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Issues in Medical Waste Management

October 1988

NTIS order #PB89-136410



Recommended Ci ta t ion :

U.S. Congress, Office of Technology Assessment, I s sues in M edica l W as te M anagement—

B a c k g r o u n d P a p e r , 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 DocumentsU.S. Government Printing Office, Washington, DC 20402-9325

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



F o r e w o r d

During th e summ er just pa ssed, we witnessed a ra sh of incidents in which m edical

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 me-dia coverage, drew public attention to issues surrounding the management of medical wastes.

Waste ma nagement in general h as become a common h eadline topic. We hear daily

about declining landfill capacity, problems in siting new incinerators, and efforts to in-

crease r ecycling. OTA’s ongoing a ssessm ent of mu nicipal solid wast e ma na gement is ad-

dressing these issues.

As par t of the assessment , OTA also examined th e sta tus of medical waste man age-

men t in t he Na tion. OTA held a one-day work shop on J uly 19, 1988, with hospita l, regu-

latory, 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 incorpo-rated in this paper.

The paper examines th e adequa cy of curr ent medical wast e disposal pra ctices an dth e potential for hum an health impacts to occur as a r esult of such pra ctices. It a lso ad-

dresses the need for additional research and databases, and discusses probable trends infuture 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 han-

dling, treatment, storage, and disposal of medical wastes.OTA is grateful for t he inpu t from th e worksh op participant s an d 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.

Mu n ic ip a l So l id Wa s t e A d v i s o r y Pa n e l

J oseph Sax, C h a i r

School of Law, University of California

Gordon Boyd

Schillinger, Salerni, and Boyd

Paul ConnettSaint Lawrence University

Randall Curlee

Oak Ridge National Laboratory

Dana Duxbury

Center for Environmental ManagementTufts University

Rodney Edwards

American Paper Institute

Jeffrey Hahn

Ogden Projects, Inc.

Michael Herz

Benjamin Cordozo School of Law

Walter J ohnson

St. Paul Metropolitan Waste Control

Commission

Richard Kattar

New England CRInc.

Raymond Naar

General Electric Plastics

Lorie Pa rkerSeattle Solid Waste Utility

Glenrose PittPrivate Consultant

Barry ScherGiant Food, Inc.

Neil Seldma n

Ins titu te for Local Self-Reliance

Peter Vardy

Waste Management, Inc.

Irvin WhiteNew York State Energy Research and

Development Authority

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop par-ticipants, 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 itscontents.

i v



O TA Mu n ic ip a l So l id Wa s t e Ma n a g e m e n t P r o j e c t S t a f f

John Andelin, Ass is tant Director , OTA

Sc ience , In fo r m a t ion , and Na tur a l Res our ces D iv i s ion

Robert Niblock, O c e a n s a n d E n v i r o n m e n t P r o g r a m M a n a g e r

K a t h r y n W a g n e r , P r i n c ip a l A u t h o r a n d A n a l y st

Howard Levenson, Project Director

Eric Washburn, O T A Con tr ac tor

Adm i n i s t r a t i ve S t a f f

Kathleen Beil Sally Van Aller



M e d ic a l Wa s t e W or k s h o p P a r t i c ip a n t s

Frank Cross

Cross/Tessitore & Associates

Lawrence Doucet

Doucet & Mainka

Allen Dusault

Massachusetts Department of Environmental

Quality and EngineeringDieter Groschel

University of Virginia Medical Center

Susan HarwoodOccupat ional Sa fety an d Health Administra tion

Christopher Haynes/Eugene Mainer

Decom Medical Waste Systems

John Joyner

Consumat Systems

Stephen Kaufman

Massachusett s General Hospital

Ode KeilJoint 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


Robert Pet ersBiomedical Waste Treatment Council

William Rutala

University of North Carolina School of Medicine

Robert SheehanMedi-Gen

Robert Spurgin

Browning-Ferris

Barbara Stank

Indus tr ies

New England Deaconist Hospital

Jacqueline Warren

Natural Resources Defense Council

Howard Wensley

Massachusett s Departm ent of Public Health

Denise Zabinski


NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop partici-

pants. 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.

v i



A d d i t i o n a l A c k n o w l e d g m e n t s

Richard Denisen

Environment al Defense Fun d

Rick ErdheimSena tor Fr an k Lau tenber g’s Office

United States Senate

Mary Ficht

American Hospital Association

Rebecca Goldberg

Environment al Defense Fun d

Reuben GuttmanService Employees International Union

Shari Haley

American Hospital Association

Judy Kowalski

Office of Technology Assessment

George Lange

Ogden-Martin Systems, Inc.

Jack Lauber

‘New York Stat e Depart ment of En vironm enta l

Rosemary Monahan

U.S. Environmental

Region 1

Sue Moreland

The Markland

Dave Ozonoff

Group

Protection Agency—

Boston Un iversity

Robert Percival

University of Maryland Law School

Harvey Rogers

National Inst i tutes

J ames Salvaggio

of Hea lth

Pennsylvania ‘Department of Environmental

Resources

Nancy Seidman

Northeast States forM an ag emen t

Thomas Super

U.S. Environmental

Coordinated Air Use

Protection Agency

C o n s e r v a t i o n “ Gary Yee

Thomas Lavelle

University of Maryland

California Air Resources Board

vi i



C o n t e n t s

In t r od u ct io n . . .“. . . . . . . . . . . . . . . . . . . . . .

C h a p t e r 1 : D e fi n i n g a n d C h a r a c t e r i z in gMed ica l Was t es . . . . . . . . . . . . . . . . . .

Amount s a nd Composition . . . . . . . . . . . . . . .

Designa tin g Infectious Was te . . . . . . . . . . . . .

Definitional Differences-EPA v. CDC . . . .

Classifying Infectious Waste as Hazardous

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

Uncert aint ies for Sta te Regulat ors . . . . . . . . .

C hap t e r 2 : H and l i ng M ed i ca l W as t e s and

P oten t i a l Occu pa t ion al Ri sk s . . . . . . .

Handling: Packaging, Storage, and

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

Pa ckagin g . . . . . . . . . . . . . . . . . . . . . . . . . . .Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Transportation . . . . . . . . . . . . . . . . . . . . . . .

Poten tia l Occup at ional Risks . . . . . . . . . . . . .

C h a p t e r 3 : C u r r e n t T e c h n o l og ie s ,

Trea tm e n t , an d D i sposa l I s sues . . . . .

In ciner at ion. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Contr olled Air In cinera tors . . . . . . . . . . . . .

Other Types of Incinerators . . . . . . . . . . . .Air Emissions and Ash . . . . . . . . . . . . . . . . . .

Concentrations of Emission

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

Possible Reasons for Higher Emission

Levels of Dioxins/Furans and HCl . . . .

Concentra tions of Constitu ents

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

Future Trends in Medical WasteIn ciner at ion. . . . . . . . . . . . . . . . . . . . . . . .

Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . .Incineration. Autoclaving and the

Importance of Proper Operation . . . . . .

Health and Environmental Risks From

Trea tm ent Technologies . . . . . . . . . . . . .

C h a p t e r 4 : R e g u l a t o r y Au t h o r i t y a n d

Cu r r en t P r a ct ice s . . . . . . . . . . . . . . . . .

Fed eral Author ity . . . . . . . . . . . . . . . . . . . . . . .

Sta te Regu lat ory 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

C ha p t e r 5 : M an ag ing M edica l Was tes—

Ins t i t u t iona l an d P o l icy I s sues . . . . . 27Policy Issues for Federal Action. . . . . . . . . . . 28

Pag e

Defining/Classifying Medical Wastes . . . . 28Regulating Small v. Large Generators of

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

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

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

R efe r en ce s. . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Fig u r e s

F igu r e P a ge

1.

2.

3.

4.

Biological Hazard Symbol . . . . . . . . . . . . . 10Typical Controlled Air Incinerator . . . . . . 15

Stages of Stat e Chan ges in MedicalWaste Management Programs—As of March 1988 . . . . . . . . . . . . . . . . . . . . . . . . . 24

Type of Medical Waste Generators

Regulated by States—As of

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

T a b l e s

Ta ble P a ge

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 ProtectionAgainst Occupational Exposure to

Hepatitis B Virus (HBV) and Human

Immunodeficiency Virus (HIV)—

Training Program Recommendations. . . .

Compliance Rates With Joint Advisory

Notice—70-Hospita l Sam ple . . . . . . . . . . .Compliance Rates With Joint AdvisoryNotice—30-Depar tm ent Sam ple . . . . . . . .

Concentra tions of Constitu ents in

Emissions From H ospital Incinerators

Without Particulate Control Devices . . . .

Dioxin and Furan Emission

Concent ra tions . . . . . . . . . . . . . . . . . . . . . . .Concentrations of Dioxins and Furans inFly Ash From Municipal and Hospital

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

Status of Selected State Infectious Waste

In cinera tor Regu lat ions . . . . . . . . . . . . . . .

Legislation Pending in Congress onMedical Wastes . . . . . . . . . . . . . . . . . . . . . .

5

12

13

13

17

17

19

26

30

. . .

Vlt{



In t roduc t i on

qWithout a dvan ce notice, on March 24, 1986, th e

GSX waste handling company informed eight

Boston, Massachusetts, h ospitals t hat it would

no longer pick up a ny of th eir hospital wast es be-

cause t he a rea lan dfills would n o longer acceptthem. For two of these hospitals, GSX did not

even ha ndle their ‘‘red bag” waste (44).

qApproximately 1,400 bags of medical waste werediscovered at a warehouse by the New York City

Fire Department when it responded to a fire No-vember 24, 1986. Subsequently, the Energy

Combustion Corporation and its president wereindicted by the Brooklyn District Attorney’s Of-fice for a llegedly covering u p t his illegal du mp-

ing. The compan y had submitted document s to

the New York State Department of Environ-

mental Conservation stating that the wastes hadbeen incinerated (21).

qTwelve children in Indianapolis, Indiana, playedwith vials of blood, two of which were infected

with AIDS, tha t t hey foun d in a t rash bin out-

side an HMO medical office in June 1987. It was

legal for the health clinic to dispose of the wastesin the open dumpster (27).

qFive emp loyees of the Los Angeles Count y-USC

Medical Center filed a $50 million lawsuit against

the county after a pipe in the basement of thefacility burst on Ju ly 9, 1987, and du mped pos-

sibly contaminated blood and fluids on workers.The California Occupational Safety and HealthAdministra tion has received other complaints

concerning the adequacy of protection providedfor employees han dling medical wastes at the

Center (56).

q A garbage slick n early a mile long along th e shorein Ocean County, New Jersey, on May 23, 1988,marked the first slick of the season. Needles,

syringes, and empty prescription bottles withNew York addresses washed upon the shore (31).

New Jersey beaches closed several times last sea-

son due to such incidents. More recently, on July

6-7, 1988, 10 miles of Long Island beaches closedwhen medical wastes washed ashore. Through-

out 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 wast es.

Recent incident s such as th ese have drawn a t-tention to issues surrounding the handling, treat-ment, and disposal of medical wastes. Medical

wastes are all the types of wastes produced by hos-

pitals, clinics, doctor offices, and other medical andresear ch facilities.1These wastes include infectious

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

wastes .2The Environmental Protection Agency

reports that approximately 3.2 million tons of med-ical wastes from hospitals are generated each year,which is about 2 percent of the total municipal solid

waste s t ream.3Currently, most generators of med-

ical waste designate between 10 to 15 percent of

it a s infectious.

Most of th e non-infectious m edical wa ste is land-filled, while most infectious wa ste from h ospitals

is incinerat ed. For infectious waste m ana gement,

an American Hospital Association survey reportedin 1983 that approximately 67 percent of U. S. hos-pitals use on-site incinerators, 16 percent use onlyautoclave (i.e., sterilization) systems and then land-

fill, and approximately another 15 percent use off-

site treatment (9,62). The degree of risks posed bymedical wastes is not known. Proper handling,treatment, and disposal of these wastes are believed

to result in minimal health and environmenta l r isks.Yet, incidents of careless or illegal disposal may pose

health r isks and aest hetic problems an d certa inlyhelp create public apprehension over current med-ical waste man agement practices.

‘This would also include wastes from research laboratories, biotech-

nology 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 hospi-

tals and larger sources of medical wastes, given that there is more read-

ily available information on these facilities, the need for assessing the

importance of smaller generators of biomedical wastes is recognized.2The term s medical wastes, hospital wastes, infectious wastes, and

biomedical wastes often are used interchangeably. An attempt is made

here to use t hese term s more precisely, i.e., the term medical wastes

refers to all types of wastes produced by a hospital or any type of fa-

cility; hospital wastes refers to all wastes produced by a hospital; in-

fectious wastes r efers t o that portion of a medical wastestr eam wh ich

has the potential to transmit disease; and biomedical wastes are thesubset of medical waste which is biological in origin (e. g., blood, body

fluids, tissue, etc.).

3Est imates 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 med-

ical wastes comprise a somewhat higher—although still relatively

small—percentage of the total municipal solid wastestream.

1



2

J ust as t he types of incidents listed above ra ise

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 mu-

nicipal landfills.4

In addition, the State of Penn-sylvania ha s imposed a one-year moratorium on

the construction of any commercial medical waste

incinerators.5In other areas, localities as well have

considered bans or moratoriums on hospital wasteincinerators. 6

In this general context, many hos-

pitals, medical facilities, and other institutions

across the country face increasingly difficult wastemanagement problems.

The situation is complicated by an uncertain andincongruous regulatory climate. Inconsistencies ex-ist in th e Federal guidelines for Sta tes regar ding

definitions and management options suggested formedical/infectious waste.

7Currently, no Federal

regulations exist that comprehensively address thehand l i ng , t r ans por t a t i on , t reatment , and disposal

of medical wast e. This would chan ge either if th e

issue of medical wastes remains part of the currentrea ut horizat ion effort for th e Resour ce Conser va-

tion and Recovery Act (RCRA)8or if any of a num-

41 n some areas, if medical wastes of any sort are accepted, an in-

spection 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 r eached between the town and the h ospital

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 t he Depart ment completes a compre-

hensive plan for medical wastes which is due July 13, 1989. Other

Stat es (e. g., Delaware) have or a re considering similar m oratoriums.

