31736 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

U.S. ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 60

[AD-FRL–5523–1]

RIN 2060–AC62

Standards of Performance for New

Stationary Sources and Emission

Guidelines for Existing Sources:

Medical Waste Incinerators

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability of

supplemental information and

reopening of public comment period.

SUMMARY: On February 27, 1995, EPA

proposed new source performance

standards (NSPS or standards) and

emission guidelines (EG or guidelines)

for new and existing medical waste

incinerator(s) (MWI) that will reduce air

pollution from MWI. Once

implemented, these standards and

guidelines will protect public health by

reducing exposure to air pollution. In

the proposal preamble, EPA made a

commitment to reconsider the proposed

NSPS and EG based on new information

submitted. Today’s action presents an

assessment of the supplemental

information submitted following the

proposal and solicits public comment

on this assessment. Today’s action also

serves to address comments received on

the proposal and reopens the comment

period for development of the MWI

standards and guidelines.

DATES: Public Meeting. A public meeting

will be held on July 10, 1996 beginning

at 9:00 a.m. At the public meeting, EPA

will review the contents of this notice

and answer questions so that

commenters can better prepare their

written comments. See ADDRESSES

below for the location of the meeting.

Comments. Comments are requested

on all information associated with the

development of MWI standards and

guidelines. Written comments must be

received on or before August 8, 1996.

See ADDRESSES below.

ADDRESSES: Public Meeting. The public

meeting will take place at the Holiday

Inn, Hotel and Suites, 625 First Street,

Alexandria, Virginia, 22314, (703) 548–

6300. Persons interested in attending

the meeting should notify Ms. Donna

Collins, U.S. Environmental Protection

Agency, Research Triangle Park, North

Carolina 27711, telephone (919) 541–

5578.

Comments. Comments should be

submitted (in duplicate, if possible) to

the following: The Air and Radiation

Docket and Information Center, ATTN:

Docket No. A–91–61, U.S.

Environmental Protection Agency, 401

M Street, SW, Washington, DC 20460.

Submissions containing proprietary

information (Confidential Business

Information) should be sent directly to

the following address, not to the public

docket, to ensure that proprietary

information is not inadvertently placed

in the docket: Attention: Mr. Rick

Copland, c/o Ms. Melva Toomer, U.S.

Environmental Protection Agency

Confidential Business Manager, 411 W.

Chapel Hill Street, Room 944, Durham,

North Carolina 27701. See

SUPPLEMENTARY INFORMATION for further

discussion of confidential business

information.

Docket. Docket No. A–91–61,

containing 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, at the Air and Radiation Docket

and Information Center, U.S.

Environmental Protection Agency, 401

M Street, SW, Washington, DC 20460,

telephone (202) 260–7548, fax (202)

260–4000. A reasonable fee may be

charged for copying. See

SUPPLEMENTARY INFORMATION for a list of

documents most directly related to

today’s notice.

FOR FURTHER INFORMATION CONTACT: Mr.

Rick Copland at (919) 541–5265 or Mr.

Fred Porter at (919) 541–5251, Emission

Standards Division (MD–13), U.S.

Environmental Protection Agency,

Research Triangle Park, North Carolina

27711.

SUPPLEMENTARY INFORMATION: Regulated

Entities. Entities potentially regulated

by the standards and guidelines are

those which operate medical waste

incinerators. Regulated categories and

entities include those listed in Table 1.

TABLE 1.—REGULATED ENTITIES a

Category Examples of regulated entities

Industry ...................................................... Hospitals, nursing homes, research laboratories, other healthcare facilities, commercial waste disposal companies.

Federal Government .................................. Armed services, public health service, Federal hospitals, other Federal healthcare facilities.

State/local/Tribal Government ................... State/county/city hospitals and other healthcare facilities.

aThis 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 MWI. 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 medical waste incinerators,

you should carefully examine the applicability criteria in sections 60.50(c) and 60.51(c) of the February 1995 proposal and sections II(B), II(H),

and II(I) of today’s notice. If you have questions regarding the applicability of the MWI standards and guidelines to a particular entity, consult the

person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Confidential Business Information.

Commenters wishing to submit

proprietary information for

consideration should clearly distinguish

such information from other comments

and clearly label it ‘‘Confidential

Business Information.’’ Information

covered by such a claim of

confidentiality will be disclosed by the

EPA only to the extent allowed and by

the procedures set forth in 40 CFR part

2. If no claim of confidentiality

accompanies a submission when it is

received, the submission may be made

available to the public without further

notice to the commenter.

Documents Available Electronically.

An electronic version of this action as

well as the February 1995 Federal

Register proposal notice are available

for download from EPA’s Technology

Transfer Network (TTN), which is a

network of electronic bulletin boards

developed and operated by EPA’s Office

of Air Quality Planning and Standards.

The TTN provides information and

technology exchange in various areas of

air pollution control. The service is free,

except for the cost of a telephone call.

Dial (919) 541–5742 for data transfer of

up to 14,400 bits per second. The TTN

is also available on the Internet (access:

TELNET ttnbbs.rtpnc.epa.gov). For more

information on the TTN, contact the

systems operator at (919) 541–5384.

Documents in the Docket. The

documents listed below are not

available through the TTN, but are

available through Air Docket No. A–91–

61 located at the Air and Radiation

Docket and Information Center (see the

ADDRESSES section earlier in this
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31737

notice). These documents provide the analyses that are summarized in this

notice.

Item No. Title

IV–A–7 .............. National Dioxin Emission Estimates from Medical Waste Incinerators.

IV–A–8 .............. Revised Economic Impacts: Existing Medical Waste Incinerators.

IV–A–9 .............. Revised Economic Impacts: New Medical Waste Incinerators.

IV–B–23 ............ PM MACT Floor Emission Levels for Potential Subcategories of the MWI Source Category.

IV–B–24 ............ Determination of the Maximum Achievable Control Technology (MACT) Floor for Existing Medical Waste Incinerators that Incinerate General Medical Waste.

IV–B–25 ............ Definition of Medical Waste.

IV–B–26 ............ Operator Training and Qualification and Incinerator Inspection Requirements.

IV–B–30 ............ Approach Used to Estimate the Capital and Annual Costs for MWI Wet Scrubbers.

IV–B–32 ............ Revised Costs for Dry Injection/Fabric Filter Controls for MWI.

IV–B–33 ............ Revised Costs for Secondary Chamber Retrofits for MWI.

IV–B–37 ............ Projections for New MWI Population.

IV–B–38 ............ Determination of the Maximum Achievable Control Technology (MACT) Floor for New Medical Waste Incinerators.

IV–B–39 ............ Annual Costs for the Operator Training and Qualification Requirements for MWI Operators.

IV–B–43 ............ Alternative Methods of Medical Waste Treatment: Availability, Efficacy, Cost, State Acceptance, Owner Satisfaction, Operator

Safety, and Environmental Impacts.

IV–B–44 ............ Determination of Medical Waste Incinerator (MWI) Size.

IV–B–45 ............ Updated Medical Waste Incinerator Data Base.

IV–B–46 ............ PM, CO, and CDD/CDF Average Emission Rates and Achievable Emission Levels for MWI with Combustion Controls.

IV–B–47 ............ Acid Gases and Metals Typical Performance and Achievable Emission Levels for Medical Waste Incinerators with Good Combustion Control.

IV–B–48 ............ Wet Scrubber Performance Memorandum.

IV–B–49 ............ Dry Scrubber Performance Memorandum.

IV–B–50 ............ Cost Impacts of the Regulatory Options for New and Existing Medical Waste Incinerator (MWI).

IV–B–51 ............ Air Emission Impacts of the Regulatory Options for New and Existing Medical Waste Incinerators (MWI).

IV–B–52 ............ Potential Solid Waste, Wastewater, and Energy Impacts of the New Source Performance Standards and Emission Guidelines

for New and Existing Medical Waste Incinerators.

IV–B–54 ............ Testing and Monitoring Options and Costs for MWI—Methodology and Assumptions.

IV–B–56 ............ Standards of Performance for Medical Waste Pyrolysis Units.

Acronyms, Abbreviations, and

Measurement Units. The following list

of acronyms, abbreviations, and

measurement units is provided to aid

the reader.

