Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources: Hospital/Medical/Infectious Waste Incinerators

SUMMARY: This action promulgates new source performance standards (NSPS

or standards) and emission guidelines (EG or guidelines) to reduce air

emissions from hospital/medical/infectious waste incinerator(s) (HMIWI)

by adding subpart Ec, standards of performance for new HMIWI, and

subpart Ce, emission guidelines for existing HMIWI, to 40 CFR part 60.

The standards and guidelines implement sections 111 and 129 of the

Clean Air Act (CAA) as amended in 1990. The standards and guidelines

apply to units whose primary purpose is the combustion of hospital

waste and/or medical/infectious waste. Sources are required to achieve

emission levels reflecting the maximum degree of reduction in emissions

of air pollutants that the Administrator has determined is achievable,

taking into consideration the cost of achieving such emission

reduction, any nonair-quality health and environmental impacts, and

energy requirements. The promulgated standards and guidelines establish

emission limits for particulate matter (PM), opacity, sulfur dioxide

(SO2), hydrogen chloride (HCl), oxides of nitrogen

(NOX), carbon monoxide (CO), lead (Pb), cadmium (Cd),

mercury (Hg), dioxins and dibenzofurans (dioxins/furans), and fugitive

ash emissions. Some of the pollutants being regulated are considered to

be carcinogens and at sufficient concentrations can cause toxic effects

following exposure. The standards and guidelines also establish

requirements for HMIWI operator training/qualification, waste

management plans, and testing/monitoring of pollutants and operating

parameters. Additionally, the guidelines for existing HMIWI contain

equipment inspection requirements and the standards for new HMIWI

include siting requirements.

DATES: Effective Dates. The standards for new sources (Sec. 60.17 and

Secs. 60.50c through 60.58c) are effective as of March 16, 1998 and the

emission guidelines for existing sources (Sec. 60.30 and Secs. 60.30e

through 60.39e) are effective as of November 14, 1997. The

incorporation by reference of certain publications listed in the

regulations is approved by the Director of the Federal Register as of

March 16, 1998. See SUPPLEMENTARY INFORMATION for a discussion of the

schedule for judicial review.

Comments. Comments on the Information Collection Request (ICR)

document associated with the final standards for new sources are

requested, as discussed in section VI.B of this preamble. Comments on

the ICR document must be received on or before November 14, 1997. Refer

to Section VI.B for further information on this request for comment.

ADDRESSES: Comments. As noted above, comments on the ICR document

associated with the final standards for new sources are requested. See

section VI.B and the SUPPLEMENTARY INFORMATION section of this preamble

for further information on obtaining a copy of the ICR document and

addresses for submitting comments on the ICR document.

Background Information. The principal background information for

the final standards and guidelines includes a background information

document entitled ``Hospital/Medical/ Infectious Waste Incinerators:

Background Information for Promulgated Standards and Guidelines--

Summary of Public Comments and Responses'' (EPA-453/R-97-006b), which

contains a summary of all the public comments submitted regarding the

changes to the standards and guidelines that were discussed in the June

20, 1996 Federal Register document (61 FR 31736) and the EPA's response

to these comments. Background information documents which present the

economic and regulatory impacts of the standards and guidelines

entitled: (1) ``Hospital/Medical/Infectious Waste Incinerators:

Background Information for Promulgated Standards and Guidelines--

Analysis of Economic Impacts for Existing Sources'' (EPA-453/R-97-

007b); (2) ``Hospital/Medical/Infectious Waste Incinerators: Background

Information for Promulgated Standards and Guidelines--Analysis of

Economic Impacts for New Sources'' (EPA-453/R-97-008b); and (3)

``Hospital/Medical/Infectious Waste Incinerators: Background

Information for Promulgated Standards and Guidelines--Regulatory Impact

Analysis for New and Existing Facilities'' (EPA-453/R-97-009b) are

available. Also a document entitled ``Fact Sheet: New Hospital/Medical/

Infectious Waste Incinerators--Promulgated Subpart Ec Standards,''

which succinctly summarizes the final standards, and a document

entitled ``Fact Sheet: Existing Hospital/Medical/Infectious Waste

Incinerators--Promulgated Subpart Ce Emission Guidelines,'' which

succinctly summarizes the guidelines, are available. See SUPPLEMENTARY

INFORMATION for instructions and addresses for obtaining these

documents.

Docket. Docket No. A-91-61, which contains supporting information

used in developing the standards and guidelines, is available for

public inspection and copying between 8:00 a.m. and 4:00 p.m., Monday

through Friday except for Federal holidays at the following address:

U.S. Environmental Protection Agency, Air and Radiation Docket and

Information Center (Mail Code 6102), 401 M Street SW, Washington DC

20460 (phone: (202) 260-7548). The docket is located at the above

address in room M-1500, Waterside Mall (ground floor, central mall). A

reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: Mr. Rick Copland at (919) 541-5265,

Combustion Group, Emission Standards Division (MD-13), U. S.

Environmental Protection Agency, Research Triangle Park, North Carolina

27711 ([email protected]) or any of the EPA Regional Office

contacts listed in Table 1 below.

Table 1.--Contacts in EPA Regional Offices

------------------------------------------------------------------------

Region Contact Phone No.

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I (Boston).................... Susan Lancey......... (617) 565-3587

II (New York)................. Christine DeRosa..... (212) 637-4022

III (Philadelphia)............ James Topsale........ (215) 566-2190

IV (Atlanta).................. Scott Davis.......... (404) 562-9127

V (Chicago)................... Douglas Aburano (MI). (312) 353-6960

[[Page 48349]]

Ryan Bahr (IN)....... (312) 353-4366

Scott Hamilton (OH).. (312) 353-4775

Charles Hatten (WI).. (312) 886-6031

Mark Palermo (IL).... (312) 886-6082

Rick Tonielli (MN)... (312) 886-6068

VI (Dallas)................... Mick Cote............ (214) 665-7219

VII (Kansas City)............. Wayne Kaiser......... (913) 551-7603

VIII (Denver)................. Meredith Bond........ (303) 312-6438

IX (San Francisco)............ Patricia Bowlin...... (415) 744-1188

X (Seattle)................... Catherine Woo........ (206) 553-1814

------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by the standards and guidelines are

those which operate hospital/medical/infectious waste incinerators.

Regulated categories and entities include those listed in Table 2.

Table 2.--Regulated Entitiesa

------------------------------------------------------------------------

Examples of

Category regulated entities

------------------------------------------------------------------------

Industry.......................................... Hospitals, nursing

homes, research

laboratories, other

health care

facilities,

commercial waste

disposal companies.

Federal Government................................ Armed services,

public health

service, Federal

hospitals, other

Federal health care

facilities.

State/local/Tribal Government..................... State/county/city

hospitals and other

health care

facilities.

------------------------------------------------------------------------

a This table is not intended to be exhaustive, but rather provides a

guide for readers regarding entities likely to be regulated by the

standards or guidelines for HMIWI. This table lists the types of

entities that EPA is now aware could potentially be regulated. Other

types of entities not listed in the table could also be regulated. To

determine whether your facility is regulated by the standards or

guidelines for hospital/medical/ infectious waste incinerators, you

should carefully examine the applicability criteria in sections 60.50c

and 60.51c of the promulgated standards, section 60.32e of the

promulgated guidelines, and in section III.A of today's notice. If you

have questions regarding the applicability of the HMIWI standards and

guidelines to a particular entity, consult a person listed in the

preceding FOR FURTHER INFORMATION CONTACT section.

Documents Available Electronically

This Federal Register document discusses: (1) The standards for new

HMIWI, (2) the guidelines for existing HMIWI, and (3) a request for

public comment on the ICR document. This preamble and regulatory text

are available electronically via the Internet. Also available

electronically are FACT SHEETS, which summarize the final standards and

guidelines. They are suggested reading for persons requiring an

overview of the standards and guidelines. Hard copies of the FACT

SHEETS can also be obtained by calling Donna Collins at (919) 541-5578.

The following five items are available electronically in file

``MWIFINAL.ZIP'':

1. ``Fact Sheet: New Hospital/Medical/Infectious Waste

Incinerators--Promulgated Subpart Ec Standards.''

2. ``Fact Sheet: Existing Hospital/Medical/Infectious Waste

Incinerators--Promulgated Subpart Ce Emission Guidelines.''

3. Federal Register document for this promulgation: ``Standards of

Performance for New Stationary Sources and Emission Guidelines for

Existing Sources: Hospital/Medical/Infectious Waste Incinerators''

(this document).

4. ``Hospital/Medical/Infectious Waste Incinerators: Background

Information for Promulgated Standards and Guidelines--Summary of Public

Comments and Responses'' (EPA-453/R-97-006b).

5. Information Collection Request document for these standards for

new sources: ``Supporting Statement for ICR No. 1730.02--1997 Standards

for New Hospital/Medical/Infectious Waste Incinerators (Subpart Ec).''

The documents are available via the Internet at ``http://

www.epa.gov/ttn/oarpg/rules.html''. The documents are also available

via the Internet through the Unified Air Toxics Website at ``http://

www.epa.gov/oar/oaqps/airtox/''.

Judicial Review

Under section 307(b)(1) of the Clean Air Act, judicial review of

the actions taken by this notice is available by filing a petition for

review in the U.S. Court of Appeals for the District of Columbia

Circuit within 60 days of today's publication of this rule. Under

section 307(b)(2) of the Clean Air Act, the requirements that are in

today's notice may not be challenged later in the civil or criminal

proceedings brought by the EPA to enforce these requirements.

Preamble Outline

The following outline is provided to aid in locating information in

the introductory text (preamble) to the final standards and guidelines.

I. Acronyms, Abbreviations, and Measurement Units

A. Acronyms

B. Abbreviations and Measurement Units

II. Introduction

A. Purpose of the Standards and Guidelines

B. Implementation of the Emission Guidelines

1. Implementation Activities

2. Public Involvement

C. Technical Basis of the Standards and Guidelines

D. February 1995 Proposal

E. June 1996 Re-proposal

F. Stakeholders and Public Involvement

III. Considerations in Developing the Final Standards and Guidelines

A. Applicability

1. Definition of Medical Waste

2. Co-fired Combustors

3. Waste Types

4. Cement Kilns

B. Pyrolysis Units

C. Waste Management Plans

D. Testing, Monitoring, and Inspection

E. Operator Training and Qualification

IV. Standards of Performance for New Sources

A. Summary of the Standards

B. Significant Issues and Changes

[[Page 48350]]

1. Combined Dry/Wet Scrubbers

2. Siting Analysis

C. Selection of MACT

D. Impacts of the Standards

V. Emission Guidelines for Existing Sources

A. Summary of the Guidelines

B. Significant Issues and Changes

C. Selection of MACT

D. Impacts of the Guidelines

VI. Administrative Requirements

A. Docket

B. Paperwork Reduction Act

C. Executive Order 12866

D. Unfunded Mandates Reform Act

E. Executive Order 12875

F. Regulatory Flexibility Act (RFA) and Small Business

Regulatory Enforcement Fairness Act of 1996 (SBREFA)

G. Submission to Congress and the General Accounting Office

H. Clean Air Act Procedural Requirements

I. Acronyms, Abbreviations, and Measurement Units

The following acronyms, abbreviations, and measurement units are

provided to clarify the preamble to the final standards and guidelines.

A. Acronyms

APCD air pollution control device

APTI Air Pollution Training Institute

CAA Clean Air Act

CAAA Clean Air Act Amendments of 1990

CEMS continuous emissions monitoring system(s)

CFBC circulating fluidized bed combustor

CFR Code of Federal Regulations

DI dry injection

EPA U.S. Environmental Protection Agency

EG emission guidelines

FF fabric filter

FR Federal Register

HAP hazardous air pollutant(s)

HMIWI hospital/medical/infectious waste incinerator(s)

ICCR Industrial Combustion Coordinated Rulemaking

ICR information collection request

MACT maximum achievable control technology

MSW municipal solid waste

MWC municipal waste combustor(s)

MWI medical waste incinerator(s)

MWP medical waste pyrolysis

MWTA Medical Waste Tracking Act

NAPH National Association of Public Hospitals

NSPS new source performance standards

NSR new source review

NYSDOH New York State Department of Health

OAQPS Office of Air Quality Planning and Standards

OMB Office of Management and Budget

ORD Office of Research and Development

PSD prevention of significant deterioration

RCRA Resource Conservation and Recovery Act

RFA Regulatory Flexibility Act

RMW regulated medical waste

SBA Small Business Administration

SBREFA Small Business Regulatory Enforcement Fairness Act

SMSA standard metropolitan statistical area

SWDA Solid Waste Disposal Act

B. Abbreviations and Measurement Units

bps=bits per second

Btu=British thermal units

Btu/yr=British thermal units per year

Cd=cadmium

CDD/CDF=dioxins/furans

CO=carbon monoxide

dioxins=polychlorinated dibenzo-p-dioxins

dscf=dry standard cubic feet (at 14.7 pounds per square inch, 68 deg.F)

dscm=dry standard cubic meters (at 14.7 pounds per square inch,

68 deg.F)

deg.F=degrees Fahrenheit

ft3=cubic feet

furans=polychlorinated dibenzofurans

g=gram (454 grams per pound)

g/yr=grams per year

gr=grains (7,000 grains per pound)

HCl=hydrogen chloride

Hg=mercury

m3=cubic meter (35.3 cubic feet per cubic meter)

mg=milligrams (10-3 grams)

Mg=megagram (1.1 tons per megagram)

Mg/yr=megagrams per year

MMm3=million cubic meters

MW=megawatt

MW-hr/yr=megawatt-hours per year

ng=nanogram (10-9 grams)

NOX=nitrogen oxides

Pb=lead

PM=particulate matter

ppmv=parts per million by volume

SO2=sulfur dioxide

TEQ basis=2,3,7,8-tetrachlorinated dibenzo-p-dioxin toxic equivalent

based on the 1989 international toxic equivalency factors

tons/d=tons per day

total mass basis=total mass of tetra-through octa-chlorinated dibenzo-

p-dioxins and dibenzofurans

II. Introduction

A. Purpose of the Standards and Guidelines

The 1990 Clean Air Act Amendments (CAAA) reflect growing public

concern about the large volume of toxic air pollutants released from

numerous categories of emission sources. Title III of the CAAA

specifically enumerated 189 hazardous air pollutants (HAP) and

instructed EPA to protect public health by reducing emissions of these

pollutants from the sources that release them. The EPA's standards are

to be issued in two phases. The first phase standards are designed to

bring all sources up to the level of emissions control achieved by

those that are already well-controlled. The second phase standards, due

a few years later, are to require further emission reductions in any

case in which the first phase measures were not by themselves

sufficient to fully protect the public health.

In this context, the CAAA singled out waste incineration for

special attention. Congress recognized both a high level of public

concern about the incineration of municipal, medical, and other solid

wastes and a number of special management concerns for these types of

sources. Consequently, section 129 of the CAA directs EPA to apply the

two-phase control approach to various categories of solid waste

incinerators, including hospital/ medical/infectious waste

incinerator(s) (HMIWI). Today's action promulgates standards and

guidelines for new and existing HMIWI under section 129. Current

methods of medical waste incineration cause the release of a wide array

of air pollutants, including several pollutants of particular public

health concern.

The EPA estimates that there are approximately 2,400 HMIWI

operating in the United States, which combust approximately 767

thousand Mg (846 thousand tons) of hospital waste and medical/

infectious waste annually. Emissions from HMIWI contain organics

(dioxins/furans), particulates (PM), metals (Cd, Pb, and Hg), acid

gases (HCl and SO2), and NOX. These pollutants

can have adverse effects on both public health and welfare. Pollutants

of principal concern to public health include dioxins/furans, PM, Pb,

Cd, and Hg. Today's standards and guidelines are set forth as emission

limits and will significantly reduce HMIWI emissions.

