United States
Environmental Protection
Agency
Solid Waste and
E.nergency Response
(OS-305)
EPA/530-SW-90-087A
December 1990
Office of Solid Waste
SEPA Medical Waste
Management in the
United States
Second Interim
Report to Congress
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EPA/530-SW-90-087A
Second Interim Report to Congress
Medical Waste Management
in the United States
December 1990
-l-vj
United States Environmental Protection Agency
Office of Solid Waste
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MEDICAL WASTE MANAGEMENT IN THE UNITED STATES
Second Interim Report to Congress
Pursuant to the
Medical Waste Tracking Act of 1988
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TABLE OF CONTENTS
TOPIC
PAGE
Executive Summary iii
Section I: Background and Introduction 1
A. Background 1
B. Introduction to the Second Interim Report 1
Section II: Evolution of the Agency's Medical Waste Program 3
Section III: The Medical Waste Program 5
A. Overview of EPA's Medical Waste Program 5
B. The Medical Waste Program--A Description of
Program Components 6
1. The Tracking System 6
2. Proper Management of Medical Waste 7
3. Information Gathering, Research and Analysis 8
4. Outreach, Education and Training 15
5. Enforcement Strategy 20
Section IV: Results of the Program and Issues for Future Consideration . . 23
A. Direct Program Effects 23
1. The Demonstration Tracking Program 23
2. Information Collection 23
B. Indirect Program Effects 23
1. Treatment Technology Innovation 24
2. Home Health Care 24
3. Beach Wash-ups 24
4. Contribution to Medical Waste Program Development . 25
C. Issues for Future Consideration 26
1. Introduction 26
2. List of Issues 26
Section V: Research Update and Forecast 30
A. Update of Chapter 1, Characterization of Medical
Waste 30
1. Overview of Characterization Efforts 30
2. Utility and Limitations of Data Collected from the
Medical Waste Reports 31
3. Summary of Results from First Reporting Period 32
4. Future Agency Activities 34
B. Update of Chapter 2, Health Hazard Assessment 35
1. Overview of Hazard Assessment Activities 35
2. Review of Activities Undertaken 36
C. Update of Chapter 3, Estimated Costs of the Demonstration
Program and Improper Management of Medical Waste ... 37
D. Update of Chapter 4, Demonstration Program Objectives
and Evaluation 38
E. Update of Chapter 5, Medical Waste Handling
Methods 38
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F. Update of Chapters 6 & 7, Medical Waste Treatment Methods
and Medical Waste Treatment Effectiveness - 38
1. Introduction 38
2. Current Activities 39
G. Update of Chapter 8, Existing State and Local
Requirements 40
1. Overview 40
2. Analyzing State Medical Waste Requirements 40
3. Assessing State Preventive Actions 41
H. Update to Chapter 9, Regulatory Options for a
National Program 41
I. Update to Chapter 10, Appropriateness of
Penalties 41
J. Update to Chapter 11, Home -^alth Care and Small
Quantity Generator Waste 41
K. Update to Chapter 12, Medical Waste Reuse, Recycling and
Reduction 42
List of Appendices 43
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EXECUTIVE SUMMARY
Since the Medical Waste Tracking Act was enacted in the fall of 1988, EPA has
developed a coordinated, multi-component program to address concerns about medical
waste management, and the lack of information on the subject. This report - the
second of three reports that EPA is required to prepare under the Act -- describes each
of the components in the program, discusses the impacts of the program, and provides
an update on the status of research activities that have been initiated for each of the 12
subject areas identified in the Act.
EPA's medical waste program is comprised of five integrated components.
Briefly, they are:
a tracking system designed to ensure . lat medical waste transported off-
site reaches its destination;
a management program designed to ensure that waste is properly
segregated, packaged, marked, labelled and stored prior to transport;
information gathering, research, and analysis to fill data gaps, evaluate the
results of Agency actions, and enable informed debate concerning the
future of Federal medical waste regulation;
an education, outreach and training program targeted at both the regulated
and unregulated communities, including Federal and State officials charged
with implementing the program, other Federal agencies involved with
medical waste (e.g., OSHA) and the home health care sector; and
an enforcement strategy designed to maximize innovative enforcement by
the covered States, encourage the regulated community to comply with the
program and deter and punish noncompliance.
The regulatory components of the program terminate at the end of the demonstration
program in June of 1991. The other components of the program, such as outreach to
the home health care sector, however, may continue indefinitely.
Although the Agency believes that it is premature to evaluate the success
of the program that has been in place approximately a year, it has identified a number
of direct and indirect effects on the management, handling, and disposal of medical
waste resulting from the program. The most significant results include the development
of a regulatory program that includes standards for tracking and managing medical
waste, and expanding the state of knowledge in several areas related to medical
waste generation, management, and disposal. The program has also had several
indirect effects, including the encouragement of innovation in treatment
technologies, the reevaluation of home health care waste management, some likely
in
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reduction in the severity of beach wash-ups, and the contribution to program
development in noncovered States.
In the first interim report, EPA summarized information that was then
available, and outlined an agenda for additional research on each of 12 specific areas
regarding medical waste that were identified in the Act. This second interim report
provides a research update and forecast on each of those subject areas. Since the
first report, EPA has made substantial progress in several areas, including
characterization of the generation and management of medical waste, and
development of guidelines for home health care waste. Additionally, several studies
are currently underway which will contribute greatly to the understanding of treatment
technologies, and the risks associated with the medical waste.
IV
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I: BACKGROUND AND INTRODUCTION
A. Background
This report was prepared pursuant to the Medical Waste Tracking Act of 1988,
Public Law 100-582, codified at 42 U.S.C. §§ 6992-6992k (the MWTA or the Act).
The MWTA requires the United States Environmental Protection Agency (EPA or the
Agency) to submit to Congress three reports evaluating EPA's medical waste program
and other medical waste issues listed in the Act. The First Interim Report to
Congress has been submitted; this report is the Second Interim Report.
The Act states that this Second Interim Report shall be due 12 months after
the effective date of the regulations -- which became effective on June 22, 1989 - and
shall (like the First Interim Report) cover 12 fMcs listed in the Act, based on the
information available at the time the Report is submitted.1
B. Introduction to the Second Interim Report
The First Interim Report is divided into twelve chapters that strictly correspond
to the topics listed in the MWTA. It reviews the information available at this early
stage of the development of the medical waste program and sets out EPA's initial
research agenda and data collection efforts.
This Second Report is written in a somewhat different format. It is divided
into five sections, each of which addresses the MWTA and EPA's medical waste
program from a slightly different perspective. Section I briefly explains the purpose
and content of this Second Interim Report. Section II reviews the key issues that led
to the passage of the MWTA, emphasizing the Congressional concerns that have
shaped the Agency's development of its medical waste program. Section III consists
of a detailed analysis of EPA's evolving medical waste program. It discusses how
EPA is building its medical waste program to encompass the MWTA and the interim
final rules2, as well as to address other issues that concerned Congress. In Section IV
the Report discusses the impact of the program - its direct and indirect effects on
the handling, disposal and management of medical waste - and sets out the signif-
icant issues that will influence the future of the program. Finally, Section V of the
Report concludes with a research update and forecast. The update discusses
individually each of the twelve chapters from the First Interim Report, describing the
progress in each area since the publication of the First Interim Report and the
Agency's future efforts with respect to each research area.
1 See 42 U.S.C. §6992g (b).
2 The interim final rules of the medical waste program were published in the
Federal Register on March 24, 1989 (54 Fed. Reg. 12326-95) and are codified at 40
C.F.R. Part 259.
1
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The final report, due in September, 1991, will more completely address the
issues raised in this Report and the First Interim Report. In the final report, the
Agency also will provide information on the effectiveness of the program and make
recommendations on whether a continuing program is needed, and if so, on the
components that such a program should include.
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II: EVOLUTION OF THE AGENCY'S MEDICAL WASTE PROGRAM
This Report begins with a discussion of the various concerns that led Congress
to pass the Act in the fall of 1988. The discussion highlights those aspects of the Act
and its legislative history that shaped the Agency's development of the medical waste
program. The rapid promulgation of the interim final rules, the speedy development
of the enforcement strategy, the prompt commencement of information gathering and
data collection, and the continuing efforts at outreach and education that are
described more fully in this Report reflect the seriousness with which the Agency has
confronted medical waste and its recognition of Congressional concerns about medical
waste.
The MWTA was enacted as a response to public concern over the degradation
of shoreline areas from wash-ups of sewage anr1 floating debris, some of which was
medical waste. The debris raising the most concern were medical wastes such as
needles, syringes, blood bags, bandages, and vials. See 134 Cong. Rec. S 10737 (daily
ed. August 3, 1988). The result of the beach wash-ups was the closure of beaches,
economic losses in affected shore communities, and public concern over the health
hazards associated with medical wastes, particularly syringes, and the general
degradation of the vulnerable shore environment. 134 Cong. Rec. S 19745 (daily ed.
August 4, 1988) and 134 Cong. Rec. H 9536 (daily ed. October 4, 1988).
There were also reports of other incidents of careless management of medical
waste; for instance, by disposal into open dumpsters, creating additional concern for
public safety. 134 Cong. Rec. H 9536 (daily ed. October 4, 1988). Concern regarding
occupational risks to waste handlers arose for similar reasons. Congress was mindful
of the environmental issues associated with the medical waste disposal practices. For
example, medical waste contains a relatively high amount of plastics, and is commonly
incinerated at facilities located in population centers. Moreover, testimony at
Congressional hearings questioned whether hospital incinerators as a general rule were
well operated or meeting established pollution standards. Congress also recognized
that landfill operators were reluctant to accept medical waste, and many States and
municipalities were enacting laws prohibiting the landfilling of medical waste. As the
options for legally and economically disposing of medical waste diminished, problems
associated with shipping medical waste increased, as did the risk of illegal dumping.3
3 The Congressional concerns discussed here are set forth in the various hearings,
and the discussions contained therein, that were held regarding the medical waste
problem. See generally. Health Hazards Posed in the Generation. Handling, and
Disposal of Infectious Wastes: Hearing Before the Subcommittee on Regulation and
Business Opportunities of the House Committee on Small Business. 100th Cong., 2d
Sess. (1988); Medical Waste and Sewage Contamination: Hearing Before the
Subcommittee on Fisheries and Wildlife Conservation of the Environment of the
Committee on Merchant Marine and Fisheries. 100th Cong. 2d Sess. (1988).
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Congress was also aware of the patchwork of State and local laws regarding
medical waste; medical waste was often unregulated or partially regulated. It -
discovered that not all States or localities had medical waste programs. Thus, many
States and municipalities were not in a position to address the problem adequately.
Even among States and municipalities that had adopted medical waste management
programs in the wake of the beach wash-ups and closings, the scope, intent and
effectiveness of the programs varied widely. In addition, because of the jurisdictional
restrictions on their authority, States and localities could not address the interstate
nature of the medical waste problem. Thus, medical waste generators sometimes
could "forum shop" to avoid State and municipal disposal regulations by shipping
waste to a State or locality without a medical waste program. Also, State legislatures
and local bodies potentially were vulnerable to influence from the local regulated
community.
The MWTA was enacted against this background of health and environmental
concerns and was intended to be a first step in addressing these concerns. 134 Cong.
Rec. S 15327 (daily ed. October 7, 1988). The Act required EPA to establish a two-
year demonstration program that addresses the medical waste management problem in
several ways. First, the demonstration program establishes a tracking system that is
designed to be implemented quickly so that, to the extent the program controls
sources contributing to wash-ups, wash-ups of medical waste in the future will be
minimized. Id. Second, the tracking, labelling, packaging and storage requirements
are designed to prevent careless management of the waste and to subject violators to
administrative, civil, and criminal penalties. 134 Cong. Rec. S 15328 (daily ed.
