Document ID: EPA-HQ-RCRA-2007-0932-0001
Agency: epa
Document Type: Proposed Rule
Title: Amendment to the Universal Waste Rule: Addition of Pharmaceuticals
Posted Date: 2008-12-02T05:00Z

[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Proposed Rules]               
[Page 73519-73544]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de08-26]                         

[[Page 73519]]

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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

[[Page 73520]]

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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:
     http://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 
http://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 http://
www.regulations.gov or e-mail. The http://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 http://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 http://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 http://
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 http://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.

[[Page 73521]]

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

    1. Submitting CBI. Do not submit this information to EPA through 
http://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

[[Page 73522]]

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: 
http://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

[[Page 73523]]

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 http://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.
---------------------------------------------------------------------------

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

    \15\ Medicinal nitroglycerin may qualify for this exclusion as 
it typically does not exhibit the characteristic of reactivity (see 
explanation in RO 14654).
---------------------------------------------------------------------------

2. Which Sources May Generate Hazardous Pharmaceutical Waste Subject to 
This Proposal? \16\
a. Health Care Facilities
---------------------------------------------------------------------------

    \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?
---------------------------------------------------------------------------

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

    \17\ Compounding occurs when pharmacists formulate prescription 
medications specifically as prescribed by a physician for a patient. 
For more information, see http://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). http://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.
---------------------------------------------------------------------------

    \19\ Ibid.
---------------------------------------------------------------------------

    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). http://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\
---------------------------------------------------------------------------

    \22\ Links for finding pharmaceutical take-back programs are 
listed at: http://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.
---------------------------------------------------------------------------

    \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). http://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 http://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 the 
burden they impose.
---------------------------------------------------------------------------

    \29\ The rinsates from the triple-rinsing of containers which 
have held commercial chemical products listed in 40 CFR 261.33(e) 
are also RCRA hazardous wastes because of the ``mixture and derived-
from rule'' (see 40 CFR 261.3(a)(2)(iv)).
---------------------------------------------------------------------------

3. Accumulation Time Limits
    Health care facilities and other pharmaceutical waste generators 
also express concern that the accumulation time limits for hazardous 
waste generators are not cost-effective with regard to hazardous 
pharmaceutical wastes. Pharmaceutical wastes are typically packaged and 
accumulated in relatively small volumes, so it can take a significant 
amount of time for a health care facility to accumulate enough waste to 
make offsite shipment using a hazardous waste transporter cost-
efficient. Thus, health care facilities have advocated longer 
accumulation times for hazardous pharmaceutical wastes.

E. What Is the Universal Waste Rule?

    This proposed rule would incorporate hazardous pharmaceutical 
wastes into 40 CFR part 273, the UWR. The UWR was promulgated on May 
11, 1995 (60 FR 25491), modifying the hazardous waste regulations by 
establishing a set of streamlined requirements for the collection of 
certain widely-dispersed hazardous wastes, which are called ``universal 
wastes.'' The UWR is designed to accomplish three general goals (see 58 
FR 8105-8106, February 11, 1993; and 60 FR 25501-25502, May 11, 1995):
     To encourage resource conservation.

[[Page 73528]]

     To improve implementation of the current RCRA subtitle C 
hazardous waste regulatory program.
     To separate universal waste from the municipal waste 
stream.
    The current federal universal wastes system includes hazardous 
waste batteries, certain hazardous waste pesticides, mercury-containing 
equipment, and hazardous waste lamps. These wastes share several 
characteristics (see 60 FR 25493, May 11, 1995): they are frequently 
generated in a wide variety of settings, often in settings other than 
the industrial settings usually associated with hazardous wastes; they 
are generated by a large community, the size of which poses 
implementation difficulties for both those facilities that are 
regulated and the regulatory agencies charged with implementing the 
hazardous waste program; and they may be present in significant volumes 
in non-hazardous waste management systems.
    Under the UWR, handlers and transporters who generate or manage 
items designated as a universal waste are subject to the management 
standards under 40 CFR part 273, rather than the full RCRA subtitle C 
hazardous waste regulations. Universal waste handlers include universal 
waste generators and collection facilities. The regulations distinguish 
between ``large quantity handlers of universal wastes'' (LQHUW; those 
who handle more than 5,000 kilograms of total universal waste at one 
time) and ``small quantity handlers of universal waste'' (SQHUW; those 
who handle 5,000 kilograms or less of universal waste at one time). The 
5,000 kilogram accumulation criterion applies to the quantity of all 
universal wastes accumulated. The streamlined standards include 
modified requirements for storage, labeling and marking, preparing the 
waste for shipment offsite, employee training, responses to releases, 
and notification.
    Transporters of universal waste are also subject to less stringent 
requirements than the full RCRA subtitle C hazardous waste 
transportation regulations. The primary difference between the 
universal waste transporter requirements and the subtitle C 
transportation requirements is that no manifest is required for the 
transport of universal waste. The details of the universal waste 
management standards for both handlers and transporters will be 
addressed later in this preamble.
    Under the UWR, destination facilities are those facilities that 
treat, store, dispose, or recycle universal wastes. Universal waste 
destination facilities are subject to all currently applicable 
requirements for hazardous waste treatment, storage, and disposal 
facilities (TSDFs), including the requirement to obtain a RCRA permit 
for such activities. Hazardous waste recycling facilities that do not 
store hazardous wastes prior to recycling may be exempt from permitting 
under the federal regulations (40 CFR 261.6(c)(2)).
    Finally, states that are authorized to implement the UWR may add 
wastes that are not federal universal wastes to their lists of 
universal wastes. Therefore, in some states, hazardous pharmaceutical 
wastes may already be regulated as universal wastes.

F. Why Is Pharmaceutical Waste Appropriate for Inclusion in the 
Universal Waste Framework?

    The Agency expects that the addition of hazardous pharmaceutical 
wastes to the UWR will improve the management of such pharmaceutical 
wastes by providing a more streamlined waste management system, while 
ensuring that they are sent to hazardous waste management facilities 
for final disposal. In addition, this proposed rulemaking would 
increase the accumulation and storage time limits in comparison to the 
full RCRA subtitle C hazardous waste regulations for hazardous 
pharmaceutical wastes, which would allow facilities to accumulate 
enough waste to make shipment through a hazardous waste hauler more 
cost-effective. Finally, while not required, this proposed rulemaking 
could facilitate the management of non-RCRA pharmaceutical wastes as 
universal wastes. If facilities choose to manage these non-RCRA 
pharmaceutical wastes as universal wastes, then: (1) Health care and 
other regulated facilities would no longer need to identify and 
separate hazardous pharmaceutical wastes from non-hazardous 
pharmaceutical wastes; and (2) the regulated community could decide to 
develop drug take-back programs, resulting in a decrease in the 
disposal of pharmaceutical wastes in municipal solid waste disposal 
facilities.
    EPA considers eight factors when evaluating whether or not it is 
appropriate to include a particular waste or wastes in the universal 
waste system. The factors were designed to determine whether regulating 
a particular hazardous waste under the streamlined standards of the UWR 
would improve overall management of the waste. These factors, which are 
codified at 40 CFR 273.81, are: (1) The waste, or category of waste, as 
generated by a wide variety of generators, should be a listed or 
characteristic hazardous waste; (2) the waste, or category of waste, 
should not be exclusive to a particular industry or group of 
industries, but generated by a wide variety of establishments; (3) the 
waste, or category of waste, should be generated by a large number of 
generators and generated frequently, but in relatively small 
quantities; (4) the systems to be used for collecting the waste, or 
category of waste (including packaging, marking and labeling 
practices), should ensure close stewardship of the waste; (5) the risks 
posed by the waste, or category of waste, during accumulation and 
transport should be relatively low compared to the risks posed by other 
hazardous waste, and specific management standards would be protective 
of human health and the environment during accumulation and transport; 
(6) the regulation of the waste, or category of waste, under 40 CFR 
part 273 will increase the likelihood that the waste will be diverted 
from non-hazardous waste management systems (e.g., the municipal solid 
waste stream) to recycling, treatment or disposal in compliance with 
subtitle C of RCRA; (7) the regulation of the waste, or category of 
waste, under 40 CFR part 273 will improve the implementation and 
compliance with the hazardous waste regulatory program; and (8) such 
factors as may be appropriate.
    The Agency weighed these factors collectively, rather than 
individually, when deciding to propose to add hazardous pharmaceutical 
waste to the universal waste system; however, as discussed in the final 
preamble of the UWR (60 FR 25492, May 11, 1995), it is not necessary 
for a particular waste or wastes to meet every factor to be classified 
as a universal waste (see 60 FR 25513). The following section discusses 
how pharmaceutical wastes meet these factors, and EPA solicits comment 
on the applicability of these factors to hazardous pharmaceutical 
wastes.
    1. The Waste, or Category of Waste, as Generated by a Wide Variety 
of Generators, Should Be a Listed or Characteristic Hazardous Waste: 
Several prescribed and over-the-counter pharmaceuticals, when 
discarded, are either listed hazardous wastes themselves or may contain 
a listed hazardous chemical as the sole active ingredient.\30\ For 
example, coumadin

[[Page 73529]]