AHA ............ American Hospital Association

Btu .............. British thermal unit

Cd ................ cadmium

CEMS .......... continuous emission monitoring system(s)

CFR ............. Code of Federal Regulations

CO ............... carbon monoxide

dioxin ......... dioxins and dibenzofurans

DI/FF ........... dry injection/fabric filter

dscf ............. dry standard cubic foot

dscm ........... dry standard cubic meter

EG ............... emission guidelines

EPA ............. Environmental Protection

Agency

ft3 ................ cubic feet

FTE ............. full time equivalent

g .................. grams

gr ................. grains

HCl .............. hydrogen chloride

Hg ................ mercury

hr ................. hour

IV ................ intravenous

lb ................. pound

MACT ......... maximum achievable control

technology

m3 ................ cubic meter

MW ............. megawatt

MSA ............ Metropolitan Statistical Area

Mg ............... megagram

mg ............... milligram

MM ............. million

MWI ............ medical waste incinerator(s)

MWTA ........ Medical Waste Tracking Act

MWC ........... municipal waste combustor

ng ................ nanogram

NOX ............. Oxides of nitrogen

NRDC Natural Resources Defense

Council

NSPS ........... new source performance

standards

NYSDOH .... New York State Department

of Health

O2 ................ oxygen

Pb ................ lead

PM ............... particulate matter

ppmdv ........ parts per million by volume

(dry basis)

SO2 .............. sulfur dioxide

STAATT ..... State and Territorial Association of Alternate Treatment

Technologies

SWDA ......... Solid Waste Disposal Act

TEQ ............. Toxic Equivalency Quality

(dioxin emissions)

TTN ............. Technology Transfer Network

TCLP ........... Toxicity Characteristics

Leachate Procedure

yr ................. year

Outline of this Notice. The

information in this section is organized

as follows:

I. Introduction

A. The Clean Air Act

B. February 1995 Proposal

C. New Information Since Proposal

D. Purpose of this Supplemental Notice

E. New Timeline for Promulgation

II. Review of New Information

A. MWI Inventory

1. Existing Population

2. Future Installations

B. Subcategorization

C. Performance and Cost of Technology

1. Good combustion

2. Wet scrubbers

3. Dry scrubbers

D. MACT Floor

1. Existing MWI

2. New MWI

E. Baseline Emissions

F. Operator Training and Qualification

G. Testing, Monitoring, and Inspection

H. Definition of Medical Waste

I. Pyrolysis Units

J. Alternative Medical Waste Treatment

Technologies

III. Regulatory Options and Impacts for

Existing MWI

A. Regulatory Options

B. National Environmental and Cost

Impacts

1. Analytical approach

2. Air Impacts

3. Water and solid waste impacts

4. Energy Impacts

5. Cost Impacts

C. Economic Impacts

1. Analytical approach

2. Industry-wide economic impacts

3. Facility-specific economic impacts

IV. Regulatory Options and Impacts for New

MWI

A. Regulatory Options

B. National Environmental and Cost

Impacts

1. Analytical approach

2. Air impacts

3. Water and solid waste impacts
31738 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

4. Energy Impacts

5. Cost Impacts

C. Economic Impacts

1. Analytical approach

2. Industry-wide economic impacts

3. Facility-specific economic impacts

V. Inclinations for Final Rule

I. Introduction

A. The Clean Air Act

The Clean Air Act amendments of

1990 added section 129, which includes

specific requirements for solid waste

combustion units. Section 129 requires

the EPA, under section 111(b), to

establish NSPS for new MWI and under

section 111(d), to establish EG for

existing MWI based on maximum

achievable control technology (MACT).

Section 129 establishes specific criteria

that must be analyzed in developing

these standards and guidelines. In

general, this involves (1) determining

appropriate subcategories within a

source category; (2) determining the

‘‘MACT floor’’ for each subcategory; (3)

assessing available air pollution control

technology with regard to achievable

emission limitations and costs; and (4)

examining the cost, nonair-quality

health and environmental impacts, and

energy requirements associated with

standards and guidelines more stringent

than the MACT floor. Section 129 also

directs EPA to establish operator

training requirements for new and

existing MWI as well as siting

requirements for new MWI.

Section 129 requires the EPA to

include numerical emission limitations

in the standards and guidelines for the

following air pollutants: particulate

matter (PM), opacity, sulfur dioxide

(SO2), hydrogen chloride (HCl), oxides

of nitrogen (NOx), carbon monoxide

(CO), lead (Pb), cadmium (Cd), mercury

(Hg), and dioxins and dibenzofurans

(referred to in this notice as ‘‘dioxin’’).

Section 129 requires that these emission

limitations reflect the maximum degree

of reduction in air emissions that the

Administrator determines is achievable,

taking into consideration the cost of

achieving such emission reduction and

any nonair-quality health and

environmental impacts and energy

requirements. This requirement is

referred to as MACT.

The MACT for new MWI may not be

less stringent than the emissions control

achieved in practice by the best

controlled similar unit. The guidelines

for existing MWI may be less stringent

than the standards for new MWI;

however, the guidelines may be no less

stringent than the average emission

limitation achieved by the best

performing 12 percent of units in the

category. These requirements that the

standards and guidelines must be no

less stringent than certain levels are

referred to as the ‘‘MACT floor.’’

The Clean Air Act requires EPA to

consider 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 it concludes that

NSPS or EG more stringent than the

MACT floor are not achievable,

considering costs and other impacts. In

no case may EPA establish emission

limitations less stringent than the

MACT floor.

Because standards and guidelines

developed under Section 129 are to

reflect the performance capabilities of

air pollution control technology, EPA

must assess air pollution control

technologies and draw conclusions

regarding their performance. This is

often misunderstood and some assume

that the regulations require the use of

specific technology. However, the

control technology used to achieve the

standards or guidelines is not specified

in the regulations. The regulations only

include specific air pollution emission

limits that a source (i.e., an MWI) must

achieve. Any control technology that

can comply with the final emission

limits may be used.

B. February 1995 Proposal

On February 27, 1995 (60 FR 10654),

EPA published proposed NSPS and EG

for MWI. The proposal was the result of

several years of effort reviewing

available information in light of the

Clean Air Act requirements described

above.

During the data-gathering phase of the

project, it was difficult to get an

accurate count of MWI nationwide. In

addition, it was difficult to find MWI

with add-on air pollution control

systems in place. Information from a

few State surveys led to an estimated

population of 3,700 existing MWI.

Subcategories were determined based

on design differences among different

types of incinerators: continuous,

intermittent, and batch. These three

design types roughly correlate to MWI

size.

A few MWI with various levels of

combustion control (no add-on air

pollution control) were tested to

determine the performance of

combustion control in reducing MWI

emissions. One MWI equipped with a

wet scrubber (add-on control) was tested

to determine the performance

capabilities of wet scrubbing systems. A

few other MWI 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

indicated that dry scrubbing systems

could achieve much lower emissions

than wet scrubbing systems.

As mentioned above, the MACT floor

for new MWI is to reflect the emissions

control achieved by the best controlled

similar unit. Dry scrubbing systems

were identified on at least one MWI in

each of the three subcategories

(continuous, intermittent, and batch).

Consequently, the MACT floor emission

levels for the proposed NSPS reflected

the performance capabilities of dry

scrubbing systems.

For existing MWI under the 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 MACT floor for existing MWI would

require the use of a dry scrubbing

system, even for small existing batch

MWI.

Following determination of the MWI

population, subcategories, performance

of technology, and MACT floors, the

Clean Air Act requires EPA to consider

standards and guidelines that are more

stringent than the floors. However,

because the MACT floors calculated for

the proposal were so stringent, EPA was

left with few options to consider.

Emission limits reflecting the capability

of dry scrubbing systems were proposed

for all sizes and types of new and

existing MWI.

As mentioned earlier, the proposed

standards and guidelines included

numerical emission limits reflecting the

performance capabilities of dry

scrubbing systems; however, the

proposed regulations would not require

the use of a dry scrubbing system.

Emission limits are included in these

regulations rather than control

equipment requirements to encourage

competition and further the

development of new technologies. Any

technology capable of achieving the

emission limitations in the regulations

may be used.
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31739

C. New Information Since Proposal

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

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

proposed standards and guidelines,

including: the existing population of

MWI, 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 has led to different

conclusions, as outlined below.

D. Purpose of This Supplemental Notice

This notice announces the availability

of new information, reviews EPA’s

assessment of the new information,

provides EPA’s inclination as to how

the new information might change the

final standards and guidelines, and

solicits comments on EPA’s assessments

and inclinations. This new information

and these assessments are documented

in more detail in a series of memoranda

included in Air Docket No. A–91–61. A

listing of these documents can be found

at the beginning of this notice. This

action also reopens the public comment

period for the development of standards

and guidelines for MWI. Today’s action

serves not only as a review of new

information and request for comment,

but also as a response to comments on

the proposed rule.

This notice is not a reproposal. The

proposal date for the MWI standards

and guidelines remains February 27,

1995. Any MWI that has commenced

construction after February 27, 1995, is

considered a new MWI and will be

subject to the NSPS, while any MWI

that commenced construction on or

before February 27, 1995, is considered

an existing MWI.

