals meet the definition of hazardous waste 
under RCRA, the federal RCRA hazardous waste regulations include an 
exclusion for all hazardous wastes generated by households.\95\ Thus 
household hazardous waste pharmaceuticals--like other household 
hazardous wastes--are not subject to the federal RCRA hazardous waste 
regulations.
---------------------------------------------------------------------------

    \95\ See the household waste exclusion at Sec.  261.4(b)(1), 
which is often referred to as the household hazardous waste or HHW 
exclusion.
---------------------------------------------------------------------------

    Despite the fact that household hazardous wastes are not regulated 
as hazardous wastes, it is important to note that ``EPA excluded 
household wastes because the legislative history of RCRA indicated an 
intent to exclude such wastes, though not because they necessarily pose 
no hazard.'' \96\ Some household products, including pharmaceuticals, 
contain ignitable, corrosive, reactive, or toxic ingredients. As a 
result, for household hazardous waste collected at a household 
hazardous waste collection program, the Agency has historically 
recommended that communities operating the collection programs manage 
the collected household hazardous waste as hazardous waste, even though 
it is not required by RCRA.\97\
---------------------------------------------------------------------------

    \96\ See 49 FR 44978; November 13, 1984.
    \97\ See memo November 1, 1988, from Porter to Regions (RCRA 
Online #11377).
---------------------------------------------------------------------------

    Similarly, the Agency recommends that, whenever possible, 
households utilize pharmaceutical collection events as the preferred 
disposal option for their unwanted pharmaceuticals.\98\ For consumers 
without access to a pharmaceutical take-back event, FDA provides 
information on the disposal of unused pharmaceuticals and step-by-step 
guidance for disposing of pharmaceuticals in the household trash.\99\
---------------------------------------------------------------------------

    \98\ For pharmaceuticals, these collection events are often 
referred to as pharmaceutical take-back events. As used in this 
preamble, a take-back event refers to one-day collection events, 
such as the DEA bi-annual pharmaceutical take back days, while a 
take-back program refers to an ongoing collection program, such as a 
DEA-approved collection receptacle at a retail store.
    \99\ For more information on the safe disposal of household 
waste pharmaceuticals, please see: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm.
---------------------------------------------------------------------------

    In a 2012 memo, the Agency recommended that collected household 
waste pharmaceuticals be incinerated-- preferably at a permitted 
hazardous waste incinerator, but when that is not feasible, at a large 
or small municipal waste combustor.\100\ The Agency believes that this 
practice is already common among collection programs since one goal of 
many collection programs is to divert pharmaceuticals from municipal 
landfills. Additionally, incineration is commonly used to meet the non-
retrievable standard of destruction required by DEA for controlled 
substances collected from consumers (``ultimate users,'' as DEA refers 
to them). The Agency included this recommendation as a requirement for 
household waste pharmaceuticals that have been collected (see Sec.  
266.506).\101\ See section XIV of this preamble for a detailed 
discussion of this provision.
---------------------------------------------------------------------------

    \100\ See memo September 26, 2012, Rudzinski to the Regional 
RCRA Division Directors (RCRA Online# 14833).
    \101\ Since pharmaceutical collection programs typically 
commingle DEA controlled substances with non-controlled substances, 
this requirement is included in a section of the regulations that 
pertains to controlled substances.
---------------------------------------------------------------------------

3. Farmers, Ranchers and Fisheries
    This final rule is a sector-specific rulemaking that applies to 
healthcare facilities and reverse distributors. As such, this final 
rule does not apply other generators of hazardous waste pharmaceuticals 
such as farmers, ranchers, and fisheries. Although these businesses 
might administer pharmaceuticals to their animals in the regular course 
of their business, they would not fall within the definition of a 
healthcare facility or a reverse distributor. The Agency designed this 
final rule to address the unique needs of the healthcare sector and 
concluded that it would not be appropriate to apply it to all sectors 
that generate hazardous waste pharmaceuticals. Other generators of 
hazardous waste pharmaceuticals, such as farmers, ranchers and 
fisheries, remain subject to the part 262 generator regulations. As 
discussed in detail in section VIII of this preamble, the definition of 
healthcare facility does include veterinary clinics and veterinary 
hospitals.
4. RCRA-Permitted or Interim Status Treatment, Storage and Disposal 
Facilities
    This final rule does not affect how RCRA-permitted or interim 
status TSDFs manage hazardous waste pharmaceuticals at their 
facilities, except indirectly when they treat hazardous waste 
pharmaceuticals to meet the land disposal restrictions (LDRs). See 
section X.H. of this preamble for additional detail.

C. Scope of Hazardous Wastes Addressed by This Final Rule

1. Hazardous Waste Pharmaceuticals
    These final regulations pertain only to those pharmaceutical wastes 
that are RCRA hazardous wastes that are generated by healthcare 
facilities or managed by reverse distributors. Under this rulemaking, 
EPA has not added additional pharmaceuticals to the hazardous waste 
listings or expanded the hazardous waste characteristics to include 
additional pharmaceuticals. Although we solicited ideas from commenters 
for possible methods or approaches for regulating additional 
pharmaceuticals as hazardous waste, any action taken to address the 
comments we received in response to this request would be a separate 
action taken by the Agency in the future and is not part of this final 
rulemaking.
2. Related Federal or State Regulations
    The generation, accumulation, transportation, treatment, storage, 
and disposal of hazardous waste pharmaceuticals are regulated under 
RCRA Subtitle C. However, hazardous waste pharmaceuticals may also be 
subject to a number of other statutes and implementing regulations 
administered by state or other federal agencies. Examples include 
pharmaceuticals that are subject to the Controlled Substances Act and 
DEA regulations; infectious pharmaceutical wastes that are subject to 
state and local medical waste regulations; pharmaceuticals with a 
radioactive component that are subject to the Atomic Energy Act (AEA) 
and pharmaceuticals that are hazardous waste as defined in 40 CFR 261.3 
that are subject to OSHA's Hazardous Waste Operations and Emergency 
Response standard. These potentially overlapping requirements make the 
appropriate management of pharmaceutical wastes a complex matter. The 
following discusses the impact of this final rule on various dually 
regulated hazardous waste pharmaceuticals.
    a. Controlled substances. Under prior regulations, any healthcare 
facility generating or managing a RCRA hazardous waste pharmaceutical 
that is also a DEA controlled substance listed in Schedule II-V\102\ 
had to comply with the RCRA hazardous waste requirements, as well as 
the requirements of the Controlled Substances Act and DEA regulations. 
DEA regulations from 2014 to implement the Secure and Responsible Drug 
Disposal Act of 2010 require that

[[Page 5837]]

controlled substances be destroyed so that they are ``non-
retrievable.'' \103\ In the preamble to both the proposed and final DEA 
rules, DEA stated that flushing alone will not meet DEA's new non-
retrievable standard.\104\ Due to difficulties associated with managing 
these hazardous waste pharmaceuticals that are also controlled 
substances, the Agency is finalizing a conditional exemption from the 
RCRA regulatory requirements for the handful of pharmaceuticals that 
are both a RCRA hazardous waste and a DEA controlled substance. That 
is, this final rule eliminates the dual regulation for RCRA hazardous 
waste pharmaceuticals that are also DEA controlled substances. A more 
detailed discussion of this conditional exemption is found in section 
XIV of this final rule.
---------------------------------------------------------------------------

    \102\ See 21 CFR part 1308 for a complete list of controlled 
substances.
    \103\ Final rule: September 9, 2014; 79 FR 53520.
    \104\ Proposed rule: December 21, 2012; 77 FR 75784, see page 
75803; and final rule: September 9, 2014; 79 FR 53520, see page 
53548).
---------------------------------------------------------------------------

    b. Medical wastes. There are instances when a hazardous waste 
pharmaceutical will also pose a biological hazard. The healthcare 
industry often refers to pharmaceutical wastes that are both RCRA 
hazardous and a biological hazard as ``dual wastes,'' and such wastes 
must be managed in accordance with RCRA and state and/or local medical 
waste regulations. As a result, the healthcare facility must send these 
dual wastes to a hazardous waste TSDF that is also permitted by their 
state to accept medical wastes. Some examples of dual wastes include 
partially administered syringes containing hazardous waste 
pharmaceuticals (e.g., physostigmine) or intravenous (IV) bags 
containing residues of a hazardous waste pharmaceutical that are 
attached to the tubing and needles used to administer the 
pharmaceutical. The RCRA hazardous waste pharmaceutical component of 
these dual wastes are included within these final subpart P management 
standards so that healthcare facilities can obtain the benefits of this 
new subpart, while ensuring the hazardous waste component of the waste 
is managed appropriately and ultimately delivered to RCRA-permitted 
TSDFs. Healthcare facilities must still manage the biological hazard in 
accordance with state and/or local medical waste requirements. EPA 
notes that autoclaving alone is not an acceptable method of treating 
hazardous wastes (pharmaceutical or non-pharmaceutical) that are also 
medical waste. In addition, as discussed in section XV of this 
preamble, EPA is exempting from RCRA regulation the residues of 
hazardous waste pharmaceuticals remaining in empty (i.e., fully 
administered) syringes.
    c. Hazardous waste pharmaceuticals with a radioactive component. 
Hazardous waste pharmaceuticals that also contain a radioactive 
component subject to the Atomic Energy Act of 1954 (AEA) (which are 
often referred to as ``mixed waste'') are also regulated by multiple 
agencies. The hazardous waste component is regulated under EPA or the 
authorized state RCRA Subtitle C programs, while either the Nuclear 
Regulatory Commission (NRC) or the Department of Energy (DOE) regulates 
the radioactive component of the waste under the AEA.\105\ Healthcare 
facilities can use this final rule to meet the obligation of complying 
with the RCRA Subtitle C hazardous waste regulations for hazardous 
waste pharmaceuticals while also complying with the appropriate AEA 
regulations. Although we do not believe that anything in this subpart 
is inconsistent with the AEA, Sec.  1006(a) of RCRA states that if the 
RCRA requirements are inconsistent with the AEA requirements, then the 
RCRA requirements do not apply. Therefore, if a healthcare facility 
that manages hazardous waste pharmaceuticals encounters specific RCRA 
requirements that are inconsistent with specific AEA requirements, only 
the AEA requirements would apply.
---------------------------------------------------------------------------

    \105\ The NRC regulates radioactive wastes generated by 
commercial or non-DOE facilities, whereas DOE regulates radioactive 
wastes generated by DOE facilities.
---------------------------------------------------------------------------

    As is discussed in the Joint NRC/EPA Guidance on Testing 
Requirements for Mixed Radioactive and Hazardous Waste an inconsistency 
occurs when compliance with one statute or set of regulations would 
necessarily cause non-compliance with the other statute or set of 
regulations.\106\ Relief from the regulatory inconsistency would be 
provided by the AEA requirement overriding the specific RCRA 
requirement. It is important to note, however, that the determination 
of an inconsistency would relieve the healthcare facility only from 
compliance with the specific RCRA requirement(s) that is deemed 
inconsistent with the AEA requirement(s); the healthcare facility would 
still be required to comply with all of the other hazardous waste 
pharmaceutical management standards.
---------------------------------------------------------------------------

    \106\ 62 FR 62079, 62085; November 20, 1997.
---------------------------------------------------------------------------

    d. Clean Air Act. The combustion of hazardous waste pharmaceuticals 
is subject to both RCRA and to Sec.  112 of the Clean Air Act. In 
general, the Clean Air Act protects human health and the environment 
from the harmful effects of air pollution by requiring reductions in 
the emissions of air pollutants. These pollutants, which are known or 
suspected to cause serious health problems, such as cancer or birth 
defects, are referred to as hazardous air pollutants (HAPs) and include 
several metals that are found in pharmaceuticals, such as selenium, 
mercury, and chromium compounds. Under Sec.  112 of the Clean Air Act, 
EPA is required to list categories of major and area sources of HAPs; 
EPA has listed Hazardous Waste Combustors as one of these categories.
    EPA is also required to establish National Emission Standards for 
Hazardous Air Pollutants (NESHAPs) for the control of HAP emissions 
from listed sources. The NESHAPs are to reflect the maximum degree of 
reduction in emissions of HAPs that is achievable. This is known as 
``maximum achievable control technology'' (MACT) and is based on 
emission levels that are achieved by the best-performing sources within 
a source category. On October 12, 2005, EPA promulgated NESHAP for 
Hazardous Waste Combustors that set MACT standards for HAPs from this 
source category.\107\ The owner or operator of a hazardous waste 
combustor is required to comply with specific emission standards that 
control HAPs to levels that reflect MACT. These standards vary based on 
the type of hazardous waste combustion source (e.g., incinerator, 
cement kiln, boiler), and in some instances based on the amount of HAPs 
that are emitted by the facility (e.g., boilers that are area sources 
can elect to comply with fewer HAP emission standards). Generally 
speaking; however, hazardous waste combustors are required to comply 
with emission standards for chlorinated dioxins and furans, mercury, 
lead, cadmium, arsenic, beryllium, chromium, hydrochloric acid/chlorine 
gas, as well as particulate matter as a surrogate to control five 
additional metals, and carbon monoxide, hydrocarbon, and destruction 
removal efficiency as surrogates to control nondioxin/furan organic 
HAPs.
---------------------------------------------------------------------------

    \107\ 70 FR 59402; October 12, 2005.
---------------------------------------------------------------------------

    Hazardous waste combustors may be subject to more stringent 
emission limitations issued under the RCRA omnibus authority provisions 
(Sec.  3005(c)(3)). This is usually where site-specific circumstances 
indicate that a MACT standard is not protective of health and the 
environment. In other words, some hazardous waste combustors also have 
a RCRA permit

[[Page 5838]]

limit that further reduces emissions of certain HAPs (e.g., mercury) 
beyond that which is required by the Clean Air Act MACT standard.
    The combustion of pharmaceuticals that meet the definition of a 
RCRA solid waste but do not meet the definition of RCRA hazardous waste 
(i.e., non-hazardous waste pharmaceuticals) is regulated by Sec.  129 
of the Clean Air Act and implementing regulations. These regulations 
established emission limits for nine substances or mixtures (i.e., 
particulate matter, carbon monoxide, dioxins/furans, sulfur dioxide, 
nitrogen oxides, hydrogen chloride, lead, mercury, and cadmium, as well 
as opacity where appropriate) from several categories incineration 
units, including: municipal waste combustors (MWCs); hospital, medical 
and infectious waste incinerators (HMIWIs); commercial and industrial 
solid waste incinerators (CISWIs); and other solid waste incinerators 
(OSWIs). The emission limits are based on the application of MACT and 
reflect the emission levels achieved by the best performers in each 
category.
3. Drug Supply Chain Security Act
    On November 27, 2013, the Drug Quality and Security Act was signed 
into law, amending the Federal Food, Drug and Cosmetic Act (FD&C 
Act).\108\ The Drug Quality and Security Act consists of two titles: 
Title I is known as the Compounding Quality Act and Title II is known 
as the Drug Supply Chain Security Act (DSCSA). The FDA was given the 
responsibility of developing the implementing regulations for both 
titles of the Drug Quality and Security Act. In a summary of the DSCSA 
written by the Congressional Research Service, a nonpartisan division 
of the Library of Congress, it states that the Act ``Establishes 
requirements to facilitate the tracing of prescription drug products 
through the pharmaceutical supply distribution chain.'' \109\ Prior to 
enactment of this federal law, several states had passed similar laws 
to ensure the pedigree of the drug supply chain. Because each state law 
was slightly different, it made compliance difficult for companies 
operating in multiple states. As a result, Congress amended the FD&C 
Act to add Sec.  585, entitled Uniform National Policy, which moots the 
pedigree laws already in effect (to the extent they are inconsistent 
with the DSCSA) and prevents states (and others) from enacting 
inconsistent pedigree laws in the future. This section, which was added 
by the DSCSA, includes sub-sections that are sometimes referred to as 
``preemption clauses.'' \110\
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    \108\ Public Law 113-54.
    \109\ https://www.congress.gov/bill/113th-congress/house-bill/3204/summary/49; accessed September 13, 2017.
    \110\ See sections 585(a) and 585(b)(1) of the FD&C Act, as 
amended by the DSCSA.
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    Since the DSCSA was signed into law, some have argued to EPA and 
RCRA-authorized states that Sec.  585 of the FD&C Act (as amended by 
the DSCSA) preempts all state hazardous waste regulatory authority as 
it may relate to the documentation of the disposition of hazardous 
waste pharmaceuticals. EPA disagrees with this interpretation of the 
DSCSA. Section 585 specifically avoids preempting state requirements, 
such as RCRA hazardous waste laws, that are unrelated to the tracing of 
products within the prescription drug distribution supply chain and 
other issues expressly addressed by the DSCSA. As stated in Sec.  
585(c), ``Nothing in this section shall be construed to preempt State 
Requirements related to the distribution of prescription drugs if such 
requirements are not related to product tracing as described in 
subsection (a) or wholesale distributor and third-party logistics 
provider licensure as described in subsection (b) applicable under 
Sec.  503(e) (as amended by the Drug Supply Chain Security Act) or this 
subchapter (or regulations issued thereunder)'' (emphasis added).
    This provision makes clear that Sec.  585 applies only to state 
requirements related to distribution of prescription drugs and only to 
the extent that these requirements are related to product tracing or 
other issues specifically addressed by the DSCSA, such as licensure. 
Thus, as EPA interprets Sec.  585, it would not apply to state 
requirements related to documentation of RCRA hazardous waste 
management activities, including disposal, because those activities are 
distinct and unrelated to the product tracing and other requirements of 
the DSCSA.
    And indeed, in EPA's consultation with FDA on this issue, FDA 
agreed with EPA's conclusion that Sec.  585 does not preempt state 
hazardous waste regulations related to the documentation of the 
management of hazardous waste pharmaceuticals. EPA's position is based 
upon our review of both the direct language and intent of the 
statute.\111\
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    \111\ For a more thorough legal analysis of this issue, see 
EPA's letter to the Minnesota Pollution Control Agency, dated April 
9, 2015, in the docket for this rulemaking EPA-HQ-RCRA-2007-0932. 
EPA consulted with FDA in the development of this letter and FDA 
agrees with the analysis and conclusions set forth in the letter.
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    To understand the connection between state hazardous waste 
regulations and the DSCSA, it is important to understand the 
relationship between the federal and state hazardous waste regulations. 
The federal RCRA program is implemented by state RCRA programs that are 
authorized by EPA under RCRA section 3006, 42 U.S.C. 6926. Authorized 
state hazardous waste regulations must, at a minimum, be equivalent to 
federal RCRA hazardous waste regulations. Under RCRA, EPA authorizes 
state hazardous waste programs to operate in lieu of the federal 
hazardous waste program.\112\ Authorized state requirements are 
federally enforceable as requirements under RCRA Subtitle C.
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    \112\ RCRA section 3006(b), 42 U.S.C. 6926(b).
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    Nothing in the DSCSA indicates that Congress intended to impliedly 
repeal federal RCRA requirements. Such an implied repeal would leave 
gaps in RCRA coverage and result in no hazardous waste regulations of 
any kind--federal or state--applying to the documentation of the 
management of hazardous waste pharmaceuticals. Given that (i) there is 
no indication of Congressional intent to repeal hazardous waste 
documentation regulations via the DSCSA (indeed, there is no mention of 
hazardous waste in the DSCSA at all), and (ii) Sec.  585(c) of the FD&C 
Act, as added by the DSCSA, expressly notes the limits of the statute's 
preemptive effect, we believe it is clear that Congress did not intend 
to impliedly repeal RCRA authorized state hazardous waste requirements 
as they apply to the documentation of the management, including 
disposal, of hazardous waste pharmaceuticals. The general rule 
enunciated by the U.S. Supreme Court is that ``when two [federal] 
statutes are capable of co-existence, it is the duty of the courts, 
absent a clearly expressed congressional intention to the contrary, to 
regard each as effective.'' \113\ Here, both RCRA and the DSCSA coexist 
easily, because neither the language nor the purpose of the DSCSA is in 
conflict with RCRA.
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    \113\ Morton v. Macari, 417 U.S. 535, 551(1974).
---------------------------------------------------------------------------

    In addition, some commenters have argued that, in the case of 
nonsaleable pharmaceutical products, DSCSA requirements preempt RCRA 
requirements and that nonsaleable pharmaceutical products are regulated 
exclusively by the FDA pursuant to the provisions of the DSCSA.\114\ 
Commenters have also argued that under the DSCSA, nonsaleable 
pharmaceutical products that are sent from wholesale distributors, 
dispensers, and repackagers as nonsaleable may be sent to a returns 
processor reverse

[[Page 5839]]

logistics provider for handling as products. These commenters believed 
that, at a minimum, the mere fact that a pharmaceutical product becomes 
nonsaleable does not mean that such pharmaceutical product is now a 
solid waste under the RCRA hazardous waste regulations.
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    \114\ The DSCSA uses the term ``drug product.''
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    EPA does not agree with these comments. The preemption provisions 
added to the FD&C Act by the DSCSA--both Sec.  585(a) and Sec.  
585(b)--only apply to the protection of the drug supply chain and do 
not apply to waste management requirements under RCRA.\115\ Under RCRA, 
EPA regulates pharmaceuticals differently than FDA does under the DSCSA 
since the goals of the statutes serve different purposes. The purpose 
of the DSCSA is to protect the security, pedigree, and quality of 
pharmaceutical products in the drug supply chain. One of the many 
purposes of RCRA is to ensure that any waste that is generated is 
``treated, stored or disposed of so as to minimize the present and 
future threat to human health and the environment.'' \116\ In addition, 
we note that the DSCSA applies only to prescription drug products (not 
to OTC drug products), so there can be no conflict between DSCSA and 
RCRA for nonsaleable OTC drug products.
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    \115\ Section 585(a) of the DSCSA contains a preemption 
provision for state requirements for tracing drug products through 
the distribution system. Section 585(b) of the DSCSA contains a 
preemption provision for state requirements for wholesale 
prescription drug distributors and third-party logistics providers.
    \116\ See 42 U.S.C. 6902(b).
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    As explained in further detail throughout this preamble, whether a 
pharmaceutical has monetary value (such as when it receives 
manufacturer credit) is not determinative of whether it is a waste 
under RCRA. Under RCRA, one considers whether a material is discarded--
and not whether it receives credit, or holds value or no value--to 
determine whether it is waste. Thus, prescription pharmaceuticals that 
are sent by healthcare facilities to reverse distributors and that will 
be discarded (even if these pharmaceuticals receive credit) will first 
be considered wastes at the healthcare facility when the decision is 
made by the healthcare facility to send them to a reverse distributor.
    Furthermore, EPA disagrees with commenters that a nonsaleable 
pharmaceutical product sent to reverse distributors should not be 
considered a waste. Nonsaleable pharmaceutical products sent to reverse 
distributors are not sent for reuse or donation, but are sent for 
disposal, and thus would be considered wastes at the healthcare 
facility. In its comments to the FDA on the Draft Guidance for 
Industry, Identifying Trading Partners Under the Drug Supply Chain 
Security Act,\117\ an industry trade association appears to confirm 
this point when it says, ``Most fundamentally, returns processors are 
unlike the trading partners described in the DSCSA. Trading partners 
are dedicated to moving products forward for dispensing and 
administration to patients. Returns processors' activities come at the 
end, when the product is no longer retained for distribution or 
dispensing and is safely removed from the supply chain.''\118\ The 
commenter goes on to say that ``the assumptions that product is being 
distributed for further use, rather than only for credit assessment 
and/or disposition'' do not appear to apply to returns processors 
(known as reverse distributors in this final rule.\119\ Similarly, a 
reverse distributor also submitted comments to the FDA on the same 
draft guidance, stating that ``once these products reach the returns 
processors for creditability assessment and final disposition 
management, they are forever removed from commerce.'' \120\ 
Furthermore, during a site visit to a large reverse distributor, EPA 
was told that none of the pharmaceuticals on site would be donated or 
redistributed or otherwise returned to commerce.\121\ After they are 
evaluated for manufacturer credit, the pharmaceuticals are sent for 
incineration. Under Sec.  261.2(b)(3) of the RCRA regulations, 
``Materials are solid waste if they are abandoned by being . . . 
Accumulated, stored, or treated (but not recycled) before or in lieu of 
being abandoned by being disposed of, burned, or incinerated.'' The 
pharmaceuticals at reverse distributors are being accumulated prior to 
being incinerated and therefore are solid wastes. Additionally, in a 
2013 memo EPA includes a series of questions to help determine whether 
a commercial chemical product is a solid and hazardous waste. One set 
of questions relates to whether the facility appears to be selling into 
commerce the material being evaluated. If the facility has no customers 
or market for the material, it can be an indication that the material 
is a solid waste.\122\
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    \117\ August 2017, docket number FDA-2017-D-1956.
    \118\ See page 6 of comment FDA-2017-D-1956-0013.
    \119\ See page 7 of comment FDA-2017-D-1956-0013.
    \120\ See page 14 of comment FDA-2017-D-1956-0011.
    \121\ See notes from site visit to Med-Turn, October 10, 2017 in 
the docket for this rulemaking EPA-HQ-RCRA-2007-0932. Med-Turn is a 
subsidiary of Inmar.
    \122\ See Section 3 of Attachment A of memo entitled Checklist 
to Assist in Evaluating Whether Commercial Chemical Products or 
Solid and Hazardous Waste Under the Resource Conservation and 
Recovery Act, May 14, 2013, Devlin to RCRA Division Directors, RCRA 
Online #14837.
---------------------------------------------------------------------------

    As explained elsewhere in the preamble, EPA distinguishes between 
reverse distributors (as defined in this rule) and reverse logistics 
centers. Reverse distributors do not reuse or donate, but in fact, 
dispose of the pharmaceuticals they receive. In sum, what DSCSA would 
consider to be a nonsaleable product is still considered to be a solid 
waste under RCRA when it is discarded according to the RCRA 
regulations, and the DSCSA does not preclude pharmaceuticals from being 
waste under RCRA.
    EPA notes that many of the implementing regulations for the DSCSA 
are still under development by the FDA and the FDA has announced that 
it is delaying enforcement of certain requirements.\123\ Section 584(d) 
of the FD&C Act, as added by the DSCSA, directs the FDA to issue 
licensing regulations for third party logistics providers (3PLs) within 
two years of the date of enactment of the DSCSA.\124\ Draft FDA 
guidance issued in August 2017 indicates that FDA plans to consider a 
returns processor or reverse logistics provider to be a type of 
3PL.\125\ However, FDA has not yet finalized this guidance or issued 
proposed or final regulations for licensing 3PLs. The listing for the 
relevant regulation in the most recent version of the public list of 
planned federal rulemaking (the Unified Agenda of Regulatory and 
Deregulatory Actions, or ``Unified Agenda'') indicates that FDA plans 
to issue a proposed DSCSA licensing regulation within the next 
year.\126\
---------------------------------------------------------------------------

    \123\ On June 30, 2017, FDA issued a draft guidance, Product 
Identifier Requirements Under the Drug Supply Chain Security Act--
Compliance Policy. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM565272.pdf.
    \124\ The DSCSA was enacted on November 27, 2013; therefore, the 
3PL licensing regulations were scheduled to be issued by FDA by 
November 27, 2015.
    \125\ August 2017, Identifying Trading Partners Under the Drug 
Supply Chain Security Act--Guidance for Industry. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM572252.pdf.
    \126\ See the Spring 2018 Unified Agenda, available at https://www.reginfo.gov/public/do/eAgendaMain.
---------------------------------------------------------------------------

    Furthermore, since 3PLs, such as reverse logistics providers, do 
not take ownership of the drugs that they manage at their facilities, 
the DSCSA requirements related to tracing drugs

[[Page 5840]]

through the supply chain, including transaction information (TI), 
transaction history (TH), and transaction statements (TS), do not apply 
to them. In the absence of relevant FDA regulations, it is difficult 
for EPA to consider the possibility of deferring to FDA for the 
regulation of reverse distributors, who we consider to be managing 
hazardous wastes. In the future, if there are duplicative regulations, 
EPA may need to revisit the regulation of reverse distributors after 
the FDA issues proposed and final licensing regulations for 3PLs in 
accordance with the DSCSA.

D. Wastes Generated at Healthcare Facilities That Are Not Included in 
the Scope of This Final Rule

    Wastes that are not included in the scope of this proposed 
rulemaking include non-hazardous wastes and non-pharmaceutical 
hazardous wastes. Pharmaceutical wastes that are not listed or 
characteristic hazardous wastes under RCRA Subtitle C may nonetheless 
pose some risks to public health and the environment. These wastes are 
discussed further below.
1. How should non-hazardous waste pharmaceuticals be disposed?
    A large portion of the pharmaceutical wastes generated at 
healthcare facilities will not meet the definition of a RCRA hazardous 
waste under RCRA Subtitle C. This final rule, therefore, does not 
require that healthcare facilities manage these waste pharmaceuticals 
under the RCRA Subtitle C hazardous waste regulations, including this 
final rule. However, a healthcare facility may choose to manage its 
non-hazardous and hazardous waste pharmaceuticals together (as 
hazardous waste pharmaceuticals) under the new subpart P regulations. 
Because all healthcare facilities operating under this subpart are 
regulated in the same way regardless of quantity of hazardous waste 
pharmaceuticals generated, managing non-hazardous waste pharmaceuticals 
as hazardous waste under this subpart would not affect the facility's 
hazardous waste generator category. While not regulated by the federal 
RCRA hazardous waste requirements, non-hazardous waste pharmaceuticals 
that are not managed under subpart P are still considered solid wastes 
under the federal regulations and must be managed in accordance with 
applicable federal, state, and/or local regulatory requirements. 
Moreover, some waste pharmaceuticals that do not qualify as ``hazardous 
wastes'' under RCRA can nonetheless be extraordinarily hazardous thus, 
extreme care may be warranted.\127\ These are discussed below in 
section VII.D.1.a.
---------------------------------------------------------------------------

    \127\ See, for example, https://www.cdc.gov/niosh/review/peer/isi/hazdrug2018-pr.html or NIOSH [2016]. NIOSH list of 
antineoplastic and other hazardous drugs in healthcare settings, 
2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB, O'Callaghan 
JP. Cincinnati, OH: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health, DHHS (NIOSH) Publication Number 
2016-161 (Supersedes 2014-138). https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf.
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    If a healthcare facility decides to segregate its hazardous and 
non-hazardous waste pharmaceuticals, EPA recommends that healthcare 
facilities follow the best management practices (BMPs) outlined in 
``Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare 
Facilities in the United States,'' (Blueprint) \128\ an EPA guidance 
document for the management, treatment, storage and disposal of non-
hazardous waste pharmaceuticals. The following summarizes the 
recommended BMPs found in the Blueprint for various categories of 
pharmaceutical wastes, including those wastes that possess hazardous 
waste-like qualities yet are not regulated as hazardous waste under 
RCRA Subtitle C.
---------------------------------------------------------------------------

    \128\ Practice Greenhealth, Revised August 2008. Published in 
2006, the development of the original Blueprint was funded by the 
Office of Solid Waste and Emergency Response and managed by EPA 
Region 1. The 2008 revision of the Blueprint was funded by the 
Healthcare Environmental Resource Center. http://practicegreenhealth.org/sites/default/files/upload-files/pharmwasteblueprint.pdf.
---------------------------------------------------------------------------

    a. Recommended best management practices for healthcare facilities 
managing non-hazardous waste pharmaceuticals possessing hazardous 
waste-like qualities. Currently, most pharmaceuticals are not regulated 
as RCRA hazardous wastes when discarded by healthcare facilities. These 
``non-RCRA-hazardous'' pharmaceuticals can be divided into two 
categories: Those that possess hazardous waste-like qualities and those 
that do not. As outlined in the Blueprint, there are pharmaceuticals 
that possess hazardous waste-like qualities, but for various reasons, 
are not regulated by the RCRA Subtitle C hazardous waste regulations. 
The Agency supports the Blueprint's recommendation of hazardous waste 
incineration as the BMP for healthcare facilities and reverse 
distributors discarding pharmaceuticals that may possess hazardous 
waste-like qualities, but are not regulated as RCRA hazardous waste. 
This recommendation would apply to pharmaceuticals with more than one 
active ingredient listed on the P- or U-lists,\129\ chemotherapeutic 
agents characterized as bulk wastes,\130\ pharmaceuticals which meet 
the hazardous drug criteria set by the National Institute for 
Occupational Safety and Health (NIOSH),\131\ pharmaceuticals with LD50s 
<= 50 mg/kg, pharmaceuticals that are carcinogenic or endocrine 
disrupting compounds, and vitamin/mineral preparations containing heavy 
metals.
---------------------------------------------------------------------------

    \129\ As noted in the comment after Sec.  261.33(d), the phrase 
``commercial chemical product'' includes formulations in which the 
P- or U-listed chemical is the sole active ingredient. Therefore, 
formulations with more than one active ingredient do not meet the 
specifications of the P- and U-listings even if one, two or all of 
the active ingredients are listed on the P- and/or U-lists.
    \130\ The descriptions ``bulk'' and ``trace'' when applied to 
chemotherapeutic wastes are industry terms and are not defined by 
the federal RCRA regulations.
    \131\ See NIOSH list of antineoplastic and other hazardous drugs 
in healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, 
Trout DB, O'Callaghan JP. Cincinnati, OH: U.S. Department of Health 
and Human Services, Centers for Disease Control and Prevention, 
National Institute for Occupational Safety and Health, DHHS (NIOSH) 
Publication Number 2016-161 (Supersedes 2014-138). https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf.
---------------------------------------------------------------------------

    b. Recommended best management practices for other non-hazardous 
waste pharmaceuticals (not possessing hazardous waste-like qualities). 
As far as other non-hazardous waste pharmaceuticals (i.e., those not 
possessing hazardous waste-like qualities), disposing of non-hazardous 
waste pharmaceuticals at healthcare facilities via drain disposal is 
strongly discouraged and not recommended by EPA. Therefore, EPA 
endorses the Blueprint's recommendation of municipal solid waste 
incineration or medical waste incineration for any non-hazardous waste 
pharmaceuticals, even when they do not possess hazardous waste-like 
qualities. The potential risk remains for active pharmaceutical 
ingredients (APIs) to be released into the environment if medical waste 
autoclaves or municipal solid waste landfills are used for the purposes 
of pharmaceutical waste treatment and disposal. For example, autoclaves 
are designed to kill pathogens and do not achieve the temperatures 
required to destroy most APIs during the autoclaving process. As a 
result, when wastewater is generated either by cleaning an autoclave, 
or during automatic blow down from autoclaves equipped with steam 
generators, there is the potential for wastewater containing APIs to be 
generated and discharged into the sewer. In addition, some limited 
studies have shown APIs present in landfill leachate collected in 
municipal solid waste landfill leachate

[[Page 5841]]

systems.132 133 Typically, the collected landfill leachate 
is subsequently sent to wastewater treatment plants for treatment, but 
their treatment technologies are not designed to remove all APIs from 
the wastewater (See section XIII for more information regarding the 
prohibition on sewering hazardous waste pharmaceuticals).
---------------------------------------------------------------------------

    \132\ Barnes, K.K., Christenson, S.C., Kolpin, D.W., Focazio, 
M.J., Furlong, E.T., Zaugg, S.D., Meyer, M.T. and Barber, L.B. 
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants 
Within a Leachate Plume Downgradient of a Municipal Landfill. 
Groundwater Monitoring & Remediation, 24: 119-126
    \133\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., 
Zaugg, S.D., and Meyer, M.T. (June 2009), Waste-Indicator and 
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water 
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental 
Contamination and Toxicology, V82.6:635-659.
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2. How should non-pharmaceutical hazardous waste be disposed?
    These newly promulgated subpart P regulations will pertain only to 
hazardous waste pharmaceuticals. Therefore, other types of hazardous 
wastes generated at healthcare facilities and reverse distributors that 
do not meet the definition of a hazardous waste pharmaceutical cannot 
be managed in accordance with this new subpart (as previously 
discussed, non-hazardous waste pharmaceuticals may be managed under 
this new subpart). For example, hazardous wastes generated in hospital 
laboratories or during cleaning and maintenance of the facility are not 
considered hazardous waste pharmaceuticals and are not included within 
the scope of this final rule. The generation of non-pharmaceutical 
hazardous wastes is often more routine and does not trigger the same 
concerns that healthcare facilities experience when managing hazardous 
waste pharmaceuticals. Also note that the 2016 Hazardous Waste 
Generator Improvements final rule added new flexibility for episodic 
generators of non-pharmaceutical hazardous waste under part 262 subpart 
L.

VIII. What terms are defined in this final rule? (Sec.  266.500)

A. Definition of Pharmaceutical

1. Summary of Proposal
    EPA proposed to define ``pharmaceutical'' as any chemical or 
biological product that is intended for use in the diagnosis, cure, 
mitigation, care, treatment, or prevention of disease or injury of a 
human or other animal; or any chemical or biological product that is 
intended to affect the structure or function of the body of a human or 
other animal. This definition included, but was not limited to dietary 
supplements as defined by the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), prescription drugs, OTC drugs, residues of pharmaceuticals 
remaining in containers, personal protective equipment contaminated 
with residues of pharmaceuticals, and clean-up material from the spills 
of pharmaceuticals. This proposed definition of ``pharmaceutical'' was 
intended to include all dose forms, including, but not limited to, 
tablets, capsules, medicinal gums or lozenges, medicinal liquids, 
ointments and lotions, IV or other compound solutions, chemotherapy 
pharmaceuticals, vaccines, allergenics, medicinal shampoos, 
antiseptics, and any delivery device, including medicinal dermal 
patches, with the primary purpose to deliver or dispense the 
pharmaceutical.
    EPA relied on the FD&C Act's definition of ``drug'' to develop the 
proposed definition of ``pharmaceutical'' but expanded on the 
definition based on comments to the 2008 Universal Waste proposed 
rulemaking. In particular, stakeholders requested that the Agency take 
a broad view in delineating what items are included in the definition 
of pharmaceutical so that the proposed standards applied broadly. Thus, 
the proposed definition of ``pharmaceutical'' did not exclude 
pharmaceuticals with a radioactive component and included items not 
specifically recognized by the FDA as drugs, such as dietary 
supplements, pharmaceutical residues in non-empty containers (including 
delivery devices), personal protective equipment contaminated with 
residues of pharmaceuticals, and clean-up material from spills of 
pharmaceuticals.
2. Summary of Comments
    The most frequent comment EPA received on the definition of 
``pharmaceutical'' was on the inclusion of personal protective 
equipment and clean-up material in the definition of pharmaceutical. 
Many commenters argued that personal protective equipment and clean-up 
material should not be included in the final definition. One commenter 
suggested that loose tablets be included in the definition of 
pharmaceutical but that personal protective equipment should not be 
included. Waste Management National Services, Inc. suggested that only 
``overtly contaminated'' personal protective equipment or clean-up 
materials be included in the definition, but not personal protective 
equipment and clean-up materials with trace contamination.\134\ Two 
commenters asked EPA to clarify which personal protective equipment is 
included in the definition of ``pharmaceutical.''
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    \134\ See comment number 0257 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    One state expressed concern that EPA proposed to take a broad view 
in delineating what items are included in the definition of 
``pharmaceutical.'' The New Jersey Department of Environmental 
Protection pointed out that although ``sharps'' did not meet the 
proposed definition of ``pharmaceutical'' that IV bags, tubing and 
syringes that come in contact with blood or pathogens could fall under 
the definition of ``pharmaceutical.'' They asked that EPA exclude these 
items from the definition.\135\
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    \135\ See comment number 0235 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    EPA requested comment on the Agency's decision to include dietary 
supplements in the definition of ``pharmaceutical'' under the final 
rule. Four states and one industry association supported the Agency's 
proposal to include dietary supplements under the definition of 
``pharmaceutical.'' One state and five industry associations did not 
support including dietary supplements in the definition of 
``pharmaceutical.'' Multiple commenters requested that EPA only include 
dietary supplements that are regulated as drugs and exclude supplements 
regulated as foods.
    EPA requested comment on the possibility of including low-
concentration nicotine products, such as electronic nicotine delivery 
systems (e-cigarettes), in the definition of ``pharmaceuticals'' under 
the final rule. EPA received multiple comments on whether to include e-
cigarettes and liquid nicotine (e-liquids) in the final definition. 
Hawaii State Department of Health and the Hematology/Oncology Pharmacy 
Association did not support including e-cigarettes or e-liquids in the 
final definition of ``pharmaceutical.'' \136\ RILA requested that EPA 
exempt all low-concentration nicotine products from the P075 listing, 
including e-cigarettes and e-liquids, but agreed that if EPA did not 
exempt these products from the P075 listing, that e-cigarette products 
should fall under the definition of ``pharmaceutical.'' \137\
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    \136\ See comment numbers 0238 and 0264 in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932).
    \137\ See comment number 0295 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
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    The American Dental Association asked that EPA specifically exclude

[[Page 5842]]

dental amalgam from the final definition of ``pharmaceutical.'' \138\
---------------------------------------------------------------------------

    \138\ See comment number 0294 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Multiple commenters pointed out that the same chemical may have a 
pharmaceutical and non-pharmaceutical use (e.g., isopropyl alcohol is 
used to clean wounds and to clean instruments and surfaces). \139\ 
Commenters asked EPA to clarify that they are regulated differently.
---------------------------------------------------------------------------

    \139\ See comment numbers 0246, 0280, 0296 in the docket for 
this rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Stericycle, Inc. requested that investigational or research drugs 
be considered pharmaceuticals because they are difficult to 
characterize.\140\
---------------------------------------------------------------------------

    \140\ See comment number 0280 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

3. Final Rule Provisions
    In this final rule, ``pharmaceutical'' means any drug or dietary 
supplement for use by humans or other animals; any electronic nicotine 
delivery system (e.g., electronic cigarette or vaping pen), or any 
liquid nicotine (e-liquid) packaged for retail for use in electronic 
nicotine delivery systems (e.g., pre-filled cartridges or vials). This 
definition includes, but is not limited to dietary supplements, as 
defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, 
as defined by 21 CFR 203.3(y); OTC drugs; homeopathic drugs; compounded 
drugs; investigational new drugs; pharmaceuticals remaining in non-
empty containers; personal protective equipment contaminated with 
pharmaceuticals; and clean-up material from spills of pharmaceuticals. 
This definition does not include dental amalgam or sharps.
    The final definition of pharmaceutical includes both prescription 
drugs, as defined by 21 CFR 203.3(y) and OTC drugs. As previously 
mentioned, commenters pointed out that the same chemical may have a 
pharmaceutical and non-pharmaceutical use.\141\ If an OTC product is 
required by the FDA to include ``Drug Facts'' on the label, it would be 
considered a pharmaceutical for the purposes of this rule.\142\ In rare 
cases, some items that are OTC pharmaceuticals may not be labeled 
appropriately with a ``Drug Facts'' label. It is the Agency's 
understanding, however, that all OTC drugs must contain a Drug Facts 
label. Therefore, if an item meets the criteria to be considered a 
pharmaceutical under subpart P but is not labeled with Drug Facts, it 
should still be managed as a pharmaceutical. Any non-pharmaceutical 
hazardous wastes must be managed pursuant to all other applicable RCRA 
regulations. The final definition of ``pharmaceutical'' also includes 
any pharmaceutical residuals remaining in non-empty containers, such as 
the pharmaceutical residuals remaining in dispensing bottles, IV bags 
and tubing, vials, unit dose packages, and delivery devises, such as 
syringes and patches. However, the final definition does not include 
sharps (e.g., needles from IV bags or syringes). Used sharps, such as 
needles or syringes with needles, are not included under the final 
definition of pharmaceutical because sharps are considered medical 
wastes, presently regulated at both the state and local level. Further, 
as discussed in section XV of this preamble, EPA is finalizing 
regulations for when pharmaceutical containers are considered empty.
---------------------------------------------------------------------------

    \141\ See comment numbers 0246, 0280, 0296 in the docket for 
this rulemaking (EPA-HQ-RCRA-2007-0932).
    \142\ See 21 CFR 201.66
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' also includes items 
contaminated with or containing pharmaceuticals, such as personal 
protective equipment contaminated with pharmaceuticals or related spill 
clean-up materials (including loose tablets accumulated during pharmacy 
floor sweepings). EPA's decision to include contaminated personal 
protective equipment under the definition of ``pharmaceutical'' 
reflects the Agency's interest in promoting a similar management scheme 
for the personal protective equipment containing pharmaceuticals and 
other types of pharmaceuticals. Only personal protective equipment that 
is already considered hazardous waste under the ``contained in'' policy 
because it is contaminated with pharmaceuticals will fall under the 
definition of pharmaceutical.\143\ These items are included in the 
definition so that facilities can manage more types of hazardous waste 
commonly found in healthcare settings under the same standards. For 
example, the contained in policy would not apply to gloves that have 
touched a warfarin pill during the course of patient care. However, if 
a healthcare worker spills a hazardous waste pharmaceutical on their 
personal protective equipment and it cannot be removed from the 
personal protective equipment, the personal protective equipment would 
be considered a hazardous waste pharmaceutical. If the personal 
protective equipment only has trace amounts of contamination it would 
not be considered a hazardous waste and therefore not be considered a 
hazardous waste pharmaceutical.
---------------------------------------------------------------------------

    \143\ See memo from Lowrance to Fields, January 3, 1989 (RCRA 
Online #11387).
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' includes dietary 
supplements for the same reason--in order to promote a consistent 
management scheme for similar waste streams. Dietary supplements are 
commonly found in various healthcare settings because they are 
recommended or prescribed by healthcare providers to patients.\144\ 
Further, retail pharmacies routinely sell vitamins and other medicinal 
minerals and supplements. When EPA uses the term ``dietary 
supplements'' in the definition of ``pharmaceutical,'' EPA is 
referencing the definition for dietary supplement used by the FD&C Act, 
as amended by the Dietary Supplement Health and Education Act of 1994 
(21 U.S.C. 321 (ff)).\145\ If a dietary supplement is required by the 
FDA to include a ``Supplement Facts'' panel on the label, it would be 
considered a pharmaceutical for the purposes of this rule.\146\ The 
FD&C Act categorizes dietary ingredients and dietary supplements under 
the general umbrella of foods and therefore does not review them before 
being marketed. In fact, several commenters suggested that because the 
FD&C Act does not regulate supplements as drugs, EPA does not have the 
authority to regulate them as pharmaceuticals under RCRA. EPA disagrees 
with the commenters, noting that any waste that is listed or exhibits a 
characteristic is regulated as a hazardous waste when discarded, 
including supplements. This final rule does not newly apply RCRA to the 
disposal of supplements that meet the definition of hazardous waste, as 
some commenters suggest; it changes which regulations apply when 
discarding supplements that are hazardous waste. EPA recognizes that 
healthcare facilities may benefit from managing dietary supplements 
along with drugs under the

[[Page 5843]]

final regulation, and thus, is including it in the final definition of 
``pharmaceutical.'' Although dietary supplements are considered 
pharmaceuticals under this definition, only the dietary supplements 
that meet the definition of hazardous waste (e.g., exhibits the 
toxicity characteristic for metal content) would be regulated under 
part 266 subpart P as hazardous waste pharmaceuticals (see the 
definition of ``hazardous waste pharmaceutical'').
---------------------------------------------------------------------------

    \144\ Including dietary supplements under the definition of 
``pharmaceutical'' does not supersede the requirements of the 
Dietary Supplement Health and Education Act of 1994, the Federal 
Food, Drug and Cosmetic Act, or FDA regulations.
    \145\ The substance of the definition is: A Product (other than 
tobacco) intended to supplement the diet that bears or contains one 
or more of the following dietary ingredients: (A): A vitamin; (B) a 
mineral; (C) an herb or other botanical; (D) an amino acid; (E) a 
dietary substance for use by man to supplement the diet by 
increasing the total dietary intake; or (F) a concentrate, 
metabolite, constituent, extract, or combination of any ingredient 
described in clause (A), (B), (C), (D), or (E); For the complete 
definition of dietary supplement, please see: https://www.gpo.gov/fdsys/pkg/USCODE-2011-title21/pdf/USCODE-2011-title21-chap9-subchapII.pdf.
    \146\ See 21 CFR 101.36.
---------------------------------------------------------------------------

    The final rule specifically excludes dental amalgam from the final 
definition of pharmaceutical. EPA promulgated new pretreatment 
standards in June 2017 to reduce discharges of mercury from dental 
offices into publicly owned treatment works.\147\ If EPA included 
dental amalgam in the final definition of pharmaceutical, it would 
subject dentists to duplicative regulatory requirements.
---------------------------------------------------------------------------

    \147\ 82 FR 27154; June 14, 2017.
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' includes electronic 
nicotine delivery systems and liquid nicotine (e-liquid) packaged for 
retail for use in electronic nicotine delivery systems. These items are 
included in the definition ``pharmaceutical'' so that facilities can 
manage more types of hazardous waste commonly found in healthcare 
settings under part 266 subpart P. The final definition of 
``pharmaceutical'' applies to finished product electronic nicotine 
delivery systems, including components and parts, sealed in final 
packaging intended for consumer use (e.g., electronic cigarettes and 
vaping pens) and e-liquid that is packaged for retail for use in the 
electronic nicotine delivery systems (e.g., pre-filled cartridges and 
vials that are sold separately to consumers or as part of kits). EPA 
intends that e-liquid used by manufacturers of tobacco products (as 
defined by the FD&C Act) not be included in the final definition of 
``pharmaceutical.'' \148\ That is, a pre-filled e-liquid cartridge 
sealed in final packaging that is to be sold or distributed to a 
consumer for use is included in the definition, but in contrast, an e-
liquid that is sold or distributed for further manufacturing, mixing, 
or packaging into a finished electronic nicotine delivery system is not 
included.\149\ EPA believes that finished products sealed in packaging 
intended for consumer use pose a lower risk for leaks and other 
releases to the environment than e-liquid that is sold or distributed 
for further manufacturing. E-liquid that is packaged for retail for use 
in electronic nicotine delivery systems, such as e-liquid that is in 
pre-filled cartridges and vials, is typically sold at lower 
concentrations and smaller quantities than e-liquid that is sold or 
distributed for further manufacturing.
---------------------------------------------------------------------------

    \148\ 26 U.S.C. 5702 (d)
    \149\ This distinction is adapted from the term ``finished 
tobacco product'' used by FDA in its regulations for e-cigarettes, 
cigars, and all other tobacco products. 81 FR 28973; May 10, 2016.
---------------------------------------------------------------------------

    The final definition of ``pharmaceutical'' includes investigational 
drugs. One commenter asked EPA to include investigational drugs in the 
definition because these drugs are difficult to characterize. The 
investigational drugs might have proprietary ingredients that the 
manufacturer might not be willing to divulge during trials. The final 
definition includes investigational drugs in order to provide clarity 
on how to manage these items when discarded. See section IX.B.2.e 
regarding the applicability of subpart P to discarded investigational 
drugs.

B. Definition of Hazardous Waste Pharmaceutical

1. Summary of Proposal
    EPA proposed to define ``hazardous waste pharmaceutical'' as a 
pharmaceutical that is a solid waste, as defined in Sec.  261.2, and is 
listed in part 261 subpart D, or exhibits one or more characteristics 
identified in part 261 subpart C. The Agency proposed to define the 
term ``hazardous waste pharmaceutical'' in order to clarify its intent 
that only pharmaceuticals that meet the definition of hazardous waste 
when disposed or discarded need to be managed under the new subpart P 
management standards.
2. Summary of Comments
    EPA requested comment on the proposed definition of ``hazardous 
waste pharmaceutical'' and specifically on whether any dietary 
supplements currently on the market meet or could potentially meet 
RCRA's definition of hazardous waste.
    The New Mexico Environment Department requested that EPA broaden 
the definition of ``hazardous waste pharmaceutical'' to include 
antineoplastic agents. The New Mexico Environment Department argued 
that EPA has not updated the P- and U-hazardous waste lists even though 
new pharmaceuticals have been developed that should be considered 
hazardous waste.\150\ Public Employees for Environmental Responsibility 
also argued that the definition of ``hazardous waste pharmaceutical'' 
is too narrow because not enough pharmaceuticals meet the 
definition.\151\ American Pharmacists Association expressed concern 
that the definition is difficult to understand because the P- and U-
hazardous waste lists are not comprehensive.\152\
---------------------------------------------------------------------------

    \150\ See comment number 0211 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
    \151\ See comment number 0247 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
    \152\ See comment number 0321 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Waste Management National Services Inc., supported the proposed 
definition of ``hazardous waste pharmaceutical'' and pointed out that 
there are dietary supplements on the market that meet the RCRA 
definition of hazardous waste because the supplements contain selenium 
or chromium.\153\
---------------------------------------------------------------------------

    \153\ See comment number 0257 in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

3. Final Rule Provisions and Response to Comments
    In this final rule, ``hazardous waste pharmaceutical'' means a 
pharmaceutical that is a solid waste, as defined in Sec.  261.2, and 
exhibits one or more characteristics identified in part 261 subpart C, 
or is listed in part 261 subpart D. A pharmaceutical is not a solid 
waste, as defined in Sec.  261.2, and therefore not a hazardous waste 
pharmaceutical, if it is legitimately used/reused (e.g., lawfully 
donated for its intended purpose) or reclaimed. An OTC pharmaceutical, 
dietary supplement, or homeopathic drug is not a solid waste, as 
defined in Sec.  261.2, and therefore not a hazardous waste 
pharmaceutical, if it has a reasonable expectation of being 
legitimately used/reused (e.g., lawfully redistributed for its intended 
purpose) or reclaimed.
    The Agency is including in the final definition of ``hazardous 
waste pharmaceutical'' that a pharmaceutical is not a solid waste, as 
defined in Sec.  261.2, and therefore not a hazardous waste 
pharmaceutical if it is lawfully donated. The Agency included this 
language to clarify that pharmaceuticals are not solid waste if they 
are donated for use (see section IX.B for more discussion).
    The Agency is defining the term ``hazardous waste pharmaceutical'' 
in order to clarify its intent that only pharmaceuticals (as defined in 
this final rule) that are hazardous waste when disposed or discarded 
need to be managed under the final subpart P management standards. For 
example, warfarin (brand name Coumadin) is a listed hazardous waste and 
when discarded meets the definition of hazardous waste pharmaceutical. 
The Agency notes that hazardous waste pharmaceuticals are hazardous 
wastes; more specifically, they are a subset of

[[Page 5844]]

hazardous waste. The term hazardous waste is defined in Sec.  260.10 as 
``a hazardous waste as defined in Sec.  261.3.'' Therefore, even though 
we do not reference Sec.  261.3 in the definition of hazardous waste 
pharmaceutical, a hazardous waste pharmaceutical is also hazardous 
waste as defined in Sec.  261.3. This is relevant to the OSHA Hazardous 
Waste Operations and Emergency Response standard (29 CFR 1910.120), 
which apply to hazardous wastes, as defined by Sec.  261.3. This final 
rule does not impact the applicability of the OSHA Hazardous Waste 
Operations and Emergency Response standards.
    Multiple commenters suggested that the proposed definition of 
``hazardous waste pharmaceutical'' was too narrow because the P- and U-
hazardous waste lists have not been updated even though new 
pharmaceuticals have been developed. Although we solicited ideas from 
commenters for possible methods or approaches for regulating additional 
pharmaceuticals as hazardous waste, any action taken to address the 
comments we received in response to this request would have to be a 
separate action taken by the Agency in the future and is not part of 
this final rulemaking. Therefore, these comments are considered to be 
out of the scope of this final action and we do not plan to address 
them at this time. That said, we do anticipate that because subpart P 
lowers regulatory barriers to over-managing non-hazardous waste 
pharmaceuticals, some healthcare facilities will choose to over-manage 
non-hazardous waste pharmaceuticals as hazardous waste pharmaceuticals 
even if they do not meet a current listing or exhibit a hazardous waste 
characteristic.

C. Definition of Reverse Distributor 154
---------------------------------------------------------------------------

    \154\ The proposed rule used the term ``pharmaceutical reverse 
distributor'' but the final rule uses the term ``reverse 
distributor.'' To avoid confusion, we use the term ``reverse 
distributor'' in this preamble, even when discussing the proposed 
rulemaking.
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1. Summary of Proposal
    EPA proposed to define reverse distributor as any person that 
receives and accumulates potentially creditable hazardous waste 
pharmaceuticals for the purpose of facilitating or verifying 
manufacturer credit. EPA proposed that any person, including forward 
distributors and pharmaceutical manufacturers, that processes 
pharmaceuticals for the facilitation or verification of manufacturer 
credit would be considered a reverse distributor. Pharmaceutical 
manufacturers often offer credit to healthcare facilities for unused 
and/or expired pharmaceuticals.\155\ Manufacturers issue credit for a 
variety of reasons: it can be a marketing incentive tool, it helps 
protect against illicit diversion \156\ or improper disposal, and it 
allows manufacturers to collect data on the returned items, which then 
can be used to help plan for future pharmaceutical production. Reverse 
distributors contract with both manufacturers and healthcare facilities 
to act as an intermediary to facilitate the crediting process.
---------------------------------------------------------------------------

    \155\ As noted in the definition of ``potentially creditable 
hazardous waste pharmaceutical,'' manufacturers provide credit for 
those pharmaceuticals that are less than one year past the 
expiration date.
    \156\ Through the return of pharmaceuticals by a pharmacy for 
manufacturer credit, manufacturers are able to maintain control of 
the pharmaceutical up to the point of its disposal, thereby, 
decreasing the risk of diversion of the pharmaceutical.
---------------------------------------------------------------------------

    EPA proposed new standards for shipping potentially creditable 
hazardous waste pharmaceuticals to reverse distributors and management 
standards of potentially creditable hazardous waste pharmaceuticals by 
reverse distributors. Thus, EPA proposed to define ``reverse 
distributor'' to clearly delineate which types of facilities were 
subject to the proposed rulemaking. The agency solicited public comment 
on its proposed definition of ``reverse distributor.'' Specifically, 
EPA asked for comment on whether the definition of ``reverse 
distributor'' captures the universe of facilities acting as reverse 
distributors for pharmaceuticals.
2. Summary of Comments
    Commenters requested that EPA clarify who would be considered a 
reverse distributor and what the functions of a reverse distributor 
are. States and industry, including manufacturers, wholesalers, and 
waste management companies, wanted to know if any facility that 
performed reverse distribution functions would be encompassed in this 
definition. Reverse distributors asked for clarification in how 3PLs 
fit into the definition of reverse distributor and whether all 
functions performed by their business would fall under the definition.
3. Final Rule Provision
    Under the final rule, reverse distributor means any person that 
receives and accumulates prescription pharmaceuticals that are 
potentially creditable hazardous waste pharmaceuticals for the purpose 
of facilitating or verifying manufacturer credit. Any person, including 
forward distributors, third-party logistics providers, and 
pharmaceutical manufacturers, that processes prescription 
pharmaceuticals for the facilitation or verification of manufacturer 
credit is considered a reverse distributor.
    In response to comments, EPA made two changes to the definition of 
``reverse distributor'' for the final rule. First, EPA proposed to use 
the term ``pharmaceutical reverse distributor'' but the final rule uses 
the term ``reverse distributor.'' EPA dropped the word 
``pharmaceutical'' from reverse distributor because the definition of 
pharmaceutical is overly broad given that it refers to both 
prescription and nonprescription pharmaceuticals. EPA received comments 
from stakeholders pointing out that in the terminology of the industry, 
reverse distributors receive prescription pharmaceuticals, while 
reverse logistics centers receive nonprescription pharmaceuticals and 
other unsold retail items. This distinction is useful to EPA in making 
the same distinction in these regulations and EPA has adopted it.
    The second change EPA made was to add the word prescription to the 
definition to further clarify that the definition does not include 
reverse logistics centers that receive nonprescription pharmaceuticals 
or other unsold retail items that are evaluated for legitimate use/
reuse or reclamation. EPA's definition of ``reverse distributor'' only 
includes prescription hazardous waste pharmaceuticals that are 
evaluated for credit and then disposed. EPA made this clarification to 
be consistent with the policy for the reverse logistics of 
nonprescription pharmaceuticals and other unsold retail items. See 
section VI of this preamble for discussion of the regulations for the 
reverse distribution of prescription hazardous waste pharmaceuticals 
and the policy for the reverse logistics of other unsold retail items, 
including nonprescription pharmaceuticals.
    EPA incorporated the changes to the final definition of ``reverse 
distributor'' in response to the comments summarized below.
4. Comments and Responses
    EPA received comments from states and industry, including 
manufacturers, wholesalers and waste management companies, asking for 
clarification on who would be considered a reverse distributor. For 
example, commenters asked whether wholesalers, forward distributors and 
3PLs meet the definition of ``reverse distributor'' even if reverse 
distribution is only a part of their business. For example, a facility

[[Page 5845]]

might act as a sorting and shipping facility or a pharmacy might act as 
a consolidation center but not evaluate for manufacturer credit. The 
definition of ``reverse distributor'' specifically states that any 
person, including forward distributors (e.g., wholesalers), 3PLs, or 
pharmaceutical manufacturers, that processes prescription 
pharmaceuticals for the facilitation or verification of manufacturer 
credit is considered a reverse distributor. Any person that is 
performing the function of a reverse distributor, even if it is a small 
part of their business, would need to operate under the reverse 
distributor standards. If a facility is not processing any hazardous 
waste prescription pharmaceuticals for facilitating or verifying 
manufacturer credit, then it would not meet the definition of ``reverse 
distributor.''
    The retail industry was especially concerned with need to 
differentiate between reverse distributors and reverse logistics 
centers. Reverse logistics centers that receive nonprescription 
pharmaceuticals (such as OTC pharmaceuticals) would not fall under this 
definition. Likewise, wholesale distributors receiving returns from 
their customers would not be considered reverse distributors. This is 
because wholesale distributors do not facilitate manufacturer credit. 
Further, according to comments received from Healthcare Distribution 
Management Association, in 2013, approximately 94% of the returns to 
wholesale distributors, were saleable.157 158 As saleable 
products, the pharmaceuticals returned to wholesale distributors would 
remain subject to the track and trace requirements of the DSCSA. 
Reverse logistics centers, which evaluate nonprescription 
pharmaceuticals for legitimate use/reuse and reclamation do not fit 
this definition.
---------------------------------------------------------------------------

    \157\ Healthcare Distribution Management Association has since 
been renamed Healthcare Distribution Alliance.
    \158\ See comment #EPA-HQ-RCRA-2007-0932-0276.
---------------------------------------------------------------------------

    EPA is also finalizing the definitions for potentially creditable 
and non-creditable hazardous waste pharmaceuticals (in parts D and E of 
this section) to differentiate between reverse distributors' function 
in evaluation of credit versus the traditional TSDF role in waste 
disposal. It is the Agency's intent that potentially creditable 
hazardous waste pharmaceuticals can be sent to reverse distributors for 
the determination of credit under subpart P. It is not the Agency's 
intent, however, for reverse distributors to serve in the capacity as 
storage facilities or TSDFs for other hazardous waste.
    Multiple state commenters asked EPA to clarify what is meant by 
``facilitate.'' The facilitation of credit encompasses the role that 
reverse distributors serve between healthcare facilities and 
manufacturers. A reverse distributor receives potentially creditable 
hazardous waste pharmaceuticals for evaluation of manufacturer credit. 
Once the evaluation is complete and it is determined that credit can be 
given, reverse distributors will issue the manufacturer credit on 
behalf of the manufacturer to the healthcare facility.
    Reverse distributors wanted to add all the other functions 
performed by reverse distributors to the regulatory definition to more 
fully define their role. EPA did not add reverse distributors' other 
functions to the definition of ``reverse distributor'' in the final 
rule. While a reverse distributor may continue to perform other lawful 
activities, they are not relevant for the purpose of defining a reverse 
distributor under this final rule. EPA's definition of reverse 
distribution focuses on issuing of manufacturer credit because although 
the pharmaceuticals are hazardous waste, they have value to the 
healthcare facility and the reverse distributor. Since these hazardous 
waste pharmaceuticals have value, there is a greater economic incentive 
to manage them with more care than typical hazardous waste. The final 
definition captures the handling of prescription hazardous waste 
pharmaceuticals that fall under RCRA and the rest of the functions can 
be regulated, as needed, under local, state and other federal 
regulations.
    The waste management industry requested clarification on the 
intersection of DEA reverse distributors and RCRA reverse distributors 
and how a reverse distributor that receives a DEA controlled substance 
as a waste would determine if they are also subject to subpart P. A 
hazardous waste pharmaceutical that is also a DEA controlled substance 
is not subject to subpart P, provided they meet the terms of the 
conditional exemption in Sec.  266.506. The conditional exemption for 
DEA controlled substances that are also RCRA hazardous waste is covered 
in section XIV of the preamble.
    The Agency also wants to clarify the difference between what is 
defined as a reverse distributor under this final rule and how DEA 
regulations define ``reverse distribute.'' The recently amended DEA 
regulatory definition of ``reverse distribute'' is to ``acquire 
controlled substances from another registrant or law enforcement for 
the purposes of: (1) Return to the registered manufacturer or another 
registrant authorized by the manufacturer to accept returns on the 
manufacturer's behalf; or (2) Destruction.'' \159\
---------------------------------------------------------------------------

    \159\ See 21 CFR 1300.01. On September 9, 2014, DEA finalized 
new definitions for ``reverse distribute'' and ``reverse 
distributor.'' Please see 79 FR 53520. The term ``reverse 
distributor'' is defined as ``a person registered with the 
Administration [DEA] as a reverse distributor.''
---------------------------------------------------------------------------

    Under DEA's definition, a reverse distributor does not necessarily 
process pharmaceuticals for the purpose of determining manufacturer 
credit: Often a reverse distributor's main function under DEA's 
definition is to destroy the controlled substances. Under EPA's 
definition, however, a reverse distributor is defined as a facility 
that accepts potentially creditable pharmaceuticals for the purposes of 
evaluating manufacturer credit. These potentially creditable hazardous 
waste pharmaceuticals may or may not be identified as controlled 
substances by DEA.\160\ Therefore, a DEA-registered reverse distributor 
may or may not meet EPA's definition of a reverse distributor and vice 
versa. For example, a reverse distributor that accepts DEA controlled 
substances that are also hazardous waste pharmaceuticals for the 
purpose of destruction (e.g., incineration) would be regulated as a 
DEA-registered reverse distributor and as a RCRA TSDF (or other 
regulated incinerator, depending on what other wastes it combusts), but 
not as a reverse distributor under part 266 subpart P. Conversely, a 
reverse distributor that processes pharmaceuticals for manufacturer 
credit, but is not a DEA registrant and therefore, cannot accept 
controlled substances, would meet the subpart P reverse distributor 
definition, but not DEA's reverse distributor definition. However, EPA 
has heard from stakeholders that most, if not all, entities that 
facilitate manufacturer credit are also DEA-registered reverse 
distributors. Therefore, such reverse distributors would meet both 
EPA's definition of reverse distributor and the DEA's definition of 
reverse distributor. Lastly, EPA's definition for reverse distribution 
does not alter or supersede the requirements of the Controlled 
Substances Act and DEA regulations.
---------------------------------------------------------------------------

    \160\ In order for a reverse distributor to be able to accept 
controlled substances, the reverse distributor must be a DEA 
registrant. See 21 CFR part 1308 for a complete list of controlled 
substances.
---------------------------------------------------------------------------

    In addition, the DOT's Pipeline and Hazardous Materials Safety 
Administration has defined the closely related term, ``reverse 
logistics,'' in a

[[Page 5846]]

recent rulemaking.\161\ EPA coordinated with the Pipeline and Hazardous 
Materials Safety Administration to ensure that our rules are 
compatible, even if the definitions differ. It is important to note 
that their final rule does not supersede EPA's RCRA Subtitle C 
regulations for solid or hazardous waste determinations or hazardous 
waste management.
---------------------------------------------------------------------------

    \161\ 79 FR 46748; August 11, 2014. The Pipeline and Hazardous 
Material Safety Administration's definition of reverse logistics 
``is the process of moving goods from their final destination for 
the purpose of capturing value, recall, replacement, proper 
disposal, or similar reason.''
---------------------------------------------------------------------------

D. Definition of Potentially Creditable Hazardous Waste Pharmaceutical

1. Summary of Proposal
    In order to distinguish hazardous waste pharmaceuticals that are 
sent by a healthcare facility to RCRA TSDFs from those hazardous waste 
pharmaceuticals that are sent by a healthcare facility to a reverse 
distributor for a determination or verification of manufacturer credit, 
the Agency proposed a definition for ``potentially creditable hazardous 
waste pharmaceutical.''
    EPA proposed to define ``potentially creditable hazardous waste 
pharmaceutical'' to mean 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.
    The proposed term did not include evaluated hazardous waste 
pharmaceuticals, residues of pharmaceuticals remaining in containers, 
contaminated personal protective equipment, and clean-up material from 
the spills of pharmaceuticals. These pharmaceuticals are typically 
unopened and in their original packaging and include both generic and 
name brand pharmaceuticals.
    Whether a pharmaceutical is eligible for manufacturer credit is 
determined solely by the manufacturer's return policy. Based on 
comments received for the 2008 Universal Waste proposed rulemaking and 
through discussions with various stakeholders, the Agency understands 
that the return policies of manufacturers change regularly. As a 
result, healthcare facilities are not always aware if a particular 
pharmaceutical will be creditable at the time that it is pulled from 
the shelves. However, the Agency also understands that there are 
instances where it is well known that a pharmaceutical will not be 
creditable. Examples of these instances include the following: If the 
pharmaceutical has been removed from the original container and 
repackaged for dispensing purposes; if an attempt was made to 
administer a pharmaceutical, but the patient refused to take it; if the 
hazardous waste pharmaceutical was generated during patient care; if 
the pharmacy receives a return of a dispensed pharmaceutical for which 
they had already received compensation by a third-party payer; or if 
the pharmaceutical is more than one year past its expiration date. In 
these instances, as well as others, the healthcare facility knows that 
it will not receive manufacturer credit. It is the Agency's intent for 
the proposed definition of ``potentially creditable hazardous waste 
pharmaceutical'' to allow the return of hazardous waste pharmaceuticals 
to reverse distributors for the determination of credit. It is not the 
Agency's intent, however, for reverse distributors to serve in the 
capacity as TSDFs when it is well known that the manufacturer will not 
give credit for those hazardous waste pharmaceuticals.
    Also, based on communication with stakeholders and the public 
comments received on the 2008 Universal Pharmaceutical Waste proposal, 
EPA understands that pharmaceutical manufacturers' policies often allow 
for credit to be issued on the return of ``partials.'' ``Partials'' is 
a term used in the industry to refer to opened containers that have had 
some contents removed. Under the proposed definition, the Agency 
considered partials to be potentially creditable hazardous waste 
pharmaceuticals.
2. Summary of Comments
    States, manufacturers and waste management companies commented that 
word changes to this definition would clarify which hazardous waste 
pharmaceuticals could or could not be returned to reverse distributors. 
Manufacturers, some states and healthcare facilities argued that all 
pharmaceuticals should go to reverse distributors to relieve the burden 
on healthcare facilities to make these individual determinations. 
Pharmacists and reverse distributors wanted further clarification on 
what distinguishes a potentially creditable hazardous waste 
pharmaceutical and how it relates to credit.
3. Final Rule Provision
    In response to comments, EPA has made five changes to the 
definition of ``potentially creditable hazardous waste pharmaceutical'' 
from the proposal. First, the final definition specifically includes 
prescription pharmaceuticals only. Second, we added the phrase 
``reasonable expectation'' to clarify that the healthcare facility does 
not have to definitively know whether something will receive 
manufacturer credit but rather indicates that they should have a 
reasonable expectation that it will. We also note that EPA could have 
proposed to use the term ``creditable hazardous waste 
pharmaceuticals,'' but chose to use the term ``potentially creditable 
hazardous waste pharmaceutical'' to convey the same concept (i.e., that 
a healthcare facility does not have to definitively know whether a 
specific item will receive manufacturer credit.) Third, we replaced 
``unadministered'' with the term ``undispensed'' to make clear that it 
is not just that a patient refused to take a prescription 
pharmaceutical, but rather that it was never dispensed to a patient at 
all. Fourth, we removed the word ``unused'' from the definition since 
the use of this term could introduce some confusion given that 
``partials'' can get manufacturer credit. Fifth, we specified that the 
pharmaceuticals be in the ``original manufacturer's packaging'' since 
repackaged prescription pharmaceuticals are not typically eligible for 
credit.\162\
---------------------------------------------------------------------------

    \162\ See email correspondence from Nicole Wilkinson of CVS 
dated February 21, 2018 and Erica Burwell of Inmar dated February 
22, 2018, both in the docket for this rulemaking EPA-HQ-RCRA-2007-
0932.
---------------------------------------------------------------------------

    For the final rule, a potentially creditable hazardous waste 
pharmaceutical means a prescription hazardous waste pharmaceutical that 
has a reasonable expectation to receive manufacturer credit and is (1) 
in original manufacturer's packaging (except pharmaceuticals that were 
subject to recall); (2) undispensed; and (3) unexpired or less than one 
year past expiration date. The term does not include evaluated 
hazardous waste pharmaceuticals or nonprescription pharmaceuticals 
including, but not limited to, OTC drugs, homeopathic drugs, and 
dietary supplements.
4. Comments and Responses
    a. Definitional Wording. EPA received many comments from states and 
industry on revising the definition to clarify which hazardous waste 
pharmaceuticals could and could not be returned to reverse 
distributors. States especially stressed that ``potentially 
creditable'' should be changed to ``reasonable expectation of credit'' 
or that EPA should define potentially creditable hazardous waste 
pharmaceuticals as those that are

[[Page 5847]]

accepted by reverse distributors for evaluation, as compared to those 
that are not. Manufacturers and states asked us to clarify whether we 
mean ``unadministered'' or ``undispensed'' or whether the term 
``unopened'' should be added to the definition. The waste management 
industry had some concern that adding expiration dates to the 
definition might prevent potentially creditable hazardous waste 
pharmaceuticals from being returned to the reverse distributor.
    In the final definition of potentially creditable hazardous waste 
pharmaceuticals, EPA has added some new phrases such as ``reasonable 
expectation of credit'' to the definition to be clear that not all 
hazardous waste pharmaceuticals should be going back to reverse 
distributors. We have also changed words like ``unadministered'' to 
``undispensed'' since the expectation of credit ends once a 
pharmaceutical has been dispensed to a patient regardless of whether 
the patient takes the pharmaceutical and deleted ``unused'' since that 
could imply it has been dispensed but not used and/or that it was never 
opened.
    We are specifically not adding the word ``unopened'' to the 
definition as some commenters had suggested, since it is EPA's 
understanding that ``partials'' can be given credit under certain 
circumstances and some pharmaceuticals may be repackaged. Although the 
definition does not include the word ``intact'' when describing 
original manufacturer's packaging, the definition of ``potentially 
creditable hazardous waste pharmaceutical'' does not include anything 
that is leaking or damaged.
    Some commenters also argued that EPA was limiting manufacturers 
from changing policies by defining potentially creditable hazardous 
waste pharmaceuticals and giving examples of what those are. EPA 
recognizes that special circumstances may arise where a prescription 
hazardous waste pharmaceutical may be given credit but not fit squarely 
within this definition. We have added an example of this in our 
definition by noting that a recalled pharmaceutical may be given credit 
although it is not in original packaging. This definition is meant to 
give examples of what is commonly done and to aid healthcare facilities 
in being able to more easily identify a potentially creditable from a 
non-creditable hazardous waste pharmaceutical. It is not intended to 
prevent a manufacturer from changing its credit policies.
    b. Evaluation of Hazardous Waste Pharmaceuticals and Credit. In 
their comments regarding potentially creditable hazardous waste 
pharmaceuticals received by reverse distributors, manufacturers and 
reverse distributors expressed concern about the burden being added to 
healthcare facilities by not allowing them to send all the hazardous 
waste pharmaceuticals together and putting the onus on them to 
determine if something is ``potentially creditable''. Healthcare 
facilities were concerned that credit policies are frequently updated 
by manufacturers and that a healthcare facility would not know if 
credit would be issued for any given pharmaceutical or not.
    Commenters also addressed the question of a bright line as to what 
is and what is not potentially creditable hazardous waste 
pharmaceuticals. Commenters asked whether generics were considered 
``potentially creditable.'' The waste management industry commenters 
asked how many times credit must be rejected before a type of 
pharmaceutical is no longer considered potentially creditable.
    It is the Agency's intent in our definition of ``potentially 
creditable hazardous waste pharmaceutical'' to allow the return of 
hazardous waste pharmaceuticals to reverse distributors for the 
determination of manufacturer credit. It is not the Agency's intent, 
however, for reverse distributors to serve in the capacity as TSDFs 
when it is well known that the manufacturer will not give credit for 
certain hazardous waste pharmaceuticals.
    EPA recognizes that in some cases a healthcare facility may not 
know if the hazardous waste pharmaceuticals will be given credit. We do 
not want to deter healthcare facilities from sending their hazardous 
waste pharmaceuticals to a reverse distributor if there is a reasonable 
expectation of credit. Whether or not credit is actually given is not a 
defining factor and it is not within EPA's expertise to know how many 
times a potentially creditable hazardous waste pharmaceutical needs to 
be rejected before it is considered ``non-creditable.'' Each 
pharmaceutical is different and is or is not creditable for various 
reasons as dictated by the manufacturer. EPA has learned since the 
proposal that generic prescription drugs can have a reasonable 
expectation of receiving manufacturer credit. EPA also agrees with 
commenters that ``partials'' can be given credit.
    EPA's intent is to prevent hazardous waste pharmaceuticals that are 
clearly ineligible for credit and are ready for disposal, due to their 
condition, previous use with a patient, or other reason, from being 
sent to the reverse distributor. Hazardous waste pharmaceuticals that 
are in original packaging and have not been dispensed to a patient 
would fit under this definition of ``potentially creditable hazardous 
waste pharmaceutical.''

E. Definition of Non-Creditable Hazardous Waste Pharmaceutical

1. Summary of Proposal
    In order to distinguish hazardous waste pharmaceuticals that have 
the potential for credit from those that have no expectation of 
receiving credit, the Agency proposed to define the term ``non-
creditable hazardous waste pharmaceutical.'' The proposed definition of 
a ``non-creditable hazardous waste pharmaceutical'' is a hazardous 
waste pharmaceutical that is not expected to be eligible for 
manufacturer credit. Examples include, but are not limited to 
pharmaceuticals that have been removed from the original container and 
repackaged for dispensing purposes; a pharmaceutical refused by a 
patient after an attempt to administer it; hazardous waste 
pharmaceuticals generated during patient care; dispensed 
pharmaceuticals returned to a pharmacy after the pharmacy had already 
received compensation by a third-party payer (e.g., health insurance 
company); or pharmaceuticals that are more than one year past their 
expiration dates. Non-creditable hazardous waste pharmaceuticals are 
typically opened and not in their original packaging and have been 
dispensed (though not administered) to a patient. These conditions of 
the non-creditable pharmaceutical are what makes them not creditable 
rather than the manufacturer's policy on the specific type of 
pharmaceutical.
2. Summary of Comments
    Commenters expressed a variety of opinions on EPA's proposed 
definition of ``non-creditable hazardous waste pharmaceutical.'' Some 
states, manufacturers and the waste management industry stated that 
they were satisfied with the proposed definition of ``non-creditable 
hazardous waste pharmaceutical.'' Wholesalers argued that the 
definition should be struck and the regulations should allow all intact 
hazardous waste pharmaceuticals to go back to a reverse distributor. 
Pharmacists, some states, and the retail industry argued that EPA 
should define ``non-creditable hazardous waste pharmaceuticals'' as 
those hazardous waste pharmaceuticals that are not accepted by reverse 
distributors for manufacturer credit.

[[Page 5848]]

3. Final Rule Provision
    For the final rule, EPA made three major changes to the definition 
of ``non-creditable hazardous waste pharmaceutical'' to address 
comments. First, EPA has added the word ``prescription'' to the first 
portion of the definition to be consistent with the use of terminology 
in the final rule that reverse distribution is the reverse flow of 
prescription hazardous waste pharmaceuticals. Second, the Agency has 
added new language to the definition to reflect the fact that 
nonprescription hazardous waste pharmaceuticals can also be considered 
non-creditable hazardous waste pharmaceuticals that must be managed 
under the healthcare facility standards in Sec.  266.502 when they do 
not have a reasonable expectation to be legitimately used/reused or 
reclaimed. For purposes of this definition, the determination is being 
made that at the healthcare facility, prescriptions that have already 
been dispensed to a patient, and free samples given to healthcare 
facilities do not have a reasonable expectation of receiving 
manufacturers credit. Third, EPA has also added examples of non-
creditable hazardous waste pharmaceuticals.
    Under the final rule, non-creditable hazardous waste pharmaceutical 
means a prescription hazardous waste pharmaceutical that does not have 
a reasonable expectation to be eligible for manufacturer credit or a 
nonprescription hazardous waste pharmaceutical that does not have a 
reasonable expectation to be legitimately used/reused or reclaimed. 
This includes but is not limited to, investigational drugs, free 
samples of pharmaceuticals received by healthcare facilities, residues 
of pharmaceuticals remaining in empty containers, contaminated personal 
protective equipment, floor sweepings, and clean-up material from the 
spills of pharmaceuticals.
    While not specifically laid out in the definition, other examples 
of non-creditable hazardous waste pharmaceuticals can be 
pharmaceuticals that have been removed from the original container and 
repackaged for dispensing purposes; pharmaceuticals in their original 
packaging when the packaging is leaking or otherwise damaged; a 
pharmaceutical refused by a patient after an attempt was made to 
administer it; pharmaceuticals generated during patient care; dispensed 
pharmaceuticals returned to a pharmacy after the pharmacy already 
received compensation by a third-party payer (e.g., health insurance 
company); or pharmaceuticals at are more than one year past their 
expiration date.
4. Comments and Responses
    Wholesalers and some reverse distributors recommended that we do 
not differentiate between potentially creditable and non-creditable 
hazardous waste pharmaceuticals and allow all hazardous waste 
pharmaceuticals that are intact and in original packaging to go to the 
reverse distributors. EPA disagrees with the commenters. EPA proposed 
this differentiation between potentially creditable and non-creditable 
hazardous waste pharmaceuticals to distinguish between a traditional 
TSDF and the function served by a reverse distributor. A reverse 
distributor should not act as a hazardous waste disposal facility for 
healthcare facilities. It is serving as the manufacturer's agent for 
determination of credit. If a reverse distributor is not determining 
credit, EPA views it as managing hazardous waste pharmaceuticals that 
do not have monetary value and thus would be subject to TSDF 
regulations. If a reverse distributor begins to routinely receive non-
creditable hazardous waste pharmaceuticals, then it is serving as a 
TSDF. EPA has made this differentiation to correctly represent the 
reverse distributor role as a manufacturer's agent for facilitating 
credit and not like a more traditional hazardous waste management 
facility.
    Pharmacists, the retail industry and some states recommended that 
we define non-creditable hazardous waste pharmaceuticals as those 
hazardous waste pharmaceuticals that do not receive credit. There are 
some situations in which pharmaceuticals are well known to not be 
eligible for credit, such as leaky containers, samples or when 
pharmaceuticals were already dispensed to patients. The Agency did not 
finalize the commenters' recommendation, however, because it could 
potentially lead to situations where a healthcare facility sends a 
hazardous waste pharmaceutical to a reverse distributor in good faith 
that manufacturer credit is forthcoming, but credit is not issued. If 
EPA accepted this recommendation, the reverse distributor could be 
determined to unlawfully be in possession of non-creditable hazardous 
waste pharmaceuticals. For this reason, the Agency added into the 
definition that non-creditable hazardous waste pharmaceuticals are 
prescription pharmaceuticals that do not have a reasonable expectation 
of receiving manufacture credit, or a nonprescription hazardous waste 
pharmaceutical that does not have a reasonable expectation to be 
legitimately used/reused or reclaimed. It should be clear to healthcare 
personnel that leaking containers, for example, are not eligible for 
credit and should be sent to a designated facility for disposal (e.g., 
a TSDF). However, it is often not clear to the healthcare facility 
personnel making the determination which hazardous waste 
pharmaceuticals will receive manufacturer credit if they were not 
dispensed and/or are in their original packaging (i.e., potentially 
creditable). The Agency does find it reasonable that healthcare 
personnel may not know if a manufacturer credit policy for a particular 
pharmaceutical has changed.
    Because it is not always clear that all hazardous waste 
pharmaceuticals will be eligible for credit due to frequent changes in 
manufacturers' policies, it is inappropriate to create a bright line in 
the definition solely based on whether the hazardous waste 
pharmaceutical would or would not receive manufacturer credit. Instead, 
this final definition takes into account this uncertainty and the 
difficulty it poses for healthcare facilities and allows for instances 
where a potentially creditable hazardous waste pharmaceutical can be 
correctly sent to a reverse distributor under the subpart P regulations 
despite not actually receiving manufacturer credit.

F. Definition of Evaluated Hazardous Waste Pharmaceutical

1. Summary of Proposal
    EPA proposed a definition for evaluated hazardous waste 
pharmaceuticals. After potentially creditable hazardous waste 
pharmaceuticals arrive at a reverse distributor, they are evaluated by 
the reverse distributor to determine whether they are eligible for 
manufacturer credit or whether they need to be transferred to another 
reverse distributor for additional verification of manufacturer credit. 
Hazardous waste pharmaceuticals that need to be transferred to another 
reverse distributor for additional verification of manufacturer credit 
will continue to be considered potentially creditable hazardous waste 
pharmaceuticals. EPA proposed that hazardous waste pharmaceuticals for 
which manufacturer credit has been issued (and no further verification 
of credit is required), as well as those that do not receive credit, be 
referred to as ``evaluated hazardous waste pharmaceuticals.''
    EPA proposed to define an ``evaluated hazardous waste 
pharmaceutical'' as a hazardous waste pharmaceutical that

[[Page 5849]]

was a potentially creditable hazardous waste pharmaceutical but has 
been evaluated by a reverse distributor to establish whether it is 
eligible for manufacturer credit and will not be sent to another 
reverse distributor for further evaluation or verification.
    It is important to define this term since the proposed management 
and shipping standards for potentially creditable hazardous waste 
pharmaceuticals differ from the proposed management and shipping 
standards for evaluated hazardous waste pharmaceuticals and the 
regulations must therefore distinguish between them. For a discussion 
of the proposed shipping and management standards for potentially 
creditable hazardous waste pharmaceuticals, see section XVI.D. and for 
a discussion of the proposed shipping and management standards for 
evaluated hazardous waste pharmaceuticals, see section XVI.B.
2. Summary of Comments
    There were few comments pertaining to this definition. One state 
sought clarification on whether under this definition, an evaluated 
pharmaceutical could be sent on to another reverse distributor. 
Pharmacists wanted further clarification that evaluated hazardous waste 
pharmaceuticals are not eligible for credit.
3. Final Rule Provision
    For the final rule, EPA made two changes to the definition of 
``evaluated hazardous waste pharmaceuticals'': (1) Adding the word 
``prescription'' to be consistent with our decision to distinguish 
between reverse distribution and reverse logistics and (2) focusing the 
definition on the evaluation process and does not rely as heavily on 
manufacturer credit.
    EPA is finalizing that ``evaluated hazardous waste pharmaceutical'' 
means a prescription hazardous waste pharmaceutical that has been 
evaluated by a reverse distributor 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.
    Under the definition of evaluated hazardous waste pharmaceutical, 
if credit has been determined and no other verification is needed, then 
the waste would be considered evaluated. If the prescription hazardous 
waste pharmaceutical needs further evaluation for credit, it can be 
sent on to another reverse distributor for that determination. It will 
not be considered evaluated until the credit is verified.
    The Agency notes that an evaluated pharmaceutical still at the 
reverse distributor is not precluded from ever being awarded 
manufacturer credit. A manufacturer may change a credit policy while an 
evaluated pharmaceutical is being accumulated at a reverse distributor. 
However, as an evaluated pharmaceutical, it is no longer managed as a 
potentially creditable pharmaceutical at the reverse distributor, then 
it must be managed as an evaluated hazardous waste pharmaceutical even 
if credit is awarded after the initial evaluation. Please refer to 
section XVII.C of this preamble for a detailed discussion of the 
reverse distributor standards.