October 7, 1988). Third, the tracking system assures that a shipment of medical
waste, in fact, reaches its intended destination, and provides a mechanism for tracing
incidents of improper disposal to responsible parties. 134 Cong. Rec. H 9537 (daily
ed. October 4, 1988) and 134 Cong. Rec. S 10745 (daily ed. August 3, 1988). Finally,
the Act requires EPA to provide information to Congress on several subjects,
including the effectiveness of the program and whether and how a broader program
should be developed. 134 Cong Rec. S 10743 (daily ed. August 3, 1988).
Under the MWTA, EPA has developed a program that includes not only the
demonstration tracking and management program prescribed by the Act but addresses
other Congressional concerns as well. The next section will describe and evaluate
EPA's medical waste program on a component-by-component basis.
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Ill: THE MEDICAL WASTE PROGRAM
A. Overview of EPA's Medical Waste Program
The complexity of the concerns and issues associated with the management of
medical waste has led EPA to create a multifaceted, broad-ranging medical waste
program. This program consists of five integrated components which have ordered
and shaped the activities undertaken by EPA. Briefly, they are:
a tracking system designed to ensure that medical waste transported off-
site reaches its destination;
a management program designed to ensure that waste is properly
segregated, packaged, marked, labelled and Stored prior to transport;
information gathering, research, and analysis to fill data gaps, evaluate
the results of Agency actions, and enable informed debate concerning
the future of Federal medical waste regulation;
an education, outreach and training program targeted at both the
regulated and unregulated communities, including Federal and State
officials charged with implementing the program, other Federal agencies
involved with medical waste (e.g., OSHA) and the home health care
sector; and
an enforcement strategy designed to maximize innovative enforcement by
the covered States, encourage the regulated community to comply with
the program and deter and punish noncompliance.
In order to implement its program, the Agency has promulgated interim final
rules,4 developed an enforcement strategy, initiated procedures to collect and analyze
data, and prepared and disseminated educational and instructional materials. The
following detailed discussion of these program components highlights the broad scope
of the Agency's medical waste program.
4 The interim final rules became effective in June, 1989 in New York, New
Jersey and Connecticut. The rules became effective in Rhode Island and Puerto Rico
in July, 1989. The States participating in the program-New York, Connecticut, Rhode
Island and New Jersey-and the Commonwealth of Puerto Rico are referred to
collectively as the "covered" States. All other States are referred to as "noncovered"
States.
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B. The Medical Waste Program - A Description of Program Components
1. The Tracking System
As its name implies, the core of the MWTA consists of the requirement that
medical waste shipped off-site is tracked to its destination. The tracking system is
based upon the well-established hazardous waste manifest system. The key to the
system is the medical waste tracking form. The form, initiated by the waste generator
or transporter5, stays with the waste until it reaches its final destination. From the
time the tracking form is initiated until it reaches its final destination (or until the
waste is both treated and destroyed) all waste handlers must complete their portion of
the form.
To bolster the effectiveness and integrity -* the tracking system, the generator,
transporter and treatment, destruction, and disposal (TDD) facility have added
responsibilities. The generator (or the transporter, if he initiates the manifest) is
responsible for determining the status of the waste shipment if he does not receive a
completed tracking form from the TDD facility. If the generator cannot resolve the
problem by locating the waste shipment, he must notify EPA and the State where he
is located, in writing, that the waste did not arrive at its intended destination. This
written declaration is referred to as an "exception report."
In order to transport medical waste, the transporter must notify EPA and the
covered State in writing (on an EPA designed form) that he is transporting medical
waste. The notification form requires each transporter to certify, under penalty of
criminal and/or civil prosecution, that he will comply with the medical waste rules
promulgated by EPA. EPA has assigned identification numbers to transporters.
Every TDD facility is required by rule to check and verify the forms against
the shipments of medical waste, attempt to resolve any discrepancies, and send a
letter to EPA and the States where the waste was generated and disposed if
discrepancies cannot be resolved. These letters are referred to as "discrepancy
reports."
By identifying all handlers of each shipment of regulated medical waste as well
as its generator and final destination, by requiring that the form follows the waste,
and by mandating exception and discrepancy reports, the tracking system constructs a
"closed circle" that facilitates proper management, encourages proper disposal and
reveals potential waste mismanagement. Exception and discrepancy reports, and other
reporting requirements of the program, also provide a cost-effective way to pinpoint
5 Generators who produce and ship off-site less than 50 pounds of medical waste
per calendar month are not required to initiate tracking forms, although they must
keep a log that records waste shipments. Transporters who pick up waste from these
generators are required to initiate manifests.
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potential violations and provide the Agency with invaluable data about the nature of
the regulated community and how the system is functioning.6
2. Proper Management of Medical Waste
EPA's regulations inaugurate a number of waste management requirements for
generators, transporters, and TDD facilities. These requirements promote sound waste
management throughout the regulated community. EPA has designed these standards
as general performance standards.
Performance standards do not constrain the regulated community to a
particular technology. They allow the regulated community the flexibility to develop a
product or products that meets the prescribed requirements. For a demonstration
program, during which the Agency is collecting -formation. studying the future of the
program and learning about the regulated community, it is particularly important to
foster development of technology that will aid proper waste management. Examples
of these performance requirements are discussed in the following paragraphs.
Generators must segregate regulated medical waste intended for off-site
transport, to the extent practicable, into three categories - sharps, fluids
and other medical waste. The segregation requirement raises
institutional awareness of the types and quantities of medical waste
generated and promotes development of appropriate management
strategies for each medical waste category.
Packaging must be rigid and leak resistant to ensure that waste handlers
and the public will be protected from exposure to the waste. The
packaging requirements can be met by a number of types of containers
or container combinations.
Storage requirements are designed to prevent unauthorized access to
storage areas as well as to maintain proper sanitary conditions. The
storage requirements preserve the integrity of the waste intended for
shipment off-site, reducing potential occupational and accidental
exposure.
The labelling of medical waste simplifies waste identification without
compromising its packaging, while marking requirements provide
information about the waste and enable identification of generators,
transporters and other handlers of medical waste.
Transporter vehicle standards are designed to contain the waste and
maintain packaging integrity during transport. The requirement that
6 A detailed discussion of the data collected by EPA during the program's first
reporting period is found in Section V.A. of this Report.
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medical waste be protected from stress or compaction is particularly
important for it lessens risks of exposure and leakage.
The medical waste program also includes performance standards designed to
prevent incomplete treatment and destruction of waste. Unless the waste is
incinerated or sent to a disposal facility, the program requires that waste must be
both treated and destroyed before tracking ends. The terms "treat" and "destroy" are
defined as performance standards that require the waste to be "treated to substantially
reduce or eliminate disease causing potential" and "destroyed so that it is rendered
unrecognizable." These general performance standards have had the effect of
stimulating development of innovative treatment and destruction techniques.7 The
Agency has excluded compaction as a form of destruction. If a facility accomplishes
only treatment QT only destruction, but not both, it must continue to track the waste.
Thus, waste Terrains within the tracking system p it poses *uy environmental or health
threat.
3. Information Gathering, Research and Analysis
One of the primary reasons for developing a demonstration medical waste
program was to facilitate the collection and analysis of information and data necessary
for an informed discussion of the problems associated with medical waste. With this
in mind, EPA is collecting information, and conducting data gathering, research and
analysis in a number of areas. The focal points of the data gathering, research and
analysis efforts are:
The characteristics of the regulated community, including medical waste
management practices;
The physical, chemical, and pathological characteristics of medical waste;
Treatment, destruction and disposal methods, including effectiveness and
any associated health risks;
Costs associated with the mismanagement of medical waste and with the
requirements of the Act; and
Enforcement and compliance with the MWTA requirements.
Each of these efforts is explained in greater detail below.
7 Additional information on treatment technology innovation is found on page 24
of this report.
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a. Characteristics of the Regulated Community
Congress has recognized that the present program and future efforts will be far
more effective if constructed with a thorough understanding of the practices of the
community it seeks to regulate. It follows that a high priority of the medical waste
program has been the development of sources of information regarding medical waste.
The primary sources of information which the Agency has developed include:
Transporter notification forms, which provide information about the
universe of transporters;
Transporter reports, which provide information about the entire medical
waste management universe;
On-site incinerator reports, which provide information about the medical
waste that is incinerated on-site;
Exception reports from generators and discrepancy reports from TDD
facilities, which provide information about the efficacy of the tracking
system; and
Information collected by States, which will complement EPA's data
gathering efforts (e.g., generator reports).
EPA has developed an automated information management system to manage
data concerning generators, transporters and TDD facilities collected during the first
six-month reporting period. The results of the data are summarized in Section VA.
of this Report.
b. Characteristics of Medical Waste Stream
At present, studies are underway to determine the chemical, physical and
pathogenic characteristics of medical waste. EPA is conducting several studies using a
variety of methodologies to develop such information both for medical waste in
general and for medical waste which presents particular problems (e.g. waste from
beach wash-ups).
A recently initiated Waste Characterization Study will analyze the generation of
medical waste in order to determine the physical and chemical characteristics of the
medical waste stream. Based upon a survey of existing data and the analysis of
several representative facilities that generate medical waste, the major components of
the medical waste stream, such as the plastic content of the waste stream, its moisture
content, its heating value and other parameters, will be identified and analyzed. The
study will also identify sources of radioactive and toxic constituents in the medical
waste stream. The study is now underway, and its results will be presented in the
Final Report to Congress.
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The pathogenic characteristics of medical waste are currently being reviewed in
EPA's Health Hazard Assessment.8 This data will be used to assess the potential
health hazards of exposure. By utilizing a "hazard assessment" methodology, this study
will complement the epidemiological analysis conducted by the Agency for Toxic
Substances and Disease Registry (ATSDR). The findings of the Health Hazard
Assessment will be discussed in greater detail in the Final Report to Congress.
c. Information Concerning Sources of Medical Waste Contributing
to Wash-Ups
Some information has already been collected regarding the composition of
medical waste items found in beach wash-ups. As noted in the First Interim Report
to Congress, information collected by six States for the 1988 beach season was
analyzed and synmarized in a Beach Wash-up ' -ventory Report.9 According to the
Report, over half the medical waste items collected were syringe-related. Such items
are produced by a number of activities not regulated by the Act, i.e. home health
care and illegal intravenous drug use.10 Through its education and outreach efforts
(discussed later in this Report) the Agency is involved in providing information to the
home health care sector about proper medical waste disposal.
In order to identify the types, quantities, and sources of marine debris, and
determine the extent to which such sources contribute to the problem of syringe-
related medical waste wash-ups on beaches, EPA is conducting a number of studies.
EPA's Office of Marine and Estuarine Protection has sponsored national beach clean-
ups through an Inter-Agency Agreement with the National Oceanic and Atmospheric
Administration (NOAA) and a grant to the Center for Marine Conservation (CMC).
This activity involves the coordination of a volunteer effort (Citizen Pollution Patrols)
to pick up trash from the nation's beaches during "Coastweeks." During the cleanup,
volunteers characterize the trash by recording the types and quantities of debris on
specially developed data cards. These data cards are returned to CMC and the
information is entered into a national Marine Debris Data Base. The data from
these cleanups is used to assess the types of debris present on beaches around the
country, and will also be used in the future to monitor the effect of various control
8 The Health Hazard Assessment is discussed in greater detail on pages 35-37 of
this Report.
9 U.S. EPA, Inventory of Medical Waste Beach Wash-Ups, June - October 1988.
(Office of Policy Planning and Information, 1989). Information for this report was
contributed by Connecticut, Maryland, Massachusetts, New Jersey, New York, and
Rhode Island.
10A number of State reports concluded that these were the primary sources of
the medical waste washing up on beaches in 1988. See Environmental Crimes Unit,
Maryland Attorney General's Office, Medical Waste Investigation Report,
(December 13, 1988).
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measures. The annual beach cleanups also serve to increase public awareness about
the marine debris problem, and to clean temporarily our nation's coasts.
