Issues in Medical Waste Management

October 1988

NTIS order #PB89-136410
Recommended Citation:

U.S. Congress, Office of Technology Assessment, Issues in Medical Waste Management—

Background Paper, OTA-BP-O-49 (Washington, DC: U.S. Government Printing Office,

October 1988).

Library of Congress Catalog Card Number 88-600595

For sale by the Superintendent of Documents

U.S. Government Printing Office, Washington, DC 20402-9325

(order form can be found in the back of this report)
Foreword

During the summer just passed, we witnessed a rash of incidents in which medical

wastes washed ashore—from Maine to the Gulf of Mexico, along the Great Lakes, and

elsewhere in the Nation. These and other incidents, which were the focus of intense media coverage, drew public attention to issues surrounding the management of medical wastes.

Waste management in general has become a common headline topic. We hear daily

about declining landfill capacity, problems in siting new incinerators, and efforts to increase recycling. OTA’s ongoing assessment of municipal solid waste management is addressing these issues.

As part of the assessment, OTA also examined the status of medical waste management in the Nation. OTA held a one-day workshop on July 19, 1988, with hospital, regulatory, and environmental experts to review the initial draft of this background paper and

to discuss other areas of interest. The conclusions of those discussions have been incorporated in this paper.

The paper examines the adequacy of current medical waste disposal practices and

the potential for human health impacts to occur as a result of such practices. It also addresses the need for additional research and databases, and discusses probable trends in

future costs and capacity as new regulations are adopted around the country. Finally, the

paper considers the possible need for further Federal involvement in regulating the handling, treatment, storage, and disposal of medical wastes.

OTA is grateful for the input from the workshop participants and other reviewers.

The preparation of this paper would have been much more difficult without such support.

As with all OTA studies, the content of this paper is the sole responsibility of OTA.
John Bazin

Anheuser-Busch Cos., Inc.

Municipal Solid Waste Advisory Panel

Joseph Sax, Chair

School of Law, University of California

Gordon Boyd

Schillinger, Salerni, and Boyd

Paul Connett

Saint Lawrence University

Randall Curlee

Oak Ridge National Laboratory

Dana Duxbury

Center for Environmental Management

Tufts University

Rodney Edwards

American Paper Institute

Jeffrey Hahn

Ogden Projects, Inc.

Michael Herz

Benjamin Cordozo School of Law

Walter Johnson

St. Paul Metropolitan Waste Control

Commission

Richard Kattar

New England CRInc.

Raymond Naar

General Electric Plastics

Lorie Parker

Seattle Solid Waste Utility

Glenrose Pitt

Private Consultant

Barry Scher

Giant Food, Inc.

Neil Seldman

Institute for Local Self-Reliance

Peter Vardy

Waste Management, Inc.

Irvin White

New York State Energy Research and

Development Authority

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants, advisory panel members, and reviewers. These participants do not, however. necessarily approve, disapprove,

or endorse this background paper. OTA assumes full responsibility for the background paper and the accuracy of its

contents.

iv
OTA Municipal Solid Waste Management Project Staff

John Andelin, Assistant Director, OTA

Science, Information, and Natural Resources Division

Robert Niblock, Oceans and Environment Program Manager

Kathryn Wagner, Principal Author and Analyst

Howard Levenson, Project Director

Eric Washburn, OTA Contractor

Administrative Staff

Kathleen Beil Sally Van Aller
Medical Waste Workshop Participants

Frank Cross

Cross/Tessitore & Associates

Lawrence Doucet

Doucet & Mainka

Allen Dusault

Massachusetts Department of Environmental

Quality and Engineering

Dieter Groschel

University of Virginia Medical Center

Susan Harwood

Occupational Safety and Health Administration

Christopher Haynes/Eugene Mainer

Decom Medical Waste Systems

John Joyner

Consumat Systems

Stephen Kaufman

Massachusetts General Hospital

Ode Keil

Joint Commission on Accreditation of Health

Care Organizations

C.C. Lee

U.S. Environmental Protection Agency

Edward Londres

New Jersey Department of Environmental

Protection

John Manuel

Ontario Ministry of the Environment

John McVicar

Centers for Disease Control

Ray Morrison

U.S. Environmental Protection Agency

Robert Peters

Biomedical Waste Treatment Council

William Rutala

University of North Carolina School of

Medicine

Robert Sheehan

Medi-Gen

Robert Spurgin

Browning-Ferris

Barbara Stank

Industries

New England Deaconist Hospital

Jacqueline Warren

Natural Resources Defense Council

Howard Wensley

Massachusetts Department of Public Health

Denise Zabinski

U.S. Environmental Protection Agency

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants. The workshop participants do not, however, necessarily approve, disapprove, or endorse this background paper.

OTA assumes full responsibility for the background paper and the accuracy of its contents.

vi
Additional Acknowledgments

Richard Denisen

Environmental Defense Fund

Rick Erdheim

Senator Frank Lautenberg’s Office

United States Senate

Mary Ficht

American Hospital Association

Rebecca Goldberg

Environmental Defense Fund

Reuben Guttman

Service Employees International Union

Shari Haley

American Hospital Association

Judy Kowalski

Office of Technology Assessment

George Lange

Ogden-Martin Systems, Inc.

Jack Lauber

‘New York State Department of Environmental

Rosemary Monahan

U.S. Environmental

Region 1

Sue Moreland

The Markland

Dave Ozonoff

Group

Protection Agency—

Boston University

Robert Percival

University of Maryland Law School

Harvey Rogers

National Institutes

James Salvaggio

of Health

Pennsylvania ‘Department of Environmental

Resources

Nancy Seidman

Northeast States for

Management

Thomas Super

U.S. Environmental

Coordinated Air Use

Protection Agency

Conservation “ Gary Yee

Thomas Lavelle

University of Maryland

California Air Resources Board

vii
Contents

Introduction . . .“. . . . . . . . . . . . . . . . . . . . . .

Chapter 1: Defining and Characterizing

Medical Wastes . . . . . . . . . . . . . . . . . .

Amounts and Composition . . . . . . . . . . . . . . .

Designating Infectious Waste . . . . . . . . . . . . .

Definitional Differences-EPA v. CDC . . . .

Classifying Infectious Waste as Hazardous

Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Uncertainties for State Regulators . . . . . . . . .

Chapter 2: Handling Medical Wastes and

Potential Occupational Risks . . . . . . .

Handling: Packaging, Storage, and

Transportation . . . . . . . . . . . . . . . . . . . . .

Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . .

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transportation . . . . . . . . . . . . . . . . . . . . . . .

Potential Occupational Risks . . . . . . . . . . . . .

Chapter 3: Current Technologies,

Treatment, and Disposal Issues.. . . .

Incineration. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Controlled Air Incinerators . . . . . . . . . . . . .

Other Types of Incinerators . . . . . . . . . . . .

Air Emissions and Ash . . . . . . . . . . . . . . . . . .

Concentrations of Emission

Constituents . . . . . . . . . . . . . . . . . . . . . . .

Possible Reasons for Higher Emission

Levels of Dioxins/Furans and HCl . . . .

Concentrations of Constituents

in Ash . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Future Trends in Medical Waste

Incineration. . . . . . . . . . . . . . . . . . . . . . . .

Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Incineration. Autoclaving and the

Importance of Proper Operation . . . . . .

Health and Environmental Risks From

Treatment Technologies . . . . . . . . . . . . .

Chapter 4: Regulatory Authority and

Current Practices . . . . . . . . . . . . . . . . .

Federal Authority . . . . . . . . . . . . . . . . . . . . . . .

State Regulatory Activities . . . . . . . . . . . . . . .

1

3

3

4

4

6

8

9

9

9

10

10

11

15

15

16

16

17

17

18

19

19

20

21

22

23

23

23

Chapter 5: Managing Medical Wastes—

Institutional and Policy Issues . . . . . 27

Policy Issues for Federal Action. . . . . . . . . . . 28

Page

Defining/Classifying Medical Wastes . . . . 28

Regulating Small v. Large Generators of

Medical Wastes . . . . . . . . . . . . . . . . . . . . 30

Research and Data Needs . . . . . . . . . . . . . . 31

Concluding Remarks . . . . . . . . . . . . . . . . . . . . 32

References. . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Figures

Figure Page

1.

2.

3.

4.

Biological Hazard Symbol . . . . . . . . . . . . . 10

Typical Controlled Air Incinerator . . . . . . 15

Stages of State Changes in Medical

Waste Management Programs—As of

March 1988 . . . . . . . . . . . . . . . . . . . . . . . . . 24

Type of Medical Waste Generators

Regulated by States—As of

March 1988 . . . . . . . . . . . . . . . . . . . . . . . . . 24

Tables

Table Page

1.

2.

3.

4.

5.

6.

7.

8.

9.

CDC/EPA Designations of Solid Wastes

and Recommended Treatment/Disposal

Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Joint Advisory Notice on the Protection

Against Occupational Exposure to

Hepatitis B Virus (HBV) and Human

Immunodeficiency Virus (HIV)—

Training Program Recommendations. . . .

Compliance Rates With Joint Advisory

Notice—70-Hospital Sample . . . . . . . . . . .

Compliance Rates With Joint Advisory

Notice—30-Department Sample . . . . . . . .

Concentrations of Constituents in

Emissions From Hospital Incinerators

Without Particulate Control Devices . . . .

Dioxin and Furan Emission

Concentrations . . . . . . . . . . . . . . . . . . . . . . .

Concentrations of Dioxins and Furans in

Fly Ash From Municipal and Hospital

Incinerators . . . . . . . . . . . . . . . . . . . . . . . . .

Status of Selected State Infectious Waste

Incinerator Regulations . . . . . . . . . . . . . . .

Legislation Pending in Congress on

Medical Wastes . . . . . . . . . . . . . . . . . . . . . .

5

12

13

13

17

17

19

26

30

. . . Vlt{
Introduction

● Without advance notice, on March 24, 1986, the

GSX waste handling company informed eight

Boston, Massachusetts, hospitals that it would

no longer pick up any of their hospital wastes because the area landfills would no longer accept

them. For two of these hospitals, GSX did not

even handle their ‘‘red bag” waste (44).

● Approximately 1,400 bags of medical waste were

discovered at a warehouse by the New York City

Fire Department when it responded to a fire November 24, 1986. Subsequently, the Energy

Combustion Corporation and its president were

indicted by the Brooklyn District Attorney’s Office for allegedly covering up this illegal dumping. The company had submitted documents to

the New York State Department of Environmental Conservation stating that the wastes had

been incinerated (21).

● Twelve children in Indianapolis, Indiana, played

with vials of blood, two of which were infected

with AIDS, that they found in a trash bin outside an HMO medical office in June 1987. It was

legal for the health clinic to dispose of the wastes

in the open dumpster (27).

● Five employees of the Los Angeles County-USC

Medical Center filed a $50 million lawsuit against

the county after a pipe in the basement of the

facility burst on July 9, 1987, and dumped possibly contaminated blood and fluids on workers.

The California Occupational Safety and Health

Administration has received other complaints

concerning the adequacy of protection provided

for employees handling medical wastes at the

Center (56).

● A garbage slick nearly a mile long along the shore

in Ocean County, New Jersey, on May 23, 1988,

marked the first slick of the season. Needles,

syringes, and empty prescription bottles with

New York addresses washed upon the shore (31).

New Jersey beaches closed several times last season due to such incidents. More recently, on July

6-7, 1988, 10 miles of Long Island beaches closed

when medical wastes washed ashore. Throughout the summer of 1988, beaches from Maine

to the Gulf of Mexico, along the Great Lakes,

and elsewhere in the Nation experienced washups

of medical wastes.

Recent incidents such as these have drawn attention to issues surrounding the handling, treatment, and disposal of medical wastes. Medical

wastes are all the types of wastes produced by hospitals, clinics, doctor offices, and other medical and

research facilities. 1 These wastes include infectious

or ‘‘red bag’ hospital wastes, hazardous (including radioactive) wastes, and any other general

wastes. 2 The Environmental Protection Agency

reports that approximately 3.2 million tons of medical wastes from hospitals are generated each year,

which is about 2 percent of the total municipal solid

waste stream.3 Currently, most generators of medical waste designate between 10 to 15 percent of

it as infectious.

Most of the non-infectious medical waste is landfilled, while most infectious waste from hospitals

is incinerated. For infectious waste management,

an American Hospital Association survey reported

in 1983 that approximately 67 percent of U. S. hospitals use on-site incinerators, 16 percent use only

autoclave (i.e., sterilization) systems and then landfill, and approximately another 15 percent use offsite treatment (9,62). The degree of risks posed by

medical wastes is not known. Proper handling,

treatment, and disposal of these wastes are believed

to result in minimal health and environmental risks.

Yet, incidents of careless or illegal disposal may pose

health risks and aesthetic problems and certainly

help create public apprehension over current medical waste management practices.

‘This would also include wastes from research laboratories, biotechnology firms, veterinary hospitals, funeral homes, nursing homes, etc.

Most of the public and regulatory attention has been focused on hospital

waste disposal; however, other sources of biomedical wastes may be

equally significant. Although this paper will also tend to focus on hospitals and larger sources of medical wastes, given that there is more readily available information on these facilities, the need for assessing the

importance of smaller generators of biomedical wastes is recognized.

2The terms medical wastes, hospital wastes, infectious wastes, and

biomedical wastes often are used interchangeably. An attempt is made

here to use these terms more precisely, i.e., the term medical wastes

refers to all types of wastes produced by a hospital or any type of facility; hospital wastes refers to all wastes produced by a hospital; infectious wastes refers to that portion of a medical wastestream which

has the potential to transmit disease; and biomedical wastes are the

subset of medical waste which is biological in origin (e. g., blood, body

fluids, tissue, etc.).

3Estimates range from 2.1 to 4.8 million tons per year. As will be

discussed below, these figures do not include medical wastes from

clinics, laboratories, and other sources. It is likely, therefore, that medical wastes comprise a somewhat higher—although still relatively

small—percentage of the total municipal solid wastestream.

1
2

Just as the types of incidents listed above raise

public concern, considerations of liability and

worker safety lead some operators of municipal solid

waste landfills and incinerators to ban or refuse to

take any medical wastes. A number of States have

banned all unsterilized infectious waste from municipal landfills.4 In addition, the State of Pennsylvania has imposed a one-year moratorium on

the construction of any commercial medical waste

incinerators. 5 In other areas, localities as well have

considered bans or moratoriums on hospital waste

incinerators. 6 In this general context, many hospitals, medical facilities, and other institutions

across the country face increasingly difficult waste

management problems.

The situation is complicated by an uncertain and

incongruous regulatory climate. Inconsistencies exist in the Federal guidelines for States regarding

definitions and management options suggested for

medical/infectious waste. 7 Currently, no Federal

regulations exist that comprehensively address the

handling, transportation, treatment, and disposal

of medical waste. This would change either if the

issue of medical wastes remains part of the current

reauthorization effort for the Resource Conservation and Recovery Act (RCRA)8 or if any of a num41n some areas, if medical wastes of any sort are accepted, an inspection fee in addition to the tipping fee is charged. For example,

the town of Brookhaven, New York, banned University Hospital’s

waste three times in a 6-month period due to alleged contamination

problems. The agreement reached between the town and the hospital

requires the hospital to pay $15 per compacted load for inspection

of the wastes and reserves the town’s right to ban the hospital’s waste

if there are future violations (24).

5The Pennsylvania Department of Environmental Conservation had

lifted a moratorium on permitting hospital incinerators in February

1988. In July the State legislature imposed a one-year moratorium

on permitting new commercial hospital incinerators. The current

moratorium will be lifted when the Department completes a comprehensive plan for medical wastes which is due July 13, 1989. Other

States (e. g., Delaware) have or are considering similar moratoriums.

‘Although the exact number of such landfill refusals or bans are

not known, discussions with a number of individuals across the country

involved with medical waste management indicate that these practices are not uncommon and appear to be increasing in frequency.

E.g., references 23 and 28.

7As will be discussed below, the Environmental Protection Agency,

Centers for Disease Control, and other Federal agencies have issued

different guidelines for infectious and medical waste management.

’42 U.S. C. 6901 et seq.

ber of bills introduced in Congress relating to medical waste issues (see discussion below) pass.

Meanwhile, the States have largely been left on

their own to devise medical waste management programs. This means important variation frequently

exists between States, as well as between local requirements and those of a State. For example, 26

States classify infectious wastes as special wastes,

13 still classify them as hazardous wastes, and 12

classify them as non-hazardous wastes (4).9 Thirtynine States have some type of regulations concerning infectious waste, at least 5 more States expect

to regulate these wastes within the year; and at least

25 States expect changes to their existing regulations by next year (4).10

The purpose of this paper is to assess the adequacy of current medical waste disposal practices;

the potential risks from such practices; the need for

additional research and databases; and the possible need for Federal requirements for the handling,

treatment, storage, and disposal of medical wastes

and future cost and capacity factors as new regulations are updated. The paper is divided into five

chapters:

1.

2.

3.

4.

5.

Defining and Characterizing Medical Wastes;

Handling Medical Wastes and Potential Occupational Risks;

Current Technologies, Treatment, and Disposal Issues;

Regulatory Authority and Current Practices;

and

Managing Medical Wastes—Institutional and

Policy- Issues. 11

‘Note that the survey includes the District of Columbia; for this

reason, figures add up to 51. See below for further discussion of this

aspect of the definitional issue. Under RCRA, there are two general

categories of wastes, each of which is subject to different regulatory

requirements. These are hazardous wastes regulated according to Subtitle C, and solid (non-hazardous) wastes regulated according to Subtitle

D. In addition, there is a third, non-statutory category of “special

wastes’ for those wastes that appear to be in a gray area between these

two categories and for which special regulatory programs will be established.

