Issues in Medical Waste Management

October 1988

NTIS order #PB89-136410

Recommended Citation:U.S. Congress, Office of Technology Assessment, Issues in Medical Waste Management—Background Paper, OTA-BP-O-49 (Washington, DC: U.S. Government Printing Office,October 1988).

Library of Congress Catalog Card Number 88-600595

For sale by the Superintendent of DocumentsU.S. Government Printing Office, Washington, DC 20402-9325

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

Foreword

During the summer just passed, we witnessed a rash of incidents in which medicalwastes washed ashore—from Maine to the Gulf of Mexico, along the Great Lakes, andelsewhere 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 management in general has become a common headline topic. We hear dailyabout declining landfill capacity, problems in siting new incinerators, and efforts to in-crease recycling. OTA’s ongoing assessment of municipal solid waste management is ad-dressing these issues.

As part of the assessment, OTA also examined the status of medical waste manage-ment in the Nation. OTA held a one-day workshop on July 19, 1988, with hospital, regu-latory, and environmental experts to review the initial draft of this background paper andto discuss other areas of interest. The conclusions of those discussions have been incorpo-rated in this paper.

The paper examines the adequacy of current medical waste disposal practices andthe potential for human health impacts to occur as a result of such practices. It also 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, thepaper considers the possible need for further Federal involvement in regulating the han-dling, treatment, storage, and disposal of medical wastes.

OTA is grateful for the input from the workshop participants and other reviewers.The preparation of this paper would have been much more difficult without such support.As with all OTA studies, the content of this paper is the sole responsibility of OTA.

John BazinAnheuser-Busch Cos., Inc.

Municipal Solid Waste Advisory Panel

Joseph Sax, ChairSchool of Law, University of California

Gordon BoydSchillinger, Salerni, and Boyd

Paul ConnettSaint Lawrence University

Randall CurleeOak Ridge National Laboratory

Dana DuxburyCenter for Environmental ManagementTufts University

Rodney EdwardsAmerican Paper Institute

Jeffrey HahnOgden Projects, Inc.

Michael HerzBenjamin Cordozo School of Law

Walter JohnsonSt. Paul Metropolitan Waste Control

Commission

Richard KattarNew England CRInc.

Raymond NaarGeneral Electric Plastics

Lorie ParkerSeattle Solid Waste Utility

Glenrose PittPrivate Consultant

Barry ScherGiant Food, Inc.

Neil SeldmanInstitute for Local Self-Reliance

Peter VardyWaste 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.

iv

OTA Municipal Solid Waste Management Project Staff

John Andelin, Assistant Director, OTAScience, Information, and Natural Resources Division

Robert Niblock, Oceans and Environment Program Manager

Kathryn Wagner, Principal Author and Analyst

Howard Levenson, Project Director

Eric Washburn, OTA Contractor

Administrative Staff

Kathleen Beil Sally Van Aller

Medical Waste Workshop Participants

Frank CrossCross/Tessitore & Associates

Lawrence DoucetDoucet & Mainka

Allen DusaultMassachusetts Department of Environmental

Quality and Engineering

Dieter GroschelUniversity of Virginia Medical Center

Susan HarwoodOccupational Safety and Health Administration

Christopher Haynes/Eugene MainerDecom Medical Waste Systems

John JoynerConsumat Systems

Stephen KaufmanMassachusetts General Hospital

Ode KeilJoint Commission on Accreditation of Health

Care Organizations

C.C. LeeU.S. Environmental Protection Agency

Edward LondresNew Jersey Department of Environmental

Protection

John ManuelOntario Ministry of the Environment

John McVicarCenters for Disease Control

Ray MorrisonU.S. Environmental Protection Agency

Robert PetersBiomedical Waste Treatment Council

William RutalaUniversity of North Carolina School of

Medicine

Robert SheehanMedi-Gen

Robert SpurginBrowning-Ferris

Barbara Stank

Industries

New England Deaconist Hospital

Jacqueline WarrenNatural Resources Defense Council

Howard WensleyMassachusetts Department of Public Health

Denise ZabinskiU.S. Environmental Protection Agency

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.

vi

Additional Acknowledgments

Richard DenisenEnvironmental Defense Fund

Rick ErdheimSenator Frank Lautenberg’s OfficeUnited States Senate

Mary FichtAmerican Hospital Association

Rebecca GoldbergEnvironmental Defense Fund

Reuben GuttmanService Employees International Union

Shari HaleyAmerican Hospital Association

Judy KowalskiOffice of Technology Assessment

George LangeOgden-Martin Systems, Inc.

Jack Lauber‘New York State Department of Environmental

Rosemary MonahanU.S. Environmental

Region 1

Sue MorelandThe Markland

Dave Ozonoff

Group

Protection Agency—

Boston University

Robert PercivalUniversity of Maryland Law School

Harvey RogersNational Institutes

James Salvaggio

of Health

Pennsylvania ‘Department of EnvironmentalResources

Nancy SeidmanNortheast States for

Management

Thomas SuperU.S. Environmental

Coordinated Air Use

Protection Agency

Conservation “ Gary Yee

Thomas LavelleUniversity of Maryland

California Air Resources Board

vii

Contents

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

Chapter 1: Defining and CharacterizingMedical Wastes . . . . . . . . . . . . . . . . . .

Amounts and Composition . . . . . . . . . . . . . . .Designating Infectious Waste . . . . . . . . . . . . .Definitional Differences-EPA v. CDC . . . .Classifying Infectious Waste as Hazardous

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

Chapter 2: Handling Medical Wastes andPotential Occupational Risks . . . . . . .

Handling: Packaging, Storage, andTransportation . . . . . . . . . . . . . . . . . . . . .

Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . .Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Transportation . . . . . . . . . . . . . . . . . . . . . . .

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

Chapter 3: Current Technologies,Treatment, and Disposal Issues.. . . .

Incineration. . . . . . . . . . . . . . . . . . . . . . . . . . . .Controlled Air Incinerators . . . . . . . . . . . . .Other Types of Incinerators . . . . . . . . . . . .

Air Emissions and Ash . . . . . . . . . . . . . . . . . .Concentrations of Emission

Constituents . . . . . . . . . . . . . . . . . . . . . . .Possible Reasons for Higher Emission

Levels of Dioxins/Furans and HCl . . . .Concentrations of Constituents

in Ash . . . . . . . . . . . . . . . . . . . . . . . . . . . .Future Trends in Medical Waste

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

Importance of Proper Operation . . . . . .Health and Environmental Risks From

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

Chapter 4: Regulatory Authority andCurrent Practices . . . . . . . . . . . . . . . . .

Federal Authority . . . . . . . . . . . . . . . . . . . . . . .State Regulatory Activities . . . . . . . . . . . . . . .

1

3344

68

9

99

101011

1515161617

17

18

19

1920

21

22

232323

Chapter 5: Managing Medical Wastes—Institutional and Policy Issues . . . . . 27

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

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

Medical Wastes . . . . . . . . . . . . . . . . . . . . 30Research and Data Needs . . . . . . . . . . . . . . 31

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

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

FiguresFigure Page1.2.3.

4.

Biological Hazard Symbol . . . . . . . . . . . . . 10Typical Controlled Air Incinerator . . . . . . 15Stages of State Changes in MedicalWaste Management Programs—As ofMarch 1988 . . . . . . . . . . . . . . . . . . . . . . . . . 24Type of Medical Waste GeneratorsRegulated by States—As ofMarch 1988 . . . . . . . . . . . . . . . . . . . . . . . . . 24

TablesTable Page1.

2.

3.

4.

5.

6.

7.

8.

9.

CDC/EPA Designations of Solid Wastesand Recommended Treatment/DisposalMethods . . . . . . . . . . . . . . . . . . . . . . . . . . . .Joint Advisory Notice on the ProtectionAgainst Occupational Exposure toHepatitis B Virus (HBV) and HumanImmunodeficiency Virus (HIV)—Training Program Recommendations. . . .Compliance Rates With Joint AdvisoryNotice—70-Hospital Sample . . . . . . . . . . .Compliance Rates With Joint AdvisoryNotice—30-Department Sample . . . . . . . .Concentrations of Constituents inEmissions From Hospital IncineratorsWithout Particulate Control Devices . . . .Dioxin and Furan EmissionConcentrations . . . . . . . . . . . . . . . . . . . . . . .Concentrations of Dioxins and Furans inFly Ash From Municipal and HospitalIncinerators . . . . . . . . . . . . . . . . . . . . . . . . .Status of Selected State Infectious WasteIncinerator Regulations . . . . . . . . . . . . . . .Legislation Pending in Congress onMedical Wastes . . . . . . . . . . . . . . . . . . . . . .

5

12

13

13

17

17

19

26

30

. . .Vlt{

Introduction

● Without advance notice, on March 24, 1986, theGSX waste handling company informed eightBoston, Massachusetts, hospitals that it wouldno longer pick up any of their hospital wastes be-cause the area landfills would no longer acceptthem. For two of these hospitals, GSX did noteven handle their ‘‘red bag” waste (44).

● Approximately 1,400 bags of medical waste werediscovered at a warehouse by the New York CityFire Department when it responded to a fire No-vember 24, 1986. Subsequently, the EnergyCombustion Corporation and its president wereindicted by the Brooklyn District Attorney’s Of-fice for allegedly covering up this illegal dump-ing. The company had submitted documents tothe New York State Department of Environ-mental Conservation stating that the wastes hadbeen incinerated (21).

● Twelve children in Indianapolis, Indiana, playedwith vials of blood, two of which were infectedwith AIDS, that they found in a trash bin out-side an HMO medical office in June 1987. It waslegal for the health clinic to dispose of the wastesin the open dumpster (27).

● Five employees of the Los Angeles County-USCMedical Center filed a $50 million lawsuit againstthe county after a pipe in the basement of thefacility burst on July 9, 1987, and dumped pos-sibly contaminated blood and fluids on workers.The California Occupational Safety and HealthAdministration has received other complaintsconcerning the adequacy of protection providedfor employees handling medical wastes at theCenter (56).

● A garbage slick nearly a mile long along the 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 July6-7, 1988, 10 miles of Long Island beaches closedwhen medical wastes washed ashore. Through-out the summer of 1988, beaches from Maineto the Gulf of Mexico, along the Great Lakes,and elsewhere in the Nation experienced washupsof medical wastes.

Recent incidents such as these have drawn at-tention to issues surrounding the handling, treat-ment, and disposal of medical wastes. Medicalwastes are all the types of wastes produced by hos-pitals, clinics, doctor offices, and other medical andresearch facilities. 1 These wastes include infectiousor ‘‘red bag’ hospital wastes, hazardous (includ-ing radioactive) wastes, and any other generalwastes. 2 The Environmental Protection Agencyreports 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 solidwaste stream.3 Currently, most generators of med-ical waste designate between 10 to 15 percent ofit as infectious.

Most of the non-infectious medical waste is land-filled, while most infectious waste from hospitalsis incinerated. For infectious waste management,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 believedto result in minimal health and environmental risks.Yet, incidents of careless or illegal disposal may posehealth risks and aesthetic problems and certainlyhelp create public apprehension over current med-ical waste management 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 hospitalwaste disposal; however, other sources of biomedical wastes may beequally 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 theimportance of smaller generators of biomedical wastes is recognized.

2The terms medical wastes, hospital wastes, infectious wastes, andbiomedical wastes often are used interchangeably. An attempt is madehere to use these terms more precisely, i.e., the term medical wastesrefers 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 refers to that portion of a medical wastestream whichhas the potential to transmit disease; and biomedical wastes are thesubset of medical waste which is biological in origin (e. g., blood, bodyfluids, tissue, etc.).