G. Definition of Household Waste Pharmaceutical

1. Summary of Proposal
    EPA proposed to define the term ``household waste pharmaceutical'' 
as a solid waste, as defined in Sec.  261.2, that also meets the 
definition of pharmaceutical, but is not a hazardous waste because it 
is exempt from RCRA Subtitle C regulation by the household waste 
exclusion in Sec.  261.4(b)(1).
    We proposed this term to distinguish this type of waste 
pharmaceutical from the hazardous waste pharmaceuticals that are 
proposed to be regulated under this new subpart.
2. Summary of Comments
    Commenters generally agreed with EPA's definition of ``household 
waste pharmaceutical'' as proposed but were concerned with 
applicability of this definition and where the household waste 
exclusion can be used. For example, one commenter asked if it extended 
to schools. A few commenters wanted to know if this applied to all DEA 
take back programs and requested that the words ``including those 
generated by DEA regulations'' be added. Lastly, commenters asked us to 
clarify the significance of the household waste pharmaceutical 
definition with respect to long-term care facilities (LTCFs).
3. Final Rule Provisions
    EPA is finalizing the definition of ``household waste 
pharmaceutical'' as proposed with one minor change. EPA changed the 
word ``exempt'' to ``excluded'' to be consistent with the title of 
Sec.  261.4(b). In the final rule, ``household waste pharmaceutical'' 
means a pharmaceutical that is a solid waste, as defined in Sec.  
261.2, but is excluded from being a hazardous waste under Sec.  
261.4(b)(1).
4. Comments and Responses
    In response to some of the commenters' concerns, EPA is defining 
the term ``household waste pharmaceutical'' as a matter of convenience 
in crafting the regulatory language as well as the preamble. By 
defining the term, we do not alter the criteria we have consistently 
relied on for determining whether a waste is considered a household 
hazardous waste. The two criteria that must be met to be a household 
hazardous waste are (1) the waste must be generated by individuals on 
the premise of a temporary or permanent residence and (2) the waste 
stream must be composed primarily of materials found in wastes 
generated by consumers in their homes. Section 261.4(b)(1) defines 
household to include single and multiple residences, hotels and motels, 
bunkhouses, ranger stations, crew quarters, campgrounds, picnic grounds 
and day-use recreation areas. This exclusion does not include schools. 
Schools generate hazardous waste from various sources throughout the 
school grounds such as chemicals from labs, cleaning supplies and 
hazardous waste pharmaceuticals from medical clinics. These wastes are 
not being generated at a temporary or permanent residence and are not 
the types of wastes that would ordinarily be generated by a consumer at 
their home. Pharmaceuticals generated at schools would not be 
considered household waste pharmaceuticals. However, hazardous waste 
pharmaceuticals generated at dormitories at schools would be considered 
household waste pharmaceuticals and thus excluded, because the 
dormitories are residences.
    Some types of healthcare facilities could be considered households. 
This final rule defines the term LTCF in Sec.  266.500. LTCF means a 
licensed entity that provides assistance with activities of daily 
living, including managing and administering pharmaceuticals to one or 
more individuals at the facility. This definition includes, but is not 
limited to, hospice facilities, nursing facilities, skilled nursing 
facilities, and the nursing and skilled nursing care portions of 
continuing care retirement communities. Not included within the scope 
of this definition are group homes, independent living communities, 
assisted living facilities, and the independent and assisted living 
portions of continuing care retirement communities. The types of 
healthcare facilities listed at the end of this definition that are not 
considered to be LTCFs are not subject to subpart P requirements and 
hazardous waste pharmaceuticals generated there continue to be excluded 
from RCRA as household hazardous wastes. For a more thorough discussion 
of the applicability

[[Page 5850]]

of the household hazardous waste exclusion at LTCFs, see section VIII.K 
of this preamble.
    While DEA controlled substances can sometimes be household waste 
pharmaceuticals, once these wastes are collected at a take back event 
or by law enforcement, DEA regulations require that any proper disposal 
must meet the DEA non-retrievable standards of destruction. 
Furthermore, this EPA rule finalizes specific requirements for the 
destruction of collected household waste pharmaceuticals, see section 
XIV of this preamble for details. Therefore, it could have been 
confusing to add ``including waste under DEA regulations'' to the 
definition of household waste pharmaceutical.

H. Definition of Non-Hazardous Waste Pharmaceutical

1. Summary of Proposal
    EPA proposed to define the term ``non-hazardous waste 
pharmaceutical.'' While hazardous waste pharmaceuticals are regulated 
under this new subpart, non-hazardous waste pharmaceuticals are not 
regulated under RCRA Subtitle C, including this new subpart. The Agency 
proposed this definition since we believed it was important to clearly 
delineate what is and is not regulated under this new subpart.
    The Agency proposed to define the term ``non-hazardous waste 
pharmaceutical'' as a pharmaceutical that is a solid waste, as defined 
in Sec.  261.2, but is not listed in 40 CFR part 261 subpart D, and 
does not exhibit a characteristic identified in 40 CFR part 261 subpart 
C. The characteristics of hazardous waste are ignitability, 
corrosivity, reactivity, and toxicity.
2. Summary of Comments
    Most commenters agreed with the definition of ``non-hazardous waste 
pharmaceutical'' as proposed. There were some comments concerning 
commingling of hazardous and non-hazardous waste. These comments are 
addressed in detail in section X.C. and XI.A. of this preamble.
3. Final Rule Provision
    The Agency is finalizing the definition of ``non-hazardous waste 
pharmaceutical'' as proposed, with no changes. In this rule, a ``non-
hazardous waste pharmaceutical'' is a pharmaceutical that is a solid 
waste, as defined in Sec.  261.2, but is not listed in 40 CFR part 261 
subpart D, and does not exhibit a characteristic identified in 40 CFR 
part 261 subpart C.

I. Definition of Non-Pharmaceutical Hazardous Waste

1. Summary of Proposal
    Like the previous definition, we proposed to define non-
pharmaceutical hazardous waste to help delineate what is and what is 
not regulated under this new subpart. We proposed to define the term 
``non-pharmaceutical hazardous waste'' as a solid waste, as defined in 
Sec.  261.2, that is listed in 40 CFR part 261 subpart D, or exhibits 
one or more characteristics identified in 40 CFR part 261 subpart C, 
but is not a pharmaceutical as defined in this section.
    The proposed definition was needed because the management of non-
pharmaceutical hazardous wastes is not regulated under subpart P; 
rather, generators of non-pharmaceutical hazardous wastes, including 
healthcare facilities and reverse distributors, remain subject to part 
262 and other applicable Subtitle C hazardous waste regulations for the 
management of those hazardous wastes.
2. Summary of Comments
    There were only a few comments on the proposed definition of ``non-
pharmaceutical hazardous waste.'' Commenters generally agreed with the 
definition, but two commenters wanted EPA to clarify how to classify a 
waste with an ingredient that is used in both pharmaceutical and non-
pharmaceutical items.
3. Final Rule Provisions
    EPA is finalizing the definition of non-pharmaceutical hazardous 
waste, as proposed, with no changes. In this final rule, ``non-
pharmaceutical hazardous waste'' is a solid waste, as defined in Sec.  
261.2, that is listed in 40 CFR part 261 subpart D, or exhibits one or 
more characteristics identified in 40 CFR part 261 subpart C, but is 
not a pharmaceutical as defined in Sec.  266.500.
4. Comments and Responses
    Multiple commenters asked EPA to clarify how a hazardous waste 
should be managed when it is used as an ingredient in both 
pharmaceuticals and non-pharmaceutical, e.g., isopropyl alcohol, which 
can be used both as an antiseptic and a degreaser. Please see the 
definition in section VIII.A. for discussion about what meets the 
definition of pharmaceutical, including how to apply the definition in 
this type of scenario. Any hazardous waste not meeting the definition 
of pharmaceutical is considered a non-pharmaceutical hazardous waste 
and should be managed under all applicable RCRA standards.

J. Definition of Healthcare Facility

1. Summary of Proposal
    EPA proposed to define ``healthcare facility'' as any person that 
provides preventative, diagnostic, therapeutic, rehabilitative, 
maintenance or palliative care, and counseling, service, assessment or 
procedure with respect to the physical or mental condition, or 
functional status, of a human or animal or that affects the structure 
or function of the human or animal body; or sells or dispenses OTC or 
prescription pharmaceuticals. The proposed definition was adapted from 
the definition of ``health care'' that the Department of Health and 
Human Services promulgated as a result of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) (45 CFR part 
160.103).\163\ The proposed definition of ``healthcare facility'' 
included, but was not limited to, hospitals, psychiatric hospitals, 
ambulatory surgical centers, health clinics, physicians' offices, 
optical and dental providers, chiropractors, LTCFs, ambulance services, 
coroners and medical examiners, pharmacies, long-term care pharmacies, 
mail-order pharmacies, retailers of OTC medications; and veterinary 
clinics and hospitals.
---------------------------------------------------------------------------

    \163\ 45 CFR part 160 http://aspe.hhs.gov/admnsimp/final/pvctxt01.htm.
---------------------------------------------------------------------------

    EPA proposed to include coroners and medical examiners in the 
definition of ``healthcare facility'' despite the fact that the 
services coroners provide occur after life. Coroners will often 
inventory, and then dispose of, any pharmaceuticals that may be found 
at the scene of a death, and commonly sewer dispose of pharmaceuticals 
by putting them down the drain.\164\ In order to reduce sewer disposal 
of pharmaceuticals and provide these facilities with the same 
management options that are available to other healthcare facilities, 
EPA included coroners in the proposed definition of healthcare 
facility.
---------------------------------------------------------------------------

    \164\ For more information on the disposal process, please see: 
Ruhoy, I.S. and Daughton, C.G. ``Types and Quantities of Leftover 
Drugs Entering the Environment via Disposal to Sewage--Revealed by 
Coroner Records,'' Sci. Total Environ., 2007, 388(1-3):137-148. 
https://cfpub.epa.gov/si/si_public_record_report.cfm?dirEntryID=168384.
---------------------------------------------------------------------------

    The proposed definition of healthcare facility did not include 
pharmaceutical manufacturers and their representatives, wholesalers, or 
any other entity that is involved in the manufacturing, processing, or 
wholesale distribution of pharmaceuticals. EPA proposed to

[[Page 5851]]

exclude manufacturing facilities from the definition of healthcare 
facility because the Agency did not anticipate that manufacturing 
facilities, which predictably generate a known range of hazardous 
wastes, face the same issues as healthcare facilities.
2. Summary of Comments
    EPA requested comment on including coroners in the definition of 
``healthcare facility.'' EPA received three comments supporting the 
inclusion of coroners in the definition of ``healthcare facility.'' One 
stakeholder was aware of coroner facilities that sewer dispose of 
pharmaceuticals and argued to include them in the definition in order 
to reduce the sewer disposal of pharmaceuticals. Two commenters 
expressed concern about including coroners in the definition of 
``healthcare facility.'' One commenter stated that including coroners 
in the definition could discourage coroners from promoting take-back 
programs.
    EPA also took comment on including compounding pharmacies in the 
definition of ``healthcare facility.'' Three commenters supported the 
inclusion of compounding pharmacies in the definition. One commenter 
stated that compounding pharmacies should be included because they do 
not predictably generate a known range of hazardous wastes and face 
problems similar to that of a healthcare facility.
    The most frequent comment the Agency received on the definition of 
``healthcare facility'' was that EPA should define wholesale 
distributors and third-party logistics providers as healthcare 
facilities or to create a separate definition for wholesale 
distributors and third-party logistics providers, but allow them to 
operate under the same standards as healthcare facilities.
3. Final Rule Provisions
    EPA is finalizing a definition for ``healthcare facility'' so that 
it is clear to whom these final regulations apply. EPA is finalizing 
that ``healthcare facility'' means any person that is lawfully 
authorized to (1) provide preventative, diagnostic, therapeutic, 
rehabilitative, maintenance or palliative care, and counseling, 
service, assessment or procedure with respect to the physical or mental 
condition, or functional status, of a human or animal or that affects 
the structure or function of the human or animal body; or (2) 
distribute, sell, or dispense pharmaceuticals, including OTC 
pharmaceuticals, dietary supplements, homeopathic drugs, or 
prescription pharmaceuticals. This definition includes, but is not 
limited to, wholesale distributors, third-party logistics providers 
that serve as forward distributors, military medical logistics 
facilities, hospitals, psychiatric hospitals, ambulatory surgical 
centers, health clinics, physicians' offices, optical and dental 
providers, chiropractors, LTCFs, ambulance services, pharmacies, long-
term care pharmacies, mail-order pharmacies, retailers of 
pharmaceuticals, and veterinary clinics and hospitals. This definition 
does not include pharmaceutical manufacturers, reverse distributors, or 
reverse logistics centers.
    Although EPA uses the term ``person,'' in the definition of 
healthcare facility, the definition of healthcare facility does not 
necessarily apply to individual healthcare providers at a site. As 
defined in Sec.  260.10, ``person'' means ``an individual, trust, firm, 
joint stock company, Federal Agency, corporation (including a 
government corporation), partnership, association, State, municipality, 
commission, political subdivision of a State, or any interstate body.'' 
Accordingly, a healthcare facility can have multiple healthcare 
providers or a sole healthcare provider. For example, an individual 
healthcare provider who works at a hospital with multiple healthcare 
providers is not considered a healthcare facility, but the hospital is 
considered a healthcare facility, under the final definition. 
Additionally, a doctor's office with a sole healthcare provider would 
also be considered a healthcare facility under this final rule.
    The proposed definition of ``healthcare facility'' did not apply to 
pharmaceutical manufacturers' representatives, wholesale distributors, 
third-party logistics providers, or any other entity that is involved 
in the wholesale distribution of prescription or OTC pharmaceuticals. 
Commenters argued that excluding wholesale distributors and third-party 
logistics providers from the definition of ``healthcare facility,'' in 
combination with the revised interpretation that the point of 
generation for potentially creditable hazardous waste pharmaceuticals 
is at the healthcare facility, could hinder wholesale distributors' and 
third-party logistics providers' ability to send potentially creditable 
pharmaceuticals through reverse distribution. These commenters were 
concerned that if they were not included in the definition of 
``healthcare facility'' they would be precluded from using reverse 
distributors. Commenters also pointed out that wholesale distributors 
and third-party logistics facilities are likely to generate hazardous 
waste pharmaceuticals unpredictably and that their workers typically do 
not have the expertise to make hazardous waste determinations. Due to 
these comments, the Agency anticipates that wholesale distributors and 
third-party logistics facilities face similar issues as healthcare 
facilities and therefore is including them in the final definition of 
``healthcare facility.''
    The final definition of ``healthcare facility'' includes wholesale 
distributors, third-party logistics providers that engage in forward 
distribution, and military medical logistics facilities. Including 
wholesale distributors and third-party logistics facilities in the 
definition of ``healthcare facility'' ensures that these facilities can 
continue sending potentially creditable hazardous waste pharmaceuticals 
through reverse distribution. EPA recognizes that wholesale 
distributors and third-part logistics providers are not accustomed to 
referring to themselves as healthcare facilities. However, it is 
helpful to have a single, umbrella term when discussing who is subject 
to this subpart.
    The final definition of ``healthcare facility'' does not apply to 
pharmaceutical manufacturers or any other entity that is involved in 
the manufacturing of OTC or prescription pharmaceuticals. The purpose 
for these sector-based regulations is to address the various issues 
that healthcare facilities and reverse distributors face when managing 
hazardous waste pharmaceuticals. The Agency does not anticipate that 
manufacturing facilities, which predictably generate a known range of 
hazardous wastes, face the same issues as healthcare facilities, and 
therefore are excluded from the definition of ``healthcare facility'' 
under this rule.
    The final definition of ``healthcare facility'' includes locations 
that sell pharmaceuticals over the internet, through the mail, or 
through other distribution mechanisms. A pharmacy does not necessarily 
have to have a ``brick and mortar'' or ``store front'' presence to be 
considered a healthcare facility for the purposes of this final rule. 
The final definition of a ``healthcare facility'' also applies to 
entities that engage in drug compounding. In general, compounding is a 
practice in which a licensed pharmacist, a licensed physician, or, in 
the case of an outsourcing facility, a person under the supervision of 
a licensed pharmacist, combines, mixes, or alters ingredients of a drug 
to create a medication tailored to the needs of an individual patient. 
EPA solicited comment on including compounding

[[Page 5852]]

pharmacies in the definition of healthcare facility and received three 
comments supporting and no comments opposing the inclusion of 
compounders in the definition. The final definition of ``healthcare 
facility'' applies to state-licensed pharmacies, federal facilities, 
and licensed physicians that compound drugs in accordance with section 
503A of the FD&C Act, and to outsourcing facilities that compound drugs 
in accordance with section 503B of the FD&C Act.
4. Comments and Responses
    The final definition does not include independently located 
coroners and medical examiners. EPA made this change in response to 
commenter concern that including coroners and medical examiners in the 
definition could discourage coroners and medical examiners from 
promoting take-back programs for household pharmaceuticals. However, 
coroners and medical examiners that are co-located with healthcare 
facilities, such as hospitals, will fall under the definition of 
``healthcare facility,'' because they are physically part the 
healthcare facility.

K. Definition of Long-Term Care Facility

1. Summary of Proposal
    The proposed definition of healthcare facility specifically 
included LTCFs as an example of a type of healthcare facility. Since 
the term ``long-term care facility'' does not have a standardized, 
industry definition, EPA proposed to define the term for purposes of 
this rule. We proposed to define a LTCF as a licensed entity that 
provides assistance with activities of daily living, including managing 
and administering pharmaceuticals to one or more individuals at the 
facility. This definition includes, but is not limited to, assisted 
living, hospices, nursing homes, skilled nursing facilities, and the 
assisted living and skilled nursing care portions of continuing care 
retirement communities. Not included within the scope of this 
definition are group homes, independent living communities, and the 
independent living portions of continuing care retirement communities.
    The facilities we proposed to include as LTCFs are licensed care 
facilities that are more similar to hospitals than to standard 
residences. Although group homes may be licensed care facilities, they 
are typically very small (fewer than 10 beds) and therefore were not 
included within the proposed definition. Similarly, independent living 
communities are not licensed care facilities, but rather are residences 
made up of individual units such as townhomes or apartments and 
therefore were not included within the proposed definition. Finally, we 
clarified in the preamble to the proposed rulemaking that private 
residences with visiting nurses would not be considered long-term care 
facilities.
    By proposing to define a LTCF as a type of healthcare facility, EPA 
was proposing to revise its policy regarding the regulatory status of 
hazardous waste from long-term care facilities. We proposed that 
hazardous waste from LTCFs would no longer be excluded as household 
hazardous waste; rather, it would be regulated as hazardous waste, 
subject to the appropriate RCRA Subtitle C management standards, 
including the standards proposed for hazardous waste pharmaceuticals 
under part 266 subpart P. In other words, the proposed revision to our 
policy regarding long-term care facilities pertained to all of the 
facilities' hazardous waste, not just the hazardous waste 
pharmaceuticals.
    The Agency proposed revising its interpretation with regard to 
hazardous wastes generated at LTCFs based on a reevaluation of how such 
facilities operate. Specifically, in order to qualify for the household 
hazardous waste exclusion of Sec.  261.4(b)(1), waste must meet two 
criteria: (1) The hazardous waste must be generated by individuals on 
the premises of a household, and (2) the hazardous waste must be 
composed primarily of materials found in the wastes generated by 
consumers in their homes.\165\ In the preamble to the proposed 
rulemaking, EPA explained that hazardous waste generated at LTCFs, even 
those pharmaceuticals that are under the control of the patient or 
resident, does not meet either criterion for the household hazardous 
waste exemption.
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    \165\ See November 13, 1984; 49 FR 44978.
---------------------------------------------------------------------------

    In brief, the explanation provided in the preamble to the proposed 
rulemaking was two-fold. First, a LTCF is more similar to a hospital 
than it is a typical residence and EPA does not consider a hospital to 
be a household. LTCFs are licensed, residential care settings that 
offer their residents a wide range of services, many of which are 
centered on administering medications and providing healthcare by 
various professional healthcare providers, such as medical technicians, 
nurse's aides, nurses, and doctors. Other services provided involve 
assistance in performing activities of daily living, such as bathing 
and eating. Given that LTCFs are licensed settings for the care of 
their residents and routinely provide healthcare services, EPA believes 
that LTCFs more closely resemble hospitals than typical residences.
    Second, we explained, the hazardous wastes generated by LTCFs do 
not meet the second criteria for the waste to be considered household 
hazardous waste. This is primarily due to the quantity and breadth of 
pharmaceutical wastes that are often generated on the premises of LTCFs 
when compared to a typical residence. This distinction about volume and 
breadth of waste is analogous to the distinction that EPA has made in 
the past about contractor or do-it-yourself waste from households: 
Waste from ``routine residential maintenance'' is exempt as household 
hazardous waste, while waste from ``building construction, renovation, 
demolition'' is not excluded.\166\
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    \166\ Memo from Petruska to McNally, February 28, 1995; RCRA 
Online #11897 that discusses the distinction about what renovation 
waste is household hazardous waste and what is not.
---------------------------------------------------------------------------

2. Summary of Comments
    EPA received a number of comments requesting changes to the 
proposed definition of ``LTCF'' that were instrumental in the final 
definition in the rule. We also received a number of comments related 
to whether hazardous waste from LTCFs should be excluded from RCRA 
Subtitle C regulations as household hazardous waste.
3. Final Rule Provisions
    Based on comments, we have made some changes to the proposed 
definition of LTCF. The final definition retains the descriptive 
portion of the definition, but the list of types of facilities included 
as a LTCF has been revised to be more consistent with how the term is 
used by DEA and the Centers for Medicare and Medicaid Services (CMS). 
This final rule defines ``LTCF'' as a licensed entity that provides 
assistance with activities of daily living, including managing and 
administering pharmaceuticals to one or more individuals at the 
facility. This definition includes, but is not limited to, hospice 
facilities, nursing facilities, skilled nursing facilities, and the 
nursing and skilled nursing care portions of continuing care retirement 
communities. Not included within the scope of this definition are group 
homes, independent living communities, assisted living facilities, and 
the independent and assisted living portions of continuing care 
retirement communities.
    The primary change we have made to the proposed definition relates 
to assisted living facilities. Under the proposed definition, an 
assisted living facility was considered a type of LTCF.

[[Page 5853]]

Under the final definition, an assisted living facility is not 
considered a type of LTCF. This change is responsive to commenter's 
concerns and will make EPA's definition more consistent with how the 
term is used by both DEA and CMS. The DEA's definition of ``long term 
care facility'' is ``a nursing home, retirement care, mental care or 
other facility or institution which provides extended health care to 
resident patients.'' \167\ DEA does not consider assisted living 
facilities to be long-term care facilities. CMS also does not consider 
assisted living facilities to be long-term care facilities. One 
commenter pointed out that ``As primary regulatory oversight of 
[assisted living] resides at the state level, regulatory requirements 
and applicable definitions differ state by state. This is why the 
Centers for Medicare and Medicaid Services (CMS) excluded [assisted 
living] in its definition of Long Term Care Facilities.'' \168\
---------------------------------------------------------------------------

    \167\ See 21 CFR 1300.01.
    \168\ Medicare Prescription Drug Benefit Manual--Chapter 5, 
Sec.  10.2, as cited by commenter EPA-HQ-RCRA-2007-0932-0289.
---------------------------------------------------------------------------

    Furthermore, commenters argued, and EPA agrees, that assisted 
living facilities differ from LTCFs in at least two ways. First, some 
assisted living facilities do not provide medication management.\169\ 
In some cases, assisted living facilities are actually prohibited from 
managing medications.\170\ Second, many assisted living facilities do 
not have on-site nursing or other medical staff.\171\ EPA believes it 
is easier for implementation of this rule, to make a determination 
about assisted living facilities as a category, rather than on the 
basis of whether they provide medication management of have on-site 
medical staff. Therefore, for ease of implementation as well as 
consistency with DEA and CMS, EPA is not considering assisted living 
facilities to be long-term care facilities for purposes of subpart P.
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    \169\ See comment EPA-HQ-RCRA-2007-0932-0242.
    \170\ See comment EPA-HQ-RCRA-2007-0932-0289.
    \171\ Overview of Assisted Living, 2009, A collaborative 
research project of American Association of Homes and Services for 
the Aging (AAHSA), American Seniors Housing Association (ASHA), 
Assisted Living Federation of American (ALFA), National Center for 
Assisted Living (NCAL), and National Investment Center for the 
Seniors Housing and Care Industry (NIC).
---------------------------------------------------------------------------

4. Comments and Responses
    a. Long-term care facilities and the household hazardous waste 
exclusion. Aside from the comments about what types of facilities 
should and should not be considered LTCFs, we received many comments 
about whether LTCFs should be eligible to use the household hazardous 
waste exclusion of Sec.  261.4(b)(1). Three states, the Hematology/
Oncology Pharmacy Association, Stericycle, Inc., Healthcare Waste 
Institute, National Waste and Recycling Association, and Public 
Employees for Environmental Responsibility agreed that LTCFs should be 
considered healthcare facilities and therefore not eligible to use the 
household hazardous waste exemption. The American Society of Consultant 
Pharmacists and the National Community Pharmacists Association 
disagreed with EPA's proposed change of interpretation that hazardous 
waste (including pharmaceuticals) generated at LTCFs will no longer be 
considered exempt as household hazardous waste. The American Society of 
Consultant Pharmacists expressed concern that this change would be a 
substantial learning curve for LTCFs and the costs may be significant. 
Covanta Energy LLC expressed concern that the impacted facilities do 
not have robust financials and would pass the costs on to consumers. An 
assisted living community commented that the facility does not have the 
authority to compel residents to surrender their medications for 
disposal and therefore the new requirement would cause the assisted 
living community to be perpetually in noncompliance. One state opposed 
classifying group homes as healthcare facilities rather than as 
households. Waste Management National Services, Inc. suggested that 
self-administered pharmaceuticals that are under residents' control 
should be considered household waste.
    EPA is finalizing that LTCFs are included within the final 
definition of healthcare facility. Accordingly, EPA is also finalizing 
that hazardous waste (including pharmaceuticals) generated at LTCFs 
will no longer be excluded as household hazardous waste: It will be 
regulated as hazardous waste, subject to the appropriate RCRA Subtitle 
C management standards, including the final subpart P management 
standards for hazardous waste pharmaceuticals. EPA is revising its 
interpretation with regard to hazardous wastes generated at LTCFs based 
on a reevaluation of how such facilities operate. Specifically, in 
order for hazardous waste to qualify for the household hazardous waste 
exclusion of Sec.  261.4(b)(1), it must meet the two criteria. EPA 
continues to believe that hazardous waste generated at LTCFs, does not 
meet either criterion for the household waste exclusion.
    In summary, EPA is finalizing that LTCFs may no longer use the 
household hazardous waste exclusion. LTCFs need to manage their 
hazardous waste pharmaceuticals in accordance with the healthcare 
facility specific management standards in this final rule and their 
non-pharmaceutical hazardous wastes in accordance with the applicable 
RCRA hazardous waste generator regulations in Sec.  262.14 (for VSQGs), 
Sec.  262.16 (for SQGs), or Sec.  262.17 (for LQGs), as well as Sec.  
262.15 (for satellite accumulation areas (SAAs)). However, even though 
LTCFs will no longer be eligible to use the household hazardous waste 
exclusion, EPA estimates that there are between 2,875 and 4,770 LTCFs 
that generate hazardous waste and that 98-99 percent of the facilities 
are VSQGs regulated under Sec.  262.14 and therefore not subject to 
part 266 subpart P (except the sewer prohibition, the empty container 
provisions and the optional provisions of Sec.  266.504).\172\ This 
means that this change in policy will primarily affect the larger long-
term care facilities, which are far fewer in number (1-2 percent of 
LTCFs).
---------------------------------------------------------------------------

    \172\ Regulatory Impact Analysis in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    It is also important to note that, because of the change to the 
definition of LTCF, this change in policy regarding the household 
hazardous waste exclusion and LTCFs will not impact residents in 
assisted living facilities. As discussed previously, assisted living 
facilities will not be considered healthcare facilities and therefore 
will continue to be considered residences that are eligible to use the 
household hazardous waste exclusion in 40 CFR 261.4(b)(1). Under the 
household hazardous waste exclusion, assisted living facilities are not 
required to manage their residents' hazardous waste, including their 
hazardous waste pharmaceuticals, under the RCRA regulations. Commenters 
confirmed our data that two-thirds of assisted living facilities are 
small facilities with 25 residents or less, many of whom would 
presumably be VSQGs.\173\ Therefore, we believe that this revised 
interpretation will have minimal environmental impact: instead of 
assisted living facilities being exempt as VSQGs, residential waste 
from assisted living facilities will be exempt as household hazardous 
waste. That said, under RCRA, states may be more stringent than the 
federal government and we are aware that some states already have a 
more stringent interpretation and do not consider assisted living 
facilities to be exempt from RCRA as households.
---------------------------------------------------------------------------

    \173\ See commenter EPA-HQ-RCRA-2007-0932-0289.

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[[Page 5854]]

    As noted previously, EPA's household hazardous waste exclusion in 
40 CFR 261.4(b)(1) exempts hazardous waste that meets two criteria: (1) 
It is generated on the premises of a temporary or permanent residence 
for individuals and (2) the waste stream is composed primarily of 
materials found in the waste generated by consumers in their 
homes.\174\ Therefore, only hazardous wastes that are generated in the 
residential areas of an assisted living facility would be excluded as 
household hazardous waste. On the other hand, hazardous wastes that are 
generated by an assisted living facility outside of the residential 
areas would not be considered excluded as household hazardous waste. 
This interpretation regarding non-residential hazardous waste generated 
at assisted living is consistent with our interpretation regarding dry 
cleaning wastes generated at hotels. Specifically, our interpretation 
has been that while hazardous waste generated in hotel rooms is 
excluded as household waste, ``dry cleaning wastes produced by the 
hotel do not meet both criteria for household waste and will not 
qualify for the household waste exclusion.'' \175\ Similarly, when it 
comes to assisted living facilities, this final rule will rely on the 
interpretation that we initially expressed in the preamble to the 
proposed rulemaking to add pharmaceuticals to Universal Waste: ``the 
[long-term care] facility itself may generate hazardous waste as a 
result of its central management of pharmaceuticals in its pharmacy or 
pharmacy-like area. These hazardous pharmaceutical wastes would be 
subject to the RCRA hazardous waste generator regulations since the 
pharmaceuticals are under the control of the facility, and thus, the 
resulting wastes are generated by the facility. However, patients and 
residents in long-term care facilities may generate hazardous wastes. 
Those pharmaceuticals that are under the control of the patient or 
resident of this LTCF, when discarded, would be subject to RCRA's 
household hazardous waste exclusion (Sec.  261.4(b)(1)). Hazardous 
pharmaceutical wastes generated by the resident are excluded from 
regulation because they are considered to be derived from the 
household.'' \176\
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    \174\ 49 FR 44978; November 13, 1984.
    \175\ See RCRA Online #13736, March 1995.
    \176\ See 73 FR 73525, December 2, 2008. Note that while the 
Universal Waste proposal used the term ``hazardous pharmaceutical 
wastes,'' this final rule uses the term ``hazardous waste 
pharmaceuticals''.
---------------------------------------------------------------------------

    Under the final rule, group homes and independent living 
communities are also not defined as LTCFs but rather are considered 
residences that are eligible to use the household hazardous waste 
exclusion. An assisted living facility, group home and independent 
living facility are eligible for the household hazardous waste 
exclusion whether they are stand-alone facilities, or whether they are 
part of a continuing care retirement community. Conversely, a nursing 
facility or skilled nursing facility is considered a LTCF, and hence a 
healthcare facility, whether it is a stand-alone facility or part of a 
continuing care retirement community. Therefore, a continuing care 
retirement community will likely have portions of the facility that are 
excluded from RCRA regulation as households, while other portions of 
the facility will be regulated under RCRA for their hazardous waste 
generation and management, including hazardous waste pharmaceuticals.
    b. Other comments. Commenters asked us to clarify the difference in 
regulatory status between in-home hospice care and in-patient hospice 
facilities. One commenter points out that ``Most hospice care is 
provided in the private residence of a patient.'' \177\ Hazardous waste 
pharmaceuticals that are generated by in-home medical care, such as in-
home hospice care, would be eligible for the household hazardous waste 
exclusion. On the other hand, hospice facilities are not considered 
residences and are not eligible for the household hazardous waste 
exclusion. Nevertheless, as discussed in section XII.D. of this 
preamble, long-term care facilities, including hospice facilities, that 
have 20 beds or fewer will be presumed to be VSQGs. Healthcare 
facilities that are VSQGs are subject to the sewer prohibition for 
hazardous waste pharmaceuticals under this final rule, the empty 
container standards in Sec.  266.507, and the optional provisions of 
Sec.  266.504, but otherwise are regulated by the reduced regulations 
of 40 CFR 262.14 for the generation and accumulation of hazardous 
waste, including hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \177\ CareFirst, Commenter EPA-HQ-RCRA-2007-0932-0239.
---------------------------------------------------------------------------

IX. Applicability (Sec.  266.501)

    Part 266 subpart P was proposed to replace the standard RCRA 
generator regulations in part 262 for the management of hazardous waste 
pharmaceuticals by healthcare facilities and reverse distributors. We 
proposed separate regulations for healthcare facilities and reverse 
distributors. Further, we proposed separate regulations for the 
management of the two types of hazardous waste pharmaceuticals--
potentially creditable hazardous waste pharmaceuticals and non-
creditable hazardous waste pharmaceuticals. When a healthcare facility 
disposes hazardous waste pharmaceuticals directly by sending it to a 
hazardous waste treatment, storage, or disposal facility, we proposed 
that these would be considered non-creditable hazardous waste 
pharmaceuticals. On the other hand, when a healthcare facility disposes 
of hazardous waste pharmaceuticals indirectly through a reverse 
distributor that facilitates manufacturer credit, we proposed that 
these would be considered potentially creditable hazardous waste 
pharmaceuticals. We proposed that when a reverse distributor receives 
the potentially creditable pharmaceuticals, it must evaluate them to 
determine whether they need to go onto another reverse distributor, in 
which case the pharmaceuticals would still be considered potentially 
creditable, or whether they will go to a TSDF, in which case they will 
be considered evaluated hazardous waste pharmaceuticals. Although EPA 
proposed that potentially creditable pharmaceuticals destined for 
reverse distributors would be considered hazardous wastes, we also 
recognized that due to the considerable value they retain in the form 
of potential credit from manufacturers, there was a strong incentive to 
manage them appropriately and we did not need to apply the standard 
RCRA regulations to them or to the reverse distributors that manage 
them. In contrast, once the credit has been established for the 
evaluated hazardous waste pharmaceuticals, the incentive to manage them 
appropriately no longer exists and we needed to apply more rigorous 
regulations. This section of the preamble discusses the types of 
facilities and pharmaceuticals that are and are not subject to this 
rulemaking. Subsequent sections of the preamble discuss the details of 
the regulations for healthcare facilities managing non-creditable 
hazardous waste pharmaceuticals and potentially creditable hazardous 
waste pharmaceuticals as well as the regulations that pertain to 
reverse distributors managing potentially creditable hazardous waste 
pharmaceuticals and evaluated pharmaceuticals.

A. What facilities are subject to the final rule?

1. Healthcare Facilities (Sec. Sec.  262.10(n) and 266.501(d))
    a. Summary of proposal. The Agency proposed that healthcare 
facilities that

[[Page 5855]]

are not VSQGs will be required to manage all hazardous waste 
pharmaceuticals generated at their facilities in accordance with the 
new part 266 subpart P (see Sec.  262.10(n)) in lieu of the part 262 
generator regulations. In other words, we proposed that these new 
management standards apply to any healthcare facility that generates 
more than 100 kg of hazardous waste per calendar month or more than 1 
kg of acute hazardous waste per calendar month (e.g., P-listed 
hazardous waste) or more than 100 kg of any residue or contaminated 
soil, water, or other debris resulting from the cleanup of a spill, 
into or on any land or water, of any acute hazardous wastes listed in 
Sec. Sec.  261.31, or 261.33(e) per calendar month. We proposed that 
part 266 subpart P applies to all healthcare facilities that generate 
above the VSQG monthly quantity limits, including LTCFs.
    Further, we proposed that subpart P is not optional for healthcare 
facilities that generate above the VSQG monthly quantity limits. EPA 
proposed to make subpart P mandatory to promote national consistency, a 
goal championed by stakeholder comments as well as EPA. We reasoned 
that having one set of standards applicable to hazardous waste 
pharmaceuticals would be less confusing to the regulated community, 
which should lead to better compliance.
    We also proposed that any healthcare facility that generates 
hazardous waste above VSQG limits is subject to the same set of 
standards for the management of its hazardous waste pharmaceuticals. 
That is, unlike under part 262, the stringency of the proposed 
regulations for healthcare facilities operating under part 266 subpart 
P does not increase as the amount of hazardous waste generated 
increases. Put another way, we proposed that there is no generator 
category for hazardous waste pharmaceuticals under part 266 subpart P. 
The SQG and LQG categories under the part 262 RCRA requirements will 
only be relevant for the healthcare facilities' non-pharmaceutical 
hazardous waste because non-pharmaceutical hazardous waste remains 
subject to those 40 CFR part 262 generator regulations (along with 
other applicable sections of the subtitle C regulations).
    We proposed that healthcare facilities generating non-creditable 
hazardous waste pharmaceuticals would be subject to the management 
standards in Sec.  266.502, the sewer prohibition in Sec.  266.505, the 
conditional exemption for hazardous waste pharmaceuticals that are also 
controlled substances in Sec.  266.506, the empty container standards 
in Sec.  266.507, and the shipping standards in Sec.  266.508.
    We proposed that healthcare facilities generating potentially 
creditable hazardous waste pharmaceuticals would be subject to the 
management standards in Sec.  266.503, the sewer prohibition in Sec.  
266.505, the conditional exemption for hazardous waste pharmaceuticals 
that are also controlled substances in Sec.  266.506, the empty 
container standards in Sec.  266.507, and the shipping standards in 
Sec.  266.509.
    We expect that most potentially creditable hazardous waste 
pharmaceuticals will be sent to reverse distributors; however, that may 
not always be the case. For example, in some cases, manufacturer credit 
can get awarded without having to physically send the potentially 
creditable hazardous waste pharmaceuticals to a reverse distributor. In 
such cases, we proposed that if they are not destined for a reverse 
distributor, then they must be managed by the healthcare facility as 
non-creditable hazardous waste pharmaceuticals.
    b. Summary of comments. Comments on the applicability section 
addressed several main areas of concern. First, commenters weighed in 
on whether the VSQGs should be subject to part 266 subpart P in its 
entirety, as opposed to just the sewer prohibition. Second, commenters 
weighed in on whether the new subpart should be mandatory. Third, 
commenters weighed in on our proposed revision to our policy related to 
the reverse distribution of pharmaceuticals. While some commenters 
agreed with our proposed revised position that pharmaceuticals going 
through reverse distribution would be considered solid waste, many 
commenters strongly objected to our proposed revised position. We have 
made several changes to the final regulations that affect 
applicability, although several of these changes are to definitions, 
rather than to the applicability section of Sec.  266.501. The primary 
focus of this section is to discuss changes made to the applicability 
section of Sec.  266.501, although changes to definitions that affect 
applicability are also noted.
    c. Final rule provisions. The final rule applies to all healthcare 
facilities that generate above any of the VSQG monthly quantity 
thresholds. Healthcare facilities that are not VSQGs do not have the 
choice of opting into part 266 subpart P in lieu of part 262. Further, 
all healthcare facilities that are subject to part 266 subpart P are 
regulated the same with respect to their hazardous waste 
pharmaceuticals, regardless of how much hazardous waste pharmaceuticals 
they generate. Note that we have made two changes to Sec.  262.10(n). 
First, we have revised the regulations so that only a healthcare 
facility that generates above the VSQG quantity thresholds are subject 
to part 266 subpart P. A healthcare facility that accumulates above the 
VSQG quantity thresholds would not be subject to part 266 subpart P; it 
would remain subject to part 262 (although as with any VSQG, it would 
be allowed to opt into subpart P). The 2016 Hazardous Waste Generator 
Improvements final rule amended the part 262 regulations to make it 
clear that a VSQG that accumulates above the quantity thresholds must 
manage its hazardous waste in accordance with the conditions of either 
the SQG or LQG regulations, but the generator would remain a VSQG.\178\ 
Second, in response to comments, we have added the following clarifying 
sentence at the end of the paragraph: A healthcare facility that is a 
very small quantity generator when counting all of its hazardous waste, 
including both its hazardous waste pharmaceuticals and its non-
pharmaceutical hazardous waste, remains subject to Sec.  262.14 and is 
not subject to part 266 subpart P, except for Sec. Sec.  266.505 and 
266.507 and the optional provisions of Sec.  266.504.\179\
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    \178\ See Sec.  262.14(a)(3) for accumulating >1 kg of acute 
hazardous waste and Sec.  262.14(a)(4) for accumulating >1000 kg 
non-acute hazardous waste.
    \179\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    We have made four changes to the proposed regulatory language of 
Sec.  266.501(d). First, we have made a conforming change to reflect 
the change in terminology in this final rule. That is, in Sec.  
266.501(d)(1)(ii), ``pharmaceutical reverse distributor'' has now been 
replaced by ``reverse distributor.'' The second change we made is to 
omit the reference to Sec.  266.504 in both Sec.  266.501(d)(1) and 
(2). Section 266.504 only applies to healthcare facilities that are 
VSQGs and should not have been referenced when discussing the 
requirements for other healthcare facilities. The third change is to 
clarify in Sec.  266.501(d)(2), that healthcare facilities managing 
potentially creditable hazardous waste pharmaceuticals are also subject 
to the notification and withdrawal standards of Sec.  266.502(a). While 
EPA believes it is extremely unlikely that a healthcare facility would 
only manage potentially creditable hazardous waste pharmaceuticals, as 
proposed, in this situation a healthcare facility would not need to 
notify as a healthcare facility. EPA is clarifying in the final rule, 
that

[[Page 5856]]

should this situation arise, a healthcare facility only managing 
potentially creditable hazardous waste pharmaceuticals and no non-
creditable hazardous waste pharmaceuticals is subject to notification.
    The fourth, and far more substantive change we made is to Sec.  
266.501(d)(2). This paragraph has been revised to reflect our decision 
that healthcare facilities are regulated under part 266 subpart P for 
the management of prescription hazardous waste pharmaceuticals going 
through reverse distribution but healthcare facilities are not 
regulated under part 266 subpart P for the management of 
nonprescription pharmaceuticals, such as OTCs, homeopathic drugs, and 
dietary supplements, going through reverse logistics because they are 
not considered solid or hazardous wastes, provided they have the 
potential to be lawfully redistributed or legitimately reused or 
reclaimed. To summarize, part 266 subpart P applies to healthcare 
facilities managing non-creditable hazardous waste pharmaceuticals, 
whether the pharmaceuticals are prescription or nonprescription. But 
part 266 subpart P applies to healthcare facilities managing 
potentially creditable hazardous waste pharmaceuticals only if they are 
prescription hazardous waste pharmaceuticals. The comments we received 
in this area and the reasoning for our decision have been discussed at 
length in section VI of the preamble to this final rule.
    Due to changes in the definition of healthcare facility and LTCF, 
there are effectively additional substantial changes to the 
applicability of the final rule. These two definitional changes have 
already been discussed, but are summarized here. In short, due to 
changes to the definition of ``healthcare facility,'' wholesale 
distributors will now be regulated under part 266 subpart P as 
healthcare facilities for the management of their hazardous waste 
pharmaceuticals. This includes 3PLs when they perform the function of a 
wholesale distributor. Unlike wholesale distributors, 3PLs do not take 
ownership of the pharmaceuticals; however, both wholesale distributors 
and 3PLs take physical custody of pharmaceuticals. Under RCRA, a 3PL 
would meet the definition of a hazardous waste generator, regardless of 
whether they own the hazardous waste pharmaceuticals.
    The final rule still applies to long-term care facilities, because 
they are still considered healthcare facilities. However, we have 
amended the proposed definition of LTCF such that assisted living 
facilities will not be considered long-term care facilities. Further, 
we have finalized a rebuttable presumption that long-term care 
facilities with 20 beds or fewer will be presumed to be VSQGs. The 
combined impact of these changes is that this final rule will apply to 
far fewer long-term care facilities than the when the rule was 
proposed.
    In other respects, Sec.  266.501(d) of the final rule remains the 
same as the proposal. That is, healthcare facilities generating non-
creditable hazardous waste pharmaceuticals would be subject to the 
management standards in Sec.  266.502, the sewer prohibition in Sec.  
266.505, the conditional exemption for hazardous waste pharmaceuticals 
that are also controlled substances in Sec.  266.506, the empty 
container standards in Sec.  266.507, and the shipping standards in 
Sec.  266.508. And healthcare facilities generating potentially 
creditable hazardous waste pharmaceuticals would be subject to the 
management standards in Sec.  266.503, the sewer prohibition in Sec.  
266.505, the conditional exemption for hazardous waste pharmaceuticals 
that are also controlled substances in Sec.  266.506, the empty 
container standards in Sec.  266.507, and the shipping standards in 
Sec.  266.509. Finally, if potentially creditable hazardous wastes are 
not destined for a reverse distributor, then they must be managed by 
the healthcare facility as non-creditable hazardous waste 
pharmaceuticals. For example, if a healthcare facility receives 
manufacturer credit for a prescription pharmaceutical without shipping 
it to a reverse distributor, then the healthcare facility is required 
to manage the hazardous waste pharmaceuticals as non-creditable 
hazardous waste pharmaceuticals.
    d. Comments and responses. Several commenters asked us to consider 
making part 266 subpart P an optional alternative to part 262, instead 
of mandatory. They argued that EPA's previous sector- or waste-specific 
regulations, such as the Academic Laboratories Rule or Universal Waste, 
are not mandatory and that generators have the option to use them in 
lieu of the standard RCRA generator regulations under part 262. On the 
other hand, several states agreed that having ``one set of standards 
will be less confusing to the regulated community.'' \180\
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    \180\ See comment numbers: EPA-HQ-RCRA-2007-0932-0242 and EPA-
HQ-RCRA-2007-0932-0304.
---------------------------------------------------------------------------

    As discussed previously, part 266 subpart P will be mandatory for 
all healthcare facilities generating above VSQG monthly quantity 
thresholds. Previous sector or waste specific regulations have all been 
considered either less stringent (Universal Waste) or equally stringent 
(Academic Laboratories rule) as the standard RCRA generator 
regulations. In contrast, part 266 subpart P is considered, on the 
whole, more stringent than the standard RCRA regulations. EPA has never 
made a more stringent RCRA regulation optional. In part, this is 
because it seems unlikely that anyone would opt into a more stringent 
regulatory scheme. If healthcare facilities chose to remain operating 
under part 262, they would not be subject to the sewer prohibition, 
which is a cornerstone of this new subpart.
    Further, if part 266 subpart P were not mandatory, another result 
would be that healthcare facilities would not be able to use the new 
provisions for empty containers or the conditional exemptions for 
hazardous waste pharmaceuticals that are also DEA controlled 
substances. But the most important consideration is that this final 
rule revises our previous policy regarding pharmaceuticals being sent 
to reverse distributors for manufacturer credit such that they are now 
considered solid, and possibly hazardous, wastes. Under part 262, a 
generator can only send its hazardous waste to an off-site facility 
that has a RCRA permit or interim status. This would require reverse 
distributors to get RCRA storage permits to be able to accept hazardous 
waste from off-site. In light of all these considerations, with the 
exception of VSQG healthcare facilities, EPA has concluded that it is 
not feasible to make part 266 subpart P an optional alternative to part 
262.
    That said, we recognize that some commenters are concerned that 
this final rule will impact their established programs for managing 
hazardous waste pharmaceuticals. In response, we would point out that, 
in some cases, compliant practices by healthcare facilities under part 
262 would also meet the standards under part 266 subpart P. For 
example, the training provisions for SQGs (Sec.  262.16(a)(9)(iii)) and 
LQGs (Sec.  262.17(a)(7)) would meet the training provisions for 
healthcare facilities under part 266 subpart P (Sec.  266.502(b)). In 
fact, the subpart P regulatory language for training personnel at 
healthcare facilities in managing non-creditable hazardous waste 
pharmaceuticals is identical to the regulatory language in part 262 for 
SQGs. For labeling, under part 266 subpart P, containers of non-
creditable hazardous waste pharmaceuticals part 266 subpart must

[[Page 5857]]

be labeled with the words ``hazardous waste pharmaceuticals,'' but 
nothing would prohibit additional labeling by the healthcare facility. 
Likewise, under part 266 subpart P, healthcare facilities are not 
required to accumulate their non-creditable hazardous waste 
pharmaceuticals in a central accumulation area (CAA), but nothing would 
prohibit them from being accumulated in a CAA. Furthermore, healthcare 
facilities have up to one year to accumulate non-creditable hazardous 
waste pharmaceuticals on site under part 266 subpart P, but nothing 
would prohibit a healthcare facility from accumulating for the shorter 
time-frames dictated by the SQG (180 days) or LQG (90 days) regulations 
in part 262.
2. Reverse Distributors (Sec. Sec.  262.10(m), 264.1, 265.1, 
266.501(e), and 270.1)
    a. Summary of proposal. The proposed rulemaking responded to 
stakeholders who have asked EPA to clarify how reverse distributors are 
regulated under RCRA, as states have applied varied hazardous waste 
regulatory approaches to reverse distributors.\181\ EPA proposed 
specific standards in 40 CFR part 266 subpart P for reverse 
distributors (as defined in this proposed rulemaking) that incorporated 
various generator standards, as well as some TSDF standards. EPA 
proposed that reverse distributors that accumulate potentially 
creditable hazardous waste pharmaceuticals or evaluated hazardous waste 
pharmaceuticals are subject to this new subpart. We proposed that 
reverse distributors are only subject to part 266 subpart P for the 
accumulation of potentially creditable hazardous waste pharmaceuticals 
and evaluated hazardous waste pharmaceuticals; if a reverse distributor 
also treats and/or disposes of hazardous waste pharmaceuticals, we 
proposed that it would be subject to the applicable RCRA Subtitle C 
TSDF regulations, including the requirement to have a permit or interim 
status. We proposed that all reverse distributors would be regulated 
the same for the accumulation of hazardous waste pharmaceuticals under 
part 266 subpart P, including any reverse distributors that would be 
considered VSQGs under part 262 (see Sec.  262.10(m)). Under the 
applicability section in Sec.  266.501(e), we proposed that reverse 
distributors would be subject to the sewer prohibition in Sec.  
266.505, the conditional exemption for hazardous waste pharmaceuticals 
that are also controlled substances in Sec.  266.506, the empty 
container standards in Sec.  266.507, the shipping standards in Sec.  
266.508 and Sec.  266.509, and the reverse distributor standards in 
Sec.  266.510, for the management of hazardous waste pharmaceuticals. 
As with healthcare facilities, if a reverse distributor generates 
other, non-pharmaceutical hazardous waste, it remains subject to part 
262 and all other applicable portions of the Subtitle C regulations 
(see Sec.  266.501(c)).
---------------------------------------------------------------------------

    \181\ Note that the proposed rule used the term ``pharmaceutical 
reverse distributor'' but final rule uses the term ``reverse 
distributor;'' therefore, the preamble will use the term ``reverse 
distributor,'' even when discussing the proposed rule.
---------------------------------------------------------------------------

    b. Summary of comments. We received a large number of comments 
regarding the foundational question of whether the pharmaceuticals 
going through reverse distribution should be considered solid or 
hazardous wastes. In section VI of the preamble we have responded 
thoroughly to that threshold question; therefore, we do not elaborate 
here. We received a few comments on other areas related to the 
applicability of part 266 subpart P to reverse distributors, which have 
led to some conforming changes in the final rule.
    c. Final rule provisions. Other than changing the term 
``pharmaceutical reverse distributor'' to ``reverse distributor,'' we 
are finalizing the regulatory text of Sec.  262.10(m) and Sec.  
266.501(e), as proposed. As a result, all reverse distributors will be 
subject to part 266 subpart P for the management of their hazardous 
waste pharmaceuticals instead of part 262. This includes any reverse 
distributors that would have been considered VSQGs under part 262. This 
also includes third-party logistics providers (3PLs) when they perform 
the function of a reverse distributor. Reverse distributors and 3PLs 
acting as reverse distributors do not take ownership of the 
pharmaceuticals; however, both take physical custody of hazardous waste 
pharmaceuticals from off-site healthcare facilities and both facilitate 
the awarding of manufacturer credit for potentially creditable 
hazardous waste pharmaceuticals.
    Under part 266 subpart P, there are no generator categories for the 
accumulation of hazardous waste pharmaceuticals; all reverse 
distributors will be regulated the same with respect to the management 
of their hazardous waste pharmaceuticals, regardless of the quantity. 
All reverse distributors will be subject to the sewer prohibition in 
Sec.  266.505, the conditional exemption for hazardous waste 
pharmaceuticals that are also controlled substances in Sec.  266.506, 
the empty container standards in Sec.  266.507, the shipping standards 
in Sec.  266.508 and Sec.  266.509, and the reverse distributor 
standards in Sec.  266.510, for the management of hazardous waste 
pharmaceuticals.
    d. Comments and responses. It is important to note that, although 
we have not made any substantive changes to the applicability section 
of the regulations pertaining to reverse distributors, a change we have 
made to the definition of reverse distributor has effectively made a 
change to the applicability of the final rule. Under the final rule, 
the term ``reverse distributor'' has been narrowed considerably, so 
that it only includes reverse distributors of prescription 
pharmaceuticals. This change has been described and explained 
thoroughly in previous sections of the preamble and will be discussed 
here only briefly. In short, under the proposed rulemaking, the term 
``pharmaceutical reverse distributor'' included facilities that 
facilitated manufacturer credit for both prescription and 
nonprescription pharmaceuticals (e.g., OTCs and dietary supplements). 
In this final rule, we have adopted the distinction drawn by commenters 
between reverse distributors, who manage prescription pharmaceuticals, 
and reverse logistics centers, who manage nonprescription 
pharmaceuticals (and all other, non-pharmaceutical retail items). While 
reverse distributors are regulated by part 266 subpart P, reverse 
logistics centers are not regulated by part 266 subpart P.
    Additionally, we have made several conforming changes to Sec. Sec.  
264.1, 265.1 and 270.1. Specifically, we added paragraphs Sec. Sec.  
264.1(g)(13), 265.1(c)(16), and 270.1(c)(2)(x). Together, these 
paragraphs make it clear that reverse distributors complying with the 
conditions for accumulating hazardous waste pharmaceuticals under part 
266 subpart P are not required to operate under the regulations for 
permitted TSDFs in part 264 or interim status TSDFs in part 265; nor 
are they required to get a RCRA permit under part 270.
3. Very Small Quantity Generators (Sec. Sec.  266.501(a) and (b))
    a. Summary of proposal. VSQGs are subject to a limited set of 
federal RCRA Subtitle C hazardous waste regulations, provided that they 
comply with the conditions set forth in Sec.  262.14.\182\ We proposed 
that subpart P would preserve

[[Page 5858]]

this current regulatory structure for the most part, such that 
healthcare facilities that generate hazardous waste pharmaceuticals and 
qualify as VSQGs would maintain their conditional exemption under Sec.  
262.14 and would not be subject to most aspects of the proposal. 
However, as part of this rulemaking, EPA proposed a prohibition on 
sewer disposal of hazardous waste pharmaceuticals by all healthcare 
facilities, including VSQG healthcare facilities (and all reverse 
distributors). (See section XIII of this preamble for a more detailed 
discussion on the sewer prohibition.) We also proposed that healthcare 
facilities that are VSQGs would be able to use the standards in Sec.  
266.504 for the management of their hazardous waste pharmaceuticals, as 
well as the standards in Sec.  266.507 for determining when their 
containers of pharmaceutical are considered empty (See sections XII and 
XV for detailed discussion of those sections of the regulations). We 
also proposed that VSQG healthcare facilities would have the ability to 
opt into using part 266 subpart P in lieu of the conditional exemption 
in Sec.  262.14.
---------------------------------------------------------------------------

    \182\ Not all authorized states recognize the VSQG (or CESGQ) 
category and may have more stringent regulatory requirements for 
VSQGs. Therefore, as noted previously, EPA recommends that 
facilities that qualify as VSQGs under the federal regulations 
contact their state and/or local environmental regulatory agencies 
to determine whether more stringent regulatory requirements apply to 
VSQGs in their state.
---------------------------------------------------------------------------

    b. Summary of comments. Many of the comments on the applicability 
section for VSQG healthcare facilities were related to whether EPA 
should maintain the conditional exemption for VSQG healthcare 
facilities or whether we should make them fully subject to subpart P. 
Several commenters urged us to be clearer in our regulatory language 
and preamble about how a healthcare facility determines whether it is a 
VSQG or not. Although this section will address this area of confusion, 
see section IX.C of the preamble for additional information about not 
counting hazardous waste pharmaceuticals toward generator category when 
they are managed under subpart P.
    c. Final rule provisions. In the final rule, healthcare facilities 
that are VSQGs (when counting all their hazardous waste, both hazardous 
waste pharmaceuticals and non-pharmaceutical hazardous waste) remain 
mostly exempt from part 266 subpart P. Note that all healthcare 
facilities, including healthcare facilities that are VSQGs, and all 
reverse distributors are subject to the sewer prohibition of Sec.  
266.505.
    Healthcare facilities that are VSQGs are also subject to Sec.  
266.504 which includes optional provisions specifically for healthcare 
facilities that are VSQGs for both their hazardous waste 
pharmaceuticals and their non-pharmaceutical hazardous waste. We note 
that although Sec.  266.501(a) states that VSQGs are subject to Sec.  
266.504, all of the provisions in Sec.  266.504 are optional. For 
example, a healthcare facility that is a VSQG operating under Sec.  
262.14 for all of its hazardous waste is not required to send its 
potentially creditable hazardous waste pharmaceuticals to a reverse 
distributor. Rather, we are providing a regulatory mechanism that 
allows a VSQG healthcare facility to use a reverse distributor to 
obtain manufacturer credit. Nor is a VSQG healthcare facility required 
to send its hazardous waste pharmaceuticals off site to be consolidated 
at another healthcare facility that is operating under subpart P. 
Again, subpart P provides a regulatory mechanism for those VSQG 
healthcare facilities that wish to manage their hazardous waste 
pharmaceuticals in a more environmentally protective manner. A VSQG 
that elects to use any of the optional provisions of Sec.  266.504 will 
not be considered to be opting into subpart P. See section XII of the 
preamble for a further discussion of Sec.  266.504.
    Several states asked us to expand the applicability of the final 
rule so that all of the healthcare facility standards in part 266 
subpart P would be mandatory for all healthcare facilities, including 
VSQGs. For example, Colorado wrote that `` . . . healthcare 
professionals can be highly mobile across the healthcare industry. As a 
result, professionals that leave a hospital setting and move to the 
[long-term care] setting have to relearn a new process for waste 
management, adding opportunity for more confusion and mismanagement. 
Colorado strongly encourages EPA to consider regulating all healthcare 
facilities (including CESQGs) that generate hazardous waste 
pharmaceuticals under the proposed regulations to minimize confusion 
and promote consistency across the entire spectrum of the healthcare 
industry settings.'' \183\ Although we agree with Colorado, we also 
believe that it would pose a burden on the large number of small 
healthcare facilities and divert resources from regulatory agencies to 
expand the applicability of the final rule to include healthcare 
facilities that are VSQGs. We have concluded that it would be best to 
let the individual states that adopt this new subpart to decide whether 
to expand the applicability to healthcare facilities that are VSQGs.
---------------------------------------------------------------------------

    \183\ See comment number: EPA-RCRA-HQ-2007-0932-0242.
---------------------------------------------------------------------------

    Additionally, in the final rule we have retained the ability for 
healthcare facilities that are VSQGs to opt into part 266 subpart P in 
lieu of operating under Sec.  262.14. A VSQG healthcare facility may 
choose this option if it does not want to have to keep track of how 
much hazardous waste pharmaceuticals and acute hazardous waste 
pharmaceuticals it is generating on a monthly basis or if it generates 
an unpredictable or fluctuating amount of hazardous waste 
pharmaceuticals each month that might exceed one or more of the VSGQ 
monthly quantity thresholds. If a healthcare facility that is a VSQG 
(counting all of its hazardous waste, including pharmaceuticals and 
non-pharmaceuticals) chooses to opt into subpart P, it must comply with 
all the standards for healthcare facilities managing non-creditable 
hazardous waste pharmaceuticals and potentially creditable hazardous 
waste pharmaceuticals, including notification as a healthcare 
facility.\184\ The VSQG healthcare facility may not selectively pick 
which provisions of part 266 subpart P it chooses to comply with; it 
would be treated the same as any other healthcare facility that is 
subject to part 266 subpart P. More specifically, if a VSQG healthcare 
facility chooses to opt into subpart P, then it would be subject to all 
the provisions identified in Sec.  266.501(d) rather than the optional 
provisions of Sec.  266.504 for VSQGs or Sec.  262.14. The final 
regulatory language has been amended to be more specific in this 
regard. That is, rather than saying a healthcare facility has the 
option of complying with ``this subpart,'' we have changed the 
regulations to say that a healthcare facility has the option of 
complying with ``Sec.  266.501(d),'' which identifies the specific 
sections of the regulations that non-VSQG healthcare facilities must 
comply with. Further, the final regulatory language clarifies that a 
VSQG healthcare facility that opts into part 266 subpart P would no 
longer be able to use the optional provisions for VSQG healthcare 
facilities in Sec.  266.504.
---------------------------------------------------------------------------

    \184\ A VSQG healthcare facility that opts into part 266 subpart 
P for managing its hazardous waste pharmaceuticals would still have 
to keep track of its monthly generation of non-pharmaceutical 
hazardous waste to verify that it is, in fact, a VSQG. Assuming it 
is a VSQG, the healthcare facility could manage its non-
pharmaceutical hazardous waste under Sec.  262.14.
---------------------------------------------------------------------------

    We have made four additional changes to the applicability section 
of the regulations pertaining to healthcare facilities that are VSQGs. 
The first two changes are conforming changes to reflect the 2016 
Hazardous Waste Generator Improvements final rule; this includes 
changing the term ``conditionally exempt small quantity generator'' to 
``very small quantity generator'' and changing the regulatory citation 
for VSQGs from Sec.  261.5 to Sec.  262.14.

[[Page 5859]]

    The third change was made to address commenters' concerns that the 
use of the term VSQG in Sec.  266.501(a) and (b) was confusing. The 
Generator Improvements final rule has now defined the term VSQG in 
260.10, which should help reduce confusion. Nevertheless, in response 
to the comments, we also have added language to Sec.  266.501(a) and 
(b) to make it clearer that we are referring to VSQGs that are below 
the VSQG quantity thresholds for all of their hazardous waste 
combined--including both their hazardous waste pharmaceuticals and 
their non-pharmaceutical hazardous waste. Such VSQGs are VSQGs for both 
their hazardous waste pharmaceuticals and their non-pharmaceutical 
hazardous waste. In large part, VSQGs are not subject to subpart P for 
the management of their hazardous waste pharmaceuticals (except the 
sewer prohibition of Sec.  266.505, the empty container standards of 
Sec.  266.507, and the optional standards of Sec.  266.504). This type 
of VSQG stands in contrast to what might be referred to as a ``subpart 
P VSQG,'' meaning a healthcare facility that generates over one or more 
of the VSQG quantity thresholds and is therefore subject to subpart P 
for its hazardous waste pharmaceuticals but becomes a VSQG for its non-
pharmaceutical hazardous waste after complying with subpart P because 
it is no longer required to count its hazardous waste pharmaceuticals 
toward its generator category.
    The fourth change to Sec.  266.501(a) is to the reference to the 
new empty container regulations of Sec.  266.507. We proposed in Sec.  
266.501(a) that a VSQG would be subject to Sec.  266.507(a) and (b). In 
both the proposed and final rules, these two paragraphs of Sec.  
266.507 define when unit dose containers and dispensing vials, and 
syringes, respectively, are empty. The purpose of the reference was to 
allow a healthcare facility to use the new empty container provisions 
in determining how much hazardous waste pharmaceuticals it generates 
and therefore whether it is subject to subpart P. Under the final rule, 
a healthcare facility is still able to use the new empty container 
provisions in Sec.  266.507 when determining how much hazardous waste 
pharmaceuticals it generates, but we have concluded that this reference 
should include all of Sec.  266.507, rather than just paragraphs (a) 
and (b) because Sec.  266.507 (c) and (d) include provisions for 
determining whether IV bags and other types of containers of hazardous 
waste pharmaceuticals are empty. Additionally, we have also amended the 
associated language in Sec.  261.7 which defines when a container of 
hazardous waste is considered empty. We had already proposed to add a 
new paragraph (c) to Sec.  261.7 to direct healthcare facilities and 
reverse distributors to Sec.  266.507. The final rule modifies the 
proposed paragraph such that the new empty container regulations in 
Sec.  266.507 are no longer limited to healthcare facilities and 
reverse distributors operating under part 266 subpart P. Section 
266.507 defines when containers of hazardous waste pharmaceuticals are 
empty and apply regardless of whether they are being managed by a 
healthcare facility, a reverse distributor, or another entity. 
Generators, including healthcare facilities, can use the new provisions 
in Sec.  266.507 in determining when the containers of hazardous waste 
pharmaceuticals are empty and the residues are no longer regulated as 
hazardous waste. In turn, this will help generators determine how much 
hazardous waste they generate and; therefore, whether they are subject 
to part 266 subpart P and/or part 262. See section XV of this preamble 
for further information about Sec.  266.507.
    d. Comments and responses. A few commenters had suggestions for 
alternative organization or placement of the applicability section 
pertaining to healthcare facilities that are VSQGs. One commenter 
suggested that we combine all of the subpart P regulations that pertain 
to VSQG healthcare facilities in one place, under Sec.  266.504, rather 
than have some in Sec.  266.501 and others in Sec.  266.504.\185\ We 
generally agree with the commenter and have included all substantive 
standards for VSQG healthcare facilities in Sec.  266.504 (see section 
XII of the preamble for a further discussion of Sec.  266.504). 
However, we believe that, when discussing the central question of who 
the subpart applies to, it is best to keep together in Sec.  266.501 
all the regulations that address applicability. And since the 
applicability section of Sec.  266.501 appears before the VSQG 
healthcare facility standards of Sec.  266.504, we believe that it is 
more helpful to the reader to know, up front in the regulations, 
whether the subpart applies. Another commenter thought we should move 
the entire applicability section so that it appears before the 
definitions section in the regulations, in order to allow ``the reader 
to determine if [s]ubpart P applies to his facility before reviewing 
any of its requirements.'' \186\ Although we agree that the 
applicability section is critical to the reader, we believe that the 
reader must have a full understanding of terms used in the 
applicability section in order to accurately determine whether the 
subpart applies. As a result, we have declined to make this suggested 
change. We requested comment on whether the applicability section for 
VSQG healthcare facilities should appear in Sec.  262.14 (formerly 
Sec.  261.5) rather than in subpart P and a couple of commenters 
responded that we should.\187\ Although that would have been an 
acceptable option for crafting the new regulations, we have concluded 
that we prefer the option of keeping the regulatory language related to 
hazardous waste pharmaceuticals contained within the same subpart when 
possible. As a result, we have declined to make this suggested change, 
as well.
---------------------------------------------------------------------------

    \185\ See comment number: EPA-HQ-RCRA-2007-0932-0280.
    \186\ See comment number: EPA-HQ-RCRA-2007-0932-0231.
    \187\ See comment numbers: EPA-HQ-RCRA-2007-0932-0231 and 0280.
---------------------------------------------------------------------------

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))

1. Summary of Proposal
    EPA proposed that the new part 266 subpart P management standards 
would apply only to hazardous waste pharmaceuticals generated or 
managed by healthcare facilities and reverse distributors. This new 
subpart was designed as a sector-specific rulemaking to address the 
unique circumstances of the healthcare sector and the reverse 
distribution of their hazardous waste pharmaceuticals. In Sec.  
266.501(f), we proposed that other entities that generate or manage 
hazardous waste pharmaceuticals would not be subject to part 266 
subpart P, but would remain subject to the standard generator 
regulations in part 262, along with other applicable Subtitle C 
regulations. For example, in the preamble to the proposed rulemaking we 
stated that pharmaceutical manufacturers and wholesalers would remain 
subject to part 262 generator regulations because they do not face the 
same challenges that healthcare facilities experience when managing 
hazardous waste pharmaceuticals. We reasoned that manufacturers and 
wholesalers generate hazardous waste pharmaceuticals that are more 
predictable and the staff have the necessary expertise to determine 
which pharmaceuticals are considered hazardous waste. However, we noted 
in the proposal that when any facility, including a pharmaceutical

[[Page 5860]]

manufacturer, meets the definition of a reverse distributor, it would 
be subject to the new regulations for reverse distributors with respect 
to those operations.
    In Sec.  266.501(c), we also proposed that this new subpart would 
only apply to the management of hazardous waste pharmaceuticals. The 
proposed new subpart was sector-specific as well as waste stream-
specific. We proposed that other, non-pharmaceutical hazardous wastes 
generated or managed by healthcare facilities and reverse distributors 
would remain subject to all applicable hazardous waste regulations.
2. Final Rule Provisions and Comments and Responses
    This final rule remains a sector-specific rule as well as a waste 
stream-specific rule. Accordingly, Sec.  266.501(c) of the final rule 
remains as proposed. That is, a healthcare facility or reverse 
distributor remains subject to all applicable hazardous waste 
regulations with respect to the management of its non-pharmaceutical 
hazardous waste. Likewise, as discussed previously, a number of 
commenters requested that we include wholesale distributors in part 266 
subpart P as healthcare facilities and in response we have amended the 
definition of healthcare facility to include wholesale distributors. 
This, of course, affects which entities are subject to the rule, but as 
we have made this change through amending the definition of healthcare 
facility, it does not necessitate a change to Sec.  266.501 of the 
regulations, which is entitled Applicability. Therefore, the final rule 
applies to the generation and management of hazardous waste 
pharmaceuticals only by healthcare facilities and reverse distributors 
and not to others that might generate or manage hazardous waste 
pharmaceuticals, such as pharmaceutical manufacturers.
    We have added paragraph (g) to Sec.  266.501 of the final rule, 
substantially expanding the list of types of wastes that are not 
subject to part 266 subpart P or to RCRA regulation in general. In some 
cases, the additions grew out of comments and in some cases, the 
additions grew out the need for additional clarity. Each of the types 
of waste that are not subject to this subpart are discussed 
individually below.
    a. Donations. As discussed previously, we have amended the 
definition of hazardous waste pharmaceutical to make it clear that a 
pharmaceutical is not a solid waste, as defined in Sec.  261.2, and 
therefore, not a hazardous waste, if it is lawfully donated for its 
intended purpose. We have made the same change to the applicability 
section of this subpart to similarly indicate that pharmaceuticals are 
not subject to subpart P when they are lawfully donated for their 
intended purpose.\188\ In fact, because pharmaceuticals that are 
lawfully donated or are otherwise legitimately used/reused or reclaimed 
are not solid wastes, as defined by Sec.  261.2, they would not be 
subject to RCRA at all. Although this is common for nonprescription 
pharmaceuticals, it is rare for prescription pharmaceuticals. Sirum, a 
commenter that is a non-profit organization that ``helps implement 
State-based programs to recycle unused medication to indigent 
patients'' in four states, concurred that ``repurposing pharmaceuticals 
happens under narrow circumstances'' and that ``in most cases, 
pharmaceuticals transported back to a reverse distributor are discarded 
by the reverse distributor.'' \189\ State donation and repository laws 
dictate the conditions under which pharmaceuticals may be donated. 
These laws are tracked by the National Conference of State 
Legislatures.\190\ EPA would note that, in addition to the state 
regulations, the FDA has guidelines for the donation of pharmaceuticals 
for international relief efforts,\191\ as does the World Health 
Organization (WHO).\192\
---------------------------------------------------------------------------

    \188\ See 40 CFR 266.501(g)(1).
    \189\ See comment number EPA-HQ-RCRA-2007-0932-0353.
    \190\ http://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx.
    \191\ See Questions and Answers for the Public Donating Drugs to 
International Humanitarian Relief Efforts https://www.fda.gov/
downloads/newsevents/publichealthfocus/ucm249617.pdf.
    \192\ http://www.who.int/selection_medicines/emergencies/guidelines_medicine_donations/en/.
---------------------------------------------------------------------------

    Sirum is providing a valuable and commendable service and EPA does 
not wish to impede their operations, which support the waste 
minimization goal of RCRA. We have amended both the definition of 
hazardous waste pharmaceutical and the applicability section to clarify 
that pharmaceuticals that are lawfully donated are not solid or 
hazardous wastes and therefore are not subject to RCRA, including this 
subpart. This would include donations to a charity, non-governmental 
organization, or to a healthcare facility that is participating in a 
donation or repository program that is authorized by the state. EPA 
concurs with Sirum that this should act ``as an incentive and path 
forward for socially responsible reverse distributors [and others] to 
donate rather than destroy pharmaceuticals within the safety of 
existing state laws that allow for these practices.'' \193\
---------------------------------------------------------------------------

    \193\ See comment number EPA-HQ-RCRA-2007-0932-0353.
---------------------------------------------------------------------------

    b. Over-the-counter pharmaceuticals going through reverse 
logistics. As discussed at length in section VI of the preamble, OTC 
pharmaceuticals, and other items meeting our definition of 
pharmaceutical that do not require a prescription, such as dietary 
supplements, or homeopathic drugs, will only be subject to this subpart 
when they are discarded by a healthcare facility. OTCs and other 
nonprescription pharmaceuticals are not considered solid or hazardous 
wastes when they are sent through reverse logistics for the purpose of 
determining whether they can be redistributed for their intended 
purpose or legitimately reused or reclaimed. We have added Sec.  
266.501(g)(2) to the applicability section to codify this position 
regarding OTC pharmaceuticals, dietary supplements and homeopathic 
drugs.
    c. Recalled hazardous waste pharmaceuticals. The Agency initially 
proposed standards for recalled non-creditable hazardous waste 
pharmaceuticals at healthcare facilities in Sec.  266.502(g)(3), and 
for potentially creditable and evaluated hazardous waste 
pharmaceuticals at reverse distributors in Sec.  266.510(a)(5). The 
finalized recall provisions for all hazardous waste pharmaceuticals are 
now in the applicability section in Sec.  266.501(g)(3) and (4).
    The Agency proposed that healthcare facilities managing recalled 
non-creditable hazardous waste pharmaceuticals could request an 
extension from the EPA Regional Administrator should they need to 
accumulate them for longer than the allotted one-year period. Likewise, 
the Agency proposed that reverse distributors managing recalled 
potentially creditable hazardous waste pharmaceuticals could request an 
extension from the EPA Regional Administrator should they need to 
accumulate them for longer than the allotted 90-day period. In the 
proposed regulations, the reasons for requesting an extension were 
characterized as ``any unforeseen circumstances beyond the control'' of 
the healthcare facility or reverse distributor. In the proposed 
preamble, we gave the specific examples of recalls and litigation as 
circumstances that are the beyond the control of the healthcare 
facility or reverse distributor, which could require longer 
accumulation than the proposed time frames. The proposed provision in 
both sections required that an extension

[[Page 5861]]

request be sent in writing (electronic or paper) to the EPA Regional 
Administrator explaining the need for the extension, the approximate 
amount of hazardous waste pharmaceuticals accumulated beyond the 
corresponding time period, and the amount of extra time requested. The 
Agency also proposed to allow the Regional Administrator discretion to 
grant, modify, or deny extension requests on a case-by-case basis. 
Lastly, the Agency solicited comment on the proposed mechanism to 
request a time extension.
    The proposed recall provisions only applied to hazardous waste 
pharmaceuticals that had limited accumulation times, i.e., non-
creditable hazardous waste pharmaceuticals at healthcare facilities, 
and potentially creditable and evaluated hazardous waste 
pharmaceuticals at reverse distributors. The finalized recall 
provisions, however, apply to all recalled hazardous waste 
pharmaceuticals.
    These proposed extension provisions were opposed by many commenters 
from both industry and state governments. Industry commenters were 
concerned about the additional burden that would arise from having to 
generate, transmit, and maintain an additional set of records every 
time they would need to request an extension of the accumulation time 
period. The commenters suggested that these situations occur more often 
than EPA indicated in the proposal. Similarly, many state agencies were 
concerned about the added burden imposed on them by requiring 
notifications that must be processed, analyzed, afforded appropriate 
consideration, and responded to. In addition, many commenters mentioned 
the possibility that these provisions would conflict with other federal 
oversight authorities, in particular, recalls overseen by the FDA and 
CPSC. Commenters were also wary of the discretion these proposed 
provisions afforded the Regional Administrator to grant extensions, 
primarily due to the lack of a mechanism to coordinate those extensions 
with other agencies that might require longer accumulation times. 
Commenters were concerned this would likely lead to a scenario in which 
the EPA Regional Administrator does not grant sufficient accumulation 
time needed to comply with other federal requirements for recalls.
    To address these adverse comments, the Agency has modified the 
final rule. The modifications also address the fact that the duration 
of a recall is highly variable, making it unreasonable to prescribe a 
specific time frame for accumulation. The Agency is finalizing 
provisions to ensure that recalled hazardous waste pharmaceuticals are 
properly managed without imposing requirements that are superfluous or 
conflict with other federal regulations and procedures.
    In an effort to avoid overreach and potentially overlapping 
regulations, the Agency consulted with FDA and CPSC to better 
understand their procedures and policies in regulating and overseeing 
recalls of OTC and prescription pharmaceuticals. We learned that almost 
all pharmaceutical recalls are overseen by FDA, however, CPSC 
occasionally oversees a recall if an item's packaging does not comply 
with special (also called child resistant) packaging requirements. We 
also learned that third-party companies (typically reverse 
distributors, as defined in subpart P) serve as recall facilitators 
contracted by the manufacturer of the recalled item, to provide recall 
logistics such as aggregating recalled items, tracking recall progress, 
and making disposition determinations. Nearly all pharmaceuticals sent 
to a recall facilitator as part of a recall are ultimately destroyed. 
However, in some cases, the content of a recalled item is reclaimed and 
put back into commerce. For example, if the outer packaging has 
incorrect information, the manufacturer may choose to place the 
contents in updated packaging so they can be lawfully sold.
    Although retailers are not permitted to sell a pharmaceutical that 
is subject to a CPSC recall, participation in a recall is not 
compulsory on the part of every consignee (entity that has purchased 
those items), which means that there is no way to compel participation, 
whether the recall is voluntary or federally mandated. The Agency had 
considered taking the position that all pharmaceuticals subject to a 
recall are waste when the recall is issued. However, because some 
recalled pharmaceuticals have the potential to be legitimately used/
reused or reclaimed, combined with the fact that they sometimes can be 
lawfully dispensed by the consignee (but not sold by a retailer), we 
concluded that pharmaceuticals subject to a recall do not necessarily 
become waste simply by virtue of being subject to that recall.
    Although many pharmaceuticals being sent by a healthcare facility 
to a recall facilitator as part of a recall could be considered solid 
waste, the Agency has determined that the combination of regulations, 
guidance and/or oversight provided by FDA and CPSC is sufficiently 
protective of human health and the environment while pharmaceuticals 
are subject to a recall. Therefore, EPA is choosing not to apply RCRA 
regulations on hazardous waste pharmaceuticals that are subject to a 
voluntary or federally-mandated recall until the decision is made to 
send some or all items for destruction (see below for further 
discussion).
    EPA is not attaching any requirements to recalled hazardous waste 
pharmaceuticals while subject to a recall. In the final rule, 
healthcare facilities and reverse distributors will not be required to 
request an extension of the accumulation time period for recalled non-
creditable hazardous waste pharmaceuticals or potentially creditable 
hazardous waste pharmaceuticals as proposed. This decision is also 
responsive to commenters who were concerned about having to operate 
under multiple and possibly conflicting federal regulatory schemes. It 
is also worth noting again that FDA and CPSC are the only federal 
agencies that regulate recalled pharmaceuticals and special packaging 
for pharmaceuticals, respectively.
    When a pharmaceutical recall is initiated, the manufacturer must 
develop, and the corresponding agency must accept, a recall strategy 
which outlines all of the actions to be taken on behalf of the 
manufacturer from start to finish. A disposition determination is a 
required component of a comprehensive recall strategy. It is EPA's 
understanding that items being managed under an FDA or CPSC recall may 
be periodically sent for destruction as part of the disposition 
strategy (other disposition options allowed by FDA and CPSC can include 
redirection, and in rare circumstances, reconditioning). It is at this 
point (upon the decision to send some or all of the recalled 
pharmaceuticals for destruction) that the Agency will apply RCRA 
regulations these hazardous waste pharmaceuticals.
    Any recalled pharmaceutical that is sent for destruction as part of 
the disposition strategy and is a RCRA hazardous waste, must be managed 
according to RCRA Subtitle C and any applicable provisions of this new 
subpart. This strategy is also in line with FDA and CPSC recall 
procedures in that they both specify that items being sent for 
destruction must comply with other applicable state, local and federal 
regulations, which may include DOT's Hazardous Material Regulations 
(HMR) and RCRA. In other words, this rule maintains the framework that 
any entity sending recalled items for destruction under a FDA or CPSC 
recall must comply with RCRA regulations but imposes these new subpart 
P regulations

[[Page 5862]]

at the point at which RCRA regulations already applied in lieu of the 
generator regulations in 40 CFR part 262.
    d. Preservation orders, investigations, and judicial proceedings. 
In addition to recalls, the proposed rulemaking included litigation 
holds as an example of a circumstance that is beyond the control of a 
healthcare facility or reverse distributor, which would be a valid 
reason to request an extension of the accumulation period. Similar to 
the proposed standards for recalled hazardous waste pharmaceuticals, 
the standards for hazardous waste pharmaceuticals under litigation 
holds were also included in Sec.  266.502(f)(3) for non-creditable 
hazardous waste pharmaceuticals at healthcare facilities, and in Sec.  
266.510(a)(5) for potentially creditable and evaluated hazardous waste 
pharmaceuticals at reverse distributors. As with recalls, we have moved 
the section of the regulations that addressed accumulation time 
extensions for litigation holds out of the healthcare facility 
standards and reverse distributor standards and into the applicability 
section of Sec.  266.501(g)(5). The final rule also uses terminology 
that is more encompassing than just litigation holds, such that we are 
choosing not to apply RCRA regulations on hazardous waste 
pharmaceuticals that are being held pursuant to preservation orders, 
investigations, and judicial proceedings (which would include 
litigation holds).\194\ Accordingly, the hazardous waste 
pharmaceuticals under a preservation order, investigation, or judicial 
proceeding are not subject to part 266 subpart P until after the 
preservation order, investigation or judicial proceeding has concluded 
and/or a decision is made to discard the hazardous waste 
pharmaceuticals. As with recalled hazardous waste pharmaceuticals, the 
final rule no longer requires healthcare facilities and reverse 
distributors to request an extension of the accumulation time period 
for hazardous waste pharmaceuticals under a preservation order, 
investigation, or judicial proceeding, as was originally proposed.
---------------------------------------------------------------------------

    \194\ See the following three memos: (1) June 23, 2017, from 
Johnson to Regional RCRA Division Directors, RCRA Online #14893; (2) 
August 11, 1988, from Lowrance to McGuire, RCRA Online #11363; and 
(3) January 6, 2014, from Devlin to Mitlo, RCRA Online #14881.
---------------------------------------------------------------------------

    Some commenters were concerned that the Agency had proposed that 
any item under a preservation order, investigation, or judicial 
proceeding would be considered waste. We would like to emphasize that 
non-waste hazardous pharmaceuticals do not automatically become a waste 
upon being directed to participate in a preservation order.
    The Agency has determined that any pharmaceuticals that were, prior 
to a preservation order, investigation, or judicial proceeding, 
determined to be waste, are not subject to RCRA when under the 
preservation order, investigation, or judicial proceeding. The Agency 
believes that sufficient protections are in place to be duly protective 
of human health and the environment while the preservation order, 
investigation, or judicial proceeding is ongoing. In addition, the 
extreme variability and multijurisdictional nature of judicial actions 
and Agency investigations make it impractical to impose RCRA standards 
while a corresponding preservation order, investigation, or judicial 
proceeding is ongoing. When lifted--for any portion or the entire 
complement of items--a new waste determination must be made. The 
location at which the waste determination is made will be the new point 
of generation. If the items are ultimately determined to be hazardous 
waste pharmaceuticals, all applicable standards in this subpart apply 
and the time frames for accumulation, inventory, etc., begin anew.
    e. Investigational drugs. Similar to recalls, FDA has specific 
regulations pertaining to investigational new drugs, including that an 
investigational new drug application must be developed and approved by 
FDA, in accordance with 21 CFR part 312. These regulations include a 
requirement that ``The sponsor shall assure the return of all unused 
supplies of the investigational drug from each individual investigator 
whose participation in the investigation is discontinued or terminated. 
The sponsor may authorize alternative disposition of unused supplies of 
the investigational drug provided this alternative disposition does not 
expose humans to risks from the drug.'' \195\ Because FDA requires 
these investigational drugs to be returned to the sponsor of the new 
drug application, EPA would not consider these returned investigational 
new drugs to be solid wastes and therefore, they would not be subject 
to RCRA, including this subpart. However, when a decision is made to 
discard the investigational new drug, or when the FDA approves the 
destruction of the investigational new drug, at that point it would be 
considered a solid waste, and if it is a hazardous waste, then it would 
be subject to subpart P, if the investigational new drug is discarded 
by a healthcare facility or a reverse distributor. However, typically, 
investigational new drugs that are part of a clinical trial are 
returned to the manufacturer at the conclusion of the clinical trial. 
In that case, if the investigational new drug is discarded by a 
manufacturer, then it would be subject to part 262, not part 266 
subpart P. We have added Sec.  266.501(g)(6) to carve out 
investigational new drugs for which an investigational new drug 
application is in effect in accordance with the FDA regulations in 21 
CFR part 312. But we have also included a sentence to make it clear 
that, when the decision of discard has been made, the investigational 
new drug is subject to subpart P, if it meets the definition of 
hazardous waste and it is discarded by a healthcare facility or a 
reverse distributor.
---------------------------------------------------------------------------

    \195\ See 21 CFR 312.59.
---------------------------------------------------------------------------

    f. Household pharmaceuticals. In the proposed rulemaking, we 
indicated that pharmaceuticals from households would continue to be 
excluded as household hazardous waste under Sec.  261.4(b)(1). However, 
this was only a discussion in the preamble, we did not include 
regulatory language in part 266 subpart P. Additionally, we proposed a 
conditional exemption for collected household pharmaceuticals in Sec.  
266.507. For added clarity in the final rule, we have included in the 
applicability section a new paragraph Sec.  266.501(g)(7). This 
paragraph indicates that household waste pharmaceuticals are not 
regulated under part 266 subpart P or other RCRA regulations. A 
household waste pharmaceutical is defined as a pharmaceutical that is a 
solid waste, as defined in Sec.  261.2, but is excluded from being a 
hazardous waste under Sec.  261.4(b)(1). This exclusion is for the 
residential generator of the household waste pharmaceuticals, as well 
as the collection and disposal of the residential trash as municipal 
solid waste.
    As discussed later in this preamble, we are finalizing a 
conditional exemption in Sec.  266.506(a)(2) for household waste 
pharmaceuticals that are collected in a take-back event or program, 
including those that are collected by an authorized collector (as 
defined by the Drug Enforcement Administration) registered with the 
Drug Enforcement Administration that commingles the household waste 
pharmaceuticals with controlled substances from an ultimate user (as 
defined by the Drug Enforcement Administration). To remain exempt as 
household waste pharmaceuticals, these collected pharmaceuticals may 
not be sewered and have to be destroyed by a method that the Drug 
Enforcement

[[Page 5863]]

Administration has publicly deemed in writing to meet their non-
retrievable standard of destruction, or combusted at one of the types 
of combustors identified in Sec.  266.506(b). We have included in the 
applicability section in Sec.  266.501(g)(7) references to the 
conditional exemption in Sec.  266.506(a)(2) and the conditions in 
Sec.  266.506(b) to clarify that household waste pharmaceuticals that 
are collected as part of a take-back event or program are distinct and 
different from those that are not part of a collection program. That 
is, when discarded directly at a residence, the household waste 
pharmaceuticals remain excluded as household hazardous waste, without 
any conditions; however, when the household waste pharmaceuticals are 
collected in a take-back event or program, they must be destroyed in 
accordance with the conditions in Sec.  266.506 to remain exempt. See 
section XIV of this preamble for a more detailed discussion of the 
conditional exemption for household waste pharmaceuticals that are 
collected in a take-back event or program.