(listed as warfarin as P001 and as U248),\31\ and products containing 
nicotine (listed as P075), as the sole active ingredient, are listed 
hazardous wastes.\32\ Other pharmaceuticals exhibit one or more 
characteristics of hazardous waste--ignitability, corrosivity, 
reactivity and/or toxicity. For example, certain topical preparations, 
including Cleocin T, Erythromycin topical solution and Retin A gel may 
exhibit the ignitibility characteristic. Acetic acid and sodium 
hydroxide are corrosive and certain nitroglycerin formulations may be 
reactive. Finally, mercury, arsenic, barium and other pharmaceuticals 
containing these metals may exhibit the TC.
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    \30\ If a chemical is listed on the P-list, then its container 
must also be managed as a hazardous waste, unless it has been 
declared ``RCRA empty'' via triple-rinsing see (40 CFR 261.7(b)(3) 
and 261.33(c)). Rinsates must also be managed as a hazardous waste 
because of the ``mixture and derived-from rule'' (see 40 CFR 
261.3(a)(2)(iv)). A container of U-listed waste must be managed as 
hazardous waste unless the waste is removed using practices commonly 
employed to remove material 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)).
    \31\ The P001 listing applies to warfarin and its salts when 
present at concentrations greater than 0.3 percent, and the U248 
listing applies to warfarin and its salts when present at 
concentrations of 0.3 percent or less.
    \32\ Please refer to 40 CFR 261.33 for the complete lists of P- 
and U-listed hazardous wastes.
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    2. The Waste, or Category of Waste, Should Not Be Exclusive to a 
Particular Industry or Group of Industries, But Generated by a Wide 
Variety of Establishments: Pharmaceutical wastes are generated by a 
variety of generators including, but not limited to: Doctors' offices; 
veterinary clinics and hospitals; morgues; retail pharmacies; long-term 
care facilities; hospitals; reverse distributors; and households. These 
entities engage in diverse activities and, as a result, generate 
varying amounts of hazardous pharmaceutical waste. Therefore, these 
generators come from a variety of sectors and range in generator status 
(LQG, SQG, or CESQG) to being exempt from the RCRA hazardous waste 
regulations under the household hazardous waste exclusion (40 CFR 
261.4(b)(1)) to LQGs.
    3. The Waste, or Category of Waste, Should Be Generated by a Large 
Number of Generators and Generated Frequently, But in Relatively Small 
Quantities: As described above, EPA believes that hazardous 
pharmaceutical wastes are generated by a wide range of generators from 
different sectors across the country. EPA believes that hazardous 
pharmaceutical wastes are also generated by a large number of 
generators as pharmaceuticals are commonly used for diagnosing, 
treating, or preventing an extremely broad range of medical problems 
and for cosmetic and lifestyle purposes. Health care facilities use 
pharmaceuticals on a daily basis and, thus, many also generate 
hazardous and non-hazardous pharmaceutical waste on a daily basis. Data 
from EPA's primary repository for information reported by LQGs, the 
2005 BRS, indicate that there is a limited number of health care-
related LQGs of hazardous pharmaceutical waste. The 2005 BRS lists 
approximately 94 hospitals, 13 reverse distributors, 22 physician's 
offices, 19 pharmacies, 19 outpatient care centers, and 6 ambulatory 
care centers in the United States that are LQGs generating hazardous 
pharmaceutical wastes. However, these BRS data do not represent 
households, CESQGs, or SQGs. In addition, these data do not represent 
any facilities that fail to report their RCRA-regulated hazardous waste 
generation activities, although, as discussed above, EPA believes that 
many health care-related facilities are unaware of their RCRA 
obligations. Therefore, the BRS data likely under-represents the total 
number of hazardous pharmaceutical waste generators in the U.S. 
Conversely, the BRS data may actually indicate that in the majority of 
healthcare-related facilities, small amounts of hazardous 
pharmaceutical wastes are generated, but not enough to categorize them 
as LQGs; or that many healthcare-related facilities are unaware of the 
RCRA hazardous waste requirements governing hazardous pharmaceutical 
wastes. Thus, the Agency believes that the generation of hazardous 
pharmaceutical waste is frequent and widespread, and it is generated in 
small amounts. However, the Agency solicits comment on this factor and 
specifically, any data that may be available regarding the number of 
generators that generate hazardous pharmaceutical waste, the frequency 
of generation, and the quantities that are generated.
    4. Systems To Be Used for Collecting the Waste, or Category of 
Waste (Including Packaging, Marking and Labeling Practices), Should 
Ensure Close Stewardship of the Waste: As discussed in the preamble of 
the 1995 UWR (60 FR 25514, May 11, 1995), the goal of this factor is to 
add those wastes to the universal waste system that are most likely to 
be collected in a manner that ensures good management. EPA believes 
that adding hazardous pharmaceutical wastes to the UWR will, by 
streamlining some waste handling requirements, ensure the close 
stewardship of these wastes as it will: (1) Help ensure the safe 
management of hazardous pharmaceutical wastes; (2) encourage the 
management of non-RCRA pharmaceutical wastes as universal wastes; and 
(3) facilitate pharmaceutical collection (take-back) programs. In 
addition, the packaging and labeling practices required for universal 
wastes will further: (1) Ensure that any hazardous pharmaceutical 
wastes being managed as universal wastes must be packed in containers 
that are structurally sound and compatible with the waste (see section 
V.D.1 for further discussion), and the container must be labeled 
appropriately with the words ``Universal Waste--Pharmaceuticals'' or 
``Waste Pharmaceuticals'' (see section V.E for further discussion); and 
(2) provide a framework for the management of any pharmaceutical waste 
that is not a RCRA listed or characteristic hazardous waste, but 
nevertheless may be hazardous to human health and the environment, and 
which the generator decides to manage as a universal waste, to be 
packed in appropriate containers and labeled as a universal waste as 
opposed to being disposed of in trash cans, containers containing 
sharps, or in sewers.
    5. Risks Posed by the Waste, or Category of Waste, During 
Accumulation and Transport Should Be Relatively Low Compared to the 
Risks Posed by Other Hazardous Waste, and Specific Management Standards 
Would Be Protective of Human Health and the Environment During 
Accumulation and Transport: Compared to other hazardous wastes, the 
environmental risks posed by most hazardous pharmaceutical wastes 
during accumulation and transport are relatively low. Most hazardous 
pharmaceutical wastes present a relatively low risk during accumulation 
and transport due to their form and packaging, which is typically in 
small, individually packaged doses, such as pills, 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 accumulated for disposal. Other pharmaceuticals, 
such as liquids and aerosols, 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 UWR 
container requirements would likely obviate this risk.
    6. Regulation of the Waste, or Category of Waste, Under 40 CFR Part 
273 Will Increase the Likelihood That the Waste Will Be Diverted From 
Non-Hazardous Waste Management Systems (e.g., the Municipal Solid Waste 
Stream) to Recycling, Treatment or Disposal in Compliance With Subtitle 
C of RCRA:

[[Page 73530]]

EPA expects the addition of pharmaceutical wastes to the universal 
waste system will increase the diversion of hazardous pharmaceutical 
wastes from non-hazardous waste management systems, as the streamlined 
UWR requirements will facilitate collection and disposal in accordance 
with the RCRA hazardous waste requirements of hazardous pharmaceutical 
wastes generated by households. In addition, identifying 
pharmaceuticals under the universal waste system also will likely 
divert non-hazardous pharmaceutical wastes from non-hazardous waste 
management systems.
    Additionally, regulation of hazardous pharmaceutical wastes under 
the UWR will facilitate the collection of commingled hazardous and non-
hazardous pharmaceutical wastes at healthcare-related and other such 
facilities.
    7. Regulation of the Waste, or Category of Waste, Under 40 CFR Part 
273 Will Improve the Implementation and Compliance With the Hazardous 
Waste Regulatory Program: Participation in the universal waste program 
by handlers of hazardous pharmaceutical wastes will improve 
implementation of and compliance with the hazardous waste regulations. 
Because hazardous pharmaceutical waste is often generated in small 
quantities by a diverse array of generators, such as hospitals, 
pharmacies, physicians' offices and veterinary clinics, among others, 
that are unfamiliar with or confused by the full RCRA hazardous waste 
rules, compliance with the full subtitle C hazardous waste requirements 
is difficult to achieve. Rather, we believe that these generators will 
find the UWR regime simpler and easier to follow and are thus more 
likely to comply with its requirements.
    For the above reasons, the Agency is proposing to add 
pharmaceutical wastes to the Universal Waste framework.

G. How Will Adding Hazardous Pharmaceutical Wastes to the Universal 
Waste Rule Help Address Pharmaceutical Waste Management Issues?

1. Application of the Universal Waste Rule to Pharmaceutical Wastes
    EPA believes that hazardous pharmaceutical wastes share the 
characteristics of other universal wastes discussed above. 
Specifically, most hazardous pharmaceutical wastes present a relatively 
low risk during accumulation and transport due to their form and 
packaging, which is typically in small, individually packaged dosages, 
such as pills or capsules. Hazardous pharmaceutical wastes are 
frequently generated in a wide variety of settings, including 
hospitals, pharmacies, long-term care facilities, veterinary offices 
and by reverse distributors, among others. They also are generated by 
several different types of personnel at these facilities, including 
pharmacists, doctors, nurses, and individual consumers. In addition, 
the RCRA hazardous waste management requirements often are unfamiliar 
to health care workers, retail pharmacy employees and other generators, 
prompting them to improperly dispose of hazardous pharmaceutical wastes 
as municipal or bulk wastes. This proposed action would streamline the 
current regulations governing these wastes, ensuring that larger 
quantities of hazardous pharmaceutical wastes are managed properly. 
Furthermore, this proposed rulemaking will bring to the generators' 
attention that hazardous pharmaceutical wastes are subject to the RCRA 
hazardous waste regulations.
    The UWR is specifically designed to reduce the complexity of the 
RCRA hazardous waste generator regulations for universal wastes. It 
streamlines the collection and handling requirements for widely 
dispersed hazardous wastes and facilitates their inclusion in the 
hazardous waste management system. By proposing to incorporate 
hazardous pharmaceutical waste in the universal waste regulations, EPA 
expects the management of hazardous pharmaceutical wastes to improve, 
while decreasing the regulatory burden for many hazardous 
pharmaceutical waste generators, large and small.
    The UWR also allows handlers to transport such materials with a 
common carrier that abides by the regulations set forth in Subpart D of 
the UWR, rather than a hazardous waste transporter, and generally would 
no longer require a handler to manifest waste to destination 
facilities.\33\ Furthermore, while the UWR regulates only RCRA 
hazardous wastes, the Agency anticipates that including pharmaceutical 
wastes in the UWR will encourage persons to manage other pharmaceutical 
wastes in the same manner, particularly those wastes that are not 
hazardous under RCRA, but which may nonetheless pose risks. Moreover, 
EPA expects that including hazardous pharmaceutical wastes in the UWR 
will facilitate the implementation of pharmaceutical take-back programs 
for retailers and commercial generators of such wastes, preventing 
mismanagement. Thus, the Agency expects that increased quantities of 
pharmaceutical wastes will be managed in destination facilities that 
are subject to the full RCRA subtitle C regulatory controls, as opposed 
to non-hazardous waste landfills and combustors. The Agency requests 
comment on the likelihood that the addition of pharmaceutical wastes to 
the universal waste system will increase the quantities of 
pharmaceutical wastes sent to hazardous waste management facilities.
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    \33\ If the universal waste will be transported through a state 
that does not recognize the waste as a universal waste, then a 
manifest must accompany the shipment for that portion of the trip.
---------------------------------------------------------------------------

a. Waste Determination
    This proposal would streamline the hazardous waste identification 
process for pharmaceutical waste generators in a number of ways. 
Specifically, the universal waste rule does not distinguish between 
acutely hazardous P-listed wastes and other hazardous wastes. As a 
result, handlers \34\ of pharmaceutical universal wastes would not be 
required to separate P-listed wastes from other hazardous wastes for 
purposes of tracking the volumes generated or accumulation volume 
limits. Additionally, while the proposal would cover only those wastes 
that are hazardous under the RCRA hazardous waste regulations, the 
streamlined management requirements may encourage facilities to manage 
the non-hazardous portion of the waste stream in a similar manner as 
the hazardous portion. That is, it could simplify the waste 
determination process by providing, but not requiring, the opportunity 
for all pharmaceutical wastes, hazardous or not, to be managed as a 
single waste stream.
---------------------------------------------------------------------------

    \34\ A handler of universal waste can be a person who generates, 
or creates, universal waste. A handler can also be a person who 
receives universal waste from generators or other handlers, 
consolidates the waste, and then sends it on to other handlers or 
treatment or disposal facilities. Universal waste handlers 
accumulate universal waste, but do not treat, recycle or dispose of 
them. See Section V.B.3. for further discussion.
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b. Accumulation Time and Generation Volume Limits
    As discussed above, handlers of universal waste are eligible for 
longer on-site accumulation time limits when compared to generators of 
hazardous waste (non-universal wastes). Also, while SQGs are subject to 
the hazardous waste generation volume limits of 1,000 kilograms per 
month, small quantity handlers of pharmaceutical universal waste would 
be subject to a higher threshold of 5,000 kilograms of all universal 
waste at any one time.
    EPA expects these increased generation volumes and accumulation 
time limits for pharmaceutical universal

[[Page 73531]]

waste to address the episodic generator status due to the generation of 
P-listed hazardous pharmaceutical wastes, which is currently affecting 
some hazardous pharmaceutical waste generators. EPA believes that the 
provisions proposed in this rulemaking would not increase the risk 
posed by the management of P-listed hazardous pharmaceutical wastes for 
several reasons. First, only eight chemicals on the P-list are used as 
pharmaceuticals, and of those eight, two are infrequently found to be 
hazardous waste in their pharmaceutical forms (see previous discussion 
of epinephrine, P042, and nitroglycerine, P081 in section IV.C.1 of 
this preamble). Thus, it is unlikely that the P-listed pharmaceutical 
wastes would be accumulated in large quantities. Furthermore, as stated 
earlier in this proposed rulemaking, the form and packaging in which 
pharmaceuticals are typically found (small, individually packaged 
doses, such as pills, capsules, or small vials) reduce the potential 
for release or exposure while they are being accumulated by handlers, 
shipped by transporters, and/or managed for disposal at destination 
facilities that are fully subject to RCRA subtitle C.
    EPA also expects that the longer accumulation times will allow 
pharmaceutical universal waste handlers to accumulate their waste in 
volumes large enough to make management of the pharmaceutical universal 
wastes more cost-effective by allowing handlers more control and 
flexibility in scheduling the removal of waste from their facility and 
by reducing the number of shipments. To the extent that this proposed 
rule results in the co-management of RCRA hazardous and non-hazardous 
pharmaceuticals with federally controlled substances, compliance with 
the Controlled Substances Act and DEA regulations might impact 
accumulation times for those wastes that are controlled substances.