Several States, including New York, California, and Texas, have

adopted relatively stringent regulations in the past few years limiting

emissions from HMIWI. The implementation of these regulations has

brought about very large reductions in HMIWI emissions and the

associated risk to public health in those States. Today EPA is

promulgating nationally applicable emission standards and guidelines

for HMIWI that build on the experience of these leading States. Like

the State regulations, the standards and guidelines promulgated today

are based on the use of add-on air pollution control systems. These

standards and

[[Page 48351]]

guidelines implement the first phase requirements of section 129

described above. As described in detail below, section 129, like

section 112, of the CAA instructs the Agency to set performance

standards that challenge industry to meet or exceed the pollution

control standards established by better controlled similar facilities.

In this way, the overall state of environmental practice is raised for

large segments of industry, a basic level of health protection is

provided to all communities, situations in which uncertainty about

total risk and hazard result in no protection for the exposed public

are avoided, and yet the cost of pollution control to industry is

constrained to levels already absorbed by similar operations. Eight

years later, in a second phase, EPA will evaluate whether the residual

public health risk warrants additional control.

The EPA's Office of Research and Development (ORD) is preparing a

national inventory of dioxin emissions as part of its Dioxin

Reassessment. This effort will include emission estimates for HMIWI.

Since the effort is not yet complete, the results are not included in

this package. The ORD is considering a very similar approach to that

used in this rulemaking and anticipates generating similar emission

estimates.

B. Implementation of the Emission Guidelines

The subpart Ce emission guidelines are unique in that, unlike the

subpart Ec NSPS, the guidelines are not direct Federal requirements for

HMIWI. The subpart Ec NSPS are Federal requirements that apply to all

new HMIWI units that commence construction after June 20, 1996 or to

existing HMIWI units that commence modification after March 16, 1998.

The subpart Ce emission guidelines require States to develop section

111(d)/129 State plans to regulate existing HMIWI built on or before

June 20, 1996. These State plans must be submitted to EPA for approval

and must be at least as protective as the guidelines. Together, 40 CFR

part 60, subpart B and subpart Ce specify the content and the general

rules for adopting and submitting the section 111(d)/129 State plans.

The CAA requires that each State submit a State plan to EPA within

1 year of EPA's adoption of the guidelines. State plans must contain

specific information and legal mechanisms necessary to implement the

guidelines. The State must make available to the public the State plan

and provide opportunity for discussion of the State plan in a public

hearing prior to submittal to EPA. The State must submit the final plan

to EPA by September 15, 1998. The EPA then has 6 months to approve or

disapprove the State plan. Plan approval or disapproval will be

published in the Federal Register. If a State plan is disapproved, EPA

will state the reasons for disapproval in the Federal Register. The

State can respond to EPA's concerns and submit a revised plan. If a

State does not submit an approvable State plan by September 15, 1999,

EPA will adopt and implement a Federal plan that applies to existing

HMIWI in the State.

1. Implementation Activities

The EPA is preparing an Enabling Document to assist States with

implementing the HMIWI guidelines. The EPA Regional Offices will mail

hard copies of the Enabling Document to their State contacts. This

document should be publicly available in the next few weeks. The public

can access this document electronically via the Internet at ``http://

www.epa.gov/ttn/oarpg/rules.html'' or ``http://www.epa.gov/oar/oaqps/

airtox/'.

In September 1997, EPA plans to broadcast a telecourse to States,

regions, and the public on the HMIWI rule and on implementation

requirements. State field offices will be notified of the telecourse.

The EPA's distance learning network telecourse schedule, as well as a

list of telecourse sites, is available at http://134.67.104.12/html/

apti/aptc.htm.

Finally, EPA will host its annual Air Toxics Workshop for EPA

Regions and States in Research Triangle Park in late August 1997. A 1-

hour session is scheduled to provide States an overview of the HMIWI

rule and to discuss implementation issues. The Air Toxics Workshop

provided for EPA Regions and States is not open to the public.

Opportunities for public participation in the implementation process

are discussed below.

2. Public Involvement

Public participation, under the provision of the CAA, is an

important right and responsibility of citizens in the State process of

developing, adopting, and implementing section 111(d)/ 129 State plans.

As with State Implementation Plans (SIP) for criteria pollutants, EPA

regulations in 40 CFR part 60, subpart B, make it clear that citizen

input on section 111(d)/129 State plans is encouraged in order to help

define appropriate emission standards and retrofit schedules. Under

Subpart B, some minimum public participation requirements are as

follows:

a. Reasonable notice of one or more public hearing(s) at least 30

days before the hearing;

b. One or more public hearing(s) on the section 111(d)/129 State

plan (or revision) conducted at location(s) within the State, if

requested;

c. Date, time, and place of hearing(s) prominently advertised in

each region affected;

d. Availability of draft section 111(d)/129 State plan for public

inspection in at least one location in each region to which it will

apply;

e. Notice of hearing provided to EPA Regional Administrator, local

affected agencies, and to other States affected;

f. Certification that the public hearing, if held, was conducted in

accordance with Subpart B State procedures; and

g. Hearing records must be retained for a minimum of 2 years; these

records must include the list of commenters, their affiliation, summary

of each presentation and/or comments submitted, and the State's

responses to those comments.

C. Technical Basis of the Standards and Guidelines

Section 129 requires the EPA to develop numerical emission

limitations in the standards for new HMIWI and guidelines for existing

HMIWI for the following: Particulate matter (PM), opacity, sulfur

dioxide (CO2), hydrogen chloride (HCl), oxides of nitrogen

(NOX), carbon monoxide (CO), lead (Pb), cadmium (Cd),

mercury (Hg), and dioxins and dibenzofurans (dioxin/furan). Section 129

requires that the standards and guidelines reflect the maximum degree

of reduction in emissions of air pollutants, taking into consideration

the cost of achieving such emission reduction, any nonair-quality

health and environmental impacts, and energy requirements that the

Administrator determines are achievable for a particular category of

sources. This control level is commonly referred to as the ``maximum

achievable control technology'' or ``MACT.'' Section 129 also provides

that standards for new sources may not be less stringent than the

emissions control achieved in practice by the best controlled similar

unit. This is commonly referred to as the ``MACT floor'' for new HMIWI.

Additionally, section 129 provides that the emission limitations in the

guidelines for existing HMIWI may not be less stringent than the

average emission limitation achieved by the best performing 12 percent

of units in the category. This is commonly referred to as the ``MACT

floor'' for existing HMIWI.

[[Page 48352]]

The CAA requires EPA to evaluate standards and guidelines more

stringent than the MACT floor, considering costs and other impacts

described above. If EPA concludes that more stringent standards and/or

guidelines are achievable considering costs and other impacts, then the

standards and/or guidelines would be established at these more

stringent levels (i.e., MACT would be more stringent than the MACT

floor). The EPA may establish NSPS or EG at the MACT floor only if EPA

concludes that the costs and/or other impacts associated with the more

stringent requirements are unreasonable. In no case may EPA establish

emission limitations less stringent than the MACT floor.

Technical data on the number and size of HMIWI, control

technologies in use, permit emission limits, and emission test data

were used to determine the MACT floors for new and existing HMIWI and

to define regulatory options more stringent than the MACT floors. The

types of data EPA considered in selecting final standards and

guidelines included emissions information from literature and State and

local agencies; and emissions test data provided by industry or

gathered during EPA's HMIWI emissions test program. Overall, the EPA

used performance test data from over 30 HMIWI to develop the standards

and guidelines.

In keeping with the Administrator's ``reinventing government''

initiative, several of the changes to the guidelines and standards were

made to streamline the regulations and provide increased flexibility

while optimizing environmental control by using common sense

initiatives. Examples of these changes include the following: (1)

Reduced testing for HMIWI demonstrating compliance with the required

emission levels; (2) narrowing the definition of medical waste; (3)

clarification of siting requirements for new HMIWI; (4) allowing HMIWI

operators to receive training and qualification through a State-

approved training program; (5) requiring facilities to develop a waste

management plan instead of banning materials from waste streams; (6)

revised text to clarify that the emission limits do not apply during

periods when units are burning only pathological, chemotherapeutic,

and/or low-level radioactive waste; (7) exemption for plants firing

small amounts of hospital waste and/or medical/infectious waste (10

percent or less by weight); (8) allowing certain records to be

maintained in either electronic or paper format without duplication;

and (9) establishing emission limits for existing HMIWI that may be met

with either a wet or dry scrubber. All of these changes are discussed

further in sections III, IV, and V of this preamble and in ``Hospital/

Medical/Infectious Waste Incinerators: Background Information for

Promulgated Standards and Guidelines--Summary of Public Comments and

Responses (EPA-453/R-97-006b). These changes improve the effectiveness

and efficiency of the standards and guidelines without any reduction in

environmental protection.

D. February 1995 Proposal

On February 27, 1995 (60 FR 10654), EPA published proposed NSPS and

EG for HMIWI. The 1995 proposal was the result of several years of

effort reviewing available information in light of the CAA requirements

described above.

During the data-gathering phase of the HMIWI project, it was

difficult to get an accurate count of the nationwide HMIWI population.

In addition, it was difficult to find HMIWI with add-on air pollution

control systems in place. Information from a few State surveys led to

an estimated population of 3,700 existing HMIWI.

The 1995 proposed standards and guidelines contained HMIWI

subcategories that were determined based on design differences among

different types of incinerators: continuous, intermittent, and batch.

These three design types roughly correlate to HMIWI size.

A few HMIWI with various levels of combustion control (no add-on

air pollution control) were tested to determine the performance of

combustion control in reducing HMIWI emissions. One HMIWI equipped with

a wet scrubber (add-on control) was tested to determine the performance

capabilities of wet scrubbing systems. A few other HMIWI equipped with

dry scrubbing systems (add-on control) were tested to determine the

performance capabilities of dry scrubbing systems. These systems were

considered typical of air pollution control systems available at the

time, and the data appeared to indicate that dry scrubbing systems

could achieve much lower emissions than wet scrubbing systems.

As mentioned above, the MACT floor for new HMIWI is to reflect the

emissions control achieved by the best controlled similar unit. Dry

scrubbing systems were identified on at least one HMIWI in each of the

three subcategories (continuous, intermittent, and batch).

Consequently, the MACT floor emission levels for the 1995 proposed NSPS

reflected the performance capabilities of dry scrubbing systems.

For existing HMIWI under the 1995 proposed emission guidelines,

State regulations and permits were used to calculate the average

emission limitation achieved by the best performing 12 percent of

units. These results were then compared with the results of the

emission tests on wet and dry scrubbing systems. This comparison led to

the conclusion that the 1995 proposed MACT floor for existing HMIWI

would require the use of a dry scrubbing system, even for small

existing batch HMIWI.

Following determination of the HMIWI population, subcategories,

performance of technology, and MACT floors, the CAA requires EPA to

consider standards and guidelines that are more stringent than the

floors. However, because the MACT floors calculated for the 1995

proposal were so stringent, EPA was left with few options to consider.

Emission limits reflecting the capability of dry scrubbing systems with

carbon were proposed for all sizes and types of new and existing HMIWI.

A proposal is essentially a request for public comment on the

information used, assumptions made, and conclusions drawn from the

evaluation of available information. Following the 1995 proposal, more

than 700 comment letters were received, some including new information

and some indicating that commenters were in the process of gathering

information for EPA to consider. The large amount of new information

that was ultimately submitted addressed every aspect of the 1995

proposed standards and guidelines, including: the existing population

of HMIWI, HMIWI subcategories, the performance capabilities of air

pollution control systems, monitoring and testing, operator training,

alternative medical waste treatment technologies, and the definition of

medical waste. In almost every case, the new information led to

different conclusions, as outlined below.

E. June 1996 Re-Proposal

On June 20, 1996, EPA published a Federal Register document to: (1)

Announce the availability of the new information received following the

1995 proposal, (2) review EPA's assessment of the new information, (3)

provide EPA's inclinations as to how the new information might change

the final standards and guidelines, and (4) solicit comments on EPA's

assessments and inclinations. In the June 20, 1996 Federal Register

document, EPA indicated that the notice was not a re-

[[Page 48353]]

proposal, but merely a notice of supplemental information. However,

some commenters stated that the 1996 notice should be considered a re-

proposal. Upon consideration of these comments, EPA now considers the

1996 notice to have been a re-proposal. The 1996 notice included all of

the elements of a re-proposal, including: A new inventory of sources;

new subcategories; revised assessments of emissions and performance of

technology; new MACT floors; new regulatory options; revised cost,

environmental, and economic impacts; an indication of EPA's selection

of MACT; and a request for public comment. More importantly, virtually

every aspect of the 1995 proposal was changed significantly by the 1996

notice, making most of the analyses and conclusions from the 1995

notice irrelevant. Therefore, in today's final rule, HMIWI which

commenced construction after June 20, 1996 are considered new sources

subject to the NSPS under Subpart Ec, and HMIWI which commenced

construction on or before June 20, 1996 are considered existing sources

subject to the EG under subpart Ce.

The 1996 re-proposal served as a response to most comments on the

1995 proposed rule. Comments on miscellaneous issues that were not

addressed in the 1996 re-proposal notice are summarized and responded

to in ``Hospital/Medical/Infectious Waste Incinerators: Background

Information for Promulgated Standards and Guidelines--Summary of Public

Comments and Responses'' (EPA-453/R-97-006b). The 1996 re-proposal

notice discussed the reanalyses of new information that led to changes

in the 1995 proposed standards and guidelines. Presented below is a

brief summary of the reanalyses that occurred following the 1995

proposal and a discussion of the EPA's inclinations that were

introduced in the 1996 re-proposal.

Following the 1995 proposal, a number of comments were received

regarding the EPA's inventory of existing HMIWI. Most commenters felt

that the EPA's inventory was inadequate and should be updated. In

response to these concerns, the EPA compiled a new inventory of

existing HMIWI based on information received from the American Hospital

Association, State agencies, HMIWI vendors, commercial medical waste

disposal companies, and other stakeholders. After several revisions,

the final HMIWI inventory contained approximately 2,400 existing HMIWI.

The Agency also reanalyzed the HMIWI subcategories based on the new

information received after the 1995 proposal. In the 1996 re-proposal,

the Agency stated that it was inclined to subcategorize the new and

existing population of HMIWI into three subcategories based on waste

charging capacity: small (200 lb/hr), medium (>200 and

500 lb/hr) and large (>500 lb/hr). While these subcategories

were based on HMIWI size, they also reflect design differences among

HMIWI.

Directly related to the issue of subcategorizing HMIWI by size is

the question of how to determine HMIWI size in a manner that is

consistent, uniform, and applicable to all HMIWI covered under the

standards and guidelines. In the 1996 re-proposal, the EPA stated that

it was inclined to base HMIWI capacity on either: (1) Volumetric waste

burning capacity factors developed using the design heat release rate

of the HMIWI and the heat content of medical waste or (2) an

enforceable limit that would restrict waste charge rate.

At the time of the 1995 proposal, relatively few emission test

reports were available to the EPA from which to draw conclusions

regarding the performance capabilities of various air pollution control

systems. Many commenters believed that EPA misjudged the performance

capabilities of various air pollution control technologies, especially

the capabilities of wet scrubbing systems. Following the 1995 proposal,

a number of emission test reports were submitted to EPA. The EPA

reviewed the data contained in these emission test reports and, as a

result, EPA's conclusions regarding the performance capabilities of

various air pollution control technologies were revised and presented

in the 1996 re-proposal.

As discussed earlier, the new information submitted led to changes

to the HMIWI inventory, subcategories, and conclusions about the

performance of technology. Because these factors can influence the MACT

floors, a review of the MACT floors was conducted. The recalculated

MACT floors and the new conclusions regarding the performance

capabilities of air pollution control technologies led to new

conclusions regarding what technologies HMIWI would have to use to

achieve the MACT floors.