C. Do Not Count Hazardous Waste Pharmaceuticals Managed Under Subpart P 
Toward Determining Generator Category (Sec. Sec.  262.13(c)(9))

1. Summary of Proposal
    EPA proposed that hazardous waste pharmaceuticals that are managed 
under part 266 subpart P are not required to be counted in determining 
a facility's hazardous waste generator category under part 262. There 
were two primary reasons this provision was proposed. First, we 
received support for this provision when we initially proposed it as 
part of the 2008 proposal to add pharmaceuticals to the Universal Waste 
program. Second, and more importantly, under part 266 subpart P, there 
are no generator categories; therefore, it is not necessary to know the 
quantity of hazardous waste pharmaceuticals being generated. EPA 
emphasized that a healthcare facility must be managing its hazardous 
waste pharmaceuticals under subpart P in order to have the benefit of 
not counting them towards its generator category (see section XIX for 
further discussion).
2. Summary of Comments
    There was widespread support among commenters for this proposed 
provision. However, a number of the commenters expressed some confusion 
and asked for further explanation and clarity regarding the effect this 
may have on determining a facility's hazardous waste generator 
category.
3. Final Rule Provisions
    We are finalizing this provision with a minor edit. Additionally, 
the provision is now in a different place in the final regulations. 
First, the minor edit was made in response to Connecticut Depart of 
Energy and Environmental Protection's (CT DEEP) objection to the 
phrasing of the proposed regulatory language. Specifically, CT DEEP 
thought the phrase ``managed under 40 CFR part 266 subpart P'' could 
lead to confusion if a healthcare facility was operating under part 266 
subpart P, but was not in full compliance with part 266 subpart P and 
whether that would be considered to be ``managed under 40 CFR part 266 
subpart P.'' \196\ In response, and to avoid this potential area of 
confusion, we have changed the regulatory language so that ``a 
hazardous waste pharmaceutical subject to or managed in accordance with 
40 CFR part 266 subpart P'' does not have to be counted toward 
determining a facility's generator category. The second change is a 
conforming change necessitated by the reorganization of the generator 
regulations in the 2016 Hazardous Waste Generator Improvements final 
rule. The list of hazardous wastes that do not have to be counted 
toward generator category had been listed in Sec.  261.5(c), but when 
the Hazardous Waste Generator Improvements final rule reorganized the 
generator regulations, this list was moved to Sec.  262.13(c). Under 
this final rule, hazardous waste pharmaceuticals that are subject to 
part 266 subpart P do not have to be counted toward determining a 
facility's generator category. This provision now appears in Sec.  
262.13(c)(9). Finally, for clarity we have added that the hazardous 
waste pharmaceuticals that are also DEA controlled substances and are 
conditionally exempt under Sec.  266.506, do not have to be counted 
toward determining generator category.
---------------------------------------------------------------------------

    \196\ See comment number: EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

4. Comments and Responses
    Several commenters asked us to clarify when a healthcare facility 
does and does not count its hazardous waste pharmaceuticals toward 
determining a facility's generator category. A healthcare facility must 
count all of its hazardous waste--including hazardous waste 
pharmaceuticals--to determine whether it is subject to part 266 subpart 
P. If a healthcare facility generates below all of the VSQG monthly 
quantity limits, then it remains subject to Sec.  262.14 for all of its 
hazardous waste and it is not subject to subpart P for its hazardous 
waste pharmaceutical, except for the sewer prohibition of Sec.  
266.505, the empty container standards of Sec.  266.507, and the 
optional provisions of Sec.  266.504. On the other hand, if a 
healthcare facility generates above any of the VSQG monthly quantity 
limits, then the healthcare facility is subject to subpart P for its 
hazardous waste pharmaceuticals. But since subpart P is only for the 
management of hazardous waste pharmaceuticals, the healthcare facility 
remains subject to part 262 for its non-pharmaceutical hazardous waste.
    The next step is for the healthcare facility to determine its new 
generator category under part 262 so it knows how to manage its non-
pharmaceutical hazardous waste. At this point, a healthcare facility 
does not need to count its hazardous waste pharmaceuticals in 
determining its generator category for its non-pharmaceutical hazardous 
waste. EPA continues to emphasize that a healthcare facility must be 
managing its hazardous waste pharmaceuticals under subpart P in order 
to have the benefit of not counting them towards its generator 
category. Put another way, a healthcare facility managing its hazardous 
waste pharmaceuticals under subpart P does not have a generator 
category for the hazardous waste pharmaceuticals, but it will be a 
VSQG, SQG or LQG for its non-pharmaceutical hazardous waste.
    When a healthcare facility that manages its hazardous waste 
pharmaceuticals under subpart P no longer counts the hazardous waste 
pharmaceuticals to determine its part 262 generator category, the 
healthcare facility may experience a change in RCRA generator category 
for its non-pharmaceutical hazardous waste. For example, a healthcare 
facility may shift from being an LQG to an SQG or even VSQG by not 
counting its hazardous waste pharmaceuticals toward its generator 
category, especially when acute hazardous waste pharmaceuticals such as 
warfarin (brand name: Coumadin) no longer need to be counted. A shift 
in generator category, should it occur, would allow a healthcare 
facility to manage its non-pharmaceutical hazardous waste, such as 
hazardous waste from laboratories, according to the reduced part 262 
generator regulations for a smaller category.
    For reverse distributors, it works somewhat differently than with 
healthcare facilities, because all reverse distributors are subject to 
part 266 subpart P for the management of their hazardous waste 
pharmaceuticals, including reverse distributors that are

[[Page 5864]]

VSQGs. In other respects, the regulations work the same, because 
reverse distributors also are not required to count their hazardous 
waste pharmaceuticals when determining their part 262 generator 
category for their non-pharmaceutical hazardous waste.
    Again, we emphasize, such dropping down in generator category only 
pertains to non-pharmaceutical hazardous waste and is only possible 
when the hazardous waste pharmaceuticals are being managed under 
subpart P. Further, EPA points out that universal wastes also are not 
counted toward a facility's generator category and what we are 
finalizing for hazardous waste pharmaceuticals has been implemented 
successfully for years within the universal waste program for 
facilities that generate both universal waste and other hazardous 
waste.
    Below are a diagram and a table to help summarize the preceding 
sections of the preamble related to the applicability of the final rule 
and the provision that allows a healthcare facility or a reverse 
distributor to not count hazardous waste pharmaceuticals when 
determining the facility's generator category for its non-
pharmaceutical hazardous waste.
BILLING CODE 6560-50-P

[[Page 5865]]

[GRAPHIC] [TIFF OMITTED] TR22FE19.000


[[Page 5866]]


[GRAPHIC] [TIFF OMITTED] TR22FE19.001

BILLING CODE 6560-50-C

[[Page 5867]]

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))

1. Summary of Proposal
    To address commenters' concerns from the 2008 Pharmaceutical 
Universal Waste proposal that regulatory agencies are unaware of 
hazardous waste pharmaceutical management activities, EPA proposed to 
require that a healthcare facility that does not qualify as a VSQG to 
submit a one-time notification as a ``healthcare facility'' to the 
appropriate EPA Regional Administrator. EPA proposed that healthcare 
facilities subject to 40 CFR part 266 subpart P will have to submit a 
notification even if the healthcare facility has previously obtained an 
EPA identification number. The required notification was meant to 
enable EPA and state regulatory agencies to identify the universe of 
healthcare facilities managing hazardous waste pharmaceuticals subject 
to the 40 CFR part 266 subpart P requirements.
    At any point, a healthcare facility's hazardous waste 
pharmaceutical generation may change due to waste minimization efforts 
or other reasons, causing the facility to legitimately decrease its 
total monthly hazardous waste generation enough to qualify as a VSQG. 
In this case, if the healthcare facility withdraws from the 40 CFR part 
266 subpart P requirements due to qualifying as a VSQG, EPA proposed 
that the healthcare facility must re-notify EPA of its choice to 
withdraw.
    Alternatively, if a healthcare facility determines that it is a 
VSQG, but does not want to keep track of the amount of hazardous waste 
pharmaceuticals it generates and whether it is above or below the VSQG 
threshold, we proposed that it can choose to operate under subpart P. 
By choosing to operate under subpart P, the VSQG healthcare facility 
must comply with all of the requirements, including the one-time 
notification that it is operating under 40 CFR part 266 subpart P. We 
proposed that healthcare facilities that are not VSQGs, however, are 
required to operate under 40 CFR part 266 subpart P for the management 
of their hazardous waste pharmaceuticals.
    The Agency proposed that this notification occur using the RCRA 
Subtitle C Site Identification Form (EPA Form 8700-12; or Site 
Identification Form). EPA believes that notification via the Site 
Identification Form is the preferred approach for notification purposes 
for several reasons. First, both state environmental regulatory 
agencies and hazardous waste generators are familiar with the form, as 
it is the form currently used by hazardous waste generators to notify 
regulators of their RCRA Subtitle C activities. Second, as stated 
previously, the use of the Site Identification Form will allow for EPA 
and state regulatory agencies to monitor the healthcare facilities 
utilizing the new regulatory requirements. Lastly, public comments 
received on previous EPA actions (e.g., Academic Laboratories 
Rulemaking (73 FR 72912; December 1, 2008)) have indicated that 
notification via the Site Identification Form is the notification 
approach typically preferred by the regulated community. We proposed 
that healthcare facilities can submit their notification as part of the 
Biennial Report, if the healthcare facility will be required to submit 
a Biennial Report due to its non-pharmaceutical hazardous waste. This 
was intended to take advantage of an existing reporting mechanism for 
LQGs or other generators already required to submit the Biennial Report 
and avoid duplicative notification requirements. Otherwise, healthcare 
facilities are required to notify within 60 days of this new subpart 
becoming effective, or within 60 days of becoming subject to this new 
subpart. We also proposed that a healthcare facility would have to keep 
a record of its notification as long as it is subject to this subpart.
    The Agency did not anticipate that the proposed notification 
requirement would place any undue economic burden upon healthcare 
facilities or the environmental regulatory agencies that process these 
notifications (see the Regulatory Impact Analysis for the proposed 
rulemaking in the rulemaking docket EPA-HQ-RCRA-2007-0932). In fact, 
under the proposed regulations, healthcare facilities would no longer 
need to count the hazardous waste pharmaceuticals managed under 40 CFR 
part 266 subpart P towards a healthcare facility's generator category. 
As a result, EPA anticipates that many healthcare facilities will 
reduce their generator category to either an SQG or VSQG for their 
other non-pharmaceutical hazardous wastes. So, while the notification 
requirement ensures that the environmental regulatory agencies are 
informed of all hazardous waste pharmaceutical management activities 
subject to the 40 CFR part 266 subpart P requirements, the fact that 
some healthcare facilities will no longer qualify as LQGs will reduce 
the number of healthcare facilities in the LQG universe.
    The Agency solicited comment on the notification requirement for 
healthcare facilities, the method of notification via the Site 
Identification Form, and whether this notification requirement will 
result in any undue burden to either healthcare facilities or state 
environmental regulatory agencies.
2. Summary of Comments
    While there was general support for requiring healthcare facilities 
to notify the EPA Regional Administrator that they are operating under 
this subpart, a number of states and industry commenters provided 
opposition to the proposed 60-day time frame. States supported 
notification but were concerned that they would not be able to process 
all of the notifications in a timely manner given that all VSQG and SQG 
facilities operating under subpart P would have to notify within 60 
days of the effective date of this rule. One suggestion was to instead 
require notification on a rolling or staggered basis to give resource-
limited states enough time to process the notices within a timely 
manner.
    States also voiced concern about the provision allowing healthcare 
facilities that are LQGs because of their non-pharmaceutical waste to 
notify as part of their normal Biennial Reporting schedule.\197\ 
Depending on the timing of the Final Rule, states were concerned about 
the possibility that LQGs would not have to notify that they are 
operating under this subpart for up to two years, during the course of 
which they could be generating large amounts of pharmaceutical waste 
and managing it under the reduced restrictions of this subpart 
unbeknownst to the state or EPA. Meanwhile VSQGs and SQGs would have to 
notify within 60 days.\198\ Another state recommended that healthcare 
facilities be required to list on the notification what their generator 
category would be if they were to count their pharmaceutical waste. The 
state was concerned that a healthcare facility could be generating LQG 
amounts of pharmaceutical waste but because they are now VSQGs, would 
be a much lower inspection priority.\199\
---------------------------------------------------------------------------

    \197\ Sec.  262.18(d)(2) requires LQGs to renotify EPA by March 
1 of each even-numbered year thereafter using EPA Form 8700-12. An 
LQG may submit this renotification as part of its Biennial Report 
required under Sec.  262.41.
    \198\ EPA-HQ-RCRA-2007-0932-0341.
    \199\ EPA-HQ-RCRA-2007-0932-0235.
---------------------------------------------------------------------------

    There was, however, no opposition to the provision that a 
healthcare facility

[[Page 5868]]

be required to maintain a copy of its notification on file as long as 
it is subject to this subpart.
3. Final Rule Provisions
    EPA is finalizing the notification provisions for healthcare 
facilities managing non-creditable hazardous waste pharmaceuticals as 
proposed, with no changes.
    All healthcare facilities as defined in Sec.  266.500 that are 
subject to the requirements of this subpart (all healthcare facilities 
that generate above the VSQG thresholds and healthcare facilities that 
are VSQGs choosing to operate under this subpart) will have to submit a 
notification to the EPA Regional Administrator using the Site ID Form 
(EPA Form 8700-12) stating that they are a healthcare facility and will 
be operating under this subpart. A healthcare facility that already has 
an EPA Identification Number must re-notify the EPA Regional 
Administrator that it will be operating under this subpart within 60 
days of becoming subject to subpart P. Healthcare facilities that do 
not have an EPA Identification Number will be required to obtain one by 
submitting the Site Identification Form (EPA Form 8700-12) within 60 
days from the effective date of this rule if they are not otherwise 
required to submit Biennial Reports. A healthcare facility that 
undergoes a change in generator category causing them to become subject 
to the requirements of this subpart must notify the EPA Regional 
Administrator within 60 days of the event that triggered the change in 
generator category.
    Healthcare facilities that are LQGs for their non-pharmaceutical 
hazardous waste, and therefore must submit a Biennial Report, may 
notify the EPA Regional Administrator according to their normal 
reporting cycle. SQGs that are required by their state to submit a 
Biennial Report may also notify EPA that they are operating under 
subpart P on their normal reporting cycle. Healthcare facilities that 
are required to submit a Biennial Report are not, however, required to 
wait to notify EPA that they are operating under subpart P on their 
Biennial Report, and may notify EPA at any point prior to submitting 
the Biennial Report. The Agency notes that any healthcare facility that 
is required to operate under subpart P must begin complying with its 
requirements as soon as the final rule becomes effective. VSQGs that 
opt into subpart P may notify the EPA whenever they choose, but they 
become subject to the requirements of this subpart on the date they 
submit the notification. All healthcare facilities must retain a copy 
of the notification as long as they are operating under this subpart.
4. Comments and Responses
    Some states were concerned about their ability to process 
notifications in a timely manner given the 60-day time frame after the 
effective date of this rule within which all non-LQG healthcare 
facilities must notify EPA that they are operating under this subpart. 
The Agency reasserts, however, that the added burden is reasonable and 
necessary for the Agency and implementing states to gain a timely 
understanding of the facilities within the universe of this rule.
    The Agency also notes that this final rule goes into effect six 
months from the date it is published in the Federal Register in EPA 
Territories and states that do not have an authorized RCRA program. 
That time frame could be even longer in authorized states which must 
first adopt this rule for it to become effective. Therefore, healthcare 
facilities in all states have a minimum of six months from the day this 
rule is published in the Federal Register, plus the 60 days in this 
requirement, to notify their state that they are operating under this 
subpart.
    One commenter suggested that the agency implement a staggered roll-
out of this notification provision to prevent them from becoming 
inundated with incoming notifications, preventing them from processing 
notifications in a timely manner. The Agency would note, however, that 
there is no provision requiring a healthcare facility to receive 
approval before it can operate under this subpart and states and 
regions can process the notifications by whatever time frames and 
methods they choose. All healthcare facilities must operate under this 
subpart immediately upon becoming subject to this rule. Therefore, as 
long as a healthcare facility that does not submit a BR notifies its 
state within 60 days that it is operating under this subpart, it will 
be in compliance. In addition, we did not propose and are not 
finalizing any time frames within which regional or state offices must 
process notifications, therefore, we defer to those agencies to develop 
their own best practices.
    Another state suggested that EPA develop a ``smart-form'' tool for 
RCRAInfo--EPA's database of RCRA-related information from required 
reporting-- that would allow healthcare facilities to notify the state 
electronically that they are operating under subpart P, directly input 
their own information, and update their information on a regular basis. 
EPA notes that it has developed an online tool called myRCRAid which 
allows generators to complete and submit the Site Identification Form 
electronically, which the Agency expects will reduce states' 
administrative burden by reducing the number of notifications that have 
to be manually input, while simultaneously reducing the potential for 
error while transferring data.
    In addition, the Site Identification Form will be modified by EPA 
in a separate action to add a section for a healthcare facility to 
indicate that it generates hazardous waste pharmaceuticals. The 
healthcare facility will no longer be required to identify on the Site 
Identification Form the specific types of hazardous waste 
pharmaceuticals it generates. The Agency also intends to add a checkbox 
to the new section which will allow a healthcare facility to indicate 
that its generator category is changing to a VSQG and it is no longer 
managing its hazardous waste pharmaceuticals according to 40 CFR part 
266 subpart P.
    Some states disagreed with the provision that allows healthcare 
facilities that file a BR to notify EPA that they are operating under 
subpart P on their normal reporting schedule, as opposed to notifying 
within 60 days of this rule becoming effective, or becoming subject to 
subpart P. This means that healthcare facilities that file a BR could 
potentially operate under this subpart for up to two years without 
having to notifying the Agency, depending on when their normal BR date 
falls in relation to the effective date of this rule. They recommended 
that all facilities, regardless of generator category, be required to 
notify within 60 days. While the Agency agrees that the possibility for 
a healthcare facility to operate for up to two years under this subpart 
without notifying EPA does, in fact, exist, we do not wish to impose 
duplicative notification requirements.
    One state requested that a healthcare facility be required to list 
on the notification what its generator category would be if it were 
required to count its hazardous waste pharmaceuticals. They were 
concerned that some facilities that are LQGs because of their hazardous 
waste pharmaceuticals would reduce their generator category as a result 
of this rule, making them a low priority for inspections, even though 
they could still be generating LQG quantities of pharmaceutical waste. 
We understand the state's concern, however, making a change like this 
would not be in line with the goals of this rule to provide streamlined 
standards. However, options available to the states with similar 
concerns are adopting more stringent requirements or using

[[Page 5869]]

historical notifications and Biennial Report data.

B. Personnel Training Requirements for Healthcare Facilities Managing 
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(b))

1. Summary of Proposal
    a. Performance-based training standards. EPA believes that the part 
262 LQG training regulations are excessive for healthcare personnel who 
sporadically generate hazardous waste pharmaceuticals at healthcare 
facilities, but believes it is necessary to have some familiarity with 
the dangers that hazardous waste pharmaceuticals can pose, making the 
VSQG training standards insufficient. Therefore, the Agency proposed 
healthcare facility-specific personnel training requirements that are 
akin to the training requirements for SQGs and small quantity universal 
waste handlers, for all healthcare facilities subject to subpart P. 
Specifically, we proposed that healthcare facilities managing hazardous 
waste pharmaceuticals in accordance with subpart P must inform all 
employees that handle or have responsibility for generating and/or 
managing hazardous waste pharmaceuticals of the proper handling and 
emergency procedures appropriate to their responsibilities during 
normal facility operations and emergencies. We indicated in the 
preamble to the proposed rulemaking that this training information can 
be disseminated through verbal communication or through distribution of 
pamphlets or other documentation. However, a healthcare facility that 
is an LQG due to its non-pharmaceutical hazardous wastes may choose to 
continue to use its existing training program as an LQG so as not to 
have different training programs.
    Under part 262 regulations, an LQG healthcare facility had to 
provide full RCRA training to its personnel involved in the generation 
and/or management of hazardous waste according to the standards in 
Sec.  262.17(a)(7). These personnel training requirements include 
either classroom instruction, on-line training, or on-the-job training 
in RCRA and require the facility to maintain documentation of that 
training. On the other hand, before this rule was finalized, under the 
part 262 regulations, an SQG healthcare facility had to meet a 
performance-based standard when training personnel involved in the 
generation and/or management of hazardous waste pharmaceuticals. 
Specifically, this entailed ensuring ``that all employees are 
thoroughly familiar with proper waste handling and emergency procedures 
relevant to their responsibilities during normal facility operations 
and emergencies. '' \200\ For comparative purposes, healthcare 
facilities that are considered VSQGs did not have any personnel 
training requirements under the part 262 regulations. Similarly, SQGs 
and LQGs, including healthcare facilities, were not required to provide 
RCRA training to personnel that only work in SAAs regulated under Sec.  
262.15. That said, healthcare personnel that are involved in the 
generation of hazardous waste pharmaceuticals must be familiar enough 
with the pharmaceuticals with which they work to know when they have 
generated a hazardous waste so that it will be managed in accordance 
with the RCRA regulations.
---------------------------------------------------------------------------

    \200\ Sec.  262.16(b)(9)(iii)
---------------------------------------------------------------------------

    b. Documentation of training. Although no regulations were 
proposed, EPA also sought comment in the preamble to the proposed 
rulemaking on whether documentation of training is necessary in order 
to verify compliance with the training requirement.
2. Summary of Comments
    a. Performance-based training standards. There were a variety of 
comments on the proposed training standards, both in support and 
opposition. Although most states agreed with the assessment that 
standard LQG regulations would be excessive if applied to healthcare 
facilities, some wanted EPA to provide more stringent and prescriptive 
language. Commenters from the waste management industry were also 
opposed to the proposed performance-based standards for similar 
reasons.
    Pharmacy trade groups generally agreed with the proposed standards, 
citing the same rationale provided in the preamble of the proposed 
rulemaking, which states that the variability in waste generated and 
turnover in employees warrants a performance-based standard, and any 
subsequent training should be left up the healthcare facility. They 
stated that most pharmacy staff are trained on proper handling and 
management of radiation and other pharmaceuticals that can pose 
significant risks as required by other accreditation and standard-
setting agencies and any prescriptive training standards under subpart 
P would be duplicative.
    b. Documentation of training. There were mixed comments on whether 
to require that a healthcare facility document that its personnel have 
been trained according to the standards set forth in 40 CFR 266.502(b). 
All of the states that commented on this issue were supportive of the 
requirement to document training. These states were mostly concerned 
with their ability to cite specific violations of the training 
provisions during inspections. Another state mentioned that many 
facilities already maintain documentation of training as a best 
management practice.
    Waste management companies also wanted EPA to require healthcare 
facilities to document that employees have been trained. They argued 
that the training standards will not have their intended effect if 
there is no requirement for documentation because healthcare facilities 
will not feel compelled to comply with them.
    Pharmacy trade groups were concerned that requiring documentation 
of training would result in added burden and generally opposed this 
provision. They argued that there are a number of standard-setting and 
accreditation agencies that already require documentation that 
employees have been trained, and as such, this requirement would be 
redundant and overly burdensome.
3. Final Rule Provisions
    a. Performance-based training standards. EPA is finalizing the 
performance-based training standards as proposed. A healthcare facility 
must train employees to the extent that they are thoroughly familiar 
with the proper handling and emergency procedures relevant to their 
responsibilities during normal operations and emergencies. The 
information can be disseminated verbally, via printed materials, or 
other means. These standards are similar to the training standards for 
SQGs and small quantity handlers of universal waste.201 202 
The agency feels that these standards provide consistency across 
generator types and do not impose any added burden on inspection and 
enforcement actions beyond what is already in place within the 
Universal Waste program.
---------------------------------------------------------------------------

    \201\ 40 CFR part 262.16 (a)(9)(iii).
    \202\ 40 CFR part 273.16.
---------------------------------------------------------------------------

    b. Documentation of training. EPA has decided not to finalize a 
standard that would have required healthcare facilities to document 
that the performance-based training standards have been met. The Agency 
thinks this requirement would have resulted in an undue increase in the 
regulatory burden for healthcare facilities. Also, there is no such 
requirement in the part 262 SQG training requirements or for small 
quantity handlers of universal waste.

[[Page 5870]]

The agency feels this approach is consistent with other RCRA 
regulations and would improve consistency with the Universal Waste 
program, especially since the requirements for healthcare facilities 
managing hazardous waste pharmaceuticals were purposefully modeled 
after the requirements for small quantity handlers of universal waste. 
The Agency ultimately concluded that, because this approach is 
sufficient for universal waste, it is also acceptable for hazardous 
waste pharmaceuticals.
4. Comments and Responses
    a. Performance-based training standard. There were a number of 
commenters from states and the waste management industry that 
recommended more rigorous and prescriptive training standards such as 
more specific minimum requirements, recurring training, and that the 
Agency specify the job titles subject to the training requirements. The 
Agency is not finalizing any of these recommendations, however, because 
we believe that the proposed performance-based standards are protective 
of human health and the environment without imposing undue burden 
either on states or industry. These standards strike an appropriate 
balance between ensuring proper management of hazardous waste 
pharmaceuticals and reducing the regulatory burden on healthcare 
facilities and healthcare personnel in a manner that also encourages 
compliance with these new regulations.
    One commenter mentioned that prescriptive RCRA training 
requirements would be duplicative given the training requirements of 
the various accreditation entities. The Agency responds that any waste 
management training for healthcare personnel would not be duplicative 
because accreditation training typically focusses on managing 
pharmaceuticals prior to becoming a waste, whereas the training 
required in subpart P is targeted specifically at management practices 
after the pharmaceuticals have become waste. As mentioned previously, 
the Agency is not finalizing prescriptive training standards in an 
effort to minimize regulatory burden and allow healthcare facilities to 
tailor their training programs in a way that best fits their 
circumstances.
    These training standards apply only to healthcare personnel. 
Healthcare personnel includes any person that manages hazardous waste 
pharmaceuticals at a healthcare facility (e.g., employees, volunteers, 
students). Environmental health and safety personnel are likely to 
manage hazardous wastes other than just hazardous waste pharmaceuticals 
at a healthcare facility, in which case, they would be subject to other 
RCRA Subtitle C training requirements.
    The Agency acknowledges that there are many pharmaceuticals that 
pose significant risk to human health and the environment, yet are not 
RCRA hazardous when they become waste. We in no way intend to imply 
that these items pose any less of a risk by virtue of being considered 
non-hazardous under RCRA and encourage healthcare facilities to provide 
all relevant training to healthcare personnel and observe industry best 
management practices.
    b. Documentation of training. After requesting comment on 
documentation of training, the Agency decided not to finalize any 
requirements for healthcare facilities to document and maintain records 
verifying that healthcare personnel have met the training requirements. 
We considered the many adverse comments and ultimately agreed that such 
requirements would be overly burdensome and more stringent than the 
training requirements in the Universal Waste rule, which were largely 
emulated in this rule. Many comments that advocated for a requirement 
to document training were from states. Although such a requirement is 
not being finalized at the federal level, any authorized state has the 
ability to impose more stringent regulations. If a state chooses to 
require documentation of training, that would be considered more 
stringent and permissible under RCRA.

C. Healthcare Facilities Making a Hazardous Waste Determination for 
Non-Creditable Pharmaceuticals (Sec.  266.502(c))

1. Summary of Proposal
    EPA proposed that, similar to the current part 262 generator 
requirements, healthcare facilities operating under subpart P would be 
required to make hazardous waste determinations on pharmaceutical 
wastes in order to determine the applicable management standards. 
Specifically, we proposed that when a healthcare facility generates a 
solid waste pharmaceutical, the healthcare facility must determine if 
the discarded pharmaceutical is listed in 40 CFR part 261 subpart D 
and/or if it exhibits one or more of the four characteristics of 
hazardous waste identified in 40 CFR part 261 subpart C. We proposed 
that, if the non-creditable pharmaceutical waste is determined to be a 
hazardous waste, then the healthcare facility must manage the non-
creditable hazardous waste pharmaceuticals in accordance with part 266 
subpart P instead of 40 CFR part 262. Pharmaceutical wastes--both 
potentially creditable and non-creditable--not meeting the definition 
of a hazardous waste (i.e., non-hazardous waste pharmaceuticals) must 
be managed in compliance with applicable federal, state and local 
regulations.
    EPA understands that healthcare facilities utilize various 
approaches when making hazardous waste determinations. For example, 
healthcare facilities may hire consultants to review their formularies 
and identify those pharmaceuticals that are hazardous wastes when 
discarded. These facilities may then identify hazardous waste 
pharmaceuticals at the pharmacy level, marking these pharmaceuticals 
with a special label so that healthcare personnel know how to properly 
dispose of the pharmaceutical when it becomes a waste. Other healthcare 
facilities may instruct personnel to dispose of all pharmaceutical 
wastes into one RCRA hazardous waste collection container. These 
healthcare facilities may then choose to manage all of the contents of 
the container as hazardous waste or they may choose to sort the 
hazardous waste portion from the non-hazardous waste pharmaceutical 
portion in an on-site hazardous waste accumulation area, also known as 
a CAA. Due to the various ways that healthcare facilities make the 
hazardous waste determination, the Agency did not propose that a 
specific approach be utilized when making the hazardous waste 
determination, only that the facility performs the hazardous waste 
determination.
    We also proposed that healthcare facilities have the option to 
manage all of their pharmaceutical wastes as hazardous, and thus, if a 
healthcare facility chooses this approach, they would not need to make 
individual hazardous waste determinations. Instead, they would have 
made a generic decision that all of their discarded pharmaceuticals are 
hazardous and manage them as hazardous waste pharmaceuticals in 
accordance with the requirements in 40 CFR part 266 subpart P. 
Accumulating all non-creditable waste pharmaceuticals in one container 
(except for those that are incompatible or cannot be incinerated 
according to the dilution prohibition) \203\ and

[[Page 5871]]

managing them under subpart P would relieve healthcare facilities from 
the burden associated with making individual hazardous waste 
determinations.
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    \203\ Sec.  268.3(c) Dilution prohibited as a substitute for 
treatment. See appendix XI of part 268 for a full list of hazardous 
wastes that are prohibited from being combusted.
---------------------------------------------------------------------------

2. Summary of Comments
    There were a wide variety of comments on this provision. Many in 
the regulated community requested some sort of a reference or 
compendium containing a comprehensive and up-to-date list of the waste 
pharmaceuticals that would be considered RCRA hazardous.
    Commenters from states were generally supportive of the provision 
allowing all waste pharmaceuticals to be managed as hazardous waste 
pharmaceuticals. They believe the provision will encourage healthcare 
facilities to manage all of their waste pharmaceuticals in an 
environmentally protective manner. One commenter did suggest that 
healthcare facilities be required to choose whether they will make 
individual hazardous waste determinations for their waste 
pharmaceuticals or manage all of them as hazardous waste 
pharmaceuticals under this subpart and maintain documentation 
reflecting their decision.
    Retail industry commenters were opposed to what they believe are 
contrary requirements, specifically, allowing a healthcare facility to 
manage all of its waste pharmaceuticals as hazardous but still require 
them to segregate incompatible hazardous waste and those prohibited 
from combustion as required by Sec.  266.502(d)(4). They believe having 
to segregate incompatible and non-combustible waste significantly 
diminishes the intended relief.
3. Final Rule Provisions
    EPA has finalized the provisions of this section with minor edits 
that further clarify that this section applies only to non-creditable 
pharmaceuticals. A healthcare facility that generates solid waste that 
is a non-creditable pharmaceutical has two options for hazardous waste 
determination. It may choose to either; (1) determine if each non-
creditable pharmaceutical is a listed or characteristic hazardous waste 
to determine whether it is subject to the subpart P requirements, or 
(2) manage all of its non-creditable waste pharmaceuticals under the 
subpart P requirements as non-creditable hazardous waste 
pharmaceuticals. A healthcare facility that chooses the latter option, 
instead of making individual hazardous waste determinations at the 
point of generation, would have made a generic decision that all of 
their non-creditable pharmaceutical waste is hazardous and place it 
into a container or containers that are managed under part 266 subpart 
P.
    The Agency wanted to provide maximum flexibility to healthcare 
facilities managing non-creditable waste pharmaceuticals while ensuring 
protection of human health and the environment, which is why we are 
finalizing the provision to allow healthcare facilities the option of 
managing all of their waste pharmaceuticals under subpart P. If a 
healthcare facility chooses to manage all of its non-creditable waste 
pharmaceuticals under the subpart P requirements, healthcare personnel 
are relieved from having to make individual hazardous waste 
determinations which might otherwise distract from their efforts in 
providing patient care.
4. Comments and Responses
    A number of commenters asked if a third party can come on site and 
make individual hazardous waste determinations for commingled non-
creditable waste pharmaceuticals. If a healthcare facility chooses to 
use a third party, typically a hazardous waste transport company, to 
come on site and make hazardous waste determinations at any time 
(typically in preparation for transport off site), that would also be 
permissible under this subpart.
    Many comments were focused on the lack of an EPA-provided reference 
guide of which pharmaceuticals are hazardous waste when discarded. The 
RCRA generator regulations have always placed the onus on the generator 
of a waste to determine whether it is solid and hazardous waste. 
Nevertheless, EPA has made efforts to aid healthcare facilities in 
making hazardous waste determinations by developing the Hazardous Waste 
Pharmaceuticals wiki.\204\ The website has served as a central location 
where users (e.g., healthcare facilities, states) can share their 
knowledge about which pharmaceuticals are listed or characteristic 
hazardous waste, and other related information. EPA has also funded a 
compliance assistance center for healthcare facilities, which provides 
information on which pharmaceuticals are hazardous waste as well as 
other hazardous wastes found in a healthcare setting.205 206
---------------------------------------------------------------------------

    \204\ Hazardous Waste Pharmaceuticals Wiki. http://hwpharms.wikispaces.com. Wiki spaces is phasing out its business of 
hosting wiki pages. The Agency plans to preserve the information 
that has been contributed to the wiki on EPA's website, but the 
content will be static.
    \205\ Healthcare Environmental Resource Center. http://www.hercenter.org.
    \206\ EPA makes no claims, promises, or guarantees about the 
accuracy, completeness, or adequacy of the contents of these sites.
---------------------------------------------------------------------------

D. No Central Accumulation Area and Satellite Accumulation Area 
Requirements for Healthcare Facilities Managing Non-Creditable 
Hazardous Waste Pharmaceuticals

1. Summary of Proposal
    Hazardous waste pharmaceuticals are generated at numerous locations 
across a healthcare facility. Under the part 262 generator regulations, 
each location at the healthcare facility with a RCRA hazardous waste 
receptacle for the disposal of hazardous waste pharmaceuticals is 
considered an SAA and is subject to volume accumulation limits and 
other provisions. Of particular concern regarding the SAA regulations 
for healthcare facilities is the one-quart accumulation limit for acute 
hazardous wastes (i.e., P-listed wastes) and the requirement that 
hazardous waste must be accumulated at or near the point of generation. 
In particular, hospitals have noted that their difficulties are with 
having an SAA in each hospital room. As a result, the proposed December 
2008 Pharmaceutical Universal Waste rule did not require the 
establishment of any accumulation areas (neither central nor satellite) 
for hazardous waste pharmaceuticals. This proposed approach was 
consistent with the current federal universal waste program, since 
facilities are not required to designate a special centralized area for 
the accumulation of universal wastes, nor are they required to have 
SAAs for universal wastes. Nevertheless, EPA understands that 
healthcare facilities will often accumulate their universal wastes 
within their 90- or 180-day hazardous waste accumulation areas. The 
part 262 generator regulations, including the SAA and CAA regulations, 
were designed more for industrial and manufacturing operations. Part 
266 subpart P is a sector-based regulatory approach designed to work 
better with how the healthcare sector operates. Therefore, consistent 
with the approach initially taken in the Universal Waste proposed 
rulemaking, the Agency designed the proposed standards for healthcare 
facilities accumulating hazardous waste pharmaceuticals under subpart P 
to operate in lieu of the SAA regulations or the CAA regulations (also 
sometimes called `` less than 90- or 180-day are as'').

[[Page 5872]]

2. Summary of Comments
    The majority of commenters on this provision were states. All but 
one state and all other commenters agreed with the proposal to 
eliminate requirements for SAAs and CAAs for healthcare facilities 
managing non-creditable hazardous waste pharmaceuticals. The lone 
dissenting state agreed with eliminating requirements for SAAs but 
expressed concern about not requiring CAAs. They recommended that 
hazardous waste pharmaceuticals be accumulated in or near a 90-day or 
180-day accumulation area for LQGs and SQGs respectively.
3. Final Rule Provisions
    The agency is finalizing the approach for part 266 subpart P to 
operate in lieu of requiring CAAs and SAAs for healthcare facilities 
managing non-creditable hazardous waste pharmaceuticals. The SAA 
regulations, in particular, were not a good fit for how healthcare 
facilities operate. Additionally, there was near-unanimous agreement 
among commenters that SAAs and CAAs are not necessary to accumulate 
hazardous waste pharmaceuticals, further supporting the agency's 
decision.
    Although there is no requirement that a healthcare facility 
accumulate its hazardous waste pharmaceuticals in a CAA, doing so is, 
nonetheless, acceptable. A healthcare facility may choose to accumulate 
hazardous waste pharmaceuticals within its 90-day or 180-day CAA if it 
has one established for its other hazardous wastes, as long as it 
maintains compliance with the accumulation time limit and container 
requirements of 40 CFR part 266 subpart P. If a healthcare facility 
chooses to accumulate its hazardous waste pharmaceuticals in a CAA, 
those hazardous waste pharmaceuticals will only be subject to the 
requirements of part 266 subpart P and not the part 262 hazardous waste 
generator standards.

E. Container Standards for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(d))

1. Summary of Proposal
    The container standards discussed in this section apply to those 
containers used by healthcare facilities to accumulate non-creditable 
hazardous waste pharmaceuticals. First, we would note that due to the 
relatively small quantities of hazardous waste pharmaceuticals that are 
typically accumulated and stored at a healthcare facility, the Agency 
understands that other types of waste management units, such as tanks, 
are not used for the management of waste pharmaceuticals. Therefore, we 
only proposed standards for containers as defined in 40 CFR 260.10. 
However, the Agency solicited comment as to whether other types of 
waste management units are also used by healthcare facilities to 
accumulate and store hazardous waste pharmaceuticals and whether EPA 
should establish technical standards for other types of waste 
management units.
    The Agency proposed to require that healthcare facilities place 
hazardous waste pharmaceuticals into containers that are structurally 
sound and that are compatible with the hazardous waste pharmaceuticals 
that will be contained within them. EPA intends this requirement to 
mean that containers used for holding non-creditable hazardous waste 
pharmaceuticals must be in good condition, with no severe rusting, 
apparent structural defects, nor deterioration. EPA also proposed that 
containers also must not have any evidence of leakage, spillage, or 
damage that could result in the release of waste under reasonably 
foreseeable circumstances. Furthermore, the Agency proposed to require 
that incompatible wastes not be placed in the same container, unless 
the commingling of incompatible hazardous wastes is conducted in such a 
way that it does not have the potential to (1) generate extreme heat or 
pressure, fire or explosion, or violent reaction; (2) produce 
uncontrolled toxic mists, fumes, dusts, or gases in sufficient 
quantities to threaten human health; (3) produce uncontrollable 
flammable fumes or gases in sufficient quantities to pose a risk of 
fire or explosions; (4) damage the structural integrity of the facility 
or container containing the hazardous waste pharmaceuticals; or (5) 
through other like means threaten human health or the environment. For 
example, the majority of a healthcare facility's non-creditable 
hazardous waste pharmaceuticals are likely organic in nature, and thus, 
compatible with each other and can be accumulated together, especially 
since they will most likely be incinerated once they are transported to 
a TSDF.
    The Agency believes that these technical standards, like similar 
technical standards that EPA has promulgated in Sec.  265.17(b) for 
interim status TSDFs,\207\ would ensure that hazardous waste 
pharmaceuticals are properly managed and would not be released into the 
environment, while at the same time providing flexibility to the 
healthcare facility in selecting those containers that are most 
appropriate for their situation.
---------------------------------------------------------------------------

    \207\ Sec.  265.17 General requirements for ignitable, reactive, 
or incompatible wastes is available. https://www.gpo.gov/fdsys/pkg/CFR-2017-title40-vol28/pdf/CFR-2017-title40-vol28-part265.pdf.
---------------------------------------------------------------------------

    In addition to the proposed container standards, the Agency also 
proposed that accumulation containers for hazardous waste 
pharmaceuticals be secured in a manner that prevents unauthorized 
access to the contents in order to prevent the diversion of hazardous 
waste pharmaceuticals or inadvertent exposures to them. Unlike most 
other hazardous wastes, some hazardous waste pharmaceuticals might 
still retain considerable value to individuals or on the black market, 
which can increase the likelihood of diversion for illicit purposes.
    Some non-creditable hazardous waste pharmaceuticals, such as metal-
bearing wastes not containing sufficient organics (e.g., P012, arsenic 
trioxide), are prohibited from being incinerated under the dilution 
prohibition.\208\ Dilution is not a substitute for treatment of certain 
restricted wastes because the hazardous constituents are not destroyed, 
removed, or immobilized before being disposed of on the land.\209\ EPA 
proposed that the hazardous waste pharmaceuticals that cannot be 
incinerated must be accumulated separately from organic wastes destined 
for incineration.
---------------------------------------------------------------------------

    \208\ Sec.  268.3(c) Dilution prohibited as a substitute for 
treatment. See appendix XI of part 268 for a full list of hazardous 
wastes that are prohibited from being combusted.
    \209\ See RCRA Policy Statement: Clarification of the Land 
Disposal Restrictions' Dilution Prohibition and the Combustion of 
Inorganic Metal-Bearing Hazardous Waste. https://www.epa.gov/hw/policy-statement-clarification-dilution-prohibition-and-combustion-inorganic-metal-bearing.
---------------------------------------------------------------------------

2. Summary of Comments
    There was considerable interest in this section with a broad range 
of comments in support, in opposition, and suggesting modifications. 
While some states were in support of the proposed standards, others 
were concerned that they would not be easily understood by healthcare 
facility workers, and that we should provide more detail about what 
constitutes a closed container. There was also a comment that 
recommended we clarify that hazardous waste pharmaceuticals can only be 
accumulated in containers, and not tanks or other accumulation units, 
and also what would constitute an acceptable container. For example, 
the commenter asked if re-sealable plastic storage bags or plastic pill 
bottles are considered a container under this subpart.

[[Page 5873]]

    Commenters from the waste management industry were generally in 
support of the proposed container standards although one commenter took 
issue with the security standards in 40 CFR 266.502(d)(3), stating that 
they are not adequate and recommending that we incorporate existing DEA 
guidance on container security standards. The commenter also suggested 
the final regulations incorporate an additional security provision 
stating that hazardous waste pharmaceuticals be put into a ``product or 
container that is specifically designed to render them inaccessible, 
non-consumable, and/or irretrievable prior to final disposal.'' A 
different waste management company echoed the concerns shared by the 
previously mentioned state that the final rule should specify that 
hazardous waste pharmaceuticals can only be accumulated in containers 
and not in other types of waste accumulation units.\210\ No commenters 
indicated that any other types of waste management units are used to 
accumulate hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \210\ See comment number EPA-HQ-RCRA-2007-0932-0257.
---------------------------------------------------------------------------

    Trade associations representing a range of stakeholders also 
generally supported the proposed provisions but were concerned about 
the requirements to segregate hazardous waste pharmaceuticals that 
cannot be incinerated. One waste treatment trade association 
recommended that the regulatory language that allows the incineration 
of certain mercury-bearing hazardous waste pharmaceuticals be changed 
to discourage the incineration of such wastes even though it is 
permissible. They believe that the proposed language may be interpreted 
as advocating for their incineration. A state association was concerned 
about the possible subjectivity of the language in 40 CFR 
262.502(d)(2), which contains standards for facilities that manage 
ignitable or hazardous waste pharmaceuticals or that mix or commingle 
incompatible wastes in the same container. They recommend instead, that 
the final rule employ the ``traditional prohibition'' on 
incompatibility.\211\
---------------------------------------------------------------------------

    \211\ See comment number EPA-HQ-RCRA-2007-0932-0216.
---------------------------------------------------------------------------

3. Final Rule Provisions
    The Agency is finalizing the container standards for non-creditable 
hazardous waste pharmaceuticals as proposed. A healthcare facility must 
place its non-creditable hazardous waste pharmaceuticals in containers 
that are structurally sound, compatible with the contents, and that 
would prevent any leaks or spills under reasonably foreseeable 
conditions. If incompatible hazardous waste pharmaceuticals are 
commingled in a container, the healthcare facility must manage the 
container such that it does not have the potential to generate 
dangerous heat and/or pressure, emit any toxic substances (e.g., mists, 
fumes, dust), produce flammable fumes or gases, damage the structural 
integrity of the container, or otherwise endanger human health and the 
environment.
    To address the concerns of commenters, EPA would like to emphasize 
that, while it is permissible for hazardous waste pharmaceuticals 
containing metals such as mercury to be incinerated if the total 
organic carbon is greater than 1%,\212\ we strongly recommend that they 
be segregated out and treated via other acceptable methods that comply 
with the land disposal restrictions.
---------------------------------------------------------------------------

    \212\ Sec.  268.3 (c) Dilution prohibited as a substitute for 
treatment.
---------------------------------------------------------------------------

    EPA is clarifying that the container standards like the other 
standards for non-creditable hazardous waste pharmaceuticals do not 
apply to hazardous waste pharmaceuticals that are also DEA controlled 
substances because these DEA controlled substances are conditionally 
exempt from RCRA.\213\ Section XIV further discusses hazardous waste 
pharmaceuticals that are also DEA controlled substances.
---------------------------------------------------------------------------

    \213\ Sec.  266.506.
---------------------------------------------------------------------------

    To reduce the risk of illicit diversion, the Agency is finalizing 
the requirement preventing unauthorized access to the contents of 
containers used to accumulate non-creditable hazardous waste 
pharmaceuticals. EPA intended this requirement to be performance-based 
and did not finalize prescriptive regulatory requirements for this 
standard. Healthcare facilities may choose to utilize containers that 
are designed to prevent unauthorized access to their contents when 
located in areas with uncontrolled access or store containers in areas 
with controlled access, such as locked storage lockers, locked closets, 
or locked rooms, to prevent unauthorized access to the contents of the 
containers. Containers used to accumulate non-creditable hazardous 
waste pharmaceuticals may also be kept behind a pharmacy counter 
because of the restricted access to those areas.
    The Agency received no comments indicating that non-creditable 
hazardous waste pharmaceuticals are accumulated in any waste management 
units other than containers. Therefore, these standards apply only to 
containers used to accumulate non-creditable hazardous waste 
pharmaceuticals. Other types of hazardous waste accumulation units are 
not permitted for the accumulation of non-creditable hazardous waste 
pharmaceuticals.
4. Comments and Responses
    Section (d)(4) of this provision regarding the requirement to 
segregate certain metal-bearing non-creditable hazardous waste 
pharmaceuticals was added as a reminder that, due to existing LDR 
regulations, a few hazardous waste pharmaceuticals cannot be 
incinerated and therefore must be segregated. This is not a new 
requirement for healthcare facilities and does not represent a change 
in the regulatory burden.
    One commenter asked if plastic bags are considered a container as 
defined in Sec.  260.10. If hazardous waste is placed inside a plastic 
bag, it meets the definition of a RCRA container and is subject to all 
applicable standards in 40 CFR 264 subpart I and 40 CFR 265 subpart I. 
Specifically, to be in compliance, a plastic bag must be compatible 
with the waste, able to prevent the contents from leaking, kept closed 
during storage except when it is necessary to add or remove waste, and 
handled or stored in a manner that prevents rupture and/or causes 
leaking. EPA would also note that, even though this commenter did not 
mention other types of containers, that cups, pill bottles, vials, etc. 
are also considered a container under RCRA.\214\
---------------------------------------------------------------------------

    \214\ See memo November 11, 2011, Rudzinski to the Regional RCRA 
Division Directors (RCRA Online #14827).
---------------------------------------------------------------------------

    Regarding the state association that suggested EPA apply the 
``traditional prohibition'' on mixing or commingling incompatible 
wastes in the same container because they were concerned about the 
possible subjectivity of the five specified conditions in 40 CFR 
262.502(d)(2), that regulatory language was taken directly from the 
general requirements for ignitable, reactive, or incompatible wastes, 
in the General Facility Standards at 40 CFR 265.17(b). This is not a 
newly designed requirement. Healthcare facilities that manage hazardous 
waste pharmaceuticals are already required to comply with this 
provision.

[[Page 5874]]

F. Labeling Standards on Containers for Healthcare Facilities Managing 
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(e))

1. Summary of Proposal
    During the period of accumulation, the Agency proposed that 
containers of hazardous waste pharmaceuticals be marked with the words 
``Hazardous Waste Pharmaceuticals.'' The Agency did not propose to 
require that the hazardous waste numbers (often referred to as 
hazardous waste codes) of the container's contents be listed on the 
label. Healthcare personnel (e.g., nurses) typically generate the 
hazardous waste pharmaceuticals. Healthcare personnel are not usually 
intimately familiar with RCRA and its regulations and are primarily 
focused on patients and their health. In addition, while a healthcare 
facility may have an environmental compliance manager or environmental 
consultant that is knowledgeable about RCRA and its regulations and can 
make hazardous waste determinations, this individual cannot be present 
to assign a hazardous waste code and label the collection receptacle 
each time a hazardous waste pharmaceutical is generated. For these 
reasons, EPA did not believe it would be practical to require 
individual hazardous waste codes on the hazardous waste pharmaceutical 
collection container at the healthcare facility.
    The Agency solicited comment on the appropriateness of the proposed 
general labeling requirement. The Agency also requested comment on 
security concerns regarding having the word ``pharmaceutical'' marked 
on the containers.
2. Summary of Comments
    The issues of determining waste codes and whether they should be 
required on labels and/or manifests cuts across a number of provisions 
in this rule. Many commenters intertwined their opinions on container 
labeling standards with manifest requirements, waste code 
determinations by healthcare workers, and LDRs. While the Agency 
understands the inter-relatedness of these issues, this section 
pertains specifically to the proposed standards of requiring the words 
``Hazardous Waste Pharmaceuticals'' on containers used to accumulate 
hazardous waste pharmaceuticals, and whether having the word 
``Pharmaceutical'' displayed on those containers increases the risk of 
illicit diversion. Many of the comments alluded to these container 
labeling requirements during on-site accumulation, but did not address 
them directly, instead focusing on how the proposed labeling standards 
to not require hazardous waste codes on containers will affect the 
manifesting, shipping, and LDR processes. We will address those 
comments in subsequent sections as appropriate.
    States had mixed views with a few voicing support for the proposed 
labeling standards, while another asked that the Agency provide more 
leeway in the required wording on the container label. Another state 
agreed with not requiring individual waste codes, but recommended that 
EPA require some sort of identification of potentially incompatible 
wastes to help prevent their inadvertent mixing. Two states were 
opposed to the proposed standards and recommended requiring individual 
hazardous waste codes on container labels to reduce the risk of 
mismanagement and incorrect treatment.
    One reverse logistics company tacitly agreed with the proposal to 
not require hazardous waste codes on containers (or manifests) and 
instead, write ``Hazardous Waste Pharmaceuticals'' on the container and 
comply with DOT requirements. They expressed agreement with the 
agency's proposal to not require hazardous waste codes on the manifest, 
which leads the Agency to conclude that not requiring hazardous waste 
codes on containers is acceptable to them as well.
    Comments from the waste treatment sector were mixed as well. One 
commenter agreed with the proposal to not require hazardous waste codes 
on container labels but wanted more flexibility in labeling. Other 
commenters from the waste treatment industry were wholly opposed to the 
proposed labeling requirements citing the need for waste codes by TSDFs 
to meet LDR standards.\215\
---------------------------------------------------------------------------

    \215\ See comment numbers EPA-HQ-RCRA-2007-0932-0333 and EPA-HQ-
RCRA-2007-0932-0297.
---------------------------------------------------------------------------

    One medical waste trade association did not explicitly agree that 
hazardous waste codes should not be required on container labels, but 
they did request that, at a minimum, hazardous waste codes should be 
included on the manifest.
    Stericycle initially disagreed with the proposal to require the 
word ``pharmaceutical'' on labels in addition to ``Hazardous Waste'' 
when it commented on the 2008 proposal to add pharmaceuticals to the 
Universal Waste rule. It has subsequently, through first-hand 
experience, determined that including the word ``pharmaceutical'' on 
containers does not increase the risk for illicit diversion. Therefore, 
in its comments to this proposed rulemaking, it is now in support of 
labeling containers of hazardous waste pharmaceuticals with the words 
``Hazardous Waste Pharmaceuticals.''
    Multiple commenters representing regional and national healthcare 
systems currently label their containers with the word 
``pharmaceuticals'' and feel it is appropriate.\216\ A commenter from 
the healthcare waste association also agrees that including the word 
``pharmaceutical'' on containers is current practice and does not 
present any additional risk of diversion.\217\
---------------------------------------------------------------------------

    \216\ See comment number EPA-HQ-RCRA-2007-0932-0297.
    \217\ See comment number EPA-HQ-RCRA-2007-0932-0296.
---------------------------------------------------------------------------

    3. Final Rule Provisions EPA is finalizing the container labeling 
requirements as proposed. Specifically, containers of non-creditable 
hazardous waste pharmaceuticals must be marked with the words 
``Hazardous Waste Pharmaceuticals'' when accumulating on-site. This 
final rule provision is consistent with the container labeling 
requirements in the Hazardous Waste Generator Improvements rule,\218\ 
in that generators are not required to label containers with hazardous 
waste codes during on-site accumulation. Previously, the regulations 
did not specify when hazardous waste codes needed to be added to 
container labels.
---------------------------------------------------------------------------

    \218\ Final rule: November 28, 2016; 81 FR 85808.
---------------------------------------------------------------------------

    The Agency was concerned about increasing the risk of diversion 
resulting from displaying the word ``pharmaceutical'' on a container. 
However, given the general support from commenters, in this final rule, 
EPA is comfortable including the word ``pharmaceutical'' on the label 
of containers used to accumulate hazardous waste pharmaceuticals. There 
was no opposition from commenters representing healthcare systems and 
pharmacy trade groups. In fact, many commented that this is has been 
standard practice for some time and has not resulted in any increased 
diversion.
4. Comments and Responses
    One state was concerned that allowing the commingling of hazardous 
waste pharmaceuticals could inadvertently lead to incompatible 
hazardous waste pharmaceuticals being mixed together, and suggested 
that EPA add a requirement to label containers with potentially 
incompatible wastes. It is the Agency's understanding that there are 
only a few pharmaceuticals that are incompatible according to DOT. 
Pressurized aerosols are the most common, although both DOT and EPA are 
considering relaxing their

[[Page 5875]]

management requirements in the near future. Other DOT incompatible 
wastes include oxidizers, acids, and bases, yet they occur infrequently 
in dosage form.\219\ In addition, there are a limited number of cases 
in which commingled incompatible pharmaceutical waste has caused a 
problem. Therefore, the Agency has determined that the risk does not 
rise to the level of requiring a specific provision and is not 
finalizing any additional labeling requirement for incompatible 
hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \219\ Smith, Charlotte A. ``Managing Pharmaceutical Waste: A New 
Implementation Blueprint.'' Pharmacy Practice News, Special Edition, 
2011.
---------------------------------------------------------------------------

    One commenter from the waste management industry suggested that EPA 
add the flexibility to label containers of hazardous waste 
pharmaceuticals with the words ``hazardous waste'' or other words that 
communicate the hazards per Sec.  262.34(c)(1)(ii).\220\ The Agency is 
not finalizing this suggestion. EPA recently revisited these provisions 
in the 2016 Hazardous Waste Generator Improvements rule to require that 
generators label containers with both the words ``hazardous waste'' and 
other words that indicate the nature of the hazard partially because 
the Agency felt that the previous requirements were too vague. In 
addition, Sec.  262.34 applied only to containers in SAAs whereas there 
are no SAAs in a subpart P healthcare facility.
---------------------------------------------------------------------------

    \220\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the 
docket for this rulemaking. The regulation cited by the commenter 
has been since moved to 262.16(b)(6) as part of the 2016 Hazardous 
Waste Generator Improvements Final Rule.
---------------------------------------------------------------------------

G. Accumulation Time Limits for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(f))

1. Summary of Proposal
    a. One-year accumulation time limit. A few hazardous waste 
pharmaceuticals are P-listed acute hazardous wastes, the most common 
being warfarin. Under the part 262 generator regulations, if a 
generator generates more than 1 kg of acute hazardous waste per 
calendar month, the generator is regulated as an LQG and subject to a 
90-day limit on accumulation. Due to this low generation/accumulation 
threshold associated with P-listed wastes, healthcare facilities are 
often LQGs. However, while healthcare facilities can generate enough P-
listed waste to become LQGs, they often do not generate sufficient 
total amounts of hazardous waste pharmaceuticals within the allowed 
accumulation period of 90 days to make off-site shipments using a 
hazardous waste transporter cost-effective.
    Under the 2008 proposed amendment to add pharmaceuticals to the 
Universal Waste program, handlers of pharmaceutical universal waste 
would have had one year to accumulate their hazardous waste 
pharmaceuticals in order to facilitate proper treatment and disposal. 
Commenters on the proposed 2008 Pharmaceutical Universal Waste rule 
indicated support for the one-year accumulation time limit. Thus, under 
part 266 subpart P, the Agency proposed to allow healthcare facilities 
to accumulate non-creditable hazardous waste pharmaceuticals for up to 
one year without triggering interim status or the need to obtain a RCRA 
permit. EPA proposed one year as an appropriate time frame because it 
strikes a balance between allowing healthcare facilities enough time to 
accumulate enough non-creditable hazardous waste pharmaceuticals to 
make it economically viable to transport their hazardous waste 
pharmaceuticals off site while ensuring that the hazardous wastes are 
not accumulated beyond the one-year storage limit under the LDR program 
(see Sec.  268.50). Under the LDR storage prohibition, the Agency 
assumes that any accumulation for up to one year is for the purpose of 
facilitating proper treatment and disposal.
    EPA proposed that healthcare facilities could use various 
approaches to demonstrate the length of time that non-creditable 
hazardous waste pharmaceuticals are accumulated on site. For example, 
EPA proposed that a healthcare facility can choose to mark the 
container label with the date that accumulation first began, maintain 
an inventory system that identifies dates when the hazardous waste 
pharmaceuticals were first accumulated, identify in the accumulation 
area the earliest date that a hazardous waste pharmaceutical became a 
hazardous waste, or any other method that clearly demonstrates the 
length of time that the hazardous waste pharmaceutical has been 
accumulated from the date it became a hazardous waste.
    b. Extensions to accumulation time limits. In the proposed time 
frames to accumulate non-creditable hazardous waste pharmaceuticals, 
EPA included a provision that allowed any healthcare facility needing 
longer than the one-year accumulation time frame to request an 
extension from the appropriate EPA Regional Administrator. The Agency 
provided several examples of situations when a healthcare facility 
might request an extension. The reasons included litigation (now 
referred to as preservation orders, investigations or judicial 
proceedings),\221\ recalls, and circumstances that are beyond the 
control of the healthcare facility. The proposed extension provision 
required that healthcare facilities send a request in writing 
(electronic or paper) to the Regional EPA Administrator explaining the 
need for the extension, the approximate amount of hazardous waste 
pharmaceuticals to be accumulated beyond the one year, and the amount 
of extra time requested. The Agency then proposed to allow the Regional 
Administrator the discretion to grant, modify, or deny the requested 
extension on a case-by-case basis. Lastly, the Agency solicited comment 
on the proposed mechanism to request a time extension.
---------------------------------------------------------------------------

    \221\ Subsequent to the proposal, the Agency became aware that 
the term ``litigation'' was not sufficiently broad to encompass all 
of the legal actions that might require a hazardous waste 
pharmaceutical to be preserved. To maintain consistency throughout 
the final rule, all instances where the term ``litigation'' or 
``litigation holds'' appeared in the proposed rule have been changed 
to ``preservation order, investigation, or judicial proceeding,'' 
except in this section which discusses what was proposed.
---------------------------------------------------------------------------

2. Summary of Comments
    a. One-year accumulation time limit. One commenter from industry 
agreed with the proposed time limits, but expressed concern about the 
ability of a healthcare facility to track accumulation times of their 
waste, and recommended that there be an additional requirement to 
inventory container contents in a manner that will ensure that the 1-
year limit is not exceeded. Another state commenter also recommended 
that Sec.  266.502(f)(2)(iv), which would have allowed containers to be 
marked in ``any other method which clearly demonstrates the length of 
time that the non-creditable hazardous waste pharmaceuticals have been 
accumulating from the date it first became a waste,'' be eliminated 
because it is too vague.
    b. Extensions to accumulation time limits. The proposed extension 
provisions were opposed by a majority of commenters from both industry 
and state governments. Industry commenters were concerned about the 
additional burden that would likely arise from having to generate, 
transmit, and maintain an additional set of records for a scenario (the 
need to accumulate hazardous waste pharmaceuticals beyond the one-year 
allotment) that they say occurs more often than EPA seems to have been 
aware of at the time of proposal. Similarly, many state agencies were 
concerned about the added burden that would be imposed by a novel

[[Page 5876]]

source of administrative workload in the form of written requests that 
must be processed, analyzed, afforded appropriate consideration/
discretion, and responded to. In addition, many commenters mentioned 
the possibility that these provisions would conflict with existing 
federal regulations, those of FDA for recalls, in particular. Other 
commenters brought up similar concerns about pharmaceuticals being 
stored pursuant to a litigation hold because of their protracted and 
unpredictable nature.
3. Final Rule Provisions
    a. One-year accumulation time limit. The Agency is finalizing a 
one-year accumulation time limit for healthcare facilities accumulating 
non-creditable hazardous waste pharmaceuticals. Healthcare facilities 
may use one of three approaches to demonstrate the length of time that 
non-creditable hazardous waste pharmaceuticals are accumulated on site. 
A healthcare facility can choose to mark the container label with the 
date that accumulation first began, maintain an inventory system that 
identifies dates when the hazardous waste pharmaceuticals were first 
accumulated, or identify in the accumulation area the earliest date 
that a hazardous waste pharmaceutical became a hazardous waste.
    The Agency reiterates that the one-year accumulation time limit 
only applies to a healthcare facility's non-creditable hazardous waste 
pharmaceuticals and does not apply to any other types of non-
pharmaceutical hazardous waste generated on-site nor to potentially 
creditable hazardous waste pharmaceuticals.
    The provision in Sec.  266.502(f)(2)(iv) has been eliminated. It 
would have allowed for the accumulation start date to be labeled in any 
manner that clearly indicates the length of time that it first began 
accumulating non-creditable hazardous waste pharmaceuticals. One 
commenter argued that the provision was overly broad and EPA agreed.
    b. Extensions to accumulation time limits. The Agency is not 
finalizing any of the proposed provisions in Sec.  266.502(f)(3) that 
would have allowed a healthcare facility to request an extension of the 
one-year accumulation period for non-creditable hazardous waste 
pharmaceuticals and has addressed commenter concerns in other areas of 
the rule.
    Recalls and preservation orders, investigations, or judicial 
proceedings (formerly referred to as litigation in the proposed 
rulemaking) were the two specific situations that the Agency attempted 
to address in the proposal as examples of unforeseen circumstances 
beyond the control of the healthcare facility. Pharmaceuticals that are 
subject to a voluntary or federally-mandated recall (most likely 
overseen by FDA, rarely CPSC) must be managed according to the 
requirements of either one or both agencies, as appropriate. Although 
many of these items could likely be considered RCRA solid waste, EPA is 
choosing not to apply RCRA regulations upon recalled pharmaceuticals 
that are managed under a voluntary or federally-mandated recall until a 
decision is made to destroy those items either in part or in whole. 
Similarly, the agency also determined that pharmaceuticals being stored 
pursuant to a preservation order, investigation, or judicial proceeding 
are not RCRA hazardous waste. Both scenarios are addressed in the 
Applicability section of the final rule in the preamble and regulations 
(see Sec. Sec.  266.501(g)(4) and 266.501(g)(5)). Because 
pharmaceuticals that have been recalled and/or are being stored 
pursuant to a preservation order, investigation, or judicial proceeding 
are not subject to this subpart, the Agency does not see the need to 
include a provision for extending accumulation time. Recall managers 
(likely reverse distributors) and states will not be burdened by 
producing and responding to such requests.
    The proposed rulemaking also discussed other unforeseen 
circumstances (other than a recall or preservation order, 
investigation, or judicial proceeding) as a legitimate reason for 
requesting an extension of the one-year period to accumulation of non-
creditable hazardous waste pharmaceuticals. However, the only 
circumstances mentioned by commenters that would necessitate an 
extension were recalls and litigation (preservation orders, 
investigations, or judicial actions). Because both of those scenarios 
are now addressed individually in the finalized Applicability section 
of the preamble and regulations, and have no associated accumulation 
time limits, the Agency saw no need to codify a provision to allow a 
healthcare facility to request an extension of the accumulation time 
limit for other reasons beyond their control. Therefore, the EPA is not 
finalizing the proposal to allow healthcare facilities to request an 
extension of the one-year accumulation time frame from the Regional 
Administrator for any reason.

H. Land Disposal Restrictions for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(g) and Sec.  
266.502(d)(4))

1. Summary of Proposal
    As required by HSWA and consistent with part 262 generator 
requirements, EPA proposed that healthcare facilities must comply with 
the LDR requirements prior to land disposal of the hazardous waste 
pharmaceuticals they generate. Since healthcare facilities are 
generators, even though they are not subject to the 40 CFR part 262 
requirements for the management of hazardous waste pharmaceuticals, we 
proposed that they must comply with the LDR requirements found at 40 
CFR part 268. The LDRs required by HSWA are in place to ensure that 
toxic constituents present in hazardous waste are properly treated to 
reduce their mobility or toxicity before hazardous waste is placed into 
or onto the land (i.e., land disposed). With limited exceptions, 
hazardous waste must be treated by a RCRA-permitted or interim status 
TSDF.
    In general, generators of hazardous waste assign the appropriate 
hazardous waste numbers (commonly called hazardous waste codes) to 
allow TSDFs to determine the specific treatment standard(s) for each 
prohibited waste. The Agency proposed that healthcare facilities 
generating non-creditable hazardous waste pharmaceuticals do not have 
to label the containers with the words ``hazardous waste'' or the 
hazardous waste codes when transporting them off site, but rather must 
label the containers with the words ``hazardous waste 
pharmaceuticals.'' Healthcare facilities do, however, need to make 
determinations as to whether wastes must be treated to meet LDR 
treatment standards. While most hazardous waste pharmaceuticals are 
likely organic in nature and may be incinerated, some hazardous waste 
pharmaceuticals may not be suitable for incineration and, therefore, 
must be segregated from the organic wastes. The hazardous waste 
pharmaceuticals not suitable for incineration include characteristic 
metal wastes (i.e., D004-D043) prohibited from being combusted because 
of the dilution prohibition of Sec.  268.3(c), as well as the listed 
wastes U151 (mercury), U205 (selenium sulfide), and P012 (arsenic 
trioxide), unless they contain greater than 1% total organic carbon. 
Put another way, hazardous waste pharmaceuticals with these metals that 
also contain greater than 1% total organic carbon may be incinerated.

[[Page 5877]]

In order to comply with the LDRs, healthcare facilities will need to 
segregate these wastes from the organic hazardous waste pharmaceuticals 
so that they can be properly treated by the TSDF. Although the Agency 
did include a requirement to segregate these metal-bearing low total 
organic carbon hazardous waste pharmaceuticals in proposed Sec.  
266.502(d)(4), the Agency requested comment on whether it is necessary 
to incorporate into the regulations at Sec.  266.502(g) a requirement 
to segregate these wastes and whether additional labeling requirements 
are necessary to identify the hazardous waste pharmaceuticals that are 
not suitable for incineration.
    Because EPA proposed that containers of non-creditable hazardous 
waste pharmaceuticals would not be required to list the hazardous waste 
codes on the label, we also proposed that waste codes are not required 
on the LDR notification.
2. Summary of Comments
    There were a variety of comments on this provision, primarily 
regarding four issues: (1) The segregation of hazardous waste 
pharmaceuticals unsuitable for incineration, (2) the incineration of 
hazardous waste pharmaceuticals with numeric treatment standards, (3) 
the LDR notification, and (4) the need for hazardous waste 
pharmaceuticals-specific waste code and treatment standard.
    Commenters from both states and the waste management industry 
requested that the agency add a requirement for healthcare facilities 
to segregate any hazardous waste pharmaceuticals that are unsuitable 
for incineration into separate containers and label them with the 
appropriate waste codes. They argued that there would be an increased 
likelihood that pharmaceuticals containing metals subject to the 
dilution prohibition would be inadvertently incinerated, resulting in 
noncompliance with LDR standards.
    Many waste management companies expressed concern about their 
ability to meet LDR standards without knowing specific waste codes and 
the added burden they would incur from having to test their ash for the 
seven hazardous waste pharmaceuticals with numeric treatment 
standards--lindane, chloroform, m-cresol, dichlorodifluoromethane, 
trichloromonofluoromethane, phenacetin and phenol.\222\ They did, 
however, agree that healthcare workers should not have to make 
hazardous waste determinations. They stated that they would have to 
alter or augment their testing protocols for residual ash which would 
add undue burden. One commenter suggested that, at a minimum, 
segregation be performed before a shipment of hazardous waste 
pharmaceuticals are transported off site for disposal, but having waste 
codes either on a label or the manifest would be preferable. They 
generally stated that they do not feel waste management should bear all 
of the added burden of LDR compliance under this rule.
---------------------------------------------------------------------------

    \222\ See 40 CFR 268.40 table ``Treatment Standards for 
Hazardous Wastes,'' which identifies maximum concentration values 
for all hazardous constituents in the waste/treatment residue prior 
to land disposal.
---------------------------------------------------------------------------

    Another common theme among commenters, from the waste management 
industry in particular, was a recommendation for a new, single 
hazardous waste code for all hazardous waste pharmaceuticals with a 
corresponding alternate treatment of standard of combustion (CMBST). 
One commenter representing the retail industry expressed concern that 
the relief provided by this rule will be negated by the requirement to 
list waste codes on the LDR notice.
3. Final Rule Provisions
    The Agency is finalizing the LDRs for non-creditable hazardous 
waste pharmaceuticals as proposed. The non-creditable hazardous waste 
pharmaceuticals generated by a healthcare facility are subject to the 
LDRs of 40 CFR part 268. A healthcare facility that generates hazardous 
waste pharmaceuticals must comply with the land disposal restrictions 
in accordance with Sec.  268.7(a) requirements, except that it is not 
required to identify the hazardous waste numbers (i.e., hazardous waste 
codes) on the LDR notification.
    To address commenters' concerns about whether hazardous waste codes 
are required on the LDR notification, the Agency has added clarifying 
language to specify that waste codes are, in fact, not required on the 
LDR notification. The Agency would note, however, that the proposed 
regulatory language did, in fact, specify in Sec.  266.502(g) that 
waste codes are not required on the LDR notice. Due to the number of 
commenters who were under the impression that waste codes would still 
be required on the LDR notice, we added an additional clarification to 
make it more obvious that waste codes are not required on the LDR 
notice.
    The final rule requires healthcare facilities that generate non-
creditable hazardous waste pharmaceuticals to comply with the LDRs. In 
response to comments, we have made one minor change for added clarity. 
The Agency has added a requirement to Sec.  266.502(d)(4) for 
healthcare facilities that generate non-creditable hazardous waste 
pharmaceuticals that are unsuitable for incineration to segregate them 
into separate containers from those containing commingled non-
creditable hazardous waste pharmaceuticals, and label them with the 
appropriate hazardous waste codes. We would note, however, that the 
dilution prohibition of Sec.  268.3 already necessitates such 
segregation, therefore, this addition in Sec.  266.502 (d)(4) is for 
the purposes of clarity and does not substantially change any of the 
proposed LDR requirements for hazardous waste pharmaceuticals.
4. Comments and Responses
    Waste management companies opposed the provision to not require 
healthcare facilities to label containers with hazardous waste codes 
because of the added burden they argue would result from having to 
conduct additional testing for pharmaceuticals with numeric treatment 
standards. Nevertheless, the Agency is not finalizing a requirement for 
healthcare facilities to label containers of non-creditable hazardous 
waste pharmaceuticals with hazardous waste codes, nor is the Agency 
finalizing any additional requirements for healthcare facility 
personnel to segregate the seven pharmaceuticals that have numeric 
treatment standards, although a vendor could include such a requirement 
in its contract with a healthcare facility.
    Unlike metal-bearing hazardous waste pharmaceuticals that may not 
be incinerated, the seven hazardous waste pharmaceuticals with 
numerical treatment standards may be incinerated or treated using any 
other treatment method to meet LDR values. Therefore, the Agency thinks 
it would cause confusion and add burden to require healthcare 
facilities to segregate the hazardous waste pharmaceuticals with 
numeric treatment standards. Further, the Agency has determined that 
several of the seven organics with numeric treatment standards also 
appear in non-pharmaceutical hazardous waste, which means that 
hazardous waste combustors are already required to test their ash to 
ensure compliance with LDRs for those constituents.
    Because this rule does not require that healthcare facilities label 
their waste with the hazardous waste codes, TSDFs will now have to 
analyze their incinerator residue (ash) for the seven organics that 
have numerical treatment standards according to the conditions 
established in the facility waste analysis plan, as they could possibly 
be present in any shipment of organic hazardous

[[Page 5878]]

waste pharmaceuticals or treatment residues. Organic hazardous waste 
pharmaceuticals (other than arsenic trioxide) may all be incinerated at 
RCRA-permitted or interim status hazardous waste combustors. Most 
organic wastes have a specified treatment standard of combustion 
(CMBST). The remaining seven organics have numerical treatment 
standards, such that no particular treatment technology is required to 
achieve the numerical LDR treatment standards. While these wastes may 
be incinerated, the ash must be analyzed for these seven organic 
constituents to demonstrate compliance with the LDR treatment standards 
before that ash can be land disposed. The Agency is not finalizing any 
standards that would affect the frequency of testing, simply that TSDFs 
test their ash for these seven constituents as part of their existing 
protocol.
    EPA is not finalizing recommendations from commenters that the 
Agency implement a new waste code or alternative treatment standards 
specifically for hazardous waste pharmaceuticals. Because the Agency 
did not propose any new waste codes or treatment standards for 
hazardous waste pharmaceuticals, the recommendation is outside the 
scope of this rule. The Agency does agree that implementing an 
alternative treatment standard of combustion for hazardous waste 
pharmaceuticals that currently have numeric treatment standards would 
be a viable solution to mitigate any added burden imposed on TSDFs that 
will have to modify their testing protocol; however, we did not receive 
the necessary data to propose such a change prior to proposal, and 
therefore cannot finalize an alternative treatment standard in this 
rule. The Agency is, however, open to considering alternative treatment 
standards for hazardous waste pharmaceuticals in possible future 
rulemakings.
    In their comments on this rule and the 2008 Universal Waste 
proposal, Environmental Technology Council (ETC) suggested revising the 
treatment standards for the organic hazardous waste pharmaceuticals 
that have numerical treatment standards to the specified treatment 
standard of combustion. Specifying combustion would relieve the TSDFs 
from demonstrating compliance with the numerical treatment 
standards.\223\ EPA explored the feasibility of making combustion an 
alternative treatment standard for the seven organic hazardous waste 
pharmaceuticals that currently have numeric LDR treatment standards. In 
fact, EPA notes that the numerical treatment standards were developed 
based on levels achieved through combustion. However, EPA has indicated 
a preference for numerical treatment standards over specifying 
treatment standards whenever possible, to allow maximum flexibility. 
Furthermore, it is not clear that pharmaceuticals would be the sole 
source of the seven organic constituents in question. Therefore, even 
if we proposed an alternative treatment standard of combustion for the 
seven organic pharmaceuticals, hazardous waste combustors would still 
be required to test their ash for these constituents to demonstrate 
compliance with numeric treatment standards if they received the 
organics from another, non-pharmaceutical source.
---------------------------------------------------------------------------

    \223\ Prohibited waste may be land disposed if it is treated 
using the technology specified in the table (e.g., CMBST:''), which 
are described in detail in Sec.  268.42, Table 1--Technology Codes 
and Description of Technology-Based Standards.
---------------------------------------------------------------------------

    Again, EPA notes that autoclaving is not an acceptable method of 
treating hazardous waste.\224\
---------------------------------------------------------------------------

    \224\ See section VII.D.1.b for further discussion.
---------------------------------------------------------------------------

I. Procedures for Healthcare Facilities Managing Rejected Shipments of 
Non-Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(h))

1. Summary of Proposal
    In rare circumstances, a healthcare facility may send its non-
creditable hazardous waste pharmaceuticals to a designated facility 
that is unable to manage the hazardous waste. For such situations, we 
proposed that healthcare facilities follow the same procedures listed 
in 40 CFR part 262 (see Sec.  262.23(f)). EPA believes that it is 
appropriate to continue current practices for rejected shipments that 
are part of the generator regulations of 40 CFR part 262 because 
rejected shipments are relatively rare and the procedures currently 
used for rejected shipments is relatively straightforward. In addition, 
healthcare facilities should be familiar with these procedures already.
2. Summary of Comments
    There were relatively few comments on this section of the proposed 
rulemaking. One state and one waste management company agreed with the 
standards as proposed. Another state suggested that, as written, the 
regulatory language contradicts itself. Specifically, the commenter 
said that proposed Sec.  266.502(h)(4) implies that a healthcare 
facility that receives a rejected shipment of non-creditable hazardous 
waste pharmaceuticals (a shipment that it initiated) must offer it for 
shipment to a new designated facility upon receipt, as opposed to the 
90-day additional accumulation period mentioned in Sec.  266.502(h). 
They reason that, because there are no time frames in the requirement, 
the Agency intended to mean upon receipt.
3. Final Rule Provisions
    The agency is finalizing the provisions in this section as proposed 
with the added clarification that a healthcare facility that sends a 
shipment of non-creditable hazardous waste pharmaceuticals to a 
designated facility must have an understanding that the designated 
facility can accept and manage the waste. However, if the healthcare 
facility later receives the shipment back as a rejected load, the 
healthcare facility must sign the manifest that was used to return the 
shipment, provide the transporter a copy of the manifest, send a copy 
of the manifest within 30 days to the designated facility that returned 
the shipment and ship the non-creditable hazardous waste 
pharmaceuticals to a new designated facility. The Agency also added 
additional clarification to Sec.  266.502(h)(4), to respond to 
comments, specifying that a healthcare facility has up to 90 days to 
ship the rejected shipment to a new designated facility.

J. Reporting Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(i))

1. Summary of Proposal
    We proposed that healthcare facilities that are required to submit 
a BR would no longer be required to include their non-creditable 
hazardous waste pharmaceuticals in the report. In addition, the Agency 
proposed that healthcare facilities managing non-creditable hazardous 
waste pharmaceuticals have reporting requirements similar to generators 
regulated under 40 CFR part 262--that is, the exception reporting 
requirement under Sec.  262.44(b) and the additional reporting 
requirement under Sec.  262.44(c).
    We proposed to incorporate and adapt the generator exception 
reporting procedures of 262.44(b) for this new subpart. Specifically, 
we proposed that if a healthcare facility does not receive a copy of 
the hazardous waste manifest from the designated facility within 60 
days, the healthcare facility must submit to the EPA Regional 
Administrator a copy of the manifest with a statement that the 
healthcare facility did not

[[Page 5879]]

receive confirmation of the non-creditable hazardous waste 
pharmaceuticals' delivery, along with an explanation of the efforts 
taken to locate the non-creditable hazardous waste pharmaceuticals and 
the results of those efforts. Likewise, we proposed that if a shipment 
of non-creditable hazardous waste pharmaceuticals from a healthcare 
facility is rejected by the designated facility and it is shipped to an 
alternate facility and if the healthcare facility does not receive a 
signed copy of the hazardous waste manifest from the alternate facility 
within 60 days, it must submit to the EPA Regional Administrator a copy 
of the hazardous waste manifest with a statement that the healthcare 
facility did not receive confirmation of the non-creditable hazardous 
waste pharmaceuticals' delivery along with an explanation of the 
efforts taken to locate the non-creditable hazardous waste 
pharmaceuticals and the results of those efforts.
    Finally, the Agency proposed that the Administrator may require 
healthcare facilities to furnish additional reports concerning the 
quantities and disposition of hazardous waste pharmaceuticals. This is 
already the case for generators operating under the 40 CFR part 262. As 
with 40 CFR part 262, it is a codification of statutory authority under 
Sec. Sec.  2002(a) and 3002(a)(6) that provides the Agency some 
flexibility in what reports may be required.
2. Summary of Comments
    The Agency received few comments on this subsection. Comments 
primarily addressed there being no requirement to include hazardous 
waste pharmaceuticals on the BR, and opinions were mixed. All pharmacy 
trade groups that commented were in favor of the proposal to not 
require hazardous waste pharmaceuticals managed under part 266 to be 
reported on the BR. States that commented were split. One state opposed 
the proposal and argued it would hinder the state's ability to 
reconcile what is treated at a TSDF with what is generated at a 
healthcare facility. Another state disagreed with the proposed 
provision and argued states will be forced to establish their own 
reporting requirements at the state level, leading to inconsistency in 
the way states determine their reporting fees. Another state was in 
agreement with the proposed provision, stating that information 
regarding amounts of non-creditable hazardous waste pharmaceuticals 
generated and treated can be captured from reverse distributor and TSDF 
reporting. One other state pointed out that the lack of a requirement 
for healthcare facilities to determine waste codes would make reporting 
in the BR difficult, if not impossible.
    Regarding the exception reporting requirements, one state suggested 
that Sec.  266.502(i)(2)(ii)(A) and (B) are unnecessary because the 
requirements in Sec.  266.502 (i)(2)(i)(A) and (B) for a healthcare 
facility that does not receive a signed copy of the manifest within 60 
days of being accepted by the initial transporter are the same, whether 
the shipment is lost or rejected and transferred to a new designated 
facility. The state suggested that Sec.  266.502(i)(2) should be 
rewritten to simply state that an exception report is only necessary if 
the healthcare facility has not received the signed manifest from the 
TSDF within 60 days. One healthcare provider suggested that the 
proposed 60-day period for a healthcare facility to receive the 
manifest from the TSDF should be shortened to 45 days because shipments 
of other non-pharmaceutical hazardous waste require receipt of the 
manifest from the TSDF within 45 days.
3. Final Rule Provisions
    The reporting requirements for healthcare facilities managing non-
creditable hazardous waste pharmaceuticals are being finalized as 
proposed. That is, non-creditable hazardous waste pharmaceuticals 
managed under this subpart at a healthcare facility are not required to 
be reported on the BR, healthcare facilities must submit an exception 
report to the Regional Administrator if they have not received a signed 
copy of the manifest within 60 days of the initial transporter 
accepting the shipment, and the Agency may require a healthcare 
facility to furnish additional reports regarding the quantity and 
disposition of non-creditable hazardous waste pharmaceuticals. When 
managing rejected shipments, the Agency believes it is advantageous to 
use established procedures that should be familiar to healthcare 
facilities, especially given that rejected shipments are relatively 
rare.
    To clarify, the exception reporting regulations for healthcare 
facilities differ from the exception reporting regulations for reverse 
distributors because they were based on the differing Sec.  262.42 
exception reporting for LQGs and SQGs. The exception reporting 
regulations for healthcare facilities were based on the corresponding 
Sec.  262.42(b) SQG regulations, whereas the reverse distributor 
exception reporting regulations were based on the Sec.  262.42(a) LQG 
regulations.
    Although commenters voiced some concern about not knowing the 
volume of non-creditable hazardous waste pharmaceuticals being 
generated at healthcare facilities, the Agency believes it is 
unnecessary to require healthcare facilities generating non-creditable 
hazardous waste pharmaceuticals to report this information. If a state 
or region wants to obtain such information, it can examine hazardous 
waste received forms in the BR submission from TSDFs. Further, one of 
the goals of this final rule is to reduce burden on healthcare 
facilities so that they will be encouraged to manage all of their waste 
pharmaceuticals under part 266 subpart P. Requiring a healthcare 
facility to report hazardous waste pharmaceuticals on its BR would 
discourage them from managing non-hazardous waste pharmaceuticals as 
hazardous. Finally, we would note that this approach is consistent with 
the Universal Waste program upon which the healthcare facility 
standards are based. Universal wastes managed under part 273 are not 
reported on the BR.
4. Comments and Responses
    As part of the part 262 generator regulations, healthcare 
facilities that are LQGs must submit a BR to the Regional Administrator 
by March 1st of every even numbered year (see Sec.  262.41). Among 
other requirements, the BR must include a description (EPA hazardous 
waste number and DOT hazard class) and quantity of each hazardous waste 
shipped off-site to a TSDF during each odd numbered year. If a 
healthcare facility is an LQG due to its non-pharmaceutical hazardous 
waste, it will continue to be required to submit a BR under part 262. 
However, it need not include in its BR hazardous waste pharmaceuticals 
managed under part 266. As discussed previously, the Agency is no 
longer requiring healthcare facilities to count hazardous waste 
pharmaceuticals managed under part 266 when determining their generator 
category under part 262. Instead, all healthcare facilities, with the 
exception of VSQGs, will be subject to this final rule for the 
management of hazardous waste pharmaceuticals. The Agency has 
determined that it does not need the information to be included in the 
BR because this final rule will bring a consistent approach to managing 
hazardous waste pharmaceuticals.
    One commenter suggested that the time frame within which a 
healthcare facility must receive a signed manifest be shortened from 60 
days to 45. The Agency did not finalize that request

[[Page 5880]]

because many standards in this final rule were based upon SQG and 
universal waste standards. Since no manifest is required for transport 
and there is no exception reporting standard in the Universal Waste 
program, the Agency used the 60-day time frame in the part 262 SQG 
standards. LQGs have a 45-day time frame to receive a signed manifest 
from a designated facility. Therefore, shortening the exception 
reporting time frame from 60 days to 45 would not be consistent with 
the goals of this rule to relieve the burden of LQG standards on 
healthcare facilities managing non-creditable hazardous waste 
pharmaceuticals.
    The Agency is not finalizing the suggestion to unify the language 
in Sec.  266.502(i)(2) to cover both missing and rejected shipments. 
The proposed language was taken from the generator requirements in 
Sec.  262.42, which addresses both situations separately. The Agency is 
not aware of the existing approach creating any problems for generators 
and is finalizing the regulatory language as proposed.