‘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 prac-

tices 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 Contr ol, 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 r elating t o med-ical wa ste issu es (see discussion below) pass.

Meanwhile, the States have largely been left on

their own to devise medical waste management pro-grams. This means important variation frequently

exists between States, as well as between local re-

quirements and th ose of a Stat e. For example, 26States classify infectious wastes as special wastes,13 sti l l classify them as h azardous wast es, and 12

classify them as non-hazardous wastes (4).9Thirty-

nine States have some type of regulations concern-

ing infectious waste, at least 5 more States expectto regulate t hese wastes within t he year; and a t least

25 Stat es expect chan ges to their existing regula-

tions by next year (4).10

The pur pose of this paper is to assess the a de-quacy of current medical waste disposal practices;

the potential risks from such practices; the need for

additional research and databases; and the possi-ble need for Federal requirements for the handling,

treatment, storage, and disposal of medical wastesand future cost a nd capacity factors a s new regu-

lations are updated. The paper is divided into fivechapters :

1.

2.

3.

4 .

5.

Defining and Characterizing Medical Wastes;Han dling Medical Wastes an d Potential Oc-

cupational Risks;

Curren t Technologies, Treatment , and Dis-

posal Issues;Regulatory Authority and Current Practices;

a n dMana ging Medical Wast es—Institutional an dPolicy

-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 t wo general

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

requirements. These are hazardous wastes regulated according to Sub-

title 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 th at app ear to be in a gray area bet ween these

two categories and for which special regulatory programs will be es-

tab l ished .IOCompare resu]ts of slighdy older su rvey, reported ear l i e r in 1988

by the National Solid Waste Management Association (51).I Ispecific, basic information is often lacking or at present not av ad -

able to OTA on a number of important topics, and these areas arenoted below.



C h a p t e r 1

Defining and Characterizing Medical Wastes

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

any other wastes that are generated from all typesof health care institutions, including hospitals,

clinics, doctor (including dental and veterinary)

offices, and medical la borat ories (42).1The main

focus of concern ha s been on th e portion of medi-

cal wastes that are defined as infectious, and howth ey ar e classified (e. g., as a solid, haza rdous, or

‘‘special’ waste) and regulated. These wastes arealso the primary focus of this paper. The main

sources of these wastes receiving attention are hos-pitals and other large facilities. Much of the infor-

mation reported here will focus on these larger

generators, but the proper disposal of oth er t ypes

of medical wast es an d of wast es from all types of

sources is a lso importan t. 2

A m o u n t s a n d C om p o s it i on

The actua l amount of medical waste genera ted

in th e United Sta tes today (or in t he past ) is not

known; even estimating this figure is problematic,

as th e num ber of different reported estimat es in-

dicate. In 1987, the Environmental ProtectionAgency (EPA) reported th e total generat ion rat e

of hos p i ta l wastes at 5,900 tons/day (83). This fig-ure is based on the n umber of hospital beds esti-

ma ted to exist (in 1985, th e estima te was 1.3 mil-

lion with a 69 percent occupa ncy rate) and a per

bed per day generation rate of 13 pounds.

The per bed per day generation figure itself, how-

ever, is difficult to pinpoint. Recent independent

estimat es of hospital waste genera tion ran ge be-

tween 16 to 23 pounds per bed per day (61). The

1 See also ref. 39. It should be noted th at extensive trea tment of the

current management of radioactive and other identified hazardous

wastes in t he medical wastestream is beyond th e 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 thesewastes.

2The am ount of medical wastes from su ch non-hospital sources is

not known. Other sources of infectious wastes, such as sewage over-

flows, can also be a significant source of environmental contamina-

tion (e. g., impacting beaches and shellfish ar eas), but ar e beyond t he

scope of this paper.

ran ge reported by hospitals in var ious su rveys of hospital waste generation is 8 to 45 pounds per bed

per day.3 EPA expected t he 13 pound per bed perday 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 appr oximately 10 poun ds

per bed per day of wastes. If this lower figure wastypical in years past, then it would indicate that the

amount of per bed generat ion of hospital wast es

may have increased significantly within the last dec-

ade. Healthcare workers and administrators do in-

dicate that the amount of disposable items used inhospitals and other medical facilities has increased

drama tically in recent years, although dat a a re notavailable to document this observation.

Few data are available on the composition of hos-

pital waste, although it is characteristically hetero-

geneous 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 anatom-ical wastes, isolation wastes), hazardous wastes

(e.g., waste pharmaceuticals, cytotoxic agents usedin chemotherapy, mercury or other heavy metals),and ra dioactive wastes.

4

The composition of the medical wast estr eam is

of concern given its effects on the incineration proc-ess. If inciner at ion occur s on-site, it is likely tha t

at least some of the hospital or facility’s wastes aremixed (if wastes are shipped off-site, given the

greater expense of treat ing infectious waste t his

3Different methodologies to calculate per bed generation figures,

may explain t he wide variat ion in estimat es. Also, of course, th e ac-

tual hospital generation figures can vary greatly on a daily basis. Some

surgical procedures generate much more waste (e. g., a heart trans-

plant) t han other r outine 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 wastesare 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 wast e is sentfor incineration).

5Particular components of the

medical wastestream of special concern when thiswaste is incinerated include t he r elatively high plas-

tic content of medical waste (to be discussed fur-

ther below). About 20 percent of the hospital waste-

stream is estimated to be plastics (83), which is

about three times the plastic portion of the munici-pal solid wast estream.

6

In a ny case, reported genera tion figures do notinclude n on-hospital m edical wast es. In 1985, ap-

proximately 6,870 hospitals and an estimated 1,000

diagnostic and research laboratories existed, in

addition to thousands of doctor offices and nurs-ing homes (5).

7Although specific estimates are not

available on the volume or composition of medi-cal wastes from these sources, it is reasonable toexpect t hat the t o t a l medical waste generation (both

hospital and non-hospital) figure is somewhat

higher.

D e s ig n a t i n g I n f e ct i o u s W a s t e

Determin ing which portion of medical wast e isinfectious goes to the heart of the definitional prob-lems associated with medical waste management.

There are two basic sources that hospital and othermedical facilities may use in determining theirworking definition of infectious wastes: EPA guide-lines and Centers for Disease Control (CDC) guide-

lines. These will be discussed below.

H ow i n fec t ious w a s t e i s de fi ned can g rea t l y

a f fec t t he cos t o f w as t e m an agem en t , an d u l t i-mately the choice of waste management d isposal

opt ions fo r genera to r s . For example, one 600-bedhospital 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 (approxi-

mately): $0.01 to $0.25/lb. for general refuse/non-infectious waste (usually landfilled); $0.10 to$0.25/lb. for incineration on-site (includes infec-

tious wastes);8and 0.30 to 1.00/1b. (although costs

may be higher in some areas) for commercial, off-

site incineration (6, 10).

Most estimat es are tha t 10 t o 15 percent of all

hospital wastes are infectious. The total range of estimates, however, is from 3 to 90 percent of a hos-

pital’s wa ste defined as infectious, dependin g on

the definitions and procedures followed (10,83).According to Lawrence Doucet, a consultant on

hospital wast e man agement, about 3 t o 5 percentof a h ospita l’s t otal wast estr eam would be classi-fied as infectious waste according to previous inter-

pretations 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 August1987, however, have apparently been interpreted

by some hospitals as classifying virtually all patient-cont act wast e as infectious (77). This can a mount

to 70 to 90 percent of total hospital wast e. T h e p o -t e n t i a l im p a c t o f s u c h a t r e n d o n m e d i c a l w a s t e

m a n a g e m e n t c o u l d b e t o b o t h i n c r e a s e t h e c o st

o f d i sposa l s ign i fi can t ly an d s t r a in ex i st ing ca-

pa c i ty fo r ma na ging in fec t ious was tes . The CDChas issued a clarification of its definition, yet con-fusion at the generator level appears to remain over

the proper classification and management of med-ical wast es (78).

Def in i t ional Dif ferences—EPA v. CDC

William Rutala, University of North Carolina

School of Medicine (Director of the Statewide In-fection Control Program), has noted that no testsexist to objectively identify infectious wastes, un-like th e case with chemical or ra diological was tes

(60).10

This has led the CDC, EPA, States, andother agencies to identify and further define infec-

tious waste by waste category based on waste char-

acteristics.

EPA defines infectious waste as “waste capableof 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.bEs t imates of the port ion of plastics in hospital wast e ran ge as high

as 30 percent.

‘See also ref. 10.qt should b e noted tha t capi t~ costs, depreciation, ad other tYPes

of costs may not be included in these figures.

91nteresting]y, a recently completed survey for the American HOS-

p i t a l Association reported that 80 percent of the hospitals are follow-

in g CD C 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, and4. resistance of the host.

Thus, the Agency notes that:

for a waste to be infectious, it must contain. . .pathogens with sufficient virulence and quantity sothat exposure to the waste by a susceptible hostcould result in an infectious disease (81).

The CDC recommendations, issued in August1987, and referred to as “universal precaution”procedures, are essentially that blood and body

fluids from “all patients be considered potentiallyinfected with HIV (huma n immu nodeficiency vi-

rus) and/or other blood-borne pathogens and [that

health care workers] a dhere rigorously to infection-cont rol precaut ions’ (77). In J un e 1988, th e CDC

attempted to clarify several issues associated withapparent confusion over the application of their1987 recommen dat ions. As part of th is effort , the

CDC now limits th e application of un iversal pr e-cautions 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 a nd do not a ddress waste ma n-

agement practices or the definition of infectiouswastes (78).

Both th e CDC an d EPA designate pa th ological

waste, blood and blood products, contaminated

sharps (e. g., scalpels, needles, blades), and microbi-ological wastes (e.g. cultures and stocks) as infec-tious. Some apparent disagreement exists betweenthe designations of and suggested t reatm ents fordifferent components of infectious wastes identified

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

include a category of isolation wast es, a categoryof contaminated animal carcasses, body parts, andbedding, and categories of surgery, autopsy and

contaminated laboratory wastes (81). The appar-

ent inconsistencies are remedied in part by the fact

that EPA refers to the CDC guidelines on isola-

tion precautions (74) an d to th e joint CDC/Nat iona lInstitutes of Health guidelines on animal carcasseswaste m anagement and other guidelines on labora-tory wastes.

ll

I l~though th e CDC does not classify an imzd carcasses as infectious

wastes, the CDC/NationaI Inst itut es of Healt h guidelines, ‘‘ Biosafety

in Microbiological and Biomedical Laboratories (75), ” recommend

incineration of infected animal carcasses and decontamination (prefer-

ably by autoclaving) before disposal for al l wastes from anima l rooms

of certain designated biosafety levels.

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

CDC a 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,CBlood and blood products (i.e., liquid blood and blood products) ., . . Yes S,I,Sew Yes S,l,Sew,CCommunicable disease isolation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes/No HP Yes S,lPathological (e.g., tissue, organs) . . . . . . . . . . . . . . . . . . . . . . . . . ... , . . Yes Yes I,SW,CBSharps (e.g., needles) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes S,lContaminated animal carcasses, body parts and bedding . . . . . . . . . . No — Yes I,SW

(not bedding)Contaminated laboratory wastes ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional

bIf consideredIW, use S or I

Surgery and autopsy wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional If consideredIW, use S or I

Dialysis unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional If consideredIW, use S or I

Contaminated equipment . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . No — Optional If consideredIW, use S or I

aAbbreviatjOnS: cDc—centerS for Djsease Control; EpA—Environmental protection Agency ; l—inc ine ra t ion ; s—s t e am 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 incinera-tion or grinding; CD—cremation or burial by mortician; IW—infectious waste.

boptional inf~t{ous waste: EPA s ta tes tha t th e dec is ion to handle these wastes as infectious should be made by a responsible, a u t h o r i z e d 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 ma jor a p p a r e n t disagreement is over the des-

ignation 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 th e app licat ion of th ese guide-

lines. This may indicate a need for fur th er clarifi-

cation of these guidelines by th e two a gencies. EP A

considers commu nicable disease wast es as infec-tious. CDC recommends that communicable dis-ease was te be tr eat ed according to hospital policy(74). Nelson Slavik notes, in his report of theproceedings of the EPA Infectious Waste Manage-

ment Meeting held in November 1987, that recent

interpreta tions by hospitals an d other generators

of the CDC universal precaution guidelines, and

th e concern over poten tial exposure to AIDS, canresult in any blood or body fluid and any item con-

taminated with them being designated as infectiouswaste.

Previously, only patient waste from th ose pat ientsin isolation would be included in the EPA’s infec-

tious waste definition; interpretation of the CDCguideline, however, could include all pa tient con-

tact wa stes a nd wa stes 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 interpreta-

tion of its recommendations (77,78). The CDC is-sued a statement in J une 1988 that ,

Universal precautions are not intended to changewaste management programs previously recom-mended by CDC for health-care settings (78).12

This at tempt at clar ificat ion by CDC, however, in

part contributes to the confusion. It is not clear whythe CDC is suggesting tha t its universal precau-

tions guidance applies only to worker precautionsand not waste ha ndling procedures.

EPA a grees with CDC t hat i ts recommenda tions

ar e not in serious disagreem ent with E PA recom-

mendations and that universal precautions are

meant to protect healthcare workers and do not ‘‘at-

tempt to define what is infectious waste” (87).Given the state of confusion at the generator level,

12According

t.

the CDC, for example, blood, some bd y fluids,

and sh arps from an isolation room sh ould be handled as if potentially

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

states that, “While any item that has had contact with blood, exu-

dates, or secretions may be potentially infectious, it is not usually con-

sidered practical or necessary to treat all such waste as infective’ (78).

though, further clarification an d perh aps jointly

i s s ued gu idance on these definitional issues is

desirable.

Currently, based on the proceedings of the EPA

meeting of experts on infectious wastes held in N o-

vember 1987, there appears to be agreement that :

Not withs tanding the r isk percept ions an d anxi-eties associat ed with t he fear of contra cting AIDS,those categories of infectious wastes that possessthe greates t potent ia l to t ran smit disease are con-tam inated sh arps, hu man blood and blood prod-ucts, pathological wastes (primarily body fluids),and laboratory wastes (70).