In the 1996 re-proposal, the EPA defined regulatory options more

stringent than the MACT floors for new and existing HMIWI and presented

the impacts of the regulatory options. After reviewing the emissions

reductions that could be achieved and the impacts of the regulatory

options, the EPA presented its inclinations as to which emission levels

the final MACT standards and guidelines might reflect. For new medium

and large HMIWI, the EPA stated that it was inclined to adopt emission

limits that could be achieved with good combustion followed by a high

efficiency wet scrubber and a DI/FF system with carbon (i.e., combined

dry/wet scrubber with carbon). The EPA stated that it was inclined to

adopt emission limits that could be achieved with good combustion and a

moderate efficiency wet scrubber for new small HMIWI and for medium

existing HMIWI. For large existing HMIWI, the EPA stated that it was

inclined to adopt emission limits that could be achieved with the use

of good combustion and a high efficiency wet scrubber. The EPA offered

no inclinations for the emission limits for small existing HMIWI.

Instead, the EPA discussed the regulatory options and impacts for small

existing HMIWI and solicited comments on which emission levels would be

suitable for the final guidelines.

Many comments were also received regarding the 1995 proposed

testing and monitoring requirements. Commenters noted that the proposed

4-hour test run was much longer than the more conventional test run of

about 1-hour. Commenters also noted that many hospitals and health care

facilities would normally not have sufficient waste on hand to

accommodate three, 4-hour test runs and the 1995 proposed emission

testing requirements would substantially increase the costs associated

with emission testing. In response to these comments, the EPA stated in

the 1996 re-proposal that it was inclined to adopt requirements that

EPA test methods be followed when performing emissions testing to

determine compliance. This requirement would ensure that compliance

testing follows the same procedures used to generate the emission data

upon which the emission limits in the regulation were based. In most

cases, three test runs of about 1 hour each would be necessary to

determine compliance. An exception to this requirement would be

emission testing to measure dioxin/furan emissions. The procedures

outlined in the EPA test method frequently lead to test runs longer

than 1 hour to ensure sufficient sample is gathered to accurately

measure dioxin/furan emissions.

Numerous comments were received on the 1995 proposed annual

emission testing requirements. While some commenters supported the

annual testing requirements, others felt that the proposed requirements

for inspections, monitoring, and operator training were sufficient and

much less expensive than

[[Page 48354]]

annual testing. Some commenters suggested that the annual emission test

requirement be replaced with a requirement for annual equipment

inspection and maintenance. Many of the commenters supportive of the

proposed inspection requirements, however, suggested that the

requirement for a ``third party'' inspection be deleted. Therefore, EPA

stated in the 1996 re-proposal that it was inclined to include

inspection and maintenance requirements wherever annual stack testing

is not required and that the inspection would not have to be conducted

by a third party.

To consider comments on the 1995 proposal regarding the frequency

of emission testing and the proposed inspection and monitoring

requirements, EPA presented a matrix of testing and monitoring options

and their associated costs in the 1996 re-proposal. The EPA noted that

almost all of the emission testing and monitoring options under

consideration cost more than the incinerator or emission control system

that would be installed to meet the emission limits in the regulations.

Consequently, the Agency stated that it was inclined to include

monitoring of operating parameters and routine Method 9 opacity tests

(instead of CO and opacity CEMS) in the final regulations to minimize

costs.

With regard to specific air pollution control device (APCD)

operating parameters to be monitored, the Agency stated that it was

inclined to require monitoring of the same parameters as outlined in

the 1995 proposal for dry scrubbers, and the following for wet

scrubbers: Scrubber exit temperature, scrubber liquor pH, scrubber

liquor flow rate, and energy input to the scrubber (e.g., pressure drop

or horsepower).

The EPA also stated in the 1996 re-proposal that it was inclined to

require initial and repeat stack testing (annual/skip testing) where

the regulations are based on good combustion and wet and/or dry

scrubbing systems; and initial stack testing and routine inspections

where the regulations are based on the use of good combustion alone.

With the annual/skip testing requirement, emission tests would be

required for the first 3 years. If these tests show that the facility

was in compliance each of these 3 years, then subsequent testing would

be done every third year. Under the inclinations presented in the 1996

re-proposal, annual or skip emission testing would only require

emission testing of a few key or critical pollutants (i.e., only those

necessary to gain a good indication that the air pollution control

system is operating properly).

A large number of comments were received on the 1995 proposed

definition of medical waste. The majority of the commenters stated that

the proposed definition of medical waste was too broad and should be

narrowed. The commenters believed that the proposed definition would be

adopted by other regulatory agencies, and as the definition became more

widespread, that it would eventually force all health care facilities

to handle most of their waste as if it were infectious. This would

result in an increase in the volume of medical waste requiring special

handling, which in turn would result in increased costs to dispose of

waste from health care facilities. These commenters stated that health

care facilities should be viewed as generating two waste streams: A

medical waste stream, which is usually defined by the potential for

disease transmission and requires special handling; and a noninfectious

waste or ``health care trash'' waste stream, which has no potential for

infection and is treated and handled as municipal waste. The commenters

urged EPA to narrow the definition of medical waste used in the HMIWI

regulations to one that includes only the infectious portion of the

waste stream.

In response to the comments concerning the 1995 proposed definition

of medical waste, the EPA stated in the 1996 re-proposal that it was

inclined to adopt a definition of medical waste that focuses on the

infectious or potentially infectious portion of the overall medical

waste stream. Given the confusion and number of varying definitions of

medical waste in use at the Federal, State and local levels, the EPA

stated that it was inclined to adopt a definition of medical waste for

the HMIWI regulations from among those definitions already in use.

Specifically, the EPA stated that it was inclined to adopt the New York

State Department of Health (NYSDOH) definition of medical waste.

In the 1996 re-proposal, the EPA also stated that it was inclined

to exclude crematories and incinerators used solely for burning

pathological waste (human or animal remains and tissues), incinerators

used solely for burning ``off-spec'' or ``out of date'' drugs or

pharmaceuticals, and incinerators used solely for burning radioactive-

type medical wastes from the HMIWI regulations. The EPA further stated

that it was inclined to adopt separate regulations for pyrolysis

treatment technologies and requested comment on the merits of continued

development of separate pyrolysis regulations.

F. Stakeholders and Public Involvement

Throughout the development of the standards and guidelines, EPA

conducted meetings with stakeholders to explain EPA conclusions and

solicit comments, data, and information. Numerous discussions were held

with governmental entities, industry representatives, and environmental

groups including, but not limited to, the following: the U.S.

Conference of Mayors; the National League of Cities; the National

Association of City and County Health Officials; the National

Association of Counties; the National Association of Public Hospitals;

the Department of Defense; the Department of Veterans Affairs; the

American Hospital Association; the Medical Waste Institute; the Sierra

Club; the Natural Resources Defense Council; vendors of pyrolysis

units, HMIWI, continuous emission monitoring systems, and air pollution

control technologies; and the general public.

The standards and guidelines being adopted today were first

proposed in the Federal Register on February 27, 1995 (60 FR 10654).

The preambles for the 1995 proposed standards and guidelines described

the rationale for the proposed standards and guidelines. Following the

1995 proposal, the EPA provided interested persons the opportunity to

comment through a written comment period and held a public hearing. The

public comment period lasted from February 27, 1995 to April 28, 1995

and all late comments were accepted. Over 700 comments were received

from private citizens, industry representatives, environmental groups,

and governmental entities. Several public meetings and meetings with

industry stakeholders were held following the 1995 proposal to discuss

EPA's assessment of new information submitted with comments, to gather

additional information, and to solicit further comments. As discussed

above in sections II.D and II.E, the comments and new information

received following the 1995 proposal led to numerous changes to the

standards and guidelines.

On June 20, 1996, EPA re-proposed the standards and guidelines in

the Federal Register. Following the 1996 re-proposal, the EPA held a

public meeting to review the contents of the re-proposal and to answer

questions so that interested parties could better prepare their written

comments. The comment period remained open from June 20, 1996 until

August 8, 1996. Again, late comments were accepted. Nearly 70 comments

were received. The comments received following the 1996 re-proposal

were carefully considered

[[Page 48355]]

and changes were made to the HMIWI standards and guidelines where

appropriate. Sections III, IV, and V of this preamble discuss the

responses to comments on the standards and guidelines that address the

major concerns of the commenters on the 1996 re-proposal.

III. Considerations in Developing the Final Standards and

Guidelines

Following the June 20, 1996 re-proposal, the EPA received numerous

comments concerning applicability of the standards and guidelines,

pollution prevention, and the testing and monitoring requirements.

Special consideration was given to these issues when developing the

final HMIWI standards and guidelines. This section discusses these

issues and changes, if any, that were made to the final HMIWI standards

and guidelines following the 1996 re-proposal. Additional discussion

and responses to specific concerns regarding these and other issues are

provided in ``Hospital/Medical/Infectious Waste Incinerators:

Background Information for Promulgated Standards and Guidelines--

Summary of Public Comments and Responses'' (EPA-453/R-97-006b).

A. Applicability

A great deal of interest and discussion has taken place regarding

which incinerators should be subject to this rule and which should not.

All comments have been considered and the following sections present

EPA's final decisions.

1. Definition of Medical Waste

This section discusses the evolution of the definition of medical

waste used in determining the applicability of the HMIWI standards and

guidelines. In the 1996 re-proposal ``medical waste'' was the term used

to describe what is today called ``medical/infectious waste'' in the

final HMIWI standards and guidelines. Similarly, the term ``medical

waste incinerator'' or ``MWI'' was used to describe what is called

``hospital/medical/ infectious waste incinerator'' or ``HMIWI'' in the

standards and guidelines promulgated today.

Section 129 of the CAA directs the EPA to adopt regulations for

solid waste incineration units that combust ``hospital waste, medical

waste, and infectious waste.'' Section 129(g)(6) states that the term

``medical waste'' shall have the meaning ``established by the

Administrator pursuant to the Solid Waste Disposal Act.'' For the 1995

proposed air emission standards and guidelines for ``MWI,'' EPA adopted

the definition of ``medical waste'' from the solid waste regulations

codified in 40 CFR part 259, subpart B. As a result, medical waste was

defined broadly as any solid waste that is generated in the diagnosis,

treatment, or immunization of human beings or animals, in research

pertaining thereto, or in the production or testing of biologicals. The

broad definition of medical waste in the 1995 proposal was not intended

to be used to identify ``infectious'' or ``potentially infectious''

items in the health care waste stream. The EPA's only intention was to

define those items likely to be burned in an ``MWI'' for the sake of

defining and regulating the air emissions from incinerators used to

burn ``hospital waste, medical waste, and infectious waste.''

As discussed earlier, the majority of the comments on the 1995

proposed definition of medical waste stated that the proposed

definition was too broad and should be narrowed. Consequently, the 1996

re-proposal announced EPA's inclination to adopt an existing and more

narrow definition of medical waste for the purpose of regulating

``MWI.'' Specifically, the EPA stated that it was inclined to adopt the

definition of medical waste created by the New York State Department of

Health (NYSDOH). While inclined to adopt the NYSDOH definition, the EPA

stated in the 1996 re-proposal that it was also considering definitions

of medical waste adopted by other regulatory agencies and national

associations as well as the 1995 proposed definition. The EPA solicited

public comment on the merits of each definition as well as other

definitions EPA should consider.

Following the 1996 re-proposal, several commenters supported a

definition of medical waste that is limited to potentially infectious

materials and several commenters agreed that the NYSDOH definition of

medical waste is appropriate. Other commenters suggested that the EPA

Office of Solid Waste (OSW) definition of regulated medical waste (RMW)

is more appropriate than the NYSDOH definition because Congress

intended for EPA to use the Solid Waste Disposal Act (SWDA) definition.

On the other hand, several commenters argued that a broad

definition of medical waste is appropriate. The commenters stated that

anything burned in an incinerator at a health care facility should be

classified as medical waste and pointed out that the CAA requires EPA

to regulate emissions from solid waste incineration units ``combusting

hospital waste, medical waste and infectious waste.'' The commenters

contended that facilities operating onsite incinerators would use them

primarily for noninfectious waste, which produces emissions similar to

medical waste when burned.

The EPA has concluded that the Medical Waste Tracking Act (MWTA)

definition of regulated medical waste is the most appropriate

definition of medical/infectious waste for the final HMIWI standards

and guidelines. As noted in the proposal and re-proposal, the EPA

considered several definitions for purposes of these regulations (e.g.,

OSHA, NYSDOH, MWTA, AHA). Although the various definitions are not

identical, they cover many of the same materials. After considering the

comments received, the EPA today is promulgating the MWTA definition

under the co-authority of section 2002 of the SWDA, 42 U.S.C. 6912, and

sections 129 and 301 of the CAA, 42 U.S.C. 7429 and 7601.

The EPA believes the MWTA definition is the most appropriate

because it includes the materials of concern, and will lead to the

least confusion in the regulated community because it is a familiar

definition. In addition, the MWTA definition has undergone public

comment at the Federal level, during both the rulemaking under the

MWTA, as well as rulemaking on these regulations. The EPA emphasizes

that the MWTA definition being promulgated today is solely for purposes

of determining which incineration units are covered by the HMIWI

regulations under section 129 of the CAA. It is not for purposes of

determining applicability of SWDA requirements. THE MWTA definition,

however, does not include hospital waste; thus, EPA also is

promulgating today under authority of sections 129 and 301 of the CAA,

42 U.S.C. 7429 and 7601, a definition of hospital waste.

The MWTA differentiates between infectious and noninfectious

wastes. The MWTA definition of RMW includes seven classes of waste

which are very similar to the classes of infectious waste included in

the NYSDOH definition. However, the MWTA definition of RMW is broader

than the NYSDOH definition of medical waste because the MWTA definition

includes some items (e.g., intravenous bags) which may not be

infectious, but are aesthetically unpleasing. The MWTA definition does

not include hazardous waste; household waste; ash from incineration of

medical/infectious waste; human corpses, remains, and anatomical parts

intended for interment or cremation; or domestic sewage materials.

[[Page 48356]]

The EPA recognizes that the MWTA definition does not fully

encompass the terms ``hospital waste, medical waste, and infectious

waste.'' The MWTA definition, as well as other definitions considered

for the final HMIWI regulations, cover ``medical waste and infectious

waste,'' but do not cover ``hospital waste.'' Commenters are correct in

pointing out that the emissions from combustion of hospital waste are

very similar to emissions from the combustion of medical/infectious

waste. Therefore, the final HMIWI standards and guidelines contain

definitions for ``hospital'' and ``hospital waste'' and the definition

of ``medical/infectious waste'' (MWTA definition). The definitions of

``hospital'' and ``hospital waste'' will subject incinerators located

at hospitals to the final standards and guidelines, whether they burn

``infectious'' waste, ``noninfectious'' waste, or a combination.

Commenters on the 1995 proposed regulations stated there are very

few, if any, incinerators that are used by hospitals to burn only

noninfectious hospital trash. Consequently, this inclusion of

``hospital waste'' along with ``medical/infectious waste'' should:

minimize the concern about the overly broad definition of medical

waste; cover the same incinerators as envisioned in the 1995 proposal

and 1996 re-proposal, resulting in the same emission reductions without

imposing additional costs; and satisfy the CAA requirement to regulate

solid waste incinerators combusting ``hospital waste, medical waste,

and infectious waste.'' On the other hand, section 129 directs EPA to

develop regulations for four categories of solid waste incinerators.

Because municipal waste combustors (MWC), industrial/commercial waste

incinerators, and other solid waste incinerators sometimes burn small

amounts of hospital waste and/or medical/infectious waste, and because

these other categories are already or will be subject to section 129

regulations, the final HMIWI regulations focus on incinerators whose

primary purpose is the disposal of hospital waste and/or medical/

infectious waste in an effort to avoid duplicative requirements.

