United Slates Solid Waste and
Environmemal Protection Emergency Response EPA/530-SW-90-051A
Agency (05-305) May 1990
OH ice of Sol»d Waste
Medical Waste
Management in the
United States
First Interim Report to Congress
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EPA/530-SW-90-051A
First Interim Report to Congress
Medical Waste Management
in the United States
May 1990
United States Environmental Protection Agency
Office of Solid Waste
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50272-101
REPORT DOCUMENTATION
PAGE
1. REPORT NO,
EPA/530-SW-90-051A
3. Recipient's Accession No.
P690 219874/AS
4. Title and Subtitle
MEDICAL WASTE MANAGEMENT IN THE UNITED STATES (FJRST INTERIM REPORT TO
CONSftESS!
5. Report Date
MAY 1990
6.
7, fcthoris)
OFFICE OF SOLID WASTE
8. Performing Organization Rept. No
9. Performing Organization Name and Address
U.S. EPA
Office Df Solid Waste
401 M. Street SW
Washingto.-, DC 204 i»0
10, Project/Task/Work Unit No.
11, Contra::iC! or Grant (a.1 No.
12, Eponswn.ig Organization Narc= and
13, Type of Report & Period Covered
INTERIM REPORT 5/90
14.
15. Supplementary Notes
16, Abstract (Limit; 200 worcs)
Under Subtitle J of RCRfl, EF'A is to report to Congress on several aspets of medical waste (tanagement and the demonstra-
tion program for tracidnq medical Hastes. This reprot is the first in a series of 3 reports which are required by, and
address the topics specified in, RCftA Section HOOta).
Medical wastes that a^e subject to the deaonst'-ation prograir. regulaticns are generated prioarUy ty hospitals, and cotn-
Prise apsro:;i,Tiately ."'/; by weight cf the municipal solid usste stream, Wastes froa hone health care, which are not
"medical wastes" unde11 th? definition of RCRA 1CK'4(4), are likely to contain a significant nunber of syrines—one of the
sieciica! items af concern to Congress when it enacted the Medical Waste Tracking Act of 1998.
17. Document Analysis a. Descriptors
b. Identifiers/Open-Ended Tersis
c. COSAT1 Field/Grou?
IB. Availability Statement
RELEASE UNLIMITED
(See ANS1-Z39.1B)
19. Security Class (This Report)
UNCLASSIFIED
20. Security Class (This Page)
UNCLASSIFIED
DPT
(For
21. No. of Paqes
0
22. Price
0
ONAL FORM 272 (4-77)
•fflerly NTIS-35)
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CONTENTS
PAGE
EXECUTIVE SUMMARY i
INTRODUCTION iv
1. CHARACTERIZATION OF MEDICAL WASTE 1-1
2. HEALTH HAZARD ASSESSMENT 2-1
3. ESTIMATED COSTS OF THE DEMONSTRATION PROGRAM AND
IMPROPER MANAGEMENT OF MEDICAL WASTES 3-1
4. DEMONSTRATION PROGRAM OBJECTIVES AND EVALUATION .... 4-1
5. MEDICAL WASTE HANDLING METHODS 5-1
6. MEDICAL WASTE TREATMENT METHODS 6-1
7. MEDICAL WASTE TREATMENT EFFECTIVENESS 7-1
8. EXISTING STATE AND LOCAL REQUIREMENTS 8-1
9. REGULATORY OPTIONS FOR A NATIONAL PROGRAM 9-1
10. APPROPRIATENESS OF PENALTIES 10-1
11. HOME HEALTH CARE AKD SMALL QUANTITY GENERATOR WASTE . . 11-1
12. MEDICAL WASTE REUSE, RECYCLING AND REDUCTION 12-1
BIBLIOGRAPHY TO THE REPORT TO CONGRESS ON MEDICAL
WASTE MANAGEMENT IN THE U.S.: FIRST INTERIM REPORT . . A-l
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LIST OF TABLES
PAGE
1-1 Sources and Quantities of Regulated Medical
Waste Generated 1-5
1-2 Transporter Notification Information (as of
August 30, 1989) 1-10
3-1 Generator Types and Characteristics 3-5
3-2 Cost Summary - Annual Costs (in Thousands) . . . 3-10
8-1 Summary of State's Regulatory Status 8-4
11-1 Estimated Annual Quantities of Home Health
Care Waste, by Source and Waste Type 11-12
12-1 Medical Waste Production, by Source 12-4
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LIST OF EXHIBITS
PAGE
11-1 Home Health Care Waste Guidelines 11-22
11-2 Home Health Care Waste Brochure 11-26
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EXECUTIVE SUMMARY
Under Subtitle J of the Resource Conservation and Recovery
Act (RCRA), EPA is to report to Congress on several aspects of
medical waste management and the demonstration program for
tracking medical wastes. This report is the first in a series of
three reports which are required by, and address the topics
specified in, RCRA Section 11008(a).
Medical wastes that are subject to the demonstration program
regulations are generated primarily by hospitals, and comprise
approximately 0.3 percent (by weight) of the municipal solid
waste stream. Wastes from home health care, which are not
"medical wastes" under the definition in RCRA 1004(40), are
likely to contain a significant number of syringes—one of the
medical items of concern to Congress when it enacted the Medical
Waste Tracking Act of 1988 (MWTA).
The health and environmental threat posed by medical waste
or its incineration is a complex question. Chapter 2 outlines
EPA's planned approach to conducting this assessment, by
responding to the Congressional mandate to evaluate health
hazards posed by routine management of medical waste. The
following topics are addressed in Chapter 2:
coordination with the Agency for Toxic Substances and
Disease Registry (ATSDR)
definitions and terms
scope of the health hazard assessment
general approach to evaluating present and potential
health hazards from exposure to medical waste
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evaluation of health hazards posed by incineration of
medical waste
evaluation of health hazards posed by the landfilling
of medical waste
evaluation of the health hazards posed by the disposal
of medical waste in sewage systems
• data gaps and research needs
The regulations which implement the two-year demonstration
program are estimated to have a cost of $24 million
(undiscounted); a very preliminary estimate of loss of value in
three states (Connecticut, New York, and New Jersey) due to
mismanaged medical wastes is in the range of $30 million. This
does not mean, however, that the regulations will result in $30
million in savings. These numbers are EPA's best estimates, but
they are based on a number of assumptions which are explained in
more detail in Chapter 3.
In assessing the "success" of the demonstration program, EPA
has defined the program's objective as ensuring that the wastes
subject to the regulations are delivered to treatment or disposal
facilities with a minimum of exposure to waste management workers
and the public. EPA intends to evaluate the program using the
criteria of stata participation, compliance with the regulations,
technical adequacy of the regulations, and the regulations'
potential effects on recreational/occupational injuries and
disease. In addition, EPA intends to evaluate the regulations'
effects on beach washups and beach closings (although some washup
items may be outside the scope of the MWTA), and on treatment and
disposal practices. EPA is also preparing to collect information
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to determine the appropriateness of penalties 'imposed in Subtitle
J enforcement actions.
Several states have enacted laws and regulatory programs, in
response to the public's concerns over the AIDS epidemic, to
address medical waste management; although not all of the state
programs EPA is aware of require tracking, they typically require
certain packaging and labeling techniques and treatment before
land disposal. As part of an evaluation of existing state and
local requirements, EPA plans to assess the appropriateness of
these state requirements and the Subtitle C requirements to
monitor and control medical waste.
Current medical waste management practices range from
handling the waste as nonhazardous municipal solid waste, to
strict segregation, packaging, labeling, and tracking (using
paper manifests) imposed either by state requirements or through
private agreement by transporters or disposal facilities. Common
treatment techniques include steam sterilization and
incineration. Certain medical wastes are commonly stored in
refrigerators, while others are typically stored indoors or
outdoors in various receptacles or containers. A number of
recycling and reuse techniques are also used.
This report outlines in more detail the topics mentioned
above, and explains EPA's planned activities to address these
topics.
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INTRODUCTION
In response to increased public concern about improperly
managed medical wastes, the Medical Waste Tracking Act of 1988
(MWTA) was enacted. Through the MWTA, Congress amended the
Resource Conservation and Recovery Act (RCRA) to add a new
Subtitle J, which establishes a two-year demonstration program
for tracking medical waste. Under Subtitle J, EPA must establish
tracking and management standards for certain medical wastes.
These standards apply to medical wastes generated in certain
states. The MWTA also requires EPA to submit a series of reports
to Congress on a number of topics related to medical waste.
Section 11002 of RCRA required EPA to promulgate regulations
by May 1, 1989, listing the types of medical wastes required to
be tracked in the demonstration program. Section 11003 required
EPA to promulgate regulations by May 1, 1989, for segregation,
packaging, labeling, and tracking those designated medical
wastes. EPA mat these statutory requirements by issuing
regulations on March 24, 1989 (54 FR 12326). The regulations,
found at 40 CFR Part 259, list the medical wastes required to be
tracked. These wastes are a subset of all medical waste, and are
defined as "regulated medical waste" at 40 CFR 259.30. In
addition, tha regulations set up the segregation, packaging,
labeling, and tracking requirements authorized by RCRA Section
11003, and a requirement for generators who incinerate medical
waste on-sita to report to EPA.
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Following publication of the regulations, several states
that were designated to participate in the program elected to
"opt out," while others petitioned EPA to be included in the
program. RCRA Section 11001 set up this "opt out" and "petition
in" procedure to allow the states' governors to determine whether
they wanted to participate in a program that is not nationwide in
scope. As a result of the states' actions, five states
(Connecticut, New Jersey, New York, Puerto Rico, and Rhode
Island) are participants in the demonstration program.
The demonstration program is of limited duration; for
Connecticut, New Jersey, and New York, the program went into
effect June 22, 1989. The other states were given 30 days longer
to prepare their respective regulated communities for compliance,
and to enable the states to coordinate their implementation
activities. The program will expire in all States on June 22, '
1991.
This report fulfills part of the requirement of RCRA Section
11008(b), which requires EPA to prepare interim reports
containing the information on several medical waste topics
available at the tine of submission. This report is structured
according to the topics outlined in Section 11008(a)(l) through
(12). Chapter 1 addresses the information required by Section
11008(a)(1); Chapter 2 addresses Section 11008(a)(2), etc. To
the extent that information items overlap, the chapters explain
where the required information is found. Generally, the
information presented in this first interim report reflects EPA's
planned information-gathering activities; to the extent that data
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Te available, they arc included here, chapters 4 and 9 are
noteworthy in that they present EPA's criteria for determining
the success of the demonstration program, outline available
tracking methods, and assess the appropriateness of federal
hazardous waste requirements and state/local requirements as
nationwide medical waste controls.
Certain terns are used in a different manner in the statute
than they are used in the regulations or in this report; where
needed, these terms have been defined specifically for each
chapter. For instance, the term "medical waste" in RCRA Section
1004(40) is more inclusive than the medical waste types listed in
Section 11002(a). In some chapters, the broadly defined term of
Section 1004(40) is used. In others, the medical waste types in
Section 11002 or in 40 CFR 259.30 are the wastes that are
discussed, where possible, the term "regulated medical waste" is
used to refer to the medical waste items listed in 40 CFR 259.30.
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CHAPTER 1
CHARACTERIZATION OF MEDICAL WASTE
l.l introduction and Overview
Section 11008(a)(1) of RCRA requires information on "the
types, number, and size of generators of medical waste (including
small quantity generators) in the United States, the types and
amounts of medical waste generated, and the on-site and off-site
methods currently used to handle, store, transport, treat, and
dispose of the medical waste, including the extent to which such
waste is disposed of in sewer systems." The on-site and off-site
methods currently used to manage medical waste are addressed in
Chapters 5 through 7. This chapter presents results of EPA's
efforts to date in characterizing the types, numbers, and size of
generators, and types and amounts of regulated medical waste
generated in the United States based on currently available
information. It also explains the Agency's long-term program to
more fully characterize the generation and management of
regulated medical waste through reporting requirements in the
medical waste tracking rule.
The waste characterization presented in this report is based
on currently available information and, when such information is
not available, on EPA's best estimates. Therefore, estimates
presented in subsequent sections should be considered preliminary
in nature. Subsequent reports will discuss the results of EPA's
longer-term efforts, which will be based on data submitted
directly by transporters and certain generators. Once submitted,
these data will allow EPA to characterize with greater certainty
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the sources, amounts, and types of regulated medical waste
generated, and the transport and management of regulated medical
waste. In future reports to Congress, the Agency will also
attempt to further characterize the generation and management of
medical waste.
Section 1.2 presents a summary of estimates of the types and
numbers of medical waste generators, and amounts of medical waste
generated by generator type, as well as a brief description of
the methodology used to develop the waste quantity estimates.
Section 1.3 describes how the information reporting requirements
in 40 CFR Part 259 will be used to characterize the generation
and management of regulated medical waste.
1.2 Medical wast* Generation
Methodology
Briefly described, the approach used to characterize the
generation of medical waste involved first categorizing the
universe of generators by industry or field of practice, and by
consulting trade associations, the U.S. Department of Health and
Human Services (HHS), and the U.S. Department of Commerce for
data on the population of each generator type. The quantities
and types of regulated medical waste generated were then
estimated for each generator type.
The estimates of waste types and quantities rely on data
from a number of sources, including published literature,
preliminary results of a survey of generators in New York and New
Jersey, approximately 50 site visits to facilities generating or
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handling medical waste, and telephone interviews with industry.
Because generators in the past have generally not maintained
records of the amounts or types of medical waste they produce,
relatively little quantitative information is currently available
regarding waste generation for many generator types. This is
especially so with smaller generators such as physicians,
dentists, veterinarians, and others. For these reasons, it was
often necessary to make reasonable "best estimates" of waste
generation rates, based on knowledge of the generator types and
their respective waste streams. For similar reasons, determining
the types (and respective amounts) of medical waste generated has
to date proved to be problematic.
Summary of Preliminary Results
Each year approximately 500,000 tons of regulated medical
waste are produced in the United States by about 375,000
generators. As a point of reference, about 158 million tons of
municipal solid waste are generated annually.' The vast majority
of the regulated medical waste (about 77 percent) is generated by
hospitals, which comprise less than 2 percent of the total number
of generators. The remainder is produced by a large, diverse
group of generators from several generator types, including
laboratories, physicians' offices, veterinarians, etc. The
majority of these generators produce relatively small quantities
(less than 50 pounds per month) of regulated medical waste.
A summary of the types and numbers of medical waste
generators and the approximate quantity of regulated medical
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waste generated by each type in the United States is presented in
Table 1-1-
As can be seen in Table 1-1, there are large variations in
the quantities of regulated medical waste generated by facilities
of different types. Not apparent from Table 1-1, however, are
results that indicate that there is a tremendous range in the
quantity of medical waste produced by facilities within each
generator type. While much of this variability can be attributed
to differences in facility size, specialty, or types of services
offered (e.g., number of beds in a hospital; number or types of
doctors sharing an office), part of the variability is due to
differences in waste management practices at individual
facilities.1'7 Thus, estimates of quantities of regulated
medical waste generated per month per facility for each generator
type, from Table 1-1, should bo interpreted carefully,
considering all the variables involved.
The differences in waste management practices between
facilities of the same "type" arise for several reasons. First,
facilities have differing opinions on which wastes should be
considered "infectious," and therefore managed more carefully
than ordinary trash. Medical waste may or may not be infectious
in nature. To evaluate and define the infectiousness of medical
waste requires knowledge of the type of pathogens present, the
quantities of those pathogens, potential modes of disease
transmission and information on the susceptible host populations.
All of these factors can affect the facility's decision regarding
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TABLE 1-1
Sources and Quantities of Regulated Medical Waste Generated
Generator
Type
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Hospitals
Laboratories
Clinics
Physicians '
Offices
Dentists'
Offices
Veterinarians
Long-Term
Health Care
Facilities
Free-standing
Blood Banks
Funeral Homes
others
Total
Number of
Generators
7,100
4,300
15,500
180,000
98,400
38,000
12,700
900
20,400
**
377,300
RMW RMW
Generated Generated
All Per
Facilities Facility
(Tons/Year) (Ibs/month)
359,000 8,400
15,400 600
16,700 180
26,400 24
7,600 13
4,600 20
29,600 -- 390
2,400 440
3,900 32
465,600
Reference*
Number
2,3
4,5
6,5,7
8,9,5,7
8,10,5
11,5,12
4,5
13,14,7
15,5
An explanation of how the quantity estimates were derived, and a
description of assumptions made, are included in a memo to the docket
for the EPA interim final rules published March 24, 1989."
This generator type includes health units in industry, schools,
correctional facilities, fire and rescue services, and others. EPA is
currently investigating the number of generators in this category (see
text for further discussion).
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the wastestreams it handles as "infectious." [See Chapter 2 for
additional discussion of the factors necessary for disease
transmission.] Second, facilities have differing incremental
costs for disposal of "potentially infectious" waste, leading to
differences in the effort taken to segregate wastes. For
example, at facilities with low incremental waste disposal costs
(e.g., those with on-site incinerators), there is little
incentive to minimize the amount of "infectious" waste generated
through careful segregation.
It has also been observed that the types of waste considered
potentially infectious for purposes of waste management at
hospitals and other health care facilities are generally fairly
conservative when compared to the minimum requirements (i.e.,
waste classes 1-7) of the demonstration program.1'' In fact, the
results of a recent nationwide survey of waste management
practices at hospitals' found that most of the hospitals surveyed
consider the following wastestreams infectious: microbiological
wastes (92% of responding hospitals), pathological wastes (94%),
human blood and blood products (91%), sharps (98%), contaminated
animal carcasses, body parts, and bedding (84%), and communicable
disease isolation wastes (98%), surgical wastes (84%), dialysis
unit wastes (81%), contaminated equipment (68%), and
miscellaneous laboratory wastes (85%). The latter four, waste
types, are not regulated as a class under the EPA regulations
(although some of these wastes may be regulated under one or more
of the other classes).
Thus, the total amount of waste estimated in Table 1-1 (most
of which is accounted for by hospitals) reflects these
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conservative waste management practices, and is likely greater
than an amount that would correspond to a strict reading of the
definition of regulated waste in the Part 259 regulations. Not
included in the quantity estimates are ordinary garbage generated
in health care settings, or home health care wastes (e.g.,
syringes used in the home). Available information on home health
care wastes is presented in Chapter 11.
Determining the number of generators for certain generator
types (e.g., physician's, dentist's, and veterinarian's offices,
blood banks) has proved to be problematic for several reasons.
First, the extent to which certain generators are actually
producing medical waste is not well known. A certain fraction of
doctors, for instance, may be retired, or may be teaching, or may
be in a specialty that does not generate regulated medical waste.
Second, the extent to which doctors or other health care
providers practice in groups is not well documented. Therefore,
the estimates of numbers of generators probably carry a large
degree of uncertainty and most accurately reflect the potential,
rather than actual, numbers of generators.
There are also many other types of facilities that may
generate regulated medical waste that are not included in
generator types listed in Table 1-1. These include health care
units at schools, universities, office buildings, factories, and
prisons, zoos, emergency service providers (e.g., fire, police,.
rescue), and others. Many of these facilities have traditionally
not been thought of as medical waste generators, and in fact, EPA
has no information on the number actually generating regulated
medical waste. It is clear, however, that the potential number
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of generators in this category is very large—by some accounts,
as many as 200,000." EPA intends to evaluate the size of this
category using information submitted in the transporter semi-
annual reports (see Section 1.3 below), and will report its
findings in subsequent reports to Congress.
1.3 Medical waste Data Collection Activities
As previously discussed, EPA is not confident that existing
estimates of the sources or amounts of medical waste generated
are accurate. The Agency has taken steps to address this problem
by incorporating three information reporting requirements into 40
CFR Part 259. The first requires transporters to notify EPA of
their intent to transport regulated medical waste. The second
requires these transporters to submit reports semi-annually
during the demonstration program, summarizing the source and
disposition of the regulated medical waste they transported. The
last requires generators who incinerate medical waste on-site to
report to EPA on the amounts of waste incinerated, the type of
incinerator used, and its operation. The information provided in
these reports will help the Agency characterize the generation,
transportation, and disposal of medical waste quantitatively.
Each of these requirements is discussed further below.
Transporter Notification
The medical waste tracking rule [see 40 CFR 259.72]
specifies that each transporter who handles regulated medical
waste that is generated in a Covered State must notify EPA for
each Covered State in which the waste was generated. EPA then
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issues one identification number to each transporter for that
transporter's operations in all Covered States.
There are several important benefits of this notification
with respect to information collection. At the beginning of the
demonstration program, EPA established a list of all transporters
who have notified EPA of their operations for each Covered State.
This information will form a valuable baseline from which changes
in the universe of haulers can be measured. EPA and the States
can also use this information in monitoring the program's
implementation and can ensure that generators utilize
transporters who are aware of and understand the regulations.
Results
By the effective date of the demonstration program, 161
transporters had notified EPA of their intention to haul
regulated medical wastes originating in Covered States." The
number of companies notifying and the number of facilities, or
terminals, for each Covered State are summarized in Table 1-2.
For each Covered State, the number of notifications, the number
of companies transporting medical waste that are located in the
State, and the number of facilities or terminals located in the
State may differ because some companies may operate several
terminals in a single State, and other companies may service
several Covered States from a single facility. Furthermore,
because the program is new, some transporters may be late in
notifying, and others may notify but not actually haul medical
waste. Thus, these results should also be considered
preliminary.
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TABLE 1-2
Transporter Notification Information
(as of August 30, 1989)
Number of Number of
Transporters Facilities
Notifying for Located in
Covered State Covered State1 Covered State2
Connecticut
New Jersey
New York
Puerto Rico
Rhode Island
42
54
113
3
29
8
25
84
3
3
Total 246 123
Total number of companies transporting Regulated Medical Waste
that is generated in Covered States: 161
SOURCE: Reference 17
Number of transporters that have notified of their intent to
transport regulated medical waste generated in the Covered State,
1 Number of facilities or terminals operated by transporters
that are located in the Covered State.
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Periodic Reorts
Under 40 CFR 259.78, transporters who haul regulated medical
waste that was generated in a Covered State must report to EPA
every 6 months. The reports must summarize the quantities of
"treated" and "untreated" regulated medical waste accepted, and
the generator type (e.g., hospital, laboratory, clinic). Methods
of medical waste treatment are discussed in Chapter 6.
Transporters also must report on the amounts of regulated
medical waste delivered to a treatment or disposal facility, or
to another transporter. This information is also broken down
into the "treated" or "untreated" categories specified in the
regulations. In addition to being useful in outreach and
enforcement activities, the information contained in these
reports will allow EPA to characterize quantitatively the waste's
generation, off -site transportation, and disposal patterns.
Data collected from the demonstration states may not be
representative of the entire United States, but should provide
valuable information. The information will enable EPA to report
on the following:
The numbers and types of generators entering regulated
medical waste into the tracking system, by State, and
for all Covered States.
The quantity of regulated medical waste entering the
tracking system, broken down by "treated" or
"untreated" categories, for each generator type.
The numbers and types (e.g., landfill, incinerator,
etc.) of facilities that dispose of or treat regulated
medical waste by State, and for all Covered States.
The quantity of "treated11 and "untreated" regulated
medical waste managed at each facility type.
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The names and numbers of transporters handling
regulated medical waste, by State, and for all Covered
States.
The quantity of "treated" and "untreated" regulated
medical waste handled by each transporter.
Changes in the numbers and types of handlers (e.g.,
generators, transporters, disposers) in the tracking
system, and changes in amounts of regulated medical
waste entering the tracking system during the
demonstration program.
Changes in off-site treatment practices during the
demonstration program.
The extent to which generators import or export
Regulated Medical Waste, outside of the Covered States
that is generated in Covered States.
on-site Incinerators
Finally, 40 CFR 259.62 requires generators who incinerate
regulated medical waste on-site to prepare and submit two
reports; the first report covers the first six months of the
demonstration program, while the second covers the thirteenth
through the eighteenth months. These reports summarize
information about the type of incinerator used, its operation,
and the amount of waste incinerated. The report also must
contain information on amounts of waste received from sources
outside the facility, such as private physicians or small group
practices. This information will be used to determine the amount
of waste that is incinerated on-site, and hence not summarized by
transporters in periodic reports.
Because on-site incinerator operators are required to submit
two reports, EPA will assess changes in incineration practices
attributable to the demonstration program.
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in suirjnary, the various information collection requirements
of the demonstration program—the transporter notification, the
transporter periodic reports, and the on-site incinerator
reports--will enable EPA to develop a more complete picture of
the medical waste management system. Future MWTA reports will
contain summaries of regulated medical waste sources and amounts,
on-site incineration practices, treatment practices, and
transportation and disposal patterns. More detailed information
concerning the Agency's plans to test incinerators is provided in
Chapter 2.
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1.4 References
1. U.S. Environmental Protection Agency, Office of Solid Waste
and Emergency Response. 1988. Report to Congress on Solid
Waste Disposal in the United States. EPA/530-SW-88-011,
October 19B8.
2. American Hospital Association. 1987. Hospital Statistics.
Chicago, Illinois.
3. Odette, R.L. 1988. Survey of Infectious Waste Management
Practices in Selected Acute Care Hospitals in the United
States. Unpublished M.S. Thesis, University of North
Carolina at Chapel Hill.
4. U.S. Department of Health and Human Services, Health Care
Financing Administration. 1987 Health Care Spending
Bulletin, 87-03, July 1987.
5. U.S. Environmental Protection Agency. 1989.
Characterization of Medical Waste Generation and Treatment
and Disposal Practices in New York and New Jersey. Draft
Report submitted to Air and Waste Management Division,
Region II, and Office of Solid Waste, January 30, 1989.
6. American Medical Association. 1985. Medical Groups in the
U.S., 1984. Chicago, Illinois.
7. U.S. Environmental Protection Agency, Office of Solid Waste.
1989. unpublished results of site visits to medical waste
generators. Washington, DC.
8. U.S. Department of Commerce, Bureau of the Census.
Statistical Abstract of the United States 1988.
9. R.L. Polk and Company. 1988. Mailing List Catalogue.
Volume II, p. 42-44.
10. American Dental Association. 1982. Distribution of
Dentists in the U.S., 19B2. Chicago, Illinois.
11. Written communication from American Veterinary Medical
Association to SAIC entitled "Distribution by Specialty
Codes and State." November 8, 1988.
12. New York Department of Health. 1988. Infectious Waste: A
Statewide Plan for Treatment and Disposal (Preliminary).
August 1988.
13. American Association of Blood Banks. 1987 Annual Report.
14. Personal communication between Lisa Englat of American
Association of Blood Banks and Barbara Scharman of SAIC
January 24, 1989.
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15. Indiana Funeral Homes Association. "State Count of Funeral
Homes." In-FU-PI-AS. March/April 1988.
16. Memorandum to the Record. Preliminary Estimates of
Quantities of Medical Waste by Generator Type. July 31,
1989. Washington, DC.
17. U.S. Environmental Protection Agency, Office of Solid Waste.
Unpublished data on transporter notifications. Washington,
DC. 1989.
18. U.S. Department of Labor, Occupational Safety and Health
Administration. Proposed Rule on Occupational Exposure to
Bloodborne Pathogens. 54 FR 23073. May 30, 1989.
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CHAPTER 2
HEALTH HAZARD ASSESSMENT
2.1 Background
Within the past few years, Congress and the general public
have expressed increased concerns about possible disease
transmission from exposure to medical waste. This heightened
public awareness may be principally attributable to the growing
concern with possible transmission of the Human Immunodeficiency
Virus that is associated with the development of the Acquired
Immunodeficiency Syndrome (AIDS), and perhaps to a lesser extent
to the increased use of disposable material and equipment.
Recent media reports of medical waste washups on our nation's
beaches coupled with incidents of children playing in dumpsters
containing needles and blood vials served as a catalyst for
public demands and Congressional mandates for regulations to
prevent the recurrence of such incidents.
