Amendment to the Universal Waste Rule: Addition of Pharmaceuticals, 73520-73544 [E8-28161]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 232 (Tuesday, December 2, 2008)]
[Proposed Rules]
[Pages 73520-73544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28161]



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Part IV





Environmental Protection Agency





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40 CFR Part 260, 261, 264, et al.



 Amendment to the Universal Waste Rule: Addition of Pharmaceuticals; 
Proposed Rule

Federal Register / Vol. 73, No. 232 / Tuesday, December 2, 2008 / 
Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 260, 261, 264, 265, 268, 270 and 273

[EPA-HQ-RCRA-2007-0932; FRL-8746-2]
RIN 2050-AG39


Amendment to the Universal Waste Rule: Addition of 
Pharmaceuticals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to add hazardous pharmaceutical wastes to the 
Universal Waste Rule. The Universal Waste Rule, originally promulgated 
on May 11, 1995, modified the Resource Conservation and Recovery Act's 
hazardous waste regulations by establishing a set of streamlined 
requirements for the collection of certain widely dispersed hazardous 
wastes, called ``universal wastes.'' This proposed rule would 
facilitate better management of pharmaceutical wastes by streamlining 
the generator requirements and encouraging generators of hazardous 
pharmaceutical wastes to manage them under the provisions of the 
Universal Waste Rule, which ensures that these hazardous pharmaceutical 
wastes are properly disposed of and treated as hazardous wastes. In 
addition, this proposed rule would facilitate the implementation of 
pharmaceutical take-back programs by removing RCRA barriers in the 
collection of pharmaceutical wastes from health care and other such 
regulated facilities, as well as facilitate the collection of 
pharmaceutical wastes from households, including non-hazardous 
pharmaceutical wastes.

DATES: Comments must be received on or before February 2, 2009. Under 
the Paperwork Reduction Act, since the Office of Management and Budget 
(OMB) is required to make a decision concerning the Information 
Collection Request (ICR) between 30 and 60 days after December 2, 2008, 
a comment to OMB is best assured of having its full effect if OMB 
receives it by January 2, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
RCRA-2007-0932, by one of the following methods:
     https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: rcra-docket@epa.gov.
     Fax: 202-566-9744.
     Mail: RCRA Docket, Environmental Protection Agency, 
Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In 
addition, please mail a copy of your comments on the information 
collection provisions to the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for 
EPA, 725 17th St., NW., Washington, DC 20503.
     Hand Delivery: EPA West Building, Room 3334, 1301 
Constitution Avenue, NW., Washington, DC 20460. Such deliveries are 
only accepted during the Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-RCRA-
2007-0932. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through https://
www.regulations.gov or e-mail. The https://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through https://www.regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket, visit the EPA Docket Center homepage at https://www.epa.gov/
epahome/dockets.htm. For additional instructions on submitting 
comments, go to the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the https://
www.regulations.gov index. 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, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in https://www.regulations.gov or in hard copy at the RCRA Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. 
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
RCRA Docket is (202) 566-0270.

FOR FURTHER INFORMATION CONTACT: Lisa Lauer, Office of Solid Waste 
(5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue, 
NW., Washington, DC 20460; telephone number: 703-308-7418; fax number: 
703-605-0595; e-mail address lauer.lisa@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    This proposed rule could affect up to 634,552 entities in 
approximately 10 industries involved in health care and/or management 
of hazardous pharmaceutical wastes, as defined in this proposed rule. 
This includes pharmacies, hospitals, physicians' offices, dentists' 
offices, other health care practitioners, outpatient care centers, 
ambulatory health care services, residential care facilities, 
veterinary clinics and reverse distributors. Of these entities, EPA's 
Biennial Reporting System (BRS) indicates that approximately 181 are 
large quantity generators (LQGs) of hazardous waste. The remainder are 
likely to be either small quantity generators (SQGs) or conditionally-
exempt small quantity generators (CESQGs). Under this proposal, 
hazardous pharmaceutical waste generators may elect to have their 
hazardous pharmaceutical waste remain regulated under the current 
Resource Conservation and Recovery Act (RCRA) generator regulations as 
set forth in 40 CFR part 262, or may choose to manage their hazardous 
pharmaceutical wastes under the Universal Waste Rule (UWR). In RCRA-
authorized states, the option of managing hazardous pharmaceutical 
waste under this proposal would be available once it has been adopted 
by the state.

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B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
https://www.regulations.gov or e-mail. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
as CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
the procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives, 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible.
     Make sure to submit your comments by the comment period 
deadline identified.
    3. Docket Copying Costs. Many documents are available only in the 
original and, therefore, must be photocopied. Patrons are allowed 100 
free photocopies. Thereafter they are charged 15 cents per page. When 
necessary, an invoice stating how many copies were made, the cost of 
the order, and where to send a check will be issued to the patron.
    Documents also are available on microfilm. The EPA/DC staff help 
patrons locate needed documents and operate the microfilm machines. The 
billing fee for printing microfilm documents is the same as for 
photocopying documents.
    Patrons who are outside of the metropolitan Washington, DC, area 
can request documents by telephone. The photocopying and microfilming 
fee is the same as for walk-in patrons. If an invoice is necessary, 
EPA/DC staff can mail one with the order.