EPA is also investigating floating debris in several harbors (Boston, New York,
Philadelphia, Baltimore, Miami, Seattle, Tacoma, San Francisco, Oakland, and Galves-
ton). The surveys often employ EPA's ocean survey vessel, the PETER W. ANDER-
SON. By towing surface nets through slicks of floating debris, collecting the debris
and sorting, identifying, and counting the resulting materials, EPA has gathered infor-
mation regarding the nature of floating debris in these areas. This information is
invaluable in the assessment of harbors as potential sources of debris to other coastal
areas. Interestingly, of the syringes found during the Harbor Studies Program, all
were the small insulin-type, not hospital-type hypodermic needles. More detailed
information about the syringes found during the study is set forth in Appendix 1 of
this Report. EPA is expanding these surveys o*' shore to determine the extent to
which materials in the harbors are being transported into the open ocean.
Syringes collected during the EPA Harbor Studies Program also were preserved
and the contents analyzed to help determine potential sources of the syringes. Chem-
ical analyses of a few of these syringes have identified insulin and cocaine. Addi-
tionally, the types of syringes found suggests that the source of much of the medical
waste found on beaches may be household users which are excluded from regulation
by the MWTA (See Appendix 1). Further analysis of these samples will be included
in the Final Report to Congress. More recent information which States have col-
lected regarding the composition of beach wash-up waste also will be compiled and, if
appropriate, included in the Final Report. EPA also is preparing a separate report
on results of the Harbor Studies Program.
EPA's Office of Marine and Estuarine Protection also is proceeding with
studies to determine the types and amounts of materials entering the marine environ-
ment from publicly owned treatment works (POTWs), combined sewer overflows
(CSOs), and storm sewers. EPA's studies involve collecting samples using nets placed
on CSO and storm sewer outfalls, and by collecting floatables directly from POTW
settling tanks.11 The New York City Department of Environmental Protection also
conducted two surveys in 1988 to determine if medical waste enters the water pollu-
tion control plants. The studies involved examining screenings and skimmings at 14
treatment plants for the presence of medical wastes. The data from one survey (July
of 1988) indicated that 119 syringes are collected by all 14 treatment plants daily,
while data from the other survey (August of 1989), which was collected after a
significant rainfall, indicated that only 12 syringes are captured daily by all 14
treatment plants.
11 U.S. EPA. 1990. Methods to Manage and Control Plastic Wastes, Report to
Congress. Prepared by the Office of Solid Waste and Emergency Response and the
Office of Water. EPA/530-SW-89-051. p. 3-14.
12 New York City Department of Environmental Protection, Medical Waste Study
41-46 (1989).
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Although POTWs are potential sources of floatables in the marine
environment, EPA emphasizes that if POTWs are properly operated, they should not
discharge floatable debris into the marine environment. However, under some
circumstances, plastics materials disposed into sanitary sewers can be discharged to
marine waters. These circumstances, which are not common, include:
Malfunctions or breakdowns. During periods of "down-time," when a
POTW is not operating because of malfunctions or breakdowns, influent
may circumvent the treatment system and be released into receiving
waters; and
Bypasses. At POTWs that cannot treat the capacity of "normal dry-
weather flow," untreated sewage may bypass treatment and be released
directly into the receiving waters; -"d
CSOs. In a community where both sewage and stormwater runoff are
combined into one system and the volume of stormwater exceeds a
treatment plant's capacity (e.g., during heavy rain), both untreated
sewage and stormwater are discharged directly into receiving waters.
A study prepared by the New York Department of Environmental Conservation (NY
DEC) also cited CSOs, raw sewage discharges caused by breakdowns at waste water
treatment plants, and stormwater outlets as likely sources of floatable debris.
According to the NY DEC report, and reports prepared EPA Region II,14 data
suggests that a major source of the debris that washed up on New York and New
Jersey beaches in 1988 and earlier was solid waste containing syringes that was
improperly managed at marine transfer stations, at Fresh Kills landfill, and on barges
enroute to Fresh Kills landfill. Local municipalities have initiated steps to correct this
problem. The City of New York and the State of New Jersey have entered into a
judicial consent decree which directs waste handling activities. The consent decree,
aimed at reducing the amount of debris entering the marine environment, includes
strict waste handling protocols, use of containment booms around loading and
unloading facilities, use of barge covers, and frequent removal of floating debris within
the containment booms.
A general conclusion can be drawn from these studies - syringes can be found
throughout the near-shore marine environment in very low numbers, and medical
13 NYDEC, Investigation: Sources of the Beach Washups of 1988. (November
1988).
14U.S. EPA. Floatables Investigation. Report, (prepared by the EPA Region II)
(1988). U.S. EPA. Methods to Manage and Control Plastic Wastes, Report to
Congress EPA/530-SW-89-051, 3-10. (Prepared by the Office of Solid Waste and
Emergency Response and the Office of Water) (1990).
12
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waste is a very minor component (<0.1%) of all floating debris. Furthermore, the
data suggests that the debris is entering the marine environment in several ways
including storm sewer outfalls, CSOs, general litter, and improper management of
municipal waste containing insulin syringes.
d. Information Concerning Treatment, Destruction and Disposal
Methods
Initially, research concerning treatment, destruction and disposal methods
consisted of an assessment of the advantages and disadvantages of the existing
principal technologies and of the factors affecting their effectiveness. The results of
this research were presented in the First Interim Report to Congress.15 Research in
this area continues; in particular, criteria are being developed to evaluate emerging
new treatment technologies.
The physical and chemical composition of the medical waste stream will have
significant implications for the effectiveness of any treatment technology. The Waste
Characterization Study will collect empirical data regarding the composition of medical
waste. These waste composition characteristics are variables that will be considered in
the assessment of treatment technologies, which will be included in the Final Report
to Congress.
Current research has focused on the most commonly used treatment
technologies and their potential health effects. These technologies will be tested using
particularly resistant indicator microorganisms to evaluate their effectiveness in
destroying pathogens. This analysis will also help to identify possible routes of
transmission for microorganisms both during the primary treatment process and any
subsequent treatment and disposal activities (e.g., off-site transport). This information
will be considered by the Agency's Office of Air and Radiation in its deliberations on
whether there is a need for regulation of medical waste incinerator emissions.
Additionally, EPA's Office of Solid Waste and Office of Air Quality Planning
and Standards are undertaking a joint testing program to evaluate emissions from
typical existing incinerator units and to determine the effects of variations in operating
conditions. Other studies, conducted jointly by the State of California Air Resources
Board and EPA's Office of Research and Development, led to the publication of a
report entitled State-of-the-Art Assessment of Thermal Treatment of Medical Waste.
The report addresses the problems of on-site hospital incinerator operation and
presents options available to incinerator operators. The State of California set its
operation and emission standards based on the data and information presented in the
report.
15See also U.S. Environmental Protection Agency, Office of Air and Radiation.
Hospital Waste Combustion Study: Data Gathering Phase. EPA-450/3-88-017,
(December 1988).
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The disposal of untreated medical waste in landfills is an increasingly
uncommon practice, as the First Interim Report to Congress observed. The msst
significant health risks associated with such disposal may be occupational risk to waste
handlers and risks faced by children playing at landfills and disposal sites.
Furthermore, the information currently available concerning pathogen survivability and
behavior in landfills may not be applicable to the pathogens found in medical waste.
Information from the Health Hazard Assessment may provide further insights into this
area.
The disposal of certain types of medical waste into wastewater treatment
systems (most notably blood and blood products) is under Agency review. At least
one State (New Jersey) and several local jurisdictions are concerned about
introduction of medical waste, especially syringes, into the wastewater treatment
system. With this in mind, EPA's Office of W.-ter will evaluate discharges of medical
waste to sewers, and examine the efficacy of existing Federal, State and local
requirements and controls.
Recognizing that waste disposal problems can be minimized by encouraging
source reduction and reduction in the toxicity of wastes, EPA has been investigating
the applicability of such measures to medical wastes. The Waste Characterization
Study will analyze options for reducing the amount of waste generated and will
identify opportunities for reducing the toxic constituents of waste items (e.g., product
reformulation to minimize toxic components).
e. Cost Analysis
The First Interim Report contains EPA's preliminary analysis of the costs of
the medical waste program to the regulated community and improper management of
medical waste. Costs were not estimated for administration of the program by EPA
and the covered States. Since the submission of the First Interim Report, data
collection efforts have continued, but no new analyses are discussed in this Report.
The Final Report to Congress will incorporate analysis of the recently collected data
on generators, waste quantities, and transportation practices in its discussion of the
costs of the medical waste program to the regulated community.
The final analysis of the cost to the regulated community of the tracking rule
will be influenced by the additional data collected about the characteristics of the
regulated community. Changes in the cost of medical waste transportation and
disposal as a result of the medical waste program will also be taken into
consideration; this information may be primarily anecdotal.
With regard to the costs to human health, local economies and the environ-
ment from medical waste mismanagement, in the Final Report EPA will examine
16 Please refer to page 37 of this Report for additional information about EPA's
cost analysis studies.
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state and local efforts to assess the impacts of beach wash-ups on local economies.
An attempt will be made to include economic evaluations of the human health and
environmental impacts of improperly managed medical waste as well, although this
information will necessarily tend to be less quantifiable.
f. Enforcement and Compliance
Information concerning the enforcement of the MWTA and the degree of com-
pliance with its requirements in covered States is being collected to support the
program's evaluation of its enforcement strategy. Furthermore, information concerning
enforcement and compliance monitoring of medical waste programs in noncovered
States is being collected to provide insights about other medical waste management
strategies.
The covered States and EPA Regions are compiling quantitative data concern-
ing the number of inspections conducted, the number of violations found, the enforce-
ment actions undertaken, and other enforcement-related information. Appendix 2 sets
forth data about the program's enforcement efforts.17 This data is being compiled on
a computerized information management system, which will be discussed in greater
detail later in this Report and in the Final Report to Congress.
Furthermore, EPA has established a Compliance Monitoring and Enforcement
Information Clearinghouse to promote the collection and exchange of enforcement-
related information. The Clearinghouse collects and catalogues complaints, inspection
reports, press releases, notices of violations' and other relevant material from a
number of covered and noncovered States, and distributes a bibliography of materials.
State and EPA Regional officials may request copies of any Clearinghouse
materials. The Agency anticipates that States will be able to carry out more effective,
aggressive enforcement than they otherwise would, because they will have enforcement
materials from the Clearinghouse available to help them develop an enforcement stra-
tegy and prepare enforcement cases. Additionally, these materials have been used to
prepare this Report and will be utilized in preparing the Final Report to Congress.
4. Outreach, Education and Training
An effective medical waste program must be well-understood by the regulated
community (e.g., physicians, dentists, medical clinics, hospitals, nursing homes); it also
must have well-established communications links with other regulatory agencies per-
forming similar or complementary functions. With this in mind, program outreach,
education, and training has been focused in five primary areas:
Outreach and education for the regulated community;
17These charts and other enforcement data are discussed on pages 20-22 of this
Report.
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Outreach and education for the unregulated universe, including individ-
uals who use items such as syringes, lancets or other medical imple-
ments, but are not subject to the Act (e.g., home health care), and the
general public;
Integration and coordination with other Federal and State agencies;
Within the program, outreach and coordination between EPA Head-
quarters, EPA Regions, and States; and
Education and training for Federal and State program personnel who
administer and implement the program.
These five primary areas are discussed in grer-~ detail below.
a. Outreach and Education for the Regulated Community
Since the commencement of the medical waste program, EPA has emphasized
outreach to and education of the regulated community. Intensive and ongoing out-
reach to the regulated community has been designed to encourage dialogue, promote
understanding of program requirements, and cultivate a high level of voluntary com-
pliance. An initial program priority was the production of high-quality written mate-
rials outlining the specific requirements and responsibilities of generators, transporters,
and TDD facilities. These instructional materials have been distributed widely.
Appendix 3 contains examples of instructional materials prepared by EPA.