Combustors subject to subparts Ea, Eb, or Cb (the NSPS and EG for MWC

larger than 250 tons per day) have been excluded from coverage under

the HMIWI regulations. In addition, any incinerator which burns 10

percent or less by weight hospital waste and medical/infectious waste

is not subject to the final HMIWI standards and guidelines. This 10

percent provision is discussed further in section A.2 ``Co-fired

Combustors'' (below).

The primary purpose of the MWTA definition of medical waste as used

for the HMIWI standards and guidelines is to define items combusted in

an HMIWI, and not to define items which could transmit disease. Only a

small fraction of ``medical/infectious'' waste is truly ``infectious.''

The EPA believes that to add or remove specific items to or from the

MWTA definition, as suggested by some commenters, would create

additional regulatory confusion because the revised definition would

essentially become a new definition of medical waste if altered. Any

waste excluded from the MWTA definition is either covered now or will

be covered in the future by other solid waste incinerator regulations.

The final standards and guidelines will apply to hospital/medical/

infectious waste incinerators. It should be noted that the definition

of medical/infectious waste adopted for the HMIWI regulations is not

the government-wide Federal definition, or even the Agency-wide EPA

definition of infectious waste. The medical/infectious waste definition

contained in the final regulations promulgated today is for use in

determining applicability of the HMIWI standards and guidelines only.

It should also be noted that ``hospital waste'' is simply waste

generated at a hospital. Most of the waste generated at a hospital (85

to 90 percent or more) is simply municipal-type waste that may be

recycled or disposed without special treatment. The use of the term

``hospital waste'' in these regulations is for use in determining

applicability of the HMIWI standards and guidelines only.

2. Co-fired Combustors

In the 1996 re-proposal, the EPA provided no inclinations regarding

the applicability of the HMIWI regulations to combustors that co-fire

medical waste with other fuels or wastes. Some examples of units that

might be used to co-fire medical waste along with other fuels or wastes

include municipal waste combustors (MWC), boilers, and industrial/

commercial waste incinerators. During the public comment period

following the 1996 re-proposal, several comments were received

questioning the applicability of the HMIWI regulations to units that

co-fire medical waste with other fuels or wastes.

One commenter provided information on a circulating fluidized bed

combustor (CFBC) steam plant which co-fires coal and medical waste. The

commenter noted that traditional HMIWI burn materials with low sulfur

content and that the proposed SO2 emission limit was

arbitrarily set higher than actual HMIWI emissions. The commenter

requested that the SO2 emission limit be raised to 100 ppm

to accommodate the CFBC without affecting other incinerators that burn

medical waste.

Other commenters requested that ``potentially infectious'' medical

waste and ``off-spec'' or ``out-of-date'' pharmaceuticals be allowed to

be combusted in MWC along with municipal solid waste (MSW) without

subjecting MWC to the HMIWI rules. The commenters noted that MWC which

co-combust municipal and medical waste are regulated under the MWC

emission standards. The commenters recommended that an exclusion be

written into the final rule that will allow MWC combusting a minimal

amount of medical waste (up to 10 percent of the waste stream) to be

excluded from the HMIWI rule. The commenters suggested that, if EPA

feels that co-combustion of MSW and medical waste in a small MWC not

covered under the MWC standards is an environmental threat, that co-

combustion should not be allowed in MWC burning less than 40 tons per

day. Other commenters stated that small MWC not regulated under the MWC

standards should not be allowed to accept medical waste without

complying with the HMIWI regulations.

Other commenters requested that a ``de minimis'' quantity exemption

be allowed for facilities that incinerate insignificant quantities of

medical waste. Some commenters requested that clinical waste in the

amount of 5 to 10 percent of the total waste stream be allowed to be

disposed of in a pathological waste incinerator.

Section 129 requires the EPA to develop NSPS and EG for MWC, HMIWI,

industrial/commercial waste incinerators, and ``other'' solid waste

incinerators. The final NSPS and guidelines applicable to MWC with

capacities of greater than 40 tons/day were promulgated in December

1995, but have since been partially vacated and remanded. In this case,

it is not the EPA's intent for MWC to be dually covered under both the

MWC regulations and the HMIWI regulations. Therefore, combustors

subject to Subparts Ea, Eb, or Cb (the NSPS and EG for MWC larger than

250 tons/day) have been excluded from coverage under the HMIWI

regulations regardless of the amount of hospital waste or medical/

infectious waste combusted. As regulations are developed under Section

129 for the other categories of solid waste incinerators, EPA will make

clear which regulations apply to which incinerators. In some cases,

incinerators

[[Page 48357]]

may be subject to more than one regulation.

Commenters requesting that MWC, boilers, and other industrial

processes that co-fire medical waste be exempted from coverage under

the HMIWI regulations generally seem to agree that these units combust

no more than 10 percent hospital waste and/or medical/infectious waste.

Therefore, the final HMIWI NSPS and guidelines contain the provision

that any incinerator or industrial process that combusts less than or

equal to 10 percent hospital waste and medical/infectious waste (by

weight) is not subject to the HMIWI NSPS and guidelines provided that

the facility notifies the Administrator of an exemption claim and

maintains records of the amount of hospital waste, medical/ infectious

waste, and other fuels or wastes combusted.

As discussed in section A.3 ``Waste Types'' (below), ``off-spec''

or ``out-of-date'' drugs are not considered to be medical/infectious

waste as defined in the final HMIWI regulations and are not considered

to be hospital waste, unless disposed with the hospital's waste. ``Off-

spec'' or ``out-of-date'' drugs are viewed the same as other fuels or

wastes (e.g., municipal waste, coal, etc.) under HMIWI regulations.

Therefore, incinerators that combust waste pharmaceuticals (i.e.,

``off-spec'' or ``out-of-date'' drugs), and combust 10 percent or less

hospital waste and medical/infectious waste (by weight) are not subject

to the HMIWI regulations. However, any incinerator that combusts waste

pharmaceuticals along with more than 10 percent hospital waste and

medical/infectious waste is subject to the HMIWI regulations.

As also discussed in section A.3 ``Waste Types'' (below),

pathological waste, chemotherapeutic waste, and low-level radioactive

waste are considered ``excluded'' wastes. While these wastes sometimes

meet the definition of hospital waste or medical/infectious waste, they

are viewed the same as ``other'' fuels or wastes (e.g., municipal

waste, coal, etc.) when calculating the amount of hospital waste and

medical/infectious waste burned in a co-fired combustor. For example, a

combustor burning 90 percent pathological waste with 10 percent

hospital waste is a co-fired combustor, even if the pathological waste

meets the definition of medical/infectious waste. However, any

incinerator that combusts pathological, chemotherapeutic, and/or low-

level radioactive waste along with more than 10 percent of other

materials meeting the definition of hospital waste and/or medical/

infectious waste is subject to the HMIWI regulations.

While incinerators that burn 10 percent or less hospital waste and

medical/infectious waste are excluded from the HMIWI regulations, this

exclusion does not mean that EPA will not develop regulations which

will cover these units in the future. The NSPS and EG that were

recently remanded for MWC with capacities between 40 tons/day and 250

tons/day will be revised and repromulgated. Furthermore, the CAA

directs the EPA to develop regulations for all solid waste

incinerators, including MWC with capacities less than 40 tons/day. The

EPA has announced that regulations for other solid waste incinerators

will be developed by the year 2000. Thus, burning of hospital waste or

medical/infectious wastes in other solid waste incineration units will

be covered by regulations developed within the next few years.

Exclusion of incinerators that burn small amounts of hospital waste or

medical/infectious waste from the HMIWI regulation is only a temporary

deferment from regulation if these units are not presently regulated

under section 129.

3. Waste Types

In the 1996 re-proposal, the EPA stated that it was inclined to

exclude crematories and incinerators used solely for burning

pathological waste from coverage under the HMIWI regulations. The EPA

also stated that it was inclined to exclude incinerators used solely

for burning low-level radioactive waste or ``off-spec'' and ``out-of-

date'' pharmaceuticals. This section discusses the major public

comments received regarding exemption of specific wastes from the HMIWI

standards and guidelines.

Several commenters requested that crematories and incinerators used

solely for burning pathological waste be excluded from the HMIWI

regulation. One commenter questioned whether animal waste is to be

included, excluded, or partially excluded from the regulation. Another

commenter stated that there are no effective alternative disposal

options for pathological waste, especially for large domestic animal

carcasses (i.e., cows and horses). Several commenters also requested

that incinerators used to burn only ``off-spec'' and ``out-of-date''

drugs or low-level radioactive waste be excluded from the regulation.

One commenter stated that crematories and incinerators used to burn

drugs, low-level radioactive waste, and pathological waste are already

covered under other regulations, or will be covered under regulations

developed through EPA's Industrial Combustion Coordinated Rulemaking

(ICCR) project. Other commenters urged EPA to exclude units permitted

under section 3005 of the SWDA from the HMIWI rule. One commenter

argued that section 129 of the CAA statutorily prohibits EPA from

regulating in the HMIWI rule hazardous waste combustion units which are

to be regulated under the Resource Conservation and Recovery Act

(RCRA).

Pathological waste, low-level radioactive waste, and

chemotherapeutic waste are different from most hospital waste and

medical/infectious waste and are often burned in incinerators which

burn these wastes exclusively. While these wastes often times meet the

definition of hospital waste or medical/infectious waste, the

combustion of these materials warrants separate consideration.

Pathological waste, chemotherapeutic waste, and low-level radioactive

waste are considered ``excluded'' wastes, regardless of whether the

waste meets the definition of hospital waste or medical/infectious

waste in the HMIWI regulations. Consequently, in determining the amount

of hospital waste and medical/infectious waste burned in a co-fired

combustor, these ``excluded'' wastes are included in the calculation as

``other'' wastes (they do not count toward the 10 percent hospital

waste and medical/infectious waste), as discussed above in section A.2.

In addition, incinerators that are otherwise subject to the HMIWI

regulations are exempt during periods when only pathological waste,

low-level radioactive waste, and/or chemotherapeutic waste is burned.

These latter units must keep records of the periods of time when only

pathological, chemotherapeutic, and low-level radioactive wastes are

burned.

With regard to crematories, human remains intended for interment or

cremation are not hospital waste or medical/infectious waste.

Consequently, crematories are not subject to the HMIWI regulations

unless they burn waste that meets the definition of hospital waste or

medical/infectious waste.

While pathological incinerators, chemotherapeutic and low-level

radioactive waste incinerators, and crematories are excluded from the

final HMIWI standards and guidelines, this exclusion does not mean that

EPA will not develop regulations which will cover these incinerators in

the future. The CAA directs the EPA to develop regulations for all

solid waste incinerators. The EPA is developing separate regulations

which will cover these units as part of the ``other'' category of solid

waste incineration

[[Page 48358]]

units within the ICCR project. The EPA has announced that regulations

for other solid waste incinerators will be developed by the year 2000.

Thus, cremation and burning of pathological, chemotherapeutic, and low-

level radioactive wastes will be covered by regulations developed

within the next few years. Exclusion of crematories and incinerators

burning pathological, chemotherapeutic, and low-level radioactive waste

from the HMIWI regulation is only a temporary deferment.

Pharmaceutical wastes such as ``off-spec'' or ``out-of-date'' drugs

are not considered to be medical/infectious waste as defined in the

final HMIWI regulations. Also, pharmaceutical wastes are not considered

to be hospital waste unless generated at a hospital and disposed with

the hospital's waste. In the HMIWI regulations ``hospital waste'' is

defined as discards generated at a hospital, excluding human remains

and unused items returned to the manufacturer. Thus, ``out-of-date''

drugs returned by a hospital to a pharmaceutical company for disposal

are not considered hospital waste. Waste pharmaceuticals are viewed the

same as other fuels and wastes (e.g., municipal waste, coal, etc.)

under the HMIWI regulations. Therefore, incinerators that combust waste

pharmaceuticals, and combust 10 percent or less hospital waste and

medical/infectious waste (by weight) are not subject to the HMIWI

regulations. However, any incinerator that combusts waste

pharmaceuticals along with more than 10 percent hospital waste and

medical/infectious waste is subject to the HMIWI regulations.

Section 129(g)(1) of the CAA specifically exempts from the HMIWI

NSPS and guidelines solid waste incinerators required to have a permit

under section 3005 of the SWDA. To be consistent with section 129, the

final HMIWI standards and guidelines specifically exempt incinerators

permitted under section 3005 of the SWDA. In addition, the definition

of medical/infectious waste in the final regulations specifically

excludes hazardous waste identified or listed under the regulations in

40 CFR Part 261.

4. Cement Kilns

Some commenters pointed out that section 129 clearly addresses

incinerators, not cement kilns. Commenters stated that HMIWI and cement

kilns using medical waste as fuel are two completely different devices

and should not be confused with each other or regulated under the same

air emissions control standards. One commenter recommended that if EPA

concludes that Congress intended to regulate cement kilns under section

129, EPA should not impose emission limitations and other requirements

that were written for HMIWI on cement kilns.

The EPA disagrees with commenters that contend EPA has no authority

to regulate cement kilns under section 129. Section 129(a)(1)(A)

requires the Administrator to establish performance standards and other

requirements for each category of solid waste incineration units.

Congress specifically listed in section 129 various categories of solid

waste incineration units that EPA must regulate. Section 129(g)(1)

broadly defines solid waste incineration unit as ``a distinct operating

unit of any facility which combusts any solid waste material * * *''

(emphasis added). This definition clearly indicates Congress' intent to

regulate more than just incinerators because the definition sweeps

within its scope any facility that is combusting any solid waste

material.

Further evidence of EPA's authority to regulate cement kilns under

section 129 is presented in ``Hospital/Medical/Infectious Waste

Incinerators: Background Information for Promulgated Standards and

Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-97-

006b). However, the EPA does recognize that cement kilns are different

from HMIWI in size, design, and operation. Accordingly, the EPA is not

regulating cement kilns under this regulation, but instead, is

determining whether separate regulations under section 129 are

appropriate for cement kilns combusting solid waste materials.

B. Pyrolysis Units

In the 1996 re-proposal, the EPA stated that it was considering a

separate regulation for pyrolysis units that would look very similar to

the HMIWI regulation in that it would contain definitions, emissions

limitations, monitoring and testing requirements to demonstrate

compliance, and reporting and recordkeeping requirements. However, the

separate pyrolysis regulation would differ from the HMIWI regulations

in that some definitions would be different, the emission limitations

would, in many cases, be more stringent than the HMIWI regulations, and

the monitoring and testing requirements would reflect the operating

parameters that are unique to pyrolysis systems.

Following the 1996 re-proposal, several commenters encouraged EPA

to promulgate separate standards for medical waste pyrolysis (MWP)

units. One commenter noted that separate regulations would contain

emission limits more stringent than the HMIWI regulations and reflect

the unique features of pyrolysis units.

Other commenters suggested that EPA modify the 1995 proposed HMIWI

regulations to include pyrolysis units and defer the final promulgation

of separate pyrolysis regulations. The commenters stated that

variations in the operating characteristics among pyrolysis

technologies would make separate pyrolysis regulations unwieldy to

implement at this time. The commenters requested that EPA modify the

HMIWI regulations to provide flexibility if a specific operator

training, siting, performance verification, compliance verification,

monitoring, recordkeeping or reporting requirement does not directly

apply to a pyrolysis system.

Other commenters stated that pyrolysis units are similar to

conventional incinerators and requested that they be included under the

HMIWI regulations. The commenters stated that, if EPA regulates

pyrolysis units separately, that MACT floor levels should be based on

available test data, and the pyrolysis regulation should be issued

concurrently with the final HMIWI regulations.