Preamble Outline

I. Statutory Authority
II. List of Abbreviations and Acronyms
III. Introduction
IV. Background
    A. What Are the Current RCRA Generator Requirements Governing 
Hazardous Pharmaceutical Waste?
    B. How Are ``Pharmaceutical'' and ``Pharmaceutical Universal 
Waste'' Defined in this Proposal?
    C. How Do the Current RCRA Hazardous Waste Regulations Apply to 
Generators of Pharmaceutical Waste?
    1. Determining Whether Pharmaceutical Waste Is Subject to the 
Hazardous Waste Regulations
    2. Which Sources May Generate Hazardous Pharmaceutical Waste 
Subject to This Proposal?
    a. Health Care Facilities
    b. Pharmacies
    c. Long-Term Care Facilities
    d. Reverse Distributors of Pharmaceuticals
    e. Pharmaceutical Take-Back Programs
    D. Why Is Management of Pharmaceutical Waste Difficult Under the 
RCRA Subtitle C Hazardous Waste Regulations?
    1. Waste Determination
    2. Change in Generator Status From Conditionally Exempt Small 
Quantity Generators to Large Quantity Generators Due to Generation 
of Acutely Hazardous Wastes
    3. Accumulation Time Limits
    E. What Is the Universal Waste Rule?
    F. Why Is Pharmaceutical Waste Appropriate for Inclusion in the 
Universal Waste Framework?
    G. How Will Adding Hazardous Pharmaceutical Waste to the 
Universal Waste Rule Help Address Pharmaceutical Waste Management 
Issues?
    1. Application of the Universal Waste Rule to Pharmaceutical 
Wastes
    a. Waste Determination
    b. Accumulation Time and Generation Volume Limits
V. Detailed Discussion of This Proposed Rule
    A. Intent and Purpose of This Proposed Rule
    B. Applicability
    1. RCRA Hazardous Pharmaceutical Wastes
    2. Households and Conditionally Exempt Small Quantity Generators
    3. Handlers of Universal Waste
    a. Small Quantity Handlers of Universal Waste
    b. Large Quantity Handlers of Universal Waste
    C. Definitions
    D. Waste Management
    1. Containers
    2. Sorting
    3. Generation of Solid Wastes
    E. Labeling/Marking
    F. Accumulation Time Limits
    G. Employee Training
    H. Responses to Releases
    I. Off-Site Shipments
    J. Tracking Universal Waste Shipments
    K. Exports
    L. Standards for Universal Waste Transporters
    M. Standards for Destination Facilities
    N. Import Requirements
    O. Land Disposal Restrictions
VI. State Authority
    A. Applicability of Rule in Authorized States
    B. Effect on State Authorization
VII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution or Usage
    I. National Technology Transfer Advancement Act
    J. Executive Order 12898: Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

I. Statutory Authority

    These regulations are proposed under the authority of sections 
2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act of 
1970, as amended by the Resource Conservation and Recovery Act of 1976 
(RCRA), and as amended by the Hazardous and Solid Waste Amendments of 
1984 (HSWA), 42 U.S.C. 6912(a), 6921, 6922, 6923, 6924, 6926, 6927, 
6930 and 6937.

II. List of Abbreviations and Acronyms

AEA Atomic Energy Act of 1954
BRS Biennial Reporting System
CERCLA Comprehensive Environmental Response, Compensation, and 
Liability Act
CESQG Conditionally Exempt Small Quantity Generator
CFR Code of Federal Regulations
CIV Schedule IV Controlled Substance
CWA Clean Water Act
DEA Drug Enforcement Administration
DOE Department of Energy
DOT Department of Transportation
EPA Environmental Protection Agency
FDA Food and Drug Administration
HIPAA Health Insurance Portability and Accountability Act
HSWA Hazardous and Solid Waste Amendments of 1984
IV Intravenous
LD50 Lethal Dose 50%
LDR Land Disposal Restrictions
LQG Large Quantity Generator
LQHUW Large Quantity Handler of Universal Waste

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NIOSH National Institute for Occupational Safety and Health
NRC Nuclear Regulatory Commission
OSHA Occupational Safety and Health Administration
POTW Publicly-Owned Treatment Works
RCRA Resource Conservation and Recovery Act
RO RCRA Online
RQ Reportable Quantity
SQG Small Quantity Generator
SQHUW Small Quantity Handler of Universal Waste
TC Toxicity Characteristic
TSDF Treatment, Storage and Disposal Facility
UWR Universal Waste Rule

III. Introduction

    This action proposes to add pharmaceutical wastes that are RCRA 
hazardous wastes to the universal waste system. Similar to other 
universal wastes, pharmaceutical wastes are produced by a large and 
diverse community of generators, often in small volumes. As discussed 
in the economic assessment prepared for this proposed rulemaking, over 
600,000 individual facilities in the United States, including 
approximately 40,000 retail pharmacies, over 7,000 hospitals, and more 
than 300,000 physicians and dental offices, may be generators of 
hazardous pharmaceutical wastes. For example, it has been estimated 
that LQG hospitals in the United States generate a total of 10,600 tons 
of RCRA hazardous pharmaceuticals waste annually, while a single retail 
pharmacy may only generate 5 pounds of hazardous pharmaceutical wastes 
in a year (``Assessment of the Potential Costs, Benefits, and Other 
Impacts of Adding Pharmaceuticals to the Universal Waste Rule, as 
Proposed.'' October 2008). Within these facilities, hazardous 
pharmaceutical waste may be generated in a single location (such as a 
pharmacy), or in multiple locations (such as hospital pharmacies, 
emergency rooms, operating rooms, and nursing stations) by many 
individuals. Pharmaceutical wastes may be RCRA hazardous because they 
contain any of 31 listed hazardous waste chemicals, although many may 
be identified by a commercial name (rather than a chemical name), 
making it more difficult to readily identify them as potentially 
hazardous waste.
    Some pharmaceutical wastes are hazardous wastes because they 
exhibit one or more of the four hazardous waste characteristics. This 
combination of a large number of individual generators, many with 
multiple generation points within their facilities, with a substantial 
number of chemicals potentially rendering pharmaceutical wastes RCRA 
hazardous, has made implementation of the RCRA hazardous waste 
regulations difficult for many of these facilities. The universal waste 
regulations help avoid such mismanagement by streamlining the 
collection requirements for certain hazardous wastes. The proposed rule 
may also reduce hazardous waste in the municipal solid waste stream by 
making it easier for universal waste handlers to collect these items 
and send them for proper disposal. Thus, expansion of the universal 
waste system to include hazardous pharmaceutical wastes may lead to 
better management of these wastes by providing a more streamlined, and 
effective waste management system. Due to the simplified requirements, 
this action, if finalized, would also provide regulatory relief to 
health care facilities, retail pharmacies, veterinary clinics and any 
other entities that generate hazardous pharmaceutical wastes. Moreover, 
this proposed rulemaking will alert generators of pharmaceutical wastes 
to the applicability of the RCRA hazardous waste regulations to their 
waste streams. Also, we anticipate that waste management systems 
established under this rule would facilitate the management of other 
pharmaceutical wastes, particularly those that may pose hazards if not 
properly managed, but are not regulated as hazardous under RCRA. 
Finally, the addition of hazardous pharmaceutical wastes to the 
Universal Waste program would facilitate the management of 
pharmaceutical wastes via pharmaceutical take-back programs by removing 
RCRA barriers (e.g., hazardous waste determination, storage 
accumulation and time limits, etc.) for health care and other such 
regulated facilities that generate hazardous pharmaceutical wastes, as 
well as facilitate the collection of pharmaceutical wastes from 
households.\1\
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    \1\ The Agency notes that this rulemaking does not affect the 
Controlled Substance Act or regulations issued there under the Drug 
Enforcement Administration (DEA). Thus, organizers of collection 
events will still be required to contact DEA to ensure compliance 
with the federal laws and regulations concerning controlled 
substances.
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IV. Background