The position is that, given the consistent recog-

nition of the potential hazards from these wastes,either due t o known diseas e association or risk of accidental injection, their ‘‘prudent’ handling and

proper disposal are warranted (70). EPA did, how-ever, solicit comm ents regar ding th e basis on wh ich

wast es should be defined as in fectious an d is cur -ren tly reviewing its definition of infectious wa stes. 13

C l a s s i f yi n g I n f e ct i o u s W a s t e a s

H a z a r d o u s W a s t e

Additional confusion arises over the question of

whether or not infectious wastes should be classi-fied and regulated as Subtitle C, RCRA hazard-ous wastes. In 1978, EPA did include r egulations

for infectious wastes in its proposed hazardous wasteregulations. The Agency never promulgated these,

however, and has not classified any infectious

wastes as hazardous wastes—even though the lan -guage of RCRA includes “infectious” as a char-acteristic to be considered in determining whetheror n ot a waste is a ha zardous waste.

14The statu-

I s5 3 Feder~ Register, June 2, 1988. The EPA published a notice

of data availability and request for comments on infectious wastes is-

sues. Comments were due August 1, 1988 and the Agency received

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

summar izing these comments as part of its ( msideration of possible

regulatory action for medical wastes (86).I+RCRA (public La w 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 com-

bination of solid wastes, which because of its quantity, concen-

tration, physical, chemical, or infectious characteristics may—

(A) cause, or significantly contribute to an increase in mortal-ity or an increase in serious irreversible, or incapacitating revers-

ible, illness; or

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

health or the environment when improperly treated, stored, trans-

ported, disposed of, or otherwise managed [emphasis added].



7

tory langua ge can be interpreted as r equiring these

wastes to be classified as ha zardous a nd t hus regu-lated under Subtitle C of RCRA.

EPA, based largely on its determination of a lackof evidence tha t in fectious wa stes ‘‘cause h ar m t o

hum an h ealth an d the environment” sufficient to

justify Federal rulemaking (under Subtitle C,RCRA), has instead issued a manual of recommen-dations for th e ma na gement of infectious wastes

(81). It should be noted, however, tha t t he st atu -tory language refers not only to whether a wast e

will ‘‘cause ha rm, but also to whether i t may

“pose a substantial present or potential hazard

. . . “ (emph ases add ed; RCRA, Section 1004).

Even so, 12 years after the passage of RCRA and8 years after making the determination that insuffi-cient evidence existed to justify Federal regulation,EPA has not undertaken or encouraged research

to subst an tiat e a lack of ‘‘a su bsta nt ial presen t orpotent ial hazard to huma n health or th e environ-

m e n t when a waste with infect ious character is -

tics is impr operly man aged (a crit erion of RCRA,

Section 1004(5) definition of hazardous waste). Al-tern atively, the Agency has not issued its assess-

ment, based on existing epidemiologic information,of the degree of risk posed by infectious or other

types of medical wast es.

To date, EP A’s a ctions ha ve not been legallychallenged. Congress ma y clar ify th e conditions u n-

der which medical wastes are to be regulated as partof the current RCRA reauthorization process. Cur-

rently, the Agency considers medical waste a solidwaste subject to RCRA, Subtitle D regulation andis in th e process of addr essing the n eed for a ddi-

tional regu lations t o contr ol infectious wast es. 15EPA did include a space for infectious waste on the“Notification of Hazardous Waste Activity” form,

which is u sed by hazardous waste generators to ap-

ply for EPA identification numbers, but no para-

graph addressing infectious wastes actually existsin th e regulations referenced on th e form.

16

Interest ingly, a ma nua l published by the J oint

Commission for the Accreditation of Hospitals

(JCAH)17

designat es infectious wastes and shar ps154(I CF R 240.101. (See refs. 73,86. )

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

261.34.17Recently, JCAH changedits name to the Joint Commission on

the Accreditation of Healthcare Organizations (JCAHO).

as hazardous wastes, along with chemical, chemo-ther apeut ic, and ra dioactive wastes. The ma nua loutlines methods for handling each type of waste,and the JCAH requires that a system to handle all

such hazardous wastes exist and be in compliancewith Fed era l, Sta te, an d local regulat ions (34). 18

In addition, the National Committee for Clinical

Laboratory Standards (NCCLS) in its proposed

guideline for clinical laboratory hazardous wasteincludes infectious waste (i. e., waste with ‘‘ infec-tious characteristics, following the RCRA, Sec-

tion 1004 definition) in its definition of hazardouswaste (49,50). F r o m a g e n e r a t o r p e r s p e c t i ve ,

grea te r cons is tency on the c la ss i f ica t ion o f in -

fe c t io u s a n d o t h e r m e d i c a l w a s t e s w o u l d h e l p

el iminate some of the current confus ion over the

p r o p e r t r e a t m e n t o f t h e se w a s t e s .

A policy debate continues over how best to clas-

sify infectious wastes, and other medical wastes, as

well. Some observers, noting the likely increase incost as more wastes become designated as infec-

tious, expect even more costly disposal if in ad di-

tion these wastes mu st be handled as hazar dous.

Further, concerns over the difficulty of siting haz-ardous waste facilities are noted. Others maintainthat hospital disposal costs are likely to increase dueto increased regulation in general and focus instead

on the most reliable waste disposal options. Argu-ments over the difficult y of siting hazardous wasteare countered by those who point out that any typeof waste facility is difficult to site (although success-

ful siting of facilities d oes occur when public par -

ticipation an d other measu res are included in th esite selection pr ocess). In a ddition, hospitals m ay

continue to treat wastes on-site (if, for example, theyha ve the spa ce to upgra de or constr uct 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 theoff-site movement of these medical wastes (21,22),

and in general to ensure greater comprehensive

management of infectious wastes.19

These purposes

18AS R u t ~ a (60) points Ou t , 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 S ta t e recently passed legislation which both providesfor 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 infectiouswast es as ha zardous wast es (some of th ese issueswill be discussed furth er below). Yet, pr oponen tsfor r egulating infectious wast es as a hazar dous wasteargue that to do so is likely to be the most expedi-

tious approach to the problem (rather than risk de-lay and confusion created by developing another

system). Furthermore, it is not clear how much flex-ibility the EPA has under RCRA to address infec-

tious waste as a waste type other than hazardous .20Again, th is issue could be clarified as par t of the

current reauthorization effort in Congress.

U n c e r t a i n t i e s f or S t a t e R e g u l a t o r s

These defin i t ional and c lass i fica t ion problems

have crea ted considerable uncerta in t ies for Sta te

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 specifypenalties. The Senate passed legislation to establish a model manifest

program for several States in the Northeast; similar legislation is pend-

ing in the House (see ch. 5).Zosee 42 U.S.C. 6903(5) and 6921.

r e g u l a t o r s . Approximately 10 States have defini-

tions of infectious waste which include the four com-mon CDC and EPA infectious wastes in their defi-nit ions (i. e., pat hological was tes, m icrobiologicalwastes, blood and blood products, and contami-nated sharps). 21 As noted above, most States des-ignate infectious wastes as special wastes, and the

tren d is for other Sta tes to do the sam e. Previously,infectious wastes were classified by States as haz-

ardous wastes because of the aforementioned RCRAdefinition. In fact, States must have a program noless stringent than the Federal Government’s. Since

the EPA has not regulated infectious wastes as haz-ardous, the trend seems to be for the States not todo so, too.

22Stat es appar ently find th e delisting of

a ha zardous waste after it has been tr eated to be

a pa rt icular ly cumber some and difficult aspect of

regulating infectious wastes a s ha zardous wastes (4).

2153 Fede rd Register, J u n e z, 1988.zz~though some States and localities ha ve moved beyond What-ever a “baseline” Federal definition of infectious wastes might be,

such a consistent definition might facilitate the development of other

Federal regulations of infectious wastes.



10

Figure 1 .–Biological Hazard Symbol

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

SOURCE: U.S. Environmental Protection Agency, Guide for Infectious WasteManagement, EPA/530-SW-W014 (Washington, DC: May 1986).

types of packages for solid/bulk wastes and sharps;bottles, flasks, or tanks are recommended for liq-

uids.4In the past, needles were re-capped, chopped,

or disposed of by other practices that are no longercommon due to their potential for worker injury

an d, in t he case of chopping, for aer osolization 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 proc-

ess which uses polymers to sterilize an d encapsu-

late sharps (and other infectious wastes) into a solid

block-like mat erial. A num ber of compan ies ha ve

also developed encapsulating systems and other

sharp disposal processes (e. g., a shredder withchemical treatment of needles and other sharps)(10). These processes ma y potent ially be cost-ef-

fective disposal options for doctor offices and other

small generators of sharps and other infectious

wast es, provided landfill operat ions would a ccept

the encapsulated wastes.

‘The CDC has sim ilar r ecomm endat ions (75,76).

Storage

Storage of the waste needs to be in areas whichare disinfected r egularly and which are mainta ined

at appropriate temperatu res (particularly if wastesare being stored prior to treatment) (62). EPA rec-

ommends that storage time be minimized, storage

areas be clearly identified with the biohazard sym-bol, packa ging be su fficient to ens ur e exclusion of

rodents and vermin, and access to the st orage ar ea

be limited (81). The importance of the duration andtemperature of storing infectious wastes is noted,due t o their association with increases in rat es of microbial growth and putrefaction.

The r ecommen dat ion by EP A for stora ge of in-

fectious waste is limited, however, to suggesting that

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

EPA does not suggest optimum storage time an d

temperature because it finds there is ‘‘no unanim-

ity of opinion’ on th ese matters. As the EP A G u i d enotes, there is State variation in specified storage

times and temperatures. State requirements oftenstipu late s tora ge times of 7 days or less for infec-tious wastes that are unrefrigerated. Sometimes

longer periods are allowed for refrigerated wastes.

Tr a n s p o r t a t i o n

EPA recommenda tions with respect t o the tra ns-portation of infectious wastes briefly address the

movement of wastes wh ile on-site an d in an even

more limited way address the movement of wastesoff-site. The r ecomm enda tions a re la rgely limitedto pruden t pr actices for m ovement 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 r uptu re pa ckaged wastes (81). Broader is-

sues, such as recordkeeping and tracking systemsfor infectious or medical wastes once they are taken

off-site, and the handling and storage of wastes attra nsfer stat ions, have not yet been addr essed.

EPA does recommend that hazard symbols

“should be in accordance with municipal, State andFederal regulations” (81). Yet, Sta te and Federal

agencies have promulgated conflicting or incom-patible guidelines with respect to the use of the bio-

hazard symbol and other transportation specifica-

tions. States often follow the EPA guidance on theuse of the biohazard symbol, but application of



11

regulations and policies of the Department of Transportation (DOT) and Department of Energy

(DOE) may su ggest more limited u se of th e sym-

bol, creating confusion for commercial handlers of

medical wastes (43).

DOT has issued regulations for t he tr ansporta-

tion of etiologic agents. These regulations may ap-ply 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

o f F e d e r a l R e g u l a t i o n s .5 This is a result of the fact

tha t the precise content of most medical waste boxes

with a bioha zard symbol is not kn own, but is likelyto contain a defined etiologic agent. Further, the

DOT regulations specify that packages of this sortbe a maximum of one liter in size.

Fur ther , th e var ious classificat ion of medical, andspecifically infectious, wastes by different States

complicates the interstate shipment of wastes. De-pending on t he Stat e, a waste may be designat ed

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 sh ipment of wastes within (and out-side of) the country. If more medical wastes areshipped between States, which is the apparent

trend, the likelihood of accidents will increase. The

desirability of more consistent an d complete guide-

lines or regulations regarding the off-site transpor-tation of infectious wastes should be considered in

this context.

P o t e n t i a l O c c u p a t i o n a l R i s k s

On October 30, 1987, the Depar tmen t of Labor(DOL) and the Department of Health and Human

Services (DHHS) issued a J oint Advisory N oticeon ‘‘Protection Against Occupational Exposure to

Hepatitis B Virus (HBV) and Human Immuno-

deficiency Virus (HIV)” (80). This Notice goes be-

yond t he CDC guideline chan ges made in August

1987 that focused on AIDS. Essentially, the univer-

sal pr ecaut ion concept is extended by t he J oint Ad-

visory N otice to occupat iona l exposur e t o Hepat i-tis B. The Notice advises healthcare workers toassu me all body fluids an d tissues t hey come int o

contact with are infected with a blood-borne disease.549 CFR 172.401

Tasks performed by healthworkers are divided

into th ree categories.6Category I includes tasks that

routinely involve exposure to blood, body fluids,

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

occasion (e. g., to adm inister first aid); an d Cat e-

gory III includes tasks that involve no exposure toblood, body fluids, or tissu es a nd for which Cat e-gory I t asks ar e not a condition of employment . The

Notice also advises that workers should not perform

Category I and 11 tasks before receiving trainingrelating to the facility’s standard operating proce-

dures (SOPS), work pra ctices, and protective cloth-

ing required for each type of task. (See table 2.)

Special work practices for the disposal of sharps,

such as using disposable, puncture-resistant con-tainers to reduce stick injuries, are noted in th e

Advisory. Fur th er, it recommen ds th at employers

should provide free voluntary Hepatitis B immu-

nization for any workers performing Category Itasks who test negative for Hepatitis antibodies. At

the request of employees, the em ployer sh ould h avea volunt ary pr ogram to monitor for Hepatitis an d

AIDS a nt ibodies following a kn own or su spected

exposure to blood, body fluid, or tissues. Thisshould include confidential medical coun seling if they are found seropositive for either virus. Em-

ployers are also encouraged to keep records of thetr aining, ta sks, etc., of employees engaged in Cat-

egory I or II tasks. Currently, the CDC estimates

that only 20 to 40 percent of healthcare workers areimmunized.