3Estimates range from 2.1 to 4.8 million tons per year. As will bediscussed below, these figures do not include medical wastes fromclinics, laboratories, and other sources. It is likely, therefore, that med-ical wastes comprise a somewhat higher—although still relativelysmall—percentage of the total municipal solid wastestream.

1

2

Just as the types of incidents listed above raisepublic concern, considerations of liability andworker safety lead some operators of municipal solidwaste landfills and incinerators to ban or refuse totake any medical wastes. A number of States havebanned all unsterilized infectious waste from mu-nicipal landfills.4 In addition, the State of Penn-sylvania has imposed a one-year moratorium onthe construction of any commercial medical wasteincinerators. 5 In other areas, localities as well haveconsidered bans or moratoriums on hospital wasteincinerators. 6 In this general context, many hos-pitals, medical facilities, and other institutionsacross the country face increasingly difficult wastemanagement problems.

The situation is complicated by an uncertain andincongruous regulatory climate. Inconsistencies ex-ist in the Federal guidelines for States regardingdefinitions and management options suggested formedical/infectious waste. 7 Currently, no Federalregulations exist that comprehensively address thehandling, transportation, treatment, and disposalof medical waste. This would change either if theissue of medical wastes remains part of the currentreauthorization effort for the Resource Conserva-tion and Recovery Act (RCRA)8 or if any of a num-

41n 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’swaste three times in a 6-month period due to alleged contaminationproblems. The agreement reached between the town and the hospitalrequires the hospital to pay $15 per compacted load for inspectionof the wastes and reserves the town’s right to ban the hospital’s wasteif there are future violations (24).

5The Pennsylvania Department of Environmental Conservation hadlifted a moratorium on permitting hospital incinerators in February1988. In July the State legislature imposed a one-year moratoriumon permitting new commercial hospital incinerators. The currentmoratorium will be lifted when the Department completes a compre-hensive plan for medical wastes which is due July 13, 1989. OtherStates (e. g., Delaware) have or are considering similar moratoriums.

‘Although the exact number of such landfill refusals or bans arenot known, discussions with a number of individuals across the countryinvolved 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 Control, and other Federal agencies have issueddifferent guidelines for infectious and medical waste management.

’42 U.S. C. 6901 et seq.

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

Meanwhile, the States have largely been left ontheir own to devise medical waste management pro-grams. This means important variation frequentlyexists between States, as well as between local re-quirements and those of a State. For example, 26States classify infectious wastes as special wastes,13 still classify them as hazardous wastes, and 12classify them as non-hazardous wastes (4).9 Thirty-nine States have some type of regulations concern-ing infectious waste, at least 5 more States expectto regulate these wastes within the year; and at least25 States expect changes to their existing regula-tions by next year (4).10

The purpose of this paper is to assess the ade-quacy of current medical waste disposal practices;the potential risks from such practices; the need foradditional research and databases; and the possi-ble need for Federal requirements for the handling,treatment, storage, and disposal of medical wastesand future cost and capacity factors as new regu-lations are updated. The paper is divided into fivechapters:

1.2.

3.

4.

5.

Defining and Characterizing Medical Wastes;Handling Medical Wastes and Potential Oc-cupational Risks;Current Technologies, Treatment, and Dis-posal Issues;Regulatory Authority and Current Practices;andManaging Medical Wastes—Institutional andPolicy - Issues. 11

‘Note that the survey includes the District of Columbia; for thisreason, figures add up to 51. See below for further discussion of thisaspect of the definitional issue. Under RCRA, there are two generalcategories of wastes, each of which is subject to different regulatoryrequirements. These are hazardous wastes regulated according to Sub-title C, and solid (non-hazardous) wastes regulated according to SubtitleD. In addition, there is a third, non-statutory category of “specialwastes’ for those wastes that appear to be in a gray area between thesetwo categories and for which special regulatory programs will be es-tablished.

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

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

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

Chapter 1

Defining and Characterizing Medical Wastes

Medical wastes include all infectious waste, haz-ardous (including low-level radioactive) wastes, andany other wastes that are generated from all typesof health care institutions, including hospitals,clinics, doctor (including dental and veterinary)offices, and medical laboratories (42). 1 The mainfocus of concern has been on the portion of medi-cal wastes that are defined as infectious, and howthey are classified (e. g., as a solid, hazardous, or‘‘special’ waste) and regulated. These wastes arealso the primary focus of this paper. The mainsources of these wastes receiving attention are hos-pitals and other large facilities. Much of the infor-mation reported here will focus on these largergenerators, but the proper disposal of other typesof medical wastes and of wastes from all types ofsources is also important.2

Amounts and Composition

The actual amount of medical waste generatedin the United States today (or in the past) is notknown; even estimating this figure is problematic,as the number of different reported estimates in-dicate. In 1987, the Environmental ProtectionAgency (EPA) reported the total generation rateof hospital wastes at 5,900 tons/day (83). This fig-ure is based on the number of hospital beds esti-mated to exist (in 1985, the estimate was 1.3 mil-lion with a 69 percent occupancy rate) and a perbed per day generation rate of 13 pounds.

The per bed per day generation figure itself, how-ever, is difficult to pinpoint. Recent independentestimates of hospital waste generation range be-tween 16 to 23 pounds per bed per day (61). The

1 See also ref. 39. It should be noted that extensive treatment of thecurrent management of radioactive and other identified hazardouswastes in the medical wastestream is beyond the scope of this paper.It is recognized, however, that proper management of such wastesis important and a challenge for many medical waste generators, giventhe usually small quantities and high cost of adequate disposal of thesewastes.

2The amount of medical wastes from such non-hospital sources isnot 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 areas), but are beyond thescope of this paper.

range reported by hospitals in various surveys ofhospital waste generation is 8 to 45 pounds per bedper day.3 EPA expected the 13 pound per bed perday rate to remain constant, as it believes it didfor the period from 1975 to 1985 (83). In 1980,however, one survey of North Carolina hospitalsreported an average of approximately 10 poundsper bed per day of wastes. If this lower figure wastypical in years past, then it would indicate that theamount of per bed generation of hospital wastesmay 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 increaseddramatically in recent years, although data are 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, foodwaste, non-infectious patient waste) and infectiouswaste (e. g., pathological wastes, human blood andblood 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 radioactive wastes.4

The composition of the medical wastestream isof concern given its effects on the incineration proc-ess. If incineration occurs on-site, it is likely thatat least some of the hospital or facility’s wastes aremixed (if wastes are shipped off-site, given thegreater expense of treating infectious waste this

3Different methodologies to calculate per bed generation figures,may explain the wide variation in estimates. Also, of course, the ac-tual hospital generation figures can vary greatly on a daily basis. Somesurgical procedures generate much more waste (e. g., a heart trans-plant) than other routine operations (83). In addition, difficulties insegregating infectious and non-infectious wastes may lead to moremixed 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 wastesmay qualify for a small quantity generator exemption from RCRArequirements (e. g., this would include most hospitals under 200 beds).Nonetheless, if some of these wastes are incinerated on-site they couldbe a source of air emission concern (83).

3

4

way, it is likely that only infectious waste is sentfor incineration).5 Particular components of themedical wastestream of special concern when thiswaste is incinerated include the relatively 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 isabout three times the plastic portion of the munici-pal solid wastestream.6

In any case, reported generation figures do notinclude non-hospital medical wastes. In 1985, ap-proximately 6,870 hospitals and an estimated 1,000diagnostic and research laboratories existed, inaddition to thousands of doctor offices and nurs-ing homes (5). 7 Although specific estimates are notavailable on the volume or composition of medi-cal wastes from these sources, it is reasonable toexpect that the total medical waste generation (bothhospital and non-hospital) figure is somewhathigher.

Designating Infectious Waste

Determining which portion of medical waste 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.

How infectious waste is defined can greatlyaffect the cost of waste management, and ulti-mately the choice of waste management disposaloptions for generators. For example, one 600-bedhospital found that it saved $250,000 annually bychanging its infectious waste designation from 13categories 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);8 and 0.30 to 1.00/1b. (although costs

may be higher in some areas) for commercial, off-site incineration (6, 10).

Most estimates are that 10 to 15 percent of allhospital wastes are infectious. The total range ofestimates, however, is from 3 to 90 percent of a hos-pital’s waste defined as infectious, depending onthe definitions and procedures followed (10,83).According to Lawrence Doucet, a consultant onhospital waste management, about 3 to 5 percentof a hospital’s total wastestream would be classi-fied as infectious waste according to previous inter-pretations of CDC guidelines for infectious wastes,while approximately 10 percent would be classifiedthat way according to the 1986 EPA guidelines(10).9

The recommendations issued by CDC in August1987, however, have apparently been interpretedby some hospitals as classifying virtually all patient-contact waste as infectious (77). This can amountto 70 to 90 percent of total hospital waste. The po-tential impact of such a trend on medical wastemanagement could be to both increase the costof disposal significantly and strain existing ca-pacity for managing infectious wastes. The CDChas issued a clarification of its definition, yet con-fusion at the generator level appears to remain overthe proper classification and management of med-ical wastes (78).

Definitional Differences—EPA v. CDC

William Rutala, University of North CarolinaSchool of Medicine (Director of the Statewide In-fection Control Program), has noted that no testsexist to objectively identify infectious wastes, un-like the case with chemical or radiological wastes(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.

bEstimates of the portion of plastics in hospital waste range as highas 30 percent.

‘See also ref. 10.qt should be noted that capit~ costs, depreciation, ad other tYPes

of costs may not be included in these figures.

91nteresting]y, a recently completed survey for the American HOS-pital Association reported that 80 percent of the hospitals are follow-ing CDC guidelines, while only 52 percent are complying with EPAguidelines (to be discussed further below) (61).

‘“See also ref. 70.

5

with the definition is the need to consider at leastfour 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 bodyfluids from “all patients be considered potentiallyinfected with HIV (human immunodeficiency vi-rus) and/or other blood-borne pathogens and [thathealth care workers] adhere rigorously to infection-control precautions’ (77). In June 1988, the CDCattempted to clarify several issues associated withapparent confusion over the application of their1987 recommendations. As part of this effort, theCDC now limits the application of universal pre-cautions to blood and other body fluids containingvisible blood, to semen and vaginal secretions, andto other specified fluids (78). The CDC also notes

that the recommendations are intended to protecthealthcare workers and do not address waste man-agement practices or the definition of infectiouswastes (78).

Both the CDC and EPA designate pathologicalwaste, blood and blood products, contaminatedsharps (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 treatments fordifferent components of infectious wastes identifiedby the CDC and EPA. (See table 1,) EPA has iden-tified several additional optional categories, whichinclude a category of isolation wastes, a categoryof contaminated animal carcasses, body parts, andbedding, and categories of surgery, autopsy andcontaminated laboratory wastes (81). The appar-ent inconsistencies are remedied in part by the factthat EPA refers to the CDC guidelines on isola-tion precautions (74) and to the joint CDC/NationalInstitutes of Health guidelines on animal carcasseswaste management and other guidelines on labora-tory wastes.ll

I l~though the CDC does not classify animzd carcasses as infectiouswastes, the CDC/NationaI Institutes of Health guidelines, ‘‘ Biosafetyin Microbiological and Biomedical Laboratories (75), ” recommendincineration of infected animal carcasses and decontamination (prefer-ably by autoclaving) before disposal for all wastes from animal roomsof certain designated biosafety levels.