E. New Timeline for Promulgation

In 1993, the EPA, the Sierra Club, and

the Natural Resources Defense Council

(NRDC) filed a consent decree with the

U.S. District Court for the Eastern

District of New York (Nos. CV–92–2093

and CV–93–0284) that required the EPA

Administrator to sign a notice of

proposed rulemaking no later than

February 1, 1995 and a notice of final

rulemaking no later than April 15, 1996.

Because of the large amount of new

information and conclusions drawn

from the new information, the EPA

deemed it necessary to issue this

supplemental Federal Register notice to

provide the public sufficient

opportunity to comment on all

information used by the Agency in

developing the NSPS and EG. The

Agency requested an extension of the

April 15, 1996 court-ordered deadline,

and the court order has been revised to

require the EPA Administrator to sign a

notice of final rulemaking no later than

July 25, 1997.

II. Review of New Information

As mentioned earlier, more than 700

comment letters were received

following the February 27, 1995

proposal. An assessment of this

information and some of EPA’s

inclinations in light of this new

information are presented below.

In general, the following process was

used to assess the new information. The

public comment letters were reviewed

and categorized by area of comment.

Information related to specific issues

(e.g., wet scrubber performance) was

reviewed; meetings were then held to

discuss specific areas of comment with

relatively small groups who were

believed to have expertise in specific

areas. For example, meetings with wet

scrubber vendors were held to discuss

the new information related to the

performance capabilities of wet

scrubbers. During the smaller meetings,

additional information was received and

comment was taken. Following the

smaller meetings, EPA conducted larger

public meetings on June 15, 1995,

September 26, 1995, and February 14,

1996, to review the assessment of new

information and take further public

comment. This Federal Register notice

provides EPA’s review of all

information received since proposal.

A. MWI Inventory

One of the essential starting points in

developing EG and NSPS is compiling

an inventory of existing sources and

projecting the number of new sources

expected to be built in the future. The

MWI inventory is the basis for the

development of MACT floors,

environmental impacts, cost impacts,

and economic impacts. The results of

these analyses are then used to

determine MACT.

The inventory of existing sources

used in this analysis is a ‘‘snapshot’’ of

the current population of existing MWI.

The inventory of new MWI potentially

subject to the NSPS is a prediction of

the number of MWI that will be built

over the next 5 years in the absence of

Federal regulations. The MWI

inventories are not exact, but are

representative of current and future

MWI populations. Consequently, they

are adequate to allow EPA to make

informed decisions in developing

standards and guidelines for new and

existing MWI.

1. Existing Population

To estimate the nationwide

population of existing MWI at proposal,

available State MWI inventory

information was gathered. Where MWI

information was not available for a

particular State, the State’s human

population was used to estimate the

MWI population. Human population

was selected as the basis for

extrapolation because it is logical that

the amount of medical waste generated

(and, therefore, the MWI population)

would correlate with human

population. This extrapolation was a

straightforward computation with

readily available data; however, detailed

State inventory data were only available

from 11 States. This method resulted in

an estimated 3,700 MWI burning general

medical waste.

Following proposal, a number of

comments were received regarding the

inventory of existing MWI. Several

commenters suggested that the

population of MWI was overestimated.

The American Hospital Association

(AHA) submitted comments that

included a compilation of

approximately 2,200 existing MWI.

To compile a new EPA inventory, the

AHA inventory was used as a starting

point. Other sources of information,

including State surveys and a data base

of MWI operating permits, were also

used to refine the inventory. Following

this initial compilation, the inventory

contained approximately 2,600 MWI.

During the September 26, 1995 public

meeting, several stakeholders voiced

concern that many of the incinerators

listed in EPA’s MWI inventory had

ceased operation. To address this

concern, the Agency requested

additional information to update the

inventory. Additional information was

received from State agencies,

commercial medical waste disposal

companies, and MWI vendors. Medical

waste incinerator units were deleted or

added based on the new information

provided. Following these revisions, the

final EPA inventory contains

approximately 2,400 MWI; this

inventory is located in the docket as

item No. IV–B–45.

The inventory also contains

information such as MWI type

(continuous/intermittent or batch fed),

capacity, and location, as well as State
31740 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

regulatory or permit emission limits.

Every MWI in the inventory is assigned

an MWI capacity in pounds per hour

(lb/hr) or pounds per batch (lb/batch).

Location information includes rural or

urban designations based on

Metropolitan Statistical Area (MSA)

boundaries for the U.S. Facilities within

MSA boundaries were considered urban

MWI; facilities outside MSA boundaries

were considered rural MWI. Emission

limitations were determined by

examining air quality permits, where

available, or examining the emission

limitations included in State

regulations.

2. Future Installations

Projections of new MWI were made to

estimate the costs and other impacts

associated with NSPS. To estimate the

number of new MWI that would be

subject to the NSPS, historical sales data

were obtained from MWI vendors. For

the proposal, it was estimated that, in

the absence of Federal regulations, 700

MWI would be installed during the 5

years following proposal (140 MWI per

year). This projection was based on

historical sales data gathered from 1985

through 1989.

To update the projection of new MWI

that would be subject to the NSPS,

additional data were gathered from MWI

vendors following the proposal.

Historical sales data were gathered

covering years 1990 to 1995. Based on

this new data, 235 MWI are expected to

be installed in the next 5 years in the

absence of the NSPS (47 per year). This

projection covers the years 1996 to

2000. The memorandum documenting

the procedures used to estimate the

population of new MWI is located in the

docket as item IV–B–37.

B. Subcategorization

Section 129 of the Clean Air Act states

that the Administrator may distinguish

among classes, types, and sizes of units

within a category in establishing the

standards and guidelines. At proposal,

the Agency concluded the MWI

population should be divided into three

subcategories: (1) Continuous MWI, (2)

intermittent MWI, and (3) batch MWI.

While these three subcategories were

based on design differences of the MWI,

they also correlate roughly with size or

MWI capacity.

During the public comment period, a

number of comments were received

regarding subcategorization. Several

commenters suggested that EPA

subcategorize directly by MWI size.

Others suggested that EPA subcategorize

MWI based on heat input capacity.

Other commenters suggested that the

Agency set standards based on the

location of MWI; these commenters

expressed concern about the lack of

medical waste disposal options in

remote rural locations.

Three criteria were subsequently

considered in reexamining potential

subcategories: size (capacity to burn

medical waste); type (continuous/

intermittent versus batch); and location

(urban versus rural). The first two are

clearly identified in Section 129 and

have been used in other Federal

regulations as criteria for

subcategorization. Location, by itself, is

not a valid criterion for

subcategorization. However, in this

case, it is used as a surrogate measure

of the availability of alternative waste

disposal options. Medical waste

incinerators located in remote areas

might be considered as a separate

‘‘class’’ of incinerator because of the

limited availability of alternative waste

disposal options in rural areas.

As mentioned earlier, the MACT floor

is the least stringent regulatory option

allowed under the Clean Air Act.

Consequently, the MACT floors were

examined using the EPA MWI inventory

for various potential MWI subcategories.

Because PM is, by far, the most common

type of emission limitation in State

regulations and permits, the PM MACT

floor was the focus in this analysis.

Subcategories were established when

significant differences in PM MACT

floors were identified.

The most common size breaks used by

States in regulating MWI occur at 100,

200, 500, 1,000, and 2,000 lb/hr. The

MACT floor emission levels for these

size breaks were evaluated to determine

appropriate size breaks for regulation.

Significant differences in MACT floors

were identified at 200 lb/hr and 500 lb/

hr. Consequently, the three size ranges

determined to be appropriate for the

purpose of regulating MWI are

presented in Table 2.

TABLE 2.—NUMBER OF MWI AND SIZE

RANGES FOR SUBCATEGORIES

MWI subcategory Size range, lb/hr

Number of

MWI

Small ................. ≤200 .................. 1,139

Medium ............. >200 and ≤500 692

Large ................. >500 .................. 542

The three basic design types of MWI

are continuous, intermittent, and batch.

A distinction between continuous and

intermittent MWI based on design type

may not be appropriate because these

two types of units are essentially

identical with the exception of the ash

handling system. Also, the information

used to develop the population of

existing MWI does not distinguish

between continuous and intermittent

MWI. Batch MWI, however, are very

different from intermittent and

continuous units. As a result, batch

MWI were further examined to

determine if the MACT floor emission

levels are different than those for

continuous and intermittent MWI

within the same size range; no

significant difference in MACT floor

emission levels was found.