Many experts and health care professionals have expressed
opinions that any health hazards posed by medical waste are
occupational and that actual threats to the general public are
unlikely, even when such wastes are mismanaged or improperly
disposed. They consider the issue to be a perceived threat of
disease from exposure to medical waste, particularly that which
nay have been in contact with blood contaminated with the AIDS
virus or other blood borne pathogens, as well as the unappealing
aesthetics of identifiable medical waste. This position was
stated by a significant number of persons who commented on the
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June 2, 1988, Notice of Data Availability on issues pertaining to
infectious waste (see 53 FR 20140), and was reiterated by
participants at the EPA Medical Waste Meeting in Annapolis, MD
(November 1988) . Comments on the EPA "Draft Manual for
Infectious Waste Management," (September, 1982) and the EPA Guide
for Infectious Waste Management also reflect this position.
[These coirments are available in the RCRA docket.] Some members
of Congress expressed a similar opinion in the legislative
history to the Medical Waste Tracking Act of 1988 by stating that
"hazards presented may be occupational rather than environmental.
. . ."; but were also concerned that mishandled infectious waste
could pose a threat in the community" (134 Cong. Rec. H9537).
while EPA believes that some medical waste, such as
intravenous bags, poses only aesthetic concerns, the Agency also
believes that other medical waste, such as cultures and stocks of
infectious agents and associated biologicals, may contain
pathogens in concentrations sufficient to cause disease in
susceptible individuals. For those wastes containing pathogens,
however, infection potential and disease transmission (discussed
later in this chapter) are complex mechanisms which involve the
interaction of multiple factors. The mere presence of pathogens
in sufficient quantities to cause disease does not necessarily
pose a hazard; a mechanism for transmission of these organisms to
a susceptible host must also exist.
Determining the potential health hazard- of improper
management of medical waste remains one of the most complex and
critical issues requiring resolution. The key question is which
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components of the medical waste stream pose true health hazards
and, therefore, require some type of regulatory control.
Congress recognized the importance of answering this question to
ensure that such wastes are regulated or tracked under Subtitle J
of RCRA and to provide information needed to determine if
national regulations might prove useful in controlling these
wastes. Thus, section 11008(a)(2) of the Medical Waste Tracking
Act of 1988 requires EPA, among other things, to assess "the
present and potential threat to human health or the environment
from medical waste or the incineration thereof ..." The
legislative history provides some insight into the intended
purpose of this assessment; suggesting that EPA should provide
information on
"...The type or category of medical waste that needs to be
tracked, or whether w« should just require the tracking of
infectious wastes" (134 Cong. Rec. H9537).
In responding to the Congressional mandate to evaluate
health hazards posed by routine management and mismanagement of
medical waste, this chapter outlines EPA's proposed approach to
performing this task. The following topics are addressed:
coordination with the Agency for Toxic Substances and
Disease Registry (ATSDR)
definitions and terms
scope of the health hazard assessment
general approach to evaluating present and potential
health hazards from exposure to medical waste
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evaluation of health hazards posed by incineration of
medical waste
evaluation of health hazards posed by the landfilling
of medical waste
evaluation of the health hazards posed by the disposal
of medical waste in sewage systems
data gaps and research needs
A subsequent interim report (due June 22, 1990) will address
data gathered and analyzed by the tine of submission. The final
report to Congress will present findings, options, and
recommendations for future research needs. EPA expects that data
from the health hazard assessment, when coupled with data on
current medical waste management practices, will provide a basis
for determining whether any types of medical waste require
controls and whether controls over certain types or categories of
medical waste which may pose a hazard to the general public can
reduce or eliminate that hazard.
2.2 Coordination with the Agency for Toxic Substances and
Disease Registry (ATSDR)
Pursuant to §11009 of Subtitle J, ATSDR is required to
report to Congress on the health effects of medical waste.
ATSDR's report will include the following:
"1) A description of the potential for infection or injury
from the segregation, handling, storage, treatment, or
disposal of medical waste.
2) An estimate of the number of people injured or infected
annually by sharps, and the nature and seriousness of those
injuries or infections.
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3) An estimate of the number of people infected annually by
other means related to waste segregation, handling, storage,
treatment, or disposal, and the nature and seriousness of
those infections.
4) For diseases possibly spread by medical waste, including
AIDS and hepatitis B, an estimate of what percentage of the
total nun±»er of cases nationally may be traceable to medical
waste."
The ATSDR report will focus on existing epidemiological data
related to the transmission of disease or injury from medical
waste handling, storage, treatment, or disposal of medical waste.
The targeted universe of generators includes hospitals, clinics,
doctors (e.g., health maintenance organizations) and dentist
offices, medical laboratories, veterinary offices and clinics,
biomedical research and manufacturing facilities, funeral homes,
other facilities covered under the medical waste definition, and
in-home health care. Injury rates were derived from scientific
literature and surveys conducted by State Health Departments and
the waste hauling industry. The information will include total
study population, rate of injury or infection, and methodology
for collecting data and determining injury or infection rate.
EPA will coordinate with ATSDR to avoid duplication of
effort. As described earlier, the EPA study will focus on
identifying and quantitating classes of infectious agents
expected to be present in medical waste, possible routes of
transmission and associated morbidity rates from exposure to
these pathogens. The Agency will attempt to incorporate ATSDR
epidemiological data as it becomes available into its health
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hazard assessment to assist in evaluating the likelihood of
disease transmission.
2.3 Definitions
In any discussion of medical waste issues, including health
hazards posed by these wastes, it is imperative there be an
understanding of technical terms not commonly used or understood
by the general public. For example, in describing the ability of
a microorganism to cause disease, one must understand terras such
as virulence, invasiveness, pathogen(ic), infective dose, etc.
Therefore, to mitigate confusion and facilitate understanding of
complex technical terms, each interim report to Congress will
include definitions of terms used in the respective report. The
final report will include a comprehensive glossary of terms. The
Agency will consult with experts from professional trade
associations and academia to ensure that the definitions are as
accurate as possible.
The following terms are used in this report:
BiologicaJLs - preparations made from organisms or from
products of their metabolism, intended for use in diagnosing
immunizing or treating humans or animals, or in research
pertaining thereto.
Disease - (in the true sense of the term) an interruption,
cessation, or disorder of body functions, systems, or organs. (A
disease, e.g., a genetic disorder may manifest itself without the
involvement of a microorganism.
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£nfeetion - the entry and development or multiplication of
an infectious agent in th» body of man or animals. Infection is
not synonymous with infectious disease; the result may be
inapparent. The presence of living infectious agents on exterior
surfaces of the body, or upon articles of apparel or soiled
articles, is not infection, but contamination of such surfaces
and articles. In addition, it should be pointed out that
antibody production, i.e. seroconversion, does not necessarily
mean that "infection" has occurred.
Infectious agent - any microorganism that is capable of
producing infection or disease and may adversely impact human
health.
Medical waste - any solid waste which is generated in the
diagnosis, treatment (e.g., provision of medical services), or
immunization of human beings or animals, in research pertaining.
thereto, or in the production or testing of biologicals. The
tern does not include any hazardous waste identified or listed
under Part 261 or any household waste as defined in Section
261.4(b)(1).
Morbidity - disease state.
Mortality - death state.
Pathogen - any microorganism capable of causing disease.
Pathogenicitv - the capability of an infectious agent to
cause disease in a susceptible host.
virulence - the disease-evoking power of a microorganism in
a given host.
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2.4 scope of Health Hazard Assessment
EPA (Office of Solid Waste) has begun a search of medical
and scientific journals, Agency files, and other information
sources to gather data in support of the medical waste health
hazard assessment. The primary focus of the health hazard
assessment will be on the disease-causing potential of medical
wastes through qualitative evaluations of pathogenicity and
exposure potential. While the Agency will address the
feasibility of performing a quantitative risk assessment for
disease potential, a preliminary review of the literature
indicates that a meaningful quantitative risk assessment may not
be feasible due to observed gaps in areas imperative to the
performance of a quantitative risk assessment, specifically dose-
response and exposure data. Therefore, the Agency will explore an
alternative means for expressing potential disease-causing
hazards to human health (possibly through a comparative health
hazard assessment). The health hazard assessment will address
categories of medical waste as defined in the statute which are
as follows:
"(1) Cultures and stocks of infectious agents and associated
biologicals, including cultures from medical and pathological
laboratories, cultures and stocks of infectious agents from
research and industrial laboratories, wastes from the production
of biologicals, discarded live and attenuated vaccines, and
culture dishes and devices used to transfer, inoculate, and mix
cultures.
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2) Pathological wastes, including tissues, organs, and body
parts that are renoved during surgery or autopsy.
3) Waste human blood and products of blood, including
serum, plasma, and other blood components.
4) Sharps that have been used in patient care or in
medical, research, or industrial laboratories, including
hypodermic needles, syringes, pasteur pipettes, broken glass, and
scalpel blades.
5) Contaminated animal carcasses, body parts, and bedding
cf animals that were exposed to infectious agents during
research, production of biologicals, or testing of
Pharmaceuticals.
6) Wastes from surgery or autopsy that were in contact with
infectious agents, including soiled dressings, sponges, drapes,
lavage tubes, drainage sets, underpads, and surgical gloves.
7) Laboratory wastes from medical, pathological,
pharmaceutical, or other research, commercial, or industrial
laboratories that were in contact with infectious agents,
including slides and cover slips, disposable gloves, laboratory
coats, and aprons.
8) Dialysis wastes that were in contact with the blood of
patients undergoing hemodialysis, including contaminated
disposable equipment and supplies such as tubing, filters,
disposable sheets, towels, gloves, aprons, and laboratory coats.
9) Discarded medical equipment and parts that were in
contact with infectious agents.
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10) Biological waste and discarded materials contaminated
with blood, excretion, exudates or secretion from human beings or
animals who are isolated to protect others from communicable
diseases."
11) Other waste material that results from the
administration of medical care to a patient by a health care
provider and is found by the Administrator to pose a threat to
human health or the environment.
EPA data collection efforts with respect to disease-causing
and injury potential will not focus on epidemiological studies.
The Agency will obtain these data from the Agency for Toxic
Substances and Disease Registry (ATSOR) report on incidence of
injuries and infection from occupational settings and public
exposure to medical waste. However, the Agency recognizes the
importance of epidemiology in assessing the risk of infection.
As alluded to earlier, disease results from the interaction of
several factors, not just the presence of pathogens. Therefore,
epidemiological data are an important link in assessing whether a
ir.echanism exists for the transfer of pathogens from objects or
materials to a susceptible host. ATSDR data should provide the
important epidemiological evidence needed to better assess the
disease-causing and injury health hazards posed by medical waste.
The Agency will incorporate available ATSDR findings into its
subsequent interim medical waste report and final report to
Congress.
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2.5 General Approach to Evaluating Health Hazards Posed by
Exposure to Medical Waste
The following section describes EPA's approach to
determining present and potential health hazards posed by medical
waste. If all of the information needed below is available, then
a quantitative risk assessment may be feasible.
Infection Hazards
To assess the infectious nature of medical waste, the Agency
will evaluate its potential to cause disease in humans. This
approach emphasizes the microbiological content of medical waste
and possible exposure scenarios; it does not consider aesthetic
concerns. Once the Agency has evaluated the disease-causing
potential of medical waste, we will evaluate the relationship
between microbial activity and disease transmission.
The section below describes the methodology for categorizing
medical waste according to its potential to contain
microorganisms capable of causing disease (i.e., pathogens). The
approach focuses on the categories of listed medical waste (as
defined in the statute) and any other categories of medical waste
identified by EPA. Sections 2, 3, and 4 address an approach to
determining the disease-causing potential of each category (and
subcategory) of medical waste that may contain pathogenic
organisms. The methodology includes identifying pathogens
present in medical waste and evaluating microbial activity and
expected disease causation from exposure to the pathogens. In
evaluating disease-causing potential, the Agency will investigate
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possible human exposures from a range of medical waste management
and- mismanagement scenarios. -
Identify and Categorize Medical Waste
The Agency will consult with hospitals and professional
trade associations, and conduct a search of the available
literature to establish a comprehensive list of wastes generated
by medical, research, and industrial facilities from "the
diagnosis, treatment, or immunization of human beings or animals,
in research pertaining thereto, or in the production or testing
of biologicals." Onca the universe of medical waste is
identified, the Agency will determine which wastes, if any, were
not included in the categories listed in the statute. Additional
categories will be established as appropriate for the health
assessment.
Each category will be evaluated for its potential to contain
organisms capable of causing disease and will be designated as
either infectious, potentially infectious or non-infectious. If
a specific category cannot be so designated due to differing
biological activity or physical characteristics of wastes within
the category, the Agency will divide the category into
subcategories using these characteristics as the basis. For
example, category 1 ("Cultures and stocks of infectious agents
and associated biologicals . . . and devices used to transfer,
inoculate, or mix cultures") includes wastes which meet both of
these criteria. Cultures and stocks are concentrated solutions
of organisms. Devices used to transfer these cultures may be
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only marginally contaminated with organisms. Thus, based on
differing physical forms and microbial activity, the Agency may
establish two subcategories. Cultures and stocks may be
designated as infectious. Devices used to transfer cultures may
be considered as potentially infectious.
Identify Types of Pathogens Present in Medical Mas to and
Associated Disease-Causing Potential
The Agency will search available information sources to
identify specific pathogens or classes of pathogens expected to
be present in medical waste categories and subcategories
designated as potentially infectious and infectious. For
example, dialysis wastes may only be contaminated with blood
borne pathogens, such as HIV and HBV. Once the spectrum of
expected pathogens in each category and subcategory of medical
waste has been determined, a profile of diseases, injuries or
other factors influencing health will be identified for each
pathogen. The Agency will gather needed information from data '
bases and representatives of the following organizations and
agencies to determine diseases associated with each type or class
of pathogen:
American Medical Record Association
Armed Forces Institute of Pathology (AFIPS)
Centers for Disease Control of the Public Health
Service, CDC,PHS
National Center for Health Statistics (NCHS)
National Library of Medicine (NLM)
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world Health Organization (WHO)
others as appropriate or identified
Following identification of a disease, taking into
consideration the potential concerns regarding the presence of
certain organisms in medical waste, the Agency will determine the
risk of disease transmission associated with exposure to class
pathogens by age and sex of the affected individual. Most
diseases are characterized by unique frequency patterns of
morbidity and mortality rates within the varying age groups and
sexes. Whenever possible, the Agency will obtain these figures
from the National Center for Health Statistics and CDC. If
numeric estimates are inadequate for use in the evaluation, the
Agency will consult additional sources such as the American
Association of Health Data Systems, the Association for Health
Records, and the Commission on Professional and Hospital
Activities.
The overall approach to determining the disease-causing
potential of pathogenic organisms present in medical waste relies
heavily on the availability of data. If data on microbial
content are inadequate for making the determination, the Agency
will consider developing a reasonable analytical strategy to
determine the potentiality of infectious medical waste that may
contain one or more classes of pathogenic organisms typically
associated with outbreaks of disease in the United States.
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Estimate Concentration of Pathogens
The Agency will use available information sources to
estimate quantities of pathogenic organisms present in each group
of potentially infectious and infectious waste. These data will
be used to determine whether pathogens are present in sufficient
quantities or doses to cause disease provided there is a
susceptible host and a route of transmission. However, any
discussion of pathogen dose must include the interrelationship of
factors such as temperature, pH, radiation (e.g., ultraviolet),
and relative humidity, host susceptibility immune status/ and
route of exposure which directly affect pathogen growth and
viability.
Relationship Between Medical Waste Microbial Activity and Disease
Transmission
To determine the probability or likelihood that a person
exposed to a pathogen in medical waste will develop a specific ,
disease as a result of that exposure, it will be necessary to
evaluate factors relating to the transmission of disease. The
ATSDR effort will be used to provide these data wherever
possible. Information on disease transmission may be available
from EPA files, OSHA, CDC, and other government agencies. The
minimum information needed will include but will not be limited.
to:
identification of possible modes of transmission (e.g.,
direct contact such as a needle stick, indirect contact
such as airborne transmission, or vector borne
transmission such as insect bites),
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concentration of each pathogen per unit of medical
waste in each exposure scenario,
infective dose for each pathogen (dose needed to induce
the related disease),
age- and sex-specific susceptibility of the disease and
individual and population ("herd") immunity to the
disease.
The Agency recognizes that the minimum data required to
evaluate disease transmission may not be available, and when
these minimum data are not available, for example, blood or other
tissue waste containing HIV virus, it will be necessary to
extrapolate from the available information. The Agency will
describe different mixes of transmission factors generated from
available facts combined with current theory on occurrence of
infection. The weight of evidence from epidemiological data that
supports each theory will be used to estimate alternative
likelihoods for the theoretic dose/response relationships. This
procedure should provide a subjective basis for making policy
decisions.
Evaluation of Other Hazards Posed bv Medical Waste
The Agency will also assess hazards posed by sub-categories
of medical waste designated as "non-infectious". This group
includes materials that are not expected to contain or have not
been in contact with infectious agents.
The Agency will use ATSDR data where possible in assessing
hazards posed by the "non-infectious1* group of medical waste. In
the absence of data, the Agency will provide a subjective
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assessment of the hazards based on the judgments and opinions of
health care experts and professionals.
2.6 Evaluation of Health Hazards Posad by Incinerating Medical
Waste
Incineration of medical waste is a very common method of
treating refuse from hospitals, biomedical research laboratories,
and similar institutions. Such wastes may be incinerated on-site
or transported off-site to regional, municipal, or commercial
waste incinerators. Hospital wastes include both infectious
wastes (i.e., wastes that contain pathogens with sufficient
virulence and quantity such that exposure to the wastes could
result in infectious disease) and non-infectious or general
housekeeping wastes. "Hospital wastes" are generated at a number
of medical facilities, including hospitals, clinics, research
facilities, geriatric care facilities, medical test facilities,
and physicians' offices. Approximately 500,000 tons of "hospital
waste" are generated each year. It is currently estimated that
approximately two thirds of the hospitals in the United States
have incinerators.
The potential sources of risk to the general population from
medical waste combustion medical incinerators are pathogens (in
stack or fugitive emissions, or ash residues), organic chemicals,
carbon monoxide, particulate matter, metals (As, Cd, Cr, Hg, and
Pb) and acid gases (hydrogen chloride, sulfur dioxide, and
nitrogen oxides). Of the groups of microorganisms (viruses,
bacteria, fungi, protozoa, and helminths), bacteria, particularly
spore formers, are believed most likely to survive in medical
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waste. Whether or not bacteria would survive the incineration
process has been tested in a number of studies. One study
compared bacteria collected from stack emissions with bacteria
collected from the ambient air and found no significant
difference between them. While bacteria were not measured in the
waste material burned, the authors concluded that the preser of
bacteria in emissions indicated that they originated in exces,
ambient air that had been added to the secondary combustion
chambers, and did not spend sufficient time exposed to high
temperatures to inactivate them.' Currently, EPA is developing
standard methods to test for pathogen emissions.
A second study used a composited sham waste that was
inoculated with cultures of Bacillus subtilis, a spore-forming
nonpathogenic bacterium, and then incinerated with a burn cycle
time of 20-30 minutes and a temperature of 760 degrees C. A
number of species of bacteria were isolated from the stack gas.
However, no fi. subtilis were found, indicating that the
inoculated bacteria had been destroyed, and that the species
present may have originated outside the waste source. The
authors postulated that the other species came into the
incinerator from the room housing it, and analysis of this air,
in fact, accounted for 91 out of 96 colonies found in the stack
emissions.' The authors did not address whether or not the
species found arose from waste that was previously or currently
present in the room.
The studies did not evaluate pathogen survival in ash.
However, pathogens may survive in the ash residue of an
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improperly operated incinerator where the mass' of waste to be
burned does not remain in the primary chamber for a sufficient
tiir.e for adequate temperatures to be reached throughout the
waste. Variables affecting pathogen survival include moisture
content, capacity, loading rate, and water formed during
combustion.
Performing a quantitative risk assessment would be extremely
difficult due to the diversity of incinerator types used, the
range of operating conditions and waste loads, the lack of dose-
response data, and the lack of exposure assessment information.
There is a need for both pathogen emission measurements from
stacks and microorganism concentration measurements in bottom and
fly ash. These measurements are needed not only under
experimental conditions that involve different kinds of
incinerators, under varying operating conditions, but also of
incinerators in actual use under normal operating conditions.
Ambient air sampling (measuring both indicator organisms and
organisms found in pre-incineration wastes) is also required for
exposure assessment at sites near hospital and municipal
incinerators burning medical wastes.
Given the difficulty of performing a quantitative risk
assessment, EPA may explore development of a testing protocol
whereby spore-forming bacteria cultures are added to the waste
and then measured in the emission and residues. The incinerator
operating parameters would then b« adjusted for complete spore
destruction. If such spores are eliminated, it could be assumed
that no other microorganisms in the waste would survive.
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Typically, existing hospital incinerators are designed to
operate at lower than optimum combustion temperatures and
residence times; and, hence, do not achieve optimum combustion
control. Also, the operators of many existing hospital
incinerators are not trained to properly load and operate the
incinerators. These design and operational deficiencies in many
existing hospital incinerators result in increased emissions.
Further, most existing facilities do not have add-on controls.
The Agency has prepared a report entitled Hospital Waste
Combustion Study! Data Gathering Phase (EPA-450/3-88-017) which
summarizes available information on hospital waste incinerators,
including the available data on air emissions. The data
presented in the report include measured emissions of organics
(dioxins and furans), carbon monoxide, particulate matter, metals
(arsenic, cadmium, chromium, and lead) and acid gases (sulfur
dioxide and hydrogen chloride). There is only limited
information in this study on the constituents of ash from the
incineration of hospital waste. The study does not include
estimates of air exposure levels and risks of cancer or noncancer
effects associated with exposure to stack emissions from hospital
incinerators or fugitive dust emissions from the handling of ash.
The Agency is in the process of expanding the emissions and
control technology data base to determine whether a new source
performance standard for new medical waste incinerators (MWIs)
should be proposed under Section 111 of the Clean Air Act.
Section 111 of the Clean Air Act directs the Administrator to
establish NSPS for any category of new stationary source of air
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pollution which ". . .causes or contributes significantly to air
pollution which may reasonably be anticipated to endanger public
health or welfare." The Act requires that NSPS reflect
". . .the degree of emission limitation and the percentage
reduction achievable through application of the best
technological system of continuous emission reduction which
(taking into consideration the cost of achieving such emission
reduction, any nonair quality health and environmental impact and
energy requirements) the Administrator determines has been
adequately demonstrated." The NSPS apply only to stationary
sources, the construction or modification of which commences
after the NSPS are proposed in the Federal Register.
To determine the level of performance achievable with the
best demonstrated technology, EPA plans to test up to four
modern, controlled-air facilities equipped with"a cross section
of candidates for best available add-on control technologies.
Some of this testing will be performed using general hospital
waste as the incinerator feed and some with "red-bag"
(infectious, biomedical waste) feed. One test is planned when
the incinerator feed contains cytotoxins. Emissions of
particulate matter, hydrogen chloride, carbon monoxide, carbon
dioxide, sulfur dioxide, nitrogen oxides, metals (arsenic,
cadmium, chromium, lead), total hydrocarbons, and dioxins/furans,
will be measured. Constituents of ash from incineration of
medical waste will also be analyzed. Pathogen destruction will
be assessed by "spiking" the feed with a known heat-resistant
spore and then sampling for this spore in the air, water, and ash
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streams. The incinerator secondary combustion chamber
temperatures will be varied to allow assessment of this variation
on emissions from the incinerator tested. Testing of these
incinerators is scheduled to begin in April 1990 with data
analysis to be completed by mid-1991.
The source information and emissions data gathered for new
medical waste incinerators will subsequently be used to conduct a
risk assessment for inclusion in the final report to congress
required under 11008 of RCRA. This assessment will be initiated
after completion of the data analysis in support of the new
source performance standards and will use all data on new
hospital incinerators that are available to EPA at that tine
(mid-1991). No data are available to conduct a risk assessment
for the older existing hospital incinerators. The Agency is,
however, evaluating the need to conduct such studies and
determining what additional resources would be necessary.
Section 111 also provides for control of existing sources
under Section lll(d). Section lll(d) procedures are invoked
whenever an NSPS is set for an air pollutant that is not
regulated or on a list to be regulated by national ambient air
quality standards or national emission standards for hazardous
air pollutants. Pollutants qualifying under this criteria are
termed "designated pollutants." EPA also issues emission
guidelines for existing sources within the source category
regulated by the NSPS. Upon promulgation of the emission
guidelines for the designated pollutants, a process is commenced,
similar to the State implementation plan process, whereby each
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State submits to the Administrator a plan establishing emission
standards and compliance schedules for existing sources within
their jurisdiction. The State plan must apply to the designated
pollutant and the source categories covered by the NSPS. The
Agency has made a preliminary determination not to include a
standard for a designated pollutant.
EPA's review of medical waste incinerators, will involve
three principal phases of activity: (1) information gathering,
(2) analysis of the information as required by the MWTA and risk
assessment, and (3) development of the NSPS. EPA will consider
the following options to limit emissions from medical waste
incinerators: (1) the development of a new source performance
standard (NSPS), (2) the development of an operator training
program for new and existing medical waste incinerators, (3) the
consideration of using best available control technology (BACT)
guidance for the voluntary use of State and local agencies prior
to our proposal of the NSPS, and (4) the possibility of
controlling existing sources. The Agency is gathering emissions
data from existing and new incinerators. The information
collected about the industry and the pollutants emitted will be
used in analytical studies to determine whether an NSPS is needed
for this industry. We will conduct studies to determine costs,
economic, environmental, and energy impacts of various regulatory
alternatives. Should EPA determine that an NSPS is needed,
several control alternatives will be considered, including
operator training, good combustion controls, wet scrubbers, and
dry scrubbers, followed by fabric filters or electrostatic
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precipitators. The most plausible regulatory alternative will be
selected based on the results of the studies. Materials
separation could also be a component of Best Demonstrated
Technology (BDT) as a control strategy for municipal waste
incinerators (MWCs) proposed under the Agency's NSPS for MWIs.
In summary, the Agency is in the process of expanding the
emissions and control technology data base for medical waste
incinerators to support the development of a new source
performance standard for new incinerators. The need for medical
waste incinerator regulations is based on: (1) our recently
completed report which characterizes hospital waste and examines
available information on medical waste incinerators and (2) the
anticipation that the Medical Waste Tracking Act will cause more
waste to be incinerated and focus public attention on the
emissions.
2.7 Evaluation of Haalth Hazard* Posad by Landftiling Medical
waste
The Agency will research information sources to determine
whether disposal of medical waste in sanitary landfills has
resulted in or could potentially result in hazards to humans or
the environment. The Agency will seek information on the fate
and transport of pathogenic microorganisms in soils (i.e., the
landfill environment), groundwater, and surface water.
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2.8 Evaluation of Health Hazards Posad by Disposal in Sewage
Systems
The Agency will research information sources to determine
whether disposal of medical waste in sewage disposal systems has
resulted in or could potentially result in hazards to humans or
the environment. The Agency will seek information on the fate
and transport of pathogenic microorganisms through sewage
disposal systems.
2.9 Data Gaps and Research Needs
As discussed earlier EPA will evaluate whether sufficient
information exists to address the questions posed by Congress
adequately. If minimum data needs cannot be fulfilled, the
Agency will propose research activities to obtain such data.
2.10 Potential Health Hazards Associated with Handling Medical
waste
To assess the potential hazards to the environment, the
Agency will use a similar process as described for assessing
hazards to human health. The Agency will discuss its progress in
the subsequent interim report to Congress.
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2.11 References
1. Kelley, H., G. Brenniman, and J. KuseX. "An evaluation of
bacterial emissions from a hospital incinerator" in
Proceedings from Vlth World, Conference on Air Quality.
Volume 2, May 1983.
2. Allen, R., G. Brenniman, R. Logue, and V. Strand. "Emission
of Airborne Bacteria from a Hospital Incinerator", JgurnaJ.
of tl^e Air Pollution jpontrol Association. Vol. 39, No. 2,
1989.