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

CDC a EPADisposal/ Disposal/

Infectious treatment Infectious treatmentSource/type of solid waste waste method waste methodMicrobiological (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 — Optionalb If considered

IW, use S or ISurgery and autopsy wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional If considered

IW, use S or IDialysis unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . No — Optional If considered

IW, use S or IContaminated equipment . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . No — Optional If considered

IW, use S or IaAbbreviatjOnS: cDc—centerS for Djsease Control; EpA—Environmental protection Agency; l—incineration; s—steam sterilization; T1—thermal inactivation; C—chemicaldisinfection 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 states that the decision to handle these wastes as infectious should be made by a responsible, authorized Person or committee atthe individual facility.

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

6

The major apparent disagreement is over the des-ignation of communicable disease/isolation wastes.Although the CDC and EPA agree that there is noinconsistency in their designations of these wastes,confusion exists in the application of these guide-lines. This may indicate a need for further clarifi-cation of these guidelines by the two agencies. EPAconsiders communicable disease wastes as infec-tious. CDC recommends that communicable dis-ease waste be treated 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 recentinterpretations by hospitals and other generatorsof the CDC universal precaution guidelines, andthe concern over potential 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 those patientsin isolation would be included in the EPA’s infec-tious waste definition; interpretation of the CDCguideline, however, could include all patient con-tact wastes and wastes of EPA’s optional category(e.g., surgical and autopsy wastes, dialysis waste,contact laboratory wastes) in the infectious wastedefinition (70). The CDC disputes this interpreta-tion of its recommendations (77,78). The CDC is-sued a statement in June 1988 that,

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

This attempt at clarification by CDC, however, inpart contributes to the confusion. It is not clear whythe CDC is suggesting that its universal precau-tions guidance applies only to worker precautionsand not waste handling procedures.

EPA agrees with CDC that its recommendationsare not in serious disagreement with EPA recom-mendations and that universal precautions aremeant 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 bdy fluids,and sharps from an isolation room should be handled as if potentiallyinfectious, but not afl wastes from this type of room. CDC furtherstates 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 and perhaps jointlyissued guidance on these definitional issues isdesirable.

Currently, based on the proceedings of the EPAmeeting of experts on infectious wastes held in No-vember 1987, there appears to be agreement that:

Not withstanding the risk perceptions and anxi-eties associated with the fear of contracting AIDS,those categories of infectious wastes that possessthe greatest potential to transmit disease are con-taminated sharps, human 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 to known disease association or risk ofaccidental injection, their ‘‘prudent’ handling andproper disposal are warranted (70). EPA did, how-ever, solicit comments regarding the basis on whichwastes should be defined as infectious and is cur-rently reviewing its definition of infectious wastes. 13

Classifying Infectious Waste asHazardous Waste

Additional confusion arises over the question ofwhether or not infectious wastes should be classi-fied and regulated as Subtitle C, RCRA hazard-ous wastes. In 1978, EPA did include regulationsfor infectious wastes in its proposed hazardous wasteregulations. The Agency never promulgated these,however, and has not classified any infectiouswastes as hazardous wastes—even though the lan-guage of RCRA includes “infectious” as a char-acteristic to be considered in determining whetheror not a waste is a hazardous waste. 14 The statu-

I s53 Feder~ Register, June 2, 1988. The EPA published a noticeof data availability and request for comments on infectious wastes is-sues. Comments were due August 1, 1988 and the Agency receivedover 100 responses. EPA is now in the process of responding to andsummarizing these comments as part of its ( msideration of possibleregulatory action for medical wastes (86).

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

U.S.C. 6903(5)), includes the following definition:(5) The term “hazardous waste” means a solid waste, or 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 humanhealth or the environment when improperly treated, stored, trans-ported, disposed of, or otherwise managed [emphasis added].

7

tory language can be interpreted as requiring thesewastes to be classified as hazardous and thus regu-lated under Subtitle C of RCRA.

EPA, based largely on its determination of a lackof evidence that infectious wastes ‘‘cause harm tohuman health and the environment” sufficient tojustify Federal rulemaking (under Subtitle C,RCRA), has instead issued a manual of recommen-dations for the management of infectious wastes(81). It should be noted, however, that the statu-tory language refers not only to whether a wastewill ‘‘cause harm, but also to whether it may“pose a substantial present or potential hazard. . . “ (emphases added; RCRA, Section 1004).

Even so, 12 years after the passage of RCRA and8 years after making the determination that insuffi-cient evidence existed to justify Federal regulation,EPA has not undertaken or encouraged researchto substantiate a lack of ‘‘a substantial present orpotential hazard to human health or the environ-m e n t when a waste with infectious characteris-tics is improperly managed (a criterion of RCRA,Section 1004(5) definition of hazardous waste). Al-ternatively, the Agency has not issued its assess-ment, based on existing epidemiologic information,of the degree of risk posed by infectious or othertypes of medical wastes.

To date, EPA’s actions have not been legallychallenged. Congress may clarify the conditions un-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 the process of addressing the need for addi-tional regulations to control infectious wastes. 15EPA did include a space for infectious waste on the“Notification of Hazardous Waste Activity” form,which is used by hazardous waste generators to ap-ply for EPA identification numbers, but no para-graph addressing infectious wastes actually existsin the regulations referenced on the form. 16

Interestingly, a manual published by the JointCommission for the Accreditation of Hospitals(JCAH)17 designates infectious wastes and sharps

154(I CFR 240.101. (See refs. 73,86. )IbEpA Form 8700-12, revised November 1985, referencing 40 CFR

261.34.17Recently, JCAH changed its name to the Joint Commission on

the Accreditation of Healthcare Organizations (JCAHO).

as hazardous wastes, along with chemical, chemo-therapeutic, and radioactive wastes. The manualoutlines methods for handling each type of waste,and the JCAH requires that a system to handle allsuch hazardous wastes exist and be in compliancewith Federal, State, and local regulations (34). 18In addition, the National Committee for ClinicalLaboratory Standards (NCCLS) in its proposedguideline 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). From a generator perspective,greater consistency on the classification of in-fectious and other medical wastes would helpeliminate some of the current confusion over theproper treatment of these wastes.

A policy debate continues over how best to clas-sify infectious wastes, and other medical wastes, aswell. Some observers, noting the likely increase incost as more wastes become designated as infec-tious, expect even more costly disposal if in addi-tion these wastes must be handled as hazardous.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 insteadon 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 does occur when public par-ticipation and other measures are included in thesite selection process). In addition, hospitals maycontinue to treat wastes on-site (if, for example, theyhave the space to upgrade or construct facilities).

Classifying infectious wastes as hazardous is seenas desirable by some in order to prosecute illegaldumping as a felony, to bring in force a manifestsystem for infectious wastes which would track theoff-site movement of these medical wastes (21,22),and in general to ensure greater comprehensivemanagement of infectious wastes. 19 These purposes

18AS Rut~a (60) points Out, since there are no Federal regulations,hospitals must comply with State and local regulations; if these donot exist, then hospitals should comply with either CDC or EPAguidelines.

lgNew York State recently passed legislation which both providesfor penalties of up to 4 years in prison and fines of up to $50,000 forillegal disposal of medical wastes (previously the penalties were up

8

could be accomplished without classifying infectiouswastes as hazardous wastes (some of these issueswill be discussed further below). Yet, proponentsfor regulating infectious wastes as a hazardous 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 anothersystem). 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, this issue could be clarified as part of thecurrent reauthorization effort in Congress.

Uncertainties for State Regulators

These definitional and classification problemshave created considerable uncertainties for State

to 15 days in jail and up to $2,500 in fines) and establishes a manifestsystem to track medical wastes. Several bills pending in Congress alsowould classify illegal dumping of medical wastes as a felony and specifypenalties. The Senate passed legislation to establish a model manifestprogram 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.

regulators. Approximately 10 States have defini-tions of infectious waste which include the four com-mon CDC and EPA infectious wastes in their defi-nitions (i. e., pathological wastes, microbiologicalwastes, blood and blood products, and contami-nated sharps). 21 As noted above, most States des-ignate infectious wastes as special wastes, and thetrend is for other States to do the same. 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. Sincethe EPA has not regulated infectious wastes as haz-ardous, the trend seems to be for the States not todo so, too.22 States apparently find the delisting ofa hazardous waste after it has been treated to bea particularly cumbersome and difficult aspect ofregulating infectious wastes as hazardous wastes (4).

2153 Federd Register, June z, 1988.zz~though some States and localities have moved beyond What-

ever a “baseline” Federal definition of infectious wastes might be,such a consistent definition might facilitate the development of otherFederal regulations of infectious wastes.

—

Chapter 2

Handling Medical Wastesand Potential Occupational Risks

The degree of risks posed by medical wastes isnot clear. Two main types of risks associated withmedical wastes can be distinguished: occupationaland environmental. Occupational exposure tohealth workers and waste handlers is often cited asthe primary type of health risk posed by medicalwastes. Yet, precise information on the types andfrequency of actual occupational injuries or illnessesdue to handling medical wastes is not readily avail-able. l Environmental risks can be posed directlyby illegal or careless management and disposalpractices or more indirectly through the emissionsand ash handling from medical waste incinerators.2

In this context, questions regarding the signifi-cance of all-large and small-generators of med-ical wastes become important. This section first de-scribes the general nature of handling (includinginitial handling, storage, and transportation) ofmedical wastes and the types of risks associated withit, and then discusses the potential magnitude ofthese risks. What is known about the possible risksassociated with incineration and other treatmentmethods for medical wastes will be discussed in sub-sequent chapters.

Handling: Packaging, Storage, andTransportation

Handling medical wastes—including initial han-dling, storage, and transportation-involves issuesof potential occupational risks and potential oper-ational problems. Improper handling of medicalwastes is closely linked to problems resulting frominadequately packaged and contained wastes as theymove about the hospital and then are transported

‘Studies do exist on needlestick injuries. For example, recent dataindicate that approximately 20 percent of all hospital needlestick in-juries are due to wastehandling. (See ref. 11; numerous other sur-veys and studies of needlestick injuries have been conducted, e.g.,refs. 45,68).

2Although not discussed extensively in this paper, accidental ex-posure through transportation mishaps is likely to be increasingly asource of concern. If more medical waste is shipped off-site in the fu-ture, the potential for accidental spills outside of the generating facil-ity will increase.

off-site for disposal. The integrity of packaging, par-ticularly of such items as sharps, is critical to en-suring the containment of wastes during their col-lection, storage, and transportation.

Packaging

Polyethylene bags are frequently used for con-taining bulk wastes (e. g., contaminated disposableand residual liquids); they may have to be doubled-bagged with polypropylene bags that are heat resis-tant if steam sterilization (see below) is used. Thesebags, however, must be opened or of such a natureas to allow steam to penetrate the waste. Color-coded bags are frequently used to aid in the segre-gation and identification of infectious wastes. Mostoften red or red-orange bags are used for infectiouswastes (hence the term ‘‘red bag’ waste). AnASTM Standard (#D 1709-75) for tensile strengthbased on a dart drop test and the mil gauge thick-ness of the plastic determine its resistance to tear-ing (62,70). Use of the biological hazard symbolon appropriate packaging is recommended by theEPA to assist in identifying medical wastes. (Seefigure 1.) In addition, EPA recommends that allof these packages close securely and maintain theirintegrity in storage and transportation (81).