The final criterion considered was

location (urban vs. rural). This analysis

focused on the small MWI because

commenters were particularly

concerned about small, rural MWI. The

MACT floor emission levels for small

urban MWI and small rural MWI,

however, were found to be essentially

the same.

Based on the new information, the

Agency is inclined to subcategorize the

existing and new population of MWI

into three subcategories as shown in

Table 2: small (≤200 lb/hr), medium

(>200 and ≤500), and large (>500). The

memorandum that details the

procedures used to assess the

subcategories is found in the docket as

item IV–B–23. Further subcategorization

may be considered in examining

standards and guidelines more stringent

than the MACT floors (see Sections III

and IV).

Directly related to the question of

using size or burning capacity to

subcategorize MWI, the proposal

requested comment on a ‘‘standard’’

method of determining MWI size for the

purpose of consistent, uniform, and

equitable application of whatever

standards and guidelines are adopted.

Comments responding to this request

focused on the design heat release rate

of the MWI expressed in British thermal

units per hour per cubic foot (Btu/hr-ft3)

in the primary combustion chamber and

the heat content of medical waste

expressed in British thermal units per

pound (Btu/lb). Most MWI

manufacturers base their design

capacities on these two factors.

In considering and/or adopting a

‘‘standard’’ means of determining MWI

size, EPA is not attempting to establish

design requirements for MWI

manufacturers. Instead, the only

purpose of adopting a standard method

for determining the size of MWI is to

ensure that all MWI of the same ‘‘size’’

are subject to the same requirements.

The design heat release rate used by

most vendors of continuous and

intermittent MWI is typically 15,000

Btu/hr-ft3. The heat content of medical

waste can vary substantially from 1,000

Btu/lb for pathological waste to over

10,000 Btu/lb for waste with a high
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31741

plastics content. The heat content

generally associated with medical waste

for the purpose of determining

nameplate capacity has been 8,500 Btu/

lb. The combination of 15,000 Btu/hr-ft3

and 8,500 Btu/lb results in a volumetric

waste burning capacity of 1.76 lb/hr-ft3.

The volume of the primary chamber is

multiplied by 1.76 to determine the size

of the MWI. A continuous or

intermittent MWI with a primary

chamber volume of 500 ft3 would be

sized at 880 lb/hr for the purpose of

determining regulatory requirements.

For batch MWI, the calculation is

slightly different. Batch MWI charge all

waste to be burned when the unit is

cold. No additional waste is added

during the combustion cycle. The unit

is then allowed to cool before ash is

removed and more waste is charged.

These units are given a designation of

pounds per batch (lb/batch) rather than

lb/hr and usually take about 12 hours to

completely burn the waste. The density

of medical waste is about 4.5 lb/ft3.

Consequently, the combination of 4.5

lb/ft3 and 12 hours per batch yields a

volumetric waste burning capacity of

0.375 lb/hr-ft3. The volume of the

primary chamber would be multiplied

by 0.375 to determine the size of the

MWI. A batch MWI with a primary

chamber volume of 500 ft3 would be

sized at 188 lb/hr for the purpose of

determining regulatory requirements. A

more detailed description of the MWI

size methods described above for

continuous, intermittent, and batch

MWI can be found in the docket as item

IV–B–44.

During a meeting with MWI vendors,

it was suggested that MWI size should

be determined by the unit’s operating

permit rather than its design capacity.

Many States allow MWI to meet less

stringent requirements associated with

smaller MWI as long as the MWI is

subject to a permit condition limiting

the amount of waste burned.

Consequently, while EPA is inclined to

determine MWI size by the criteria

described above, EPA is also

considering inclusion of an option to

allow an MWI to change its size

designation by operating under a

Federally enforceable requirement

limiting the amount of waste burned

(i.e., waste feed rate—lb/hr). For

example, a continuous or intermittent

MWI with a 340 ft3 primary chamber,

with a design capacity of about 600 lb/

hr (i.e., ‘‘large’’), using the procedure

outlined above, could be considered a

‘‘medium’’ MWI by operating under a

Federally enforceable requirement

limiting its charge rate to no more than

500 lb/hr. A batch MWI with a 1,000 ft3

primary chamber, with a design

capacity of about 4,500 lb/batch or 375

lb/hr (i.e., ‘‘medium’’), using the

procedure outlined above, could be

considered a ‘‘small’’ MWI by operating

under a Federally enforceable

requirement limiting its charge rate to

no more than 2,400 lb/batch (200 lb/hr).

Finally, some commenters expressed

concern about facilities installing

multiple small MWI at one location in

an effort to be subject to less stringent

requirements. Commenters believed this

should not be allowed. Consequently,

EPA is inclined to combine the waste

burning capacity of multiple units at

one location to determine size. As stated

above, such facilities could still operate

under a Federally enforceable permit

limiting their operating capacity to

change their size designation.

C. Performance and Cost of Technology

Section 129 of the Clean Air Act

directs the EPA to develop regulations

for MWI that are based on the use of

MACT, which is defined as the

maximum reduction in emissions of air

pollution the EPA considers achievable,

considering costs, environmental, and

energy impacts. However, Section 129

also states that, for existing MWI, these

regulations can be no less stringent than

the average of the best 12 percent of

existing MWI, and for new MWI, they

can be no less stringent than the best

similar MWI. These minimum

stringency requirements for the

regulations are referred to as the ‘‘MACT

floors.’’ The emission limits in the final

regulations can be no less stringent than

the ‘‘MACT floor’’ emission levels.

The ‘‘MACT floors’’ for the

regulations are discussed in detail in

another section of this notice. However,

these ‘‘MACT floors’’ are only the

starting point for determining MACT.

Since MACT is the maximum reduction

in air pollution emissions that is

achievable, considering costs, environmental and energy impacts, if more

stringent emission levels than the

MACT floor emission levels are

achievable, the EPA must identify these

more stringent emission levels and

consider them in selecting the MACT

emission limits for MWI.

The EPA determines whether more

stringent emission levels than the

MACT floor emission levels are

achievable by identifying various air

pollution control technologies used to

reduce emissions from MWI. Next, the

EPA gathers and analyzes data on these

technologies and draws conclusions

regarding their performance—in terms

of their ability to reduce air pollution

emissions. The EPA then is able to

determine MACT as follows.

After the MACT floors have been

determined, the EPA can identify what

air pollution control technologies would

need to be used by MWI to achieve or

comply with regulations based on these

MACT floors. Then the EPA can identify

those air pollution control technologies

that are capable of achieving more

stringent emission levels than the

MACT floors. The EPA is then able to

analyze and consider these more

stringent emission levels in terms of the

cost, environmental, and energy impacts

associated with their use compared to

the use of the air pollution control

technologies that can achieve the MACT

floor emission levels. This analysis and

consideration serves as the basis for the

EPA to determine MACT.

All of this analysis, with its focus and

discussion of air pollution control

technology, is often misunderstood and

leads some to assume that the

regulations require the use of a specific

air pollution control technology, which

is not the case. The air pollution control

technology used to achieve or comply

with the regulations is not specified in

the regulations. The regulations only

include emission limits (i.e.,

concentration levels in the gases

released to the atmosphere) for specific

air pollutants (e.g., hydrogen chloride,

lead, etc.) that an MWI must achieve.

The decision on how to meet these

emission limits is left to the MWI owner

or operator; an MWI owner or operator

may select any equipment or any means

available to comply with these emission

limits.

At the time of 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. The data indicated that

dry scrubbing systems could achieve

much lower emission levels than wet

scrubbing systems and that either type

of scrubbing system could achieve much

lower emission levels than combustion

controls (i.e., good combustion) alone.

Following proposal, a number of

emission test reports were submitted to

EPA. Many commenters believe that

EPA misjudged the performance

capabilities of various air pollution

control technologies, especially the

capabilities of wet scrubbing systems.

The EPA has reviewed the data

contained in these emission test reports

and, as summarized below, EPA’s

conclusions regarding the performance

capabilities of various air pollution

control technologies have been revised.

Relatively few comments were

received regarding EPA’s estimates of

the costs of air pollution control

technology. The majority of the
31742 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

comments regarding cost pertained to

wet scrubbing systems. The

reassessment of costs is discussed

briefly below for each control

technology.

1. Good Combustion

Combustion controls (i.e., good

combustion) are effective in reducing

emissions of combustion-related

pollutants, such as PM, CO, and dioxin,

but are not effective in reducing

emissions of waste-related pollutants,

such as acid gases or metals. For the

combustion-related pollutants,

combustion controls can be divided into

two levels (i.e., 1-second and 2-second

residence time) and the achievable

emission levels associated with the use

of each of these levels have been

reassessed. In addition, achievable

emission levels for waste-related

pollutants were also reassessed. For

waste-related pollutants, performance

between the two levels of combustion

control is not distinguishable. The

results of the reassessment of

combustion control are shown in Table

3 and are available as item Nos. IV–B–

46 and IV–B–47 in the docket.