IOCompare resu]ts of slighdy older survey, reported earlier in 1988

by the National Solid Waste Management Association (51).

I Ispecific, basic information is often lacking or at present not avadable to OTA on a number of important topics, and these areas are

noted below.
Chapter 1

Defining and Characterizing Medical Wastes

Medical wastes include all infectious waste, hazardous (including low-level radioactive) wastes, and

any other wastes that are generated from all types

of health care institutions, including hospitals,

clinics, doctor (including dental and veterinary)

offices, and medical laboratories (42). 1 The main

focus of concern has been on the portion of medical wastes that are defined as infectious, and how

they are classified (e. g., as a solid, hazardous, or

‘‘special’ waste) and regulated. These wastes are

also the primary focus of this paper. The main

sources of these wastes receiving attention are hospitals and other large facilities. Much of the information reported here will focus on these larger

generators, but the proper disposal of other types

of medical wastes and of wastes from all types of

sources is also important.2

Amounts and Composition

The actual amount of medical waste generated

in the United States today (or in the past) is not

known; even estimating this figure is problematic,

as the number of different reported estimates indicate. In 1987, the Environmental Protection

Agency (EPA) reported the total generation rate

of hospital wastes at 5,900 tons/day (83). This figure is based on the number of hospital beds estimated to exist (in 1985, the estimate was 1.3 million with a 69 percent occupancy rate) and a per

bed per day generation rate of 13 pounds.

The per bed per day generation figure itself, however, is difficult to pinpoint. Recent independent

estimates of hospital waste generation range between 16 to 23 pounds per bed per day (61). The

1 See also ref. 39. It should be noted that extensive treatment of the

current management of radioactive and other identified hazardous

wastes in the medical wastestream is beyond the scope of this paper.

It is recognized, however, that proper management of such wastes

is important and a challenge for many medical waste generators, given

the usually small quantities and high cost of adequate disposal of these

wastes.

2The amount of medical wastes from such non-hospital sources is

not known. Other sources of infectious wastes, such as sewage overflows, can also be a significant source of environmental contamination (e. g., impacting beaches and shellfish areas), but are beyond the

scope of this paper.

range reported by hospitals in various surveys of

hospital waste generation is 8 to 45 pounds per bed

per day.3 EPA expected the 13 pound per bed per

day rate to remain constant, as it believes it did

for the period from 1975 to 1985 (83). In 1980,

however, one survey of North Carolina hospitals

reported an average of approximately 10 pounds

per bed per day of wastes. If this lower figure was

typical in years past, then it would indicate that the

amount of per bed generation of hospital wastes

may have increased significantly within the last decade. Healthcare workers and administrators do indicate that the amount of disposable items used in

hospitals and other medical facilities has increased

dramatically in recent years, although data are not

available to document this observation.

Few data are available on the composition of hospital waste, although it is characteristically heterogeneous in nature. The mix of materials includes,

in addition to general refuse (e. g., office paper, food

waste, non-infectious patient waste) and infectious

waste (e. g., pathological wastes, human blood and

blood products, contaminated sharps and anatomical wastes, isolation wastes), hazardous wastes

(e.g., waste pharmaceuticals, cytotoxic agents used

in chemotherapy, mercury or other heavy metals),

and radioactive wastes.4

The composition of the medical wastestream is

of concern given its effects on the incineration process. If incineration occurs on-site, it is likely that

at least some of the hospital or facility’s wastes are

mixed (if wastes are shipped off-site, given the

greater expense of treating infectious waste this

3Different methodologies to calculate per bed generation figures,

may explain the wide variation in estimates. Also, of course, the actual hospital generation figures can vary greatly on a daily basis. Some

surgical procedures generate much more waste (e. g., a heart transplant) than other routine operations (83). In addition, difficulties in

segregating infectious and non-infectious wastes may lead to more

mixed waste disposal that is treated as infectious.

‘It should be noted here that not all of these hazardous or toxic wastes

are regulated by the Resource Conservation and Recovery Act

(RCRA), and, in addition, many of the generators of these wastes

may qualify for a small quantity generator exemption from RCRA

requirements (e. g., this would include most hospitals under 200 beds).

Nonetheless, if some of these wastes are incinerated on-site they could

be a source of air emission concern (83).

3
4

way, it is likely that only infectious waste is sent

for incineration).5 Particular components of the

medical wastestream of special concern when this

waste is incinerated include the relatively high plastic content of medical waste (to be discussed further below). About 20 percent of the hospital wastestream is estimated to be plastics (83), which is

about three times the plastic portion of the municipal solid wastestream.6

In any case, reported generation figures do not

include non-hospital medical wastes. In 1985, approximately 6,870 hospitals and an estimated 1,000

diagnostic and research laboratories existed, in

addition to thousands of doctor offices and nursing homes (5). 7 Although specific estimates are not

available on the volume or composition of medical wastes from these sources, it is reasonable to

expect that the total medical waste generation (both

hospital and non-hospital) figure is somewhat

higher.

Designating Infectious Waste

Determining which portion of medical waste is

infectious goes to the heart of the definitional problems associated with medical waste management.

There are two basic sources that hospital and other

medical facilities may use in determining their

working definition of infectious wastes: EPA guidelines and Centers for Disease Control (CDC) guidelines. These will be discussed below.

How infectious waste is defined can greatly

affect the cost of waste management, and ultimately the choice of waste management disposal

options for generators. For example, one 600-bed

hospital found that it saved $250,000 annually by

changing its infectious waste designation from 13

categories to the 4 designated by the CDC (59).

General cost figures for disposal are (approximately): $0.01 to $0.25/lb. for general refuse/noninfectious waste (usually landfilled); $0.10 to

$0.25/lb. for incineration on-site (includes infectious wastes);8 and 0.30 to 1.00/1b. (although costs

may be higher in some areas) for commercial, offsite incineration (6, 10).

Most estimates are that 10 to 15 percent of all

hospital wastes are infectious. The total range of

estimates, however, is from 3 to 90 percent of a hospital’s waste defined as infectious, depending on

the definitions and procedures followed (10,83).

According to Lawrence Doucet, a consultant on

hospital waste management, about 3 to 5 percent

of a hospital’s total wastestream would be classified as infectious waste according to previous interpretations of CDC guidelines for infectious wastes,

while approximately 10 percent would be classified

that way according to the 1986 EPA guidelines

(10).9

The recommendations issued by CDC in August

1987, however, have apparently been interpreted

by some hospitals as classifying virtually all patientcontact waste as infectious (77). This can amount

to 70 to 90 percent of total hospital waste. The potential impact of such a trend on medical waste

management could be to both increase the cost

of disposal significantly and strain existing capacity for managing infectious wastes. The CDC

has issued a clarification of its definition, yet confusion at the generator level appears to remain over

the proper classification and management of medical wastes (78).

Definitional Differences—EPA v. CDC

William Rutala, University of North Carolina

School of Medicine (Director of the Statewide Infection Control Program), has noted that no tests

exist to objectively identify infectious wastes, unlike the case with chemical or radiological wastes

(60). 10 This has led the CDC, EPA, States, and

other agencies to identify and further define infectious waste by waste category based on waste characteristics.

EPA defines infectious waste as “waste capable

of producing an infectious disease’ (81). Coupled

5Actual data on the amount of waste incinerated on-site v, off-site,

and whether waste is usually mixed or not, are not currently available.

bEstimates of the portion of plastics in hospital waste range as high

as 30 percent.

‘See also ref. 10.

qt should be noted that capit~ costs, depreciation, ad other tYPes

of costs may not be included in these figures.

91nteresting]y, a recently completed survey for the American HOSpital Association reported that 80 percent of the hospitals are following CDC guidelines, while only 52 percent are complying with EPA

guidelines (to be discussed further below) (61).

‘“See also ref. 70.
5

with the definition is the need to consider at least

four factors necessary for the induction of disease:

1. presence of a pathogen of sufficient virulence,

2. dose,

3. portal of entry, and

4. resistance of the host.

Thus, the Agency notes that:

. . . for a waste to be infectious, it must contain

pathogens with sufficient virulence and quantity so

that exposure to the waste by a susceptible host

could result in an infectious disease (81).

The CDC recommendations, issued in August

1987, and referred to as “universal precaution”

procedures, are essentially that blood and body

fluids from “all patients be considered potentially

infected with HIV (human immunodeficiency virus) and/or other blood-borne pathogens and [that

health care workers] adhere rigorously to infectioncontrol precautions’ (77). In June 1988, the CDC

attempted to clarify several issues associated with

apparent confusion over the application of their

1987 recommendations. As part of this effort, the

CDC now limits the application of universal precautions to blood and other body fluids containing

visible blood, to semen and vaginal secretions, and

to other specified fluids (78). The CDC also notes

that the recommendations are intended to protect

healthcare workers and do not address waste management practices or the definition of infectious

wastes (78).

Both the CDC and EPA designate pathological

waste, blood and blood products, contaminated

sharps (e. g., scalpels, needles, blades), and microbiological wastes (e.g. cultures and stocks) as infectious. Some apparent disagreement exists between

the designations of and suggested treatments for

different components of infectious wastes identified

by the CDC and EPA. (See table 1,) EPA has identified several additional optional categories, which

include a category of isolation wastes, a category

of contaminated animal carcasses, body parts, and

bedding, and categories of surgery, autopsy and

contaminated laboratory wastes (81). The apparent inconsistencies are remedied in part by the fact

that EPA refers to the CDC guidelines on isolation precautions (74) and to the joint CDC/National

Institutes of Health guidelines on animal carcasses

waste management and other guidelines on laboratory wastes.ll

I l~though the CDC does not classify animzd carcasses as infectious

wastes, the CDC/NationaI Institutes of Health guidelines, ‘‘ Biosafety

in Microbiological and Biomedical Laboratories (75), ” recommend

incineration of infected animal carcasses and decontamination (preferably by autoclaving) before disposal for all wastes from animal rooms

of certain designated biosafety levels.

Table 1 .—CDC/EPA Designations of Solid Wastes and Recommended Treatment/Disposal Methods

CDCa EPA

Disposal/ Disposal/

Infectious treatment Infectious treatment

Source/type of solid waste waste method waste method

Microbiological (e.g., stocks and cultures of infectious agents) . . . . . Yes S,l Yes S,I,TI,C

Blood and blood products (i.e., liquid blood and blood products) ., . . Yes S,I,Sew Yes S,l,Sew,C

Communicable disease isolation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes/No HP Yes S,l

Pathological (e.g., tissue, organs) . . . . . . . . . . . . . . . . . . . . . . . . . ... , . . Yes Yes I,SW,CB

Sharps (e.g., needles) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes S,l

Contaminated animal carcasses, body parts and bedding . . . . . . . . . . No — Yes I,SW

(not bedding)

Contaminated laboratory wastes ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optionalb

If considered

IW, use S or I

Surgery and autopsy wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional If considered

IW, use S or I

Dialysis unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional If considered

IW, use S or I

Contaminated equipment . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . No — Optional If considered

IW, use S or I

aAbbreviatjOnS: cDc—centerS for Djsease Control; EpA—Environmental protection Agency; l—incineration; s—steam sterilization; T1—thermal inactivation; C—chemical

disinfection for liquids only; Sew—sanitary sewer (EPA requires secondary treatment); HP—in accordance with hospital policy; SW—steam sterilization with incineration or grinding; CD—cremation or burial by mortician; IW—infectious waste.

boptional inf~t{ous waste: EPA states that the decision to handle these wastes as infectious should be made by a responsible, authorized Person or committee at

the individual facility.

SOURCE: W. Rutala, “Infectious Waste–A Growing Problem for Infection Control,” ASHJS/S: The /nfection Control Forum 9(4):2-6, 1987.
6

The major apparent disagreement is over the designation of communicable disease/isolation wastes.

Although the CDC and EPA agree that there is no

inconsistency in their designations of these wastes,

confusion exists in the application of these guidelines. This may indicate a need for further clarification of these guidelines by the two agencies. EPA

considers communicable disease wastes as infectious. CDC recommends that communicable disease waste be treated according to hospital policy

(74). Nelson Slavik notes, in his report of the

proceedings of the EPA Infectious Waste Management Meeting held in November 1987, that recent

interpretations by hospitals and other generators

of the CDC universal precaution guidelines, and

the concern over potential exposure to AIDS, can

result in any blood or body fluid and any item contaminated with them being designated as infectious

waste.

Previously, only patient waste from those patients

in isolation would be included in the EPA’s infectious waste definition; interpretation of the CDC

guideline, however, could include all patient contact wastes and wastes of EPA’s optional category

(e.g., surgical and autopsy wastes, dialysis waste,

contact laboratory wastes) in the infectious waste

definition (70). The CDC disputes this interpretation of its recommendations (77,78). The CDC issued a statement in June 1988 that,

Universal precautions are not intended to change

waste management programs previously recommended by CDC for health-care settings (78).12

This attempt at clarification by CDC, however, in

part contributes to the confusion. It is not clear why

the CDC is suggesting that its universal precautions guidance applies only to worker precautions

and not waste handling procedures.

EPA agrees with CDC that its recommendations

are not in serious disagreement with EPA recommendations and that universal precautions are

meant to protect healthcare workers and do not ‘‘attempt to define what is infectious waste” (87).

Given the state of confusion at the generator level,

12According t. the CDC, for example, blood, some bdy fluids,

and sharps from an isolation room should be handled as if potentially

infectious, but not afl wastes from this type of room. CDC further

states that, “While any item that has had contact with blood, exudates, or secretions may be potentially infectious, it is not usually considered practical or necessary to treat all such waste as infective’ (78).

though, further clarification and perhaps jointly

issued guidance on these definitional issues is

desirable.

Currently, based on the proceedings of the EPA

meeting of experts on infectious wastes held in November 1987, there appears to be agreement that:

Not withstanding the risk perceptions and anxieties associated with the fear of contracting AIDS,

those categories of infectious wastes that possess

the greatest potential to transmit disease are contaminated sharps, human blood and blood products, pathological wastes (primarily body fluids),

and laboratory wastes (70).

The position is that, given the consistent recognition of the potential hazards from these wastes,

either due to known disease association or risk of

accidental injection, their ‘‘prudent’ handling and

proper disposal are warranted (70). EPA did, however, solicit comments regarding the basis on which

wastes should be defined as infectious and is currently reviewing its definition of infectious wastes. 13

Classifying Infectious Waste as

Hazardous Waste

Additional confusion arises over the question of

whether or not infectious wastes should be classified and regulated as Subtitle C, RCRA hazardous wastes. In 1978, EPA did include regulations

for infectious wastes in its proposed hazardous waste

regulations. The Agency never promulgated these,

however, and has not classified any infectious

wastes as hazardous wastes—even though the language of RCRA includes “infectious” as a characteristic to be considered in determining whether

or not a waste is a hazardous waste. 14 The statuI s53 Feder~ Register, June 2, 1988. The EPA published a notice

of data availability and request for comments on infectious wastes issues. Comments were due August 1, 1988 and the Agency received

over 100 responses. EPA is now in the process of responding to and

summarizing these comments as part of its ( msideration of possible

regulatory action for medical wastes (86).

I+RCRA (public Law 94-580), in Sect! .n 1004 (codified as 42

U.S.C. 6903(5)), includes the following definition:

(5) The term “hazardous waste” means a solid waste, or combination of solid wastes, which because of its quantity, concentration, physical, chemical, or infectious characteristics may—

(A) cause, or significantly contribute to an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness; or

(B) pose a substantial present or potential hazard to human

health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed [emphasis added].
7

tory language can be interpreted as requiring these

wastes to be classified as hazardous and thus regulated under Subtitle C of RCRA.

EPA, based largely on its determination of a lack

of evidence that infectious wastes ‘‘cause harm to

human health and the environment” sufficient to

justify Federal rulemaking (under Subtitle C,

RCRA), has instead issued a manual of recommendations for the management of infectious wastes

(81). It should be noted, however, that the statutory language refers not only to whether a waste

will ‘‘cause harm, but also to whether it may

“pose a substantial present or potential hazard

. . . “ (emphases added; RCRA, Section 1004).

Even so, 12 years after the passage of RCRA and

8 years after making the determination that insufficient evidence existed to justify Federal regulation,

EPA has not undertaken or encouraged research

to substantiate a lack of ‘‘a substantial present or

potential hazard to human health or the environmen t when a waste with infectious characteristics is improperly managed (a criterion of RCRA,

Section 1004(5) definition of hazardous waste). Alternatively, the Agency has not issued its assessment, based on existing epidemiologic information,

of the degree of risk posed by infectious or other

types of medical wastes.

To date, EPA’s actions have not been legally

challenged. Congress may clarify the conditions under which medical wastes are to be regulated as part

of the current RCRA reauthorization process. Currently, the Agency considers medical waste a solid

waste subject to RCRA, Subtitle D regulation and

is in the process of addressing the need for additional regulations to control infectious wastes. 15

EPA did include a space for infectious waste on the

“Notification of Hazardous Waste Activity” form,

which is used by hazardous waste generators to apply for EPA identification numbers, but no paragraph addressing infectious wastes actually exists

in the regulations referenced on the form. 16

Interestingly, a manual published by the Joint

Commission for the Accreditation of Hospitals

(JCAH)17 designates infectious wastes and sharps

154(I CFR 240.101. (See refs. 73,86. )

IbEpA Form 8700-12, revised November 1985, referencing 40 CFR

261.34.