In general, compaction or grinding of infectiouswastes is not recommended by EPA before treat-ment. Even though it can reduce the volume ofwaste needing storage, compaction is not encour-aged due to the possibility of packages being vio-lated and the potential for aerosolization of microor-ganisms. Commercially available grinding systemsthat first involve sterilization before shredding orcompaction may alleviate this latter concern (62).3

Sharps are of concern, not only because of theirinfectious potential, but also because of the directprick/stab type of injury they can cause. For sharps,puncture-proof containers are currently the pre-ferred handling package. EPA recommends these

3Yet, waste haulers note that proper handling of wastes is jeopardizedby any compaction that occurs at some point before disposal.

9

10

Figure 1 .–Biological Hazard Symbol

NOTE: Symbol is fluorescent orange or orange-red, and dimensions are 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.4 In the past, needles were re-capped, chopped,or disposed of by other practices that are no longercommon due to their potential for worker injuryand, in the case of chopping, for aerosolization ofmicroorganisms during the chopping procedure(62).

New technologies for containing needles andfacilitating their safe handling continue to emerge.For example, one company has announced a proc-ess which uses polymers to sterilize and encapsu-late sharps (and other infectious wastes) into a solidblock-like material. A number of companies havealso developed encapsulating systems and othersharp disposal processes (e. g., a shredder withchemical treatment of needles and other sharps)(10). These processes may potentially be cost-ef-fective disposal options for doctor offices and othersmall generators of sharps and other infectiouswastes, provided landfill operations would acceptthe encapsulated wastes.

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

Storage

Storage of the waste needs to be in areas whichare disinfected regularly and which are maintainedat appropriate temperatures (particularly if wastesare being stored prior to treatment) (62). EPA rec-ommends that storage time be minimized, storageareas be clearly identified with the biohazard sym-bol, packaging be sufficient to ensure exclusion ofrodents and vermin, and access to the storage areabe limited (81). The importance of the duration andtemperature of storing infectious wastes is noted,due to their association with increases in rates ofmicrobial growth and putrefaction.

The recommendation by EPA for storage 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 andtemperature because it finds there is ‘‘no unanim-ity of opinion’ on these matters. As the EPA Guidenotes, there is State variation in specified storagetimes and temperatures. State requirements oftenstipulate storage times of 7 days or less for infec-tious wastes that are unrefrigerated. Sometimeslonger periods are allowed for refrigerated wastes.

Transportation

EPA recommendations with respect to the trans-portation of infectious wastes briefly address themovement of wastes while on-site and in an evenmore limited way address the movement of wastesoff-site. The recommendations are largely limitedto prudent practices for movement of the wasteswithin a facility, such as placement of the wastesin rigid or semi-rigid and leak-proof containers, andavoidance of mechanical loading devices whichmight rupture packaged wastes (81). Broader is-sues, such as recordkeeping and tracking systemsfor infectious or medical wastes once they are takenoff-site, and the handling and storage of wastes attransfer stations, have not yet been addressed.

EPA does recommend that hazard symbols“should be in accordance with municipal, State andFederal regulations” (81). Yet, State and Federalagencies 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 ofTransportation (DOT) and Department of Energy(DOE) may suggest more limited use of the sym-bol, creating confusion for commercial handlers ofmedical wastes (43).

DOT has issued regulations for the transporta-tion of etiologic agents. These regulations may ap-ply to most medical wastes contained in packagesbearing the biohazard symbol, as a result of theDOT’s definition of “etiologic agent” in the Codeof Federal Regulations. 5 This is a result of the factthat the precise content of most medical waste boxeswith a biohazard symbol is not known, but is likelyto contain a defined etiologic agent. Further, theDOT regulations specify that packages of this sortbe a maximum of one liter in size.

Further, the various classification of medical, andspecifically infectious, wastes by different Statescomplicates the interstate shipment of wastes. De-pending on the State, a waste may be designatedeither as a hazardous, solid, or special waste, orsimply as freight for the purposes of interstatecommerce. Some States have manifest systems,others do not. These factors complicate, but do notprevent, the shipment of wastes within (and out-side of) the country. If more medical wastes areshipped between States, which is the apparenttrend, the likelihood of accidents will increase. Thedesirability of more consistent and complete guide-lines or regulations regarding the off-site transpor-tation of infectious wastes should be considered inthis context.

Potential Occupational Risks

On October 30, 1987, the Department of Labor(DOL) and the Department of Health and HumanServices (DHHS) issued a Joint Advisory Noticeon ‘‘Protection Against Occupational Exposure toHepatitis B Virus (HBV) and Human Immuno-deficiency Virus (HIV)” (80). This Notice goes be-yond the CDC guideline changes made in August1987 that focused on AIDS. Essentially, the univer-sal precaution concept is extended by the Joint Ad-visory Notice to occupational exposure to Hepati-tis B. The Notice advises healthcare workers toassume all body fluids and tissues they come intocontact with are infected with a blood-borne disease.

549 CFR 172.401

Tasks performed by healthworkers are dividedinto three categories. 6 Category I includes tasks thatroutinely involve exposure to blood, body fluids,or tissues; Category II tasks routinely do not in-volve exposure to these substances, but could onoccasion (e. g., to administer first aid); and Cate-gory III includes tasks that involve no exposure toblood, body fluids, or tissues and for which Cate-gory I tasks are not a condition of employment. TheNotice also advises that workers should not performCategory I and 11 tasks before receiving trainingrelating to the facility’s standard operating proce-dures (SOPS), work practices, 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 theAdvisory. Further, it recommends that employersshould provide free voluntary Hepatitis B immu-nization for any workers performing Category Itasks who test negative for Hepatitis antibodies. Atthe request of employees, the employer should havea voluntary program to monitor for Hepatitis andAIDS antibodies following a known or suspectedexposure to blood, body fluid, or tissues. Thisshould include confidential medical counseling ifthey are found seropositive for either virus. Em-ployers are also encouraged to keep records of thetraining, tasks, etc., of employees engaged in Cat-egory I or II tasks. Currently, the CDC estimatesthat 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 letternotes that as many as 18,000 healthcare workersper year may be infected by the Hepatitis B virusand several hundred will become acutely ill or jaun-diced from the virus. Ten percent will become long-term carriers and as many as 300 healthcare work-ers may die each year as a result of Hepatitis B in-fections or complications. The letter also states thatthe Occupational Safety and Health Administra-tion (OSHA, part of DOL) will respond to em-ployee complaints and conduct inspections to en-sure proper procedures are being followed.

bIt should be noted, that the use of Categories I, II, and 111 arenot 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 tasks. No workershould 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 Reporl, vol. 38,Aug. 21, 1987.

It is not clear, however, that healthcare and otherworkers are being adequately informed 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 ofsome healthcare facilities in establishing infectioncontrol programs in response to the Joint AdvisoryNotice. Hospitals and other healthcare employersare reportedly providing ‘‘minimal training pro-grams and [may be requiring] workers to sign aform stating that they’ve been trained [in order]to prevent future liability’ to the facility (36,68).

In 1987, OSHA began enforcing some of its ex-isting regulations to respond to the hazard presentedby occupational exposure to blood and body fluids.These include regulations for sanitation and waste

disposal; personal protection equipment (PPE);housekeeping; sign and tags; and the applicationof the General Duty Clause of the OccupationalSafety and Health Act. A detailed description ofthis program can be found in OSHA’s instructionsto its compliance officers (79).

In addition, OSHA sought input through an Ad-vance Notice of Proposed Rulemaking about theneed for and content of additional regulations. TheService Employees International Union, AFL-CIO,CLC (SEIU), and the American Federation ofState, County, and Municipal Employees (ASFME)petitioned OSHA in September 1986 to issue astandard to protect healthcare workers from poten-tial exposure to Hepatitis B and AIDS and makethe Hepatitis B vaccination available to high riskworkers free of charge (1,66). OSHA expects to is-sue regulations by the end of 1988.

SEIU, while waiting for OSHA to respond totheir petition, conducted “an informal survey ofinfectious disease control practices within forty hos-pital departments in four urban centers experienc-ing high rates of AIDS infection, the results ofwhich became available in June 1987,7 (See tables3 and 4.) The SEIU survey, while not statisticallysignificant due to the small sample size, concludedthat ‘‘employer voluntary compliance of infectioncontrol guidelines is spotty at best, even in health-care institutions located in urban areas experienc-ing high rates of AIDS infection” (66). SEIU high-lighted several issues relating to the managementof medical wastes. For example, it noted that studiesof 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 bebased on the known modes of transfer (i.e., ex-posure), not arbitrary occupational and industrysector 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 (thisincludes workers such as janitors, mortuary and cemetery workers,technicians, and police officers) may be exposed to 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 sizehospitals Large Medium Small

Personal protective equipment (PPE):Gloves readily available. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sufficient quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Right sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Masks or goggles available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Fluid resistant gown available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Work practices/equipment:Handwashing facilities in vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Ambubags available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Needle disposal containers in vicinity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Self-sheathing needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Linen red bagged . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Standard operating procedures:Procedures developed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .PPE routinely used when contact with bodily fluids is anticipated . . . . . . . . . . . . . . . . . .

Training:Educational materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .OSHA worker brochure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Training in universal bloodborne disease precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Medical:Hepatitis B vaccine available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

If available, free of charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Confidential HIV testing available . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

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

87%14606148

87%72811991

36%70

74%o

63

70%1002650

100%6020

10020

100%40

1002580

0 %

60

80%2050

8 0 %

7500

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%

Sufficient quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 44Work 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 78Standard 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 0Medical: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 Proposed Rulemakin9 to Control Occupational Exposures

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

14

workers are at risk and should be covered byOSHA’s infectious waste regulations (34). Solidwaste workers have been exposed to transmittablediseases on the job through such practices as com-paction of untreated wastes in standard refuse ve-hicles. This can result in the aerosolization of path-ogens and potentially lead to disease transmission.

Some observers, however, maintain that suchrisks are minimal (8,60). They maintain, for ex-ample, that if wastes are properly packaged andhandled, two of the factors necessary for diseasetransmission are not present, i.e., mode of trans-mission and portal of entry. A frequently citedstudy, performed in West Germany in 1983, doesreport that there is no microbiologic evidence thatbiomedical wastes are more infective than residen-tial waste (37). These issues, however, have notbeen extensively researched in the United Statesto determine the degree of risks posed by infectiouswastes. In any case, those actually working associ-ated with the housekeeping, janitorial, and refusehandling and disposal of medical wastes indicatethat packaging frequently (although actual num-bers are not available) does not hold wastes, andthat workers are exposed. Bags and boxes may leakfluids, or sharps may protrude (51,66).

In general, the establishment of standard oper-ating procedures (SOPS) is regarded as an effec-tive way to better ensure the proper handling, stor-age, and transportation of medical wastes.8 Forexample, the segregation of medical wastes has acritical 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 wastemanagement.

portation of wastes. EPA recommends that infec-tious wastes be segregated at the point of origin;that distinctive and clearly marked plastic bags andcontainers for infectious wastes be used; and thebiological hazard symbol be used as appropriate(81). Hospitals tend to segregate wastes into at leastinfectious 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 thewastes.

Even though segregation of wastes is consideredkey to a successful waste management program, itis 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 considerthe delivery of health care to be their primary mis-s ion , not sorting wastes into [seemingly] arbitrarycategories (58). For this reason some hospitalsapparently find it easier to designate all wastes fromcertain areas of the 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 infectiouswaste into the general wastestream (58,62). If allthe wastes are mixed, then they would probably beconsidered infectious and managed as such (i. e.,sterilization or incineration v. landfilling or seweruse). Once again, the central importance of the def-inition of medical wastes becomes apparent. Thehospital’s definitions of wastes affects the segrega-tion of the wastes within the hospital and their han-dling, treatment, and ultimate disposal.