TABLE 3.—ACHIEVABLE EMISSION

LEVELS FOR COMBUSTION CONTROL

Pollutant/combustion level

Achievable

emission

levels

PM, gr/dscf:

1-sec .................................... 0.35

2-sec .................................... 0.25

Dioxin, ng/dscm:

1-sec .................................... 9,000

2-sec .................................... 800

TEQ dioxin, ng/discm:

1-sec .................................... 275

2-sec .................................... 15

TABLE 3.—ACHIEVABLE EMISSION LEVELS FOR COMBUSTION CONTROL—

Continued

Pollutant/combustion level

Achievable

emission

levels

CO, ppmdv:

1-sec .................................... 700

2-sec .................................... 40

HCl, ppmdv ............................. 3,100

SO2, ppmdv ............................ 55

NOx, ppmdv ............................ 250

Pb, mg/dscm ........................... 10

Cd, mg/dscm ........................... 4

Hg, mg/dscm ........................... 7.5

Most of the achievable emission levels

associated with combustion control

have changed little from the proposal;

the exceptions are the achievable

emission levels for dioxin and Hg. The

conclusion drawn at proposal regarding

the achievable emission level for dioxin

was driven by two relatively high data

points from two different MWI. A

thorough review of these two MWI and

the tests conducted at these two MWI

raise numerous questions and doubts

about whether good combustion was

actually employed at these MWI during

the emission tests. Consequently, EPA

no longer considers these emission tests

representative of good combustion.

The situation is similar with regard to

achievable Hg emission levels; at

proposal, the conclusion regarding

achievable emission level for Hg was

driven by one very high data point.

Following proposal, the hospital

operating this MWI instituted several

common waste management practices

employed by other hospitals, and the

MWI was retested by the EPA. The new

data point is very similar to all the other

data points. Consequently, the earlier

data point is no longer considered

representative of achievable Hg

emission levels.

While no specific comments were

received regarding the cost of good

combustion, the costs were reassessed

and updated for consistent comparison

with other costs. This information is

described in more detail in item IV–B–

33 in the docket.

2. Wet Scrubbers

Following proposal, a number of

comments were submitted to the EPA

concerning the performance capabilities

of wet scrubbing systems. Some

commenters claimed that the wet

scrubbing system tested by EPA was not

representative of current wet scrubber

technology and that the scrubber was

not designed for high efficiency PM

removal. The commenters submitted a

number of emission test reports from

wet scrubbing systems and urged EPA to

reconsider the performance capabilities

of these systems.

The EPA has reviewed these emission

test reports and revised its previous

conclusions on the performance

capabilities of wet scrubbing systems.

Wet scrubbing systems are capable of

achieving three different levels of

performance, depending on their design

and operation. For convenience, these

three levels of performance have been

termed low efficiency, moderate

efficiency, and high efficiency. A

summary of EPA’s revised conclusions

regarding achievable emission levels

associated with the use of wet scrubbing

systems is shown in Table 4. A full

discussion of these revised conclusions

is available as item No. IV–B–48 in the

docket.

TABLE 4.—ACHIEVABLE EMISSION LEVELS FOR WET SCRUBBERS

Pollutant, units

Achievable emission levels

Low Moderate High

PM, gr/dscf .......................................................................................................................... 0.05 .................. 0.03 .................. 0.015.

dioxin, ng/dscm ................................................................................................................... 125 ................... 125 ................... 125.

TEQ dioxin, ng/dscm ........................................................................................................... 2.3 .................... 2.3 .................... 2.3.

HCl, ppmdv .......................................................................................................................... 15 or 99% ......... 15 or 99% ......... 15 or 99%.

Pb, mg/dscm ....................................................................................................................... 1.2 or 70% ........ 1.2 or 70% ........ 1.2 or 70%.

Cd, mg/dscm ....................................................................................................................... 0.16 or 65% ...... 0.16 or 65% ...... 0.16 or 65%.

Hg, mg/dscm ....................................................................................................................... 0.55 or 85% ...... 0.55 or 85% ...... 0.55 or 85%.

Percent reflects achievable percentage reduction in emissions. No levels are shown for CO, SO2, or NOx because wet scrubbers on MWI

achieved no further reductions beyond good combustion for these pollutants.

Note that for the waste-related

pollutants, the achievable emission

levels in the table are expressed as a

numerical concentration level or a

percent reduction. The composition of

the waste burned in an MWI is not

uniform; as a result, the concentration

levels of waste-related pollutants from

an MWI varies. On occasion, however,

a momentary rise or ‘‘spike’’ in the

concentration level of a waste-related

pollutant may occur; while a wet

scrubbing or dry scrubbing system can

reduce this concentration level

considerably, the system can not

necessarily reduce it to the

concentration levels shown in the table.

For this reason, conclusions regarding
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31743

achievable emission levels associated

with the use of wet or dry scrubbing

systems for waste-related pollutants

must include a percent reduction

component to accurately reflect the

performance capabilities of wet and dry

scrubbing systems.

Also note that the EPA has no

emission data upon which to assess the

performance capabilities of wet

scrubbing systems that might utilize

activated carbon. The EPA knows of no

wet scrubbing system currently

operating on an MWI using activated

carbon, although vendors have

mentioned this technique could be

done. Activated carbon used with a dry

scrubber (discussed below) provides

enhanced removal of Hg and dioxin.

Thus, the use of activated carbon with

a wet scrubbing system, in an

appropriate manner such as a fixed bed,

should achieve the same enhanced

performance levels.

Along with new information

regarding the performance of wet

scrubbers, EPA received new

information regarding the cost of wet

scrubbing systems. Figure 1 shows the

relationship between cost and size of

MWI for each level of wet scrubber

performance. These costs are not

substantially different from those used

at proposal. The key difference is the

distinction in costs between wet

scrubbers of different efficiency. This

information is described in more detail

in item IV–B–30 in the docket.

BILLING CODE 6560–50–P

BILLING CODE 6560–50–C

3. Dry Scrubbers

Very few comments were submitted to

EPA following proposal that questioned

EPA’s conclusions on the performance

capabilities of dry scrubbing systems.

These capabilities were reassessed,

however, to consider data contained in

several emission test reports submitted

to EPA from dry scrubbing systems

using activated carbon.

The results of this reassessment of dry

scrubbing system performance is shown

in Table 5. The conclusions summarized

in this table are similar to those at

proposal. Note, however, that as

discussed above under wet scrubbing

systems, the achievable emission levels

associated with the use of dry scrubbing

systems for waste-related pollutants are

now expressed as a numerical

concentration level or a percent

reduction. A discussion of this

reassessment is available as item No.

IV–B–49 in the docket.

TABLE 5.—ACHIEVABLE EMISSION LEVELS FOR DRY SCRUBBERS WITH ACTIVATED CARBON INJECTION

Pollutant, units Achievable

emission levels

PM, gr/dscf ......................... 0.015.

dioxin, ng/dscm .................. 25.

TEQ dioxin, ng/dscm ......... 0.6.

HCl, ppmdv ........................ 100 or 93%.

Pb, mg/dscm ...................... 0.07 or 98%.

Cd, mg/dscm ...................... 0.04 or 90%.

Hg, mg/dscm ...................... 0.55 or 85%.

Percent reflects achievable percentage reduction in emissions. No levels are shown for

CO, SO2, or NOx because dry scrubbers on

MWI’s achieved no further reductions beyond

good combustion for these pollutants.

While no specific comments were

received regarding the cost of dry

scrubbers, the costs were reassessed and

updated for consistent comparison with

other costs. Figure 2 shows the

relationship between cost and size of

MWI for dry scrubbing systems. This

information is described in more detail

in item IV–B–32 in the docket.
31744 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

BILLING CODE 6560–50–C

D. MACT Floor

1. Existing MWI

The Clean Air Act specifies in Section

129 that the degree of reduction in

emissions that is deemed achievable for

existing MWI shall not be less stringent

than the average emission limitation

achieved by the best performing 12

percent of units in a category; this

requirement is referred to as the ‘‘MACT

floor’’ for existing MWI. Section 302(k)

of the Clean Air Act defines the term

‘‘emission limitation’’ as ‘‘a requirement

established by the State or

Administrator which limits the

quantity, rate, or concentration of

emissions of air pollutants on a

continuous basis.’’

Air quality permits and State

regulations were examined to determine

the average emission limitations

achieved by the best performing 12

percent of MWI in each of the three

subcategories considered at proposal

(continuous, intermittent, and batch

MWI). Table 6 presents the MACT floor

emission levels identified at proposal.