A. What Are the Current RCRA Generator Requirements Governing Hazardous 
Pharmaceutical Waste?

    Any facility that generates RCRA hazardous pharmaceutical waste is 
subject to the RCRA generator regulations at 40 CFR part 262.\2\ There 
are three categories of RCRA hazardous waste generators. A facility's 
generator status depends on the total amount of hazardous waste 
generated at the entire site in a calendar month, and that generator 
status determines the waste management requirements applicable to the 
facility under RCRA. Facilities that generate 1000 kg or more of 
hazardous waste per month, or greater than 1 kg of acute hazardous 
waste per month, are considered LQGs. Other facilities qualify as SQGs 
if they generate more than 100 kg per month, but less than 1000 kg per 
month of hazardous waste. SQGs are subject to fewer requirements than 
LQGs. For example, SQGs do not need to complete a biennial report, and 
have fewer personnel training and contingency planning requirements 
than LQGs (see 40 CFR 262.34(d)(5)). Additionally, facilities qualify 
as CESQGs if they generate less than or equal to 100 kg of hazardous 
waste per month, or less than or equal to1 kg of acutely hazardous 
waste per month. CESQGs are not subject to the RCRA subtitle C 
hazardous waste regulations, provided that they comply with the 
requirements set forth in 40 CFR 261.5(f)(3) and (g)(3). Finally, under 
the household hazardous waste exclusion in 40 CFR 261.4(b)(1), 
hazardous wastes generated by households are not subject to the 
hazardous waste regulations.
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    \2\ For more information on the current requirements for 
hazardous waste generators, please see the following EPA Web site: 
https://www.epa.gov/osw/hazard/generation/index.htm.
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    Because RCRA generator status is determined on a monthly basis, it 
is possible that a generator's status can change from one month to the 
next, depending on the amount of hazardous waste generated in a 
particular month. This is commonly referred to as ``episodic 
generation.'' If a generator's status does in fact change, the 
generator is required to comply with the respective regulatory 
requirements for that class of generators for any hazardous waste 
generated in that particular month (i.e., LQG, SQG, CESQG).

B. How Are ``Pharmaceutical'' and ``Pharmaceutical Universal Waste'' 
Defined in This Proposal?

    For the purposes of this proposed rule, ``pharmaceutical'' refers 
to ``any chemical product, vaccine or allergenic (including any product 
with the primary purpose to dispense or deliver a chemical product, 
vaccine or allergenic), not containing a radioactive component, that is 
intended for use in the diagnosis, cure, mitigation, treatment, or 
prevention of disease or injury in man or other animals; or any 
chemical product, vaccine or allergenic (including any product with the 
primary purpose to dispense or deliver a chemical product, vaccine or 
allergenic), not containing a radioactive

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component, that is intended to affect the structure or function of the 
body in man or other animals. This definition includes products such as 
transdermal patches, and oral delivery devices such as gums or 
lozenges. This definition does not include sharps or other infectious 
or biohazardous waste, dental amalgams, medical devices not used for 
delivery or dispensing purposes, equipment, contaminated personal 
protective equipment or contaminated cleaning materials.'' \3\ This 
proposed definition is meant to include, but is not limited to, pills 
or tablets, medicinal gums or lozenges, medicinal liquids, ointments 
and lotions, intravenous (IV) or other compounded solutions, 
chemotherapy drugs, vaccines, allergenics, medicinal shampoos, 
antiseptics and medicinal dermal patches, and any delivery devices with 
the primary purpose to deliver or dispense a chemical product, vaccine 
or allergenic.
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    \3\ Definition of ``pharmaceutical'' is adapted from the Federal 
Food, Drug and Cosmetic Act's definition of ``drug'' (21 U.S.C. 
321(g)(1)(B)).
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    In contrast, this definition does not include sharps (e.g., needles 
from IV bags or syringes),\4\ infectious or biohazardous ``red-bag'' 
waste,\5\ waste chemicals from laboratories, medical devices (e.g., 
blood pressure cuffs, mercury thermometers, x-ray films and fixers),\6\ 
dental amalgams, personal protective equipment contaminated with 
hazardous pharmaceuticals (e.g., scrubs, gowns, gloves, etc.) \7\ or 
any materials used to clean up spills of hazardous pharmaceutical 
wastes. In addition, residues resulting from the manufacture, 
production, or distribution of such pharmaceuticals, including off-
specification pharmaceutical products, are not considered 
pharmaceutical wastes for purposes of this proposal (see discussion of 
40 CFR 273.81(b) at 60 FR 25514/1, May 11, 1995, which states that the 
Agency does not believe that wastes generated primarily in an 
industrial setting are appropriate for the universal waste system).
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    \4\ Used sharps, such as needles or syringes with needles, are 
not included under this proposed rule as sharps are considered 
medical wastes, presently regulated at the state and local level. In 
addition sharps pose both an unreasonable physical danger and 
biohazard danger to those sorting wastes and so have not been 
included in the proposed rule. See Technical Manual on Controlling 
Occupation Exposure to Hazardous Drugs found at https://www.osha.gov/
dts/osta/otm/otm_vi/otm_vi_2.html see (c)(1)(b) and Response 
Regarding Needlestick Injuries in the Sharps Recycling Industry (RO 
11778).
    \5\ Infectious or biohazardous ``red-bag'' wastes are medical 
wastes, which are regulated at the state and local level.
    \6\ Medical devices (with the exception of devices with a 
primary purpose of dispensing or delivering a chemical product, 
vaccine or allergenic) are not regulated under this proposal, since 
they do not fall within the definition of pharmaceutical. These 
wastes may be regulated when disposed based on whether or not they 
are listed or are characteristic hazardous wastes.
    \7\ The Agency considers contaminated PPE to be comparable to 
clean-up materials as contaminated PPEs may be ``different in form 
and composition from the universal waste they come from.'' (60 FR 
25528/3, May 11, 1995).
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    In addition, for the purposes of this rulemaking, the term 
``pharmaceutical universal waste'' means a pharmaceutical that is a 
hazardous waste as defined in Sec.  261.3, and containers (e.g., 
bottles, vials, IV bags, tubes of ointment/gels/creams, ampules, etc.) 
which have held any hazardous pharmaceutical waste and which would be 
classified as hazardous waste under Sec.  261.7. The Agency decided to 
define ``pharmaceutical universal waste'' to ensure that any container 
which has held hazardous pharmaceutical wastes (and thus is also 
considered a hazardous pharmaceutical waste, unless that container is 
considered ``RCRA-empty'' 8 9) could also be managed in the 
universal waste system. Please see section V.C. of this preamble for 
additional discussion on the inclusion of the definition of 
``pharmaceutical universal waste.''
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    \8\ Under the current generator regulations, containers once 
holding listed wastes are themselves considered listed hazardous 
wastes due to the residues remaining in the containers (see 40 CFR 
261.33(c)), unless the containers are ``RCRA empty'' in accordance 
with 40 CFR 261.7. A container holding a P-listed hazardous waste is 
considered ``RCRA empty'' if it has been triple-rinsed with an 
appropriate solvent or has been cleaned by a method that has been 
proven in scientific literature or by tests conducted by the 
generator to achieve the equivalent removal (see 40 CFR 
261.7(b)(3)). A container holding a U-listed waste is considered 
``RCRA empty'' if all wastes have been removed that can be removed 
using practices commonly employed to remove materials from the 
container and no more than one inch of residue or 3% by weight of 
the U-listed chemical remains if the container is less than or equal 
to 119 gallons in size (40 CFR 261.7(b)(1)).
    \9\ EPA has interpreted 40 CFR 261.33 to mean that any syringe 
containing the residue of a P- or U-listed pharmaceutical is not 
considered a listed hazardous waste as the drug residue remaining in 
a syringe is considered to have been used for its intended purpose, 
and would be hazardous only if the residue exhibits a hazardous 
waste characteristic (see 54 FR 31335, 31336; July 28, 1989; 
``Epinephrine Residue in a Syringe is Not P042,'' RCRA Online (RO) 
13718; letter to Mr. Gary Chilcott (Sure-Way Systems Inc.) 
from Robert Dellinger RO 14788).
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    The Agency is aware that the definitions in this proposed rule may 
overlap with similar definitions in other statutes implemented by other 
agencies. For example, the Federal Food, Drug, and Cosmetic Act (FFDCA) 
and the Controlled Substances Act both define and regulate aspects of 
pharmaceuticals, and what the FFDCA considers a ``device,'' EPA may 
consider a ``container.'' Definitions from these other statues should 
not be confused with those set out in this proposed rule. To avoid 
confusion, EPA has made an effort to use different terminology (such as 
``pharmaceutical'' instead of the FFDCA term ``drug'') and to provide 
definitions appropriate to waste management under the UWR framework in 
this proposed rule. Thus, in order to determine whether a particular 
waste may be managed as a pharmaceutical universal waste, the generator 
must look to the definitions in this proposed rule, and not rely on the 
definitions contained in other regulatory programs.