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CHAPTER 3
ESTIMATED COSTS OP TEE DEMONSTRATION PROGRAM
AND IMPROPER MANAGEMENT OP MEDICAL WASTES
This chapter discusses EPA's efforts to date to estimate
"the present and potential costs (A) to local economies, persons,
and the environment from improper handling, storage,
transportation, treatment or disposal of medical waste and (B) to
generators, transporters, and treatment, storage, and disposal
facilities from regulations" promulgated under the MWTA. This
discussion will include the methodology and results of the
Agency's preliminary cost analysis, and some of the sources of
information EPA expects to use in refining these cost estimates
for the final report.
EPA has analyzed the costs of the regulation with available
data. The cost analysis includes cost estimates for management
practices required by the demonstration program for the five
States participating in the program (Connecticut, New Jersey, New
York, Puerto Rico, and Rhode Island). These costs differ from
what was stated in the preamble to the rule, since the earlier
costs were estimated for the ten states originally targeted for
involvement. In this cost analysis, state administrative costs,
as well as potential indirect costs associated with changes in
waste management practices, have not been analyzed; their
combined effects on the costs of the rule are unclear.
Information from the demonstration program and comments received
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on the inter. final regulation will be used to refine these
estinates.
Estimation of the costs associated with improper management
of medical wastes are more difficult to develop. EPA has
developed two preliminary estimates of costs associated with
improper management of medical wastes—those costs to beach users
from lost beach days, and a quantitative estimate of the inherent
value of clean beaches to State residents/ which are discussed
in section 3.6. Currently there is not enough information
available to develop precise estimates of the quantity of
improperly managed medical wasta each year, or the resulting
impact on "local economies/ persons and the environment from
improper handling, storage, transportation, treatment or disposal
of medical wastes." EPA is working to develop a better
understanding of these factors, and hopes to develop rough cost
estimates as these factors become better defined.
3.1 Cost Methodology
The methodology presented here for estimating the costs "to
generators, transporters, and treatment, storage, and disposal
facilities from regulations" setting up the tracking program
estimates only the direct costs incurred through compliance with
the rule for the five states currently participating in the
demonstration program. The methodology involves the following
steps: (1) characterizing the regulated community in terms of the
numbers and types of generators in the ten states, and the
numbers of transporters affected; (2) estimating the medical
3-2
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waste generation rates for each of the generator types and their
rate of waste shipments transported off site; (3) accounting for
both current state regulations and existing waste nanagenent
practices governing medical wastes that are similar to the
requirements of 40 CFR Part 259; and (4) estimating direct
compliance costs for packaging, tracking, generator recordkeeping
for generators of less than 50 pounds of regulated medical waste
per month, transporter recordkeeping and reporting, and
incinerator recordkeeping and reporting.
This cost analysis does not address the potential indirect
cost effects of the tracking system. For example, medical waste
disposal capacity in the demonstration states may be reduced if
landfill facilities become more reluctant to accept medical
wastes; the combination of packaging, labeling, and tracking
requirements may cause increasing numbers of landfill
owner/operators to refuse handling medical wastes. As a result,
medical waste disposal costs could increase. On the other hand,
increased use of alternate treatment technologies may decrease
the volume of waste regulated under the tracking rule, and thus
may decrease complianca costs. For example, both on-site
incineration and treatment and destruction exclude waste from the
Part 259 requirements. Information on changes in waste
management practices, as the demonstration program continues, may
indicate some of the indirect economic effects of the rule.
Some of the estimates discussed in this chapter vary
slightly from those in tha preamble discussion of the Medical
Waste Tracking Rule (54 FR 12326). This is because EPA has
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refined estimates for some of the input variables (e.g., waste
generation rates, frequency of shipments) and the universe has
changed.
3.2 Characterizing the Regulated community
In order to estimate the direct compliance costs imposed on
the regulated community by the federal medical waste tracking
rules, the regulated community is divided into three groups:
medical waste generators, transporters, and treatment and
disposal facilities.
Generators
The major generators of medical wastes, that are
potentially subject to regulation fall into ten types (nine
specific generator typos and "other generators"), listed in Table
3-1. Chapter 1 describes the methodology used to develop these
generator types. However, the generator estimates in Chapter 1
are national estimates, whereas the generator estimates given
here are EPA's estimates of the number of generators (by type) in
the five states. The waste generation estimates are the same for
both chapters.
EPA obtained most of the data on the numbers for each
generator type in each of the five states from the Department of
Health and Human Services and professional associations (e.g.,
the American Medical Association, and the American Dental
Association, etc.). The preamble to the Part 259 regulations (54
EB 12366) explains some of these estimates in more detail. EPA
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TABLE 3-1
Generator Types and characteristics
Generator
Hospitals
Physicians' Offices
Dentists
Nursing Homes
Clinics
Medical Laboratories
Funeral Homes
Veterinarians
Blood Banks
Other
Number
560
24,907
21,779
1,225
1,647
549
3,062
4,081
161
2,500
Waste Per
Month Per
Gen. (Ibs)
8,800
50
25
400
100
600
25
25
400
25
Shipments
Per Year
Per Gen.
260
12
12
12
26
52
12
12
52
12
Total
60,471
SOURCE: References 2-10
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recognizes that these estimates are preliminary and is continuing
to collect more detailed information to further refine these
estimates. Other medical waste generator groups, besides those
included in this analysis, may exist; EPA requested comment and
input on these additional generator types.
Transporters and Treatment/Disposal Facilities
The Agency has limited information concerning the number of
transporters and treatment and disposal facilities. Data on the
number of transporters affects cost estimates, because the total
transporter reporting requirement costs are dependent on the
number of transporters that must submit such reports.
Information on transporter numbers is complicated by the fact
that medical waste transporters often operate in multiple states
and some states have no licensing requirements for transporters.
EPA estimates the total number of transporters, based on
notifications to EPA, in the five participating States to be
approximately 180. For the purposes of this analysis, the number
of treaters and disposers has no impact on costs, since their
costs are a function of the number of shipments.
3.3 Medic*! wast* Generation Rates
Table 3-1 presents the estimated average quantity of
regulated medical waste generated by an average facility within
each generator type. The facility size and the waste generation
rates vary significantly within generator types, particularly for
hospitals. In estimating waste generation rates for hospitals,
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EPA estimated an average per bed waste generation rate, coupled
with data on numbers of beds and hospitals, to determine waste
generation. The methodology used to develop the nationwide wasta
generation estimates in Chapter 1 is the same methodology that
was used to develop these generation rate estimates for the five
states analyzed here.
The total number of shipments for each generator category is
based on available waste generation rates and from interviews
with both generators and transporters. EPA estimates that
hospitals ship out waste five times per week, blood banks and
medical laboratories once a week, and the remaining generator
categories either once every other week or once a month. Table
3-1 summarizes waste generation and waste shipment rate
estimates.
3.3 Regulatory Costs
To estimate direct compliance costs, EPA first divided each
of the major requirements of the rule into its component tasks
and estimated the labor hours and material costs associated with
completion of each task. The requirements of the rule fall into
five tasks: packaging, tracking, incineration recordkeeping and
reporting, generator recordkeeping (for generators of less than
50 pounds per month), and transporter reporting and
recordkeeping. Costs for the first four tasks are estimated for
generators; only costs for tracking are estimated for
transporters and disposers.
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Medical waste generators have voluntarily adopted a number
of current waste management practices that are substantively
similar to the requirements set forth in the tracking rule.
Where this cost analysis accounts for these baseline practices,
reduced or eliminated materials costs or required task times
result. For example, the cost analysis assumes that generators
already segregate sharps and fluids; it applies no additional
compliance costs (for either materials or labor time) for this
requirement of the rule. In addition, this costs analysis
accounts for existing State regulations that are similar to the
tracking rule. Where State requirements are similar to the
tracking rula, no incremental cost is assigned in that State for
that particular requirement. For purposes of this analysis, EPA
used the State requirements in effect while the 40 CFR Part 259
regulations were being developed. Although New York and New
Jersey have since rewritten State requirements to reflect the
tracking rule, these recent changes are not incorporated into
this cost analysis; EPA assumes these revisions are a direct
result of the tracking rula, and thus costs for these State
requirements are actually incremental costs to the federal rule.
The assumptions used regarding State requirements are
described in more detail in the preamble to the interim final
regulations (54 FR 12368) and in the background memo submitted to
the docket, Estimates of Costs for 40 CFR Part 259." October
1989. The costs estimated for complying with each component of
the rule are described there as wall; soma of tha cost estimates
have been refinad sinca publication in the Federal Register.
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3.4 Results
During the two-year demonstration period, the tracking rule
will irapose average annual compliance costs of approximately $12
million, for a total estimated 2-year program cost of $24 million
(undiscounted). Table 3-2 summarizes estimated compliance costs
by component and generator type for the original ten states.
The results indicate that physicians' offices, due to their
large number, and hospitals, due to their high medical waste
generation rate, together account for over one-sixth of all
costs. EPA estimates that all generators combined bear
approximately one-third (70 percent) of the total costs of the
tracking rule, with the remaining costs divided between
transporters and disposers.
The following paragraphs will discuss costs for specific
requirements of the rule. The average costs are estimated based
upon total cost of the rule in the five participating states.
These averages include facilities located in states where some
requirements of the rule are already required by the state and
therefore assigned as baseline costs and not incremental costs—
not included in this analysis. Thus, for instance, while the
average cost overall for physician offices is $36 dollars per
facility, the average cost of a facility located a State where no
requirements are assumed in the baseline is $144 per facility. -
Likewise, the average cost of a physician office, located in a
State where all the rule's requirements are assumed as baseline
costs, would be zero.
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TABLE 3-2
Cost Summary-Annual Coats (in Thousands)'
Regulated Community
Total
Packaging Manifest Incin.
Req. Req. Req.
Reporting
Req." Total
Hospitals
Physicians' Offices
Dentists
Nursing Homes
Clinics
Medical Laboratories
Funeral Homes
Veterinarians
Blood Banks
Other
Transporters
Disposal Facilities
580
360
150
160
50
170
10
30
20
50
0
0
90
250
200
30
60
90
20
20
20
80
4,910C
3,410
500
0
0
0
0
0
0
0
0
0
0
0
0
280
250
10
20
10
40
70
0
30
0
0
1, 170
900
590
190
130
260
70
110
30
140
4,910
3,410
1,560
9,150
500
690
11,910
SOURCE: References 2-11
'Cost may not add due to rounding.
"For generators of less than 50 pounds per month.
'Average annual cost over the 2 years of the demonstration program.
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EPA estimates that the overall average compliance costs of
the tracking rule on a per generator facility basis range from
$2,093 per year for hospitals to $22 per year for funeral homes.
EPA estimates that the average incremental cost per pound of
generated nedical waste for these same two generator categories
is $0.02 for hospitals and $0.07 for funeral homes. The lower
per pound cost for hospitals is due to the fact that hospitals
frequently incinerate their waste; also, hospitals dispose of
more waste per shipment and, therefore, their per-pound tracking
costs are lower than funeral homes. The cost analysis estimates
that the average incremental cost to generators in all the
generator categories is $0.04 per pound of regulated medical
waste.
The highest per facility compliance cost is estimated for
hospitals that do not incinerate their waste and that do not
currently meet the requirements of 40 CFR Part 259. For a
"typical" hospital (one that generates an average of one ton of
medical waste per week), the estimated highest cost is $16,723
per year. In contrast, a facility that generates more than 50
pounds of regulated medical waste per month and already meets the
Part 259 requirements will have no additional compliance costs.
The packaging requirements are likely to impose costs of
approximately $1.6 million per year. Th« amount of waste
generated per year for all generators in a category is the
driving force behind the costs for this component; thus
physicians' offices and hospitals together account for over half
of the total packaging costs. The remaining eight generator
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categories incur estimated aggregate annual packaging costs that
range front $12,000 for funeral homes to $173,000 for medical
laboratories.
The costs of compliance with the tracking requirements ($9.0
million per year) account for approximately three-fourths of the
total compliance costs. EPA estimates that the generators will
incur approximately $838,000 of these tracking costs per year.
Physician offices will account for $251,000 of this estimate,
dentists will account for $201,000, and the remaining eight
generator categories account for less than $100,000 each. The
additional tracking costs are distributed between transporters
and disposal facilities. Transporters incur average annual
tracking system costs of approximately $4.8 million, and
disposers incur approximately $3.4 million. Included in the
transporter costs Is a one-time requirement to notify EPA of
intent to transport regulated medical wastes, the cost of which
will total approximately $3,000.
Incinerator recordkeeping and reporting requirements will
total approximately $504,000 for the estimated 375 hospitals in
the participating States that currently use on-site incinerators.
Generators of less than 50 pounds per month of regulated
nedical waste, although usually exempt from the tracking
requirements, are required to maintain a log of their generated
wastes. This requirement will impose relatively small costs on
these generators ($691,000 par year in aggregate). For example,
the estimated 12,454 physician offices that are generators of
less than 50 pounds of regulated medical waste per month will
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have recordkeeping costs of approximately $281,000 (or $23 per
office) per year.
3.5 Sensitivity Analysis
These estimates may understate actual costs. For example,
transport vehicle and disposal costs are assumed to be unchanged.
For various reasons, landfills are apparently less willing (and
in some cases unwilling) to accept medical waste, a phenomenon
which suggests that the rule will increase disposal costs two
additional ways. First, landfills willing to accept regulated
medical waste will be able to charge more for the service.
Second, the increased cost of land disposal will stimulate the
demand for incineration.
Limited information suggests that the current price for
medical waste incineration is about $0.30 per pound.'2 Based on
Table 3-1, about 56 million pounds of regulated medical waste
(that is not currently incinerated on-site) are generated per
year in the states targeted for participation in the program.
Assuming constant returns to scale in incineration, every l
percent of this wast* shifted from land disposal to off-site
incineration will increase total costs by about $169,404 per
year. Thus, if just 10 percent of the medical waste is shifted
to off-site incineration, the annual cost of the rule will be
about 14 percent higher than estimated. Savings from avoiding
landfill disposal fees, increased on-site management, and
alternative treatment technologies will offset this amount, while
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limited incineration capacity combined with increased demand will
tend to increase it.
In addition, the cost analysis does not estimate the effects
of §259.73, which requires regulated medical waste to be
transported in a leak-resistant, fully enclosed, cargo-carrying
body that is maintained in good sanitary condition. However, the
rule does not prohibit the transport of regulated medical waste
simultaneously with other waste. The Agency does not have data
to analyze rigorously how these transporter vehicle requirements
will affect current practices and costs. However, limited
information supplied by transporters and generators indicates
that in many instances medical wastes are already transported in
vehicles meeting the Part 259 requirements. To the extent that
current practices do not reflect these requirements, transporter
costs will be incurred.
The cost figures provided here are meant to be rough
estimates of the actual costs of implementing the management
standards and tracking requirements in the tracking rule. In
future reports, the cost estimates will be refined as new data
are obtained. The Agency has encouraged generators,
transporters, and disposers to submit cost information that they
consider relevant to assessing the actual costs of the
demonstration program.
3.6 Cost of Improperly Managed Medical Waste
EPA is working to identify impacts to "local economies,
persons and the environment from the improper handling, storage,
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transportation, treatment or disposal of medical waste."
Although the Agency has ngt currently quantified the costs of
each of these threats, they may be significant. The "present or
potential threat to human health and the environment posed by
medical waste or the incineration thereof" is discussed more
thoroughly in Chapter 2 of this report.
EPA has developed preliminary cost estimates for the impacts
on persons of the appearance of medical wastes on the beaches in
states proposed for inclusion in the demonstration program. For
the purposes of this particular cost analysis, EPA assumed that
all medical wastes appearing on beaches is waste which will be
regulated by the tracking rule. Data sources on which to base
this analysis are sparse, and the Agency has estimated costs
based on limited data.
The Agency recognizes that the sources of beach wash-ups are
not certain. A recent study " suggests that combined sewer
overflows and transfer operations at municipal solid waste
landfills located near water bodies contribute to the problem..
Moreover, household waste generators, a known source of "medical-
like waste" found on beaches, are excluded from the definition of
"medical waste" by statute. Wastes falling into this category
include insulin syringes used at home and other aedical wastes
generated at home. The management and disposal of these sources
of medical wastes will not be regulated by the tracking rule.
Therefore, it is likely that the 40 CFR Part 259 regulations may
not directly or significantly affect these potential sources for
washups.
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For purposes of assessing related costs, the Agency
developed two approaches. The methodology used for these two
approaches is detailed more fully in the March 1990 memo,
"Methodology for Costs and Benefits Analysis for the First
Interim Report to Congress on Medical Waste." The two
methodological approaches are simplistic, but do provide some
quantitative estimation of the effects of medical waste. The
first approach is based on value of clean beaches that accrue
specifically to beach users (e.g., sunbathers, swimmers,
strollers). It uses an estimate of the economic value of a
beach-day visit and the number of lost beach-day visits due to
medical waste wash-ups. The second approach is based on a
broader range of losses due to medical waste wash-ups that accrue
not only to beach users, but also to other groups such as those
who value the option to visit the beach and those among the
general population who are not completely indifferent to the fact
that medical waste is washing up on the nation's beaches. Both
methodologies involve simple extrapolations based on rough
approximations of the relevant parameters. They are therefore
extremely sensitive to the assumptions used and are, at best,
accurate by perhaps an order of magnitude.
The first method estimates the economic value of beach day
visits lost due to medical-vaste related beach closings in
Connecticut, New York and New Jersey at approximately $30
million. This figure is obtained by extrapolation based on very
limited data concerning New Jersey beach visitation. The second
approach uses a different method of extrapolation to obtain an
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estimated loss of $39 million for the five states participating
in the denonstration program. In both cases, the 40 CFR Part 259
regulations were assumed to eliminate all beach closings due to
nedical waste. As indicated, however, the program is not
expected to significantly reduce the nonregulated medical waste
wash-ups. It should also be noted that some of the beach
closings which did occur during the summer did not involve
medical waste but were instead attributable to general refuse and
poor water quality.
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3.7 References
1. U.S. Environmental Protection Agency. Medical Waste
Benefits Analysis. Memorandum from R. Burke to Docket No.
F-89-MTPF-FFFFF, March 1989.
2. American Hospital Association. Hospital Statistics. 1987.
3. American Medical Association. Physician Characteristics and
Distribution in the U.S.. 1986.
4. R.L. Polk and Co. Mailing List Catalogue. Taylor, MI, 1988.
5. American Dental Association. Distribution of Dentists in
the U.S. 1982.
6. U.S. Dept. of Health and Human Services. Health care
Spending Bulletin. Washington, D.C., 1987.
7. American Medical Association. Medical Groups in the U.S..
1984.
8. National Funeral Directors Association. StateCount of
Funeral Homes.
9. American Veterinary Medical Association. Distribution by
Specialty Codes and State.
10. U.S. Environmental Protection Agency. Characterization of
Medical Waste Generation and Treatment and Disposal
Practices in New York and New Jersey. Draft Report,
Washington, D.C., 1989.
11. U.S. Environmental Protection Agency. Estimates o£ Costs
for 40 CFR Part 259. Memorandum from S. Rasmussen,
Washington, D.C., October 1989.
12. Habib, I. Comment fIWMA-00043 on June 2, 1988 Federal
Register notice, July 25, 1988.
13. New York State Department of Environmental Conservation.
Investigationi Sources of the Beach Washups in 1988.
Albany, NY, December 1988.
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14. Ofiara, D. and 1. Brown, "Marine Pollution Events of 1988
and Their Effect on Travel, Tourism, and Recreational
Activities in New Jersey," paper presented at the Floatables
Wastes in the Ocean Conference, State University of New
York, Stonybrook, NY, Mar. 21, 1989.
15. R.L. Associates and U.S. Travel Data Center, "The Economic
Impact of Visitors to the New Jersey Shore the Summer of
1988," study conducted for the New Jersey Division of Travel
and Tourism, Nov. 1988.
16. Thomas Conoscenti & Associates, Inc., Long Island
Tourist/Convention Estimates for1987 & 1988. prepared for
the Long Island Tourism and Convention Commission, 1988.
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CHAPTER 4
DEMONSTRATION PROGRAM OBJECTIVES AND EVALUATION
This chapter evaluates the success of the demonstration
program, and outlines the other available and potentially
available methods for tracking medical waste. Sections 4.1
through 4.3 discuss the objectives and goals of the MWTA and
demonstration program, measures for evaluating its success, and
overall conclusions about the success of the program. Section
4.4 discusses the Agency's plans to evaluate changes in
management practices attributable to the demonstration program.
Sections 4.5 and 4.6 describe other tracking methods available.
4.1 Objectives of the KWTA
As stated in the preamble to the interim final rule, the
KWTA was enacted due to health and environmental concerns arising
from medical waste. These concerns included the degradation of
shoreline areas from wash-ups of waste, particularly in
Connecticut, New Jersey, and New York during the summer of 1988.
Public safety concerns were created by reports of careless
management of medical waste, such as in open dumpsters. The Act
was intended to be a first step in addressing these problems.
The primary objective of the MWTA is to ensure that
regulated medical wastes which are generated in a Covered State
and which may pose environmental (including aesthetic) problems
are delivered to disposal or treatment facilities with a minimum
of exposure to waste management workers and the public. The
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Agency issued interim final rules on March 24, 1989 that
established a regulatory program to accomplish this objective.
The tracking rule itself helps to ensure that waste reaches the
proper destination since it requires accounting of all waste
transported, and makes effective civil and criminal sanctions for
violation. Additionally, the regulations will ensure that
regulated medical wastes will be packaged securely and labeled
and marked. Proper packaging reduces the chances of waste
handlers and the public being exposed to these wastes. Labeling
and narking ensures easy identification of regulated medical
waste will help deter the improper management of the waste and
make it more likely that the waste will be handled with greater
care than general refuse.
However, the specific requirements in the tracking rule may
not significantly reduce the amount of medical waste deposited on
beaches, which was the principal concern behind the Act. The
MWTA does not address several sources of medical waste which are
known to contribute significantly to beach waste wash-ups. These
sources include household medical care and intravenous drug use.
It would not be appropriate to judge the success of the
demonstration program in tracking medical waste, based solely on
the amount of medical waste washing up on beaches. The Agency
intends to evaluate the success of the overall program (both
regulatory and nonregulatory) in:
tracking and managing medical wastes that fall within
the scope of the Act, i.e., wastes from institutions
and commercial sources.
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addressing the medical waste problem in general, i.e.,
beach wash-ups, mismanagement of home health-care
wastes.
collecting and evaluating information to better
understand the problem.
4.2 Measuring Effectiveness
Demonstration Program Operations
The first set of criteria to measure success concentrates on
the operations of the demonstration program. The program's
primary focus is on medical waste handled off-site in Covered
States. Four areas are discussed: State participation,
compliance, regulatory analysis, and recreational and
occupational injuries. For each area, the information the Agency
plans to report on in subsequent reports is described. In
addition, information currently available is provided.
State Participation
The KWTA is designed to be implemented jointly by EPA and
the States. EPA was directed to establish a program for tracking
medical waste and to list the types of medical wastes to be
tracked. Participation in the demonstration program was
determined by the States. The ten States covered in the MWTA
(New York, New Jersey, Connecticut, and the States contiguous to
the Great Lakes) were in the demonstration program unless they
opted out. New York, New Jersey, and Connecticut could only opt
out if they had implemented a medical waste tracking program that
was no less stringent than the federal program/ while the Great
4-3
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Lakes states could opt out by making a written reo^Jest. All
other states had the opportunity to be included in the
demonstration program by petitioning the EPA Administrator.
The Great Lakes States all opted out of the program. The
major reasons why the Great Lakes states opted out are that they
had already enacted or were in the process of enacting state
programs tailored to their specific needs, and that they had
limited funding available to implement the relatively low
priority program.
Many of the Great Lakes states were already well on their
way to developing or implementing regulations that they believed
to be more appropriate for their respective states. (Tracking
mechanisms vary from an eight part form in Pennsylvania to no
tracking mechanism in Connecticut, Indiana, Michigan, Minnesota,
Ohio, Pennsylvania, and Wisconsin.) States voiced concern that
new Federal requirements would conflict with existing state laws
and regulations; also, they felt it would be difficult to get
their legislature(s) to repeal existing State regulations to
enact a program of short (two years) duration.' A general
concern was that the cost to implement the federal regulations
(e.g., the tracking form) would be more costly than the program's
benefits justified. Nonetheless, the Act seems to have
encouraged a great deal of legislative and regulatory activity in
the Great Lakes states. In addition, Rhode Island and Puerto
Rico decided to opt-in to the program.
The success of the demonstration program is dependent on
strong state implementation of the program. The demonstration
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program cannot be accurately assessed without taking into account
the implementation activities of the States. In subsequent
reports, the activities undertaken by each Covered State will be
briefly described.
Compliance
The extent of compliance with the tracking program may have
a significant effect on the demonstration program's success, and
it would be very difficult to assess the impact of the program if
ncncompliance is widespread. Generators' compliance with
packaging requirements will affect public and worker exposure to
medical waste. Exception and discrepancy reports are essential
for EPA to investigate stray shipments and deter illegal dumping.
EPA will work with the participating States to determine what
parts of the rules have been difficult for parties to comply with
and for EPA and States to enforce. In order to determine the
extent of compliance, EPA and the states will be conducting
inspections of generators, transporters, and disposal facilities
and will collect information on the number of inspections, number
of violations, number of enforcement actions, number of penalties
assessed and collected, and number of exception/discrepancy
reports.
Regulatory Analysis
EPA has undertaken an on-going effort to evaluate the
interim final regulation issued on March 24, 1989. Several parts
of the rule (for instance, the definition of medical waste
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subject to the tracking requirements) are based on EPA's best
technical judgment. EPA will consider whethar the regulations
should be clarified or otherwise modified during the life of the
program.
Public comments were sought when the interim final rule was
promulgated. Some of the comments may provide additional
information and recommendations relevant to an evaluation of the
demonstration program. In subsequent reports, EPA will evaluate
these comments and other information and expert opinion on the
extent to which of the regulations created a successful program.
Recreational and Occupational Injuries and Disease
The demonstration program has the potential to decrease
recreational and occupational injuries. First, a larger quantity
of medical waste will be packaged securely, reducing the chances
that waste handlers and the public are exposed to medical waste.
Second, the identification of medical waste (labels, marking
tags, tracking form) should help deter the improper management of
the waste and make it more likely that the waste will be handled
with appropriate care. The analysis of public comments will
allow EPA to determine if its interim final standards are
adequately protective, and the analysis of compliance will
indicate the extent to which exposure is actually reduced.
In addition, documentation from the analysis and information
gathering process conducted by ATSDR under Section 11009 may
provide relevant findings. For example, the information on the
number of people injured by sharps and the nature of those
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injuries may suggest ways the demonstration program could be
modified to reduce such injuries. In subsequent reports, these
and other sources of information will be evaluated to determine
improvements in public health protection due to the regulations.
Overall Medical Waste Management
There are certain limitations in evaluating the
demonstration program against measures that involve the overall
management of all medical wastes. For instance, the
demonstration program only applies to certain medical wastes
generated in Covered States; household waste is excluded; waste
from illegal intravenous drug use is not addressed; and
treatment/disposal practices and impacts (such as air emissions)
are not covered under the authority of the program. Because
"medical waste" as defined under RCRA excludes domestic sewage,
the RCRA medical waste program does not require generators to
track medical waste that is disposed to the sewer. As a result,
the tracking program will not directly produce data on the
quantity of medical waste discharged to the sewer or detect any
shift to using the sewer for disposal. Generators of less than
50 pounds per month of regulated medical waste are exempted from
the full tracking requirements. Chapter 11 describes in more
detail issues and concerns regarding regulated medical waste from
small quantity generators and households. Despite these
constraints, it is still appropriate to consider the impact of
the demonstration program generally on medical waste management,
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including beach wash-ups/closings and treatment/disposal
practices.
Beach Wash-ups/Closings
This is an imprecise measure of success for the
demonstration program, since not all the waste wash-up will be
addressed within the scope of the demonstration program.