TABLE 6.—PROPOSED MACT FLOOR EMISSION LEVELS FOR EXISTING MWI

[February 1995]

Pollutant, units

MWI subcategory

Batch Intermittent Continuous

PM, gr/dscf ............................................................................................................................. 0.03 0.03 0.02

CO, ppmdv ............................................................................................................................. 91 90 76

Dioxin, ng/dscm ...................................................................................................................... NF NF NF

HCI, ppmdv ............................................................................................................................ 911 115 43

(35%) (92%) (97%)

SO2, ppmdv ............................................................................................................................ NF NF NF

NOX, ppmdv ........................................................................................................................... NF NF NF

Pb, mg/dscm .......................................................................................................................... NF NF NF

Cd, mg/dscm .......................................................................................................................... NF NF NF

Hg, mg/dscm .......................................................................................................................... NF NF NF

NF=No Floor—the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction.

Note that the table indicates no floor

for most pollutants. While a numerical

value was calculated for each pollutant,

most pollutant MACT floors reflected

uncontrolled emissions. Nevertheless,

based on conclusions drawn at proposal

regarding performance of technology,

the MACT floor values included in

Table 6 for CO, PM, and HCl indicated,

at proposal, that all existing MWI would

need good combustion and dry

scrubbers to meet the MACT floors for

CO, PM, and HCl.

As discussed in earlier sections, the

new information submitted following

proposal led to changes to the MWI

inventory and subcategories. Because

these factors can influence the MACT

floors, a review of the MACT floors was

conducted. Recall that the inventory

includes emission limitations for each

pollutant based on State permits and

regulations. For each pollutant, the MWI

inventory was sorted by subcategory
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31745

and then by stringency of emission limit

(most stringent to least stringent) within

each subcategory. For each pollutant,

the emission limitations for the top 12

percent of units in each subcategory

were averaged to determine the MACT

floor emission levels. The results of

these calculations to determine the

MACT floor emission levels for existing

MWI in each subcategory based on the

new MWI inventory are presented in

Table 7.

TABLE 7.—REVISED MACT FLOOR EMISSION LEVELS FOR EXISTING MWI

Pollutant, units

MWI subcategory

Small Medium Large

PM, gr/dscf ............................................................................................................................. 0.086 0.043 0.021

CO, ppmdv ............................................................................................................................. 156 98 87

Dioxin, ng/dscm ...................................................................................................................... NF NF NF

HCI, ppmdv ............................................................................................................................ NF 589 101

(57%) (93%)

SO2, ppmdv ............................................................................................................................ NF NF NF

NOX, ppmdv ........................................................................................................................... NF NF NF

Pb, mg/dscm .......................................................................................................................... NF NF NF

Cd, mg/dscm .......................................................................................................................... NF NF NF

Hg, mg/dscm .......................................................................................................................... NF NF NF

NF=No Floor—the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction.

Based on the recalculated MACT

floors and the new conclusions drawn

regarding the performance capabilities

of air pollution control technologies

(Section II.C.), it appears that large MWI

would have to use good combustion and

a high efficiency wet scrubber to

achieve the MACT floor emission levels,

while a medium-sized MWI would have

to install at least good combustion and

a moderate efficiency wet scrubber. Dry

scrubbers could also be used in

conjunction with good combustion to

meet the MACT floor emission levels for

medium and large MWI. Available data

showing the performance capabilities of

good combustion appears to indicate

that the 0.086 gr/dscf PM MACT floor

for small MWI is not achievable with

good combustion alone. However, MWI

manufacturers have indicated they

routinely guarantee achieving 0.08 gr/

dscf with good combustion.

Consequently, the MACT floor for small

MWI would require the use of good

combustion practices; based on the

claims of MWI manufacturers, add-on

scrubbing systems would not be needed

in all cases to meet the MACT floor.

Regulatory options reflecting more

stringent guidelines for existing MWI

are examined in Section III of this

notice. A memorandum that documents

the procedures used to determine the

MACT floors for existing MWI is located

in the docket as item IV–B–24.

2. New MWI

The Clean Air Act specifies in Section

129 that the degree of reduction in

emissions that is deemed achievable for

new MWI shall not be less stringent that

the emissions control achieved by the

best-controlled similar unit; this

requirement is referred to as the ‘‘MACT

floor’’ for new MWI. The MACT floor

emission levels identified at proposal

for new MWI are presented in Table 8.

These MACT floor values reflect

conclusions at proposal about the

performance capabilities of dry

scrubbing systems because such systems

were identified on at least one MWI in

each subcategory and because dry

scrubbing systems were considered

capable of achieving lower emissions

than wet scrubbing systems.

TABLE 8.—PROPOSED MACT FLOOR EMISSION LEVELS FOR NEW MWI

[February 1995]

Pollutant, units

MWI subcategory

Batch Intermittent Continuous

PM, gr/dscf ............................................................................................................................. 0.013 0.013 0.013

CO, ppmdv ............................................................................................................................. 50 50 50

Dioxin, ng/dscm ...................................................................................................................... 1,500 450 80

HCl, ppmdv ............................................................................................................................. 42 42 42

(97%) (97%) (97%)

SO2, ppmdv ............................................................................................................................ NF NF NF

NOX, ppmdv ........................................................................................................................... NF NF NF

Pb, mg/dscm .......................................................................................................................... 0.1 0.1 0.1

Cd, mg/dscm .......................................................................................................................... 0.05 0.05 0.05

Hg, mg/dscm .......................................................................................................................... NF NF 0.47

(85%)

NF=No Floor—the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction.

Again, the new information submitted

following proposal led to changes to the

MWI inventory, subcategories, and

conclusions about performance of

technology. Because these factors can

influence the MACT floors, a review of

the MACT floors was conducted. The

revised inventory of existing MWI was

examined to identify the best-controlled
31746 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

MWI in each subcategory. The revised MACT floor emission levels for new

MWI are shown in Table 9.

TABLE 9.—REVISED MACT FLOOR EMISSION LEVELS FOR NEW MWI

Pollutant, units

MWI subcategory

Small Medium Large

PM, gr/dscf ............................................................................................................................. 0.03 0.015 0.015

CO, ppmdv ............................................................................................................................. 40 40 40

Dioxin, ng/dscm ...................................................................................................................... 125 125 25

HCl, ppmdv ............................................................................................................................. 15 15 15

(99%) (99%) (99%)

SO2, ppmdv ............................................................................................................................ NF NF NF

NOx, ppmdv ............................................................................................................................ NF NF NF

Pb, mg/dscm .......................................................................................................................... 1.2 0.07 0.07

(70%) (98%) (98%)

Cd, mg/dscm .......................................................................................................................... 0.16 0.04 0.04

(65%) (90%) (90%)

Hg, mg/dscm .......................................................................................................................... 0.55 0.55 0.55

(85%) (85%) (85%)

NF=No Floor—the MACT floor emission levels for these pollutants reflect uncontrolled emissions. Numbers in parentheses indicate percent reduction.

The small MWI subcategory consists

of MWI operating at a throughput of 200

pounds per hour (lb/hr) or less of

medical waste. The MACT floor for new

small MWI consists of the emission

levels that are achievable with good

combustion and a moderate efficiency

wet scrubber. The MACT floor is based

on these emissions levels because small

existing MWI equipped with this air

pollution control have been identified.

No small existing MWI have been

identified with high-efficiency wet

scrubbers or dry scrubbers.

The medium MWI category consists of

MWI operating at a throughput of

greater than 200 lb/hr and less than or

equal to 500 lb/hr of medical waste. The

MACT floor for new medium-sized MWI

is based on emission levels that are

achievable with good combustion and a

combination of two control

technologies, the high efficiency wet

scrubber and the dry injection/fabric

filter (DI/FF) dry scrubber system

without carbon. At least one existing

MWI 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 is 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. While no

combined dry/wet scrubber systems

were identified on medium MWI,

several such systems are currently in

operation on large MWI, as mentioned

below. In addition, as also mentioned

below, spray dryer/fabric filter systems

could also meet the MACT floor

emission levels for medium-sized MWI.

The large MWI subcategory consists of

all MWI operating at a throughput of

greater than 500 lb/hr of medical waste.

As with the MACT floor for new

medium MWI, the MACT floor for new

large MWI is based on the emission

levels that are achievable with good

combustion and a combination of two

control technologies, the high efficiency

wet scrubber and the DI/FF dry scrubber

system with carbon. Several existing

facilities in the large category currently

control emissions with a combined dry/

wet system. In addition, one existing

MWI equipped with a spray dryer/fabric

filter system with carbon was tested

during the EPA testing program and this

test demonstrated that this scrubbing

technology could also meet the MACT

floor emission levels presented in Table

9.