C. How Do the Current RCRA Hazardous Waste Regulations Apply to 
Generators of Pharmaceutical Waste?

1. Determining Whether Pharmaceutical Waste Is Subject to the Hazardous 
Waste Regulations
    Any person who generates a ``solid waste'' is required by 40 CFR 
262.11 to determine whether such waste meets the definition of RCRA 
hazardous waste. Proper hazardous waste determination is essential to 
the success of, and is the foundation of, the ``cradle to grave'' RCRA 
hazardous waste program. The hazardous waste determination process can 
be simplified into several basic steps:
    (1) Is the material in question a solid waste (as defined in 40 CFR 
261.2)?
    (2) Is the solid waste excluded from regulation as a hazardous 
waste under 40 CFR 261.4?
    (3) Is it or does it contain a hazardous waste listed in Subpart D 
of Part 261?
    (4) Does the waste exhibit any of the characteristics defined in 
Subpart C of Part 261 (ignitability, corrosivity, reactivity or 
toxicity)?
    The RCRA hazardous waste generator regulations are applicable to 
all pharmaceutical wastes that meet the definition of ``hazardous 
waste'' set out in subtitle C of RCRA. Some pharmaceutical wastes are 
listed hazardous waste under 40 CFR 261.31-33, while some may exhibit 
one or more of the four chemical or physical characteristics of 
ignitability, corrosivity, reactivity or toxicity, as defined in 40 CFR 
261.21-24. Others may qualify as ``mixed waste'' when they contain both 
hazardous waste subject to the requirements of RCRA and source, special 
nuclear, or byproduct material (i.e., a radioactive component) subject 
to the requirements of the Atomic Energy Act of 1954 (AEA) (52 FR 
15939, May 1, 1987).\10\ The

[[Page 73524]]

following is a non-comprehensive list of chemicals that have 
pharmaceutical uses and which would, when discarded, be listed or 
characteristic hazardous wastes:
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    \10\ As noted in the definition of pharmaceutical, 
pharmaceuticals that contain a radioactive component, such as mixed 
wastes, would not be eligible for management under the universal 
waste rule.
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     P-listed pharmaceutical wastes \11\ include arsenic 
trioxide (P012), phentermine (CIV) (P046, listed as alpha, alpha-
dimethyl-benzeneethanamine), epinephrine (P042),\12\ physostigmine 
(P204), nicotine (P075), physostigmine salicylate (P188), nitroglycerin 
(P081), and warfarin (>0.3%) (P001).
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    \11\ The P- and U-lists list as hazardous certain commercial 
chemical products when they are discarded or intended to be 
discarded. These listings consist of commercial chemical products 
having the generic names listed, off-specification species, 
container residues, and spill residues. Chemicals on the P list are 
identified as acute hazardous wastes (40 CFR 261.33(e)) and those on 
the U list are identified as toxic wastes (40 CFR 261.33(f)).
    \12\ The Agency clarified its regulation at 40 CFR 261.33, 
explaining that epinephrine salts are not included in the 
epinephrine P042 listing (since the listing only specifies 
epinephrine and not epinephrine salts); the salts, therefore, would 
be hazardous only if the waste epinephrine salt exhibited one or 
more of the hazardous waste characteristics (see ``Scope of 
Hazardous Waste Listing P042 (Epinephrine),'' October 15, 2007, 
RO14778).
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     U-listed pharmaceutical wastes include chloral hydrate 
(CIV) (U034),\13\ paraldehyde (CIV) (U182), chlorambucil (U035), phenol 
(U188), cyclophosphamide (U058), reserpine (U200), daunomycin (U059), 
resorcinol (U201), dichlorodifluoromethane (U075), diethylstilbestrol 
(U089), selenium sulfide (U205), hexachlorophene (U132), streptozotocin 
(U206), lindane (U129), trichloromonofluoromethane (U121), melphalan 
(U150), uracil mustard (U237), mercury (U151), warfarin (0.3%) (U248), 
and mitomycin C (U010).
---------------------------------------------------------------------------