17Recently, JCAHchangedits name to the Joint Commission on

the Accreditation of Healthcare Organizations (JCAHO).

as hazardous wastes, along with chemical, chemotherapeutic, and radioactive wastes. The manual

outlines methods for handling each type of waste,

and the JCAH requires that a system to handle all

such hazardous wastes exist and be in compliance

with Federal, State, and local regulations (34). 18

In addition, the National Committee for Clinical

Laboratory Standards (NCCLS) in its proposed

guideline for clinical laboratory hazardous waste

includes infectious waste (i. e., waste with ‘‘ infectious characteristics, following the RCRA, Section 1004 definition) in its definition of hazardous

waste (49,50). From a generator perspective,

greater consistency on the classification of infectious and other medical wastes would help

eliminate some of the current confusion over the

proper treatment of these wastes.

A policy debate continues over how best to classify infectious wastes, and other medical wastes, as

well. Some observers, noting the likely increase in

cost as more wastes become designated as infectious, expect even more costly disposal if in addition these wastes must be handled as hazardous.

Further, concerns over the difficulty of siting hazardous waste facilities are noted. Others maintain

that hospital disposal costs are likely to increase due

to increased regulation in general and focus instead

on the most reliable waste disposal options. Arguments over the difficult y of siting hazardous waste

are countered by those who point out that any type

of waste facility is difficult to site (although successful siting of facilities does occur when public participation and other measures are included in the

site selection process). In addition, hospitals may

continue to treat wastes on-site (if, for example, they

have the space to upgrade or construct facilities).

Classifying infectious wastes as hazardous is seen

as desirable by some in order to prosecute illegal

dumping as a felony, to bring in force a manifest

system for infectious wastes which would track the

off-site movement of these medical wastes (21,22),

and in general to ensure greater comprehensive

management of infectious wastes. 19 These purposes

18AS Rut~a (60) points Out, since there are no Federal regulations,

hospitals must comply with State and local regulations; if these do

not exist, then hospitals should comply with either CDC or EPA

guidelines.

lgNew York State recently passed legislation which both provides

for penalties of up to 4 years in prison and fines of up to $50,000 for

illegal disposal of medical wastes (previously the penalties were up
8

could be accomplished without classifying infectious

wastes as hazardous wastes (some of these issues

will be discussed further below). Yet, proponents

for regulating infectious wastes as a hazardous waste

argue that to do so is likely to be the most expeditious approach to the problem (rather than risk delay and confusion created by developing another

system). Furthermore, it is not clear how much flexibility the EPA has under RCRA to address infectious waste as a waste type other than hazardous .20

Again, this issue could be clarified as part of the

current reauthorization effort in Congress.

Uncertainties for State Regulators

These definitional and classification problems

have created considerable uncertainties for State

to 15 days in jail and up to $2,500 in fines) and establishes a manifest

system to track medical wastes. Several bills pending in Congress also

would classify illegal dumping of medical wastes as a felony and specify

penalties. The Senate passed legislation to establish a model manifest

program for several States in the Northeast; similar legislation is pending in the House (see ch. 5).

Zosee 42 U.S.C. 6903(5) and 6921.

regulators. Approximately 10 States have definitions of infectious waste which include the four common CDC and EPA infectious wastes in their definitions (i. e., pathological wastes, microbiological

wastes, blood and blood products, and contaminated sharps). 21 As noted above, most States designate infectious wastes as special wastes, and the

trend is for other States to do the same. Previously,

infectious wastes were classified by States as hazardous wastes because of the aforementioned RCRA

definition. In fact, States must have a program no

less stringent than the Federal Government’s. Since

the EPA has not regulated infectious wastes as hazardous, the trend seems to be for the States not to

do so, too.22 States apparently find the delisting of

a hazardous waste after it has been treated to be

a particularly cumbersome and difficult aspect of

regulating infectious wastes as hazardous wastes (4).

2153 Federd Register, June z, 1988.

zz~though some States and localities have moved beyond Whatever a “baseline” Federal definition of infectious wastes might be,

such a consistent definition might facilitate the development of other

Federal regulations of infectious wastes.
—

Chapter 2

Handling Medical Wastes

and Potential Occupational Risks

The degree of risks posed by medical wastes is

not clear. Two main types of risks associated with

medical wastes can be distinguished: occupational

and environmental. Occupational exposure to

health workers and waste handlers is often cited as

the primary type of health risk posed by medical

wastes. Yet, precise information on the types and

frequency of actual occupational injuries or illnesses

due to handling medical wastes is not readily available. l Environmental risks can be posed directly

by illegal or careless management and disposal

practices or more indirectly through the emissions

and ash handling from medical waste incinerators.2

In this context, questions regarding the significance of all-large and small-generators of medical wastes become important. This section first describes the general nature of handling (including

initial handling, storage, and transportation) of

medical wastes and the types of risks associated with

it, and then discusses the potential magnitude of

these risks. What is known about the possible risks

associated with incineration and other treatment

methods for medical wastes will be discussed in subsequent chapters.

Handling: Packaging, Storage, and

Transportation

Handling medical wastes—including initial handling, storage, and transportation-involves issues

of potential occupational risks and potential operational problems. Improper handling of medical

wastes is closely linked to problems resulting from

inadequately packaged and contained wastes as they

move about the hospital and then are transported

‘Studies do exist on needlestick injuries. For example, recent data

indicate that approximately 20 percent of all hospital needlestick injuries are due to wastehandling. (See ref. 11; numerous other surveys and studies of needlestick injuries have been conducted, e.g.,

refs. 45,68).

2Although not discussed extensively in this paper, accidental exposure through transportation mishaps is likely to be increasingly a

source of concern. If more medical waste is shipped off-site in the future, the potential for accidental spills outside of the generating facility will increase.

off-site for disposal. The integrity of packaging, particularly of such items as sharps, is critical to ensuring the containment of wastes during their collection, storage, and transportation.

Packaging

Polyethylene bags are frequently used for containing bulk wastes (e. g., contaminated disposable

and residual liquids); they may have to be doubledbagged with polypropylene bags that are heat resistant if steam sterilization (see below) is used. These

bags, however, must be opened or of such a nature

as to allow steam to penetrate the waste. Colorcoded bags are frequently used to aid in the segregation and identification of infectious wastes. Most

often red or red-orange bags are used for infectious

wastes (hence the term ‘‘red bag’ waste). An

ASTM Standard (#D 1709-75) for tensile strength

based on a dart drop test and the mil gauge thickness of the plastic determine its resistance to tearing (62,70). Use of the biological hazard symbol

on appropriate packaging is recommended by the

EPA to assist in identifying medical wastes. (See

figure 1.) In addition, EPA recommends that all

of these packages close securely and maintain their

integrity in storage and transportation (81).

In general, compaction or grinding of infectious

wastes is not recommended by EPA before treatment. Even though it can reduce the volume of

waste needing storage, compaction is not encouraged due to the possibility of packages being violated and the potential for aerosolization of microorganisms. Commercially available grinding systems

that first involve sterilization before shredding or

compaction may alleviate this latter concern (62).3

Sharps are of concern, not only because of their

infectious potential, but also because of the direct

prick/stab type of injury they can cause. For sharps,

puncture-proof containers are currently the preferred handling package. EPA recommends these

3Yet, waste haulers note that proper handling of wastes is jeopardized

by any compaction that occurs at some point before disposal.

9
10

Figure 1 .–Biological Hazard Symbol

NOTE: Symbol is fluorescent orange or orange-red, and dimensions are specified for use.

SOURCE: U.S. Environmental Protection Agency, Guide for Infectious Waste

Management, EPA/530-SW-W014 (Washington, DC: May 1986).

types of packages for solid/bulk wastes and sharps;

bottles, flasks, or tanks are recommended for liquids.4 In the past, needles were re-capped, chopped,

or disposed of by other practices that are no longer

common due to their potential for worker injury

and, in the case of chopping, for aerosolization of

microorganisms during the chopping procedure

(62).

New technologies for containing needles and

facilitating their safe handling continue to emerge.

For example, one company has announced a process which uses polymers to sterilize and encapsulate sharps (and other infectious wastes) into a solid

block-like material. A number of companies have

also developed encapsulating systems and other

sharp disposal processes (e. g., a shredder with

chemical treatment of needles and other sharps)

(10). These processes may potentially be cost-effective disposal options for doctor offices and other

small generators of sharps and other infectious

wastes, provided landfill operations would accept

the encapsulated wastes.

‘The CDC has similar recommendations (75,76).

Storage

Storage of the waste needs to be in areas which

are disinfected regularly and which are maintained

at appropriate temperatures (particularly if wastes

are being stored prior to treatment) (62). EPA recommends that storage time be minimized, storage

areas be clearly identified with the biohazard symbol, packaging be sufficient to ensure exclusion of

rodents and vermin, and access to the storage area

be limited (81). The importance of the duration and

temperature of storing infectious wastes is noted,

due to their association with increases in rates of

microbial growth and putrefaction.

The recommendation by EPA for storage of infectious waste is limited, however, to suggesting that

‘‘storage times be kept as short as possible’ (81).

EPA does not suggest optimum storage time and

temperature because it finds there is ‘‘no unanimity of opinion’ on these matters. As the EPA Guide

notes, there is State variation in specified storage

times and temperatures. State requirements often

stipulate storage times of 7 days or less for infectious wastes that are unrefrigerated. Sometimes

longer periods are allowed for refrigerated wastes.

Transportation

EPA recommendations with respect to the transportation of infectious wastes briefly address the

movement of wastes while on-site and in an even

more limited way address the movement of wastes

off-site. The recommendations are largely limited

to prudent practices for movement of the wastes

within a facility, such as placement of the wastes

in rigid or semi-rigid and leak-proof containers, and

avoidance of mechanical loading devices which

might rupture packaged wastes (81). Broader issues, such as recordkeeping and tracking systems

for infectious or medical wastes once they are taken

off-site, and the handling and storage of wastes at

transfer stations, have not yet been addressed.

EPA does recommend that hazard symbols

“should be in accordance with municipal, State and

Federal regulations” (81). Yet, State and Federal

agencies have promulgated conflicting or incompatible guidelines with respect to the use of the biohazard symbol and other transportation specifications. States often follow the EPA guidance on the

use of the biohazard symbol, but application of
11

regulations and policies of the Department of

Transportation (DOT) and Department of Energy

(DOE) may suggest more limited use of the symbol, creating confusion for commercial handlers of

medical wastes (43).

DOT has issued regulations for the transportation of etiologic agents. These regulations may apply to most medical wastes contained in packages

bearing the biohazard symbol, as a result of the

DOT’s definition of “etiologic agent” in the Code

of Federal Regulations. 5 This is a result of the fact

that the precise content of most medical waste boxes

with a biohazard symbol is not known, but is likely

to contain a defined etiologic agent. Further, the

DOT regulations specify that packages of this sort

be a maximum of one liter in size.

Further, the various classification of medical, and

specifically infectious, wastes by different States

complicates the interstate shipment of wastes. Depending on the State, a waste may be designated

either as a hazardous, solid, or special waste, or

simply as freight for the purposes of interstate

commerce. Some States have manifest systems,

others do not. These factors complicate, but do not

prevent, the shipment of wastes within (and outside of) the country. If more medical wastes are

shipped between States, which is the apparent

trend, the likelihood of accidents will increase. The

desirability of more consistent and complete guidelines or regulations regarding the off-site transportation of infectious wastes should be considered in

this context.

Potential Occupational Risks

On October 30, 1987, the Department of Labor

(DOL) and the Department of Health and Human

Services (DHHS) issued a Joint Advisory Notice

on ‘‘Protection Against Occupational Exposure to

Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV)” (80). This Notice goes beyond the CDC guideline changes made in August

1987 that focused on AIDS. Essentially, the universal precaution concept is extended by the Joint Advisory Notice to occupational exposure to Hepatitis B. The Notice advises healthcare workers to

assume all body fluids and tissues they come into

contact with are infected with a blood-borne disease.

5

49 CFR 172.401

Tasks performed by healthworkers are divided

into three categories. 6 Category I includes tasks that

routinely involve exposure to blood, body fluids,

or tissues; Category II tasks routinely do not involve exposure to these substances, but could on

occasion (e. g., to administer first aid); and Category III includes tasks that involve no exposure to

blood, body fluids, or tissues and for which Category I tasks are not a condition of employment. The

Notice also advises that workers should not perform

Category I and 11 tasks before receiving training

relating to the facility’s standard operating procedures (SOPS), work practices, and protective clothing required for each type of task. (See table 2.)

Special work practices for the disposal of sharps,

such as using disposable, puncture-resistant containers to reduce stick injuries, are noted in the

Advisory. Further, it recommends that employers

should provide free voluntary Hepatitis B immunization for any workers performing Category I

tasks who test negative for Hepatitis antibodies. At

the request of employees, the employer should have

a voluntary program to monitor for Hepatitis and

AIDS antibodies following a known or suspected

exposure to blood, body fluid, or tissues. This

should include confidential medical counseling if

they are found seropositive for either virus. Employers are also encouraged to keep records of the

training, tasks, etc., of employees engaged in Category I or II tasks. Currently, the CDC estimates

that only 20 to 40 percent of healthcare workers are

immunized.

In October 1987, DOL/DHHS sent letters to approximately 500,000 healthcare employers to inform them of the Advisory Notice (80). The letter

notes that as many as 18,000 healthcare workers

per year may be infected by the Hepatitis B virus

and several hundred will become acutely ill or jaundiced from the virus. Ten percent will become longterm carriers and as many as 300 healthcare workers may die each year as a result of Hepatitis B infections or complications. The letter also states that

the Occupational Safety and Health Administration (OSHA, part of DOL) will respond to employee complaints and conduct inspections to ensure proper procedures are being followed.

bIt should be noted, that the use of Categories I, II, and 111 are

not required by OSHA, but are used on a voluntary basis.
Table 2.-Joint Advisory Notice on the Protection

Against Occupational Exposure to Hepatitis B Virus

(HBV) and Human Immunodeficiency Virus (HIV)–

Training Program Recommendations

According to the Joint Advisory Notice, “The employer

should establish an initial and periodic training program for

all employees who perform Category I and II tasks. No worker

should engage in any Category I or II task before receiving

training pertaining to the Standard Operating Procedures

(SOPS), work practices, and protective equipment required

for that task.”

The training program should ensure that all workers:

1.

2.

3.

4.

5.

6.

7.

Understand the modes of transmission of HBV and HIV.

Can recognize and differentiate Category I and II tasks.

Know the types of protective clothing and equipment

generally appropriate for Category I and II tasks, and

understand the basis for selection of clothing and

equipment.

Are familiar with appropriate actions to take, and persons to contact, if unplanned Category I tasks are encountered.

Are familiar with and understand all the requirements

for work practices and protective equipment specified

in SOPS covering the tasks they perform.

Know where protective clothing and equipment is kept;

how to use it properly; and how to remove, handle, decontaminate, and dispose of contaminated clothing or

equipment.

Know and understand the limitations of Protective clothing and equipment. For example, ordinary gloves offer

no protection against needlestick Injuries. Employers

and workers should be on guard against a sense of security not warranted by the protective equipment being

used.

8. Know the corrective actions to take in the event of spills

or personal exposure to fluids or tissues, the appropriate reporting procedures, and the medical monitoring

recommended in cases of suspected parenteral exposure.

SOURCE: U.S. Department of Health and Human Services, Centers for Disease

Control, “Recommendations for Prevention of l-tfV Transmission in

Health-Care settings,” bfortrld)fy and Mortality Wee/r/y Reporl, vol. 38,

Aug. 21, 1987.

It is not clear, however, that healthcare and other

workers are being adequately informed of the advisory and trained in the new recommended procedures. For example, in California concerns have

been raised by some unions over the approach of

some healthcare facilities in establishing infection

control programs in response to the Joint Advisory

Notice. Hospitals and other healthcare employers

are reportedly providing ‘‘minimal training programs and [may be requiring] workers to sign a

form stating that they’ve been trained [in order]

to prevent future liability’ to the facility (36,68).

In 1987, OSHA began enforcing some of its existing regulations to respond to the hazard presented

by occupational exposure to blood and body fluids.

These include regulations for sanitation and waste

disposal; personal protection equipment (PPE);

housekeeping; sign and tags; and the application

of the General Duty Clause of the Occupational

Safety and Health Act. A detailed description of

this program can be found in OSHA’s instructions

to its compliance officers (79).

In addition, OSHA sought input through an Advance Notice of Proposed Rulemaking about the

need for and content of additional regulations. The

Service Employees International Union, AFL-CIO,

CLC (SEIU), and the American Federation of

State, County, and Municipal Employees (ASFME)

petitioned OSHA in September 1986 to issue a

standard to protect healthcare workers from potential exposure to Hepatitis B and AIDS and make

the Hepatitis B vaccination available to high risk

workers free of charge (1,66). OSHA expects to issue regulations by the end of 1988.