K. Recordkeeping Requirements for Healthcare Facilities Managing Non-
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.502(j))

1. Summary of Proposal
    The Agency proposed that healthcare facilities managing non-
creditable hazardous waste pharmaceuticals maintain records similar to 
the records that must be kept by generators regulated under 40 CFR part 
262 (see Sec.  262.40). Specifically, we proposed that healthcare 
facilities must keep a signed copy of each hazardous waste manifest as 
a record for three years from the date that the non-creditable 
hazardous waste pharmaceutical was accepted by the initial hazardous 
waste transporter. If the healthcare facility is required to file an 
exception report because it does not receive a signed copy of the 
manifest from the designated facility within 60 days of the date that 
the hazardous waste pharmaceutical was accepted by the initial 
transporter, then the healthcare facility must keep a copy of each 
exception report for a period of at least three years from the date of 
the report. In addition, EPA proposed that a healthcare facility must 
keep records of any test results, waste analyses or other 
determinations made on hazardous waste pharmaceuticals regarding which 
pharmaceuticals are hazardous wastes for three years from the date of 
the test, analysis, or other determination. The Agency also proposed 
that any of the retention periods be automatically extended during the 
course of ongoing enforcement actions against any activity associated 
with hazardous waste pharmaceutical management or as requested by the 
Regional Administrator to ensure that the appropriate records are 
available and can be reviewed as part of any enforcement action.
2. Summary of Comments
    There were very few comments on this proposed provision. All but 
one of the commenters were states, all of which agreed with the 
proposed standard. One commenter suggested that we specify that all 
three types of records (manifest, exception reports, and test results/
analysis/waste determinations) be kept on site.
3. Final Rule Provisions
    The recordkeeping requirement is being finalized as proposed, with 
two changes. First, the Agency added a fifth provision in Sec.  
266.502(j)(5) to address comments requesting that all records be kept 
on site. The added provision also requires that all records must be 
readily available upon request by an inspector. The Agency understands 
that some records may be kept at off-site locations (e.g., 
headquarters), which is acceptable as long as those records are able to 
be produced in a timely manner upon the request of an inspector.
    The second change was an addition to Sec.  266.502(j)(3) that 
relieves a healthcare facility from the requirement to retain 
documentation of hazardous waste determinations in Sec.  266.502(c) if 
it chooses to manage all of its non-creditable waste pharmaceuticals as 
hazardous waste under subpart P. As discussed elsewhere, a goal of this 
rule is to encourage healthcare facilities to manage all of their waste 
pharmaceuticals under subpart P to reduce the amount of pharmaceuticals 
entering surface and groundwater via sewering and landfill leachate. 
The relief provided in Sec.  266.502(j)(3) provides additional 
incentive for healthcare facilities to manage their non-creditable non-
hazardous pharmaceutical waste under subpart P.
    A healthcare facility must keep a copy of the signed manifest for a 
period of at least three years from the date the shipment was accepted 
by the initial transporter. A healthcare facility must also keep a copy 
of any exception report for a period of at least three years from the 
date of the report. To make the recordkeeping consistent with the 2016 
Generator Improvements final rule, a healthcare facility must keep any 
information used to support its hazardous waste determination for at 
least three years from the date the waste was last sent to on-site or 
off-site treatment, storage or disposal, unless it chooses to manage 
all of its non-creditable pharmaceutical waste as hazardous waste under 
subpart P. The periods of retention will be automatically extended in 
the event of any enforcement activity or as requested by the Regional 
Administrator.

L. Response to Spills for Healthcare Facilities Managing Non-Creditable 
Hazardous Waste Pharmaceuticals (Sec.  266.502(k))

1. Summary of Proposal
    For non-creditable hazardous waste pharmaceuticals generated and 
managed by healthcare facilities under this subpart, the Agency 
proposed basic spill response requirements, including the requirement 
that healthcare facilities immediately contain all spills of, and other 
residues from, hazardous waste pharmaceuticals. In addition, we 
proposed that healthcare facilities determine whether any material 
(e.g., residue, contaminated clean-up materials, or debris resulting 
from the spill) is or contains a hazardous waste pharmaceutical and, if 
so, that the healthcare facility manage it under the management 
standards for non-creditable hazardous waste pharmaceuticals. 
Commenters to the original 1993 proposed rulemaking for establishing 
the Universal Waste program overwhelmingly supported these release 
response measures (60 FR 25528; May 11, 1995). Thus, we believe it was 
appropriate to include them again in this proposal for healthcare 
facilities managing non-creditable hazardous waste pharmaceuticals 
since it was based on the Universal Waste program.
2. Summary of Comments
    One waste management company was in support of the proposed 
standards while another voiced its concern with the proposed preamble 
language discussing the requirement to report releases into the 
environment greater than the reportable quantity without knowing the 
waste codes of the wastes that had been spilled. They recommended that 
the Agency establish a reportable quantity for hazardous waste 
pharmaceuticals so large releases are appropriately reported to EPA. 
Similarly, one pharmacist trade association recommended that the Agency 
define what constitutes a release because the proposed regulatory 
language and preamble are unclear, and therefore it is also unclear 
when a release needs to be reported to the Agency.

[[Page 5881]]

    One state commenter pointed out that these standards should also 
apply to healthcare facilities that accumulate potentially creditable 
hazardous waste pharmaceuticals. They recommend that this standard 
apply to all hazardous waste pharmaceuticals and that after a spill is 
cleaned up, the determination of credit potential must be made again. 
All other states agreed with the proposed standards for responding to 
spills.
3. Final Rule Provisions
    The standards in this subsection are being substantially finalized 
as proposed with two changes.
    First, we changed the word ``release'' to ``spill'' in the 
regulations in response to a commenter that expressed concern about 
having to comply with CERCLA requirements for spills of non-creditable 
hazardous waste pharmaceuticals. It was not the Agency's intent to 
imply that spills occurring inside a healthcare facility are 
automatically subject to CERCLA. The proposed preamble language was 
intended to differentiate between three scenarios: Spills that are 
cleaned up immediately, spills that are not cleaned up immediately, and 
releases to the environment. Spills that are cleaned up immediately 
must be managed under this subpart. Spills that are not cleaned up 
immediately would generally constitute illegal disposal, which may 
result in further action by EPA or an authorized state. The proposal 
also mentioned that hazardous waste is included in the definition of 
hazardous substance under CERCLA, and any release to the environment 
would trigger CERCLA authority in addition to RCRA. In many cases, a 
spill of a hazardous waste pharmaceuticals that occurs inside a 
healthcare facility does not constitute a release to the environment 
under CERCLA.\225\ Therefore, this standard applies to spills that do 
not constitute a release to the environment, and there are no reporting 
requirements for spills unless they result in a release to the 
environment. This requirement makes no assertions about when or how 
CERCLA applies to spills of both non-creditable hazardous waste 
pharmaceuticals and potentially creditable hazardous waste 
pharmaceuticals. The new terminology is also consistent with the term 
used in the definition of non-creditable hazardous waste 
pharmaceuticals in Sec.  266.500, which refers to spills as opposed to 
releases.
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    \225\ Spills are likely to occur upon impermeable surfaces both 
inside of and outside of a healthcare facility which limits the 
potential for release into the environment. Under CERCLA, a release 
to the environment also includes releases into the atmosphere. Since 
many pharmaceuticals are in pill form, spilled pharmaceuticals would 
rarely, constitute a release to the environment under CERCLA.
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    Second, we addressed the comment from the state that requested a 
clarification regarding whether the spill response requirements apply 
to potentially creditable hazardous waste pharmaceuticals and non-
creditable hazardous waste pharmaceuticals. The Agency agrees that the 
applicability of this proposed provision--whether it applies only to 
non-creditable hazardous waste pharmaceuticals or to both potentially 
creditable hazardous waste pharmaceuticals and non-creditable hazardous 
waste pharmaceuticals--was unclear. The regulatory language has been 
changed to reflect that the standards in this subsection apply only to 
spilled non-creditable hazardous waste pharmaceuticals. Further, the 
proposed regulations required that a healthcare facility determine 
whether, after being cleaned up, spilled non-creditable hazardous waste 
pharmaceuticals are potentially creditable or non-creditable, implying 
that non-creditable hazardous waste pharmaceuticals could become 
potentially creditable. The Agency did not intend to imply that spilled 
non-creditable hazardous waste pharmaceuticals could become potentially 
creditable. The regulatory language has been modified to simply require 
that spilled non-creditable hazardous waste pharmaceuticals and clean-
up material be contained and managed as non-creditable hazardous waste 
pharmaceuticals. To address this regulatory gap that commenters 
identified regarding spilled potentially creditable hazardous waste 
pharmaceuticals, the Agency has added a corresponding subsection 
containing standards for response to spills of potentially creditable 
hazardous waste pharmaceuticals at a healthcare facility to the 
regulatory language at Sec.  266.503(f).

M. Management of Non-Creditable Hazardous Waste Pharmaceuticals by 
Long-Term Care Facilities That Collect Them From Individuals Who Self-
Administer

1. Summary of Proposal
    The Agency proposed that a LTCF must collect hazardous waste 
pharmaceuticals from its residents that self-administer their 
medication and manage them under this subpart. This provision was 
proposed in order to require the proper management of all hazardous 
waste pharmaceuticals at LTCFs. LTCFs are similar to hospitals in that 
they are both healthcare providers, but they differ with respect to who 
owns the pharmaceuticals dispensed to patients. While hospitals own the 
pharmaceuticals they dispense, the pharmaceuticals dispensed at long-
term care facilities belong to the residents of the facility. EPA 
understands that, while long-term care facilities often maintain each 
individual's pharmaceuticals in a centralized location, such as a 
pharmaceutical cart, there are instances where some individuals at some 
types of LTCFs may keep and self-administer their own pharmaceuticals. 
Under the proposal, long-term care facilities would have had to collect 
and manage all hazardous waste pharmaceuticals generated on site, 
regardless of ownership, in accordance with these same proposed subpart 
P management standards for healthcare facilities. EPA believed this 
approach would prohibit and prevent sewering of hazardous waste 
pharmaceuticals at these locations.
2. Summary of Comments
    There was very little agreement with the proposed requirement for 
LTCFs to collect hazardous waste pharmaceuticals from patients that 
self-administer their medication. Most commenters argued that hazardous 
waste pharmaceuticals generated by residents who self-administer are 
household hazardous waste and that LTCFs are not allowed by law to 
perform any mandatory collection actions and have no authority to 
compel residents to surrender their unused medications. In addition, 
they commented that medication prescribed under Medicare Subpart D is 
considered the property of the resident. One commenter also pointed out 
that this provision would be unlawful and even dangerous to enforce 
because it would entail inspectors having to enter private residences, 
which is prohibited by many state statutes, and search through garbage 
bags and dumpsters to ensure that hazardous waste pharmaceuticals have 
not been illegally disposed.
    Also, one commenter mentioned that this provision would add 
significant cost to the residents because waste management expenses are 
not covered under Medicare and pharmacies are not allowed to offer 
waste collection services for less than cost and would therefore be 
required to pass the full cost onto the residents.
3. Final Rule Provisions
    The Agency is not finalizing the proposed provisions in this 
subsection. As discussed previously, after consideration of the 
comments, the Agency modified the definition of LTCF

[[Page 5882]]

to specifically exclude assisted living facilities, group homes, 
independent living communities, and the independent/assisted living 
portions of continuing care retirement communities. The Agency agrees 
that the hazardous waste pharmaceuticals generated at these types of 
facilities meet the criteria for the household hazardous waste 
exclusion in Sec.  261.4(b)(1) and are therefore not under the purview 
of RCRA regulations. Accordingly, we have also deleted proposed Sec.  
266.502(l) and the final rule does not require LTCFs to collect 
hazardous waste pharmaceuticals for their residents that have custody 
of and self-administer their medication. The Agency does, however, 
reiterate that this definition of LTCFs classified them as a type of 
healthcare facility. As such, LTCFs are subject to all the provisions 
being finalized for hazardous waste pharmaceuticals that are present in 
an LTCF's central pharmacy, because the hazardous waste being generated 
is not the property of the residents. Additionally, hazardous waste 
pharmaceuticals that are in the custody of the LTCF on behalf of the 
resident must be managed under this subpart. That said, the Agency 
expects that most LTCFs will be VSQGs and therefore only subject to a 
limited subset of the regulations in this rule, including the sewer 
prohibition of Sec.  266.505, the empty container standards of Sec.  
266.507, and the optional provisions of Sec.  266.504. In fact, Sec.  
266.504(d) of the final rule includes a presumption that an LTCF with 
fewer than 20 beds is a VSQG.
    Although not regulated under this subpart, the Agency recommends 
that assisted living facilities, group homes, independent living 
communities, and the independent and assisted living portions of 
continuing care retirement communities develop voluntary pharmaceutical 
collection programs for both hazardous and non-hazardous waste 
pharmaceuticals as a best management practice, as allowed by DEA 
regulations, to ensure proper management, avoid flushing, and minimize 
the potential for accidental poisonings, misuse or abuse.

N. Healthcare Facilities That Accept Hazardous Waste Pharmaceuticals 
From Off-Site Very Small Quantity Generator Healthcare Facilities 
(Sec.  266.502(l))

1. Summary of Proposal
    Typically, hazardous waste pharmaceuticals from healthcare 
facilities are transported either to a reverse distributor, if it is 
potentially creditable, or to a permitted or interim status hazardous 
waste TSDF, if it is not. However, stakeholders have informed EPA that 
in some cases, hazardous waste pharmaceuticals are transported to 
another healthcare facility.
    Until EPA finalized the Hazardous Waste Generator Improvements rule 
on November 28, 2016, CESQG regulations of Sec.  261.5 did not allow a 
generator to send its hazardous waste off site to another generator, 
unless the receiving generator was one of the seven types of facilities 
listed in Sec.  261.5(f)(3)(i)-(vii) or Sec.  261.5(g)(i)-(vii), which 
included landfills permitted by state law.\226\ The 2016 Hazardous 
Waste Generator Improvements final rule added a new provision for the 
consolidation of hazardous waste from VSQGs to LQGs under the control 
of the same person.\227\ Person is defined under RCRA in Sec.  260.10 
and control is defined as ``the power to direct policies at the 
facility under RCRA in Sec.  260.10.'' 228 229 This 
provision now allows the same company to consolidate its VSQG hazardous 
waste at its LQG sites.
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    \226\ The Hazardous Waste Generator Improvements final rule 
renamed CESGGs as VSQGs, moved the regulations from Sec.  261.5 to 
Sec.  262.14 and added an eighth type of facility.
    \227\ 40 CFR 262.14(a)(5)(viii).
    \228\ Person means an individual, trust, firm, joint stock 
company, Federal Agency, corporation (including a government 
corporation), partnership, association, State, municipality, 
commission, political subdivision of a State, or any interstate 
body.
    \229\ For purposes of this provision, ``control'' means the 
power to direct the policies of the healthcare facility, whether by 
the ownership of stock, voting rights, or otherwise, except that 
contractors who operate facilities on behalf of a different person 
shall not be deemed to control such healthcare facility.
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    Specific to healthcare facilities, EPA is aware of two situations 
in which VSQGs would like to consolidate their hazardous waste 
pharmaceuticals at other healthcare facilities. The first situation is 
LTCFs that are VSQGs that return their hazardous waste pharmaceuticals 
to long-term care pharmacies that they contract with. The second 
situation involves military bases, where the off-post clinics that are 
generally VSQGs would like to send their hazardous waste 
pharmaceuticals back to the base clinics or pharmacies on the nearby 
base.\230\
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    \230\ See notes from 11-28-12 meeting with U.S. Army Institute 
of Public Health in the docket for this rule (EPA-HQ-RCRA-2007-0932-
0209).
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    Since long-term care pharmacies are not generally under the control 
of the same person as the LTCF, the proposed healthcare facility 
consolidation provision was broader than what was finalized in the 2016 
Hazardous Waste Generator Improvements rule to accommodate the 
contractual relationship between long-term care facilities and long-
term care pharmacies. The Agency proposed this consolidation provision 
to allow healthcare facilities that are VSQGs to send their hazardous 
waste pharmaceuticals to another healthcare facility rather than send 
it to a municipal solid waste landfill.
    Specifically, EPA proposed to allow VSQG healthcare facilities to 
send their hazardous waste pharmaceuticals to an off-site healthcare 
facility without a hazardous waste manifest, provided the receiving 
healthcare facility meets four conditions. First, the receiving 
healthcare facility must be contracted to supply pharmaceutical 
products to the VSQG LTCF, or the VSQG healthcare facility and the 
receiving healthcare facility must both be under the control of the 
same person, as defined by Sec.  260.10.\231\ Second, the receiving 
healthcare facility must be managing its hazardous waste 
pharmaceuticals in accordance with subpart P. Third, the hazardous 
waste pharmaceuticals from the VSQG must be managed by the receiving 
healthcare facility as hazardous waste pharmaceuticals in accordance 
with subpart P once it arrives at the receiving healthcare facility. 
Fourth, the receiving healthcare facility must keep and maintain 
records of the hazardous waste pharmaceuticals received from the off-
site VSQG healthcare facilities for three years from receipt of 
shipment.
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    \231\ For purposes of this provision, ``control'' means the 
power to direct the policies of the healthcare facility, whether by 
the ownership of stock, voting rights, or otherwise, except that 
contractors who operate facilities on behalf of a different person 
shall not be deemed to control such healthcare facility.
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    As proposed, these conditions would ensure the proper management of 
the hazardous waste pharmaceuticals: Once they are received by the 
healthcare facility, they are subject to the same management standards 
EPA proposed for hazardous waste pharmaceuticals managed by healthcare 
facilities.
    EPA took comment on two aspects of this exclusion: (1) Whether any 
additional conditions should be imposed in this provision and (2) 
whether to expand the scope of the provision to facilities that do not 
meet the proposed definition of a healthcare facility in this rule.
2. Summary of Comments
    Overall, states, waste management and the healthcare industry were 
supportive of the proposal to allow VSQG healthcare facilities to 
consolidate their hazardous waste

[[Page 5883]]

pharmaceuticals at another healthcare facility, provided the four 
conditions outlined above are met. One state, however, did oppose this 
provision unless the receiving healthcare facility is subject to all of 
the LQG requirements under part 262. They recommended that hazardous 
waste pharmaceuticals from VSQGs be consolidated at larger healthcare 
facilities under the 2016 Hazardous Waste Generator Improvements final 
rule to ensure more stringent standards are met by the receiving 
facility. Some states and pharmacists raised concerns that some of the 
language within the conditions was too narrow to serve the purpose that 
the language was trying to achieve.
3. Final Rule Provision
    EPA is finalizing the provision to allow healthcare facilities that 
are operating under subpart P to receive hazardous waste 
pharmaceuticals from VSQGs with minor changes. Healthcare facilities 
that are VSQGs for their pharmaceutical and non-pharmaceutical waste 
may send their potentially creditable and non-creditable hazardous 
waste pharmaceuticals to an off-site healthcare facility operating 
under subpart P, without a hazardous waste manifest, provided the 
receiving healthcare facility meets the four conditions in Sec.  
266.502(l)(1)-(4) or Sec.  266.503(b)(1)-(4), as applicable.
    Several conforming changes were made to reflect the change in 
terminology from CESQG to VSQG and to reflect the reorganization of the 
VSQG regulations from Sec.  261.5 to Sec.  262.14. There are three more 
substantive changes from the proposal. First, under Sec.  266.502(l)(1) 
where we proposed that one way a healthcare facility could receive 
hazardous waste pharmaceuticals from an off-site VSQG healthcare 
facility was to have a contractual relationship to provide the 
pharmaceutical products to the LTCF, we broadened the language to allow 
cases in which a ``business relationship'' between the LTCF and long-
term care pharmacy exists.
    Under the final rule, a healthcare facility under subpart P may 
accept non-creditable hazardous waste pharmaceuticals from an off-site 
healthcare facility that is a VSQG under Sec.  262.14, without a permit 
or without having interim status, provided the receiving healthcare 
facility:
    (1) Is under the control of the same person, as defined in Sec.  
260.10, as the VSQG healthcare facility that is sending the non-
creditable hazardous waste pharmaceuticals off site, or has a 
contractual or other documented business relationship whereby the 
receiving healthcare facility supplies pharmaceuticals to the VSQG 
healthcare facility;
    (2) Is operating under subpart P for the management of its non-
creditable hazardous waste pharmaceuticals;
    (3) Manages the non-creditable hazardous waste pharmaceuticals that 
it receives from off site in compliance with subpart P; and
    (4) Keeps records of the non-creditable hazardous waste 
pharmaceuticals shipments it receives from off site for three years 
from the date that the shipment is received.
    It is important to note that a VSQG healthcare facility that 
chooses to send their waste for consolidation to an off-site healthcare 
facility is not considered to be operating under subpart P and does not 
need to notify as a VSQG operating under subpart P.
    The second substantive change was to include a parallel provision 
in Sec.  266.503 for potentially creditable hazardous waste 
pharmaceuticals. This addition allows healthcare facilities that are 
VSGQs two options for where to send their potentially creditable 
hazardous waste pharmaceuticals. The first option is to send them 
directly to a reverse distributor.\232\ The second option is to send 
them to a healthcare facility operating under part 266 subpart P, 
provided the receiving facility meets the conditions of 266.503(b)(1)-
(4).
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    \232\ As allowed by 40 CFR 266.504(a).
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    The third change related to off-site consolidation of hazardous 
waste pharmaceuticals is to add paragraph Sec.  262.14(a)(5)(x). 
Section 262.14(a)(5) of the VSQG regulations consists of a list of 
types of facilities to which VSQGs can send their hazardous waste. 
Section 262.14(a)(5)(viii) allows VSQGs to send their hazardous waste 
to large quantity generators under the control of the same person as 
the VSQG, provided certain conditions are met. This provision is 
similar to the provision we are finalizing in this rule for healthcare 
facilities that are VSQGs. Therefore, for consistency, we have added 
paragraph (x) to the list of facilities in Sec.  262.14(a)(5) such that 
a healthcare facility that is a VSQG can send its non-creditable 
hazardous waste pharmaceuticals and potentially creditable hazardous 
waste pharmaceuticals to an off-site healthcare facility (as defined in 
Sec.  266.500) that meets the conditions in Sec.  266.502(l) and Sec.  
266.503(b), as applicable.
4. Comments and Responses
    Some states and pharmacists noted that language in the first 
condition may have the unintended consequence of prohibiting healthcare 
facilities from consolidating their hazardous waste pharmaceuticals due 
to their relationship with the consolidating facility. The first 
condition that a receiving healthcare facility must be under the 
control of the same person or contracted to supply pharmaceutical 
products to the VSQG's LTCF might prevent some long-term care 
facilities from taking advantage of this provision. Long-term care 
facilities that would otherwise be eligible to take advantage of this 
exclusion might not use it since CMS does not prevent long-term care 
facilities and/or their residents from using more than one long-term 
care pharmacy. This allows the long-term care facilities and the 
residents to shop for the ``best and most competitive'' pricing for 
medications and to change as needed.\233\ Commenters believed that 
adding ``business relationship'' in addition to a contractual 
relationship for the healthcare facility and receiving facility to both 
be under the control of the same person would relieve this concern.
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    \233\ https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html.
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    Furthermore, pharmacists raised the concern that a long-term care 
pharmacy would not want to take responsibility for returned 
pharmaceuticals under this condition as proposed unless they could 
confirm that they were the ones that distributed the pharmaceuticals in 
the first place (a receipt of purchase or similar documentation), since 
the management of these wastes is costly and may not be covered by the 
various healthcare programs. According to the CMS website, the managing 
of returned pharmaceuticals at long-term care pharmacies varies from 
state to state and is not a specific requirement of the Medicare/
Medicaid program.\234\ This consolidation provision was created so that 
VSQGs could consolidate their hazardous waste pharmaceuticals for 
proper management. If the provision as written is preventing long-term 
care facilities from potentially consolidating their hazardous waste, 
then it is thwarting the intended outcome of this provision and that is 
why EPA decided to add ``business relationship'' to the first condition 
for VSQG consolidation.
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    \234\ https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html.
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    One state commenter recommended that the receiving healthcare 
facilities must either be an LQG or comply with the LQG requirements 
under part 262, since LQGs have more protective management standards 
during accumulation. First, under part 266 subpart P, healthcare 
facilities do not

[[Page 5884]]

have a generator category for their hazardous waste pharmaceuticals; 
all healthcare facilities are regulated the same under part 266 subpart 
P. Second, if EPA limited this consolidation provision to LQGs, then 
there would be a very small subset of receiving healthcare facilities 
that would be able to take advantage of this provision. Since subpart P 
allows healthcare facilities operating under this subpart to not count 
their hazardous waste pharmaceuticals towards their generator category, 
some healthcare facilities may no longer be LQGs for their other 
hazardous waste. It is highly unlikely that a long-term care pharmacy 
would remain an LQG under this rule since the majority of the hazardous 
waste that would be handled at these pharmacies would be 
pharmaceuticals. If we were to limit this provision to only LQG 
receiving facilities, then we would be preventing LTCFs from 
consolidating at long-term care pharmacies. Therefore, we determined 
that requiring the receiving facilities to be LQGs or to comply with 
LQG standards as a condition of the consolidation provision would 
severely limit the value of this provision.
    In addition, the Agency is not finalizing a requirement for 
healthcare facilities that receive hazardous waste pharmaceuticals from 
VSQG healthcare facilities to manage the received pharmaceutical waste 
under the part 262 LQG standards. The Agency does not see the necessity 
in having more stringent management standards for healthcare facilities 
that receive pharmaceutical waste, because subpart P management 
standards are the same for all non-VSQG healthcare facilities, 
regardless of the amount of hazardous waste pharmaceuticals they 
generate. The Agency has determined that the subpart P standards are 
sufficiently protective of human health and the environment since all 
pharmaceuticals at a receiving healthcare facility must be managed 
under the same subpart P standards, regardless of whether they were 
generated on site or received from off site. If a state determines that 
the standards being finalized for healthcare facilities that receive 
hazardous waste pharmaceuticals from off-site are not adequate, that 
state may implement its own standards, provided they are more 
stringent.
    The waste management industry, as well as some states, recommended 
that EPA require a notification when a facility was receiving hazardous 
waste pharmaceuticals and at least some minimal requirements for 
labeling, recordkeeping, and documentation of shipments. One state also 
recommended that we issue licenses to facilities that were receiving 
hazardous waste pharmaceuticals in order to track who was taking 
advantage of this provision. Consistent with our rationale for the 
limited shipping requirements for ``potentially creditable hazardous 
waste pharmaceuticals'' in this rule, the Agency believes that the 
shipping of hazardous waste pharmaceuticals poses a relatively low risk 
of release to the environment but a high risk for diversion of the 
pharmaceuticals when labeled ``pharmaceuticals.'' The hazardous waste 
that are being shipped often are in pill form or blister packs and not 
fifty-gallon drums of liquids that can be easily spilled. They are not 
likely to pose the same risks that typical hazardous waste could cause 
during shipping and transport, but there is a real risk to them being 
stolen if attention is brought to the contents of the containers. If 
the four conditions are met, the Agency believes this ensures the 
proper management of hazardous waste pharmaceuticals and adding new 
labeling and shipping requirements is unnecessary to accomplish that 
goal. Furthermore, the part 262 VSQG regulations do not require 
labeling or recordkeeping, and VSQGs might not take advantage of this 
consolidation provision if the requirements are too onerous, thus 
continuing to put their hazardous waste pharmaceuticals in municipal 
solid waste landfills.
    The waste management industry asked for clarification on hazardous 
waste pharmaceuticals consolidation across state lines that have 
different requirements for VSQGs. There is nothing in this section that 
prevents a healthcare facility from sending their hazardous waste 
pharmaceuticals to a healthcare facility in another state provided both 
states have adopted this provision. Each state has their own 
requirements, so it would be prudent for VSQG healthcare facilities to 
make sure that the state in which they are consolidating has adopted 
this provision and does not impose any additional requirements on the 
receiving healthcare facility that accepts this waste.
    EPA also received comments on what types of facilities could take 
advantage of this provision, specifically whether this provision will 
include wholesale drug distribution centers. In the final rule, EPA has 
defined wholesale distributors as a type of healthcare facility under 
Sec.  266.500. Wholesale distributors were not an example that was 
given to us at proposal for this consolidation provision, but if all 
four conditions were met and there was a contractual or business 
relationship between the VSQG healthcare facility and the wholesale 
distributor, they would not be precluded from using this provision. 
However, we would note that when a wholesale distributor receives 
hazardous waste pharmaceutical return from a healthcare facility, the 
pharmaceuticals are usually restocked, which means they are 
pharmaceutical products and not hazardous waste pharmaceuticals.
    Lastly, a non-profit organization asked us to clarify if these 
consolidated hazardous waste pharmaceuticals would be eligible for 
redistribution or evaluation for donation once consolidated to the 
receiving facility. In regard to redistribution or evaluation for 
donation, if the receiving healthcare facility can lawfully donate or 
redistribute the consolidated hazardous waste pharmaceuticals, there is 
nothing in this provision that prevents that from occurring, but those 
shipments would not fall under the consolidation provision in subpart 
P. If a VSQG is sending products to another facility, then the 
receiving facility should evaluate the received pharmaceuticals as they 
would any other products they receive for continued use, redistribution 
to secondary markets, donation and/or any other lawful possibilities. 
At this point, they are not a solid or hazardous waste and not subject 
to the requirements in Sec.  266.502(l) or Sec.  266.503(b).
    EPA would also note that this provision is optional and it is not 
meant to impose undue burden on healthcare facilities. This section 
does not require a VSQG healthcare facility to ship their hazardous 
waste pharmaceuticals to a receiving healthcare facility. VSQG 
healthcare facilities continue to have the option, unless the state 
regulations are more stringent, of sending their hazardous waste 
pharmaceuticals to any of the types of facilities specified in Sec.  
262.14, including a municipal solid waste landfill.

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))

1. Summary of Proposal
    EPA proposed standards for healthcare facilities managing 
potentially creditable hazardous waste pharmaceuticals in Sec.  266.503 
of subpart P. As with non-creditable hazardous waste pharmaceuticals, a 
healthcare

[[Page 5885]]

facility must determine which potentially creditable pharmaceuticals 
are listed or characteristic hazardous wastes, in order to determine 
which potentially creditable pharmaceuticals are subject to regulation 
under this subpart.
    Accordingly, we proposed that a healthcare facility that generates 
a solid waste that is a potentially creditable pharmaceutical must 
determine whether the potentially creditable solid waste pharmaceutical 
is a potentially creditable hazardous waste pharmaceutical (i.e., is 
listed in 40 CFR part 261 subpart D or exhibits a characteristic 
identified in 40 CFR part 261 subpart C).
    We also proposed that a healthcare facility may choose to manage 
all of its potentially creditable waste pharmaceuticals (both hazardous 
and non-hazardous) together as potentially creditable hazardous waste 
pharmaceuticals while accumulating on site and when shipping off site 
under Sec.  266.509. If a healthcare facility chooses this approach of 
commingling its hazardous and non-hazardous potentially creditable 
waste pharmaceuticals, it would not need to make individual hazardous 
waste determinations, but would have made a generic decision that all 
of its potentially creditable waste pharmaceuticals are hazardous and 
would manage them as potentially creditable hazardous waste 
pharmaceuticals in accordance with the requirements in 40 CFR part 266 
subpart P.
    We proposed that healthcare facilities may choose to manage 
potentially creditable non-hazardous waste pharmaceuticals as 
potentially creditable hazardous waste pharmaceuticals under the 
shipping standards of Sec.  266.509. Additionally, EPA proposed that 
healthcare facilities would be prohibited from sending hazardous waste 
other than potentially creditable hazardous waste pharmaceuticals to a 
reverse distributor. This was in keeping with our position that a 
reverse distributor's function in managing hazardous waste should be 
limited to managing hazardous waste pharmaceuticals that have a 
reasonable expectation of receiving manufacturer credit and not non-
creditable hazardous waste pharmaceuticals or other non-pharmaceutical 
hazardous waste.
2. Summary of Comments
    Pharmacists, some wholesalers, and manufacturers expressed concern 
that making hazardous waste determinations at their facilities would 
require additional staff, additional training on making hazardous waste 
determination, as well as more storage space in which to hold the 
hazardous waste as the determinations are being made.
    We received mixed comments on commingling potentially creditable 
non-hazardous and hazardous waste pharmaceuticals. Healthcare 
facilities and pharmacists were in favor of EPA allowing commingling 
potentially creditable non-hazardous and hazardous waste 
pharmaceuticals, and the benefit it offers in handling their 
pharmaceutical waste or continuing the common practice of commingling 
potentially creditable non-hazardous and hazardous waste 
pharmaceuticals when sent to reverse distributors. On the other hand, 
waste management and states raised concerns that commingling 
potentially creditable non-hazardous and hazardous waste 
pharmaceuticals may prevent healthcare facilities from sending their 
waste across state lines or to certain reverse distributors, due to 
state regulations and/or reverse distributors' policies.
3. Final Rule Provisions
    EPA is finalizing the standards as proposed, with some minor 
changes. Under this section, a healthcare facility has two choices: (1) 
Make a hazardous waste determination on each potentially creditable 
waste pharmaceutical and determine individually which are hazardous 
waste and thus subject to regulation under this subpart or, (2) 
commingle all potentially creditable pharmaceutical waste whether or 
not it is hazardous waste and manage the commingled pharmaceuticals 
under this subpart and thereby not have to make individual hazardous 
waste determinations.
    EPA removed ``even if the solid waste pharmaceuticals do not 
exhibit a characteristic identified in 40 CFR part 261 subpart C and 
are not listed in 40 CFR part 261 subpart D'' from the non-hazardous 
waste provision of this section since it was redundant with 
determinations of solid waste pharmaceuticals and whether they are 
potentially creditable or not.
    EPA has also modified the regulatory language in the final rule to 
make clear that when a healthcare facility commingles potentially 
creditable non-hazardous and hazardous waste pharmaceuticals, the 
healthcare facility is choosing to subject the potentially creditable 
non-hazardous waste pharmaceuticals to all of subpart P while being 
managed at a healthcare facility and in preparation for shipping off-
site. Once potentially creditable non-hazardous and hazardous waste 
pharmaceuticals are commingled they are subject to all applicable 
subpart P management standards while they remain commingled. As a 
practical matter, however, we expect that the primary impact to 
healthcare facilities will be that potentially creditable non-hazardous 
waste pharmaceuticals are subject to the shipping standards of Sec.  
266.509. Once potentially creditable non-hazardous waste 
pharmaceuticals are shipped off site to a reverse distributor, a 
reverse distributor may choose to segregate the non-hazardous waste 
pharmaceuticals from the hazardous waste pharmaceuticals. This process 
of segregation by the reverse distributor would require the reverse 
distributor to make new hazardous waste determinations on the 
commingled pharmaceuticals.
4. Comments and Responses
    We received many comments on making hazardous waste determinations 
and commingling potentially creditable non-hazardous and hazardous 
waste pharmaceuticals. While the commenters raised valid concerns on 
why making hazardous waste determinations can be burdensome on a 
healthcare facility, or why commingling potentially creditable non-
hazardous and hazardous waste pharmaceuticals may not work for all 
facilities, EPA made only minor editorial changes to this section of 
the final rule. The Agency determined that more substantive changes 
were unnecessary because this provision contains sufficient flexibility 
by providing healthcare facilities with two options.
    a. Making hazardous waste determinations. Pharmacists, some 
wholesalers, and manufacturers expressed concern that being required to 
make hazardous waste determinations at their facilities would impose 
undue burden because they would have to hire additional staff and train 
them to make accurate waste determination. They argue that they would 
also need to allocate more space in which to store waste as the 
determinations are being made. Some commenters stated that making 
hazardous waste determinations may prevent healthcare facilities from 
sending their hazardous waste pharmaceuticals to reverse distributors 
at all. In support of the comments above, manufacturers and wholesalers 
argued that reverse distributors have the appropriate RCRA expertise to 
make accurate waste determinations, that they have served as a 
consolidation point for unused and hazardous waste pharmaceuticals for 
many years, and that the process has been effective and successful. The 
Agency notes, however, that allowing potentially creditable

[[Page 5886]]

pharmaceuticals to be sent to a reverse distributor without a hazardous 
waste determination being made at the point of generation violates a 
basic tenet of RCRA, because the decision to send them to a reverse 
distributor is effectively a decision to discard. In addition, the 
burden mentioned by commenters associated with making individual waste 
determinations would likely be significantly mitigated by exercising 
the option to manage all potentially creditable waste pharmaceuticals 
as potentially creditable hazardous waste pharmaceuticals.
    b. Commingled waste stream. As previously noted, we received mixed 
comments on commingling potentially creditable non-hazardous hazardous 
waste pharmaceuticals.
    EPA proposed the option of commingling potentially creditable non-
hazardous and hazardous waste pharmaceuticals to mitigate the burden of 
complying with the management standards, particularly for healthcare 
personnel making hazardous waste determinations. Given that many 
healthcare facilities currently commingle their potentially creditable 
non-hazardous and hazardous waste pharmaceuticals, we expect the 
practice to continue. However, if commingling causes undue burden on a 
facility due to state regulations, reverse distributor policies, or 
other reasons, then the healthcare facility does not have to utilize 
this option and can make individual hazardous waste determinations in 
accordance with Sec.  266.503(a). This is an individual decision for 
each healthcare facility and each healthcare facility may choose what 
works best for managing its potentially creditable pharmaceutical 
waste.
    Retailers and reverse distributors recommended that healthcare 
facilities should be allowed to make a determination about whether the 
item will be managed as hazardous when it becomes a waste at the time 
of arrival at the retail store or healthcare facility. They believe 
this practice would be impeded if all pharmaceuticals must be managed 
as potentially creditable hazardous waste pharmaceuticals when they 
become waste. If this is common practice among healthcare facilities, 
then the need to commingle their waste may not be something that is 
important. Allowing the commingling of all solid waste pharmaceuticals 
is meant to ease the burden on healthcare facilities that are not 
currently making hazardous waste determinations, or do not wish to make 
them, by allowing them to manage and ship all of their potentially 
creditable waste pharmaceuticals together.

B. Accepting Potentially Creditable Hazardous Waste Pharmaceuticals 
From an Off-Site Healthcare Facility That Is a Very Small Quantity 
Generator (Sec.  266.503(b))

1. Summary of Proposal
    EPA proposed to allow healthcare facilities operating under subpart 
P to accept potentially creditable and non-creditable hazardous waste 
pharmaceuticals from an off-site VSQG healthcare facility without a 
hazardous waste manifest, provided four conditions are met. We proposed 
this provision in Sec.  266.502(m) under the standards for managing 
non-creditable hazardous waste pharmaceuticals.\235\ We proposed that 
healthcare facilities operating under subpart P could accept both 
potentially creditable and non-creditable hazardous waste 
pharmaceuticals from an off-site healthcare facility that is a VSQG. 
Previously, the part 262 VSQG regulations did not allow a healthcare 
facility to send its hazardous waste off-site to another healthcare 
facility, unless the receiving healthcare facility is one of the eight 
types of facilities listed in Sec.  262.14(a)(5)(i-viii). For more 
detailed information on our proposal, please refer to section X.N.
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    \235\ This provision is now found at Sec.  266.502(l).
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2. Summary of Comments
    EPA only received one comment in this section concerning changes to 
the generator category of the receiving facility. A trade association 
of pharmacists was concerned that allowing VSQG consolidation would 
affect the generator category of the receiving healthcare facility, and 
that it would need to report as an LQG.
3. Final Rule Provision
    In the proposed rulemaking, EPA intended to allow healthcare 
facilities to accept both potentially creditable and non-creditable 
(including commingled) hazardous waste pharmaceuticals from an off-site 
VSQG healthcare facility, provided the receiving healthcare facility 
complies with the four conditions of Sec.  266.502(m) (now in Sec.  
266.502(l)). In the final rule, we clarified our intention to allow 
healthcare facilities to accept both potentially creditable and non-
creditable (including commingled) hazardous waste pharmaceuticals from 
an off-site VSQG healthcare facility by placing similar standards in 
Sec.  266.503(b) under the standards for managing potentially 
creditable hazardous waste pharmaceuticals. This does not reflect a 
change from what was proposed, only that the consolidation standards 
apply to healthcare facilities receiving both non-creditable and 
potentially creditable hazardous waste pharmaceuticals.
    Under the final rule, a healthcare facility that is a VSQG can send 
both its potentially creditable hazardous waste pharmaceuticals and 
non-creditable (including commingled) hazardous waste pharmaceuticals 
to an off-site healthcare facility operating under subpart P, provided 
the receiving healthcare facility complies with the four requirements 
of the respective sections. Regulations for the receiving healthcare 
facilities now appear in Sec.  266.502(l) for non-creditable hazardous 
waste pharmaceuticals and in Sec.  266.503(b) for potentially 
creditable hazardous waste pharmaceuticals. VSQG healthcare facilities 
that send their hazardous waste pharmaceuticals to an off-site 
healthcare facility are subject to the regulations in Sec.  266.504(b), 
with further discussion in section XII.B of the preamble.
    Under Sec.  266.503(b) of the final rule, a healthcare facility may 
accept potentially creditable hazardous waste pharmaceuticals from an 
off-site healthcare facility that is a VSQG under Sec.  262.14, without 
a permit or without having interim status, provided the receiving 
healthcare facility:
    (1) Is under the control of the same person, as defined in Sec.  
260.10, as the VSQG healthcare facility that is sending potentially 
creditable hazardous waste pharmaceuticals off site, or has a 
contractual or other documented business relationship whereby the 
receiving healthcare facility supplies pharmaceuticals to the VSQG 
healthcare facility;
    (2) Is operating under subpart P for the management of its 
potentially creditable hazardous waste pharmaceuticals;
    (3) Manages the potentially creditable hazardous waste 
pharmaceuticals that it receives from off site in compliance with 
subpart P; and
    (4) Keeps records of the potentially creditable hazardous waste 
pharmaceuticals shipments it receives from off site for three years 
from the date that the shipment is received.
    It is important to note that a VSQG healthcare facility that 
chooses to consolidate its hazardous waste pharmaceuticals at an off-
site healthcare facility is not considered to be operating under 
subpart P, and does not need to notify as a VSQG operating under 
subpart P.

[[Page 5887]]

4. Comments and Responses
    A pharmacists' association was concerned that allowing for VSQG 
consolidation would change the generator category of the receiving 
healthcare facilities and that the consolidating facility would need to 
report as an LQG. All healthcare facilities operating under part 266 
subpart P are regulated the same, regardless of the amount of hazardous 
waste pharmaceuticals they generate. Further, healthcare facilities 
managing their hazardous waste pharmaceuticals under this subpart do 
not count their hazardous waste pharmaceuticals toward their generator 
category so consolidation of this additional hazardous waste 
pharmaceuticals at their facilities would not change the generator 
category of the receiving healthcare facility.

C. Accumulation Time, Container Management and Labeling for Healthcare 
Facilities Managing Potentially Creditable Hazardous Waste 
Pharmaceuticals

    Under the hazardous waste generator regulations in part 262, EPA 
requires specific management standards for containers that hold 
hazardous waste. However, potentially creditable hazardous waste 
pharmaceuticals pose a lower risk of release into the environment than 
traditional industrial hazardous waste. The risk of release is lower 
for several reasons.
    First, potentially creditable hazardous waste pharmaceuticals must 
be in original manufacturers' packaging by definition and are often in 
their outer packaging as well, providing two layers of protection from 
leaks or spills.\236\ Second, potentially creditable hazardous waste 
pharmaceuticals are typically generated in the pharmacy area of a 
healthcare facility where there is restricted access, creating a layer 
of security for these pharmaceuticals. Third, EPA has been informed 
that it is common practice at healthcare facilities for potentially 
creditable waste pharmaceuticals that are destined for a reverse 
distributor to be taken from the shelves of the pharmacy periodically 
and promptly boxed for off-site shipment.
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    \236\ See 73 FR 73529; December 2, 2008.
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    For the reasons listed above, EPA did not propose specific 
standards for managing and labeling containers of potentially 
creditable hazardous waste pharmaceuticals at healthcare facilities. 
For the same reasons, we also did not propose a limit on how long 
healthcare facilities may accumulate containers of potentially 
creditable hazardous waste pharmaceuticals.
    This is not to say that all potentially creditable hazardous waste 
pharmaceuticals waste pharmaceuticals are safe and pose no risk of 
spill or release into the environment. It is important to note that the 
accumulation of some potentially creditable hazardous waste 
pharmaceuticals, such as liquids and aerosols, may pose more of a risk 
due to possible spills or leaks than solid pills. However, EPA believes 
that the small quantities in which liquid and aerosol potentially 
creditable hazardous waste pharmaceuticals are generated, along with 
the DOT packaging requirements (49 CFR parts 173, 178, and 180), 
significantly reduces the risks of spills or releases to the 
environment.
    In addition, to further mitigate the potential for spills or leaks, 
as a best management practice, EPA encourages healthcare facilities to 
place the original containers, and packaging containing liquids and 
aerosols pharmaceuticals, in separate individual containers (e.g., 
sealed storage bag) before placing them in the accumulation container.
1. Accumulation Time and Container Management of Potentially Creditable 
Hazardous Waste Pharmaceuticals
    a. Summary of proposal. EPA did not propose a limit on how long 
healthcare facilities may accumulate containers of potentially 
creditable hazardous waste pharmaceuticals or specific standards for 
how the containers must be managed during accumulation.
    b. Summary of comments. Most commenters were in favor of adding 
some guidelines for accumulation time and container management. Some 
states commented that the proposed standards for non-creditable 
hazardous waste pharmaceuticals should be applied to both non-
creditable and potentially creditable hazardous waste pharmaceuticals 
to prevent confusion from having multiple accumulation standards, and 
to provide extra protection of human health and the environment.
    c. Final rule provisions. EPA is not finalizing a time limit for 
accumulating containers of potentially creditable hazardous waste 
pharmaceuticals. EPA is also not finalizing specific container 
management standards for healthcare facilities that accumulate 
containers of potentially creditable hazardous waste pharmaceuticals
    d. Comments and responses. Several states expressed concern about 
the security of potentially creditable hazardous waste pharmaceuticals 
during accumulation. These commenters agreed that potentially 
creditable hazardous waste pharmaceuticals should be accumulated in a 
designated area that is labeled and kept locked or sealed according to 
best management practices for that facility as an additional deterrent 
to illicit diversion. Commenters also expressed concerned that not 
having designated accumulation areas could lead to situations where 
healthcare facility personnel may misplace or forget the locations of 
accumulation containers. States were concerned that the potential for 
healthcare facilities to receive manufacturer credit does not 
sufficiently encourage proper management.
    As previously discussed, potentially creditable hazardous waste 
pharmaceuticals do not pose the same risks as other hazardous wastes. 
We received many comments, especially from the retail industry, about 
the condition of packages being important for being eligible and 
receiving manufacturer credit. For example, broken and/or leaking 
containers cannot be sent to a reverse distributor per the definition 
of ``potentially creditable hazardous waste pharmaceuticals,'' so there 
is an incentive to manage these items carefully. There is also an 
incentive to not overaccumulate wastes in healthcare facilities since 
manufacturer credit is only issued by reverse distributors and in many 
cases, cannot be collected by a healthcare facility until the reverse 
distributor receives them.
    It is also important to note that many of these potentially 
creditable hazardous waste pharmaceuticals are already being generated 
and stored in secure areas, such as pharmacies, and being handled by 
personnel that have pharmaceutical expertise. EPA is also recommending 
that liquids and aerosols be put in sealed plastic bags, containers, or 
other management practices during accumulation to reduce the risk of 
spills and releases.
    As for labeling the accumulation area with the words pharmaceutical 
waste, the concern still remains for increasing the potential for 
illicit diversion of these potentially creditable hazardous waste 
pharmaceuticals by bringing attention to the fact that it contains 
pharmaceuticals. Therefore, the Agency is not finalizing a requirement 
for healthcare facilities to label accumulation areas for potentially 
creditable hazardous waste pharmaceuticals.
    Finally, if a state is uncomfortable with our approach to the 
accumulation of potentially creditable hazardous waste pharmaceuticals, 
it may choose to be more stringent in this regard when it adopts the 
rule.

[[Page 5888]]

2. Labeling Requirements for Containers of Potentially Creditable 
Hazardous Waste Pharmaceuticals
    a. Summary of proposal. EPA did not propose specific labeling 
standards for containers holding potentially creditable hazardous waste 
pharmaceuticals while they are accumulated on-site at a healthcare 
facility because they are in original manufacturer packaging, they are 
already labeled, and any additional labeling would be duplicative or 
apply to secondary containers, such as boxes used to ship to reverse 
distributors.
    In addition, due to concerns regarding illicit diversion of 
pharmaceuticals, EPA believes that it is safer not to call attention to 
the fact that these containers hold pharmaceuticals. Unlike floor or 
patient care pharmaceutical waste, the potentially creditable hazardous 
waste pharmaceuticals returned to a reverse distributor often have high 
black-market value that makes them susceptible to diversion. Thus, EPA 
did not propose to require a label for containers used to accumulate 
potentially creditable hazardous waste pharmaceuticals.
    b. Summary of comments. Many states believe that labeling should be 
required for all containers of hazardous waste to ensure proper 
management and disposal. Proper management, according to comments, 
includes accumulation in designated locations with individual 
containers labeled for inspection.
    Other commenters expressed concerns that containers that are not 
labeled are subject to inaccurate waste determinations and will be 
mishandled and treated as non-creditable hazardous waste 
pharmaceuticals and sent to a TSDF rather than as potentially 
creditable which could ultimately be destined for a reverse 
distributor.
    c. Final rule provision. EPA is not finalizing labeling standards 
for containers of potentially creditable hazardous waste 
pharmaceuticals accumulated by healthcare facilities.
    d. Comments and responses. While the commenter's concerns apply to 
hazardous waste in general and for hazardous waste going to a TSDF, we 
do not believe they are equally applicable to containers of potentially 
creditable hazardous waste pharmaceuticals. First, containers of 
potentially creditable hazardous waste pharmaceuticals are in original 
manufacturer's packaging (or have been repackaged for use in a LTCF) 
and thus the contents are easily identifiable. Second, if a healthcare 
facility does not label an accumulation container on site and then 
forgets about it or misidentifies where it needs to go, then no 
manufacturer credit will be issued for those potentially creditable 
hazardous waste pharmaceuticals. Likewise, if a healthcare facility 
does label the containers on site and the contents are illicitly 
diverted, then the healthcare facility will not receive the 
manufacturer credit for those items. Healthcare facilities have a 
monetary incentive to keep track of what is in these containers, 
regardless of whether they are labeled, and to make sure they arrive 
unmolested at the reverse distributor.
    Additionally, by imposing labeling requirements, EPA does not want 
to deter the practice of commingling potentially creditable hazardous 
waste pharmaceuticals with potentially creditable non-hazardous waste 
pharmaceuticals since both are typically transported together to a 
reverse distributor.
    Therefore, EPA concludes that it is not necessary to require any 
labeling standards for potentially creditable hazardous waste 
pharmaceuticals.

D. No Biennial Reporting for Potentially Creditable Hazardous Waste 
Pharmaceuticals Generated at Healthcare Facilities (Sec.  266.503(d))

1. Summary of Proposal
    The Agency proposed that healthcare facilities are not subject to 
biennial reporting requirements under Sec.  262.41 with respect to 
potentially creditable hazardous waste pharmaceuticals managed under 
this subpart.
2. Summary of Comments
    One state commented that it would prefer to be notified about who 
is handling this waste to ensure that healthcare facilities are 
adhering to the prohibition on sewering, since they will not know who 
is handling this waste.
3. Final Rule Provision
    The Agency is finalizing as proposed that healthcare facilities are 
not subject to biennial reporting requirements under Sec.  262.41 with 
respect to potentially creditable hazardous waste pharmaceuticals 
managed under this subpart. Potentially creditable hazardous waste 
pharmaceutical quantities will be captured by the reverse distributors' 
required biennial reports,\237\ therefore, a requirement for healthcare 
facilities to report quantities of potentially creditable hazardous 
waste pharmaceuticals generated would be duplicative.
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    \237\ This provision is found at Sec.  266.510(c)(9)(i)
---------------------------------------------------------------------------

4. Comments and Responses
    One state was concerned that they would not know which healthcare 
facilities are generating potentially creditable hazardous waste 
pharmaceuticals. All healthcare facilities operating under this subpart 
will be required to submit a one-time notification that they are 
subject to subpart P (Sec.  266.502(a)(1)). States will, therefore, be 
informed of what healthcare facilities are operating under subpart P 
and can inspect accordingly.

E. Recordkeeping Requirements for Healthcare Facilities Managing 
Potentially Creditable Hazardous Waste Pharmaceuticals (Sec.  
266.503(e))

1. Summary of Proposal
    EPA proposed to require healthcare facilities to keep records of 
the shipments of potentially creditable hazardous waste pharmaceuticals 
to reverse distributors.
    Specifically, we proposed that healthcare facilities that initiate 
a shipment of potentially creditable hazardous waste pharmaceuticals to 
a reverse distributor keep (1) records of advance notification, (2) 
shipping papers or bills of lading, and (3) records of delivery 
confirmation. We proposed that a healthcare facility must retain these 
records for three years after the shipment was initiated. These records 
document that shipments of potentially creditable hazardous waste 
pharmaceuticals have been taken into the control and custody of the 
receiving reverse distributor and have not been diverted. In most 
cases, retaining records for three years should be sufficient for 
inspection purposes; however, we proposed that the periods of retention 
are automatically extended during unresolved enforcement activity, or 
at the request of the EPA Regional Administrator.
2. Summary of Comments
    One state agreed that three years was a sufficient retention period 
to enable inspectors to identify issues upon inspection. State and 
local governments requested clarification about what types of 
documentation (e.g., shipping papers/bills of lading) satisfies the 
requirement. One commenter argued that the receiving facility should 
document efforts made to locate shipments that did not arrive.
3. Final Rule Provision
    EPA is finalizing the proposed recordkeeping provision for 
potentially creditable hazardous waste pharmaceuticals for healthcare 
facilities and reverse distributors that initiate a

[[Page 5889]]

shipment to another reverse distributor with two changes. First, as we 
discuss later in the shipping standards, we have eliminated the 
requirement for healthcare facilities to provide advance notification 
of shipments of potentially creditable hazardous waste pharmaceuticals 
to reverse distributors. Thus, we have removed the requirement to keep 
a record of the advance notification. Second, EPA removed the reference 
to bills of lading from the recordkeeping requirement while keeping 
shipping papers since bills of lading are a type of shipping papers 
under DOT regulations. This is also responsive to comments asking for 
clarification. Healthcare facilities initiating shipments of 
potentially creditable hazardous waste pharmaceuticals must keep, (1) 
delivery confirmation for each shipment and (2) shipping papers 
prepared in accordance with 49 CFR part 172 subpart C, if applicable. 
EPA is finalizing that these records must be retained for three years 
unless there is an unresolved enforcement activity or a request by the 
EPA Regional Administrator to keep them longer. In that case, the 
period of retention is automatically extended. EPA is finalizing this 
requirement as proposed despite input from commenters, as this is 
standard practice with enforcement activity. At the request of 
commenters, we have added a requirement that all records must be 
readily available upon request by an inspector.

F. Response to Spills for Healthcare Facilities Managing Potentially 
Creditable Hazardous Waste Pharmaceuticals (Sec.  266.503(f))

1. Summary of Proposal
    EPA proposed response requirements for spills of non-creditable 
hazardous waste pharmaceuticals but did not propose similar response 
requirements for releases of potentially creditable hazardous waste 
pharmaceuticals.
2. Summary of Comments
    A commenter suggested that spills of potentially creditable 
hazardous waste pharmaceuticals should also be subject to the same 
containment and cleanup requirements as non-creditable hazardous waste 
pharmaceuticals. The commenter also asked whether EPA intended that all 
spills of potentially creditable hazardous waste pharmaceuticals render 
them non-creditable.
3. Final Rule Provision
    EPA agrees with comments that all spills of hazardous waste 
pharmaceuticals, both potentially creditable and non-creditable, must 
be contained, and that all spills of potentially creditable hazardous 
waste pharmaceuticals renders them non-creditable. Therefore, in 
response to this comment, we have added a similar provision to the 
healthcare facility standards of Sec.  266.503(f) for responding to 
releases of potentially creditable hazardous waste pharmaceuticals.
    The standards in this section are based upon what is being 
finalized in the standards for response to spills of non-creditable 
hazardous waste pharmaceuticals at healthcare facilities in Sec.  
266.502(k). The final rule requires that a healthcare facility must 
immediately contain all spills of potentially creditable hazardous 
waste pharmaceuticals and manage the spill clean-up materials as non-
creditable hazardous waste pharmaceuticals in accordance with subpart 
P.
    It is EPA's understanding that unused/undispensed pharmaceuticals 
that remain in original manufacturer's packaging often receive 
manufacturer credit even if the packaging has been opened. In the event 
of a spill, a healthcare facility should reevaluate whether any 
pharmaceuticals that remain in their containers (not spilled) are still 
eligible to receive manufacturer credit per the definition of 
potentially creditable hazardous waste pharmaceutical in Sec.  266.500. 
The healthcare facility must determine whether the pharmaceuticals that 
remain in the containers are potentially creditable and manage them 
according to subpart P. Even if a healthcare facility determines that 
the remaining pharmaceuticals are potentially creditable, it must also 
ensure that the decision is consistent with the manufacturer's 
policies. It is important to note that this only applies to whatever 
might be left in the container and was not spilled.

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))

1. Summary of Proposal
    VSQGs are subject to a limited set of federal RCRA Subtitle C 
hazardous waste regulations, provided that they comply with the 
conditions set forth in Sec.  262.14.\238\ Under Sec.  262.14, VSQGs 
are limited in where they may send their hazardous waste for treatment 
and disposal.\239\ In Sec.  266.504(a), we proposed to allow VSQG 
healthcare facilities to send their potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor. Without this change, 
VSQGs would have been required to send all their hazardous waste 
pharmaceuticals, including those that are potentially creditable, to 
one of the types of facilities in Sec.  262.14, which does not include 
a reverse distributor. Although we proposed to make this change within 
part 266 subpart P, we requested comment on whether stakeholders would 
prefer this change to be made within the VSQG regulations in Sec.  
262.14 (formerly the CESQG regulations in Sec.  261.5) instead. VSQGs 
are still required to send their non-pharmaceutical hazardous waste and 
their non-creditable hazardous waste pharmaceuticals to one of the 
types of facilities listed in Sec.  262.14.\240\
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    \238\ Since the hazardous waste pharmaceutical rule was 
proposed, Sec.  261.5 has been renumbered to Sec.  262.14 as part of 
the reorganization of the generator regulations in the Generator 
Improvements final rule and this will be referenced later in this 
section.
    \239\ Since the Pharmaceutical rule was proposedSec.  
261.5(f)(3)(i)-(vii) for acute hazardous waste and Sec.  
261.5(g)(3)(i)-(vii) for non-acute hazardous waste has been combined 
and renumbered to Sec.  262.14(a)(5)(i)-(vii) for acute and non-
acute hazardous waste in the Hazardous Waste Generator Improvements 
final rule.
    \240\ A VSQG healthcare facility may be able to send its 
hazardous waste pharmaceuticals for consolidation at another 
healthcare facility operating under subpart P as allowed by Sec.  
266.504(b), or a large quantity generator and 262.14(a)(5)(viii), 
see section X of the preamble for further discussion.
---------------------------------------------------------------------------

2. Summary of Comments
    States, waste management and reverse distributors supported 
allowing VSQG healthcare facilities to send their potentially 
creditable hazardous waste to reverse distributors. These same 
commenters were also in favor of including their change in both this 
rule and Sec.  262.14 to ensure that all healthcare facilities that 
might have potentially creditable hazardous waste pharmaceuticals would 
be aware of this provision and be able to take advantage of it.
3. Final Rule Provision
    We are finalizing this provision as proposed, with minor edits. In 
general, this final rulemaking will preserve the current regulatory 
scheme for VSQGs: healthcare facilities that qualify as VSQGs for their 
total count of hazardous waste pharmaceuticals and non-pharmaceutical 
hazardous waste will maintain their conditional exemption under Sec.  
262.14 and will not be subject

[[Page 5890]]

to most aspects of this proposal. Healthcare facilities that are VSQGs 
are subject to three provisions of part 266 subpart P: The sewer ban in 
Sec.  266.505, the empty container standards in Sec.  266.507, and the 
optional provisions in Sec.  266.504.
    In response to commenter's request for clarity, the final rule 
makes it clear that Sec.  266.504 applies to VSQG healthcare facilities 
that are VSQGs when counting both its hazardous waste pharmaceuticals 
and non-pharmaceutical hazardous waste. Section 266.504 does not apply 
to healthcare facilities that become VSQGs under this rule as a result 
of not having to count their hazardous waste pharmaceuticals. Such 
healthcare facilities are VSQGs with respect to their non-
pharmaceutical hazardous waste only and must operate under subpart P 
for their hazardous waste pharmaceuticals.
    Under the final rule, a healthcare facility that is a VSQG when 
counting both its hazardous waste pharmaceuticals and non-
pharmaceutical hazardous waste may choose to send its potentially 
creditable hazardous waste pharmaceuticals to a reverse distributor. In 
response to comments, EPA has added a conforming change to the VQSG 
generator provision in Sec.  262.14(a)(5)(ix) for added clarity on this 
point. It is a restatement of Sec.  266.504(a) which allows VSQG 
healthcare facilities to send their potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor.
    A healthcare facility that is a VSQG for both their hazardous waste 
pharmaceuticals and non-pharmaceutical hazardous waste is given a 
choice. The healthcare facility may

     Operate as a standard VSQG under part 262 rules, and 
can use the optional provisions in Sec.  266.504, or
     Operate under as a healthcare facility under part 266 
subpart P.
4. Comments and Responses
    The waste management industry requested that EPA regulate all 
healthcare facilities under the proposed subpart P requirements 
regardless of generator category. While this rule's requirements are 
meant to create uniformity for healthcare facilities managing hazardous 
waste pharmaceuticals, we want to avoid creating undue burden on VSQGs 
and have declined to make them subject to part 266 subpart P except for 
the sewer prohibition in Sec.  266.505, the empty container provisions 
in Sec.  266.507 and the optional provisions in Sec.  266.504..

B. Off-Site Collection of Hazardous Waste Pharmaceuticals Generated by 
Healthcare Facilities (Sec.  266.504(b))

1. Summary of Proposal
    EPA proposed that a healthcare facility that is a VSQG may send its 
hazardous waste pharmaceuticals to another healthcare facility provided 
the receiving healthcare facility meets certain conditions. These 
conditions were proposed in Sec.  266.502(m) of this subpart.
2. Summary of Comments
    One state was concerned about how consolidation might affect the 
generator category of the receiving facility. The commenter also raised 
concerns about the receiving facility performing some functions of a 
reverse distributor.
3. Final Rule Provision
    EPA is finalizing the proposed provision with conforming changes 
that correspond with other sections within this rule and one additional 
change. The first conforming change added the words ``hazardous waste 
pharmaceuticals and non-pharmaceutical hazardous waste'' to clarify 
that only healthcare facilities that are VSQGs for both their hazardous 
waste pharmaceuticals and their non-pharmaceutical hazardous waste may 
take advantage of this provision. The second conforming change 
converted the term CESQG to VSQG according to the 2016 Hazardous Waste 
Generator Improvements final rule. EPA notes that the consolidation 
provisions for healthcare facilities that receive both non-creditable 
hazardous waste pharmaceuticals and potentially creditable hazardous 
waste pharmaceuticals from off-site were added to the regulations in 
Sec. Sec.  266.502(l) and 266.503(b) (sections X.N and XI.B of the 
preamble), respectively. The final change added flexibility for VSQGs 
to meet the consolidation provisions that were added as part of the 
2016 Hazardous Waste Generator Improvements final rule in lieu of the 
subpart P off-site consolidation provisions. In this case, the 
receiving LQG would have to meet the conditions in Sec.  262.17(f) 
while the VSQG healthcare facility would have to meet the conditions in 
Sec.  262.14(a)(5)(viii).
    The final rule provision allows a healthcare facility that is a 
VSQG for both hazardous waste pharmaceuticals and non-pharmaceutical 
hazardous waste to send its hazardous waste pharmaceuticals off-site 
provided either of the following is met: (1) The receiving healthcare 
facility meets the conditions in Sec.  266.502(1) and Sec.  266.503(b) 
of this subpart, as applicable, or (2) the VSQG healthcare facility 
meets the conditions in Sec.  262.14(a)(5)(viii), and the receiving 
large quantity generator meets the conditions in Sec.  262.17(f).
4. Comments and Responses
    One commenter asked for clarification about whether EPA will allow 
consolidation of a healthcare facility's potentially creditable or non-
creditable hazardous waste pharmaceuticals at a reverse distributor. In 
response, the Agency is clarifying that subpart P does not allow 
healthcare facilities to consolidate any pharmaceutical waste at a 
reverse distributor. Healthcare facilities may only consolidate their 
waste at another facility that meets the definition of a healthcare 
facility as defined in Sec.  266.500. See sections X.N and XI.B, 
respectively, for further discussion about healthcare facilities that 
receive non-creditable and potentially creditable hazardous waste 
pharmaceuticals from off-site healthcare facilities.

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))

1. Summary of Proposal
    We proposed that a LTCF that is a VSQG that has an on-site DEA 
collection receptacle could use the collection receptacle for its 
hazardous waste pharmaceuticals, even if they are not controlled 
substances. We reasoned that since DEA already allows controlled 
substances to be commingled with non-controlled substances, it was 
consistent to allow VSQG hazardous waste pharmaceuticals that are not 
controlled substances to be placed in DEA authorized collection 
receptacles along with controlled substances. Further, we reasoned that 
the management of VSQG hazardous waste pharmaceuticals as DEA 
controlled substances is preferable to management as municipal solid 
waste because it provides greater protection to patients, visitors, and 
workers at LTCFs to have the hazardous waste pharmaceuticals in DEA 
authorized collection receptacles than down the sewer or in the 
facility's regular trash.
2. Summary of Comments
    The few comments we received on this specific provision of the 
proposed rulemaking were mostly supportive.
3. Final Rule Provisions
    We are finalizing the provision that allows an LTCF that is a VSQG 
to use

[[Page 5891]]

a DEA authorized collection receptacle to dispose of its hazardous 
waste pharmaceuticals with three minor changes. The first change is to 
clarify again that this provision only applies to LTCFs that are VSQGs 
for both hazardous waste pharmaceuticals and non-pharmaceutical 
hazardous waste and are therefore not subject to subpart P (except the 
sewer prohibition of Sec.  266.505, the empty container standards of 
Sec.  266.507, and the optional provisions of Sec.  266.504). The 
second change is to clarify that the DEA authorized collection 
receptacle that the VSQG LTCF uses to dispose of its hazardous waste 
pharmaceuticals must be on-site. The third change is to exclude items 
such as contaminated personal protective equipment or clean-up residues 
from being placed into the DEA authorized collection receptacle. 
Although these items meet our new definition of pharmaceutical, a DEA 
authorized collection receptacle is designed for the collection of the 
pharmaceuticals themselves and not larger items that might be 
contaminated by the pharmaceuticals, such as contaminated PPE or clean-
up residues. For instance, they are required to have small openings and 
limited volumes, making their use for contaminated PPE and clean-up 
residues impractical.
4. Comments and Responses
    One commenter thought that this proposed provision was ``not 
feasible'' because ``take-back kiosks for controlled substances are 
intended to be used by end users and not the DEA registrant.'' \241\ In 
many, if not most, cases at an LTCF, the hazardous waste 
pharmaceuticals will be from an ultimate user and the DEA regulations 
permit the collection receptacles to be used for collecting both 
controlled and non-controlled substances from ultimate users. There are 
more limited cases where an LTCF may have its own inventory of non-
controlled hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \241\ See comment number EPA-HQ-RCRA-2007-0932-0280.
---------------------------------------------------------------------------

    Although EPA concurs with the commenters that the DEA authorized 
collection receptacles are only for controlled substances from ultimate 
users, EPA does not believe that the same limitation needs to be placed 
on the pharmaceuticals from VSQGs that are hazardous waste but not 
controlled substances. In fact, it could be argued that long-term care 
facilities that are VSQGs would be allowed to use DEA authorized 
collection receptacles for their hazardous waste pharmaceuticals even 
without this new provision, provided the waste from the DEA authorized 
collection receptacles is treated or disposed at one of the types of 
facilities identified in Sec.  262.14(a)(5) (e.g., facilities that are 
permitted or have interim status to manage hazardous waste and 
facilities that are permitted, licensed or registered by a state to 
manage hazardous waste, municipal waste or non-municipal waste). 
Nevertheless, we did propose, and are finalizing the provision in Sec.  
266.504(c) making it clear that an LTCF that is a VSQG can place its 
hazardous waste pharmaceuticals in an on-site DEA collection 
receptacle.
    However, as the commenter pointed out, it is important to note that 
the DEA regulations for controlled substances are much narrower in what 
may be placed in a collection receptacle; DEA only allows controlled 
substances from ultimate users (patients) to be placed in collection 
receptacles that are at long-term care facilities. As a result, if a 
LTCF (or any other healthcare facility) is a DEA registrant, it may not 
place its inventory of controlled substances in a collection 
receptacle, even if it is a VSQG.

D. Long-Term Care Facilities With 20 Beds or Fewer Are Presumed To Be 
Very Small Quantity Generators (Sec.  266.504(d))

1. Summary of Proposal
    EPA took comment on whether we should provide a rebuttable 
presumption that LTCFs with fewer than 10 beds are assumed to be VSQGs 
and thus would not be required to keep track of the amount of hazardous 
waste generated each month. The Agency did not propose regulatory 
language for this provision. EPA asked commenters to submit data to 
support a 10-bed cutoff to show that LTCFs with fewer than 10 beds are 
generally VSQGs. Alternatively, if commenters supported a different 
cutoff for the rebuttable assumption, EPA asked that the commenters 
submit information to support their suggested cutoff.
2. Summary of Comments
    Comments on the rebuttable presumption for LTCFs with fewer than 10 
beds varied. One state did not support providing a rebuttable 
presumption for LTCFs with fewer than 10 beds and argued that all 
generators should be required to count the hazardous waste they 
generate.\242\ One state expressed support for providing a rebuttable 
presumption and requested that EPA keep the cutoff at 10 beds.\243\ One 
state did not support providing the rebuttable presumption because most 
healthcare facilities in their state, including LTCFs, have more than 
10 beds but generate only VSQG quantities of hazardous waste.\244\
---------------------------------------------------------------------------

    \242\ See comment number EPA-HQ-RCRA-2007-0932-0238 in the 
docket for this rulemaking.
    \243\ See comment number EPA-HQ-RCRA-2007-0932-0242 in the 
docket for this rulemaking.
    \244\ See comment number EPA-HQ-RCRA-2007-0932-0332 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Two healthcare industry commenters that supported the rebuttable 
presumption asked that EPA increase the cutoff from 10 beds to 20 
beds.\245\ One healthcare industry commenter supported the rebuttable 
presumption and asked that EPA increase the bed cutoff from 10 beds to 
15 beds.\246\
---------------------------------------------------------------------------

    \245\ See comment numbers EPA-HQ-RCRA-2007-0932-0239 and EPA-HQ-
RCRA-2007-0932-0282 in the docket for this rulemaking.
    \246\ See comment number EPA-HQ-RCRA-2007-0932-0328 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

3. Final Rule Provisions
    Under the final rule, EPA is finalizing a rebuttable presumption in 
Sec.  266.504(d) that LTCFs with 20 beds or fewer are assumed to be 
VSQGs and thus are not required to demonstrate the amount of hazardous 
waste generated each month. Under this presumption, LTCFs are only 
subject to the requirements for VSQG healthcare facilities as described 
elsewhere in this proposal, including the requirement not to sewer 
hazardous waste pharmaceuticals (Sec.  266.505), the empty container 
standards (Sec.  266.507), and the optional provisions of Sec.  
266.504. Under the final rule, the EPA Regional Administrator has the 
responsibility to demonstrate that a LTCF with 20 beds or fewer 
generates quantities of hazardous waste that are in excess of the VSQG 
limits as defined in Sec.  260.10 if the EPA Regional Administrator 
wishes to mandate that the LTCF operate under subpart P. A LTCF with 
more than 20 beds that operates as a VSQG under Sec.  262.14 must 
demonstrate that it generates quantities of hazardous waste that are 
within the VSQG limits as defined by Sec.  260.10.
    Based on available data, EPA believes it is reasonable to be 
responsive to the healthcare industry commenters who supported the 
rebuttable presumption and to increase the cutoff to 20 beds. The 
available information on hazardous waste generation at LTCFs suggests 
that LTCFs with 20 beds or fewer are generally VSQGs. Although EPA did 
not receive any data from the healthcare industry commenters, one state 
commented that most healthcare facilities in their state, including 
LTCFs, have many more than 10 beds but generate only VSQG quantities of

[[Page 5892]]

hazardous waste.\247\ Additionally, EPA estimates that there are 
between 2,875 and 4,770 long-term care facilities that generate 
hazardous waste and that 98 to 99 percent of the facilities are 
VSQGs.\248\ Although EPA estimates that there are few LTCF hazardous 
waste generators that are SQGs or LQGs, EPA does not have data on the 
number of beds at each facility, making it difficult to estimate a 
facility size threshold at which a LTCF becomes an SQG or an LQG. EPA 
conducted additional analysis using data on the average size of LTCFs 
in the United States and data on the average volume of hazardous waste 
generated annually at LTCFs that submitted a biennial hazardous waste 
report between 2001 and 2015 in order to estimate the average size at 
which a LTCFs become SQGs or LQGs.\249\ The estimates suggest that 
LTCFs with fewer than 20 beds will generally be VSQGs. Therefore, EPA 
concludes that it is reasonable to provide a rebuttable presumption 
that LTCFs with 20 beds or fewer are assumed to be VSQGs and thus are 
not required to demonstrate the amount of hazardous waste generated 
each month.
---------------------------------------------------------------------------

    \247\ See comment number EPA-HQ-RCRA-2007-0932-0332 in the 
docket for this rulemaking.
    \248\ Regulatory Impact Analysis in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932).
    \249\ See memorandum ``Long-Term Care Facility Summary Data and 
Hazardous Waste Generation Data'' in the docket for this rulemaking 
(EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

XIII. Sewer Disposal Prohibition (Sec.  266.505)

A. Regulatory Background on the Domestic Sewage Exclusion

    Under RCRA and the Subtitle C hazardous wastes regulations, if a 
material is not a solid waste, then it cannot be considered a hazardous 
waste. Under Sec.  261.4(a)(1)(ii) of the RCRA regulations, ``Any 
mixture of domestic sewage and other wastes that passes through a sewer 
system to a publicly-owned treatment works for treatment'' is not a 
solid waste for purposes of Subtitle C regulation. This exclusion was 
finalized by EPA on May 19, 1980, based on the reasoning that ``Mixed 
waste streams that pass through sewer systems to publicly-owned 
treatment works (POTWs) will be subject to controls under the Clean 
Water Act (CWA). The Agency's construction grants program provides 
financial assistance for the proper treatment of these wastes. In 
addition, the Agency's pretreatment program provides a basis for EPA 
and the local communities to ensure that users of sewer and treatment 
systems do not dump wastes in the system that will present 
environmental problems.'' \250\
---------------------------------------------------------------------------

    \250\ May 19, 1980; 45 FR 33097.
---------------------------------------------------------------------------

    In 1984, Congress enacted the Hazardous and Solid Waste Amendments 
(HSWA) to the Solid Waste Disposal Act (SWDA), as amended by RCRA. HSWA 
included a new Section 3018, entitled Domestic Sewage. This section 
directed EPA to do two things with respect to the Sec.  261.4(a)(1)(ii) 
exclusion for mixtures of domestic sewage and other wastes: (1) Submit 
a Report to Congress (RTC) that describes the types, size and number of 
generators which dispose of such wastes in this manner, the types and 
quantities of wastes disposed of in this manner, and identify 
significant generators, wastes and waste constituents not regulated 
under existing Federal law or regulated in a manner sufficient to 
protect human health and the environment; and (2) based on the report, 
revise the appropriate existing regulations to ``ensure that substances 
. . . which pass through a sewer system to a publicly owned treatment 
works are adequately controlled to protect human health and the 
environment.''
    EPA submitted its Report to Congress on February 7, 1986 (Domestic 
Sewage Study). Subsequent to the Report to Congress, EPA issued an 
advance notice of proposed rulemaking on August 22, 1986; \251\ a 
response to comments on the advanced notice of proposed rulemaking on 
June 22, 1987; \252\ a notice of proposed rulemaking (NPR) on November 
23, 1988; \253\ and a final rule on July 24, 1990.\254\ That final rule 
expanded an existing prohibition on the discharge of pollutants which 
create a fire or explosion hazard in the POTW, so that it included, but 
was not limited to, ``waste streams with a closed cup flashpoint of 
less than 140 degrees Fahrenheit or 60 degrees Centigrade using the 
test methods specified in 40 CFR 261.21.'' \255\ Although the RCRA 
characteristic of reactivity (D003) was not specifically mentioned in 
the CWA regulations, discharges of some D003 reactive hazardous wastes 
are also prohibited by this section of the CWA regulations: (1) 
Chemicals that react violently with water \256\ and (2) chemicals that 
form potentially explosive mixtures with water.\257\
---------------------------------------------------------------------------

    \251\ See the advance notice of proposed rulemaking in August 
22, 1986; 51 FR 30166.
    \252\ See the response to comments in June 22, 1987; 52 FR 
23477.
    \253\ See the proposed rule November 23, 1988; 53 FR 47632.
    \254\ See the final rule in July 24, 1990; 55 FR 30082.
    \255\ See the prohibition in 40 CFR 403.5(b)(1).
    \256\ See 40 CFR 261.23(a)(2).
    \257\ See 40 CFR 261.23(a)(3).
---------------------------------------------------------------------------

    The 1990 CWA final rule added a new prohibition such that no 
discharge shall ``result in the presence of toxic gases, vapors or 
fumes within the POTW in a quantity that may cause acute worker health 
and safety problems.'' \258\ Similarly, although the RCRA 
characteristic of reactivity (D003) was not specifically mentioned in 
this section of the CWA regulations, discharges of some D003 reactive 
hazardous wastes are also prohibited by this section: (1) Chemicals 
that, when mixed with water, generate toxic gases, vapors or fumes in 
quantity sufficient to present a danger to human health or the 
environment \259\ or (2) cyanide or sulfide bearing waste which, when 
exposed to pH conditions between 2 and 12.5, can generate toxic gases, 
vapors or fumes in a quantity sufficient to present a danger to human 
health or the environment.\260\
---------------------------------------------------------------------------

    \258\ See 40 CFR 403.5(b)(7).
    \259\ See 40 CFR 261.23(a)(4).
    \260\ See 40 CFR 261.23(a)(5).
---------------------------------------------------------------------------

    In addition, some D002 corrosive hazardous wastes were prohibited 
prior to the 1990 CWA final rule and remain prohibited. Under RCRA, a 
waste is considered D002 for corrosivity if it has a pH of less than or 
equal to 2 (strongly acidic) or greater than or equal to 12.5 (strongly 
basic). Section 403.5(b)(2) of the CWA regulations prohibits discharges 
with a pH of less than 5.0, except under limited circumstances. 
Therefore, acidic D002 hazardous waste is prohibited from being 
discharged under the CWA regulations.
    Note that although the exclusion for mixtures of domestic sewage 
and other wastes is found under the RCRA regulations in Sec.  
261.4(a)(1)(ii), and it was HSWA, which is an amendment to RCRA, that 
directed the review of and amendments to that exclusion, the sewer ban 
of liquid ignitable D001 hazardous wastes and some D002 and D003 
hazardous wastes was established under 40 CFR 403.5(b), which is under 
the CWA regulations. Also note that EPA left open the possibility of 
additional future action when it stated in the preamble to the July 24, 
1990, final rule, its intent ``to carefully review the effect of this 
rule and promulgate in the future any additional regulations that 
experience reveals are necessary to improve control over hazardous 
waste and other industrial user discharges to POTWs.'' \261\
---------------------------------------------------------------------------

    \261\ July 24, 1990 Federal Register; 55 FR 30084.

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[[Page 5893]]

B. Summary of Proposal

    In 2015, EPA proposed to impose a sewer ban on all hazardous waste 
pharmaceuticals managed by healthcare facilities and reverse 
distributors. That is, healthcare facilities and reverse distributors 
subject to part 266 subpart P would not be able to use the RCRA 
domestic sewage exclusion in Sec.  261.4(a)(1)(ii) any longer for their 
hazardous waste pharmaceuticals. They would be prohibited from 
disposing of pharmaceuticals that are listed hazardous waste and/or 
exhibit one or more of the four hazardous waste characteristics (i.e., 
ignitability, corrosivity, reactivity, or toxicity) by putting them 
down a drain (e.g., sink, toilet, or floor drain).
    EPA proposed this sewer prohibition of hazardous waste 
pharmaceuticals for several reasons. First, as described in detail in 
the preamble to the proposed rulemaking, a number of studies had shown 
that flushing of leftover medications had become a prevalent practice 
used in lieu of proper hazardous waste management and that experience 
had, indeed, revealed that additional regulations were ``necessary to 
improve control over hazardous waste and other industrial user 
discharges to POTWs.'' \262\
---------------------------------------------------------------------------

    \262\ July 24, 1990 Federal Register; 55 FR 30084.
---------------------------------------------------------------------------

    Second, although EPA establishes national regulations under the CWA 
(called effluent limitations guidelines and pretreatment standards) to 
reduce discharges of pollutants from industries to surface waters and 
POTWs, currently there are no national effluent limitations or 
pretreatment standards that apply to healthcare facilities discharging 
pharmaceuticals to POTWs. Furthermore, traditional wastewater treatment 
operations implemented at POTWs are designed to remove conventional 
pollutants, such as suspended solids and biodegradable organic 
compounds. They are not designed to remove pharmaceuticals that are 
present in discharges from medical and veterinary facilities. While 
some POTWs may have implemented advanced treatment technologies, these 
technologies are not designed to remove pharmaceuticals. EPA released a 
study in 2009 in which over 100 chemicals (including some 
pharmaceuticals) were analyzed in the influent and effluent at nine 
POTWs.\263\ Although it was a limited study and difficult to generalize 
the results to all POTWs, it does indicate that the capabilities of 
treatment technologies currently employed by POTWs does not include 
treatment to remove active pharmaceutical ingredients (APIs).\264\ In a 
more recent study, EPA measured concentrations of 56 APIs in effluent 
samples from 50 large POTWs across the country and discovered at least 
one API in each sample.\265\ In addition, as stated in EPA's Health 
Services Industry study, ``synthetic compounds, such as 
pharmaceuticals, are often manufactured to be resistant to metabolic 
transformation. As a result, some pharmaceutical compounds that are 
present in the influent to POTWs may pass through treatment systems at 
conventional POTWs and discharge to receiving waters.'' \266\
---------------------------------------------------------------------------

    \263\ EPA, Occurrence of Contaminants of Emerging Concern in 
Wastewater from Nine Publicly Owned Treatment Works, August 2009; 
EPA-821-R-09-009.
    \264\ Eggen RI, Hollender J, Joss A, Sch[auml]rer M, Stamm C, 
``Reducing the Discharge of Micropollutants in the Aquatic 
Environment: The Benefits of Upgrading Wastewater Treatment Plant.'' 
Environmental Science and Technology 2014, 48(14) 7683-7689.
    \265\ Kostich MS, Batt AL, Lazorchak JM, ``Concentrations of 
prioritized pharmaceuticals in effluents from 50 large wastewater 
treatment plants in the US and implications for risk estimation.'' 
Environmental Pollution 2014, 184:354-9.
    \266\ Health Services Industry Study: Management and Disposal of 
Unused Pharmaceuticals (Interim Technical Report) August 2008; EPA-
821-R-08-013.
---------------------------------------------------------------------------

    Third, the pharmaceuticals entering the environment, through 
flushing or other means, are having a negative effect on aquatic 
ecosystems and on fish and animal populations. A recent article 
highlighted the scientific literature that examines the effect of 
pharmaceuticals on freshwater ecosystems, particularly the effect of 
pharmaceuticals on key ecological processes.\267\ The RIA for the 
proposed rulemaking more fully summarized the scientific literature 
with regard to ecological effects.\268\ The scientific research with 
regard to human health effects due to pharmaceuticals in the 
environment is still ongoing. Nevertheless, the important features and 
risks of the problem can be summarized as follows: \269\
---------------------------------------------------------------------------

    \267\ Richmond EK, Grace MR, Kelly JJ, Reisinger AJ, Rosi EJ, 
Walters, DM. ``Pharmaceuticals and personal care products (PPCPs) 
are ecological disrupting compounds (EcoDC).'' Elem Sci Anth 2017, 
5:66.
    \268\ See page 147 of the Regulatory Impact Analysis for the 
proposed rule in the docket EPA-HQ-RCRA-2007-0932-0151.
    \269\ A. Ginebreda et al., Environmental risk assessment of 
pharmaceuticals in rivers: Relationships between hazard indexes and 
aquatic macroinvertebrate diversity indexes in the Llobregat River 
(NE Sapin). Environ Int. (2009), doi:10.1016/j.envint.2009.10.003.
---------------------------------------------------------------------------

    (1) Pharmaceuticals are intrinsically bioactive compounds; 
therefore, they can potentially impact living systems.
    (2) There is a continuous and worldwide increase in their use and, 
thus, on their subsequent input into the environment.
    (3) Many of the hundreds of frequently prescribed pharmaceuticals 
are known for targeted effects and adverse off-target side effects, a 
problem that can be exacerbated by interactive effects during therapy 
involving co-administration and disposal.
    While healthcare facilities that are VSQGs were generally not 
subject to the proposed rulemaking, EPA proposed that the sewer ban of 
hazardous waste pharmaceuticals also apply to healthcare facilities 
that are VSQGs. The RIA for the rule projects that the vast majority of 
healthcare facilities are VSQGs (81-86 percent).\270\ Some particular 
types of healthcare facilities have an even larger proportion of VSQGs: 
For example, the RIA estimates that of the LTCFs that generate 
hazardous waste, 98-99 percent of LTCFs are VSQGs.\271\ EPA was and 
remains concerned that these smaller healthcare facilities are more 
likely to dispose of their hazardous waste pharmaceuticals via the 
sewer. EPA estimates that there are between 50,900 and 84,800 
healthcare facilities that are VSQGs.\272\ Given this large number, the 
combined impact of sewer disposal by healthcare facilities that are 
VSQGs has an even greater potential to provide a substantial impact on 
the environment, as well as human health. EPA solicited comment on 
whether it was appropriate to apply the proposed ban on the sewer 
disposal of hazardous waste pharmaceuticals to all healthcare 
facilities, including healthcare facilities that are VSQGs. Comments 
submitted to the Agency in response to this request are discussed in 
the next section.
---------------------------------------------------------------------------

    \270\ See the Regulatory Impact Analysis for the final rule in 
the docket EPA-HQ-RCRA-2007-0932.
    \271\ Ibid.
    \272\ Ibid.
---------------------------------------------------------------------------

    We note that EPA's proposed ban on sewering hazardous waste 
pharmaceuticals is consistent with other federal state, and local 
actions. For example, the DEA has finalized regulations to implement 
the Secure and Responsible Drug Disposal Act of 2010.\273\ DEA's 
regulations require a ``non-retrievable'' method of destruction of 
controlled substances. The preamble to DEA's proposed and final rules 
state that flushing does not meet the non-retrievable standard for 
destruction.\274\ According to the preamble of the DEA final rule, DEA 
received 20 comments supporting their position against

[[Page 5894]]

flushing controlled substances.\275\ The comments supporting the 
prohibition against sewering came from states, regional, and local 
hazardous waste management programs, recycling associations, non-
governmental organizations (NGOs), trade associations and environmental 
organizations. Many of these commenters noted that wastewater treatment 
systems do not eliminate many of the drugs that are flushed into the 
sewers and requested that DEA clearly state in the regulatory language, 
not just preamble, that sewering is not allowable as a means of 
destruction.
---------------------------------------------------------------------------

    \273\ September 9, 2014; 79 FR 53520.
    \274\ Proposed rule: December 21, 2012; 77 FR 75784 (see page 
75803); and Final rule: September 9, 2014; 79 FR 53520 (see page 
53548).
    \275\ September 9, 2014; 79 FR 53520 (see page 53548).
---------------------------------------------------------------------------

    In addition, four states, the District of Columbia, and local 
California jurisdictions have taken action to limit the sewering of 
pharmaceuticals and another state has introduced a bill. ``Colorado has 
prohibited the discharging of solid/hazardous waste down the drain 
since the adoption of RCRA in the 1980s.'' \276\ In 2009, Illinois 
passed the Safe Pharmaceutical Disposal Act, which prohibits healthcare 
facilities from flushing any solid dosage form other than DEA schedule 
II drugs into public sewers or septic systems.\277\ In 2012, New Jersey 
passed a similar law that prohibits healthcare facilities from 
discharging prescription medications into public sewers or septic 
systems.\278\ In 2002, California banned the use of lindane in 
pharmaceuticals after it found that lindane was adversely impacting 
wastewater quality. The authors of the paper ``Outcomes of the 
California Ban on Pharmaceutical Lindane: Clinical and Ecologic Impacts 
state that ``This is the first time that a pharmaceutical has been 
outlawed to protect water quality.'' \279\ After researching and 
documenting environmental benefits of the ban, the authors conclude, 
``This ban serves as a model for governing bodies considering limits on 
the use of lindane or other pharmaceuticals.'' Also in California, some 
county departments, such as Sacramento County and Contra Costa County, 
prohibit sewering of hazardous waste pharmaceuticals.\280\ And the 
District of Columbia has promulgated municipal regulations, effective 
January 1, 2011, that prohibits healthcare facilities from flushing 
pharmaceutical products.\281\ The Connecticut legislature has also 
considered a bill to ban the discharge of medication into public or 
private wastewater collection systems or septic systems, although it 
has not yet become law.\282\ Nevertheless, the Connecticut Department 
of Energy and Environmental Protection's (CT DEEP) ``current hazardous 
waste management regulations essentially ban sewer disposal of RCRA 
waste by requiring all generators in Connecticut, including [VSQGs], to 
ensure delivery by a licensed waste transporter with an EPA ID Number 
to a facility authorized to receive the waste.'' \283\
---------------------------------------------------------------------------

    \276\ See comment number: EPA-HQ-RCRA-2007-0932-0242.
    \277\ Illinois Public Act 096-0221.
    \278\ Nicknamed Bateman's Law, after Senator Christopher ``Kip'' 
Bateman (R-Somerset) that sponsored the legislation.
    \279\ Humphreys, et al. Environmental Health Perspectives. 2008 
March; 116(3) 297-302.
    \280\ See comment number: EPA-HQ-RCRA-2007-0932-0378.
    \281\ DCMR Title 22-B Chapter 5 Safe Disposal of Unused 
Pharmaceuticals in Health Care Facilities
    \282\ State of Connecticut General Assembly, January Session 
2013, Raised Bill No. 6439. An Act Concerning the Disposal and 
Collection of Unused Medication.
    \283\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    The Agency sought comment on several areas related to the 
prohibition on sewering hazardous waste pharmaceuticals. First, the 
Agency requested comment on whether the sewer ban should apply to 
healthcare facilities that are VSQGs. Second, we requested comment on 
the trade-offs inherent in prohibiting sewer disposal; that is, would 
the benefit of the reduction in aquatic risk be outweighed by 
additional opportunities for diversion and the possibility of 
inadvertent exposures for certain workers? Third, we sought comment on 
whether it would be appropriate to allow any exceptions to the sewer 
ban, such as for leftover portions of hazardous wastes that are also 
controlled substances.\284\ Finally, the Agency sought comment on 
whether it would be helpful to incorporate in 40 CFR 261.4(a)(1)(ii), a 
cross-reference to the CWA regulations that prohibit the sewering of 
certain hazardous wastes.
---------------------------------------------------------------------------

    \284\ In a DEA letter dated October 17, 2014, DEA refers to 
leftover, partially administered drugs as ``pharmaceutical 
wastage.'' https://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf
---------------------------------------------------------------------------

C. Summary of Comments

    Nearly a third of the commenters to the proposed rulemaking 
commented on the proposed prohibition of sewering hazardous waste 
pharmaceuticals. Commenters were nearly unanimous in their support for 
the prohibition on sewering of hazardous waste pharmaceuticals. Support 
was expressed by a broad and diverse set of commenters, including state 
and local governments, sewer districts, environmental groups, and waste 
management companies. Although some commenters had suggestions for 
minor exceptions, few commenters expressed complete opposition to the 
prohibition on sewering. Furthermore, there was widespread support from 
commenters for applying the prohibition on sewering hazardous waste 
pharmaceuticals to healthcare facilities that are VSQGs. As one 
commenter noted, ``given the large number of small generators . . . If 
each of these small generators were allowed to discharge even a small 
amount of pharmaceuticals, the overall volume would be significant. 
''\285\
---------------------------------------------------------------------------

    \285\ See comment number EPA-HQ-RCRA-2007-0932-0337.
---------------------------------------------------------------------------

D. Final Rule Provisions

    Given the environmental concerns described above combined with the 
overwhelming support that we received from commenters, we are 
finalizing the prohibition of sewering hazardous waste pharmaceuticals. 
The prohibition on sewering hazardous waste pharmaceuticals applies to 
all reverse distributors and all healthcare facilities, including 
healthcare facilities that are VSQGs. Furthermore, EPA is not providing 
any exceptions to the prohibition on sewering. Therefore, the 
prohibition on sewering hazardous waste pharmaceuticals applies to all 
hazardous waste pharmaceuticals that are generated by any healthcare 
facilities and reverse distributors, including hazardous waste 
pharmaceuticals that are also controlled substances and any 
pharmaceutical wastage from partial administration of hazardous waste 
pharmaceuticals. How the sewer prohibition intersects with the disposal 
of pharmaceutical wastage will be discussed in greater detail in 
section XIV.D.2. rather than this section.
    In response to commenters' suggestions, we are making some minor 
editorial changes, including adding two cross references to the CWA 
prohibitions on sewering hazardous wastes in Sec.  403.5(b). One cross 
reference will be added to Sec.  261.4(a)(1)(ii) and the other cross 
reference will be added to Sec.  266.505. We also eliminated the second 
sentence of the proposed prohibition, which read: The exclusion in 
Sec.  261.4(a)(1)(ii) for mixtures of domestic sewage and other wastes 
that pass through a sewer system to a publicly owned treatment works 
does not apply to hazardous waste pharmaceuticals.