The various arguments for and against developing separate

regulations for pyrolysis units lead to three options for developing

regulations for pyrolysis units: (1) Regulate pyrolysis under the

standards and guidelines being promulgated today; (2) exempt pyrolysis

units from the HMIWI regulations and simultaneously promulgate separate

regulations for pyrolysis units; and (3) exempt pyrolysis units from

the HMIWI regulation and defer the development of separate regulations.

Pyrolysis technology is different from conventional incineration.

Because air is generally not used in the pyrolysis treatment process,

the volume of exhaust gas produced from pyrolysis treatment is likely

to be far less than the volume of gas produced from the burning of

waste in an HMIWI. Although conventional combustion does not occur

during pyrolysis treatment, there are some emissions from the pyrolysis

process.

As discussed in the 1996 re-proposal, the EPA developed a draft

regulation for pyrolysis units. The 1996 re-proposal pointed out that

the draft regulatory text was incomplete and it included placeholders

and requests for information where such information was lacking. The

EPA requested

[[Page 48359]]

comments to help fill in the missing information.

Following the 1996 re-proposal, the EPA received information for

use in developing the separate pyrolysis regulation from vendors of

pyrolysis technology. As pointed out by one commenter and supported by

the information received from pyrolysis vendors, there are variations

in the operating characteristics among pyrolysis technologies that

would make separate regulations for pyrolysis units very difficult to

implement at this time. As a result, the EPA has concluded that

sufficient information is not available to develop a separate and

uniform regulation for pyrolysis technology that would contain

requirements that are technically feasible for all pyrolysis units.

Because separate regulations for pyrolysis technology cannot be

developed at this time, the EPA considered modifying the HMIWI

regulations to include pyrolysis units. However, nearly all aspects of

the HMIWI regulations would have to be altered to accommodate pyrolysis

units including the format of the emission limits, the operator

training requirements, siting requirements, the testing and monitoring

requirements, and the reporting and recordkeeping requirements.

Furthermore, the HMIWI subcategories and MACT floors would not be

appropriate for pyrolysis units. Due to variations in the operating

characteristics of pyrolysis technologies and the differences between

HMIWI and pyrolysis technologies, it is unclear how the HMIWI

regulations could be modified to feasibly cover pyrolysis technologies

as well as HMIWI.

Section 129 requires EPA to develop NSPS and EG for ``solid waste

incineration units * * * combusting hospital waste, medical waste, and

infectious waste.'' As discussed above, pyrolysis and conventional

incineration are not the same. Because regulations developed for HMIWI

are not appropriate for pyrolysis technologies, pyrolysis treatment

technologies have specifically been excluded from coverage under the

final HMIWI standards and guidelines. The EPA may consider these

devices in future regulatory development.

C. Waste Management Plans

During the public comment period following the 1996 re-proposal,

several commenters stated that the EPA standards for HMIWI are reliant

on pollution control and give little attention to pollution prevention.

The commenters stated that recycling and pollution prevention measures

could yield greater reductions in emissions than add-on controls alone.

Some commenters stated that Congress intended for EPA to use process

changes or substitution of materials to help eliminate emissions. Some

commenters stated that dioxin/furan, HCl, and Hg emissions could be

controlled through a pollution prevention program that reduces or

eliminates incineration of chlorinated materials and batteries. One

commenter requested that EPA suggest pollution prevention measures for

controlling Hg as well as other pollutant precursors (i.e., lead,

cadmium, chlorine, nitrogen, fluorine, and sulfur). The commenter

maintained that the economic impact of the HMIWI regulations could be

reduced significantly if EPA required medical facilities to institute

pollution prevention techniques.

The types of materials sent to an HMIWI vary from facility to

facility depending on facility operating practices, which are defined

by purchasing decisions, waste handling procedures, and other practices

that affect the types of materials incinerated.

In the February 1995 proposal, the EPA stated that it had no data

to indicate the effects of waste handling practices on emissions of

various pollutants and requested comments on the extent to which

operating practices could influence emissions. To evaluate the

effectiveness of waste segregation programs, the EPA specifically

solicited detailed descriptions of programs and results of performance

tests conducted to demonstrate pollutant emission levels from the HMIWI

prior to implementation of the program and subsequent to implementation

of the program. In addition, the EPA solicited comments on how such a

program could be incorporated into the HMIWI regulations.

Following the 1995 proposal, the EPA received no data to

conclusively indicate the effectiveness of waste segregation programs

in reducing emissions from HMIWI. Therefore, the final HMIWI standards

and guidelines are primarily based on air pollution controls rather

than pollution prevention. However, as discussed in the 1996 re-

proposal, EPA has included pollution prevention measurements in setting

the Hg emission limit for good combustion. To ensure that emissions of

Hg from facilities with good combustion controls meet the final

emission guidelines for Hg, EPA is requiring that these facilities

conduct a Hg emission test. If the facility fails the emission test,

the facility will need to implement Hg pollution prevention measures or

install an APCD to meet the emission limits.

The EPA has investigated the impacts on emissions of shifting the

waste composition from chlorinated plastics to non-chlorinated

polymers. However, the outcome of this investigation is inconclusive. A

number of studies have concluded that the chlorine content of the waste

is directly related to dioxin/furan emissions, while other studies

suggest there is no relationship between the chlorine content of the

waste and dioxin/furan emissions. At this point, the effectiveness of a

pollution prevention program directed at reducing dioxin/furan

emissions through shifting the waste composition from chlorinated

plastics to nonchlorinated polymers would be questionable.

A number of health care facilities have implemented waste

management measures to reduce the overall volume of waste. However, it

should be stressed that each health care facility is unique and site-

specific strategies must be developed that achieve the most efficient

results. Through the development of individual waste management

programs, health care facilities can achieve significant reductions in

their waste stream, reduce the volume of waste to be incinerated, and

thereby reduce the amount of air pollution emissions associated with

that waste. Therefore, the final HMIWI standards and guidelines require

that health care facilities which operate incinerators develop and

implement a waste management plan.

The waste management plan would identify both the feasibility and

the approach to separate certain components of solid waste from the

health care waste stream in order to reduce the amount of toxic

emissions from incinerated waste. The waste management plan may include

elements such as paper, cardboard, plastics, glass, battery, or metal

recycling; or purchasing recycled or recyclable products. A waste

management plan may include different goals or approaches for different

areas or departments of the facility and need not include new waste

management goals for every waste stream. It should identify, where

possible, reasonably available additional waste management measures,

taking into account the effectiveness of waste management measures

already in place, the costs of additional measures, the emission

reductions expected to be achieved, and any other environmental or

energy impacts they might have. A copy of the waste management plan

would be submitted to EPA along with the results of the initial

performance test demonstrating compliance with the emission limits. In

addition, the waste

[[Page 48360]]

management plan may be reviewed by the Joint Commission on

Accreditation of Health Care Organizations during the accreditation

process.

Health care facilities are encouraged to review and incorporate

into their waste management plans the waste minimization techniques

discussed in ``An Ounce of Prevention: Waste Reduction Strategies for

Health Care Facilities,'' which is published by the American Society

for Health Care Environmental Services of the American Hospital

Association. This document may be obtained by contacting AHA Services,

Inc., P.O. Box 92683, Chicago, Illinois 60675-2683, or by calling 800-

242-2626. The cost of the document is $50.00 plus $10.95 for shipping

and handling. The document is available for public inspection at EPA's

Air and Radiation Docket and Information Center (Docket A-91-61, item

IV-J-124). See the ADDRESSES section at the beginning of this preamble

for the location of the Docket. Note that because of copyright law,

this document may not be copied. This document was approved for

incorporation by reference by the Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

D. Testing, Monitoring, and Inspection

Section 129(c) of the CAA requires the EPA to include emissions

monitoring and testing requirements in the regulation. The purpose of

these requirements is to allow the EPA to determine whether a source is

operating in compliance with the regulations.

In the 1996 re-proposal, the EPA stated that it was inclined to

adopt requirements that EPA test methods be followed when performing

any emission testing required to determine compliance with the HMIWI

regulations. In most cases, three test runs of about 1 hour each would

be necessary to determine compliance. The EPA also stated in the 1996

re-proposal that it was inclined to include in-house inspection and

maintenance requirements wherever annual stack testing was not

required. To minimize costs, the EPA stated that it was inclined to

include requirements for monitoring of operating parameters and routine

Method 9 (stack opacity) testing in the final regulations instead of CO

and opacity continuous emissions monitoring systems (CEMS) for onsite

HMIWI. Where the regulations are based on wet and/or dry scrubbing

systems, the EPA stated that it was inclined to require initial and

repeat stack testing (annual/skip testing where annual testing is

required for the first 3 years and, if these tests show compliance,

subsequent testing would be done every third year). Where the

regulations are based, in part, on the use of good combustion alone,

the EPA stated that it was inclined to require initial stack testing

and routine inspections. The EPA solicited public comment on all of the

testing and monitoring inclinations presented in the 1996 re-proposal.

In addition, because some CEMS vendors questioned the CEMS and

parameter monitoring costs developed by EPA, the EPA solicited public

comment on the costs of CEMS and monitoring of operating parameters.

Several comments concerning the EPA's inclinations for monitoring

and testing were received following the 1996 re-proposal. One commenter

requested that EPA require CEMS for CO, HCl, SO2,

NOX, Hg, and PM. The commenter contended that CEMS for CO,

HCl, SO2, NOX, Hg, and PM would eliminate the

need for stack testing. The commenter stated that the only way to

ensure compliance at all times, as mandated by the CAA, is through the

continuous use of CEMS. One commenter stated that EPA should require

continuous monitoring of CO emissions from all HMIWI, continuous

opacity monitoring at large incinerators, and continuous monitoring of

HCl emissions from very large (>1000 lb/hr) incinerators. The commenter

indicated that continuous monitoring of CO and O2 is the

only way to ensure that good combustion is occurring. The commenter

concluded that CO and O2 ``process'' monitors should be

sufficient for HMIWI with capacities less than 500 lb/hr. The commenter

stated that EPA's inclination not to require continuous monitoring is

based on inaccurate CEMS costs.

A number of commenters supported EPA's inclination to determine

compliance using parameter monitoring and routine inspection and

maintenance rather than CEMS. One of the commenters supported

monitoring of operating parameters and routine Method 9 testing

combined with initial stack testing and annual inspections to ensure

compliance with the rule. Another commenter stated that an initial

stack test for the primary pollutants and regular inspection,

maintenance, and daily recording of operating parameters would be

appropriate. One commenter stated that monitoring of operating

parameters with no CEMS and substitute stack testing with annual

inspections would provide an excellent means to attain low emissions

for minimal costs for small HMIWI. Other commenters recommended

monitoring operating parameters and routine Method 9 testing with

initial stack testing and no repeat testing. Another commenter

suggested that an initial performance test and monitoring is sufficient

and that additional tests are not necessary especially given operator

training, inspections, and monitoring.

The most direct means of ensuring compliance with emission limits

is the use of CEMS. As a matter of policy, the first and foremost

option considered by EPA is to require the use of CEMS to demonstrate

continuous compliance with specific emission limits. Other options are

considered only when CEMS are not available or when the impacts of

including such requirements are considered unreasonable. When

monitoring options other than CEMS are considered, there is always a

tradeoff between the cost of the monitoring requirement and the quality

of the information collected with respect to determining actual

emissions. While monitoring of operations (operating parameters) cannot

provide a direct measurement of emissions, it is usually much less

expensive than CEMS, and the information provided can be used to ensure

that the incinerator and associated air pollution control equipment are

operating properly. This information provides EPA and the public with

assurance that the reductions envisioned by the regulations are being

achieved.

For the 1996 re-proposal, testing and monitoring costs were

developed for a range of options, and the Agency concluded that the

cost of CEMS were unreasonably high relative to the cost of the

incinerators and air pollution control systems needed for compliance.

Based on comments and information received as a result of the 1996 re-

proposal, the cost estimates for CEMS and parameter monitoring have

been revised. While the cost estimates for CEMS have been significantly

reduced and additional costs have been included for parameter

monitoring, it appears that the annual costs of monitoring requirements

which include CEMS are still quite high compared to the cost of the

incinerator and air pollution control device required to meet the

emission limits.

A large HMIWI costs approximately $120,000/yr to operate, while an

add-on APCD can cost from $150,000 to $300,000/yr to operate. The most

comprehensive monitoring option including CEMS for HCl and CO costs

about $95,000/yr. This option costs nearly as much to operate as the

incinerator itself and could represent as much as half the cost of the

APCD. In addition, the only emissions that are directly measured are

HCl and CO. Consequently, the most comprehensive

[[Page 48361]]

monitoring option that could be selected for large HMIWI is considered

unreasonable.

There are no direct measurements of dioxin/furan or toxic metals.

Particulate matter and Hg CEMS are currently under development but have

not been demonstrated in the United States to be capable of accurately

and reliably measuring PM or Hg emissions for use in determining

compliance with PM or Hg emission limits at this time. With regard to

SO2 and NOX, the emission limits in the final

regulations reflect uncontrolled emissions. Therefore, it is

unreasonable to impose a cost (of monitoring) where no emission

reduction benefit will be gained.

Looking at other options for large HMIWI, the only CEMS available

are CO/O2 and opacity. For a large HMIWI equipped with a

sophisticated APCD like a wet scrubber, dry scrubber, or combined dry/

wet scrubber, these CEMS provide very little information regarding the

pollutants that are of most concern to the public (i.e., dioxin/furan

and toxic metals). Consequently, because the APCD already represents a

substantial increase in the cost of incineration and because the more

comprehensive monitoring options do not provide much information

regarding the pollutants of most concern, the final monitoring and

testing requirements for HMIWI equipped with APCD reflect routine stack

testing coupled with continuous monitoring of operating parameters.

Where incinerators are not equipped with add-on air pollution

control (i.e., units utilizing good combustion alone), EPA agrees with

commenters that CO provides the best measure of good combustion.

However, regulations based on good combustion alone only apply to small

existing HMIWI meeting certain ``remote'' criteria (see section V.B).

For these small existing HMIWI using only good combustion, the

incinerator costs about $35,000/yr to operate and the air pollution

control costs about $10,000/yr to operate. Monitoring options including

CO CEMS for compliance are clearly unreasonable at about $54,000/yr

(five times the cost of the air pollution control). The monitoring

option which includes a CO ``process'' monitor costs about $17,000/yr

while the option that relies on operating parameters costs about

$10,000/yr. The EPA does not believe that the CO ``process'' monitor

provides enough additional information to justify the $7,000/yr

additional cost, especially considering that the air pollution control

only costs $10,000/yr. Consequently, where the regulations are based on

good combustion alone, the monitoring requirements consist of an

initial stack test coupled with continuous monitoring of operating

parameters and annual inspections.

The specific values for operating parameters are chosen by the

owner or operator and are established during the initial performance

test demonstrating compliance with the emission limits. After the

performance test, monitoring of the operating parameters is the only

way to determine, on a continuous basis, whether the source is

operating in compliance. Operation outside the bounds of an established

operating parameter is a violation of an operating parameter limit. In

addition, under certain conditions, operation outside the bounds of one

or more parameter limits constitutes a violation of a specific emission

limit. This latter provision was included in the 1995 proposed

regulations and is retained in the final regulations. The owner or

operator has the flexibility to choose the values for the operating

parameters and may conduct repeated performance tests to ``fine tune''

the operating parameter limits, if desired.

With regard to the testing requirements, annual testing is required

for the first 3 years. If these tests show that the facility is in

compliance each of these 3 years, then subsequent testing would be done

every third year. Initial testing includes testing for the following

pollutants: PM, CO, HCl, dioxin/furan, Pb, Cd, Hg, and opacity. The

annual/skip or ``repeat'' testing only includes testing for PM, CO,

HCl, and opacity. Where good combustion alone serves as the basis for

the emission limits, the Agency only requires facilities to perform an

initial compliance test for PM, CO, dioxin/furan, Hg, and opacity,

annual incinerator inspections, annual opacity testing, and parameter

monitoring (charge rate and secondary chamber temperature). Minimum

sampling times of 1 hour (4 hours for dioxin/furan) have been included

in the final regulations for all HMIWI.