SEIU, while waiting for OSHA to respond to

their petition, conducted “an informal survey of

infectious disease control practices within forty hospital departments in four urban centers experiencing high rates of AIDS infection, the results of

which became available in June 1987,7 (See tables

3 and 4.) The SEIU survey, while not statistically

significant due to the small sample size, concluded

that ‘‘employer voluntary compliance of infection

control guidelines is spotty at best, even in healthcare institutions located in urban areas experiencing high rates of AIDS infection” (66). SEIU highlighted several issues relating to the management

of medical wastes. For example, it noted that studies

of non-healthcare occupational exposures to bloodborne diseases are almost non-existent, but that exposure of these other types of workers to such diseases is known. SEIU, therefore, maintains that the

scope of coverage of OSHA regulations should be

based on the known modes of transfer (i.e., exposure), not arbitrary occupational and industry

sector categories.

The National Solid Waste Management Association (NSWMA) also maintains that solid waste

7SEIU represents 850,000 service workers in the public and private sectors, of which 275,000 are healthcare workers in hospitals, nursing homes, and a variety of other health and medical facilities. In addition, at least half of their membership in other types of jobs (this

includes workers such as janitors, mortuary and cemetery workers,

technicians, and police officers) may be exposed to blood, blood products, body fluids, and injuries from sharps.
13

Table 3.—Compliance Rates With Joint Advisory Notice—70-Hospital Sample (In percent responding “Yes”)

Ail Hospital size

hospitals Large Medium Small

Personal protective equipment (PPE):

Gloves readily available. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sufficient quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Right sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Masks or goggles available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fluid resistant gown available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Work practices/equipment:

Handwashing facilities in vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Ambubags available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Needle disposal containers in vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Self-sheathing needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Linen red bagged . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard operating procedures:

Procedures developed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PPE routinely used when contact with bodily fluids is anticipated . . . . . . . . . . . . . . . . . .

Training:

Educational materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OSHA worker brochure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Training in universal bloodborne disease precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Medical:

Hepatitis B vaccine available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

If available, free of charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Confidential HIV testing available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

if available, counseling provided . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SOURCE: Service Employee International Union, AFL-CIO, CLC, “Comments on OSHA’s Advance Notice of Propoaed Rulemaking to Control Occupational Exposures

to Hepatitis Band AIDS’’(Waahington, DC: Jan. 26,1988)

87%

14

60

61

48

87%

72

81

19

91

36%

70

74%

o

63

70%

100

26

50

100%

60

20

100

20

100%

40

100

25

80

0 %

60

80%

20

50

8 0 %

75

0

0

Table 4.—Compliance Rates With Joint Advisory Notice—30-Department Sample (in percent responding ’’Yes”)

Correctional Med. labs Mental health

Nursing Blood facilities and HMOs rehab. clinics

home(8) bank(2) (4) (7) (9)

Persona/protective equipment (PPE):

Gloves readily available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50% 100%0 100% 100% 89%

Sufficient quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 0 100 57 63

Right sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 0 50 57 75

Masks or goggles available . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 100 50 71 56

Fluid resistant gown available . . . . . . . . . . . . . . . . . . . . . . . . . 75 100 50 14 44

Work practices/equipment:

Handwashing facilities in vicinity . . . . . . . . . . . . . . . . . . . . . . . 63% 0% 75% 100% 780/0

Ambubags available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 0 75 29 63

Needle disposal containers in vicinity . . . . . . . . . . . . . . . . . . . 83 0 67 100 63

Self-sheathing needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 0 14 0

Linen red bagged . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 100 43 78

Standard operating procedures:

Procedures developed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0% O% 75% 57% 22%

PPE routinely used when contact with bodily fluids

is anticipated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 0 75% 100% 78%

Training:

Educational materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50% 500/0 100% 86% 00/0

OSHA worker brochure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 0

Training in universal bloodborne disease precautions . . . . . 75 0

Medical:

Hepatitis B vaccine available . . . . . . . . . . . . . . . . . . . . . . . . . . 38% 100% 75% 100% 67%

If available, free of charge . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 100 75 80 57

Confidential HIV testing available . . . . . . . . . . . . . . . . . . . . . . o 25 29 22

If available, counseling provided . . . . . . . . . . . . . . . . . . . . . o 25 43 0

SOURCE: Service Employee International Union, AFL-CIO, CLC, ”Comments on OSHA’s Advance Notice of Proposed Rulemakin9 to Control Occupational Exposures

to Hepatitis Band AIDS’’ (Washington, DC: Jan. 26,1988)
14

workers are at risk and should be covered by

OSHA’s infectious waste regulations (34). Solid

waste workers have been exposed to transmittable

diseases on the job through such practices as compaction of untreated wastes in standard refuse vehicles. This can result in the aerosolization of pathogens and potentially lead to disease transmission.

Some observers, however, maintain that such

risks are minimal (8,60). They maintain, for example, that if wastes are properly packaged and

handled, two of the factors necessary for disease

transmission are not present, i.e., mode of transmission and portal of entry. A frequently cited

study, performed in West Germany in 1983, does

report that there is no microbiologic evidence that

biomedical wastes are more infective than residential waste (37). These issues, however, have not

been extensively researched in the United States

to determine the degree of risks posed by infectious

wastes. In any case, those actually working associated with the housekeeping, janitorial, and refuse

handling and disposal of medical wastes indicate

that packaging frequently (although actual numbers are not available) does not hold wastes, and

that workers are exposed. Bags and boxes may leak

fluids, or sharps may protrude (51,66).

In general, the establishment of standard operating procedures (SOPS) is regarded as an effective way to better ensure the proper handling, storage, and transportation of medical wastes.8 For

example, the segregation of medical wastes has a

critical impact on the handling, storage, and trans-

*See, e.g., ref. 17. It is certainly an important aspect of the approaches recommended by CDC, OSHA, and EPA for medical waste

management.

portation of wastes. EPA recommends that infectious wastes be segregated at the point of origin;

that distinctive and clearly marked plastic bags and

containers for infectious wastes be used; and the

biological hazard symbol be used as appropriate

(81). Hospitals tend to segregate wastes into at least

infectious and non-infectious groups (61 ,62). Critical to the proper functioning of this system is knowledge of the waste types and their hazards by healthcare workers, and their cooperation to segregate the

wastes.

Even though segregation of wastes is considered

key to a successful waste management program, it

is also generally regarded as a highly problematic

practice. That is, there is some difficulty in ensuring that healthcare workers will reliably segregate

wastes. In part this results from the fact that, understandably, ‘‘most nurses and physicians consider

the delivery of health care to be their primary mission, not sorting wastes into [seemingly] arbitrary

categories (58). For this reason some hospitals

apparently find it easier to designate all wastes from

certain areas of the hospital as infectious.

Although this approach may be more costly,

given that disposal costs for infectious waste are generally higher than those for general refuse, it does

minimize the chances for crossover of infectious

waste into the general wastestream (58,62). If all

the wastes are mixed, then they would probably be

considered infectious and managed as such (i. e.,

sterilization or incineration v. landfilling or sewer

use). Once again, the central importance of the definition of medical wastes becomes apparent. The

hospital’s definitions of wastes affects the segregation of the wastes within the hospital and their handling, treatment, and ultimate disposal.
Chapter 3

Current Technologies, Treatment,

and Disposal Issues

Incineration

The incineration of medical waste has many of

the same advantages and disadvantages associated

with the incineration of any type of waste. That

is, advantages include significant volume reduction

of the wastes, while requiring little processing of

wastes before treatment. Disadvantages include

high costs and potential pollution risks associated

with incineration processes. The discussion in this

chapter will focus on issues and concerns more specific to the incineration of medical wastes.

As noted earlier, hospitals generate approximately 2.1 to 4.8 million tons of medical waste per

year (9,83). Of that, about 10 to 15 percent, or

about 210,000 to 720,000 tons, is generally considered infectious waste. Hospitals often incinerate both infectious and non-infectious waste together.

The total amount of medical waste incinerated per

year is unknown. 1 In fact, the exact number of medical waste incinerators currently operating is not

known. 2

Hospital incinerators burn a much smaller volume of waste than municipal incinerators. Of the

158 million tons of municipal solid waste generated

per year, approximately 15 million tons are incinerated (15). What concerns some observers is that

many of the hospital incinerators are located in

heavily populated areas (which could lead to greater

potential exposure) and appear to have relatively

high emission rates of some pollutants of concern

given their size.

Limited data indicate that small, on-site incinerators can emit relatively high levels of some pollutants, but few risk assessments have been performed on these incinerators, hindering the ability

to definitively evaluate the relative degree of risks

IEPA estimated that the total amount of hospital waste incinerated,

when including the waste incinerated off-site, is about 80 percent of

the total hospital waste in the United States (42).

‘One estimate is that over 7,000 medical waste incinerators of the

most frequently used type, i.e., controlled air systems, have been installed during the past two decades (8).

from these sources compared with other sources.

Most hospital incinerators have short stacks, which

may allow incinerator emissions to enter hospitals

through air-conditioning ducts and windows (40).

One study found that the concentrations of chromium, cadmium, and 2,3,7,8 tetra-chlorinated

dibenzo-p-dioxin (TCDD) equivalents were approximately two times higher in the hospital air intake than the maximum ambient ground level concentrations (13).

The three types of incinerators used most frequently for hospital waste treatment in the United

States are: controlled air, multiple chamber air, and

rotary kiln models (83). (See figure 2.) All three

types can use primary and secondary combustion

chambers to ensure maximum combustion of the

Figure 2.—Typical Controlled Air Incinerator

Gas discharge

Reed

ion

rge

Primary combustion air ports

SOURCE: C. Brunner, “Biomedical Waste Incineration,” paper presented at 80th

Annual Meeting of the Air Pollution Control Association, New York,

NY, June 1987.

15
16

waste. Many hospitals also may have small (usually older) incinerators used only for pathological

wastes. 3 Most, probably over 90 percent, of the hospital incinerators installed during the last two decades have been controlled air units, which tend to

be modular (8). Large municipal incineration operations are usually of a different design, since often

more capacity is needed than a modular unit can

provide. Consequently, there are relatively fewer

modular municipal waste incinerators.

As noted above, some concerns associated with

the incineration of medical wastes are not unlike

those associated with the incineration of most municipal solid wastes (e. g., the effects of burning plastics). Other concerns are more specific to the medical wastestream, such as the highly mixed nature

of medical wastes (e. g., infectious, hazardous, and

general refuse wastes) and the potential for incomplete pathogen destruction. Both types of concerns

will be discussed in this section, although limited

data are available on either type of concern. First,

the types of incinerators most frequently used for medical wastes will be briefly discussed and compared.

Controlled Air Incinerators

Most of the incinerators built for medical waste

treatment in the last 15 to 20 years have been controlled air (sometimes referred to as starved air)

incinerators. These burn waste in two or more

chambers under conditions of both low and excess

stoichiometric oxygen requirements. In the primary

chamber, waste is dried, heated, and burned at between 40 and 80 percent of the stoichiometric oxygen requirement. Combustible gas produced by this

process is mixed with excess air and burned in the

secondary chamber. Excess air is introduced into

the secondary chamber at usually between 100 and

150 percent of the stoichiometric requirement. A

supplementary fuel burner is used to maintain elevated gas temperatures and provide for complete

combustion.

Temperatures in the incinerator are controlled

through adjustments in the air levels. Air in both

chambers is modulated to maintain proper operating temperatures. Furnace exit temperatures are

usually maintained in the normal range between

3

It is not known how many of these types of incinerators are still

in use.

1,400 and 2,000 “F. There are also three and four

stage-controlled air incinerators that feature flue gas

recirculation.

One advantage of using low levels of air in the

primary chamber is that there is very little entrainment of particulate matter in the flue gas. For example, multiple-chamber air incinerators have average particulate emission factors of 7 pounds per ton,

compared with 1.4 pounds per ton for controlled

air units. Available data indicate that many controlled air incinerators can be operated to meet existing particulate standards that are at or below 0.08

grains per dry standard cubic foot (gr/dscf) (corrected to 12 percent carbon dioxide) (3,83). Many

States, however, are adopting lower standards (e.g.,

0.015 gr/dscf) for incinerators, which probably

would require additional control technologies. Additional controls may raise capital costs and require

expansion space (which may or may not be available). Additional controls, however, would capture

finer particulate and some other pollutants.

Advantages of the controlled air system include

high thermal efficiency as a result of lower stoichiometric air use, higher combustion efficiencies, and

low capital costs (which may increase as more controls are required). As with all types of incinerators, disadvantages include potential incomplete

combustion under poor operating conditions and

problems associated with achieving proper operating temperatures during startup of a batch unit.4

Other Types of Incinerators

Most incineration systems constructed before the

early 1960s were of the multiple-chamber types

(sometimes referred to as excess air types). They

operated with high excess air levels and thus needed

scrubbers to meet air pollution control standards

(8). Few multiple-chamber incinerator units are being installed today. Instead, older units of this type

are used primarily for non-infectious wastes (3,8).

A small number of rotary kiln incinerators are

currently operating, although greater use of them

is being promoted by some. These incineration systems feature a cylindrical, refractory-lined (usually

brick) combustion primary chamber. This chamber

‘In batch units, the waste is placed in the furnace in batches and

allowed to burn out. Combustion of the waste first occurs in the primary (ignition) chamber, through the introduction of heat by a burner.
—

17

rotates slowly (between 1 and 3 rpm) on a slightly

inclined, horizontal axis. This rotation provides excellent turbulence (i. e., mixing). Yet, the rotary

kiln systems tend to be costly to operate and maintain, usually require shredding (i. e., some size reduction of wastes), and usually require emission

controls (3,8,83).

Variations of all types of incineration processes

and other ‘‘innovative’ technologies continue to

appear. At present, however, controlled air incinerators are popular due to their relatively low (capital, operating and maintenance) cost and their ability to meet existing air standards without air

pollution controls. As a result, the controlled air

incineration industry is healthy. It remains in a relatively constant state of change and development,

although there are frequent turnovers, mergers, and

company failures in the industry (8).

Air Emissions and Ash

Concentrations of Emission Constituents

As of 1987, most States recommended but did

not require control of opacity and particulate emissions from hospital incinerators (83). The reported

range of concentrations of constituents in hospital

incinerator emissions are presented in table 5. The

raw data on emissions can be analyzed by normalizing the data to the amount of waste burned. Table

6 shows that for both polychlorinated dibenzodioxins (PCDDs, commonly referred to as dioxins)

and polychlorinated dibenzofurans (PCDFs, commonly referred to as furans), hospital incinerator

emissions are on the average one to two orders of

magnitude higher per gram of waste burned than

emissions from municipal incinerators. The single

exception to this is the Hampton, Virginia, facility, which in the past emitted upper bound dioxin

and furan levels that are one order of magnitude

‘Additional data may soon be available as a result of a settlement

approved by the U.S. District Court of the District of Columbia between EPA and two environmental groups. The settlement includes

a requirement for EPA to study emissions of dioxins and durans from

hospital incinerators, the current regulations of State and local governments, and available control technologies of such emissions by January 31, 1989. By March 3, 1989, EPA is to complete a study of operating procedures for hospital incinerators. (See Environmental Defense

Fund and National Wildlife Federation v. Thomas, Civ. No., 85-0973

(D. D.C.))

Table 5.—Concentrations of Constituents in

Emissions From Hospital incinerators Without

Particulate Control Devices

Constituent Range of emissions

Arsenic . . . . . . . . . . . . . . . . . . . . . . . . ..1-5 .99 gr/dscf

Cadmium . . . . . . . . . . . . . . . . . . . . . . . .24.7-140 gr/dscf

Chromium . . . . . . . . . . . . . . . . . . . . . . .2.15-30.9 gr/dscf

Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . .532-1190 gddscf

Nickel . . . . . . . . . . . . . . . . . . . . . . . . . . .2.22-8.0 gr/dscf

TCDD . . . . . . . . . . . . . . . . . . . . . . . . . . .3.3-38.5 ng/Nm3

Total dioxins . . . . . . . . . . . . . . . . . . . . .51.8-450 ng/Nm3

TCDF . . . . . . . . . . . . . . . . . . . . . . . . . . .18.9-79.8 ng/Nm3

Total furans . . . . . . . . . . . . . . . . . . . . . .117.3-785 ng/Nm3

HCI . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41-2095 ppmv

SO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19-50 ppmv

NO x . . . . . . . . . . . . . . . . . . . . . ........155-270 ppmv

abbreviations: grldscf = grains per dry standard cubic foot; nglNma = nanOgrams per standard cubic meter; ppmv = parts per million volume.

SOURCE: U.S. Environmental Protection Agency, “Hospital Waste Combustion

Study, Data Gathering Phase,” final draft, October 1987.

Table 6.—Dioxin and Furan Emission Concentrations

(in ng/Nm3)

Facilities Total dioxins Total furans

Hospitals:a

A . . . . . . . . . . . . . . . . . . . . . . . 160-260 386-700

B . . . . . . . . . . . . . . . . . . . . . . . 290-450 700-785

c . . . . . . . . . . . . . . . . . . . . . . . 117-197 52-84

Municipalities:

Hampton, NY . . . . . . . . . . . . . 243-10,700 . 400-37,500

North Andover, Mass.. . . . . . 225 323

Marion Co., Oregon . . . . . . . 1.13

Prince Edward Island,

Canada . . . . . . . . . . . . . . . . 60-125 100-160

Tulsa, Okla. . . . . . . . . . . . . . . 18.9 15.5

Wurzburg . . . . . . . . . . . . . . . . 22.1 27.9

Akron, Ohio . . . . . . . . . . . . . . 258 679

aExact Iwations of hospitals were not reported in the study.