V. Detailed Discussion of This Proposed Rule

A. Intent and Purpose of This Proposed Rule

    The Agency believes that pharmaceutical wastes meet the criteria 
for being identified as a universal waste and, thus, inclusion in the 
universal waste system is appropriate. Similarly, some states have 
already added hazardous pharmaceutical wastes to their universal waste 
programs \35\ in order to streamline their management and to facilitate 
their collection, and a number of other states have also considered 
doing so.\36\
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    \35\ Florida (62-730.186, F.A.C.) and Michigan (MICH. ADMIN. 
CODE R 299.9228 (2007)) have added pharmaceutical wastes to their 
UWRs. The Agency requests comment on how this proposed rule, if 
finalized, would affect Michigan's and Florida's authorization to 
run their pharmaceutical universal waste programs.
    \36\ EPA has explained that authorized states may expand their 
universal waste programs to include a waste that is not considered a 
universal waste under the federal regulations, as long as the waste 
meets the established universal waste criteria and the waste is a 
recognized hazardous waste in that particular state (60 FR 25537, 
May 11, 1995; also see ``Universal Waste Question and Answer 
Document,'' RO 14088).
---------------------------------------------------------------------------

    It should be noted, however, that the inclusion of hazardous 
pharmaceutical wastes in the universal waste system will not supersede 
or otherwise amend other laws or regulations and would only become 
effective if adopted and implemented by individual authorized states. 
Therefore, any entity involved in the handling or transport of 
pharmaceutical wastes as universal wastes must continue to comply with 
all requirements of the Controlled Substances Act and DEA regulations 
(21 CFR parts 1300-1316) for the handling of Schedule II through V 
drugs. Furthermore, any entity involved in the handling or transport of 
pharmaceutical wastes as universal wastes must comply with the U.S. 
Department of Health and Human Services' HIPAA standards in 45 CFR 
Parts 160, 162, and 164.
    With this proposal, EPA intends to stay within the existing UWR's 
framework. Therefore, the management requirements for pharmaceutical 
universal waste in this proposed rule do not significantly differ from 
the existing requirements for other universal wastes in 40 CFR part 
273. By proposing to add hazardous pharmaceutical wastes to the UWR, 
EPA is not reopening, and does not seek new comment upon, any 
provisions of the UWR not specifically addressed in this notice.

B. Applicability

1. RCRA Hazardous Pharmaceutical Wastes
    If finalized, the UWR will regulate only those pharmaceuticals that 
are RCRA hazardous waste. Under the current federal hazardous waste 
regulations, until a pharmaceutical is actually discarded, or the 
decision is made to discard the material, the pharmaceutical is not 
subject to the RCRA hazardous waste regulations since a material must 
first be a solid waste before it can be considered a hazardous waste 
(see 40 CFR 261.2 for the regulatory definition of solid waste). Once a 
generator establishes that a pharmaceutical is a solid waste under 
RCRA, the generator must then determine if the pharmaceutical waste is 
excluded from regulation and if not, whether it is a RCRA hazardous 
waste by verifying whether the waste appears on any of the hazardous 
wastes lists (F-list, K-list, P-list, or U-list),\37\ and/or exhibits 
at least one of four characteristics--ignitability, corrosivity, 
reactivity, or toxicity.\38\ An unused or expired drug that is being 
returned for potential credit to a reverse distributor is still 
considered to potentially have value for the pharmacy or hospital and 
so is not considered a solid waste. See Section IV.C.2.d for further 
discussion. On the other hand, pharmaceuticals that have no reasonable 
expectation of generating a manufacturer credit, and are not useable, 
must be managed as a waste. For example, opened or partially used 
containers of pharmaceuticals would not be considered to have value 
because they cannot be returned to a reverse distributor for possible 
credit, and so would be considered waste. When a pharmaceutical is no 
longer useable or the decision is made by the generator to discard the 
material, the RCRA regulations apply, and the generator must determine 
whether the waste is RCRA hazardous, and thus, manage it under the RCRA 
Subtitle C hazardous waste regulations.
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    \37\ It is unlikely that pharmaceutical wastes would appear on 
the F- and K-lists as these lists represent wastes generated during 
common manufacturing and industrial processes (non-specific source 
wastes) and wastes generated by specific industries (source specific 
wastes), respectively. For more information, see 40 CFR 261.31 for 
the F-list, and 40 CFR 261.32 for the K-list.
    \38\ For additional information on hazardous waste 
identification, please see http://www.epa.gov/osw/hazard/wastetypes/
wasteid/index.htm.
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    EPA is proposing to include within the universal waste system all 
pharmaceuticals that are hazardous wastes. Under this proposal, 
entities generating hazardous pharmaceutical wastes would have two 
options for managing them. Facilities may choose to continue managing 
these hazardous wastes under the full subtitle C hazardous waste 
regulations at 40 CFR parts 260 to 268 and 270, or they may choose to 
manage their hazardous pharmaceutical wastes as universal wastes using 
the requirements laid out in 40 CFR part 273. It is important to note 
that only pharmaceutical wastes that are listed or characteristic 
hazardous wastes (40 CFR 261.21-.33) are required to be managed under 
either the subtitle C hazardous waste regulations or, where allowed, 
under the UWR. However, as noted previously, EPA intends the UWR to 
encourage generators of hazardous wastes to manage the non-hazardous 
portions of

[[Page 73532]]

the waste stream in a similar manner as the hazardous portion. 
Therefore, EPA supports a generator's decision to use the universal 
waste management framework to manage any pharmaceutical waste even if 
it is not regulated as hazardous waste, but which nonetheless may pose 
a risk to human health or the environment when not properly managed. 
For example, a health care facility may decide to take advantage of the 
streamlined requirements and manage pharmaceutical wastes containing 
the drugs listed in Appendix A of the National Institute for 
Occupational Safety and Health (NIOSH) Alert, ``Preventing Occupational 
Exposure to Antineoplastic and Other Hazardous Drugs in Health Care 
Settings '' \39\ as universal wastes, in addition to the facility's 
RCRA hazardous waste drugs as a way of ensuring the safe disposal of 
these drugs. Other pharmaceutical wastes containing categories of non-
regulated drugs that may be managed as universal wastes are outlined in 
the Hospitals for a Healthy Environment's ``Managing Pharmaceutical 
Waste: A 10-Step Blueprint for Health Care Facilities in the United 
States'' (August 2008).\40\ For instance, a health care facility may 
choose to co-manage the following with pharmaceutical universal wastes 
as best management practices, although they are not RCRA hazardous 
wastes:
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    \39\ http://cdc.gov/niosh/docs/2004-165/2004-165c.html.
    \40\ http://www.hercenter.org/hazmat/tenstepblueprint.pdf.
---------------------------------------------------------------------------

     Any drug that contains a P-or U-listed chemical, 
regardless of whether or not that P-or U-listed chemical is the sole 
active ingredient \41\;
---------------------------------------------------------------------------

    \41\ Under the federal RCRA hazardous waste regulations, in 
order to be a P- or U-listed waste, the chemical in question must, 
among other things, contain the P- or U-listed chemical as the sole 
active ingredient. (Comment after 40 CFR 261.33(d); 45 FR 78541, 
Nov. 25, 1980.) Therefore, if a pharmaceutical has more than one 
active ingredient, and one or more of those active ingredients are 
P- and/or U-listed chemicals, then that pharmaceutical is not a 
listed hazardous waste. Additionally, if a P- or U-listed chemical 
is an inactive ingredient in a pharmaceutical, then that 
pharmaceutical is also not a listed hazardous waste (see comment to 
Section 261.33 (d); RO s 11350 and 13530). However, while 
the pharmaceuticals in these examples are not considered listed 
hazardous wastes, they may still be RCRA hazardous wastes if they 
exhibit at least one of the four RCRA characteristics of hazardous 
waste.
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     Chemotherapy drugs; and
     Drugs meeting OSHA and NIOSH hazardous drug criteria.
    It is important to note that this rulemaking would not apply to any 
hazardous pharmaceutical waste that also contains a radioactive 
material component (i.e. , mixed wastes). Mixed wastes are regulated by 
multiple agencies: The hazardous portion of the waste is regulated by 
EPA or the authorized state, while the radioactive component of the 
waste is regulated under the AEA by either the Nuclear Regulatory 
Commission (NRC) or the Department of Energy (DOE).\42\ Section 1006 of 
RCRA states that if RCRA regulations are inconsistent with the AEA 
requirements, then the RCRA requirements do not apply. Therefore, if 
generators managing a mixed hazardous pharmaceutical waste under RCRA 
subtitle C encounter RCRA requirements that are inconsistent with the 
AEA requirements, the AEA requirements apply. However, as discussed in 
the Joint NRC/EPA Guidance on Testing Requirements for Mixed 
Radioactive and Hazardous Waste (62 FR 62079, 62085; November 20, 
1997), an inconsistency occurs when compliance with one statute or set 
of regulations would necessarily cause non-compliance with the other 
and relief from an inconsistency would be limited to that specific RCRA 
requirement, and that the determination of an inconsistency would not 
relieve the generator from all other RCRA requirements.
---------------------------------------------------------------------------

    \42\ The NRC regulates radioactive wastes generated by 
commercial or non-DOE facilities, whereas DOE regulates radioactive 
wastes generated by DOE facilities.
---------------------------------------------------------------------------

    The Agency would like this opportunity to reiterate that RCRA, as 
well as this proposed rulemaking, does not supersede the requirements 
of the Controlled Substances Act and DEA regulations for the disposal 
of controlled substances. Thus, any entity generating, collecting, 
handling or managing a RCRA hazardous pharmaceutical waste that is also 
a controlled substance in Schedule II-V \43\ must abide by RCRA as well 
as the requirements of the Controlled Substances Act and DEA 
regulations. Three examples of listed hazardous wastes that are also 
controlled substances are phentermine (alpha, alpha-dimethyl-
benzenethanamine, P046), chloral hydrate (U034), and paraldehyde 
(U182). Not being an exhaustive list, there are possibly other 
controlled substances that exhibit characteristics of hazardous waste. 
EPA is requesting comment regarding how hazardous wastes that are 
controlled substances are currently being managed; if the inclusion of 
federally controlled substances in the federal universal waste program 
will change how these co-regulated wastes are being managed; and, if 
there are any negative effects on properly managing these wastes under 
both set of regulations. Finally, EPA seeks information on the volumes 
of controlled substances that are hazardous wastes disposed of 
annually.
---------------------------------------------------------------------------

    \43\ See 21 CFR 1308 for a complete list of controlled 
substances.
---------------------------------------------------------------------------

    Due to the stringent management of pharmaceutical wastes that are 
both controlled substances and RCRA hazardous wastes and their expected 
low volumes of generation due to the limited numbers of listed control 
substances, EPA also is seeking comment on whether or not hazardous 
pharmaceutical wastes that are also Schedule II-V controlled substances 
should be included in the federal universal waste program.
    The Agency requests information on whether health care facilities, 
reverse distributors and other hazardous pharmaceutical waste 
generators will choose to manage their pharmaceutical wastes as 
universal wastes if this proposed rule is finalized. Specifically, the 
Agency is requesting information on the likelihood of the following 
scenarios: (1) Facilities choosing to manage their hazardous and non-
hazardous pharmaceutical wastes as universal wastes; (2) facilities 
choosing to manage their hazardous pharmaceutical wastes and only 
certain categories (such as certain chemotherapy drugs) of 
pharmaceutical wastes not currently regulated as hazardous waste as 
universal wastes; (3) facilities choosing to manage only their 
hazardous pharmaceutical wastes as universal wastes; and (4) facilities 
choosing to manage their hazardous pharmaceutical wastes as hazardous 
wastes, not universal wastes. Furthermore, the Agency requests an 
explanation of why generators would choose one approach over another. 
Additionally, the Agency solicits information on the amount of 
pharmaceutical wastes generated at various health care facilities, as 
well as these facilities' pharmaceutical waste management practices. 
Finally, the Agency is seeking any cost information for the 
aforementioned scenarios.
2. Households and Conditionally Exempt Small Quantity Generators
    Currently, under the household hazardous waste exclusion in 40 CFR 
261.4(b)(1) of the federal hazardous waste program, hazardous wastes 
from households are not subject to the hazardous waste regulations, 
including the UWR provisions. However, EPA encourages ``households'' to 
dispose of any pharmaceutical wastes generated in their homes through 
local household hazardous waste management programs or community take-
back programs. Links for finding pharmaceutical take-back programs and 
donation programs