Chapter 3

Current Technologies, Treatment,and Disposal Issues

Incineration

The incineration of medical waste has many ofthe same advantages and disadvantages associatedwith the incineration of any type of waste. Thatis, advantages include significant volume reductionof the wastes, while requiring little processing ofwastes before treatment. Disadvantages includehigh costs and potential pollution risks associatedwith incineration processes. The discussion in thischapter will focus on issues and concerns more spe-cific to the incineration of medical wastes.

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, orabout 210,000 to 720,000 tons, is generally con-sidered infectious waste. Hospitals often inciner-ate both infectious and non-infectious waste together.The total amount of medical waste incinerated peryear is unknown. 1 In fact, the exact number of med-ical waste incinerators currently operating is notknown.2

Hospital incinerators burn a much smaller vol-ume of waste than municipal incinerators. Of the158 million tons of municipal solid waste generatedper year, approximately 15 million tons are inciner-ated (15). What concerns some observers is thatmany of the hospital incinerators are located inheavily populated areas (which could lead to greaterpotential exposure) and appear to have relativelyhigh emission rates of some pollutants of concerngiven their size.

Limited data indicate that small, on-site inciner-ators can emit relatively high levels of some pol-lutants, but few risk assessments have been per-formed on these incinerators, hindering the abilityto definitively evaluate the relative degree of risks

IEPA estimated that the total amount of hospital waste incinerated,when including the waste incinerated off-site, is about 80 percent ofthe total hospital waste in the United States (42).

‘One estimate is that over 7,000 medical waste incinerators of themost 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, whichmay allow incinerator emissions to enter hospitalsthrough air-conditioning ducts and windows (40).One study found that the concentrations of chro-mium, cadmium, and 2,3,7,8 tetra-chlorinateddibenzo-p-dioxin (TCDD) equivalents were ap-proximately two times higher in the hospital air in-take than the maximum ambient ground level con-centrations (13).

The three types of incinerators used most fre-quently for hospital waste treatment in the UnitedStates are: controlled air, multiple chamber air, androtary kiln models (83). (See figure 2.) All threetypes can use primary and secondary combustionchambers to ensure maximum combustion of the

Figure 2.—Typical Controlled Air Incinerator

Gas discharge

Reed

ion

rge

Primary combustion air ports

SOURCE: C. Brunner, “Biomedical Waste Incineration,” paper presented at 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) incinerators used only for pathologicalwastes. 3 Most, 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 oftenmore capacity is needed than a modular unit canprovide. Consequently, there are relatively fewermodular municipal waste incinerators.

As noted above, some concerns associated withthe incineration of medical wastes are not unlikethose 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 natureof medical wastes (e. g., infectious, hazardous, andgeneral refuse wastes) and the potential for incom-plete pathogen destruction. Both types of concernswill be discussed in this 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.

Controlled Air Incinerators

Most of the incinerators built for medical wastetreatment 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 morechambers under conditions of both low and excessstoichiometric oxygen requirements. In the primarychamber, waste is dried, heated, and burned 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 thesecondary chamber. Excess air is introduced intothe secondary chamber at usually between 100 and150 percent of the stoichiometric requirement. Asupplementary fuel burner is used to maintain ele-vated gas temperatures and provide for completecombustion.

Temperatures in the incinerator are controlledthrough adjustments in the air levels. Air in bothchambers is modulated to maintain proper oper-ating temperatures. Furnace exit temperatures areusually maintained in the normal range between

3It is not known how many of these types of incinerators are stillin use.

1,400 and 2,000 “F. There are also three and fourstage-controlled air incinerators that feature flue gasrecirculation.

One advantage of using low levels of air in theprimary 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 units. Available data indicate that many con-trolled air incinerators can be operated to meet ex-isting particulate standards that are at or below 0.08grains per dry standard cubic foot (gr/dscf) (cor-rected to 12 percent carbon dioxide) (3,83). ManyStates, 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 requireexpansion space (which may or may not be avail-able). Additional controls, however, would capturefiner particulate and some other pollutants.

Advantages of the controlled air system includehigh thermal efficiency as a result of lower stoichio-metric air use, higher combustion efficiencies, andlow capital costs (which may increase as more con-trols are required). As with all types of incinera-tors, disadvantages include potential incompletecombustion under poor operating conditions andproblems associated with achieving proper operat-ing temperatures during startup of a batch unit.4

Other Types of Incinerators

Most incineration systems constructed before theearly 1960s were of the multiple-chamber types(sometimes referred to as excess air types). Theyoperated 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 arecurrently operating, although greater use of themis being promoted by some. These incineration sys-tems feature a cylindrical, refractory-lined (usuallybrick) combustion primary chamber. This chamber

‘In batch units, the waste is placed in the furnace in batches andallowed to burn out. Combustion of the waste first occurs in the pri-mary (ignition) chamber, through the introduction of heat by a burner.

—

17

rotates slowly (between 1 and 3 rpm) on a slightlyinclined, horizontal axis. This rotation provides ex-cellent turbulence (i. e., mixing). Yet, the rotarykiln systems tend to be costly to operate and main-tain, usually require shredding (i. e., some size re-duction of wastes), and usually require emissioncontrols (3,8,83).

Variations of all types of incineration processesand other ‘‘innovative’ technologies continue toappear. 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 existing air standards without airpollution controls. As a result, the controlled airincineration industry is healthy. It remains in a rela-tively constant state of change and development,although there are frequent turnovers, mergers, andcompany failures in the industry (8).

Air Emissions and Ash

Concentrations of Emission Constituents

As of 1987, most States recommended but didnot require control of opacity and particulate emis-sions from hospital incinerators (83). The reportedrange of concentrations of constituents in hospitalincinerator emissions are presented in table 5. Theraw data on emissions can be analyzed by normaliz-ing the data to the amount of waste burned. Table6 shows that for both polychlorinated dibenzo-dioxins (PCDDs, commonly referred to as dioxins)and polychlorinated dibenzofurans (PCDFs, com-monly referred to as furans), hospital incineratoremissions are on the average one to two orders ofmagnitude 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 dioxinand furan levels that are one order of magnitude

‘Additional data may soon be available as a result of a settlementapproved by the U.S. District Court of the District of Columbia be-tween EPA and two environmental groups. The settlement includesa requirement for EPA to study emissions of dioxins and durans fromhospital incinerators, the current regulations of State and 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 DefenseFund 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/dscfLead . . . . . . . . . . . . . . . . . . . . . . . . . . . .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/Nm3)

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 Waste

Disposal” (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 moredioxins and furans per gram of waste burned thanmunicipal incinerators. Given the smaller volumeof medical waste incinerated, overall emissions fromall medical waste incinerators are less than thosefrom existing incinerators. Yet, since hospital in-cinerators are usually located in densely populatedareas, potential exposure may be greater.

‘The Hampton facility has recently been retrofitted, and its emis-sions have been significantly reduced (46).

18

Possible Reasons for Higher Emission Levelsof Dioxins/Furans and HCl

Higher concentrations of dioxins and furans maybe associated with medical waste incineration emis-sions due to:

1. the frequent startups and shutdowns these in-cinerators undergo;

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

ing and oxygen controls); and4. differences in the waste feed composition as

compared with municipal solid waste.

Studies have shown that dioxins and furans canbe formed after leaving the furnace, by the cataly-sis at low temperatures of precursors (such as chlo-rophenol and benzene) and chlorine atoms on flyash 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. Disagreementexists over whether pyrolysis of PVC in hospitalincinerators can produce chlorobenzene (a potentialdioxin precursor). EPA has studied the phenomenonof ‘transient puffs” (referring to upset conditions)in test incinerators burning PVC and polyethylene.During waste charging, hospital incinerators oftenexperience high carbon monoxide emissions, in-dicating poor combustion. These transient puffsgenerate large quantities of products of incompletecombustion (PICs), including dioxins (40).

Almost all hospital incinerators are operated onan intermittent basis (83). Frequent startups andshutdowns of medical waste incinerators may leadto increased dioxin formation and may volatilizecertain waste components, including pathogens. Astudy of dioxin emissions from the Westchester mu-nicipal incinerator in New York State found thatduring cold starts (without auxiliary fuel), dioxinand furan emissions were at least 10 times higherthan under normal operation (14,38). The studyconcluded that dioxins are formed in cool sectionsof the incinerator (between 400 and 800 ‘F). Ifstartups and shutdowns of medical waste inciner-ators are undertaken without auxiliary fuel, poorcombustion 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 related to the levels of dioxins andfurans in the stack of a municipal incinerator, atleast under the limited set of conditions during thetest. Instead, formation of these compounds waspartly related to the thoroughness of the combus-tion process. Poor combustion, which occurred attemperatures below 1500 ‘F and which was indi-cated by high carbon monoxide levels, resulted insubstantial increases in dioxin and furan formationin the furnace (52).7

Moreover, differences in waste composition mayinfluence the formation of dioxins and furansthrough 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 percentof all hospital wastes (71).

Laboratory studies have found that pyrolysis ofvarious plastics produces chlorinated aromatichydrocarbons. For example, pyrolysis of PVC hasresulted in the formation of benzene, 1,1,1-trichlo-roethane, trichloroethylene, and tetrachloroethylene(85). On this basis, it is conceivable that pyrolysisof 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 temperature are re-quired (7). In addition, computerized combustioncontrols that regulate the level of oxygen in the fur-nace can improve destruction of precursors (40).

The concentrations of hydrogen chloride (HCl)also appear to be consistently higher, on average,compared with municipal waste combustors. Onereason for this may be higher levels of PVC in med-ical waste (39).8 EPA has reported that plastics com-prise approximately 20 percent (by weight) of allhospital waste, compared with 5 to 10 percent inmunicipal solid waste (55). Virtually all of the chlo-rine present in these wastes is converted to HCl dur-

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

PVC and not other types of plastics. OTA does not have data on howmuch PVC is in the plastic portion of the medical wastestream.

19

ing the actual combustion ‘process, assuming a highcombustion efficiency. The chlorinated plastics maycontribute to some of the high emission rates of HCland possibly dioxins. HCl may be controlled bymonitoring waste input or through the installationof appropriate air pollution control technologies(e. g., acid gas scrubbers).

Concentrations of Constituents in Ash

Little data has been reported describing the con-centrations of the constituents of medical inciner-ator ash. Heavy metals have been found in hospi-tal incinerator emissions and are expected to bepresent in incinerator ash. Lead and cadmium, forexample, are found in radioisotope shielding as wellas pigments and additives in plastics (40). Limiteddata from one hospital showed that extractions ofthe fly ash sample were well above EP Toxicitylimits for cadmium and lead. Extractions from thebottom ash sample were well below EP Toxicitylimits (7). One study summarized dioxin and fu-ran concentrations in fly ash from three hospitalincinerators and four municipal incinerators (19).(See table 7.) The data reveal that concentrationsof both dioxins and furans are considerably higherin hospital incinerator fly ash than in municipal in-cinerator fly ash.