However, one of the principal concerns behind the MWTA was the
beach closings caused by the wash-up of medical waste. The
Agency plans to take several actions to evaluate the impact of
the demonstration program on beach wash-ups/closings.
EPA will continue the beach wash-ups study started in
1988 for six states—Connecticut, Maryland,
Massachusetts, New Jersey, New York, and Rhode Island.
This study is an inventory which includes the following
data: date of wash-up, state, beach location, and
quantity and type of medical waste.
The majority of the medical waste reported in the 1988
inventory is syringe-related waste. The Agency will in
1989 and 1990 analyze samples of the syringe-related
wastes in order to attempt to determine their source.
Possible sources include those covered under the
demonstration program (hospitals, physicians, dentists,
etc.) as veil aa sources outside the scope of the
program (household use, intravenous drug use).
Subsequent reports will also summarize other beach
wash-up related studies that may be available.
The next interim report will include information from the
1989 summer beach season, while the final report will include
studies from the 1990 season.
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4.3 conclusions on the Success of the Demonstration Program
In the next two reports, EPA will describe the success of
the demonstration program in tracking and managing regulated
medical waste, based on information available on state
participation, compliance, regulatory analysis, recreational and
occupational injuries, and beach wash-ups/closings.
EPA will assess the overall merits of the demonstration
tracking system, in light of the shifts in monetary and
nonmonetary costs to various affected groups, and its usefulness
as a potential national program.
EPA will also assess other benefits of the program such as
increases in public awareness, changes in perceptions of the
health and safety risks of handling wastes or visiting the beach,
and collection of information that will allow for a better
understanding of the program. Because the demonstration program
is only one of a number of lavs enacted to address beach wash-
ups, it is not entirely appropriate to judge the medical waste'
tracking program's success based on restored public confidence in
beach-going. However, EPA will note veil-documented changes in
public risk perceptions for Congress' information, in future
reports.
4.4 Treatment/Disposal Practices
Section 11008(a)(4)(B) requests information on changes in
incineration and storage practices attributable to the
demonstration program. These waste management changes may affect
patterns of public and worker exposure to the waste. For
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instance, increased on-site incineration to avoid costs
associated with tracking wastes shipped off-site, reduce
exposures associated with waste pick-up and off-site handling,
but result in greater exposure of patients and nearby residents
to the incinerator emissions. The transporter and incinerator
reports required by subsections §§259.62 and 259.78 will indicate
some changes in incineration and other management methods during
the demonstration program. In future reports, EPA will attempt
to evaluate the relationships between these management changes
and public/worker exposure.
4.5 Available Tracking Methods
Section 11008(a)(4)(C) requires EPA to report on other
available methods for tracking medical waste. Currently, there
exist a significant variety of shipment management systems that
are being implemented by industry and commerce. The types of
such systems range from the basic shipping paper and multiple-
copy manifest systems to automated systems implementing bar codes
and automated optical scanners to monitor and record transfer and
movement of materials. Other divergent approaches exist as well;
strict regulation of transporters, for example, is one potential
solution to effective management of regulated wastes. The Agency
has, in the past, implemented several tracking-type systems to
assist in the implementation of its environmental regulations,
and in selecting those methods has reviewed a range of
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alternative systems to those utilized. For tracking medical
waste, EPA has developed and is implementing a system which will
effectively monitor regulated medical waste
transactions;
assure all parties involved of the waste's proper
management; and
meet all requirements set forth by Congress.
Current Practices
Medical waste shipments have been managed and tracked more
recently using a variety of methods. The methods employed depend
on the individual state and local regulations and the transporter
involved in the movement of the material. The State of Illinois,
for example, has regulated infectious wastes originating at
hospitals as "Special Wastes" which require the use of a 6-part
manifest and the submission of signed copies to the State
regulatory agency. The States of New York and New Jersey have
required the use of special 4-part manifest forms since their
Emergency Rules went into effect in August of 1988; copies of the
form are not sent to the states under this approach. The State
of Pennsylvania is proposing to implement an 8-part tracking form
utilizing the uniform Hazardous Waste Manifest. These state
tracking requirements are discussed in more detail in Chapter 8.
Independent transporters have, in some instances, taken it
upon themselves to implement various forms of medical waste
tracking for a variety of reasons, including client reassurance,
compliance with other States' regulations, attempts to reduce
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their potential liabilities, or simply to facilitate business
transactions such as billing.
The Medical Waste Tracking System
The Agency has developed a medical waste tracking system for
implementation in the demonstration program which is based upon a
standardized multiple-copy manifest-type fora. The tracking fora
is similar in format to the Federal Uniform Hazardous Waste
Manifest (UHWM) required for the transport of hazardous wastes,
and the medical waste manifest forms used by New York and New
Jersey. It provides the necessary paper trail to document the
transport and transfer of individual shipments of regulated
medical waste from the point of generation to the designated
point for treatment, destruction, or disposal, but the system
does not require copies of the form to be sent to state
regulatory agencies.
Alternative Tracking Systems
Currently, there are a range of other shipment management
systems that are being implemented or in development. Systems
range from the basic shipping paper for an individual package to
advanced on-time surveillance techniques to trace the minute-by-
minute movement of the vehicle and its contents. In general, the
available and potentially-available systems applicable to medical
waste tracking fall into three basic categories: (1) paper-based
documentation; (2) computer-based documentation/tracking; and (3)
real-time tracking systems. Additionally, in a more
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retrospective approach, there are several methods for tracing
wastes once they have been mismanaged.
Paper-Based Systems
To date, EPA has relied on paper-based tracking systems.
Paper-based documentation is the most prevalent method currently
in use today in commerce and includes the employment of shipping
papers, coupons, multiple-copy manifests, and tracking forms,
among others. Generally, this type of system monitors shipments
every tirae there is a transfer to another party. These systems
have been developed and refined to suit the requirements of their
intended applications:
Shipping papers or bills of lading are commonly employed in
the transport of commercial goods, including DOT-designated
hazardous materials. Such forms serve multiple purposes by
providing documentation of the material or goods being
shipped, special handling information if required,
destination information, and a record of receipt for the
transporter when signed off by the receiving party;
additionally, billing information may be included.
coupon systems are currently employed on the state and local
levels for documenting municipal waste disposal. New Jersey
has developed and implemented such a system; it enables the
State to track the origin and volume of municipal waste, as
well as its actual destination. The licensed hauler
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completes one part of the state-provided coupon form with
company identification and shipment origin information; a
breakdown of the waste load by municipality and volume is
completed on the reverse side of the coupon. Upon delivery
to the disposal facility, the facility operator completes
its section of the coupon, and retains that portion as a
record. The hauler retains the other portion for its own
recordkeeping. Other coupon systems are used on a smaller
scale for recordkeeping and to facilitate charging for
deliveries of municipal-type wastes to local landfills.
Multiple-copy manifest* and tracking forms are currently in
use on a broad scale. The Uniform Hazardous Waste Manifest
(UHWM) system for hazardous waste shipments has been in
place since 1984. It incorporates a four-part minimum form
which provides all parties that handle a hazardous waste
shipment with a copy for their records, with an additional
copy for the receiving facility to sand back to the original
generator upon receipt of the shipment. An integral part of
the UHWM system is the requirement for discrepancy reporting
by facilities, recordkeeping, and exception reporting
(reports of "stray" shipments) by generators. The multiple-
copy system produces a well-documented paper trail (chain-
of-custody) which allows an individual waste shipment to be
tracked from its site of generation to its destination.
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Pre-notification systems are based on the premise that an
anticipated shipment that does not arrive is suspect, and is
investigated by the receiving facility. In theory, actual
tracing of individual shipments need only be carried out for
those shipments, and not for all other scheduled deliveries
that arrive intact and on-time. Currently, EPA's Office of
Toxic Substances is proposing a manifest system for
polychlorinated biphenyls (PCBs). which incorporates a pre-
notification procedure. Under the proposed system,
generators intending to ship PCBs are required to submit an
advance notification to the destination facility that a PCB
shipment is scheduled. A copy of the corresponding manifest
form must be forwarded as well. This action alerts the
receiving facility to prepare for the shipment's arrival and
to initiate investigation if the shipment does not reach the
facility within the allotted time period. Similarly,
utilities intending to ship spent nuclear fuel for long-term
storage must complete a multi-step advance notification
process for their shipments.3
Computerized Documentation/Tracking
The advent and prevalence of computer technology has
provided the opportunity for development of computer-based
tracking systems. Proprietary automated computer manifesting,
tracking and report systems for shipment of hazardous waste and
low-level nuclear materials for generators, transporters, and
receivers of such materials have been developed. As updated
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information is entered by each party handling a shipment, a
centralized computer system can generate manifests, maintain
manifest information and track progress of shipments. Some of
these systems can be programmed to submit reports automatically
to regulatory agencies.
Other types of available computer-driven systems rely on the
use of bar coding and optical scanning equipment. Currently,
such technology is used by industry in a quality control
capacity. Producers of health care products may identify their
products by product number, lot number, and production date
through the use of bar codes and use optical scanners to record
product information throughout the numerous manufacturing and
handling stages. Combined with centralized computer systems,
these systems facilitate the management of inventory and shipment
information and enable the producers to remove expired or
recalled stock. These computerized methods have application to
the management and control of medical waste shipments through
centralized tracking of individual packages. For example, one
company has had a similar system in-place for the past two years
which records shipment information for its medical waste
transport activities.' The system uses a combination of bar code
labels and optical scanners and is supported by personal
computers.
Tracking Systems
Another advancing concept currently employed is that of
"real-time" management. Real-time information can provide the
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user with an up-to-the-minute monitoring and status reports of
the subject of interest, whether it is a package or an entire
vehicle. This system allows constant surveillance. Overnight
delivery services implement advanced, state-of-the-art systems
like this to manage, track and trace individual parcels across
the U.S. and elsewhere. These systems combine time-saving
equipment such as bar code readers with portable data collection
units and on-board computer/transmitters, configured to send
shipment data to a collection and processing point and a
centralized computer system. The system can trace an individual
package at any point along its route and verify its delivery to
the designated address. Inventory, time-tracing, lost parcels,
and invoicing are all greatly facilitated by this system. Such
systems have been considered as a realistic option to provide
real-time data systems for the movement of radioactive wastes.
In addition to computer-based systems, the plausibility of
employing satellite surveillance of high-risk shipments is also
being investigated.9
On a smaller scale, a similar system has been installed by
one blood supplier for tracking donor blood throughout its
product life. Blood bags that have been distributed that were
provided by a disqualified donor can quickly be removed from
circulation before they are utilized.
Tracing
While medical waste tracking systems may be necessary to
ensure the appropriate management and disposal of such material
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and to provide a reliable record of these transactions, there are
a variety of "after the fact" aste tracing techniques which, in
conibination with tracking, may assist in the enforcement of
nedical waste regulations. Such techniques may also deter others
from mismanaging these materials.
Floatable identification tags are required by the State of
New York to be included by the generator in each bag of
infectious waste it disposes off-site/ If the material is
improperly disposed on land or in the water, the tags assist the
investigator in identifying the source of the waste.
Confetti-style identification tags have been proposed as a
method for identifying parties responsible for mismanaged medical
waste. This technique involves the inclusion of multiple, small
identification tags in each package of medical waste to be
disposed of off-site. If the tags are found in mismanaged waste
or washed up on a beach, an investigation can be initiated. The
number and small size of the tags could deter anyone from
attempting to remove them prior to improper disposal/
Micro-coded particles have been developed which can be used
to mark materials or individual items for positive product
identification. One product utilizes combinations of unique
color-coding schemes which are then assigned to each individual
source. The smaller sized particles can be spray-applicated to
mark products subject to theft and are included in commercial
explosives to allow tracing of their illegal use by
identification of manufacturer, lot, batch, type, etc.* Such a
system may be applicable to medical waste either by including
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coded particles in each package or spraying the liquid form. An
investigator could identify the source of whole packages or
individual items such as syringes that would not be traceable
otherwise.
Product coding/recordkeeping using ink-jet coding of
products with alphanumeric or bar codes during manufacturing nay
be used to trace sources of mismanaged medical waste. Currently,
such coding has been used on consumer products ranging from beer
cans to non-prescription drugs, primarily for inventory and
quality control. Use of such coding schemes by manufacturers
could allow the tracking of a product from its point of
generation or production through to disposal. Very sophisticated
recordkeeping processes would be required to implement this
system.
4.6 Advantages/Disadvantages
This section briefly describes some of the advantages and
disadvantages of the various tracking approaches that have been
described above.
Paper-based systems have been the standard by which most
commodities and other regulated materials are managed and tracked
in transit. Advantages for these, other than their prevalence,
are the relative low implementation and maintenance cost,
simplicity in use, and, for multiple-copy forms, the existence of
a copy for recordkeeping. Disadvantages vary with the specific
systems but generally include the susceptibility to human error
either in completion or in handling; furthermore, record
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maintenance and data summaries are labor intensive and time-
consuming. Pre-notification may require the provision of
additional forms which must be handled and processed, six or
eight-part manifest forms which provide copies for submission to
regulatory agencies can require a time-consuming, labor intensive
process to match up corresponding copies. Other, simpler paper-
based tracking approaches such as the basic shipping paper may
not provide the necessary control for high-risk material
shipments.
Computer-based tracking systems are less well-characterized
since they have only recently been implemented to any significant
degree in a regulatory capacity. Advantages include a potential
reduction of human error, both in data input and direction of
shipments and corresponding documentation. These methods can
save time and reduce the labor required for processing status
reports and recordkeeping. Disadvantages include the significant
start-up, as well as maintenance costs for advanced systems, the
significant training of personnel to use these systems, and the
potential for breakdown and resulting "down" time.
Real-time systems, which are a subset of the computer-based
systems, have similar strengths, and may provide excellent
shipment monitoring and tracking of individual packages or entire
shipments, with the capability for immediate tracing when
necessary. These systems can provide the user and the regulatory
official with immediate status reports of shipments and can save
time if corrective or enforcement action becomes necessary. In
addition to the disadvantages cited for the computer-based
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systems, the real-time concept requires a high degree of
cooperative effort and extensive implementation to operate
effectively.
Tracking System Evaluation
The Agency has historically relied on paper-based tracking
and tracing for regulation of materials transportation. The
record of these efforts has been documented. During the
demonstration program, EPA will evaluate the effectiveness of the
medical waste tracking form system to monitor regulated medical
wastes adequately from their point of generation to their
destination. During this evaluation process, there will be
sufficient time to examine other available alternatives for
tracking medical waste more thoroughly. EPA will evaluate the
potential success each system would have in tracking regulated
medical waste; EPA will also assess the systems' use in rural
areas, and use by small quantity generators as required under
H008(a) (4) (C) .
The Agency evaluation will be organized as follows:
Systems identification will continue so that we can evaluate
a comprehensive set of systems with potential application to
the management of medical waste. Currently, the more
prevalent or better advertised systems are known to the
Agency; other systems may exist and need to be identified
and reviewed.
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Information collection will be instituted to create an
adequate base on which to evaluate each of the systems.
Contact with users and designers of the systems will provide
an additional valuable source of this data.
Development of evaluation methods will determine the
criteria to measure and rate the systems. Presently, a
number of criteria are considered crucial to the analysis:
COST: The projected cost of each system, both in terms
of implementation costs, start-up costs and maintenance
costs, is a significant issue. The evaluation will
attempt to identify all direct and indirect costs
associated with each alternative system to understand
the potential cost-effectiveness of each. Other
criteria described below are directly tied to the issue
of costs.
IMPLEMENTATIONi The ease and speed of implementation
of each tracking system is of significant importance.
New methods and different technologies will necessitate
greater effort and time than those methods that are
currently in use. Tracking regulated medical waste can
only be effective if the system is operating
efficiently.
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LEVEL OP EFFORT: The level of effort necessary to
implement and maintain a tracking system is directly
tied to the issue of cost. More complex and labor-
intensive systems will require added degrees of
manpower and time, which will be directly reflected in
the associated costs.
SKILL/TRAINING REQUIREMENTS: Each system will be
evaluated on the basis of the level of special skill or
training that individuals will require in their day-to-
day operations. The more basic and familiar systems
will necessarily require less specialized skills. In
addition to affecting the regulated community, the
individual tracking system will impose varying degrees
of specialized skill requirements for regulators
monitoring and enforcing the medical waste program.
ENFORCEMENT: The nature and basis of each alternative
tracking system will directly affect its enforceability
by the Agency and other regulatory agencies.
Effectiveness of a tracking program will be directly
related to the actual or perceived extent of
enforcement against illegal activities. Therefore, the
Agency will evaluate each by an appraisal of the
regulatory community's capability to monitor and
respond to prohibited activities involving regulated
medical wastes.
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EFFECTIVENESS: The Agency will proceed with a
comprehensive analysis and projection of the potential
effectiveness each system would have if implemented for
the tracking of regulated medical waste. EPA will use
the information concerning past and current experience
with the tracking systems implemented to date.
The criteria, as developed, will be applied equally to all
identified tracking methods to identify the relative
advantages and disadvantages of each.
The comprehensive evaluation of tracking systems will
require a thorough analysis of the medical waste tracking system
that has been developed and implemented in the demonstration
program. The demonstration program will provide an opportunity
to analyze the tracking system's effectiveness in both rural and
urban settings and to analyze the effects of including small
quantity generators in the tracking system. The format of the
analysis and evaluation will include a comparison of the relative
advantages and disadvantages of each identified tracking system.
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4.6 References
1. U.S. Environmental Protection Agency. Summary of meeting
vith Great Lakes States. Memorandum from P. Mushovic,
Washington, D.C., May 1989.
2. Thompson, J.R. Letter to William Reilly. April 21, 1989.
3. U.S. Congress, Office of Technology Assessment.
Transportation of Hazardous Materials, OTA-SET-304,
Washington, D.C., 1986.
4. Telephone communication with M. Lease, SAIC, and Jacquelyn
Flora of Browning-Ferris Industries, May 1989.
5. Ref. 1.
6. U.S. Environmental Protection Agency, Office of Solid Waste.
Background Document, Resource Conservation and Recovery Act,
Subtitle J - Demonstration Wedical Waste Tracking Program,
Section 11003 - Tracking of Medical Waste, 40 CFR Part 259,
Subparts E - J. Washington, D.C., 1989.
7. Grayson, M. Letter to Jonathan Cannon. April 16, 1989.
8. Kerns, w. Letter to Denise Zabinski. August 11, 1988.
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CHAPTER 5
HEDICAL WASTE HANDLING METHODS
5.1 Introduction
Section 1100B (a)(5) of RCRA as amended by the Medical Waste
Tracking Act (MWTA) of 1988 requires that EPA describe the
available and potentially available methods for handling,
storing, transporting, and disposing of medical waste and the
advantages and disadvantages of these methods. This chapter
addresses packaging, which includes labeling and narking; on-site
storage; off-site transportation; and disposal to landfills,
sanitary sewers and the ocean. (Treatment of medical waste is
discussed in the following chapter.) The term "handling" will be
used to describe generically any or all of these practices.
Section 5.2 describes current handling practices likely to
be in use in states not participating in the demonstration
program. Some of this information is based on site visits in New
York and New Jersey before the 40 CFR Part 259 regulations were
promulgated. Sections 5.3 - 5.5 describe the standards
implemented in the rule, emerging or alternative handling
techniques, and potential methods for evaluating medical waste
handling practices.
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5.2 current Practices
Handling and Packaging Practices
Medical waste handling methods, e.g., packaging, depend
largely upon the disposal method or location of the disposal
facility, and the existence or lack of state and local
regulations. This section describes the handling methods that
are currently used to prepare medical waste for transport off-
site for incineration, transport off site for land disposal,
disposal or incineration on site, sewer disposal, and ocean
disposal.
for Off-Site Incineration
Medical wastes destined for incineration off-site, excluding
sharps and fluids, are generally packaged in plastic bags at the
point of generation. These bags are either red in color or
labeled with a biohazard symbol for identification. The waste
nay be single- or double-bagged. The weight of the waste often
determines whether one or two bags are used.'
Waste that is transported by commercial haulers is usually
consolidated and prepared for off-sita transport in cardboard
boxes and/or in reuseable bins, drums, etc. Vehicles used to
haul the waste may or may not be compactor trucks, depending on
existing state or local regulations. In addition, secondary
containers or additional packaging may be required by state or
local regulations, or by the disposal facility. Waste
transported by the generator is not always as carefully packaged
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and may not be placed in a secondary container.33 Medical waste
generated in laboratories is typically autoclaved prior to
packaging and transport off site to an incinerator.
Medical waste is sometimes compacted prior to packaging or
transport. A survey conducted in King County, Washington found
that 31% of the hospitals surveyed compacted sharps and liquid
wastes. Other generators (medical offices, laboratories, and
veterinary offices) did not compact sharps or liquid wastes.4
Sharps, such as needles, scalpels and syringes, which may
pose a threat to worker safety, are commonly contained in rigid,
puncture-resistant sharps containers as the primary packaging.
The majority of hospitals and other medical facilities use such
sharps containers.1' The practice of clipping the sharps for
disposal has become less common because of the risk of needle
stick injuries.' Other types of glassware are typically placed
into plastic bags which are then placed into rigid cardboard
containers or reusable drums or bins.
Liquids that are not sewered are commonly contained in
rigid, break-resistant containers. Some auctioned fluids are
suctioned directly into rigid plastic disposable containers.
Small quantities of liquids from lab specimens (such as blood
vials) are often poured directly into plastic bag(s) and then
placed in a box or other container.'
For Landfill Disposal
The majority of medical waste is transported off-site for
disposal in municipal landfills. The waste is typically packaged
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in plastic bags and handled as general municipal solid waste
(placed in a dumpster until transport and sometimes compacted).
In states or localities where only treated medical waste can be
landfilled, the regulations usually specify a method such as
steam sterilization. This waste, destined for landfill disposal,
is often packaged on site in autoclavable (e.g., polypropylene)
bags, decontaminated, and then handled as general solid waste.
For On-Site Treatment or Disposal
Facilities with on-site treatment and disposal capabilities,
e.g., incinerators, are primarily concerned with packaging
medical waste to ensure worker safety. Single or double red bags
are often used; however, less care is taken to segregate medical
wastes from other .wastes. The medical waste is rarely placed in
secondary containers or marked, and is often moved about the
facility in open carts.
For Sever and Ocean Disposal
EPA considers sanitary waste that passes through a sewer
system to be "domestic sewage," which is excluded from the
definition of solid waste under RCRA Section 1004(27). In
addition, EPA interprets the domestic sewage exclusion to include
mixtures of sanitary wastes and other wastes that pass through a
sewer system leading to a publicly owned treatment works for
treatment [see 45 FR 33097, May 19, 1980], Such mixtures are not
"solid waste," and thus are not "medical waste" under RCRA once
they enter the sewer system that will mix them with sanitary
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wastes prior to storage or treatment by a publicly owned
treatment works. Some body fluids resulting from medical
procedures such as surgery, or from autopsy, are suctioned and
discharged directly into the sewer system.' Others are placed in
temporary holding containers and then poured into the sewer
system. Recent amendments to the Federal Water Pollution Control
Act (contained in Public Law 100-688) may affect these practices;
in addition, state or local requirements may also affect these
practices.
Ocean disposal of medical waste is prohibited or restricted
as a result of the United States Public Vessel Medical Waste
Anti-Dumping Act of 1988, the Marine Protection, Research and
Sanctuaries Act of 1972, and the Act to Prevent Pollution from
Ships. The U.S. Navy has altered handling practices and is
presently evaluating methods that treat, compact, package and
store ship-generated medical waste on board, or that treat and
destroy medical waste, thereby allowing its disposal at sea.
Storage
Medical waste that is transported off-site for disposal may
be stored in indoor or outdoor storage areas. The location and
capacity of a storage area depends on the quantity of medical
waste generated, the frequency of pick-ups, urban versus rural
location, and whether on site or off site disposal will occur.
Facilities that generate large volumes of waste and/or are
located in urban areas often store the waste inside and have
frequent pick ups due to limited storage capacity. A facility
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with fewer pick-ups may prefer to store the waste outdoors for
aesthetic reasons. Storage time can vary from less than 6 hours
to one month, or "as needed."10
Medical waste intended for on-site treatment (e.g.,
incinerator) is generally stored in rooms near the incineration
facility. Outdoor storage is less common, except where space may
be a problem. In a small, rural hospital, for example, storage
may be more convenient outside even if the waste must be brought
inside again for treatment. Some storage areas have a lock
and/or limited access." IJ
In general, wastes that may become putrescant quickly (e.g.,
bulk pathological wastes) are stored in refrigeration units until
transport or treatment."
Transport
Trucks are the most common type of vehicle used to pick up
and transport medical waste. New York's municipal solid waste is
sometimes transported by barge. Small vehicles similar to vans
are used to pick up small quantities of medical waste from
individual practitioners. Dump trucks are sometimes used in
rural areas. Flat-bed trucks are also used when the waste is
stored in large containers (roll on - roll off) which can be
removed from the facility for transport to a disposal facility.
Compactor trucks are used when landfills allow such disposal.
When medical wastes are hauled long distances to disposal sites,
tractor trailers are often used. Some haulers also employ
refrigerated trucks for transport; however, this is not an
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industry-wide practice. EPA does not believe rail transport is
used for medical waste transportation except when such waste is
included in municipal solid waste. One railroad presently moves
some municipal solid waste from East Coast states to the Midwest
for disposal. '*
Commercial transporters are commonly used to haul medical
waste off site for incineration (or for other disposal in
addition to landfilling). Commercial transporters are especially
popular in urban areas where they can make several pick-ups in a
snail area.'1
The practice of shipments of sharps via the U.S. Postal
Service and specialized sharps transporters has been growing and
is gaining in popularity for generators of small quantities of
sharps. With respect to the specialized transporters, the
generator is typically supplied with containers in which the
sharps can be packaged for transport to a final disposal
location. These transporters typically serve small generators
(e.g., nursing homes and physicians) although the practice is
expanding to larger generators such as hospitals."" In New
Jersey, a pharmacy that supplies Pharmaceuticals and sharps to
nursing homes has engaged in collecting and transporting the used
sharps for disposal."
Generators of small quantities of waste or generators in
rural areas are more likely to transport waste to the disposal
facility themselves. Generators of small amounts of medical
waste, e.g., individual practitioners, often transport the waste
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to a larger generator (a hospital or laboratory) who in turn
disposes of or arranges for the disposal of the waste."
Landfill Disposal
Most medical waste that is not incinerated, and ash from
incineration, is disposed in landfills. While infectious medical
waste is often treated (steam sterilized) prior to landfilling,
depending on state and local regulations, several types of
generators dispose of small quantities of untreated medical waste
directly in landfills."
A landfill operator's self-imposed restrictions may also
determine what is disposed of and how the waste is handled. For
example, landfills serving urban areas sometimes do not accept
certain wastes from medical waste generators, even though they
are allowed to under existing state or local laws.3' Where
capacity is less of a problem, e.g., in rural areas, there are
generally more liberal policies about accepting waste. The
controls that the landfill places on medical waste directly
affect generators, and cause them to adapt to the standards set
by the landfill operator.
5.3 Standards Implemented by the Rule
The regulations, promulgated at 40 CFR Part 259, address
current required handling methods of medical waste through
standards for segregating, packaging, storing, labeling, marking,
and transport of the waste.
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Segregation
Section 259.40 requires generators to segregate sharps,
(including sharps containing residual fluids) and fluids (in
quantities greater than 20 cubic centimeters), from other
regulated medical waste to the "extent practicable" if the waste
is intended for off-site transport and disposal.
Packaging
The packaging requirements are designed to protect waste
handlers and the public from exposure to regulated medical waste.
General requirements for packaging regulated medical waste have
been established in 40 CFR 259.41. Prior to off-site transport,
regulated medical waste that is not "oversized" must be packaged
in rigid and leak-resistant containers that are impervious to
moisture, sufficiently strong to prevent tearing or bursting
under normal handling, and sealed to prevent leakage during
shipment.