SOURCE: C.C. Lee, G. Huffman, and T. Shearer, “A Review of Biomedical Waste

Disposal” (U.S. Environmental Protection Agency, Feb. 19, 1988).

higher than the upper bound levels reported for hospital incinerators. G

Thus, hospital incinerators tend to produce more

dioxins and furans per gram of waste burned than

municipal incinerators. Given the smaller volume

of medical waste incinerated, overall emissions from

all medical waste incinerators are less than those

from existing incinerators. Yet, since hospital incinerators are usually located in densely populated

areas, potential exposure may be greater.

‘The Hampton facility has recently been retrofitted, and its emissions have been significantly reduced (46).
18

Possible Reasons for Higher Emission Levels

of Dioxins/Furans and HCl

Higher concentrations of dioxins and furans may

be associated with medical waste incineration emissions due to:

1. the frequent startups and shutdowns these incinerators undergo;

2. less stringent emission controls;

3. poorer combustion control (e. g., waste mixing and oxygen controls); and

4. differences in the waste feed composition as

compared with municipal solid waste.

Studies have shown that dioxins and furans can

be formed after leaving the furnace, by the catalysis at low temperatures of precursors (such as chlorophenol and benzene) and chlorine atoms on fly

ash particles (19). This suggests that destruction

of precursors in the furnace and control of temperatures in the stack are important factors in preventing formation of dioxins and furans. Disagreement

exists over whether pyrolysis of PVC in hospital

incinerators can produce chlorobenzene (a potential

dioxin precursor). EPA has studied the phenomenon

of ‘transient puffs” (referring to upset conditions)

in test incinerators burning PVC and polyethylene.

During waste charging, hospital incinerators often

experience high carbon monoxide emissions, indicating poor combustion. These transient puffs

generate large quantities of products of incomplete

combustion (PICs), including dioxins (40).

Almost all hospital incinerators are operated on

an intermittent basis (83). Frequent startups and

shutdowns of medical waste incinerators may lead

to increased dioxin formation and may volatilize

certain waste components, including pathogens. A

study of dioxin emissions from the Westchester municipal incinerator in New York State found that

during cold starts (without auxiliary fuel), dioxin

and furan emissions were at least 10 times higher

than under normal operation (14,38). The study

concluded that dioxins are formed in cool sections

of the incinerator (between 400 and 800 ‘F). If

startups and shutdowns of medical waste incinerators are undertaken without auxiliary fuel, poor

combustion may allow dioxin precursors (e. g., chlorophenols) to escape up the stack, increasing catalysis of dioxins and furans on fly ash particles.

A study by the New York State Energy and Research Development Authority (NYSERDA), however, found that the presence of polyvinyl chloride

(PVC) was not related to the levels of dioxins and

furans in the stack of a municipal incinerator, at

least under the limited set of conditions during the

test. Instead, formation of these compounds was

partly related to the thoroughness of the combustion process. Poor combustion, which occurred at

temperatures below 1500 ‘F and which was indicated by high carbon monoxide levels, resulted in

substantial increases in dioxin and furan formation

in the furnace (52).7

Moreover, differences in waste composition may

influence the formation of dioxins and furans

through increased concentrations of precursors.

Medical waste can contain organic solvents that

may act as aromatic precursors and chemicals such

as anti-neoplastic agents (classified as RCRA hazardous waste) and bactericide. In addition, cytotoxic wastes represent approximately 1 to 2 percent

of all hospital wastes (71).

Laboratory studies have found that pyrolysis of

various plastics produces chlorinated aromatic

hydrocarbons. For example, pyrolysis of PVC has

resulted in the formation of benzene, 1,1,1-trichloroethane, trichloroethylene, and tetrachloroethylene

(85). On this basis, it is conceivable that pyrolysis

of plastics may occur in the primary combustion

chamber of controlled air units, causing the formation of dioxin and furan precursors. To reduce formation of these precursors, increased turbulence

(mixing), retention time, and temperature are required (7). In addition, computerized combustion

controls that regulate the level of oxygen in the furnace can improve destruction of precursors (40).

The concentrations of hydrogen chloride (HCl)

also appear to be consistently higher, on average,

compared with municipal waste combustors. One

reason for this may be higher levels of PVC in medical waste (39).8 EPA has reported that plastics comprise approximately 20 percent (by weight) of all

hospital waste, compared with 5 to 10 percent in

municipal solid waste (55). Virtually all of the chlorine present in these wastes is converted to HCl dur7See refs. 2,65.

qt should & not~, however, that HCl is contained primarily in

PVC and not other types of plastics. OTA does not have data on how

much PVC is in the plastic portion of the medical wastestream.
19

ing the actual combustion ‘process, assuming a high

combustion efficiency. The chlorinated plastics may

contribute to some of the high emission rates of HCl

and possibly dioxins. HCl may be controlled by

monitoring waste input or through the installation

of appropriate air pollution control technologies

(e. g., acid gas scrubbers).

Concentrations of Constituents in Ash

Little data has been reported describing the concentrations of the constituents of medical incinerator ash. Heavy metals have been found in hospital incinerator emissions and are expected to be

present in incinerator ash. Lead and cadmium, for

example, are found in radioisotope shielding as well

as pigments and additives in plastics (40). Limited

data from one hospital showed that extractions of

the fly ash sample were well above EP Toxicity

limits for cadmium and lead. Extractions from the

bottom ash sample were well below EP Toxicity

limits (7). One study summarized dioxin and furan concentrations in fly ash from three hospital

incinerators and four municipal incinerators (19).

(See table 7.) The data reveal that concentrations

of both dioxins and furans are considerably higher

in hospital incinerator fly ash than in municipal incinerator fly ash.

Total dioxin levels in hospital incinerator fly ash

samples were between 1 and 2 ppm, which is much

Table 7.—Concentrations of Dioxins and Furans in

Fly Ash From Municipal and Hospital Incinerators

(rig/g, equivalent to parts per billion)

Incinerator type

Constituent Municipal Hospital

2,3,7,8-TCDD . . . . . . . . . . . . . . . . . . . . 0.03-0.34 1.4-3.4

Tetra CDD . . . . . . . . . . . . . . . . . . . . . . 0.6-7.5 94-404

Penta CDD . . . . . . . . . . . . . . . . . . . . . . 1.2-13,2 208-487

Hexa CDD . . . . . . . . . . . . . . . . . . . . . . 1.4-15.8 271-411

Hepta CDD. . . . . . . . . . . . . . . . . . . . . . 1.8-25.6 189-307

Octa CDD. . . . . . . . . . . . . . . . . . . . . . . 1.9-23.1 123-245

Total dioxins . . . . . . . . . . . . . . . . . . 6.9-80.3 1155-1737

Tetra CDF . . . . . . . . . . . . . . . . . . . . . . 9.0-32.1 199-376

Penta CDF . . . . . . . . . . . . . . . . . . . . . . 10.2-38.3 285-647

Hexa CDF . . . . . . . . . . . . . . . . . . . . . . 8.0-31.7 253-724

Hepta CDF. . . . . . . . . . . . . . . . . . . . . . 3.4-15.9 125-286

Octa CDF . . . . . . . . . . . . . . . . . . . . . . . 0.7-4.6 25-134

Total furans . ..................31.3-1 19,5 895-2140

SOURCE: H. Hagenmaier, M. Kraft, H. Brunner, and R. Haag, “Catalytic Effects

of Fly Ash From Waste Incineration Facilities on the Formation and

Decomposition of Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans,” Erwirorrrnerrt, Scierrm and Technology 21(1 1):

1080-1084, 1987,

higher than the range of 7 to 80 ppb for the municipal fly ash samples. (See table 7.) In addition,

none of the fly ash samples from the hospital incinerators had concentrations of the 2,3,7,8-TCDD

isomer alone that were below 1.4 ppb. A concentration of 1.4 ppb of total 2,3,7,8-TCDD equivalents is the figure that CDC and EPA Headquarters have used as an indicator of safe concentrations

of dioxin in ash. If total toxic equivalents are calculated, hospital incinerators actually exceed the

dioxin standards by about two orders of magnitude.

It is important to note, however, that this comparison is based on a limited sample, and caution is

required when attempting to draw any conclusions

based on the reporting of so few studies.

Future Trends in Medical Waste

Incineration

There are a number of factors (in addition to the

definitional issues discussed above) which may influence the waste disposal practices of hospitals in

the future. First, the stringency of the emission

standards that hospital incinerators will need to

meet will determine the type and cost of air pollution controls. The cost and engineering feasibility

of retrofitting existing hospital incinerators with acid

gas scrubbers and/or particulate matter controls,

and computerized combustion controls, may force

many hospitals to cease on-site incineration in favor of off-site centralized incineration. g The capital costs of larger regional incinerators are presumed

to be lower per ton of waste than smaller individual hospital incinerators (6). Other costs, such as

transportation, however, need to be considered.

Also, generators of wastes using a regional facility

rather than incinerating wastes on-site may not realize a cost savings.

Second, increased regulation of ash disposal may

provide further impetus for hospitals to utilize offsite management of wastes or residuals. Even those

hospitals that continue to incinerate wastes on-site

may be forced to contract with a centralized ash

management facility. It is unlikely that disposal of

‘See, for exampIe, refs. 6,39); Currently, insurance is apparendy

available for hospital incinerators (e. g., refs. 27,31) and financing for

construction of off-site facilities is also available (18). Future concerns

in these areas do exist as well as concerns over potential siting problems and other difficulties associated with the construction of most

waste facilities of any type today.
incinerator ash in existing municipal landfills will

continue to be allowed. This may result in the need

to send the ash to more stringently controlled landfills or monofills. Regardless of whether ash is regulated under either Subtitle C or as a special waste

under Subtitle D, relatively short-term liability costs

associated with RCRA corrective action as well as

longer term liability associated with Superfund

could increase insurance and other operating costs

for these ash disposal facilities.

Controlled air incinerators have traditionally

been popular for medical wastes. As noted above,

this is apparently due to the fact that they can

achieve relatively lower particulate emissions, as

compared with rotary kiln incinerators (which tend

to be higher priced due at least in part to the need

for emission controls, such as fabric filters or electrostatic precipitators) (3). As best available control technology (BACT) emission standards below

0.08 gr/dscf for particulate matter (PM) are promulgated, however, controlled air facilities will require additional emission controls and may lose one

cost advantage over rotary kiln models.

For example, New York recently proposed PM

standards for new hospital incinerators of 0.01

gr/dscf for facilities processing more than 50 tons

per day and 0.015 gr/dscf for facilities processing

less than 50 tons per day, as well as a standard of

0.03 gr/dscf for existing facilities. In contrast, the

new Pennsylvania PM standard is 0.08 gr/dscf for

modular facilities, which can probably be met by

many controlled air facilities without emissions controls. Mid-sized units must meet 0.03 gr/dscf and

large units must meet 0.015 gr/dscf. The 0.03 and

0.015 standards will require air pollution control

devices.

Alternative technologies are being studied for

medical waste disposal. For example, the Department of Energy announced its participation in a

demonstration project at a hospital in Pennsylvania

to incinerate hospital wastes with coal in a fluidized

bed boiler. The temperatures at which coal burns

in these combustors is about 1,600 ‘F, which is considered sufficient to render most medical waste noninfectious. Limestone is added to the bed to absorb

sulfur. Moreover, both the limestone and the coal

ash itself, are chlorine-capturing agents. The fluidized bed combustion could allow hospitals to incinerate waste on-site and also to produce energy

for heat, steam, or other hospital uses (64).

Autoclaving

Autoclaving, or steam sterilization, is a process

to sterilize medical wastes prior to disposal in a

landfill.10 Since the mid-1970s, steam sterilization

has been a preferred treatment method for microbiological laboratory cultures. Other wastes (e. g.,

pathological tissue, chemotherapy waste, and sharps)

may not be adequately treated by some sterilization operations, however, and thus require incineration (72). OTA has no data on the total amount

of medical wastes sterilized in the country.

Typically, for autoclaving, bags of infectious

waste are placed in a chamber (which is sometimes

pressurized). Steam is introduced into the container

for roughly 15 to 30 minutes. Steam temperatures

are usually maintained at 250 ‘F (63). Some hospital autoclaves, however, are operated at 270 ‘F

(61). This higher temperature sterilizes waste more

quickly, allowing shorter cycle times.

Several studies indicate that the type of container

(e.g., plastic bags, stainless steel containers), the

addition of water, and the volume and density of

material have an important influence on the effectiveness of the autoclaving process (41 ,54,63). Each

of these factors influences the penetration of steam

to the entire load and, consequently, the extent of

pathogen destruction. Autoclaving parameters

(e.g., temperature and residence/cycle time) are determined by these factors.

Since there is no such thing as a “standard load”

for an autoclave, adjustments need to be made by

an operator based on variation in these factors. As

with many technologies, proper operation of autoclaves is key to effective functioning (i. e., in this

case, sufficient pathogen destruction to render

wastes non-hazardous).

One method of assuring that pathogen destruction has taken place is the use of biological indicators, such as Bacillus stearothermophilus. Elimination of this organism (as measured by spore tests)

from a stainless steel container requires a cycle time

IOEthylene oxide and other gas sterilization processes, as well ~ some

chemical (including the use of radioactive) processes, are also used

to treat wastes.
21

of at least 90 minutes of exposure. This is considerably longer than is currently provided by standard

operating procedures (61 ,63). This conservative approach, however, may provide more pathogen destruction than is necessary to reduce microbiological contamination to non-infectious levels (63).

Chemical disinfection (e. g., with formaldehyde,

xylene, alcohol) is used to sterilize reusable items.

Recently, sodium hypochlorite has been used in a

process to disinfect disposable products. Partial destruction of the material is achieved, but additional

incineration and high capital costs are associated

with the process as well.

Several factors have led some hospitals to abandon autoclaving. For example, problematic operating conditions can lead to incomplete sterilization. In addition, landfill and off-site incinerator

operators are increasingly refusing to receive such

wastes, questioning whether the waste has actually

been treated. The refusals are partly in response

to the fact that most autoclave “red bags’ do not

change color and thus appear no different from nonautoclaved red bags (even though they often are

labeled or in some way identified as “autoclave”).

This also has led to more cumbersome documentation and/or identification requirements in an effort to avoid refusals (72).

Incineration v. Autoclaving; and the

Importance of Proper Operation

Autoclaves must achieve minimum temperatures

and be operated according to appropriate cycle

times to ensure adequate destruction of pathogens.

Primary and secondary chamber temperatures of

1,400 ‘F and 1,600 ‘F, respectively, must be

reached in hospital incinerators to ensure adequate

combustion and minimum air emissions (83). Normally, these temperatures would ensure the destruction of pathogens in the waste, however, if an incinerator is loaded and fired-up cold, pathogens

could conceivable escape from the stack. Data is

not readily available to evaluate this point further.

At the typical operating temperature of an autoclave

(250 “F), the cycle time of 45 to 90 minutes is necessary to reduce pathogen concentrations in most

hospital waste below infectious levels (63).

The proper operation of incinerators and autoclaves is critical to their effective functioning.

Proper operation is dependent on at least four conditions: 1) trained operators; 2) adequate equipment (i. e., proper design, construction, controls

and instrumentation); 3) regular maintenance; and

4) repair. For example, trained operators need to

be knowledgeable in the operation of the incinerator and in the proper handling of medical wastes.

It is not clear, however, that workers are consistently receiving adequate training in the operation

of incinerators or autoclaves, and consequently that

most units are operating properly. 11

Autoclaves do provide some advantages over incinerators, which may increase their attractiveness

as a disposal option, particularly if incineration regulations become much more stringent and thereby

increase incineration costs. For example, operation

and testing of incinerators is more complex and difficult than that for autoclaves (57). In addition,

environmental releases from incinerators probably

contain a broader range of constituents (e. g., dioxins, heavy metals) than autoclaves.

Autoclaves are also less costly to purchase and

operate and require less space. These cost advantages, however, may be lessened if incineration is

also required.

A major difficulty associated with autoclaving is

the reluctance of landfill and (off-site) incinerator

operators to accept medical wastes. This, along with

other difficulties associated with autoclaving, such

as ensuring the proper operation of the autoclaving process (e. g., sufficient residence time to ensure pathogen destruction), the more limited capacity of most autoclaves, and the time-consuming

process for autoclaving compared with incineration,

make it a less common waste treatment method for

most facilities (53). 12

I IEpA is preparing a training manual for the operators of hospital

incinerators and an air compliance inspection guide.

lzRecently, new technologies for autoclaving have been announced.

For example, one company has introduced a large mobile autoclaving unit (moved on a semi-trailer) that can sterilize approximately

1,500 pounds of waste per hour. Materials ‘ ‘cook’ at 275 ‘F and are

then allowed to cool. Special autoclaving bags are apparently not necessary, and the process is advertised as an economical disposal option

for certain medical wastes. See announcement in Infectious Waste

News, June 18, 1987.
22

Health and Environmental Risks From

Treatment Technologies13

The few risk assessments that have been performed on individual hospital incinerators have predicted health risks (specifically, cancer risks) that

are comparable to those predicted for municipal incinerators (20,47). Important differences, however,

in risk assessment methodologies and the sitespecific nature of these risk assessments precludes

meaningful comparisons between projected cancer

risks. For example, most risk assessments account

for risks associated with inhalation, but not for those

associated with ingestion. In addition, the age of

facilities under investigation varies considerably,

and older facilities tend to have less-than-optimal

operating conditions and/or less air pollution control equipment.