Total dioxin levels in hospital incinerator fly ashsamples were between 1 and 2 ppm, which is much

Table 7.—Concentrations of Dioxins and Furans inFly Ash From Municipal and Hospital Incinerators

(rig/g, equivalent to parts per billion)

Incinerator type

Constituent Municipal Hospital2,3,7,8-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 1155-1737Tetra 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 19,5 895-2140SOURCE: H. Hagenmaier, M. Kraft, H. Brunner, and R. Haag, “Catalytic Effects

of Fly Ash From Waste Incineration Facilities on the Formation andDecomposition of Polychlorinated Dibenzo-p-dioxins and Polychlori-nated Dibenzofurans,” Erwirorrrnerrt, Scierrm and Technology 21(1 1):1080-1084, 1987,

higher than the range of 7 to 80 ppb for the mu-nicipal fly ash samples. (See table 7.) In addition,none of the fly ash samples from the hospital in-cinerators had concentrations of the 2,3,7,8-TCDDisomer alone that were below 1.4 ppb. A concen-tration of 1.4 ppb of total 2,3,7,8-TCDD equiva-lents is the figure that CDC and EPA Headquar-ters have used as an indicator of safe concentrationsof dioxin in ash. If total toxic equivalents are cal-culated, hospital incinerators actually exceed thedioxin 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 isrequired when attempting to draw any conclusionsbased on the reporting of so few studies.

Future Trends in Medical WasteIncineration

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 tomeet will determine the type and cost of air pollu-tion controls. The cost and engineering feasibilityof retrofitting existing hospital incinerators with acidgas scrubbers and/or particulate matter controls,and computerized combustion controls, may forcemany hospitals to cease on-site incineration in fa-vor of off-site centralized incineration. g The capi-tal costs of larger regional incinerators are presumedto be lower per ton of waste than smaller individ-ual hospital incinerators (6). Other costs, such astransportation, however, need to be considered.Also, generators of wastes using a regional facilityrather than incinerating wastes on-site may not real-ize a cost savings.

Second, increased regulation of ash disposal mayprovide further impetus for hospitals to utilize off-site management of wastes or residuals. Even thosehospitals that continue to incinerate wastes on-sitemay be forced to contract with a centralized ashmanagement facility. It is unlikely that disposal of

‘See, for exampIe, refs. 6,39); Currently, insurance is apparendyavailable for hospital incinerators (e. g., refs. 27,31) and financing forconstruction of off-site facilities is also available (18). Future concernsin these areas do exist as well as concerns over potential siting prob-lems and other difficulties associated with the construction of mostwaste facilities of any type today.

incinerator ash in existing municipal landfills willcontinue to be allowed. This may result in the needto send the ash to more stringently controlled land-fills or monofills. Regardless of whether ash is reg-ulated under either Subtitle C or as a special wasteunder Subtitle D, relatively short-term liability costsassociated with RCRA corrective action as well aslonger term liability associated with Superfundcould increase insurance and other operating costsfor these ash disposal facilities.

Controlled air incinerators have traditionallybeen popular for medical wastes. As noted above,this is apparently due to the fact that they canachieve relatively lower particulate emissions, ascompared 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-trostatic precipitators) (3). As best available con-trol technology (BACT) emission standards below0.08 gr/dscf for particulate matter (PM) are pro-mulgated, however, controlled air facilities will re-quire additional emission controls and may lose onecost advantage over rotary kiln models.

For example, New York recently proposed PMstandards for new hospital incinerators of 0.01gr/dscf for facilities processing more than 50 tonsper day and 0.015 gr/dscf for facilities processingless than 50 tons per day, as well as a standard of0.03 gr/dscf for existing facilities. In contrast, thenew Pennsylvania PM standard is 0.08 gr/dscf formodular facilities, which can probably be met bymany controlled air facilities without emissions con-trols. Mid-sized units must meet 0.03 gr/dscf andlarge units must meet 0.015 gr/dscf. The 0.03 and0.015 standards will require air pollution controldevices.

Alternative technologies are being studied formedical waste disposal. For example, the Depart-ment of Energy announced its participation in ademonstration project at a hospital in Pennsylvaniato incinerate hospital wastes with coal in a fluidizedbed boiler. The temperatures at which coal burnsin 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 absorbsulfur. Moreover, both the limestone and the coalash itself, are chlorine-capturing agents. The flui-dized bed combustion could allow hospitals to in-

cinerate waste on-site and also to produce energyfor heat, steam, or other hospital uses (64).

Autoclaving

Autoclaving, or steam sterilization, is a processto sterilize medical wastes prior to disposal in alandfill.10 Since the mid-1970s, steam sterilizationhas been a preferred treatment method for micro-biological laboratory cultures. Other wastes (e. g.,pathological tissue, chemotherapy waste, and sharps)may not be adequately treated by some steriliza-tion operations, however, and thus require inciner-ation (72). OTA has no data on the total amountof medical wastes sterilized in the country.

Typically, for autoclaving, bags of infectiouswaste are placed in a chamber (which is sometimespressurized). Steam is introduced into the containerfor roughly 15 to 30 minutes. Steam temperaturesare usually maintained at 250 ‘F (63). Some hos-pital autoclaves, however, are operated at 270 ‘F(61). This higher temperature sterilizes waste morequickly, allowing shorter cycle times.

Several studies indicate that the type of container(e.g., plastic bags, stainless steel containers), theaddition of water, and the volume and density ofmaterial have an important influence on the effec-tiveness of the autoclaving process (41 ,54,63). Eachof these factors influences the penetration of steamto the entire load and, consequently, the extent ofpathogen destruction. 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 autoclave, adjustments need to be made byan operator based on variation in these factors. Aswith many technologies, proper operation of auto-claves is key to effective functioning (i. e., in thiscase, sufficient pathogen destruction to renderwastes non-hazardous).

One method of assuring that pathogen destruc-tion has taken place is the use of biological indica-tors, such as Bacillus stearothermophilus. Elimi-nation of this organism (as measured by spore tests)from a stainless steel container requires a cycle time

IOEthylene oxide and other gas sterilization processes, as well ~ somechemical (including the use of radioactive) processes, are also usedto treat wastes.

21

of at least 90 minutes of exposure. This is consider-ably longer than is currently provided by standardoperating procedures (61 ,63). This conservative ap-proach, however, may provide more pathogen 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.Recently, sodium hypochlorite has been used in aprocess to disinfect disposable products. Partial de-struction of the material is achieved, but additionalincineration and high capital costs are associatedwith the process as well.

Several factors have led some hospitals to aban-don autoclaving. For example, problematic oper-ating conditions can lead to incomplete steriliza-tion. In addition, landfill and off-site incineratoroperators are increasingly refusing to receive suchwastes, questioning whether the waste has actuallybeen treated. The refusals are partly in responseto the fact that most autoclave “red bags’ do notchange 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).

Incineration v. Autoclaving; and theImportance of Proper Operation

Autoclaves must achieve minimum temperaturesand be operated according to appropriate cycletimes to ensure adequate destruction of pathogens.Primary and secondary chamber temperatures of1,400 ‘F and 1,600 ‘F, respectively, must bereached in hospital incinerators to ensure adequatecombustion and minimum air emissions (83). Nor-mally, these temperatures would ensure the destruc-tion of pathogens in the waste, however, if an in-cinerator is loaded and fired-up cold, pathogenscould conceivable escape from the stack. Data isnot 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-essary to reduce pathogen concentrations in mosthospital 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, controlsand instrumentation); 3) regular maintenance; and4) repair. For example, trained operators need tobe knowledgeable in the operation of the incinera-tor and in the proper handling of medical wastes.It is not clear, however, that workers are consist-ently receiving adequate training in the operationof incinerators or autoclaves, and consequently thatmost units are operating properly. 11

Autoclaves do provide some advantages over in-cinerators, which may increase their attractivenessas a disposal option, particularly if incineration reg-ulations become much more stringent and therebyincrease incineration costs. For example, operationand testing of incinerators is more complex and dif-ficult than that for autoclaves (57). In addition,environmental releases from incinerators probablycontain a broader range of constituents (e. g., di-oxins, heavy metals) than autoclaves.

Autoclaves are also less costly to purchase andoperate and require less space. These cost advan-tages, however, may be lessened if incineration isalso required.

A major difficulty associated with autoclaving isthe reluctance of landfill and (off-site) incineratoroperators to accept medical wastes. This, along withother difficulties associated with autoclaving, suchas ensuring the proper operation of the autoclav-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 it a less common waste treatment method formost facilities (53). 12

I IEpA is preparing a training manual for the operators of hospitalincinerators and an air compliance inspection guide.

lzRecently, new 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 arethen allowed to cool. Special autoclaving bags are apparently not nec-essary, and the process is advertised as an economical disposal optionfor certain medical wastes. See announcement in Infectious Waste

News, June 18, 1987.

22

Health and Environmental Risks FromTreatment Technologies13

The few risk assessments that have been per-formed on individual hospital incinerators have pre-dicted health risks (specifically, cancer risks) thatare comparable to those predicted for municipal 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 risks associated with inhalation, but not for thoseassociated with ingestion. In addition, the age offacilities under investigation varies considerably,and older facilities tend to have less-than-optimaloperating conditions and/or less air pollution con-trol equipment.

There are two important points regarding hos-pital incinerator emissions: 1) hospital incineratorsdo 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 beendeveloped for aggregate cancer risks from all hos-pital incinerators that can be compared with EPA’snational estimates for municipal incinerators. Ad-ditionally, no national estimates of non-cancer ef-fects associated with hospital incinerator emissionshave been undertaken.

IJNote, currently most of the attention here is on risks from theincineration of biomedical wastes. Additional information, as avail-able, will be added on risks associated with autoclaving and Iandfilling.

The risks associated with incinerator emissionshave been estimated by States for individual mu-nicipal incinerators and by EPA for all municipalincinerators (48,82). In contrast, few risk assess-ments have been performed for hospital incinera-tors. The New Jersey Department of Environ-mental Protection (N.J. DEP) performed a riskanalysis on four hospital incinerators for seven car-cinogens (four metals, two VOCs and TCDD),HCl, and criteria pollutants (20). Only TCDD wasfound to pose a cancer risk of greater than one ina million. 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 analysis of a proposed hospital incinera-tor in Michigan predicted upper bound dioxin can-cer risks that were one order of magnitude lowerthan those predicted by N.J. DEP (12). The NewJersey 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 upperbound cancer risk. One review of data on dioxinand furan emissions from hospital incinerators hasfound emission rates of total dioxins and total fu-rans generally higher than those from municipalincinerators (42).

The New Jersey results are consistent with thenational risk assessment performed by EPA on mu-nicipal incinerators insofar as they indicate that di-oxins are responsible for most of the cancer riskassociated with incinerator emissions (82). EPA’sanalysis, which examined the risk from municipalincinerators on a national basis, found that dioxinsposed the greatest risk of cancer by two orders ofmagnitude, compared with the second most signif-icant carcinogen present, cadmium.

Chapter 4

Regulatory Authority and Current Practices

Federal Authority

The two Federal laws that most directly providethe government with the authority to regulate orcontrol the management of infectious wastes insome way are the Resource Conservation and Re-covery Act (RCRA) and the Occupational Safetyand Health Act (OSHA). 1 In addition, New SourcePerformance Standards (NSPS) of the Clean AirAct may apply to hospital incinerators.2 Any spe-cial State and local regulations for general and in-fectious wastes also apply. Certain chemical wastesgenerated in healthcare facilities are considered haz-ardous waste and may be subject to provisions ofRCRA, and radioactive waste disposal must conformwith Nuclear Regulatory Commission standards.3

The agency with the most comprehensive au-thority to provide Federal leadership on themanagement of medical wastes is EPA. EPA hasauthority under RCRA to regulate the handling,storage, treatment, transportation, and disposal ofmedical wastes. Its regulations would apply to pub-lic and private facilities of all types.

Currently, as noted above, the Agency has onlyissued a guidance document for the managementof infectious wastes. Other medical wastes are con-sidered to be like any other solid waste and are sub-ject to relevant RCRA Subtitle D regulations.