[[Page 5895]]

    Oklahoma Department of Environmental Quality (OK DEQ) expressed 
concern that this ``second sentence could be interpreted that EPA is 
exerting RCRA authority over domestic sewage if it contains [hazardous 
waste pharmaceuticals]--an area that has been exclusively under Clean 
Water Act jurisdiction since the first regulations were promulgated in 
1980.'' \286\ EPA had proposed the second sentence in an attempt to be 
abundantly clear that the proposed prohibition on sewering hazardous 
waste pharmaceuticals supersedes the exclusion in Sec.  
261.4(a)(1)(ii). We did not intend to assert RCRA jurisdiction over 
domestic sewage; therefore, we have concluded that it is better to 
remove the sentence in order to avoid the concern expressed by OK DEQ. 
Nevertheless, we wish to emphasize that the prohibition on sewering 
hazardous waste pharmaceuticals being finalized in Sec.  266.505 does, 
in fact, supersede the exclusion in Sec.  261.4(a)(1)(ii). To make that 
point clear, we are amending Sec.  261.4(a)(1)(ii) to state that any 
mixture of domestic sewage and other wastes that passes through a sewer 
system to a publicly-owned treatment works for treatment, except as 
prohibited by Sec. Sec.  266.505 and Clean Water Act requirements at 40 
CFR 403.5(b), is not a solid waste.
---------------------------------------------------------------------------

    \286\ See commenter number EPA-HQ-RCRA-2007-0932-0231.
---------------------------------------------------------------------------

E. Comments and Responses

    Many comments suggested various ways in which we should broaden the 
applicability of the prohibition on sewering hazardous waste 
pharmaceuticals. In some cases, commenters urged us to apply the 
prohibition to all pharmaceuticals, not just hazardous waste 
pharmaceuticals. Subtitle D of RCRA, which governs the management of 
non-hazardous (solid) waste, does not provide EPA the statutory 
authority to apply the prohibition to non-hazardous waste 
pharmaceuticals. Nevertheless, EPA strongly recommends against sewering 
any pharmaceuticals. The American Water Works Association asked us to 
extend the prohibition to prevent the sewering of pharmaceuticals that 
are radioactive and patient waste containing radioactive 
pharmaceuticals. As discussed previously, hazardous waste 
pharmaceuticals that also contain a radioactive component subject to 
the Atomic Energy Act of 1954 (i.e., ``mixed waste'') are regulated by 
multiple agencies. The hazardous waste component is regulated under EPA 
or the authorized state RCRA programs, while either the NRC or the 
Department of Energy regulates the radioactive component of the waste 
under the Atomic Energy Act.\287\ Therefore, a ``mixed waste'' 
pharmaceutical that is both radioactive and RCRA hazardous waste is 
prohibited from being discharged to the sewer. We strongly recommend 
against sewering other radioactive pharmaceuticals and patient waste 
containing radioactive pharmaceuticals.
---------------------------------------------------------------------------

    \287\ The NRC regulates radioactive wastes generated by 
commercial or non-DOE facilities, whereas DOE regulates radioactive 
wastes generated by DOE facilities.
---------------------------------------------------------------------------

    Other commenters suggested that the prohibition should not be 
limited to discharges to POTWs; rather, it should also apply to 
discharges to septic tanks, privately owned treatment works and 
federally owned treatment works. Section 261.4(a)(1)(ii) allows the 
discharge of what would otherwise be a hazardous waste to POTWs, 
without being considered a solid or hazardous waste. The prohibition on 
discharges of hazardous waste pharmaceuticals being finalized today is 
intended to reduce the scope of that exclusion in the existing 
regulations. Discharges of hazardous waste to other types of sewage 
systems, such as septic tanks, privately owned treatment works and 
federally owned treatment works are not allowed by exclusion in Sec.  
261.4(a)(1)(ii). Therefore, the discharge of hazardous wastes to septic 
tanks, privately owned treatment works and federally owned treatment 
works is already prohibited, even though it is not explicitly stated.
    We note that although our RCRA statutory authority limits us to 
apply the prohibition on sewering narrowly to pharmaceuticals that are 
RCRA hazardous wastes, EPA strongly recommends as a best management 
practice to not sewer any waste pharmaceutical (i.e., hazardous or non-
hazardous) from any source or location. This recommendation against 
sewering pharmaceuticals includes households and assisted living 
facilities, except in the relatively rare situation when households and 
assisted living facilities are specifically directed by FDA guidance to 
flush certain potentially dangerous drugs down the toilet (as noted on 
pharmaceutical packaging), when a drug take-back option is not readily 
available, to help ensure that they are not misused or accidentally 
ingested or touched.\288\ In lieu of sewering, we recommend that 
households, including residents of assisted living facilities, follow 
the guidelines developed by the U.S. Office of National Drug Control 
Policy (ONDCP), the FDA, and EPA for the disposal of unwanted household 
pharmaceuticals. In summary, the guidelines for households disposing of 
pharmaceuticals are as follows (in order of preference):
---------------------------------------------------------------------------

    \288\ https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/UCM337803.pdf.
---------------------------------------------------------------------------

    (1) Use a drug take-back event or program, when available;
    (2) Dispose in household trash, after mixing the unwanted medicines 
with an unpalatable substance such as dirt, cat litter, or used coffee 
grounds and placing in a sealed container; and
    (3) Only if the drug label specifically instructs you to, flush the 
unwanted medicine down the toilet.\289\
---------------------------------------------------------------------------

    \289\ https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm.
---------------------------------------------------------------------------

    We also note that the CWA prohibitions on discharges of hazardous 
waste in Sec.  403.5(b) are broader than just pharmaceuticals and apply 
beyond healthcare facilities and reverse distributors. Like all of the 
prohibited discharges under the CWA regulations, the prohibitions of 
hazardous waste discharges apply to any industrial user. Additionally, 
the CWA prohibitions on hazardous waste discharges apply to all D001 
ignitable liquids, acidic D002 hazardous wastes, and D003 reactive 
hazardous wastes that (1) react violently with water,\290\ (2) form 
potentially explosive mixtures with water,\291\ or (3) result in the 
presence of toxic gases, vapors or fumes within the POTW in a quantity 
that may cause acute worker health and safety problems,\292\ not just 
pharmaceuticals that exhibit those characteristics.
---------------------------------------------------------------------------

    \290\ See 40 CFR 261.23(a)(2).
    \291\ See 40 CFR 261.23(a)(3).
    \292\ See 40 CFR 403.5(b)(7).
---------------------------------------------------------------------------

    Some commenters asked us to include some exceptions to the 
prohibition on discharges of hazardous waste pharmaceuticals. 
Specifically, one commenter who supported our proposed ban on sewering 
of hazardous waste pharmaceuticals, and even supported extending it to 
non-hazardous waste pharmaceuticals, suggested that we allow exceptions 
``for those that do not contain active pharmaceutical ingredients, such 
as sterile water and 0.9% sodium chloride for injection and 
irrigation.'' \293\ First, as a point of clarification, because sterile 
water and 0.9% sodium chloride are not hazardous waste, they would not 
be subject to the prohibition of discharging hazardous waste 
pharmaceuticals to the

[[Page 5896]]

sewer. And even though, as a general rule, we strongly recommend 
against sewering any pharmaceutical, regardless of whether it meets our 
definition of hazardous waste, we agree with the commenter that it 
seems unnecessary to prohibit the sewering of sterile water and 0.9% 
sodium chloride.
---------------------------------------------------------------------------

    \293\ See comment number EPA-HQ-RCRA-2007-0932-0230.
---------------------------------------------------------------------------

    Other commenters asked us to make other exceptions to the 
prohibition on discharging hazardous waste pharmaceuticals. For 
example, the Healthcare Waste Institute suggested that we allow the 
discharge of hazardous waste pharmaceuticals that are specifically 
allowed by the local wastewater treatment agency or POTW.\294\ CT DEEP 
made a similar suggestion, saying that we should allow discharges if 
they are ``explicitly authorized by a National Pollutant Discharge 
Elimination System (NPDES) or State pretreatment permit.'' \295\ We 
have concluded that such an allowance is unnecessary because no known 
pretreatment standards or local limits have been established that 
specifically allow for the discharge of any pharmaceuticals. Note that 
40 CFR part 439 separately regulates discharges from pharmaceutical 
manufacturers to POTWs and waters of the U.S. Furthermore, in the 
absence of water quality standards for specific drugs, we would like to 
avoid a situation where local wastewater treatment agencies might feel 
pressured to make judgments on which discharges would be acceptable 
without knowing the effects on aquatic life or the synergistic effects 
of multiple drugs.
---------------------------------------------------------------------------

    \294\ See comment number EPA-HQ-RCRA-2007-0932-0296.
    \295\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    We received few comments related to our inquiry about trade-offs 
inherent in prohibiting sewer disposal. Sharps Compliance did note that 
as ``our experience as a DEA authorized collector has shown, 
regulations that ban the sewering in conjunction with a proactive 
collection and destruction program offer the best protection against 
both environmental harm and the risk of diversion.'' \296\ In addition, 
CT DEEP commented they do ``not believe there is an unfavorable risk 
trade-off inherent in prohibiting sewer disposal,'' indicating both 
risks are manageable.\297\
---------------------------------------------------------------------------

    \296\ See comment number EPA-HQ-RCRA-2007-0932-0248.
    \297\ See comment number EPA-HQ-RCRA-2007-0932-0341.
---------------------------------------------------------------------------

    Eli Lilly was one of the few commenters that opposed the 
prohibition on sewering hazardous waste pharmaceuticals, even though, 
as a manufacturer, they are not subject to the prohibition.\298\ They 
expressed two reasons for their opposition: (1) They do not believe 
that a total prohibition is based on sound risk management decisions 
and should be more flexible to exclude pharmaceuticals which FDA says 
should be disposed of down the drain, and (2) they believe that an 
effluent guideline under the CWA regulations is more appropriate and 
that EPA's Office of Water has decided not to promulgate an effluent 
guideline for the healthcare industry. As discussed previously, the 
prohibition on sewering hazardous waste pharmaceuticals and the FDA 
flush list do not conflict with one another. The prohibition applies to 
healthcare facilities (which does not include assisted living 
facilities) and reverse distributors, while the FDA flush list is 
directed to households and assisted living facilities and includes the 
caveat that flushing takes place only when a drug take-back option is 
not readily available. As to the commenter's second point, while it is 
true that the Office of Water has not yet promulgated an effluent 
guideline for the healthcare industry, this should not be taken as a 
sign that a decision has been made affirmatively that an effluent 
guideline is not appropriate at some time in the future. Rather, the 
Office of Water has preferred that the Office of Resource Conservation 
and Recovery (ORCR) first focus on preventing intentional discharges of 
hazardous waste pharmaceuticals. We firmly believe that the prohibition 
of sewering hazardous waste pharmaceuticals would complement any future 
action taken by the Office of Water to issue effluent guidelines for 
the healthcare industry.
---------------------------------------------------------------------------

    \298\ See comment number EPA-HQ-RCRA-2007-0932-0249.
---------------------------------------------------------------------------

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

    Prior to this final rulemaking, the management and disposal of a 
pharmaceutical that was both a RCRA hazardous waste and a DEA 
controlled substance was regulated under both the RCRA Subtitle C 
hazardous waste regulations, which is under EPA's or the authorized 
state's purview, and the Controlled Substances Act and its implementing 
regulations, which is under DEA's purview. At the time of the proposal, 
EPA was aware of only a handful of pharmaceuticals in common usage that 
are both hazardous waste and controlled substances and therefore 
subject to regulation by both EPA and the DEA. These are identified in 
Table 3:

                     Table 3--Pharmaceuticals Still Used in Healthcare That Are DEA Controlled Substances and RCRA Hazardous Wastes
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloral; chloral hydrate...........  Acetaldehyde, trichloro-;   Sedative.............  U034, toxic..........  IV                  Used in hospital
                                      Aquachloral, Noctec,                                                                          pediatric units;
                                      Somnote, Supprettes.                                                                          common ingredient in
                                                                                                                                    vet anesthetics.
Fentanyl sublingual spray..........  Subsys....................  Analgesic............  D001, ignitable......  II                  Ignitable due to
                                                                                                                                    alcohol content.
Phenobarbital......................  Bellergal-S, Donnatal,      Anticonvulsant.......  D001, ignitable......  IV                  Ignitable due to
                                      Luminal,.                                                                                     alcohol content.
Testosterone gels..................  Androgel, Fortesta, Testim  Hormone..............  D001, ignitable......  III                 Ignitable due to gel
                                                                                                                                    base.
Valium injectable..................  Diazepam..................  Anti-anxiety.........  D001, ignitable......  IV                  Ignitable due to
                                                                                                                                    alcohol content.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 5897]]

    Chloral hydrate (U034), which is listed for toxicity, is the only 
dually regulated hazardous waste/controlled substance that is a listed 
hazardous waste.\299\ The other four dually regulated hazardous wastes/
controlled substances in common use are considered hazardous because 
they exhibit the characteristic of ignitibility (D001). While the 
active ingredient is not ignitable, these particular forms of the 
pharmaceuticals are ignitable because they are prepared in ignitable 
solutions, such as alcohol.
---------------------------------------------------------------------------

    \299\ Note that EPA's U034 listing includes chloral hydrate, see 
memo dated April 6, 1998; Brandes to Knauss, RCRA Online #14175
---------------------------------------------------------------------------

    EPA is aware of three additional hazardous waste pharmaceuticals 
that are DEA controlled substances, but it is our understanding that 
they are no longer in common usage, although there may be legacy 
supplies remaining in healthcare facilities. See Table 4.

                         Table 4--DEA Controlled Substances and RCRA Hazardous Wastes Pharmaceuticals That Are Not in Common Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Paraldehyde........................  1,3,5-Trioxane, 2,4,6-      Anticonvulsant.......  U182 toxic...........  IV                  No longer in common
                                      trimethyl-; Paral.                                                                            use.
Paregoric..........................  camphorated tincture of     Analgesic,             D001 ignitable.......  III                 No longer in common
                                      opium.                      expectorant,                                                      use.
                                                                  antidiarrheal.
Opium Tincture.....................  Laudanam..................  Analgesic,...........  D001 ignitable.......  II                  No longer in common
                                                                 antidiarrheal........                                              use.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Similarly, as noted in Table 5, phentermine is a controlled 
substance, but the medical form is a phentermine salt, and the salts 
are no longer considered to be within the scope of the P046 
listing.\300\
---------------------------------------------------------------------------

    \300\ See memo dated February 17, 2012; from Devlin to RCRA 
Division Directors, RCRA Online #14831.

           Table 5--Pharmaceuticals That Are DEA Controlled Substances and RCRA Hazardous Wastes Salt(s) No Longer Considered Hazardous Waste
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phentermine........................  alpha, alpha-               Appetite suppressant.  P046, Acutely toxic..  IV                  If in salt form, it
                                      Dimethylphenethyl amine;                                                                      does not meet the
                                      Benzeneethanamine,                                                                            P046 listing and
                                      alpha,alpha-dimethyl-;                                                                        medical dosage forms
                                      Adipex-P, Atti Plex P,                                                                        are salts.
                                      Fastin, Ionamin,
                                      Kraftobese, Panshape M,
                                      Obe-Nix, Pentercot,
                                      Phentride, Pro-Fast,
                                      Raphtre, Supramine, Tara-
                                      8, Termene, Termine,
                                      Zantryl.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    EPA requested comment on whether these are, indeed, the only 
pharmaceuticals in common usage that are regulated both as DEA 
controlled substances, and when discarded, as RCRA hazardous waste.
    To eliminate duplicative regulation for these handful of hazardous 
wastes that are also controlled substances, EPA proposed to 
conditionally exempt from RCRA Subtitle C regulation those hazardous 
wastes that are also DEA controlled substances. Specifically, EPA 
proposed that hazardous wastes that are also controlled substances will 
be exempt from all RCRA Subtitle C requirements, including 40 CFR part 
266 subpart P, provided they meet two conditions: (1) They are 
combusted at a permitted large or small municipal waste combustor or a 
permitted or interim status hazardous waste combustor (incinerator or 
cement kiln) and (2) they are managed and disposed of in compliance 
with all applicable DEA regulations for controlled substances.
    The first condition we proposed was to ensure that the controlled 
substances are destroyed in an environmentally protective manner by a 
high-temperature combustor, such as a large or small municipal waste 
combustor or a permitted or interim status hazardous waste combustor 
(incinerator or cement kiln). At the time of proposal, DEA had not 
specified or endorsed a method by which the controlled substances 
should be destroyed to meet the non-retrievable standard. Although many 
hazardous wastes/controlled substances were being destroyed by 
incineration, it was not required by DEA. At the time, EPA was 
concerned that in the future DEA might allow a technology that lacks 
environmental controls and permits. Therefore, combustion of the 
hazardous wastes/controlled substances, which requires permitting, 
operating and monitoring standards, was proposed as a condition of the 
exemption. However, EPA requested comment on whether there are 
additional technologies that would be appropriate to include for the 
destruction of hazardous waste pharmaceuticals that are also controlled 
substances.
    The second condition we proposed was to ensure that dually 
regulated hazardous wastes/controlled substances are managed under 
another rigorous regulatory program since they will not be managed in 
accordance with the RCRA Subtitle C regulations. Although developed for 
different reasons, both EPA's hazardous waste and DEA's controlled 
substance regulatory programs are designed to track the regulated 
material from cradle to grave. EPA requested comment on whether the 
tracking that DEA requires for controlled substances is sufficient to 
act in lieu of the RCRA manifest.
    We considered proposing a third condition that the hazardous waste 
pharmaceuticals that are also DEA controlled substances would be 
subject

[[Page 5898]]

to the sewer prohibition of Sec.  266.505. At the time of proposal, 
however, we concluded that because combustion in specific units was a 
condition of the exemption, that it was unnecessary to state that the 
hazardous waste/controlled substances may not be sewered.
    EPA also proposed a related conditional exemption for household 
pharmaceuticals, including those that are collected in DEA authorized 
collection receptacles and commingled with DEA controlled substances. 
Specifically, we proposed that collected household pharmaceuticals will 
continue to be excluded from RCRA regulation as household hazardous 
waste, provided they comply with the same two conditions. The Agency 
has a long-standing recommendation that household hazardous waste 
collection programs manage the collected waste as hazardous waste.\301\ 
As such, the Agency recommends that collected household waste 
pharmaceuticals be incinerated--preferably at a permitted hazardous 
waste incinerator, but when that is not feasible, at a large or small 
municipal waste combustor.\302\ The Agency believes that this practice 
is already common among collection programs since one goal of many 
collection programs is to divert pharmaceuticals from municipal 
landfills. Additionally, incineration is commonly used to meet the 
``non-retrievable'' standard of destruction required by DEA for 
controlled substances collected from consumers (ultimate users, as DEA 
refers to them). Nevertheless, the Agency proposed to make this 
recommendation a requirement for collected household waste 
pharmaceuticals in Sec.  266.506.\303\ We strongly believe that if a 
program goes to the expense of collecting the waste, including waste 
pharmaceuticals, it should manage the waste as hazardous waste, rather 
than manage it as municipal solid waste, which the household could do 
absent the collection program. However, the current household waste 
exemption does not require an entity that hosts a household hazardous 
waste collection event to manage the collected waste as hazardous 
waste. Typically, the parties conducting household hazardous waste 
collection events have been government entities--municipalities and 
counties. It is relatively new that retail pharmacies and others are 
becoming interested in performing this function. To encourage this 
practice, while at the same time ensuring that collection programs are 
managing the collected waste properly, we proposed to codify our policy 
that pharmaceuticals that are household hazardous waste (i.e., 
``household waste pharmaceuticals'') and are collected in DEA 
authorized collection receptacles where they may be commingled \304\ 
with controlled substances continue to be excluded from RCRA 
regulation, provided they are (1) combusted at a municipal solid waste 
or hazardous waste combustor, and (2) managed in accordance with all 
applicable DEA regulations.\305\
---------------------------------------------------------------------------

    \301\ See memo from J. Winston Porter to Regions, dated November 
1, 1988; RCRA Online #11377.
    \302\ See memo September 26, 2012, Rudzinski to the Regional 
RCRA Division Directors (RCRA Online#14833) and memo October 2, 
2015, Johnson to RCRA Division Directors (RCRA Online #14853).
    \303\ Since pharmaceutical collection programs typically 
commingle DEA controlled substances with non-controlled substances, 
this requirement is included in a section of the regulations that 
pertains to controlled substances.
    \304\ DEA does not prohibit co-mingling of controlled substances 
with non-controlled substances provided they are all then managed as 
controlled substances.
    \305\ See 40 CFR 26.506(a)(2).
---------------------------------------------------------------------------

B. Summary of Comments

    Many of the commenters, including states, healthcare facilities, 
and waste management companies, supported both conditional exemptions 
as a way to eliminate the duplicative regulation by DEA and EPA and 
commenters thought that the DEA tracking, shipping and recordkeeping 
are sufficient to operate in lieu of RCRA. Several commenters suggested 
that we expand the types of treatment that are allowed to destroy the 
hazardous waste pharmaceuticals that are also controlled substances. In 
some cases, commenters suggested that we allow additional combustion 
units such as hospital, medical, infectious waste incinerators 
(HMIWIs); commercial, industrial solid waste incinerators (CISWIs); and 
other solid waste incinerators (OSWIs) to combust hazardous waste 
pharmaceuticals that are also controlled substances. Other commenters 
suggested that we allow forms of destruction beyond combustion, such as 
oxidation treatment\306\ or chemical digestion,\307\ or any technology 
that achieves DEA's standard of non-retrievable.\308\
---------------------------------------------------------------------------

    \306\ See Comment number EPA-HQ-RCRA-2007-0932-0287.
    \307\ See Comment number EPA-HQ-RCRA-2007-0932-0375.
    \308\ See Comment number EPA-HQ-RCRA-2007-0932-0333.
---------------------------------------------------------------------------

C. Final Rule Provisions

    We are finalizing both conditional exemptions for hazardous wastes 
that are also controlled substances, with some changes. First, we have 
amended the regulatory language in Sec.  266.506(a)(2) to be more 
consistent with the preamble to the proposed rulemaking and to be more 
consistent with how the conditional exemption in Sec.  266.506(a)(1) 
was crafted. In the preamble to the proposed rulemaking, we discussed 
the conditional exemption in terms of the waste pharmaceuticals from 
take-back events and programs, while in the proposed regulatory 
language, the conditional exemption was focused on the collector of the 
waste pharmaceuticals. We revised the regulatory language in Sec.  
266.506(a)(2) to conditionally exempt the collected household waste 
pharmaceuticals, as opposed to the collector of the household waste 
pharmaceuticals. Additionally, one commenter pointed out that the 
proposed regulatory language could be read to mean that if the 
household waste pharmaceuticals were not commingled with DEA controlled 
substances, then the requirement to combust them would not apply.\309\ 
EPA did not intend to make this distinction. Although we understand 
that most, if not all, take-back events and programs do, in fact, 
commingle controlled substances with non-controlled substances, EPA 
proposed to place conditions on collectors of household waste 
pharmaceuticals with the understanding that this proposed regulatory 
language would capture all pharmaceuticals collected at take-back 
events and programs. The revised regulatory language in this final rule 
makes it clearer that the household waste pharmaceuticals collected 
during a take-back event or program must be destroyed by combustion or 
other DEA-approved method, whether or not the household waste 
pharmaceuticals are commingled with DEA controlled substances.
---------------------------------------------------------------------------

    \309\ See comment number EPA-HQ-RCRA-2007-0932-0261.
---------------------------------------------------------------------------

    Also in response to comments, we are expanding the types of 
combustors that are allowed to destroy the conditionally exempt 
hazardous waste pharmaceuticals. Under the final rule, five types of 
combustors will be allowed to destroy hazardous waste pharmaceuticals 
that are also DEA controlled substances and the pharmaceuticals from 
take-back events and programs: (1) Permitted large municipal waste 
combustors (MWCs), (2) permitted small MWCs, (3) permitted HMIWIs, (4) 
permitted CISWIs and (5) permitted hazardous waste combustors (either 
an incinerator or other combustor, such as a cement kiln).
    In addition to the five types of permitted combustors allowed to 
destroy the conditionally exempt

[[Page 5899]]

pharmaceuticals, EPA is building in flexibility to the final regulation 
to allow for the possibility that future technologies might be 
developed that meet the DEA non-retrievable standard. Specifically, we 
are allowing any method of destruction for the conditional exemption 
that DEA has publicly approved in writing as able to meet its non-
retrievable standard. While it is reasonable to defer to the DEA's 
judgement in this matter to approve methods of destruction that are 
environmentally protective, we feel it is necessary to limit future 
allowable destruction technologies for the conditionally exempt 
pharmaceuticals to those that are publicly approved by the DEA as 
meeting the non-retrievable standard. This is intended to avoid a 
situation where parties might make unsubstantiated claims that their 
product is capable of meeting the DEA non-retrievable standard in order 
to qualify for the conditional exemption. Furthermore, any method that 
DEA might specify must not conflict with federal environmental laws or 
regulations. Also, because combustion is no longer specified as the 
only allowable method of destruction, we have concluded that an 
additional change to the regulations is needed to make it clear that 
the hazardous waste pharmaceuticals that are also DEA controlled 
substances are subject to Sec.  266.505, and therefore, may not be 
sewered.
    Both types of conditionally exempt hazardous waste pharmaceuticals 
(i.e., those that are DEA controlled substances and those that are 
collected household waste pharmaceuticals) will be able to take 
advantage of the expanded list of allowable types of combustors. For 
healthcare facilities and reverse distributors that generate and manage 
the handful of hazardous waste pharmaceuticals that are also controlled 
substances, we think it will be helpful to have additional destruction 
methods for these previously dually regulated wastes. Also, the 
expanded list of allowable types of combustors will be helpful for 
those operating take-back programs and events. The Agency is a strong 
supporter of take-back programs and events for household 
pharmaceuticals as an alternative to disposing of leftover, unwanted 
medications in the trash or in the toilet or down the sink (except in 
cases where the FDA-approved labeling instructs patients to immediately 
flush the unneeded medication down the toilet if a take-back option is 
not readily available). In expanding the types of combustors that are 
allowed to burn the pharmaceuticals from take-back events, we strive to 
strike a balance between maximizing flexibility while still being 
protective of human health and the environment. Under the revised list 
in the final rule, the universe of allowable combustors will 
substantially increase in number. There are 77 municipal solid waste 
combustion facilities (also referred to as waste-to-energy facilities) 
in 22 states,\310\ and 21 commercial hazardous waste combustion 
facilities (i.e., those that accept waste from off-site) in 12 
states.\311\ There are currently 33 HMIWIs units in the U.S.: 11 of the 
33 are commercial HMIWIs, while the other 22 HMIWI units only combust 
their own waste.\312\ There are approximately 75 CISWIs facilities in 
the U.S.\313\ We note that the types of combustors we are allowing to 
accept the conditionally exempt pharmaceuticals are not obligated to 
accept the conditionally exempt pharmaceuticals. Of course, we strongly 
encourage all the various types of allowable combustors to work with 
their communities and regulators in developing viable options for 
destroying the pharmaceuticals from take-back events. In particular, we 
encourage the ``captive'' combustors that currently only combust their 
own waste to consider amending their permits to allow them to accept 
pharmaceuticals from take-back events and programs.
---------------------------------------------------------------------------

    \310\ Energy Recovery Council, 2016 Directory of Waste-to-Energy 
Facilities; http://energyrecoverycouncil.org/wp-content/uploads/2016/06/ERC-2016-directory.pdf.
    \311\ Memo from Rudzinski to Regions, dated September 26, 2012; 
RCRA Online #14833.
    \312\ See comment number EPA-HQ-RCRA-2007-0932-0280.
    \313\ See CISWI inventory EPA-HQ-OAR-2016-0664-0002.
---------------------------------------------------------------------------

    We have concluded that it is reasonable to expand the list of 
allowable combustors able to accept the conditionally exempt 
pharmaceuticals because the combustion of pharmaceuticals that meet the 
definition of a RCRA solid waste but do not meet the definition of RCRA 
hazardous waste (i.e., non-hazardous waste pharmaceuticals) is 
regulated by Sec.  129 of the Clean Air Act. The statute requires EPA 
to establish emission limits for nine air pollutants (i.e., particulate 
matter, carbon monoxide, dioxins/furans, sulfur dioxide, nitrogen 
oxides, hydrogen chloride, lead, mercury, and cadmium) from several 
categories of solid waste incineration units, including MWCs; HMIWIs; 
and CISWIs. EPA has established emission limits for each of the 
categories based on the application of maximum available control 
technology (MACT) which reflect the emission levels achieved by the 
best performers in each category.
    In addition to complying with emission limitations, solid waste 
incineration units are also subject to comprehensive operating, 
monitoring and reporting requirements. In light of the common framework 
used to develop emission limits and requirements for MWC, CISWI, and 
HMIWI units, we believe that it is appropriate to include HMIWIs and 
CISWIs as types of combustors that are allowed to burn the 
pharmaceuticals from take-back events.
    While the Agency has expanded the list of allowable combustors to 
include HMIWIs and CISWIs, we have not expanded the list to include 
other solid waste incinerators (OSWIs). OSWIs are small units that have 
fewer emission controls than other types of combustors. Further, there 
are only a handful of new OSWIs in operation and the legal status of 
existing OSWIs is uncertain due to litigation. EPA is also not 
expanding the list of allowable combustors to include human and pet 
crematoriums. Crematoriums are not regulated under the Clean Air Act 
and typically do not use air pollution control devices to limit toxic 
air pollutants such as mercury and dioxins and furans. We believe that 
crematoriums would not provide adequate public health and environmental 
protection when burning non-hazardous waste pharmaceuticals. If solid 
or hazardous wastes are burned in a crematorium, it would make the 
crematorium subject to the Clean Air Act.

D. Comments and Responses

    In its comment, Cardinal Health included a list of pharmaceuticals 
that it manages as both RCRA hazardous waste and DEA controlled 
substances.\314\ In most cases, their comments reinforced the list that 
we included in the proposed rulemaking. In two cases, Cardinal Health 
identified additional forms of drugs that were included in the table of 
DEA controlled substances and hazardous wastes in the preamble to the 
proposed rulemaking. First, Cardinal Health identified Axiron as the 
brand name of an additional form of testosterone that is a solution 
applied to the underarms that is also ignitable. Second, Cardinal 
Health identified Diastat as the brand name of an additional form of 
valium that is a gel intended for rectal administration that is also 
ignitable. We have amended our list of DEA controlled substances and 
RCRA hazardous wastes by including Axiron and Diastat in Table 6 below 
to be more

[[Page 5900]]

complete and accurate. However, there is no corresponding regulatory 
change being made. The regulations conditionally exempt all RCRA 
hazardous wastes that are also DEA controlled substances; the table 
identifying which drugs are both is included in the preamble for 
informational purposes:
---------------------------------------------------------------------------

    \314\ See comment number EPA-HQ-RCRA-2007-0932-0250.

                      Table 6--Pharmaceuticals Still Used in Healthcare That Are DEA Controlled Substances & RCRA Hazardous Wastes
                                                         [Amendments in bold based on comments]
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Name of drug                    Other name(s)             Medical uses           RCRA HW code        DEA CS schedule          Comment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chloral; chloral hydrate...........  Acetaldehyde, trichloro-;   Sedative.............  U034 toxic...........  IV                  Used in hospital
                                      Aquachloral, Noctec,                                                                          pediatric units;
                                      Somnote, Supprettes.                                                                          common ingredient in
                                                                                                                                    vet anesthetics.
Fentanyl sublingual spray..........  Subsys....................  Analgesic............  D001 ignitable.......  II                  Ignitable due to
                                                                                                                                    alcohol content.
Phenobarbital......................  Bellergal-S, Donnatal,      Anticonvulsant.......  D001 ignitable.......  IV                  Ignitable due to
                                      Luminal,.                                                                                     alcohol content.
Testosterone gels/solutions........  Androgel, Axiron,           Hormone..............  D001 ignitable.......  III                 Ignitable due to
                                      Fortesta, Testim.                                                                             alcohol content.
Valium injectable/gel..............  Diazepam, Diastat.........  Anti-anxiety.........  D001 ignitable.......  IV                  Ignitable due to
                                                                                                                                    alcohol content.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Cardinal Health's comment also indicated that the company manages 
Somatropin (brand names Humatrope and Genotropin) as a DEA controlled 
substance and a RCRA hazardous waste. M-cresol, which is a contaminant 
identified on the toxicity characteristic list in Sec.  261.24 (D024), 
is used as a preservative in Somatropin. Per legislations, all anabolic 
steroids are considered controlled substances; \315\ however, 
Somatropin is considered a human growth hormone, not an anabolic 
steroid.\316\ Therefore, although Somatropin may be a RCRA hazardous 
waste for its m-Cresol content, it is not a DEA controlled substance.
---------------------------------------------------------------------------

    \315\ The Anabolic Steroids Control Act of 1990 placed anabolic 
steroids into Schedule III of the Controlled Substances Act (CSA) as 
of February 27, 1991.
    \316\ https://www.fda.gov/Drugs/DrugSafety/ucm237839.htm; 
accessed 8/24/2017.
---------------------------------------------------------------------------

    The two conditional exemptions we are finalizing in this rule are 
intended to eliminate any duplicative regulations for pharmaceuticals 
that are RCRA hazardous wastes and DEA controlled substances. 
Nevertheless, there are several remaining areas where DEA and EPA 
regulations intersect, even if they are not duplicative. The Agency 
would like to address these intersecting areas in effort to reduce 
confusion and aid compliance.
1. Only Household (Ultimate User) Waste May Be Collected in DEA 
Authorized Collection Receptacles
    It is important to note that in order to qualify for the 
conditional exemption, a retail pharmacy (or other DEA authorized 
collector pharmacy) can use the DEA authorized collection receptacle to 
collect waste generated only at households (DEA refers to this as waste 
from ``ultimate users'') and brought to the store for collection. The 
hazardous waste generated by the retail pharmacy and store, including 
hazardous waste pharmaceuticals, are not excluded household wastes 
under RCRA and may not be placed in the DEA authorized receptacle.\317\ 
Depending on the amount generated, the hazardous waste pharmaceuticals 
generated by the retail pharmacy and store must be managed under either 
Sec.  262.14 (as a VSQG) or under part 266 subpart P. Furthermore, 
states generally regulate non-hazardous waste and it is possible that 
they may have licensing or permitting requirements for the collection 
of solid waste. Because EPA would like to see the use of DEA authorized 
collection receptacles become widespread, we encourage states to 
streamline any requirements that may create a barrier to the use of the 
DEA authorized collection receptacles.
---------------------------------------------------------------------------

    \317\ DEA also prohibits retail pharmacy stock/inventory from 
being placed in the collection receptacle or mail-back envelopes 
(see 21 CFR 1317.05(a)).
---------------------------------------------------------------------------

2. Sewer Prohibition, Conditional Exemption and Pharmaceutical Wastage
    In response to comments, EPA has decided against making any 
exceptions to the sewer prohibition. Some commenters suggested that EPA 
should allow RCRA hazardous wastes that are also DEA controlled 
substances to be sewered. On the other hand, many commenters suggested, 
and EPA agrees, that it would be inappropriate to make exceptions to 
the sewer prohibition, even for the handful of hazardous wastes that 
are also controlled substances. In part, commenters thought it was bad 
environmental policy to allow sewering of any hazardous waste 
pharmaceuticals. Commenters were also concerned that it would send a 
mixed message to the regulated community about our goals and lead to 
confusion about which hazardous waste pharmaceuticals could and could 
not be sewered. As a result, all hazardous waste pharmaceuticals are 
prohibited from being sewered, including the handful that are also DEA 
controlled substances.
    Under the DEA regulations, a registrant's inventory of controlled 
substances is already prohibited from being sewered as a means of 
meeting the non-retrievable standard.\318\ Likewise, under the CWA 
regulations, RCRA ignitable hazardous wastes (D001) are prohibited from 
being discharged to the sewer.\319\ As noted in Table 6, four out of 
the five RCRA hazardous wastes that are also DEA controlled substances 
are hazardous waste due to being ignitable and hence are already 
prohibited from being sewered by the CWA regulations. In effect, this 
new RCRA regulation only prohibits the sewering of one additional DEA 
controlled substance that is also a RCRA hazardous waste: Chloral 
hydrate, which is listed for toxicity. In summary, a RCRA hazardous 
waste that is also DEA controlled substance that is part of a DEA 
registrant's inventory may not be sewered.
---------------------------------------------------------------------------

    \318\ See the preamble to DEA's final rule 79 FR 53548; 
September 9, 2014 and the preamble to DEA's proposed rule 77 FR 
75803; December 21, 2012.
    \319\ See the Clean Water Act regulations at 40 CFR 403.5(b)(1).

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

[[Page 5901]]

    DEA does allow controlled substance ``pharmaceutical wastage'' to 
be disposed of in accordance with applicable federal, state, and local 
laws, regulations, and healthcare facility policies, including sewering 
or putting down the drain.\320\ DEA uses the term ``pharmaceutical 
wastage'' to refer to leftover, unadministered pharmaceuticals (``e.g., 
some of the substance remains in a vial, tube, transdermal patch, or 
syringe after administration but cannot or may not be further 
utilized'' \321\). While DEA allows pharmaceutical wastage of 
controlled substances to be sewered, the CWA regulations already 
prohibit the discharge of any RCRA ignitable hazardous waste and, under 
this RCRA rule, EPA is not creating any exceptions to the sewer 
prohibition. As a result, neither inventory nor pharmaceutical wastage 
of DEA controlled substances that are also RCRA hazardous wastes may be 
sewered.
---------------------------------------------------------------------------

    \320\ See DEA letter to registrants re: Clarifying disposal of 
pharmaceutical wastage dated Oct 17, 2014; http://www.deadiversion.usdoj.gov/drug_disposal/dear_practitioner_pharm_waste_101714.pdf.
    \321\ Ibid.
---------------------------------------------------------------------------

    Even though inventory and pharmaceutical wastage are prohibited 
from being sewered, both inventory and pharmaceutical wastage would be 
eligible for the conditional exemption being finalized in this rule in 
Sec.  266.506 for RCRA hazardous wastes that are also DEA controlled 
substances. As discussed previously, EPA is finalizing the conditional 
exemption that the few RCRA hazardous waste pharmaceuticals that are 
also DEA controlled substances would be exempt from RCRA regulation, on 
the condition that they are (1) managed in accordance with DEA 
regulations and (2) incinerated by one of five types of permitted 
combustors or destroyed by another method that has been publicly 
approved by DEA, and (3) are not sewered.
    Therefore, if inventory or pharmaceutical wastage is both a RCRA 
hazardous waste and a DEA controlled substance it would not be allowed 
to be sewered, it would have to be incinerated (or destroyed by another 
method publicly approved by DEA). Prior to incineration, however, the 
inventory and pharmaceutical wastage, both of which are conditionally 
exempt under RCRA, are regulated differently by DEA. The leftover 
inventory of DEA controlled substances remains fully subject to DEA 
regulations, which includes tracking and witnessed destruction. On the 
other hand, controlled substance pharmaceutical wastage is no longer 
regulated by DEA. Therefore, only pharmaceutical wastage could be 
collected in a container at the healthcare facility prior to 
incineration. If this container were used to collect only conditionally 
exempt pharmaceutical wastage prior to incineration, it would not be 
subject to the subpart P container standards. It is more likely, 
however, that a container used to collect the conditionally exempt 
pharmaceutical wastage would also be used to collect regulated 
hazardous waste, in which case the container would be subject to 
subpart P container standards. In either case, as DEA states in its 
guidance, ``Although Part 1317 does not apply to pharmaceutical 
wastage, the DEA strongly encourages all practitioners to continue to 
adhere to security controls and procedures that ensure pharmaceutical 
wastage is not diverted. For example, most institutional practitioners 
have implemented policies that require two persons to witness and 
record destruction of pharmaceutical wastage.'' \322\ In support of 
DEA's guidance, EPA strongly recommends that any container that is used 
to collect pharmaceutical wastage that will include DEA controlled 
substances contain some sort of absorbent or chemical reactant in order 
to bind or chemically alter the contents and thus deter the diversion 
of the collection container for controlled substance recovery.
---------------------------------------------------------------------------

    \322\ Ibid.
---------------------------------------------------------------------------

3. Long-Term Care Facilities and the DEA Regulations
    This section will discuss the intersection of the DEA regulations 
and the RCRA hazardous waste regulations that pertain to LTCFs.
    Under the DEA regulations, most LTCFs are not registrants and until 
recently have had few options for properly and securely disposing of 
the controlled substances from its patients (ultimate users). DEA's 
2014 final regulations to implement the Secure and Responsible Drug 
Disposal Act of 2010 are designed to help alleviate the problem that 
LTCFs face when discarding their patients' controlled substances. DEA's 
2014 final rule allows, but does not require, retail pharmacies and 
hospital/clinics with an on-site pharmacy that are DEA registrants to 
modify their registrations to become ``collectors'' and to place 
collection receptacles at LTCFs (or at the retail pharmacy or hospital/
clinic with an on-site pharmacy) for the collection of controlled 
substances from ultimate users. Per the DEA regulations, if a DEA 
authorized collection receptacle is placed in a LTCF, only the ultimate 
users' controlled substances may be placed in the DEA collection 
receptacle. If an LTCF is a DEA registrant and discards DEA controlled 
substances from its inventory, they may not be placed in the DEA 
authorized collection receptacle and must be otherwise destroyed to 
meet the non-retrievable standard.
    Under the 2014 DEA final rule, LTCFs now have three options for 
managing their patients' controlled substances. First, if a DEA 
registered retail pharmacy or hospital/clinic with an on-site pharmacy 
places a collection container at an LTCF, the staff from the LTCF may 
place the patients' controlled substances in the collection 
receptacles. Second, although LTCFs are not allowed to conduct a 
facility-wide collection event for their patients' controlled 
substances for mail-back programs, they are allowed to assist patients 
who choose to use a mail-back program for their own controlled 
substances, on an individual-by-individual basis. And third, law 
enforcement can pick up patients' controlled substances for disposal. 
With these changes to DEA's regulation, LTCFs can now dispose of 
patients' controlled substances in a more environmentally protective 
way and EPA strongly encourages the use of any of these three 
collection methods. It should be noted that the 2014 DEA regulations do 
not mandate the placement of collection receptacles at long-term care 
facilities or patient participation in mail-back programs or take-back 
events.
    As for the RCRA regulations, this rule finalizes the provision that 
hazardous waste from LTCFs will no longer be considered exempt as 
household hazardous waste. Instead, it will need to be managed as 
regulated hazardous waste. This interpretation will apply to all the 
hazardous waste generated by a LTCF, not just its hazardous waste 
pharmaceuticals (although the Agency expects that much of the hazardous 
waste generated by LTCFs consists of hazardous waste pharmaceuticals). 
Notwithstanding this revised interpretation, there are four other 
regulatory provisions that might affect how a LTCF will actually have 
to manage its hazardous waste pharmaceuticals under this final rule
    First, we have added to the final rule a presumption that LTCFs 
with 20 beds or fewer will be VSQGs.\323\ And those LTCFs that have 
more than 20 beds may still qualify as VSQGs (for all of their 
hazardous waste) if they generate less than 100 kg of hazardous waste 
and less

[[Page 5902]]

than 1 kg of acute hazardous waste per calendar month. In fact, based 
on the RIA for the final rule, EPA estimates that 98-99 percent of 
LTCFs that generate hazardous waste are VSQGs.\324\ As VSQGs, the long-
term care facilities will be subject to the reduced regulatory 
provisions of 40 CFR 262.14 for all of their hazardous waste (including 
those that are controlled substances), and only the sewer prohibition 
provision of this new subpart for their hazardous waste 
pharmaceuticals. Only the other 1-2 percent of LTCFs that generate 
hazardous waste will be subject to part 266 subpart P.
---------------------------------------------------------------------------

    \323\ See 40 CFR 266.504(d).
    \324\ See the Regulatory Impact Analysis for this final rule in 
the docket EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    Second, this final rule allows an LTCF that is a VSQG (for all of 
its hazardous waste) to send its hazardous waste pharmaceuticals to an 
off-site healthcare facility that either supplies the LTCF with its 
pharmaceuticals (e.g., a long-term care pharmacy) or is under the 
control of the same person and that is operating under subpart P.\325\ 
Note that this provision is limited to hazardous waste pharmaceuticals 
and not to those that are also controlled substances because the DEA 
allows controlled substances to be returned to a long-term care 
pharmacy only when they are subject to a recall.
---------------------------------------------------------------------------

    \325\ See 40 CFR 266.502(l) and 266.503(b) for non-creditable 
and creditable hazardous waste pharmaceuticals, respectively.
---------------------------------------------------------------------------

    Third, this final rule also allows a healthcare facility, including 
a LTCF that is a VSQG, to use an on-site DEA authorized collection 
receptacle to dispose of its hazardous waste pharmaceuticals (see Sec.  
266.504(c)). It could be argued that VSQGs would already be allowed to 
use DEA authorized collection receptacles for their hazardous waste 
pharmaceuticals even without this new provision, provided the waste 
from the DEA authorized collection receptacles is treated or disposed 
at one of the types of facilities identified in Sec.  262.14(a)(5) 
(e.g., facilities that are permitted or have interim status to manage 
hazardous waste and facilities that are permitted, licensed or 
registered by a state to manage hazardous waste, municipal waste or 
non-municipal waste). Nevertheless, we did propose, and are finalizing 
the provision in Sec.  266.504(c) making it clear that healthcare 
facilities that are VSQGs can place their hazardous waste 
pharmaceuticals in an on-site DEA collection receptacle. DEA already 
allows controlled substances to be commingled with non-controlled 
substances. Therefore, EPA believes it is consistent to allow VSQG 
hazardous waste pharmaceuticals that are not controlled substances to 
be placed in DEA collection receptacles with controlled substances. EPA 
believes that management of VSQGs' hazardous waste pharmaceuticals as 
DEA controlled substances is preferable because it provides greater 
protection to patients, visitors, and workers at healthcare facilities 
to have the hazardous waste pharmaceuticals accumulating in DEA-
authorized collection receptacles rather than in the regular trash. 
However, it is important to note that the DEA regulations for 
controlled substances are much narrower in what may be placed in a 
collection receptacle; DEA only allows controlled substances from 
patients to be placed in collection receptacles that are at LTCFs. To 
reiterate, under the DEA regulations, if a LTCF, or any other 
healthcare facility, is a DEA registrant it may not place its own 
inventory of controlled substances in a collection receptacle, even if 
it is a VSQG under RCRA.
    Fourth, for the LTCFs that are not VSQGs, the handful of RCRA 
hazardous waste pharmaceuticals that are also DEA controlled substances 
will not be subject to RCRA, provided they meet three conditions: (1) 
They are combusted at a small or large MWC, a HMIWI, a CISWI or a 
hazardous waste combustor (or destroyed by another method publicly 
approved by DEA), (2) they are managed and disposed of in compliance 
with all applicable DEA regulations for controlled substances, and (3) 
they are not sewered. DEA allows LTCFs to put their patients' 
controlled substances into an on-site collection receptacle; therefore, 
an LTCF could also place its patients' controlled substances that are 
also RCRA hazardous waste into a DEA authorized collection receptacle 
(alternatively, patients could use another allowable take-back method, 
such as mail-back envelopes) in order to meet the conditional 
exemption. However, we must stress that only LTCFs would be able to use 
collection receptacles (or another allowable take-back method) to meet 
the conditional exemption for RCRA hazardous wastes that are also DEA 
controlled substances, because they are the only type of facility that 
DEA allows to place their patients' wastes into an on-site collection 
container. Other healthcare facilities, such as hospitals, could not 
meet the conditional exemption by placing their DEA controlled 
substances that are also RCRA hazardous wastes in a collection 
receptacle because DEA does not allow patients at hospitals to use on-
site collection receptacles. No registrant healthcare facility, 
including an LTCF, would be able to use the collection receptacle to 
meet the terms of the conditional exemption for any of its own 
inventory of DEA controlled substances that are also RCRA hazardous 
wastes because DEA does not allow registrants to use collection 
receptacles for their own inventory.
    For those LTCFs that are not VSQGs, the hazardous waste 
pharmaceuticals that are not controlled substances (and therefore not 
conditionally exempt) will be subject to part 266 subpart P, while the 
other hazardous wastes will be subject to the SQG or LQG regulations, 
as applicable, in part 262.
    See Table 7 for a summary of the intersection of RCRA and DEA 
regulations for the disposal of hazardous waste pharmaceuticals at 
LTCFs:

                  Table 7--Intersection of RCRA & DEA Regulations at Long-Term Care Facilities
----------------------------------------------------------------------------------------------------------------
                                                             RCRA regulatory requirements
                                     ---------------------------------------------------------------------------
  Types of pharmaceutical waste at                                  DEA authorized        Can be returned to an
      long-term care facilities                                   collection methods      off-site HCF owned by
                                          How RCRA applies          allowed for HW        the same person or LTC
                                                                   pharmaceuticals?             pharmacy?
----------------------------------------------------------------------------------------------------------------
Hazardous Waste Pharmaceuticals that
 are NOT Controlled Substances:
    if LTCF is a VSQG...............  Sec.   262.14 and sewer  Yes. Sec.   266.504(c)..  Yes.
                                       prohibition.
    if LTCF is not a VSQG...........  part 266 subpart P.....  No......................  No.
Hazardous Waste Pharmaceuticals that
 are also Controlled Substances:

[[Page 5903]]

 
    if LTCF is a VSQG...............  Sec.   262.14 and sewer  Yes. Only from patients.  Only if subject to a
                                       prohibition.                                       recall.
    if LTCF is not a VSQG...........  Conditionally exempt     Yes. Only from patients   Only if subject to a
                                       from RCRA (Sec.          (DEA collection methods   recall.
                                       266.506) if:             meet the terms of the
                                       Combusted (or    RCRA conditional
                                       other DEA approved       exemption).
                                       destruction method)..
                                       Comply with
                                       DEA regulations.
----------------------------------------------------------------------------------------------------------------

XV. Management of Residues in Pharmaceutical Containers (Sec.  266.507)

A. Regulatory Background

    Over the years, EPA has received numerous inquiries regarding the 
regulatory status of residues in various types of containers that once 
held pharmaceuticals that are considered hazardous waste when 
discarded. Stakeholders have been particularly concerned about residues 
in containers that once held pharmaceuticals that are on the ``P-list'' 
of acutely hazardous commercial chemical products in Sec.  261.33(e) 
because a generator becomes an LQG if it generates more than 1 kg of 
acute hazardous waste per calendar month.\326\ The regulatory status of 
acute and non-acute commercial chemical product residues remaining in a 
container are specifically addressed in Sec.  261.33:
---------------------------------------------------------------------------

    \326\ Additionally, acute hazardous wastes are included on the 
F-list of Sec.  261.31; however, none of those acute hazardous 
wastes are pharmaceuticals.
---------------------------------------------------------------------------

    ``The following materials or items are hazardous wastes if and when 
they are discarded or intended to be discarded . . . (c) Any residue 
remaining in a container or in an inner liner removed from a container 
that has held any commercial chemical product or manufacturing chemical 
intermediate having the generic name listed in paragraphs (e) or (f) of 
this section, unless the container is empty as defined in Sec.  
261.7(b).''
    In Sec.  261.7(b)(1), there are two ways a container that held a 
non-acute hazardous waste can be considered ``empty.'' The container is 
considered empty if all wastes have been removed that can be removed 
using the practices commonly employed to remove materials from that 
type of container, e.g., pouring, pumping, aspirating, and (1) no more 
than 2.5 centimeters (one inch) of residue remain on the bottom of the 
container or inner liner, or (2) No more than 3 percent by weight of 
the total capacity of the container remains in the container or inner 
liner if the container is less than or equal to 119 gallons in size; or 
no more than 0.3 percent by weight of the total capacity of the 
container remains in the container or inner liner if the container is 
greater than 119 gallons in size.
    Therefore, it is important to note that if the container that held 
the non-acute hazardous waste pharmaceutical does not have its contents 
removed by a commonly employed practice even though it has one inch or 
less of residue remaining or has 3 percent or less by weight of the 
total capacity of the container remaining,\327\ the container is still 
not considered ``RCRA empty.'' If the container is not ``RCRA empty,'' 
then the residues are regulated as hazardous waste (since the residues 
are within the container, the container must be managed as hazardous 
waste, as well, even if it is not itself hazardous waste).
---------------------------------------------------------------------------

    \327\ We are assuming that containers that hold pharmaceuticals 
are in containers less than 119 gallons in size.
---------------------------------------------------------------------------

    According to Sec.  261.7(b)(3), there are three ways that a 
container that held an acute hazardous waste can be considered empty:
    (1) The container or inner liner has been triple rinsed using a 
solvent capable of removing the commercial chemical product or 
manufacturing chemical intermediate;
    (2) The container or inner liner has been cleaned by another method 
that has been shown in the scientific literature, or by tests conducted 
by the generator, to achieve equivalent removal; or
    (3) In the case of a container, the inner liner that prevented 
contact of the commercial chemical product or manufacturing chemical 
intermediate with the container, has been removed.
    According to these requirements, if the container that held the P-
listed pharmaceutical is not triple rinsed, or cleaned by another 
method that has been demonstrated to achieve equivalent removal, or had 
the inner liner removed, the container is not considered ``RCRA 
empty,'' even though the pharmaceutical may have been fully removed. If 
the container is not ``RCRA empty,'' then the residues are regulated as 
acute hazardous waste.
    In November 2011, EPA issued guidance about containers that once 
held P-listed pharmaceuticals \328\ that provides three possible 
regulatory approaches for generators:
---------------------------------------------------------------------------

    \328\ Rudzinski to RCRA Division Directors, November 11, 2011, 
RCRA Online #14827.
---------------------------------------------------------------------------

    (1) Count only the weight of the hazardous waste residues toward 
generator category
    (2) Demonstrate an equivalent removal method to render containers 
RCRA empty
    (3) In the case of warfarin, show that the concentration in the 
residue is below the P-listed concentration
    This guidance was intended as a short-term solution that worked 
within the confines of the existing RCRA hazardous waste regulations. 
In 2015, we proposed to amend the regulations that pertain to residues 
in containers that once held pharmaceuticals that are RCRA hazardous 
wastes. EPA proposed different regulatory solutions for different types 
of containers found in healthcare settings. Specifically, the proposal 
addressed the following three categories of containers: (1) Unit-dose 
containers (e.g., packets, cups, wrappers, blister packs, and delivery 
devices) and dispensing bottles and vials; (2) dispensed syringes; and 
(3) other containers, including delivery devices. Generally, commenters 
were supportive of the need for these new empty container standards 
specifically developed for the types of small containers used in the 
healthcare setting, although they did have suggestions for changes. 
Each category

[[Page 5904]]

of container is discussed separately below. Today's new ``empty 
container'' regulations in Sec.  266.507 will replace the November 2011 
guidance as it pertained to residues of hazardous waste pharmaceuticals 
in containers, although the memo will remain in effect for non-
pharmaceutical hazardous wastes.

B. Stock, Dispensing and Unit-Dose Containers (Sec.  266.507(a))

1. Summary of Proposal
    We proposed that a dispensing bottle, vial, or ampule (not to 
exceed 1 liter or 1,000 pills) or a unit-dose container (e.g., a unit-
dose packet, cup, wrapper, blister pack or delivery device) would be 
considered empty and the residues would not be regulated as hazardous 
waste if the hazardous waste pharmaceuticals have been removed from the 
dispensing or unit-dose container by commonly employed methods.
    This proposal applied to containers that once held acute or non-
acute hazardous waste pharmaceuticals. Under the proposal, for 
containers that once held non-acute hazardous waste pharmaceuticals, it 
would not be necessary to measure the remaining contents. Likewise, 
under the proposal, for containers that once held acute hazardous waste 
pharmaceuticals, it would not be necessary to triple rinse the 
containers or demonstrate an equivalent removal method. Rather, we 
proposed that a dispensing or unit-dose container would be considered 
empty if all pharmaceuticals have been removed using the practices 
commonly employed to remove materials from that type of container--
thus, the residues (and therefore the container as well) may be 
disposed of as non-hazardous waste.
    We proposed this new ``RCRA empty'' standard for containers used 
within a healthcare setting for two reasons. First, this approach will 
help eliminate the sewering of pharmaceuticals. In a healthcare 
setting, if containers are triple rinsed, the rinsate will likely be 
poured down the drain, which is not a good environmental practice. We 
think it is important that the residues be managed in a more controlled 
manner--such as in municipal solid waste landfills-- rather than poured 
down the drain. Second, although the ``empty container'' regulations of 
Sec.  261.7 apply to all sizes of containers, they were developed with 
larger, industrial-sized containers in mind. For the most part, the 
containers that hold pharmaceuticals are smaller in size than a 55-
gallon drum; therefore, the amount of residue will likely be much less 
in these containers. In the preamble to the proposed rulemaking, we 
explained that we selected the 1,000-pill/1-liter limit because, in our 
observation, EPA had rarely seen dispensing bottles larger than that. 
We specifically sought comment on whether larger containers are used 
for dispensing pharmaceuticals and, if so, which pharmaceuticals they 
are used for and what RCRA hazardous waste codes would apply.
    In the proposal, EPA presented data from three stakeholders helping 
to confirm the assumption that very little residue remains in 
containers after the pharmaceuticals (e.g., pills) have been removed. 
In addition, EPA's Office of Research and Development conducted similar 
research.\329\ A summary of the results is in the preamble to the 
proposed rulemaking, while the full results from each of the four 
sources are included in the docket for the proposed rulemaking.\330 
331\
---------------------------------------------------------------------------

    \329\ Tolaymat, T. and A. El Badawy. Evaluation of P-Listed 
Pharmaceutical Residues in Empty Pharmaceutical Containers. U.S. 
Environmental Protection Agency, Washington, DC, EPA/600/R-14/167, 
2015.
    \330\ September 25, 2018; 80 FR 58052.
    \331\ EPA-HQ-RCRA-2007-0932-0153 through 0156.
---------------------------------------------------------------------------

    EPA is aware that there are certain limitations with the data from 
the four sources. For instance, in one of the studies, no replicate 
samples were tested. In another study, only warfarin residues were 
tested. However, given the size of the containers involved and the 
nominal quantities of residues involved, the Agency proposed to allow 
the residues in dispensing bottles, vials and ampules, and single-unit 
dose containers that once held hazardous waste pharmaceuticals to be 
managed as non-hazardous waste provided the pharmaceutical product has 
been removed (e.g., all pills have been removed).
    As part of the proposal, EPA raised the concern of potential 
diversion of the pharmaceutical containers that may occur when the 
pharmaceutical residues and containers are discarded in the municipal 
waste stream. The Agency proposed that RCRA-empty pharmaceutical 
containers that are original pharmaceutical packages (and therefore 
susceptible to diversion) should be destroyed prior to placing them in 
the trash. These types of containers would include dispensing bottles, 
vials, or ampules typically used in pharmacies, but would not include 
paper or plastic cups, or blister packs used for dispensing singles 
doses to patients. In the preamble to the proposal, we explained that 
the means of destruction could include crushing or shredding the 
container.
2. Summary of Comments
    The comments for this section can be broken into two major groups. 
One group of comments expressed concern with the 1,000-pill/1-liter 
size limit to pharmaceutical dispensing containers and commenters asked 
EPA to consider allowing the new RCRA-empty standard for pharmaceutical 
dispensing containers to apply to larger pharmaceutical containers or 
even to all dispensing containers, regardless of size.
    As part of its comments, CVS Health included results from an 
analysis conducted on containers that held warfarin.\332\ Their tests 
included brand name and generic warfarin stock bottles, testing the 
largest stock bottles with the highest prescription strength warfarin 
typically found in a CVS Health Pharmacy, although their comments do 
not specify the size of the largest stock bottle, nor do they specify 
the highest prescription strength of warfarin. That said, their results 
do offer similar results as the studies used in support of the 
proposal, indicating the range of total residues detected was 0.0-19.8 
mg (excluding outliers).
---------------------------------------------------------------------------

    \332\ See comment number EPA-HQ-RCRA-2007-0932-0312.
---------------------------------------------------------------------------

    Another group of comments objected to the proposed requirement to 
destroy the containers before disposing of them in municipal solid 
waste landfills. Commenters objected to this proposed provision for 
several reasons. First, the most common reason given by commenters that 
objected to this provision was they disagreed with EPA that diversion 
of these containers is occurring. Many states commented that this has 
never been a problem in their state and that the issues with these 
types of containers arise from purchase of empty vials on the internet 
and counterfeit labels made on home computers, not from dumpster 
diving. Second, there was concern that this would be a costly option 
since many healthcare facilities would now need to hire someone or buy 
equipment to destroy the containers. Many commenters thought the same 
goals could be reached through more cost-effective means such as 
defacing the label to render the containers unusable for illicit 
purposes. Third, a few commenters were also concerned with the release 
of the residues in these containers upon destruction and the effect 
that could have on the workers. This set of commenters included the one 
state that favored destruction of the containers. Finally, some 
commenters noted that these empty containers are already being disposed 
of in locked

[[Page 5905]]

dumpsters and there are adequate institutional controls to address any 
public health risk from use of discarded containers in counterfeit drug 
sales.
3. Final Rule Provisions
    In response to comments, we have made three substantive changes to 
the regulations proposed in Sec.  266.507(a) that define when a 
dispensing or unit-dose container is empty. First, based on comments, 
we now recognize that we used the term ``dispensing'' bottle, vial, or 
ampule incorrectly. Dispensing bottles are those that are provided to 
patients when they get a prescription filled. Although a healthcare 
facility such as a pharmacy may dispose of some dispensing bottles, 
they are more likely to dispose of the stock bottles that they use to 
fill the dispensing bottles provided to the patients. As a result, we 
have modified the regulatory language to include stock bottles in 
addition to dispensing bottles, vials or ampules, and unit-dose 
containers.
    Second, after reviewing comments and asking for additional support 
and clarification from commenters, including the Army Public Health 
Center, CVS Health and the Department of Veterans Affairs, the Agency 
has increased the size of the dispensing containers from 1,000 pills to 
10,000 pills.\333\ The Army Public Health Center states that they 
``routinely procure containers containing 1K, 2K, and even 5K or 10K 
pill counts'' for refilling the automated dispensing machines at their 
facilities.\334\ This exceeds the size of dispensing containers that we 
and others tested, but given that the contents are solid pills, 
capsules and tablets, and that the residues we and others detected are 
very small, we determined that it is appropriate to increase the size 
of the stock or dispensing container to 10,000 pills.
---------------------------------------------------------------------------

    \333\ See the email correspondence from Lisa Strutz (APHC); 
Donald Dempsey (CVS Health); and Peter Carbrey (VA) in the 
supporting materials of the docket for this final rulemaking (EPA-
HQ-RCRA-2007-0932).
    \334\ See the email correspondence from Lisa Strutz (APHC) to 
Kristin Fitzgerald (EPA), dated February 9, 2017, in the supporting 
materials of the docket for this final rulemaking (EPA-HQ-RCRA-2007-
0932).
---------------------------------------------------------------------------

    However, we have kept the maximum volume for stock and dispensing 
containers at a maximum of 1 liter since this volume limit would apply 
to liquids (and other non-pill formulations), which are harder to fully 
remove, and commenters did not provide sufficient information to 
support increasing the volume limit. Further, it is not clear from 
comments or subsequent correspondence whether any containers larger 
than 1 liter are in use for pharmaceuticals that would be hazardous 
waste when discarded. Stock or dispensing containers that exceed 1 
liter would be considered ``other containers'' under Sec.  266.507(d). 
As such, under the final rule, if they held pharmaceuticals that are 
non-acute hazardous waste, then they would be able to use Sec.  
261.7(b)(1) to show that they are empty.
    The third substantive change is that we have removed the proposed 
requirement to destroy the empty pharmaceutical containers prior to 
disposal. We share commenters' concerns about possible worker exposure 
during the process of crushing or shredding the containers. However, 
EPA remains concerned about the diversion of the empty containers for 
illicit purposes. Therefore, we strongly encourage healthcare 
facilities to use best management practices, such as locked dumpsters 
and defacing labels, to prevent the diversion of these containers, but 
the extra step of destroying these containers will not be required.
    Thus, under the final rule, a stock bottle, dispensing bottle, 
vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose 
container (e.g., a unit-dose packet, cup, wrapper, blister pack, or 
delivery device) is considered empty and the residues are not regulated 
as hazardous waste provided the pharmaceuticals have been removed from 
the stock bottle, dispensing bottle, vial, ampule, or the unit-dose 
container using the practices commonly employed to remove materials 
from that type of container.
    In Sec.  261.33(c), we have also added a reference to the new empty 
container provisions for hazardous waste pharmaceuticals in Sec.  
266.507 as a conforming change. Previously, Sec.  261.33(c) referenced 
only the empty container provisions of Sec.  261.7(b).
4. Comments and Responses
    One commenter asked us to add an explicit reference to acute/P-
listed hazardous waste in this section of the regulations. We believe 
this is unnecessary since Sec.  261.7(c) indicates that containers of 
hazardous waste pharmaceuticals (which includes acute and non-acute 
hazardous waste pharmaceuticals) are subject to Sec.  266.507 in lieu 
of Sec.  261.7 for determining when they are empty. Nevertheless, we 
agree with the commenter that all of the new empty container provisions 
in Sec.  266.507 apply to containers that held either non-acute or 
acute hazardous waste pharmaceuticals. Under the new subpart P 
provisions, for containers that once held non-acute waste 
pharmaceuticals to be considered empty, it will not be necessary to 
measure the remaining contents, and for containers that once held acute 
hazardous waste pharmaceuticals, it will not be necessary to triple-
rinse the containers or demonstrate an equivalent removal method.

C. Syringes (Sec.  266.507(b))

1. Summary of Proposal
    EPA proposed that the residues remaining in a syringe would not be 
regulated as hazardous waste provided the syringe had been used to 
administer a pharmaceutical to a patient, the syringe is placed in a 
sharps container (if appropriate), and is managed in accordance with 
all applicable federal, state, and local medical waste or regulated 
waste regulations. As with all of the new empty container standards 
proposed in Sec.  266.507, this proposed provision applied to syringes 
used to administer pharmaceuticals that are acute or non-acute 
hazardous waste when discarded.
    Prior to the proposal, EPA issued guidance regarding the regulatory 
status of residues in syringes in December 1994 and April 2008.\335 
336\ In the December 1994 RCRA/Superfund Hotline Q&A about whether 
epinephrine residues in a discarded syringe would be P042, EPA stated, 
``Drug residues often remain in a dispensing instrument after the 
instrument is used to administer medication. EPA considers such 
residues remaining in a dispensing instrument to have been used for 
their intended purpose. The epinephrine remaining in the syringe, 
therefore, is not a commercial chemical product and not a P042 
hazardous waste. The epinephrine could be a RCRA hazardous waste, 
however, if it exhibits a characteristic of hazardous waste.'' \337\ In 
the April 2008 memo, EPA clarified that the 1994 interpretation extends 
to other P- and U-listed pharmaceuticals that have been used to 
administer the pharmaceutical by syringe.
---------------------------------------------------------------------------

    \335\ December 1994, RCRA Online #13718.
    \336\ Memo from Dellinger to Chilcott, April 14, 2008, RCRA 
Online #14788.
    \337\ Note that since this Q&A was issued, EPA issued guidance 
indicating that epinephrine salts are not included in the scope of 
the P042 listing and therefore, most, if not all, medical 
applications of epinephrine are not P042 (October 15, 2007; RCRA 
Online #14778).
---------------------------------------------------------------------------

    EPA thinks that it is important to clarify in regulation when 
syringes are considered RCRA empty as this has been a source of many 
questions over the years. As part of the decision making, EPA is aware 
of the need to

[[Page 5906]]

minimize the potential for exposures of healthcare workers to the 
sharps, which may be contaminated with bloodborne pathogens, as well as 
to the contents of the syringes.
    The preamble to the proposed rulemaking also noted that sharps 
containers containing syringes are typically autoclaved prior to 
disposal. EPA expressed concern that the residues remaining in the 
syringes could be aerosolized during autoclaving and inadvertently 
expose workers to the aerosolized hazardous waste residues, posing 
risks via pulmonary exposure to those present during venting of the 
autoclave. Research suggests that autoclaving may even increase the 
toxicity of certain drugs.\338\ As a result, EPA requested comment on 
whether it is necessary to place a limit on the volume of residue or 
the volume of the syringe to which this new provision would apply or 
whether any other conditions would be appropriate.
---------------------------------------------------------------------------

    \338\ Daughton CG, Drugs and the Environment: Stewardship & 
Sustainability, National Exposure Research Laboratory, Environmental 
Sciences Division, US EPA, Las Vegas, NV; NERL-LV-ES 10/081, EPA/
600/R-10/106; September 2010 (https://cfpub.epa.gov/si/si_public_record_report.cfm?dirEntryID=228503).
---------------------------------------------------------------------------

2. Summary of Comments
    As noted above, commenters generally supported EPA's goal of 
codifying new standards for defining when containers are considered 
empty, including syringes. EPA received many comments requesting that 
the Agency clarify what it means when it uses the term ``dispensed.'' 
Further, they noted that although the proposed regulations used the 
term ``dispensed,'' in several cases in the preamble, we used the term 
``fully dispensed'' and they requested clarification about which was 
correct. Commenters also noted that EPA used the term ``dispensed'' 
inappropriately and stated that the term ``administered'' was more 
appropriate. The Agency received mixed comments on whether any residues 
or contents should be left in the syringes when disposing of the 
syringe. In the case of autoclaving residues in syringes, almost all 
commenters agreed that the hazardous waste pharmaceutical residues 
should not be autoclaved. Some commenters believed that the contents 
should be disposed of in a gauze pad or equivalent while others argued 
that this was in contradiction to NIOSH recommendations for minimizing 
exposure to hazardous drugs. Some commenters were comfortable with 
leaving contents in the syringes, suggesting that would be in 
compliance with OSHA \339\ and DOT.\340\
---------------------------------------------------------------------------

    \339\ OSHA Title 29 CFR 1910.1030 Bloodborne Pathogens.
    \340\ DOT Title 49 CFR 172.343 subpart D--Marking; 172 subpart 
E--Labeling Standards; 172.432 Subpart E.
---------------------------------------------------------------------------

3. Final Rule Provisions
    We have made two substantive changes to this section of the 
regulations that define when syringes are considered empty for the sake 
of RCRA regulation. First, EPA agrees with commenters that we used the 
term ``dispensed'' inappropriately in the proposed rulemaking. FDA 
defines ``dispense to patients to mean the act of delivering a 
prescription drug product to a patient or an agent of the patient.'' 
\341\ Dispensed pharmaceuticals are then administered directly to the 
patient. EPA has revised the regulations to address commenters' 
concerns. In the final rule, to avoid confusion, when discussing 
syringes we do not use the term dispensed, fully dispensed, or 
administered. Instead, under the final rule, a syringe is considered 
empty and the residues are not regulated as hazardous waste provided 
the contents have been removed by fully depressing the plunger of the 
syringe. Thus, the final regulations convey an intent that is more 
similar to the proposed preamble use of the term ``fully dispensed.'' 
This reflects commenters' and EPA's desire to avoid the possibility of 
autoclaving syringes that may have a large portion of their hazardous 
waste pharmaceutical contents remaining.
---------------------------------------------------------------------------

    \341\ See 21 CFR 208.3.
---------------------------------------------------------------------------

    Commenters affirmed EPA's concerns about aerosolizing the 
autoclaved hazardous waste in sharps containers and we have concluded 
that hazardous waste incineration of hazardous waste pharmaceuticals 
remaining in non-empty syringes is more appropriate. A recent 
literature search also supports this position. The NIOSH and the 
American Society of Hospital Pharmacists (ASHP) have both published 
articles regarding autoclaving of sharps. The 2004 NIOSH alert states, 
``Do not place hazardous drug-contaminated sharps in red sharps 
containers that are used for infectious wastes, since these are often 
autoclaved or microwaved.'' \342\ The ASHP article states, ``Sharps 
used in the preparation of hazardous drugs should not be placed in red 
sharps containers or needle boxes, since these are most frequently 
disinfected by autoclaving or microwaving, not by incineration, and 
pose a risk of aerosolization to waste-handling employees.'' \343\
---------------------------------------------------------------------------

    \342\ NIOSH. ``Preventing Occupational Exposures to 
Antineoplastic and Other Hazardous Drugs in Health Care Settings.'' 
Publication Number 2004-165, Department of Health and Human 
Services, Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), Cincinnati, 
OH, 2004. 58 pp; http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf.
    \343\ ASHP. ``ASHP guidelines on handling hazardous drugs.'' 
American Journal of Health-System Pharmacy 2006, 63:1172-1193; 
http://dx.doi.org/10.2146/ajhp050529.
---------------------------------------------------------------------------

    A syringe with a fully depressed plunger will have a minute amount 
of residue and the syringe can be considered empty under the final 
rule. Thus the residue in the empty syringe (as well as the syringe) 
will not be regulated as hazardous waste. A syringe that does not have 
a fully depressed plunger could have anything from a small amount to 
99% of hazardous waste pharmaceutical contents still left in it. 
Therefore, we have concluded that it is impracticable to impose an 
alternate bright line for determining whether a partially administered 
syringe is empty. Further, we concur with ASHP and NIOSH regarding 
concerns about the safety of autoclave operators and believe the 
standard in this final rule will help prevent exposing workers to 
volatilized hazardous waste pharmaceutical residues during the 
autoclaving process.
    The second substantive change we made in the final rule is to 
clarify that if a syringe contains a pharmaceutical that is a hazardous 
waste and it is not empty because the plunger is not fully depressed, 
the syringe must be placed with its remaining hazardous waste 
pharmaceuticals into a container that is managed and disposed of as a 
non-creditable hazardous waste pharmaceutical under this subpart as 
well as any applicable federal, state, and local requirements for 
sharps containers and medical or regulated waste. We note that the new 
empty syringe provisions being finalized today supersedes the previous 
EPA interpretations expressed in guidance memos in December 1994 and 
April 2008.\344 345\
---------------------------------------------------------------------------

    \344\ December 1994, RCRA Online #13718.
    \345\ Memo from Dellinger to Chilcott, April 14, 2008, RCRA 
Online #14788.
---------------------------------------------------------------------------

    We note that a syringe can become empty in three ways: (1) Fully 
depressing the plunger of the syringe by administering the contents of 
the syringes to a patient, or (2) fully depressing the plunger by 
injecting the contents of the syringe into another delivery device such 
as an IV bag, or (3) fully depressing the plunger of the syringe by 
emptying the remaining contents into a hazardous waste collection 
container.

[[Page 5907]]

4. Consultation With OSHA
    As part of the final rule process, EPA consulted with OSHA to gain 
a better understanding of its Bloodborne Pathogens standard and how it 
interacts with other regulations for the disposal of sharps and the 
contents within the syringes. The Bloodborne Pathogens standard states 
that ``[u]niversal precautions shall be observed to prevent contact 
with blood or other potentially infectious materials. Under 
circumstances in which differentiation between body fluid types is 
difficult or impossible, all body fluids shall be considered 
potentially infectious materials.'' \346\ It also states that disposal 
of a sharp shall be done ``immediately or as soon as feasible.'' \347\ 
Further, OSHA requires that containers for contaminated sharps shall be 
``easily accessible to personnel and located as close as is feasible to 
the immediate area where sharps are used or can reasonably anticipated 
to be found.'' \348\ When workers travel to a remote location to 
discard a sharp, it increases the possibility of an accidental 
needlestick, increases the chances that needles and other sharps will 
be improperly discarded, and creates potential hazards for other staff 
members. The determination of whether or not a sharps disposal 
container is as close as feasible should be made on a case-by-case 
basis by OSHA.\349\
---------------------------------------------------------------------------

    \346\ See 29 CFR 1910.1030(d)(1).
    \347\ See 29 CFR 1910.1030(d)(4)(iii)(A)(1).
    \348\ See 29 CFR 1910.1030(d)(4)(iii)(A)(2)(i).
    \349\ OSHA Compliance Directive CPL 02-02-069 Enforcement 
Procedures for the Occupational Exposure to Bloodborne Pathogens 
https://www.osha.gov/OshDoc/Directive_pdf/CPL_02-02-069.pdf.
---------------------------------------------------------------------------

    Therefore, the practice of emptying the contents of the syringe 
would not violate the OSHA standard if the containers are as close as 
feasible. Any related work practices must also be such that they do not 
create additional hazards to workers (e.g., containers are located in 
close proximity to the work area to avoid employees travelling with 
used sharps to disposal receptacles located outside the point of use). 
Furthermore, nothing in this new subpart requires workers to recap 
needles or other sharps, or otherwise manually manipulate the sharp or 
needle during emptying, such as unscrewing the needle from the syringe.
    As part of this consultation, OSHA addressed the issue of waste 
disposal. OSHA's Bloodborne Pathogens compliance directive states: 
``[W]hile OSHA specifies certain features of the regulated waste 
containers, including appropriate tagging, the ultimate disposal method 
(landfilling, incinerating, and so forth) for medical waste falls under 
the purview of the EPA and possibly State and local regulations'' 
(``Disposal of all regulated waste shall be in accordance with 
applicable regulations of the United States, States and Territories, 
and political subdivisions of States and Territories'' 
(1910.1030(d)(4)(iii)(C))).\350\
---------------------------------------------------------------------------

    \350\ Ibid.
---------------------------------------------------------------------------

    The Agency also received comment that we should recommend the extra 
protective step that all syringes/sharps be incinerated. Any sharps 
container that contains hazardous waste must be treated to meet the LDR 
requirements in part 268. In most cases, the LDR treatment standard for 
hazardous waste pharmaceuticals is incineration. On the other hand, if 
a sharps container does not contain hazardous waste pharmaceuticals 
because all the syringes have been emptied by fully depressing the 
plunger, then the RCRA hazardous waste regulations would not apply to 
these sharps containers (although these sharps containers are still 
solid wastes).
    Regardless of whether sharps containers have regulated hazardous 
waste pharmaceutical residues, they could contain bloodborne pathogens 
or other infectious materials. Thus, OSHA's Bloodborne Pathogens 
standard requires that ``disposal of all regulated waste shall be in 
accordance with applicable regulations of the United States, States and 
Territories, and political subdivisions of States and Territories.'' 
\351\ Many states have medical waste regulations that require the 
treatment of regulated medical waste, including sharps containers, to 
render it non-infectious, which is often achieved by autoclaving, prior 
to disposal as solid waste.
---------------------------------------------------------------------------

    \351\ See 29 CFR 1910.1030(d)(4)(iii)(C).
---------------------------------------------------------------------------

D. Other Containers, Including Delivery Devices (Sec.  266.507(c) & 
(d))

1. Summary of Proposal
    EPA proposed that the residues remaining in other types of unused 
or used containers, including delivery devices, such as IV bags and 
tubing, inhalers, aerosols, nebulizers, tubes of ointments, gels, or 
creams, would be regulated as hazardous waste if the residues are acute 
or non-acute hazardous waste. In some cases, such as with IV bags, the 
volume of hazardous waste being disposed is much larger than with 
residues contained in syringes or unit-dose containers. It is extremely 
difficult to determine how much residue remains in tubes of ointments, 
gel, or cream. In the case of aerosols, it would be inadvisable to 
remove the contents of the container. Since EPA proposed that hazardous 
waste pharmaceuticals managed under subpart P would not be counted 
towards a facility's generator category, we argued that managing these 
residues and containers as hazardous waste under the proposed 
provisions should not pose the same burden that generators had been 
facing in with keeping track of the monthly amount of residues in 
containers that are not ``RCRA empty.''
2. Summary of Comments
    Comments were mixed in this section. Some commenters agreed with 
EPA that it is difficult to determine if containers such as inhalers, 
aerosol cans, tubes of ointments, gels, or creams meet the RCRA empty 
standards within Sec.  261.7 and, therefore, managing them under the 
streamlined requirements of subpart P would be protective. Other 
commenters wanted EPA to allow these other containers to continue to 
meet the definition of empty within Sec.  261.7 or develop specific 
empty container standards for them within subpart P. One commenter 
recommended that EPA revise the regulations to state that IV bags and 
their tubing, inhalers, aerosols, nebulizers, tubes of ointments, and 
gels or creams are RCRA empty and not subject to hazardous waste 
regulations if they contain non-acute hazardous waste and their 
contents are fully administered.
3. Final Rule Provision
    In response to comments, the final rule contains an empty container 
standard for IV bags separate from other containers, including delivery 
devices. The Agency stated in the proposal that it is very hard to 
determine if aerosols, tubes of ointments, gels and creams, inhalers, 
and nebulizers are empty due to their containers and contents. As 
commenters pointed out, this is not the case for IV bags and tubing 
since they are transparent and the liquids inside can be easily 
observed.
    Taking approaches suggested from commenters, EPA is finalizing in 
Sec.  266.507(c) that an IV bag is considered empty and the residues 
are not regulated as hazardous waste provided the pharmaceuticals in 
the IV bag have been fully administered to a patient. In cases where 
the IV bag has not been fully administered and the IV bag held non-
acute hazardous waste pharmaceuticals, then IV bag can be shown to be 
empty and the remaining residues not regulated as hazardous waste per 
Sec.  261.7(b)(1). If an IV bag is not empty through either of these 
means because it either has not been fully

[[Page 5908]]

administered or cannot meet the requirements of Sec.  261.7(b)(1) or 
because it contained an acute hazardous waste pharmaceutical, the IV 
bag must be placed with its remaining hazardous waste pharmaceuticals 
into a container that managed and disposed of as a non-creditable 
hazardous waste pharmaceutical under this subpart.
    In the final rule, EPA has also altered the requirements for other 
types of containers including delivery devices. Commenters pointed out 
that a healthcare facility should not be precluded from proving that 
these containers meet the RCRA-empty standards in Sec.  261.7 simply 
due to the type of container or contents. EPA agrees with the 
commenters that these types of containers which held non-acute 
hazardous waste pharmaceuticals should be able to use the RCRA empty 
container standards under Sec.  261.7 and has changed the final rule to 
allow this. If the containers meet the RCRA empty standard under Sec.  
261.7 then the non-acute hazardous waste pharmaceutical residues (and 
the container) are not regulated as hazardous waste and can be managed 
as solid waste.
    If these other containers, a category that includes but is not 
limited to inhalers, aerosols, nebulizers, tubes of ointments, gels or 
creams, once held an acute hazardous waste pharmaceutical or if they 
held a non-acute hazardous waste pharmaceutical but cannot meet the 
RCRA empty container standard of Sec.  261.7, then the residues of 
these hazardous waste pharmaceuticals (and their containers) must be 
managed as non-creditable hazardous waste pharmaceuticals under this 
subpart.
4. Comments and Responses
    One commenter was concerned that managing all other containers that 
held hazardous waste pharmaceuticals as non-empty could cause a VSQG 
healthcare facility to bump up in generator category to an LQG. This 
will no longer be a concern since a healthcare facility now has the 
option to prove that their other containers that held non-acute 
hazardous waste pharmaceuticals meet the RCRA empty container standards 
in Sec.  261.7 and they can manage the residues (and containers) as 
non-hazardous waste. Otherwise, if these other containers are not 
considered empty, then the residues (and containers) must be managed as 
non-creditable hazardous waste pharmaceuticals under subpart P and 
hazardous waste pharmaceuticals managed under subpart P do not count 
towards determining the generator category. Further, we note that a 
healthcare facility can use the new empty container provisions in Sec.  
266.507 when determining whether they generate enough hazardous waste 
to become subject to part 266 subpart P.