There are two important points regarding hospital incinerator emissions: 1) hospital incinerators

do not generally achieve emission levels as low as

those reported for municipal incinerators; but 2)

they tend to burn a much smaller volume of waste

and so emit smaller quantities of toxic constituents.

Yet, the closer proximity of many hospital incinerators to populations is also an important consideration. In any case, no national estimates have been

developed for aggregate cancer risks from all hospital incinerators that can be compared with EPA’s

national estimates for municipal incinerators. Additionally, no national estimates of non-cancer effects associated with hospital incinerator emissions

have been undertaken.

IJNote, currently most of the attention here is on risks from the

incineration of biomedical wastes. Additional information, as available, will be added on risks associated with autoclaving and Iandfilling.

The risks associated with incinerator emissions

have been estimated by States for individual municipal incinerators and by EPA for all municipal

incinerators (48,82). In contrast, few risk assessments have been performed for hospital incinerators. The New Jersey Department of Environmental Protection (N.J. DEP) performed a risk

analysis on four hospital incinerators for seven carcinogens (four metals, two VOCs and TCDD),

HCl, and criteria pollutants (20). Only TCDD was

found to pose a cancer risk of greater than one in

a million. The upper bound cancer risks from chromium and cadmium, the second and third most significant carcinogens, were both one order of magnitude lower than TCDD.

A risk analysis of a proposed hospital incinerator in Michigan predicted upper bound dioxin cancer risks that were one order of magnitude lower

than those predicted by N.J. DEP (12). The New

Jersey risk assessment only examined the tetra dioxin homolog and did not include other dioxin

homologs or furans in the analysis. This may have

resulted in some underestimation of the upper

bound cancer risk. One review of data on dioxin

and furan emissions from hospital incinerators has

found emission rates of total dioxins and total furans generally higher than those from municipal

incinerators (42).

The New Jersey results are consistent with the

national risk assessment performed by EPA on municipal incinerators insofar as they indicate that dioxins are responsible for most of the cancer risk

associated with incinerator emissions (82). EPA’s

analysis, which examined the risk from municipal

incinerators on a national basis, found that dioxins

posed the greatest risk of cancer by two orders of

magnitude, compared with the second most significant carcinogen present, cadmium.
Chapter 4

Regulatory Authority and Current Practices

Federal Authority

The two Federal laws that most directly provide

the government with the authority to regulate or

control the management of infectious wastes in

some way are the Resource Conservation and Recovery Act (RCRA) and the Occupational Safety

and Health Act (OSHA). 1 In addition, New Source

Performance Standards (NSPS) of the Clean Air

Act may apply to hospital incinerators.2 Any special State and local regulations for general and infectious wastes also apply. Certain chemical wastes

generated in healthcare facilities are considered hazardous waste and may be subject to provisions of

RCRA, and radioactive waste disposal must conform

with Nuclear Regulatory Commission standards.3

The agency with the most comprehensive authority to provide Federal leadership on the

management of medical wastes is EPA. EPA has

authority under RCRA to regulate the handling,

storage, treatment, transportation, and disposal of

medical wastes. Its regulations would apply to public and private facilities of all types.

Currently, as noted above, the Agency has only

issued a guidance document for the management

of infectious wastes. Other medical wastes are considered to be like any other solid waste and are subject to relevant RCRA Subtitle D regulations.

In contrast, the CDC does not have authority

to issue regulations. OSHA may issue regulations

or guidelines to protect the health and safety of

workers, but they apply only to private facilities

(unless a State extends the coverage to employees

of public facilities as well).4 At present, OSHA does

regulate employee exposure to toxic substances under the General Industry Health standards.5

1

42 U .S. C. 6901 et seq.; 29 U.S. C. 651 et seq., respectively,

2

42 U. S.C. 7411. It is important to note that NSPS apply only if

the source is over 50 tons per day, which few medical facilities are.

In any case, these standards only apply to conventional criteria pollutants. Potential air toxics are not regulated at the national level at

this time.

340 CFR 260-265; 122-124; 10 CFR 20, respectively. These types

of wastes, because of their need to be handled specially and the existence of regulations governing their disposal, will not be discussed extensively here.

4

29 U.S.C. 652(5); 655(b); 657(c); 657(g)(2).

5

29 U.S.C. 655.

Under Section 6 of OSHA, the Labor Secretary

is given general authority to promulgate such standards in order to assure the ‘‘attainment of the highest degree of health and safety protection of the employee.” Yet, the feasibility of the standards must

be considered, and they must be set on the basis

of the best available evidence. There is apparently

nothing in the definitions of terms in OSHA that

would preclude the application of the law’s authority to the regulation of infectious wastes.6 At this

time, however, OSHA has limited its specific activity on occupational exposure to infectious wastes

to its rulemaking activity to control occupational

exposures to Hepatitis B and AIDS.

State Regulatory Activities

Given the general lack of regulation on the national level, States have developed their own infectious or medical waste programs. As the Council

of State Governments (CSG) report, State Infectious Waste Regulatory Programs, notes, without

a Federal baseline and without Federal funds ‘‘to

support the creation of a new environmental regulatory program [to manage infectious wastes],

states, regardless of size or location, are in the process of meeting the public’s demand for protection.

It is [a] clear state-generated initiative . . .” (emphasis added) (4). Local governments (e. g., towns,

cities, and counties) may also develop special medical requirements of one sort or another. This has

led to tremendous variation in the regulation of

these wastes.

The variation in State activities is worthy of

Federal attention for at least two reasons. First,

stricter regulations in one State may encourage

the shipment of wastes to other States with less

stringent regulations. Second, many States, in

the absence of Federal guidance, apparently are

“leap-frogging” one another to adopt the most

stringent regulations. One of the most striking features of recent State action on medical/infectious

waste issues is its rapidity. As the CSG notes, many

cThe definiton of the term employer appears sufficiently broad to

include hospitals and possibly other generators; the definition of toxic

materials or harmful physical agents’ also appears broad enough to

include infectious wastes (21 CFR 19 10.20(c)( 11 )). See ref. 16.

23
24

State legislative sessions are only a few months long

and only meet every other year. Yet, States have

been responding quickly to public concern over

medical wastes: 88 percent of the States in 1988,

compared with 57 percent in 1986 are or will be

regulating infectious wastes (4). (See figure 3.)

Eleven States split the jurisdiction over infectious

wastes between solid waste management offices and

health department offices, while other States designate one or the other of these types of offices as

the lead authority. Enforcement authority is usually in the solid waste office for off-site disposal,

with the air pollution control board responsible for

regulating incinerator emissions, and with the hospital licensure office responsible for monitoring onsite generation, treatment, and disposal of infectious wastes. Seven States delegate this authority

to county health departments, and in five it is

delegated to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (4).7

A majority of States target hospitals in their regulation of infectious wastes. Of these, three-quarters

also regulate clinics, but only half also include doctor and dental offices, veterinary hospitals, and

other small generators (4). (See figure 4.) Five

States currently exempt or are proposing to explicitly

exempt small quantity generators from infectious

7The JCAHO inspects hospitals periodically and determines their

accreditation. Despite their recognized authority, and potential to effect the waste management practices of hospitals, there has been criticism of the thoroughness of their inspections. See, e.g., ref. 53.

Figure 3.-Stages of State Changes in

Medical Waste Management ProgramsAs of March 1988

Draft/d

SOURCE:

1s(

The Council of State Governments, State Infectious Waste Regulatory

Programs (Lexington, KY: 19SS).

Figure 4.-Types of Medical Waste

Generators Regulated by StatesAs of March 1988

Hospitals

Clinics

Veterinary hospitals

Doctors/dentists

Biomedical/

pharmaceutical

Research

Other

I 1 I I 1 i

o 10 20 30 40 50

Number of States

SOURCE: The Council of State Governments, State Infectious Waste Reguh?tory

Programs (Lexington, KY: 1988).

waste regulations or policies (4).8 Regulating infectious wastes on the basis of listed generators

versus types of wastes can lead to some important

incongruities. In Rhode Island, for example, wastes

from animal research in a laboratory associated with

a hospital are subject to infectious waste regulations,

however, wastes from animal research at a laboratory unaffiliated with a hospital are not subject to

the regulations (4). As will be discussed further below, whether small quantity generators should be

exempt from infectious waste regulations is a significant, unresolved issue.

Unless a State specifically regulates infectious

wastes as hazardous wastes (4),9 permits are not

likely to be required by States. Instead, infectious

waste guidances and rules appear to be the norm

and are designed to be “self-enforcing. The Council of State Governments identifies the logic as:

Best management practices (emphasizing biosafety), liability issues, and haulers’ refusals to handle red-bagged wastes are recognized and depended

upon as strong voluntary compliance inducements

(4).

A concern expressed by some hospital administrators, however, is that the regulations proposed

or adopted by some States are inappropriate, unrealistic, and costly. For example, the New York

State Department of Environmental Conservation’s

8These are: California, Indiana, Minnesota, Missouri, and Ohio.

‘This is true for: the District of Columbia, Hawaii, Iowa, Kentucky,

Maine, and Washington.
25

(DEC) draft regulations, referred to as the “most

far-reaching and comprehensive waste management

laws in the nation’ for solid and infectious waste

management, contain the following incinerator

emission standards:

●

●

●

0.010 grains per dry standard cubic foot of flue

gas, corrected to 7 percent oxygen (for new

facilities processing over 50 tons/day);

90 percent reduction of hydrogen chloride

(HCl) emissions;10

At least 1 second residence time at least 1,800

‘F for combustion gas. 11

These new regulations are expected by many,

including the DEC, to increase the cost of on-site

incineration of infectious wastes (31). This may lead

to more off-site treatment of hospital wastes.

One hospital consultant’s opinion of the New

York State regulations, and other State regulations,

based on best available control technology for incineration of infectious wastes is that:

. . . [they] appear to have no technical basis, and

many are also reflective of unproven, unrealistic,

and sometimes unattainable technology . . . . .

What appears most disturbing, however, is that

there appears to be no evidence or documentation

which show that there will be any significant environmental benefits or reduced health risks if such

proposed legislation is enacted (8).

He maintains that more analysis is needed before such standards are adopted. The need for

standards set on the basis of sound analysis is rarely

disputed. Currently, lacking such an analysis, it is

unclear which level of standards are most appropriate. Variation between the levels adopted by

States is readily evident, however, and is one justification frequently noted for the development of national standards. (See table 8.)

IOun]ess it is &monStrated that either the stack concentration is

less than 50 parts per million by volume, dry basis corrected to 7 percent oxygen; or, the uncontrolled emission rate is less than 4 pounds

per hour and the total charging rate is less than 500 pounds per hou

I I For multichm~r incinerators, these parameters must be met aftf--

the primary combustion chamber, which must be maintained at no

less than 1,400 “F.

More than half of the States require or plan to

require treatment (e. g., autoclaving) of infectious

wastes before land disposal. Yet, under certain conditions, at least 12 States allow infectious wastes

to be landfilled without treatment. Seventy-two percent of the States name incineration in their existing or proposed regulations as a recommended

treatment for medical wastes. Five States require

incineration (4). 12 Twenty-three States are considering establishing performance standards, which

could be in addition to any other applicable standards set by State air control agencies for incinerators. Twenty-seven States recommend steam sterilization as a treatment process for infectious wastes.

Fourteen of these States specify or are considering

specifying time/temperature/pressure standards.

Eighteen States include chemical treatment as an

alternative, and other treatment alternatives are

considered on a case-by-case basis by other States

(4).

Handling of infectious wastes on-site is usually

governed by State health departments. They issue

guidelines usually based on the periodically issued

recommendations on biosafety from JCAHO, CDC,

NIH, EPA, and OSHA (4). Packaging and labeling requirements are included in the infectious

waste regulations of31 States. These include such

requirements as rigid containers, double bagging,

and labeling requirements. Storage requirements

(currently in place in 7 States and being considered by 14 others) include such elements as the

length of time wastes can be maintained on-site and

refrigeration requirements. Transportation requirements (including the designation of only non-compacting trucks for transporting infectious wastes,

requiring truck labeling and shipping procedures,

and specifying cleaning procedures) and recordkeeping requirements (usually recordkeeping by the

generator rather than a manifest system of submitting records to the State) are being considered by

three-fifths of the States (4).

I zThese are: Alaska, Arkansas, Colorado, New Hampshire, and

Tennessee.
26

Table 8.—Status of Selected State Infectious Waste incinerator Regulations”

Parameter New York Pennsylvania Minnesota Mississippi California Wisconsin

Air emissions:

Particulate 0.01 gr/dscf

(for new and

old facilities

over 50 tons/

day); 0.015 (for

new facilities if

less than 50

tons/day); 0.03

(for existing

facilities if less

0.1 gr/dscf (for 0.01 gr/dscf 0.2 gr/dscf (at 0.1 gr/dscf at 0.03 gr/dscf at

existing facili- (for facilities 12 ”/0 C02) 120/0 CO2 (for 120/0 CO2 for

ties); 0.08 gr/ less than 1000 existing facili- greater than

dscf (for new Ibs/hr) ties); 0.08 (for 200 Ibs/hr)

facilities less new facilities)

than 500 Ibs/

hr); 0.03 (for

facilities of

500-2000 Ibs/

hr); and 0.015

than 50 tons/

day

(for facilities

over 2000 lbs/

hr)

Visible

emissions

(opacity) 40% 20% 50/0 (as measured by U.S.

EPA Method 9

300/0 (anytime

10% for any 3

minute hourly

average)

Hourly average

100/0 maximum

content, 6

minutes average less than

20%0

90% HCI

reduction, or

50 ppm HCI

50 ppm

—

30 ppm (or 50 ppm at 120/0

90°/0 reduction)

Testing

required

HCL (acid gas) — —

— CO2 over any

continuous 1

hour period

30 ppm (or

75% reduction

S O2 —

Carbon

monoxide 99 ”/0 75 ppm at 70/0

reduction

Hourly average

no more than

100 ppm at 70/0

02

Hourly average

no more than

100 ppm at 70/0

02

— —

Combustion:

Efficiency 99.9 ”/0 — —

Yes

— —

Operator training:

Training Yes

Certification Yes

Solid waste:

Residual

burn out —

Yes

— —

—

—

—

—

— — — Maximum ash

content 5°/0,

no visible

unburned

combustibles

Abbreviations: grldacf = grains Per dry standard cubic foot; mm = parts per million %%rIy States are currently revising their regulations for infectious waste incineration. These figures should not be cited without confirming their current status.

SOURCE: Adapted from F. Cross, “Comments on Background Paper,” prepared for OTA WorkshoP on Biomedical Waste Management (Washington, DC: July 19, 1988);

R. Kerr, New York State Department of Environmental Conservation, personal communication, Sept. 20, 19SB; J. Salvaggio, Pennsylvania Department of Environmental Resources, personal communication, Sept. 20, 19BB; and Gary Yee, California Air Resources Board, personal communication, Sept. 21, 198S.
Chapter 5

Managing Medical Wastes—

Institutional and Policy Issues

Whether the Federal Government should further

regulate the management of medical/infectious

wastes is an open issue. Within the policy debate

over whether and how medical wastes should be

regulated are classic divisions between those maintaining there is a need to document actual harm

from medical wastes, and those primarily concerned

with the potential harm posed by these wastes. Most

environmental laws passed in the last 20 years have

embodied a ‘ ‘preventive’ approach to human

health and environmental risks as the basis for regulatory action. In practice, however, a more ‘ ‘reactive’ basis for policy development is often used.

This latter approach reflects the incomplete shift

of the ‘‘burden of proof’ with which administrative agencies have had to cope in justifying the actual regulation of environmental practices. This

pragmatic approach to regulation, in an effort to

conserve regulatory resources, essentially finds regulation justified only when the relative degree of

risks posed by the activities are known and appear

high. It is in this context that the debate takes place

over whether current management problems associated with medical waste disposal warrant Federal

regulation.

At the moment, two regulatory trends are

emerging in medical waste management, both

primarily driven by the more “preventive”

mode of regulation: one trend is toward regulating greater quantities of potentially infectious

wastes; and the other trend is toward tightening

controls over incineration and other disposal options. As one hospital consultant noted,

More and more waste quantities are required to

be treated as “infectious,” of which smaller percentages are truly infectious; but, simultaneously,

viable treatment and disposal options are being

eliminated or made cost-prohibitive (8).

The concern of some generators of medical waste

is that some, if not all, ‘ ‘viable’ management options will become less available (or more costly) due

to the adoption of stricter air emission regulations

by a number of States. This could affect, at least

on a temporary basis, the availability of sufficient

capacity in some areas for managing medical waste.

Several other general trends also appear to be

emerging in the management of medical wastes.

These include: 1) the likelihood of further regulation, at least at the local and State levels of government; 2) possible increases in off-site commercial and regional incineration facilities, depending

on the levels of standards set in such regulations

and on other cost factors; 3) an increase in the transportation of medical wastes if there is more off-site

disposal (which will probably provide further impetus to establishing manifest or recordkeeping systems of some sort); 1 and 4) the likelihood of increased costs for disposing of medical wastes as

more treatment becomes necessary and more stringent controls are adopted.

As noted above, most States are currently developing or revising regulatory programs that address medical wastes. The stringency of the emissions standards that medical incinerators must

comply with will determine the type and cost of necessary air pollution controls. The cost and engineering constraints (e. g., space) of retrofitting

existing hospital incinerators with acid gas scrubbers and/or particulate matter controls may force

many hospitals to cease on-site incineration in

favor of off-site incineration at regional, centralized facilities. Regional facilities, however, are

likely to face siting difficulties.