In contrast, the CDC does not have authorityto issue regulations. OSHA may issue regulationsor guidelines to protect the health and safety ofworkers, but they apply only to private facilities(unless a State extends the coverage to employeesof public facilities as well).4 At present, OSHA doesregulate 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 any case, these standards only apply to conventional criteria pol-lutants. Potential air toxics are not regulated at the national level atthis time.

340 CFR 260-265; 122-124; 10 CFR 20, respectively. These typesof 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 Secretaryis given general authority to promulgate such stand-ards in order to assure the ‘‘attainment of the high-est degree of health and safety protection of the em-ployee.” Yet, the feasibility of the standards mustbe considered, and they must be set on the basisof the best available evidence. There is apparentlynothing in the definitions of terms in OSHA thatwould preclude the application of the law’s author-ity to the regulation of infectious wastes.6 At thistime, however, OSHA has limited its specific activ-ity on occupational exposure to infectious wastesto its rulemaking activity to control occupationalexposures to Hepatitis B and AIDS.

State Regulatory Activities

Given the general lack of regulation on the na-tional level, States have developed their own infec-tious or medical waste programs. As the Councilof State Governments (CSG) report, State Infec-tious Waste Regulatory Programs, notes, withouta Federal baseline and without Federal funds ‘‘tosupport the creation of a new environmental reg-ulatory program [to manage infectious wastes],states, regardless of size or location, are in the proc-ess of meeting the public’s demand for protection.It is [a] clear state-generated initiative . . .” (em-phasis added) (4). Local governments (e. g., towns,cities, and counties) may also develop special med-ical requirements of one sort or another. This hasled to tremendous variation in the regulation ofthese wastes.

The variation in State activities is worthy ofFederal attention for at least two reasons. First,stricter regulations in one State may encouragethe shipment of wastes to other States with lessstringent regulations. Second, many States, inthe absence of Federal guidance, apparently are“leap-frogging” one another to adopt the moststringent regulations. One of the most striking fea-tures of recent State action on medical/infectiouswaste issues is its rapidity. As the CSG notes, many

cThe definiton of the term employer appears sufficiently broad toinclude hospitals and possibly other generators; the definition of toxicmaterials or harmful physical agents’ also appears broad enough toinclude infectious wastes (21 CFR 19 10.20(c)( 11 )). See ref. 16.

23

24

State legislative sessions are only a few months longand only meet every other year. Yet, States havebeen responding quickly to public concern overmedical wastes: 88 percent of the States 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 andhealth department offices, while other States des-ignate one or the other of these types of offices asthe lead authority. Enforcement authority 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 isdelegated to the Joint Commission on Accredita-tion of Healthcare Organizations (JCAHO) (4).7

A majority of States target hospitals in their reg-ulation of infectious wastes. Of these, three-quartersalso regulate clinics, but only half also include doc-tor and dental offices, veterinary hospitals, andother small generators (4). (See figure 4.) FiveStates currently exempt or are proposing to explicitlyexempt small quantity generators from infectious

7The JCAHO inspects hospitals periodically and determines theiraccreditation. Despite their recognized authority, and potential 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/dentistsBiomedical/

pharmaceutical

Research

OtherI 1 I I 1 io 10 20 30 40 50

Number of States

SOURCE: The Council of State Governments, State Infectious Waste Reguh?toryPrograms (Lexington, KY: 1988).

waste regulations or policies (4).8 Regulating in-fectious wastes on the basis of listed generatorsversus types of wastes can lead to some importantincongruities. In Rhode Island, for example, wastesfrom animal research in a laboratory associated witha hospital are subject 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 beexempt from infectious waste regulations is a sig-nificant, unresolved issue.

Unless a State specifically regulates infectiouswastes as hazardous wastes (4),9 permits are notlikely to be required by States. Instead, infectiouswaste guidances and rules appear to be the normand are designed to be “self-enforcing. The Coun-cil of State Governments identifies the 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 adminis-trators, however, is that the regulations proposedor adopted by some States are inappropriate, un-realistic, and costly. For example, the New YorkState Department of Environmental Conservation’s

8These are: California, Indiana, Minnesota, Missouri, and Ohio.‘This is true for: the District of Columbia, Hawaii, Iowa, Kentucky,

Maine, and Washington.

25

(DEC) draft regulations, referred to as the “mostfar-reaching and comprehensive waste managementlaws in the nation’ for solid and infectious wastemanagement, contain the following incineratoremission standards:

●

●

●

0.010 grains per dry standard cubic foot of fluegas, 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 residence time at least 1,800‘F for combustion gas. 11

These new regulations are expected by many,including the DEC, to increase the cost of on-siteincineration of infectious wastes (31). This may leadto more off-site treatment of hospital wastes.

One hospital consultant’s opinion of the NewYork State regulations, and other State regulations,based on best available control technology for in-cineration of infectious wastes is that:

. . . [they] appear to have no technical basis, andmany are also reflective of unproven, unrealistic,and sometimes unattainable technology . . . . .What appears most disturbing, however, is thatthere appears to be no evidence or documentationwhich show that there will be any significant envi-ronmental benefits or reduced health risks if suchproposed legislation is enacted (8).

He maintains that more analysis is needed be-fore such standards are adopted. The need forstandards 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 byStates 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 either the stack concentration isless than 50 parts per million by volume, dry basis corrected to 7 per-cent oxygen; or, the uncontrolled emission rate is less than 4 poundsper hour and the total charging rate is less than 500 pounds per hou

I I For multichm~r incinerators, these parameters must be met aftf--the primary combustion chamber, which must be maintained at noless than 1,400 “F.

More than half of the States require or plan torequire treatment (e. g., autoclaving) of infectiouswastes before land disposal. Yet, under certain con-ditions, at least 12 States allow infectious wastesto 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 requireincineration (4). 12 Twenty-three States are consid-ering establishing performance standards, whichcould 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 treatment as analternative, and other treatment alternatives areconsidered on a case-by-case basis by other States(4).

Handling of infectious wastes on-site is usuallygoverned by State health departments. They issueguidelines 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 infectiouswaste 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 andrefrigeration requirements. Transportation require-ments (including the designation of only non-com-pacting trucks for transporting infectious wastes,requiring truck labeling and shipping procedures,and specifying cleaning procedures) and record-keeping requirements (usually recordkeeping by thegenerator rather than a manifest system of submit-ting records to the State) are being considered bythree-fifths of the States (4).

I zThese are: Alaska, Arkansas, Colorado, New Hampshire, andTennessee.

26

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

Parameter New York Pennsylvania Minnesota Mississippi California WisconsinAir emissions:Particulate 0.01 gr/dscf

(for new andold facilitiesover 50 tons/day); 0.015 (fornew 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, or50 ppm HCI50 ppm

—

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

Testingrequired

HCL (acid gas) — —

— CO2 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.

Chapter 5

Managing Medical Wastes—Institutional and Policy Issues

Whether the Federal Government should furtherregulate the management of medical/infectiouswastes is an open issue. Within the policy debateover whether and how medical wastes should beregulated are classic divisions between those main-taining there is a need to document actual harmfrom medical wastes, and those primarily concernedwith the potential harm posed by these wastes. Mostenvironmental laws passed in the last 20 years haveembodied a ‘ ‘preventive’ approach to humanhealth and environmental risks as the basis for reg-ulatory action. In practice, however, a more ‘ ‘re-active’ basis for policy development is often used.This latter approach reflects the incomplete shiftof 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 ofrisks posed by the activities are known and appearhigh. It is in this context that the debate takes placeover whether current management problems asso-ciated with medical waste disposal warrant Federalregulation.

At the moment, two regulatory trends areemerging in medical waste management, bothprimarily driven by the more “preventive”mode of regulation: one trend is toward regu-lating greater quantities of potentially infectiouswastes; and the other trend is toward tighteningcontrols over incineration and other disposal op-tions. As one hospital consultant noted,

More and more waste quantities are required tobe treated as “infectious,” of which smaller per-centages are truly infectious; but, simultaneously,viable treatment and disposal options are beingeliminated or made cost-prohibitive (8).

The concern of some generators of medical wasteis that some, if not all, ‘ ‘viable’ management op-tions will become less available (or more costly) dueto the adoption of stricter air emission regulations

by a number of States. This could affect, at leaston a temporary basis, the availability of sufficientcapacity in some areas for managing medical waste.

Several other general trends also appear to beemerging in the management of medical wastes.These include: 1) the likelihood of further regula-tion, at least at the local and State levels of gov-ernment; 2) possible increases in off-site commer-cial and regional incineration facilities, dependingon the levels of standards set in such regulationsand on other cost factors; 3) an increase in the trans-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 asmore 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 medical wastes. The stringency of the emis-sions standards that medical incinerators mustcomply with will determine the type and cost of nec-essary air pollution controls. The cost and engi-neering constraints (e. g., space) of retrofittingexisting hospital incinerators with acid gas scrub-bers and/or particulate matter controls may forcemany hospitals to cease on-site incineration infavor of off-site incineration at regional, central-ized facilities. Regional facilities, however, arelikely to face siting difficulties.

Increased transportation of medical wastes to re-gional facilities, or to facilities that are located out-side a State and in some cases outside of the coun-try, will further increase disposal costs. It is also

‘ontario, Canada, has a manifest system in place and would 1 ilwthe United States to establish a manifest system of some sort to facili-tate estimating hctter 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 Jersey) arc establish ing or have established manifest s~rs-tems of some sort for medical wastes.

2 7

28

likely to increase health risks to the public, giventhe greater potential for accidental exposure dueto spills and possible illegal dumping or disposal.These concerns provide support for proposalsthat require manifest or recordkeeping systemsto track the movement of these wastes. The Sen-ate passed legislation (S. 2680) in August 1988 thatwill require EPA to establish a model tracking sys-tem in New York, New Jersey, and Connecticutfor medical wastes. Similar legislation is pendingin the House (H. R. 3515, H.R. 51 19).

Policy Issues for Federal Action

To best address issues associated with thesetrends, at least two types of policy activities are rele-vant: 1) further development and enforcement ofstandard operating procedures (SOPS) by hospitalsand other medical waste generators for the han-dling, storage, treatment, and disposal of thesewastes; and 2) further 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 overthe management of medical wastes, the increasedlevel of local and State regulatory activity (whichhas led to nationwide variation in the treatment ofthese wastes), the interstate transportation of med-ical wastes, and the current absence of a compre-hensive medical waste policy at the national level.

The Federal Government could usefully specifyits policy(ies) regarding medical wastes in anumber of areas: 1) designation of a lead author-ity (presumably EPA) to clarify the definition,classification, and regulation of these wastes; 2)the establishment of emission standards and ashregulations for medical waste incinerators, auto-claving/landfilling performance standards, andpossibly operator training guidelines/regula-tions; 3) handling, storage and transportationguidelines/regulations to ensure worker safetyand possible establishment of some sort of amanifest system; and 4) research and data needson medical waste practices. Some of these issuescould be addressed under RCRA’s current au-thority or could be clarified as part of the RCRA

re-authorization process.2 Other relevant lawsare OSHA, the Clean Air Act, and possibly theToxic Substances Control Act.

A number of important, related issues notedthroughout this paper re-surface as the implicationsof these areas for possible further policy develop-ment are discussed. The implications of three ofthese areas, the definition/classification of medicalwastes, the issue of small quantity generators ofmedical wastes, and research and data needs asso-ciated with medical waste management are dis-cussed briefly to indicate the range of regulatoryissues the Federal Government will need to addressif it revises or expands its role in medical wastemanagement.