    \13\ EPA has interpreted the listing of chloral (U034) to 
include chloral hydrate (see letter to Elizabeth Knauss (Florida 
Department of Environmental Protection) from William Brandes; RO 
14175).
---------------------------------------------------------------------------

     Characteristic \14\ pharmaceutical wastes include those 
that may exhibit the ignitability characteristic, such as solutions 
containing more than 24% alcohol. Others may exhibit the reactivity 
characteristic, such as nitroglycerine. Pharmaceuticals exhibiting the 
corrosivity characteristic are generally limited to compounding 
chemicals, including strong acids, such as glacial acetic acid, and 
strong bases, such as sodium hydroxide. Depending on the concentration 
in different pharmaceutical preparations, pharmaceuticals may also 
exhibit the toxicity characteristic (TC) because they contain arsenic 
(D004), barium (D005), cadmium (D006), chloroform (D022), chromium 
(D007), lindane (D013), m-cresol (D024), mercury (D009), selenium 
(D010), or silver (D011) at concentrations exceeding the regulatory 
criteria.
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    \14\ Characteristic hazardous wastes are hazardous wastes that 
are not found on any of the lists, but are still hazardous waste 
because they exhibit one or more of the four characteristics defined 
in 40 CFR part 261, Subpart C.
---------------------------------------------------------------------------

    On the other hand, there are exceptions. Specifically, EPA has 
interpreted 40 CFR 261.33 to mean that any syringe containing the 
residue of a P-or U-listed drug is not considered a listed hazardous 
waste and would be hazardous only if the residue exhibits a hazardous 
waste characteristic (see ``Epinephrine Residue in a Syringe is Not 
P042,'' December 1994, RO 13718). In addition, the P- and U-
lists consist of commercial chemical products, which are defined as 
commercially pure grades and technical grades of the listed chemicals 
or chemical formulations in which the listed chemical is the sole 
active ingredient, which has not been used for its intended purpose 
(see 40 CFR 261.33(e) comment; 54 FR 31335, 31336; July 28, 1989). EPA 
considers such residues remaining in a syringe after administration to 
a patient to have been used for its intended purpose. Furthermore, the 
Agency clarified its regulation at 40 CFR 261.33, explaining that 
epinephrine salts are not included in the epinephrine P042 listing 
(since the listing only specifies epinephrine and not epinephrine 
salts); the salts, therefore, would be hazardous only if the waste 
epinephrine salt exhibited one or more of the hazardous waste 
characteristics (see ``Scope of Hazardous Waste Listing P042 
(Epinephrine),'' October 15, 2007, RO 14778). Finally, if a 
listed hazardous waste is listed solely because it exhibits the 
characteristics of ignitability, corrosivity and/or reactivity, and the 
waste does not exhibit the characteristic for which it was listed, then 
it is not a hazardous waste (66 FR 27286, May 16, 2001).\15\ As always, 
because local and state regulations can be broader (i.e., more 
inclusive) or more stringent than the federal regulations, EPA 
recommends that the regulated community contact their local regulatory 
authorities to determine what exemptions and interpretations apply in 
their state.
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    \15\ Medicinal nitroglycerin may qualify for this exclusion as 
it typically does not exhibit the characteristic of reactivity (see 
explanation in RO 14654).
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2. Which Sources May Generate Hazardous Pharmaceutical Waste Subject to 
This Proposal? \16\
a. Health Care Facilities
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    \16\ The Agency seeks comments on the following descriptions of 
current pharmaceutical waste handling practices. Specifically, how 
much pharmaceutical waste do health care facilities typically 
generate per month? Of that amount, what percentage is RCRA 
hazardous waste? What method of disposal are health care facilities 
utilizing for pharmaceutical wastes, including hazardous and non-
hazardous? Additionally, the Agency seeks information regarding 
pharmaceutical waste management costs. In particular, what are the 
costs of collecting and treating hazardous pharmaceutical waste?
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    Hazardous pharmaceutical wastes may be generated through a wide 
variety of activities in a number of different areas within a health 
care facility. For example, in the health care facility's pharmacy, 
waste may be generated by: IV preparation; general compounding \17\; 
spills from or breakage or damage to pharmaceutical containers; 
discontinued or unused preparations; unused unit dose repacks; and 
outdated pharmaceuticals. In the other areas of the health care 
facility, waste may be generated by partially used vials, syringes, and 
IVs containing pharmaceuticals, as well as patients' personal 
medications.\18\
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    \17\ Compounding occurs when pharmacists formulate prescription 
medications specifically as prescribed by a physician for a patient. 
For more information, see https://www.iacprx.org/site/
PageServer?pagename=What_is_Compounding.
    \18\ The Healthcare Environmental Resource Center and Practice 
Greenhealth. ``Managing Pharmaceutical Waste: A 10-Step Blueprint 
for Health Care Facilities in the United States'' (Revised August 
2008). https://www.hercenter.org/hazmat/tenstepblueprint.pdf.
---------------------------------------------------------------------------

    At hospitals, pharmacies generally stock thousands of different 
items, each of which must be evaluated against state and federal 
hazardous waste regulations to determine whether any of the items would 
be considered a hazardous waste if discarded.\19\ In addition to the 
hospital pharmacy, pharmaceutical wastes are generated by health care 
workers at other locations across the hospital and are generally placed 
in waste bins in patient rooms, nursing stations, operating rooms and 
emergency rooms. At some hospitals, the wastes are then collected at a 
central location, such as the pharmacy or central accumulation area. At 
other hospitals, wastes may be picked up at the nursing stations by a 
contracted waste handling company. Hospitals, like other generators, 
are responsible for determining whether their wastes are RCRA solid 
wastes and, if so, whether they are hazardous wastes subject to 
regulation under RCRA subtitle C. The