The distribution of these booklets has been facilitated by a large-scale program
of presentations to the regulated community. EPA Region I and Region II have co-
sponsored programs with the covered States. Personnel from EPA Headquarters and
Regions frequently give presentations at trade association meetings. New York, New
Jersey, Puerto Rico, Rhode Island and Connecticut have each undertaken presentation
programs; EPA personnel have participated in many of these presentations, outlining
the Federal program and responding to the questions and concerns of the regulated
community. At the time of submission of this Report, at least 45 presentations had
been held. EPA is also continuing outreach to segments of the regulated community
that are highly regulated, and therefore known to EPA, such as medical waste
transporters and hospitals that operate on-site incinerators by sending booklets and
letters reminding them of the periodic reporting requirements.
Several outreach efforts are now planned for additional segments of the
regulated community. States have indicated that outreach to various professional
organizations (e.g. American Medical Association) can enhance compliance; EPA
personnel currently are considering the initiation of such efforts. As the volume of
interstate shipments of medical waste increases, outreach to TDD facilities will receive
16
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more attention. Finally, various informational materials are being translated into
Spanish to facilitate outreach efforts in Puerto Rico.18
b. Outreach and Education for the Unregulated Universe
In order to address an important Congressional concern regarding waste
generated outside the scope of the Act, EPA has conducted outreach to explain
proper disposal techniques to individuals who use medical implements such as syringes
in the home. The home health care community is the most significant unregulated
community that EPA has attempted to reach because some of the medical debris
discovered on beaches has been linked to disposal of insulin syringes. The means by
which insulin syringes could end up on a beach are discussed in section III.B.3.C.
Substantive guidelines have been develop-^ for the disposal of home health
care medical wastes; these were presented in the First Interim Report to Congress.
Since the submission of the First Report, the guidelines have been written in brochure
form and distributed to EPA Regional personnel, States, professional organizations
and health care professionals.19 Appendix 4 contains EPA's pamphlet entitled
"Disposal Tips for Home Health Care." The guidelines are expected to advance
proper waste management in the home and encourage health care professionals to
educate their patients regarding proper medical waste management practices.
Outreach also has included providing medical waste-related information to the
general public and the media to clarify the actual and potential hazards present.
Agency personnel have conducted lectures at medical schools to instruct medical
students concerning proper medical waste management practices.
In order to reach children and individuals with low literacy skills, the Agency is
currently developing an instructional pamphlet to teach juveniles (such as diabetics)
about -proper disposal of sharps, such as syringes and lancets. The Agency expects
this pamphlet to be distributed in Fall, 1990.
Incinerator operator training is a crucial variable influencing the effectiveness
of medical waste incineration. Therefore, the Agency has developed a Medical Waste
Incinerator Operator Training Course. The course materials have been distributed to
all the States, and they were encouraged to conduct or require operator training as
18The materials that will be available in Spanish include the informational
booklets for generators, transporters, and TDD facilities; the MWTA interim final
rules; and the interpretive question and answer memoranda produced by the Agency
and discussed in d. below.
1925,000 copies of the brochure (EPA/530-SW-90-014A) and 160,000 copies of
the flier (EPA/530-SW-90-014B) have been produced.
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part of their regulatory or permitting programs.20 Additionally, EPA presented a
workshop on medical and institutional waste incineration six times in the past year at
various locations across the United States.21
c. Integration and Coordination with Other Federal and State
Agencies
From the early stages of its development, EPA has recognized that interagency
coordination is a cost-effective method of increasing program implementation. EPA
sought and received input from several States and Federal agencies which has been
crucial to the initial development of the program.
As the program has matured, the Agency has been oarticularly attentive to the
relationship of ;ts regulations, standards, and a. ' ities with ihose of other Federal
agencies such as the Centers for Disease Control (CDC), the Agency for Toxic
Substances and Disease Registry (ATSDR), and the Occupational Safety and Health
Administration (OSHA). In particular, pursuant to its blood-borne pathogen standard,
OSHA has begun to regulate many of the same facilities that fall under the MWTA
rules. The Agency recognizes the importance of the relationship between the MWTA
regulations and OSHA's regulations.
EPA has also attempted to work with appropriate agencies in noncovered
States to aid program implementation. This is particularly important for several
reasons. First, EPA's enforcement strategy encourages the States to initiate
enforcement actions; EPA Regions will provide assistance or, in certain cases outlined
below, may take direct action. Second, transporters cross State boundaries and TDD
facilities are found in both covered and noncovered States. Thus, in order to
implement the program consistently, an active State/Federal partnership is essential.
^U.S. EPA, Control Technology Center: Operation and Maintenance of Hospital
Medical Waste Incinerators. March 1989, EPA-450/3-89-002; Hospital Incinerator
Operator Training Course: Volume I (Student Handbook'). March 1989, EPA-450/
3-89-003; Hospital Incinerator Operator Training Course: Volume II (Presentation
Slides! March 1989, EPA-450/3-89-004; Hospital Incinerator Operator Training
Course: Volume III (Instructor Handbook! March 1989, EPA-450/3-89-010.
Volumes I and n are available through the National Technical Information Service.
For those interested in conducting the course, Volume III and the course projection
slides are available through the EPA Air Pollution Training Institute.
21 U.S. EPA, Center for Environmental Research Information, Seminar -
Medical and Institutional Waste Incineration. CERI 89-247, (November 1989).
^OSHA's Bloodborne Pathogen Standard (54 Fed. Reg. 23042-139 (May 30,
1989)) was published as a proposed rule and is expected to be finalized by January,
1991. It applies to health care workers who come in contact with infectious or
potentially infectious body fluids.
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Representatives of interested States and EPA Regions have been invited to participate
in program training activities (see below).
d. Internal Program Coordination
The medical waste program has led to the development of a number of
innovative structures to ensure rapid and effective communication between EPA
Headquarters, EPA Regions and States.
Periodic Federal/State roundtable meetings have provided invaluable
opportunities for information exchange, feedback, and program development. The
first such roundtable was held in Washington, D.C. shortly before program
implementation; the second took place in New York City in November, 1989; the
third was held i" Washington, D.C. in June, 19cr>; and the fourth was held in Boston,
Massachusetts in August, 1990.
As a result of a suggestion made at the first roundtable, EPA Headquarters
developed an ongoing series of interpretive Question and Answer Memoranda. These
Memoranda have provided the States and EPA Regions with interpretations of
difficult questions about the MWTA rule and have also been made available to the
regulated community.
States often have similar concerns about medical waste; they also may have
unique interests and resources. EPA encourages innovative projects and initiatives,
which can provide useful information, complement other program activities, and serve
as "experiments" with potentially significant implications for future national action.
The Agency set aside nearly $800,000 for project-specific grants available to all States,
both covered and noncovered. A total of 16 proposals were submitted by 10 States.
These proposals were reviewed by a committee of representatives from EPA's Office
of Waste Programs Enforcement, Office of Solid Waste, Region IV and the State of
Utah. Nine proposals were selected based on their ability to complement and extend
other program activities and the lack of alternative funding sources. States will
provide 5% of the funding for each project. These selected proposals are listed and
described in Appendix 5.
e. Education and Training for Federal and State Program Personnel
The thorough education of Federal and State personnel implementing the
medical waste requirements has been an important element of the program. This
training has been directed at inspectors and their supervisors as well as program
managers. There are four primary objectives of the training provided to these
personnel:
learning health and safety techniques to assure personnel health and
safety;
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understanding the unique characteristics of medical waste and the
regulated community;
increasing the effectiveness of enforcement activities; and
certifying field inspectors to conduct inspections in accordance with
applicable OSHA and State occupational health directives.
These objectives are clearly interconnected. For example, inspectors who are
aware of the unique characteristics of medical waste will be prepared to protect
themselves against exposure to the waste, and also to conduct more effective
inspections.
Several raining initiatives have been unc* -taken since the initial development
of the medical waste program. In May and June, 1989 a one-day health and safety
course was offered twice to EPA, State and contractor personnel. In the Fall of 1989,
a one-day course was developed and presented which specifically addressed
enforcement issues related to the MWTA regulations as well as presenting health and
safety training specifically targeted to medical waste inspectors. Encouraged by the
positive reactions to this course, an expanded two-day Medical Waste Enforcement
Workshop has been developed and is being presented to State and Federal personnel
in four locations. The course teaches inspection and investigation techniques, reviews
the Federal medical waste program, presents health and safety training, and acts as a
forum for idea exchange between EPA and State personnel.
5. Enforcement Strategy
The MWTA contains strong enforcement authorities. It empowers EPA, or its
duly designated representative, to conduct facility inspections and request information
about the generation, storage, treatment, disposal or handling of medical waste for
purposes of developing, or assisting in development of, any regulation or report, or for
enforcing the provisions of the Act. The Agency or its representative also can
conduct monitoring or testing, take samples, and have access to all facility medical
waste records.
Compliance orders can be issued to any violator of the Act assessing a civil
penalty and requiring compliance with the law and regulations. The Act allows the
Agency to assess and seek civil penalties of up to $25,000 per day for each violation.
In the event that records, reports, documents or material information is knowingly
falsified, or the provisions of the Act or rule are knowingly violated, the MWTA
incorporates criminal sanctions subjecting the convicted violator to a fine of not more
than $50,000 per day of violation or imprisonment of up to 5 years. If any person
knowingly creates a situation that places another person in imminent danger of death
or serious bodily injury, a criminal fine of up to $250,000 or imprisonment of up to
15 years may be imposed. Under this provision, a defendant organization may receive
a criminal penalty assessment of up to $1,000,000.
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Based on these strong enforcement authorities and the goals of the MWTA,
EPA "has developed an enforcement strategy designed to promote rapid and
widespread compliance with the medical waste program. The strategy encourages
States to lead enforcement efforts with EPA support. According to the strategy, the
Agency's enforcement role includes:
developing enforcement guidance so that the objectives of the Act are
carried out;
developing handbooks, brochures, and other informational materials to
encourage widespread voluntary compliance;
maintaining databases, including transporter notifications and reports and
incinerator reports; and
handling specific cases involving potential violations.
In the long term, States will take the lead in conducting inspections and
bringing enforcement actions. Initially however, EPA is taking a major role in
enforcement, especially in Region II, until States can obtain necessary enforcement
personnel. To strengthen enforcement of the Act, the interim final rule establishes
the presumption that any regulated medical waste found at a facility in a covered
State is presumed to have been generated in that State. Furthermore, the MWTA
provides that States may use applicable State authority or Federal authority to pursue
enforcement.
During the first year of the program, EPA has actively enforced the Act and
regulations. The Agency has conducted inspections and taken enforcement actions in
both covered and noncovered States, and coordinated its enforcement activities with
State personnel. Thus, EPA has played a large role in enforcement during the
program's start-up phase. In the second year, EPA enforcement initiatives will be
targeted to support state enforcement actions in situations in which States solicit EPA
intervention. Although the Agency anticipates relatively little Federal enforcement
action in States that are implementing an effective program, EPA involvement may be
appropriate in the following circumstances:
during the start-up phase of the program;
at Federal facilities, if the State requests EPA assistance; and
in following up on regulated medical wastes transported to noncovered
States and to Indian tribal lands where there is no comparable state or
tribal statute.
Enforcement efforts during the first twelve months of the medical waste
program are summarized in Appendix 2. The Agency has aggressively pursued serious
violators (11 administrative actions have been undertaken) and has issued 257 warning
21
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letters or notices of violation for less serious infractions. As of June 1, 1990,
approximately 510 inspections had been conducted and approximately $690,000 in
penalties have been assessed.
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IV: RESULTS OF THE PROGRAM AND ISSUES FOR FUTURE
CONSIDERATION
The medical waste program was established approximately one year ago. At
this point, it is premature to examine the program's success, although the available
evidence indicates that the program has already had a number of direct and indirect
effects on the management, handling and disposal practices of medical waste. These
results are discussed in this Section. The Final Report to Congress will contain a
detailed examination of the program's success and a more thorough review of its
effects.