The ``repeat'' testing requirements will ensure, on an ongoing

basis, that the APCD is operating properly, that no deterioration in

performance has occurred, and that no changes have been made to the

operating system or the type of waste burned. Where ``repeat'' testing

is not required, annual inspections, annual opacity testing, and

parameter monitoring will ensure that the HMIWI is in good working

order. However, cost considerations were the only reason for excluding

the repeat testing for units with good combustion alone. Good

combustion alone with its associated monitoring are provided in order

to minimize costs for a small number of incinerators in remote areas

where alternatives to incineration might be unavailable. Initial

testing for good combustion units includes testing for PM, CO, dioxin/

furan, Hg, and opacity. The Hg testing is required to ensure that units

are segregating Hg bearing wastes and meeting the Hg emission limit.

Rather than require third-party inspections, which could be

burdensome for small remote facilities, the final guidelines allow for

in-house equipment inspections. However, EPA plans to work with States

to give higher priority to these small remote facilities in terms of

enforcement inspections. Either the EPA or the State will inspect these

small remote facilities annually for the first three years after the

State plan is approved. Following the three-year period, these sources

will be placed on the regular enforcement inspection schedule.

E. Operator Training and Qualification

The final operator training and qualification requirements are

almost identical to those described in the 1996 re-proposal. The final

requirements provide flexibility by allowing State-approved training

and qualification programs. Where there are no State-approved programs,

the final regulations include minimum requirements for training and

qualification. The EPA has a training manual available through its Air

Pollution Training Institute (APTI). For further information, contact

APTI at (919) 541-2497. In addition, EPA plans to work with the

American Hospital Association to develop a correspondence course for

those facilities that may not have access to adequate training. As

discussed above, EPA plans to work with States to give higher priority

to the small remote units in terms of enforcement inspections,

including a review of operator training.

IV. Standards of Performance for New Sources

This section presents a summary of the final standards, including

identification of the source category and pollutants being regulated,

and presentation of the final emission limits and their associated

performance testing, monitoring, recordkeeping and reporting

requirements. This section discusses the most significant changes to

the standards presented in the June 20, 1996 Federal Register document.

Also discussed in this section is the rationale for the selection of

MACT and a summary of the impacts of the final standards.

A. Summary of the Standards

The final standards (subpart Ec) apply to each new HMIWI for which

[[Page 48362]]

construction commenced after June 20, 1996 or to an existing HMIWI for

which modification commenced after March 16, 1998. Hospital/medical/

infectious waste incinerators for which construction commenced on or

before June 20, 1996 are not covered under the subpart Ec standards;

they are considered existing sources and are subject to the guidelines

under subpart Ce (see section V of this notice).

A HMIWI is defined as any device that combusts any amount of

medical/infectious waste or hospital waste. The terms medical/

infectious waste and hospital waste are discussed in section III.A and

defined in Sec. 60.51c. An incinerator is not subject to subpart Ec

during periods when only pathological, low-level radioactive, or

chemotherapeutic waste (all defined in Sec. 60.51c) is burned provided

that the owner or operator keeps records of the periods of time when

only pathological, low-level radioactive, and/or chemotherapeutic waste

is burned. Any combustor required to have a permit under section 3005

of the SWDA is exempt from subpart Ec as are incinerators subject to

subpart Cb, Ea, or Eb. New incinerators, processing operations, or

boilers that co-fire medical/infectious waste or hospital waste with

other fuels or wastes and that combust 10 percent or less medical/

infectious waste and hospital waste by weight (on a calendar quarter

basis) are not subject to the emission limits under subpart Ec, but

must keep records of the amount of each fuel and waste fired.

The HMIWI source category is divided into three subcategories based

on waste burning capacity: Small (200 lb/hr), medium (>200

to 500 lb/hr), and large (>500 lb/hr). Waste burning capacity is

determined either by the maximum design capacity or by the ``maximum

charge rate'' established during the most recent performance test. In

other words, a source may change its size designation by establishing a

``maximum charge rate'' lower than its design capacity. For example, a

``medium'' unit with a design capacity of 250 lb/hr may establish a

maximum charge rate of 200 lb/hr and be considered a ``small'' unit for

purposes of the standards. Separate emission standards apply to each

subcategory of new HMIWI. A summary of the final emission limits for

new or modified HMIWI is presented in Table 3.

Table 3.--Summary of Promulgated Emission Limits for New HMIWI

----------------------------------------------------------------------------------------------------------------

Emission limits

Pollutant (test method) --------------------------------------------------------------------------

Small HMIWI Medium HMIWI Large HMIWI

----------------------------------------------------------------------------------------------------------------

Particulate matter (EPA Method 5 or 69 mg/dscm (0.03 gr/ 34 mg/dscm (0.015 gr/ 34 mg/dscm (0.015 gr/

Method 29). dscf). dscf). dscf).

Carbon monoxide (EPA Method 10 or 40 ppmv................ 40 ppmv................ 40 ppmv.

Method 10B).

Dioxins/furans (EPA Method 23)....... 125 ng/dscm total CDD/ 25 ng/dscm total CDD/ 25 ng/dscm total CDD/

CDF (55 gr/10\9\ dscf) CDF (11 gr/10 \9\ CDF (11 gr/10 \9\

or 2.3 ng/dscm TEQ dscf) or 0.6 ng/dscm dscf) or 0.6 ng/dscm

(1.0 gr/10 \9\ dscf). TEQ (0.26 gr/10 \9\ TEQ (0.26 gr/10 \9\

dscf). dscf).

Hydrogen chloride (EPA Method 26).... 15 ppmv or 99% 15 ppmv or 99% 15 ppmv or 99%

reduction. reduction. reduction.

Sulfur dioxide (testing not required) 55 ppmv................ 55 ppmv................ 55 ppmv.

Nitrogen oxides (testing not 250 ppmv............... 250 ppmv............... 250 ppmv.

required).

Lead (EPA Method 29)................. 1.2 mg/dscm (0.52 gr/10 0.07 mg/dscm (0.03 gr/ 0.07 mg/dscm (0.03 gr/

\3\ dscf) or 70% 10 \3\ dscf) or 98% 10 \3\ dscf) or 98%

reduction. reduction. reduction.

Cadmium (EPA Method 29).............. 0.16 mg/dscm (0.07 gr/ 0.04 mg/dscm (0.02 gr/ 0.04 mg/dscm (0.02 gr/

10 \3\ dscf) or 65% 10 \3\ dscf) or 90% 10 \3\ dscf) or 90%

reduction. reduction. reduction.

Mercury (EPA Method 29).............. 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/

10 \3\ dscf) or 85% 10 \3\ dscf) or 85% 10 \3\ dscf) or 85%

reduction. reduction. reduction.

----------------------------------------------------------------------------------------------------------------

In addition to the emission limits, new or modified large HMIWI are

subject to a 5 percent visible emission limit for fugitive emissions

generated during ash handling and all new or modified HMIWI are subject

to a 10 percent stack opacity limit. Performance tests for fugitive

emissions from ash handling must be conducted using EPA Reference

Method 22. Stack opacity must be determined using EPA Reference Method

9.

Table 4 summarizes the additional requirements for new or modified

HMIWI under the NSPS, including the operator training and qualification

requirements, siting requirements, compliance and performance testing

requirements, monitoring requirements, and reporting and recordkeeping

requirements. A summary of dates for compliance with the promulgated

standards for new HMIWI is presented in Table 5. These dates apply to

all new or modified HMIWI.

Table 4.--Summary of Additional Requirements Under the NSPS for New

HMIWI

------------------------------------------------------------------------

Additional requirements

-------------------------------------------------------------------------

Operator Training and Qualification Requirements:

Complete HMIWI operator training course.

Qualify operators.

Maintain information regarding HMIWI operating procedures

and review annually.

Siting Requirements:

Prepare a siting analysis that considers air pollution

control alternatives that minimize, on a site-specific basis and to

the maximum extent practicable, potential risks to public health

and the environment.

[[Page 48363]]

Waste Management Plan:

Prepare a waste management plan that identifies the

feasibility and approach to separate certain components of a health

care waste stream.

Compliance and Performance Testing Requirements:

Conduct an initial performance test to determine compliance

with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and

opacity limit, and establish operating parameters.

Conduct annual performance tests to determine compliance

with the PM, CO, and HCl emission limits and opacity limit.

Facilities may conduct performance tests for PM, CO, and

HCl every third year if the previous three HMIWI performance tests

demonstrate that the facility is in compliance with the emission

limits for PM, CO, or HCl.

Perform annual fugitive testing (large HMIWI only).

Monitoring Requirements:

Install and maintain equipment to continuously monitor

operating parameters including secondary chamber temperature, waste

feed rate, bypass stack, and APCD operating parameters as

appropriate.

Obtain monitoring data at all times during HMIWI operation.

Reporting and Recordkeeping Requirements:

Maintain for 5 years records of results from initial

performance test and all subsequent performance tests, operating

parameters, any maintenance, the siting analysis, and operator

training and qualification.

Submit the results of the initial performance test and all

subsequent performance tests.

Submit reports on emission rates or operating parameters

that have not been recorded or that exceeded applicable limits.

Provide notification of intent to construct, construction

commencement date, planned initial start-up date, planned waste

type(s) to be combusted, the waste management plan, and

documentation resulting from the siting analysis.

------------------------------------------------------------------------

Note: This table depicts major provisions of the NSPS and does not

attempt to show all requirements. The regulatory text of Subpart Ec

should be relied upon for a full and comprehensive statement of the

requirements of the NSPS.

Table 5.--Compliance Times Under the NSPS for New HMIWI

------------------------------------------------------------------------

Requirement Compliance time

------------------------------------------------------------------------

Effective date............................... 6 months after

promulgation of NSPS.

Operator training and qualification On effective date or upon

requirements. initial start up,

whichever is later.

Initial compliance test...................... On effective date or

within 180 days of

initial start up,

whichever is later.

Performance test............................. Within 12 months

following initial

compliance test and

annually thereafter.

Facilities may conduct

performance tests every

third year if the

previous three

performance tests

demonstrate compliance

with the emission

limits.

Operator parameter monitoring................ Continuously, upon

completion of initial

compliance test.

Recordkeeping................................ Continuously, upon

completion of initial

compliance test.

Reporting.................................... Annually, upon completion

of initial compliance

test; semiannually, if

noncompliance.

------------------------------------------------------------------------

Note: This table depicts major provisions of the NSPS and does not

attempt to show all requirements. The regulatory text of Subpart Ec

should be relied upon for a full and comprehensive statement of the

requirements of the NSPS.

B. Significant Issues and Changes

The most significant changes to the standards made following the

June 20, 1996 Federal Register document are discussed below. Further

discussion of these changes as well as other comments and responses

regarding the NSPS are provided in ``Hospital/Medical/ Infectious Waste

Incinerators: Background Information for Promulgated Standards and

Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-97-

006b).

1. Combined Dry/Wet Scrubbers

As discussed in the 1996 re-proposal, the MACT floor for medium and

large HMIWI was based on emission limits achievable with good

combustion and a dry injection/fabric filter (DI/FF) combined with a

high efficiency wet scrubber (combined dry/wet system).

During the public comment period following the 1996 re-proposal,

several commenters questioned the basis for the MACT floors for new

medium and large HMIWI. The commenters contended that the revised MACT

floor emission levels were based on invalid test data and invalid

assumptions as to the applicability and technical feasibility of

combination dry/wet scrubbing systems. The commenters stated that the

combined dry/wet system is not proven technology. Some commenters

stated that the pollutant-by-pollutant approach used to determine the

MACT floor for new medium and large units resulted in a MACT floor that

can not be accomplished with any type of economic feasibility. Other

commenters stated that the costs of requiring a wet scrubber in

addition to a dry scrubber far outweigh the air pollution control

benefits.

The EPA recognizes that the pollutant-by-pollutant approach for

determining the MACT floor can, as it does in this case, cause the

overall cost of the regulation to increase. For example, the pollutant-

by-pollutant approach for the HMIWI regulation results in a MACT floor

for HCl based on a high efficiency wet scrubber, while the MACT floor

for other pollutants reflects the performance of a dry scrubber.

Compared to the dry scrubber alone, the addition of the wet scrubber

adds considerable cost to the regulation while achieving a relatively

small additional reduction in HCl. However, as mentioned later in this

notice, a spray dryer/fabric filter system with carbon injection could

be used instead of a combined dry/wet scrubber to achieve all of the

emission limits at a lower cost than the combined system. On the other

hand, EPA interprets section 129 of the CAA to require that the MACT

floor be determined in this manner, and EPA believes that Congress did

in fact intend that sources subject to regulations developed under

section 129 meet emission limits that are achieved by the

[[Page 48364]]

best controlled unit for each pollutant as long as the control systems

are compatible with each other. To EPA's knowledge, there is no

technical reason why these two air pollution control systems cannot be

combined (discussed later).

Section 129(a)(2) of the CAA specifies that ``the degree of

reduction in emissions that is deemed achievable for new units in a

category shall not be less stringent than the emissions control

achieved in practice by the best controlled similar unit, as determined

by the Administrator.'' This requirement identifies the least stringent

emissions standards that the EPA may adopt for new HMIWI (i.e., the

MACT floor).

At least one existing HMIWI in the medium subcategory is controlled

with a high efficiency wet scrubber and another is equipped with a DI/

FF system without carbon. The MACT floor for new medium HMIWI was based

on both of these technologies (i.e., a combined dry/wet scrubber

system) because the wet scrubber achieves the lowest dioxin, HCl, and

Hg emissions, but the DI/FF without carbon injection achieves the

lowest Pb and Cd emissions (note: as discussed elsewhere, the DI/FF

system with carbon injection achieves the same or lower dioxin and Hg

emissions as a wet scrubber). While no combined dry/wet scrubber

systems were identified on medium HMIWI, these systems are currently in

operation on large HMIWI. As discussed later, test data appear to

indicate that combining the two systems is technically feasible.

Similarly, the MACT floor for new large HMIWI was based on the emission

levels that are achievable with good combustion and a combined dry/wet

system with activated carbon.

The EPA does not agree that the MACT floors are to be based upon

one overall unit. Rather, the EPA believes that section 129 supports

its interpretation that it is legally permissible to set the MACT floor

pollutant-by-pollutant, as long as the various MACT floors do not

result in standards that are not achievable.

Section 129(a)(2) requires the EPA to establish technology based

emission standards that ``reflect the maximum degree of reduction in

emission of air pollutants listed under section (a)(4) that the

Administrator, taking into consideration the cost of achieving such

emission reduction and any nonair quality health and environmental

impacts and energy requirements, determines is achievable . . .''

Congress further specified in section 129(a)(2) the minimum reduction

that could satisfy this requirement (i.e., the MACT floor) for new

sources as ``the emission control that is achieved in practice by the

best controlled similar unit, as determined by the Administrator.''

This language does not expressly address whether the floor may be

established pollutant-by-pollutant. The ``emission control achieved by

the best controlled similar unit'' can be read either to mean emission

control as to a particular pollutant, or emission control that is

achieved by the unit as a whole. Nevertheless, the MACT floor reflects

the least stringent emission standards that EPA may adopt in accordance

with section 129(a)(2) regardless of costs.

Other statutory provisions are relevant, although they also do not

decisively address this issue. Section 129(a)(4) requires MACT

standards for, at a minimum, PM, opacity, SO2, HCl,

NOX, CO, Pb, Cd, Hg, and dioxin/furan emitted by HMIWI. This

provision certainly appears to direct maximum reduction of each

specified pollutant. Moreover, although the provisions do not state

whether there is to be a separate floor for each pollutant, the fact

that Congress singled out these pollutants suggests that the floor

level of control need not be limited by the performance of devices that

only control some of these pollutants well.