[[Page 73525]]

hospital must then manage the wastes accordingly.
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    \19\ Ibid.
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    Doctors' offices, veterinary clinics and other small health care 
facilities manage their pharmaceutical wastes in a similar manner as 
hospitals, although on a smaller scale. However, through communications 
with outside stakeholders, EPA understands that many health care 
facilities may be unaware of the applicability of the RCRA hazardous 
waste regulations to their hazardous pharmaceutical waste.
    Many times, at health care facilities, pharmaceuticals are sent to 
a regulated medical waste incinerator (rather than a RCRA-permitted 
incinerator). Additionally, many health care facilities dispose of 
their pharmaceutical wastes down the drain.\20\ EPA generally considers 
sewer disposal inadvisable for pharmaceuticals and discourages this 
practice, unless specifically required by the label. For these and 
other reasons, pharmaceutical waste management has become an 
increasingly critical issue in environmental management for health care 
facilities.
---------------------------------------------------------------------------

    \20\ Under RCRA regulation 261.4(a)(1)(ii), EPA provides an 
exclusion from the definition of ``solid waste'' for ``any mixture 
of domestic sewage and other wastes that passes through a sewer 
system to a publicly-owned treatment works for treatment.'' This 
RCRA domestic sewage exclusion can apply to industrial hazardous 
waste discharged to publicly owned treatment works (POTW) via a 
general use sewer system. EPA, acting under its authority under 
section 307(b) of the Clean Water Act (CWA), regulates in certain 
circumstances industrial discharges that are introduced to POTWs 
thorough a national pretreatment program. Section 307(b) and its 
implementing regulations at 40 CFR part 403 require that industrial 
facilities pretreat pollutants discharged to POTWs to the extent 
that these pollutants interfere with, pass through, or are otherwise 
incompatible with the operations of the POTW. Pretreatment 
requirements apply to pollutants introduced to a POTW by a user of 
the POTW whether introduced indirectly through sewers or directly 
(for example, by truck or rail). The RCRA domestic sewage exclusion 
however, does not apply if the industrial hazardous waste never 
mixes with sanitary waste in the pipe prior to treatment or storage 
at the POTW (e.g., the hazardous waste arrives at the POTW via a 
dedicated pipeline or by truck or rail). In addition, if the mixture 
of hazardous waste and sanitary waste leaks from the sewer line 
prior to arriving at the POTW, this mixture does not qualify for the 
domestic sewage exclusion (see explanation in the March 10, 1997, 
letter to Mr. William Warren from David Bussard; RO 14068). 
Finally, please note that states may issue regulations that are more 
stringent or broader in scope than the federal hazardous waste 
regulations and, therefore, not all local environmental regulations 
include the domestic sewage exclusion.
---------------------------------------------------------------------------

b. Pharmacies
    Pharmacies, such as those found in retail drug stores and health 
care facilities, including long-term care facilities, may be subject to 
the RCRA hazardous waste generator regulations. Pharmacies may generate 
hazardous pharmaceutical wastes via compounding or preparation, or if 
any portion of their pharmaceutical stock expires, is damaged, or is 
returned by the consumer. Pharmacies can stock thousands of different 
items, each of which must be evaluated against state and federal 
hazardous waste regulations to determine whether the item would be 
considered a hazardous waste when discarded.\21\ If the pharmacy's 
pharmaceutical wastes meet the RCRA definition of hazardous waste, the 
pharmacy would be considered a hazardous waste generator, subject to 
the requirements of its particular generator status.
---------------------------------------------------------------------------

    \21\ The Healthcare Environmental Resource Center and Practice 
Greenhealth. ``Managing Pharmaceutical Waste: A 10-Step Blueprint 
for Health Care Facilities in the United States'' (Revised August 
2008). https://www.hercenter.org/hazmat/tenstepblueprint.pdf.
---------------------------------------------------------------------------

c. Long-Term Care Facilities
    Nursing homes, assisted living centers, and other long-term care 
facilities also may be subject to the RCRA hazardous waste generator 
regulations. However, many long-term care facilities may be unaware of 
the applicability of the RCRA hazardous waste regulations to their 
hazardous pharmaceutical waste.
    Most long-term care facilities generate two types of hazardous 
pharmaceutical waste. First, the facility itself may generate hazardous 
wastes as a result of its central management of pharmaceuticals in its 
pharmacy or pharmacy-like area. These hazardous pharmaceutical wastes 
would be subject to the RCRA hazardous waste generator regulations 
since the pharmaceuticals are under the control of the facility, and, 
thus, the resulting wastes are generated by that facility (see 40 CFR 
part 262). The long-term care facilities, like other generators, are 
responsible for determining whether the wastes it generates are 
hazardous wastes subject to regulation under RCRA subtitle C. If so, 
the facility must then manage the wastes accordingly. Long-term care 
facilities face many of the same issues that health care facilities and 
pharmacies do in managing hazardous pharmaceutical waste, as discussed 
above.
    Secondly, patients and residents in long-term care facilities may 
generate hazardous wastes. Those pharmaceuticals that are under the 
control of the patient or resident of the long-term care facility, when 
discarded, would be subject to RCRA's household hazardous waste 
exclusion (40 CFR 261.4(b)(1)). Hazardous pharmaceutical wastes 
generated by the resident are excluded from regulation because they are 
considered to be derived from a household.
d. Reverse Distributors of Pharmaceuticals
    Based on information provided by reverse distribution companies, 
the Agency understands that pharmaceutical manufacturers often offer 
credit on the return of their unused or expired pharmaceuticals as a 
financial incentive to pharmacies, hospitals and other health care 
facilities to stock their products, (since many drugs are expensive and 
may have short shelf lives). Reverse distributors of pharmaceuticals 
provide a service to the health care industry by keeping track of the 
manufacturer return policies and facilitating the return of these 
unused or expired drugs for potential credit from the manufacturer. In 
addition, this reverse distribution system for pharmaceuticals helps 
ensure that unused and expired pharmaceuticals do not get diverted to 
inappropriate uses, and that the returned pharmaceuticals, are managed 
appropriately.
    Because unused or expired pharmaceuticals are being returned (via 
the reverse distributor) for possible manufacturer credit, they still 
have potential value to the pharmacy or hospital and are thus not 
considered wastes. Therefore, when a health care facility hires a 
reverse distributor to manage its unused/expired pharmaceuticals, the 
health care facility can ship the unused or expired pharmaceuticals by 
using commercial carriers or mail-in services. Once the unused or 
expired pharmaceuticals reach the reverse distributor, the reverse 
distributor determines which drugs are eligible for credit from the 
manufacturer or distributor, and ensures that the health care facility 
receives the proper credit. Once credit is recorded (for eligible 
drugs), the manufacturer will instruct the reverse distributor to 
either dispose of the drug or to ship it back (to the manufacturer's 
facility). Thus, for those credited pharmaceuticals that the 
manufacturer has instructed the reverse distributor to dispose of, and 
for those pharmaceuticals not eligible for credit, reverse distributors 
must determine which are RCRA solid and hazardous wastes. Then, they 
must manage all such wastes in accordance with federal, state, and/or 
local environmental regulations.
    The Agency notes that this discussion pertains only to reverse 
distributors of pharmaceuticals and does not attempt to describe 
reverse distribution systems that may exist for any other consumer 
product. EPA requests comment on the