The regulation of medical waste also has raised a number of issues that will
need to be addressed as part of any review of the future of medical waste regulation.
Some of those issues are discussed in this Sect'---r|. Other issues will be set forth in
the Final Report to Congress.
A. Direct Program Effects
Several results of the medical waste program are direct and relatively clear.
The most significant include the implementation of a functioning demonstration
tracking program and the collection of essential information.
1. Demonstration Tracking Program
A coordinated, functioning Federal demonstration tracking and management
program has been established and seems to be successfully tracking the management
and disposal of medical waste in the States it covers. The management performance
standards which this program contains are leading to the development of model
practices within the regulated community to ensure the proper handling and
management of medical waste. The demonstration program also has raised awareness
about existing and potential treatment technologies and has led to studies about their
benefits and drawbacks.
2. Information Collection
Information collected pursuant to the program is expanding the Agency's
knowledge concerning the nature of medical waste and the universe of medical waste
generators, transporters, and TDD facilities. Although some of this information has
been included and analyzed in this Report (see Appendix 6 and Section V.A.), the
Final Report will contain a comprehensive review and analysis of much additional
information. Data collection and analysis will facilitate more informed discussion of
Federal medical waste regulation.
B. Indirect Program Effects
In addition to its direct effects, the medical waste program seems to be having
several indirect effects, which include the encouragement of innovation in treatment
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technologies, the reevaluation of home health care waste management, some reduction
in the severity of beach wash-ups, and the contribution to program development'in
noncovered States and foreign countries. The program will provide, to the extent
possible, further analysis of these indirect effects in the Final Report to Congress.
1. Treatment Technology Innovation
The medical waste program provides an exclusion from the tracking
requirements for medical waste that has been both treated and destroyed. This
exclusion has encouraged the development of innovative treatment and destruction
technologies.
New treatment technologies for medical waste are often adapted from other
uses. For example, gamma irradiation, which rr- been used to sterilize reusable
medical instruments, is now being developed for medical waste treatment.
Microwaving techniques are also being adapted for treating medical waste.
Most of the innovative treatment methods are for the treatment and/or
disposal of sharps and are being developed for the small quantity generator (i.e.,
physicians', dentists', or veterinarian's offices). The Agency is in the process of
developing a program to evaluate these systems to ensure that they meet the
definitions of treatment and/or destruction found in the interim final rule. The
Agency does not have the explicit authority under the MWTA, however, to "approve"
or "certify" these technologies.
2. Home Health Care
The program has encouraged a reevaluation of home health care waste
management. Although the Agency has not documented changes in waste disposal
practices, it believes that its education and outreach efforts targeted at persons
generating home health care waste, along with publicity about the sources of waste
contributing to the problem, are likely to have a positive impact in the way home
health care wastes are disposed of.
3. Beach Wash-ups
It is not possible to correlate directly the effects of the program with the
number of beach wash-ups or the amount of medical waste on beaches. The
frequency and severity of beach wash-ups are influenced by many factors, many of
which whose study are beyond the scope of the Act, including weather patterns,
management practices for municipal solid waste, and the amount of medical waste (or
"look-alike" waste) disposed of hi sewers and on the streets. Nevertheless, it is likely
that the program may be responsible for reducing the severity of beach wash-ups by
increasing awareness of the problem and its sources among health care providers, the
public and local government.
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By encouraging good waste management practices among the regulated and
unregulated (e.g., home users) communities and by publicizing the problems associated
with improper management, the Agency believes that the program decreases the
amount of medical waste that is disposed of improperly. Furthermore, EPA is
conducting or sponsoring a number of projects that address the problem of floating
debris in general, of which medical waste is one component. These include National
Beach Cleanups, the National Harbor Surveys, and the "Floatables Action Plan" in
New York and New Jersey. Additionally, the publicity generated by these programs
may indirectly influence more responsible behavior.
4. Contribution to Medical Waste Program Development
Concern over medical waste management and Federal action, including the
implementation of the medical waste program, has spurred a flurry of activity both in
other States and other nations. Additionally, the Federal program has influenced
medical waste programs in the covered States. The number of States regulating
medical waste and the comprehensiveness of such programs are growing rapidly.
According to the National Solid Waste Management Association, medical waste
regulation has greatly expanded since July, 198823. Since that time:
8 states have passed medical waste legislation;
10 states have promulgated new or revised regulations;
4 states have passed new laws and promulgated regulations.
Significantly, at least twelve states recently have begun to track medical waste via a
manifest system.
The covered States have amended their regulatory programs in light of the
Federal program. Additionally, some of the covered States have moved to regulate
areas that are not controlled by the Federal program. The Final Report to Congress
will discuss in detail the changes in the covered States' programs.
The program has also attracted interest from several other countries. Australia
has recently implemented a medical waste tracking and management program quite
similar to the EPA's program; Canada and Japan have expressed interest in the
program as well.
^National Solid Waste Management Association, Special Report: Medical Waste
Management (1989).
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C. Issues For Future Consideration
1. Introduction
Since the commencement of the medical waste program approximately one year
ago, a number of issues have emerged that relate to the future of the program.
These issues are discussed below and will be elaborated further in the Final Report.
The Final Report will also address other issues that may arise in the second year of
the demonstration program.
In the Final Report, the Agency will evaluate more fully the success of the
program in controlling mismanagement of medical waste and make recommendations
on the need for, and content of, future Federal regulation* regarding medical waste.
2. List of Issues
a. Developing a Uniform Definition of Medical Waste
Developing a uniform definition of medical waste that is easy for the regulated
community to understand and implement and for EPA to enforce has been
problematic. Since promulgation of the rule, the regulated community has often
requested interpretations of the definition of medical waste. In particular, the Agency
has noted confusion among generators regarding certain waste items, including:
the scope of the blood products category (which lists "... items that are
saturated and/or dripping with blood..."); and
the status of personal care items generated by a patient that are
unrelated to the condition being treated (such as a disposable razor).
Generators are uneasy because they are required to use their best judgement in
some cases to determine whether a specific item is regulated, and they fear that an
incorrect decision will lead to possible enforcement action.
b. Use of Aesthetics as a Criterion to Regulate Medical Waste
The MWTA gives EPA broad authority to regulate medical waste. In its
interim final rule, EPA has used aesthetic concerns as one criterion for determining
what to list as a regulated medical waste in addition to health criteria. Some of these
determinations have been controversial. For example, discarded intravenous bags are
considered medical waste, even if they contained sterile solutions and pose little or no
risk to human health.
c. Other Sources of Medical Waste
Congress enacted the MWTA because of widespread concern about beaches
polluted with medical debris such as syringes. At present, the extent to which sources
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that are excluded by the MWTA (and are therefore not regulated under this program)
contribute to the problem of beach wash-ups and other mismanagement incidents is
unclear. Examples of unregulated sources include wastes such as syringes that are
generated in the home or on city streets by drug users and are improperly disposed of
(e.g., onto the ground or into storm water systems), or properly disposed of and
subsequently mismanaged (e.g., into household trash) and medical items that are
discharged to sanitary sewers and may be released through CSOs or other means.24
EPA has attempted to address home health care waste sources through its outreach
efforts (see pages 17-18). Its home health care booklet was written to provide
guidance for appropriate waste disposal.
In 1988, the Clean Water Act was amended to prohibit the discharge of
medical waste to navigable waters.25 EPA's Office of Water is currently evaluating
alternatives to implement these amendments.
d. Refining and Improving the Tracking System
The current paper-based tracking system, which revolves around the manifest,
has been subject to a large number of "paper discrepancies." These are discrepancy
reports that are caused by mere human error and not illegal activity. They occur for
several reasons, including miscounting the number of boxes in a waste shipment or
improper affixing of labels to boxed waste.
These types of discrepancies are.not surprising. A single truck may contain
several hundred boxes of medical waste, and the waste may originate from many
generators and therefore be accompanied by several manifests. The result is
increased unloading time and paperwork burden on waste handlers, and a strain on
Federal and State enforcement personnel who must track down and resolve these
discrepancies, taking away valuable time from situations in which investigation and
enforcement are clearly warranted. EPA is investigating other options for tracking
waste, and will recount its results in the Final Report.
e. Inadequacy of the Data to Address Certain Issues Listed by
Congress in the MWTA
Despite the broad information gathering power in the MWTA, because of
inadequacy of data EPA has not been able to address adequately some of the ques-
tions on which it is required to report to Congress. For example, EPA has not been
able to quantify risks to human health and the environment posed by mismanagement
of medical waste because information necessary for a quantitative health assessment,
24 A more detailed discussion of the sources of wastes that contribute to beach
wash-ups is found on pp. 10-13.
25The discharge prohibition is contained in Section 3202 of Title III of the Ocean
Dumping Ban Act of 1988, Pub. Law 100-688, which amended the Clean Water Act.
27
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such as the types and quantities of pathogens found in waste, survivability of
pathogens in the environment, infective dose of specific pathogens, and general *
information on exposure to medical waste, is lacking or is not in a usable format.
This lack of information led the Agency to conduct a qualitative health assessment
rather than a quantitative one. In section V.B. of this Report, EPA provides an
update on its plan to conduct a qualitative health assessment. The Agency's
qualitative assessment will attempt to address some of the concerns raised by
Congress. This lack of data also affected ATSDR's study of the health effects of
medical waste on waste handlers. In that study, the epidemiological data used to
develop rates of disease and injury pertained mostly to HIV (Human
Immunodeficiency Virus or the AIDS virus) and HBV (Hepatitis B virus), and was
not related specifically to medical waste.
Collecting pre-MWTA baseline informal?-" on topics such as waste generation,
waste management practices, and waste management/disposal costs has been
problematic. This information is necessary to assess changes attributable to the
demonstration program. This is because most facilities (especially small quantity
generators) generally did not maintain records of their waste disposal practices prior
to implementation of the demonstration program, and because waste management
practices vary widely between facilities and are driven by factors other than Federal
regulations such as availability and cost of disposal options, and State and local
regulations. The information that the Agency has collected has been largely
anecdotal.
This lack of data further explains, in part, the broad spectrum of opinion that
exists on whether medical waste poses a potential health problem, and the extent to
which medical waste should be regulated, if at all.
f. Standards for Waste Treatment, Destruction, and Disposal
Facilities
There are no provisions in the MWTA that explicitly empower the Agency to
promulgate treatment and disposal standards or TDD facility standards; EPA has not
included such standards in the current federal regulations. Rather, EPA has defined
the terms "treatment" and "destruction" in general terms, and has not established
objective (i.e., measurable) standards for determining when a waste has been both
treated and destroyed (and therefore excluded from further regulation). In fact, EPA
has not concluded that treatment and/or destruction standards are needed considering
the fact that the risks posed by mismanagement of medical waste are not well
understood (but appear likely to be minimal). Furthermore, EPA has not concluded
that the presence of physical hazards alone (e.g., exposure to syringes or glassware)
warrant regulation up to the point where the waste is destroyed. The Agency is
assessing whether there is a need to regulate the discharge of medical waste to
sanitary sewers. The data gathered during this first year of the program suggests that
liquid medical wastes (e.g. blood, blood products, and other fluids) are commonly
disposed of into waste water treatment systems in some areas.
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g. Nationwide Consistency in Medical Waste Management
In the absence of a federal program, States and municipalities will continue to
pass laws and promulgate regulations regarding medical waste. A waste transporter or
TDD facility that conducts its business across state boundaries thus will be faced with
complying with numerous (potentially conflicting) medical waste programs.
Congressional testimony has revealed that substantial costs could be imposed upon the
regulated community if it were forced to comply with a patchwork of medical waste
programs26. Also, it has become clear from the reports submitted by transporters that
much medical waste is shipped across State boundaries. Because State authority
generally ends at its boundaries, it may be difficult for a State to conduct compliance
monitoring and enforce its program if medical waste is shipped out-of-state.