Regulatory options reflecting more

stringent standards for new MWI are

examined in Section IV of this notice. A

memorandum that documents the

procedures used to determine the

MACT floors for new MWI is located in

the docket as item IV–B–38.

E. Baseline Emissions

To estimate the environmental

impacts of the standards and guidelines

for MWI, an estimate of baseline

emissions must be made (i.e., emissions

in the absence of Federal regulations). In

the February 1995 proposal, baseline

emissions were estimated for PM, CO,

dioxin, HCl, SO2, NOx, Pb, Cd, and Hg.

When this estimate was developed, very

little information was available

regarding the actual number of MWI and

the level of air pollution control

associated with each. The emission

estimate was derived from an estimated

3,700 MWI assumed to be operating

with little, if any, air pollution control.

As discussed in previous sections,

new information has led to new

conclusions about the MWI inventory,

performance of technology, and control

levels associated with each existing

MWI. As a result, revised estimates of

baseline emissions from existing MWI

have been calculated and are presented

in Table 10.

TABLE 10.—ANNUAL BASELINE

EMISSIONS FOR EXISTING MWI

Pollutant, units Baseline

emissions

PM, Mg/yr ............................... 940

CO, Mg/yr ............................... 460

Dioxin g/yr ............................... 7,200

Dioxin g TEQ/yr ...................... 150

HCl, Mg/yr ............................... 5,700

SO2, Mg/yr .............................. 250

NOx, Mg/yr .............................. 1,200

Pb, Mg/yr ................................ 11

Cd, Mg/yr ................................ 1.2

Hg, Mg/yr ................................ 15

To convert Mg/yr to ton/yr, multiply by 1.1.

To convert g/yr to lb/yr, divided by 453.6.

The results of these emission

estimates are significantly lower than

estimates developed at proposal. For

example, the estimate of baseline

emissions of dioxin toxic equivalency

(TEQ) was 5,100 grams per year (g/yr) at

proposal; the current estimate is 150 g/

yr. At proposal, the estimate of Hg

emissions from existing MWI was 64.6

tons per year (tons/yr); the current

estimate is 16.0 tons/yr.

The primary reason for the lower

baseline emission estimate is the much

greater level of emission control found
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31747

at existing MWI than was assumed at

proposal. Comment is requested on the

methodology and assumptions used to

estimate baseline emissions from

existing MWI. Where information on

specific air pollution control equipment

was not available, EPA used State

regulatory emission limits to predict the

type of air pollution control equipment

installed on each existing MWI.

Information is requested which would

more accurately reflect the actual air

pollution control equipment installed

on each existing MWI. In addition,

emission factors for each type of air

pollution control equipment were

developed based on compliance test

reports. Comment is requested on

whether these emission factors reflect

actual air emissions from these control

devices over the life of the equipment.

At proposal, baseline emissions were

also estimated for new MWI in the fifth

year after adoption of the NSPS. These

estimates were based on a projected

number of new MWI and their

associated emission controls that would

be installed in the five years following

promulgation of the standards. As with

the estimation of baseline emissions for

existing MWI, the estimate of baseline

emissions for new MWI has also

changed significantly. This change is

due primarily to the lower projected

number of new MWI and the emission

control level associated with each MWI.

The revised baseline emissions

estimates for new MWI are presented in

Table 11.

TABLE 11.—ANNUAL BASELINE

EMISSIONS FOR NEW MWI

Pollutant, units Baseline

emissions

PM, Mg/yr ............................... 28

CO, Mg/yr ............................... 14

Dioxin g/yr ............................... 47

Dioxin g TEQ/yr ...................... 1.1

HCl, Mg/yr ............................... 64

SO2, Mg/yr .............................. 28

NOx, Mg/yr .............................. 130

Pb, Mg/yr ................................ 0.39

Cd, Mg/yr ................................ 0.051

Hg, Mg/yr ................................ 0.21

To convert Mg/yr to ton/yr, multiply by 1.1.

To convert g/y to 1b/yr, divided by 453.6.

The memoranda documenting these

revised estimates of baseline emissions

from new and existing MWI can be

found in the docket as items IV-B–51

and IV-A–6.

F. Operator Training and Qualification

The proposed standards and

guidelines included operator training

and qualification requirements for each

MWI operator. These operator training

and qualification requirements included

completion of (1) 24 hours of classroom

instruction, (2) 4 hours of hands-on

training, (3) an examination developed

and administered by the course

instructor, and (4) a handbook or other

documentation covering the subjects

presented during the course. The

instructor of the operator training course

was not to be employed by the owner

or operator of the facility. To obtain

qualification, an operator was to

complete the training course and have

either a minimum level of experience or

satisfy comparable or more stringent

criteria established by a national

professional organization. The proposed

standards and guidelines also required

the owner or operator of the facility to

develop and annually update a sitespecific operating manual. This manual

would summarize regulations, operating

procedures, and reporting and

recordkeeping requirements in

accordance with the proposed standards

and guidelines. The proposal required

that each MWI be operated by a trained

and qualified operator or by an

individual under the direct supervision

of a trained and qualified operator. The

trained and qualified operator would

have to be on duty and at the facility at

all times while the incinerator is in

operation.

Many comments were received on the

proposed operator training and

qualification requirements. The majority

of the public comments on operator

training and qualification were related

to the third party training requirement

and to the duration that operators must

be present while the MWI is burning

waste. Many commenters stated that the

EPA should allow facilities the option of

providing training by in-house

personnel because the facility’s own

personnel would be most familiar with

the operation and maintenance of the

incinerator. The commenters indicated

that smaller facilities that do not have

the personnel could use the services of

trainers and inspectors that are not

affiliated with the facility.

Many commenters stated that the

amount of time that the operator was

required to be present was excessive.

Under the proposal, the operator would

have to be on-duty and at the facility

during the time that the combustion air

blowers are operating. Several

commenters suggested that this would

require operators to be at the incinerator

even when waste was not being burned.

Several commenters also suggested that

the trained and qualified operator

should be easily accessible (either at the

facility or on-call) while the incinerator

is operating.

The EPA is inclined to adopt the

operator training and qualification

requirements briefly summarized below

and discussed in greater length in

document number IV–B–26, which is

available in the Docket. Cost estimates

for operator training and qualification

are documented in item IV–B–39.

The owner or operator of an MWI

would be responsible for ensuring that

one or more operators at the facility are

qualified. Operator training may be

obtained through a State-approved

program or by completing a training

course with (1) 24 hours of classroom

instruction, (2) an examination designed

and administered by the course

instructor, and (3) reference material

distributed to the attendees covering

course topics.

Operators may obtain qualification by

completing a training course and having

one of the following levels of

experience: (1) at least 6-months’

experience as an MWI operator, (2) at

least 6-months’ experience as the direct

supervisor of a qualified MWI operator,

or (3) completion of at least two burn

cycles under the observation of two

qualified operators. To maintain

qualification, the operator would be

required to complete and pass an annual

review or refresher course of at least 4

hours.

A fully trained and qualified operator

would have to be easily accessible,

either at the facility or on-call at all

times while the incinerator is in

operation. The trained and qualified

operator may operate the MWI directly

or be the direct supervisor of one or

more individuals that charge waste,

remove ash, etc. As proposed, the

emission guidelines for existing MWI

would require that, 1 year after approval

of the State plan, MWI must be operated

by a trained and qualified operator.

G. Testing, Monitoring, and Inspection

Section 129(c) of the Clean Air Act

requires the EPA to develop regulations

that include monitoring and testing

requirements. The purpose of these

requirements is to allow the EPA to

determine whether a source is operating

in compliance with the regulations.

As mentioned earlier, at proposal

relatively few emission test reports were

available to EPA to judge the

performance of air pollution control

technologies. These test reports were the

result of EPA emission testing at several

MWI. For a variety of reasons, EPA

gathered data during these emission

tests using three, 4-hour test runs. The

results of the three test runs were then

averaged at each MWI to calculate a

measured emission level. This

calculated emission level represented an
31748 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

average emission value over the 12-hour

period (i.e., three, 4-hour runs).

As a result, EPA’s assessments of the

performance capabilities of air pollution

control technologies and conclusions

regarding the appropriate emission

limits to include in the proposed

regulations were based on the measured

performance of technology averaged

over a 12-hour period. Emission levels,

however, tend to fluctuate somewhat as

part of normal operation. Consequently,

during short periods of time, emission

levels may occasionally be greater or

lower than the average emission level

over a 12 hour period.