Sharps must be packaged in containers that meet the above
requirements, and that are puncture-resistant as well. Fluids in
quantities greater than 20 cubic centimeters must be packaged in
containers that meet the above requirements, and are also break-
resistant and tightly lidded or stoppered. Reusable containers
are permissible; in many cases, containers that can be loaded on
pallets and mechanically moved can be used, as long as the
containers are not subjected to undue stress or compaction during
transport, loading and unloading.
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while EPA d not establish specific requirements for
oversized medical waste, EPA recommends that these wastes should
be managed in a manner that protects the handler and the public
from exposure.
Labeling
Section 259.44 requires generators to label packages
containing untreated regulated medical waste with the words
"infectious waste" or "medical waste," or with the universal
biohazard symbol. Each layer of packaging or container used to
meet the packaging requirements must be so labeled. Treated
medical waste does not require a label on the package.
Marking
The outer surface of all regulated medical waste containers
that are used to meet the packaging requirements must be marked
to identify the generator, if the waste is transported off-site.
The outermost surface of the outermost container must also
identify the transporter(s) and the date of shipment. The
markings must be water resistant. Other markings such as bar
codes are also allowed. Markings are required by Section 259.45
to help identify those persons responsible when waste that has
been mismanaged or improperly disposed is found.
Storage
Medical waste stored on site prior to off-site transport or
on-site treatment or disposal must be (1) stored in a manner and
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location that protects the integrity of the packaging; (2)
afforded protection from water, rain and wind; (3) maintained in
a non-putrescent state; (4) stored with access limited to
authorized employees; and (5) protected from animals. If stored
in outside storage areas, the regulated medical waste oust be in
units such as dumpsters, sheds, and tractor trailers that are
locked to prevent unauthorized access.
Transport
Section 259.73 specifies that regulated medical waste must
be transported in a leak-resistant, fully enclosed, cargo-
carrying body that is maintained in good sanitary condition.
Compaction of packaged waste must be avoided because it can
destroy the packaging, markings, and labels and increase the
potential of exposure to handlers or the public from regulated
medical waste.
5.4 Evolving Handling and Management
Handling
A variety of new types of containers are being developed in
which sharps can be directly placed and contained for shipment.
These include both fiberboard boxes and plastic containers. The
advantages of these types of containers is that they can be
closed, limiting exposure in the event of mishandling, and are
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rigid and leak- and puncture-resistant, other management and/or
containment systems will be addressed in the next interim report
that could minimize the handling of bags and other containers by
healthcare workers and waste handlers.
Harking
Evolving methods of marking medical waste to identify its
source include the use of bar codes and optical scanning
equipment or readers. Bar code systems (discussed in greater
detail in Chapter 4) are useful only to individuals capable of
decoding the information; otherwise, they are not an effective
method of identifying the generator or transporter of waste. New
York has required generators to place floatable tags in each
package of waste in order to identify the generator of the waste
washed up on a beach. Other tracing or detection methods with
potential application include confetti sized markers or tags or
micro coated particles, as discussed previously in Chapter 4.
Compaction
Compaction of medical waste during or prior to packaging is
discussed in Chapters 6 and 7 because it is a method that reduces
the waste's volume. The regulations at 40 CFR 259.73 prohibit
compaction of containers of regulated medical waste during
loading onto a transport vehicle, during transit, and during
unloading. However, systems exist within hospitals in which
unpackaged and/or untreated medical waste is being compacted into
bulk containers prior to transport off site. Some of the systems
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in use are capable of loading compacted waste in bags into a
dumpster, incinerator or truck without direct handling of the
bags. However, potential problems for the haulers and
destination facilities may exist when the bags are unloaded from
a truck during final disposal.
The Department of Defense (DOD) is presently evaluating
various treatment and compaction options to contain and store
medical waste while vessels are at sea. Compaction could be
beneficial in urban areas where both storage space and disposal
location are problems; however, EPA believes that certain
untreated medical wastes should only be compacted if the
compaction takes place in a closed chamber which eliminates the
possibility of exposure to infectious agents through aerosols.
Transport
Systems are evolving which minimize handling of regulated
medical waste by the healthcare worker and waste handler.
Automated systems are available that will treat, compact, and
package waste placing it directly in bins that can be
mechanically loaded and unloaded, thus avoiding direct handling
by the healthcare worker. System applicability depends on the
amount of waste generated, existing management techniques and
their acceptance, and the facility's ability to meet new capital
and operational and maintenance costs.
Rail shipment may be evolving as an alternative to transport
by truck. Although EPA cannot cite a specific instance of the
transport of medical waste by rail, one rail company is presently
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ir.oving municipal solid waste to midwestern States for disposal".
Intermediate length truck hauls (400 to 600 miles) of medical
waste are occurring from sites of generation in New York and New
Jersey to disposal facilities in Ohio, Quebec, and South
Carolina. The economic viability for intermodal truck-rail
transport may soon be present. Roll-on/roll-off containers and
trailers on flat cars may be viable future transport options.
Due to the shortage of landfill capacity within the State of
New Jersey, some municipalities are compacting municipal solid
waste at bale and transfer stations and are shipping it to out of
state landfills." A similar system could ba implemented for
medical waste. If medical waste destined for a landfill has been
properly treated, the potential threat posed by exposure to
pathogens through compaction may be reduced. However, the
physical danger from sharps, which results when bags and boxes
are crushed from compaction, is still present.
5.5 Methods to Evaluate Medical Waste Handling
The effectiveness of alternative medical waste handling
practices can be evaluated on the basis of several factors
including cost, operational ease, reliability and the reduction
of potential hazards. A variety of measures could be considered
by the health care industry and waste management industry to
evaluate the available and potentially available handling and
management method, as follows:
Capital cost for purchase of handling system
Operational and maintenance costs
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Time required to implement each handling system,
including necessary training
Systen integrity and reliability
Likelihood of self-implementation
Effectiveness in reducing worker exposure to the waste,
and
Effectiveness in reducing the public's exposure.
In future reports, EPA plans to evaluate the alternative
handling methods presented in this chapter, using the last two
measures.
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5.6 References
1. Region II, EPA (SAIC). characterization of Medical Waste
Generation and Treatment and Disposal Practices in New York
and tiev Jersey. January 30, 1989.
2. Reference 1.
3. Science Applications International Corporation. Site visit
reports of generators of medical waste in New York and New
Jersey. November, 1988.
4. Turnberg, Wayne L., Seattle-King County Department of Public
Health. An examination and Risk Evaluation of Infectious
Waste in King County, Washington. March 18, 1988.
5.
6.
7.
e.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
Reference
Reference
Reference
Reference
Reference
Reference
Reference
Reference
Reference
1.
4.
3.
1.
3.
4.
3.
4.
3.
Traffic World. "Railroads Look at Solid Waste, see Bulk
Commodity for the Future." May 1989.
Reference
Reference
Telephone
28, 1988.
Reference
Reference
Reference
Reference
Reference
1.
1.
conversation with SAIC and BioSafety. November
1.
1.
1.
1.
14.
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23. Kaste Age. "Transfer of Baled Wastes is One Solution."
DeceirJaer, 1988.
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CHAPTER 6
MEDICAL WASTE TREATMENT METHODS
Section 11008 (a) (6) requires EPA to report on available and
potentially available methods for treating medical waste. There
are a variety of available methods for treatment of medical waste
to render the waste noninfectious or less infectious, and
unrecognizable. In accordance with the breadth of processes
specified in H008(a)(6)( the term "treatment", as used in this
and the following chapter, includes processes that cause waste to
become less recognizable. This usage is thus broader than the
definition of treatment found at 40 CFR 259.10(a), which limits
treatment methods to those
...designed to change the biological character or
composition of any regulated medical waste so as to reduce
or eliminate its potential for causing disease.
The principal available and potentially available techniques
for treating medical wastes are:
Incineration
Steam Sterilization
Gas Sterilization
Chemical Disinfection with Grinding
Thermal Inactivation
Irradiation
Microwave Treatment
• Grinding and Shredding
Compaction
The following sections describe each method and discuss the
advantages and disadvantages of each. At this point it is not
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possible to estimate the proportions of Section 11002 waste types
that are subjected to each treatment technique, or to various
combinations of treatment techniques. Some of this information
nay become available as the incinerator and transporter reports
required by 40 CFR 259.78 and §259.62 are submitted; if it does,
EPA will provide it in future reports, in addition, further
information on the treatment processes described here and others
(such as chemical disinfection) will be provided in future
reports.
6.1 Incineration
Incineration is a process in which wastes are burned under
controlled conditions to oxidize the carbon and hydrogen present
in the waste. Incineration can be used to treat many types of
waste; materials which are not incinerable remain as residue,
along with unburned combustibles.
Three principal categories of medical waste incinerators are
used in the U.S. These classes are:
Modular, starved air incinerators
Rotary kilns
Retort or batch incinerators
Rotary Kilns
The rotary kilns consist of a large metal drum lined with
ceramic bricks. The kiln is tilted at a slight angle and is
slowly rotated. The waste is introduced at the upper end and
moves slowly through the device. The kiln rotation is a means to
mix or stir the burning bed and transports the solids through the
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kiln. Auxiliary fuel and air are sometimes used to aid in the
destruction of organic material. The amount of auxiliary fuel
used depends on the desired temperature, the quantity of air
introduced and the heat content of the waste. The waste material
burns as it moves through the kiln and residual ash is
continuously removed from the lower end.
The gases formed by the burned waste move from the Xiln into
a stationary chamber called a secondary chamber. More air and
fuel are added to aid in the destruction of the organic compounds
in the gas. Typically the kiln is operated at around 1600'F and
the secondary chamber around 2000°F. The gases leaving the
secondary chamber enter the heat recovery and air pollution
control equipment, if the incinerator is equipped with these
devices. Otherwise, the gases leaving the secondary chamber are
emitted to the atmosphere.
Modular, Starved Air Incinerators
In this type of system, wastes are pushed through the
primary combustion chamber in new facilities by compressor rams,
and loaded manually in older facilities. Air is blown up through
the waste from below. The devices are known as starved air
incinerators because controlled (substoichiometric) quantities of
air are introduced into the primary chamber to partially burn the
organic material. The partially burned organic compounds are
discharged (leave) the primary chamber and enter into the
secondary combustion chamber.
The exhaust gases flow from the primary chamber into the
secondary chamber where additional air is added. Often auxiliary
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fuel is added to aid in the complete destruction of all of the
unburned material in the gas. As in a rotary Kiln, the gases
leaving a modular starved air incinerator may pass through heat
recovery equipment and/or air cleaning equipment, or may be
emitted directly into the atmosphere. This type of incinerator
has uncontrolled particulate emission levels of about 0.1 grains
per day, standard cubic feet, if the unit is well-designed, well-
operated, and well-controlled.
Retort or Batch Incinerators
Retort incinerators are the simplest type of incinerator.
The operator preheats the waste burning chamber and places the
waste inside. Preheating is not always conducted, but is
recommended. Retort incinerators which are filled full of waste
(i.e., "stuff-and-burn") cannot be preheated; but they may be
designed to allow preheating of the after burner chamber. Fuel
and air are introduced through burners. The incinerator operates
until all the waste is burned; after a cool-down period, it is
opened and the ash is quenched and removed. These incinerators
could also be equipped with heat recovery and are rarely
controlled by add on air pollution control equipment.
Advantages
Incinerators can potentially destroy any material containing
organic carbon, including pathogens found in medical wastes.
Incinerators typically reduce the volume and mass of material
that must be disposed of in landfills by 80 to 95 percent. In
addition, materials are less recognizable after incineration.
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The heat from incineration can be recovered and used to
generate steam, which can be used directly or can be used to
generate electricity. Heat recovery devices reduce the net
operating cost of the incinerator by creating a useful product.
Disadvantages
Air emissions from incinerators contain several pollutants
of concern and is one of the principal disadvantages of using
incinerators. In addition, incinerators are complex and require
trained operators. The trend toward more stringent regulations
will increase the complexity of incineration equipment. Rotary
kiln incinerators have a number of moving parts, and thus may
require more extensive maintenance than other techniques.
Incinerators also represent a moderate risk to operators and
maintenance personnel due to the high operating temperatures and
the potential for fires. It is difficult to routinely test the
ability of an incinerator to destroy pathogens. Medical waste
incinerator ash may be a hazardous waste under RCRA Subtitle C
regulations. This issue was previously addressed in Chapter 2,
above.
6.2 Steam Sterilization
Steam sterilization, also known as autoclaving, is a
commonly used method for decontaminating wastes. The term
"sterilization" can be misleading in that waste is not actually
sterilized in all cases. However, the tern "steam sterilization"
is commonly used because the sama process is used for sterilizing
equipment.
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The waste is placed in a sealed chamber and exposed to steam
at the required temperature and pressure for a specified time.
The conditions commonly recommended for hospital sterilization
are processing for 12 minutes in contact with saturated steam at
Advantages
The equipment used in steam sterilization is simple to
operate. The technology is proven and has been used for many
years in the health care industry. Steam sterilization is
capable of decontaminating most medical wastes classes. It does
reduce the volume and render some plastic materials non-
recognizable. Additionally, there are biological indicators
currently available which provide quality assurance for equipment
friction.
Disadvantages
The process does not reduce the mass of material that must
be disposed of after treatment. The steam sterilization process
can produce extremely offensive odors. If odors are released,
then volatile organic compounds may also be released into the
ambient air. The odorous material could include toxic emissions.
Also, steam sterilization does not affect the recognizability of
most non-plastic wastes. Operators must be alert for wastes that
can be volatilized by the high temperatures; in addition, a
potential safety hazard exists because of the hot surfaces in the
autoclave.
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6.3 Gaa Sterilization
In gas sterilization processes, waste is exposed to a gas.
The wastes are placed in an air tight chamber; air is evacuated
and a sterilizing agent, such as ethylene oxide or formaldehyde,
is introduced. The gas penetrates the waste and kills infectious
agents. Gas sterilization is rarely used1 to treat medical
wastes.
Advantages
Gas sterilization can be used to treat reusable items that
cannot be subjected to heat and moisture.
Disadvantages
The use of gas sterilization is complicated by the potential
worker exposure to the disinfectant gas, because ethylene oxide
and formaldehyde are probable human carcinogens.1 In addition,
gas sterilization does not reduce waste volume or waste weight,
nor does it affect waste recognizability. In gas sterilization
processes, the toxic gases are vented to the atmosphere after
use; treated materials contain residues of the sterilizing agent
that are released over time.
6.4 chemical Disinfection With Grinding
Chemical disinfection processes involve contacting medical
wastes with a liquid chemical disinfectant. The wastes are
initially ground to ensure that the chemical agent can penetrate
the wastes and to aid in disposal of the residues. The materials
then enter a bath where they are mixed with the disinfectant.
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The resulting liquids, including any remaining disinfecting
agents, are released to the sewer system while the solid residues
are drained of the disinfectant and disposed of in a landfill.
Public Law 100-688, Title III, Subtitle B, §3202, adopted by
Congress on October 19, 1988, forbids the discharge of medical
wastes to navigable waters. EPA is considering the need to
develop regulations to implement that prohibition. The Agency is
concerned that certain pathogens may remain infectious even after
they pass through a sewage treatment plant. Dischargers should
not dispose of any medical wastes to the sewer without first
checking with public health and municipal sewage treatment
authorities to determine whether the disposal presents any risk
to the public.
Advantages
The grinding will reduce the volume of the waste but will
not reduce the mass. Wastes are generally rendered
unrecognizable by the process, if the grinding results in a
finely divided residua.
Disadvantages
The chemicals used as disinfectants may present a moderate
risk to operators and maintenance personnel. Depending on the
disinfectant used, the spent disinfectant solution may exhibit
characteristics which make it unsuitable for disposal in
municipal sewage systems. In addition, the ability of the
process to render the waste less infectious has not been
thoroughly evaluated.
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6.5 Thermal Inactivation
Thermal inactivation involves heating a waste to
temperatures which destroy infectious agents. Generally this
method is used only for large volumes of liquid wastes.'
Typically, the liquid wastes are placed in a chamber which is
heated to a pre-detennined temperature. The wastes are held in
the chamber for a specified period of time and then released.
Non-liquid wastes may be subjected to dry heat in an oven.
Advantage^
Thermal inactivation can be used for liquids, which are not
effectively treated by either steam or gas sterilization. The
treated liquid waste can be discharged into a municipal sewer
system.
Disadvantages
The extensive time and energy requirements preclude common
use for treatment of wast* in solid fora.' Thermal inactivation
does not alter the physical fora or quantity of waste that must
be disposed of after treatment. Federal, state, or local
requirements for discharge to a sewer system may include a
maximum temperature limitation; thus, heat exchangers may be
needed to reduce a treated liquid waste's temperature.
6.6 Irradiation
Irradiation with ultraviolet or ionizing radiation is a
potentially available method for treating medical wastes. The
process involves using ionizing radiation from a source such as
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cobalt 60, to destroy infectious agents, or using ultraviolet
radiation. .onizing radiation techniques are similar to those
currently being used to sterilize medical supplies, food, and
other consumer products.
Advantages
Ionizing radiation has demonstrated two advantages over
conventional treatment techniques: little energy input is
required,'because the equipment requires only a small amount of
electricity and no heat, and it is suitable for use on materials
which cannot be thermally treated.
Ionizing radiation technology is complex and requires highly
trained operating and support personnel. The radiation source in
the device will eventually decay and require replacement.
Disposal of the decayed source is a significant problem. The
ability of source to activate trace metals present in the waste
has not been well characterized.
Human exposure to ultraviolet radiation can cause adverse
health effects.
6.7 Microwave Treatment
Microwaves are being used to treat medical wastes, although
the technology has not yet been applied commercially in the
United States. Using this technique, wastes are first ground and
shredded to improve the effectiveness of the treatment system.
Next the wastes are sprayed with water. An auger moves the
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wastes past a series of microwave power packs which subject the
waste to nicrowaves. The microwaves heat the waste to 20C'F, and
volatile materials and water are driven off during the process.
Advantages
The grinding reduces the volume and recognizability of waste
to be treated by as much as SO percent. However, the weight is
essentially unaffected. Portable microwave treatment facilities
are commercially available.
Disadvantages
The main disadvantage of microwave treatment systems is that
they are not capable of treating pathological wastes such as body
parts or animal carcasses. Also, the potential for the release
of volatile material may exist.
6.0 Grinding and Saredding
Grinding and shredding are used to convert medical wastes
into a more homogeneous form that can be easily handled. In
these processes, medical wastes are physically broken into
smaller particles. The equipment is sometimes maintained at a
negative pressure to ensure that no material escapes from the
device. Needle-clipping devices are sometimes used to remove
needles from syringes.
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Advantages
Grinding will reduce the volume of the waste material. In
addition, the processes nay render the waste partially
unrecognizable.
Disadvantages
There may be some health risk associated with operation of
the equipment, because there is a potential for pathogens to form
an aerosol as a result of the grinding and shredding process.
(.9 compaction
Compaction techniques are used to reduce waste volume; they
can also affect wast* recognizability. A hydraulic ram is
generally used to compress the waste against a rigid surface. It
is not a technique designed to render a medical waste non-
infectious or less infectious.
Advantages
Compaction reduces waste volume; it can render waste less
recognizable to varying degrees.
Disadvantages
compaction can destroy the integrity of containers, causing
dispersion of materials. There is a potential for aerosols to
form and be released; also, liquids can drain out of the device.
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6.10 References
1. Lee, C.H., T.J. Montville, and A.J. sinskey. "Comparison of
the Efficacy of steam Sterilization Indicators." Applied
and Environmental Microbiology, 37(b), pp. 113-117, 1979.
2. Layne, P., w. Westbrook, K. Hendry, and T. Pierson. Review
and Evaluation of Existing Literature on Generation,
Management, and Potential Health Effects of Medical tfaste.
Contract No. 68-01-7075, U.S. Environmental Protection
Agency, Washington, D.C., November 1988.
3. U.S. Environmental Protection Agency, Carcinogen Assessment
Group. List of Carcinogens. Washington, D.C., April 24,
1980.
4. U.S. Environmental Protection Agency, Office of Solid Waste.
EPA Guide for Infectious Waste Management. EPA/530-SW-86-
014, May 1986.
5. Reference 4.
6. 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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CHAPTER 7
MEDICAL WASTE TREATMENT EFFECTIVENESS
For each of the treatment methods identified in Chapter 6,
operating procedures can affect the method's effectiveness in
reducing the waste's disease-causing potential, or in rendering
the waste less recognizable. As required under 11008(a)(7) this
chapter outlines the effectiveness, including operating factors
affecting effectiveness, available quality assurance procedures,
required maintenance, and operator training requirements of the
methods identified in the previous chapter. In future reports,
EPA will further develop this information by compiling available
information, and will consider the need for conducting tests of
treatment effectiveness.
7.1 incineration
Factors Affecting Effectiveness
The same general factors influence the effectiveness of all
common types of medical waste incinerators.
Incineration temperature is one of the factors which
influence the effectiveness of an incinerator. High
temperatures increase the destruction of organic
compounds.
The residence tine of the solid materials in the
incinerator is also important. The longer the solids
are allowed to remain in the incinerator the more
complete the destruction of organic materials will be.
However, long residence times for solids reduce the
throughput rate of the incinerator. Rotary kilns
operate most efficiently when large quantities of waste
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are to be incinerated. In contrast, batch incinerators
cannot process large quantities of waste efficiently.
The mixing of the waste with the combustion of high
temperature air is another parameter that affects the
completeness of the combustion and the treatment
effectiveness. Of the three classes of incinerators,
rotary kilns are generally the most effective at mixing
the solid materials. The kiln's rotation aids in
nixing the wastes and helps ensure that no pockets of
unburned material are formed. This is particularly
useful when carcasses and other wastes with high
moisture contents are burned. The large amount of
water in these materials tends to cause them to burn
more slowly than the surrounding material. If the
pockets are not broken up, unburned material may pass
through the incinerator.
The characteristics of the waste can influence
incinerator temperature and required residence times.
Waste material which contains large quantities of
plastics and paper has a high heat content and will
burn quickly and produce high temperatures. Wastes
which contain large amounts of fluids and large bulky
moist objects will burn slowly and produce relatively
low temperatures. Additional fuel may be needed to
burn large quantities of wet wastes.
Quality Assurance and Quality Control Procedures
Monitoring an incinerator is a relatively difficult task,
because the wastes are highly variable. For effective
incineration, it Is necessary to continuously monitor the
incinerator to ensure that the required temperature is
maintained, the required quantity of air is being supplied, and
the waste's characteristics are appropriately accounted for.
Maintenance and Operator Training
Due to the complexity of incineration systems, relatively
frequent maintenance is required. Maintenance includes
replacement of worn refractory, removal of ash deposits on walls
7-2
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and ducting, cleaning and replacement of air inlets, and repair
of worn mechanical parts.
Because operator training is necessary for effective
incinerator operation, E-PA has developed a training course for
hospital incinerator operators available through the EPA Regional
Offices.' Course materials have been distributed to State
agencies responsible for administering the Clean Air Act that
wish to conduct operator training programs. Proper incinerator
operating techniques nay reduce maintenance and repair cost in
addition to reducing air emissions.
7.2 fltaan Sterilization
FactorsAffecting Effectiveness
Three important factors in steam sterilization processes are
temperature, pressure, and exposure time. The size and material
of the load, the material of the autoclave bag and the container,
and the waste's configuration in the chamber also affect the
steam penetration and heat transfer.
For effective treatment, all of the material within a steam
sterilizing unit must be exposed to steam at a certain
temperature for a sufficient length of time. Materials to be
sterilized are generally placed in polyethylene bags which are
then placed in a steel or polypropylene container and loaded in
the unit. The exposure time can be lengthened to compensate for
poor heating or poor steam penetration.
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QualityAssurance and QualityControl Procedures
The steaa temperature and pressure in the chamber are the
parameters routinely monitored. The cycle time can be adjusted
by the operator to account for load to load variations in the
waste.
Two methods of quality control can be utilized to ensure
proper equipment function; chemical indicator* and biological
indicators. A chemical indicator that changes color when a
certain temperature is reached can be used to verify that a
specific temperature has been achieved. However, such indicators
do not show the length of time the waste has been exposed to
steam at that temperature.
Another quality control method involves placing spore strips
of Bacillus stearothermophilua, in the autoclave with a load of
waste. B. stearothermophilus is used as a biological indicator.
It is able to survive in elevated temperatures by forming spores.
The viability of the destruction of Bf stearothermophilus spores
during the decontamination period ensures that virtually all
heat-resistant bacterial pathogens are inactivated.
Maintenance and Operator Training
Autoclaves require some maintenance. In addition, although
they are relatively simple to operate, operator training is
needed because of the potential safety hazards.
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7.3 Gas Sterilization
Factors Affecting Effectiveness
To be effective, the sterilizing agent in a gas sterilizing
unit must be able to penetrate the wastes and must be present in
a sufficient concentration. The presence of organic matter or
soiling agents on the waste surface can interfere with the
sterilizing agent's action. Cycle time, relative humidity, and
temperature in the unit also affect the technique's
effectiveness.
Quality Assurance and Quality Control Procedures
The effectiveness of a gas sterilization system can be
periodically checked using spores of a bacterial species that is
resistant to the sterilizing agent.
Maintenance and Operator Training
Some operator training is required to operate a gas
sterilization unit because of the potential exposure to compounds
such as ethylene oxide or formaldehyde.
7.4 Chemical Disinfection
Factors Affecting Effectiveness
In chemical disinfection, infectious agents must be exposed
to a chemical disinfectant that acts against the microorganisms
present in the waste. Waste particle size, porosity, and
7-5
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permeability all affect the ability of the chenicals to penetrate
the material. Grinding the waste prior to treatment reduces the
size of the material, and increases the potential effectiveness
of the method. As with gas sterilization, soiling or organic
matter present on the waste surfaces can also reduce
effectiveness.
Quality Assurance and Quality Control Procedures
Currently, no standard procedures exist to monitor the
effectiveness of the treatment. One facility uses a direct
contact procedure to culture bacteria present in the waste after
treatment.' Since the wastes are ground prior to treatment, it
is not possible to place a separate container of indicator
organisms in the waste to monitor the treatment.
Hainte_nance^nd_ Operator Training
Some periodic maintenance is required; the grinding
apparatus in particular is subject to wear. However, little
specialized operator training is required.
7.5 Thermal Inactivation
Factors Affactin? Effectiveness
The principal factors influencing the effectiveness of heat
inactivation are the cycle length and temperature, which are
determined by the pathogens' resistance to heat. For dry heat
7-6
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nethods, circulation of the heated air is necessary to ensure
that all waste reaches the required temperature.
Quality Assurance and QualityControl Procedures
The only continuous monitoring currently available for these
units is temperature. Pathogen destruction monitoring involves
periodically spifcing the waste with a fcnown quantity of heat-
resistant bacteria and testing viability after treatment.
7.6 Irradiation
Factors Affecting Effectiveness
To be affected by ultraviolet radiation, microorganisms must
have direct exposure to the UV rays for a sufficient length of
time. Relative humidity can affect the treatment effectiveness
of ultraviolet radiation. With ionizing radiation, higher
exposure rates are more effective at destroying infectious
agents.' However, the minimum required exposure rate has not yet
been determined.
Quality Assurance andQuality Control Procedures
As with steam sterilization and ga« sterilization, periodic
testing with an indicator microorganism may be conducted to
ensure that infectious agents arc destroyed.
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Maintenance and Operator Training
Little routine maintenance is required for irradiation
units; periodically the radiation source must be replaced.
Extensive operator training is required to operate the equipment.
7.7 Microwave Treatment
Factors Impacting Effectiveness
The volume and density of the waste is an important factor,
and affects the required treatment time. Microwaves are limited
in their ability to penetrate large and dense objects; thus, this
technique is not preferred for treatment of pathological wastes
such as body parts or animal carcasses. The microwave frequency
is also an important parameter. Increasing the intensity of the
microwaves decreases the time required to decontaminate the waste
and increases the ability of the waves to penetrate large
objects.