[[Page 73533]]

are listed at: http://www.epa.gov/ppcp/links.html#state.
    CESQGs are subject to limited waste management requirements under 
40 CFR 261.5. Specifically, CESQGs are not required to obtain an EPA ID 
number or to comply with the same accumulation and storage, 
manifesting, or recordkeeping and reporting requirements as SQGs or 
LQGs. However, CESQGs are required to identify which wastes are 
hazardous wastes, comply with some accumulation requirements and ensure 
that their hazardous wastes are properly treated or disposed. Under the 
existing UWR provisions, CESQGs may choose to manage certain hazardous 
wastes in accordance with either the CESQG regulations under 40 CFR 
261.5 or under the UWR at 40 CFR part 273. In addition, the provision 
under 40 CFR 273.8(b), which requires any universal waste that is mixed 
with a household or CESQG waste to be handled as a universal waste in 
accordance with 40 CFR part 273, will remain unchanged by this 
proposal, if finalized.
    The Agency requests information on whether persons exempted from 
subtitle C regulation would choose to manage their pharmaceutical 
wastes under the UWR.
3. Handlers of Universal Waste
    A handler of universal waste can be a person who generates 
universal waste. A handler can also be a person who receives universal 
waste from generators or other handlers, consolidates the waste, and 
then sends it on to other handlers or treatment or disposal facilities. 
Universal waste handlers accumulate universal waste, but do not treat, 
recycle or dispose of them. In addition, each location that is 
generating or collecting universal waste is considered a separate 
universal waste handler. Therefore, if a company has several locations 
at which universal waste is generated or collected, each location is a 
separate handler. Finally, the accumulation threshold that 
distinguishes between small and large handlers does not refer to any 
one category of universal waste, but refers to the total quantity of 
all universal waste accumulated on-site (UW pesticides, mercury-
containing equipment, etc.).
    As an example of who may be treated as a universal waste handler, 
if hazardous pharmaceutical wastes are added to the UWR, a hospital 
that is currently a LQG under the subtitle C regulations can decide to 
manage its hazardous pharmaceutical waste as a universal waste, as a 
universal waste handler.\44\ Additionally, reverse distributors may 
choose to become universal waste handlers under the UWR and may choose 
to accept universal waste from other universal waste handlers for 
purposes of consolidation.\45\ Under this scenario, reverse 
distributors may accept both pharmaceutical universal waste and unused 
and ``creditable'' pharmaceutical products from health care facilities, 
but, due to requirements under current DEA regulations, reverse 
distributors may not accept controlled substances from consumers or 
other persons who are not registered with DEA.\46\
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    \44\ Wastes that are managed as universal wastes do not count 
toward the facility's hazardous waste generator status. See 40 CFR 
261.5; 262.10. However, while the facility may be recognized as a 
handler for the purposes of universal waste, it is still considered 
a generator if any other listed or characteristic hazardous wastes 
are generated in addition to the universal wastes. See 40 CFR 
261.5(c).
    \45\ Currently under RCRA, reverse distributors can only accept 
pharmaceuticals that are product and not waste. Please see 
discussion in section IV.C.2.d of this preamble.
    \46\ See http://www.deadiversion.usdoj.gov/faq/general.htm#pre_
med for more information.
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    Under this proposal, most of the existing universal waste 
requirements currently applicable to SQHUWs and LQHUWs would also apply 
to handlers of hazardous pharmaceutical wastes. For both SQHUWs and 
LQHUWs, these requirements include labeling and marking, accumulation 
time limits, employee training, response to releases, requirements 
related to off-site shipments, and export requirements. Sections 
V.B.3.a and V.B.3.b discuss the specific differences between the small 
quantity handler and large quantity handler requirements for universal 
wastes.
a. Small Quantity Handler of Universal Waste
    As defined in 40 CFR 273.9, a SQHUW is a universal waste handler 
who accumulates less than 5,000 kilograms total of universal waste at 
any time (e.g., batteries, pesticides, mercury-containing equipment 
(MCE), lamps and pharmaceuticals (as proposed), calculated 
collectively). SQHUWs do not need to notify EPA of their universal 
waste activities (as noted under 40 CFR 273.12) and are not required to 
obtain an EPA identification number prior to managing universal wastes. 
In addition, SQHUWs have less stringent requirements for the training 
of employees (discussed in section V.G.) and for the tracking of 
universal wastes (discussed in section V.J.) compared to the 
requirements for LQHUWs. However, if a SQHUW accumulates 5,000 kg or 
more of universal waste at any one time, that handler must then comply 
with all LQHUW requirements and must continue to do so for the 
remainder of the calendar year.
    EPA is proposing to maintain and is soliciting comment on 
maintaining the current SQHUW threshold and notification requirements 
for those small quantity handlers that would be managing hazardous 
pharmaceutical wastes as universal wastes. EPA is not soliciting 
comment on or considering changes to these requirements for SQHUWs of 
other universal wastes.
b. Large Quantity Handlers of Universal Waste
    A LQHUW is defined in 40 CFR 273.9 as a universal waste handler who 
accumulates 5,000 kilograms or more of universal waste at any time 
(e.g., the total amount of batteries, pesticides, MCE, lamps and 
pharmaceuticals (as proposed), calculated collectively). As is 
discussed in subpart C of 40 CFR part 273 of the existing regulations, 
LQHUWs must send written notification of their universal waste 
management to the Regional Administrator, and receive an EPA 
identification number before meeting or exceeding the 5,000 kg storage 
limit. However, a LQHUW is not required to notify/re-notify that he is 
handling universal waste if he has already notified EPA and obtained an 
identification number for other hazardous waste management activities. 
Once the 5,000 kg threshold is met, the designation of LQHUW is 
retained by the handler for the remainder of the calendar year; 
however, the handler may reevaluate his status as a LQHUW in the 
following calendar year. In addition to the notification requirements, 
LQHUWs have more stringent training and waste tracking requirements 
than SQHUWs. These requirements are discussed further in sections V.G. 
and V.J. of this preamble, respectively.
    EPA is proposing to maintain the existing LQHUW threshold and 
notification requirements for those large quantity handlers that would 
be managing hazardous pharmaceutical wastes as universal wastes and 
solicits comments on this proposal. EPA is not soliciting comment on or 
considering changes to these requirements for LQHUWs of other universal 
wastes.

[[Page 73534]]

C. Definitions

    As used in this proposed rule,\47\ the term ``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 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.'' The definition of 
pharmaceutical is adapted from the Federal Food, Drug and Cosmetic 
Act's definition for ``drug.'' 21 U.S.C. 321(g)(1)(B) and (C). As 
discussed above, this definition is meant to include, but is not 
limited to, such things as pills or tablets, medicinal gums or 
lozenges, medicinal liquids, ointments and lotions, 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 dispense or deliver a 
chemical product, vaccine or allergenic.
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    \47\ Please see discussion in section IV.B of this preamble for 
more information regarding the definitions proposed for this 
rulemaking.
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    In contrast, the definition of pharmaceutical is not intended to 
include sharps (e.g., needles from IV bags or syringes),\48\ waste 
chemicals from laboratories, medical devices (e.g., blood pressure 
cuffs, mercury thermometers, x-ray films and fixers),\49\ dental 
amalgams, infectious or biohazardous ``red-bag'' waste,\50\ personal 
protective equipment contaminated with hazardous pharmaceuticals (e.g., 
scrubs, gowns, gloves), any materials used to clean up spills of 
hazardous pharmaceutical wastes, or wastes resulting from 
pharmaceuticals manufacturing or distribution.
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    \48\ 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 http://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).
    \49\ Medical devices (with the exception of devices with a 
primary purpose of dispensing or delivering a chemical product, 
vaccine or allergenic of delivery devices) 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.
    \50\ Infectious or biohazardous ``red-bag'' wastes are medical 
wastes, which are regulated at the state and local level.
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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., pill 
bottles, vials, IV bags, and tubes of ointment/gel/cream, 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'' 51, 52) could also be managed in 
the universal waste system. As a result of defining ``pharmaceutical 
universal waste'' for the reason described above, the ``Applicability'' 
section in Sec.  273.6 of the proposed regulatory text will not be 
parallel to the ``Applicability'' sections for the other universal 
waste regulations included in the federal RCRA subtitle C hazardous 
waste regulations.\53\ Specifically, the Agency has proposed to omit 
the regulatory language describing what pharmaceuticals would not be 
covered under 40 CFR part 273 of the proposed pharmaceutical universal 
waste rule. The reason for proposing this omission is that discussing 
what is not covered would be redundant as the proposed definition of 
``pharmaceutical universal waste'' clearly addresses that 40 CFR part 
273 would apply to pharmaceuticals and ``non-empty'' containers of 
pharmaceutical waste that are hazardous wastes. The Agency notes that 
these proposed modifications were only made in order to avoid 
redundancy with the definitions proposed in 40 CFR 260.10 and 273.9.
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    \51\ 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)). Please see footnote 6 for more details.
    \52\ 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 
(``Epinephrine Residue in a Syringe is Not P042,'' RO 
13718; letter to Mr. Gary Chilcott (Sure-Way Systems Inc.) 
from Robert Dellinger RO 14788).
    \53\ The ``Applicability'' sections for each universal waste are 
found in subpart A of part 273. Each ``Applicability'' section 
describes the following: (1) What wastes are included under 40 CFR 
273; (2) what wastes are not covered under 40 CFR 273; and (3) when 
the material becomes a ``waste.''
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    The Agency is requesting comment on the proposed definition of 
``pharmaceutical.'' Specifically, EPA is seeking comment on whether the 
definition of ``pharmaceutical'' is clear and appropriate, and whether 
it encompasses the full range of pharmaceuticals available. In 
addition, EPA is seeking comment on whether this definition 
inadvertently includes items not intended to be incorporated into the 
universal waste system, such as dental or medical devices. The Agency 
is also requesting comment on, in order to add hazardous pharmaceutical 
wastes to the UWR, whether additional elements not included in this 
proposal need to be added to this proposed definition. Finally, the 
Agency requests comment on whether the proposed definition of 
``pharmaceutical universal waste'' is clear and appropriate.