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))

1. Summary of Proposal
    Under part 266 subpart P, hazardous waste pharmaceuticals generated 
in a healthcare facility fall into two categories: (1) Non-creditable 
hazardous waste pharmaceuticals (e.g., partially administered for 
patient care), and (2) potentially creditable hazardous waste 
pharmaceuticals (e.g., unused, unadministered). This section discusses 
the proposed requirements for shipping non-creditable hazardous waste 
pharmaceuticals. For information regarding the shipment of potentially 
creditable hazardous waste pharmaceuticals from healthcare facilities 
and reverse distributors, see section XVI.D. of this preamble.
    Generally, non-creditable hazardous waste pharmaceuticals differ 
from potentially creditable hazardous waste pharmaceuticals in that 
they have been partially administered and often are not in their 
original packaging. In addition, since there is not a reasonable 
expectation that prescription non-creditable hazardous waste 
pharmaceuticals are eligible to receive manufacturer credit, they are 
shipped off site to a TSDF rather than a reverse distributor. Due to 
concerns that a healthcare facility might send all of its hazardous 
waste pharmaceuticals to a reverse distributor even if there is not a 
reasonable expectation of receiving manufacturer credit--essentially 
using the reverse distributor as a TSDF--EPA proposed that non-
creditable hazardous waste pharmaceuticals generated at healthcare 
facilities, when shipped off site, must be shipped to a designated 
facility (e.g., an interim status or permitted hazardous waste TSDF), 
as was required under part 262 (unless the healthcare facility has 
interim status or a RCRA permit to store or treat hazardous waste and 
chooses to store or treat the non-creditable hazardous waste 
pharmaceuticals on site instead of shipping them to a designated 
facility).
    Specifically, EPA proposed that healthcare facilities shipping non-
creditable hazardous waste pharmaceuticals to a designated facility for 
treatment or disposal must continue to comply with the existing 
Department of Transportation (DOT) pre-transport requirements for 
packaging, labeling and marking, and that the non-creditable hazardous 
waste pharmaceuticals must continue to be shipped using a hazardous 
waste transporter and be tracked with a hazardous waste manifest. 
However, to avoid unnecessarily burdening the healthcare facility 
staff, who the Agency assumes are typically unfamiliar with RCRA, EPA 
proposed that the hazardous waste numbers (often called hazardous waste 
codes) are not required to be entered into the hazardous waste manifest 
for non-creditable hazardous waste pharmaceuticals. In lieu of 
hazardous waste codes, EPA proposed that the words, ``hazardous waste 
pharmaceuticals'' must be entered in the ``special handling and 
additional information'' box on the manifest (this box was called Item 
14 at the time of the proposal).
    We also proposed that all existing RCRA recordkeeping requirements 
regarding hazardous waste manifesting as well as all applicable DOT 
shipping requirements continue to apply to healthcare facilities 
shipping non-creditable hazardous waste pharmaceuticals to a TSDF for 
treatment or disposal (see section X.K).
2. Summary of Comments
    Comments on this section of the proposed rulemaking were mixed. 
Commenters generally agreed with the proposed standards for packaging, 
labeling, marking, placarding, and shipping papers. Adverse comments 
were mostly in regard to the decision to not require individual waste 
codes on the manifest for a healthcare facility sending non-creditable 
hazardous waste pharmaceuticals to a TSDF for disposal. In fact, 
commenters were generally concerned about the proposal to not require 
individual waste codes anywhere in the management standards for 
healthcare facilities managing non-creditable hazardous waste 
pharmaceuticals. Whether the comments were regarding waste code 
determinations, labeling containers with waste codes, or including 
waste codes on the manifest, the overarching concern was that TSDFs 
would not know the specific contents of shipments received, resulting 
in an increase to their burden, and possibly would be detrimental to 
human health and the environment. Therefore, the adverse comments 
regarding the lack of a proposed requirement to input individual waste 
codes on the manifest are applicable more broadly to the subject of 
whether or not the

[[Page 5909]]

information that individual waste codes convey should somehow be 
provided to a TSDF by the healthcare facility shipping non-creditable 
hazardous waste pharmaceuticals.
    Some states agreed with the proposal to not require individual 
waste codes on the manifest, while others commented that it is 
important to have waste codes at all steps where they would otherwise 
be required under previous RCRA regulations. Comments from waste 
management companies were also mixed, with some supporting the proposal 
to not require individual hazardous waste codes on the manifest, while 
others agreed with the proposal but suggested including a profile of 
likely constituents to alert TSDFs of potential waste contents to aid 
in LDR compliance.
    Those waste management companies that disagreed with the proposed 
standards cited the added burden imposed by not knowing the specific 
waste constituents included in a shipment, which would make compliance 
with LDR standards more difficult. They were primarily concerned about 
the added burden of having to either begin testing their ash for wastes 
that have a numeric treatment standard, or modify existing testing 
protocols. One commenter from the healthcare industry disagreed with 
the elimination of individual hazardous waste codes on manifests from 
healthcare facilities shipping non-creditable hazardous waste 
pharmaceuticals, arguing that healthcare workers are capable of making 
accurate hazardous waste determinations. They also stated that 
hazardous waste codes are integral to properly managing hazardous 
waste. One waste management commenter stated that continuing to require 
waste codes on LDR notices altogether negates any actual relief because 
healthcare facilities will have to determine appropriate waste codes 
before sending hazardous waste pharmaceuticals off site to a TSDF 
whether or not they are required on the container label or manifest.
    One reverse distributor also agreed with the proposed standards 
under the condition that the Agency agree that pharmaceuticals being 
sent to a reverse distributor are not waste.
3. Final Rule Provisions
    The agency is finalizing the majority of the proposed requirements 
in this section. Before being shipped off site, all shipments of non-
creditable hazardous waste pharmaceuticals must comply with applicable 
DOT pre-transport requirements for packaging (49 CFR parts 173, 178, 
and 180), labeling (49 CFR part 172 subpart E), and marking (49 CFR 
part 172 subpart D). There are, however, three notable changes being 
finalized.
    First, Sec.  266.508(a)(1)(v) has been removed and a healthcare 
facility shipping hazardous waste pharmaceuticals to a TSDF for 
disposal must instead comply with Sec.  266.508(a)(2)'s manifest 
requirement to meet DOT's shipping papers requirement.
    Second, the agency has decided to modify the proposal to not 
require any hazardous waste codes in Item 13 (Waste Codes) of the 
hazardous waste manifest for shipments of non-creditable hazardous 
waste pharmaceuticals being sent to a TSDF, and write the words 
``Hazardous Waste Pharmaceuticals'' in Item 14 (Special Handling 
Instructions and Additional Information). The Agency is instead 
finalizing a requirement to write only one waste code-- ``PHARMS''--in 
Item 13, and not impose any requirements for what must be written in 
Item 14. After further consideration of the impacts this proposed 
requirement would impose on implementation and data collection, the 
Agency decided it had to be modified. During the development of this 
rule, the Agency has also been developing the electronic manifest 
system (e-Manifest) which requires that some code be written in Item 
13. We chose the PHARMS code because it both meets the required number 
of characters and communicates the nature of the waste. Since the waste 
will now be sufficiently characterized in Item 13, the Agency feels 
there is no longer the need to require the words ``hazardous waste 
pharmaceuticals'' in Item 14.
    This new PHARMS code is for manifesting and reporting purposes only 
and is not an official EPA hazardous waste code. Because it will be 
written in the same place as other official EPA hazardous waste codes, 
it may also be referred to colloquially as a ``hazardous waste code.'' 
However, it does not modify any existing LDR treatment standards, nor 
does it enact any new or alternate LDR treatment standards for 
hazardous waste pharmaceuticals. Many commenters throughout the 
proposed rulemaking suggested that EPA promulgate an alternative 
treatment standard of the ``CMBST'' code specifically for hazardous 
waste pharmaceuticals with numeric treatment standards. The agency 
considered incorporating these suggestions into the proposed 
rulemaking, but did not receive the necessary data to support such an 
action. The Agency does, however, generally agree that implementing a 
new alternative treatment standard for hazardous waste pharmaceuticals 
might help mitigate burden on the regulated community while remaining 
protective of human health and the environment. The Agency remains open 
to considering the addition of an alternative treatment standard for 
hazardous waste pharmaceuticals in future rulemakings.
    Although the Agency is now requiring the PHARMS code in Item 13 for 
shipments of non-creditable hazardous waste pharmaceuticals from a 
healthcare facility to a TSDF, hazardous waste codes are not required 
on the manifest, which was preferred by some commenters. As a result, 
TSDFs treating hazardous waste pharmaceuticals will have to assume that 
shipments of hazardous waste pharmaceuticals contain the few that have 
numeric treatment standards in order to demonstrate compliance with 
LDRs.
    The third change made to the regulations was to modify the 
regulatory language in Sec.  266.508(a) slightly to clarify that 
shipments of non-creditable hazardous waste pharmaceuticals being sent 
from a healthcare facility for disposal must be sent to a designated 
facility and accompanied by a hazardous waste manifest. As part of the 
manifest requirements in 40 CFR part 262 subpart B, shipments of non-
creditable and evaluated hazardous waste pharmaceuticals must be sent 
to a designated facility via a hazardous waste transporter. One 
commenter noted that the proposed language could have been interpreted 
to mean that such shipments are also allowed to go elsewhere, which was 
not the Agency's intent.
    Another substantive change to the regulatory language that resulted 
from incorporating commenters' concerns was to remove the requirements 
for shipping papers in Sec.  266.508(a)(1)(v). A commenter pointed out 
that the requirement is unnecessary given the requirements in Sec.  
266.508(a)(2) and the Agency agreed. Section 266.508(a)(1)(v) would 
have required a healthcare facility shipping non-creditable hazardous 
waste pharmaceuticals to a TSDF to prepare shipping papers in 
accordance with 49 CFR 172 subpart C; however, the subsequent paragraph 
(Sec.  266.508(a)(2)) outlines the requirements for manifesting a 
shipment of non-creditable hazardous waste pharmaceuticals. Requiring 
both shipping papers and a manifest is redundant and could have 
possibly resulted in confusion and contradictory requirements. The 
hazardous waste manifest requirements, if complied

[[Page 5910]]

with, duly satisfy DOT's shipping paper requirements.
    The wording in Sec.  266.508(a) was modified slightly to clarify 
that healthcare facilities and reverse distributors that ship non-
creditable and evaluated hazardous waste pharmaceuticals off site, 
respectively, are required to send them to a designated facility.
    Finally, to be consistent with the Hazardous Waste Generator 
Improvements final rule, we have added paragraph 266.508(a)(1)(iii)(C) 
to mirror Sec.  262.32(d), which addresses marking for lab packs. 
Specifically, lab packs of hazardous waste pharmaceuticals that will be 
treated using the alternative treatment standard of incineration, as 
allowed by Sec.  268.42(c), do not have to marked or labeled with EPA 
hazardous waste numbers. However, lab packs that contain D004 
(arsenic), D005 (barium), D006 (cadmium), D007 (chromium), D008 (lead), 
D010 (selenium) or D011 (silver), the EPA hazardous waste number must 
be marked or labeled with the EPA hazardous waste numbers (or 
electronic means may be used). These specific metals must be identified 
because Sec.  268.42(c)(4) requires any incinerator residues from lab 
packs that contain any of these specific metals to undergo further 
treatment prior to land disposal.

B. Shipping Evaluated Hazardous Waste Pharmaceuticals From Reverse 
Distributors to Treatment, Storage, and Disposal Facilities (Sec.  
266.508(a))

1. Summary of Proposal
    For reverse distributors, once a potentially creditable hazardous 
waste pharmaceutical has been evaluated and it has been determined that 
it is not destined for another reverse distributor for further 
evaluation or verification of credit, EPA proposed that the hazardous 
waste pharmaceuticals be referred to as ``evaluated hazardous waste 
pharmaceuticals.'' As with shipping non-creditable hazardous waste 
pharmaceuticals, when evaluated hazardous waste pharmaceuticals are 
shipped off-site, EPA proposed that they must be shipped in accordance 
with the existing DOT pre-transport requirements under 49 CFR parts 
172-80 for packaging, labeling, marking, placarding, and shipping 
papers. We also proposed that they must be shipped in accordance with 
the existing RCRA manifest requirements of 40 CFR part 262 subpart B, 
which requires all relevant waste codes be listed in Item 13 and that 
they be shipped via a hazardous waste transporter to a designated 
facility. This continues current practices under existing regulations 
for this type of hazardous waste pharmaceutical and does not represent 
an increase in burden. EPA argued that the use of a hazardous waste 
manifest and a hazardous waste transporter are appropriate at this 
point for two reasons. First, once credit for the hazardous waste 
pharmaceuticals has been verified, the potential for mismanagement is 
greater because evaluated pharmaceuticals no longer retain any value 
and will cost the reverse distributor money to dispose. Second, TSDFs 
are accustomed to receiving hazardous waste via a hazardous waste 
transporter with a hazardous waste manifest and it would place 
administrative and compliance burdens on the receiving TSDF to accept 
shipments of hazardous waste with alternative tracking.
    EPA proposed that a reverse distributor must list all appropriate 
hazardous waste codes on the manifest when shipping evaluated hazardous 
waste pharmaceuticals to a TSDF. This differs from the requirements for 
a healthcare facility shipping non-creditable hazardous waste 
pharmaceuticals to a TSDF. Unlike non-creditable hazardous waste 
pharmaceuticals generated at a healthcare facility, hazardous waste 
pharmaceuticals received by reverse distributors are typically in the 
manufacturer's original, intact, and labeled packaging (if not, they 
are likely non-creditable hazardous waste pharmaceuticals and should be 
sent to a TSDF), so the information needed to determine the appropriate 
hazardous waste codes once evaluated should be readily available to the 
reverse distributor. Also, reverse distributors are currently required 
to include hazardous waste codes on the manifest and it is expected 
that they have the necessary expertise in the management of these 
hazardous wastes that healthcare personnel lack. Under the reverse 
distributor standards in Sec.  266.510(c)(10)(ii), EPA also proposed 
that reverse distributors must keep copies of hazardous waste manifests 
for three years from the date evaluated hazardous waste pharmaceuticals 
are shipped to a TSDF.
2. Summary of Comments
    Comments in this section were mixed. Many commenters addressed the 
standards for healthcare facilities sending shipments of non-creditable 
hazardous waste pharmaceuticals to a TSDF but did not specifically 
mention the standards for shipping evaluated hazardous waste 
pharmaceuticals to a TSDF. Nevertheless, many of the concerns expressed 
by commenters with the standards for healthcare facilities shipping 
non-creditable hazardous waste pharmaceuticals to a TSDF are relevant 
because the standards in Sec.  266.508 are the same for healthcare 
facilities shipping non-creditable hazardous waste pharmaceuticals as 
they are for reverse distributors shipping evaluated hazardous waste 
pharmaceuticals, with the exception of Sec.  266.508(a)(2)(i) and (ii). 
The few that commented directly on the proposed shipping standards for 
evaluated hazardous waste pharmaceuticals being shipped from a reverse 
distributor to a TSDF agreed with the standards as proposed.
    Reverse distributor and waste management industry commenters were 
in agreement with the proposed standards for shipping evaluated 
hazardous waste pharmaceuticals to a TSDF, but to reiterate, did not 
agree with the standards for shipping non-creditable hazardous waste 
pharmaceuticals from a healthcare facility to a TSDF (no waste codes on 
the manifest). Many commenters on this section simply stated that waste 
codes should be included on a manifest, referring to the requirements 
in Sec.  266.508(a)(2)(i) and (ii) which do not require waste codes on 
the manifest for healthcare facilities shipping non-creditable 
hazardous waste pharmaceuticals to a TSDF. Since those standards only 
apply to healthcare facilities shipping non-creditable hazardous waste 
pharmaceuticals to a TSDF and not reverse distributors sending 
evaluated hazardous waste pharmaceuticals to a TSDF, the agency assumes 
that those same commenters are generally in agreement with the 
requirement for reverse distributors shipping evaluated hazardous waste 
pharmaceuticals to a TSDF to comply with all of the manifest standards 
in 40 CFR part 262 subpart B, which includes a requirement to list all 
applicable EPA hazardous waste codes on the manifest.
3. Final Rule Provisions
    The Agency is finalizing the standards for shipping evaluated 
hazardous waste pharmaceuticals from a reverse distributor to a TSDF 
with minor changes. First, Sec.  266.508(a)(1)(v) has been removed. The 
standards for shipping papers for reverse distributors sending 
evaluated hazardous waste pharmaceuticals to a TSDF are contained 
instead in subparagraph Sec.  266.508(a)(2) (i.e., the manifest).
    Second, the clarification to the regulatory language mentioned 
previously, which specifies that non-creditable hazardous waste

[[Page 5911]]

pharmaceuticals must go only to a TSDF, also applies to evaluated 
hazardous waste pharmaceuticals. As mentioned above, commenters were 
concerned that the proposed regulatory language appeared to make it 
optional for a reverse distributor to ship evaluated hazardous waste 
pharmaceuticals to a TSDF for disposal, although it was not intended to 
read that way. The finalized regulatory language was modified to 
clarify that a reverse distributor shipping evaluated hazardous waste 
pharmaceuticals must send them to a TSDF for treatment and disposal. 
This change pertains to both evaluated pharmaceuticals being shipped 
from a reverse distributor as well as non-creditable hazardous waste 
pharmaceuticals being shipped from a healthcare facility.
    To summarize, reverse distributors sending evaluated hazardous 
waste pharmaceuticals to a TSDF for disposal are required to comply 
with all standards in Sec.  266.508(a), which includes a requirement to 
list all applicable waste codes in Item 13 of the manifest, even though 
healthcare facilities sending non-creditable hazardous waste 
pharmaceuticals to a TSDF do not. They are not, however, required to 
write the word PHARMS in Item 13 or on the container label in addition 
to all other applicable waste codes.

C. Shipping Non-Creditable or Evaluated Hazardous Waste Pharmaceuticals 
for Import or Export (Sec. Sec.  266.508(b) and 266.508(c))

1. Summary of Proposal
    Under part 262, a healthcare facility or reverse distributor may 
not import hazardous waste pharmaceuticals unless it has a RCRA permit 
or interim status that allows it to accept hazardous waste from off 
site and complies with the requirements for importing hazardous waste 
in 40 CFR part 262 subpart H. Under part 266, EPA did not propose to 
change the regulations as they apply to the import of non-creditable or 
evaluated hazardous waste pharmaceuticals. Likewise, under part 262, a 
healthcare facility or reverse distributor may not export (non-
creditable nor evaluated) hazardous waste pharmaceuticals unless it 
complies with requirements for exporting hazardous waste in 40 CFR part 
262 subpart H. Under part 266, EPA did not propose to change the 
regulations as they apply to the export of (non-creditable or 
evaluated) hazardous waste pharmaceuticals.\352\
---------------------------------------------------------------------------

    \352\ In the proposed rule we referenced part 262 subparts E and 
F when discussing this provision. Part 262 subparts E and F have 
since been replaced by part 262 subpart H; see the Hazardous Waste 
Export-Import Revisions final rule, 81 FR 85696; December 31, 2016.
---------------------------------------------------------------------------

    EPA requested comment on the likelihood that non-creditable 
hazardous waste pharmaceuticals that are shipped from a healthcare 
facility to a domestic TSDF, would then be exported to a TSDF in a 
foreign country. In addition, EPA did not anticipate that hazardous 
waste pharmaceuticals would be destined for transboundary shipments for 
purposes of recovery operations and therefore potentially subject to 40 
CFR part 262 subpart H; however, we also requested comment on whether 
this is the case.
2. Summary of Comments
    We received no comments on the proposed standards for importing and 
exporting non-creditable or evaluated hazardous waste pharmaceuticals.
3. Final Rule Provisions
    Since part 266 subpart P was proposed, the hazardous waste import 
and export regulations under part 262 have been revised.\353\ The 
export regulations which had been in part 262 subpart E are now in part 
262 subpart H. Likewise, the import regulations which had been in part 
262 subpart F are also now in part 262 subpart H. The requirements for 
both importing and exporting non-creditable hazardous waste 
pharmaceuticals are being substantially finalized as proposed. The only 
change being made from the proposed requirements is to update the 
reference to the revised part 262 regulations, in order to conform to 
the changes implemented in the Hazardous Waste Imports and Exports 
Improvement Rule. Whereas the proposed Sec.  266.508(b) and (c) refer 
to the standards in 40 CFR part 262 subpart E and F, they now refer to 
40 CFR part 262 subpart H.
---------------------------------------------------------------------------

    \353\ See the final Hazardous Waste Export-Import Revisions 
rule, 81 FR 85696; December 31, 2016.
---------------------------------------------------------------------------

D. Shipping Potentially Creditable Hazardous Waste Pharmaceuticals 
(Sec.  266.509).

1. Summary of Proposal
    This section discusses the proposed requirements for shipping 
potentially creditable hazardous waste pharmaceuticals from a 
healthcare facility to a reverse distributor and between reverse 
distributors. The return of potentially creditable waste 
pharmaceuticals (hazardous and non-hazardous) to a reverse distributor 
can involve multiple shipping steps before the pharmaceuticals are 
transported for ultimate treatment and disposal. In comments on the 
2008 Pharmaceutical Universal Waste proposal and in response to EPA's 
request for information,\354\ reverse distributors described various 
scenarios. For example, a healthcare facility typically sends waste 
pharmaceuticals to the reverse distributor with which it has a 
contract. However, some manufacturers will only provide manufacturer 
credit after the pharmaceuticals have been returned to the reverse 
distributor with which the manufacturer has a contract. Thus, if the 
reverse distributor with which the healthcare facility has a contract 
differs from the reverse distributor with which the manufacturer has a 
contract, then the healthcare facility's reverse distributor must send 
the pharmaceuticals on to the manufacturer's reverse distributor for 
the manufacturer credit to be given to the healthcare facility. In some 
cases, a pharmaceutical manufacturer may require the reverse 
distributor to ship the pharmaceuticals back to them so they can 
perform the verification and issue credit themselves. The estimated 
amount of pharmaceuticals transported from reverse distributors to 
manufacturers for verification varies. Based on our request for 
information, reverse distributors indicated that the percent of 
potentially creditable hazardous waste pharmaceuticals transported to 
manufacturers ranged from an estimated 25 percent to 93 percent of 
total volume, depending on the contractual agreement between the 
reverse distributor and the manufacturer. The scenarios described 
previously occur routinely and are an integral part of the process by 
which manufacturers issue credit.
---------------------------------------------------------------------------

    \354\ See the survey of reverse distributors in docket number: 
EPA-HQ-RCRA-2007-0932-0158 through 0160.
---------------------------------------------------------------------------

    As explained in section IV.A, EPA proposed that all pharmaceuticals 
transported to reverse distributors for manufacturer credit are solid 
wastes, some of which would also be considered hazardous wastes. The 
finalized regulations have been modified, however, such that only 
prescription pharmaceuticals going through reverse distribution for 
manufacturer credit are solid wastes, while OTC pharmaceuticals going 
through reverse logistics are outside of this rule. Under the part 262 
regulations, hazardous waste, including hazardous waste 
pharmaceuticals, must be manifested to a permitted or interim

[[Page 5912]]

status TSDF and shipped using a hazardous waste transporter to ensure 
the cradle-to-grave system of RCRA is maintained. However, compared to 
other hazardous wastes, EPA believes that the risk of environmental 
release posed by most potentially creditable hazardous waste 
pharmaceuticals during accumulation and transport is relatively low. 
The risk is low because of the form and packaging of most potentially 
creditable hazardous waste pharmaceuticals, which is typically in 
small, individually packaged doses (such as with many tablets and 
capsules) or small vials. These small volumes of individually wrapped 
or packaged pharmaceuticals, when aggregated in a larger container, are 
unlikely to spill or be released into the environment since they are 
essentially double-packed when transported to a reverse distributor. 
Potentially creditable hazardous waste pharmaceuticals that are in 
liquid and aerosol forms may pose more of a risk during accumulation 
and transport due to possible spillage or leakage, but the small 
quantities in which they are generated, along with the DOT packaging 
requirements of 49 CFR parts 173, 178, and 180, would likely mitigate 
this risk (see EPA's recommendation regarding liquids and aerosols in 
section XI.C.1). Further, the 2008 Pharmaceutical Universal Waste 
proposal specifically sought comment regarding the risks of 
transportation of hazardous waste pharmaceuticals and no commenters 
identified environmental risks.
    Due to the low risk to human health and release to the environment, 
EPA proposed to allow potentially creditable hazardous waste 
pharmaceuticals to be shipped without a hazardous waste manifest and 
without the use of hazardous waste transporters when the healthcare 
facility is sending potentially creditable hazardous waste 
pharmaceuticals to a reverse distributor or when a reverse distributor 
is sending potentially creditable hazardous waste pharmaceuticals to 
another reverse distributor. The same DOT shipping requirements would 
continue to apply to shipments of potentially creditable hazardous 
waste pharmaceuticals (provided they are classified as DOT hazardous 
materials) that applied prior to this final rule. Nothing in this final 
rule changes how DOT shipping requirements apply to shipments of 
prescription pharmaceuticals to reverse distributors.
    EPA proposed an alternate tracking method for potentially 
creditable hazardous waste pharmaceuticals--with two requirements in 
lieu of requiring a hazardous waste manifest and the use of hazardous 
waste transporters. First, EPA proposed that for each shipment, 
healthcare facilities and reverse distributors must provide in writing 
(via letter or electronic communication), advance notice of the intent 
to send a shipment to the receiving reverse distributor. We also 
proposed that the receiving reverse distributor must provide 
acknowledgement to the shipper that they received the advance notice. 
This requirement was intended to function like a manifest, tracking the 
potentially creditable hazardous waste pharmaceuticals en route to the 
reverse distributor. Second, EPA proposed that for each shipment, the 
receiving reverse distributor must provide confirmation to the 
healthcare facility or reverse distributor that initiated the shipment, 
that the shipment of potentially creditable hazardous waste 
pharmaceuticals has been received. The Agency proposed this requirement 
in direct response to concerns expressed by commenters over the lack of 
tracking of pharmaceutical waste in the 2008 Pharmaceutical Universal 
Waste proposal.
    The Agency proposed that, if a healthcare facility or reverse 
distributor initiates a shipment of potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor and does not receive 
delivery confirmation within seven calendar days, that the healthcare 
facility or reverse distributor that initiated the shipment must 
contact the shipper and the intended recipient promptly to (1) report 
that the confirmation was not received, and (2) to determine the status 
and whereabouts of the potentially creditable hazardous waste 
pharmaceuticals that were shipped.
    The Agency proposed that if a healthcare facility or reverse 
distributor exports potentially creditable hazardous waste 
pharmaceuticals, it must generally comply with 40 CFR part 262 subpart 
E, except that it is not required to manifest the potentially 
creditable hazardous waste pharmaceuticals. The Agency also proposed 
that any person that imports potentially creditable hazardous waste 
pharmaceuticals, must comply with the proposed requirements for the 
shipment of potentially creditable hazardous waste pharmaceuticals, in 
lieu of the requirements for hazardous waste imports found at 40 CFR 
part 262 subpart F.\355\
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    \355\ Part 262 subparts E and F have since been replaced by part 
262 subpart H; see the Hazardous Waste Export-Import Revisions final 
rule, 81 FR 85696; December 31, 2016.
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    EPA proposed to require healthcare facilities (Sec.  266.503(d)) 
and reverse distributors (Sec.  266.510(b)(4)) to keep records of the 
shipments of potentially creditable hazardous waste pharmaceuticals to 
reverse distributors. Specifically, we proposed that healthcare 
facilities and reverse distributors that initiate a shipment to a 
reverse distributor must keep (1) records of advance notification 
regarding shipments of potentially creditable hazardous waste 
pharmaceuticals, (2) delivery confirmation for three years after the 
shipment was initiated, and (3) shipping papers or bills of lading. The 
Agency argued that these records are necessary to ensure that 
potentially creditable hazardous waste pharmaceuticals reach their 
intended destination and are not diverted.
    In most cases, retaining records for three years should be 
sufficient for inspection purposes; however, we proposed that the 
periods of retention would be automatically extended during unresolved 
enforcement activity, or at the request of the EPA Regional 
Administrator. The Agency sought comment on whether additional 
recordkeeping is necessary to document the cases when the reverse 
distributor does not receive a shipment of potentially creditable 
pharmaceuticals within seven calendar days and the steps must be taken 
to locate the shipment.
2. Summary of Comments
    The majority of comments focused on the provision to allow 
shipments of potentially creditable hazardous waste pharmaceuticals to 
be sent via carrier (i.e., not by hazardous waste transporter), the 
requirements for advance notice of shipment and delivery confirmation, 
and the time frame within which delivery confirmation is received 
before the shipper must take action to locate a missing shipment.
    Comments on whether the Agency should allow shipments of 
potentially creditable hazardous waste pharmaceuticals to be sent via 
carriers such as USPS, UPS, and FedEx without a manifest were mixed. 
Only a few states commented on this provision specifically. The 
majority of states agreed that shipping via carriers provides 
sufficiently low risk of release or illicit diversion. However, one 
state was concerned that we did not propose a requirement to reconcile 
the contents of what was shipped with what was received. That same 
commenter, as well as a handful of others, also voiced concern about 
whether DOT regulations would permit hazardous waste

[[Page 5913]]

pharmaceuticals to be lawfully shipped via carrier in the first place. 
Manufacturers, waste management companies, healthcare industry groups, 
and pharmacy trade associations were all generally in agreement with 
the proposed shipping standards for potentially creditable hazardous 
waste pharmaceuticals.
    One of the primary points of contention in this subsection was the 
proposed standard that would require a shipper to provide advance 
notice of its intent to ship potentially creditable hazardous waste 
pharmaceuticals to a reverse distributor. Reverse distributors 
objected, arguing it would impart undue financial and administrative 
burden, which would require them to hire additional staff to adequately 
process advance notices, track, and confirm the delivery of thousands 
of shipments per year. A national trade association of retailers 
expressed similar concerns. They did not support the proposed advance 
notice and delivery confirmation requirements and argued the 
requirements would add undue burden due to the high volume of shipments 
large retailers send per year. The commenters suggested that the 
proposed notification and delivery standards either be removed or 
modified to match current inventory and accounting practices.\356\ One 
pharmaceutical manufacturer also disagreed with the proposed standard, 
but gave no reasoning as to why, other than they thought it was 
unnecessary. States generally agreed with the proposed standard and a 
few suggested the Agency finalize additional requirements like 
reconciling what was in the notice with the contents of the package 
after delivery which would also require an inventory of each container. 
One state was concerned about its ability to confirm that a shipment 
has reached its final destination (TSDF) in scenarios where a shipment 
is sent to an out-of-state reverse distributor or a second reverse 
distributor. Healthcare facilities and pharmacist trade groups either 
agreed with the proposed standards or did not mention these standards 
specifically. One pharmacist trade group said they want some 
clarification about what constitutes advance notice.\357\
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    \356\ See comment number EPA-HQ-RCRA-2007-0932-0295.
    \357\ See comment number EPA-HQ-RCRA-2007-0932-0284.
---------------------------------------------------------------------------

    There were numerous comments both in agreement with and opposition 
to the proposed requirement to take action to locate a shipment of 
potentially creditable hazardous waste pharmaceuticals if no delivery 
confirmation is received within seven days from the day the shipment 
leaves the shipper's facility. Most comments were related to the time 
frame within which the shipper must receive delivery confirmation, but 
a few commenters from the retail and reverse distribution industries 
opposed the requirement altogether because of the added financial, 
procedural, and administrative burden they argue it would impose. Many 
commenters were concerned that the proposed time frame was too short 
and would result in frequent situations in which the shipper would be 
required to undertake efforts to locate a shipment that eventually 
arrives without intervention sometime after the seven days. Some 
commenters noted that seven days is the minimum transit time for a 
standard cross-country shipment under ideal conditions, which provides 
no buffer for unforeseen circumstances that may cause delays such as 
inclement weather or some other service disruption. One state suggested 
a 35-day time frame as an alternative because it would be the same as 
the time frame specified for delivery confirmation of universal waste 
shipped via carrier per the universal waste rule.\358\
---------------------------------------------------------------------------

    \358\ See comment number EPA-HQ-RCRA-2007-0932-0238.
---------------------------------------------------------------------------

    There were limited comments regarding the proposed standards for 
healthcare facilities and reverse distributors importing and/or 
exporting potentially creditable hazardous waste pharmaceuticals. The 
only concern raised was whether shipments sent to or received from U.S. 
territories (e.g., Puerto Rico, Guam) are considered exports/imports, 
and if so, they recommended that the Agency confer with other 
appropriate federal agencies and their reverse distributor contractors.
3. Final Rule Provisions
    In response to comments, the Agency has made several changes to the 
proposed standards for shipping potentially creditable hazardous waste 
pharmaceuticals. First, we have made a minor change to make our 
regulatory language more consistent with DOT's terminology and clarify 
to whom the regulations refer. Specifically, in Sec.  266.509(c), we 
changed the word shipper to carrier. As originally proposed, the word 
shipper could have been interpreted to refer to the party that prepares 
and offers a shipment of potentially creditable hazardous waste 
pharmaceuticals, whereas the regulations apply to the company providing 
transportation of a shipment of potentially creditable hazardous waste 
pharmaceuticals. To clarify, a shipper is the party that prepares and 
offers a shipment to be transported by a carrier.
    Second, we have eliminated the requirement in Sec.  266.509(a)(1) 
for a healthcare facility or reverse distributor that ships potentially 
creditable hazardous waste pharmaceuticals to provide advance notice of 
the shipment. The Agency believes that the proposed advance notice 
requirement goes beyond the manifest requirements and would have 
resulted in undue burden on both the shippers and the receiving reverse 
distributors while only nominally more protective of human health and 
the environment. We would, however, recommend that, as a best practice, 
shippers of potentially creditable hazardous waste pharmaceuticals 
provide advance notice to the recipients to the extent practicable. 
Conforming changes have been made throughout the regulations that 
reflect the elimination of the requirement to provide advance notice of 
shipments of potentially creditable hazardous waste pharmaceuticals.
    Third, the proposed requirement that a reverse distributor that 
receives a shipment of potentially creditable hazardous waste 
pharmaceuticals must provide delivery confirmation to the facility that 
initiated the shipment is being finalized as proposed, with the added 
clarification that the shipment is not considered delivered until it is 
under the custody and control of the receiving reverse distributor. 
Requiring delivery confirmation provides assurance that the shipment 
was actively received by the reverse distributor and the chain of 
custody maintained. Without this confirmation from the receiving 
reverse distributor personnel, it is possible for a shipment to be 
delivered to the destination location but not necessarily taken into 
their custody and control (e.g., left unattended outside the building).
    Under this final rule, healthcare facilities and reverse 
distributors may use carriers, such as USPS, UPS, and FedEx for 
shipments of potentially creditable hazardous waste pharmaceuticals to 
and between reverse distributors, as long as personnel are present to 
receive and take control of the shipments upon arrival. EPA believes 
that carriers are able to provide safe shipment since these potentially 
creditable hazardous waste pharmaceuticals present low risk of release 
during transport.
    In addition, all of the carriers EPA is aware of offer services 
that meet the delivery confirmation requirement.

[[Page 5914]]

Delivery confirmation can be paper-based or electronic and must 
indicate that personnel from the receiving reverse distributor have 
taken the shipment into their custody and control. One way for 
healthcare facilities and reverse distributors sending shipments of 
potentially creditable hazardous waste pharmaceuticals to a reverse 
distributor via carrier may comply with the delivery confirmation 
requirement would be to utilize the delivery confirmation service 
provided by most carriers (e.g., Return Receipt from USPS, Delivery 
Confirmation from UPS, or Signature Proof of Delivery from FedEx). 
Typically, personnel at the receiving reverse distributor will sign for 
a shipment confirming that it is now in their custody and control. That 
signature will then be made available to the shipper, which satisfies 
the delivery confirmation requirement.
    EPA has learned that some stakeholders use alternative electronic 
tracking methods outside of those offered by carriers. One alternative 
electronic tracking method is to apply barcoding on pharmaceutical 
packaging or on containers containing multiple pharmaceutical packages. 
A barcode is a unique identifier that links the container to a database 
with detailed information about its contents and includes the exact 
quantities of each item included in the shipment (inventories). 
Typically, when a reverse distributor receives a barcoded shipment, it 
will scan the barcodes upon receipt, and the sender will receive 
electronic notification that the shipment has arrived at its 
destination and is in the custody and control of the reverse 
distributor. This type of barcode tracking would meet the delivery 
confirmation requirement of this final rule. Another type of 
alternative electronic tracking that would satisfy the delivery 
confirmation requirement is radio frequency identification (RFID). 
Similar to barcodes, RFID tags are placed inside a container, or 
integrated into the container itself, and linked to inventories and 
other detailed information. The RFID tags are read when they arrive at 
the receiving facility and that information is made available to the 
shipper, confirming that the shipment has been taken into the custody 
and control of the receiving reverse distributor.\359\
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    \359\ See comment number EPA-HQ-RCRA-2007-0932-0268.
---------------------------------------------------------------------------

    Fourth, we have eliminated the regulatory language that was 
proposed in Sec.  266.509(a)(2). We had referenced the DOT pre-
transport regulations that apply to shipments of non-creditable 
hazardous waste pharmaceuticals. However, in 2016, DOT revised the 
Hazardous Materials Regulations (HMR) as they apply to shipments of 
items in reverse logistics.\360\ As a result, many of the DOT pre-
transport requirements we had referenced no longer apply to shipments 
of hazardous materials in reverse logistics. In response, we have 
eliminated the reference to the DOT pre-transport requirements and 
instead modified our final regulations in Sec.  266.509(a) to refer to 
the entire HMR, rather than specific provisions within the HMR. 
Healthcare facilities and reverse distributors that send shipments of 
potentially creditable hazardous waste pharmaceuticals to reverse 
distributors need only comply with the applicable sections of DOT's HMR 
for shipments in reverse logistics.
---------------------------------------------------------------------------

    \360\ March 31, 2016; 62 FR 18527.
---------------------------------------------------------------------------

    We note that healthcare facilities and reverse distributors must 
meet the applicable DOT hazardous material shipping requirements only 
when shipping potentially creditable hazardous waste pharmaceuticals 
that meet the definition of DOT hazardous material. Under the DOT 
regulations, a RCRA hazardous waste that requires a manifest is 
considered a Class 9 hazardous material. Potentially creditable 
hazardous waste pharmaceuticals do not require a manifest; therefore, 
the DOT shipping requirements will apply when potentially creditable 
hazardous waste pharmaceuticals are shipped to reverse distributors 
only when the hazardous wastes are otherwise classified as DOT 
hazardous materials (i.e., DOT hazard class 1-8). We added regulatory 
language (that was adapted from the Universal Waste regulations) to 
reflect this.
    Fifth, the Agency has finalized the requirement that the shipper of 
potentially creditable hazardous waste pharmaceuticals must receive a 
delivery confirmation from the reverse distributor, however, the Agency 
has extended the time frame within which the shipper must receive the 
delivery confirmation from the reverse distributor from the proposed 
seven days to 35 days, after which the shipper must begin taking 
actions to locate a shipment if the delivery confirmation is not 
received. Many commenters suggested 14 days as an alternative to the 
proposed seven-day time frame, while others suggested far longer or to 
eliminate the time frame altogether. Upon reconsideration of the issue 
and how it pertains more generally to other RCRA hazardous waste 
programs, the Agency decided that 35 days was more appropriate, while 
remaining duly protective of human health and the environment and 
reducing burden on the regulated community. The time frame to receive 
delivery confirmation for shipments of potentially creditable hazardous 
waste pharmaceuticals is also now in line with the standard for 
delivery confirmation under universal waste, which is also 35 days. In 
addition, one of the overarching goals of this rule was to enact 
universal waste-like standards for hazardous waste pharmaceuticals, to 
which this provision conforms. Some states wanted the Agency to go 
further and require that the EPA Regional Administrator be notified 
whenever a shipment has not been received within the allotted time 
frame. Although the Agency understands the utility of such a provision, 
it is not being adopted because of the added burden it would impose on 
both states and the regulated community. In addition, the Agency 
prefers, in this instance, to allow states the flexibility to implement 
more stringent reporting standards for missing shipments of potentially 
creditable hazardous waste pharmaceuticals according to their 
individual circumstances and preferences.
    After considering these comments, the Agency determined that it is 
necessary to require a delivery confirmation in order to ensure 
shipments of potentially creditable hazardous waste pharmaceuticals 
have been received and taken into the custody and control of the 
destination facility as a way to approximate the manifest system 
without requiring the use of hazardous waste transporters or manifests. 
In response to comments, we have reconsidered the proposed seven-day 
time frame for the shipper to receive delivery confirmation; the Agency 
decided that 35 days is more appropriate. It strikes a balance between 
being duly protective of human health and the environment, reducing 
burden, and is now in line with universal waste standards.
    Sixth, we have made several changes to the pre-transport 
requirements that we proposed in Sec.  266.509(a)(1) and (2). Because 
of the removal of the requirement for advance notice of shipments of 
potentially creditable hazardous waste pharmaceuticals, we renumbered 
the section such that it all appears in Sec.  266.509(a) now. What was 
proposed in Sec.  266.509(a)(2) and is now in Sec.  266.509(a), has 
been modified to reflect the removal of Sec.  266.508(a)(1)(v) which 
previously contained a requirement that DOT shipping papers be 
generated. The Agency believes that the shipping papers requirement--

[[Page 5915]]

although duplicative for shipments of non-creditable hazardous waste 
pharmaceuticals from a healthcare facility or evaluated hazardous waste 
pharmaceuticals from a reverse distributor--is appropriate for 
shipments of potentially creditable hazardous waste pharmaceuticals 
given that they are not manifested. Therefore, the requirement for DOT 
shipping papers has been added to Sec.  266.509(a). Language was also 
added to clarify that shipments of potentially creditable hazardous 
waste pharmaceuticals from a healthcare facility or reverse distributor 
to a reverse distributor do not require a manifest. This language was 
taken from the universal waste standards in Sec.  273.52(a) which is 
consistent with the goal of developing universal waste-like shipping 
standards for potentially creditable hazardous waste pharmaceuticals.
    As with the export of non-creditable hazardous waste 
pharmaceuticals, the proposed standards for healthcare facilities or 
reverse distributors that export potentially creditable hazardous waste 
pharmaceuticals to a foreign destination have also been modified to 
reflect the changes made to the import/export rules of part 262. 
Specifically, the Agency is finalizing requirements that exporters of 
potentially creditable hazardous waste pharmaceuticals must comply will 
all applicable sections of 40 CFR part 262 subpart H, except for the 
manifest requirements of Sec.  262.83(c), in addition to the 
requirements for shipping potentially creditable hazardous waste 
pharmaceuticals in Sec.  266.509(a) through (c).
    Subsequent to when this rule was proposed in September 2015, the 
Hazardous Waste Import-Export Revisions rule was finalized in 
2016.\361\ As a result, the Agency has had to make conforming changes 
to this final rule to reflect the changes made by the Import-Export 
Revisions final rule. Because the regulations for importing and 
exporting hazardous waste were previously located in separate 
subparts--exports in subpart E and imports in subpart F--the proposed 
requirements in this rule were also separated into discreet subsections 
and referred to their respective subparts (exporting and importing) of 
40 CFR part 262. A significant change enacted by the Import-Export 
Revisions Rule was to consolidate into subpart H the multiple related 
subparts in 40 CFR 262 regarding import, export, and transboundary 
movements of hazardous waste that had been in subparts E and F.
---------------------------------------------------------------------------

    \361\ See the Hazardous Waste Export-Import Revisions final 
rule, 81 FR 85696; December 31, 2016.
---------------------------------------------------------------------------

    The essence of the proposed regulations has not changed in the 
finalized requirements. That is, a healthcare facility or reverse 
distributor exporting potentially creditable hazardous waste 
pharmaceuticals is still subject to the same or similar provisions as 
were proposed, only now they must comply with 40 CFR part 262 subpart H 
instead, except for the manifesting requirements, and paragraphs (a) 
through (c) of Sec.  266.509.
    For healthcare facilities and reverse distributors that import 
potentially creditable hazardous waste pharmaceuticals, the 
requirements are being finalized as proposed, except that due to the 
conforming changes necessitated by the Hazardous Waste Export-Import 
Revisions Final Rule, they must now comply with the shipping standards 
for potentially creditable hazardous waste pharmaceuticals in lieu of 
40 CFR part 262 subpart H (instead of part 262 subpart F). One other 
clarification was added to the regulatory language specifying that 
potentially creditable hazardous waste pharmaceuticals are subject to 
all applicable provisions in this subpart immediately after entering 
the United States.
4. Comments and Responses
    The commenter that requested an official definition of advance 
notice also requested an official definition for delivery 
confirmation.\362\ The Agency is purposely leaving this standard 
sufficiently broad as to allow the implementing agencies discretion to 
determine the best implementation strategies on a case-by-case basis.
---------------------------------------------------------------------------

    \362\ See comment number EPA-HQ-RCRA-2007-0932-0284.
---------------------------------------------------------------------------

    EPA notes that a reverse distributor is not required to segregate 
the potentially creditable hazardous waste pharmaceuticals from the 
potentially creditable non-hazardous waste pharmaceuticals when they 
are destined for another reverse distributor. However, if the 
potentially creditable pharmaceuticals are not segregated, the reverse 
distributor must follow the tracking procedures for the entire 
shipment. On the other hand, if a reverse distributor chooses to 
segregate the potentially creditable hazardous waste pharmaceuticals 
from the non-hazardous waste pharmaceuticals prior to shipping to 
another reverse distributor, only the potentially creditable hazardous 
waste pharmaceutical portion would have to be shipped according to 
these standards.

XVII. Standards for Reverse Distributors (Sec.  266.510)

A. Background on Reverse Distributor Operations

    Reverse distributors act as intermediaries between healthcare 
facilities and pharmaceutical manufacturers. They receive shipments of 
potentially creditable hazardous waste pharmaceuticals from healthcare 
facilities and, on behalf of manufacturers, facilitate the process of 
crediting healthcare facilities for these pharmaceuticals. From 
stakeholder input, EPA site visits, and comments on the proposed 
rulemaking, EPA's understanding is that when a reverse distributor 
receives a shipment of potentially creditable hazardous waste 
pharmaceuticals, the reverse distributor sorts through the shipment and 
often uses barcodes to scan items into its computer system. Based on 
manufacturers' ``business rules'' (i.e., manufacturers' return 
policies), the reverse distributors determine which potentially 
creditable hazardous waste pharmaceuticals can receive manufacturer 
credit, as well as which must be sent on to another reverse distributor 
for completion of the crediting process. ``Business rules'' (i.e. 
manufacturers' return policies) refers to the rules that govern the 
disposition of retail items agreed to by the manufacturer, retailer, 
and reverse distributor or reverse logistics center.\363\
---------------------------------------------------------------------------

    \363\ This definition is derived from the definition of 
``business rules'' in the ``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.
---------------------------------------------------------------------------

    In many cases, there is more than one reverse distributor involved 
in establishing and verifying manufacturer credit for a particular 
potentially creditable hazardous waste pharmaceutical. For instance, 
reverse distributors may have contracts with specific pharmaceutical 
manufacturers such that only a specific reverse distributor may 
facilitate credit for a particular manufacturer's pharmaceuticals. If 
the receiving reverse distributor has a contract with the healthcare 
facility, but not with the pharmaceutical manufacturer, then the 
receiving reverse distributor sends the returned pharmaceutical on to 
the reverse distributor that has a contract with the pharmaceutical 
manufacturer in order to facilitate the manufacturer credit process.
    Because manufacturers' business rules change over time, sometimes a 
reverse distributor receives a potentially creditable hazardous waste

[[Page 5916]]

pharmaceutical that is not eligible for credit immediately, and the 
reverse distributor retains the potentially creditable hazardous waste 
pharmaceutical on site until it is credit eligible (often called 
``aging'' a pharmaceutical). For example, manufacturers only issue 
credit for expired pharmaceuticals. As a result, sometimes a reverse 
distributor receives an unexpired hazardous waste pharmaceutical that 
is otherwise creditable but awaiting its expiration date. The reverse 
distributor then retains the potentially creditable hazardous waste 
pharmaceutical on site until after it has expired and thus becomes 
eligible for manufacturer credit. In some cases, even after the reverse 
distributor has awarded manufacturer credit, a pharmaceutical 
manufacturer may request that the hazardous waste pharmaceuticals be 
transported back to the manufacturer to verify the amount of 
pharmaceuticals and manufacturer credit.
    On the other hand, if the potentially creditable hazardous waste 
pharmaceuticals are not sent on to another reverse distributor and the 
reverse distributor awards the manufacturer credit to the healthcare 
facility itself, it then manages the hazardous waste pharmaceuticals on 
site until they are sent off site for treatment and disposal. As 
discussed previously, after a potentially creditable hazardous waste 
pharmaceutical has been evaluated and no additional reverse 
distributors will be involved in the manufacturer's crediting process, 
EPA uses the term ``evaluated hazardous waste pharmaceutical.'' This is 
to distinguish between the potentially creditable hazardous waste 
pharmaceuticals awaiting determination within the reverse distribution 
system versus the evaluated hazardous waste pharmaceuticals that will 
not be sent to another reverse distributor for evaluation. Both are 
considered hazardous waste pharmaceuticals, but they are managed 
differently under this subpart.
    EPA is not aware of any reverse distributor that facilitates 
manufacturer credit that also has interim status or a permit to treat 
or dispose of hazardous waste on-site.\364\ Therefore, EPA anticipates 
that reverse distributors eventually send all evaluated hazardous waste 
pharmaceuticals off site for treatment and disposal.
---------------------------------------------------------------------------

    \364\ Several DEA reverse distributors have RCRA interim status 
or a permit to treat or dispose of hazardous waste, but these DEA 
reverse distributors do not facilitate manufacturer credit.
---------------------------------------------------------------------------

B. EPA's Rationale for Finalizing New RCRA Management Standards for 
Reverse Distributors

    This final rule establishes standards for the management of both 
potentially creditable hazardous waste pharmaceuticals and evaluated 
hazardous waste pharmaceuticals that reverse distributors receive and 
manage. The management standards discussed in this section apply only 
to reverse distributors of prescription pharmaceuticals that are 
potentially creditable hazardous waste pharmaceuticals or evaluated 
hazardous waste pharmaceuticals. The management standards discussed in 
this section do not apply to the reverse logistics systems that may 
exist for other retail items. In response to comments, EPA is codifying 
our existing interpretation that nonprescription pharmaceuticals that 
are sent through reverse logistics are not solid wastes 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 (see the definition of hazardous waste pharmaceutical under 
section VIII and section IX, the applicability section). 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 or 
reclaimed (see section VI). Therefore, reverse logistics centers that 
receive and manage nonprescription pharmaceuticals will not be 
regulated under this subpart and will not be subject to the standards 
for reverse distributors.
    The current federal RCRA hazardous waste generation regulations at 
40 CFR part 262 provide that only designated facilities, such as RCRA-
permitted and interim status TSDFs, may receive hazardous waste from 
off site for treatment, storage, or disposal. However, the Agency does 
not believe it is necessary for reverse distributors to obtain permits 
or have interim status to store hazardous waste pharmaceuticals in 
order to protect human health and the environment. Thus, EPA is 
finalizing a new category of hazardous waste management facilities 
under RCRA called a ``reverse distributor,'' which is defined as any 
person that receives and accumulates prescription pharmaceuticals that 
are potentially creditable hazardous waste pharmaceuticals for the 
purpose of facilitating or verifying manufacturer credit. The 
definition specifies that any person, including forward distributors, 
third-party logistics providers, and pharmaceutical manufacturers, that 
processes prescription hazardous waste pharmaceuticals for the 
facilitation or verification of manufacturer credit is considered a 
reverse distributor. EPA is finalizing that reverse distributors are 
not required to have interim status or a RCRA permit to accumulate 
hazardous waste pharmaceuticals and they may only accept potentially 
creditable hazardous waste pharmaceuticals from off site provided they 
comply with the standards in this final rule. Reverse distributors may 
not treat or dispose of hazardous waste on-site unless authorized to do 
so as a RCRA-permitted or interim status TSDF.
    As discussed earlier in this document, EPA's previous 
interpretation allows reverse distributors to be generators of 
hazardous waste pharmaceuticals after a decision is made about whether 
the pharmaceuticals will be repurposed. As a hazardous waste generator, 
a reverse distributor had to comply with the LQG, SQG, or VSQG 
generator regulations, depending on the total volume of hazardous waste 
generated in a calendar month. Some smaller reverse distributors might 
have stayed under the hazardous waste quantity limits for VSQGs, which 
would mean that under the federal RCRA regulations, these VSQG reverse 
distributors would not have had to notify EPA as a generator and their 
hazardous waste pharmaceuticals could be disposed of with municipal and 
non-municipal solid waste (see Sec.  262.14). However, the Agency has 
concerns with VSQG reverse distributors not notifying EPA that they are 
managing hazardous waste. EPA is even more concerned about reverse 
distributors that currently qualify as VSQGs placing the hazardous 
waste pharmaceuticals into the municipal and non-municipal solid waste 
stream and sending them to non-hazardous waste landfills. Some studies 
have shown active pharmaceutical ingredients present in landfill 
leachate that is collected in municipal solid waste landfill leachate 
systems.\365 366\ Landfill leachate is generally transported to a 
wastewater treatment

[[Page 5917]]

plant to be treated before discharge; however, some pharmaceutical 
compounds pass through treatment and are discharged, becoming a 
potential contributor of the pharmaceutical compounds detected in our 
nation's waters.
---------------------------------------------------------------------------

    \365\ Barnes, K.K., Christenson, S.C., Kolpin, D.W., Focazio, 
M.J., Furlong, E.T., Zaugg, S.D., Meyer, M.T. and Barber, L.B. 
(2004), Pharmaceuticals and Other Organic Waste Water Contaminants 
Within a Leachate Plume Downgradient of a Municipal Landfill. 
Groundwater Monitoring & Remediation, 24: 119-126.
    \366\ Buszka, P.M., Yeskis, D.J., Kolpin, D.W., Furlong, E.T., 
Zaugg, S.D., and Meyer, M.T. (2009), Waste-Indicator and 
Pharmaceutical Compounds in Landfill-Leachate-Affected Ground Water 
near Elkhart, Indiana, 2000-2002. Bulletin of Environmental 
Contamination and Toxicology, 82.6:635-659.
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    In this final rule, EPA is revising its position regarding 
prescription pharmaceuticals that are potentially creditable hazardous 
waste pharmaceuticals, such that they will be considered discarded at 
the healthcare facilities, not at the reverse distributors. This 
revision is based on new information demonstrating to EPA that 
prescription pharmaceuticals returned to a reverse distributor are 
rarely, if ever, recycled or reused, and therefore the decision to send 
a potentially creditable hazardous waste pharmaceutical to a reverse 
distributor is a decision to discard the pharmaceutical (as discussed 
previously in section VI). Comments on the December 2008 Pharmaceutical 
Universal Waste proposal indicated that notification to EPA by reverse 
distributors and tracking of shipments of potentially creditable 
hazardous waste pharmaceuticals are critical and must be included in 
any regulatory scheme to ensure the safe management of potentially 
creditable hazardous waste pharmaceuticals.
    Although EPA maintains its position as stated in the proposed 
rulemaking preamble that hazardous waste pharmaceuticals going to 
reverse distributors are solid wastes at the healthcare facility, there 
are important differences between reverse distributors and traditional 
TSDFs. Only between 2-6 percent of the potentially creditable 
pharmaceuticals that are received by reverse distributors are listed or 
characteristic hazardous wastes.\367\ Therefore, the vast majority of 
the potentially creditable pharmaceutical waste that a reverse 
distributor receives is not considered a characteristic or listed 
hazardous waste pharmaceutical under the existing definition of 
hazardous waste. This stands in contrast to a typical TSDF, whose 
primary function is to manage hazardous waste. As a result, a reverse 
distributor generally manages a smaller volume of hazardous waste than 
a typical permitted TSDF.
---------------------------------------------------------------------------

    \367\ See EPA's request of information from reverse 
distributors, as well as their responses to EPA in the docket for 
this rulemaking: EPA-HQ-RCRA-2007-0932-0157, EPA-HQ-RCRA-2007-0932-
0158, EPA-HQ-RCRA-2007-0932-0159, EPA-HQ-RCRA-2007-0932-0160, EPA-
HQ-RCRA-2007-0932-0161, EPA-HQ-RCRA-2007-0932-0162, EPA-HQ-RCRA-
2007-0932-0163, EPA-HQ-RCRA-2007-0932-0164.
---------------------------------------------------------------------------

    In addition, because the pharmaceuticals in the reverse 
distribution system are receiving manufacturer credit, they are moved 
through the system efficiently. In fact, one national pharmacy retail 
chain informed EPA that the value of the credit they receive from 
manufacturers for returned pharmaceuticals is approximately $1 billion 
a year.\368\ Healthcare facilities and reverse distributors have a 
vested interest in having potentially creditable hazardous waste 
pharmaceuticals processed and credited quickly and managed 
appropriately so money is not lost in the process.
---------------------------------------------------------------------------

    \368\ Meeting with representatives from CVS (August 11, 2012); 
see the docket for meeting notes (EPA-HQ-RCRA-2007-0932-0188).
---------------------------------------------------------------------------

    Furthermore, potentially creditable hazardous waste pharmaceuticals 
generally present a low risk of release to the environment as they 
typically are still in the manufacturer's packaging, which in some 
cases includes inner and outer packaging (e.g., plastic bottle inside a 
box). Since there is a relatively low human health and environmental 
risk of release associated with the low volumes of potentially 
creditable hazardous waste pharmaceuticals shipped to reverse 
distributors for crediting purposes, and because EPA is not aware of 
any incidents of mismanagement resulting in environmental harm or 
releases of hazardous waste pharmaceuticals by reverse distributors, 
EPA believes that it is not necessary to require reverse distributors 
to obtain RCRA hazardous waste storage permits with respect to typical 
reverse distribution operations, such as receiving, sorting, 
consolidating, and reshipping potentially creditable hazardous waste 
pharmaceuticals.
    Thus, EPA is taking a tailored approach to regulating reverse 
distributors by regarding them as a new type of RCRA hazardous waste 
entity--a reverse distributor. This approach balances EPA's revised 
interpretation that the point of generation for prescription 
pharmaceuticals that are potentially creditable hazardous waste 
pharmaceuticals is at the healthcare facility, not the reverse 
distributor, with the fact that potentially creditable hazardous waste 
pharmaceuticals have value which provides an incentive for proper 
management.
    EPA is establishing new management standards for reverse 
distributors in 40 CFR part 266 subpart P. These entities will not be 
subject to 40 CFR parts 262, 264, 265, or 270. Generally, EPA is 
finalizing that reverse distributors comply with standards that are 
similar to the current federal LQG standards, in combination with 
certain requirements that permitted or interim status hazardous waste 
TSDFs must meet. We are establishing one set of requirements for all 
reverse distributors, regardless of the amount of potentially 
creditable hazardous waste pharmaceuticals they receive. EPA believes 
this uniform set of standards will make it easier for reverse 
distributors to comply with the new subpart, in part because the burden 
of having to count hazardous waste pharmaceuticals on a monthly basis, 
especially the 1 kg of acute hazardous waste pharmaceuticals, will be 
removed.
    EPA is finalizing that a reverse distributor will not be required 
to have a hazardous waste permit or interim status for on-site 
accumulation of creditable and evaluated hazardous waste 
pharmaceuticals provided it follows the final reverse distributor 
standards. As mentioned previously, the on-site accumulation of 
creditable and evaluated hazardous waste pharmaceuticals generally 
presents low risk of release to the environment because they are 
typically in the manufacturer's packaging. However, for activities such 
as treatment or disposal of hazardous waste pharmaceuticals or other 
hazardous waste, a reverse distributor must either obtain a RCRA permit 
or have interim status, as these activities pose a higher risk of 
release. EPA has determined that requirements similar to LQG standards 
for on-site accumulation of hazardous waste that are found in Sec.  
262.17 are appropriate. As discussed previously, the value of the 
potentially creditable pharmaceuticals creates an incentive for proper 
management and the risk of release is low. Furthermore, many reverse 
distributors are already LQGs and, therefore, this final rule should 
not represent a large shift in current practices or increased 
burden.\369\ However, once credit is provided, the value of the 
pharmaceuticals is eliminated and therefore the evaluated hazardous 
waste pharmaceuticals have a greater potential for mismanagement. As a 
result, EPA is finalizing additional standards for the management of 
evaluated hazardous waste pharmaceuticals at reverse distributors.
---------------------------------------------------------------------------

    \369\ See the Regulatory Impact Analysis in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    EPA received numerous comments that expressed concern that the 
standards for reverse distributors would be burdensome for reverse 
logistics

[[Page 5918]]

centers that handle nonprescription pharmaceuticals. For example, one 
commenter expressed concern that the reverse distributor inventory 
requirements for both potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals would be 
burdensome for facilities that receive and manage nonprescription 
pharmaceuticals because these reverse logistics centers do not 
currently maintain an inventory for these retail items.\370\ EPA is 
codifying our existing interpretation that nonprescription 
pharmaceuticals that are sent through reverse logistics are not solid 
wastes 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 (see section VI for more discussion). 
Therefore, reverse logistics centers will not be regulated under part 
266 subpart P and will not be subject to the standards for reverse 
distributors. As a result, comments received on the impact of the 
reverse distributor standards on reverse logistics centers that receive 
and manage nonprescription pharmaceuticals are outside the scope of the 
final rule and are not discussed in this section. EPA also received 
numerous general comments expressing concern that finalizing new RCRA 
management standards for reverse distributors would be burdensome. 
However, some specific provisions included in the proposed reverse 
distributor standards received few comments.
---------------------------------------------------------------------------

    \370\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

C. Detailed Discussion of Final Reverse Distributor Standards

    The final standards for reverse distributors are organized into 
three sections. The first section applies to the reverse distributor 
for the management of all potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals (Sec.  
266.510(a)). The second section includes additional standards that 
would apply to the management of the potentially creditable hazardous 
waste pharmaceuticals that will be sent to another reverse distributor 
for further evaluation or verification of credit and therefore continue 
to be regulated as potentially creditable hazardous waste 
pharmaceuticals (Sec.  266.510(b)). The third section includes 
additional standards that apply to the management of the evaluated 
hazardous waste pharmaceuticals that will not be sent to another 
reverse distributor, but instead will be sent to a permitted or interim 
status TSDF (Sec.  266.510(c)).
1. Standards for Reverse Distributors Managing Potentially Creditable 
Hazardous Waste Pharmaceuticals and Evaluated Hazardous Waste 
Pharmaceuticals (Sec.  266.510(a))
    This portion of the preamble discusses the standards that apply to 
reverse distributors for the management of all hazardous waste 
pharmaceuticals on site, including potentially creditable hazardous 
waste pharmaceuticals and evaluated hazardous waste pharmaceuticals. 
Unlike the following two sections, the standards discussed in this 
section apply to all prescription hazardous waste pharmaceuticals at a 
reverse distributor, regardless of the subsequent destination of the 
hazardous waste pharmaceuticals. We note that a reverse distributor 
must follow these standards for the management of hazardous waste 
pharmaceuticals even if it generates other, non-pharmaceutical 
hazardous waste that is managed under 40 CFR part 262. Note that we 
have reorganized Sec.  266.510(a) since the proposal to more accurately 
reflect the flow of hazardous waste pharmaceuticals at a reverse 
distributor. The subsequent preamble section follows the organization 
of the final regulations.
a. Notification
    Summary of Proposal. EPA proposed that a reverse distributor must 
notify EPA of its hazardous waste pharmaceutical activities using the 
Site ID Form (EPA Form 8700-12). Under the RCRA Subtitle C program, 
SQGs, LQGs, and TSDFs must submit a Site ID Form to EPA. EPA proposed 
that a reverse distributor that does not have an EPA ID number will be 
required to submit the Site ID Form to obtain one and that a reverse 
distributor that already has an EPA ID number will need to notify EPA 
as a reverse distributor.
    Summary of Comments. EPA received two comments in support of the 
proposed notification requirements. One state supported all of the 
proposed notification requirements.\371\ Inmar, Inc. supported the 
requirement that reverse distributors must notify EPA using EPA Form 
8700-12.\372\
---------------------------------------------------------------------------

    \371\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \372\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(1) 
that a reverse distributor must notify EPA of its hazardous waste 
pharmaceutical activities using the Site ID Form (EPA Form 8700-12). 
The Agency will revise the Site ID Form to include a box to allow 
notifications by reverse distributors. EPA believes it is appropriate, 
and in line with comments received on the proposal, to require reverse 
distributors to notify EPA. Under the final rule, a reverse distributor 
that does not have an EPA ID number will be required to submit the Site 
ID Form to obtain one. A reverse distributor that already has an EPA ID 
number will need to notify EPA as a reverse distributor. The time frame 
in both cases is within 60 days of the effective date of this subpart 
or within 60 days of becoming subject to this subpart. Some reverse 
distributors may also be generators of other types of hazardous waste 
(e.g., from cleaning and maintenance operations). Therefore, it is 
possible that a reverse distributor may notify on the same notification 
form as both a generator of hazardous waste and as a reverse 
distributor.
b. Inventory
    Summary of Proposal. EPA proposed that reverse distributors must 
keep an inventory of the potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals that are 
on site. EPA proposed that the inventory must include the identity 
(e.g., name or National Drug Code) and quantity of each potentially 
creditable hazardous waste pharmaceutical and evaluated hazardous waste 
pharmaceutical. EPA also proposed that a reverse distributor must 
inventory each potentially creditable hazardous waste pharmaceutical 
upon arrival at the reverse distributor.
    Summary of Comments. EPA received comments from states and industry 
in support of the proposed inventory requirement.\373\ One state 
suggested that EPA also require reverse distributors to include the 
name of the healthcare facility that shipped the potentially creditable 
hazardous waste pharmaceuticals to the reverse distributor.\374\
---------------------------------------------------------------------------

    \373\ See comment numbers EPA-HQ-RCRA-2007-0932-0235, EPA-HQ-
RCRA-2007-0932-0257, EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-RCRA-2007-
0932-0296, EPA-HQ-RCRA-2007-0932-0300, and EPA-HQ-RCRA-2007-0932-
0341 in the docket for this rulemaking.
    \374\ See comment number EPA-HQ-RCRA-2007-0932-0235 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Retail Industry Leaders Association argued that the inventory 
requirements for reverse distributors should be reduced.\375\ Inmar, 
Inc. did not support the inventory requirements and argued

[[Page 5919]]

that they are duplicative because reverse distributors must already 
inventory and track prescription pharmaceuticals.\376\ Inmar, Inc. 
wrote that at least four states currently require the maintenance of 
drug inventories by law.\377\ Both Inmar, Inc. and RILA expressed 
concern that the inventory requirements would be particularly 
burdensome for their facilities that handle nonprescription 
pharmaceuticals. Inmar, Inc. pointed out that their reverse logistics 
centers do not maintain an inventory for nonprescription 
pharmaceuticals.\378\
---------------------------------------------------------------------------

    \375\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the 
docket for this rulemaking.
    \376\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
    \377\ See the EPA correspondence with Inmar dated March 29, 2017 
in the docket for this rulemaking EPA-HQ-RCRA-2007-0932.
    \378\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    EPA received multiple comments from industry that expressed concern 
that the reverse distributor must inventory each potentially creditable 
hazardous waste pharmaceutical upon arrival.\379\ One commenter 
expressed concern that the reverse distributor must complete an 
inventory upon arrival because packages of potentially creditable 
hazardous waste pharmaceuticals can remain unopened for up to 5 
business days.\380\ Healthcare Distribution Management Association 
\381\ pointed out that reverse distributors sometimes receive tens of 
thousands of products in a day and do individual product accounting 
when the credit determination is made.\382\
---------------------------------------------------------------------------

    \379\ See comment numbers EPA-HQ-RCRA-2007-0932-0295, EPA-HQ-
RCRA-2007-0932-0276, EPA-HQ-RCRA-2007-0932-0352, and EPA-HQ-RCRA-
2007-0932-0340 in the docket for this rulemaking.
    \380\ See comment number EPA-HQ-RCRA-2007-0932-0278 in the 
docket for this rulemaking.
    \381\ Now renamed Heathcare Distribution Alliance.
    \382\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Commenters on the proposed rulemaking also pointed out that reverse 
distributors are already required to inventory and track prescription 
pharmaceuticals under licensing and accreditation programs overseen by 
the National Association of Boards of Pharmacy.\383\
---------------------------------------------------------------------------

    \383\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(2) 
that reverse distributors must keep an inventory of the potentially 
creditable hazardous waste pharmaceuticals and evaluated hazardous 
waste pharmaceuticals that are on site. In response to comments, we 
have made several changes to what was proposed but have determined that 
an inventory is a key requirement to protect public health by helping 
to prevent the diversion of hazardous waste pharmaceuticals. An 
inventory will allow the reverse distributor to know which hazardous 
waste pharmaceuticals they have on-site at any time. Based on 
stakeholder input and site visits, the Agency believes that in many 
cases, reverse distributors already maintain inventories of 
pharmaceuticals and this requirement is not expected to be burdensome 
for the reverse distributors to implement. According to responses from 
reverse distributors to a 2011 request for information, four out of 
eight of them indicated that they already keep inventories as best 
management practices or because it is required by the Board of Pharmacy 
in their state.\384\ The inventory must include the identity (e.g., 
name or National Drug Code) and quantity of each potentially creditable 
hazardous waste pharmaceutical and evaluated hazardous waste 
pharmaceuticals. In response to commenter concern that the inventory 
requirement would be duplicative, EPA clarified in the regulatory 
language of the final rule that if the reverse distributor already 
meets the inventory requirements because of other regulatory 
requirements, such as State Board of Pharmacy regulations, the facility 
is not required to provide a separate inventory.
---------------------------------------------------------------------------

    \384\ See EPA's request of information from reverse 
distributors, as well as their responses to EPA in the docket for 
this rulemaking: EPA-HQ-RCRA-2007-0932-0157, EPA-HQ-RCRA-2007-0932-
0158, EPA-HQ-RCRA-2007-0932-0159, EPA-HQ-RCRA-2007-0932-0160, EPA-
HQ-RCRA-2007-0932-0161, EPA-HQ-RCRA-2007-0932-0162, EPA-HQ-RCRA-
2007-0932-0163, EPA-HQ-RCRA-2007-0932-0164.
---------------------------------------------------------------------------

    EPA proposed that a reverse distributor must inventory each 
potentially creditable hazardous waste pharmaceutical upon arrival at 
the reverse distributor. The final rule has been revised to state that 
reverse distributors must inventory each potentially creditable 
hazardous waste pharmaceutical within 30 calendar days of arriving at 
the reverse distributor. EPA made this change in response to commenter 
concern that the Agency did not provide enough time for reverse 
distributors to inventory potentially creditable hazardous waste 
pharmaceuticals. As previously mentioned, comments pointed out that 
reverse distributors sometimes receive tens of thousands of products in 
one day and need additional time to inventory each potentially 
creditable hazardous waste pharmaceutical.\385\ EPA is also aware that 
many reverse distributors inventory the potentially creditable 
hazardous waste pharmaceutical at the same time that they evaluate the 
potentially creditable hazardous waste pharmaceutical to determine if 
it will receive manufacturer credit. When a reverse distributor 
receives a shipment of potentially creditable hazardous waste 
pharmaceuticals, the reverse distributor sorts through the shipment and 
often uses barcodes to scan items into its system and make a credit 
determination. EPA believes that 30 days is an adequate amount of time 
for the reverse distributor to sort through shipments of hazardous 
waste pharmaceuticals and inventory the potentially creditable 
hazardous waste pharmaceuticals. The Agency has determined that because 
of the value of the potentially creditable hazardous waste 
pharmaceuticals, and the low risk these materials present, increasing 
the amount of time reverse distributors have to complete the inventory 
will not increase risk of release to the environment.
---------------------------------------------------------------------------

    \385\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

c. Evaluating Potentially Creditable Hazardous Waste Pharmaceuticals 
Within 30 Days
    Summary of Proposal. The key role the reverse distributor plays in 
managing the issuing of credit from a manufacturer to a healthcare 
facility is sorting through shipments of potentially creditable 
hazardous waste pharmaceuticals and evaluating them to determine which 
must be transported to another reverse distributor for further 
evaluation of manufacturer credit and which will be sent off site for 
treatment and disposal. The reverse distributors often use barcodes to 
scan items into their systems.
    EPA proposed that this evaluation process must be completed within 
21 days of arriving at the reverse distributor. Likewise, EPA proposed 
that if the reverse distributor is a manufacturer, the manufacturer 
must finish verifying the appropriate credit within 21 calendar days of 
receiving the shipment of potentially creditable hazardous waste 
pharmaceuticals. The Agency proposed that the 21 calendar days for 
evaluating the potentially creditable hazardous pharmaceuticals counts 
as part of the total 90 calendar days that each reverse distributor is 
allowed to accumulate hazardous waste pharmaceuticals on site.
    Summary of Comments. The most frequent comment EPA received on the 
proposed requirement that reverse distributors complete the evaluation 
process within 21 days of arriving at the reverse distributor is that 
the proposed time frame was too short. Waste Management National 
Services, Inc.