Quality Assurance and Quality Control Procedures
Equipment operating parameters such as power and wave
attenuation are used to monitor the device on a continuous basis.
Direct measurement* of pathogen destruction are not made on a
continuous basis. As with the majority of the medical waste
treatment equipment, pathogen destruction can be tested on a
periodic basis through the use of spore strips and spiked
samples.
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Maintenance and Operator Training
Due to the complexity of the equipment, all nainter.ance or.
microwave units must be performed by trained technicians.
Operation of the system also requires significant training.
7.8 Grinding and Shredding
Factors Affecting^Effectivenesa
The principal factors affecting grinding or shredding
processes are the quantity of metal and glass present in the
wastestrean, the size of the waste, and the presence of fibrous,
rubber, or soft plastic materials. Metala and glass can wear
down the grinding edges, while fibrous, rubber, or soft plastic
materials may become caught on the hammermills and cause the
equipment to malfunction.
Quality Assurance and Quality Control Procedures
with respect to rendering the waste less recognizable, the
operator would observe the shredded waste's size distribution to
verify that the equipment is functioning properly.
tfaifltenan.ee and Operator Training
Grinding equipment requires relatively frequent maintenance
due to the wear inherent in the grinding process. Some operator
training is necessary if the operators perform the maintenance.
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7.9 Compaction
factors Affecting Effectiveness
Mechanical operation of the equipment is the most
significant factor affecting compaction effectiveness. The
physical form and composition of the material also have an
effect.
Quality Assurance and Quality Control Procedures
Operators can visually inspect the compacted waste to
determine if it has been adequately compacted.
Maintenance and Operator Training
Some maintenance is necessary to ensure proper mechanical
operation. Operators need little specialized training, unless
they perform maintenance.
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7.10 References
1. U.S. Environmental Protection Agency. Hospital Incinerator
Operator Training- Course, EPA-450/3-89/003 (3 volumes),
Research Triangle ParX, NC, March 1989.
2. Rutala, W.A., M. Steigel, and F. Sarrubi. "Decontamination
of Laboratory Microbiological Waste by Steam Sterilization."
Applied and Environmental Microbiology, Vol. 43, pp. 1311-
1316, 1982.
3. U.S. Environmental Protection Agency. EPA Guide for
Infectious Haste Management, EPA/530-SW-86-014, May 1986.
4. U.S. Environmental Protection Agency. Maryland Medical
Laboratory's Waste Treatment System, memorandum, Washington,
O.C., December 1988.
5. Cross, F. "Comparison of Disposal, Incineration, Chemical,
Pulping, Radiation, and sterilization Techniques for
Infectious Waste," Infectious Waste Disposal Conference,
Washington, D.C., November 29-30, 1988.
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CHAPTER 8
EXISTING STATE AKD LOCAL REQUIREMENTS
This chapter addresses the requirements of RCRA Section
11008(a)(8), which asks for information on "existing state and
local controls on the handling, storage, transportation,
treatment, and disposal of medical waste, including the
enforcement and regulatory supervision thereof." EPA has
responded to this mandate by talcing several steps to collect and
analyze the regulatory requirements of the ten states targeted
for inclusion in the demonstration medical waste tracking program
and the two states that have chosen to opt into the program.
This chapter describes the requirements of these twelve states
(New York, New Jersey, Connecticut, Pennsylvania, Ohio, Indiana,
Illinois, Minnesota, Michigan, Wisconsin, Rhode Island, and
Puerto Rico) and, to the extent possible, pending proposed
regulations.1 In future reports, EPA will assess the available
information on this topic, in relation to the Chapter 9
evaluation of state requirements as appropriate nationwide
controls. One focus will be state requirements that appear to be
innovative, or appropriate models that are adaptable by other
states.
When characterizing medical waste regulations, it is
important to be aware of certain characteristics of these rules
and the problems they address. Medical waste regulation is both
1 The information included here is correct as of June 15, 1989
although some later regulations are summarized.
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a relatively recent occurrence and a rapidly evolving area of
law. Many states are in the process of either developing or
amending their regulations in an attempt to address th« problems
this wastestream poses. The MWTA mandate contributes to this
dynamic environment. To understand medical waste regulations it
is important to realize that these rules often are the product of
more than one administrative agency, and sometimes of different
divisions within agencies. Typically, if two state agencies
regulate medical waste, the state health agency regulates on-site
management and the state environmental agency regulates off-site
management.
The term "medical waste" is used frequently throughout this
chapter to refer to wastes resulting from health care activities.
Various states use slightly different descriptive terns. For
example, Minnesota uses the terms "infectious waste" and
"pathological waste" to distinguish the differing risks posed by
these wastes, and sets different regulatory standards for these
two waste types. Similarly, Pennsylvania regulates "infectious
and chemotherapeutic waste" but does not use the term "medical
waste."
Regulatory Summary
The twelve states can be characterized as states that have
medical waste regulations in effect, are presently re-examining,
developing or revising these regulations, and have generally
chosen comprehensive regulatory programs over more limited ones.
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Typical requirements among these states include packaging,
labeling, pre-disposal treatraent, tracking, and certain
permitting requirements. Table 8-1 summarizes the regulatory
provisions each state has in place; the remaining sections of
this chapter elaborate on what these provisions require and how
they are implemented.
Regulatory Status
Of the twelve states discussed in this chapter, ten
(Illinois, Minnesota, New Jersey, New York, Indiana, Michigan,
Pennsylvania, Wisconsin, Rhode Island, and Puerto Rico) currently
have at least some specific medical waste regulations in place.
Two of the twelve states (Connecticut and Ohio) do not have
medical waste regulations in place. Both of these states are
developing regulations which are expected to be in place soon.
Of the ten states with specific medical waste regulations,
eight have fairly comprehensive rules, while Puerto Rico and
Wisconsin have limited provisions.
Of the twelve MWTA states, only Illinois regulates medical
waste as a state hazardous waste. However, Illinois' program
does not subject medical waste to typical hazardous waste
requirements as much aa it sets out specific treatment and
transport requirements for medical waste from hospitals. The
other states with regulations typically classify medical waste as
a special category of solid waste. The regulatory provisions
addressing medical wastes range in length from a single paragraph
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Table 8-1.
Summary of States' Regulatory Status
Covered States
Have Medical Waste
Regulations
Developing/Amending
Medical Waste
Regulations
Packaging and
Labeling
Require Treatment'
Prior to Disposal
Require Records:
-Generators
-Transporters
-Treatment/
Disposal
Require Tracking
Require Permits:
-Generators
-Transporters
-Treatment/
Disposal'
Exclusions
NY NJ CT
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Opt Cut Covered States
MN PA WI' IL' IN OH' MI
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
For at least certain wastes, but not necessarily all
wastes.
Permits nay be required under other state environmental
laws.
Wisconsin's requirements shown here are based on
guidelines. Although compliance is not required at
present, voluntary compliance is strongly encouraged.
Licensed transporters must follow guidelines.
Illinois requirements apply to hospitals only.
Note that Ohio's requirements are based on statute or
draft regulations.
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Table 8-1.
Summary of Statei1 Regulatory Statue (Cont.)
Opt In Covered States
Have Medical Waste
Regulations
Developing/Amending
Medical Waste
Regulations
Packaging
Requirements
Labeling
Requirements
Require Treatment'
Prior to Disposal
Require
Recordkeeping:
-Generators
-Transporters
-Treatment/Disposal
Require Tracking
Require Permits:
-Generators
-Transporters
-Treatment/
Disposal1
Exclusions
RI PR
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
' For at least certain wastes, but not necessarily all
wastes.
1 permits may be required under other state environmental
laws.
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to many pages; the prograirr- vary from a quite limited set of
requirements to well developed regulatory programs.
The present status of each state is briefly described below.
All twelve states are active in the medical waste area; they are
considered to have medical waste regulations if they have
specific provisions addressing such wastes. States are not
included as having medical waste regulations if medical waste is
only subject to the state's nonhazardous solid waste regulations.
The twelve states (those states originally specified in the HWTA
and those that have opted into the program) are referred to as
MWTA states for purposes of this discussion.
Connecticut is operating under the Federal demonstration
tracking program and is preparing to adopt amended
medical waste regulations by early 1990. These
regulations will be consistent with the Federal
regulations, and in some areas may regulate more wastes
and/or be more stringent than the Federal regulations.
Illinois is currently evaluating its medical waste
regulations. The Governor has recently appointed a study
group to review the existing regulations.
Indiana has recently finalized medical wast* regulations
that address the areas of packaging, labeling and
treatment.
Michigan enacted interim medical waste regulations on
April 26, 1989, which were intended to address potential
problems occurring in the summer of 1989. The rules are
similar in scope to the Federal regulations.
Minnesota has enacted new, comprehensive infectious waste
regulations as of May 22, 1989; the waste management and
recordkeeping provisions will be effective Jan. 1, 1990.
Minnesota's Infectious Waste Control Act contains
provisions based on a report produced by the Minnesota
Attorney General's office.
New Jersey responded to 1988'a mismanagement incidents by
enacting emergency regulations in August 1988 to address
the tracking of medical waste. New Jersey passed
legislation (March 19B9) authorizing the State to adopt
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the Federal medical waste regulations, including certain
provisions that are more stringent than the Federal
requirements. These regulations were adopted in
emergency fora and became effective on June 26, 1989.
New Jersey's legislation requires the study of important
issues related to medical waste management such as
economics, handling and disposal issues. The regulations
described in this chapter are these latest requirements.
The state is presently operating subject to the Federal
demonstration tracking program.
New York also initially responded to the mismanagement
incidents of 1988 by enacting emergency regulations, and
also has plans to implement a long tern medical waste
management plan. New York also is operating under the
Federal demonstration tracking program; for purposes of
consistency with the Federal program and enhanced state
enforcement capability, New York has recently amended the
state regulations to approximate the Federal
requirements. These regulations were effective July 10,
1989. The regulations described in this chapter are
these latest requirements.
Ohio has filed comprehensive draft infectious waste
rules. The rules are expected to become effective by
winter of 1989.
Pennsylvania has existing regulations that were effective
April 9, 1988. The State has enacted legislation (Act
93} which requires the registration of infectious and
chemotherapeutic wast* transporters, the tracking of such
waste, and the review of existing regulations. The State
has proposed regulations to implement the requirements of
Act 93, and anticipates that they will be effective in
the winter of 1990.
Puerto Rico has limited provisions addressing medical
waste, and is considering developing new regulations.
Rhode Island has regulations that address medical waste
management. These regulations were amended in October of
1988, and apply only to health-care facilities and
laboratories that are licensed by the Rhode Island
Department of Health.
The State of Wisconsin finalized its medical waste
guidelines in May 1989. If medical waste ia not properly
handled and disposed of, it may violate a number of state
laws, including but not limited to, Section 29.29,
144.44, 144.64, and 144.76 of the Guidelines for the
Handling and Treatment of Medical/Infectious Hastes. As
a result, several penalties may be imposed for violators
of those statutes.
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of the twelve states discussed here, those that do not
presently have medical waste regulations are Connecticut and
Ohio. Connecticut has proposed regulations, which are expected
to be finalized in 1990. Ohio has recent legislation that
requires the development of medical waste regulations; these
regulations have been drafted and should be effective in the next
few months. Thus, nearly all twelve states have some form of
medical waste regulations, either in place or in the works.
8.1 Definition of Medical wast*
Nine of the ten MWTA States that have existing medical waste
regulations include a definition of medical waste in the
regulations. Puerto Rico does not presently have a regulatory
definition of medical waste. Ohio also includes in its statute a
definition of the wastestreams to be regulated. All of these
definitions vary, sometimes significantly, in their content as
well as in their approach to identifying medical wastes of
concern. Some of the definitions only address wastes from
specific facilities. For example, only waste from hospitals is
regulated in Illinois.
These states use three basic approaches, as veil as
combinations of these approaches, to define medical waste.
First, some states use a definition based on the infectious
characteristic of a waste. One state, Wisconsin, defines a waste
as infectious if it is capable of causing an infectious disease.
The second approach to defining these wastes is listing waste
types or categories; for instance, a definition may designate
8-8
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blood and blood products as infactious medical waste. A third
approach is to designate such wastes according to their source,
such as designating all waste from an isolation patient as
infectious medical waste.
All of the states that define medical waste use a definition
based on soae combination of the approaches described above. A
combination of approaches can define the wastes subject to
regulation in a manner that limits regulatory coverage to wastes
that pose a potential risk. Another reason for the combined
approach is that the regulations can be difficult to implement
unless the wastes are specifically described, either by
designating the source or by using descriptive terms. Wisconsin
employs a definition based on the infectious characteristic of
the waste in the administrative rule that governs infectious
waste; however, Wisconsin's guidelines use categories and the
reporting form designates the sources. New York and New Jersey
regulate the same seven waste classes regulated under the
demonstration tracking program. Kev York regulates additional
wastes as well. Both of these definitions are a combination of
the listing and source based approaches.
When the definitions used by states other than New Jersey
and New York are compared to the definition contained in RCRA
Section 11002, three states include essentially the same types as
the non-optional (1-5) medical waste types in the Act. These
states are Michigan, Ohio and Pennsylvania. Several other states
are close to including the non-optional types. None of the MWTA
States, however, match all of the waste types (Sec. 11002 (a)(l-
8-9
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10)) in the Act. Rhode Island's definition coaes close to
ratching all ten waste types if generators include certain
discretionary waste types as medical waste.
Exclusions
Certain states exclude some medical waste from certain
managenent requirements. Wisconsin provides for a small quantity
generator (less than fifty pounds per month) exemption from
licensing requirements for transportation or storage. Illinois
provides for a small quantity generator exemption from tracking
requirements. New Jersey exempts generators of less than three
cubic feet of medical waste per month from the requirement to use
a registered transporter if the generator transports only that
waste to another generator for storage or disposal. Illinois and
New York also exclude small quantity generators from the
requirement to use a permitted transporter. Ohio's statute
provides that generators of less than 50 pounds of medical waste
per month are not subject to certain generator standards.
New York, Ohio, Pennsylvania, and Michigan also exclude
household waste from regulation as infectious waste, and Michigan
excludes agricultural businesses. New Jersey excludes waste from
self-administered medical care, or care provided by a spouse,
family member, or non-profit health care provider. Rhode Island
provides for variances where hardship conditions exist and no
threat to health would result. Connecticut proposes to exclude
household waste. Minnesota's statute currently exempts
household, farm operation, and agricultural business infectious
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or pathological waste from management requirements, but requires
the state agencies with jurisdiction to study the issue further.
8.2 Handling
Segregation
Several of the MWTA States expressly require the segregation
of medical waste from other wastes. Michigan, Minnesota, Hew
Jersey, New York, Ohio, Rhode Island, Pennsylvania, and Wisconsin
require such segregation. Generally, segregation is required at
the point of generation, or as soon as practicable after the
waste is generated.
Connecticut and Ohio also propose to require (and New
Jersey, New York, and Wisconsin require) that sharps be separated
from other medical waste. Rhode Island and Pennsylvania require
that medical waste posing multiple environmental hazards be
segregated for treatment in accordance with regulatory and
individual facility management plan requirements.
New Jersey and New York have adopted segregation
requirements for fluids in quantities greater than twenty cubic
centimeters; this requirement is consistent with the Federal
requirement for segregating fluid medical waste. Illinois does
not expressly require segregation of medical vast* from other
waste.
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Packaging and Labeling
Most of the MWTA States currently require packaging and
labeling of medical wast*. Michigan, Minnesota, New York,
Pennsylvania, Rhode Island, and New Jersey all have current
packaging requirements. Wisconsin recommends such requirements
in guidance. Ohio proposes to adopt packaging requirements.
Illinois does not have packaging and labeling requirements for
medical wastes.
Typical packaging requirements in effect consist of double
bagging the waste in polyethylene bags, sealing these bags, and
labeling them; sometimes the requirements also specify placing
the bags in a second bin, pail, drum, carton or box, which is
also sealed and labeled. Reusable outer containers must be kept
clean and in good repair.
Several of the states also have special packaging
requirements for sharps. Minnesota, New Jersey, New York,
Pennsylvania, and Rhode Island provide that sharps must be placed
in puncture-resistant containers. Ohio's statute requires that
sharps be placed in sharps containers at the point of generation.
Usually these containers must also be labeled as infectious
waste. In Wisconsin and Minnesota, sharps containers must be
handled so as to preclude loss of their contents.
None of the states require that actual medical vast* items
(e.g., sharps or equipment) be labeled or marked with some fora
of identification for purposes of tracking; however, New York
does require that two floatable identification tags be included
in each bag of medical waste.
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Storage
Some of the states impose specific storage requirements upon
handlers of aedical waste. Connecticut, Michigan, Minnesota, New
Jersey, New York, Pennsylvania and Rhode Island generally require
that medical waste be stored in a sanitary manner, separate from
other types of waste, and with limited access. Pennsylvania and
Rhode Island also impose limitations on the amount of time
medical wasta can be stored under various conditions. New York
imposes storage time limitations for certain generators
(hospitals, nursing homes, and clinical laboratories). Ohio's
proposed regulations contain restrictions similar to those
mentioned above, including the limitation on the time of storage.
Illinois requires permits for off-site storage; the permits
require the wastes to be stored in an environmentally sound
manner. Indiana's statute specifies that untreated medical waste
be stored in a "secure area." Puerto Rico's regulations address
control of fires and odors in waste storage areas. Wisconsin has
guidelines that address refrigeration and other storage
conditions.
a.3 Treatment
Required nedical waste treatment typically consists of
incineration or some fora of decontamination (steam, chemical or
other). Illinois, Pennsylvania, and Rhode Island specify in
their regulations that medical waste must either be incinerated
or sterilized prior to sanitary landfill disposal. New Jersey
and New York specify that medical vast* must be incinerated,
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sterilized, or otherwise decontaminated, while Wisconsin
specifies incineration or other treatment to render the waste
non-infectious. Puerto Rico requires incineration or
sterilization prior to burial in a landfill.
In most of the states, treatment must meet some specified
standards. Frequently, these arc general performance standards
that require treatment to render the waste non-infectious;
occasionally, design standards arc included. For incineration,
several states refer to other regulatory provisions which specify
standards for incinerator performance and/or design.
Of those states with developing regulations, Connecticut
proposes to require incineration or sterilization, and Indiana's
statute requires effective treatment (reduction of pathogenic
qualities to safe levels). Ohio's draft regulations require
treatment which renders the waste non-infectious; allowed methods
are incineration, autoclaving, and chemical treatment of
cultures.
The various states do not all require that the same wastes
be subject to treatment, or that similar wastes be subject to the
same treatment. Three factors contribute to these differing
treatment requirements. First, as noted previously, each of the
states defines medical waste in a different manner. Second, the
states do not all regulate the same generators of medical waste.
Certain states require treatment for only one group of
generators; in Illinois only hospitals have waste treatment
requirements. Others, such as Pennsylvania, require treatment
for any waste which meets the characteristic or waste type
8-14
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criteria in that state's definition. Finally, some states, such
as Rhode Island, specify different treatment methods for
different categories of medical waste. For instance, liquid
wastes from microbiological laboratories must be autoclaved,
while pathological wastes must be incinerated.
Pennsylvania requires that sharps be rendered unusable prior
to disposal, while Rhode Island requires that they be treated.
New Jersey provides under a separate criminal justice statute,
directed toward control of intravenous drug abuse, that needles
and syringes discarded or abandoned in any public or private
place, accessible to any other person, must be destroyed. For
needles this means breaking the needle from the hub or mangling
the needle, and for syringes this means breaking the nipple from
the barrel, or melting the plunger and the barrel together.
Destruction of the entire hypodermic (needle and syringe) is also
acceptable if accomplished by grinding, crushing or incinerating
the entire unit, or by any other method approved by the
department of health. Minnesota prohibits sharps from being
compacted, or from being disposed at facilities where waste is
hand-sorted.
8.4 Disposal
Medical waste is typically disposed either through
landfilling or sewer disposal. Most states require treatment of
these wastes prior to disposal. All ten of the twelve states
discussed here that have current medical waste regulations
require the treatment of some medical wastes prior to landfill
8-15
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disposal. Minnesota does allow untreated medical waste to be
landfilled if the disposal facility has been issued a special
permit. Ohio's statute requires such treatment prior to land
disposal. Rhode Island has recent legislation prohibiting
landfilling of medical waste at state facilities.
With respect to treatment residues, some of the states have
specific provisions for the disposal of ash; most of the states
consider treated medical waste (either ash or treatment residue)
as solid waste, to be disposed of in a manner consistent with
their solid waste regulations (i.e., landfilled). For example,
ash in Illinois is considered a special waste and disposal
requires special permitting.
One method of disposal where treatment requirements differ
significantly from those for landfilling is sewer disposal. Nine
states do not require the treatment of liquid medical waste
before it is sewer disposed. Host of these states place minimal
restrictions on such disposal and require that it be consistent
with existing state sever regulations. New York, Illinois, and
Indiana allow the disposal of untreated liquid or semi-liquid
medical waste to the sewer system under applicable regulations.
Pennsylvania allova disposal of blood, urine, feces and other
body fluids if the system has secondary treatment. Ohio allows
blood, body fluids, and excretion to be discharged to a disposal
system provided the discharge is consistent with the system's
water pollution permit. New Jersey allows untreated bulk blood
to be sewer disposed, but requires liquid microbiological
laboratory wastes to be autoclaved before sewer disposal. Rhode
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Island allows sanitary sever disposal of bulk blood and bcdy
fluids where permission is granted from the sewer authority and
other conditions are met. Wisconsin, Minnesota, and Puerto Rico
do not expressly address sever disposal in their medical waste
regulations. Wisconsin requires treatment before disposal in a
solid waste disposal facility, and thus apparently allows sewer
disposal, while Minnesota generally allows sewer disposal,
treating it as a natter for local regulation.
8.5 Recordkeeping and Reporting
States have begun to impose recordkeeping requirements on
medical waste generators, transporters, and treatment/disposal
facilities in an effort to collect information on this
wastestream and thus better control it. For example, New Jersey
requires generators of 300 or more pounds per year to complete
daily logs of medical waste generated, treated, or disposed on-
site, and/or sent off-site. (Generators of less than 300 pounds
per year must maintain similar log* on a monthly basis.) New
York and Illinois require generators to maintain records of on-
site treatment and destruction. Minnesota requires generators
and other waste handlers to prepare management plans; these plans
include descriptions of waste handling procedures, and a
statement of the waste quantities handled.
Connecticut proposes to require transporters to maintain
logs which indicate for each shipment the quantity and shipment
dates of medical waste transported, and the source and delivery
points for the waste. Ohio's draft regulations require
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generators to keep monthly totals of generated waste quantities.
In addition, states that require the tracking of medical waste
generally require generators, transporters, and disposal
facilities to maintain records of tracking form information.
with respect to treatment/disposal facilities, Illinois
currently requires medical waste treatment facilities to keep
records of the amounts treated, treatment effectiveness, and
operation of treatment equipment. Pennsylvania requires the
submission of certain treatment analyses. New York requires
facilities to maintain records of the waste handled. Connecticut
proposes to require steam sterilization units to maintain logs
containing information on the operation and effectiveness of each
treatment operation. Ohio's draft regulations require treatment
facilities to keep records of waste quantities received, and
operational/maintenance/quality control logs.
In addition to recordkeeping, certain information must be
submitted to the states in the form of reports. New Jersey
requires that an annual medical waste generator report be
submitted; facilities that treat, destroy, or dispose medical
waste also must submit annual reports. New York requires medical
waste generators and transporters to submit annual reports.
Consistent with the Federal requirements, New Jersey and New York
require generators who incinerate medical waste on-site to submit
periodic reports. Minnesota requires that waste management plans
be submitted periodically.
Connecticut proposes to require generators to prepare annual
reports summarizing the information from all tracking documents
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generated during the year, including a description of the waste
generated and transported off-site, the quantity by weight of
such waste, transporter information, and treatment and disposal
facility information. Ohio's draft regulations require
generators and treatment facilities to submit annual summaries
including information on infectious waste quantities generated or
received.
As part of the development process for medical waste
regulations, Pennsylvania is conducting a study of medical waste
generation and management. Wisconsin is requesting reporting
from treatment facilities (primarily incinerators), and from
landfill operators. Information requested includes source,
amount and type of waste, treatment method, and final
disposition.
8.6 Tracking
Several of the MWTA states either currently require or
propose to require the tracking of medical waste. In every case
where tracking is required or proposed, the tracking system
consists of manifesting the waste from the point of generation
through disposal. Pennsylvania, Illinois, New Jersey, New York
and Rhode Island currently require such tracking, while
Connecticut proposes to adopt such requirements. Ohio's draft
regulations require shipping papers to accompany shipments of
treated infectious waste.
Pennsylvania has required • four-part manifest for
generators and an eight-part manifest for hospitals since March
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1, 1990. Ohio's draft regulations require a multi-part fora,
with each handler retaining a copy. After the infectious waste
is treated, a copy of the shipping paper is returned to the
generator as assurance that the waste has been properly treated.
Another shipping paper accompanies the shipments to a licensed
disposal facility. Pennsylvania's regulations require hospitals
to complete an eight-part manifest; proposed regulations would
require all other generators to complete a four-part manifest.
New Jersey and New York utilize four part tracking forms.
These States require that copies of the completed tracking form
must be sent back to the generator within 35 days of shipment; if
a copy is not received by the generator within 45 days of
shipment he or she must notify the regulatory authority.
Connecticut proposes to require tracking under provisions similar
to the Federal tracking requirements.
Illinois utilizes a six part tracking form, and requires
generators to submit a copy of the tracking form to the state
when it is first completed by the generator. The
treatment/disposal facility must sand copies of the manifest to
both the generator and the State of Illinois on a monthly basis.
8.7 Permitting/licensing
Permitting and/or licensing can give th« regulating
authority additional control over the parties involved in waste
management. This section summarizes specific medical waste
management permitting requirements. A somewhat lesser, but
related form of control is registration. This chapter does not
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attempt to distinguish between these forms of control, but future
reports will examine these mechanisms.
Ohio proposes to require all generators of over 50 pounds of
medical waste per month to register with the state. New Jersey
also has registration requirements for all generators of
regulated medical waste. The other states focus on requiring the
registration of transporters.
Pennsylvania, Illinois, Minnesota, New Jersey, and New York
require medical waste transporters to have permits or register
with the state. Connecticut and Ohio propose to require
registration for transporters. Wisconsin requires that medical
waste be transported by a licensed service.
Some of the states provide for exemptions from transporter
permitting requirements. Pennsylvania allows generators of less
than 100 kg/month to transport their own waste without a permit.
Illinois provides that generators of less than 100 kg of medical
waste per month are exempt from transporter permitting
requirements. For generators of under 50 pounds of medical waste
per month, Ohio provides exemptions from having to utilize
registered transporters; New York allows these small generators
to transport their own waste without a permit if they have
notified the State of New York.
Medical waste treatment facilities include incinerators and
sterilization facilities. .Ohio's draft regulations address
permitting treatment facilities with specific requirements, and
require licenses in addition to permits issued under the Ohio
Division of Air Pollution Control. Most of the MWTA states
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currently require "permits for incinerators under air quality
regulations; the permits may or may not specifically address
issues related to medical waste treatment.
Landfills also generally require permits; however, like
incinerator permits, landfill permits generally do not focus on
medical waste management issues. Exceptions are in Ohio and Kew
Jersey, where disposal facilities must have permits and licenses
to accept medical wastes. In Pennsylvania, landfills must obtain
specific permit approval for processed infectious and
chemotherapeutic waste.
8.8 Enforcement
EPA has limited information at present on states'
enforcement of their state medical waste regulations, but is
developing an information clearinghouse that will contain this
information. In future reports, this information obtained will
be described. At present, EPA is only aware of the substantial
penalties available in Minnesota, ranging from administrative to
civil and criminal penalties. Administrative penalties may be up
to $10,000; civil penalties may be imposed up to $10,000 per day
of violation. Criminal penalties of up to $10,000 and/or one
year imprisonment ($25,000 and/or up to two years imprisonment
for subsequent offenses) are available.