D. Waste Management

    As it is stated in 40 CFR 273.11 and 273.31, all universal waste 
handlers are prohibited from disposing of universal wastes, or diluting 
or treating universal waste, except for responding to releases (as 
provided in 40 CFR 273.17 and 273.37), or managing specific wastes (as 
provided in 40 CFR 273.13 and 273.33). Handlers of pharmaceutical 
universal wastes must manage these wastes in a manner that prevents 
releases of universal wastes or components thereof into the environment 
(as is required for other universal wastes; see 40 CFR 273.13 and 
273.33). These existing provisions are mostly maintained in this 
proposed rulemaking--that is, paragraphs 273.13(e) and 273.33(e) of 
these proposed regulations address the specific waste management 
requirements proposed for pharmaceutical wastes by small and large 
quantity handlers, respectively. Some other aspects of universal waste 
handling would be revised only for pharmaceutical wastes by this 
proposal as described immediately below.
1. Containers
    To prevent their release into the environment, the Agency is 
proposing to require that pharmaceutical universal wastes must be 
packed into containers

[[Page 73535]]

that are structurally sound and compatible with the pharmaceutical 
wastes that will be contained within them. That is, the containers must 
not have any evidence of leakage, spillage or damage that could result 
in the release of waste under reasonably foreseeable circumstances. EPA 
intends this requirement to mean that containers used for holding 
pharmaceutical universal wastes must be in good condition, with no 
severe rusting, apparent structural defects, or deterioration. 
Furthermore, the Agency is proposing to require that incompatible 
wastes not be placed in the same container, unless in compliance with 
40 CFR 265.17(b).
    Unlike the container requirements for other universal wastes, the 
proposed container requirements for pharmaceutical universal wastes do 
not include the requirement that containers be ``closed.'' EPA believes 
that requiring closed containers for pharmaceutical wastes would 
provide a burden that is unwarranted in these situations as most 
pharmaceutical universal wastes would be unused and in their original 
packaging when disposed, and so accumulating these wastes in a larger 
container would pose little, if any, risk of release through spillage, 
leakage or emission to the air. Thus, as proposed, accumulation 
containers for pharmaceutical universal wastes may be open, covered, or 
sealed, as long as the performance standard to prevent releases is 
met.\54\ However, the Agency also understands that there are likely to 
be pharmaceutical universal wastes that have been removed from their 
original packaging, or that will be in liquid or semi-solid form when 
discarded into the universal waste container. Therefore, handlers must 
take any appropriate measures necessary to prevent releases of these 
wastes. Such measures may mean covering the container to prevent 
emissions or placing the collection container in an inconspicuous space 
or securing the container to a building support, cart or other 
equipment to prevent releases due to the container being tipped or 
knocked over.
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    \54\ Please note that persons managing controlled substances 
must comply with all requirements of the Controlled Substances Act 
and DEA regulations for the handling and disposal of controlled 
substances.
---------------------------------------------------------------------------

    EPA seeks comment on whether the proposed container management 
standards are appropriate for pharmaceutical universal wastes. 
Additionally, EPA seeks comment on whether the containers should be 
required to be ``closed'' or ``covered,'' except when waste is being 
added to or removed from the containers, in order to prevent releases 
during accumulation. Specifically, EPA is requesting information on 
scenarios in which a ``closed'' or ``covered'' requirement would be 
appropriate. EPA is not seeking, nor will we respond to, comments on 
whether to remove the term ``closed'' from the container requirements 
of the other types of universal wastes, since that is not the subject 
being addressed in this proposed rule. Finally, EPA also requests 
comment on whether handlers of pharmaceutical universal wastes should 
be required to maintain the pharmaceutical wastes in their original 
packaging if received as such.
2. Sorting
    The Agency is proposing specifically to allow, but not require, 
sorting of pharmaceutical universal wastes. Sorting is currently 
allowed for handlers of universal waste batteries (see 40 CFR 
273.13(a)(2) for SQHUW and 40 CFR 273.33(a)(2) for LQHUW). For 
pharmaceutical universal wastes, the proposed rule allows sorting 
provided the handler ensures compliance with all applicable OSHA 
regulations \55\ and ensures that employees tasked with sorting the 
pharmaceutical wastes are thoroughly familiar with the pharmaceutical 
universal waste handling and emergency procedures. Handlers also should 
not commingle sharps, such as needles, scalpel blades or scissors, 
medical devices \56\ or infectious wastes, with the pharmaceutical 
wastes being managed. If a handler sorts pharmaceutical universal 
wastes to separate those that are incompatible or to segregate out non-
universal wastes from the pharmaceutical universal wastes, EPA 
recommends that handlers keep pharmaceutical universal wastes in their 
original packaging, to decrease chemical exposure for employees 
handling the wastes, as well as the risk of reactions between any 
possible incompatible materials. Alternatively, the Agency encourages, 
but is not requiring, handlers generating pharmaceutical universal 
waste to place any pharmaceutical that is not in its original packaging 
\57\ or is contained in packing that could be compromised \58\ 
(especially liquids, IV bags, IV bag tubing, etc.) into a separate 
individual container, such as a sealed zipper storage bag, prior to 
placing the pharmaceutical universal waste into the universal waste 
accumulation container. Adhering to these precautions would further 
protect the personnel sorting the wastes and would prevent 
contamination of the commingled waste should any bags, tubing, or vials 
leak or break. Furthermore, the individual containers would prevent 
entanglement of tubing, thereby reducing sorting time.
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    \55\ For more information on applicable OSHA standards, see 
OSHA's Bloodborne Pathogens Standard at 29 CFR 1910.1030, Technical 
Manual on Controlling Occupation Exposure to Hazardous Drugs, found 
at http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html and 
Compliance Assistance document for the Health Care Industry, found 
at http://www.osha.gov/dcsp/compliance_assistance/quickstarts/
health_care/health_care.html#Step%201.
    \56\ Some medical devices, such as mercury thermometers, may 
meet the definition of ``mercury-containing equipment'' in 40 CFR 
273.9 and thus may be eligible for management under the UWR as 
``Universal Waste--Mercury Containing Equipment.'' (Please see 
subpart B and C of the UWR for the small quantity and large quantity 
handler standards, respectively, for mercury-containing equipment.)
    \57\ That is, any pharmaceutical that is not already contained 
in a blister pack, bottle, box, etc., but is loose.
    \58\ Any pharmaceutical contained in packaging that can be 
punctured (e.g., IV bags) or broken (e.g., glass vials), etc.
---------------------------------------------------------------------------

    EPA seeks comment on the proposed pharmaceutical universal waste 
sorting provisions. Specifically, the Agency requests comments on 
whether sorting of pharmaceutical universal wastes should be required, 
or whether requiring sorting is unnecessary due to the forms in which 
pharmaceuticals are typically found. Finally, the Agency requests 
examples of accidents that have occurred, or may occur, at health care 
facilities or reverse distributors due to incidents of incompatible 
hazardous pharmaceutical wastes being stored together.
3. Generation of Solid Wastes
    As a result of sorting activities, solid wastes (both 
pharmaceutical and non-pharmaceutical) may be generated. It is the 
responsibility of the handler to determine if the generated solid waste 
is a listed hazardous waste or exhibits a hazardous waste 
characteristic (see subparts C and D in 40 CFR part 261). If it is 
determined that the waste is hazardous, but it does not meet the 
definition of ``pharmaceutical,'' then it must be managed in compliance 
with all applicable requirements of 40 CFR parts 260 through 268 and 
270. The handler would also be considered a generator of hazardous 
waste and would therefore be subject to the generator requirements at 
40 CFR part 262. However, if it is determined that the generated solid 
waste is not hazardous, then it can be managed as a solid waste, and 
must be managed in accordance with all applicable federal, state or 
local solid waste regulations.

[[Page 73536]]

E. Labeling/Marking

    The Agency is proposing that universal waste handlers managing 
pharmaceutical universal waste label each individual pharmaceutical 
universal waste item or accumulating container holding the 
pharmaceutical universal waste with the words ``Universal Waste--
Pharmaceuticals,'' or ``Waste Pharmaceuticals.'' These requirements can 
be found in 40 CFR 273.14(f) and 273.34(f) of the proposed rule. The 
Agency is requesting comments on the appropriateness of the proposed 
general labeling requirements for pharmaceutical universal wastes. 
Specifically, the Agency requests comment on whether, in order for the 
destination facility to have sufficient information on the 
pharmaceutical universal wastes they receive, universal waste handlers 
should be required to include on the label the relevant chemical 
information or the hazardous waste code.

F. Accumulation Time Limits

    The existing UWR contains a one year accumulation limit for both 
SQHUWs and LQHUWs, as well as requirements for demonstrating the 
accumulation time (e.g., dating the label when the item first becomes a 
waste, or maintaining an inventory system identifying the date when the 
item became a waste). The UWR allows accumulation for more than one 
year if it is solely for accumulating such quantities of universal 
waste as are necessary to facilitate proper recovery, treatment, or 
disposal. See 40 CFR 273.15(a)-(c) and 273.35(a)-(c). Thus, we assume 
that any accumulation up to one year is for this purpose but, for any 
accumulation beyond one year, the handler bears the burden of 
demonstrating that accumulation is solely to facilitate proper 
recovery, treatment or disposal.
    The Agency is proposing to continue to use these accumulation time 
limits for pharmaceutical universal wastes. The Agency is requesting 
comments, however, on whether a different time limit is appropriate for 
handlers of pharmaceutical universal wastes and whether small and large 
pharmaceutical universal waste handlers should be subject to different 
accumulation time limits. In addition, the Agency is seeking comment 
and data on whether any pharmaceutical wastes or mixtures of 
pharmaceutical wastes tend to become more dangerous with age. EPA is 
not seeking, nor will it respond to, comments on whether to change the 
accumulation time limits for handlers of other types of universal 
wastes, which are not covered in this proposal.

G. Employee Training

    The employee training requirements for small and large quantity 
handlers of universal waste can be found in 40 CFR 273.16 and 273.36, 
respectively. The Agency is proposing that the employee training 
requirements for pharmaceutical universal wastes be the same as the 
training requirements for other universal wastes.\59\ Briefly, the 
existing universal waste training requirements require that LQHUW 
ensure that all employees are thoroughly familiar with the proper waste 
handling and emergency procedures related to their responsibilities 
during normal facility operations and emergencies.\60\ SQHUW must 
inform all employees that handle or have responsibilities for managing 
universal waste of the proper handling and emergency procedures 
appropriate to the type(s) of universal wastes managed at the 
facility.\61\ A basic employee training requirement is necessary to 
ensure that employees are specifically familiar with the waste handling 
procedures under the UWR. The Agency believes that training provided 
under other programs that would meet any or all of the 40 CFR part 273 
training requirements may be used to fulfill these requirements. As 
long as the substantive standards of the training provisions are met, 
the handler has fulfilled the training requirement. There is no 
requirement that the training provided to meet these requirements must 
be separate from other training given to employees. In addition, the 
Agency strongly urges handlers to familiarize their employees with the 
regulations of the U.S. Department of Health and Human Services 
(regarding HIPAA), DEA, OSHA and DOT as these agencies' regulations may 
impose additional training requirements beyond those of the UWR.
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    \59\ For further discussion of the UWR employee training 
requirements, see 60 FR 25527-25528; May 11, 1995.
    \60\ LQHUW are not required to keep employee training records 
(see 60 FR 25528; May 11, 1995).
    \61\ SQHUW may inform their employees of proper handling and 
emergency procedures via verbal communication or through the 
distribution of pamphlets or other documentation (see 60 FR 25528; 
May 11, 1995).
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    The Agency is requesting comments on whether this rule should 
require specialized training for some or all handlers for sorting 
pharmaceutical universal wastes. EPA is not seeking, nor will the 
Agency respond to, comments on whether to change the training 
requirements for handlers of other types of universal wastes which are 
not covered in this proposal.

H. Responses to Releases

    The response to releases requirements for small and large quantity 
handlers of universal waste are found in 40 CFR 273.17 and 273.37. 
These regulations include basic release responses, including the 
requirement that handlers immediately contain all releases of, and 
other residues from, universal wastes. Then the handlers must determine 
whether any material resulting from the release is hazardous waste and, 
if so, must manage it under the full RCRA subtitle C hazardous waste 
regulations. Handlers, however, are not subject to facility-wide 
corrective action when there is a release of universal waste.
    Any releases of universal waste not cleaned up constitutes illegal 
disposal allowing further action by EPA under RCRA. In addition, any 
releases of hazardous substances above the reportable quantity (RQ) 
thresholds must be reported under the Comprehensive Environmental 
Response, Compensation, and Liability Act (CERCLA) (see CERCLA section 
103 (42 U.S.C. 9603(a))). Since universal wastes are hazardous wastes 
and, thus, hazardous substances under CERCLA, reporting for universal 
waste releases is required if RQs are exceeded (see 40 CFR 302.4 for 
RQs for hazardous substances). Such reports provide notification to the 
Agency concerning releases and would thus allow the Agency to take 
action, if necessary, under either RCRA or CERCLA.
    This notice does not propose to change any of the existing 
requirements for responding to releases of hazardous pharmaceutical 
wastes.