In October 1987, DOL/DHHS sent letters to ap-proximately 500,000 healthcare employers to in-form them of the Advisory Notice (80). The letter

notes that as ma ny as 18,000 healthcare workers

per year m ay be infected by the Hepa titis B viru s

and several hundred will become acutely ill or jaun-diced from the virus. Ten percent will become long-

term carr iers an d as ma ny as 300 healthcare work-

ers may die each year as a result of Hepatitis B in-

fections or complications. The letter also stat es th at

the Occupat ional Sa fety an d Health Administra-tion (OSHA, part of DOL) will respond to em-

ployee complaints an d condu ct inspections to en-sure proper procedures are being followed.

bI t 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 ProtectionAgainst Occupational Exposure to Hepatitis B Virus(HBV) and Human Immunodeficiency Virus (HIV)–

Training Program Recommendations

According to the Joint Advisory Notice, “The employershould establish an initial and periodic training program forall employees who perform Category I and II task s. No worker

should engage in any Category I or II task before receivingtraining pertaining to the Standard Operating Procedures(SOPS), work practices, and protective equipment requiredfor 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 equipmentgenerally appropriate for Category I and II tasks, andunderstand the basis for selection of clothing andequipment.Are familiar with appropriate actions to take, and per-sons to contact, if unplanned Category I tasks are en-countered.Are familiar with and understand all the requirementsfor work practices and protective equipment specifiedin SOPS covering the tasks they perform.Know where protective clothing and equipment is kept;how to use it properly; and how to remove, handle, de-contaminate, and dispose of contaminated clothing orequipment.Know and understand the limitations of Protective cloth-ing and equipment. For example, ordinary gloves offerno protection against needlestick Injuries. Employersand workers should be on guard against a sense of secu-rity not warranted by the protective equipment beingused.

8. Know the corrective actions to take in the event of spillsor personal exposure to fluids or tissues, the appropri-ate reporting procedures, and the medical monitoringrecommended in cases of suspected parenteral exposure.

SOURCE: U.S. Department of Health and Human Services, Centers for DiseaseControl, “Recommendations for Prevention of l-tfV Transmission inHealth-Care settings,” bfortrld)fy and Mortality Wee/r/y Repo r l , vol. 38,Aug. 21, 1987.

It is not clear, however, that healthcare and other

workers a re being adequa tely inform ed of the advi-sory and trained in the new recommended proce-

dures. For example, in California concerns havebeen raised by some unions over the approach of

some healthcare facilities in establishing infectioncontrol programs in response to the Joint Advisory

Notice. Hospitals and other healthcare employersare reportedly providing ‘‘minimal training pro-

grams and [may be requiring] workers to sign aform sta ting th at t hey’ve been tr ained [in order ]

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

In 1987, OSHA began enforcing some of its ex-isting 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 an d ta gs; an d th e applicat ion

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 Ad-vance Notice of Proposed Rulemaking about the

need for and conten t of additional r egulations. TheService 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 poten-t ial exposure t o Hepatitis B and AIDS and m ake

th e Hepat itis B vaccina tion available to high r isk

workers free of charge (1,66). OSHA expects to is-

sue 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 hos-

pital departments in four urban centers experienc-ing high rates of AIDS infection, the results of

which became available in June 1987,7 (See tables

3 and 4.) The SEIU sur vey, while not st at istically

significant due to the small sample size, concludedth at ‘‘employer volun ta ry complia nce of infection

contr ol guidelines is spotty at best, even in h ealth-care institutions located in urban areas experienc-ing high rates of AIDS infection” (66). SEIU high-

lighted several issues relating to the managementof medical wast es. For example, it noted th at studies

of non-healthcare occupational exposures to blood-borne diseases are almost non-existent, but that ex-

posure of these other types of workers to such dis-eases is known. SEIU, therefore, maintains that thescope of coverage of OSHA regulations should be

based on the known modes of transfer (i.e., ex-

posure), not arbitrary occupational and industry

sector categories.

The National Solid Waste Management Asso-

ciation (NSWMA) also maintains that solid waste

7SEIU represents 850,000 service workers in the public and pri-

vate sectors, of which 275,000 are healthcare workers in hospitals, nurs-ing homes, and a variety of other health and medical facilities. In addi-

tion, at least half of their membership in other types of jobs (this

includes workers such as janitors, mortuary and cemetery workers,

techn icians, an d police officers) ma y be exposed t o blood, blood prod-

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

87 %1460

6148

87 %72811991

36 %70

74 %o

63

70 %1002650

100%60 20

10020

100%40

1002580

0 %

60

80 %2050

8 0 % 75

00

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

Correctional Med. labs Mental healthNursing Blood facilities and HMOs rehab. clinicshome(8) bank(2) (4) (7) (9)

Persona/protective equipment (PPE): Gloves readily available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 % 100%0 100% 100% 89 %

Su fficien t q ua lity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 0 100 57 63Right sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 0 50 57 75

Masks or goggles available . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 100 50 71 56Fluid resistant gown available . . . . . . . . . . . . . . . . . . . . . . . . . 75 100 50 14 44

Work practices/equipment: Handwashing facilities in vicinity . . . . . . . . . . . . . . . . . . . . . . . 63% 0% 75% 100% 780/0Ambubags available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 0 75 29 63Needle disposal containers in vicinity . . . . . . . . . . . . . . . . . . . 83 0 67 100 63Self-sheathing needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 0 14 0Linen 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% 00/0OSHA worker brochure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 0Training 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 57Confidential HIV testing available . . . . . . . . . . . . . . . . . . . . . . o 25 29 22

If available, counseling provided . . . . . . . . . . . . . . . . . . . . . o 25 43 0SOURCE: Service Employee International Union, AFL-CIO,CLC, ”Comments on OSHA’s Advance Notice of ProposedRulemakin9 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 com-paction of untreated wastes in standard refuse ve-hicles. This can r esult in the aerosolization of path -ogens and potentially lead to disease transmission.

Some observers, however, maintain that such

risks are minimal (8,60). They maintain, for ex-

ample, that if wastes ar e properly packaged an d

ha ndled, two of the factors necessary for diseas e

tr an smission a re not pr esent, i.e., mode of tran s-mission and portal of entry. A frequently cited

stu dy, performed in West Germ an y in 1983, does

report that there is no microbiologic evidence that

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

been extensively researched in t he Un ited Stat es

to determine the degree of risks posed by infectiouswastes. In any case, those actually working associ-ated with the housekeeping, janitorial, and refuseha ndling an d disposal of medical wastes indicate

tha t packaging frequently (although actual n um-

bers ar e not available) does not h old wastes, an dtha t workers a re exposed. Bags and boxes ma y leakfluids, or sharps may protrude (51,66).

In general, the establishment of standard oper-at ing procedur es (SOPS) is regar ded as an effec-

tive way to better ensure the proper handling, stor-age, and transportation of medical wastes.

8F or

example, the segregat ion of medical wastes h as a

critical impact on the handling, storage, and trans-

*See, e.g., ref. 17. It is certainly an important aspect of the ap-

proaches recommended by CDC, OSHA, and EPA for medical waste

management.

portat ion of wastes. EP A recommends t ha t infec-

tious wast es be segregated at th e point of origin;

that distinctive and clearly marked plastic bags and

cont ainer s for infectious wast es be used; and t hebiological hazard symbol be used as appropriate(81). Hospitals tend to segregate wastes into at least

infectious and non-infectious groups (61 ,62). Crit-

ical to the proper functioning of this system is knowl-edge of the waste types and their hazards by health-

care workers, and their cooperation to segregate the

wastes.

Even though segregation of wastes is consideredkey to a successful waste management program, it

is also generally regarded as a highly problematicpractice. That is, there is some difficulty in ensur-

ing that healthcare workers will reliably segregatewastes. In part this results from the fact that , un-

derstandably, ‘‘most nurses and physicians consider

the delivery of health care to be their primary mis-

s i o n , not sorting wastes into [seemingly] arbitrary

categories (58). For this reason some hospitals

appar ently find it easier to designate all wast es fromcert ain a rea s of th e hospital as infectious.

Although this approach may be more costly,

given that disposal costs for infectious waste are gen-

erally higher than those for general refuse, it doesminimize the chances for crossover of infectious

waste int o the general wast estrea m (58,62). If all

the wastes are mixed, then they would probably beconsidered in fectious an d ma na ged as su ch (i. e.,

sterilization or incineration v. landfilling or seweruse). Once again, th e centra l importance of the def-

inition of medical was tes becomes a ppar ent. Th ehospital’s definitions of wastes affects the segrega-tion of the wastes within the hospital and their han-

dling, treatm ent, an d ultimat e disposal.



C h a p t e r 3

Current Technologies , Trea tment ,

and Disposal Issues

In c in e r a t io n

The incineration of medical waste has many of

the same advantages and disadvantages associatedwith the incineration of any type of waste. That

is, advan ta ges include s ignifican t volume r eductionof 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 issu es an d concerns m ore spe-cific to th e incinera tion of medical wa stes.

As noted earlier, hospitals generate approxi-mately 2.1 to 4.8 million tons of medical waste peryear (9,83). Of that, about 10 to 15 percent, or

about 210,000 to 720,000 tons, is generally con-

sidered infectious wa ste. Hospita ls often inciner-

at e both infectious an d non-infectious waste together.

The total amount of medical waste incinerated peryear is unkn own.

1In fact, the exact nu mber of med-

ical waste incinerat ors current ly operat ing is not

known.2

Hospital incinerators bur n a m uch sma ller vol-

ume of waste t han mun icipal incinerat ors. Of the158 million tons of municipal solid waste generated

per year, approximately 15 million tons are inciner-

ated (15). What concerns some observers is that

many of the hospital incinerators are located in

heavily populated areas (which could lead to greater

potential exposur e) and appea r t o have relativelyhigh em ission r at es of some polluta nt s of concern

given t heir size.

Limited data indicate that small, on-site inciner-at ors can em it r elatively high levels of some pol-

lutan ts, but few risk assessment s have been per-

formed on these incinerators, hindering the ability

to definitively evaluate the relative degree of risks

I E PA estimated that the total amount of hospital waste incinerated,

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

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

‘One estima te is that over 7,000 medical wast e incinerators of the

most frequently used type, i.e., controlled air systems, have been in-

stalled 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 hospitalsth rough a ir-conditioning ducts a nd wind ows (40).

One stu dy found t hat the concentr at ions of chro-mium, cadmium, and 2,3,7,8 tetra-chlorinated

dibenzo-p-dioxin (TCDD) equivalents were ap-proximately two times higher in the hospital air in-

take than the maximum ambient ground level con-centra tions (13).

The th ree types of incinera tors used most fre-

quently for hospital waste treatment in the United

States are: controlled air, multiple chamber air, androtary kiln models (83). (See figure 2.) All three

types can use primar y and secondar y combust ion

cham bers to ensur e ma ximum combustion of the

Figure 2.—Typical Controlled Air Incinerator

Ga s discharge

Reed

ion

rge

Primary combustion air ports

SOURCE: C. Brunner, “Biomedical Waste Incineration,” paper presented at 80thAnnual Meeting of the Air Pollution Control Association, New York,NY, June 1987.

15



16

waste. Many hospitals also may have small (usu-ally older) incinera tors used only for pa th ologicalwastes.

3Most, probably over 90 percent, of the hos-

pital incinerators installed during the last two dec-

ades have been controlled air units, which tend tobe modular (8). Large municipal incineration oper-

ations are usually of a different design, since often

more capacity is needed tha n a modular unit canprovide. Consequ ent ly, there a re r elatively fewer

modular municipal waste incinerators.

As n oted a bove, some concern s a ssociated with

the incineration of medical wastes are not unlike

those associated with the incineration of most mu-nicipal solid wastes (e. g., the effects of burning plas-tics). Other concerns are more specific to the med-ical wastestream, such as the highly mixed nature

of medical wastes (e. g., infectious, hazardous, andgeneral refuse wastes) and the potential for incom-

plete pathogen destruction. Both types of concerns

will be discussed in t his section, although limiteddata are available on either type of concern. First,

the types of incinerators most frequently used for med-

ical wastes will be briefly discussed and compared.

C on t r o ll ed Ai r Inc i ne ra t o r s

Most of the incinerators built for medical wastetreat ment in the last 15 to 20 years have been con-

trolled 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 primarychamber, waste is dried, heated, and bur ned at be-

tween 40 and 80 percent of the stoichiometric oxy-gen requirement. Combustible gas produced by thisprocess is mixed with excess air and burned in the

secondary chamber. Excess air is introduced into

the secondar y cham ber at usually between 100 and150 percent of the stoichiometric requirem ent . A

supplementa ry fuel burner is used t o maintain ele-

vated gas temperat ures and provide for complete

combustion.

Temperatur es in t he incinerat or a re contr olled

th rough adjust ment s in the a ir levels. Air in bothcham bers is modulated to maint ain pr oper oper-

ating temperatures. Furnace exit temperatures areusua lly mainta ined in the normal ra nge between

3It is not known how man y of these types of incinerat ors are st ill

in use.

1,400 an d 2,000 “F. There a re also th ree an d four

stage-controlled air incinerat ors tha t featu re flue gas

recirculation.

One a dvant age of usin g low levels of air in t he

primary chamber is that there is very little entrain-

ment of particulate matter in the flue gas. For ex-

ample, multiple-chamber air incinerators have aver-age particulate emission factors of 7 pounds per ton,

compared with 1.4 pounds per ton for controlledair u nits. Available data indicate t hat man y con-

trolled air incinerators can be operated to meet ex-isting particulate standards that are at or below 0.08

grains per dry standard cubic foot (gr/dscf) (cor-

rected to 12 percent carbon dioxide) (3,83). Many

States, however, are adopting lower standards (e.g.,0.015 gr/dscf) for incinerators, which probablywould require additional control technologies. Ad-

ditional controls may raise capital costs and require

expansion spa ce (which may or ma y not be avail-

able). Additional controls, however, would capturefiner particulate and some other pollutants.

Advantages of the controlled air system include

high thermal efficiency as a result of lower stoichio-

metric air use, higher combustion efficiencies, andlow capital costs (which ma y increase a s m ore con-

trols are required). As with all types of incinera-

tors, disadvantages include potential incompletecombustion under poor operating conditions and

problems associated with achieving proper operat-

ing temperat ures during star tup of a batch unit.4

O t h e r T y p e s o f I n c in e r a t o r s

Most incineration systems constructed before theearly 1960s were of the multiple-chamber types

(sometimes referred t o as excess air types). They

operated with high excess air levels and thus neededscrubbers to meet air pollution control standards

(8). Few multiple-chamber incinerator units are be-

ing installed today. Instead, older units of this typeare used primarily for non-infectious wastes (3,8).

A small number of rotary kiln incinerators are

currently operating, although greater use of themis being promoted by some. These incinera tion sys-

tems feature a cylindrical, refractory-lined (usually

brick) combustion primary chamber. This chamber

‘In batch un its, the waste is placed in the furna ce in batches and

allowed to burn out. Combustion of the waste first occurs in the pri-

mary (ignition) chamber, through the introduction of heat by a burner.