A more detailed discussion of the legal basis for this pollutant-

by-pollutant approach is contained in section 3.4.2 of ``Hospital/

Medical/Infectious Waste Incinerators: Background Information for

Promulgated Standards and Guidelines--Summary of Public Comments and

Responses'' (EPA-453/R-97-006b). Quantitative information about the

costs and air pollution control performance of both wet scrubbers and

dry scrubbers is summarized in the 1996 re-proposal (61 FR 31743). As

discussed in the 1996 re-proposal, detailed descriptions of costs and

air pollution control performance of these systems are available in

Docket A-91-61, items IV-B-30, IV-B-32, IV-B-48, and IV-B-49. See the

ADDRESSES section of this preamble for the location and telephone

number for the docket.

The EPA also notes that it followed this approach of setting the

MACT floors and MACT standards pollutant-by-pollutant in the proposed

MWC rules that were published on September 20, 1994 pursuant to section

129 and codified in 40 CFR part 60, Subparts Eb and Cb. Commenters on

that rule also expressed concerns about the achievability of the

resulting standards. The EPA notes that large MWC units (more than 250

tons/day capacity) are achieving the promulgated standards (in fact,

several combined systems were in operation at the time of

promulgation); thus, the approach of proposing MACT standards

pollutant-by-pollutant did not lead to unachievable or economically

infeasible standards in this case.

In response to commenters' concerns regarding the technical

feasibility of combined dry/wet systems, a review of the available data

documenting the performance of combined dry/wet scrubber systems was

conducted. Although limited emissions data are available for HMIWI with

combined dry/wet control systems, the available data indicate that the

MACT floor emission levels for new HMIWI are achievable and technically

feasible. The performance of dry scrubbers with activated carbon

injection and the performance of wet scrubbers is well documented. The

available data for combination dry/wet systems provide no indication of

operational or emissions problems that occur as a result of combining

dry and wet control systems. Finally, as mentioned in the 1996 re-

proposal, one existing HMIWI equipped with a spray dryer/fabric filter

system with carbon injection was tested during the EPA testing program,

and this test demonstrated that this scrubbing technology could be used

instead of a combined dry/wet scrubber to achieve all of the emission

limits.

2. Siting Analysis

Section 129 of the CAA states that performance standards for new

HMIWI must incorporate siting requirements that minimize, on a site-

specific basis and to the maximum extent practicable, potential risks

to public health or the environment. The Agency is directed by the CAA

to promulgate siting requirements that meet the minimum criteria

outlined in the CAA. In the 1995 proposal, the siting requirements were

patterned after the Prevention of Significant Deterioration (PSD)

requirements within the New Source Review (NSR) program. Additionally,

the originally proposed siting requirements included provisions for a

public meeting and the preparation of a comment/response document that

would be made available to the public.

Following the 1996 re-proposal, commenters requested that EPA do

away with the siting requirements because they will be costly and will

impede the permitting process. Other commenters requested that EPA

adopt siting requirements that are consistent with those that have been

developed and enacted by most of the State environmental agencies. The

commenters noted that States are equally concerned with minimizing

potential risks to the environment, and that most have taken

appropriate steps

[[Page 48365]]

in the development of their own siting criteria. The commenters

indicated that requiring siting analyses in addition to those required

by States and under the National Environmental Policy Act would be

duplicative and would not enhance environmental protection. Other

commenters supported the EPA's 1995 proposal to require an opportunity

for public comments and a hearing on siting decisions.

In reviewing the 1995 proposed siting requirements and the comments

received, the Agency is promulgating siting requirements as outlined in

the CAA. The siting requirements promulgated today require the

potential owner of an affected facility to prepare an analysis of the

impacts of the affected facility. The analysis must consider air

pollution control alternatives that minimize, on a site-specific basis,

to the maximum extent practicable, potential risks to public health or

the environment. In considering such alternatives, the analysis may

consider costs, energy impacts, non-air environmental impacts, or any

other factors related to the practicability of the alternatives.

Analyses of facility impacts prepared to comply with State, local, or

other Federal regulatory requirements may be used to satisfy the

requirements of this section, as long as they include the consideration

of air pollution control alternatives specified above. The owner or

operator of the affected facility must complete and submit the siting

requirements to EPA.

C. Selection of MACT

The EPA considered three regulatory options for adoption as the

final standard for new HMIWI. These regulatory options are discussed in

Appendix A of ``Hospital/Medical/Infectious Waste Incinerators:

Background Information for Promulgated Standards and Guidelines--

Summary of Public Comments and Responses'' (EPA-453/R-97-006b). As

required by section 129(a)(2) of the CAA, the Administrator reviewed

the emissions reductions achievable with each regulatory option and the

cost, nonair quality environmental, and energy impacts of the

regulatory options. Based on this review, the Administrator determined

that the most cost-effective and achievable emission standards for

promulgation are based on emission limits achievable with good

combustion and a moderate efficiency wet scrubber for new small HMIWI,

and good combustion and a combined dry/wet control system with carbon

for new medium and large HMIWI. These final emissions standards reflect

the MACT floor emission levels for new small and large HMIWI, but are

more stringent than the MACT floor for new medium HMIWI.

The MACT floor for new small HMIWI was based on emission limits

achievable through use of good combustion and a moderate efficiency wet

scrubber. Consideration of the impact of this MACT floor indicates that

few new small HMIWI are likely to be constructed due to the substantial

increase in the cost of a new small HMIWI as a result of the moderate

efficiency wet scrubber and the availability of alternative means of

medical waste disposal.

One regulatory option more stringent than this MACT floor would

reflect the use of good combustion and a high efficiency wet scrubber.

Consideration of this option indicates that the nationwide impacts

would be negligible, primarily because few new small HMIWI would be

constructed (i.e., because of switching to alternative means of medical

waste disposal). Where a typical new small HMIWI was constructed,

however, the high efficiency wet scrubber would only reduce PM

emissions by a small amount and would increase air pollution control

costs by about 15 percent. As a result, the EPA established the MACT

emission limitations for small new HMIWI based on the use of good

combustion and a moderate efficiency wet scrubber (i.e., the MACT

floor).

The MACT floor for new medium HMIWI was based on emission limits

achievable through the use of good combustion and a combined dry/wet

control system without activated carbon. On a national basis, because

of switching to the use of alternative means of medical waste disposal,

the addition of activated carbon to the combined dry/wet system results

in negligible cost increase. For a typical new medium HMIWI, the

addition of carbon would reduce emissions of dioxin significantly and

would increase air pollution control costs by less than 4 percent. As a

result, the EPA established the MACT emission limitations for new

medium HMIWI based on good combustion and a combined dry/wet scrubber

system with activated carbon.

The MACT floor for new large HMIWI was based on emission limits

achievable through use of good combustion and a combined dry/wet

scrubber with activated carbon. There is no air pollution control

technology which could achieve lower emissions than this system.

Consequently, EPA established the MACT emission limitations for new

large HMIWI based on good combustion and a combined dry/wet scrubber

system with activated carbon (i.e., the MACT floor).

D. Impacts of the Standards

There are a number of alternatives to onsite incineration of

hospital waste and medical/infectious waste, including recycling or

direct landfilling of non-infectious waste, and off-site commercial

waste disposal or any of several waste disinfection technologies (e.g.,

steam autoclaving, microwave irradiation, macrowave irradiation,

chemical treatment, thermal treatment, and biological treatment) for

infectious waste. Many facilities that may have purchased an HMIWI in

the absence of the HMIWI standards may find it more cost effective to

dispose of their waste using one of these alternatives. As discussed in

the June 1996 re-proposal, while further study is warranted, there

appears to be no significant or substantial adverse economic,

environmental, or health and safety issues associated with the

increased use of the alternative waste treatment technologies.

In some cases, facilities that ``switch'' to alternative methods of

waste disposal may further decrease their waste disposal costs by

segregating their waste into infectious and noninfectious portions, and

recycling or landfilling (rather than treating) their noninfectious

waste. To account for facilities switching to alternative methods of

waste disposal, the impacts of the standards were developed based on

three compliance scenarios: no switching (scenario A), switching with

waste segregation (scenario B), and switching without waste segregation

(scenario C).

In the absence of the new standards, EPA projects that 85 new small

HMIWI, 90 new medium HMIWI, 60 new large HMIWI, and 10 new commercial

HMIWI would have been installed over the next five years. Scenario A

preserves this assumption and estimates the costs of the additional

control measures that would be required for these 245 new facilities to

meet the standards at $36.2 million annually. The EPA believes that

Scenario A is unrealistic and grossly overstates the national costs

associated with the standards. Under Scenarios B and C, no new small or

medium HMIWI are projected to be installed. Facilities that would have

installed these units are assumed to find alternate methods of waste

disposal. Under Scenario B, no new large HMIWI (other than commercial

units) are projected to be installed either. The EPA believes that the

total costs of the final standards for new sources in the fifth year

after

[[Page 48366]]

implementation will fall somewhere between the $12.1 million/yr

estimate for Scenario B and the $26.2 million/yr estimate for Scenario

C.

Table 6 presents baseline emissions (i.e., emissions in the absence

of the MACT emission standards) and the emissions that are expected to

occur under the final MACT standard. A range of emissions is presented

in Table 6 to account for the emissions that could occur under

switching scenarios B and C as a result of the NSPS. Table 6 also

presents the percent reduction in emissions achieved under the final

MACT standard for new HMIWI.

Table 6.--Baseline Emissions, Emissions in the Fifth Year After Implementation of the Final NSPS, and Emissions

Reduction

[Metric Units]

----------------------------------------------------------------------------------------------------------------

Emissions under the final Emissions reduction,

Pollutant, units Baseline NSPS percent

----------------------------------------------------------------------------------------------------------------

PM, Mg/yr............................... 28 2.1 to 4.1................. 85 to 92.

CO, Mg/yr............................... 14 6.5 to 14.................. 0 to 52.

CDD/CDF, g/yr........................... 47 5.9 to 12.................. 74 to 87.

TEQ CDD/CDF, g/yr....................... 1.1 0.14 to 0.28............... 74 to 87.

HCl, Mg/yr.............................. 64 1.5 to 3.1................. 95 to 98.

SO2, Mg/yr.............................. 28 14 to 28................... 0 to 52.

NOX, Mg/yr.............................. 130 65 to 130.................. 0 to 52.

Pb, Mg/yr............................... 0.39 0.031 to 0.06.............. 85 to 92.

Cd, Mg/yr............................... 0.051 4.6 x 10-3 to 8.9 x 10-3... 83 to 91.

Hg, Mg/yr............................... 0.21 0.056 to 0.12.............. 45 to 74.

----------------------------------------------------------------------------------------------------------------

To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6.

As discussed further in Appendix A of ``Hospital/Medical/Infectious

Waste Incinerators: Background Information for Promulgated Standards

and Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-

97-006b), the EPA is not able to calculate a monetized value for most

of these emission reductions. However, using ``Benefit-Cost Analysis of

Selected NSPS for Particulate Matter'' as a basis, EPA has calculated a

monetized value for reductions in PM emissions using an estimate of

$6,075 (1993 dollars) per ton of PM. This yields annualized benefits of

PM reductions for the standards ranging from $157,300 to $170,000 (1993

dollars).

As a result of the MACT standards for new HMIWI, industries that

generate hospital waste and/or medical/infectious waste (i.e.,

hospitals, nursing homes, etc.) are expected to experience average

price increases in the range of 0.00 to 0.16 percent, depending on the

industry. These industries are expected to experience output and

employment impacts in the range of 0.00 to 0.21 percent. In addition,

the revenue impacts for these industries are expected to range from an

increase of 0.05 percent to a decrease of 0.05 percent as a result of

the standards. For hospitals, 0.03 percent is estimated as the price

increase necessary to recover annual control costs. The expected

average price increase for each hospital patient-day is expected to be

less than 35 cents. The average price impact for the commercial medical

waste incinerator industry is approximately a 4.1 percent increase in

price.

Facilities with onsite HMIWI that are currently uncontrolled may

experience impacts ranging from 0.03 to 1.70 percent, depending on the

industry. For many of these facilities, the economic impacts of

switching to an alternative method of waste disposal are much lower

than the economic impacts of choosing to install emission control

equipment. The decision to switch to an alternative method of waste

disposal should preclude facilities from experiencing a significant

economic impact. The impacts that would be incurred by medical/

infectious waste generators that currently use an offsite waste

incineration service range from 0.00 to 0.02 percent and are considered

negligible impacts.

The option of switching to an alternative method of waste disposal

will be an attractive option for many facilities that are considering

the purchase of a new HMIWI and should preclude facilities from

experiencing a significant economic impact. However, two types of HMIWI

operators may not be able to switch to an alternative: commercial HMIWI

operators, because their line of business is commercial incineration;

and onsite HMIWI that burn a small amount of waste and are located far

away from an urban area, because they may not have access to other

methods of waste disposal. However only a few, if any, of the projected

10 new commercial HMIWI over the next 5 years, and at the most, only a

few of the projected 85 new small onsite HMIWI over the next 5 years

are likely to be significantly impacted by the regulation (under all

three regulatory options). A ``significant impact'' does not

necessarily imply a facility closure or the need to cancel plans to

open up or expand a facility. For example, operators of small, remote

onsite HMIWI may still have switching opportunities. As the commercial

incineration industry continues to grow (with additional impetus being

provided by the EG and NSPS), it is possible that services will be

extended to remote, isolated areas that are currently not served.

Onsite autoclaving is another possible treatment alternative. If a

facility had planned to invest in a new HMIWI, it stands to reason that

an onsite alternative technology of comparable cost would be

affordable.

The economic impact analysis examines possible economic impacts

that may occur in industries that will be directly affected by this

regulation. Therefore, the analysis includes an examination of

industries that generate hospital waste or medical/infectious waste or

dispose of such waste. Secondary impacts such as subsequent impacts on

APCD vendors and HMIWI vendors are not estimated due to data

limitations. Air pollution control device vendors are expected to

experience an increase in demand for their products due to the

regulation. This regulation is also expected to increase demand for

commercial HMIWI services. However, due to economies of scale, this

regulation is expected to shift demand from smaller incinerators to

larger incinerators. Therefore, small HMIWI vendors potentially may be

adversely affected by the regulation. Lack of data on the above effects

prevent

[[Page 48367]]

quantification of the economic impacts on these secondary sectors.

No increase in the total national usage of natural gas for

combustion controls is expected to result from the final HMIWI

standards. The total national usage of electrical energy for the

operation of add-on control devices as a result of the final MACT

standards is expected to increase by less than 9,800 megawatt hours per

year (MW-hr/yr) (33.4 billion British thermal units per year [10\9\

Btu/yr]). As discussed in the 1996 re-proposal, compared to the amount

of energy used by health care facilities such as hospitals

(approximately 2,460 MMm \3\/yr of natural gas and 23.2 million MW-hr/

yr of electricity), the increase in energy usage that results from

implementation of the HMIWI emission standards is insignificant.

Less than 43,600 Mg/yr (48,000 tons/yr) of additional solid waste

is expected to result from the adoption of the final MACT standards. As

discussed in the 1996 re-proposal, compared to municipal waste, which

is disposed in landfills at an annual rate of over 91 million Mg/yr

(100 million tons/yr), the increase in solid waste from the

implementation of the final HMIWI standards is insignificant.

Less than 3.3 million gallons of additional wastewater would be

generated in the fifth year by HMIWI as a result of the final NSPS.

This amount is the equivalent of wastewater produced annually by one

small hospital. Therefore, when considering the wastewater produced

annually at health care facilities nationwide, the increase in

wastewater resulting from the implementation of the MACT emission

standards for new HMIWI is insignificant.