8.9 Summary
In summary, there are a variety of existing controls on
medical waste management that are imposed by the twelve MWTA
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states (Connecticut, Illinois, Indiana, Michigan, Minnesota, New
Jersey, New York, Ohio, Pennsylvania, Rhode Island, Wisconsin,
and Puerto Rico). The controls range from none at present
(Connecticut and Ohio) to regulating hospital waste as a type of
hazardous waste (Illinois). Many of these states have chosen to
impose packaging, storage, treatment, and tracking requirements,
and some impose disposal limitations as well.
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CHAPTER 9
REGULATORY OPTIONS FOR A NATIONAL PROGRAM
Section 11008(a)(9) of RCRA requests an evaluation of the
"appropriateness of using any existing State requirements or the
requirements contained in Subtitle C as nationwide requirements
to monitor and control medical waste." In conducting this
evaluation, EPA will carefully review existing State medical and
infectious waste requirements, and will also consider elements of
the Subtitle c program to assess the need for a national medical
waste monitoring and control program.
In Section 11008(a)(9), EPA interprets the word "monitor" to
mean the tracking or awareness of a waste's movement, in order to
assure that it is ultimately disposed of properly. Packaging,
labeling, and marking requirements are part of a monitoring
program, as are recordkeeping and reporting requirements
associated with the waste's movement. Several alternatives
available to track or monitor medical vast* have been presented
in Chapter 4. In future reports, this chapter will discuss the
appropriateness of nationwide tracking requirements generally, as
well as the appropriateness of storage, treatment, and disposal
standards to "control" medical waste on a nationwide basis.
Several program implementation issues will be evaluated (e. g.,
the need for facility permits, additional reporting requirements,
and generator/disposer identification numbers). Innovative
relationships between EPA and the states, to improve program
implementation, will be evaluated aa well.
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9.1 Nationwide Tracking
The first issue in evaluating the need for nationwide
tracking requirements is the impact of mismanagement on public
health and the environment. To the extent possible in the final
report, EPA expects to weigh the results of the health and
environmental impact study outlined in Chapter 2, the costs of
mismanagement developed in Chapter 3, and the "success" of the
demonstration program evaluated in Chapter 4, in order to present
a recommendation on the need for a nationwide tracking program
that is similar to the present demonstration program.
The need for a Federal presence in intraatate medical waste
shipments is one activity to be considered in examining
regulatory options. Federal regulation of interstate shipments
to promote uniformity will also be examined. Experience with the
hazardous waste program has shown the need for uniform
information requirements which accompany hazardous waste
shipments.
EPA will consider comments received on the March 24, 1989
interim final regulation in determining whether the program
should be expanded nationwide (with any changes deemed
appropriate after analysis of the public comments), and will
consider whether certain elements of the Subtitle C program
(e.g., identification numbers for generators and treatment or
disposal facilities) should be incorporated into a national
tracking program.
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9.2 Development of Control Options
EPA intends to review state regulations and the Subtitle C
requirements, and to evaluate these and other requirements as
appropriate medical waste control and monitoring methods. The
options prepared will then be evaluated to address costs,
advantages and disadvantages, and implementation and
effectiveness. Most importantly, EPA will consider information
on the health hazards of medical waste to determine the extent of
control needed for the various management practices.
Controls will be evaluated for the following waste
management practices:
Storage. EPA intends to evaluate the need for storage
requirements, at the generator's site or prior to off-site
treatment or disposal. Individual state requirements, the
storage requirements for hazardous waste, and other options will
be addressed in the context of the potential public health
hazards from current storage practices.
Treatment. Chapters 6 and 7 present an evaluation of the
available treatment technologies. The different techniques'
effectiveness may vary substantially from process to process and
from cycle to cycle; in future reports, EPA will evaluate their
effectiveness and will attempt to incorporate this information
into the health hazard assessment described in Chapter 2. A
review of existing state regulations may find appropriate
requirements for the various treatment options. Under the
Subtitle C regulations, treatment of hazardous waste generally
requires a permit. As previously discussed, EPA has begun
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developing regulations for hospital incinerators under the Clean
Air Act.
Disposal. After evaluating health impacts, EPA will
consider whether any state requirements are appropriate, or
whether sons form of treatment standards should be placed on
certain types of medical wastes that are disposed in landfills.
EPA will also consider whether any controls needed should be
implemented through a facility permitting program, or through
other means of compliance determination.
9.3 Federal/State Relations
A number of implementation issues arise when considering a
nationwide program for monitoring and controlling medical waste.
EPA will consider the Subtitle C approach, with its structured
state authorization process, and a rang* of other, less
structured approaches which could include:
- A model state program approach, in which states may choose
elements of a program which reflect state or regional priorities.
States could select the most appropriate elements, and enforce
and implement the program using their own state authorities.
- An approach where states adopt minimum federal regulations
verbatim, using state authority, and include additional
requirements which they determine are necessary. This approach
raises several enforcement and implementation issues which EPA
will explore.
- The approach adopted under the RCRA Subtitle I program,
which requires a state seeking to implement a program to
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demonstrate that the state's requirements and approach for each
of several program elements are no less stringent than the
federal program.
In future reports, EPA will evaluate the advantages and
disadvantages of the various approaches, and will continue to
identify other approaches.
9.4 Export of Medical Wast*
Due to increasing international concern about exports of
various wastestreams, EPA and other Federal agencies are
evaluating waste export practices in general. Current RCRA
authority for regulating exports is limited to exports of
hazardous waste. At this time EPA does not plan to list medical
wastes as hazardous wastes; thus, transboundary movement of
medical waste is not subject to the hazardous waste export
notification requirements. However, the recent United Nations
Environmental Prograa (UNEP) global convention on hazardous waste
exports would place restrictions on transboundary movement of a
broad range of waste, including infectious waste. The United
States is studying the convention.
In evaluating the need for restricting medical waste
exports, EPA will consider the export restrictions developed
under Subtitle C for hazardous waste. These restrictions, found
at 40 CFR 262.50 to 262.58, impose requirements on certain
generators to provide an advance notification of their intent to
export hazardous waste. If EPA obtains an Acknowledgement of
Consent from the receiving country, the shipment can take place,
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provided certain additional requirements are met by the exporter.
EPA will evaluate these requirements as possible controls on the
transboundary movement of medical waste. EPA will also consider
other, more stringent controls that would be required if the U.S.
choses to ratify the UNEP convention.
In addition, EPA will reconsider the appropriateness of the
Subtitle J requirements for regulated medical waste exports. The
regulations at 40 CFR 259.53 require the generator to request the
receiving facility to provide written confirmation of the waste's
receipt. In Section 259.74(e), transporters who transport
regulated medical waste across an international boundary or
deliver the waste to certain receiving facilities in a foreign
country must sign the tracking form and verify delivery. The
transporter then provides written confirmation to the generator
by mailing the signed copies of the tracking form. EPA took this
approach because of the lack of authority to require foreign
facilities to sign and return tracking forms.
EPA intends to evaluate the comments received on the March
24, 1989 interim final rule, and will continue to identify other
possible approaches to controlling transboundary movement of
medical waste.
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CHAPTER 10
APPROPRIATENESS OP PENALTIES
Section 11005 of Subtitle J provides civil penalties of up
to $25,000 per day of noncompliance. Administrative orders
assessing civil penalties must take into account the seriousness
of the violation and any good faith efforts to comply with
applicable requirements. In addition, civil penalties assessed
by the United States or the States must be in accordance with
EPA's "RCRA Civil Penalty Policy." That policy seta out EPA's
policy for determining appropriate administrative penalties for
violations under Subtitle C.
Calculating penalties under the policy consists of: (1)
determining a gravity-based penalty for a particular violation;
(2) considering economic benefits of noncompliance, where
appropriate; and (3) adjusting the penalty for special
circumstances, such as respondents' good faith efforts to comply,
their degree of willfulness or negligence, compliance history and
ability to pay. On March 30, 1989, EPA issued guidance' on use
of the policy for determining civil penalties, in both
administrative and civil cases, for Subtitle J violations.
In addition to civil penalties/ Subtitle J provides for
imprisonment of up to two years or a fine of up to $50,000 per
day of violation for criminal violations. Criminal violations
involving knowing endangerment are punishable by imprisonment of
up to 15 years or a fine of up to $250,000, $1,000,000 for
defendants that are organizations.
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Section 11008(a)(10) of Subtitle J requires EPA to report to
rongress on:
The appropriateness of the penalties provided in Section
1100i5] for insuring compliance with the requirements of
[Subtitle J], including a review of the level of penalties
imposed under this subtitle.
(Note: this provision erroneously refers to Section 11006. As
is clear from the legislative history, the reference was intended
to be Section 11005.)
EPA views that the report required by Section 11008(a)(10)
must address two questions: first, whether penalty maximums
provided by Section 11005 are appropriate for Subtitle J
violations, and second, whether civil penalties assessed and
collected for these violations are appropriate with respect to
their being in accordance with the RCRA Civil Penalty Policy.
These two questions are related since use of the penalty policy
allows for assessing civil penalties below statutory maximums.
There is no data at this time upon which to base any
conclusions. Final penalty determinations are made only after
discovery of violations and the conclusion of the settlement or
litigation process. The demonstration program is still too new
for this to have occurred.
EPA's efforts at this tine, therefore, concentrate on
collecting information that will form the basis for analyses in
the second interim and the final Report to Congress. EPA is
currently setting up procedures for collection by EPA
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headquarters of administrative and judicial complaints, orders
and decrees issued under Subtitle J.
These information collection procedures will cover EPA
Regions, participating states, and the U.S. Department of
Justice.
EPA is also considering a review of penalties obtained by
States using their own legal authorities for violations involving
medical waste management practices. EPA recognizes that it may
be difficult to identify and collect information on these State
violations and then compare it to information involving
specifically federal violations. These comparisons, however, may
shed some light on what is an appropriate penalty level,
especially since there liXely is no direct data on what penalty
levels ensure compliance. In addition/ the amount of information
on penalties for federal violations may be limited due to
concerns regarding the constitutionality of states' use of direct
federal authority.
At this point, EPA does not plan any analyses-of civil
penalties for violations of State authorities that would require
determinations of what penalties would have resulted from the use
of the RCRA Civil Penalty Policy. EPA believes there is little
value in oaking these after-the-fact determinations in an area
where decisions are very case specific and necessarily involve
the exercise of some subjective judgment and enforcement
discretion.
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10.1 Raferancas
1. U.S. Environnental Protection Agency. Guidance en Use of
RCRA Civil Penalty Policy in Assessment of Penalties Under
the Medical Wasta Tracking Act of 1983, Washington, D.C.,
March 30, 1989.
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CHAPTER 11
BOHE HEALTH CAM W*D SMALL QUANTITY GENERATOR WASTE
This chapter addresses the information requested in RCRA
Section 11008(a)(ll) relating to waste generated from home
medical care. Because EPA encourages health care professionals
to transport these wastes from the patient's home and manage them
as regulated medical waste, the guidelines provided in this
chapter are intended for wastes from individuals who self-
administer medical care in their homes.
Section 11008(a)(ll) also requests information on the effect
of excluding small quantity generators from medical waste
management regulations, and potential guidelines for small
quantity generator handling of medical waste. Discussions with
state officials and health care organizations indicate that under
the definition of "regulated medical waste'1 in the EPA rule, the
universe of generators in the less than 50 pounds per month
category would be extremely large (in excess of 100,000). As a
result, EPA has determined that some fora of exemption from the
full tracking requirements is appropriate for generators of less
than 50 pounds per month, because the paperwork burden resulting
from tracking each shipment individually would overwhelm
generators, transporters, treaters and disposers. Requiring
tracking forms to accompany shipments from all generators,
regardless of size, could make the whole tracking system
virtually impossible to administer and thus ineffective.
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Therefore, generators of less than 50 pounds per month of
regulated medical waste are responsible for: proper packaging,
labeling, and narking of waste; use of transporters who have
notified EPA; and use of a log to record when waste is
transported off-site (see §259.50 (e)(2)). These generators are
not required to complete a tracking form for each shipment, nor
are they required to comply with the associated exception
reporting requirements. These two exemptions should result in a
significant reduction of the paperwork burden for medical waste
managers. EPA believes this limited exemption achieves the
appropriate balance between the need to ensure that even very
small quantities of medical vast* are properly managed and the
need to develop a program that can be quickly and easily
implemented. To the extent that management practices of small
quantity generator medical waste affect the demonstration
program, the effects will be discussed in future reports.
As a result, EPA has determined that some fora of exemption
from the full tracking requirements is appropriate for small
quantity generators (generators of less than 50 pounds per
calendar month), because the program's success would be affected
by the burden of unnecessary paperwork. However, waste from
these generators is not completely excluded. Therefore, this
Chapter deals primarily with household-generated waste.
11.1 Background
Skyrocketing health care costs have resulted in shortened
hospital stays, increased availability of out-patient treatment
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and diagnostic procedures, and a general trend toward hone health
care for post-surgical, terminally ill, and bedridden patients.
As a result, each year millions of patients undergo treatment and
diagnostic procedures at hone. A significant portion of this
care is provided by family members and friends; however, home
health cara providers such as visiting nursea and medical
technicians also provide health care. In many cases home health
care is self-administered (e.g., diabetics often self-administer
insulin).
If this trend in home health care continues, the number of
medically related devices used at home and disposed of in
household waste will also increase. Once disposed of in the
domestic waste stream, these wastes may pose a potential risk of
injury to family members and refuse workers. The potential risk
of infection from these wastes generally appears to be minimal.
In Chapter 2 a procedure for evaluating the infectious and injury
hazards of medical wastes was outlined. Haste items generated
from home health care, although excluded from the definition of
medical waste, differ from some of the Section 11002 waste types
only in their source (e.g., sharps). EPA anticipates that the
type of health hazards from home health care wastes will be
similar to those from medical wastes; however, the degree of
hazard may differ. In a future report we will address the degree
of potential hazard.
Section 1004(40) of RCRA specifically excludes any
household waste, as defined in regulations under subtitle C, from
the definition of "medical waste." [Household waste is defined
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in 40 CFR 261.4(b)(l) as material derived from households,
including single and multiple residences, hotels and motels,
bunkhouses, ranger stations, crew quarters, campgrounds, picnic
grounds, and day-use recreation areas.] Thus, waste generated
from home health care is excluded from tracking, segregation, and
packaging requirements under Subtitle J of RCRA and, therefore,
remains unregulated unless covered by State or local regulations.
However, section 1100B(a)(11)(A) of the Medical Waste Tracking
Act requires EPA to report on the effect of excluding households
(and small quantity generators) from regulation. Section
11008(a)(11)(B) requires the Agency to establish guidelines for
the handling, storage, treatment, and disposal of these wastes.
In carrying out the congressional mandate under section
11008(a)(11)(A), the Agency plans to refine its estimate of the .
quantity of health care waste which is being generated in
households. In conducting this evaluation, EPA is comparing the
hone health care wastes to the medical waste types listed in
section 11002 of the Medical Waste Tracking Act or regulated at
40 CFR 259.30(a) and will evaluate potential impacts on public
health and the environment from excluding such waste from
Subtitle J regulation. In response to section 11008(a)(11)(B),
this report also describes the educational activities currently
underway.
This section of the report to Congress provides available
estimates on quantities of household healthcare waste generated
per year and outlines EPA's strategy for public education on
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proper management and disposal of these wastes. The following
specific topics are addressed:
identification and characterization of home health care
waste,
estimated quantities of health care waste generated and
disposed of from households,
impacts from excluding home health care waste from
regulation under Subtitle J,
EPA's home health care waste education program,
recommendations for safe handling of home health care
waste, and
alternative disposal options.
11.2 Identification and Characterisation of Home Health care
Watte
The first step in identifying the waste items generated from
home health care that are listed in section 11002 or regulated
under Subtitle J require* certain information regarding typical
home health care practices (i.e., the types of treatment and
diagnostic procedures generally conducted in the patient's home).
The following medical procedure* are often administered to
elderly and acutely and chronically ill hone care patients:'
1. dialysis
2. administration of medication by injection, 'nebulization
(i.e., fine mist or spray), or IV (i.e., parenterally)
3. respiratory care
4. total parenteral nutrition (i.e., feeding by IV)
5. suctioning of body fluids
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6. changing of surgical drassings
7. sanitizing of equipment and other medical devices
Although this list is not exhaustive, it includes procedures
that are likely to generate wastes that nay pose health hazards
to family members or waste handlers. These wastes may be
infectious, aesthetically displeasing, or result in physical
injury.
Wastes generated from these procedures often vary in
quantity and type dua to variations in treatment regimen,
frequency and duration of treatment or diagnostic procedure, and
general condition of the patient. For example, cara of acutely
ill patients may generate needles and syringes (i.e., sharps)
from administration of medication, IV sets, suction tubing,
dressings and gauze containing blood and body fluids, and other
wastes depending upon treatment regimen or diagnostic procedure.1
Diabetics typically generate needles and syringes from self-
administration of insulin and, to a lesser extent, lancets from
blood glucose tests. Wastes from hone dialysis vary according to
dialysis method. Needles, filters (dialyzers), and tubing are
generated from hemodialysis; however, peritoneal dialysis
typically generates dialysis bags.' Although many home care
patients require respiratory support, the equipment is generally
sanitized for reuse and spent disinfecting solutions are
discharged to the sewer or septic system.'
The following materials and medical devices are some of the
waste items listed in RCRA section 11002, or in the RCRA Subtitle
-------
J regulations at 40 CFR Part 239, and ara likely to «nter the
domestic waste stream from administration of the home health care
procedures identified above:
1. used and unused sharps such as needles and syringes,
and lancets
2. IV sets including tubing and bags
3. dialysis sets including tubing, filters and materials
contaminated with the blood of patients undergoing
dialysis
4. soiled surgical dressings and other materials
contaminated with blood or blood products (e.g.,
gloves, gauze, dressings, disposal pads, etc.)
EPA does not expect the waste types listed in RCRA section
11008 (a)(l), (a)(2), (a)(5)-(a)(7), (a)(9), or (a)(10) to be
generated in home health car* settings in significant quantities.
Finally, items such as syringes and needles that have been used
by intravenous drug abusers may be considered as household waste.
The next report should provide some data on quantities of
household waste generated by drug abusers.
11.3 Estimated Quantities of HOB* Health Car* Waste
The data presented here are derived from published
information from national organizations, and discussions with
medical device manufacturers and home health care
representatives. The estimates presented represent minimum
volumes of home generated health care vast* because limited data
exist with respect to total numbers of patients receiving such
care. Although some data are available from studies on total
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volumes of medical wast* generated from health care institutions
such as hospitals and clinics, minimal data are available on the
prevalence of waste generated from home health care. EPA will
continue to explore the availability of data, and will report
findings in the subsequent interim report. The final report will
address data gaps and research needs.
Estimated- Number Of Sharps
Diabetics. Approximately 1.4 billion insulin syringes were
used by outpatients in 1987.' However, this estimate may include
syringes generated from hospital outpatient clinics, as well as
those generated in other places where diabetics self-administer
medication. An estimate of one billion insulin syringes used in
home car* in 1987 is derived from another source,' which yields
an estimate of over 1 billion ayringea used by diabetic
outpatients.
Approximately 300 million self-administered blood glucose
tests were performed by diabetics in 1987.' These tests require
a lancet for blood letting. Thus, assuming a single use of each
lancet, 300 million can be used as an estimate for lancets
generated and disposed of p«r year.
Dialysis. There were approximately 5,000 horn* hemodialysis
patients during 1986. Each of these patients used, on average, 18
needles per weak.' Thus, approximately 5 million needles and
syringes per year are generated from home hemodialysis patients.
Total Pare/iCera! Nutrition (TPN). There are approximately
4,000-6,000 patients receiving TPN (i.e., intravenous (IV)
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feeding) at any given time during the calendar year. Each
patient uses, on average, 4 sharps par day for administration of
fluids and ancillary drugs.' " Therefore, the estimated number
of sharps per year from TPN is 6-9 million.
Total Sharps Genoratod From Home Haalth Care Per year. In
estimating total sharps generated and disposed of per year, the
Agency used the upper bounds of the estimated ranges. Thus, the
data estimates that approximately 1.4 billion sharps per year are
used and discarded in domestic waste streams. This estimate is
based on the assumption that all sharps used in home health care
are disposed of in household trash receptacles (i.e., sharps are
not transported outside of the home for disposal at hospitals,
clinics, or other facilities). It may overestimate the total
number in household trash, because diabetics may self-administer
medication at locations other than the home (e.g., in the
workplace or places of recreation) and some may be removed from
the home by health care providers. It is important to recognize
that these figures do not include patients who may be receiving
intravenous antibiotics or chemotherapeutic drugs. Also, figures
are not currently available for patients who self-administer
allergy injections. However, the Agency has been informed by the
National Institutes of Health that allergy patients are advised
against self-administering allergy injections.
Estimated Quantities of Home Health Care Wastes Other Than Sharps
Dialysis Wastes. Approximately 80,000 waste dialyzing units
from home hemodialyais patients were generated in 1986.
11-9
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Approximately 10,500 renal patients received continuous
ambulatory peritoneal dialysis, which generated 15.3 million
waste fluid bags per year. It is estimated that at least one
half of these patients also disposed of tubing sets at each
change of fluid. Therefore, a minimum ot 7.6 million tubing sets
must also be considered as waste generated by patients being
treated at hone (assuming the fluid changes are made in the
patients' residences). Actual volumes generated are expected to
be higher because an accurate assessment requires data on the
actual frequency of tubing changes." "
Total Parenteral Nutrition. Approximately 1.5 million fluid
bags per year are generated and disposed of from home health care
patients receiving IV feedings.11
Total Estimates For Wastes Other Than Sharps. Since there
are no reliable estimates on the numbers of patients being
treated at home for the vide variety of medical conditions that
nay result in other waste items/ EPA cannot at this time provide
an estimate. It is likely that these wastes are only a small
proportion of the total residential waste stream. We will
address the feasibility of conducting a study to obtain needed
information.
11.4 Effects of Excluding Boa* Health care waste Froa Regulation
under Subtitle j
An evaluation of the impacts from excluding household
medical wast* from regulation requires information on the
universe of patients receiving medical care at home, estimates of
waste generation rates per patient, current household medical
11-10
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waste disposal practices, and an assessment of the effects of the
exclusion on municipal waste handlers and potential public
exposure.
Although the hone health care waste stream has not been
completely characterized here, the results in Table 11-1 show
that, except for sharps, the wastes identified are generated in
very small quantities when compared to the regulated medical
waste estimates in Chapter 1. The Agency has determined that
significant numbers of sharps are generated in the home health
care setting, and that sharps pose hazards of physical injury and
have the potential to transmit pathogens and cause infection.
Therefore, EPA has initiated an education program aimed primarily
at sharps used in home health care.
11.5 EPA Bom* Health Care Waste Education Prograa
The Agency has implemented the initial phase of its
household health care wasta educational program. The primary
focus of the prograa is to provide guidance on proper packaging
and disposal of home health care waste prior to placement in the
household waste stream. Through public education, the Agency
hopes to reduce potential risks to family members and refuse
workers from improper management of wastes such as sharps.
The Agency has developed guidelines for proper management
of medical wasta from home health care (see Section 11.6 below).
In addition, the Agency is co-sponsoring a public service message
which summarizes guidelines for safe packaging of sharps and
other household medical waste (see Exhibit 11-1). The message
11-11
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TABLE 11-1
Estimated Annual Quantities of BOB* Health car* Wast*,
by Source and Vast* Typ*
Soureas and Quantities I mill ions)
Waste Tyce Dialysis Diabetics TPN
Needles & Syringes 5.0 1,400
Lancets N/A 300
Tubing 7.6 N/A
IV and Fluid Bags 15.3 N/A
Equipment Filters .08 N/A
** » Information Not Available
No. of items
Was^e T,ypi fmillionai
Needles & Syringes 1,400
Lancets 300
Tubing 7.6
IV and Fluid Bags 16.8
Equipment Filters .08
9.0
N/A
**
1.5
N/A
Weight
ftons^
7,000
150
950
1,000
40
SOURCE: References 5-19
11-12
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highlights sharps disposal; however, it also includes guidance on
disposal of other homa haalth care wastes such as soiled
dressings, gloves, etc. EPA, in conjunction with the other
sponsoring organizations, has also prepared an information
brochure for health care professionals, which provides background
information on the EPA medical waste program, it was designed
for use by those disseminating the public service message to
patients or persons who use or purchase sharps for home health
care (see Exhibit 11-2).
These guidelines represent minimum recommendations for
citizens to package their wastes from home medical care. Some
States and localities may recommend additional procedures.
Options for developing a long-tern approach to managing these
wastes are presented in section 11.7.
11.6 Recommendations for Packaging, Storage, aad Disposal of
Home Haalth Care Waste
This section provides detailed guidelines for proper
packaging, storage and disposal of wastes from home health care.
Although such waste is not "medical waste" as the term is defined
in RCRA Section 1004(40), EPA recommends that health care
professionals providing home health care remove these wastes from
the patient's home and manage them as regulated medical waste.
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Househg|j Health Care Waste
EPA recommends that the following wastes from home health
care be placed in protective packaging before placement into
household trash receptacles:
• needles and syringes, lancets, and other sharps
materials soiled with blood or blood products (e.g.,
gauze, dressings, disposable sheets and pads, tubing
and catheters)
• other medical devices (e.g. peritoneal dialysis bags)
Recommended Packaging and Handling Methods
Needles and Syringes, Lancets, and Other Sharps. These
materials should be placed in a tightly closed, hard plastic or
metal container before disposal in household trash receptacles.
The Agency does not recommend the use of glass containers or soft
plastic containers. Class containers may break, and soft plastic
containers may tear or puncture during handling. Examples of
hard plastic and metal containers typically present in the
household are:
• metal coffee cans
• hard plastic milk or juice containers
• hard plastic soft drink or beverage containers
To avoid spillage, the Agency recommends that caps be
tightly fastened. Non-screw caps and lids (e.g., plastic coffee
can lids) should be secured with heavy duty tape such as duct
11-14
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tape. While the containers are being used to accumulate the
sharps, EPA recommends storing them out of the reach of young
children.
In its 1986 guidance document, the Agency states that
"clipping of needles is not recommended, unless the clipping
device effectively contains needle parts which might otherwise
become airborne and pose a hazard" and "devices used to clip
needles within a totally enclosed system are acceptable."" These
devices are available commercially and may be used in home health
care. However, when such devices are not available, the Agency
continues to discourage clipping of needles. Recapping of
needles should likewise be avoided due to risk of needlestick
injury. Where State or local law requires destruction of needles
before disposal, patients and health care workers should consult
with State or local officials for further information.
Gauze, Dressings, Disposable Sheets and Pads Soiled with
Blood or Blood Products. These materials should be placed in
tightly secured plastic bags before disposal in household trash
receptacles. Although plastic bags are preferred because they
resist fluid leakage, when plastic is not available heavy-duty
paper bags (e.g., supermarket paper bags) may be used. Items to
be placed in paper bags should be wrapped in absorbent paper
(such as newspaper or paper towels) before placement in the bag.
This practice will help to absorb fluids and reduce seepage.
Paper bags should also be tightly secured with rubber bands,
string, tape, or plastic fasteners.
11-15
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In cases where materials are saturated or dripping with
blood or body fluids, the Agency recommends wrapping these items
in absorbent paper prior to placement in either plastic or paper
bags to reduce respective pooling or seepage of fluid.
Other Medical Devices. These items should be packaged in
the same manner as materials soiled with blood and blood
products; however, when fluid seepage is not a problem, items may
be discarded directly into plastic or paper bags without wrapping
in absorbent material.
Liquids may be poured down a drain or in the toilet, for
disposal in either the home septic system or the public sewer
system. If indoor plumbing facilities are not available, these
liquids should be placed in a leak- and break-resistant container
that is tightly capped or stoppered, before placement in the
household trash receptacle.