—

17

rotat es slowly (between 1 and 3 rpm ) on a slightlyinclined, horizont al a xis. This rotat ion provides ex-

cellent tu rbu lence (i. e., mixing). Yet, the rotary

kiln systems tend to be costly to operate and main-

tain, usually require shredding (i. e., some size re-duction of wastes), and usually require emission

controls (3,8,83).Variations of all types of incineration processes

and other ‘‘inn ovative’ technologies continue to

appear. At present, however, controlled air inciner-

ators are popular due to their relatively low (capi-tal, operating and maintenance) cost and their abil-ity to meet ex i s t ing air standards without air

pollution controls. As a result, the controlled air

incineration industr y is healthy. I t remains in a rela-

tively consta nt sta te of chan ge and development,

although there a re frequent tur novers, mergers, and

company failures in the industry (8).

A i r E m i s si o n s a n d A s h

C o n c e n t r a t i o n s o f E m i s si on C o n s t it u e n t s

As of 1987, most States recommended but did

not require control of opacity and particulate emis-

sions from hospital incinerators (83). The reportedrange of concentrations of constituents in hospital

incinerator emissions are presented in table 5. Theraw data on emissions can be analyzed by normaliz-

ing the data to the amount of waste burned. Table

6 shows that for both polychlorinated dibenzo-

dioxins (PCDDs, commonly referred to as dioxins)

an d polychlorin at ed dibenzofur an s (PCDFs, com-monly referred to as furans), hospital incinerator

emissions a re on t he a verage one to two orders of

magnitude higher per gram of waste burned thanemissions from municipal incinerators. The singleexception to this is the Hampton, Virginia, facil-

ity, which in the past emitted upper bound dioxinan d fura n levels that are one order of magnitu de

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

approved by the U.S. District Court of the District of Columbia be-

tween EPA and two environmental groups. The settlement includes

a r equirement for EPA to study emissions of dioxins and duran s fromhospital incinerators, the curr ent regulations of State an d local gov-

ernments, and available control technologies of such emissions by Jan-

uary 31, 1989. By March 3, 1989, EPA is to complete a study of oper-

ating 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 inEmissions From Hospital incinerators Without

Particulate Control Devices

Constituent Range of emissions

Arsenic . . . . . . . . . . . . . . . . . . . . . . . . ..1-5 .99 gr/dscfCadmium . . . . . . . . . . . . . . . . . . . . . . . .24.7-140 gr/dscfChromium . . . . . . . . . . . . . . . . . . . . . . .2.15-30.9 gr/dscf

Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . .532-1190 gddscfNickel . . . . . . . . . . . . . . . . . . . . . . . . . . .2.22-8.0 gr/dscfTCDD . . . . . . . . . . . . . . . . . . . . . . . . . . .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 ppmvSO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19-50 ppmvNO x . . . . . . . . . . . . . . . . . . . . . ........155-270 ppmvabbreviations: grldscf = grains per dry standard cubic foot; nglNma

=nanO-

grams per standard cubic meter; ppmv = parts per million volume.

SOURCE: U.S. Environmental Protection Agency, “Hospital Waste CombustionStudy, Data Gathering Phase,” final draft, October 1987.

Table 6.—Dioxin and Furan Emission Concentrations(in ng/Nm

3)

Facilities Total dioxins Total furans

Hospitals: a

A . . . . . . . . . . . . . . . . . . . . . . . 160-260 386-700B . . . . . . . . . . . . . . . . . . . . . . . 290-450 700-785c . . . . . . . . . . . . . . . . . . . . . . . 117-197 52-84

Municipalities: Hampton, NY . . . . . . . . . . . . . 243-10,700 . 400-37,500North Andover, Mass.. . . . . . 225 323Marion Co., Oregon . . . . . . . 1.13Prince Edward Island,

Canada . . . . . . . . . . . . . . . . 60-125 100-160Tulsa, Okla. . . . . . . . . . . . . . . 18.9 15.5Wurzburg . . . . . . . . . . . . . . . . 22.1 27.9Akron, 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 WasteDisposal” (U.S. Environmental Protection Agency, Feb. 19, 1988).

higher than the upper bound levels reported for hos-

pital incinerators.G

Thus, hospital incinerators tend to produce more

dioxins and furans per gram of waste burned thanmu nicipal incinera tors. Given th e smaller volume

of medical waste incinerated, overall emissions from

all medical waste incinera tors ar e less th an t hose

from existing incinera tors. Yet, since hospital in-

cinerators are usually located in densely populatedarea s, potent ial exposure m ay be greater.

‘The Ham pton facility has r ecently been retr ofitted, and its emis-

sions have been significantly reduced (46).



18

P oss i b l e R easons fo r H i ghe r E m i s s i on L eve ls

o f D i ox i n s / F u rans and H C l

Higher concentrations of dioxins and furans may

be associated with medical waste incineration emis-

sions due to:

1. the frequent start ups and sh utdowns these in-

cinerators undergo;2. less stringent emission controls;3. poorer combustion control (e. g., waste mix-

ing and oxygen controls); and

4. differences in t he wa ste feed composition ascompared with municipal solid waste.

Studies have shown t hat dioxins a nd furan s canbe formed after leaving the furna ce, by th e cat aly-

si s a t l ow t e m p e r a t u r e s of precursors (such as chlo-rophenol and benzene) and chlorine atoms on fly

ash particles (19). This suggests that destructionof precursors in the furnace and control of temper-atures in the stack are important factors in prevent-ing formation of dioxins and furans. Disagreement

exists over wh ether pyrolysis of PVC in hospital

incinerators can produce chlorobenzene (a potential

dioxin precursor). EPA has studied the phenomenonof ‘tr an sient puffs” (referr ing t o upset conditions)in test incinerators burning PVC and polyethylene.

During waste charging, hospital incinerators often

experience high carbon monoxide emissions, in-

dicating poor combustion. These transient puffs

generate large quantities of products of incompletecombustion (PICs), including dioxins (40).

Almost all hospital incinerators are operated on

an intermit tent basis (83). Frequent startups andshutdowns of medical waste incinerators may lead

to increased dioxin formation and may volatilizecertain waste components, including pathogens. Astudy of dioxin emissions from the Westchester mu-

nicipal incinerat or in New York Sta te foun d th atdur ing cold sta rt s (with out a uxiliary fuel), dioxin

and furan emissions were at least 10 t imes higher

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

concluded that dioxins are formed in cool sectionsof the incinerator (between 400 and 800 ‘F). If startups and shutdowns of medical waste inciner-

ators a re u nderta ken without auxiliary fuel, poor

combustion may allow dioxin precursors (e. g., chlo-

rophenols) to escape up the stack, increasing catal-ysis of dioxins and furans on fly ash particles.

A study by the New York State Energy and Re-

search Development Authority (NYSERDA), how-

ever, found that the presence of polyvinyl chloride(PVC) was not r elated t o the levels of dioxins an d

furans in the stack of a municipal incinerator, at

least under the limited set of conditions during thetest. Instead, formation of these compounds was

par tly related to the th oroughn ess of th e combus-tion process. Poor combustion, which occurred attemp erat ur es below 1500 ‘F a nd wh ich was indi-cated by h igh carbon monoxide levels, resu lted in

substantial increases in dioxin and furan formationin 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 thatmay act as aromatic precursors and chemicals suchas anti-neoplastic agents (classified as RCRA haz-

ardous waste) and bactericide. In addition, cyto-toxic wastes represent approximately 1 to 2 percent

of all hospital wastes (71).

Laboratory studies have found that pyrolysis of

various plastics produces chlorinated aromatichydrocarbons. For example, pyrolysis of PVC has

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

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

of plastics may occur in the primary combustionchamber of controlled air units, causing the forma-tion of dioxin and furan precursors. To reduce for-

mation of these precursors, increased turbulence

(mixing), retention time, and t emperatur e ar e re-

quired (7). In addit ion, computer ized combust ioncontrols that regulate the level of oxygen in the fur-na ce can improve destr uction of precursors (40).

The concentrations of hydrogen chloride (HCl)also appear to be consistently higher, on average,

compa red with mun icipal waste combust ors. Onereason for th is ma y be higher levels of PVC in med-

ical waste (39).8EPA has reported that plastics com-

prise a pproximately 20 per cent (by weight) of allhospital wast e, compared with 5 to 10 percent in

municipal solid waste (55). Virtually all of the chlo-

rine present in th ese wastes is converted t o HCl dur-

7See refs. 2,65.qt should& not~, however, that HCl is conta ined primarily in

PVC and not other types of plastics. OTA does not have data on howmuch 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 HCland possibly dioxins. HCl may be controlled by

monitoring waste input or through the installationof appropriate air pollution control technologies

(e. g., acid gas scrubbers).

C oncen t r a t i ons o f C ons t i t uen t s in Ash

Little data has been reported describing the con-

centrations of the constituents of medical inciner-ator a sh. Heavy meta ls have been found in hospi-

tal incinerat or em issions and ar e expected t o be

present in incinerator ash. Lead and cadmium, forexample, are found in radioisotope shielding as wellas pigments and additives in plastics (40). Limited

dat a from one hospita l showed th at 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 fu-ran concentr ations in fly ash from t hree h ospital

incinerators and four municipal incinerators (19).(See table 7.) The dat a r eveal that concentr ations

of both dioxins and furans are considerably higherin hospital incinerator fly ash than in municipal in-cinerator fly ash.

Tota l dioxin levels in hospital incinera tor 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 1.4-3.4Tetra CDD . . . . . . . . . . . . . . . . . . . . . . 0.6-7.5 94-404Penta CDD . . . . . . . . . . . . . . . . . . . . . . 1.2-13,2 208-487Hexa CDD . . . . . . . . . . . . . . . . . . . . . . 1.4-15.8 271-411Hepta CDD. . . . . . . . . . . . . . . . . . . . . . 1.8-25.6 189-307Octa CDD. . . . . . . . . . . . . . . . . . . . . . . 1.9-23.1 123-245

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

Tetra CDF . . . . . . . . . . . . . . . . . . . . . . 9.0-32.1 199-376Penta CDF . . . . . . . . . . . . . . . . . . . . . . 10.2-38.3 285-647Hexa CDF . . . . . . . . . . . . . . . . . . . . . . 8.0-31.7 253-724Hepta CDF. . . . . . . . . . . . . . . . . . . . . . 3.4-15.9 125-286Octa 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 Effectsof Fly Ash From Waste Incineration Facilities on the Formation andDecomposition of Polychlorinated Dibenzo-p-dioxins and Polychlori-

nated Dibenzofurans,” Erwirorrrnerr t , Scierrm an d Technology 21(1 1):1080-1084, 1987,

higher th an the r an ge of 7 to 80 ppb for the mu -

nicipal fly ash s am ples. (See ta ble 7.) In a ddition,

none of the fly ash sa mples from t he h ospital in-

cinerators had concentrations of the 2,3,7,8-TCDDisomer alone that were below 1.4 ppb. A concen-

tr at ion of 1.4 ppb of total 2,3,7,8-TCDD equiva-

lents is the figur e that CDC and E PA Headquar-ters have used as an indicator of safe concentrations

of dioxin in a sh. If tota l toxic equivalent s ar e cal-

culated, hospital incinerators actually exceed the

dioxin standards by about two orders of magnitude.It is important to note, however, that this compar-

ison is based on a limited sample, and caution is

required when attempting to draw any conclusionsbased on the reporting of so few studies.

Futu re T rend s in Med ic a l Was te

In c in e r a t io n

There are a number of factors (in addition to thedefinitional issues discussed above) which may in-

fluence the waste disposal practices of hospitals inthe future. First, the stringency of the emissionstandards that hospital incinerators will need to

meet will determine the type and cost of air pollu-tion cont rols. The cost an d engineer ing feasibility

of retr ofitting existing hospital in cinera tors with acid

gas scrubbers an d/or pa rticulate ma tter controls,

an d compu ter ized combustion controls, may force

many hospitals to cease on-site incineration in fa-vor of off-site centralized incineration. g The c a p i -

t a l costs of larger regional incinerators are presumed

to be lower per ton of waste tha n smaller individ-ual hospital incinerators (6). Other costs, such astransportation, however, need to be considered.

Also, generators of wastes using a regional facilityrath er th an incinerating wastes on-site ma y not real-

ize a cost s avings.

Second, increased regulation of ash disposal mayprovide further impetus for hospitals to utilize off-site management of wastes or residuals. Even those

hospitals that continue to incinerate wastes on-sitemay 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 th ese areas do exist a s well as concerns over potential siting prob-

lems and other difficulties associated with the construction of most

waste facilities of any type today.



incinerator ash in existing municipal landfills willc o n t i n u e t o b e a l lo w e d . Th i s m a y r e s u l t i n t h e n e e dto send th e ash to more str ingently controlled land-fills or monofills. Regardless of whether ash is reg-

ulated under either Subtitle C or as a special wasteunder Subtitle D, r elatively short-term liability costs

associated with RCRA corrective action as well aslonger term liability associated with Superfund

could increase insurance and other operating costsfor th ese as h disposal facilities.

Controlled air incinerators have traditionally

been popular for medical wastes. As noted a bove,

this is apparently due to the fact that they can

achieve relatively lower pa rt iculat e emissions, as

compared with rotary kiln incinerators (which tendto be higher priced due at least in part to the needfor emission controls, such as fabric filters or elec-

tr ostatic precipitators) (3). As best available con-

trol technology (BACT) emission standards below

0.08 gr/dscf for particulate matter (PM) are pro-mulgated, however, controlled air facilities will re-

quire additional emission controls and may lose one

cost advantage over rotary kiln models.

For exam ple, New York r ecent ly proposed P M

standards for new hospital incinerators of 0.01

gr/dscf for facilities processing more than 50 tonsper day and 0.015 gr/dscf for facilities processing

less than 50 tons per da y, as well as a stan dard of

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

new Pen nsylvania P M sta nda rd is 0.08 gr/dscf for

modular facilities, which can probably be met by

many controlled air facilities without emissions con-tr ols. Mid-sized units mu st m eet 0.03 gr/dscf and

large un its mu st m eet 0.015 gr/dscf. The 0.03 and

0.015 sta nda rds will require a ir pollut ion cont rol

devices.