Increased transportation of medical wastes to regional facilities, or to facilities that are located outside a State and in some cases outside of the country, will further increase disposal costs. It is also

‘ontario, Canada, has a manifest system in place and would 1 ilw

the United States to establish a manifest system of some sort to facilitate estimating hctter the amounts of medical wastes entering Canada from the United States, in order to better plan for the management of it. Some States (e. g., Massachusetts, New York, Missouri,

and New Jersey) arc establish ing or have established manifest s~rstems of some sort for medical wastes.

2 7
28

likely to increase health risks to the public, given

the greater potential for accidental exposure due

to spills and possible illegal dumping or disposal.

These concerns provide support for proposals

that require manifest or recordkeeping systems

to track the movement of these wastes. The Senate passed legislation (S. 2680) in August 1988 that

will require EPA to establish a model tracking system in New York, New Jersey, and Connecticut

for medical wastes. Similar legislation is pending

in the House (H. R. 3515, H.R. 51 19).

Policy Issues for Federal Action

To best address issues associated with these

trends, at least two types of policy activities are relevant: 1) further development and enforcement of

standard operating procedures (SOPS) by hospitals

and other medical waste generators for the handling, storage, treatment, and disposal of these

wastes; and 2) further clarification and coordination of regulatory programs at the local, State, and

Federal levels of government. In particular, the possibility of further Federal involvement warrants discussion, given the increased public concern over

the management of medical wastes, the increased

level of local and State regulatory activity (which

has led to nationwide variation in the treatment of

these wastes), the interstate transportation of medical wastes, and the current absence of a comprehensive medical waste policy at the national level.

The Federal Government could usefully specify

its policy(ies) regarding medical wastes in a

number of areas: 1) designation of a lead authority (presumably EPA) to clarify the definition,

classification, and regulation of these wastes; 2)

the establishment of emission standards and ash

regulations for medical waste incinerators, autoclaving/landfilling performance standards, and

possibly operator training guidelines/regulations; 3) handling, storage and transportation

guidelines/regulations to ensure worker safety

and possible establishment of some sort of a

manifest system; and 4) research and data needs

on medical waste practices. Some of these issues

could be addressed under RCRA’s current authority or could be clarified as part of the RCRA

re-authorization process.2 Other relevant laws

are OSHA, the Clean Air Act, and possibly the

Toxic Substances Control Act.

A number of important, related issues noted

throughout this paper re-surface as the implications

of these areas for possible further policy development are discussed. The implications of three of

these areas, the definition/classification of medical

wastes, the issue of small quantity generators of

medical wastes, and research and data needs associated with medical waste management are discussed briefly to indicate the range of regulatory

issues the Federal Government will need to address

if it revises or expands its role in medical waste

management.

The definition of medical wastes under RCRA

is of critical importance to determining the type of

regulatory effort EPA is likely to undertake. Its

clarification is also likely to facilitate State actions

and commercial development of medical waste

incineration. Another important dimension of the

medical waste management issue is which types of

sources should be regulated, i.e., the question of

whether small generators of medical wastes should

be exempted. Further research into the nature of

the risks (both occupational and environmental)

associated with medical wastes, research on new

treatment technologies, and performance data for

existing facilities is desirable in order to develop

more informed and effective policies.

Defining/Classifying Medical Wastes

If infectious wastes are classified and regulated

as hazardous under RCRA, a comprehensive management program is likely for infectious wastes. For

example, regulating infectious wastes as hazardous

wastes under RCRA could address transportation

issues associated with infectious waste management.

This would involve: 1) recordkeeping concerning

the waste transported, its source and delivery

points; 2) transportation of the waste only if properly labeled; 3) compliance with the manifest system (Section 3002); and 4) transportation only to

‘Some issues, e.g., concerning occupational risks, could be addressed

under other statutory authority, such as OSHA. The focus here is

on RCRA given the primary focus of this paper on waste disposal

issues.
29

the waste facility that the manifest form designates

as holding a proper permit.3 In addition, waste

treatment, storage, and disposal facilities would be

subject to hazardous waste standards and permitting procedures.4

As the Council for State Governments (CSG) has

noted, existing State infectious waste programs do

not tend to include three requirements usually associated with hazardous waste laws. These are requirements for contingency plans and spill management, closures, and financial assurances (4).

As noted above, in RCRA, the statutory definition of hazardous waste includes ‘ ‘infectious’ as

a defining characteristics EPA interprets RCRA

as providing it with discretionary authority to classify infectious wastes as either hazardous wastes or

solid wastes. b EPA, in 1978, did include infectious

waste as part of its first set of proposed hazardous

waste regulations. The final rule published in 1980,

however, stated that infectious waste regulations

would be published separately. As the CSG notes,

. . . [e]ight years and two reauthorizations of RCRA

later, still no Federal regulations have been promulgated (4).

Instead, in 1986, the EPA issued its Guide for

Infectious Waste Management stating that

. . . [w]hile the Agency has evaluated management

techniques for infectious waste, considerable evidence that these wastes cause harm to human

health and the environment is needed to support

Federal rulemaking (emphasis added; 81).

RCRA (Section 1004), however, states that the

term ‘‘hazardous waste’ refers to a waste with infectious characteristics which may

. . . pose a substantial present or potential hazard

to human health or the environment . . . (emphasis added).

’42 U. S.C. 6924.

442 U. S.C. 6924; 6925.

542 U.S. C. 6903(5).

642 U.S. C. 6903(5); 6921. The hazardous characteristics, of wh ich

infectious is one, listed in 6903 are to be considered when the ,4dministrator of EPA identifies or lists hazardous wastes as pcr 6921.

EPA, however, in their regulatory interpretation, left the infectious

characteristic out of the defin it ion of ‘‘hazardous waste’ (40 C FR

240. IOl(m)).

Recently, EPA has increased its attention to infectious and medical waste issues. In early 1988,

EPA assigned for the first time a full-time staff person to handle infectious waste issues. In June, the

Agency issued a request for comment on infectious

waste issues in the Federal Register. Most recently

the Agency has formed a task force to address infectious waste issues. Publicly, the Agency has not

ruled out the possibility that ultimately it may issue regulations, although at present its efforts seem

to be on developing an education program.

As noted above, infectious wastes are unlike other

types of hazardous wastes that can be consistently

identified by a test. Detection of infectious microbes

in landfill leachate is not highly likely given that

they are generally less persistent in the environment

than toxic substances such as heavy metals, oils,

solvents, etc. Exposure to sunlight or dry air can

render infectious wastes non-infectious. It is also

true, however, that infectious microbes in medical wastes could multiply and are potentially contagious under certain conditions. In this context,

developing a separate statutory category for infectious and medical wastes is seen by some observers

as desirable. Applicable hazardous waste provisions

from RCRA Subtitle C could be adopted and appropriate adjustments made given the particular nature of the medical wastestream.

It is not entirely clear how EPA may ultimately

define, classify, and regulate infectious wastes (or

if it will). As noted above, EPA’s June 2, 1988,

Federal Register request for comment on infectious

wastes issues indicates the initiation of some information gathering action on this issue. EPA’s position in the summer of 1988 was that an education

program, but not regulation, was justified. Later

in 1988, after several congressional hearings, EPA

announced that it would consider the need for Federal regulation and established a task force on medical waste issues.

Meanwhile, Congress, as part of the RCRA reauthorization process, will address the issue of infectious and medical waste management (H. R.

3515; S. 2773).7 H.R. 3515 is the more detailed

‘The House En~,rg> and Commerce Subcommittee on Transportation, Tourism. and Hazardous Materials held one hearing October

(continued on next page)
30

of the two bills with respect to medical waste management. For example, it would require EPA to

issue regulations for all aspects of infectious waste

management including generation, transportation,

treatment, storage, and disposal.

H.R. 3515 distinguishes between medical and

infectious wastes. Infectious wastes would only

be classified as hazardous wastes under this bill

if they were mixed with hazardous wastes already regulated under Subtitle C. In September

1988, a substitute for H.R. 3515 added a provision to establish a demonstration tracking system

for medical waste in New York, New Jersey, Connecticut, and the Great Lakes States. * As of September 21, 1988, the House Energy and Commerce

(continued from previous page)

21, 1987, on the rcgu]ation of infectious wastes. The House Small

Business Subcommittee on Regulation and Business Opportunities

held a hearing on .August 9, 1988, on medical waste issues.

8The Senate passed legislation (S. 2680) which would establish a

model tracking s}!stem for New York State, New Jersey, and Connecticut. Similar legislation (H. R. 51 19), in addition to H.R. 5215,

is pending in the House.

Committee was scheduled to “mark up” H.R.

3515.

A number of other bills regarding medical waste

management issues have been introduced. As indicated in table 9, the proposed pieces of legislation address a number of aspects of medical waste

management, beyond the definition and classification issues. Some significant action on several of

the bills appears likely before the current session

of Congress ends. g

Regulating Small v. Large Generators

of Medical Wastes

Whether incineration emission standards should

be set at the Federal level and on what basis (tech-

‘For example. a bill (H. R. 5231 ) to amend the Marine Protection,

Research and Sanctuaries Act (Public Law 92-532; MPRSA, commonly referred to as the Ocean Dumping Act) of 1972 is expected

to reach the floor of the House before the end of the current session.

The bill would increase criminal penalties for illegal ocean dumping

of medical waste and provide recovery of damages associated with illegal dumping. The Senate included similar provisions in the amendments of MPRSA (S. 2030) that it passed in August 1988.

Table 9.–Legislation Pending in Congress on Medical Wastes (as of Sept. 20, 1988)a

Bill number Sponsor (original)

H.R. 1156 Dwyer (D-NJ)

H.R. 3467 Rinaldo (D-NJ)

H.R. 3478 Saxton (D-NJ)

H.R. 3515 Luken (D-OH)

H.R. 3595 Hughes (D-NJ)

H.R. 5119 Florio (D-NJ)

H.R. 5130, 5225 Hughes (D-NJ)

H.R. 5231 Studds (D-MA)

H.R. 5249 Davis (R-Ml)

H.R. 5302 Hertel (D-Ml)

S. Res. 470 Riegle (D-Ml)

s. 1751 Lautenberg (D-NJ)

S. 2628 Lautenberg (D-NJ)

S. 2726 Dodd (D-CT)

S. 2773 Baucus (D-MT)

Brief summary

Permits citizens of one State to bring Federal civil action against any person in another

State creating a public nuisance through improper management of medical wastes

Requires that within 12 months after completing a study of infectious and pathologic

waste, EPA must determine whether to regulate these wastes as hazardous wastes

under Subtitle C of RCRA

Amends MPRSA (Public Law 92-532). Bans the dumping of medical wastes in ocean and

navigable waters

Amends RCRA (Public Law 94-580) to require EPA to regulate the management of infectious and medical wastes; provisions include definition of waste types by EPA, and

establishment of a model manifest system in New York, New Jersey, Connecticut, and

the Great Lake States

Requires vessels to manifest the transport of municipal or other nonhazardous wastes

to ensure they are not illegally disposed of at sea

Amends RCRA to regulate medical wastes by requiring EPA to establish a model tracking system for New Jersey and New York

Amends U. S. C., Title 18, to provide penalties for illegal ocean dumping of medical wastes

Amends MPRSA to increase criminal penalties for illegal ocean dumping of medical

wastes and provide for recovery of damages associated with illegal dumping

Purpose is to protect the Great Lakes from the improper disposal of medical wastes

Establishes a pilot program for the tracking of medical wastes in States bordering the

Great Lakes

A resolution relating to medical wastes improperly disposed of in the Great Lakes

Requires vessels to manifest the transport of municipal or other nonhazardous wastes

to ensure they are not illegally disposed of at sea

Amends RCRA to establish a pilot program to track medical wastes in New York and

New Jersey

Amends RCRA to require EPA to regulate medical wastes

Amends RCRA to define infectious waste and the basis for regulating infectious waste

Abbreviations: EPA = U.S. Environmental Protection Agency; MPRSA = Marine Protection, Research, and Sanctuaries Act (also referred to as the Ocean Dumping

Act); RCRA = Resource Conservation and Recovery Act (also referred to as the Solid Waste Disposal Act); U.S.C. = United States Code

~he Senate passed legislation (S. 2680) in August 1988, which would establish a model tracking system for New York State, New Jersey, and Connecticut. The Senate

also passed in August amendments to MPRSA (S. 2030) that include a provision prohibiting the dumping of medical waste in the oceans and navigable waters. Similar

bills (H.R. 3515, H.R. 5119, H.R. 3478, H.R. 5231, respectively) are pending in the House.
31

nology - or health-based) is an open issue, as is

whether small generators (e. g., doctor offices, home

care) should be exempt from medical waste regulations. While hospitals and clinics may generate

larger quantities of wastes, those generated by

smaller facilities may be more susceptible to direct

public exposure. The two incidents of children playing with untreated wastes in the summer of 1987,

which focused national attention on medical waste

management, occurred outside of doctor offices—

not hospitals (32).

A problem is how these smaller generators can

efficiently and economically dispose of their infectious wastes. Commercial off-site facilities may not

be readily available or may be highly costly. Hospitals which could accept the waste (if there are not

State or local regulations prohibiting it) may be

reluctant to do so for potential liability reasons.

Some hospitals allow affiliated doctors to dispose

of infectious wastes, and potentially funeral homes

(with crematories) could also accept wastes from

doctor offices. Again, liability issues and other factors (e. g., the additional staff time for handling such

waste) may make these types of facilities reluctant

to accept such wastes.

The relative risk posed by wastes from home-care

patients and other infectious materials generated

in homes versus that produced by commercial

generators is not known. Although the public’s general concern about AIDS and infectious wastes has

led to a focus on hospital wastes, most treatment

of AIDS is apparently done on an out-patient

basis. 10 As hospital stays have generally become

shorter in recent years, home care of patients has

increased. Infected wastes from these individuals,

as well as such items as disposable diapers and feminine sanitary products, are potentially infective

wastes, and they are directly landfilled in most

cases. Information on appropriate packaging and

special disposal procedures may be one way to encourage prudent disposal of home-care infectious

wastes. 11

It is not clear, however, whether these wastes,

any more than it is clear whether hospital wastes

(especially those which have been treated by autoclaving or some other sterilization process), pose

a significant contamination problem when landfilled. 12 EPA has noted that no groundwater impacts associated with landfilling any medical wastes

have been identified to date (84). Yet, with little

information on the quantities of infectious waste

from small generators, as well as on the risks of

these wastes, it is an open question as to what types

of controls are appropriate. Controls could focus

on handling and direct exposure (through improper

disposal) and/or on environmental risks from disposal of these wastes.

The feasibility of controlling small quantity

generators presents another policy dilemma. 13 Currently, the confusion over how best to address this

issue is evident in proposed legislation in some

States. California, for example, has two bills pending, one of which (S. 1448) would prohibit any person from disposing of untreated infectious wastes;

the other (S. 2469) requires the disposal of sharps

in puncture-proof containers, except those from private homes, physicians’ offices, or health-care facilities.

Research and Data Needs

As noted throughout this paper, little data exists on the management of medical waste. Indeed,

the ‘‘vital signs’ for medical waste management

are thereby difficult to read or interpret. Basic information on sources, amounts, composition,

and treatment/disposal of medical waste is not

known in any useful detail. In addition, insufficient research data exist to determine to what degree medical wastes are a public health problem.

Information on occupational exposure to hazards

associated with managing these wastes is not available. Comprehensive data on the operation of incinerators (e. g., types, comparisons of air emissions

levels for a range of pollutants (including patho10It is also worth noting that CDC studies found that HIV does

not persist well in the eni’ircmment, at least not after drying, which

causes a 90 to 99 per{ c.nt concentration reduction within several hours.

See ref. 77.

1 J For example, Pun{. tur(.. proof containers could be provided With

the sale of syringes (which in many areas can only be purchased with

a prescription) (48a)

I zItems such as disposable diapers and feminine sanitary products

are not generally considered a serious source of infectious contaminant ion to landfills. I t is on this basis that some observers maintain

that these wastes do not warrant special waste handling procedures,

and that bans of these products are unjustified.

jJThe Association for Practitioners in Infection cOINrOl has recently

proposed a guideline for infection control in home-care which covers

waste treatment in this setting (69).
32

gens), ash content analysis, etc.) do not exist at this

time.

As Ode Keil, Joint Commission on Accreditation of Healthcare Organizations, noted at the

OTA Workshop on Medical Waste Management,

held July 19, 1988, “We have a problem, but we

do not have a scientific analysis of the problem to

support development of a rational system. It appears it would be highly prudent for Congress

and Federal agencies to address the inadequacy

of data and research, and therefore information,

on medical wastes and their management. This

is essential for determining the need for and

nature of any regulatory program for medical

wastes.

A number of possible areas for further research

and information gathering exist. Several key areas

include:

1.

2.

3.

4.

5.

developing the basis for a consistent, concrete

definition of medical wastes, which all relevant Federal agencies issue jointly or at least

adopt;

the nature and extent of occupational risk, including risks not only to healthcare workers,

but housekeeping, maintenance and other

relevant workers as well;

use and comparison of different incineration

processes and other technologies, including

emission rates and health risk assessments of

these disposal options;

examination of the use of sewers for medical

waste disposal (e. g., the survival of viruses in

sewer discharges; problems associated with

combined sewer overflows, such as beach

washups of medical wastes; etc.);

identification of potential waste reduction options for medical facilities; and

6. comparisons of State regulatory programs,

specifically to highlight experiences relevant

to the development of possible Federal programs (e. g., model programs for managing

medical wastes from small generators; manifest systems, etc.).