The definition of medical wastes under RCRAis of critical importance to determining the type ofregulatory effort EPA is likely to undertake. Itsclarification is also likely to facilitate State actionsand commercial development of medical wasteincineration. Another important dimension of themedical waste management issue is which types ofsources should be regulated, i.e., the question ofwhether small generators of medical wastes shouldbe exempted. Further research into the nature ofthe risks (both occupational and environmental)associated with medical wastes, research on newtreatment technologies, and performance data forexisting facilities is desirable in order to developmore informed and effective policies.

Defining/Classifying Medical Wastes

If infectious wastes are classified and regulatedas hazardous under RCRA, a comprehensive man-agement program is likely for infectious wastes. Forexample, regulating infectious wastes as hazardouswastes under RCRA could address transportationissues associated with infectious waste management.This would involve: 1) recordkeeping concerningthe waste transported, its source and deliverypoints; 2) transportation of the waste only if prop-erly labeled; 3) compliance with the manifest sys-tem (Section 3002); and 4) transportation only to

‘Some issues, e.g., concerning occupational risks, could be addressedunder other statutory authority, such as OSHA. The focus here ison RCRA given the primary focus of this paper on waste disposalissues.

29

the waste facility that the manifest form designatesas 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 donot tend to include three requirements usually asso-ciated with hazardous waste laws. These are re-quirements for contingency plans and spill man-agement, closures, and financial assurances (4).

As noted above, in RCRA, the statutory 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 orsolid wastes. b EPA, in 1978, did include infectiouswaste as part of its first set of proposed hazardouswaste regulations. The final rule published in 1980,however, stated that infectious waste regulationswould be published separately. As the CSG notes,

. . . [e]ight years and two reauthorizations of RCRAlater, still no Federal regulations have been promul-gated (4).

Instead, in 1986, the EPA issued its Guide forInfectious Waste Management stating that

. . . [w]hile the Agency has evaluated managementtechniques for infectious waste, considerable evi-dence that these wastes cause harm to humanhealth and the environment is needed to supportFederal rulemaking (emphasis added; 81).

RCRA (Section 1004), however, states that theterm ‘‘hazardous waste’ refers to a waste with in-fectious characteristics which may

. . . pose a substantial present or potential hazardto human health or the environment . . . (empha-sis added).

’42 U. S.C. 6924.442 U. S.C. 6924; 6925.542 U.S. C. 6903(5).642 U.S. C. 6903(5); 6921. The hazardous characteristics, of wh ich

infectious is one, listed in 6903 are to be considered when the ,4d-ministrator of EPA identifies or lists hazardous wastes as pcr 6921.EPA, however, in their regulatory interpretation, left the infectiouscharacteristic out of the defin it ion of ‘‘hazardous waste’ (40 C FR240. 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, theAgency issued a request for comment on infectiouswaste issues in the Federal Register. Most recently

the Agency has formed a task force to address in-fectious waste issues. Publicly, the Agency has notruled out the possibility that ultimately it may is-sue regulations, although at present its efforts seemto be on developing an education program.

As noted above, infectious wastes are unlike othertypes of hazardous wastes that can be consistentlyidentified by a test. Detection of infectious microbesin landfill leachate is not highly likely given thatthey are generally less persistent in the environmentthan toxic substances such as heavy metals, oils,solvents, etc. Exposure to sunlight or dry air canrender infectious wastes non-infectious. It is alsotrue, however, that infectious microbes in medi-cal wastes could multiply and are potentially con-tagious under certain conditions. In this context,developing a separate statutory category for infec-tious and medical wastes is seen by some observersas desirable. Applicable hazardous waste provisionsfrom RCRA Subtitle C could be adopted and ap-propriate adjustments made given the particular na-ture of the medical wastestream.

It is not entirely clear how EPA may ultimately

define, classify, and regulate infectious wastes (orif it will). As noted above, EPA’s June 2, 1988,Federal Register request for comment on infectiouswastes issues indicates the initiation of some infor-mation gathering action on this issue. EPA’s posi-tion in the summer of 1988 was that an educationprogram, but not regulation, was justified. Laterin 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 toissue regulations for all aspects of infectious wastemanagement including generation, transportation,treatment, storage, and disposal.

H.R. 3515 distinguishes between medical andinfectious wastes. Infectious wastes would onlybe classified as hazardous wastes under this billif they were mixed with hazardous wastes al-ready regulated under Subtitle C. In September1988, a substitute for H.R. 3515 added a provi-sion to establish a demonstration tracking systemfor medical waste in New York, New Jersey, Con-necticut, and the Great Lakes States. * As of Sep-tember 21, 1988, the House Energy and Commerce

(continued from previous page)

21, 1987, on the rcgu]ation of infectious wastes. The House SmallBusiness Subcommittee on Regulation and Business Opportunitiesheld a hearing on .August 9, 1988, on medical waste issues.

8The 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-dicated in table 9, the proposed pieces of legisla-tion address a number of aspects of medical wastemanagement, beyond the definition and classifica-tion issues. Some significant action on several ofthe bills appears likely before the current sessionof Congress ends. g

Regulating Small v. Large Generatorsof Medical Wastes

Whether incineration emission standards shouldbe set at the Federal level and on what basis (tech-

‘For example. a bill (H. R. 5231 ) to amend the Marine Protection,Research and Sanctuaries Act (Public Law 92-532; MPRSA, com-monly referred to as the Ocean Dumping Act) of 1972 is expectedto reach the floor of the House before the end of the current 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 summaryPermits citizens of one State to bring Federal civil action against any person in another

State creating a public nuisance through improper management of medical wastesRequires that within 12 months after completing a study of infectious and pathologic

waste, 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, andestablishment 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 JerseyAmends 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 DumpingAct); 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 Senatealso 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.

31

nology - or health-based) is an open issue, as iswhether small generators (e. g., doctor offices, homecare) should be exempt from medical waste regu-lations. While hospitals and clinics may generatelarger quantities of wastes, those generated bysmaller facilities may be more susceptible to directpublic exposure. The two incidents of children play-ing with untreated wastes in the summer of 1987,which focused national attention on medical wastemanagement, occurred outside of doctor offices—not hospitals (32).

A problem is how these smaller generators canefficiently and economically dispose of their infec-tious wastes. Commercial off-site facilities may notbe readily available or may be highly costly. Hos-pitals which could accept the waste (if there are notState or local regulations prohibiting it) may bereluctant to do so for potential liability reasons.Some hospitals allow affiliated doctors to disposeof infectious wastes, and potentially funeral homes(with crematories) could also accept wastes fromdoctor offices. Again, liability issues and other fac-tors (e. g., the additional staff time for handling suchwaste) may make these types of facilities reluctantto accept such wastes.

The relative risk posed by wastes from home-carepatients and other infectious materials generatedin homes versus that produced by commercialgenerators is not known. Although the public’s gen-eral concern about AIDS and infectious wastes hasled to a focus on hospital wastes, most treatmentof AIDS is apparently done on an out-patientbasis. 10 As hospital stays have generally becomeshorter in recent years, home care of patients hasincreased. Infected wastes from these individuals,as well as such items as disposable diapers and femi-nine sanitary products, are potentially infectivewastes, and they are directly landfilled in mostcases. Information on appropriate packaging andspecial disposal procedures may be one way to en-courage prudent disposal of home-care infectiouswastes. 11

It is not clear, however, whether these wastes,any more than it is clear whether hospital wastes(especially those which have been treated by auto-claving or some other sterilization process), posea significant contamination problem when land-filled. 12 EPA has noted that no groundwater im-pacts associated with landfilling any medical wasteshave been identified to date (84). Yet, with littleinformation on the quantities of infectious wastefrom small generators, as well as on the risks ofthese wastes, it is an open question as to what typesof controls are appropriate. Controls could focuson handling and direct exposure (through improperdisposal) and/or on environmental risks from dis-posal of these wastes.

The feasibility of controlling small quantitygenerators presents another policy dilemma. 13 Cur-rently, the confusion over how best to address thisissue is evident in proposed legislation in someStates. California, for example, has two bills pend-ing, one of which (S. 1448) would prohibit any per-son from disposing of untreated infectious wastes;the other (S. 2469) requires the disposal of sharpsin puncture-proof containers, except those from pri-vate homes, physicians’ offices, or health-care fa-cilities.

Research and Data Needs

As noted throughout this paper, little data ex-ists on the management of medical waste. Indeed,the ‘‘vital signs’ for medical waste managementare thereby difficult to read or interpret. Basic in-formation on sources, amounts, composition,and treatment/disposal of medical waste is notknown in any useful detail. In addition, insuffi-cient research data exist to determine to what de-gree medical wastes are a public health problem.Information on occupational exposure to hazardsassociated with managing these wastes is not avail-able. Comprehensive data on the operation of in-cinerators (e. g., types, comparisons of air emissionslevels for a range of pollutants (including patho-

10It is also worth noting that CDC studies found that HIV doesnot persist well in the eni’ircmment, at least not after drying, whichcauses a 90 to 99 per{ c.nt concentration reduction within several hours.See ref. 77.

1 J For example, Pun{. tur(.. proof containers could be provided Withthe sale of syringes (which in many areas can only be purchased witha prescription) (48a)

I zItems such as disposable diapers and feminine sanitary productsare not generally considered a serious source of infectious contami-nant ion to landfills. I t is on this basis that some observers maintainthat these wastes do not warrant special waste handling procedures,and that bans of these products are unjustified.

jJThe Association for Practitioners in Infection cOINrOl has recentlyproposed a guideline for infection control in home-care which coverswaste treatment in this setting (69).

32

gens), ash content analysis, etc.) do not exist at thistime.

As Ode Keil, Joint Commission on Accredita-tion of Healthcare Organizations, noted at theOTA Workshop on Medical Waste Management,held July 19, 1988, “We have a problem, but wedo not have a scientific analysis of the problem tosupport development of a rational system. It ap-pears it would be highly prudent for Congressand Federal agencies to address the inadequacyof data and research, and therefore information,on medical wastes and their management. Thisis essential for determining the need for andnature of any regulatory program for medicalwastes.

A number of possible areas for further researchand information gathering exist. Several key areasinclude:

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 leastadopt;the nature and extent of occupational risk, in-cluding risks not only to healthcare workers,but housekeeping, maintenance and otherrelevant workers as well;use and comparison of different incinerationprocesses and other technologies, includingemission rates and health risk assessments ofthese disposal options;examination of the use of sewers for medicalwaste disposal (e. g., the survival of viruses insewer discharges; problems associated withcombined sewer overflows, such as beachwashups of medical wastes; etc.);identification of potential waste reduction op-tions for medical facilities; and

6. comparisons of State regulatory programs,specifically to highlight experiences relevantto the development of possible Federal pro-grams (e. g., model programs for managingmedical wastes from small generators; mani-fest systems, etc.).

Concluding Remarks

This chapter highlights the types of regulatoryissues that could be clarified by Congress and/orthe EPA and other Federal 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-mation on the risks posed by these wastes and ontheir actual management, and for more researchof alternative treatment technologies and manage-ment techniques. Nonetheless, the need for re-search should not be taken as a suggestion forpostponing consideration of adopting a compre-hensive regulatory program to address medicalwaste management. In fact, research effortscould be a part of a regulatory program, if it ispromulgated in phases.

The most coherent Federal policy for medicalwaste management is likely to result only if the va-riety of issues (e. g., the definition, classification,nature of risks, types of available disposal options,and the implications of regulatory action) discussedin this paper are comprehensively addressed. At aminimum, this preliminary assessment of the sta-tus of medical waste management practices in theUnited States today indicates that to adequately ad-dress the public’s growing concern over the man-agement of medical wastes, policy makers will needto address these issues as expediently as possible.

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