Alternative technologies are being studied for

medical waste disposal. For example, the Depart -

ment 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 temp erat ur es at wh ich coal burn s

in these combustors is about 1,600 ‘F, which is con-

sidered sufficient to render most medical waste non-infectious. Limestone is added to the bed to absorb

sulfur. Moreover, both th e limestone an d th e coal

ash itself, are chlorine-capturing agents. The flui-dized bed combustion could allow hospitals to in-

cinera te wast e on-site and a lso to produce energy

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

Au toc lav ing

Autoclaving, or steam sterilization, is a process

to sterilize medical wastes prior to disposal in a

landfill.10 Since the m id-1970s, steam s terilizationhas been a preferred treatment method for micro-biological laboratory cultures. Other wastes (e. g.,path ological tissue, chemotherapy wast e, and sh arps)

may not be adequately treated by some steriliza-

tion operations, however, and thus require inciner-ation (72). OTA has no data on the total amount

of medical wastes st erilized in t he coun tr y.

Typically, for autoclaving, bags of infectious

waste are placed in a chamber (which is sometimespressurized). Steam is introduced into the container

for roughly 15 to 30 minutes. Steam temperatures

ar e usu ally maint ained a t 250 ‘F (63). Some h os-pital a ut oclaves, however, are opera ted a t 270 ‘F

(61). This higher temperature sterilizes waste morequickly, allowing shorter cycle times.

Several studies indicate that the type of container

(e.g., plast ic bags, stainless steel cont ainer s), theaddition of water, and the volume and density of

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

of these factors influences th e penetr ation of steamto the ent ire load an d, consequent ly, th e extent of

pathogen destruct ion. Autoclaving parameters

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

Since there is no such thing as a “standard load”for an au toclave, adjust ment s need to be ma de by

an operator based on variation in these factors. Aswith many technologies, proper operation of auto-claves is key t o effective fun ctioning (i. e., in t his

case, sufficient pathogen destruction to render

wastes non-hazardous).

One method of assuring that pathogen destruc-

tion has taken place is the use of biological indica-tors, such as B ac i l l us s t e aro the rm oph i lus . Elimi-nation of this organism (as measured by spore tests)

from a sta inless steel conta iner r equires 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 m inut es of exposur e. This is consider-ably longer than is currently provided by standard

operating procedures (61 ,63). This conservative ap-proach, however, ma y provide more pa th ogen de-

struction than is necessary to reduce microbiolog-

ical contamination to non-infectious levels (63).

Chemical disinfection (e. g., with formaldehyde,

xylene, alcohol) is used to sterilize reusable items.

Recent ly, sodium hypochlorite ha s been u sed in aprocess to disinfect disposable products. Partial de-

str uction of the ma terial is achieved, but a dditionalincinerat ion an d high capita l costs are ass ociated

with t he pr ocess as well.

Several factors have led some hospitals to aban-

don autoclaving. For example, problematic oper-

at ing conditions can lead t o incomplete st eriliza-

tion. In addit ion, lan dfill an d off-site in ciner at or

operators are increasingly refusing to receive suchwastes, quest ioning whether the wa ste ha s actually

been treat ed. The refusals are pa rtly in response

to th e fact th at most a ut oclave “red ba gs’ do not

change color and thus appear no different from non-

autoclaved red bags (even though they often arelabeled or in some way identified as “autoclave”).This also has led to more cumbersome documen-

tation and/or identification requirements in an ef-fort to avoid refusals (72).

I n c i n e r a t i o n v . A u t o c l a v i n g ; a n d t h e

I m p o r t a n c e of P r o p e r O p e r a t i o n

Autoclaves m ust achieve minimum temperat ures

and be operated according to appropriate cycle

times to ensure adequate destruction of pathogens.Primar y and secondar y cham ber temperatu res of

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

reached in hospital incinerators to ensure adequatecombustion and minimum air emissions (83). Nor-

mally, these temperatures would ensure the destruc-

tion of pat hogens in t he was te, however, if an in-

cinerator is loaded and fired-up cold, pathogens

could conceivable escape from th e sta ck. 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 nec-essar y to redu ce pat hogen concentr at ions in most

hospital waste below infectious levels (63).

The proper operation of incinerators and au-

toclaves is critical to their effective functioning.Proper operation is dependent on at least four con-

ditions: 1) trained operators; 2) adequate equip-

ment (i. e., proper design, construction, controls

and instrum entat ion); 3) regular m aintenan ce; and

4) repair. For example, tra ined operat ors need to

be knowledgeable in the operation of the incinera-tor an d in t he proper ha ndling of medical wastes.It is not clear, however, th at worker s ar e consist-

ently receiving adequate training in the operation

of incinera tors or a utoclaves, and consequen tly tha t

most units are operating pr operly.11

Autoclaves do provide some advantages over in-cinerators, which may increase their attractiveness

as a disposal option, particularly if incineration reg-

ulations become much more stringent and therebyincrease incineration costs. For example, operation

an d test ing of incinera tors is m ore complex an d dif-

ficult than that for autoclaves (57). In addition,environmental releases from incinerators probably

cont ain a broader r an ge of constitu ent s (e. g., di-

oxins, heavy metals) than autoclaves.

Aut oclaves ar e also less costly to purchase an d

operate a nd requ ire less space. These cost advan -

ta ges, however, may be lessened if inciner at ion isalso requir ed.

A major difficulty associated with autoclaving is

th e r eluctan ce of landfill and (off-site) incinera tor

operators to accept medical wastes. This, along with

other difficulties associated with autoclaving, such

as en suring t he proper operation of the au toclav-ing process (e. g., sufficient residence time to en-

sure pathogen destruction), the more limited ca-pacity of most autoclaves, and the time-consumingprocess for autoclaving compared with incineration,

make i t a less common waste treatm ent m ethod formost facilities (53). 12

I IEpA is preparing a training man u a l for the operators of hospital

incinerators and an air compliance inspection guide.lzRecently, n ew technologies for autoclaving have been announced.

For example, one company has introduced a large mobile autoclav-

ing unit (moved on a semi-trailer) that can sterilize approximately1,500 pounds of waste per hour. Materials ‘ ‘cook’ at 275 ‘F and are

th en allowed to cool. Special au toclaving bags are app aren tly not nec-essar y, and th e process is advertised as a n economical disposal option

for certain medical wastes. See announcement in Infectious Waste

News, June 18, 1987.



22

H e a l t h a n d E n v i r o n m e n t a l R i s k s F r om

T r e a t m e n t T e c h n o l o g i e s13

The few risk assessments tha t ha ve been per-

formed on individual hospital incinerators have pre-

dicted health risks (specifically, cancer risks) thatare compar able to those predicted for mu nicipal in-

cinerators (20,47). Important differences, however,in risk assessment methodologies and the site-

specific nature of these risk assessments precludesmeaningful comparisons between projected cancerrisks. For example, most risk assessments accountfor r isks associated with inha lation, but not for those

associated with ingestion. In addition, the age of

facilities u nder investigation var ies considera bly,

and older facilities tend to have less-than-optimal

operating conditions and/or less air pollution con-trol equipment.

There are two important points r egarding hos-

pital incinerator emissions: 1) hospital incinera tors

do not generally achieve emission levels as low asthose reported for municipal incinerators; but 2)

they tend to burn a much smaller volume of wasteand so emit smaller quantities of toxic constituents.

Yet, the closer proximity of many hospital inciner-

ators to populations is also an important consider-

ation. In any case, no national estimates have been

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

national estimates for municipal incinerators. Ad-ditionally, no national estimates of non-cancer ef-fects a ssociated with hospital incinera tor em issionshave been underta ken.

I JNote , cur ren t ly most of the attention here is on risks from the

incineration of biomedical wastes. Additional information, as avail-

able, will be added on risks associated with autoc l av ing an d Iandfilling.

The risks associated with incinerator emissionsha ve been estimat ed by Sta tes for individual mu-

nicipal incinerat ors and by EPA for all mun icipalincinera tors (48,82). In cont ra st, few risk a ssess-

ment s ha ve been performed for h ospita l incinera -

tors. The New Jersey Department of Environ-

mental Protection (N.J. DEP) performed a risk

ana lysis on four hospital incinera tors for seven car-cinogens (four metals, two VOCs and TCDD),HCl, and criteria pollutants (20). Only TCDD was

foun d to pose a cancer risk of great er th an one in

a m illion. The upper bound cancer risks from chro-mium and cadmium, the second and third most sig-nificant carcinogens, were both one order of mag-

nitude lower than TCDD.

A risk an alysis of a pr oposed hospital incinera -

tor in Michigan predicted upper bound dioxin can-cer r isks th at were one order of magnitu de lower

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

Jersey risk assessment only examined the tetra di-

oxin homolog and did not include other dioxinhomologs or furans in the analysis. This may haveresulted in some underestimation of the upper

boun d cancer r isk. One r eview of data on dioxin

and furan emissions from hospital incinerators hasfoun d emission ra tes of tota l dioxins an d tota l fu-

ran s generally higher th an those from mun icipal

incinerators (42).

The New Jersey results ar e consistent with t he

national risk assessment performed by EPA on mu-nicipal incinera tors insofar as t hey indicate t ha t di-oxins a re r esponsible for m ost of th e cancer r isk

ass ociat ed with in ciner at or emissions (82). EPA’sanalysis, which examined the risk from municipal

incinerators on a national basis, found that dioxinsposed the grea test risk of can cer by t wo order s of

magnitude, compared with the second most signif-icant carcinogen present, cadmium.



C h a p t e r 4

Regulatory Authori ty and Current Pract ices

F ed e r a l A u t h o r i t y

The two Federal laws that most directly provide

the government with th e au thority to regulate orcontrol the management of infectious wastes in

some way are the Resource Conservation and Re-covery Act (RCRA) and the Occupational Safety

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

Performance Standards (NSPS) of the Clean Air

Act m ay apply to hospital incinerat ors.2Any spe-

cial State and local regulations for general and in-fectious wast es a lso apply. Certa in chemical wa stesgenerated in healthcare facilities ar e considered ha z-

ar dous waste a nd m ay be subject t o provisions of

RCRA, and radioactive waste disposal must conform

with Nuclear Regulatory Commission standards.3

T h e a g e n c y w i t h t h e m o st c o m p r e h e n s iv e a u -t h o r i t y t o p r o v i d e F e d e r a l l ea d e r s h i p o n t h e

man agemen t o f medica l was tes i s EPA. EPA has

authori ty under RCRA to regula te the handl ing ,

s torage , t rea tment , t ra nsport a t ion , and d isposal of

m e d i c a l w a s t e s . I t s r e g u l a t i o n s w o u l d a p p l y t o p u b -

l ic and p rivat e facil it ies of al l types.

Curr ent ly , as n oted above, the Agency has only

issued a guidance document for the mana gement

o f i n f e c t i o u s w a s t e s . O t h e r m e d i c a l w a s t e s a r e c o n -

s i d e r e d t o b e li k e a n y o t h e r s o l id w a s t e a n d a r e s u b - j ec t to re levan t RCRA Subt itle D regulations.

In contrast, the CDC does not have authorityto issue regulations. OSHA may issue regulationsor guidelines to protect the health and safety of

worker s, but th ey apply only to private facilities

(unless a State extends the coverage to employeesof public facilities as well).

4At present, OSHA does

regulate employee exposure to toxic substances un-der the General Industry Health standards.

5

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

242 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 an y case, these standar ds only apply to conventional criteria pol-

lutant s. Potential air toxics are not regulated at th e 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 exis-

tence of regulations governing their disposal, will not be discussed ex-

tensively here.429 U.S.C. 652(5); 655(b); 657(c); 657(g)(2).

529 U.S.C. 655.

Under Section 6 of OSHA, the Labor Secretar y

is given general authority to promulgate such stand-

ar ds in order to assur e the ‘‘att ainmen t of the h igh-

est degree of health and safety protection of the em-ployee.” Yet, th e feasibility of th e st an dar ds m ust

be considered, and they must be set on the basisof the best available evidence. There is apparentlynothing in th e definitions of term s in OSHA tha t

would preclude the application of the law’s author-ity to th e regulat ion of infectious wast es.

6At this

time, however, OSHA has limited its specific activ-ity on occupational exposure to infectious wastes

to its ru lemaking activity t o control occupational

exposures to Hepatitis B and AIDS.

S t a t e R e gu l a t o r y A c t iv i t i es

Given t he genera l lack of regulat ion on th e na-

tional level, States have developed their own infec-tious or medical wast e programs. As th e Coun cil

of State Governments (CSG) report, S ta t e I n f e c -

t i ous Was t e R e gu la tory P rogram s , notes, without

a F ederal baseline a nd with out Feder al funds ‘‘to

support t he creation of a new environment al reg-

ulatory program [to manage infectious wastes],states, regardless of size or loca t ion , are in the proc-

ess of meeting the public’s demand for protection.It is [a] clear sta te-genera ted init iative . . .” (em-

phasis added) (4). Local governments (e. g., towns,

cities, and counties) may also develop special med-ical requirem ents of one sort or a nother. This h as

led to tremendous variation in the regulation of

these wastes.

The var i a t ion in S ta te a c t iv it i es is wor th y o f

Federa l a t ten t ion for a t leas t two reasons. Fi rs t ,

s t r i ct e r r e g u la t i o n s i n o n e S t a t e m a y e n c o u r a g e

the sh ipm ent o f was tes to other S ta tes wi th l es s

s t r i n g e n t r e g u l a t i o n s . S e c o n d , m a n y S t a t e s , i n

the absence of Federa l gu idance , apparent ly are

“l e a p -f r o g gi n g ” o n e a n o t h e r t o a d o p t t h e m o s t

s t r i n g e n t r e g u l a t i o n s . O n e o f t h e m o s t s t r i k i n g f e a -

tu r es of recent Sta te ac t ion on medical /infect ious

w a s t e i s s u e s i s it s r a p i d i t y . A s t h e C S G n o t e s , m a n y

cThe defini ton of the term employer app ears su fficiently broad to

include hospitals and possibly other generators; the definition of toxic

materials or h armful 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 th e Sta tes in 1988,

compared with 57 percent in 1986 are or will beregulating infectious wastes (4). (See figure 3.)