I. Off-Site Shipments

    The requirements for off-site shipments under the UWR are included 
in 40 CFR 273.18 and 273.38. To summarize the off-site shipment 
requirements of the UWR, handlers of both small and large quantities of 
universal waste are prohibited from sending or taking universal waste 
to a place other than another universal waste handler, a destination 
facility, or a foreign destination. Universal waste handlers can either 
contract with someone else to transport their universal waste or 
transport it themselves.\62\ If a universal waste being offered for 
off-site transportation meets the definition of hazardous materials 
under DOT 49 CFR 171-180, the

[[Page 73537]]

handler of the universal waste must package, label, mark, and placard 
the shipment in accordance with the DOT regulations under 49 CFR parts 
172-180 and must prepare the proper shipping papers.
---------------------------------------------------------------------------

    \62\ If a handler chooses to self-transport universal wastes 
off-site, that handler must comply with the universal waste 
transporter requirements found in subpart D of the universal waste 
regulations.
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    Under the UWR, both the shipper (a small or large quantity handler 
of universal waste who is shipping the universal waste to another 
handler or destination facility) and the receiving facility (a small or 
large quantity handler of universal waste, or destination facility 
receiving a shipment of universal waste from another universal waste 
handler) share certain responsibilities for the proper handling of the 
universal wastes being shipped. For instance, in order to prevent or 
limit rejected shipments, 40 CFR 273.18(d) and 273.38(d) of the UWR 
specify that the shipper of the universal waste must ensure that a 
receiving universal waste handler agrees to receive the shipment prior 
to the waste being sent. In addition, 40 CFR 273.18(e) and 273.38(e) of 
the rule specify that if the shipper sends universal waste to another 
handler or destination facility and the shipment is rejected, the 
shipping handler must receive the waste back or agree with the 
receiving facility on a destination facility to which the shipment will 
be sent. Sections 273.18(f), 273.38(f) and 273.61(b) provide that if an 
unsuitable shipment containing universal waste is received, the 
receiving facility, in turn, may reject the full shipment or a portion 
of the shipment. At that time, the receiving facility must notify the 
shipper of the rejection and discuss reshipment of the load.\63\ In 
addition, 40 CFR 273.18(g), 273.38(g), and 273.61(c) of the UWR address 
the procedures to be followed if a handler receives a shipment of 
hazardous waste that is not a universal waste. Specifically, these 
subsections state that should such a shipment be received, the 
receiving facility must immediately notify the appropriate regional EPA 
office (or the authorized state, when appropriate) of the illegal 
shipment and provide the name, address, and phone number of the 
shipper. The EPA regional office (or state) would provide instructions 
to the receiving facility for managing the hazardous waste. Finally, 
when a handler of universal waste receives a shipment of non-hazardous, 
non-universal waste, the handler must manage the waste in compliance 
with applicable federal or state solid waste regulations.
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    \63\ The receiving facility may send the rejected shipment back 
to the original shipper or to a mutually agreed upon destination 
facility.
---------------------------------------------------------------------------

    This notice does not propose to change any of the existing 
requirements applicable to the off-site shipping of universal waste, 
including pharmaceutical waste managed as universal waste.

J. Tracking Universal Waste Shipments

    Manifests are not required for any shipments of universal waste by 
small and large quantity handlers of universal waste. Small quantity 
handlers are not required to track shipments,\64\ including shipments 
to destination facilities. However, the UWR does include a basic 
recordkeeping requirement to track waste shipments arriving at and 
leaving from handlers of LQHUWs. These basic tracking requirements are 
found in 40 CFR 273.19 and 273.39.
---------------------------------------------------------------------------

    \64\ If the universal waste will be transported through a state 
that does not recognize the waste as a universal waste, then a 
manifest is required.
---------------------------------------------------------------------------

    For each shipment of universal waste received at or sent by a large 
quantity handler, the record \65\ must include the name and address of 
the universal waste handler or foreign shipper to or from whom the 
universal waste was sent; the quantity of each type of universal waste 
sent or received (e.g., batteries, pesticides, thermostats, MCEs, 
lamps, and pharmaceuticals, if this rule is finalized as proposed); and 
the date of receipt of the shipment of universal waste.
---------------------------------------------------------------------------

    \65\ The required records may take the form of a log, invoice, 
manifest, bill of lading or other shipping document.
---------------------------------------------------------------------------

    This notice does not propose to change any of the existing 
requirements applicable to the tracking of universal waste shipments, 
including pharmaceutical waste managed as universal waste.

K. Exports

    The export requirements for small and large handlers of universal 
waste are found in 40 CFR 273.20 and 273.40, respectively. A handler 
sending universal waste to a foreign destination, without first sending 
the waste to a consolidation point or destination facility, would be 
subject to the requirements equivalent to the existing hazardous waste 
export requirements found at subpart E of 40 CFR part 262, even though 
a manifest would not be required. Thus, all universal waste shipments 
would follow procedures for notification and consent which are 
independent of the manifest procedures. Also, as discussed in the 
previous section, LQHUW are required to keep records of where they send 
universal waste, and from where they receive universal waste, including 
foreign destinations or shippers.
    This notice does not propose to change any of the existing 
requirements applicable to the export of universal wastes, including 
pharmaceutical waste managed as universal waste.

L. Standards for Universal Waste Transporters

    The requirements for universal waste transporters are found under 
40 CFR 273.50 through 273.56. Briefly, universal waste transporters are 
prohibited from disposing and diluting or treating universal wastes; 
must handle universal wastes in compliance with all applicable DOT 
regulations; and must only transport universal wastes to handlers, 
destination facilities, or to foreign destinations. In addition, 
transporters may only store universal wastes for ten days or less; \66\ 
must respond to releases; and must follow certain export requirements, 
if shipping to a foreign destination.\67\
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    \66\ A transporter storing a universal waste for more than ten 
days will be considered a handler and must comply with the standards 
for either a small or large quantity handler, whichever is 
appropriate.
    \67\ For a more detailed discussion regarding the universal 
waste transporter requirements, please see 60 FR 25532--25533 of the 
May 11, 1995, final UWR.
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    This notice does not propose to change any of the existing 
requirements applicable to transporters of universal wastes, including 
pharmaceutical wastes managed as universal wastes.

M. Standards for Destination Facilities

    As described in 40 CFR 273.9 of the existing UWR, a destination 
facility is ``a facility that treats, disposes of, or recycles a 
particular category of universal waste, except those management 
activities described in paragraphs (a) and (c) of 40 CFR 273.13 and 
273.33. A facility at which a particular category of universal waste is 
only accumulated is not a destination facility for purposes of managing 
that category of universal waste.'' The standards for destination 
facilities can be found under 40 CFR part 273, subpart E of the 
existing UWR, and they are briefly summarized below.
    The standards state that destination facilities are subject to all 
applicable requirements of 40 CFR parts 264, 265, 266, 268, 270 and 124 
of Title 40 and, if the destination facility recycles universal wastes 
without storing them before they are recycled, to 40 CFR 261.6(c)(2). 
In addition, the notification requirement under Sec.  3010 of RCRA 
still applies to destination facilities accepting universal wastes.
    Destination facilities also have requirements for off-site 
shipments of

[[Page 73538]]

universal wastes. Similar to the off-site shipment standards for 
universal waste handlers (previously discussed in section V.I of this 
preamble), destination facilities can only send or take universal 
wastes to handlers, other destination facilities or foreign destination 
facilities. Destination facilities can also reject shipments or 
portions of shipments containing universal wastes, but the destination 
facility owner or operator must notify the shipper of the rejection and 
arrange for re-shipment. Analogous to the handler requirements with 
which small and large quantity handlers of universal waste must comply, 
if a destination facility receives a shipment of hazardous waste that 
is not a universal waste, the facility must notify its regional EPA 
office (or authorized state). Finally, if the facility receives non-
hazardous, non-universal waste in the shipment, the destination 
facility may manage the waste in any manner that is in compliance with 
applicable federal or state and local solid waste regulations.
    Tracking of universal waste shipments also applies to destination 
facilities. The UWR requires that the owner or operator of a 
destination facility keep the same records for receipt of universal 
waste shipments as those kept by handlers of large quantities of 
universal wastes (discussed in section of V.J. of this preamble). A 
record must be kept for each shipment of universal waste received at 
the facility. The record may be in the form of a log, invoice, 
manifest, bill of lading or other shipping document, and must include 
the following information: (1) The name and address of the universal 
waste handler or foreign shipper from whom the universal waste was 
sent; (2) the quantity of each type of universal waste received; and 
(3) the date of receipt of the shipment of universal waste. In 
addition, destination facilities are required to maintain these records 
for three years.
    This notice does not propose to change any of the existing 
requirements applicable to destination facilities that manage universal 
wastes, including pharmaceutical wastes managed as universal wastes.

N. Import Requirements

    Pharmaceutical universal wastes entering the country would be 
subject to the same UWR provisions as any other universal waste. The 
import requirements for universal wastes are found in 40 CFR 273.70. 
This section clarifies that universal wastes that are imported from 
another country must be managed, upon entry into the United States, in 
compliance with the appropriate universal waste requirements for 
transporters, handlers, or destination facilities, depending on the 
universal waste management activities conducted within the United 
States.
    This notice does not propose to change any of the existing 
universal waste requirements applicable to the import of universal 
wastes, including pharmaceutical wastes managed as universal wastes.

O. Land Disposal Restrictions

    Pursuant to the Land Disposal Restrictions (LDR) provisions of the 
Hazardous and Solid Waste Amendments of 1984 (HSWA), all hazardous 
wastes listed or identified in accordance with RCRA section 3001 are 
prohibited, on specified timetables, from land disposal unless they are 
appropriately treated or otherwise meet the specified treatment 
standard. The regulations for the LDR program in 40 CFR part 268 apply 
to persons who generate or transport hazardous waste and owners and 
operators of hazardous waste treatment, storage, and disposal 
facilities, unless they are specifically excluded from regulation in 40 
CFR parts 261 or 268.
    As discussed in the preambles for the proposed and final UWR (58 FR 
8123--8124, February 11, 1993; 60 FR 25534--25535, May 11, 1995, 
respectively), handlers and transporters of universal wastes must 
comply with all of the substantive LDR requirements, but not the 
administrative requirements. These substantive requirements include: 
(1) A prohibition on accumulating prohibited hazardous wastes directly 
on the land (land disposal); (2) a requirement to treat wastes to meet 
the treatment standards prior to land disposal; (3) a prohibition on 
dilution; and (4) a prohibition on waste accumulation, except for 
purposes of accumulating quantities sufficient for proper recovery, 
treatment or disposal. Destination facilities are required to comply 
with all of the 40 CFR part 268 LDR requirements for universal waste, 
which include both the substantive and administrative requirements.
    This notice does not propose to change any of the existing 
requirements with respect to the land disposal restrictions for 
universal wastes, including pharmaceutical wastes managed as universal 
wastes.