[[Page 5920]]

requested that EPA allow additional time for reverse distributors to 
evaluate potentially creditable hazardous waste pharmaceuticals.\386\ 
One state requested that EPA allow reverse distributors to have 30 days 
to complete the evaluation process.\387\ RILA and PharmaLink, Inc. 
requested that EPA allow reverse distributors to have 60 days to 
complete the evaluation process.\388\ GENCO, Qualanex, LLC, and 
Healthcare Waste Institute of the National Waste and Recycling 
Association requested that there be no time limit set for reverse 
distributors to complete the evaluation process.\389\ One state 
suggested that it is not critical to require the evaluation to take 
place in a certain number of days if the days count toward the total 
number of days that hazardous waste pharmaceuticals are allowed to 
accumulate on site.\390\
---------------------------------------------------------------------------

    \386\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the 
docket for this rulemaking.
    \387\ See comment number EPA-HQ-RCRA-2007-0932-0313 in the 
docket for this rulemaking.
    \388\ See comment numbers EPA-HQ-RCRA-2007-0932-0295 and EPA-HQ-
RCRA-2007-0932-0349 in the docket for this rulemaking.
    \389\ See comment numbers EPA-HQ-RCRA-2007-0932-0336, EPA-HQ-
RCRA-2007-0932-0352, and EPA-HQ-RCRA-2007-0932-0296 in the docket 
for this rulemaking.
    \390\ See comment number EPA-HQ-RCRA-2007-0932-0235 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    EPA also received multiple comments in support of the requirement 
that reverse distributors complete the evaluation process in a short 
time frame. One state supported the requirement that reverse 
distributors complete the evaluation process in a short time 
frame.\391\ Clean Harbors Environmental Services argued that 21 days is 
more than adequate for a reverse distributor to evaluate potentially 
creditable hazardous waste pharmaceuticals.\392\
---------------------------------------------------------------------------

    \391\ See comment number EPA-HQ-RCRA-2007-0932-0315 in the 
docket for this rulemaking.
    \392\ See comment number EPA-HQ-RCRA-2007-0932-0333 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule, EPA is requiring in 
Sec.  266.510(a)(3) that reverse distributors evaluate potentially 
creditable hazardous waste pharmaceuticals within 30 calendar days of 
arriving at the reverse distributor. Likewise, EPA is finalizing in 
Sec.  266.510(a)(4) that if the reverse distributor is a manufacturer, 
the manufacturer must finish verifying the appropriate credit within 30 
calendar days of receiving the shipment of potentially creditable 
hazardous waste pharmaceuticals.
    EPA is now aware that reverse distributors sometimes receive tens 
of thousands of products in one day and that sometimes reverse 
distributors need more than 21 days to evaluate the potentially 
creditable hazardous waste pharmaceuticals.\393\ As mentioned 
previously, commenters pointed out that many reverse distributors 
inventory the potentially creditable hazardous waste pharmaceuticals at 
the same time that they evaluate the potentially creditable hazardous 
waste pharmaceuticals to determine if they will be credited.\394\ 
Therefore, the Agency is finalizing that both the inventory and the 
evaluation process must be completed in 30 days to ensure that reverse 
distributors have adequate time to sort through shipments of 
potentially creditable hazardous waste pharmaceuticals.\395\ In the 
case where healthcare facilities do not segregate hazardous waste 
pharmaceuticals from non-hazardous waste pharmaceuticals as part of the 
evaluation process, reverse distributors will effectively make a 
hazardous waste determination in order to determine which 
pharmaceuticals are hazardous waste pharmaceuticals and thus subject to 
this subpart.
---------------------------------------------------------------------------

    \393\ See comment numbers EPA-HQ-RCRA-2007-0932-0276 and EPA-HQ-
RCRA-2007-0932-0257 in the docket for this rulemaking.
    \394\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the 
docket for this rulemaking.
    \395\ Although RILA requested that EPA allow reverse 
distributors to have 60 days to complete the evaluation process, 
RILA was primarily concerned that it would be difficult for reverse 
distributors to sort through over-the-counter pharmaceuticals and 
dietary supplements within the proposed time frame (see comment 
number EPA-HQ-RCRA-2007-0932-0295 in the docket for this 
rulemaking). However, the Agency thinks that 30 days is a sufficient 
amount of time for reverse distributors to sort through shipments of 
potentially creditable hazardous waste pharmaceuticals, which does 
not include over-the-counter pharmaceuticals and dietary supplements 
under the final regulations (see the definition of ``potentially 
creditable hazardous waste pharmaceuticals'' in 266.500).
---------------------------------------------------------------------------

    The Agency is finalizing that the 30 calendar days for evaluating 
the potentially creditable hazardous pharmaceuticals do not count as 
part of the total 180 calendar days that the hazardous waste 
pharmaceuticals are allowed to accumulate on site at the reverse 
distributor. The Agency has determined that because of the value of the 
potentially creditable hazardous waste pharmaceuticals and the low risk 
these materials present, increasing the amount of time reverse 
distributors have to evaluate shipments of potentially creditable 
hazardous waste pharmaceuticals will not increase risk of release to 
the environment. Additionally, because most potentially creditable 
hazardous waste pharmaceuticals are in their original packaging, if the 
original packaging for gels or liquids is intact and sealed or the 
pharmaceuticals have been repackaged (e.g., for unit dosing) and the 
repackaged packaging for gels and liquids is intact and sealed, they 
are considered to meet the closed container standard, and therefore EPA 
has determined that having a longer accumulation time is not a hazard 
to human health and the environment.\396\
---------------------------------------------------------------------------

    \396\ For more discussion of the closed container standard see 
memo from Devlin to RCRA Division Directors, November 3, 2011 (RCRA 
Online #14826).
---------------------------------------------------------------------------

    EPA is finalizing that once an evaluation is made on the incoming 
potentially creditable hazardous waste pharmaceuticals, if they are 
destined for another reverse distributor, they are still considered 
potentially creditable hazardous waste pharmaceuticals. There are 
additional regulations in this subpart at Sec.  266.510(b) that pertain 
to these potentially creditable hazardous waste pharmaceuticals. If, 
however, they are destined for an interim status or permitted TSDF, 
they are considered ``evaluated hazardous waste pharmaceuticals.'' 
There are additional regulations in this rule at Sec.  266.510(c) that 
pertain to these evaluated hazardous waste pharmaceuticals.
d. Accumulation Time Limit
    Summary of Proposal. EPA proposed that, like LQGs, reverse 
distributors may accumulate potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site 
for up to 90 calendar days without having interim status or a permit. 
However, because of the value of the potentially creditable hazardous 
waste pharmaceuticals, and the low risk these materials present because 
they are in original manufacturer's packaging that would meet our 
typical requirement for closed containers, the Agency decided not to 
propose specific container management standards.
    The Agency proposed that the 90-day time limit begin when the 
potentially creditable hazardous waste pharmaceuticals initially arrive 
at the reverse distributor. The Agency also proposed that there is a 
90-day accumulation limit for the hazardous waste pharmaceuticals at 
each reverse distributor. Some potentially creditable hazardous waste 
pharmaceuticals travel through more than one reverse distributor to 
receive manufacturer credit. The Agency proposed that in such cases, 
each reverse distributor that receives the potentially creditable 
hazardous waste pharmaceuticals has a 90-day accumulation limit.
    EPA did not propose a specific method that reverse distributors 
must use to document that accumulation does not exceed 90 calendar 
days. EPA

[[Page 5921]]

anticipated that most reverse distributors would use the inventory 
system to verify the 90-calendar day time frame rather than taking the 
extra step of labeling containers with dates for verification. EPA also 
proposed to allow a reverse distributor to request from EPA an 
extension of the 90-day accumulation time limit for situations when the 
hazardous waste pharmaceuticals are involved in litigation, a recall, 
or in unforeseen circumstances beyond the control of the reverse 
distributor. Under the part 262 generator regulations, the extension of 
time typically allowed is limited to an extra 30 days for LQGs. 
However, due to the complex nature of pharmaceutical litigation and 
recalls, EPA proposed to allow the EPA Regional Administrator to grant 
a time extension at their discretion on a case-by-case basis.
    Summary of Comments. The most frequent comment EPA received on the 
proposed on-site accumulation time limit was that the 90-day 
accumulation limit was too short. Waste Management National Services, 
Inc. did not support the 90-day accumulation limit, arguing that there 
are many reasons why a reverse distributor would experience significant 
changes in the volumes of returns it receives, including recalls.\397\ 
Inmar, Inc. did not support the 90-day accumulation limit, arguing that 
its facilities receive thousands of shipments every day and it would be 
impractical to ensure a 90-day accumulation limit.\398\ Healthcare 
Distribution Management Association pointed out that the 90-day 
accumulation limit is too short because manufacturers frequently take 
longer than 90 days to make credit determinations.\399\ Waste 
Management National Services, Inc., Qualanex, LLC, and PharmaLink, Inc. 
requested that EPA not require the 90-day accumulation to begin until 
the potentially creditable hazardous waste pharmaceuticals become 
evaluated hazardous waste pharmaceuticals.\400\ Stericycle, Inc. 
requested that EPA extend the accumulation time limit from 90 days to 
180 days and suggested that there should not be an accumulation time 
limit for hazardous waste pharmaceuticals being held due to 
recall.\401\ GENCO and Healthcare Waste Institute of the National Waste 
and Recycling Association also requested that EPA extend the 
accumulation time limit from 90 days to 180 days.\402\ RILA Association 
requested that EPA extend the accumulation time limit from 90 days to 
one year.\403\ National Pharmaceutical Returns requested that EPA place 
no accumulation time limit on potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals.\404\
---------------------------------------------------------------------------

    \397\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the 
docket for this rulemaking.
    \398\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
    \399\ See comment number EPA-HQ-RCRA-2007-0932-0276 in the 
docket for this rulemaking.
    \400\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0352, and EPA-HQ-RCRA-2007-0932-0349 in the docket 
for this rulemaking.
    \401\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the 
docket for this rulemaking.
    \402\ See comment numbers EPA-HQ-RCRA-2007-0932-0336 and EPA-HQ-
RCRA-2007-0932-0296 in the docket for this rulemaking.
    \403\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the 
docket for this rulemaking.
    \404\ See comment number EPA-HQ-RCRA-2007-0932-0310 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    EPA received multiple comments suggesting that the accumulation 
time limits did not accommodate situations where reverse distributors 
receive unexpired pharmaceuticals that are otherwise creditable but are 
awaiting their expiration date or situations where reverse distributors 
``age'' potentially creditable pharmaceuticals until they are eligible 
for manufacturer credit.\405\
---------------------------------------------------------------------------

    \405\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    One state supported the 90-day accumulation limit.\406\ One state 
agreed that the 90-day accumulation limit is reasonable but did not 
support allowing each reverse distributor to have a 90-day accumulation 
period because it increases the potential for mismanagement.\407\
---------------------------------------------------------------------------

    \406\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \407\ See comment number EPA-HQ-RCRA-2007-0932-0300 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. In response to comments, EPA is providing 
additional time for reverse distributors accumulating hazardous waste 
pharmaceuticals. Specifically, EPA is finalizing in Sec.  266.510(a)(5) 
that reverse distributors may accumulate potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals on site for up to 180 calendar days without having 
interim status or a permit as long as they meet the conditions of this 
subpart. The Agency is finalizing that the 180-day time limit begins 
once the reverse distributor evaluates the potentially creditable 
hazardous waste pharmaceutical and determines if the potentially 
creditable hazardous waste pharmaceuticals must be transported to 
another reverse distributor for further evaluation of manufacturer 
credit or if it will be sent off site for treatment and disposal. As 
mentioned in the previous section, reverse distributors are required to 
inventory and evaluate potentially creditable hazardous waste 
pharmaceuticals within 30 calendar days of arriving at the reverse 
distributor. Therefore, the potentially creditable hazardous waste 
pharmaceuticals can be accumulated at each reverse distributor for no 
more than 210 days in total after arrival.
    The Agency is finalizing that there is a 180-day accumulation limit 
for the hazardous waste pharmaceutical at each reverse distributor. 
Some potentially creditable hazardous waste pharmaceuticals travel 
through more than one reverse distributor to receive manufacturer 
credit. Under the final rule, each reverse distributor that receives 
the potentially creditable hazardous waste pharmaceuticals has a new 
180-day accumulation limit. Under the final rule, the 180-day time 
limit begins when the reverse distributor evaluates potentially 
creditable hazardous waste pharmaceuticals and to determine which 
potentially creditable hazardous waste pharmaceuticals must be 
transported to another reverse distributor and which ones will be sent 
off site for treatment and disposal.
    Under the final rule, EPA is not requiring a specific method that 
reverse distributors must use to document that accumulation does not 
exceed 180 calendar days. EPA anticipates that most reverse 
distributors will use the inventory system to verify the 180-calendar 
day time frame rather than taking an addition step of labeling 
containers with dates for verification. As discussed previously, EPA is 
finalizing that a reverse distributor must inventory potentially 
creditable hazardous waste pharmaceuticals within 30 calendar days of 
arriving at the reverse distributor. Many reverse distributors utilize 
barcoding and scanners to log potentially creditable pharmaceuticals 
into a database upon arrival or soon after a shipment arrives.
    Because of the value of the potentially creditable hazardous waste 
pharmaceuticals, and the low risk these materials present, the Agency 
is not requiring specific container management standards in the final 
rule. Furthermore, potentially creditable hazardous waste 
pharmaceuticals are typically still in the manufacturer's packaging, 
which would meet our typical requirement for closed containers.
    Under the final rule, EPA has eliminated the proposed provision 
allowing reverse distributors to request an extension of the 
accumulation time limit. In order to accommodate situations where 
hazardous waste

[[Page 5922]]

pharmaceuticals are involved in unforeseen circumstances beyond the 
control of the reverse distributor, the Agency increased the 
accumulation time limit from 90 days to 180 days. As discussed 
previously, the Agency also increased the amount of time reverse 
distributors can take to evaluate potentially creditable hazardous 
waste pharmaceuticals from 21 to 30 days. Additionally, in order to 
accommodate situations when hazardous waste pharmaceuticals are 
involved in litigation or a recall, under the final rule, the Agency 
decided that hazardous waste pharmaceuticals that are either involved 
in an investigation or judicial proceeding or are subject to a 
voluntary or federally-mandated recall are not required to be managed 
under subpart P (see section IX for a detailed discussion). As a 
result, we do not anticipate the need for reverse distributors to seek 
accumulation time extensions and therefore we have deleted proposed 
Sec.  266.510(a)(5).
    In order to accommodate situations when reverse distributors 
receive unexpired pharmaceuticals that are otherwise creditable but are 
awaiting their expiration date (i.e., aging in a holding morgue), EPA 
has added a provision in Sec.  266.510(a)(5)(ii) to allow reverse 
distributors to accumulate these unexpired pharmaceuticals for up to 
180 days after the expiration date provided that the unexpired 
pharmaceuticals are managed in accordance with the container labeling 
and management standards for evaluated hazardous waste pharmaceuticals 
found at Sec.  266.510(c)(4)(i)-(vi) while they are aging. This 
includes labeling containers with the words ``hazardous waste 
pharmaceuticals;'' ensuring the containers are in good condition, 
managed to prevent leaks and compatible with the contents; and keeping 
containers closed.
    Once a reverse distributor evaluates a hazardous waste 
pharmaceutical and determines that it is not destined for another 
reverse distributor, the reverse distributor must manage that hazardous 
waste pharmaceutical according to the standards for evaluated hazardous 
waste pharmaceuticals (unless, as previously mentioned, the hazardous 
waste pharmaceuticals are unexpired pharmaceuticals that are otherwise 
creditable but are awaiting their expiration date). The evaluated 
hazardous waste pharmaceuticals can be accumulated for up to 180 
calendar days without having interim status or permits and they must be 
managed in accordance with the standards for evaluated hazardous waste 
pharmaceuticals in Sec.  266.510(c). Although reverse distributors must 
manage the hazardous waste pharmaceuticals that are not destined for 
another reverse distributor in accordance with the standards for 
evaluated hazardous waste pharmaceuticals, the reverse distributor can 
decide at any point during the accumulation time that the evaluated 
hazardous waste pharmaceuticals have become eligible for manufacturer 
credit. If the evaluated hazardous waste pharmaceuticals become 
eligible for manufacturer credit, the reverse distributor does not get 
additional calendar days beyond the 180-day accumulation time limit to 
accumulate the hazardous waste pharmaceuticals. If the evaluated 
hazardous waste pharmaceutical becomes eligible for manufacturer 
credit, and the hazardous waste pharmaceutical will still not be sent 
to another reverse distributor for further evaluation, the reverse 
distributor must continue to manage the hazardous waste pharmaceutical 
in accordance with the standards for evaluated hazardous waste 
pharmaceuticals.
    EPA does not anticipate a scenario where an evaluated hazardous 
waste pharmaceutical becomes eligible for manufacturer credit and the 
reverse distributor needs to send the hazardous waste pharmaceutical to 
another reverse distributor for further evaluation. A reverse 
distributor is unlikely to utilize resources to accumulate a 
pharmaceutical that another reverse distributor is required to evaluate 
due to contractual arrangements with pharmaceutical manufacturers. 
Although EPA does not anticipate this scenario, if an evaluated 
hazardous waste pharmaceutical becomes eligible for manufacturer credit 
and the reverse distributor determines that it should go to another 
reverse distributor to be further evaluated for manufacturer credit, 
the reverse distributor can then resume managing the hazardous waste 
pharmaceutical pursuant to the standards for potentially creditable 
hazardous waste pharmaceuticals that are going on to another reverse 
distributor (Sec.  266.510(b)). However, the reverse distributor does 
not get additional time to accumulate the hazardous waste 
pharmaceuticals. That is, the reverse distributor can only accumulate 
the hazardous waste pharmaceuticals for a total of 180 days after the 
initial evaluation process is complete. Overall, this approach balances 
the requests from commenters to accommodate situations where reverse 
anticipate that a manufacturer's policy might change and that evaluated 
hazardous waste pharmaceuticals might become eligible for manufacturer 
credit with EPA's belief that it is necessary to limit total 
accumulation time to 180 days.
e. Security
    Summary of Proposal. EPA proposed that reverse distributors must 
meet a performance-based security requirement which is based on the 
existing interim status TSDF security requirements found at Sec.  
265.14. Due to increased thefts of pharmaceuticals from pharmacies 
reported in recent years in major media outlets, EPA was concerned that 
reverse distributors could face such thefts since they accumulate 
unused pharmaceuticals.\408\ Further, commenters on the 2008 
Pharmaceutical Universal Waste proposal suggested that pharmaceutical 
universal waste handlers should meet the TSDF facility security 
requirement. EPA agreed with the commenters that the requirements in 
the interim status TSDF security regulations would be appropriate to 
adopt and apply to reverse distributors to prevent the illicit use of 
these pharmaceuticals, thereby safeguarding human health. EPA's 
proposal required that they must prevent unknowing entry, and minimize 
the possibility for the unauthorized entry into the portion of the 
facility where potentially creditable and evaluated hazardous waste 
pharmaceuticals are kept (e.g., a receiving area and accumulation 
area).
---------------------------------------------------------------------------

    \408\ ``Pharmacies Besieged by Addicted Thieves'' by Abby 
Goodnough Published: February 6, 2011 http://www.nytimes.com/2011/02/07/us/07pharmacies.html.
---------------------------------------------------------------------------

    Summary of Comments. Inmar, Inc. and RILA did not support the 
proposed security requirements and argued that they are duplicative 
because protective security measures are already required by other 
state and federal laws.\409\ One state and two industry commenters 
expressed support that reverse distributors must meet a performance-
based security standard.\410\ One industry commenter pointed out that 
this requirement should not be an added burden since reverse 
distributors should already have significant security systems in place 
and one industry commenter pointed out that the requirements are 
consistent with the

[[Page 5923]]

way that reverse distributors operate.\411 412\
---------------------------------------------------------------------------

    \409\ See comment numbers EPA-HQ-RCRA-2007-0932-0377 and EPA-HQ-
RCRA-2007-0932-0295 in the docket for this rulemaking.
    \410\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0280, and EPA-HQ-RCRA-2007-0932-0315 in the docket 
for this rulemaking.
    \411\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the 
docket for this rulemaking.
    \412\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(6) 
that reverse distributors must meet a performance-based security 
requirement which is based on the existing interim status TSDF security 
requirements found at Sec.  265.14. EPA believes that the requirements 
that appear in the interim status TSDF security regulations are 
appropriate to adopt and apply to reverse distributors to prevent the 
illicit use of these pharmaceuticals thereby safeguarding human health. 
The security requirement of Sec.  265.14(a) requires a facility to 
``prevent the unknowing entry, and minimize the possibility for the 
unauthorized entry, of persons or livestock onto the active portion of 
his facility.'' EPA is finalizing a similar requirement for reverse 
distributors: they must prevent unknowing entry and minimize the 
possibility for the unauthorized entry into the portion of the facility 
where potentially creditable and evaluated hazardous waste 
pharmaceuticals are kept (e.g., a receiving area and accumulation 
area).
    Based on site visits and comments received on the proposed 
rulemaking, EPA recognizes that many reverse distributors may already 
meet the proposed security standard through the use of key cards that 
allow only authorized personnel into specific areas of the reverse 
distributor, camera surveillance systems, and cages for storing 
pharmaceuticals. Some reverse distributors may use fences and signs. 
EPA is including several examples of acceptable security measures in 
the regulatory text, but reverse distributors are not limited to the 
examples provided. Further, EPA does not believe this requirement is 
duplicative because we included a provision in the regulations that if 
a reverse distributor already meets the performance-based security 
standard by complying with other regulations, such as DEA's 
regulations, then the reverse distributor would not need to install 
additional security. Furthermore, in response to comments we added a 
reference to the State Board of Pharmacy regulations as a second 
example of other regulations that could be used to fulfill the 
performance based security requirement.
f. Contingency Plan and Emergency Procedures
    Summary of Proposal. The Agency proposed to require that reverse 
distributors meet standards that are the same as those that appear in 
the federal LQG regulations for developing a contingency plan and 
emergency procedures at 40 CFR part 265 subpart D. EPA noted in the 
proposal that a reverse distributor should be prepared to respond to 
potential emergencies just like LQGs and TSDFs. Since many reverse 
distributors are already LQGs, they should already have contingency 
plans to address the hazards on site. It may be possible that the 
reverse distributors would have to amend their contingency plans to 
include the potentially creditable hazardous waste pharmaceuticals, 
which have been considered products, not hazardous waste, but the 
Agency pointed out in the proposal that such modifications should not 
impose much burden.
    Summary of Comments. One state and two industry commenters 
supported the requirement that reverse distributors meet the same 
contingency planning standards as LQGs at 40 CFR part 265 subpart 
D.\413\ Inmar, Inc. supported the proposed contingency plan and 
emergency procedures requirements and pointed out that most of their 
facilities are LQGs and already follow these requirements.\414\ RILA 
argued that the contingency planning and emergency procedures 
requirements should not apply to reverse distributors that handle lower 
volumes of hazardous waste than an SQG generates because the nature of 
the waste does not warrant the more stringent requirements.\415\
---------------------------------------------------------------------------

    \413\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0341, and EPA-HQ-RCRA-2007-0932-0377 in the docket 
for this rulemaking.
    \414\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
    \415\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(a)(7) 
that reverse distributors meet standards that are the same as those 
that appear in the federal LQG regulations for developing a contingency 
plan and emergency procedures. Since this rule was proposed, the 2016 
Hazardous Waste Generator Improvements rule has been finalized and has 
placed the contingency plan and emergency procedures for LQGs in part 
262 subpart M, entitled ``Preparedness, Prevention and Emergency 
Procedures for Large Quantity Generators.'' As a result, this final 
rule now references the LQG standards in part 262 subpart M rather than 
the interim status TSDF standards part 265 subpart D. EPA believes that 
a reverse distributor should be prepared to respond to potential 
emergencies just like LQGs and TSDFs. Reverse distributors that are 
LQGs should already have contingency plans to address the hazards on-
site. Commenters pointed out that reverse distributors that currently 
operate as SQGs will face a burden under this requirement, but EPA's 
data shows that most reverse distributors are already LQGs.\416\ It is 
possible that the reverse distributors will have to amend their 
contingency plans to include the potentially creditable hazardous waste 
pharmaceuticals, which have been considered products, not hazardous 
waste, but EPA does not believe that such modifications will impose 
much burden.
---------------------------------------------------------------------------

    \416\ See the Regulatory Impact Analysis in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    Comments and Responses. One state recommended that EPA establish a 
similar requirement to 40 CFR 264.31 (failure of a facility owner or 
operator to maintain or operate facility to minimize possibility of 
fire, explosion or releases of hazardous waste or hazardous waste 
constituents) for reverse distributors.\417\ EPA included similar 
language in the regulations at Sec.  266.510(c)(4)(v).
---------------------------------------------------------------------------

    \417\ See comment number EPA-HQ-RCRA-2007-0932-0235 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

g. Closure
    Summary of Proposal. Due to the generally low risk of release to 
the environment of the hazardous waste pharmaceuticals that reverse 
distributors will accumulate on site, as well as the value of the 
hazardous waste pharmaceuticals, EPA proposed a performance-based 
closure standard for reverse distributors that incorporated the federal 
LQG closure standard found at Sec.  265.111. Specifically, when a 
reverse distributor closes its operations related to hazardous waste 
pharmaceuticals, EPA proposed that it must control or minimize post-
closure releases of hazardous waste into the environment. EPA expected 
that this would entail removing the containers of both potentially 
creditable hazardous waste pharmaceuticals as well as evaluated 
hazardous waste pharmaceuticals from the facility before closure.
    Summary of Comments. Waste Management National Services, Inc., the 
California Department of Toxic Substances Control, and the Connecticut 
Department of Energy and Environmental Protection support the 
requirement for a performance-based closure standard that is based on 
the

[[Page 5924]]

federal LQG closure standard.\418\ Inmar, Inc. requested that EPA 
clarify that the reverse distributor closure requirement only apply to 
the closure of the facility and not to the closure of accumulation 
areas.\419\
---------------------------------------------------------------------------

    \418\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0315, and EPA-HQ-RCRA-2007-0932-0341 in the docket 
for this rulemaking.
    \419\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule at Sec.  266.510(a)(8), 
EPA is requiring a performance-based closure standard that is based on 
the federal LQG closure standard. Since the rule was proposed, the 2016 
Hazardous Waste Generator Improvements rule has been finalized and has 
incorporated the LQG closure standards into the new LQG regulations in 
Sec.  262.17. As a result, this final rule now references the LQG 
closure standard in Sec. Sec.  262.17(a)(8)(ii) and (iii) rather than 
incorporating the regulatory language of Sec.  265.111. The LQG closure 
standards are substantially the same as before. Therefore, when a 
reverse distributor closes its operations related to hazardous waste 
pharmaceuticals, it must control or minimize post-closure releases of 
hazardous waste constituents into the environment. This will entail 
removing the containers of both potentially creditable hazardous waste 
pharmaceuticals as well as evaluated hazardous waste pharmaceuticals 
from the facility before closure. The closure standards apply when the 
reverse distributor closes its operations related to hazardous waste 
pharmaceuticals rather than when the reverse distributor closes an 
accumulation area.
h. Reporting
    Summary of Proposal. In some instances, a shipment arriving at a 
reverse distributor may inadvertently include items that are not 
potentially creditable pharmaceuticals. These shipments can include 
wastes that are clearly not eligible to receive credit, such as patient 
care waste (e.g., IV bags and tubing), contaminated personal protective 
equipment (PPE), medical waste, or other inappropriate wastes. Reverse 
distributors are not the appropriate waste management facility for 
medical or infectious wastes and these wastes must be managed and 
transported from the healthcare facility to an appropriate waste 
disposal facility. In some cases, these non-creditable wastes may be 
hazardous waste. These non-creditable hazardous wastes are prohibited 
from being transported from a healthcare facility to a reverse 
distributor and should have been manifested from the healthcare 
facility to a designated facility, such as a permitted or interim 
status TSDF.
    EPA proposed that if a shipment including these unauthorized wastes 
arrives at a reverse distributor from a healthcare facility, the 
reverse distributor must submit an unauthorized waste report to the EPA 
Regional Administrator within 15 days. EPA adapted the existing 
requirement for situations when permitted and interim status TSDFs 
receive unmanifested hazardous waste (Sec.  264.76 and Sec.  265.76, 
respectively) to make it appropriate for situations when unauthorized 
waste arrives at a reverse distributor. EPA also proposed additional 
requirements for when inappropriate hazardous waste arrives at a 
reverse distributor.
    First, EPA proposed that the reverse distributor must send a copy 
of the unauthorized waste report to the healthcare facility that sent 
the unauthorized waste. This requirement was intended to alert the 
healthcare facility of its mistake in order to prevent further 
shipments of non-creditable hazardous waste or non-pharmaceutical 
hazardous waste.
    Second, EPA proposed that the reverse distributor must manage the 
unauthorized waste that it receives in accordance with all applicable 
regulations. Third, the Agency proposed that the EPA Regional 
Administrator may require reverse distributors to furnish additional 
reports concerning the quantities and disposition of potentially 
creditable hazardous waste pharmaceuticals and evaluated hazardous 
waste pharmaceuticals.
    Summary of Comments. The most frequent comment that EPA received on 
the proposed reporting requirements is that 15 days is not enough time 
to submit an unauthorized waste report to the EPA Regional 
Administrator. Four commenters argued that 15 days is not enough time 
to submit an unauthorized waste report to the EPA Regional 
Administrator.\420\ Two industry commenters pointed out that it may 
take up to 30 days for shipments to be processed.\421\ Healthcare Waste 
Institute of the National Waste and Recycling Association suggested 
that reverse distributors be required to submit an unauthorized waste 
report within 15 days of processing a shipment of hazardous waste 
rather than within 15 days of receiving the hazardous waste.\422\
---------------------------------------------------------------------------

    \420\ See comment numbers EPA-HQ-RCRA-2007-0932-0257, EPA-HQ-
RCRA-2007-0932-0278, EPA-HQ-RCRA-2007-0932-0296, and EPA-HQ-RCRA-
2007-0932-0352 in the docket for this rulemaking.
    \421\ See comment numbers EPA-HQ-RCRA-2007-0932-0257 and EPA-HQ-
RCRA-2007-0932-0352 in the docket for this rulemaking.
    \422\ See comment number EPA-HQ-RCRA-2007-0932-0296 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    CT DEEP supported the reporting requirements and wrote that the 
requirement might incentivize healthcare facilities not to ship 
unauthorized wastes to reverse distributors.\423\ RILA did not support 
the reporting requirements and wrote that reverse distributors should 
not be required to submit an unauthorized waste report when shipments 
of non-creditable hazardous waste pharmaceuticals arrive at the reverse 
distributors because the healthcare facilities are not capable of 
evaluating creditworthiness.\424\ Waste Management National Services, 
Inc. requested that EPA only require reverse distributors to send a 
copy of the unauthorized waste report to a specific healthcare facility 
three times, arguing that it is not the reverse distributor's 
responsibility to continue this reporting.\425\ National Pharmaceutical 
Returns pointed out that reverse distributors receive a large amount of 
unauthorized waste pharmaceuticals that healthcare facilities think are 
potentially creditable and therefore the reporting requirements will be 
time consuming.\426\ One state requested the EPA clarify if a reverse 
distributor may refuse to take a shipment.\427\
---------------------------------------------------------------------------

    \423\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \424\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the 
docket for this rulemaking.
    \425\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the 
docket for this rulemaking.
    \426\ See comment number EPA-HQ-RCRA-2007-0932-0310 in the 
docket for this rulemaking.
    \427\ See comment number EPA-HQ-RCRA-2007-0932-0259 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. In response to comments, EPA is finalizing 
at Sec.  266.510(a)(9) that if a shipment from a healthcare facility 
arrives at a reverse distributor that includes hazardous waste that it 
is not authorized to receive, the reverse distributor must submit an 
unauthorized waste report to the EPA Regional Administrator within 45 
days of receiving the hazardous waste rather than the proposed 15 days. 
However, EPA is finalizing, as proposed, the additional requirements 
for when shipments of unauthorized waste arrive at reverse 
distributors. First, the reverse distributor must send a copy of the 
unauthorized waste report to the healthcare facility that sent the 
unauthorized waste. Second, the reverse distributor cannot reject the 
shipment of non-creditable hazardous waste and must manage the 
unauthorized waste in accordance with all applicable

[[Page 5925]]

regulations (e.g., part 262 or medical waste regulations). Healthcare 
facilities are not equipped as well as reverse distributors to manage 
the hazardous waste and EPA is concerned that rejecting shipments of 
non-creditable hazardous waste will prolong mismanagement. Third, the 
Agency is finalizing as proposed that the EPA Regional Administrator 
may require reverse distributors to furnish additional reports 
concerning the quantities and disposition of potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals. This provides the Agency with some flexibility in what 
reports may be required.
    Comments and Responses. The Agency believes that commenters 
understood this provision to apply more broadly than we intended. We 
are aware that healthcare facilities often do not know whether a 
hazardous waste pharmaceutical will receive manufacturer credit at the 
reverse distributor. EPA did not intend for a reverse distributor to 
generate an unauthorized waste report each time a hazardous waste does 
not receive credit. Rather, a reverse distributor must generate an 
unauthorized waste report when it receives waste that it is not 
authorized to receive or manage. EPA reworded the regulations to 
include better examples of unauthorized waste, which includes, but is 
not limited to, non-pharmaceutical hazardous waste and medical or 
infectious waste.
    In order to prevent exposing employees to unnecessary risk, EPA 
recommends as a best management practice that reverse distributors keep 
to a minimum the sorting of shipments that contain unauthorized waste 
since the shipment may include hazardous waste, including infectious or 
radioactive healthcare waste. As a result, it is possible that a 
reverse distributor that receives a shipment that includes non-
creditable waste may be unsure whether the shipment includes hazardous 
waste. In such cases, EPA recommends that the reverse distributor 
assume the shipment includes hazardous waste and submit an unauthorized 
waste report. Further, we recommend that reverse distributors work with 
their clients to reduce the occurrence of further inappropriate 
shipments.
i. Recordkeeping
    Summary of Proposal. EPA proposed three recordkeeping requirements 
to provide transparency for the movement of potentially creditable 
hazardous waste pharmaceuticals and as a means of verification upon 
inspection. First, EPA proposed that a reverse distributor must keep a 
copy of its notification (EPA Form 8700-12) to EPA to indicate that it 
is a reverse distributor operating under 40 CFR part 266 subpart P. EPA 
proposed that a reverse distributor must keep the record of 
notification for as long as it is subject to these requirements. 
Second, EPA proposed that a reverse distributor must keep copies of the 
records associated with shipments of potentially creditable hazardous 
waste pharmaceuticals that it receives. This included a copy of the 
proposed advance notification from the healthcare facility or other 
reverse distributor, a copy of delivery confirmation, shipping papers 
or bills of loading, and any unauthorized waste reports. The Agency 
proposed that these shipping records must be kept for three years from 
the date the reverse distributor receives the shipment. Third, EPA 
proposed that a reverse distributor must keep a copy of its inventory 
at all times as long as the reverse distributor remains subject to this 
subpart. Finally, EPA proposed that periods of record retention 
indicated previously for a reverse distributor will be automatically 
extended during an enforcement action, or as requested by the EPA 
Regional Administrator to ensure that the appropriate records are 
available and can be reviewed as part of any enforcement action.
    Summary of Comments. EPA received multiple comments on the 
recordkeeping requirements. GENCO did not support the recordkeeping 
requirements, arguing the requirements would impose burden.\428\ Inmar, 
Inc. argued that reverse distributors are already required to keep 
records under other regulatory requirements related to receipt, 
storage, duration, and shipping of controlled and uncontrolled 
substances.\429\
---------------------------------------------------------------------------

    \428\ See comment number EPA-HQ-RCRA-2007-0932-0336 in the 
docket for this rulemaking.
    \429\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Stericycle, Inc., the Healthcare Waste Institute of the National 
Waste and Recycling Association, and Waste Management National 
Services, Inc. expressed concern about the requirement that a reverse 
distributor must keep a copy of its inventory for as long as the 
facility is subject to this subpart.\430\ Stericycle, Inc. argued that 
it is not reasonable to require the inventory be maintained for the 
life of the facility.\431\ The Illinois Council of Health-System 
Pharmacists requested that EPA clarify whether reverse distributors 
must maintain only a current inventory or that all inventories as they 
change must be maintained.\432\
---------------------------------------------------------------------------

    \430\ See comment numbers EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-
RCRA-2007-0932-0296, and EPA-HQ-RCRA-2007-0932-0257 in the docket 
for this rulemaking.
    \431\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the 
docket for this rulemaking.
    \432\ See comment number EPA-HQ-RCRA-2007-0932-0228 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing the proposed recordkeeping 
requirements at Sec.  266.510(a)(10) with some minor changes in order 
to provide transparency for the movement of potentially creditable 
hazardous waste pharmaceuticals and as a means of verification upon 
inspection. First, EPA is finalizing that a reverse distributor must 
keep a copy of its notification (EPA Form 8700-12) to EPA to indicate 
that it is a reverse distributor operating under 40 CFR part 266 
subpart P. A reverse distributor must keep the record of notification 
for as long as it is subject to these requirements.
    Second, EPA is finalizing that a reverse distributor must keep 
copies of the records associated with shipments of potentially 
creditable hazardous waste pharmaceuticals that it receives. This 
includes a copy of delivery confirmation, shipping papers or bills of 
lading, and any unauthorized waste reports. We have revised the 
regulation language such that these shipping records must be kept for 
three years from the date the shipment arrives at the reverse 
distributor rather than when the reverse distributor ``receives'' the 
shipment since this standard is more precise.
    Third, EPA is finalizing that a reverse distributor must keep a 
copy of its current inventory at all times as long as the reverse 
distributor remains subject to this subpart. The inventory is a living 
document that will constantly be updated and must be available for 
inspection. In order to clarify that a reverse distributor must 
maintain only a current inventory rather than all inventories even if 
they have changed, EPA revised the final regulatory language in Sec.  
266.510(a)(2) such that a reverse distributor must keep a copy of its 
current inventory. This recordkeeping change is being made to be 
consistent with that change in Sec.  266.510(a)(2).
    Finally, EPA is finalizing that periods of record retention 
referred to in this section are automatically extended during an 
enforcement action, or as requested by the EPA Regional Administrator 
to ensure that the appropriate records are available and can be 
reviewed as part of any

[[Page 5926]]

enforcement action. The Agency recommends reverse distributors keep 
electronic versions of these records rather than paper or hard copy 
versions of these records.
    Note that additional recordkeeping requirements may also pertain to 
reverse distributors. For example, a reverse distributor that manifests 
its non-pharmaceutical hazardous waste is subject to the manifest 
recordkeeping requirements of Sec.  262.40. Further, as discussed in 
subsequent sections, there are additional recordkeeping requirements 
that apply to reverse distributors for the management of potentially 
creditable hazardous waste pharmaceuticals destined for another reverse 
distributor (Sec.  266.510(b)) and others that apply to reverse 
distributors for the management of evaluated hazardous waste 
pharmaceuticals (Sec.  266.510(c)).
2. Additional Standards for Reverse Distributors Managing Potentially 
Creditable Hazardous Waste Pharmaceuticals Destined for Another Reverse 
Distributor (Sec.  266.510(b))
    This section discusses the additional standards that apply to a 
reverse distributor for the management of potentially creditable 
hazardous waste pharmaceuticals that require further evaluation or 
verification of manufacturer credit at another reverse distributor. 
Since these pharmaceuticals retain their value and there is greater 
incentive to manage them carefully in order to receive full 
manufacturer credit, EPA is requiring few regulatory standards for the 
management of the potentially creditable hazardous waste 
pharmaceuticals that are destined for another reverse distributor.
    a. Where potentially creditable hazardous waste pharmaceuticals can 
be sent.
    Summary of Proposal. EPA proposed a limit of three transfers of 
potentially creditable hazardous waste pharmaceuticals before the 
hazardous waste pharmaceuticals are ultimately transported to a 
permitted or interim status TSDF. The Agency proposed that the three 
possible types of transfers were: \433\
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    \433\ A healthcare facility or reverse distributor also has the 
option of sending its hazardous waste pharmaceuticals to a RCRA-
permitted or interim status TSDF.
---------------------------------------------------------------------------

    (1) A healthcare facility may send potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor, which may or may not be 
a manufacturer;
    (2) the first reverse distributor may send the potentially 
creditable hazardous waste pharmaceuticals to another reverse 
distributor, which may or may not be a manufacturer;
    (3) the second reverse distributor can only send the potentially 
creditable hazardous waste pharmaceuticals on to a reverse distributor 
that is a manufacturer.
    Because EPA proposed that each reverse distributor could accumulate 
hazardous waste pharmaceuticals up to 90 days after arriving at the 
reverse distributor, this proposed chain of transfers ensured that the 
potentially creditable hazardous waste pharmaceuticals would be 
accumulated for no more than 270 days in total after leaving a 
healthcare facility and before being transported to a RCRA-permitted or 
interim status TSDF for treatment and disposal.\434\ As described 
previously, this is consistent with current practice among reverse 
distributors because of the contractual arrangements that reverse 
distributors have with specific manufacturers.
---------------------------------------------------------------------------

    \434\ Although the proposal did allow for the possibility to 
request an accumulation time limit, the final rule does not.
---------------------------------------------------------------------------

    Summary of Comments. One state did not support allowing three 
transfers of potentially creditable hazardous waste pharmaceuticals 
before the hazardous waste pharmaceuticals are required to be 
transported to a TSDF and requested that EPA consider a maximum of two 
transfers prior to transportation to a TSDF.\435\ Two industry 
commenters opposed EPA's proposed limit on the number of times a 
potentially creditable hazardous waste pharmaceutical may be 
transferred before it must be transported to a TSDF.\436\ One of the 
industry commenters argued that reverse distributors have no knowledge 
about the pedigree of products prior to receipt and as such cannot be 
held accountable as to how many times a product is handled before 
transport to a TSDF.\437\
---------------------------------------------------------------------------

    \435\ See comment number EPA-HQ-RCRA-2007-0932-0261 in the 
docket for this rulemaking.
    \436\ See comment numbers EPA-HQ-RCRA-2007-0932-0349 and EPA-HQ-
RCRA-2007-0932-0377 in the docket for this rulemaking.
    \437\ See comment number EPA-HQ-RCRA-2007-0932-0349 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. The final regulations for reverse 
distributors continue to be structured so that there is a limit to the 
number of transfers of potentially creditable hazardous waste 
pharmaceuticals that may occur before they are ultimately transported 
to a TSDF for treatment and disposal. Stakeholders expressed concern 
that the 2008 Pharmaceutical Universal Waste proposal would have 
allowed hazardous waste pharmaceuticals to be shipped repeatedly and 
indefinitely from one universal waste handler to another. From 
discussions with reverse distributors and reviewing comments received 
on the proposed rulemaking, the Agency believes a reasonable limit is 
three transfers of potentially creditable hazardous waste 
pharmaceuticals before the hazardous waste pharmaceutical is ultimately 
transported to a TSDF. The three possible types of transfers are: \438\
---------------------------------------------------------------------------

    \438\ A healthcare facility or reverse distributor also has the 
option of sending its hazardous waste pharmaceuticals to a RCRA-
permitted or interim status TSDF.
---------------------------------------------------------------------------

    (1) A healthcare facility may send potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor, which may or may not be 
a manufacturer;
    (2) the first reverse distributor may send the potentially 
creditable hazardous waste pharmaceuticals to another reverse 
distributor, which may or may not be a manufacturer (Sec.  
266.510(b)(1)); and
    (3) the second reverse distributor can only send the potentially 
creditable hazardous waste pharmaceuticals on to a reverse distributor 
that is a manufacturer (Sec.  266.510(b)(2)).
    Therefore, if a reverse distributor receives potentially creditable 
hazardous waste pharmaceuticals from a healthcare facility, the reverse 
distributor must send those potentially creditable hazardous waste 
pharmaceuticals to another reverse distributor (which may or may not be 
a manufacturer) or must manage them as evaluated hazardous waste 
pharmaceuticals under Sec.  266.510(c). However, a reverse distributor 
that receives potentially creditable hazardous waste pharmaceuticals 
from another reverse distributor is more limited in where it can send 
the potentially creditable hazardous waste pharmaceuticals. It can send 
potentially creditable hazardous waste pharmaceuticals to a reverse 
distributor that is the manufacturer or else must manage them as 
evaluated hazardous waste pharmaceuticals under Sec.  266.510(c).
    The Agency disagrees with the commenter who argued that reverse 
distributors cannot be accountable for how many times a hazardous waste 
pharmaceutical is transferred because reverse distributors do not have 
a record of transfers of the potentially creditable hazardous waste 
pharmaceuticals prior to receipt.\439\ It is not necessary for a 
reverse distributor to have a record of previous transfers. It is only 
necessary for a reverse distributor to know

[[Page 5927]]

whether a shipment of potentially creditable hazardous waste 
pharmaceuticals originated from a healthcare facility or another 
reverse distributor. EPA believes it is reasonable for a reverse 
distributor to know the origin of a shipment that arrives at their 
facility.
---------------------------------------------------------------------------

    \439\ See comment number EPA-HQ-RCRA-2007-0932-0349 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Regardless of the origin or the destination of the potentially 
creditable hazardous waste pharmaceuticals, each reverse distributor 
must make an evaluation of them within 30 calendar days and may only 
accumulate the hazardous waste pharmaceuticals on site for no more than 
180 calendar days after the evaluation before it ships them off-site to 
another reverse distributor or a RCRA-permitted or interim status TSDF 
(resulting in a maximum of 210 days). The 180 calendar day accumulation 
time starts after the 30 calendar days to make an evaluation. In the 
proposal, reverse distributors only had 90 days to accumulate hazardous 
waste pharmaceuticals on-site, including the 21 calendar days to make 
an evaluation. EPA made this conforming change to align with the change 
in Sec.  266.510(a)(5) that allows reverse distributors to accumulate 
hazardous waste pharmaceuticals on-site for up to 180 calendar days 
without having interim status or a permit. In addition, all shipments 
of evaluated hazardous waste pharmaceuticals are subject to Sec.  
266.508 and shipments of all potentially creditable hazardous waste 
pharmaceuticals are subject to Sec.  266.509.
    Although this chain of transfers will allow potentially creditable 
hazardous waste pharmaceuticals to be accumulated for up to 630 days in 
total after leaving a healthcare facility and before being transported 
to a RCRA-permitted or interim status TSDF for treatment and disposal, 
EPA does not expect that potentially creditable hazardous waste 
pharmaceuticals will be accumulated for this time period in practice. 
First, it is unlikely that a reverse distributor will expend resources 
to accumulate potentially creditable hazardous waste pharmaceuticals on 
site for the full 180 calendar days if the potentially creditable 
hazardous waste pharmaceuticals are destined for another reverse 
distributor. Second, the desire to receive manufacturer credit in a 
timely manner will also make it unlikely that reverse distributors will 
accumulate potentially creditable hazardous waste pharmaceuticals for 
the full 180 days.
    EPA anticipated that some healthcare facilities that are VSQGs will 
send their potentially creditable hazardous waste pharmaceuticals 
directly to reverse distributors. We allow for this under Sec.  
266.504(a). On the other hand, healthcare facilities that are VSQGs may 
choose to consolidate all their hazardous waste pharmaceuticals (both 
creditable and non-creditable) at an off site healthcare facility, as 
allowed by Sec.  266.504(b). In this later case, the consolidated 
potentially creditable hazardous waste pharmaceuticals at an off-site 
VSQG in Sec.  266.504(b) are not counted as one of the 3 allowable 
transfers of potentially creditable hazardous waste pharmaceuticals 
under Sec.  266.510(b).
    Under the final rule, manufacturers cannot send hazardous waste 
pharmaceuticals to a reverse distributor because the hazardous waste 
pharmaceuticals are no longer considered potentially creditable 
hazardous waste pharmaceuticals. Since manufacturers are unable to 
issue credit to themselves, it is not possible for the hazardous waste 
pharmaceuticals to be considered potentially creditable hazardous waste 
pharmaceuticals.
    b. Recordkeeping for reverse distributors shipping potentially 
creditable hazardous waste pharmaceuticals to another reverse 
distributor.
    Summary of Proposal. EPA proposed that reverse distributors must 
keep records (paper or electronic) for each shipment of potentially 
creditable hazardous waste pharmaceuticals that it initiates to another 
reverse distributor (whether it is a manufacturer or not). This 
included a copy of the advance notification provided to the other 
reverse distributor, a copy of delivery confirmation, as well as 
shipping papers or bill of lading. EPA proposed that the reverse 
distributor must keep these shipping records for three years from the 
date it initiates the shipment.
    Summary of Comments. EPA received few comments on the recordkeeping 
requirements for reverse distributors that ship potentially creditable 
hazardous waste pharmaceuticals to another reverse distributor. One 
state asked EPA to clarify what it means by ``shipping papers.'' \440\
---------------------------------------------------------------------------

    \440\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing in Sec.  266.510(b)(4) 
that reverse distributors must keep records (paper or electronic) 
readily available upon request by an inspector for each shipment of 
potentially creditable hazardous waste pharmaceuticals that it 
initiates to another reverse distributor (whether it is a manufacturer 
or not). This includes a copy of delivery confirmation, as well as DOT 
shipping papers. EPA has clarified in the regulations that it is the 
DOT shipping papers prepared in accordance with 49 CFR part 172 subpart 
C we are referring to as ``shipping papers''; EPA is not adding a 
requirement for additional shipping papers. The regulations do not 
specifically mention that reverse distributors keep a copy of a bill of 
lading, as this is only one type of shipping paper that reverse 
distributors can use to comply with 49 CFR part 172 subpart C. EPA is 
finalizing that these shipping records must be kept for three years 
from the date of shipment.
3. Additional Standards for Reverse Distributors Managing Evaluated 
Hazardous Waste Pharmaceuticals (Sec.  266.510(c))
    This section discusses the additional standards that apply to a 
reverse distributor for the management of evaluated hazardous waste 
pharmaceuticals. In general, the term evaluated hazardous waste 
pharmaceuticals refers to hazardous waste pharmaceuticals that were 
potentially creditable hazardous waste pharmaceuticals but have been 
evaluated by a reverse distributor to establish whether they are 
eligible for manufacturer credit and will not be sent to another 
reverse distributor for further evaluation or verification. While 
potentially creditable hazardous waste pharmaceuticals have value in 
the form of manufacturer credit, evaluated hazardous waste 
pharmaceuticals do not. Therefore, in order to minimize the potential 
for their mismanagement, EPA believes it is necessary to have 
additional standards for the evaluated hazardous waste pharmaceuticals. 
These standards generally resemble the standards for LQG CAAs.
    a. Accumulation area.
    Summary of Proposal. EPA proposed that once a reverse distributor 
completes its evaluation of a potentially creditable hazardous waste 
pharmaceutical and the reverse distributor knows that the hazardous 
waste pharmaceutical is destined for treatment and disposal at a RCRA-
permitted or interim status TSDF, rather than another reverse 
distributor, the pharmaceutical is considered an evaluated hazardous 
waste pharmaceutical. EPA proposed that a reverse distributor must 
establish an on-site accumulation area where it will accumulate these 
evaluated hazardous waste pharmaceuticals. An on-site accumulation area 
is needed so that the evaluated hazardous waste pharmaceuticals are 
segregated and clearly distinguished from the

[[Page 5928]]

potentially creditable hazardous waste pharmaceuticals.
    Summary of Comments. One state supported the requirement for 
reverse distributors to establish on-site accumulation areas for 
evaluated hazardous waste pharmaceuticals.\441\
---------------------------------------------------------------------------

    \441\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing as proposed that a reverse 
distributor must establish an on-site accumulation area where it will 
accumulate evaluated hazardous waste pharmaceuticals in Sec.  
266.510(c)(1). An on-site accumulation area is needed so that the 
evaluated hazardous waste pharmaceuticals are segregated and clearly 
distinguished from the potentially creditable hazardous waste 
pharmaceuticals that have fewer requirements and are destined for 
another reverse distributor.
    b. Weekly inspections.
    Summary of Proposal. EPA proposed that the accumulation area for 
evaluated hazardous waste pharmaceuticals must be inspected at least 
weekly to ensure containers are not leaking and that diversion of the 
evaluated hazardous waste pharmaceuticals is not occurring. Under the 
recordkeeping requirements for reverse distributors, the Agency 
proposed that a reverse distributor must keep a log of the weekly 
inspections of the on-site accumulation area and that the log must be 
retained for at least three years from the date of inspection. The log 
is necessary to validate the weekly inspections.
    Summary of Comments. One state commented that weekly inspections 
are not sufficient to determine whether or not diversion of evaluated 
hazardous waste pharmaceuticals is occurring and requested EPA require 
additional security provisions.\442\ Washington State Department of 
Ecology requested that EPA clarify the intent of ``at least weekly'' 
and argued that they interpret ``at least weekly'' to mean once within 
every seven days.\443\
---------------------------------------------------------------------------

    \442\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \443\ See comment number EPA-HQ-RCRA-2007-0932-0272 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. In response to comments, EPA is finalizing 
that the accumulation area for evaluated hazardous waste 
pharmaceuticals must be inspected at least once every seven days to 
ensure containers are not leaking and that diversion of the hazardous 
waste pharmaceuticals is not occurring. We agree with the commenter 
that phrasing the standard as ``at least once every seven days'' is 
more precise than ``at least weekly'' and will avoid the situation 
where a reverse distributor could inspect early in one week and late 
the following week and still claim it is inspecting weekly. Under the 
recordkeeping requirements for reverse distributors in Sec.  
266.510(c)(10), the Agency is finalizing that a reverse distributor 
must keep a log of the weekly inspections of the on-site accumulation 
area and that the log must be retained for at least three years from 
the date of inspection. The log is necessary to validate the weekly 
inspections.
    c. Personnel training.
    Summary of Proposal. EPA proposed to require that reverse 
distributors meet the same federal classroom or on-the-job personnel 
training regulations that LQGs must meet (Sec.  265.16). However, the 
Agency specified in the proposal that the personnel that need to be 
trained are those persons who handle the evaluated hazardous waste 
pharmaceuticals in the on-site accumulation area. EPA argues that these 
personnel are the individuals handling and managing the evaluated 
hazardous waste pharmaceuticals and must have appropriate hazardous 
waste training.
    Summary of Comments. Two industry commenters and one state 
supported the personnel training criteria for reverse 
distributors.\444\ One state argued that the training requirements 
should be applied to the personnel who handle potentially creditable 
hazardous waste pharmaceuticals in addition to the personnel who handle 
evaluated hazardous waste pharmaceuticals on site.\445\ Inmar, Inc. 
pointed out that personnel at reverse distributors are already required 
to receive training under other regulatory requirements.\446\
---------------------------------------------------------------------------

    \444\ See comment numbers EPA-HQ-RCRA-2007-0932-0280, EPA-HQ-
RCRA-2007-0932-0296, and EPA-HQ-RCRA-2007-0932-0304 in the docket 
for this rulemaking.
    \445\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \446\ See comment number EPA-HQ-RCRA-2007-0932-0377 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule, reverse distributors 
must meet the same classroom or on-the-job personnel training 
requirements that LQGs must meet. EPA is finalizing that the personnel 
that need to be trained are those persons who handle the evaluated 
hazardous waste pharmaceuticals. Since these personnel are the 
individuals handling and managing the hazardous waste pharmaceuticals, 
they must have appropriate hazardous waste training. As mentioned 
previously, EPA received multiple comments in support of the training 
requirements for reverse distributors. Additionally, EPA does not 
believe the training requirements will add burden because EPA believes 
most reverse distributors currently operate as LQGs.\447\ Since the 
proposed rulemaking, the 2016 Hazardous Waste Generator Improvement 
rule was finalized. As part of its reorganization, the personnel 
training regulations for LQGs are now incorporated into Sec.  
262.17(a)(7) and no longer refer to Sec.  265.16. As a result, the 
Sec.  266.510(c)(3) training requirements for personnel managing 
evaluated hazardous waste pharmaceuticals at reverse distributors now 
reference Sec.  262.17(a)(7) instead of Sec.  265.16.
---------------------------------------------------------------------------

    \447\ See the Regulatory Impact Analysis in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    d. Labeling and management of containers in on-site accumulation 
area.
    Summary of Proposal. EPA proposed that while containers of 
evaluated hazardous waste pharmaceuticals are in the on-site 
accumulation area, they must be marked with the words, ``hazardous 
waste pharmaceuticals.'' EPA proposed this term in order to distinguish 
them from the non-hazardous waste pharmaceuticals and from the 
hazardous waste pharmaceuticals that are still considered potentially 
creditable. The Agency did not propose to require an accumulation start 
date on the label for the containers of evaluated hazardous waste 
pharmaceuticals.
    In terms of container management standards, the Agency proposed 
requirements that are similar to the container management standards for 
LQGs, but the Agency proposed to include some requirements specific to 
evaluated hazardous waste pharmaceuticals. For example, LQGs must keep 
all containers of hazardous waste closed. However, EPA proposed to 
require that only containers with hazardous waste pharmaceuticals that 
are liquids or gels be kept closed during accumulation due to the low 
potential for release to the environment for those hazardous waste 
pharmaceuticals that are in a solid form. The Agency did not propose to 
require other containers of evaluated hazardous waste pharmaceuticals 
to be closed during accumulation, although we expect that reverse 
distributors would choose to do so as a best management practice. 
Further, because most evaluated hazardous waste pharmaceuticals are in 
their original packaging, we proposed that if the original packaging 
for gels or liquids is intact and sealed or the pharmaceuticals have 
been repackaged (e.g., for unit dosing) and the repackaged packaging 
for gels and liquids is intact and sealed, they are

[[Page 5929]]

considered to meet the proposed closed container standard.
    As with LQGs, EPA proposed that containers of evaluated hazardous 
waste pharmaceuticals must be maintained in good condition to prevent 
leaks and the container material must be compatible with the evaluated 
hazardous waste pharmaceuticals placed in the container. Another 
requirement that was tailored to reverse distributors was the proposal 
that reverse distributors that accumulate evaluated hazardous waste 
pharmaceuticals must segregate the pharmaceuticals that are prohibited 
from being combusted because of the dilution prohibition of Sec.  
268.3(c) and accumulate them in separate containers from other 
evaluated hazardous waste pharmaceuticals.
    The LQG regulations in part 262 include management standards for 
several types of accumulation units that EPA did not propose to include 
for the management of evaluated hazardous waste pharmaceuticals. For 
instance, the proposal only set standards for the accumulation of 
evaluated hazardous waste pharmaceuticals in containers. EPA did not 
think it was necessary to include standards for accumulation units such 
as tanks, containment buildings, or drip pads because reverse 
distributors do not currently use these types of accumulation units. In 
addition, the Agency did not propose to require reverse distributors to 
meet the air emission standards found in 40 CFR part 265 subpart CC as 
required in Sec.  262.34(a)(1)(i) for LQGs because the Agency 
anticipated that they will not be applicable. Additionally, 40 CFR part 
265 subpart AA--air emissions standards for process vents--and subpart 
BB--air emission standards for equipment leaks--are not applicable to 
the activities of a reverse distributor.
    Summary of Comments. EPA received numerous comments on the proposed 
requirements for labeling and management of containers of evaluated 
hazardous waste pharmaceuticals in on-site accumulation areas at 
reverse distributors. One state supported that containers be marked 
with the words ``hazardous waste pharmaceuticals,'' but three states 
and one industry commenter requested that EPA require reverse 
distributors to label containers with the accumulation start date.\448\ 
Stericycle, Inc. agreed that there is not a need to include standards 
for accumulation units such as tanks, containment buildings, or drip 
pads.\449\ Clean Harbors argued that the only way to prevent diversion 
of hazardous waste pharmaceuticals is for all containers to be closed 
and sealed.\450\ One state requested that EPA prohibit reverse 
distributors from mixing or commingling incompatible hazardous waste 
pharmaceuticals in the same container rather than only requiring 
reverse distributors to manage containers to prevent dangerous 
situations, such as fire explosion or release of toxic fumes.\451\ One 
commenter agreed that the 40 CFR part 265 subpart AA--air emissions 
standards for process vents--and subpart BB--air emission standards for 
equipment leaks--are not applicable to the activities of a reverse 
distributor and its management of hazardous waste pharmaceuticals.\452\
---------------------------------------------------------------------------

    \448\ See comment numbers EPA-HQ-RCRA-2007-0932-0211, EPA-HQ-
RCRA-2007-0932-0235, EPA-HQ-RCRA-2007-0932-0341, and EPA-HQ-RCRA-
2007-0932-0257 in the docket for this rulemaking.
    \449\ See comment number EPA-HQ-RCRA-2007-0932-0280 in the 
docket for this rulemaking.
    \450\ See comment number EPA-HQ-RCRA-2007-0932-0333 in the 
docket for this rulemaking.
    \451\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \452\ See comment number EPA-HQ-RCRA-2007-0932-0296 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Final standards for labeling and management 
of containers at an on-site accumulation area are found at Sec.  
266.510(c)(4). EPA is finalizing that while containers of evaluated 
hazardous waste pharmaceuticals are in the accumulation area, they must 
be marked with the words, ``hazardous waste pharmaceuticals.'' Under 
the final rule, reverse distributors are not required to mark an 
accumulation start date on the label for the containers, because the 
reverse distributor's inventory will likely be used to verify the 
accumulation start date. However, a reverse distributor may choose an 
alternate method, such as marking the date on each container, to ensure 
that the containers of evaluated hazardous waste pharmaceuticals are 
not accumulated at the reverse distributor for more than 180 days. As 
explained previously, EPA prefers to allow a performance-based standard 
that allows flexibility to verify the 180-day accumulation time rather 
than require dating on the container labels. Most of the commenters 
that requested accumulation start dates on labels were states. Although 
the requirement is not being finalized at the federal level, any 
authorized state has the ability to impose more stringent regulations. 
If a state chooses to require the accumulation start date on the 
container label, that would be considered more stringent and 
permissible under RCRA.
    In terms of container management standards, the Agency is 
finalizing the proposed requirements that are similar to the container 
management standards for LQGs as well as the additional management 
requirements specific to evaluated hazardous waste pharmaceuticals. 
Specifically, only containers with evaluated hazardous waste 
pharmaceuticals that are liquids or gels must be kept closed during 
accumulation, although EPA expects that all containers of evaluated 
hazardous waste pharmaceuticals will be closed given that evaluated 
hazardous waste pharmaceuticals are in their original packaging. As 
with the proposal, if the original packaging for gels or liquids is 
intact and sealed or the pharmaceuticals have been repackaged (e.g., 
for unit dosing) and the repackaged packaging for gels and liquids is 
intact and sealed, they are considered to meet the closed container 
standard.
    EPA is also finalizing that containers of evaluated hazardous waste 
pharmaceuticals must be maintained in good condition to prevent leaks 
and the container material must be compatible with the hazardous waste 
pharmaceuticals placed in the container. In addition, a reverse 
distributor that manages any container of ignitable or reactive 
evaluated hazardous waste pharmaceuticals or any container of 
commingled incompatible evaluated hazardous waste pharmaceuticals must 
manage the container to prevent dangerous situations, such as fire, 
explosion, or release of toxic fumes. These regulations are consistent 
with the LQG container management regulations in part 262 and already 
apply to LQG reverse distributors accumulating hazardous waste on site. 
The Agency is also finalizing that reverse distributors that accumulate 
evaluated hazardous waste pharmaceuticals must segregate the 
pharmaceuticals that are prohibited from being combusted because of the 
dilution prohibition of Sec.  268.3(c) and accumulate them in separate 
containers from other evaluated hazardous waste pharmaceuticals. The 
dilution prohibition of Sec.  268.3(c) already prohibits the 
incineration of some hazardous waste pharmaceuticals. This new 
provision highlights this prohibition to the reverse distributors 
accumulating the hazardous waste pharmaceuticals prior to sending off 
site for treatment and disposal.
    Comments and Responses. EPA is finalizing management standards only 
for containers used to accumulate evaluated hazardous waste 
pharmaceuticals because commenters

[[Page 5930]]

confirmed that reverse distributors do not use other types of hazardous 
waste accumulation units, such as tanks, containment buildings, or drip 
pads.
    In addition, the Agency is not requiring reverse distributors to 
meet the air emission standards found in 40 CFR part 265 subpart CC as 
required for LQGs in Sec.  262.17(a)(1)(i) because the Agency 
anticipates that they will not be applicable. Specifically, Sec.  
265.1083(c) of subpart CC exempts tanks, surface impoundments, and 
containers from the organic air emission standards if the hazardous 
waste entering the accumulation unit has an average volatile organic 
concentration of less than 500 parts per million by weight, while Sec.  
265.1080(b)(2) of subpart CC exempts containers with a capacity of less 
than 0.1 m\3\ (26 gallons) from the standards. EPA understands that the 
only evaluated hazardous waste pharmaceuticals that have the potential 
for air emissions are liquids and gels, but they generally do not 
contain volatile organics. Thus, they do not release organic air 
emissions, which is what the 40 CFR part 265 subpart CC air emission 
standards for tanks, surface impoundments, and containers were 
promulgated to control. Moreover, because evaluated hazardous waste 
pharmaceuticals are often in their original packaging, and EPA is 
requiring that liquid and gel evaluated hazardous waste pharmaceuticals 
must be in intact, sealed packaging or otherwise in closed containers, 
EPA believes that the container air emission standards are unnecessary. 
In addition, the Agency anticipates that the packaging and containers 
for hazardous waste pharmaceuticals will have a capacity of less than 
0.1 m\3\ (26 gallons) further limiting the applicability of the 
container air emission standards. Similarly, EPA does not anticipate 
that the 40 CFR part 265 subpart AA (air emissions standards for 
process vents) and subpart BB (air emission standards for equipment 
leaks) are applicable to the activities of a reverse distributor and 
its management of evaluated hazardous waste pharmaceuticals. Therefore, 
like 40 CFR part 265 subpart CC discussed previously, EPA is not 
requiring that 40 CFR part 265 subparts AA and BB apply to reverse 
distributors.
    e. Hazardous waste numbers (codes).
    Summary of Proposal. EPA proposed that RCRA hazardous waste numbers 
(commonly called ``hazardous waste codes'') must be marked on the 
container label in order to ensure that they are readily visible and 
cannot be separated from the hazardous waste. In the proposal, the 
Agency did not require that the reverse distributor be the party that 
adds the hazardous waste codes to the containers. The proposed 
regulations allowed a vendor to perform this duty on behalf of the 
reverse distributor.
    Summary of Comments. Two states supported the requirement that 
hazardous waste codes be placed on containers of evaluated hazardous 
waste pharmaceuticals.\453\ Waste Management National Services, Inc. 
argued that it is not practical to include all hazardous waste codes on 
each container label and instead suggested that codes be listed on the 
hazardous waste profile developed with the TSDF and on the 
manifest.\454\
---------------------------------------------------------------------------

    \453\ See comment numbers EPA-HQ-RCRA-2007-0932-0300 and EPA-HQ-
RCRA-2007-0932-0341 in the docket for this rulemaking.
    \454\ See comment number EPA-HQ-RCRA-2007-0932-0257 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Under the final rule, EPA is requiring that 
the containers of evaluated hazardous waste pharmaceuticals be marked 
with the applicable RCRA hazardous waste numbers (codes) at Sec.  
266.510(c)(5). The hazardous waste codes must be added prior to 
shipping evaluated hazardous waste pharmaceuticals off site, although 
they may be placed on the container label at any time during on-site 
accumulation. The hazardous waste numbers must be marked on the 
container label in order to ensure that it is readily visible and 
cannot be separated from the hazardous waste. It is necessary that the 
hazardous waste numbers are on the containers so that transporters, 
transfer facilities, and TSDFs know how to properly transport, 
consolidate, treat, store and dispose of the hazardous waste in 
compliance with the applicable RCRA regulations. In the final rule, the 
Agency is not requiring that the reverse distributor be the party that 
adds the hazardous waste numbers to the containers. The regulations 
allow a vendor to perform this duty on behalf of the reverse 
distributor. In practice, however, if a vendor is responsible for 
assigning hazardous waste numbers, personnel from the reverse 
distributor may need to assist in the process. To be consistent with 
the Hazardous Waste Generator Improvements final rule, we have added a 
sentence to Sec.  266.510(c)(5) indicating that a nationally recognized 
electronic system, such as bar coding or radio frequency 
identification, may be used to identify the EPA Hazardous Waste 
number(s).
    f. Shipping evaluated hazardous waste pharmaceuticals.
    Summary of Proposal. Although it is already stated in Sec.  
266.508(a) under the section of the regulations that pertains to 
shipping standards, for clarity, EPA proposed to repeat in the Sec.  
266.510 the reverse distributor regulations that reverse distributors 
that ship evaluated hazardous waste pharmaceuticals off site must do so 
in accordance with the proposed shipping requirements in Sec.  
266.508(a). This includes the applicable DOT packaging, marking and 
labeling requirements, as well as the requirement to utilize the 
hazardous waste manifest when shipping the evaluated hazardous waste to 
a designated facility.
    Summary of Comments. Two states generally supported the shipping 
requirements for evaluated hazardous waste pharmaceuticals.\455\ One 
state supported that EPA repeat in Sec.  266.510 the requirements 
pertaining to shipping standards although it is already stated in Sec.  
266.508(a).\456\
---------------------------------------------------------------------------

    \455\ See comment numbers EPA-HQ-RCRA-2007-0932-0261 and EPA-HQ-
RCRA-2007-0932-0341 in the docket for this rulemaking.
    \456\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. For clarity, the final reverse distributor 
regulations state that a reverse distributor must ship evaluated 
hazardous waste pharmaceuticals that are destined for a permitted or 
interim status treatment, storage or disposal facility in accordance 
with the applicable shipping standards in Sec.  266.508(a) or (b). This 
includes the applicable DOT packaging, marking and labeling 
requirements, as well as the requirement to utilize the hazardous waste 
manifest when shipping the evaluated hazardous waste to a permitted or 
interim status TSDF.
    g. Procedures for managing rejected shipments.
    Summary of Proposal. The Agency proposed to require that reverse 
distributors meet the same procedures that LQGs must meet for rejected 
shipments in Sec.  262.42(c). Specifically, if a designated permitted 
or interim status TSDF identified on the hazardous waste manifest 
cannot accept a shipment of evaluated hazardous waste pharmaceuticals 
from a reverse distributor and the TSDF returns the shipment to the 
reverse distributor, EPA proposed that the reverse distributor must 
sign either item 18c of the original manifest or item 20 of a new 
manifest. In addition, the proposal allowed the reverse distributor to 
consolidate the rejected hazardous waste pharmaceuticals on site for up 
to 90 days provided they were managed in the on-site accumulation area 
and in accordance with the reverse distributor standards for evaluated 
hazardous waste pharmaceuticals. EPA also proposed that reverse 
distributors send a copy of

[[Page 5931]]

the manifest to the designated facility that returned the shipment to 
the reverse distributor within 30 days of delivery.
    Summary of Comments. One state requested the EPA clarify that a 
reverse distributor that receives a rejected shipment does not have to 
transport it off site upon receipt by the reverse distributor.\457\ One 
state argued that a reverse distributor does not need 90 days to 
accumulate rejected hazardous waste pharmaceuticals in the on-site 
accumulation area and argued that 30 days is sufficient.\458\
---------------------------------------------------------------------------

    \457\ See comment number EPA-HQ-RCRA-2007-0932-0231 in the 
docket for this rulemaking.
    \458\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. The Agency is finalizing in Sec.  
266.510(c)(7) that reverse distributors must meet the same procedures 
that LQGs must meet for rejected shipments in Sec.  262.42(c). Under 
part 262, these rejected shipment procedures already apply to LQG 
reverse distributors. Furthermore, EPA anticipates that a rejected 
shipment is a relatively infrequent occurrence and therefore should not 
be a burden to reverse distributors. In addition, the final rule allows 
the reverse distributor to consolidate the rejected hazardous waste 
pharmaceuticals on site for up to 90 days provided they are managed in 
the on-site accumulation area and in accordance with the reverse 
distributor standards for evaluated hazardous waste pharmaceuticals. 
Although one state requested EPA only allow accumulation for 30 days, 
any authorized state has the ability to impose more stringent 
regulations. If a state chooses to shorten the accumulation time, that 
would be considered more stringent and permissible under RCRA.
    h. Land disposal restrictions.
    Summary of Proposal. EPA proposed that reverse distributors are 
subject to the same LDRs that apply to LQGs with respect to their 
evaluated hazardous waste pharmaceuticals. In addition, EPA proposed to 
amend the testing, tracking, and recordkeeping requirements for 
generators, treaters and disposal facilities at Sec.  268.7 to add the 
words, ``pharmaceutical reverse distributors'' to the title of that 
section to make the applicability of the treatment standards clear.
    Summary of Comments. EPA received multiple comments in support of 
the requirement that reverse distributors meet the same LDRs that apply 
to LQGs with respect to their evaluated hazardous waste 
pharmaceuticals, including two states.\459\ The Oregon Association of 
Clean Water Agencies wrote that applying the LDRs will reduce mobility 
of pharmaceutical constituents in landfill leachate, which is 
frequently routed to POTWs in Oregon.\460\
---------------------------------------------------------------------------

    \459\ See comment numbers EPA-HQ-RCRA-2007-0932-0315 and EPA-HQ-
RCRA-2007-0932-0341 in the docket for this rulemaking.
    \460\ See comment number EPA-HQ-RCRA-2007-0932-0288 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. As required by HSWA, EPA is finalizing that 
reverse distributors are subject to the same land disposal restrictions 
that apply to LQGs with respect to their evaluated hazardous waste 
pharmaceuticals. In addition, EPA is amending the titles at Sec. Sec.  
268.7 and 268.7(a) to add the words, ``reverse distributors'' to make 
the applicability of the land disposal restrictions clear. SQG and LQG 
reverse distributors are already subject to LDRs for their hazardous 
waste pharmaceuticals. Therefore, this provision does not impose 
additional burden on reverse distributors.
    i. Reporting.
    Summary of Proposal. EPA proposed that reverse distributors submit 
a biennial report (BR) for the evaluated hazardous waste 
pharmaceuticals that are transported to a TSDF in order for the Agency 
to have as complete a picture of the amount of hazardous waste 
generated, treated, stored, or disposed of annually. The Agency 
proposed that the BR should only include the evaluated hazardous waste 
pharmaceuticals, and not the potentially creditable hazardous waste 
pharmaceuticals that a reverse distributor sends to another reverse 
distributor. Specifically, EPA proposed that a reverse distributor 
comply with the LQG BR requirements in Sec.  262.41, except for Sec.  
262.41(a)(7), which included the requirement to report changes in 
volume and toxicity of waste achieved during the year in comparison to 
previous years. The Agency did not propose that a reverse distributor 
provide such information because it does not have control of the volume 
or toxicity of the hazardous waste pharmaceuticals it receives from 
healthcare facilities, and thus has no ability to reduce the volume or 
toxicity of the hazardous waste pharmaceuticals.
    EPA proposed that reverse distributors provide an exception report 
when a TSDF does not return the hazardous waste manifest to the reverse 
distributor for shipments of evaluated hazardous waste pharmaceuticals. 
Likewise, EPA proposed that reverse distributors meet LQG exception 
reporting when a shipment from a reverse distributor is rejected by the 
designated facility and forwarded onto an alternate facility. These 
proposed standards were adapted from the exception reporting for LQGs 
in Sec.  262.42(a).
    Summary of Comments. One state supported both of the proposed 
reporting requirements for reverse distributors managing evaluated 
hazardous waste pharmaceuticals that are transported to a TSDF.\461\ 
RILA argued that the requirement that reverse distributors submit a BR 
for the evaluated hazardous waste pharmaceuticals that are transported 
to a TSDF is effectively more stringent than current generator 
requirements that only require generators to submit a biennial report 
if they generate over 1000 kg of hazardous waste in a month.\462\
---------------------------------------------------------------------------

    \461\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \462\ See comment number EPA-HQ-RCRA-2007-0932-0295 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. EPA is finalizing at Sec.  266.510(c)(9)(i) 
that reverse distributors submit a BR for the evaluated hazardous waste 
pharmaceuticals that are transported to a TSDF in order for the Agency 
to have as complete a picture of the amount of hazardous waste 
generated, treated, stored, or disposed of annually. The BR should only 
include the evaluated hazardous waste pharmaceuticals, and not the 
potentially creditable hazardous waste pharmaceuticals that a reverse 
distributor sends to another reverse distributor. EPA does not expect 
that requiring reverse distributors to submit a BR for evaluated 
hazardous waste pharmaceuticals will be burdensome because most reverse 
distributors currently operate as LQGs and already submit a BR.\463\ 
Specifically, under the final rule, reverse distributors must comply 
with the LQG BR requirements in Sec.  262.41. EPA proposed that reverse 
distributors had to comply with the LQG BR requirements in Sec.  262.41 
except Sec.  262.41(a)(7), which included the requirement to report 
changes in volume and toxicity of waste achieved during the year in 
comparison to previous years. However, since the proposed rulemaking, 
the 2016 Hazardous Waste Generator Improvement rule was finalized. As 
part of that final rule, Sec.  262.41(a)(7) was removed from the 
generator requirements. Thus, the final rule only states that reverse 
distributors must

[[Page 5932]]

comply with the LQG BR requirements in Sec.  262.41.
---------------------------------------------------------------------------

    \463\ See the Regulatory Impact Analysis in the docket for this 
rulemaking EPA-HQ-RCRA-2007-0932.
---------------------------------------------------------------------------

    Consistent with the LQG regulations in part 262, EPA is finalizing 
at Sec.  266.510(c)(9)(ii) that reverse distributors must provide an 
exception report when a TSDF does not return the signed hazardous waste 
manifest to the reverse distributor for shipments of hazardous waste 
pharmaceuticals to a designated facility within 45 days of shipment. 
Likewise, EPA is finalizing that reverse distributors must provide an 
exception report when a shipment from a reverse distributor is rejected 
by the designated facility and forwarded onto an alternate facility and 
the reverse distributor does not receive a copy of the manifest with 
the signature of the owner or operator of the alternate facility within 
35 days. These standards were adapted from the exception reporting for 
LQGs in Sec.  262.42(a), while the standards for healthcare facilities 
managing non-creditable hazardous waste pharmaceuticals were adapted 
from the exception reporting for SQGs Sec.  262.42(b). EPA is 
finalizing that a reverse distributor that does not receive a copy of 
the manifest within 35 days of the date the evaluated hazardous waste 
pharmaceuticals were accepted by the initial transporter must contact 
the transporter or TSDF to determinate the status of the evaluated 
hazardous waste pharmaceuticals. EPA is also finalizing that a reverse 
distributor must submit a copy of an exception report if it has not 
received a copy of the manifest within 45 days of the date the 
evaluated hazardous waste pharmaceuticals were accepted by the initial 
transporter. The exception report must include a legible copy of the 
manifest for which the reverse distributor does not have confirmation 
of delivery and a cover letter explaining efforts taken to locate the 
evaluated hazardous waste pharmaceuticals.
    j. Recordkeeping.
    Summary of Proposal. In total, EPA proposed five recordkeeping 
requirements that pertain to evaluated hazardous waste pharmaceuticals 
at reverse distributors. First, EPA proposed that a reverse distributor 
keep a log (written or electronic) of its weekly inspections of the on-
site accumulation area. The other four recordkeeping requirements that 
EPA proposed for reverse distributors are the same as the LQG 
recordkeeping requirements that appear in Sec. Sec.  262.17(a)(7)(iv) 
and (v), 262.40, and 262.42; these include training documentation, 
hazardous waste manifest records, records of biennial reports, and 
exception reporting.
    Summary of Comments. Hennepin County supported the requirement for 
reverse distributors to document training.\464\
---------------------------------------------------------------------------

    \464\ See comment number EPA-HQ-RCRA-2007-0932-0386 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    Final Rule Provisions. Many of the final recordkeeping requirements 
that pertain to evaluated hazardous waste pharmaceuticals have been 
discussed in the sections previously, but for clarity, it is useful to 
restate them in this recordkeeping section, so that reverse 
distributors can refer to one section to determine their recordkeeping 
requirements related to evaluated hazardous waste pharmaceuticals. In 
total, EPA is finalizing five recordkeeping requirements that pertain 
to evaluated hazardous waste pharmaceuticals at reverse distributors 
that can be found listed at Sec.  266.510(c)(10). First, EPA is 
requiring that a reverse distributor keep a log (written or electronic) 
of its inspections of the on-site accumulation area. The other four 
recordkeeping requirements that EPA is requiring under the final rule 
for reverse distributors are the same as the LQG recordkeeping 
requirements in part 262. These include hazardous waste manifest 
records, records of biennial reports, exception reporting and training 
documentation.
4. When a Reverse Distributor Must Have a RCRA Hazardous Waste Permit 
(Sec.  266.510(d))
    a. Summary of proposal. In the proposed rulemaking, EPA did not 
require that a reverse distributor have a RCRA permit or interim status 
for accumulating potentially creditable and evaluated hazardous waste 
pharmaceuticals, provided that the reverse distributor follows all the 
conditions of the permitting exemption in Sec.  266.510. However, EPA 
proposed that a reverse distributor must have a RCRA permit (or interim 
status) if it treats or disposes of hazardous waste on site or if it 
accepts manifested hazardous waste from off site.
    b. Summary of comments. One state supported the proposed 
requirement that a reverse distributor must have a RCRA permit (or 
interim status) if it treats or disposes of hazardous waste on site or 
if it accepts manifested hazardous waste from off site.\465\ Clean 
Harbors argued that EPA's rationale for not requiring a hazardous waste 
storage permit is flawed and argued that the requirement for obtaining 
a full RCRA permit be based on the amount of time a potentially 
creditable hazardous waste pharmaceutical is stored.\466\ The 
Environmental Technology Council argued that reverse distributors 
should be required to obtain permits or interim status for 
storage.\467\
---------------------------------------------------------------------------

    \465\ See comment number EPA-HQ-RCRA-2007-0932-0341 in the 
docket for this rulemaking.
    \466\ See comment number EPA-HQ-RCRA-2007-0932-0333 in the 
docket for this rulemaking.
    \467\ See comment number EPA-HQ-RCRA-2007-0932-0297 in the 
docket for this rulemaking.
---------------------------------------------------------------------------

    c. Final rule provisions. Under the final rule, EPA is not 
requiring that a reverse distributor have a RCRA permit or interim 
status for accumulating potentially creditable and evaluated hazardous 
waste pharmaceuticals, provided that the reverse distributor follows 
all the conditions of the permitting exemption in Sec.  266.510. In 
other words, a reverse distributor will be subject to regulation as a 
TSDF and require a RCRA permit (or interim status) if it does not meet 
the conditions of Sec.  266.510. In addition, EPA is finalizing that a 
reverse distributor must have a RCRA permit (or interim status) if it 
treats or disposes of hazardous waste on site or if it accepts 
manifested hazardous waste from off site. A reverse distributor is 
required to reject shipments of manifested hazardous waste that it may 
inadvertently receive from off site because a reverse distributor is 
not a designated facility and therefore is not eligible to receive 
hazardous waste shipped with a manifest. EPA believes that this 
approach to regulation of reverse distributors that accumulate 
potentially creditable and evaluated hazardous waste pharmaceuticals 
strikes an appropriate balance because it recognizes that reverse 
distributors are different from typical hazardous waste TSDFs for 
permitting purposes, while it still imposes certain conditions for 
exemption from permitting requirements that provide the necessary 
environmental protection.

XVIII. Amendments to the Part 268 Prohibitions on Storage

    The Agency is finalizing conforming changes that we proposed to the 
prohibitions on storage of restricted waste in Sec.  268.50. We are 
finalizing two new subparagraphs in Sec.  268.50(a) to make it clear 
that the storage prohibitions apply to both healthcare facilities and 
reverse distributors operating under part 266 subpart P. Specifically, 
we are adding paragraph (4) for healthcare facilities and paragraph (5) 
for reverse distributors to extend the application of the existing 
storage prohibition to facilities operating under subpart P. Under the 
LDR storage prohibition the storage of restricted hazardous wastes is

[[Page 5933]]

prohibited unless certain conditions are met. Healthcare facilities 
must comply with the applicable requirements in Sec. Sec.  266.502 and 
266.503 and reverse distributors must comply with Sec.  266.510 when 
accumulating hazardous waste pharmaceuticals on site.

XIX. Implementation and Enforcement

A. Healthcare Facilities

1. Determining Whether a Healthcare Facility Is Subject to Part 266 
Subpart P
    EPA is finalizing that healthcare facilities that are currently 
considered LQGs or SQGs are subject to the final 40 CFR part 266 
subpart P requirements for the management of hazardous waste 
pharmaceuticals. Thus, a healthcare facility that generates more than 
100 kg of hazardous waste per month, or more than 1 kg of acute 
hazardous waste per calendar month, or more than 100 kg of any residue 
or contaminated soil, water, or other debris resulting from the cleanup 
of a spill, into or on any land or water, of any acute wastes listed in 
Sec. Sec.  261.31, or 261.33(e), must manage its hazardous waste 
pharmaceuticals in compliance with the 40 CFR part 266 subpart P 
requirements. In addition, healthcare facilities that are VSQGs are 
subject to the prohibition on sewering hazardous waste pharmaceuticals 
in Sec.  266.505, the empty container standards in Sec.  266.507, and 
the optional standards of Sec.  266.504.
    To determine whether a healthcare facility is subject to 40 CFR 
part 266 subpart P or is a VSQG regulated under Sec.  262.14, a 
healthcare facility must count all the hazardous waste--pharmaceutical 
and non-pharmaceutical--it generates in a calendar month. Note that in 
the final rule EPA has revised which pharmaceuticals are considered 
hazardous wastes. Specifically, EPA is finalizing that potentially 
creditable hazardous waste pharmaceuticals transported to a reverse 
distributor are considered a solid and hazardous waste from the point 
of generation at the healthcare facility and therefore must be counted 
when determining whether the healthcare facility is a VSQG regulated 
under Sec.  262.14 or whether it is regulated under 40 CFR part 266 
subpart P for its hazardous waste pharmaceuticals. This differs from 
previous healthcare facility practice of not counting the potentially 
creditable hazardous waste pharmaceuticals it sends to a reverse 
distributor towards its hazardous waste generator category. Therefore, 
although a healthcare facility may have been considered a VSQG under 
that previous practice, when it begins counting its potentially 
creditable hazardous waste pharmaceuticals, it may no longer be a VSQG. 
In that case, the healthcare facility would be subject to the 40 CFR 
part 266 subpart P requirements for its hazardous waste 
pharmaceuticals.
2. Healthcare Facilities Managing Hazardous Waste Pharmaceuticals Under 
Part 266 Subpart P
    EPA is finalizing that all healthcare facilities operating Under 
part 266 subpart P will be subject to the same regulations for the 
management of their hazardous waste pharmaceuticals, regardless of the 
quantity of hazardous waste pharmaceuticals generated. A healthcare 
facility that generates both pharmaceutical and non-pharmaceutical 
hazardous waste must manage the non-pharmaceutical hazardous waste 
pursuant to part 262, but need not count its hazardous waste 
pharmaceuticals toward determining the facility's monthly hazardous 
waste generator category. Therefore, although a facility that 
previously may have been considered an LQG, once it no longer counts 
its hazardous waste pharmaceuticals towards its monthly hazardous waste 
generator category, it may no longer be an LQG. As a result, it is 
possible that the healthcare facility may not need to manage its non-
pharmaceutical hazardous waste pursuant to the LQG regulations in Sec.  
262.17, but rather can operate under the reduced regulations for SQGs 
in Sec.  262.16 or for VSQGs in Sec.  262.14. In addition, if a 
healthcare facility that is a VSQG does not want to keep track of the 
amount of hazardous waste pharmaceuticals it generates to ensure it 
does not exceed the VSQG quantity limits, it can choose to operate 
under this final rule. If it chooses to operate under this final rule, 
however, a healthcare facility must comply with all the requirements of 
this subpart for the management of its hazardous waste pharmaceuticals.
    Following publication of the final rule, EPA plans extensive 
outreach to educate healthcare facilities and reverse distributors on 
the provisions of this final rule.

B. Reverse Distributors and Reverse Logistics Centers

1. Prescription Pharmaceuticals Sent to Reverse Distributors Are Solid 
Wastes
    EPA proposed to change how RCRA would apply to pharmaceuticals 
returned to reverse distributors to obtain manufacturers credit. EPA 
proposed that the decision by a healthcare facility to send a 
pharmaceutical to a reverse distributor is the decision to discard the 
pharmaceutical. Due to many comments on this proposed change, the 
Agency is now making a clear distinction in the final rule between 
reverse distribution, in the case of prescription pharmaceuticals, and 
reverse logistics in the case of all other pharmaceuticals--including 
over-the counter pharmaceuticals and dietary supplements, as well as 
other unsold consumer items (see section VI for a discussion of the 
comments). EPA is finalizing that the decision by a healthcare facility 
to send a prescription pharmaceutical to a reverse distributor is the 
decision to discard the prescription pharmaceutical. Therefore, under 
this final rule, once the healthcare facility makes the decision to 
send a prescription pharmaceutical to a reverse distributor for credit, 
it is a solid waste at the healthcare facility. A portion of the 
potentially creditable solid waste prescription pharmaceuticals at 
healthcare facilities that are destined for a reverse distributor will 
also meet the definition of hazardous waste and as a result, these 
potentially creditable hazardous waste prescription pharmaceuticals 
would need to be managed in accordance with the final 40 CFR part 266 
subpart P requirements.
    In addition, the Agency notes that the change in EPA's position 
concerning reverse distribution and the management standards discussed 
in this final rule pertain only to the reverse distribution of 
prescription hazardous waste pharmaceuticals and does not apply to the 
reverse logistics of other pharmaceuticals or to the reverse logistics 
systems that may exist for other unsold consumer items.
2. Nonprescription Pharmaceuticals Sent to Reverse Logistics Centers 
Are Not Solid Wastes
    EPA proposed that the decision by a healthcare facility to send any 
pharmaceutical to a reverse distributor is the decision to discard the 
pharmaceutical, but is now making a clear distinction in the final rule 
between reverse distribution of prescription pharmaceuticals and 
reverse logistics of nonprescription pharmaceuticals and other unsold 
retail items. In response to comments, EPA is codifying our previous 
policy that the decision by a healthcare facility to send 
nonprescription pharmaceuticals to a reverse logistics center is not a 
decision to discard if the nonprescription pharmaceuticals have a 
reasonable expectation of being legitimately used/reused (e.g., 
lawfully redistributed for their intended purpose) or reclaimed. In 
other words, EPA is finalizing that nonprescription pharmaceuticals are 
not

[[Page 5934]]

solid wastes, and therefore not hazardous waste pharmaceuticals if they 
have a reasonable expectation of being legitimately used/reused (e.g., 
lawfully redistributed for their intended purpose) or reclaimed.
3. Reverse Distributors Managing Hazardous Waste Pharmaceuticals Under 
Part 266 Subpart P
    EPA is finalizing that all reverse distributors are subject to 40 
CFR part 266 subpart P and will be subject to the same standards with 
respect to their hazardous waste pharmaceuticals, regardless of the 
amount of hazardous waste pharmaceuticals they manage. Even reverse 
distributors that are currently VSQGs will be regulated under 40 CFR 
part 266 subpart P for the management of their hazardous waste 
pharmaceuticals. Therefore, a reverse distributor subject to 40 CFR 
part 266 subpart P will no longer have to keep track of the amount of 
hazardous waste pharmaceuticals that it generates on a monthly basis.

C. Healthcare Facilities and 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'')

    Most, if not all, healthcare facilities and reverse distributors 
generate at least some hazardous wastes other than pharmaceuticals. 
These non-pharmaceutical hazardous wastes will continue to be regulated 
under 40 CFR part 262 (and other applicable Subtitle C regulations). 
The standards established by this rulemaking apply only to the 
management of hazardous waste pharmaceuticals at healthcare facilities 
and reverse distributors. Healthcare facilities and reverse 
distributors likely generate or manage other types of hazardous wastes. 
For example, hospitals may generate non-pharmaceutical hazardous 
wastes, such as solvents in their diagnostic laboratories; those 
hazardous wastes must still be managed in accordance with the part 262 
generator regulations (such as the RCRA SAA regulations (Sec.  
262.15)), or if it is a teaching hospital, the Academic Laboratories 
Rule (if it has opted into part 262 subpart K). Retail stores, 
including pharmacies and grocery stores, may have non-pharmaceutical 
hazardous wastes on-site as well, which must be managed in accordance 
with the 40 CFR part 262 regulations and all other applicable RCRA 
Subtitle C regulations. For example, fluorescent bulbs may be managed 
under the universal waste program (40 CFR part 273). For reverse 
distributors, this rule only applies to the management of potentially 
creditable hazardous waste pharmaceuticals and evaluated hazardous 
waste pharmaceuticals. Some reverse distributors may generate other 
non-pharmaceutical hazardous wastes from activities, such as cleaning 
and maintenance; other RCRA Subtitle C regulations will apply to those 
non-pharmaceutical hazardous wastes.