V. Emission Guidelines for Existing Sources

This section presents a summary of the final emission guidelines,

including identification of the source category and pollutants being

regulated, and presentation of the final emission limits and their

associated performance testing, monitoring, recordkeeping and reporting

requirements. This section discusses the most significant changes to

the guidelines presented in the June 20, 1996 Federal Register

document. Also discussed in this section is the rationale for the

selection of MACT and a summary of the impacts of the final guidelines.

A. Summary of the Guidelines

The final guidelines (subpart Ce) apply to each existing HMIWI for

which construction commenced on or before June 20, 1996. Hospital/

medical/infectious waste incinerators for which construction commenced

after June 20, 1996 or modification commenced after March 16, 1998 are

not subject to the final subpart Ce guidelines; they are considered new

sources and are subject to the standards under subpart Ec (see section

IV of this document).

A HMIWI is defined as any device that combusts any amount of

medical/infectious waste or hospital waste. The terms ``medical/

infectious waste'' and ``hospital waste'' are discussed in section

III.A and defined in Sec. 60.51c. An incinerator is not subject to

subpart Ce during periods when only pathological, low-level

radioactive, or chemotherapeutic waste (all defined in Sec. 60.51c) is

burned provided that the owner or operator keeps records of the periods

of time when only pathological, low-level radioactive, or

chemotherapeutic waste is burned. Any unit required to have a permit

under section 3005 of the Solid Waste Disposal Act is exempt from

subpart Ce as are incinerators subject to subpart Cb, Ea, or Eb.

Existing incinerators, processing operations, or boilers that co-fire

hospital waste and/or medical/infectious waste with other fuels or

wastes and combust 10 percent or less medical/infectious waste and

hospital waste by weight (on a calendar quarter basis) are not subject

to the emission limitations but must keep records of the amounts of

each fuel and waste burned.

The HMIWI source category is divided into three subcategories based

on waste burning capacity: small (200 lb/hr), medium (>200

to 500 lb/hr), and large (>500 lb/hr). Waste burning capacity is

determined either by the maximum design capacity or by the ``maximum

charge rate'' established during the most recent performance test. In

other words, a source may change its size designation by establishing a

``maximum charge rate'' lower than its design capacity. For example, a

``medium'' unit with a design capacity of 250 lb/hr may establish a

maximum charge rate of 200 lb/hr and be considered a ``small'' unit for

purposes of the emission guidelines. Separate emission guidelines apply

to each subcategory of existing HMIWI. A summary of the final emission

limits for existing HMIWI is presented in Table 7. In addition to the

emission limits presented in Table 7, all HMIWI are subject to a 10

percent stack opacity limitation. Stack opacity will be determined

using EPA Reference Method 9.

Table 7.--Summary of Promulgated Emission Limits for Existing HMIWI

----------------------------------------------------------------------------------------------------------------

Emission limits

Pollutant (test method) --------------------------------------------------------------------------

Small HMIWI Medium HMIWI Large HMIWI

----------------------------------------------------------------------------------------------------------------

Particulate matter (EPA Method 5 or 115 mg/dscm (0.05 gr/ 69 mg/dscm (0.03 gr/ 34 mg/dscm (0.015 gr/

Method 29). dscf). dscf). dscf).

Carbon monoxide (EPA Method 10 or 40 ppmv................ 40 ppmv................ 40 ppmv.

Method 10B).

Dioxins/furans (EPA Method 23)....... 125 ng/dscm total CDD/ 125 ng/dscm total CDD/ 125 ng/dscm total CDD/

CDF (55 gr/109 dscf) CDF (55 gr/109 dscf) CDF (55 gr/109 dscf).

or 2.3 ng/dscm TEQ or 2.3 ng/dscm TEQ or 2.3 ng/dscm TEQ

(1.0 gr/109 dscf). (1.0 gr/109 dscf). (1.0 gr/109 dscf).

Hydrogen chloride (EPA Method 26).... 100 ppmv or 93% 100 ppmv or 93% 100 ppmv or 93%

reduction. reduction. reduction

Sulfur dioxide (testing not required) 55 ppmv................ 55 ppmv................ 55 ppmv.

Nitrogen oxides (testing not 250 ppmv............... 250 ppmv............... 250 ppmv.

required).

Lead (EPA Method 29)................. 1.2 mg/dscm (0.52 gr/ 1.2 mg/dscm (0.52 gr/ 1.2 mg/dscm (0.52 gr/

103 dscf) or 70% 103 dscf) or 70% 103 dscf) or 70%

reduction. reduction. reduction.

Cadmium (EPA Method 29).............. 0.16 mg/dscm (0.07 gr/ 0.16 mg/dscm (0.07 gr/ 0.16 mg/dscm (0.07 gr/

103 dscf) or 65% 103 dscf) or 65% 103 dscf) or 65%

reduction. reduction. reduction.

[[Page 48368]]

Mercury (EPA Method 29).............. 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/

103 dscf) or 85% 103 dscf) or 85% 103 dscf) or 85%

reduction. reduction. reduction.

----------------------------------------------------------------------------------------------------------------

The emission limits for small existing HMIWI presented in Table 7

are more stringent than the MACT floor emission limits for small

existing HMIWI. However, the final HMIWI guidelines contain alternative

emission limits which are based on the MACT floor for small existing

HMIWI that meet certain ``rural criteria.'' The ``rural criteria''

stipulates that an HMIWI is allowed to meet alternative emission limits

if it is located at least 50 miles from the nearest Standard

Metropolitan Statistical Area (SMSA) boundary and burns no more than

2,000 pounds of hospital waste and medical/infectious waste per week.

The SMSA is defined by the Office of Management and Budget (OMB). For

purposes of these emission guidelines, the list of areas comprising

each SMSA as of June 30, 1993 will be used to determine whether a small

HMIWI meets the ``rural criteria.'' The list of areas comprising each

SMSA is presented in OMB Bulletin No. 93-17 entitled ``Revised

Statistical Definitions for Metropolitan Areas.'' This document may be

obtained by contacting the National Technical Information Services,

5285 Port Royal Road, Springfield, Virginia 22161, or by calling (703)

487-4650 and requesting document No. PB 93-192-664. This document is

available for public inspection and copying at EPA's Air and Radiation

Docket and Information Center (Docket A-91-61, item IV-J-125). See the

ADDRESSES section at the beginning of this preamble for the telephone

number and location of the Docket. This document has been approved for

incorporation by reference by the Director of the Federal Register in

accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The emission limits

that correspond with these alternative guidelines for rural HMIWI are

presented in Table 8. For further discussion of the ``rural criteria''

and rationale for the alternative emission limits for small existing

HMIWI in rural areas, see section V.B ``Significant Issues and

Changes'' (below).

Table 8.--Summary of Alternative Emission Limits for Small Existing

HMIWI That Meet the Rural Criteria

------------------------------------------------------------------------

Pollutant (Performance test method) Emission limits

------------------------------------------------------------------------

Particulate matter (EPA Method 5)...... 197 mg/dscm (0.086 gr/dscf).

Carbon monoxide (EPA Method 10 of 10B). 40 ppmv.

Dioxins/furans (EPA Method 23)......... 800 ng/dscm total CDD/CDF (350

gr/10 \9\ dscf) or 15 ng/dscm

TEQ (6.6 gr/10 \9\ dscf).

Hydrogen chloride (testing not 3,100 ppmv.

required).

Sulfur dioxide (testing not required).. 55 ppmv.

Nitrogen oxides (testing not required). 250 ppmv.

Lead (testing not required)............ 10 mg/dscm (4.4 gr/10 \3\

dscf).

Cadmium (testing not required)......... 4 mg/dscm (1.7 gr/10 \3\ dscf).

Mercury (EPA Method 29)................ 7.5 mg/dscm (3.3 gr/10 \3\

dscf).

------------------------------------------------------------------------

Table 9 summarizes the additional requirements for existing HMIWI

under the emission guidelines, including the operator training and

qualification requirements, inspection requirements, compliance and

performance testing requirements, monitoring requirements, and

reporting and recordkeeping requirements. Table 10 summarizes the

additional requirements under the emission guidelines for small

existing HMIWI that meet the rural criteria. With the exception of the

compliance and performance testing requirements and the inspection

requirements, existing HMIWI that meet the small rural criteria are to

comply with the same additional requirements as all other existing

HMIWI. A summary of dates for compliance with the promulgated

guidelines for existing HMIWI is presented in Table 11. These dates

apply to all existing HMIWI.

Table 9.--Summary of Additional Requirements Under the Emission

Guidelines for Existing HMIWI

------------------------------------------------------------------------

Additional requirements

-------------------------------------------------------------------------

Operator Training and Qualification Requirements:

Complete HMIWI operator training course.

Qualify operators.

Maintain information regarding HMIWI operating procedures

and review annually.

Waste Management Plan:

Prepare a waste management plan that identifies the

feasibility and approach to separate certain components of a health

care waste stream.

Compliance and Performance Testing Requirements:

Conduct an initial performance test to determine compliance

with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and

opacity limit, and establish operating parameters.

Conduct annual performance tests to determine compliance

with the PM, CO, and HCl emission limits and opacity limit.

Facilities may conduct performance tests for PM, CO, and

HCl every third year if the previous three performance tests

demonstrate that the facility is in compliance with the emission

limits for PM, CO, and HCl.

[[Page 48369]]

Monitoring Requirements:

Install and maintain equipment to continuously monitor

operating parameters including secondary chamber temperature, waste

feed rate, bypass stack, and APCD operating parameters as

appropriate.

Obtain monitoring data at all times during HMIWI operation.

Reporting and Recordkeeping Requirements:

Maintain for 5 years records of results from the initial

performance test and all subsequent performance tests, operating

parameters, and operator training and qualification.

Submit the results of the initial performance test and all

subsequent performance tests.

Submit reports on emission rates or operating parameters

that have not been recorded or which exceeded applicable limits.

------------------------------------------------------------------------

Note: This table depicts the major provisions of the emission guidelines

and does not attempt to show all requirements. The regulatory text of

Subpart Ce should be relied upon for a full and comprehensive

statement of the requirements of the final guidelines.

Table 10.--Summary of Additional Requirements Under the Emission

Guidelines for Existing HMIWI that Meet the Rural Criteria

------------------------------------------------------------------------

Additional requirements

-------------------------------------------------------------------------

Operator Training and Qualification Requirements:

Complete HMIWI operator training course.

Qualify operators.

Maintain information regarding HMIWI operating procedures

and review annually.

Inspection Requirements:

Provide for an annual equipment inspection of the

designated facility.

Waste Management Plan:

Prepare a waste management plan that identifies the

feasibility and approach to separate certain components of a health

care waste stream.

Compliance and Performance Testing Requirements:

Conduct an initial performance test to determine compliance

with the PM, CO, CDD/CDF, and Hg emission limits and opacity limit,

and establish operating parameters.

Conduct annual tests to determine compliance with the

opacity limit.

Monitoring Requirements:

Install and maintain equipment to continuously monitor

operating parameters including secondary chamber temperature, waste

feed rate, bypass stack, and APCD operating parameters as

appropriate.

Obtain monitoring data at all times during HMIWI operation.

Reporting and Recordkeeping Requirements:

Maintain for 5 years records of results from the initial

performance test and all subsequent performance tests, operating

parameters, inspections, any maintenance, and operator training and

qualification.

Submit the results of the initial performance test and all

subsequent performance tests.

Submit reports on emission rates or operating parameters

that have not been recorded or which exceeded applicable limits.

------------------------------------------------------------------------

Note: This table depicts the major provisions of the emission guidelines

and does not attempt to show all requirements. The regulatory text of

Subpart Ce should be relied upon for a full and comprehensive

statement of the requirements of the final guidelines.

Table 11.--Compliance Times Under the Emission Guidelines for Existing

HMIWI

------------------------------------------------------------------------

Requirement Compliance time

------------------------------------------------------------------------

State Plan submittal........................... Within 1 year after

promulgation of EPA

emission guidelines.

Operator training and qualification Within 1 year after EPA

requirements. approval of State

Plan.

Inspection requirements........................ Within 1 year after EPA

approval of State

Plan.

Initial compliance test........................ Within 1 year after EPA

approval of State plan

or up to 3 years after

EPA approval of State

plan if the source is

granted an extension.

Repeat performance test........................ Within 12 months

following initial

compliance test and

annually thereafter.

Parameter monitoring........................... Continuously, upon

completion of initial

compliance test.

Recordkeeping.................................. Continuously, upon

completion of initial

compliance test.

Reporting...................................... Annually, upon

completion of initial

compliance test;

semiannually, if

noncompliance.

------------------------------------------------------------------------

B. Significant Issues and Changes

This section discusses the most significant changes to the

guidelines made following the June 20, 1996 Federal Register document.

Further discussion of these changes as well as other comments and

responses regarding the emission guidelines are provided in ``Hospital/

Medical/Infectious Waste Incinerators: Background Information for

Promulgated Standards and Guidelines--Summary of Public Comments and

Responses'' (EPA-453/R-97-006b).

As discussed in the 1996 re-proposal, the MACT floor for small

existing HMIWI was based on emission limits achievable through use of

good combustion alone (i.e., without add-on control). The EPA presented

regulatory options more stringent than the MACT floor for small

existing HMIWI in the 1996 re-proposal and stated that it had no

inclination as to which regulatory

[[Page 48370]]

option might be selected for the final emission guidelines for small

HMIWI. The EPA solicited public comment on the available regulatory

options for the guidelines for small existing HMIWI.

During the public comment period, the EPA received several comments

containing suggestions for the final emission guidelines for small

existing HMIWI. A number of commenters requested that the emission

guidelines for small existing HMIWI be based on the MACT floor. Other

commenters requested that the guidelines for small HMIWI require small

HMIWI in urban locations to meet emission guidelines more stringent

than the MACT floor and allow small HMIWI in rural locations to meet

the MACT floor emission limits. These commenters noted that cost-

effective alternatives to onsite incineration may not be available to

facilities operating small HMIWI in rural locations and that emission

limits based on wet scrubbers would cause these facilities financial

hardship. Other commenters contended that emission limits for small

incinerators consistent with no more than good combustion would result

in largely uncontrolled emissions, and would encourage medium-sized

units to change their size designation to small by burning less waste

per hour while operating more hours per day. These commenters stated

that there are cost-effective alternatives to incineration and

requested that small existing HMIWI be subject to emission limits

consistent with wet scrubbers.

Guidelines for small existing HMIWI based on the use of good

combustion and low efficiency wet scrubbing could cause the cost of

waste disposal to more than double for facilities that install the

equipment necessary to meet the emission guidelines. Even guidelines

based on the MACT floor (good combustion alone) would cause a

significant increase in costs for such facilities. The EPA's cost

projections show that the costs of retrofitting small existing HMIWI to

meet the MACT floor would be about $18 million annually, while the cost

of going beyond the floor (guidelines based on low efficiency wet

scrubbers) for the estimated 1,025 small HMIWI that do not meet the

``remote'' criteria (discussed later) would be an additional $47

million. However, as noted by commenters and observed by States that

have implemented stringent HMIWI regulations, there are a number of

cost-effective alternatives to onsite incineration for most facilities

that operate small HMIWI. Therefore, many health care facilities

operating small HMIWI could switch to alternative means of waste

disposal if the emission guidelines are based on the use of good

combustion and low efficiency wet scrubbing. In fact, EPA's modeling

projects that most existing facilities, except those meeting the

``remote'' criteria, would find it more economical to switch to

alternative means of waste disposal than to retrofit their small

incinerators even to meet the MACT floor, and virtually all such

facilities would switch rather than retrofit small incinerators with

low efficiency wet scrubbers. Under the switching scenario, the costs

for non-``remote'' small facilities range from $6 to $13 million for

guidelines based on the MACT floor, and from $6 to $2

This text is long and has been trimmed here. Open the source document for the complete record.