EPA has not determined whether a federal program is desirable to impose
regulatory uniformity and consistency. Such a piogram could contain provisions such
as uniform tracking, management standards and other requirements, and enforcement
authorities that reach beyond state boundaries.
26 See Infectious Waste - 1-Year Update on Practices. Policy, and Public
Protection: Hearing Before the Subcommittee on Regulation and Business
Opportunities of the House Committee on Small Business. 101st Cong., 1st Sess. 40,
45 (1989).
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V. RESEARCH UPDATE AND FORECAST
The Act requires EPA to report on 12 specific areas regarding medical waste.
Much of this information is presented in the Sections I through IV of this Report; for
ease of reference, however, this Section presents this information according to the 12
Chapters of the First Interim Report and provides details about the Agency's future
activities.
A. Update of Chapter 1, Characterization of Medical Waste
1. Overview of Characterization Efforts
In the First Interim Report to Congress, EPA presented preliminary estimates
of the numbers of generators potentially affecte- by the nutf and the quantities of
regulated medical waste generated in the covereu states and nationwide. EPA also
provided preliminary figures on the number of transporters handling and transporting
regulated medical waste.
In the First Interim Report, the Agency also explained its long-term strategy for
collecting data to characterize more fully and accurately the generation and
management of medical waste through reporting requirements included in the interim
final rule.
Specifically, the rule requires transporters who carry medical waste generated in
a covered State and medical waste generators with on-site incinerators which are
located in a covered State to submit periodic reports to the Agency. The rule
includes three reporting requirements:
the Medical Waste Transporter Notification;
the Semi-Annual Medical Waste Transporter Report; and
the On-Site Medical Waste Incinerator Report.
These reports, collectively referred to as the Medical Waste Reports, were
designed to address several basic questions regarding the generation and management
of medical waste, including:
What are the types and numbers of facilities that generate medical
waste?
What types of generators produce medical waste and how much
regulated medical waste is generated by each of the generator types?
What would be the effect of excluding small quantity generators (e.g.,
less than 50 pounds per month) from regulation?
What treatment and disposal practices are currently in use?
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What quantity of waste is transported off-site for treatment or disposal?
What quantity of waste is treated or incinerated on-site?
To what extent is medical waste shipped out-of-state for disposal?
The first reporting period began in June, 198927 and ended in December, 1989.
Reporting data was due to the Agency in February, 1990. This update presents the
results from the first reporting period, and describes the activities that EPA will be
undertaking in the future to characterize generation, management, transportation and
disposal practices.28
2. Utility and Limitations of the Data Collected from the Medical Waste
Reports
To facilitate data processing, EPA developed an automated information
management system that supports data entry, tracking the status of forms, issuance of
identification numbers and reporting of summary data. To date, EPA has received
and processed 215 transporter reports (or letters) and 252 on-site incinerator reports.
EPA believes that this represents a response rate of approximately 90% for
transporters for the first reporting period. The response rates for on-site incinerators
have not been estimated because the Agency has not determined the size of the
regulated universe. We do believe, however, that the response rate for large facilities
(e.g., hospitals) is high because the number of hospitals is known, and most (>85%)
were either listed on transporter reports, or submitted an on-site incinerator report.
EPA believes that the results presented in Section 3 (below) provide a
relatively accurate picture of the numbers and types of medical waste generators who
either ship waste off-site or incinerate waste on-site; the number and types of
treatment and disposal facilities; and the number of transporters who haul medical
waste off-site. The Agency also believes that general conclusions about the covered
States can be drawn from the quantity information, such as the percentage of
regulated medical waste that is incinerated on-site, the percentage of all regulated
medical waste that is generated by each generator type, and the percentage of
regulated medical waste that is generated by small quantity generators.
There are, however, limitations on specific conclusions that can be drawn from the
data. For instance, the total quantity of medical waste generated (and therefore
first reporting period began in July 1989 for Puerto Rico and Rhode
Island because they entered the program one month later than Connecticut, New
York and New Jersey.
^Exhibits that compile the data collected during the first reporting period are
presented in Appendix 6.
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waste generation rates) is likely underreported for the first reporting period because,
early in the effective period of the regulation, many generators may not have property
segregated medical waste, or properly maintained records, or initially used a
transporter who had notified EPA.29
Additionally, there are some generators and some waste quantities that are not
captured by the Medical Waste Reports because of statutory exclusions or exemptions
included in the rule. For -example, quantities of medical waste disposed of into
sanitary sewers, treated and destroyed on-site, mailed through the United States Postal
Service, or transported personally by small quantity generators directly to a disposal
facility are not captured. The results presented in this Report include only data on
medical waste that is incinerated on-site or shipped off-site using a transporter who
has notified EPA. Therefore, the number of medical waste generators and the
quantities reported here are subsets of the tots1 number ot medical waste generators
located in the covered States, and the total quantities of medical waste generated in
the covered States, respectively.
The activities that EPA will be taking to improve response rates and quantify
the numbers of generators and quantities of waste not captured in the Medical Waste
Reports are outlined in Section 4 below.
3. Summary of the Results from the First Reporting Period
a. Characterization of Medical Waste Generation
During the first six months of the medical waste program, approximately 48,000
tons of medical waste were produced by 16,400 generators in the covered States. The
universe of medical waste generators who produced this waste is large and diverse,
ranging from physicians' and dentists' offices to laboratories to hospitals. The number
of medical waste generators and quantities of regulated medical waste generated in
each of the covered States is presented in Exhibit 1 of Appendix 6.
The vast majority of the medical waste (about 90%) is produced by hospitals,
which comprise only about 4% of the generators reported. Nearly 80% of the
generators in the covered States are comprised of doctors, dentists, veterinarians, and
clinics. This 80%, however, generates only a very small percentage (3%) of the
medical waste that is generated in the covered States. The remaining generators are
in many different industry sectors including laboratories, funeral homes, nursing
homes, industrial facilities and others. Information on the number of generators and
29As previously discussed, each transporter who notifies EPA must complete
Transporter Reports and record every generator from whom he receives regulated
medical waste. EPA estimates the quantity of medical waste generated and shipped
off-site for treatment and disposal based on the Transporter Reports.
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quantity of medical waste generated, by type of generator, is presented in Appendix 6,
Exhibits 2 and 3.
The information submitted in the transporter semi-annual reports also allows
EPA to determine waste generation rates for generators who ship waste off-site, and
the percentage of generators who generate less than 50 pounds per month (small
quantity generators or SQGs). During the first reporting period, 86% of all
generators produced less than 50 pounds per month of medical waste. Information on
the number of generators who are SQGs for each generator type is presented in
Appendix 6, Exhibit 2. This is especially interesting in light of the fact that the
MWTA authorized, and EPA promulgated, regulations that included special provisions
containing very limited regulatory relief for SQGs. Although SQGs must comply with
all pre-transport regulations (segregating, packaging, storing labelling and marking),
the regulations allow SQGs to maintain logs in TU of initiating a tracking form, or to
personally transport waste (without obtaining an EPA identification number) to a
disposal facility without using a tracking form. This information will also allow the
Agency to determine the possible impacts of exempting small quantity generators from
regulation or reducing their reporting requirements in the future.
The number of generators estimated from the Medical Waste Reports
summarized in Appendix 6, Exhibit 2 is lower than the estimates provided in the First
Interim Report to Congress. In the First Report, EPA estimated that there were
roughly 60,000 generators, while in this Report EPA estimates that there are about
16,400 generators located in the five covered States. This estimate, however, includes
only those generators who actually produce medical waste and either incinerate it on-
site or ship it off-site using a transporter who has notified EPA. EPA believes, based
on anecdotal information, that there are a substantial number of SQGs (10,000-
15,000) that mail sharps off-site through the United States Postal Service (USPS).
EPA currently is collecting information on this group of generators by working with
companies marketing such services and will provide results in the Final Report.
In addition, estimates presented in the First Report were based on very limited
information collected by Federal agencies and trade associations, and were premised
on a number of conservative assumptions made by EPA. In fact, this number
represents the estimated number of generators potentially affected by the regulations.
Thus, the number of generators contained in the First Report included facilities that
may not actually generate any medical waste (e.g., physicians whose practice involves
largely consultation). Additionally, because the extent to which doctors or other
health care providers practice in groups was not well documented in the available
data sources, the First Report may have overestimated the number of generating
entities (e.g., the number of physicians' offices). When comparing estimates
specifically by generator category, the number of physicians, dentists, and veterinarians
account for the major differences in estimates between this Report and the First
Report.
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b. Characterization of Medical Waste Management Practices
Most (98%) of the regulated medical waste generated during the first six
months of the reporting period was incinerated. The remainder was either landfilled
(1%) or treated and destroyed in a manner other than incineration (1%) (and then
landfilled). Of the 48,000 tons30 of regulated medical waste that was generated, 61%
(29,600 tons) was shipped off-site to 82 disposal facilities, including 68 off-site
incinerators, 8 landfills, and 6 treatment and/or destruction facilities. The remaining
39% (18,600 tons) was incinerated on-site by generators at approximately 250 facilities,
primarily hospitals.31 The number of each of the different types of treatment and
disposal facilities is presented in Appendix 6, Exhibit 4, and the amount of medical
waste that goes to each of the disposal alternatives, in each State, is presented in
Appendix 6, Exhibit 5.
During the first six months of the demonstration program, 132 transporters
hauled approximately 29,600 tons of regulated medical waste that was generated in
the covered States to disposal facilities all over the country. The amount of waste
that is shipped out-of-state for disposal varies considerably from State to State. For
example, only 20% of the medical waste generated in Rhode Island is shipped out-of-
state for disposal, while 59% of the medical waste generated in New York is shipped
out-of-state for disposal. Information on the extent to which medical waste is shipped
out-of-state for disposal, for each of the covered States, is presented in Appendix 6,
Exhibit 6. Of all the regulated medical waste that is shipped off-site for disposal,
only about 2% is treated (e.g., autoclaved) prior to shipment.
4. Future Agency Activities
In the next 12 months, EPA will be conducting a number of activities to
characterize more fully medical waste generation, transportation, and disposal
practices, and develop a "waste flow model" describing medical waste generation and
management practices in the covered States and nationwide. The Agency will conduct
the activities outlined below:
Collect and summarize data obtained in the subsequent reporting
periods;
'"There is a slight difference (<1%) between the quantity of regulated medical
waste generated (Exhibit 2 of Appendix 6 (48,411 tons)) and the quantity disposed
(Exhibit 5 of Appendix 6 (48,233)). The difference is due to inaccuracies in reporting
of quantities by transporters.
31 As discussed earlier in this Report, treatment and destruction are defined as
performance standards. An example of treated and destroyed waste is medical waste
that has gone through both an autoclave and a grinder.
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Work with the States and EPA Regional offices to supplement the infor-
mation collected from the Medical Waste Reports (e.g., quantity infor-
mation by waste class);
Collect information, as needed, to refine assumptions underlying the
Agency's medical waste flow model (e.g., estimate numbers of regulated
generators and amounts of waste not being captured by the Medical
Waste Reports);
Collect information regarding the physical and chemical characteristics of
the medical waste stream;
Extrapolate the data collected in the covered States to develop
nationwide estimates of the numb?--- of generators, transporters, and
treatment and disposal facilities as well as the quantities of medical
waste generated, transported, and treated and disposed;
Use the data from the Medical Waste Reports to identify trends in
medical waste generation, transportation, and treatment and disposal
practices; and
Continue education and enforcement activities to ensure that generators
and transporters maintain required records and submit the required
reports.
B. Update of Chapter 2, Health Hazard Assessment
1. Overview of Hazard Assessment Activities
In the First Interim Report to Congress, EPA proposed a methodology for
assessing the potential health hazards of exposure to medical waste. According to this
methodology, EPA intended to:
evaluate the medical waste types listed in the MWTA to determine if
they warrant reorganizing to facilitate the health assessment;
identify pathogens that may be present in the various types of medical
waste;
designate qualitatively the "infectiousness" of each type of medical waste
(e.g. infectious, potentially infectious, non-infectious);
quantify the pathogens in each type of medical waste; and
translate these findings with respect to potential health hazards.