D. State Enforcement Activities and Interpretations

    States have taken a variety of approaches regarding hazardous waste 
pharmaceuticals. One major goal of this final rule is to provide 
clarity on this topic, and thereby promote national consistency, which 
should promote better compliance among healthcare facilities, including 
pharmacies.
    In 2012, Connecticut's Department of Energy and Environmental 
Protection (DEEP) took enforcement actions at seven CVS stores for 
violations of the RCRA hazardous waste regulations. Consent orders from 
CT DEEP direct CVS stores in the state to follow a set of best 
management practices.\468\ A number of the practices developed in these 
consent orders mirror some of the practices EPA is finalizing in this 
rule, particularly with regard to pharmaceuticals destined for a 
reverse distributor. CT DEEP asserts RCRA jurisdiction over the 
pharmaceuticals destined for reverse distributors by applying specific 
management practices. For example, CVS must maintain records of each 
shipment of non-dispensable pharmaceuticals to a reverse distributor, 
including confirmation of receipt of the non-dispensable 
pharmaceuticals from the receiving reverse distributor. The best 
practices also include procedures for addressing situations when CVS 
does not receive delivery confirmation of shipment to a reverse 
distributor. Further, the consent order sets out separate, more 
comprehensive practices for the non-dispensable pharmaceuticals that 
are not suitable for reverse distribution.
---------------------------------------------------------------------------

    \468\ See the docket for this rulemaking EPA-HQ-RCRA-2007-0932-
0173.
---------------------------------------------------------------------------

    Aside from best management practices developed by Connecticut as 
part of a consent order, at least two other states have developed 
guidance documents that apply conditions to the management of hazardous 
wastes pharmaceuticals in exchange for enforcement discretion. In 
particular, in 2008, the Washington State Department of Ecology issued 
guidance titled, Interim Enforcement Policy: Pharmaceutical Waste in 
Healthcare.\469\ This interim enforcement discretion policy had some 
elements in common with this final rule for hazardous waste 
pharmaceuticals. For instance, a healthcare facility was required to 
notify the Department of Ecology that it was operating under the policy 
and had to train its staff involved in pharmaceutical waste management. 
Only a time limit, rather than a quantity limit, applied to the 
accumulation of the hazardous waste pharmaceuticals on site. Of 
particular note is that Washington State prohibited disposing of most 
hazardous waste pharmaceuticals down the toilet or drain. In 
anticipation of this final rule, Washington State updated the interim 
policy in June 2017 to provide regulated facilities with the 
opportunity to use some of the provisions outlined in the proposed 
rulemaking, such as allowing facilities to send creditable 
pharmaceuticals to a reverse distributor for evaluation without 
providing hazardous waste codes.\470\
---------------------------------------------------------------------------

    \469\ See the 2008 interim enforcement policy in the docket for 
this rulemaking EPA-HQ-RCRA-2007-0932-0181.
    \470\ See the 2017 interim enforcement policy at https://fortress.wa.gov/ecy/publications/documents/0704024.pdf or in the 
docket for this rulemaking (EPA-HQ-RCRA-2007-0932).
---------------------------------------------------------------------------

    In 2011, Minnesota's Pollution Control Agency (MPCA) issued a fact 
sheet titled Reverse Distribution of Pharmaceuticals: Guidance for 
Minnesota Healthcare Providers.\471\ In this guidance, Minnesota 
states, ``Whether a pharmaceutical is eligible for return credit does 
not affect its product or waste status. In Minnesota, if a 
pharmaceutical is not used or reused for its intended purpose, it is a 
waste. The MPCA considers health care practitioners and pharmacies to 
be generators of these pharmaceutical wastes. Nevertheless, the MPCA 
believes that the established reverse distribution system provides an 
environmentally protective method for handling waste pharmaceuticals. 
Therefore, it will allow Minnesota health care practitioners and 
pharmacies to manage certain pharmaceuticals through reverse 
distribution, subject to additional requirements discussed in this fact 
sheet.'' This is similar to the approach that EPA is finalizing for 
potentially creditable hazardous waste pharmaceuticals. For example, 
like EPA's final rule, MPCA does not require hazardous waste 
pharmaceuticals destined for a reverse distributor to be

[[Page 5935]]

counted toward determining a healthcare facility's generator category. 
In addition, MPCA does not require hazardous waste pharmaceuticals to 
be accompanied by a hazardous waste manifest when shipped to a reverse 
distributor. By finalizing a rule that is consistent with state 
approaches, EPA is bringing national consistency to the management of 
hazardous waste pharmaceuticals, while avoiding disruption to practices 
already in place.
---------------------------------------------------------------------------

    \471\ See the guidance document in the docket for this 
rulemaking (EPA-HQ-RCRA-2007-0932-0178).
---------------------------------------------------------------------------

E. Intersection of Part 266 Subpart P With the Hazardous Waste 
Generator Improvements Rule

    The Hazardous Waste Generator Improvements rule was finalized on 
November 28, 2016.\472\ This rule finalized a much-needed update to the 
hazardous waste generator regulations in part 262 to make the rules 
easier to understand, facilitate better compliance, provide greater 
flexibility in how hazardous waste is managed and close important gaps 
in the regulations. This section of preamble discusses three portions 
of the Hazardous Waste Generator Improvements final rule that might 
impact healthcare facilities and reverse distributors that are subject 
to part 266 subpart P.
---------------------------------------------------------------------------

    \472\ See November 28, 2016; 81 FR 85732.
---------------------------------------------------------------------------

1. Episodic Generation
    One of the key provisions with which EPA added regulatory 
flexibility allows a hazardous waste generator to avoid increased 
burden of a higher generator category when generating episodic waste 
provided the episodic waste is properly managed in accordance with part 
262 subpart L. Healthcare facilities and reverse distributors will be 
able to take advantage of this added regulatory flexibility (assuming 
their state has adopted this provision).
    A healthcare facility that is a VSQG for both hazardous waste 
pharmaceuticals and non-pharmaceutical hazardous waste can use the 
episodic generation provision of part 262 subpart L for all of its 
hazardous waste, including its hazardous waste pharmaceuticals. If a 
healthcare facility is generally operating under Sec.  262.14 as a 
VSQG, but has an episodic event, it would be far less burdensome to 
comply with part 262 subpart L than to come into compliance with all 
the provisions of part 266 subpart P for the short duration of the 
episodic event. For example, if a VSQG healthcare facility is directed 
to dispose of recalled pharmaceuticals, it could use the episodic 
generator provisions of part 262 subpart L to avoid an increase in 
hazardous waste generator category. However, if a healthcare facility 
that is a VSQG generates hazardous waste in excess of the allowable 
amounts as a VSQG,\473\ and it chooses not to use the episodic 
generator provisions in part 262 subpart L, it would become subject to 
part 266 subpart P for its hazardous waste pharmaceuticals.
---------------------------------------------------------------------------

    \473\ See the definition of very small quantity generator in 40 
CFR 2601.10.
---------------------------------------------------------------------------

    As discussed previously, healthcare facilities and reverse 
distributors that are subject to part 266 subpart P for their hazardous 
waste pharmaceuticals may still be subject to part 262 for the 
management of their non-pharmaceutical hazardous waste. A healthcare 
facility or reverse distributor operating under part 266 subpart P for 
its hazardous waste pharmaceuticals may not use the episodic generator 
standards of part 262 subpart L with respect to its hazardous waste 
pharmaceuticals. Under part 266 subpart P, all healthcare facilities 
are regulated the same regardless of amounts of hazardous waste 
pharmaceuticals generated and all reverse distributors are regulated 
the same, regardless of amounts of hazardous waste pharmaceuticals 
managed, making the need for episodic generation provisions 
unnecessary. On the other hand, if a healthcare facility or reverse 
distributor is generally operating as a VSQG or SQG for its non-
pharmaceutical hazardous waste, but has an episodic event, the 
healthcare facility may use the provisions in part 262 subpart L for 
its non-pharmaceutical hazardous waste.
2. Small Quantity Generator Re-Notification
    The 2016 Hazardous Waste Generator Improvements final rule added a 
new requirement for periodic re-notification by SQGs.\474\ Under this 
new provision, SQGs must re-notify EPA starting in 2021 and every four 
years thereafter using EPA Form 8700-12. This re-notification must be 
submitted by September 1st of each year in which re-notifications are 
required.\475\ Healthcare facilities and reverse distributors operating 
under part 266 subpart P may also be subject to part 262 for the 
management of its non-pharmaceutical hazardous waste. If a healthcare 
facility or reverse distributor is an SQG for its non-pharmaceutical 
hazardous waste, then it will be subject to this re-notification 
requirement under part 262. Therefore, in order to avoid duplicative 
notification requirements, under part 266 subpart P, EPA is not 
requiring re-notification by healthcare facilities and reverse 
distributors.
---------------------------------------------------------------------------

    \474\ See 40 CFR 262.18(d)(1).
    \475\ See 81 FR 85777-8; November 28, 2016 for the preamble 
discussion explaining the need for re-notification.
---------------------------------------------------------------------------

3. Very Small Quantity Generators That Accumulate More Than 1 Kg of 
Acute Hazardous Waste
    The 2016 Hazardous Waste Generator Improvements final rule 
clarified in Sec.  262.14(a)(3) that if a VSQG accumulates at any time 
greater than 1 kg of acute hazardous waste,\476\ all quantities of that 
acute hazardous waste are subject to the additional conditions for 
exemption for LQGs. More specifically, the acute hazardous waste must 
be held on site for no more than 90 days beginning on the date when 
more than 1 kg is exceeded, and the acute hazardous waste is subject to 
the LQG conditions for exemption in Sec.  262.17(a) through (g). In 
other words, while the acute hazardous waste becomes subject to the 
stricter standards for LQGs when the accumulation limits are exceeded, 
the generator continues to be considered a VSQG, provided the generator 
continues to generate within the VSQG thresholds identified in the 
definition of VSQG in Sec.  260.10.
---------------------------------------------------------------------------

    \476\ Or more than 100 kg of any residue or contaminated soil, 
water, or other debris resulting from the cleanup of a spill, into 
or on any land or water, of any acute hazardous waste listed in 
Sec.  261.31 or 261.33(e).
---------------------------------------------------------------------------

    If a healthcare facility that is a VSQG accumulates more than 1 kg 
of acute hazardous waste,\477\ then it will remain subject to Sec.  
262.14(a)(3); the healthcare facility will not become subject to part 
262 subpart P.
---------------------------------------------------------------------------

    \477\ Or more than 100 kg of any residue or contaminated soil, 
water, or other debris resulting from the cleanup of a spill, into 
or on any land or water, of any acute hazardous waste listed in 
Sec.  261.31 or 261.33(e).
---------------------------------------------------------------------------

XX. State Authorization

A. Applicability of Rules in Authorized States

    Under section 3006 of RCRA, EPA may authorize states to administer 
the RCRA Subtitle C hazardous waste program. Following authorization, 
the authorized state program operates in lieu of the federal 
regulations. EPA retains authority to enforce the authorized state 
Subtitle C program, although authorized states have primary enforcement 
authority. EPA also retains its authority under RCRA sections 3007, 
3008, 3013, and 7003. The standards and requirements for state 
authorization are found at 40 CFR part 271.
    Prior to enactment of the Hazardous and Solid Waste Amendments of 
1984 (HSWA), a state with final RCRA authorization administered its 
hazardous waste program entirely in

[[Page 5936]]

lieu of EPA administering the federal program in that state. EPA did 
not issue permits for any facilities in that state, since the state was 
now authorized to issue RCRA permits. When new, more stringent federal 
requirements were promulgated, the state was obligated to enact 
equivalent authorities within specified time frames. However, the new 
requirements did not take effect in an authorized state until the state 
adopted the equivalent state requirements.
    In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which 
was added by HSWA, new requirements and prohibitions imposed under HSWA 
authority take effect in authorized states at the same time that they 
take effect in unauthorized states. While states must still adopt HSWA-
related provisions as state law to retain authorization, EPA implements 
the HSWA provisions in authorized states, including the issuance of any 
permits pertaining to HSWA requirements, until the state is granted 
authorization to do so.
    Authorized states are required to modify their programs only when 
EPA promulgates federal requirements that are more stringent or broader 
in scope than existing federal requirements.\478\ RCRA section 3009 
allows the states to impose standards more stringent than those in the 
federal program (see 40 CFR 271.1). Therefore, authorized states may, 
but are not required to, adopt federal regulations, both HSWA and non-
HSWA, that are considered less stringent than previous federal 
regulations.
---------------------------------------------------------------------------

    \478\ EPA notes that decisions regarding whether a state rule is 
more stringent or broader in scope than the federal program are made 
when the Agency authorizes a state program for a particular rule.
---------------------------------------------------------------------------

B. Effect on State Authorization

    This action adds a new subpart P to 40 CFR part 266, and it is 
being finalized in part under the authority of HSWA and in part under 
non-HSWA authority. The bulk of 40 CFR part 266 subpart P is being 
finalized under non-HSWA authority. Thus, the amendments promulgated 
under non-HSWA authority are applicable on the effective date only in 
those states that do not have final authorization of their base RCRA 
programs. Only the prohibition of sewering hazardous waste 
pharmaceuticals (Sec.  266.504) is being finalized under HSWA authority 
in section 3018 of RCRA. The amendments promulgated under the authority 
of HSWA (i.e., the prohibition on sewering hazardous waste 
pharmaceuticals) are applicable on the effective date of the final rule 
in all states. Moreover, authorized states are required to modify their 
programs only when EPA promulgates federal regulations that are more 
stringent or broader in scope than the authorized state regulations. 
For those changes that are less stringent, states are not required to 
modify their programs.
    While some provisions of part 266 subpart P are considered less 
stringent than the current federal standards, other provisions of the 
final rule are considered more stringent than the current federal 
standards. Taken as a whole, we consider the entire new subpart P under 
40 CFR part 266 entitled ``Standards for the Management of Specific 
Hazardous Wastes and Specific Types of Hazardous Waste Management 
Facilities'' (sections VIII-XVII of this preamble) to be more stringent 
than the current federal standards. Therefore, authorized states will 
be required to modify their programs to adopt these revisions. When a 
state adopts this new subpart, if elements of the state program are 
more stringent than this new subpart, the state has the option of 
retaining those more stringent elements. Likewise, when a state adopts 
this new subpart, the state has the option of adding elements that are 
more stringent or broader in scope than this new subpart.
    On the other hand, one final revision is less stringent than the 
current hazardous waste regulations. The amendment to exempt from the 
P075 listing the nicotine patches, gums and lozenges that are FDA-
approved OTC nicotine replacement therapies is less stringent that the 
current hazardous waste regulations (section V of this preamble). Thus, 
authorized states may, but are not required to, adopt the change to the 
P075 listing.

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

    The Universal Waste program allows states to add waste streams to 
their own state program, even when the waste stream has not been added 
to the federal Universal Waste program, provided the state has adopted 
and been authorized for the petition process in Sec. Sec.  260.20 and 
260.23. Two states have added hazardous waste pharmaceuticals to their 
Universal Waste programs: Florida and Michigan. Because the added 
subpart P under CFR part 266 is considered more stringent than either 
the ``traditional RCRA'' standards or the Universal Waste program, both 
Florida and Michigan will be required to modify their programs to adopt 
an approach at least as stringent as the amendments. Furthermore, 
because the Agency has determined that it is not appropriate to add 
hazardous waste pharmaceuticals to the Universal Waste program, both 
Florida and Michigan must remove hazardous waste pharmaceuticals from 
their Universal Waste program when they adopt this new subpart, 
although they may continue to regulate non-hazardous waste 
pharmaceuticals under the Universal Waste program, to the extent 
allowed under state law. In addition, states may choose to add non-
hazardous waste pharmaceuticals to their Universal Waste program or may 
regulate them more stringently as part of their hazardous waste program 
but states may not add hazardous waste pharmaceuticals to their 
Universal Waste program in the future. Accordingly, we have amended the 
regulations in Sec.  273.80(a) and added Sec.  273.80(d) to reflect 
this decision that states may not add hazardous waste pharmaceuticals 
to their 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

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review. Pursuant to 
the terms of Executive Order 12866, as affirmed in Executive Order 
13563, the Agency has determined that this rule is a significant 
regulatory action because it contains novel policy issues, as defined 
under section 3(f)(4) of the Order. Any changes made in response to OMB 
recommendations have been documented in the docket.
    As discussed in section I above, EPA prepared an economic analysis 
of the potential costs and benefits associated with this action. This 
analysis, Regulatory Impact Analysis for EPA's Final Regulations for 
the Management of Hazardous Waste Pharmaceuticals, indicates that the 
rule is projected to result in net annual cost savings of approximately 
$12.99 million to $14.96 million based on a discount rate of 7 percent 
or $12.98 to $14.95 million based on a discount rate of 3 percent. The 
full analysis is available in the docket for this rule.

B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is considered an Executive Order 13771 deregulatory

[[Page 5937]]

action. Details on the estimated cost savings of this final rule can be 
found in EPA's analysis of the potential costs and benefits associated 
with this action.

C. Paperwork Reduction Act

    The information collection activities in this rule have been 
submitted for approval to the Office of Management and Budget (OMB) 
under the PRA. The Information Collection Request (ICR) document that 
EPA prepared has been assigned EPA ICR number 2486.02, OMB control 
number 0250-0212. You can find a copy of the ICR in the docket for this 
rule, and it is briefly summarized here.
    EPA is finalizing in this rule, under a new subpart P to 40 CFR 
part 266, new and revised reporting and recordkeeping requirements for 
healthcare facilities and reverse distributors. These requirements, 
which are also identified in the ICR supporting this action, will 
enable EPA and state regulatory agencies to identify the universe of 
healthcare facilities managing hazardous waste pharmaceuticals. In 
addition, the requirements include provisions for tracking of hazardous 
waste pharmaceuticals that are sent to reverse distributors.
    EPA will use the collected information to ensure that hazardous 
waste pharmaceuticals are being managed in a protective manner. The 
tracking requirements ensure that these wastes arrive at their intended 
destinations rather than diverted for illicit purposes or managed at 
facilities not equipped to manage these wastes. These tracking 
requirements will also help facilities identify shipments that do not 
arrive at their destination as planned, allowing generators to take 
corrective action that will ensure that future shipments are 
transported to the appropriate location. Information marked on 
containers of hazardous waste pharmaceuticals will assist handlers and 
transporters in ensuring proper management during storage and shipment.
    Respondents/affected entities: Drug wholesalers, supermarkets and 
other grocery stores, pharmacies and drug stores, warehouse clubs and 
supercenters, veterinary clinics, physicians' offices, dentists' 
offices, other health practitioners, outpatient care centers, other 
ambulatory health care services, hospitals, nursing care facilities, 
continuing care retirement communities, and reverse distributors.
    Respondent's obligation to respond: The recordkeeping and 
notification requirements are mandatory and are being promulgated under 
section 3001 of RCRA.
    Estimated number of respondents: 13,373.
    Frequency of response: The frequency of response varies.
    Total estimated burden: EPA estimated the total annual burden to 
respondents to be approximately 43,577 hours. Burden is defined at 5 
CFR 1320.3(b).
    Total estimated cost: EPA estimated the total estimated annual cost 
of this paperwork burden to respondents to be approximately $2,543,409.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB 
approves this ICR, the Agency will announce that approval in the 
Federal Register and publish a technical amendment to 40 CFR part 9 to 
display the OMB control number for the approved information collection 
activities contained in this final rule.

D. Regulatory Flexibility Act

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. In 
making this determination, the impact of concern is any significant 
adverse economic impact on small entities. An agency may certify that a 
rule will not have a significant economic impact on a substantial 
number of small entities if the rule relieves regulatory burden, has no 
net burden or otherwise has a positive economic effect on the small 
entities subject to the rule. As documented in the Regulatory Impact 
Analysis found in the docket for this proposal, EPA does not expect the 
rule to result in an adverse impact to a significant number of small 
entities. EPA estimates that there are at least 10,481 to 15,114 small 
entities that will be impacted by this rule. However, small entities 
are expected to experience a net cost savings under the final rule, and 
for the small entities that are expected to experience a net cost under 
the final rule, the RIA estimates the costs, at most, to represent 
0.013 percent of annual revenues for small entities. We have therefore 
concluded that this action will either relieve regulatory burden or 
have no net regulatory burden for all directly regulated small 
entities.

E. Unfunded Mandates Reform Act

    As documented in the Regulatory Impact Analysis found in the docket 
for this rule, this action does not contain an unfunded mandate of $100 
million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. As indicated 
previously, the annual net cost savings is estimated to be between 
approximately $13 million and $15 million (based on a discount rate of 
7%). Thus, this rule is not subject to the requirements of sections 202 
or 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of 
UMRA because it contains no regulatory requirements that might 
significantly or uniquely affect small governments. While some 
hospitals are publicly owned, the requirements affecting those 
facilities are not unique in that they are the same as those affecting 
all facilities in the proposed rulemaking. Also, using data on revenues 
of hospitals owned by state and local governments, EPA estimated that 
the costs of the rule borne by state and local governments represent 
less than 0.001% of their revenues. Therefore, the costs incurred by 
small governments are not expected to be significant.

F. Executive Order 13132: Federalism

    As documented in the Regulatory Impact Analysis found in the docket 
for this rule, this action does not have federalism implications. It 
will not have substantial direct effects on the states, on the 
relationship between the national government and the states, or on the 
distribution of power and responsibilities among the various levels of 
government.

G. Executive Order 13175: Consultation With Tribal Governments

    This action may have tribal implications as specified in Executive 
Order 13175. The final rule will neither impose substantial direct 
compliance costs on tribal government, not preempt tribal law. Under 
the RCRA statute, the federal government implements hazardous waste 
regulations directly in Indian Country. Thus, the final rule would not 
impose any direct costs on tribal governments.
    To assess the potential tribal implications of the action, EPA 
compiled data on the number of tribally run healthcare facilities in 
the U.S. and estimated the costs of this action for these facilities. 
As documented in the Regulatory Impact Analysis in the docket for this 
rule, the rule is not expected to impose a substantial burden on tribal 
governments.
    EPA consulted with tribal officials under the EPA Policy on 
Consultation and Coordination with Indian Tribes early in the process 
of developing this regulation to permit them to have meaningful and 
timely input into its

[[Page 5938]]

development. A summary of that consultation is provided in the docket 
for this rule (see EPA-HQ-RCRA-2008-0932).
    As required by section 7(a), the EPA's Tribal Consultation Official 
has certified that the requirements of the executive order have been 
met in a meaningful and timely manner. A copy of the certification is 
included in the docket for this action.

H. Executive Order 13045: Children's Health

    This action is not subject to Executive Order 13045 because it is 
not economically significant as defined in Executive Order 12866 and 
because the EPA does not believe the environmental health or safety 
risks addressed by this proposed action present a disproportionate risk 
to children. This action's health and risk assessments are contained in 
the Regulatory Impact Analysis for EPA's Final Regulations for the 
Management of Hazardous Waste Pharmaceuticals, found in the docket for 
this action.

I. Executive Order 13211: Energy Supply

    This action is not a ``significant energy action'' because it is 
not likely to have a significant adverse effect on the supply, 
distribution or use of energy. The final rule does not directly 
regulate energy production or consumption. Changes in the management of 
hazardous waste pharmaceuticals stipulated in this action are not 
expected to impact energy production or distribution and will have 
minimal impact on energy consumptions.

J. National Technology Transfer and Advancement Act

    This final rulemaking does not involve technical standards.

K. Executive Order 12898: Environmental Justice

    EPA believes that this action does not have disproportionately high 
and adverse human health or environmental effects on minority 
populations, low-income populations and/or indigenous peoples, as 
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The 
documentation for this decision is contained in the Regulatory Impact 
Analysis, which can be found at regulations.gov under docket number 
EPA-HQ-RCRA-2007-0932.
    To meet the requirements of Executive Order 12898, EPA analyzed 
potential environmental justice impacts associated with the diversion 
of hazardous waste pharmaceuticals from sewer disposal to hazardous 
waste combustion facilities. Populations living near and downstream 
from wastewater treatment plants may also benefit from the elimination 
of sewering of hazardous waste pharmaceuticals. To the extent that 
minority and/or low-income populations near or downstream from 
wastewater treatment plants make up a disproportionately high portion 
of the overall population, this final action may result in positive 
environmental justice impacts.
    Overall, EPA expects that this action may positively affect U.S. 
environmental justice populations, although the size of the impact will 
vary by wastewater treatment plant. A reduction in sewering expected 
under the final rule may benefit relatively large minority and low-
income populations in close proximity to or downstream from wastewater 
treatment plants. The diversion of hazardous waste pharmaceuticals from 
wastewater treatment plants to combustion facilities, however, may 
increase the environmental burden borne by environmental justice 
populations near these combustion facilities. Although these effects 
offset each other to a certain degree, the number of minority and low-
income individuals near wastewater treatment facilities exceeds the 
number near hazardous waste combustion facilities. This suggests that, 
on the whole, the final action may benefit environmental justice 
populations.

L. Congressional Review Act

    EPA will submit a report containing this rule and other information 
required by the Congressional Review Act (5 U.S.C. 801 et seq.) to the 
U.S. Senate, the U.S. House of Representatives, and the Comptroller 
General of the United States prior to publication in the Federal 
Register. A major rule cannot take effect until sixty (60) days after 
it is published in the Federal Register. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2). This final authorization will be 
effective August 22, 2019.

List of Subjects

40 CFR Part 261

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

40 CFR Part 262

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

40 CFR Part 264

    Environmental protection, Air pollution control, Hazardous waste, 
Insurance, Packaging and containers, Reporting and recordkeeping 
requirements, Security measures, Surety bonds.

40 CFR Part 265

    Environmental protection, Air pollution control, Hazardous waste, 
Insurance, Packaging and containers, Reporting and recordkeeping 
requirements, Security measures, Surety bonds, Water supply.

40 CFR Part 266

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

40 CFR Part 268

    Environmental protection, Hazardous waste, Reporting and 
recordkeeping requirements.

40 CFR Part 270

    Environmental protection, Administrative practice and procedure, 
Confidential business information, Hazardous materials transportation, 
Hazardous waste, Reporting and recordkeeping requirements, Water 
pollution control, Water supply.

40 CFR Part 273

    Environmental protection, Hazardous materials transportation, 
Hazardous waste.

    Dated: December 11, 2018.
Andrew R. Wheeler,
Acting Administrator.

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

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

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

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


0
2. Section 261.4 is amended by revising paragraph (a)(1)(ii) to read as 
follows:


Sec.  261.4  Exclusions.

    (a) * * *
    (1) * * *
    (ii) Any mixture of domestic sewage and other wastes that passes 
through a sewer system to a publicly-owned treatment works for 
treatment, except as prohibited by Sec.  266.505 and Clean Water Act 
requirements at 40 CFR 403.5(b). ``Domestic sewage'' means

[[Page 5939]]

untreated sanitary wastes that pass through a sewer system.
* * * * *

0
3. Section 261.7 is amended by adding paragraph (c) to read as follows:


Sec.  261.7  Residues of hazardous waste in empty containers.

* * * * *
    (c) Containers of hazardous waste pharmaceuticals are subject to 
Sec.  266.507 for determining when they are considered empty, in lieu 
of this section, except as provided by Sec.  266.507(c) and (d).

0
4. Section 261.33 is amended by:
0
a. Revising paragraph (c); and
0
b. Revising the four entries for ``P075'' in the table in paragraph 
(e).
    The revisions read as follows:


Sec.  261.33  Discarded commercial chemical products, off-specification 
species, container residues, and spill residues thereof.

* * * * *
    (c) Any residue remaining in a container or in an inner liner 
removed from a container that has held any commercial chemical product 
or manufacturing chemical intermediate having the generic name listed 
in paragraphs (e) or (f) of this section, unless the container is empty 
as defined in Sec.  261.7(b) or Sec.  266.507 of this chapter.
    [Comment: Unless the residue is being beneficially used or reused, 
or legitimately recycled or reclaimed; or being accumulated, stored, 
transported or treated prior to such use, re-use, recycling or 
reclamation, EPA considers the residue to be intended for discard, and 
thus, a hazardous waste. An example of a legitimate re-use of the 
residue would be where the residue remains in the container and the 
container is used to hold the same commercial chemical product or 
manufacturing chemical intermediate it previously held. An example of 
the discard of the residue would be where the drum is sent to a drum 
reconditioner who reconditions the drum but discards the residue.]
---------------------------------------------------------------------------

    \1\ CAS Number given for parent compound only.
---------------------------------------------------------------------------

* * * * *
    (e) * * *

------------------------------------------------------------------------
                               Chemical
    Hazardous waste No.      abstracts No.            Substance
------------------------------------------------------------------------
 
                              * * * * * * *
P075......................     \1\ 54-11-5  Nicotine, & salts (this
                                             listing does not include
                                             patches, gums and lozenges
                                             that are FDA-approved over-
                                             the-counter nicotine
                                             replacement therapies).
 
                              * * * * * * *
P075......................     \1\ 54-11-5  Pyridine, 3-(1-methyl-2-
                                             pyrrolidinyl)-, (S)-, &
                                             salts (this listing does
                                             not include patches, gums
                                             and lozenges that are FDA-
                                             approved over-the-counter
                                             nicotine replacement
                                             therapies).
 
                              * * * * * * *
P075......................     \1\ 54-11-5  Nicotine, & salts (this
                                             listing does not include
                                             patches, gums and lozenges
                                             that are FDA-approved over-
                                             the-counter nicotine
                                             replacement therapies).
 
                              * * * * * * *
P075......................     \1\ 54-11-5  Pyridine, 3-(1-methyl-2-
                                             pyrrolidinyl)-, (S)-, &
                                             salts (this listing does
                                             not include patches, gums
                                             and lozenges that are FDA-
                                             approved over-the-counter
                                             nicotine replacement
                                             therapies).
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

PART 262--STANDARDS APPLICABLE TO GENERATORS OF HAZARDOUS WASTE

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

    Authority: 42 U.S.C. 6906, 6912, 6922-6925, 6937, 6938, and 
6939g.

0
6. Section 262.10 is amended by adding paragraphs (m) and (n) to read 
as follows:


Sec.  262.10  Purpose, scope and applicability.

* * * * *
    (m) All reverse distributors (as defined in Sec.  266.500) are 
subject to 40 CFR part 266 subpart P for the management of hazardous 
waste pharmaceuticals in lieu of this part.
    (n) Each healthcare facility (as defined in Sec.  266.500) must 
determine whether it is subject to 40 CFR part 266 subpart P for the 
management of hazardous waste pharmaceuticals, based on the total 
hazardous waste it generates per calendar month (including both 
hazardous waste pharmaceuticals and non-pharmaceutical hazardous 
waste). A healthcare facility that generates more than 100 kg (220 
pounds) of hazardous waste per calendar month, or more than 1 kg (2.2 
pounds) of acute hazardous waste per calendar month, or more than 100 
kg (220 pounds) per calendar month of any residue or contaminated soil, 
water, or other debris, resulting from the clean-up of a spill, into or 
on any land or water, of any acute hazardous wastes listed in Sec.  
261.31 or Sec.  261.33(e), is subject to 40 CFR part 266 subpart P for 
the management of hazardous waste pharmaceuticals in lieu of this part. 
A healthcare facility that is a very small quantity generator when 
counting all of its hazardous waste, including both its hazardous waste 
pharmaceuticals and its non-pharmaceutical hazardous waste, remains 
subject to Sec.  262.14 and is not subject to part 266 subpart P, 
except for Sec. Sec.  266.505 and 266.507 and the optional provisions 
of Sec.  266.504.

0
7. Section 262.13 is amended by adding paragraph (c)(9) to read as 
follows:

[[Page 5940]]

Sec.  262.13  Generator category determination.

* * * * *
    (c) * * *
    (9) Is a hazardous waste pharmaceutical, as defined in Sec.  
266.500, that is subject to or managed in accordance with 40 CFR part 
266 subpart P or is a hazardous waste pharmaceutical that is also a 
Drug Enforcement Administration controlled substance and is 
conditionally exempt under Sec.  266.506.
* * * * *

0
8. Section 262.14 is amended by adding paragraphs (a)(5)(ix) and (x) to 
read as follows:


Sec.  262.14  Conditions for exemption for a very small quantity 
generator.

    (a) * * *
    (5) * * *
    (ix) A reverse distributor (as defined in Sec.  266.500), if the 
hazardous waste pharmaceutical is a potentially creditable hazardous 
waste pharmaceutical generated by a healthcare facility (as defined in 
Sec.  266.500).
    (x) A healthcare facility (as defined in Sec.  266.500) that meets 
the conditions in Sec. Sec.  266.502(l) and 266.503(b), as applicable, 
to accept non-creditable hazardous waste pharmaceuticals and 
potentially creditable hazardous waste pharmaceuticals from an off-site 
healthcare facility that is a very small quantity generator.
* * * * *

PART 264--STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE 
TREATMENT, STORAGE, AND DISPOSAL FACILITIES

0
9. The authority citation for part 264 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6924, 6925, and 6939g.


0
10. Section 264.1 is amended by adding paragraph (g)(13) to read as 
follows:


Sec.  264.1  Purpose, scope and applicability.

* * * * *
    (g) * * *
    (13) Reverse distributors accumulating potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals, as defined in Sec.  266.500. Reverse distributors are 
subject to regulation under 40 CFR part 266 subpart P in lieu of this 
part for the accumulation of potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals.
* * * * *

PART 265--INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF 
HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES

0
11. The authority citation for part 265 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6906, 6912, 6922, 6923, 6924, 6925, 
6935, 6936, 6937, and 6939g.

0
12. Section 265.1 is amended by adding paragraph (c)(16) to read as 
follows:


Sec.  265.1  Purpose, scope, and applicability.

* * * * *
    (c) * * *
    (16) Reverse distributors accumulating potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals, as defined in Sec.  266.500. Reverse distributors are 
subject to regulation under 40 CFR part 266 subpart P in lieu of this 
part for the accumulation of potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals.
* * * * *

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

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

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

Subpart O--[Reserved]

0
14. Add reserved subpart O.

0
15. Add subpart P, consisting of Sec. Sec.  266.500 through 266.510, to 
read as follows:
Subpart P--Hazardous Waste Pharmaceuticals
Sec.
266.500 Definitions for this subpart.
266.501 Applicability.
266.502 Standards for healthcare facilities managing non-creditable 
hazardous waste pharmaceuticals.
266.503 Standards for healthcare facilities managing potentially 
creditable hazardous waste pharmaceuticals.
266.504 Healthcare facilities that are very small quantity 
generators for both hazardous waste pharmaceuticals and non-
pharmaceutical hazardous waste.
266.505 Prohibition of sewering hazardous waste pharmaceuticals.
266.506 Conditional exemption for hazardous waste pharmaceuticals 
that are also controlled substances and household hazardous waste 
pharmaceuticals collected in a take-back event or program.
266.507 Residues of hazardous waste pharmaceuticals in empty 
containers.
266.508 Shipping non-creditable hazardous waste pharmaceuticals from 
a healthcare facility or evaluated hazardous waste pharmaceuticals 
from a reverse distributor.
266.509 Shipping potentially creditable hazardous waste 
pharmaceuticals from a healthcare facility or a reverse distributor 
to a reverse distributor.
266.510 Standards for the management of potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals at reverse distributors.

Subpart P--Hazardous Waste Pharmaceuticals


Sec.  266.500  Definitions for this subpart.

    The following definitions apply to this subpart:
    Evaluated hazardous waste pharmaceutical means a prescription 
hazardous waste pharmaceutical that has been evaluated by a reverse 
distributor in accordance with Sec.  266.510(a)(3) and will not be sent 
to another reverse distributor for further evaluation or verification 
of manufacture credit.
    Hazardous waste pharmaceutical means a pharmaceutical that is a 
solid waste, as defined in Sec.  261.2, and exhibits one or more 
characteristics identified in part 261 subpart C or is listed in part 
261 subpart D. A pharmaceutical is not a solid waste, as defined in 
Sec.  261.2, and therefore not a hazardous waste pharmaceutical, if it 
is legitimately used/reused (e.g., lawfully donated for its intended 
purpose) or reclaimed. An over-the-counter pharmaceutical, dietary 
supplement, or homeopathic drug is not a solid waste, as defined in 
Sec.  261.2, and therefore not a hazardous waste pharmaceutical, if it 
has a reasonable expectation of being legitimately used/reused (e.g., 
lawfully redistributed for its intended purpose) or reclaimed.
    Healthcare facility means any person that is lawfully authorized 
to--
    (1) Provide preventative, diagnostic, therapeutic, rehabilitative, 
maintenance or palliative care, and counseling, service, assessment or 
procedure with respect to the physical or mental condition, or 
functional status, of a human or animal or that affects the structure 
or function of the human or animal body; or

[[Page 5941]]

    (2) Distribute, sell, or dispense pharmaceuticals, including over-
the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or 
prescription pharmaceuticals. This definition includes, but is not 
limited to, wholesale distributors, third-party logistics providers 
that serve as forward distributors, military medical logistics 
facilities, hospitals, psychiatric hospitals, ambulatory surgical 
centers, health clinics, physicians' offices, optical and dental 
providers, chiropractors, long-term care facilities, ambulance 
services, pharmacies, long-term care pharmacies, mail-order pharmacies, 
retailers of pharmaceuticals, veterinary clinics, and veterinary 
hospitals. This definition does not include pharmaceutical 
manufacturers, reverse distributors, or reverse logistics centers.
    Household waste pharmaceutical means a pharmaceutical that is a 
solid waste, as defined in Sec.  261.2, but is excluded from being a 
hazardous waste under Sec.  261.4(b)(1).
    Long-term care facility means a licensed entity that provides 
assistance with activities of daily living, including managing and 
administering pharmaceuticals to one or more individuals at the 
facility. This definition includes, but is not limited to, hospice 
facilities, nursing facilities, skilled nursing facilities, and the 
nursing and skilled nursing care portions of continuing care retirement 
communities. Not included within the scope of this definition are group 
homes, independent living communities, assisted living facilities, and 
the independent and assisted living portions of continuing care 
retirement communities.
    Non-creditable hazardous waste pharmaceutical means a prescription 
hazardous waste pharmaceutical that does not have a reasonable 
expectation to be eligible for manufacturer credit or a nonprescription 
hazardous waste pharmaceutical that does not have a reasonable 
expectation to be legitimately used/reused or reclaimed. This includes 
but is not limited to, investigational drugs, free samples of 
pharmaceuticals received by healthcare facilities, residues of 
pharmaceuticals remaining in empty containers, contaminated personal 
protective equipment, floor sweepings, and clean-up material from the 
spills of pharmaceuticals.
    Non-hazardous waste pharmaceutical means a pharmaceutical that is a 
solid waste, as defined in Sec.  261.2, and is not listed in 40 CFR 
part 261 subpart D, and does not exhibit a characteristic identified in 
40 CFR part 261 subpart C.
    Non-pharmaceutical hazardous waste means a solid waste, as defined 
in Sec.  261.2, that is listed in 40 CFR part 261 subpart D, or 
exhibits one or more characteristics identified in 40 CFR part 261 
subpart C, but is not a pharmaceutical, as defined in this section.
    Pharmaceutical means any drug or dietary supplement for use by 
humans or other animals; any electronic nicotine delivery system (e.g., 
electronic cigarette or vaping pen); or any liquid nicotine (e-liquid) 
packaged for retail sale for use in electronic nicotine delivery 
systems (e.g., pre-filled cartridges or vials). This definition 
includes, but is not limited to, dietary supplements, as defined by the 
Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 
21 CFR 203.3(y); over-the-counter drugs; homeopathic drugs; compounded 
drugs; investigational new drugs; pharmaceuticals remaining in non-
empty containers; personal protective equipment contaminated with 
pharmaceuticals; and clean-up material from spills of pharmaceuticals. 
This definition does not include dental amalgam or sharps.
    Potentially creditable hazardous waste pharmaceutical means a 
prescription hazardous waste pharmaceutical that has a reasonable 
expectation to receive manufacturer credit and is--
    (1) In original manufacturer packaging (except pharmaceuticals that 
were subject to a recall);
    (2) Undispensed; and
    (3) Unexpired or less than one year past expiration date. The term 
does not include evaluated hazardous waste pharmaceuticals or 
nonprescription pharmaceuticals including, but not limited to, over-
the-counter drugs, homeopathic drugs, and dietary supplements.
    Reverse distributor means any person that receives and accumulates 
prescription pharmaceuticals that are potentially creditable hazardous 
waste pharmaceuticals for the purpose of facilitating or verifying 
manufacturer credit. Any person, including forward distributors, third-
party logistics providers, and pharmaceutical manufacturers, that 
processes prescription pharmaceuticals for the facilitation or 
verification of manufacturer credit is considered a reverse 
distributor.


Sec.  266.501  Applicability.

    (a) A healthcare facility that is a very small quantity generator 
when counting all of its hazardous waste, including both its hazardous 
waste pharmaceuticals and its non-pharmaceutical hazardous waste, 
remains subject to Sec.  262.14 and is not subject to this subpart, 
except for Sec. Sec.  266.505 and 266.507 and the optional provisions 
of Sec.  266.504.
    (b) A healthcare facility that is a very small quantity generator 
when counting all of its hazardous waste, including both its hazardous 
waste pharmaceuticals and its non-pharmaceutical hazardous waste, has 
the option of complying with Sec.  266.501(d) for the management of its 
hazardous waste pharmaceuticals as an alternative to complying with 
Sec.  262.14 and the optional provisions of Sec.  266.504.
    (c) A healthcare facility or reverse distributor remains subject to 
all applicable hazardous waste regulations with respect to the 
management of its non-pharmaceutical hazardous waste.
    (d) With the exception of healthcare facilities identified in 
paragraph (a) of this section, a healthcare facility is subject to the 
following in lieu of parts 262 through 265:
    (1) Sections 266.502 and 266.505 through 266.508 of this subpart 
with respect to the management of:
    (i) Non-creditable hazardous waste pharmaceuticals, and
    (ii) Potentially creditable hazardous waste pharmaceuticals if they 
are not destined for a reverse distributor.
    (2) Sections 262.502(a), 266.503, 266.505 through 266.507, and 
266.509 of this subpart with respect to the management of potentially 
creditable hazardous waste pharmaceuticals that are prescription 
pharmaceuticals and are destined for a reverse distributor.
    (e) A reverse distributor is subject to Sec. Sec.  266.505 through 
266.510 of this subpart in lieu of parts 262 through 265 with respect 
to the management of hazardous waste pharmaceuticals.
    (f) Hazardous waste pharmaceuticals generated or managed by 
entities other than healthcare facilities and reverse distributors 
(e.g., pharmaceutical manufacturers and reverse logistics centers) are 
not subject to this subpart. Other generators are subject to 40 CFR 
part 262 for the generation and accumulation of hazardous wastes, 
including hazardous waste pharmaceuticals.
    (g) The following are not subject to 40 CFR parts 260 through 273, 
except as specified:
    (1) Pharmaceuticals that are not solid waste, as defined by Sec.  
261.2, because they are legitimately used/reused (e.g., lawfully 
donated for their intended purpose) or reclaimed.
    (2) Over-the-counter pharmaceuticals, dietary supplements, or 
homeopathic drugs that are not solid wastes, as

[[Page 5942]]

defined by Sec.  261.2, because they have a reasonable expectation of 
being legitimately used/reused (e.g., lawfully redistributed for their 
intended purpose) or reclaimed.
    (3) Pharmaceuticals being managed in accordance with a recall 
strategy that has been approved by the Food and Drug Administration in 
accordance with 21 CFR part 7 subpart C. This subpart does apply to the 
management of the recalled hazardous waste pharmaceuticals after the 
Food and Drug Administration approves the destruction of the recalled 
items.
    (4) Pharmaceuticals being managed in accordance with a recall 
corrective action plan that has been accepted by the Consumer Product 
Safety Commission in accordance with 16 CFR part 1115. This subpart 
does apply to the management of the recalled hazardous waste 
pharmaceuticals after the Consumer Product Safety Commission approves 
the destruction of the recalled items.
    (5) Pharmaceuticals stored according to a preservation order, or 
during an investigation or judicial proceeding until after the 
preservation order, investigation, or judicial proceeding has concluded 
and/or a decision is made to discard the pharmaceuticals.
    (6) Investigational new drugs for which an investigational new drug 
application is in effect in accordance with the Food and Drug 
Administration's regulations in 21 CFR part 312. This subpart does 
apply to the management of the investigational new drug after the 
decision is made to discard the investigational new drug or the Food 
and Drug Administration approves the destruction of the investigational 
new drug, if the investigational new drug is a hazardous waste.
    (7) Household waste pharmaceuticals, including those that have been 
collected by an authorized collector (as defined by the Drug 
Enforcement Administration), provided the authorized collector complies 
with the conditional exemption in Sec. Sec.  266.506(a)(2) and 
266.506(b).


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

    (a) Notification and withdrawal from this subpart for healthcare 
facilities managing hazardous waste pharmaceuticals--(1) Notification. 
A healthcare facility must notify the EPA Regional Administrator, using 
the Site Identification Form (EPA Form 8700-12), that it is a 
healthcare facility operating under this subpart. A healthcare facility 
is not required to fill out Box 10.B. (Waste Codes for Federally 
Regulated Hazardous Waste) of the Site Identification Form with respect 
to its hazardous waste pharmaceuticals. A healthcare facility must 
submit a separate notification (Site Identification Form) for each site 
or EPA identification number.
    (i) A healthcare facility that already has an EPA identification 
number must notify the EPA Regional Administrator, using the Site 
Identification Form (EPA Form 8700-12), that it is a healthcare 
facility as part of its next Biennial Report, if it is required to 
submit one; or if not required to submit a Biennial Report, within 60 
days of the effective date of this subpart, or within 60 days of 
becoming subject to this subpart.
    (ii) A healthcare facility that does not have an EPA identification 
number must obtain one by notifying the EPA Regional Administrator, 
using the Site Identification Form (EPA Form 8700-12), that it is a 
healthcare facility as part of its next Biennial Report, if it is 
required to submit one; or if not required to submit a Biennial Report, 
within 60 days of the effective date of this subpart, or within 60 days 
of becoming subject to this subpart.
    (iii) A healthcare facility must keep a copy of its notification on 
file for as long as the healthcare facility is subject to this subpart.
    (2) Withdrawal. A healthcare facility that operated under this 
subpart but is no longer subject to this subpart, because it is a very 
small quantity generator under Sec.  262.14, and elects to withdraw 
from this subpart, must notify the appropriate EPA Regional 
Administrator using the Site Identification Form (EPA Form 8700-12) 
that it is no longer operating under this subpart. A healthcare 
facility is not required to fill out Box 10.B. (Waste Codes for 
Federally Regulated Hazardous Waste) of the Site Identification Form 
with respect to its hazardous waste pharmaceuticals. A healthcare 
facility must submit a separate notification (Site Identification Form) 
for each EPA identification number.
    (i) A healthcare facility must submit the Site Identification Form 
notifying that it is withdrawing from this subpart before it begins 
operating under the conditional exemption of Sec.  262.14.
    (ii) A healthcare facility must keep a copy of its withdrawal on 
file for three years from the date of signature on the notification of 
its withdrawal.
    (b) Training of personnel managing non-creditable hazardous waste 
pharmaceuticals at healthcare facilities. A healthcare facility must 
ensure that all personnel that manage non-creditable hazardous waste 
pharmaceuticals are thoroughly familiar with proper waste handling and 
emergency procedures relevant to their responsibilities during normal 
facility operations and emergencies.
    (c) Hazardous waste determination for non-creditable 
pharmaceuticals. A healthcare facility that generates a solid waste 
that is a non-creditable pharmaceutical must determine whether that 
pharmaceutical is a hazardous waste pharmaceutical (i.e., it exhibits a 
characteristic identified in 40 CFR part 261 subpart C or is listed in 
40 CFR part 261 subpart D) in order to determine whether the waste is 
subject to this subpart. A healthcare facility may choose to manage its 
non-hazardous waste pharmaceuticals as non-creditable hazardous waste 
pharmaceuticals under this subpart.
    (d) Standards for containers used to accumulate non-creditable 
hazardous waste pharmaceuticals at healthcare facilities. (1) A 
healthcare facility must place non-creditable hazardous waste 
pharmaceuticals in a container that is structurally sound, compatible 
with its contents, and that lacks evidence of leakage, spillage, or 
damage that could cause leakage under reasonably foreseeable 
conditions.
    (2) A healthcare facility that manages ignitable or reactive non-
creditable hazardous waste pharmaceuticals, or that mixes or commingles 
incompatible non-creditable hazardous waste pharmaceuticals must manage 
the container so that it does not have the potential to:
    (i) Generate extreme heat or pressure, fire or explosion, or 
violent reaction;
    (ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in 
sufficient quantities to threaten human health;
    (iii) Produce uncontrolled flammable fumes or gases in sufficient 
quantities to pose a risk of fire or explosions;
    (iv) Damage the structural integrity of the container of non-
creditable hazardous waste pharmaceuticals; or
    (v) Through other like means threaten human health or the 
environment.
    (3) A healthcare facility must keep containers of non-creditable 
hazardous waste pharmaceuticals closed and secured in a manner that 
prevents unauthorized access to its contents.
    (4) A healthcare facility may accumulate non-creditable hazardous 
waste pharmaceuticals and non-hazardous non-creditable waste 
pharmaceuticals in the same container, except that non-creditable 
hazardous waste pharmaceuticals prohibited from being combusted because 
of the dilution prohibition of Sec.  268.3(c) must be accumulated in 
separate containers and

[[Page 5943]]

labeled with all applicable hazardous waste numbers (i.e., hazardous 
waste codes).
    (e) Labeling containers used to accumulate non-creditable hazardous 
waste pharmaceuticals at healthcare facilities. A healthcare facility 
must label or clearly mark each container of non-creditable hazardous 
waste pharmaceuticals with the phrase ``Hazardous Waste 
Pharmaceuticals.''
    (f) Maximum accumulation time for non-creditable hazardous waste 
pharmaceuticals at healthcare facilities. (1) A healthcare facility may 
accumulate non-creditable hazardous waste pharmaceuticals on site for 
one year or less without a permit or having interim status.
    (2) A healthcare facility that accumulates non-creditable hazardous 
waste pharmaceuticals on-site must demonstrate the length of time that 
the non-creditable hazardous waste pharmaceuticals have been 
accumulating, starting from the date it first becomes a waste. A 
healthcare facility may make this demonstration by any of the following 
methods:
    (i) Marking or labeling the container of non-creditable hazardous 
waste pharmaceuticals with the date that the non-creditable hazardous 
waste pharmaceuticals became a waste;
    (ii) Maintaining an inventory system that identifies the date the 
non-creditable hazardous waste pharmaceuticals being accumulated first 
became a waste;
    (iii) Placing the non-creditable hazardous waste pharmaceuticals in 
a specific area and identifying the earliest date that any of the non-
creditable hazardous waste pharmaceuticals in the area became a waste.
    (g) Land disposal restrictions for non-creditable hazardous waste 
pharmaceuticals. The non-creditable hazardous waste pharmaceuticals 
generated by a healthcare facility are subject to the land disposal 
restrictions of 40 CFR part 268. A healthcare facility that generates 
non-creditable hazardous waste pharmaceuticals must comply with the 
land disposal restrictions in accordance with Sec.  268.7(a) 
requirements, except that it is not required to identify the hazardous 
waste numbers (i.e., hazardous waste codes) on the land disposal 
restrictions notification.
    (h) Procedures for healthcare facilities for managing rejected 
shipments of non-creditable hazardous waste pharmaceuticals. A 
healthcare facility that sends a shipment of non-creditable hazardous 
waste pharmaceuticals to a designated facility with the understanding 
that the designated facility can accept and manage the waste, and later 
receives that shipment back as a rejected load in accordance with the 
manifest discrepancy provisions of Sec.  264.72 or Sec.  265.72 of this 
chapter may accumulate the returned non-creditable hazardous waste 
pharmaceuticals on site for up to an additional 90 days provided the 
rejected or returned shipment is managed in accordance with paragraphs 
(d) and (e) of this section. Upon receipt of the returned shipment, the 
healthcare facility must:
    (1) Sign either:
    (i) Item 18c of the original manifest, if the original manifest was 
used for the returned shipment; or
    (ii) Item 20 of the new manifest, if a new manifest was used for 
the returned shipment;
    (2) Provide the transporter a copy of the manifest;
    (3) Within 30 days of receipt of the rejected shipment, send a copy 
of the manifest to the designated facility that returned the shipment 
to the healthcare facility; and
    (4) Within 90 days of receipt of the rejected shipment, transport 
or offer for transport the returned shipment in accordance with the 
shipping standards of Sec.  266.508(a).
    (i) Reporting by healthcare facilities for non-creditable hazardous 
waste pharmaceuticals--(1) Biennial reporting by healthcare facilities. 
Healthcare facilities are not subject to biennial reporting 
requirements under Sec.  262.41, with respect to non-creditable 
hazardous waste pharmaceuticals managed under this subpart.
    (2) Exception reporting by healthcare facilities for a missing copy 
of the manifest--(i) For shipments from a healthcare facility to a 
designated facility. (A) If a healthcare facility does not receive a 
copy of the manifest with the signature of the owner or operator of the 
designated facility within 60 days of the date the non-creditable 
hazardous waste pharmaceuticals were accepted by the initial 
transporter, the healthcare facility must submit:
    (1) A legible copy of the original manifest, indicating that the 
healthcare facility has not received confirmation of delivery, to the 
EPA Regional Administrator for the Region in which the healthcare 
facility is located; and
    (2) A handwritten or typed note on the manifest itself, or on an 
attached sheet of paper, stating that the return copy was not received 
and explaining the efforts taken to locate the non-creditable hazardous 
waste pharmaceuticals and the results of those efforts.
    (B) [Reserved]
    (ii) For shipments rejected by the designated facility and shipped 
to an alternate facility. (A) If a healthcare facility does not receive 
a copy of the manifest for a rejected shipment of the non-creditable 
hazardous waste pharmaceuticals that is forwarded by the designated 
facility to an alternate facility (using appropriate manifest 
procedures), with the signature of the owner or operator of the 
alternate facility, within 60 days of the date the non-creditable 
hazardous waste was accepted by the initial transporter forwarding the 
shipment of non-creditable hazardous waste pharmaceuticals from the 
designated facility to the alternate facility, the healthcare facility 
must submit:
    (1) A legible copy of the original manifest, indicating that the 
healthcare facility has not received confirmation of delivery, to the 
EPA Regional Administrator for the Region in which the healthcare 
facility is located; and
    (2) A handwritten or typed note on the manifest itself, or on an 
attached sheet of paper, stating that the return copy was not received 
and explaining the efforts taken to locate the non-creditable hazardous 
waste pharmaceuticals and the results of those efforts.
    (B) [Reserved]
    (3) Additional reports. The EPA Regional Administrator may require 
healthcare facilities to furnish additional reports concerning the 
quantities and disposition of non-creditable hazardous waste 
pharmaceuticals.
    (j) Recordkeeping by healthcare facilities for non-creditable 
hazardous waste pharmaceuticals. (1) A healthcare facility must keep a 
copy of each manifest signed in accordance with Sec.  262.23(a) for 
three years or until it receives a signed copy from the designated 
facility which received the non-creditable hazardous waste 
pharmaceuticals. This signed copy must be retained as a record for at 
least three years from the date the waste was accepted by the initial 
transporter.
    (2) A healthcare facility must keep a copy of each exception report 
for a period of at least three years from the date of the report.
    (3) A healthcare facility must keep records of any test results, 
waste analyses, or other determinations made to support its hazardous 
waste determination(s) consistent with Sec.  262.11(f), for at least 
three years from the date the waste was last sent to on-site or off-
site treatment, storage or disposal. A healthcare facility that manages 
all of its non-creditable non-hazardous waste pharmaceuticals as

[[Page 5944]]

non-creditable hazardous waste pharmaceuticals is not required to keep 
documentation of hazardous waste determinations.
    (4) The periods of retention referred to in this section are 
extended automatically during the course of any unresolved enforcement 
action regarding the regulated activity, or as requested by the EPA 
Regional Administrator.
    (5) All records must be readily available upon request by an 
inspector.
    (k) Response to spills of non-creditable hazardous waste 
pharmaceuticals at healthcare facilities. A healthcare facility must 
immediately contain all spills of non-creditable hazardous waste 
pharmaceuticals and manage the spill clean-up materials as non-
creditable hazardous waste pharmaceuticals in accordance with the 
requirements of this subpart.
    (l) Accepting non-creditable hazardous waste pharmaceuticals from 
an off-site healthcare facility that is a very small quantity 
generator. A healthcare facility may accept non-creditable hazardous 
waste pharmaceuticals from an off-site healthcare facility that is a 
very small quantity generator under Sec.  262.14, without a permit or 
without having interim status, provided the receiving healthcare 
facility:
    (1) Is under the control of the same person (as defined in Sec.  
260.10) as the very small quantity generator healthcare facility that 
is sending the non-creditable hazardous waste pharmaceuticals off-site 
(``control,'' for the purposes of this section, means the power to 
direct the policies of the healthcare facility, whether by the 
ownership of stock, voting rights, or otherwise, except that 
contractors who operate healthcare facilities on behalf of a different 
person as defined in Sec.  260.10 of this chapter shall not be deemed 
to ``control'' such healthcare facilities) or has a contractual or 
other documented business relationship whereby the receiving healthcare 
facility supplies pharmaceuticals to the very small quantity generator 
healthcare facility;
    (2) Is operating under this subpart for the management of its non-
creditable hazardous waste pharmaceuticals;
    (3) Manages the non-creditable hazardous waste pharmaceuticals that 
it receives from off site in compliance with this subpart; and
    (4) Keeps records of the non-creditable hazardous waste 
pharmaceuticals shipments it receives from off site for three years 
from the date that the shipment is received.


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

    (a) Hazardous waste determination for potentially creditable 
pharmaceuticals. A healthcare facility that generates a solid waste 
that is a potentially creditable pharmaceutical must determine whether 
the potentially creditable pharmaceutical is a potentially creditable 
hazardous waste pharmaceutical (i.e., it is listed in 40 CFR part 261 
subpart D or exhibits a characteristic identified in 40 CFR part 261 
subpart C). A healthcare facility may choose to manage its potentially 
creditable non-hazardous waste pharmaceuticals as potentially 
creditable hazardous waste pharmaceuticals under this subpart.
    (b) Accepting potentially creditable hazardous waste 
pharmaceuticals from an off-site healthcare facility that is a very 
small quantity generator. A healthcare facility may accept potentially 
creditable hazardous waste pharmaceuticals from an off-site healthcare 
facility that is a very small quantity generator under Sec.  262.14, 
without a permit or without having interim status, provided the 
receiving healthcare facility:
    (1) Is under the control of the same person, as defined in Sec.  
260.10, as the very small quantity generator healthcare facility that 
is sending the potentially creditable hazardous waste pharmaceuticals 
off site, or has a contractual or other documented business 
relationship whereby the receiving healthcare facility supplies 
pharmaceuticals to the very small quantity generator healthcare 
facility;
    (2) Is operating under this subpart for the management of its 
potentially creditable hazardous waste pharmaceuticals;
    (3) Manages the potentially creditable hazardous waste 
pharmaceuticals that it receives from off site in compliance with this 
subpart; and
    (4) Keeps records of the potentially creditable hazardous waste 
pharmaceuticals shipments it receives from off site for three years 
from the date that the shipment is received.
    (c) Prohibition. Healthcare facilities are prohibited from sending 
hazardous wastes other than potentially creditable hazardous waste 
pharmaceuticals to a reverse distributor.
    (d) Biennial Reporting by healthcare facilities. Healthcare 
facilities are not subject to biennial reporting requirements under 
Sec.  262.41 with respect to potentially creditable hazardous waste 
pharmaceuticals managed under this subpart.
    (e) Recordkeeping by healthcare facilities. (1) A healthcare 
facility that initiates a shipment of potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor must keep the following 
records (paper or electronic) for each shipment of potentially 
creditable hazardous waste pharmaceuticals for three years from the 
date of shipment:
    (i) The confirmation of delivery; and
    (ii) The shipping papers prepared in accordance with 49 CFR part 
172 subpart C, if applicable.
    (2) The periods of retention referred to in this section are 
extended automatically during the course of any unresolved enforcement 
action regarding the regulated activity, or as requested by the EPA 
Regional Administrator.
    (3) All records must be readily available upon request by an 
inspector.
    (f) Response to spills of potentially creditable hazardous waste 
pharmaceuticals at healthcare facilities. A healthcare facility must 
immediately contain all spills of potentially creditable hazardous 
waste pharmaceuticals and manage the spill clean-up materials as non-
creditable hazardous waste pharmaceuticals in accordance with this 
subpart.


Sec.  266.504  Healthcare facilities that are very small quantity 
generators for both hazardous waste pharmaceuticals and non-
pharmaceutical hazardous waste.

    (a) Potentially creditable hazardous waste pharmaceuticals. A 
healthcare facility that is a very small quantity generator for both 
hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste 
may send its potentially creditable hazardous waste pharmaceuticals to 
a reverse distributor.
    (b) Off-site collection of hazardous waste pharmaceuticals 
generated by a healthcare facility that is a very small quantity 
generator. A healthcare facility that is a very small quantity 
generator for both hazardous waste pharmaceuticals and non-
pharmaceutical hazardous waste may send its hazardous waste 
pharmaceuticals off-site to another healthcare facility, provided:
    (1) The receiving healthcare facility meets the conditions in Sec.  
266.502(l) of this subpart and Sec.  266.503(b), as applicable; or
    (2) The very small quantity generator healthcare facility meets the 
conditions in Sec.  262.14(a)(5)(viii) and the receiving large quantity 
generator meets the conditions in Sec.  262.17(f).
    (c) Long-term care facilities that are very small quantity 
generators. A long-

[[Page 5945]]

term care facility that is a very small quantity generator for both 
hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste 
may dispose of its hazardous waste pharmaceuticals (excluding 
contaminated personal protective equipment or clean-up materials) in an 
on-site collection receptacle of an authorized collector (as defined by 
the Drug Enforcement Administration) that is registered with the Drug 
Enforcement Administration provided the contents are collected, stored, 
transported, destroyed and disposed of in compliance with all 
applicable Drug Enforcement Administration regulations for controlled 
substances.
    (d) Long-term care facilities with 20 beds or fewer. A long-term 
care facility with 20 beds or fewer is presumed to be a very small 
quantity generator subject to Sec.  262.14 for both hazardous waste 
pharmaceuticals and non-pharmaceutical hazardous waste and not subject 
to this subpart, except for Sec. Sec.  266.505 and 266.507 and the 
other optional provisions of this section. The EPA Regional 
Administrator has the responsibility to demonstrate that a long-term 
care facility with 20 beds or fewer generates quantities of hazardous 
waste that are in excess of the very small quantity generator limits as 
defined in Sec.  260.10. A long-term care facility with more than 20 
beds that operates as a very small quantity generator under Sec.  
262.14 must demonstrate that it generates quantities of hazardous waste 
that are within the very small quantity generator limits as defined by 
Sec.  260.10.


Sec.  266.505  Prohibition of sewering hazardous waste pharmaceuticals.

    All healthcare facilities--including very small quantity generators 
operating under Sec.  262.14 in lieu of this subpart--and reverse 
distributors are prohibited from discharging hazardous waste 
pharmaceuticals to a sewer system that passes through to a publicly-
owned treatment works. Healthcare facilities and reverse distributors 
remain subject to the prohibitions in 40 CFR 403.5(b)(1).


Sec.  266.506  Conditional exemptions for hazardous waste 
pharmaceuticals that are also controlled substances and household waste 
pharmaceuticals collected in a take-back event or program.

    (a) Conditional exemptions. Provided the conditions of paragraph 
(b) of this section are met, the following are exempt from 40 CFR parts 
262 through 273:
    (1) Hazardous waste pharmaceuticals that are also listed on a 
schedule of controlled substances by the Drug Enforcement 
Administration in 21 CFR part 1308, and
    (2) Household waste pharmaceuticals that are collected in a take-
back event or program, including those that are collected by an 
authorized collector (as defined by the Drug Enforcement 
Administration) registered with the Drug Enforcement Administration 
that commingles the household waste pharmaceuticals with controlled 
substances from an ultimate user (as defined by the Drug Enforcement 
Administration).
    (b) Conditions for exemption. The hazardous waste pharmaceuticals 
must be:
    (1) Managed in compliance with the sewer prohibition of Sec.  
266.505; and
    (2) Collected, stored, transported, and disposed of in compliance 
with all applicable Drug Enforcement Administration regulations for 
controlled substances; and
    (3) Destroyed by a method that Drug Enforcement Administration has 
publicly deemed in writing to meet their non-retrievable standard of 
destruction or combusted at one of the following:
    (i) A permitted large municipal waste combustor, subject to 40 CFR 
part 62 subpart FFF or applicable state plan for existing large 
municipal waste combustors, or 40 CFR part 60 subparts Eb for new large 
municipal waste combustors; or
    (ii) A permitted small municipal waste combustor, subject to 40 CFR 
part 62 subpart JJJ or applicable state plan for existing small 
municipal waste combustors, or 40 CFR part 60 subparts AAAA for new 
small municipal waste combustors; or
    (iii) A permitted hospital, medical and infectious waste 
incinerator, subject to 40 CFR part 62 subpart HHH or applicable state 
plan for existing hospital, medical and infectious waste incinerators, 
or 40 CFR part 60 subpart Ec for new hospital, medical and infectious 
waste incinerators.
    (iv) A permitted commercial and industrial solid waste incinerator, 
subject to 40 CFR part 62 subpart III or applicable state plan for 
existing commercial and industrial solid waste incinerators, or 40 CFR 
part 60 subpart CCCC for new commercial and industrial solid waste 
incinerators.
    (v) A permitted hazardous waste combustor subject to 40 CFR part 63 
subpart EEE.


Sec.  266.507  Residues of hazardous waste pharmaceuticals in empty 
containers.

    (a) Stock, dispensing and unit-dose containers. A stock bottle, 
dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 
pills); or a unit-dose container (e.g., a unit-dose packet, cup, 
wrapper, blister pack, or delivery device) is considered empty and the 
residues are not regulated as hazardous waste provided the 
pharmaceuticals have been removed from the stock bottle, dispensing 
bottle, vial, ampule, or the unit-dose container using the practices 
commonly employed to remove materials from that type of container.
    (b) Syringes. A syringe is considered empty and the residues are 
not regulated as hazardous waste under this subpart provided the 
contents have been removed by fully depressing the plunger of the 
syringe. If a syringe is not empty, the syringe must be placed with its 
remaining hazardous waste pharmaceuticals into a container that is 
managed and disposed of as a non-creditable hazardous waste 
pharmaceutical under this subpart and any applicable federal, state, 
and local requirements for sharps containers and medical waste.
    (c) Intravenous (IV) bags. An IV bag is considered empty and the 
residues are not regulated as hazardous waste provided the 
pharmaceuticals in the IV bag have been fully administered to a 
patient. If an IV bag is not empty, the IV bag must be placed with its 
remaining hazardous waste pharmaceuticals into a container that is 
managed and disposed of as a non-creditable hazardous waste 
pharmaceutical under this subpart, unless the IV bag held non-acute 
hazardous waste pharmaceuticals and is empty as defined in Sec.  
261.7(b)(1).
    (d) Other containers, including delivery devices. Hazardous waste 
pharmaceuticals remaining in all other types of unused, partially 
administered, or fully administered containers must be managed as non-
creditable hazardous waste pharmaceuticals under this subpart, unless 
the container held non-acute hazardous waste pharmaceuticals and is 
empty as defined in Sec.  261.7(b)(1) or (2). This includes, but is not 
limited to, residues in inhalers, aerosol cans, nebulizers, tubes of 
ointments, gels, or creams.


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

    (a) Shipping non-creditable hazardous waste pharmaceuticals or 
evaluated hazardous waste pharmaceuticals. A healthcare facility must 
ship non-creditable hazardous waste pharmaceuticals and a reverse 
distributor must ship evaluated hazardous waste pharmaceuticals off-

[[Page 5946]]

site to a designated facility (such as a permitted or interim status 
treatment, storage, or disposal facility) in compliance with:
    (1) The following pre-transport requirements, before transporting 
or offering for transport off-site:
    (i) Packaging. Package the waste in accordance with the applicable 
Department of Transportation regulations on hazardous materials under 
49 CFR parts 173, 178, and 180.
    (ii) Labeling. Label each package in accordance with the applicable 
Department of Transportation regulations on hazardous materials under 
49 CFR part 172 subpart E.
    (iii) Marking. (A) Mark each package of hazardous waste 
pharmaceuticals in accordance with the applicable Department of 
Transportation (DOT) regulations on hazardous materials under 49 CFR 
part 172 subpart D;
    (B) Mark each container of 119 gallons or less used in such 
transportation with the following words and information in accordance 
with the requirements of 49 CFR 172.304:
    HAZARDOUS WASTE--Federal Law Prohibits Improper Disposal. If found, 
contact the nearest police or public safety authority or the U.S. 
Environmental Protection Agency.

Healthcare Facility's or Reverse distributor's Name and Address--------
Healthcare Facility's or Reverse distributor's EPA Identification 
Number-----------------------------------------------------------------
Manifest Tracking Number-----------------------------------------------

    (C) Lab packs that will be incinerated in compliance with Sec.  
268.42(c) are not required to be marked with EPA Hazardous Waste 
Number(s), except D004, D005, D006, D007, D008, D010, and D011, where 
applicable. A nationally recognized electronic system, such as bar 
coding or radio frequency identification, may be used to identify the 
EPA Hazardous Waste Number(s).
    (iv) Placarding. Placard or offer the initial transporter the 
appropriate placards according to Department of Transportation 
regulations for hazardous materials under 49 CFR part 172 subpart F.
    (2) The manifest requirements of 40 CFR part 262 subpart B, except 
that:
    (i) A healthcare facility shipping non-creditable hazardous waste 
pharmaceuticals is not required to list all applicable hazardous waste 
numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-22.
    (ii) A healthcare facility shipping non-creditable hazardous waste 
pharmaceuticals must write the word ``PHARMS'' in Item 13 of EPA Form 
8700-22.
    (b) Exporting non-creditable hazardous waste pharmaceuticals or 
evaluated hazardous waste pharmaceuticals. A healthcare facility or 
reverse distributor that exports non-creditable hazardous waste 
pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject 
to 40 CFR part 262 subpart H.
    (c) Importing non-creditable hazardous waste pharmaceuticals or 
evaluated hazardous waste pharmaceuticals. Any person that imports non-
creditable hazardous waste pharmaceuticals or evaluated hazardous waste 
pharmaceuticals is subject to 40 CFR part 262 subpart H. A healthcare 
facility or reverse distributor may not accept imported non-creditable 
hazardous waste pharmaceuticals or evaluated hazardous waste 
pharmaceuticals unless they have a permit or interim status that allows 
them to accept hazardous waste from off site.


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

    (a) Shipping potentially creditable hazardous waste 
pharmaceuticals. A healthcare facility or a reverse distributor who 
transports or offers for transport potentially creditable hazardous 
waste pharmaceuticals off-site to a reverse distributor must comply 
with all applicable U.S. Department of Transportation regulations in 49 
CFR part 171 through 180 for any potentially creditable hazardous waste 
pharmaceutical that meets the definition of hazardous material in 49 
CFR 171.8. For purposes of the Department of Transportation 
regulations, a material is considered a hazardous waste if it is 
subject to the Hazardous Waste Manifest Requirements of the U.S. 
Environmental Protection Agency specified in 40 CFR part 262. Because a 
potentially creditable hazardous waste pharmaceutical does not require 
a manifest, it is not considered hazardous waste under the Department 
of Transportation regulations.
    (b) Delivery confirmation. Upon receipt of each shipment of 
potentially creditable hazardous waste pharmaceuticals, the receiving 
reverse distributor must provide confirmation (paper or electronic) to 
the healthcare facility or reverse distributor that initiated the 
shipment that the shipment of potentially creditable hazardous waste 
pharmaceuticals has arrived at its destination and is under the custody 
and control of the reverse distributor.
    (c) Procedures for when delivery confirmation is not received 
within 35 calendar days. If a healthcare facility or reverse 
distributor initiates a shipment of potentially creditable hazardous 
waste pharmaceuticals to a reverse distributor and does not receive 
delivery confirmation within 35 calendar days from the date that the 
shipment of potentially creditable hazardous waste pharmaceuticals was 
sent, the healthcare facility or reverse distributor that initiated the 
shipment must contact the carrier and the intended recipient (i.e., the 
reverse distributor) promptly to report that the delivery confirmation 
was not received and to determine the status of the potentially 
creditable hazardous waste pharmaceuticals.
    (d) Exporting potentially creditable hazardous waste 
pharmaceuticals. A healthcare facility or reverse distributor that 
sends potentially creditable hazardous waste pharmaceuticals to a 
foreign destination must comply with the applicable sections of 40 CFR 
part 262 subpart H, except the manifesting requirement of Sec.  
262.83(c), in addition to paragraphs (a) through (c) of this section.
    (e) Importing potentially creditable hazardous waste 
pharmaceuticals. Any person that imports potentially creditable 
hazardous waste pharmaceuticals into the United States is subject to 
paragraphs (a) through (c) of this section in lieu of 40 CFR part 262 
subpart H. Immediately after the potentially creditable hazardous waste 
pharmaceuticals enter the United States, they are subject to all 
applicable requirements of this subpart.


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

    A reverse distributor may accept potentially creditable hazardous 
waste pharmaceuticals from off site and accumulate potentially 
creditable hazardous waste pharmaceuticals or evaluated hazardous waste 
pharmaceuticals on site without a hazardous waste permit or without 
having interim status, provided that it complies with the following 
conditions:
    (a) Standards for reverse distributors managing potentially 
creditable hazardous waste pharmaceuticals and evaluated hazardous 
waste pharmaceuticals--(1) Notification. A reverse distributor must 
notify the EPA Regional Administrator, using the Site Identification 
Form (EPA Form 8700-12), that it is a reverse distributor operating 
under this subpart.
    (i) A reverse distributor that already has an EPA identification 
number must notify the EPA Regional Administrator, using the Site 
Identification Form (EPA Form 8700-12), that it is a reverse

[[Page 5947]]

distributor, as defined in Sec.  266.500, within 60 days of the 
effective date of this subpart, or within 60 days of becoming subject 
to this subpart.
    (ii) A reverse distributor that does not have an EPA identification 
number must obtain one by notifying the EPA Regional Administrator, 
using the Site Identification Form (EPA Form 8700-12), that it is a 
reverse distributor, as defined in Sec.  266.500, within 60 days of the 
effective date of this subpart, or within 60 days of becoming subject 
to this subpart.
    (2) Inventory by the reverse distributor. A reverse distributor 
must maintain a current inventory of all the potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals that are accumulated on site.
    (i) A reverse distributor must inventory each potentially 
creditable hazardous waste pharmaceutical within 30 calendar days of 
each waste arriving at the reverse distributor.
    (ii) The inventory must include the identity (e.g., name or 
national drug code) and quantity of each potentially creditable 
hazardous waste pharmaceutical and evaluated hazardous waste 
pharmaceutical.
    (iii) If the reverse distributor already meets the inventory 
requirements of this paragraph because of other regulatory 
requirements, such as State Board of Pharmacy regulations, the facility 
is not required to provide a separate inventory pursuant to this 
section.
    (3) Evaluation by a reverse distributor that is not a manufacturer. 
A reverse distributor that is not a pharmaceutical manufacturer must 
evaluate a potentially creditable hazardous waste pharmaceutical within 
30 calendar days of the waste arriving at the reverse distributor to 
establish whether it is destined for another reverse distributor for 
further evaluation or verification of manufacturer credit or for a 
permitted or interim status treatment, storage, or disposal facility.
    (i) A potentially creditable hazardous waste pharmaceutical that is 
destined for another reverse distributor is still considered a 
``potentially creditable hazardous waste pharmaceutical'' and must be 
managed in accordance with paragraph (b) of this section.
    (ii) A potentially creditable hazardous waste pharmaceutical that 
is destined for a permitted or interim status treatment, storage or 
disposal facility is considered an ``evaluated hazardous waste 
pharmaceutical'' and must be managed in accordance with paragraph (c) 
of this section.
    (4) Evaluation by a reverse distributor that is a manufacturer. A 
reverse distributor that is a pharmaceutical manufacturer must evaluate 
a potentially creditable hazardous waste pharmaceutical to verify 
manufacturer credit within 30 calendar days of the waste arriving at 
the facility and following the evaluation must manage the evaluated 
hazardous waste pharmaceuticals in accordance with paragraph (c) of 
this section.
    (5) Maximum accumulation time for hazardous waste pharmaceuticals 
at a reverse distributor. (i) A reverse distributor may accumulate 
potentially creditable hazardous waste pharmaceuticals and evaluated 
hazardous waste pharmaceuticals on site for 180 calendar days or less. 
The 180 days start after the potentially creditable hazardous waste 
pharmaceutical has been evaluated and applies to all hazardous waste 
pharmaceuticals accumulated on site, regardless of whether they are 
destined for another reverse distributor (i.e., potentially creditable 
hazardous waste pharmaceuticals) or a permitted or interim status 
treatment, storage, or disposal facility (i.e., evaluated hazardous 
waste pharmaceuticals).
    (ii) Aging pharmaceuticals. Unexpired pharmaceuticals that are 
otherwise creditable but are awaiting their expiration date (i.e., 
aging in a holding morgue) can be accumulated for up to 180 days after 
the expiration date, provided that the unexpired pharmaceuticals are 
managed in accordance with paragraph (a) of this section and the 
container labeling and management standards in 266.510(c)(4)(i) through 
(vi).
    (6) Security at the reverse distributor facility. A reverse 
distributor must prevent unknowing entry and minimize the possibility 
for the unauthorized entry into the portion of the facility where 
potentially creditable hazardous waste pharmaceuticals and evaluated 
hazardous waste pharmaceuticals are kept.
    (i) Examples of methods that may be used to prevent unknowing entry 
and minimize the possibility for unauthorized entry include, but are 
not limited to:
    (A) A 24-hour continuous monitoring surveillance system;
    (B) An artificial barrier such as a fence; or
    (C) A means to control entry, such as keycard access.
    (ii) If the reverse distributor already meets the security 
requirements of this paragraph because of other regulatory 
requirements, such as Drug Enforcement Administration or State Board of 
Pharmacy regulations, the facility is not required to provide separate 
security measures pursuant to this section.
    (7) Contingency plan and emergency procedures at a reverse 
distributor. A reverse distributor that accepts potentially creditable 
hazardous waste pharmaceuticals from off site must prepare a 
contingency plan and comply with the other requirements of 40 CFR part 
262 subpart M.
    (8) Closure of a reverse distributor. When closing an area where a 
reverse distributor accumulates potentially creditable hazardous waste 
pharmaceuticals or evaluated hazardous waste pharmaceuticals, the 
reverse distributor must comply with Sec.  262.17(a)(8)(ii) and (iii).
    (9) Reporting by a reverse distributor--(i) Unauthorized waste 
report. A reverse distributor must submit an unauthorized waste report 
if the reverse distributor receives waste from off site that it is not 
authorized to receive (e.g., non-pharmaceutical hazardous waste, 
regulated medical waste). The reverse distributor must prepare and 
submit an unauthorized waste report to the EPA Regional Administrator 
within 45 calendar days after the unauthorized waste arrives at the 
reverse distributor and must send a copy of the unauthorized waste 
report to the healthcare facility (or other entity) that sent the 
unauthorized waste. The reverse distributor must manage the 
unauthorized waste in accordance with all applicable regulations. The 
unauthorized waste report must be signed by the owner or operator of 
the reverse distributor, or its authorized representative, and contain 
the following information:
    (A) The EPA identification number, name and address of the reverse 
distributor;
    (B) The date the reverse distributor received the unauthorized 
waste;
    (C) The EPA identification number, name, and address of the 
healthcare facility that shipped the unauthorized waste, if available;
    (D) A description and the quantity of each unauthorized waste the 
reverse distributor received;
    (E) The method of treatment, storage, or disposal for each 
unauthorized waste; and
    (F) A brief explanation of why the waste was unauthorized, if 
known.
    (ii) Additional reports. The EPA Regional Administrator may require 
reverse distributors to furnish additional reports concerning the 
quantities and disposition of potentially creditable hazardous waste 
pharmaceuticals and evaluated hazardous waste pharmaceuticals.

[[Page 5948]]

    (10) Recordkeeping by reverse distributors. A reverse distributor 
must keep the following records (paper or electronic) readily available 
upon request by an inspector. The periods of retention referred to in 
this section are extended automatically during the course of any 
unresolved enforcement action regarding the regulated activity, or as 
requested by the EPA Regional Administrator.
    (i) A copy of its notification on file for as long as the facility 
is subject to this subpart;
    (ii) A copy of the delivery confirmation and the shipping papers 
for each shipment of potentially creditable hazardous waste 
pharmaceuticals that it receives, and a copy of each unauthorized waste 
report, for at least three years from the date the shipment arrives at 
the reverse distributor;
    (iii) A copy of its current inventory for as long as the facility 
is subject to this subpart.
    (b) Additional standards for reverse distributors managing 
potentially creditable hazardous waste pharmaceuticals destined for 
another reverse distributor. A reverse distributor that does not have a 
permit or interim status must comply with the following conditions, in 
addition to the requirements in paragraph (a) of this section, for the 
management of potentially creditable hazardous waste pharmaceuticals 
that are destined for another reverse distributor for further 
evaluation or verification of manufacturer credit:
    (1) A reverse distributor that receives potentially creditable 
hazardous waste pharmaceuticals from a healthcare facility must send 
those potentially creditable hazardous waste pharmaceuticals to another 
reverse distributor within 180 days after the potentially creditable 
hazardous waste pharmaceuticals have been evaluated or follow paragraph 
(c) of this section for evaluated hazardous waste pharmaceuticals.
    (2) A reverse distributor that receives potentially creditable 
hazardous waste pharmaceuticals from another reverse distributor must 
send those potentially creditable hazardous waste pharmaceuticals to a 
reverse distributor that is a pharmaceutical manufacturer within 180 
days after the potentially creditable hazardous waste pharmaceuticals 
have been evaluated or follow paragraph (c) of this section for 
evaluated hazardous waste pharmaceuticals.
    (3) A reverse distributor must ship potentially creditable 
hazardous waste pharmaceuticals destined for another reverse 
distributor in accordance with Sec.  266.509.
    (4) Recordkeeping by reverse distributors. A reverse distributor 
must keep the following records (paper or electronic) readily available 
upon request by an inspector for each shipment of potentially 
creditable hazardous waste pharmaceuticals that it initiates to another 
reverse distributor, for at least three years from the date of 
shipment. The periods of retention referred to in this section are 
extended automatically during the course of any unresolved enforcement 
action regarding the regulated activity, or as requested by the EPA 
Regional Administrator.
    (i) The confirmation of delivery; and
    (ii) The DOT shipping papers prepared in accordance with 49 CFR 
part 172 subpart C, if applicable
    (c) Additional standards for reverse distributors managing 
evaluated hazardous waste pharmaceuticals. A reverse distributor that 
does not have a permit or interim status must comply with the following 
conditions, in addition to the requirements of paragraph (a) of this 
section, for the management of evaluated hazardous waste 
pharmaceuticals:
    (1) Accumulation area at the reverse distributor. A reverse 
distributor must designate an on-site accumulation area where it will 
accumulate evaluated hazardous waste pharmaceuticals.
    (2) Inspections of on-site accumulation area. A reverse distributor 
must inspect its on-site accumulation area at least once every seven 
days, looking at containers for leaks and for deterioration caused by 
corrosion or other factors, as well as for signs of diversion.
    (3) Personnel training at a reverse distributor. Personnel at a 
reverse distributor that handle evaluated hazardous waste 
pharmaceuticals are subject to the training requirements of Sec.  
262.17(a)(7).
    (4) Labeling and management of containers at on-site accumulation 
areas. A reverse distributor accumulating evaluated hazardous waste 
pharmaceuticals in containers in an on-site accumulation area must:
    (i) Label the containers with the words, ``hazardous waste 
pharmaceuticals'';
    (ii) Ensure the containers are in good condition and managed to 
prevent leaks;
    (iii) Use containers that are made of or lined with materials which 
will not react with, and are otherwise compatible with, the evaluated 
hazardous waste pharmaceuticals, so that the ability of the container 
to contain the waste is not impaired;
    (iv) Keep containers closed, if holding liquid or gel evaluated 
hazardous waste pharmaceuticals. If the liquid or gel evaluated 
hazardous waste pharmaceuticals are in their original, intact, sealed 
packaging; or repackaged, intact, sealed packaging, they are considered 
to meet the closed container standard;
    (v) Manage any container of ignitable or reactive evaluated 
hazardous waste pharmaceuticals, or any container of commingled 
incompatible evaluated hazardous waste pharmaceuticals so that the 
container does not have the potential to:
    (A) Generate extreme heat or pressure, fire or explosion, or 
violent reaction;
    (B) Produce uncontrolled toxic mists, fumes, dusts, or gases in 
sufficient quantities to threaten human health;
    (C) Produce uncontrolled flammable fumes or gases in sufficient 
quantities to pose a risk of fire or explosions;
    (D) Damage the structural integrity of the container of hazardous 
waste pharmaceuticals; or
    (E) Through other like means threaten human health or the 
environment; and
    (vi) Accumulate evaluated hazardous waste pharmaceuticals that are 
prohibited from being combusted because of the dilution prohibition of 
Sec.  268.3(c) (e.g., arsenic trioxide (P012)) in separate containers 
from other evaluated hazardous waste pharmaceuticals at the reverse 
distributor.
    (5) Hazardous waste numbers. Prior to shipping evaluated hazardous 
waste pharmaceuticals off site, all containers must be marked with the 
applicable hazardous waste numbers (i.e., hazardous waste codes). A 
nationally recognized electronic system, such as bar coding or radio 
frequency identification, may be used to identify the EPA Hazardous 
Waste Number(s).
    (6) Shipments. A reverse distributor must ship evaluated hazardous 
waste pharmaceuticals that are destined for a permitted or interim 
status treatment, storage or disposal facility in accordance with the 
applicable shipping standards in Sec.  266.508(a) or (b).
    (7) Procedures for a reverse distributor for managing rejected 
shipments. A reverse distributor that sends a shipment of evaluated 
hazardous waste pharmaceuticals to a designated facility with the 
understanding that the designated facility can accept and manage the 
waste, and later receives that shipment back as a rejected load in 
accordance with the manifest discrepancy provisions of Sec.  264.72 or 
Sec.  265.72 of this chapter, may accumulate the returned evaluated 
hazardous waste pharmaceuticals on

[[Page 5949]]

site for up to an additional 90 days in the on-site accumulation area 
provided the rejected or returned shipment is managed in accordance 
with Sec.  266.510(a) and (c). Upon receipt of the returned shipment, 
the reverse distributor must:
    (i) Sign either:
    (A) Item 18c of the original manifest, if the original manifest was 
used for the returned shipment; or
    (B) Item 20 of the new manifest, if a new manifest was used for the 
returned shipment;
    (ii) Provide the transporter a copy of the manifest;
    (iii) Within 30 days of receipt of the rejected shipment of the 
evaluated hazardous waste pharmaceuticals, send a copy of the manifest 
to the designated facility that returned the shipment to the reverse 
distributor; and
    (iv) Within 90 days of receipt of the rejected shipment, transport 
or offer for transport the returned shipment of evaluated hazardous 
waste pharmaceuticals in accordance with the applicable shipping 
standards of Sec.  266.508(a) or (b).
    (8) Land disposal restrictions. Evaluated hazardous waste 
pharmaceuticals are subject to the land disposal restrictions of 40 CFR 
part 268. A reverse distributor that accepts potentially creditable 
hazardous waste pharmaceuticals from off site must comply with the land 
disposal restrictions in accordance with Sec.  268.7(a) requirements.
    (9) Reporting by a reverse distributor for evaluated hazardous 
waste pharmaceuticals--(i) Biennial reporting by a reverse distributor. 
A reverse distributor that ships evaluated hazardous waste 
pharmaceuticals off-site must prepare and submit a single copy of a 
biennial report to the EPA Regional Administrator by March 1 of each 
even numbered year in accordance with Sec.  262.41.
    (ii) Exception reporting by a reverse distributor for a missing 
copy of the manifest.
    (A) For shipments from a reverse distributor to a designated 
facility. (1) If a reverse distributor does not receive a copy of the 
manifest with the signature of the owner or operator of the designated 
facility within 35 days of the date the evaluated hazardous waste 
pharmaceuticals were accepted by the initial transporter, the reverse 
distributor must contact the transporter or the owner or operator of 
the designated facility to determine the status of the evaluated 
hazardous waste pharmaceuticals.
    (2) A reverse distributor must submit an exception report to the 
EPA Regional Administrator for the Region in which the reverse 
distributor is located if it has not received a copy of the manifest 
with the signature of the owner or operator of the designated facility 
within 45 days of the date the evaluated hazardous waste pharmaceutical 
was accepted by the initial transporter. The exception report must 
include:
    (i) A legible copy of the manifest for which the reverse 
distributor does not have confirmation of delivery; and
    (ii) A cover letter signed by the reverse distributor, or its 
authorized representative, explaining the efforts taken to locate the 
evaluated hazardous waste pharmaceuticals and the results of those 
efforts.
    (B) For shipments rejected by the designated facility and shipped 
to an alternate facility. (1) A reverse distributor that does not 
receive a copy of the manifest with the signature of the owner or 
operator of the alternate facility within 35 days of the date the 
evaluated hazardous waste pharmaceuticals were accepted by the initial 
transporter must contact the transporter or the owner or operator of 
the alternate facility to determine the status of the hazardous waste. 
The 35-day time frame begins the date the evaluated hazardous waste 
pharmaceuticals are accepted by the transporter forwarding the 
hazardous waste shipment from the designated facility to the alternate 
facility.
    (2) A reverse distributor must submit an Exception Report to the 
EPA Regional Administrator for the Region in which the reverse 
distributor is located if it has not received a copy of the manifest 
with the signature of the owner or operator of the alternate facility 
within 45 days of the date the evaluated hazardous waste 
pharmaceuticals were accepted by the initial transporter. The 45-day 
timeframe begins the date the evaluated hazardous waste pharmaceuticals 
are accepted by the transporter forwarding the hazardous waste 
pharmaceutical shipment from the designated facility to the alternate 
facility. The Exception Report must include:
    (i) A legible copy of the manifest for which the generator does not 
have confirmation of delivery; and
    (ii) A cover letter signed by the reverse distributor, or its 
authorized representative, explaining the efforts taken to locate the 
evaluated hazardous waste pharmaceuticals and the results of those 
efforts.
    (10) Recordkeeping by a reverse distributor for evaluated hazardous 
waste pharmaceuticals. (i) A reverse distributor must keep a log 
(written or electronic) of the inspections of the on-site accumulation 
area, required by paragraph (c)(2) of this section. This log must be 
retained as a record for at least three years from the date of the 
inspection.
    (ii) A reverse distributor must keep a copy of each manifest signed 
in accordance with Sec.  262.23(a) for three years or until it receives 
a signed copy from the designated facility that received the evaluated 
hazardous waste pharmaceutical. This signed copy must be retained as a 
record for at least three years from the date the evaluated hazardous 
waste pharmaceutical was accepted by the initial transporter.
    (iii) A reverse distributor must keep a copy of each biennial 
report for at least three years from the due date of the report.
    (iv) A reverse distributor must keep a copy of each exception 
report for at least three years from the submission of the report.
    (v) A reverse distributor must keep records to document personnel 
training, in accordance with Sec.  262.17(a)(7)(iv).
    (vi) All records must be readily available upon request by an 
inspector. The periods of retention referred to in this section are 
extended automatically during the course of any unresolved enforcement 
action regarding the regulated activity, or as requested by the EPA 
Regional Administrator.
    (d) When a reverse distributor must have a permit. A reverse 
distributor is an operator of a hazardous waste treatment, storage, or 
disposal facility and is subject to the requirements of 40 CFR parts 
264, 265, and 267 and the permit requirements of 40 CFR part 270, if 
the reverse distributor:
    (1) Does not meet the conditions of this section;
    (2) Accepts manifested hazardous waste from off site; or
    (3) Treats or disposes of hazardous waste pharmaceuticals on site.

PART 268--LAND DISPOSAL RESTRICTIONS

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

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


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


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

    (a) Requirements for generators and reverse distributors. * * *
* * * * *

[[Page 5950]]


0
18. Section 268.50 is amended by adding paragraphs (a)(4) and (5) to 
read as follows:


Sec.  268.50  Prohibitions on storage of restricted wastes.

    (a) * * *
    (4) A healthcare facility accumulates such wastes in containers on 
site solely for the purpose of the accumulation of such quantities of 
hazardous waste pharmaceuticals as necessary to facilitate proper 
recovery, treatment, or disposal and the healthcare facility complies 
with the applicable requirements in Sec. Sec.  266.502 and 266.503 of 
this chapter.
    (5) A reverse distributor accumulates such wastes in containers on 
site solely for the purpose of the accumulation of such quantities of 
hazardous waste pharmaceuticals as necessary to facilitate proper 
recovery, treatment, or disposal and the reverse distributor complies 
with Sec.  266.510 of this chapter.
* * * * *

PART 270--EPA ADMINISTERED PERMIT PROGRAMS: THE HAZARDOUS WASTE 
PERMIT PROGRAM

0
19. The authority citation for part 270 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912, 6924, 6925, 6927, 6939, and 
6974.

0
20. Section 270.1 is amended by adding paragraph (c)(2)(x) to read as 
follows:


Sec.  270.1  Purpose and scope of these regulations.

* * * * *
    (c) * * *
    (2) * * *
    (x) Reverse distributors accumulating potentially creditable 
hazardous waste pharmaceuticals and evaluated hazardous waste 
pharmaceuticals, as defined in Sec.  266.500. Reverse distributors are 
subject to regulation under 40 CFR part 266 subpart P for the 
accumulation of potentially creditable hazardous waste pharmaceuticals 
and evaluated hazardous waste pharmaceuticals.
* * * * *

PART 273--STANDARDS FOR UNIVERSAL WASTE MANAGEMENT

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

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


0
22. Section 273.80 is amended by revising paragraph (a) and adding 
paragraph (d) to read as follows:


Sec.  273.80  General.

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

[FR Doc. 2019-01298 Filed 2-21-19; 8:45 am]
 BILLING CODE 6560-50-P