Eleven States split the jurisdiction over infectiouswastes between solid waste management offices and

health department offices, while other States des-

ignat e one or th e other of th ese types of offices as

the lead a uth ority. Enforcement aut hority is usu-

ally in the solid waste office for off-site disposal,

with the air pollution control board responsible forregulating incinerator emissions, and with the hos-

pital licensure office responsible for monitoring on-site generation, treatment, and disposal of infec-

tious wastes. Seven States delegate this authorityto county health departments, and in five it is

delegated to th e J oint Commission on Accredita-

tion of Healthcare Organizations (JCAHO) (4).7

A majority of Sta tes ta rget hospitals in th eir reg-ulation of infectious wastes. Of these, three-quarters

also regulate clinics, but only half also include doc-tor and dental offices, veterinary hospitals, andother small generators (4). (See figure 4.) Five

States currently exempt or are proposing to explicitly

exempt sma ll qua nt ity genera tors from infectious

7The JCAHO inspects hospitals periodically and determines their

accreditation. Despite their recognized auth ority, and potent ial to ef-

fect the waste management practices of hospitals, there has been crit-

icism of the thoroughness of their inspections. See, e.g., ref. 53.

Figure 3.-Stages of State Changes inMedical Waste Management Programs-

As of March 1988

Draf t /d

SOURCE:

1s(

The Council of State Governments, State Infectious Waste RegulatoryPrograms (Lexington, KY: 19SS).

Figure 4.-Types of Medical WasteGenerators Regulated by States-

As of March 1988

Hospitals

Clinics

Veterinary hospitals

Doctors/dentists

Biomedical/ pharmaceutical

Research

OtherI 1 I I 1 io 10 20 30 40 50

Number of States

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

Programs (Lexington, KY: 1988).

waste regulations or policies (4).8Regulating in-

fectious wastes on the basis of listed generators

versus types of wastes can lead to some importantincongruities. In Rhode Island, for example, wastes

from animal research in a laboratory associated with

a h ospital a re su bject to infectious waste regulations,

however, wastes from animal research at a labora-tory unaffiliated with a hospital are not subject tothe regulations (4). As will be discussed further be-low, whether small quantity generators should be

exempt from infectious waste regulations is a sig-nificant, u nr esolved issue.

Unless a Sta te specifically regulat es infectiouswastes as hazardous wastes (4),

9permits are not

likely to be required by States. Instead, infectiouswaste guidances and rules appear t o be the n orm

and are designed to be “self-enforcing. The Coun-

cil of State Governm ents identifies t he logic as:

Best management practices (emphasizing bio-safety), liability issues, and haulers’ refusals to han-dle red-bagged wastes are recognized and dependedupon as strong voluntary compliance inducements(4).

A concern expressed by some hospital adm inis-

trators, however, is that the regulations proposedor a dopted by some Sta tes ar e inappropriate, un-

realistic, and costly. For example, the New York State Department of Environmental Conservation’s8

These are: California, Indiana, Minnesota, Missouri, and Ohio.‘This is true for: the District of Columbia, Hawaii, Iowa, Kentucky,

Maine, and Washington.



25

(DEC) dra ft regulat ions, referred t o as th e “most

far-reaching and comprehensive waste management

laws in the nation’ for solid and infectious wastemanagement , contain the following incinerator

emission standards:

q

q

q

0.010 grains per dry standard cubic foot of flue

gas, corrected to 7 percent oxygen (for newfacilities processing over 50 tons/day);

90 percent reduction of hydrogen chloride

(HCl) emissions;10

At least 1 second r esidence time a t least 1,800‘F for combustion gas.

11

These new regulations are expected by many,

including t he DE C, to increase th e cost of on-site

incineration of infectious wastes (31). This may lead

to more off-site tr eat ment of hospital wast es.

One hospital consultant’s opinion of the New

York State regulations, and other State regulations,

based on best available control technology for in-cinera tion of infectious wast es is th at :

. . . [they] appear to have no technical basis, andmany are also reflective of unproven, unrealistic,an d sometimes u nat taina ble technology . . . . .What appears most disturbing, however, is thatthere appears to be no evidence or documentationwhich show tha t th ere will be any significant envi-ronmental benefits or reduced health risks if suchproposed legislation is enacted (8).

He ma intains th at more analysis is needed be-

fore such standards are adopted. The need for

standards set on the basis of sound analysis is rarelydisputed. Currently, lacking such an analysis, it isunclear which level of standards are most appro-priate. Variation between the levels adopted by

States is readily evident, however, and is one justifi-

cation frequently noted for the development of na-

tional standards. (See table 8.)

IOun]ess it is &monStrated that ei ther the st ack concentration is

less than 50 parts per million by volume, dry basis corrected to 7 per-

cent oxygen; or, the uncontrolled emission rat e is less than 4 pounds

per hour and the total charging rate is less than 500 pounds per houI 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 th an half of the Sta tes require or plan to

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

wastes before land disposal. Yet, under certain con-ditions, at least 12 Stat es allow infectious wa stes

to be landfilled without treatment. Seventy-two per-

cent of the States name incineration in their exist-

ing or proposed regulations as a recommendedtreatment for medical wastes. Five States r e q u i r e

incineration (4).12

Twenty-three States are consid-ering establishing performance standards, which

could be in addition to any other applicable stand-ards set by State air control agencies for incinera-

tors. Twenty-seven States recommend steam sterili-

zation as a treatment process for infectious wastes.

Fourteen of these States specify or are consideringspecifying time/temperature/pressure standards.

Eighteen States include chemical t reatment as analterna tive, and other treatm ent alternat ives 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 issuedrecommendations on biosafety from JCAHO, CDC,NIH, EPA, and OSHA (4). Packaging and label-

ing requirements are included in the infectious

waste regulations of31 States. These include suchrequirements as rigid containers, double bagging,

and labeling requirements. Storage requirements

(currently in place in 7 States and being consid-

ered by 14 others) include such elements as thelength of time wastes can be maintained on-site and

refrigeration requirements. Transportation require-ments (including the designation of only non-com-pacting tru cks for tra nsporting infectious wastes,

requiring truck labeling and shipping procedures,and specifying cleaning procedures) and record-

keeping requirements (usually recordkeeping by the

generat or r ather than a m anifest system of submit-ting records to the St at e) ar e being considered by

th ree-fifth s of th e Sta tes (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 andold facilitiesover 50 tons/day); 0.015 (for

new facilities ifless than 50tons/day); 0.03(for existingfacilities 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 atexisting facili- (for facilities 12 ”/0 C02) 120/0 CO2 (for 120/0 CO2 forties); 0.08 gr/ less than 1000 existing facili- greater thandscf (for new Ibs/hr) ties); 0.08 (for 200 Ibs/hr)facilities less new facilities)

than 500 Ibs/hr); 0.03 (forfacilities of500-2000 Ibs/hr); and 0.015

than 50 tons/day

(for facilitiesover 2000 lbs/hr)

Visibleemissions(opacity) 40% 20% 50/0 (as meas-

ured by U.S.EPA Method 9

300/0 (anytime10% for any 3minute hourlyaverage)

Hourly average100/0 maximumcontent, 6minutes aver-age less than20%090% HCIreduction, or

50 ppm HCI50 ppm

—

50 ppm at 120/030 ppm (or90°/0 reduction)

Testingrequired

HCL (acid gas) — —

— CO 2 over anycontinuous 1hour period

30 ppm (or75% reduction

S O2

—

Carbonmonoxide 99 ”/0 75 ppm at 70/0

reductionHourly averageno more than100 ppm at 70/002

Hourly averageno more than100 ppm at 70/002

— —

Combustion: Efficiency 99.9 ”/0 — —

Yes

— —

Operator training: Training YesCertification Yes

Solid waste: Residual

burn out —

Yes — —

——

——

— — — Maximum ashcontent 5°/0,no visibleunburnedcombustibles

Abbreviations: grldacf = grains Per dry standard cubic foot; mm = parts per million %%rIy States are currently revising their regulations for infectious waste incinera-tion. 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 En-

vironmental Resources, personal communication, Sept. 20, 19BB; and Gary Yee, California Air Resources Board, personal communication, Sept. 21, 198S.



C h a p t e r 5

Managing Medical Wastes—

Institutional and Policy Issues

Whether the Federal Government should furtherregulate the management of medical/infectious

wast es is an open issue. Within t he policy debate

over whether and how medical wastes should be

regulated a re classic divisions between th ose main-taining there is a need to d o c u m e n t actual harmfrom medical wastes, and those primarily concerned

with the po ten t ia l har m posed by these wast es. Most

environmental laws passed in the last 20 years have

embodied a ‘ ‘preventive’ approach to human

health and environmental risks as the basis for reg-

ula tory a ction. In pr actice, however, a more ‘ ‘re-active’ bas is for p olicy developme nt is often us ed.

This latt er app roach reflects t he incomplete sh iftof the ‘‘burden of proof’ with which administra-

tive agencies have had to cope in justifying the ac-tual regulation of environmental practices. Thispragmatic approach to regulation, in an effort toconserve regulatory resources, essentially finds reg-

ulation 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 asso-ciated with medical waste disposal warrant Federalregulation.

At t h e m o m e n t , t w o r e g u l a t o r y t r e n d s a r e

em er g i ng i n m ed i ca l w as t e m a na gem en t , bo t h

p r i m a r i l y d r i v e n b y t h e m o r e “ p r e v e n t i v e ”

m ode o f r egu l a t i on : one t r end i s t ow ard r egu -

l a t ing greater quan t i t ies of potent ia l ly infec t ious

was t e s; and t he o the r t rend i s t oward t i gh t en ing

cont ro ls over inc inera t ion an d o ther d isposal op-

t i ons . As one h osp i t a l consu l t an t no ted ,

M o r e a n d m o r e w a s t e q u a n t i t i es a r e r e q u i r e d t ob e t r e a t e d a s “ i n f e c t io u s , ” o f w h i c h s m a l le r p e r -cen ta ges a r e t r u ly in f ec t ious ; bu t , s imul ta neou s ly ,v ia b l e t r e a t m e n t a n d d i s p o s a l o p t i on s a r e b e i n ge l imina ted or made cos t - pr oh ib i t ive ( 8 ) .

The concern of some genera tor s of medical wasteis tha t some, if not a l l , ‘ ‘viable’ ma na geme nt op-

t i o n s w i l l b e c o m e l e s s a v a i l a b l e ( o r m o r e c o s t l y ) d u e

t o t h e a d o p t i o n o f s t r i c t e r a i r e m i s si o n r e g u l a t i o n s

by a nu mber of Sta tes. This could affect, at leaston a temporary basis, the availability of sufficientcapacity in some areas for managing medical waste.

Several other general t rends a lso appear to be

emerging in the management of medical wastes.

These include: 1) the likelihood of fur th er regula-tion, at least at th e local and St at e levels of gov-

ernment; 2) possible increases in off-site commer-cial and regional incineration facilities, dependingon the levels of sta nda rds set in s uch regulat ions

and on other cost factors; 3) an increase in the tra ns-

portation of medical wastes if there is more off-sitedisposal (which will probably provide further impe-

tus to establishing manifest or recordkeeping sys-tems of some sort); 1

and 4) the likelihood of in-creased costs for disposing of medical wastes as

more treatment becomes necessary and more strin-gent controls are adopted.

As noted above, most States are currently de-

veloping or revising regulatory programs that ad-

dress m edical wast es. The strin gency of th e emis-

sions standards that medical incinerators must

comply with will determine the type and cost of nec-essary air pollution controls. T he cos t and eng i -

neer ing cons t r a in t s ( e . g ., space) o f r e t r o fi t t ing

e x is t i n g h o s p i t a l in c i n e r a t o r s w i t h a c i d g a s s c r u b -bers and /or par t icu la te mat ter cont r o ls may force

man y hosp i t a l s to cease on-s i t e inc inera t ion in

favor of off-si te incineration at regional , central-

ized faci l i t ies . Regiona l faci l i t ies , however , a r e

l ikely to face si t in g difficult ies.

I n c r e a s e d t r a n s p o r t a t i o n o f m e d i c a l w a s t e s t o r e -

g i o n a l f a c i li t i e s , o r t o f a c i l it i e s t h a t a r e l o c a t e d o u t -

s id e a S t a t e a n d i n s o m e c a s e s o u t s i d e o f t h e c o u n -

t ry, wil l further increase disposal costs. It is also

‘onta rio, Canada, ha s a man ifest system in place and would 1 ilw

the U nited Sta tes to establish a manifest system of some sort to facili-

tate estimating hct te r the amounts of medical wastes entering Can-

ada from the United States, in order to better plan for the manage-

ment of it. Some States (e. g. , Massachusetts, New York, Missouri,

and New J ersey) a r c establish ing or ha ve established manifest s~rs-

tems of some sort for medical wastes.

2 7



28

likely to increase h ealth risks to th e public, giventhe greater potential for accidental exposure due

to spills and possible illegal dum ping or disposal.T h e s e c o n c e r n s p r o v id e s u p p o r t f o r p r o p o s a ls

t h a t r e q u i r e m a n i f e st o r r e c o r d k e e p i n g sy s t e m s

t o t r a c k t h e m o v em e n t o f t h e s e w a s t e s . The Sen-

at e passed legislation (S. 2680) in August 1988 th at

will require EPA to establish a model tracking sys-tem in New York, New Jersey, and Connecticutfor medical wastes. Similar legislation is pen ding

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

P ol i cy I ssu es f or F edera l A c t i on

To best address issues associated with these

trends, at least two types of policy activities are rele-vant: 1) further development and enforcement of standard operating procedures (SOPS) by hospitals

and other medical waste generat ors for t he ha n-dling, storage, treatment, and disposal of these

wastes; an d 2) fur th er clarification and coordina -

tion of regulatory programs at the local, State, andFederal levels of government. In particular, the pos-

sibility of further Federal involvement warrants dis-

cussion, given the increased public concern over

the management of medical wastes, the increasedlevel of local and State regulatory activity (whichhas led to nationwide variation in the treatment of

these wastes), the interstate transportation of med-ical wast es, and t he curr ent a bsence of a compre-hensive medical waste policy at the national level.