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EPA further proposed to use the epidemiological findings in the ATSDR
Report to Congress to support its determinations on the health hazards of medical
waste32. Because ATSDR has limited its report to HIV and HBV transmission and
injuries, EPA will use ATSDR's findings to support any conclusions pertaining to the
potential transmission of these two viruses from exposure to medical waste.
2. Review of Activities Undertaken
This update chronicles EPA's activities regarding the health hazard assessment
since the First Interim Report. Because the health assessment has not yet been
completed, specific details of findings will not be available until the Final Report to
Congress.
Upon re-examining the types of medical -aste enumerated in the Act, EPA
determined they were suitable for performing a health assessment. In some cases,
however, subcategories within types of waste were created to further assist in the
health assessment. A comprehensive list of medical waste items has been developed.
This list led to the delineation of three additional types of waste (for a total of 13
types) for purposes of the health assessment.
In performing the second phase, pathogen identification, EPA is examining
research facility wastes and health care facility wastes separately. Although the wastes
from research facilities are quite similar to those from health care facilities, the
pathogens in research facilities tend to be in greater concentrations, are known, and
CDC guidelines33 govern their handling and disposal.
In health care facility wastes, the pathogens present are largely unknown.
Using the CDCs Guideline for Isolation Precautions in Hospitals. EPA derived a list
of approximately 70 classes of pathogenic bacteria, viruses, fungi, and protozoa that
may be present in health care facilities. This list did not account for such factors as
survivabUity outside the host. Information about reservoirs (i.e., where infectious
agents normally live and reproduce, such as in the human body or the soil) and
sources (i.e., object or person from which an infectious agent passes immediately to a
host) of the pathogens, the fluids, excretions, secretions, and body tissues that can
contain the various pathogens and mode of transmission were used to link pathogens
subjectively to types of medical waste. Because many pathogens die rapidly outside
their hosts, EPA developed a methodology for excluding such pathogens from
continued analysis. Further, many pathogens were excluded if they had low incidence
rates and are the target of required immunization programs, making it very unlikely
that they will be found in the waste. It is interesting to note that the pathogens not
^Section 11009 of the MWTA (42 U.S.C. § 6992h) requires ATSDR to prepare
a Report to Congress on the health effects of medical waste.
33 Centers for Disease Control, Classification of Etiologic Agents on the Basis of
Hazard (July, 1974).
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excluded by the study methodology are the same as those reported in published
studie's in which samples of medical waste were analyzed for pathogen content.
The pathogens that were not excluded are being analyzed with respect to the
factors necessary for disease transmission. This additional analysis should qualitatively
elucidate those wastes warranting concern for public exposure. Information on
infective dose and survivability has been and continues to be collected for the
pathogens of concern. While some information on infective dose is readily available,
it primarily pertains to the enteric bacteria. Information collected thus far (for
bacteria and viruses) on survivability show rapid die-off of pathogens exposed to
various environmental conditions.
Epidemiological data searches (other than those performed by ATSDR) for
disease transmission from exposure to medical ' aste either in the workplace or in the
community have been conducted. Unfortunately, epidemiological information is scarce
and tends to focus on occupational exposures such as needle-stick injuries.
Presently, work is also being performed to develop exposure scenarios. This
work is being performed in conjunction with the work identifying handling methods
for medical waste to determine how the public may come in contact with the waste.
C. Update of Chapter 3, Estimated Costs of the Demonstration Program and
Improper Management of Medical Waste
Cost-related data is not yet available for analysis. Nevertheless, this update
sets forth a list of current Agency efforts and a forecast of the cost and benefit
analysis to be included in the Final Report.
The Agency will refine its cost analysis of the interim final rule to
incorporate data on generators, transporters and TDD facilities and
waste volume.
The Agency will seek information on changes in medical waste disposal
and transporter costs resulting from the tracking program. It is not yet
known whether the Agency will be able to collect more than anecdotal
information.
The Agency will collect and discuss data concerning state and local
efforts to assess the costs to local communities from improperly managed
medical waste resulting in beach wash-ups.
To the extent possible, the Agency will include other impacts of
improperly managed medical waste (such as impacts to human health
and the environment). At this time, EPA believes that it is unlikely that
data will be available to conduct any form of quantified analysis.
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D. Update of Chapter 4, Demonstration Program Objectives and Evaluation
Since passage of the MWTA, EPA and the covered States have established a
coordinated regulatory program for the tracking and management of medical waste.
Although the Agency believes that it is premature to fully evaluate the success of the
program, it believes that the regulations are successful in controlling the management
(e.g., packaging, labelling, storage, etc.) and tracking of waste that is shipped off-site
for disposal in the States it covers. EPA also believes that the program has to some
extent been successful in addressing its broader goals of increasing public awareness
and encouraging sound waste management practices by those excluded from the
regulations by statute, but contributing to the problem (e.g., household waste).
Section IV of this Report includes a more thorough discussion of the direct and
indirect impacts of the program.
In the next 12 months of the demonstration program, EPA will continue to
monitor the program and collect information that will allow it to evaluate more fully
the success of program in meeting the objectives of the MWTA and Congress.
Information will be collected on the extent to which the regulations were complied
with; the appropriateness of the scope of the wastes that are regulated; the
functioning of the tracking requirements; the appropriateness of the management
standards; and on the changes in waste management practices that result from the
program.
In the Final Report, EPA will also expand on information presented in the
First Report regarding alternative methods for tracking wastes, and will evaluate the
advantages and disadvantages of extending such requirements to rural areas and small
quantity generators. These discussions will be based on the information collection
efforts described in Section V.A. of this report.
E. Update of Chapter 5, Medical Waste Handling Methods
EPA is analyzing waste handling methods for inclusion in the Final Report to
Congress. This analysis will include medical waste handling method flow charts for
certain generator groups. The flow charts will be reviewed by at least two persons or
groups familiar with waste handling practices (e.g., representatives of trade associations
or facilities). The charts will compare waste handling methods in covered States to
waste handling methods in noncovered States. The Agency also will prepare a report
that summarizes and integrates the information from these generator groups.
F. Update of Chapters 6 & 7; Medical Waste Treatment Method and Medical
Waste Treatment Effectiveness
1. Introduction
As an initial step to evaluating medical waste treatment technologies, EPA has
conducted an overall assessment of available treatment technologies which includes:
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what types of waste can be treated by a specific technology;
what operating conditions influence the treatment method;
what residuals are produced from the treatment method; and
what studies have been conducted on the effectiveness of the treatment
method and on-going research initiatives.
This initial assessment was presented in the First Interim Report.
2. Current Activities
Current activities to thoroughly evaluate --eatment technologies have focused on
the most commonly used methods (prior to ultimate land disposal or discharge to
sewers). Each of the most commonly used treatment technologies will be tested, if
possible, to determine its ability to render medical waste non-infectious or less
infectious and unrecognizable. Additionally, EPA will be examining what
technological parameters influence the effectiveness of that treatment technology (e.g.,
quality assurance, operator training, equipment maintenance). Considering the
extreme microbial variation within the overall medical waste stream, EPA will be
utilizing indicator microorganisms to study the effectiveness of specific treatment
technologies. This approach will be taken because there are variations in waste
streams from different types of generators; variations in waste streams generated from
different locations with the facility; and inadequate information regarding the actual
microbial content of medical waste. Moreover, indicator organisms are representative
of the most resistant type of organism for that particular treatment technology.
These studies also will be used to help identify possible routes of transmission
for microorganisms during the treatment process and any additional treatment and
disposal activities required for each technology to ensure proper and final waste
disposition.
As noted in the First Interim Report to Congress, the MWTA listed several
procedures as treatment which do not influence the biological composition of the
medical waste, but instead address the appearance of the waste (i.e. grinding,
shredding and compaction). Some treatment technologies utilize one or more of these
procedures in conjunction with an actual biological treatment method to either make
the waste unrecognizable or significantly reduce the volume of waste to be disposed
of.
Additionally, as a result of the MWTA many new treatment methods are
emerging, primarily for the small quantity generator. EPA is in the process of
developing criteria to evaluate these new methods and determining if the treatment
method meets the intent and definition of "treatment" and/or "destruction" found in
the interim final rule.
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G. Update on Chapter 8, Existing State and Local Requirements
»
1. Overview
The Agency is carrying out at least two projects related to State and local
requirements that will be made part of the Final Report, including:
analysis of state regulations; and
assessment of preventive action taken by covered States.
These projects are discussed in detail below.
2. Ar-Jyzing State Medical Waste R.w Nations
EPA is researching the existing medical waste requirements for the five covered
States in order to update their current medical waste regulations. Additionally, the
Agency will study existing and planned medical waste regulations in the seven States
that "opted out" of the demonstration program. This information will be analyzed and
compared to the major elements of the medical waste programs in the covered States.
The objective of this analysis is:
to determine if the States that opted out have programs, and if so, what
are the major differences between the programs; and
to support the evaluation of the effectiveness of the demonstration
program by determining whether problems experienced by the States that
opted out could have been avoided if they had remained in the program.
The Agency is compiling a list of the most important factors for successful
medical waste management programs (e.g., tracking, packaging, disposal methods,
comprehensiveness of medical waste definition) and developing a table or matrix to
summarize such information. In the process of obtaining information about State
programs, EPA will update its state contact list.
The key areas of information collection are:
nature of the medical waste program (regulatory or nonregulatory);
treatment of home health care sector (inclusion or exclusion); and
scope of the programs.
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3. Assessing State Preventive Actions
The Agency will research the specific steps (in addition to promulgation of
medical waste regulations) that the covered States have taken to control the sources
of medical waste. In addition, information will be collected in the covered States
concerning the number of wash-ups, beach closings, and the amounts and types of
items.
H. Update to Chapter 9, Regulatory Options For a National Program
The Agency recognizes that many states have regulations which address medical
waste. Thus, EPA has decided to evaluate and develop "Model State Guidelines for
Medical Waste Management" through a cooperative agreement with an independent
non-profit organization. The recipient of the cc- -nerative agreement will be a national
organization, able to obtain information from various state regulatory agencies, and
with the technical expertise to develop guidance for waste management activities. The
recipient will be asked to address the following:
developing a medical/infectious waste definition;
developing approaches for medical waste handling, treatment,
transportation, and disposal;
make recommendations on management of home-health care waste; and
developing criteria for managing medical waste mixed with other waste
streams, such as medical waste mixed with radioactive waste and medical
waste mixed with hazardous waste.
The results of this study will be incorporated into the Final Report to Congress.
I. Chapter 10, Appropriateness of Penalties
The Agency is currently collecting information on the numbers and types of
inspections and enforcement actions, and following up on actions taken to ensure
compliance at problem facilities, and to evaluate the appropriateness of penalties
provided by the MWTA. EPA is also meeting periodically with the States to
coordinate programs and identify and discuss issues, including the appropriateness of
penalties provided by the Act. Because the program has been in place for less than a
year, however, the Agency believes that it is premature to make such a determination
in this Report.
J. Chapter 11, Home Health Care and Small Quantity Generator Waste
In the First Report, EPA estimated the types and quantities of health care
wastes generated in households, discussed the effect of excluding households and small
quantity generators from the regulations, and outlined its strategy for public education
on the proper management and disposal of home health care waste.
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Since that time, EPA has been active in two general areas. First, using
information submitted by transporters and operators of on-site incinerators, EPA" has
refined its estimate of the numbers and types of generators, including the percentage
of generators that are small quantity generators (see also section V.A.). Second, EPA
has developed a brochure in conjunction with approximately a dozen trade
associations to promote the safe disposal of home health care wastes. EPA will
continue these initiatives and report more fully on the effect of excluding households
and small quantity generators from regulations, and on additional education and
outreach efforts in the Final Report.