[[Page 73526]]

accuracy of this description of the functions and operations of reverse 
distributors of pharmaceuticals, and solicits any additional 
information and data regarding the operations, material and waste 
handling procedures (including the handling of hazardous wastes) of 
reverse distributors of pharmaceuticals. EPA also solicits comment on 
its understanding of when it is determined that unused and/or expired 
pharmaceuticals managed in pharmaceutical reverse distribution systems 
become waste, and hence potentially subject to the universal waste 
regulations proposed in this rule.
e. Pharmaceutical Take-Back Programs
    Pharmaceutical take-back or collection programs are periodic or on-
going events intended to allow patients and consumers to bring their 
unused drugs to a central location, such as a local pharmacy or police 
station for proper management and disposal. Some communities have begun 
to arrange these programs for their citizens, but they are not widely 
available. Take-back programs generally facilitate the proper handling 
and disposal of drugs that may be hazardous wastes under RCRA.\22\ 
Household hazardous wastes are not required to be managed under the 
federal RCRA hazardous waste management scheme. However, once such 
household hazardous pharmaceutical wastes are consolidated at the 
collection point, most communities manage the waste in compliance with 
the full hazardous waste management regulations, even though such 
wastes retain their household hazardous waste exemption.\23\
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    \22\ Links for finding pharmaceutical take-back programs are 
listed at: https://www.epa.gov/ppcp/links.html#state.
    \23\ Please check with state and local environmental regulations 
as some may be more stringent than the federal regulation and may 
require that collected household hazardous wastes be managed as 
hazardous wastes.
---------------------------------------------------------------------------

    The Agency supports the establishment of these take-back programs 
as they redirect hazardous and non-hazardous pharmaceutical wastes 
generated by households, from municipal trash handling systems and 
sewer systems to hazardous waste management facilities. It should be 
noted that in establishing and operating pharmaceutical take-back 
programs, community organizers should seek input from their state and/
or local environmental agencies. Additionally, they must seek 
assistance from the U.S. DEA to ensure the programs comply with federal 
laws and regulations concerning the handling and management of 
controlled substances.\24\ This proposed action does not alter any 
federal statutory or regulatory requirements relating to controlled 
substances; thus all take-back programs must maintain compliance with 
the Controlled Substances Act and DEA regulations.
---------------------------------------------------------------------------

    \24\ Without law enforcement involvement, these programs are not 
able to accept narcotics or other drugs that are controlled 
substances under DEA regulations, which preclude transfer of a 
controlled substance originally prescribed to a patient to any other 
entity, with the exception of law enforcement officers.
---------------------------------------------------------------------------

    While EPA believes that this rulemaking, if finalized, will 
simplify pharmaceutical take-back programs by streamlining the 
requirements for handling hazardous pharmaceutical wastes received as 
part of a take-back program,\25\ the Agency seeks comment on how this 
proposed action may affect community take-back programs. Beyond the 
take-back programs themselves, EPA seeks comments on whether this 
rulemaking could have unforeseen consequences in the generation, 
characterization, and management of hazardous pharmaceutical wastes 
that would potentially increase risks to human health or the 
environment.
---------------------------------------------------------------------------

    \25\ We believe this proposal would remove RCRA barriers for 
health care and other such regulated facilities that generate 
hazardous pharmaceutical wastes, as well as facilitate the 
collection of pharmaceutical wastes from households.
---------------------------------------------------------------------------

D. Why Is Management of Pharmaceutical Waste Difficult Under the RCRA 
Subtitle C Hazardous Waste Regulations?

    In its proposal for the Universal Waste management system, EPA 
discussed the differences between large industrial or manufacturing 
facilities' generation of hazardous waste and hazardous waste 
generation by commercial, non-manufacturing entities (58 FR 8102, 
February 11, 1993). In that discussion, the Agency expressed concern 
about the difficulties of implementing the RCRA hazardous waste 
regulatory program for commercial products that are hazardous when 
discarded at the end of their useful life, which are widely dispersed 
in commerce, and which may be generated as waste in relatively small 
volumes by large numbers of generators nationwide. Pharmaceuticals, 
when discarded, are such wastes. Specifically, pharmaceutical waste is 
generated at a large number of facilities nationwide, potentially at 
several locations within a facility, such as at hospital nursing 
stations, pharmacies, and patient, emergency and operating rooms, and 
typically in relatively small quantities. Furthermore, thousands of 
pharmaceuticals are approved for use, so individual generators of 
hazardous pharmaceutical wastes may generate hundreds of different 
types of pharmaceutical waste, some of which may be regulated as RCRA 
hazardous, and some of which are not.\26\ Sorting out the RCRA 
regulated pharmaceutical wastes from the non-hazardous pharmaceutical 
wastes at a hospital nursing station or emergency room can be 
difficult, and establishing separate collection of these small volumes 
of hazardous waste from multiple points within a facility, such as a 
hospital, in particular, can be complicated and burdensome for these 
generators. In contrast, industrial generators tend to generate only a 
few predictable waste streams in large quantities at relatively few 
generation points in the facility.
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    \26\ See discussion in Section IV.C.1 above. There are 
approximately 31 chemical ingredients used in drugs that are P or U 
listed, and which may make the waste drugs RCRA hazardous. This may 
translate into a hundred or more different commercial products. For 
example, warfarin and salts (P001) is used in at least 6 commercial 
pharmaceutical products, and Melphalan (U150) is used in 5 products. 
Further, pharmaceuticals may also contain chemicals from the TC 
regulatory list, such as arsenic or chromium (please see 40 CFR 
261.24 for a complete list of TC chemicals and their regulatory 
thresholds).
---------------------------------------------------------------------------