VI. State Authority

A. Applicability of Rule in Authorized States

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

B. Effect on State Authorization

    This notice proposes regulations that would not be promulgated 
under the authority of HSWA. Thus, the standards proposed would be 
applicable on the effective date only in those states that do not have 
final authorization. This proposed rule is less stringent than the 
current hazardous waste standards. Therefore, authorized states would 
not

[[Page 73539]]

be required to modify their programs to adopt regulations consistent 
with and equivalent to these proposed standards. Nevertheless, because 
EPA believes that this proposed rule would encourage better overall 
management of hazardous pharmaceutical wastes, EPA strongly encourages 
states to adopt this rule once it is promulgated.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), 
this action is a ``significant regulatory action.''
    Pursuant to the terms of Executive Order 12866, the Agency has 
determined that this proposed rule is a significant regulatory action 
because it contains novel policy issues. Accordingly, EPA submitted 
this action to the Office of Management and Budget (OMB) for review 
under EO 12866 and any changes made in response to OMB recommendations 
have been documented in the docket for this action.
    In addition, EPA prepared an analysis of the potential costs and 
benefits associated with this action. This analysis is contained in the 
document entitled, Assessment of the Potential Costs, Benefits, and 
Other Impacts of Adding Pharmaceuticals to the Universal Waste Rule, As 
Proposed (referred to as the Assessment document). Findings from this 
document are summarized below. This document, and any changes made in 
response to OMB review, is maintained in the RCRA docket established 
for this action. Interested persons are encouraged to read and comment 
on all aspects of this document.
    The following section summarizes the findings from our Assessment 
document, as identified above. A detailed review of our analytical 
methodology, data sources, findings, and limitations are presented in 
the full Assessment document.
    The Agency has identified the following facilities potentially 
affected by the proposed rule: pharmacies, hospitals, physicians' 
offices, dentists' offices, other health practitioners, outpatient care 
centers, other ambulatory health care services, residential care 
facilities, reverse distributors, and veterinary clinics. While the BRS 
has only limited data for the types of facilities likely to be affected 
by the proposed rule, it includes sufficient data to develop an 
approximation of the total tonnage of hazardous pharmaceutical waste 
generated by hospitals and reverse distributors. In total, the affected 
hospitals and reverse distributors generated a total of 14,200 tons of 
hazardous pharmaceutical waste during 2005, based on BRS data. 
Therefore, it is expected that on the order of 14,000 tons of hazardous 
pharmaceutical waste could be managed as universal waste each year.
    The proposed rule is optional, which means that individual 
facilities may choose to be regulated under the UWR, or continue to 
operate under the existing RCRA subtitle C hazardous waste regulations. 
The assessment assumes that facilities will only choose to be subject 
to the rule if it is deemed to be in their interest. For purposes of 
the economic assessment, it is assumed that only facilities that would 
experience a reduction in hazardous waste management costs would choose 
to be subject to the proposed rule. The aggregate annualized cost 
savings associated with the proposed rule are estimated to range from 
$33.9 to $35.2 million for hospitals and reverse distributors combined. 
For other types of facilities, the data necessary to support a 
nationwide estimate of the cost impacts are not readily available. 
However, based on a 2003 survey by King County, Washington, cost 
savings associated with ambulatory care facilities, retail pharmacies, 
and veterinary clinics are estimated to range from $0 to $162.3 
thousand for King County. The Agency also evaluated an alternative 
scenario under which facilities possibly in non-compliance with the 
RCRA hazardous waste regulations decide to opt into the universal waste 
system. For more information regarding this alternative baseline, 
please see the Assessment document in the docket.
    EPA anticipates that the proposed addition of hazardous 
pharmaceutical waste to the UWR will facilitate the environmentally-
sound collection and disposal of this waste. Although EPA has not 
quantified the environmental impacts of the proposed rule, the Agency 
expects that the rule will reduce the release of pharmaceutically 
active compounds to the environment and also reduce the incidence of 
any adverse effects associated with human and ecosystem exposure to 
these substances.

B. Paperwork Reduction Act

    The information collection requirements in this proposed rule have 
been submitted for approval to OMB under the Paperwork Reduction Act, 
44 U.S.C. 3501 et seq. The Information Collection Request (ICR) 
document prepared by EPA has been assigned EPA ICR number 2324.01.
    The information requirements established for this proposed 
rulemaking, and identified in the ICR supporting this action are 
largely self-implementing. This process would ensure that (1) regulated 
entities managing hazardous pharmaceutical wastes are held accountable 
to the applicable requirements; and (2) state inspectors can verify 
compliance when needed. For example, the universal waste proposal 
requires LQHUWs and SQHUWs to demonstrate the length of time that 
hazardous pharmaceutical wastes have been accumulated from the date 
they were received or became a waste. The proposal also requires LQHUWs 
and destination sites to keep records of all shipments sent and 
received. Further, the proposal requires waste handlers and destination 
facilities to notify EPA under certain circumstances (e.g., when large 
amounts of hazardous pharmaceutical waste are accumulated or when 
illegal shipments are received).
    EPA will use the collected information in the event of an 
inspection to ensure that hazardous pharmaceutical waste is being 
managed in a protective manner. The information aids the Agency in 
tracking waste shipments and identifying improper management practices. 
In addition, information kept in facility records helps handlers, 
processors and destination facilities to ensure that all facilities are 
managing these wastes properly.
    EPA has carefully considered the burden imposed upon the regulated 
community by the proposed regulations. EPA is confident that those 
activities required of respondents are necessary and, to the extent 
possible, has attempted to minimize the burden imposed. EPA believes 
strongly that if the minimum requirements specified under the proposed 
regulations are not met, neither the facilities nor EPA can ensure that 
hazardous pharmaceutical wastes are being managed in a manner 
protective of human health and the environment.
    EPA estimates that the total annual respondent burden for the new 
paperwork requirements in the proposed rule is approximately 960 hours 
per year, and the annual respondent cost for the new paperwork 
requirements in the rule is approximately $54,000. The estimated annual 
hourly burden ranges from 0.8 to 2.5 hours per respondent for the 1,119 
respondents who will likely choose to manage their hazardous 
pharmaceutical

[[Page 73540]]

wastes under the UWR.\68\ However, in addition to the new paperwork 
requirements in the rule, the Agency also estimated the burden and cost 
that generators are currently subject to in complying with the existing 
RCRA hazardous waste information collection requirements for hazardous 
pharmaceutical wastes (e.g., preparation of hazardous waste manifests, 
biennial reporting, etc.). Taking both the new proposed and existing 
RCRA requirements into account, EPA expects the proposed rule would 
result in a net reduction in national annual paperwork burden to the 
1,119 respondents of approximately 935 hours or $39,000. As summarized 
in the Economics Background Document and in the prior sub-section of 
this notice, EPA expects this net cost savings to be further 
supplemented by annual cost savings to these same facilities from 
reduced disposal costs. The net cost to EPA of administering the rule 
is expected to be negligible, since facilities are not required under 
this proposed rule to submit any information to the Agency for review 
and approval. Burden is defined at 5 CFR 1320.3(b).
---------------------------------------------------------------------------

    \68\ Many generators of hazardous pharmaceutical wastes are 
CESQGs, and thus 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). It is likely that many 
CESQGs may decide not to manage their hazardous pharmaceutical 
wastes under the UWR.
---------------------------------------------------------------------------

    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 EPA's 
regulations in 40 CFR are listed in 40 CFR part 9.
    To comment on the Agency's need for this information, the accuracy 
of the provided burden estimates, and any suggested methods for 
minimizing respondent burden, EPA has established a public docket for 
this rule, which includes this ICR, under Docket ID number EPA-HQ-RCRA-
2007-0932. Submit any comments related to the ICR to EPA and OMB. See 
ADDRESSES section at the beginning of this notice for where to submit 
comments to EPA. Send comments to OMB at the Office of Information and 
Regulatory Affairs, Office of Management and Budget, 725 17th Street, 
NW., Washington, DC 20503, Attention: Desk Office for EPA. Since OMB is 
required to make a decision concerning the 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. The final rule will 
respond to any OMB or public comments on the information collection 
requirements contained in this proposal.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small 
entities, small entity is defined as: (1) A small business as defined 
by the Small Business Administration's (SBA) regulations at 13 CFR 
121.201; (2) a small governmental jurisdiction that is a government of 
a city, county, town, school district or special district with a 
population of less than 50,000; and (3) a small organization that is 
any not-for-profit enterprise which is independently owned and operated 
and is not dominant in its field.
    After considering the economic impacts of this proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. In 
determining whether a rule has a significant economic impact on a 
substantial number of small entities, the impact of concern is any 
significant adverse economic impact on small entities, since the 
primary purpose of the regulatory flexibility analyses is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604. 
Thus, 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, or otherwise has a positive economic effect 
on all of the small entities subject to the rule.
    The small entity analysis conducted for this proposed rule 
indicates that streamlining the requirements for hazardous 
pharmaceutical wastes would generally result in savings to affected 
entities compared to the baseline requirements. Under a scenario 
assuming full compliance, the proposed rule is not expected to result 
in a net cost to any affected entity. Thus, adverse impacts are not 
anticipated. Costs could increase for entities that are not complying 
with the current requirements, but even these costs, which are not 
properly attributable to the current proposed rulemaking, would not be 
expected to result in significant impacts on a substantial number of 
small entities. We have therefore concluded that this proposed rule 
will relieve regulatory burden for all affected small entities. We 
continue to be interested in the potential impacts of the proposed rule 
on small entities and welcome comments on issues related to such 
impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 
1531-1538 for State, local, or tribal governments or the private 
sector. UMRA generally excludes from the definition of ``Federal 
governmental mandate'' (in sections 202, 203, and 205) and from the 
definition of ``federal private sector mandate'' duties that arise from 
participation in a voluntary federal program. If finalized, this rule 
will be voluntary because it will be less stringent than the current 
regulations. As a result, state governments will not be required to 
adopt the change, and the private sector will not be required to 
participate. In any event, EPA has determined that this proposed rule 
does not contain a Federal mandate that may result in expenditures of 
$100 million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any one year. The total cost impact 
of the proposed action results in cost savings estimated to be between 
at least $33.9 million to $35.2 million per year. Therefore this action 
is not subject to the requirements of sections 202 and 205 of UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by state and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that 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.''
    This proposed rule 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

[[Page 73541]]

levels of government, as specified in Executive Order 13132. This 
proposed rulemaking directly affects primarily generators of hazardous 
pharmaceutical wastes as defined in this proposal. There are no state 
and local government bodies that incur direct compliance costs by this 
rulemaking.
    Thus, Executive Order 13132 does not apply to this proposed rule. 
In the spirit of Executive Order 13132 and consistent with EPA policy 
to promote communications between EPA and state and local governments, 
EPA specifically solicits comment on this proposed rule from state and 
local officials.

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

    Executive Order 13175, entitled ``Consultation and Coordination 
With Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' EPA has concluded that this 
proposed rule may have tribal implications to the extent that entities 
generating hazardous pharmaceutical wastes on tribal lands could be 
affected. However, this proposed rule will neither impose substantial 
direct compliance costs on tribal governments nor preempt tribal law.
    EPA did not consult directly with representatives of Tribal 
governments early in the process of developing this proposal. However, 
EPA did conduct outreach with the affected industry. Thus, EPA believes 
it has captured the concerns that also would have been expressed by 
representatives of Tribal governmental. EPA solicits additional 
comments on this proposed rule from Tribal officials.

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

    This action is not subject to EO 13045 (62 F.R. 19885, April 23, 
1997) because it is not economically significant as defined in EO 
12866, and because the Agency does not have reason to believe the 
environmental health or safety risks addressed by this proposed action 
will present a disproportionate risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution or Usage

    This proposed rule is not a ``significant energy action'' as 
defined in Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) because it is not likely to have a significant 
adverse effect on the supply, distribution, or use of energy. Further, 
we have concluded that the proposed rule is not likely to have any 
adverse energy effects.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA''), Public Law No. 104-113, 12(d) (15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g. , materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. NTTAA directs EPA to 
provide Congress, through OMB, explanations when the Agency decides not 
to use available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards. 
Therefore, EPA is not considering the use of any voluntary consensus 
standards.

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

    Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes 
federal executive policy on environmental justice. Its main provision 
directs federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse human health or environmental effects of their programs, 
policies, and activities on minority populations and low-income 
populations in the United States.
    EPA has determined that this proposed rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it does not 
affect the level of protection provided to human health or the 
environment. While the Agency is proposing to streamline the management 
requirements governing hazardous pharmaceutical wastes, EPA expects 
that such an action will actually increase compliance with the 
hazardous waste regulations and reduce exposures to both hazardous and 
non-hazardous pharmaceutical wastes by the public, including minority 
populations and low-income populations.

List of Subjects

40 CFR Part 260

    Environmental protection, Administrative practice and procedure, 
Confidential business information, Hazardous waste, Reporting and 
recordkeeping requirements.

40 CFR Part 261

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

40 CFR Part 264

    Environmental protection, Hazardous waste, Packaging and 
containers, 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 268

    Environmental protection, Hazardous waste, Reporting and 
recordkeeping requirements.

40 CFR Part 270

    Environmental protection, Hazardous materials transportation, 
Reporting and recordkeeping requirements.

40 CFR Part 273

    Environmental protection, Hazardous materials transportation, 
Hazardous waste.

    Dated: November 20, 2008.
Stephen L. Johnson,
Administrator.
    For the reasons set out in the preamble, title 40, Chapter I of the 
Code of Federal Regulations, is proposed to be amended as follows:

PART 260--HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL

    1. The authority citation for part 260 continues to read as 
follows:

    Authority: 42 U.S.C 6905, 6912(a), 6921-6927, 6930, 6934, 6935, 
6937, 6938, 6939, and 6974.