The Fed era l Governm ent could usefu l ly speci fy

i t s po l icy (i e s ) r ega rd ing m ed ica l w as t e s i n a

num ber of area s: 1) designat ion of a lead au thor -

i t y (p r esuma bly EPA) to c l a r i fy the de fin i t ion ,

c las si fi ca t ion , and r egu la t ion o f the se wa s tes ; 2 )

the es tab l i shment of emiss ion s tandards and ash

regula t ions for medical waste inc inera tors , au to-

c lav ing / l andf i l l ing per formance s t andards , and

poss i b ly ope ra t o r t r a i n i ng gu i de l i ne s /r egu l a -

t i ons ; 3 ) ha nd l ing , s t o rage an d t r an spo r t a t i on

guide l ines / r egu la t ions to ensure worker s a fe ty

an d poss ib l e e s t ab l i shm ent o f som e so r t o f a

manifes t system; and 4) research and data needs

on med ical waste pr act ices . Some of these i ssues

c o u ld b e a d d r e s s ed u n d e r R C R A’s c u r r e n t a u -

thor i ty or could be c lar i fied as par t o f the RCRA

r e - au t ho r i za t i on p roces s .2

O t h e r r e le v a n t l a w s

ar e OSHA, th e Clean Ai r Act , an d poss ib ly th e

T ox ic S ub s t an ces C on t r o l Ac t .

A n u m b e r o f im p o r t a n t , r e l a t e d i s su e s n o t e d

t h r o u g h o u t t h i s p a p e r r e -s u r f a c e a s t h e i m p l i c a t io n s

of these ar eas for possib le fur ther pol icy develop-

men t a r e d i s cus sed . The impl ica t ions o f th r ee o f t h e s e a r e a s , t h e d e f i n i t i o n / c l a s s i f i c a t i o n o f m e d i c a l

wa s tes , the i s sue o f smal l quan t i ty genera to r s o f

m e d i c a l w a s t e s , a n d r e s e a r c h a n d d a t a n e e d s a s s o -

c i a t e d w i t h m e d i c a l w a s t e m a n a g e m e n t a r e d i s-

cussed briefly to indicat e th e ra nge of regulat oryissues the Federal Government will need to address

if it revises or expands its role in medical waste

management .

The definition of medical wastes under RCRAis of critical importance to determining the type of

regulatory effort EPA is likely to undertake. Itsclarification is also likely to facilitate State actions

and commercial development of medical wasteincineration. Another important dimension of themedical 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. Furth er research into the nat ure of the risks (both occupational and environmental)associated with medical wastes, research on newtreatment technologies, and performance data forexisting facilities is desira ble in order to developmore informed and effective policies.

Defin ing/Class i fy ing Medica l Wast es

I f i n f e c t i o u s w a s t e s a r e c l a s s i f i e d a n d r e g u l a t e d

as hazar dous under RCRA, a compreh ensive man -

a g e m e n t p r o g r a m i s l i k e l y f o r i n f e c t i o u s wastes. For

example, regulating infectious wastes as hazardouswastes under RCRA could address transportation

issues associated with infectious wast e ma nagement .

This would involve: 1) recordkeeping concerningthe waste transported, its source and delivery

points; 2) transportation of the waste only if prop-

erly labeled; 3) compliance with th e ma nifest sys-tem (Section 3002); an d 4) tra nsport at ion only to

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

under other statutory authority, such as OSHA. The focus here ison 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, wastetreatment, storage, and disposal facilities would besubject to hazardous waste standards and permit-ting procedures.

4

As the Council for State Governments (CSG) hasnoted, existing State infectious waste programs do

not tend to include three requirements usually asso-ciated with hazardous waste laws. These are re-

quirements for contingency plans a nd spill man -agement, closures, and finan cial assuran ces (4).

As noted above, in RCRA, the st at ut ory defini-

tion of hazardous waste includes ‘ ‘infectious’ asa defining characteristics EPA interprets RCRAas providing it with discretionary authority to clas-

sify infectious wastes as either hazardous wastes or

solid wastes.bEPA, 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 th at infectious waste r egulationswould be published separately. As the CSG notes,

. . . [e]ight years an d two reau thorizat ions of RCRAlater, st i l l no Federal regulations have been promul-gated (4).

Instea d, in 1986, the EP A issued its Guide for

I n fec t ious Wa s te Mana gem en t stat ing that

. . . [w]hile the Agency has evaluated managementtechniques for infectious waste, considerable evi-dence that these wastes cause harm to humanhealth a nd t he environment is needed to support

Federal rulemaking (emphasis added; 81).

RCRA (Section 1004), however, states that the

ter m ‘‘ha zard ous wast e’ refers to a wa ste with in-

fectious char acterist ics which may

. . . pose a substant ial present or potent ial hazardto human heal th or the environment . . . (empha-sis added).

’42 U. S.C. 6924.442 U. S.C. 6924; 6925.5

42 U.S. C. 6903(5).64 2 U.S. C. 6903(5); 6921. The haza r dou s characteristics, of wh ich

infectious is one, listed in 6903 are to be considered when t he ,4d-ministrat or of EPA identifies or lists hazardous wast es as pcr 6921.

EPA, however, in their regulator y interpretation, left the infectious

characteristic out of the defin it ion of ‘‘hazardous waste’ (40 C F R

240. IOl(m)).

Recently, EPA has increased its attention to in-fectious and medical waste issues. In early 1988,

EPA assigned for the first time a full-time staff per-

son to handle infectious waste issues. In June, the

Agency issued a request for comment on infectiouswaste issues in the Federa l Reg is ter . Most recently

the Agency ha s formed a t ask force to addr ess in-fectious waste issues. Publicly, the Agency has notruled out the possibility that ultimately it may is-sue regulations, although at present its efforts seem

to be on developing an education program.

As noted above, infectious wa stes a re u nlike other

types of hazardous wastes that can be consistentlyidentified by a test. Detection of infectious microbesin lan dfill leacha te is not h ighly likely given th at

they are generally less persistent in the environment

tha n toxic substa nces such as heavy meta ls, oils,

solvents, etc. Exposure to sunlight or dry air can

render infectious wastes non-infectious. It is alsotrue, however, that infectious microbes in medi-

cal wastes could mu ltiply and are potent ially con-

tagious under certa in conditions. In this context,

developing a separate statutory category for infec-tious and medical wastes is seen by some observers

as desirable. Applicable hazardous waste provisionsfrom RCRA Subtitle C could be adopted and ap-

propriate adjustments made given the particular na-

tur e of the medical wastestr eam.

It is n ot en tirely clear how EPA may u ltimatel y

define, classify, and regulate infectious wastes (orif it will). As noted above, EPA’s June 2, 1988,Federa l Reg is ter request for comment on infectiouswastes issues indicates the initiation of some infor-

mation gathering action on this issue. EPA’s posi-

t ion in the summer of 1988 was that an educationprogram, but not regulation, was justified. Later

in 1988, after several congressional hearings, EPAannounced that it would consider the need for Fed-eral regulation and established a task force on med-

ical waste issues.

Meanwhile, Congress, as part of the RCRA re-

authorization process, will address the issue of in-fectious 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 Transpor-

tation, Tourism. and Hazardous Materials held one hearing October

(continued on next page)



30

of the two bills with respect to medical waste man-agement. For example, it would require EPA to

issue regulations for all aspects of infectious waste

management including generation, transportation,treat ment, st orage, and disposal.

H.R. 3515 d i s t ingu i shes be tw een med ica l and

infec t ious w as tes . In fec t ious wa s tes would on lybe c lass i f ied as hazardous wastes under th is b i l l

i f t h e y w e r e m i x ed w i t h h a z a r d o u s w a s t e s a l -

r e a d y r e g u l a t e d u n d e r S u b t i t l e C . I n S e p t e m b e r

1988, a subs t i tute for H.R. 3515 added a provi-

s ion to es tab l i sh a demonst r a t ion t r acking system

for medical wa ste in New York , New J ersey, Con-

necticu t , and t he Gr eat La kes Sta tes. * As of Sep-

tember 21, 1988, the House Ener gy 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 hear ing on .August 9, 1988, on medical waste issues.8

The Senate passed legislation (S. 2680) which would establish amodel tracking s}!stem for New York State, New Jersey, and Con-

necticut. 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 wastemanagement issues have been introduced. As in-

dicat ed in ta ble 9, the proposed pieces of legisla-

tion address a number of aspects of medical waste

management, beyond the definition and classifica-tion issues. Some significant action on several of th e bills appear s likely before the curr ent session

of Congress e n d s .g

R egu l a t i ng S m a l l v. L a rge G ene r a t o r s

of Medica l Wastes

Whether incineration emission standards shouldbe set at the Federal level and on what basis (tech-

‘For examp le. a bill (H. R. 5231 ) to amend the Marine Protection,

Research and Sanctuaries Act (Public Law 92-532; MPRSA, com-

monly referred to as the Ocean Dumping Act) of 1972 is expected

to reach th e floor of the House before th e end of the curr ent session.

The bill would increase criminal penalties for illegal ocean dumpingof medical waste and provide recovery of damages associated with ille-

gal dumping. The Senate included similar provisions in the amend-

ments 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 anotherState creating a public nuisance through improper management of medical wastes

Requires that within 12 months after completing a study of infectious and pathologicwaste, EPA must determine whether to regulate these wastes as hazardous wastesunder Subtitle C of RCRA

Amends MPRSA (Public Law 92-532). Bans the dumping of medical wastes in ocean andnavigable waters

Amends RCRA (Public Law 94-580) to require EPA to regulate the management of infec-tious and medical wastes; provisions include definition of waste types by EPA, and

establishment of a model manifest system in New York, New Jersey, Connecticut, andthe Great Lake States

Requires vessels to manifest the transport of municipal or other nonhazardous wastesto ensure they are not illegally disposed of at sea

Amends RCRA to regulate medical wastes by requiring EPA to establish a model track-ing system for New Jersey and New York

Amends U. S. C., Title 18, to provide penalties for illegal ocean dumping of medical wastesAmends MPRSA to increase criminal penalties for illegal ocean dumping of medical

wastes and provide for recovery of damages associated with illegal dumpingPurpose is to protect the Great Lakes from the improper disposal of medical wastesEstablishes a pilot program for the tracking of medical wastes in States bordering the

Great LakesA resolution relating to medical wastes improperly disposed of in the Great LakesRequires vessels to manifest the transport of municipal or other nonhazardous wastes

to ensure they are not illegally disposed of at seaAmends RCRA to establish a pilot program to track medical wastes in New York and

New Jersey

Amends RCRA to require EPA to regulate medical wastesAmends 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. Similarbills (H.R. 3515, H.R. 5119, H.R. 3478, H.R. 5231, respectively) are pending in the House.



32

gens) , ash content analysis, etc.) do not exist at this

t ime.

As Ode Keil, Joint Commission on Accredita-

tion of Healthcare Organizations, noted at theOTA Workshop on Medical Waste Management,held J uly 19, 1988, “We have a problem, but we

do not ha ve a scientific ana lysis of th e problem tosupport developmen t of a r at iona l system. I t a p -

pear s i t would be h igh ly p ruden t fo r Congres s

and Federa l agencies to address the inadequacy

of data and research , and therefore informat ion ,

o n m e d i c a l w a s t e s a n d t h e i r m a n a g e m e n t . T h i s

is e s s en t i a l fo r d e t e r m i n i n g t h e n e e d f or a n d

n a t u r e o f a n y r e g u l a t or y p r o g r a m f or m e d i ca l

wastes .

A n u m b e r o f p o s s ib l e a r e a s f o r fu r t h e r r e s e a r c h

a n d i n fo r m a t i o n g a t h e r i n g e x i s t. Se v e r a l k e y a r e a s

i n c l u d e :

1.

2.

3.

4.

5.

developing the basis for a consistent, concretedefinition of medical wastes, which all rele-

vant Federal agencies issue jointly or at least

adopt;the n atu re an d extent of occupational risk, in-cluding risks not only to healthcare workers,but housekeeping, maintenance and other

relevant workers as well;

use and comparison of different incinerationprocesses a nd other technologies, including

emission r ates an d health risk assessments of these disposal options;examination of the use of sewers for medical

waste disposal (e. g., the survival of viruses insewer dischar ges; problems as sociated with

combined sewer overflows, such as beach

washups of medical wastes; etc.);

identification of potential waste reduction op-

tions for medical facilities; and

6 . compar i sons of Sta te r egu la to ry p r ogram s ,

s p e c i f i c a l l y t o h i g h l i g h t e x p e r i e n c e s r e l e v a n t

to the d evelopment of possib le Feder a l pro-

gram s ( e . g ., model p r ogram s fo r managing

medical wastes from small generators; mani-fest systems, etc.).

C o n c l u d i n g R e m a r k s

This cha pter h ighlights t he types of regulat ory

issues t ha t could be clarified by Congress a nd/or

the E PA and other F ederal agencies when exam-

ining the adequacy of current medical waste man-agement policies. One critical need that is readilyapparent and rarely disputed with respect to med-ical waste management is the need for more infor-ma tion on th e risks posed by these wastes a nd on

their actual m ana gement, an d for m ore research

of alternative treatment technologies and manage-ment techniques. N o n e t h e l e s s, t h e n e e d f o r r e -

search should no t be t aken as a sugges t ion fo r

pos tpon ing cons idera t ion o f adopt ing a compre-

h e n s i v e r e g u la t o r y p r o g r a m t o a d d r e s s m e d ic a l

w a s t e m a n a g e m e n t . I n f a c t , r e s e a r c h e f fo r t s

could be a pa r t o f a r egu la to ry p r ogram , i f i t i s

p r o m u l g a t e d i n p h a s e s.

The mos t coheren t Feder a l po li cy for m edica l

w a s t e m a n a g e m e n t i s l i k e l y t o r e s u l t o n l y i f t h e v a -

riet y of issues (e. g., the definit ion, classificat ion,

n a t u r e o f r i s k s , t y p e s o f a v a i l a b l e d i s p o s a l o p t i o n s ,

a n d t h e i m p l ic a t i o n s o f r e g u l a t o r y a c t i o n ) d i sc u s s e d

i n t h i s p a p e r are c o m p r e h e n s i v e l y addressed. At a

minimum, this prel iminary assessment of the sta-tus of medical waste management practices in theUnited States today indicates that to adequately ad-

dress th e pu blic’s growing concern over the ma n-

agement of medical wastes, policy makers will need

to address these issues as expediently as possible.



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