    The Agency's information about pharmaceutical waste management is 
limited. However, we do know that there are over 7,000 hospitals, and 
approximately 72,000 long-term-care facilities, 27,000 veterinary care 
facilities, 40,000 retail pharmacies, and several hundred thousand 
offices of doctors, dentists and other health care service providers in 
the United States, all of which are likely to generate some volume of 
pharmaceutical wastes and many of which will generate some that are 
RCRA hazardous. Yet, based on the 2005 Biennial Report, only 94 
hospitals and 19 pharmacies, for example, reported themselves to be 
LQGs of hazardous waste, and no long-term care or veterinary care 
facilities did so. While the vast majority of pharmaceutical waste 
generators are undoubtedly SQGs or CESQGs, information provided by 
generators themselves show a low level of knowledge about RCRA and its 
regulatory requirements, even on the part of some large facilities.
    The following sections provide an overview of some of the 
difficulties that generators of hazardous pharmaceutical waste have 
expressed concerning the current hazardous waste generator regulations.
1. Waste Determination
    As a result of communications with pharmaceutical waste generators, 
the

[[Page 73527]]

Agency understands that numerous health care facilities are either 
unaware of how the hazardous waste regulations apply to pharmaceutical 
wastes or, even if there is knowledge of RCRA, they have problems with 
training the workers that are generating these wastes on how to manage 
hazardous wastes properly.
    Other issues compound these difficulties in making hazardous waste 
determinations for pharmaceutical wastes. Pharmacists, nurses, and 
other health care workers generally do not receive training on 
hazardous waste management during their academic studies, while safety 
and environmental service managers may not be familiar with the active 
ingredients and formulations of the hundreds of available 
pharmaceutical products that may be used at a health care facility to 
enable them to make hazardous waste determinations.\27\ Yet these 
health care workers are often the generators of pharmaceutical wastes. 
Environmental service managers cannot be present as pharmaceutical 
wastes are being generated to make a hazardous waste determination and 
implement proper waste management. Making a hazardous waste 
determination is a multi-step process. First, generators must determine 
if the pharmaceutical waste in question is a solid waste (as defined in 
40 CFR 261.2). If the pharmaceutical is a solid waste, then the 
generator must determine if it is a solid waste excluded from 
regulation. If the waste is not excluded, the generator must determine 
whether the pharmaceutical waste is a listed hazardous waste in subpart 
D of Part 261. If the solid waste is not or does not contain a listed 
hazardous waste, the worker must then determine whether the solid waste 
exhibits any of the hazardous characteristics defined in subpart C of 
Part 261. While the hazardous waste determination could be made for 
pharmaceuticals that may become waste before they leave the pharmacy 
(by the pharmacists and the environmental manager together), 
implementing a separate collection system for these small volumes of 
hazardous pharmaceutical wastes could be burdensome, particularly in 
facilities with multiple points of generation.
---------------------------------------------------------------------------

    \27\ The Healthcare Environmental Resource Center and Practice 
Greenhealth. ``Managing Pharmaceutical Waste: A 10-Step Blueprint 
for Health Care Facilities in the United States'' (Revised August 
2008). https://www.hercenter.org/hazmat/tenstepblueprint.pdf.
---------------------------------------------------------------------------

    Failure to comply with the hazardous waste regulations by 
improperly managing and disposing of such waste can and has resulted in 
violations of the RCRA hazardous waste regulations, leading to large 
penalties for all types of health care facilities, from doctors' and 
veterinarians' offices and clinics, to pharmacies, long-term care 
facilities, and hospitals (see Profile of the Health Care Industry, EPA 
Office of Compliance Sector Notebook Project, EPA Publication  
EPA/310-R-05-002, also found at https://www.epa.gov/compliance/
resources/publications/assistance/sectors/notebooks/health.pdf).
    In addition to the hazardous waste regulations, pharmaceuticals are 
subject to a number of other statutes administered by other federal 
agencies and their regulatory regimes, and health care facilities have 
expressed confusion regarding the overlap between these other 
regulations and the hazardous waste requirements. Examples include 
pharmaceuticals that are controlled substances and subject to the 
Controlled Substances Act and DEA regulations; pharmaceuticals that 
have been prescribed to a patient and are subject to the Health 
Insurance Portability and Accountability Act (HIPAA) patient privacy 
requirements; pharmaceuticals with a radioactive component and are 
subject to the Atomic Energy Act (AEA); and infectious pharmaceutical 
wastes that are subject to state and local medical waste 
regulations.\28\ These potentially overlapping requirements (both with 
RCRA and with each other) make the appropriate management of 
pharmaceutical wastes a complex matter.
---------------------------------------------------------------------------

    \28\ Some state and local regulations may be more stringent than 
others regarding the regulation of infectious wastes. Some states 
require that wastes that are both infectious and hazardous be 
treated for both properties, whereas other states require that these 
``dual'' wastes be treated as hazardous.
---------------------------------------------------------------------------

2. Change in Generator Status From Conditionally Exempt Small Quantity 
Generators to Large Quantity Generators Due to Generation of Acutely 
Hazardous Wastes
    Hospitals and other health care facilities have also reported that 
their RCRA hazardous waste generator status periodically shifts from 
CESQG to LQG status due to the acutely hazardous (P-listed) 
pharmaceutical wastes they generate, since P-listed wastes have a low 
threshold for triggering a change in generator status (as CESQGs cannot 
generate or accumulate more than one kilogram per month), and CESQGs 
could find themselves easily exceeding this threshold to become a LQG. 
In addition, the requirements that containers once holding P-listed 
hazardous wastes are themselves considered P-listed hazardous wastes 
(see 40 CFR 261.33(c)), unless considered ``RCRA empty'' either by 
triple-rinsing with an appropriate solvent \29\ or cleaning by a method 
that has been proven in scientific literature or by tests conducted by 
the generator to achieve the equivalent removal (see 40 CFR 
261.7(b)(3)) can also contribute to a change in generator status. 
Therefore, in the event that such containers have not been properly 
cleaned, the weight of these containers that hold, or that have held, 
P-listed wastes quickly add up to exceed one kilogram, pushing 
facilities into LQG status and, thus, subjecting them to more stringent 
requirements than facilities with SQG or CESQG status. These 
requirements clearly add to the complexity and burden of managing 
pharmaceutical waste appropriately under the RCRA hazardous waste 
regulations and, given the number of different pharmaceuticals 
generated as waste and their small volumes, the benefit of the 
additional P-list requirements may not always be commensurate with th