    2. Section 260.10 is amended as follows:
    a. By adding the definition of ``pharmaceutical'' in alphabetical 
order.
    b. By adding the definition of ``pharmaceutical universal waste'' 
in alphabetical order.
    c. By republishing the introductory text of and revising paragraphs 
(3) and

[[Page 73542]]

(4) and adding paragraph (5) to the definition of ``Universal Waste'' 
to read as follows:

Sec.  260.10  Definitions.

* * * * *
    Pharmaceutical means any chemical product, vaccine or allergenic 
(including any product with the primary purpose to dispense or deliver 
a chemical product, vaccine or allergenic), not containing a 
radioactive component, that is intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease or injury in man or 
other animals; or any chemical product, vaccine or allergenic 
(including any product with the primary purpose to dispense or deliver 
a chemical product, vaccine or allergenic), not containing a 
radioactive component, that is intended to affect the structure or 
function of the body in man or other animals. This definition includes 
products such as transdermal patches, and oral delivery devices such as 
gums or lozenges. This definition does not include sharps or other 
infectious or biohazardous waste, dental amalgams, medical devices not 
used for delivery or dispensing purposes, equipment, contaminated 
personal protective equipment or contaminated cleaning materials.
* * * * *
    Pharmaceutical Universal Waste means a pharmaceutical that is a 
hazardous waste as defined in Sec.  261.3, and containers which have 
held any hazardous pharmaceutical waste and which would be classified 
as hazardous waste under Sec.  261.7.
* * * * *
    Universal Waste means any of the following hazardous wastes that 
are managed under the universal waste requirements of part 273 of this 
chapter:
* * * * *
    (3) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (4) Lamps as described in Sec.  273.5 of this chapter; and
    (5) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.
* * * * *

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

    3. 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.

    4. Section 261.9 is amended as follows:
    a. By revising paragraphs (c) and (d).
    b. By adding paragraph (e) to read as follows:

Sec.  261.9  Requirements for universal waste.

* * * * *
    (c) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (d) Lamps as described in Sec.  273.5 of this chapter; and
    (e) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.

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

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

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

    6. Section 264.1 is amended as follows:
    a. By revising paragraphs (g)(11)(iii) and (iv).
    b. By adding paragraph (g)(11)(v) to read as follows:

Sec.  264.1  Purpose, scope, and applicability.

* * * * *
    (g) * * *
    (11) * * *
    (iii) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (iv) Lamps as described in Sec.  273.5 of this chapter; and
    (v) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.
* * * * *

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

    7. 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, and 6937.

    8. Section 265.1 is amended as follows:
    a. By revising paragraphs (c)(14)(iii) and (iv).
    b. By adding paragraph (c)(14)(v) to read as follows:

Sec.  265.1  Purpose, scope and applicability.

* * * * *
    (c) * * *
    (14) * * *
    (iii) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (iv) Lamps as described in Sec.  273.5 of this chapter; and
    (v) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.
* * * * *

PART 268--LAND DISPOSAL RESTRICTIONS

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

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

    10. Section 268.1 is amended as follows:
    a. By revising paragraphs (f)(3) and (4).
    b. By adding paragraph (f)(5) to read as follows:

Sec.  268.1  Purpose, scope and applicability.

* * * * *
    (f) * * *
    (3) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (4) Lamps as described in Sec.  273.5 of this chapter; and
    (5) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.

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

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

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

    12. Section 270.1 is amended as follows:
    a. By revising paragraphs (c)(2)(viii)(C) and (D).
    b. By adding paragraph (c)(2)(viii)(E) to read as follows:

Sec.  270.1  Purpose and scope of these regulations.

* * * * *
    (c) * * *
    (2) * * *
    (viii) * * *
    (C) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (D) Lamps as described in Sec.  273.5 of this chapter; and
    (E) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.
* * * * *

PART 273--STANDARDS FOR UNIVERSAL WASTE MANAGEMENT

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

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

    14. Section 273.1 is amended as follows:
    a. By revising paragraphs (a)(3) and (4).
    b. By adding paragraph (a)(5) to read as follows:

Sec.  273.1  Scope.

    (a) * * *

[[Page 73543]]

    (3) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (4) Lamps as described in Sec.  273.5 of this chapter; and
    (5) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.
* * * * *
    15. Add Sec.  273.6 to read as follows:

Sec.  273.6  Applicability--Pharmaceutical Universal Wastes.

    (a) Pharmaceutical Universal Wastes covered under this part 273. 
The requirements of this part apply to persons managing pharmaceutical 
universal wastes, as described in Sec.  273.9.
    (b) Generation of pharmaceutical universal wastes.
    (1) A partially-used pharmaceutical becomes a pharmaceutical 
universal waste on the date it is discarded.
    (2) An unused pharmaceutical becomes a pharmaceutical universal 
waste on the date the handler decides to discard it.
    16. Section 273.9 is amended by adding the definitions of 
``Pharmaceutical'' and ``Pharmaceutical Universal Waste'' in 
alphabetical order and by revising the definitions of ``Large quantity 
handler of universal waste,'' ``Small quantity handler of universal 
waste,'' and by republishing the introductory text and revising 
paragraphs (3) and (4), and adding paragraph (5), to the definition 
``Universal waste'' to read as follows:

Sec.  273.9  Definitions.

* * * * *
    Large Quantity Handler of Universal Waste means a universal waste 
handler (as defined in this section) who accumulates 5,000 kilograms or 
more total of universal waste (batteries, pesticides, mercury-
containing equipment, lamps, or pharmaceutical universal wastes, 
calculated collectively) at any time. This designation as a large 
quantity handler of universal waste is retained through the end of the 
calendar year in which the 5,000-kilogram limit is met or exceeded.
* * * * *
    Pharmaceutical means any chemical product, vaccine or allergenic 
(including any product with the primary purpose to dispense or deliver 
a chemical product, vaccine or allergenic), not containing a 
radioactive component, that is intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease or injury in man or 
other animals; or any chemical product, vaccine or allergenic 
(including any product with the primary purpose to dispense or deliver 
a chemical product, vaccine or allergenic), not containing a 
radioactive component, that is intended to affect the structure or 
function of the body in man or other animals. This definition includes 
products such as transdermal patches, and oral delivery devices such as 
gums or lozenges. This definition does not include sharps or other 
infectious or biohazardous waste, dental amalgams, medical devices not 
used for delivery or dispensing purposes, equipment, contaminated 
personal protective equipment or contaminated cleaning materials.
* * * * *
    Pharmaceutical Universal Waste means a pharmaceutical that is a 
hazardous waste as defined in Sec.  261.3 of this chapter, and 
containers which have held any hazardous pharmaceutical waste and which 
would be classified as hazardous waste under Sec.  261.7 of this 
chapter.
* * * * *
    Small Quantity Handler of Universal Waste means a universal waste 
handler (as defined in this section) who does not accumulate 5,000 
kilograms or more of universal waste (batteries, pesticides, mercury-
containing equipment, lamps, or pharmaceutical universal wastes, 
calculated collectively) at any time.
* * * * *
    Universal Waste means any of the following hazardous wastes that 
are subject to the universal waste requirements of this part 273:
* * * * *
    (3) Mercury-containing equipment as described in Sec.  273.4 of 
this chapter;
    (4) Lamps as described in Sec.  273.5 of this chapter; and
    (5) Pharmaceutical Universal Wastes as described in Sec.  273.6 of 
this chapter.
* * * * *
    17. Section 273.13 is amended by adding paragraph (e) to read as 
follows:

Sec.  273.13  Waste Management.

* * * * *
    (e) Pharmaceutical Universal Wastes. A small quantity handler of 
universal waste must manage pharmaceutical universal wastes in a way 
that prevents releases of any universal waste or component of a 
universal waste to the environment, as follows:
    (1) A small quantity handler of universal waste must contain 
pharmaceutical universal wastes in a container that is structurally 
sound, compatible with the pharmaceutical universal wastes, and that 
lacks evidence of leakage, spillage, or damage that could cause leakage 
under reasonably foreseeable conditions.
    (i) Incompatible wastes must not be placed in the same container, 
unless in compliance with Sec.  265.17(b) of this chapter.
    (2) A small quantity handler of universal waste may sort 
pharmaceutical universal wastes provided the handler:
    (i) Ensures compliance with applicable OSHA regulations; and
    (ii) Ensures that employees sorting pharmaceutical universal wastes 
are thoroughly familiar with proper pharmaceutical universal waste 
handling and emergency procedures;
    (3) A small quantity handler of universal waste who generates a 
solid waste as a result of the sorting activities under paragraph 
(e)(2) of this section must determine whether the solid waste exhibits 
a characteristic of hazardous waste or is a listed hazardous waste 
identified in 40 CFR part 261, subparts C and D.
    (i) If the solid waste is a listed hazardous waste or exhibits a 
characteristic of hazardous waste, it must be managed in compliance 
with all applicable requirements of 40 CFR parts 260 through 272. The 
handler is considered the generator of hazardous waste and is subject 
to 40 CFR part 262.
    (ii) If the solid waste is not hazardous, the handler may manage 
the waste in a manner that is in compliance with applicable federal, 
state or local solid waste regulations.
    18. Section 273.14 is amended by adding paragraph (f) to read as 
follows:

Sec.  273.14  Labeling/marking.

* * * * *
    (f) Pharmaceutical universal waste, or a container in which the 
pharmaceutical universal waste is contained, must be labeled or marked 
clearly with either of the following phrases: ``Universal Waste--
Pharmaceuticals'' or ``Waste Pharmaceuticals.''
    19. Section 273.32 is amended by revising paragraph (b)(4) to read 
as follows:

Sec.  273.32  Notification.

* * * * *
    (b) * * *
    (4) A list of all the types of universal waste managed by the 
handler (e.g., batteries, pesticides, mercury-containing equipment, 
lamps, and pharmaceutical universal wastes); and
    20. Section 273.33 is amended by adding paragraph (e) to read as 
follows:

Sec.  273.33  Waste management.

* * * * *
    (e) Pharmaceutical Universal Wastes. A large quantity handler of 
universal waste must manage pharmaceutical

[[Page 73544]]

universal waste in a way that prevents releases of any universal waste 
or component of a universal waste to the environment, as follows:
    (1) A large quantity handler of universal waste must contain 
pharmaceutical universal wastes in a container that is structurally 
sound, compatible with the pharmaceutical universal wastes, and that 
lacks evidence of leakage, spillage, or damage that could cause leakage 
under reasonably foreseeable conditions.
    (i) Incompatible wastes must not be placed in the same container, 
unless in compliance with Sec.  265.17(b) of this chapter.
    (2) A large quantity handler of universal waste may sort 
pharmaceutical universal wastes provided the handler:
    (i) Ensures compliance with applicable OSHA regulations; and
    (ii) Ensures that employees sorting pharmaceutical universal wastes 
are thoroughly familiar with proper pharmaceutical universal waste 
handling and emergency procedures;
    (3) A large quantity handler of universal waste who generates a 
solid waste as a result of the sorting activities under paragraph 
(e)(2) of this section must determine whether the solid waste exhibits 
a characteristic of hazardous waste or is a listed hazardous waste 
identified in 40 CFR part 261, subparts C and D.
    (i) If the solid waste is a listed hazardous waste or exhibits a 
characteristic of hazardous waste, it must be managed in compliance 
with all applicable requirements of 40 CFR parts 260 through 272. The 
handler is considered the generator of hazardous waste and is subject 
to 40 CFR part 262.
    (ii) If the solid waste is not hazardous, the handler may manage 
the waste in a manner that is in compliance with applicable federal, 
state or local solid waste regulations.
    21. Section 273.34 is amended by adding paragraph (f) to read as 
follows:

Sec.  273.34  Labeling/marking.

* * * * *
    (f) Pharmaceutical universal waste, or a container in which the 
pharmaceutical waste is contained, must be labeled or marked clearly 
with either of the following phrases: ``Universal Waste--
Pharmaceuticals'' or ``Waste Pharmaceuticals.''

[FR Doc. E8-28161 Filed 12-1-08; 8:45 am]

BILLING CODE 6560-50-P