K. Chapter 12, Medical Waste Reuse, Recycling and Reduction
Since the First Interim Report, the Agency has collected no additional
information regarding the reuse or reduction ir -olume of medical waste. The
Agency has, however, initiated a study to assess (among other things) the potential for
waste minimization. The study has two primary objectives. The first is to identify
practices or techniques that can be used to reduce the volume of waste that is
generated. The second is to identify techniques that can be adopted to reduce the
potential threat posed by medical waste. This will include identifying the sources of
toxic constituents (e.g., heavy metals) in the waste stream, and suggesting product
reformulation or waste component segregation to avoid having toxics enter the waste
stream, or to avoid having materials managed in a environmentally harmful way.
Results of this initiative will be summarized in the Final Report.
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APPENDICES
Appendk 1
Appendix 2
Appendix 3
Appendk 4
Appendix 5
Appendix 6
Syringe related information -
EPA Harbor Studies program
Enforcement Information
EPA Instructional Booklets
Home Health Care Disposal Tip
Pamphirt
Grant Proposals & Descriptions
Information Charts and Materials
from the First Reporting Period
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APPENDIX 1
*
TABLE 1.
SUMMARY OF CONDITION OF SYRINGES RECEIVED ON FEBRUARY 1, 1990
FOUND DURING EPA HARBOR STUDIES PROGRAM
Each sample was packaged in a ziploc bag. Some samples contained more than one
item suitable for analysis and were numbered accordingly. The descriptions below are
of the contents of each ziploc bag. One bullet indicates which samples suitable for
analysis. Two bullets mark the samples which were sent to the laboratory for
analysis.
SAMPLE NUMBER
AAK-441
AAK-480
AAK-416
AAK-511
AAK-509
SAMPLE DESCRIPTION
One ziploc containing one 1 cc syringe with
plunger completely depressed. Needle is capped,
plunger is uncapped.
One ziploc containing:
(1) One 1 cc syringe with needle uncapped; plunger is
completely depressed and uncapped.
(2) One 1 cc syringe with both ends capped and the
plunger completely depressed; tape is wrapped
around the plunger cap.
(3) One 1 cc syringe with the needle capped and the
plunger half-way depressed.
(4) One 1 cc syringe with no caps, no needle and the
plunger completely depressed.
One syringe; the needle cap is approximately 1-
l/2" long, but the needle is approximately !/2M in
length; the plunger is uncapped and mostly
depressed.
One ziploc containing:
(1) One 1 cc syringe with both ends capped.
(2) One small ziploc.
One ziploc containing:
(1) One 1 cc syringe with needle capped and the
plunger uncapped and completely depressed.
(2) One 1 cc syringe with the needle capped and the
plunger uncapped and completely depressed.
A-l
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AAK-510
AAK-289A2
AAK-257
AAK-287
AAL-228
AAL-226
AAK-190
AAK-535
(3) One 1 cc syringe with the needle capped and the
plunger uncapped and completely depressed.
(4) One 1 cc syringe with both ends capped.
(5) One 1 cc syringe with no caps and no needle, the
plunger is completely depressed.
(6) Miscellaneous: two needle caps
One ziploc containing:
(1) One plastic bag containing one 1 cc syringe with
the needle capped and the plunger uncapped and
completely depressed; the syringe appears to be
coated in yellow paint with hair emerging from the
plunger-end of the barrel
(2) Miscellaneous: ' syringe cap.
One 1 cc syringe with a capped needle and
uncapped plunger; the needle is bent so as to stick
through the cap.
One syringe with the needle capped (the cap is
curved and tapered), and plunger depressed.
(1) One 1 cc syringe capped at both ends.
(2) One 1 .cc syringe capped at both ends.
(3) One syringe barrel with no caps, needle or plunger.
One 1 cc syringe with a capped needle (the cap is
punctured), the plunger depressed and uncapped, and
black solids in the barrel.
One 1 cc syringe with a capped needle (cap is
punctured), the plunger depressed and uncapped.
One ziploc containing:
(1) One capped needle (1 '/V') with similar bore size
to that used in hematology.
(2) One 1 cc syringe with no needle, no caps and the
plunger broken and a quarter depressed.
One ziploc containing one 1 cc syringe with both
ends uncapped, a bent needle, and the rubber end
of the plunger only, remaining in the barrel; contains
a clear fluid.
A-2
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AAK-168 One ziploc containing one syringe barrel (no needle
attached), one syringe plunger and one syringe cap.
AAK-191 (1) One broken 1 cc syringes with a plunger and a bent
needle (neither ends capped).
AAL-232 (1) One 1 cc syringe with both ends capped.
(2) One 1 cc syringe with both ends capped.
(3) One 1 cc syringe with the needle capped (the cap
is larger than typical tapered, but the needle is a
typical '/21' length), and the plunger partially
depressed.
(4) One 1 cc syringe with no needle, plunger
completely depressed and neither end capped.
(5) One 1 cc s_, "ige with a capped needle which is
bent back inside barrel and an uncapped plunger
almost completely depressed.
(6) One 1 cc syringe with a capped needle and an
uncapped plunger completely depressed.
(7) Miscellaneous: 2 syringe caps.
AAK-293 One 1 cc syringe with a bent needle, the plunger
completeJy depressed and both ends uncapped.
AAL-230 (1) One 1 cc syringe with the barrel half filled with
red-brown substance (apparently blood), the
uncapped needle is bent (approximately 20°), plunger
is half-way depressed and uncapped.
(2) One 1 cc syringe capped a both ends, although
the needle is bent back outside the cap.
(3) One 1 cc syringe with an uncapped bent needle
(approximately 110°) and an uncapped plunger
completely depressed.
(4) Miscellaneous: plunger and 2 syringe caps.
AAK-262 2 syringe caps.
A-3
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TABLE 2.
SAMPLE IDENTIFICATION
AML Account Number: 15011
SAMPLE NUMBER AML NUMBER RESULTS
0 AAL-230(1) 09421272/0 Positive: insulin, cocaine
1 AAK-416 09421275/0 Negative
2 AAK-480(3) 09421273/0 Positive: cocaine, lidocaine
3 AAL-232(3) 09421272/0 Positive: Insulin
4 AAK-19K1) 09421271/0 Negative
REMAINING SAMPLES:
AAK-191(1)
AAK-190(2)
AAK-190(3)
AAK-257
AAK-287(1)
AAK-287(2)
AAK-289A2
AAK-293
AAK-441
AAK-480(1)
AAK-480(2)
AAK-480(4)
-AAK-509(1)
AAK-509(2)
AAK-509(3)
AAK-509(4)
AAK-509(5)
AAK-510(1)
AAK-510(2)
AAK-Sll(l)
AAK-535
AAL-226
AAL-228
AAL-230(2)
AAL-230(3)
AAL-232(1)
AAL-232(2)
AAL-232(4)
AAL-232(5)
AAL-232(6)
A-4
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APPENDIX 2
ENFORCEMENT INFORMATION
TABLE 1
INSPECTIONS BY EPA'
State Number of Facilities Inspected
New York 249
New Jersey 213
Puerto Rico 28
North Carolina 1
Pennsylvania 1
South Carolina 1
Connecticut and
Rhode Island (combined) 1.9
TOTAL 512
* This table does not include inspections conducted by State agencies.
A-5
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TABLE 2
L
TYPES OF ENFORCEMENT ACTIONS BY EPA
Type of Action Number of Facilities
Inspections 512
Warning Letters or
Notices of Violations 257
Administrative Actions 11*
One Administrative Action is currently in draft form.
TABLE 3
PENALTIES ASSESSED BY EPA
EPA Region I $ 67,000
EPA Region II S625.50Q
TOTAL $692,500
A-6
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APPENDIX 3
EPA Instructional Booklets
A-7
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APPENDIX 4
Home Health Care Disposal Tip Pamphlet
A-8
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APPENDIX 5
PROPOSED MEDICAL WASTES GRANTS
STATE
Louisiana
Washington
California
PURPOSE
Training: To address the
needs of sanitary landfills
and/or MWI operators, and
to develop a training
program for LDEQ's field
inspectors. Approved:
Complements on-going
educational efforts " ->
targeting specific audiences
that may not have been
adequately addressed during
previous training sessions
attended by EPA.
Home Health Education and
Awareness: To educate the
public on proper disposal of
home generated infectious
waste, and to differentiate
between real and perceived
risks. Approved:
Complements on-going
educational efforts by
addressing fact vs. fiction
risk issues concerning MW
generated in the home.
Development of New
Medical Waste Disposal
Technical: To improve and
develop an approval process
of new medical waste
disposal technologies.
Approved: Complements
on-going research activities
that involve certification
requirements for new
treatment technologies.
S AMOUNT-5% matching
34,000
57,000
108,500
A-9
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STATE PURPOSE S AMOUNT-5% matching
Connecticut MW Tracking: Use of 76,000
electronic reporting and
recordkeeping without hard
copy requirements.
Approved: Complements
on-going activities by
possibly offering a
standardized recordkeeping
system at the national label.
This project goes beyond
what we would expect
covered States to do with
operating grants.
Michigan Waste Composition/Volume 125,000
Study: Develop operational
data on medical
wastestreams generated in
Michigan. Approved: Data
from study may be
nationally applicable.
Existing data gathering
efforts being conducted by
OSW to determine
generation rates and volume
amounts.
NOTE: Four additional states' proposals received preliminary approval. These states
declined to submit formal grant applications.
The remaining funds appropriated for State implementation of the demonstration program
were distributed to the Covered States through the EPA Regional Offices.
A-10
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APPENDIX 6
Information Charts and Materials
from the First Reporting Period
A-ll
-------
Figure 1
K)
34,214
NEW YORK
519
Tots. BMW Generated (Tons pe, Six Months)
ol
-------
Figure 2
Total Number of Medical Waste Generators and Quantity of
Medical Waste Generated by Generator Type
Type of Generator
Hospitals
laboratories
Clinics
Physicians
Dentists
Veterinarians
Long Term Health
Blood Banks
Other
Total
Numovf or \j*n*f «uo»»
599
997
1,320
8.045
ZS84
597
725
22
1.449
16,438
Quantity of RMW
Generated (Tons/6 mo.)
43,557
1,747
993
384
75
32
528
167
928
48,411
Percent that
Generate
-------
Number of Facilities
So en o y> o
o o o o o
?
0)
«
0
O
£
1
i
i
f
o
I
(0
ll
CO
or
§
£
i
A-14
-------
Figure 5
Quantity of Regulated Medical Waste (tons/six months)
Treated and Disposed by Destination
Ccwmd
Non-Comrad SUM*
Destination
Connecticut
New Jersey
New York
Puerto Rico
Rhode island
Arkansas
Florida
Indiana
Massachusetts
Maryland
North Carolina
North Dakota
Ohio
South Carolina
Virginia
Canada
Total:
Medical Waste
Incinerated
On-srte (tons)
420
4,813
12.410
95
859
.
18397
only pofts^M lo
Waste
tted
[tons)
Medical Waste Transported Off-Site (tons)
Incinerator
1.799
509
1,163
275
1.038
ZS73
382
163
186
343
-,:32
1,759
851
7.908
3.473
1.053
28.607
Landfill
87
181
18
286
Treatment
and/or
Destruction
21.4
0.11
225
498
743
Total (tons)
Treated &
Disposed
2.306
5.322
13.775
388
1.897
2.573
382
<1
163
186
1.343
4.132
1.984
1.347
7,908
3.473
1.053
48.233
i would not dtaptay any qtnrtttM in Ms
A-15
-------
Figure 6
Total Quantity of Regulated Medical Waste Generated (tons/six months)
and Percentage of Waste Exported Out-of-State for Treatment or Disposal
Covered State*
Connecticut
Quantity
OlRMW
Generated
3.146
New Jersey 9.186
NewYortc 34,214
Puerto Rico
Rhode island
433
1.432
Percent Transported
Out-of>State tor
Treat" it and DisposrJ
35
47
59
0
20
A-16
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