Concluding Remarks

This chapter highlights the types of regulatory

issues that could be clarified by Congress and/or

the EPA and other Federal agencies when examining the adequacy of current medical waste management policies. One critical need that is readily

apparent and rarely disputed with respect to medical waste management is the need for more information on the risks posed by these wastes and on

their actual management, and for more research

of alternative treatment technologies and management techniques. Nonetheless, the need for research should not be taken as a suggestion for

postponing consideration of adopting a comprehensive regulatory program to address medical

waste management. In fact, research efforts

could be a part of a regulatory program, if it is

promulgated in phases.

The most coherent Federal policy for medical

waste management is likely to result only if the variety of issues (e. g., the definition, classification,

nature of risks, types of available disposal options,

and the implications of regulatory action) discussed

in this paper are comprehensively addressed. At a

minimum, this preliminary assessment of the status of medical waste management practices in the

United States today indicates that to adequately address the public’s growing concern over the management of medical wastes, policy makers will need

to address these issues as expediently as possible.
References

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

American Federation of State, County and Municipal Employees, AFL-CIO (AFSCME), “Background to a Petition to OSHA To Develop an

Emergency Temporary Standard for Prevention

of Transmission of Bloodborne Infection in the

Workplace” (Washington, DC: Sept. 19, 1986).

Basic, J., “Regulating Incinerator Emissions: Performance Standards v. Design Standards, ” paper

presented at the First National Symposium on Incineration of Infectious Wastes, Washington, DC,

May 5-6, 1988.

Brunner, C., “Biomedical Waste Incineration, ’

paper presented at the 80th Annual Meeting of the

Air Pollution Control Association, New York, NY,

June 1987.

The Council of State Governments, State Infectious Waste Regulatory Programs (Lexington,

KY: 1988).

Cox, K., “Hospital Wastes: How Much Is Generated and How Are They Managed?’ contract

supplement for Municipal Solid Waste Assessment

submitted to OTA, June 2, 1988.

Cross, F., “The Case for Regional Incineration

of Hospital Wastes, paper presented at the First

National Symposium on Incineration of Infectious

Wastes, Washington, DC, May 2-4, 1988.

Cross, F., “Comments on Background Paper, ”

prepared for OTA Workshop on Biomedical Waste

Management, Washington, DC, July 19, 1988.

Doucet, L., ‘‘State-of-the-Art Hospital and Institutional Waste Incineration: Selection, Procurement

and Operations, “ paper presented at the 75th Annual Meeting of The Association of Physical Plant

Administrators of Universities and Colleges,

Washington, DC, July 24, 1988.

Doucet, L., “Infectious Waste Incineration Market Perspectives and Potentials, ” paper presented

at Wastes-to-Energy ’87 Conference, Washington,

DC, September 1987.

Doucet, L., Hospital/Infectious Waste Incineration Dilemmas and Resolutions (Peekskill, NY:

Doucet & Mainka, P. C., 1988).

Doucet, L. and Mainka, P. C., personal communication, Aug. 9, 1988.

Doucet, L., and Tiny, J., “Hospital Incinerator

Emissions, Risks and Permitting-A Case Study, ”

paper presented at the 80th Annual Meeting of Air

Pollution Control Association, New York, NY,

June 1987.

Fiedler, L., Air Quality Division, Michigan Department of Natural Resources, “Case II: Mercy

Hospital Permit to Install Application, ” presented

14

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

at the Hospital Infectious Waste and Hospital

Sterilization Workshop, Baltimore, MD, 1988.

Fossa, A.J., Kerr, R. S., Columbus A. S., and

Waterfall R., “Air Emissions Characterization of

Municipal Waste Combustors in New York State, ”

paper 87-57.5, presented at the 80th Annual Meeting of Air Pollution Control Association, New

York, NY, June 1987.

Franklin Associates, Update of Solid Waste Data,

March 1988.

Gilmore, C., “Brief Summary of Several Federal

Statutes Which Arguably Provide the Federal Government the Authority To Control the Disposal of

Infectious Hospital Wastes, ” report to Congress

(Washington, DC: Congressional Research Service, The Library of Congress, Aug. 7, 1987).

Gordon, J., “Considerations in the Handling of

Wastes Within the Hospital, ” paper presented at

the First National Symposium on Incineration of

Infectious Wastes, Washington, DC, May 5, 1988.

Gregory, W., Smith Barney, personal communication, June 16, 1988.

Hagenmaier, J., Kraft, M., Brunner, H., and

Haag, R., “Catalytic Effects of Fly Ash From

Waste Incineration Facilities on the Formation and

Decomposition of Polychlorinate Dibenzo-p-dioxins

and Polychlorinated Dibenzofurans, Environment, Science and Technology 21(1 1): 1080-1084,

1987.

Held, J., “Potential Risk Posed by Hospital Incinerators in New Jersey, ’ New Jersey Department of Environmental Protection, manuscript,

Apr. 20, 1988.

Holtzman, E., “D.A. Holtzman Announced Indictment of Medical Waste Company. . . ,“ press

release, Brooklyn District Attorney’s Office, Brooklyn, Ny, July 30, 1987.

Holtzman, E., Testimony before the U.S. House

of Representatives, Committee on Small Business,

Subcommittee on Regulation and Business Opportunities, Hearing on Health Hazards Posed in the

Generation, Handling, and Disposal of Infectious

Wastes, Aug. 9, 1988.

Infectious Waste News, “Brookhaven, Ny, Accepts Local Hospital’s Waste After Banning It

Three Times From Landfill, ” Infectious Waste

News, p. 4, June 18, 1987.

Infectious Waste News, “Two Children Stuck

With Untreated Needles While Playing in Trash

Container, ” Infectious Waste News, p. 3, June 18,

1987.

Infectious Waste News, “Alexander and Alex33
34

26.

27.

28.

29.

30.

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

ander To Offer Environmental Insurance to Hospitals and Other Polluters, ” Infectious Waste

News, p. 6, July 2, 1987.

Infectious Waste News, “ECS Offers Insurance

Coverage for Infectious Waste Industry, ” Infectious Waste News, p. 4, July 2, 1987.

Infectious Waste News, “Twelve Children Find

and Play With Vials of AIDS-Infected Blood From

Open Trash Bin, ” Infectious Wastes News, pp.

2-3, July 2, 1987.

Infectious Waste News, ‘‘Long Island County Executive Wants To Ban Hospital Incinerators, ” Infectious Waste News, p. 4, July 30, 1987.

Infectious Waste News, “Infectious Waste Disposal Crisis Coming to Head, ” Infectious Waste

News, p. 3, Mar. 10, 1988.

Infectious Waste News, “OSHA’s Infectious

Waste Rules Need to Cover Refuse Industry, Too,

NSWMA Says, ” Infectious Waste News, pp. 1-

2, Mar. 10, 1988.

Infectious Waste News, “First Garbage Slick of

Season Washes Upon New Jersey Shore, ” Infectious Waste News, p. 5, June 16, 1988.

Infectious Waste News, “Baltimore County Considers Moratorium on Infectious Wastes Incinerators, ” Infectious Waste News, pp. 1-2, June 18,

1988.

Joint Commission on Accreditation of Hospitals,

Monograph: Managing Hazardous Wastes and

Materials (Chicago, IL: JCAH, 1986).

Joint Commission on Accreditation of Hospitals,

Accreditation Manual for Hospitals (Chicago, IL:

JCAH, 1988).

Jones, W., “Incinerator Operations and Maintenance, ” paper presented at the International Symposium on Incineration of Industrial and Hazardous Wastes, Washington, DC, May 5, 1988.

Kaiser-Permanente, “Guidelines for Preventing

Transmission of Infections in Health Care Settings, ” 1988.

Kalnowski, G., Wiegard, H., and Ruden, H.,

“The Microbial Contamination of Hospital Waste, ”

Zbl.Bakt.Hyg.I. Abt. Orig.B 178:364-379, 1983.

Kerr, R., New York State Department of Environmental Conservation, personal communication, Sept. 20, 1988.

Lauber, J., “Controlled Commercial/Regional Incineration of Biomedical Wastes, paper presented

at The Incineration of Low-Level Radioactive and

Mixed Wastes 1987 Conference, St. Harles, IL,

Apr. 21-24, 1987.

Lauber, J., New York State Department of Environmental Conservation, personal communication, September 1988.

41.

42.

43.

44.

45.

46.

47.

48.

48a.

49.

50.

51.

52.

53.

54.

Lauber, J., Battles, D., and Busley, D., “Decontaminating Infectious Laboratory Wastes by Autoclaving, ’ Applied Environmental Microbiology

44(3):690-694, September 1982.

Lee, C. C., et al., “A Review of Biomedical Waste

Disposal: Incineration, ” fact sheet (Cincinnati,

OH: Office of Research and Development, U.S.

Environmental Protection Agency, Feb. 19, 1988).

Mainen, E., “Testimony of Eugene Mainen,

Ph. D., Decom Medical Waste Systems, Inc., ” paper presented at the OTA Workshop on Medical

Waste Management, Washington, DC, July 19,

1988.

Massachusetts Department of Environmental Quality Engineering, “Infectious Hospital Waste, ” internal memorandum, Apr. 16, 1986.

McCormick, R. D., and Maki, D. G., “Epidemiology of Needlestick Injuries in Hospital Personnel, ” American Journal of Medicine 70:928-932,

1981.

McDonald, B., Energy Systems Associates, personal communication, Sept. 13, 1988.

Michigan Department of Natural Resources, “Permit to Install Municipal Incinerator at Russell and

Ferry Streets, Detroit, Michigan, ” Apr. 9, 1986.

Michigan Department of Natural Resources, “Municipal Waste Combustion Study: Assessment of

Health Risks Associated With Municipal Waste

Combustion Emissions, ” September 1987.

Moreland, S., The Markland Group, Washington, DC, personal communication, Aug. 16, 1988.

National Committee for Clinical Laboratory Standards, Clinical Laboratory Hazardous Waste 6(15)

(Villanova, PA: NCCLS, September 1986).

National Committee for Clinical Laboratory Standards, Protection of Laboratory Workers From Infectious Disease Transmitted by Blood and Tissue

7(9) (Villanova, PA: NCCLS, November 1987).

National Solid Waste Management Association,

Infectious Waste State Program Survey, Technical Bulletin 88-2 (Washington, DC: NSWMA,

Feb. 29, 1988).

New York State Energy and Research Development Authority, “Results of the Combustion and

Emissions Research Project at the Vicon Incinerator Facility in Pittsfield, Massachusetts, final report (vol. 1), Report 87-16, June 1987.

New York State Legislative Commission on Solid

Waste Management, “Hemorrhage From The

Hospitals: Mismanagement of Infectious Waste in

New York State, ” staff report to Assemblyman

Maurice D. Hinchey, Chairman (Albany, NY:

LCSWM, Mar. 25, 1986).

Perkins, J., Principles and Methods of Steriliza-
35

55.

56.

57.

58.

59.

60,

61.

62.

63.

64.

65.

66.

67.

68.

tion in Health Sciences, 2d ed. (Springfield, IL:

Charles C. Thomas Publishers, 1983).

Powell, F., ‘‘Air Pollutant Emissions From the Incineration of Hospital Wastes: The Alberta Experience, ‘Journal of the Air Pollution Control Association 37(7), July 1987.

Quinn v. County of Los Angeles, Case No.

C669760, L.A. Superior Court of the State of California.

Reinhardt, P., “A Comparison of Incineration

With Other Treatment Methods for Infectious

Waste” (University of Wisconsin, May 1988).

Rogers, H., ‘‘Infectious Waste Characterization,

paper presented at the First National Symposium

on Incineration of Infectious Wastes, Washington,

DC, May 5, 1988.

Rutala, W., “Cost-Effective Application of the

Centers for Disease Control Guidelines for Handwashing and Hospital Environmental Control,

American Journal of Infectious Control 13:218-

224, 1984.

Rutala, W., ‘‘Infectious Waste—A Growing Problem for Infection Control, ” ASEPSIS: The Infection Control Forum 9(4):2-6, 1987.

Rutala, W., ‘‘Management of Infectious Waste by

United States Hospitals, ” paper delivered to the

28th ICAAC, Los Angeles, CA, 1988.

Rutala, W., and Sarubbi, F., “Management of

Infectious Waste From Hospitals, ” Infectious

Waste Management 4(4): 198-203, 1983.

Rutala, W., Stiegel, M., and Sarubbi, F., “Decontamination of Laboratory Microbiological

Waste by Steam Sterilization, Applied and Environmental Microbiology 43(6): 1311-1316, June

1982.

Sansbury, T., ‘‘Hospital To Test Clean Coal Process for Waste Burning, The Journal of Commerce, July 19, 1988.

Schifftner, K., and Patterson, R., “Engineering

Efficient Pathological Waste Incinerator Scrubbers, ” paper presented at the First National Symposium on Incineration of Infectious Wastes,

Washington, DC, May 5-6, 1988.

Service Employees International Union, AFLCIO, CLC (SEIU), “Comments on OSHA’s Advance Notice of Proposed Rulemaking To Control

Occupational Exposures to Hepatitis B and AIDS”

(Washington, DC: Jan. 26, 1988).

Service Employees International Union, AFLCIO, CLC (SEIU), “Health and Safety Memorandum” (Washington, DC: Jan. 25, 1988).

SEIU Local 250, “Needlestick Survey Results:

San Francisco Area Private, Non-Profit Hospitals”

(Washington, DC: SEIU, December 1987).

69.

70.

71.

72,

73.

74.

75.

76.

77.

78

79.

80.

Simmons, B., Trusler, M., and Scott, R., “Infection Control Guidelines for Home Health”

(Methodist Health Systems, Memphis, Tennessee), draft manuscript, 1988.

Slavik, N., “Report on the Proceedings of the EPA

Infectious Waste Management Meeting” (Washington, DC: Nov. 12, 1987).

Slavik, N., Presentation at the Biomedical Waste

Research Committee Workshop, UCLA, May 19-

20, 1988.

Spurgin, R., “Off-Site—A Comparison With OnSite Treatment Technologies, ” paper presented at

Hospital Solid Waste Management Conference,

San Francisco, CA, Sept. 20, 1988.

T. Super, U.S. Environmental Protection Agency,

personal communication, Sept. 7, 1988.

U.S. Department of Health and Human Services,

Centers for Disease Control “Guidelines for Isolation Precautions in Hospitals, ” Infection Control 4:245-325, 1983.

U.S. Department of Health and Human Services,

Centers for Disease Control/National Institutes of

Health, “Biosafety in Microbiological and Biomedical Laboratories” (Atlanta, GA: 1984).

U.S. Department of Health and Human Services,

Centers for Disease Control “Guidelines for Handwashing and Hospital Environmental Control’

(Atlanta, GA: 1985).

U.S. Department of Health and Human Services,

Centers for Disease Control, “Recommendations

for Prevention of HIV Transmission in HealthCare Settings, Morbidity and Mortality Weekly

Report, vol. 36, Aug. 21, 1987.

U.S. Department of Health and Human Services,

Centers for Disease Control, ‘ ‘Update: Universal

Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus,

and Other Bloodborne Pathogens in Health-Care

Settings, ” Morbidity and Mortality Weekly Report, June 24, 1988.

U.S. Department of Labor, Occupational Safety

and Health Administration, Office of Health Compliance Assistance, “Enforcement Procedures for

Occupational Exposure to Hepatitis B Virus (HBV)

and Human Immunodeficiency Virus (HIV), ”

OSHA Instruction CPL 2-2.44A (Washington,

DC: Aug. 15, 1988).

U.S. Department of Labor and U.S. Department

of Health and Human Services, ‘‘Protection Against

Occupational Exposure to Hepatitis B Virus

(HBV) and Human Immunodeficiency Virus

(HIV), Joint Advisory Notice, Oct. 19, 1987. With

letter from William E. Brock, Secretary of Labor,

and Otis R. Bowen, Secretary of Health and Hu-
36

81.

82.

83.

84.

man Services, to healthcare employers concerning

this notice, dated Oct. 30, 1987.

U.S. Environmental Protection Agency, Guide for

Infectious Waste Management, EPA/530-SW-86-

014 (Washington, DC: May 1986). 85.

U.S. Environmental Protection Agency, Municipal Waste Combustion Study, Report to Congress,

EPA/530-SW-87-021a, June 1987.

U.S. Environmental Protection Agency, “Hospital Waste Combustion Study, Data Gathering 86.

Phase, ” final draft (prepared by the Radian Corp.),

October 1987. 87.

U.S. Environmental Protection Agency, “Survey

of State and Territorial Subtitle D Municipal

Landfill Facilities, ” draft final report, prepared by

Westat, Inc., for Office of Solid Waste, October

1987.

Yasuhara, A., and Morita, M., “Formation of

Chlorinated Aromatic Hydrocarbons by Thermal

Decomposition of Vinylidene Chloride Polymer,

Environmental Science Technology 22(6):646-650,

1988.

D. Zabinski, U.S. Environmental Protection

Agency, personal communication, Sept. 7, 1988.

D. Zabinski, U.S. Environmental Protection

Agency, personal communication, July 19, 1988.