Recommended Storage and Disposal
Properly packaged household medical waste should be placed
into home trash receptacles and made available for the next
scheduled municipal or private trash picJcup. If such pickup is
unavailable, persons should transport the waste, as other
household waste, to the sanitary landfill or municipal
incinerator. Disposal of medical waste into the sewer system is
addressed in Chapter 6.
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Consistency with Other Household Medical Was^a Guidance
Although existing guidance on management of home health care
waste is limited, the Agency guidelines are comparable to
recommendations provided by the Association for Practitioners in
Infection Control (APIC)." The APIC recommendations address,
among other things, proper home health care practices for primary
protection of patients from disease and infection.
APIC recommends that needles be placed in capped puncture
resistant containers and placed in trash receptacles when filled.
APIC also recommends discharging body fluids to the toilet and
placing soiled dressings, used gloves, and disposable equipment
in plastic bags before discarding them. Other health care
groups, such as the American Medical Association, have been
contacted to assist in guidance development concerning this
issue.
11.7 Alternative Management option*
EPA recommended guidelines for home health care waste
provide a starting point for reducing potential risks posed by
these wastes. However, the success of a voluntary program for
managing household medical waste depends upon two major factors—
ease of implementation and public willingness to participate.
The Agency recognizes that some patients may show an
unwillingness to participate and others may be unable to provide
materials needed to safely package medical waste originating from
home health care. For example, in cases where bedridden patients
are totally dependent on others for care, food preparation may
11-17
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not occur in the patient's home. Thus, items such as disposable
plastic jugs and containers needed for proper packaging of sharps
may not be readily available in the home. Also, many poor and
elderly patients nay not have adequate supplies of plastic or
paper oags for packaging of these wastes, or they nay be
unwilling to change current household waste management practices.
Therefore, the Agency is seeking alternative or additional
options for managing medical waste from home health care.
EPA is coordinating with suppliers of medical devices,
pharmaceutical and home health care associations, and waste
management associations to gather data on alternative disposal
options for household medical waste which will reduce potential
risks associated with improper disposal of these wastes. EPA is
exploring the following options:
Option I
Some manufacturers and distributors of medical devices are
providing sharps containers to certain l^me care patients." Some
of these companies provide pickup of filled containers; others
instruct patients in proper disposal of the container. However,
at this time, the Agency is not sure whether this service can be
provided-to all patients at a reasonable cost.
Option II
The National Solid Waste Management Association has
suggested the use of pharmacies as horn* health care waste
collection centers or drop-off points for sharps and other
11-18
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designated wastes. Under this approach, patients would return
properly packaged used sharps and certain other medical devices
to designated pharmacies. The phandacy would bear the
responsibility for proper storage and disposal of these wastes.
This alternative to home disposal of sharps raises the following
important issues which nay discourage pharmacy participation in
the program:
increased risk of worker exposure from additional waste
handling,
limited storage areas,
the need for uniform packaging of sharps (by patients)
to facilitate pharmacy storage, and
a shift in disposal costs from the household to the
pharmacy.
The benefits derived from central collection centers may not
outweigh the potential risks posed by increased handling and
transportation of these wastes (i.e, motor vehicle transport from
private homes to pharmacies) by Individuals.
One variation on this option includes having individuals pay
a deposit for the us* of a rigid, puncture-resistant container,
which they return to the pharmacy filled with used sharps, to
receive their deposits back."
Option III
The medical supply industry is also evaluating the use of
prepaid disposal systems such as mail-back of used sharps and
other medical devices. This option may have some utility in
11-19
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certain situations; however, it should ba fully evaluated because
of potential increased risks to workers and home health care
workers or other persons who must repackage the waste materials
for mailing. In addition, the Postal Service is considering
limitations on certain shipments (see 54 FR 11970).
Option IV
Another option, although not an alternative to disposal with
municipal refuse, involves manufacturer packaging of needles and
syringes (and other sharps) in hard plastic packages that can be
resealed or tightly capped for disposal. This approach is
similar to the packaging used by certain razor blade
manufacturers where the blade dispenser contains a compartment
for used bladea. A used sharp, once repackaged in its original
rigid packaging, can be safely discarded into the household trash
receptacle.
Option V
One final option is to encourage municipalities to conduct
special programs for collection of these materials, which could
be held, for example, in conjunction with a household toxics
waste collection program. The household waste programs are
typically conducted as an event when residents are encouraged to
bring household chemicals to a central collection point, where
the wastes are packaged and shipped to a hazardous waste
facility. A potential drawback to this approach is the
relatively infrequent scheduling of the events; with wastes that
11-20
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contain organic materials, some decay may occur. However, this
approach may be valid for certain wastes that pose special
concerns (for example, sharps).
Agency Action. EPA will evaluate the above listed options,
and report progress in subsequent reports.
11-21
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Exhibit 11-1.
BOMB HEALTH CARS WASTE GUIDELINES
Educating Your Patients
Every year, Americans use over one billion sharp objects in their
hones to administer health care. These "sharps" include lancets,
needles, and syringes. If they are not disposed of in puncture-
resistant containers, they can injure trash handlers, can
increase the risk of infection if they come in contact with
contaminated materials such as bandages, dressings, and surgical
gloves, and can pollute the environment.
As health-care professionals, you plan an important role in
instructing your patients and clients on hov to safely practice
health care at home. Through this brochure, we are asked your
help in distributing the attached disposal tips to them. The
tear-out explains hov to safely dispose of sharps and other
contaminated medical waste, such as bandages and soiled
disposable sheets.
We urge you to distribute the disposal tips tear-out to your
patients and to encourage them to read it. You might also place
this information in areas easily accessible to all your patients
and clients.
11-22
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You can get additional free copies of this brochure or reprints
of the tear-out by sending the attached order fora to the EPA.
For further information on medical waste, you can call the RCRA
Hotline Monday through Friday, 8:30 a.m. to 7:30 p.a. EST. The
national toll-free numer is (800) 424-9346; for the hearing
impaired, it is TDD (800) 553-7672. In Washington, DC, the
number is (202) 382-3000 or TDD (202) 475-9652.
Disposal Tips for Home Health-care
You can help prevent injury, illness, and pollution by following
some simple steps when you dispose of the sharp objectives and
contaminated materials you use in administering health care in
your home. You should place:
Needles,
Syringes,
Lancets, and
Other sharp objects
in a hard-plastic or metal container with a screw-on or tightly
secured lid.
A coffee can will do, but you should be sure to reinforce the
plastic lid with heavy-duty tape. Do not put sharp objects in
11-23
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any container that will be recycled or returned to a store. Do
not use glass or clear plastic containers. Finally, nake sure
that you keep containers with sharp objects out of the reach of
young children.
We also recommend that:
soilded bandages,
disposable sheets, and
medical gloves
be placed in securely fastened plastic bags before you put them
in the garbage can with your other trash.
Your state or community environmental programs may have other
requirements or suggestions for disposing of your medical waste.
You should contact them for any information you may need.
More Information
For additional free copies of these disposal tips, pleas* call
the RCRA Hotline Monday through Friday, 8:30 a.m. to 7:30 p.m.
EST. The national toll-free number is (800) 424-9346; for the
hearing impaired, it is TDD (800) 553-7672. In Washington, DC,
the number is (202) 382-3000 or TDD (202) 475-9652.
11-24
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HOB* Health-Car* Spongers
This program is sponsored by:
U.S. Environmental Protection Agency
American Diabetes Association
American Hospital Association
American Society for Hospital Engineering
American Society for Healthcare Environmental Services
Association for Practitioners in Infection Control
Association for State and Territorial Health Officials
Health Industry Distributors Association (HIDA)
Health Industry Manufacturers Association
National Association for Hone Care
National Solid wastes Management Association
visiting Nurse Association
11-25
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Exhibit 11-2.
HOKB HEALTH CARE WASTE BROCHURE
An Important Message to Health Care Professionals
The Horn* Health-Car* Program
Improper handling of wastes from home health-care activities may
pose a risk of injury, infection, and environmental
contamination. EPA and its co-sponsors have begun a program to
educate recipients and providers of in-home health care.
The home health-care program focuses on the proper packaging and
containment of needles, syringes, and other sharp objects before
they are put into trash cans or other household receptacles.
Each year, over one billion sharp objects are used in self-
administered health care.
Because you--the health-care professional—play an important role
in providing information and guidance to your patients and
clients, EPA seeks your assistance in distributing the
information provided in the attached flyer. The goal is to
provide this information to every person who purchases or uses
needles, syringes, or sharp objects in health-care activities in
the home or who purchase* any medication that is routinely
administered by injection.
11-26
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The flyer which makes up the last page of this brochure outlines
simple procedures for disposing of household medical waste in a
safe, environmentally sound manner. These procedures will reduce
risks of injury, infection, and environmental pollution. Some
general guidelines on proper disposal of other contaminated itens
such as bandages, dressings, soiled disposable sheets, and
medical gloves are also included. We recommend that you place
the flyers in areas easily accessible to all patients and
clients.
The Federal Medical Waste Prograa
In response to incidents such as medical waste washing up on
beaches, Congress enacted the Medical Waste Tracking Act of 1988.
Under this law, EPA published regulations on March 24, 1989,
setting up a demonstration program in several states to track
medical wastes froa where they are generated to where they are
disposed. The regulations apply to medical practitioners and
facility owners or operators who generate, transport, treat, or
dispose of certain medical wastes.
Home health-care waste has been excluded from the Medical Waste
Tracking Act, and therefore such wastes are not regulated. Even
though home health-care wastes are excluded from the law,
Congress has requested EPA to investigate whether these wastes
contribute to health or environmental problems and to evaluate
the need for alternative guidelines for handling these wastes.
11-27
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Based on the outcome of the study, Congress may require
additional regulation of household waste. While the study
continues, EPA believes it is prudent to begin a nonregulatory,
educational approach to handling waste from home health-care
activities.
Hev Home Health-Car* Provider! can Help
You can help by informing your patients about safe disposal
methods. For example, sharp objects (such as lancets or syringes
with needles) that are not placed in puncture-resistant
containers can cause physical injury, increase the risk of
infection if associated with infectious materials, and
contaminate the environment. The debris found on New York
beaches contained a small proportion (approximately one percent)
of syringes, blood vials, and other medical materials. This
debris appears to have resulted from improper waste-management
practices such as littering by individuals or during bulk waste
transfer operation!. The extent to which home health-care wastes
are part of this problem is not known. However, syringes and
other sharp object! placed in household trash can be released to
the environment during waste handling and transfer operations and
pose a physical hazard to handler* and anyone else who comes in
contact with then.
EPA, along with its co-sponsors, have established guidelines to
ensure the proper containment of such materials before they leave
11-28
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the home and become part of the waste stream. We urge you to
participate in this education program by distributing the flyer
and encouraging your patients and clients to read it.
For further information on medical waste, please call the RCRA
Hotline Monday through Friday, 8:30 a.m. to 7:30 p.m. EST. The
national toll-free number is (800) 424-9346; for the hearing
impaired, TDD (800) 553-7672. In Washington, D.C., the number is
(202) 382-3000, or TDD (202) 475-9652. For additional free
copies of this brochure or reprints of the flyers, please
complete and mail the attached order fora or call the RCRA
Hotline.
Office of Solid Waste
United States
Environmental Protection Agency
401 M Street, S.w.
Washington, DC 20460
11-29
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11.8 References
1. Hughes, C., Telephone communication with C. Hughes, National
Association of Hone Health Care and Jacqueline Sales, April,
1989.
2. Ibid.
3. Bovmann, R., Telephone communication with R. Bowman,
National Association of Patients on Hemodialysis and
Transplantation and John H. Keene, April, 1989.
4. Dunne, P., Telephone communication with P. Dunne, SW Medical
Home Care, member American Association of Respiratory Care
and Jacqueline Sales, April 1989.
5. American Diabetes Association, Direct and Indirect Costs of
Diabetes in the United states in 1987. Alexandria,
Virginia, 1988.
6. Harris, A., Telephone communication with A. Harris, Becton-
DicXenson, Inc. and John H. Keene, April 1989.
7. American Diabetes Association, Direct and Indirect Costs of
Diabetes in the United States in 1987.
8. The Urban Institute, U.S. Renal Data System, April 1989,
9. Sykes, T., Telephone communication with T. Sykes, Abbott
Laboratories Home Care Division and John H. Keene, April
1989.
10. Kohlmeyer, C., Telephone communication with C. Kohlmeyer,
Baxter Health Care Corp. and John H. Keene, April 1989.
11. The Urban Institute, U.S. Renal Data System, April 1989
12. Telephone communication with Chief Nurse, Renal Dialysis
Unit, Medical College of Virginia Renal Dialysis Unit and
John H. Keene, April 1989.
13. King, M., Telephone communication with M. King, Abbott
Laboratories Hoae Care Division and John Keene, April 1989.
14. U.S. Environmental Protection Agency, Office of Solid Haste.
EPA Guide for Infectious Paste Management. EPA/530-SW-86-
014, May 1986.
15. Association for Practitioners in Infection Control (APIC),
"APIC Curriculua for Infection Control Practice," Vol. Ill,
1988.
16. Bridges, B., Telephone communication with B. Bridges,
Sherwood Medical and John H. Keene, April 1989.
11-30
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CHAPTER 12
KEDICAL WASTE RZUBI, RECYCLING AKD REDUCTION
Section 11008(a)(12) of RCRA requests information on
"available and potentially available methods for the reuse or
reduction of the volume of medical waste generated." Chapters 6
and 7 addressed some of the available methods for reducing the
volume of medical wastes that have been generated. This chapter
briefly describes some of the possible source reduction
strategies to reduce, avoid, or eliminate a waste's generation,
as veil as possible recycling and reuse techniques.
12.1 Recycling and Reuse
Potential recycling and reuse techniques generally fall into
two types: recycling techniques that involve substantial
reprocessing in ways that usually affect the waste's structural
integrity, and techniques that involve a cleaning/disinfection
process and subsequent reuse (without significantly affecting the
waste's structural integrity). An example of the former
technique is the recycling of glassware by remelting and forming
into glass again; an example of the latter is the cleaning,
sanitizing, and sterilization of a disposable or reusable medical
device.
The various recyclable materials of a medical facility's
wastestream that can be reprocessed by remanufacturing include
glassware, paper, metals, and plastics. EPA is aware of one
facility that recycles laboratory glassware by returning it to a
12-1
-------
glass recycling facility'. Plastics nay also be recycled by
melting and reextrusion; for plastic medical wastes, this
technique say be feasible in some situations'. At this tim« EPA
has no information on the number of facilities recycling paper,
or netal-containing medical wastes. In future reports, EPA will
address the extent of recycling and the feasibility of these
techniques in greater detail.
Use, of medical supplies is widely practiced for certain
items. Tor instance, laboratory glassware is frequently cleaned
and sterilized for reuse, and bed linens are laundered for reuse.
Reprocessing or reuse of single-use medical devices raises a
number of technical, economic, ethical, and legal issues. The
presence of residues from the reprocessing could affect the
quality of a patient's care; the health care facility may be
concerned about potential liability from reusing the device;
devices that were not designed for multiple uses could fail when
reused, and there may be inadequate or non-existent quality
control for the sterilization procedures used1.
12.2 Source Reduction
Health care facilities nay have a number of options
available for avoiding, reducing or eliminating a medical waste's
generation. If some wastes are generated due to overpurchasing
items with a limited shelf life, or due to storage or handling
practices that cause materials to be less useful, improvements in
these materials management practices can potentially yield
reductions in wastes generated. Instituting procedures for
12-2
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employes suggestions and developing employee training and "waste
awareness" are other possible methods.
EPA intends to conduct a more in-depth review of facility's
equipment and supply use practices which nay reveal other waste
reduction possibilities. For example, it may be possible to
modify the design of medical equipment so that less waste is
generated. Material* substitutions may be evaluated in the final
report for waste reduction potential. EPA intends to investigate
these ideas and report on them in future reports to Congress.
12.3 Qeneration Rates
Medical facilities can evaluate their waste management
practices using indicators of waste quantity and composition.
Chapter 1 discusses the amounts of medical wastes generated
(although that analysis is limited to regulated medical wastes).
A large medical waste generator, such aa a hospital, can assess
its own waste generation rates according to the different waste
sources in the facility. For example, one study found that an
important variable in hospital waste generation rates is the
total paid staff of a unit, for a 24-hour period, excluding
doctors'. Table 12-1 lists the correlations found; although the
data nay not reflect current waste generation rates, they
illustrate one technique in which a hospital could systematically
identify large waste sources.
12-3
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Tmtole 12-1.
Medical wast* Production, by Source
SOURCE GENERATION RATE
(lb/day)
Heavy-care units 4.47 times the number of paid
(surgery, burns, maternity) staff for those units
Light-care units 2.77 times the number of paid
(psychiatric, neurology) staff for those units
X-ray, emergency room, 0.48 times the number of
central supply patients treated
Laboratory and clinics 0.19 times the number of
tests or patients
12.4 Agency Action
In future reports, EPA will evaluate the potential for
recycling the various components of the medical wastestream, and
the extent to which facilities already use recycling techniques.
In addition, EPA will attempt to assess the potential reduction
in single-use/disposable medical supplies, while considering the
reasons that have caused health care facilities to increase their
use.
12-4
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12.5 References
Ceo/Resource Consultants, Inc. Memorandum, Washington,
D.c., May 15, 1989.
Telephone conversation with Denise Zabinski and Sidney
Rankin, Center for Plastic Recycling Research, Rutgers, NJ,
February 1989.
Georgetown University Medical Center. International
Conference on the Reuse of Disposable Medical Devices: Legal
and Public Policy Issues, Washington, D.C., November 1986.
Burchinal, J.C. and P. Wallace. Hospital Solid Waste
Disposal in Community Facilities. U.S. Environmental
Protection Agency, Washington, D.C., 1973.
12-5
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BIBLIOGRAPHY TO THE REPORT TO CONGRESS
ON MEDICAL WASTE MANAGEMENT IN THE U.S.:
FIRST INTERIM REPORT
Allen, R., G. Branniman, R. Logue, and V. Strand. "Emission of
Airborne Bacteria from a Hospital Incinerator", Journal of
•fcfie Air Pollution Control Association. Vol. 39, No. 2, 1989.
American Association of Blood Banks. 1987 Annual Report.
American Dental Association. 1982. Distribution of Dentists in
the U.S., 1982. Chicago, Illinois.
American Diabetes Association, Direct and Indirect Costs of
Diabetes in the United States in 1987. Alexandria,
Virginia, 1988.
Amarican Diabetes Association, pj,ree^ and Indir«q<^ Costs of
Diabetes in the United States in 1987.
American Hospital Association. 1987. Hospital statistics.
Chicago, Illinois.
American Medical Association. 1985. Medical Groups in the U.S.,
1984. Chicago, Illinois.
American Medical Association, Physician Characteristics and
Distribution in the U.S.. 1986.
American Veterinary Medical Association. Distribution bv
Specialty Codes and State.
Association for Practitioners in Infection Control (APIC), "APIC
Curriculum for Infection Control Practice," Vol. Ill, 1988.
Bowmann, R., Telephone communication with R. Bowman, National
Association of Patients on Hemodialysis and Transplantation
and John H. Keen*, April, 1989.
Bridges, B., Telephone communication with B. Bridges, Sherwood
Medical and John H. Keene, April 1989.
Burchinal, J.C. and P. Wallace. Hospital Solid Waste Disposal in
Community Facilities. U.S. Environmental Protection Agency,
Washington, D.C., 1973.
Cross, F. "Comparison of Disposal, Incineration, Chemical,
Pulping, Radiation, and Sterilization Techniques for
Infectious Waste," Infectious Waste Disposal Conference,
Washington, D.C., November 29-30, 1988.
A-l
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Dunne, P., Telephone communication with P. Dunne, SW Medical Home
Care, member American Association of Respiratory Care and
Jacqueline Sales, April .1989.
Geo/Resource Consultants, Inc. Memorandum, Washington, D.C., May
15, 1989
Georgetown University Medical Center. International Conference
on the Reuse of Disposable Medical Devices; Legal a.nd Publig
Policy Issues. Washington, D.C., November 1986.
Grayson, M. Letter to Jonathan Cannon. April 16, 1989.
Habib, I. Comment IIWMA-00043 on June 2, 1988 Federal Register
notice, July 25, 1988.
Harris, A., Telephone communication with A. Harris, Becton
Dickenson, Inc. and John H. Keene, April 1989.
Hughes, c., Telephone communication with C. Hughes, National
Association of Home Health Care and Jacqueline Sales, April,
1989.
Ibid.
Indiana Funeral Homes Association. "State Count of Funeral
Homes." \n-Fy-DJ-AS. March/April 1988.
Kelley, H., G. Brenniman, and J. Kusek. "An evaluation of
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Xerns, W. Letter to Denis* ZabinsKi. August 11, 1988.
King, M., Telephone communication with M. Xing, Abbott
Laboratories Horn* Car* Division and John Keene, April 1989.
Kohlmeyer, C., Telephone communication with C. Kohlmeyer, Baxter
Health Care Corp. and John H. Keen*, April 1989.
Layne, P., W. Hestbrook, K. Hendry, and T. Pierson. Reyjev and
Evaluation of Existing Literature on Generation. Management.
and Potential, Health Effects of Medical Waste. Contract No.
68-01-7075, U.S. Environmental Protection Agency,
Washington, D.C., November 1988.
Lee, C.H., T.J. Montville, and A.J. Sinskey. "Comparison of the
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A-2
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Memorandum to the Record. Preliminary Estimates of Quantities of
Medical Waste by Generator Type. July 31, 1989.
Washington, DC.
National Funeral Directors Association, state Count of Funeral
Homes.
New York Department of Health. 1988. Infectious Waste: A
Statewide Plan for Treatment and Disposal (Preliminary).
August 198S.
New York State Department of Environmental Conservation.
Investioaitj.9n; Sources of the pea.ch Washuos in 1988.
Albany, NY, December 1988.
Odette, R.L. 1988. Survey of Infectious Waste Management
Practices in Selected Acute Care Hospitals in the United
States. Unpublished M.S. Thesis, University of North
Carolina at Chapel Hill.
Ofiara, D. and B. Brown, "Marine Pollution Events of 1988 and
Their Effect on Travel, Tourism, and Recreational Activities
in New Jersey," paper presented at the Floatables Wastes in
the Ocean Conference, State University of New York,
Stonybrook, NY, Mar. 21, 1989.
Personal communication between Lisa Englat of American
Association of Blood Bank* and Barbara Scharman of SAIC
January 24, 1989.
R.L. Associates and U.S. Travel Data Center, "The Economic Impact
of visitors to the New Jersey Shore the Summer of 1988,"
study conducted for the New Jersey Division of Travel and
Tourism, Nov. 1988.
R.L. Polk and Company. 1988. Hailing List Catalogue. Volume
II, p. 42-44.
Region II, EPA (SAIC). Characterization of Medical Waste
ggr^era^ion and Treatment and Disposal Practices in Hew York
and New Jersey. January 30, 1989.
Rutala, W.A., M. Steigel, and F. Sarrubi. "Decontamination of
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Appj|§4 and Environmental Microbiology. Vol. 43, pp. 1311-
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Science Applications International Corporation. Site visit
reports of generators of medical waste in New York and New
Jersey. November, 1988.
A-
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Sykes, T., Telephone communication with T. Sykes, Abbott
Laboratories Home Care Division and John H. Keene, April
1989.
Telephone communication with Chief Nurse, Renal Dialysis Unit,
Medical College of Virginia Renal Dialysis Unit and John H.
Keene, April 1989.
Telephone communication with M. Lease, SAIC, and Jacquelyn Flora
of Browning-Ferris Industries, May 1989.
Telephone conversation with Denise Zabinski and Sidney Rankin,
Center for Plastic Recycling Research, Rutgers, NJ, February
1989.
Telephone conversation with SAIC and BioSafety. November 28,
1988.
The Urban Institute, U.S. Renal Data System, April 1989.
Thomas Conoscenti & Associates, Inc., Long Island
Tourist/Convention Estimates for 1987 &1988. prepared for
the Long Island Tourism and Convention Commission, 1988.
Thompson, J.R. Letter to William Reilly. April 21, 1989.
Traffic World. "Railroads Look at Solid Waste, see Bulk
Commodity for the Future." Nay 1989.
Turnberg, Wayne L., Seattle-King County Department of Public
Health. An examination and Risk Evaluation of Infectious
Waste in Kin? County. Washington. March 18, 1988.
U.S. Congress, Office of Technology Assessment. Transportation
ofHazardous Materials. OTA-SET-304, Washington, D.C., 1986.
U.S. Department of Commerce, Bureau of the Census. Statistical
Abstract of the United States 1988.
U.S. Department of Health and Hunan Services, Health Care
Financing Administration. 1987 Health Car* spending
Bulletin, 87-03, July 1987.
U.S. Dept. of Health and Huaan services. Health care Spending
Bulletin. Washington, D.C., 1987.
U.S. Department of Labor, Occupational Safety and Health
Administration. Proposed Rule on Occupational Exposure to
Bloodborne Pathogens. 54 FR 23073. May 30, 1989.
A-4
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U.S. Environmental Protection Agency, Office of Solid Waste.
Background Document. Resourceconservation and Recovery Act.
Subtitle J - Demonstration Mp^ieal Waste Tracking Program.
Section 11QQ3 - Tracking of Medical Waste. 40 CFR Parfr }59,
Suboarts E - J. Washington, D.C., 1989.
U.S. Environmental Protection Agency. Characterization of
Medical Waste Generation and Treatment and Disposal
Practices^rx New York and New Jersey. Draft Report,
Washington, D.C., 1989.
U.S. Environmental Protection Agency. 1989. Characterization of
Medical Waste Generation and Treatment and Disposal
Practices in New York and New Jersey. Draft Report
submitted to Air and Waste Management Division, Region II,
and Office of Solid Waste, January 30, 1989.
U.S. Environmental Protection Agency, Office of Solid Waste. EPA
Guide for Infectious Waste Management. EPA/530-SW-86-014,
May 1986.
U.S. Environmental Protection Agency. Estimates of Costs for 4Q
CFR Part 259. Memorandum from S. Rasmussen, Washington,
D.C., October 1989.
U.S. Environmental Protection Agency. Guidance on Use of RCRA
Civil. _Penaltv Policy in Assessment of Penalties Under the
Medical Wfstg Tracking frc$ p{ 1988. Washington, D.C., March
30, 1989.
U.S. Environmental Protection Agency, figs,gj.feaj. jncine_r§59r
Operator Training Course. EPA-450/3-89/003 (3 volumes),
Research Triangle Park, NC, March 1989.
U.S. Environmental Protection Agency, Office of Air and
Radiation. Hospital Waste Combustion Study; Data Gathering
Phase. EPA/450/3-88-017, December 1988.
U.S. Environmental Protection Agency, Carcinogen Assessment
Group. List of Carcinogens. Washington, D.C., April 24,
1980.
U.S. Environmental Protection Agency. Maryland Medical,
Laboratory's Waste Treatment System, memorandum, Washington,
D.C., December 1988.
U.S. Environmental Protection Agency. Medical Waste Benefits
Ajiaryqj.9- Memorandum from R. Burke to Docket No. F-89-MTPF-
FFFFF, March 1989.
A-5
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U.S. Environmental Protection Agency, office of solid waste and
Emergency Response. 1988. Report to Congress on Solid
waste Disposal in the United states. EPA/530-SW-ea-oil,
October 1988.
U.S. Environmental Protection Agency. Summary of meeting vi^ft
Great Lakes states. Memorandum from P. Mushovic,
Washington, D.C., Kay 1989.
U.S. Environmental Protection Agency, Office of Solid Waste.
Unpublished data on transporter notifications. Washington,
DC. 19B9.
U.S. Environmental Protection Agency, Office of Solid Waste.
19B9. Unpublished results of site visits to medical waste
generators. Washington, DC.
waste^Age. "Transfer of Baled wastes is one Solution."
December, 1988.
Written communication from American Veterinary Medical
Association to SAIC entitled "Distribution by Specialty
Codes and State." November 8, 1988.
A-6
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