In developing a regulation based on

the performance of a particular

technology, the level of performance

demanded by the regulation must be

consistent with the level of performance

that technology can achieve. The period

of time over which emissions are

measured and then averaged to

determine compliance with the

regulation, therefore, must correspond

to the period of time over which

emission levels were measured and

averaged in determining the emission

limits included in the regulation. If this

is not the case, a regulation could

include emission limits that a

technology can achieve if emissions are

averaged over a relatively long period of

time, but not if emissions are averaged

over a much shorter period of time. For

this reason, the proposed regulation

required emission testing to determine

compliance by averaging the results of

three, 4-hour test runs, consistent with

the procedures followed in gathering the

emission data used to establish the

emission limits included in the

regulation.

Many comments were received

regarding this proposed requirement to

determine compliance using three, 4-

hour test runs. These commenters noted

that a 4-hour test run was much longer

than the more conventional test run of

about 1-hour; additionally, many

hospitals and healthcare facilities would

normally not have sufficient waste on

hand to accommodate three, 4-hour test

runs. Finally, several commenters stated

that the proposed emission testing

requirements would substantially

increase the costs associated with

emission testing. Consequently, these

commenters urged EPA to revise the

emission testing requirements and adopt

the more conventional approach of

relying on test runs of about an hour in

length.

As mentioned earlier, more than two

dozen test reports were submitted to

EPA following the proposal, and these

test reports now form the basis for

revised conclusions regarding the

performance capabilities of technology

and the emission limits these

technologies can achieve. The EPA test

methods were used to perform the

emission testing summarized in these

reports. These methods include

procedures that require the collection of

a sufficient sample to accurately

measure emission levels. For most air

pollutants, this sample generally

corresponds to a test run of about an

hour. The revised conclusions discussed

earlier, therefore, regarding the

performance capabilities of emission

control technologies and the emission

limits these technologies can achieve,

are based (for the most part) on emission

test data generated by averaging the

results of three test runs of about an

hour each (i.e., a 3-hour test).

For this reason, the EPA is inclined to

state in the final regulations adopted for

MWI that EPA test methods be followed

when performing any emission testing

required to determine compliance with

the regulations. This requirement will

ensure that compliance testing follows

the same procedures used to generate

the emission data upon which the

emission limits in the final regulation

were based. In most cases, three test

runs of about an hour each would be

necessary to determine compliance with

the final regulations.

An exception to this requirement is

emission testing to measure dioxin

emissions. The procedures in the EPA

test method to ensure sufficient sample

is gathered to accurately measure dioxin

emissions frequently leads to test runs

longer than 1 hour. Whatever the length

of the emission test, however, the

emission testing procedures included in

the EPA test method for measuring

dioxin emissions were followed in the

emission test reports submitted to EPA

following proposal. As discussed

earlier, these emission test reports serve

as the basis for the dioxin emission

limits included in the final regulations

and, as a result, the length of testing

necessary to determine compliance will

automatically be consistent with the

length of testing used to determine the

emission limits included in the

regulations.

The proposed regulations also would

have required annual emission testing to

determine compliance. While some

commenters supported emission testing

annually or even more frequently (such

as every 6 months), a number of

commenters believed that annual testing

would be unnecessary or that testing

should be required no more than every

5 years. Commenters felt that the

requirements for inspections,

monitoring, and operator training are

sufficient and much less expensive than

annual emission testing.

Other commenters suggested that the

annual emission testing requirement be

replaced with a requirement for annual

equipment inspection/maintenance to

ensure that burner settings, air flow

rates, and other operation parameters

are properly adjusted. While the

proposal includes a requirement for

annual equipment inspection and

maintenance, this requirement would

have applied only to existing MWI until

air pollution control equipment had

been installed and the MWI was in

compliance with all the emission limits

in the regulations. The purpose of the

proposed annual equipment inspection

and maintenance requirements was to

ensure that the MWI was in good

working order and physically capable of

operating as well as it could operate

until compliance with the emission

limits was demonstrated. A MWI in

poor operating condition will likely

have higher emissions than a MWI in

good operating condition.

While some commenters stated

inspections are not necessary and others

suggested that EPA should let the States

decide whether inspections are

necessary, most commenters were

generally supportive of annual

inspection and maintenance

requirements. Several commenters also

stated that biannual inspections would

not be unreasonable. Many of the

commenters supportive of inspection

requirements, however, suggested that

the requirement for a ‘‘third party’’

inspection be deleted. These

commenters stated in-house personnel

are more familiar with the details and

operating intricacies of the equipment

installed at their sites. In addition,

serious liability concerns could arise

from injury or damage caused by ‘‘third

party’’ inspection or maintenance. At

this point, EPA is inclined to include

inspection and maintenance

requirements wherever annual stack

testing is not required (see document IVB–26 in the docket for a description of

injection/maintenance requirements).

The inspection would not have to be

conducted by a third party.

The proposal also included various

monitoring requirements, requiring the

use of continuous emission monitoring

systems (CEMS) for some pollutants and

the monitoring of operating parameters

for other pollutants. Some commenters

supported the proposed requirements

for CO, opacity, and oxygen (O2) CEMS.

Another commenter suggested that the

requirements should be extended to

require CEMS for Hg, HCl, and PM; the

commenter suggested that such

instruments are available. On the other
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31749

hand, several other commenters

objected to the CEMS requirements in

the proposed rule. These commenters

stated that CEMS are not justified,

especially for small MWI, because they

are too expensive. These commenters

believe that monitoring operating

parameters is a sufficient substitute for

CEMS once compliance has been

demonstrated by an initial emission test.

The monitoring requirements in the

proposal for monitoring operating

parameters were structured around the

use of dry scrubber systems. Those who

commented on these specific

requirements generally agreed that

monitoring of these operating

parameters was appropriate for dry

scrubbing systems.

No monitoring requirements were

included for monitoring operating

parameters for wet scrubbing systems.

The EPA solicited information regarding

an appropriate set of operating

parameters for wet scrubbing systems.

The EPA was inclined and is still

inclined to include specific operating

parameter monitoring requirements in

the final regulations for wet scrubbing

systems as well as for dry scrubbing

systems. To accommodate MWI using

an air pollution control system other

than a dry or wet scrubbing system, EPA

is inclined to include provisions in the

final regulations for petitioning the

Administrator to monitor specific

operating parameters associated with

the other air pollution control system.

A number of commenters responded

to EPA’s request for suggestions of

monitoring requirements for operating

parameters suitable for wet scrubbing

systems. Suggested parameters included

pressure drop across the system, liquor

flow rate, flue gas temperature, liquor

pH, and horsepower or amperage. While

EPA is inclined to include the same

requirements in the final regulations for

monitoring operating parameters for dry

scrubbing systems as proposed, EPA is

inclined to include requirements in the

final regulations for monitoring the

following operating parameters for wet

scrubbing systems: scrubber exit

temperature, scrubber liquor pH,

scrubber liquor flow rate, and energy

input to the scrubber (e.g., pressure drop

or horsepower).

To consider the comments outlined

above regarding the frequency of

emission testing and the proposed

inspection and monitoring

requirements, a matrix of options was

developed. This matrix of options and

their annual costs are summarized in

Table 12. Each cell or box in this table

represents a combination of emission

testing and monitoring requirements

(some combinations also include

inspection requirements). The range in

the costs shown in each cell is a

reflection of how the cost of emission

testing and monitoring is likely to vary

depending on the emission limits

included in the final regulation (i.e.,

whether the emission limits are based

on the use of good combustion alone or

good combustion and wet or dry

scrubbing). These costs vary somewhat

because the operating parameters

monitored in each case would be

somewhat different.

TABLE 12.—MONITORING/TESTING OPTIONS AND ANNUAL COSTS

[Thousand $/yr]

Monitoring options

Testing options

A

Initial and repeat stack

testing

B

Initial stack

testing; inspection

C

Substitute

stack testing;

inspection

1—CO CEMS (App F); Opacity CEM (no App F); Operating Parameters .................................. 110–119 100–104 99–102

2—Opacity and CO CEMS (no App F); Operating Parameters .................................................. 96–104 85–89 83–86

3—Opacity CEMS (no App. F); Operating Parameters ............................................................... 37–46 27–31 26–29

4—Operating Parameters; Quarterly Method 9 ........................................................................... 10–15 7.5–11 5.8–8.8

Table 12 presents the 12 possible

combinations of three emission testing

options and four monitoring options

that the EPA is considering including in

the final regulations. A more detailed

explanation of these emission testing

and monitoring options, as well as their

costs, is available in the docket as item

IV–B–54. The following discussion,

however, briefly outlines the essential

requirements of each of the monitoring

and emission testing options.

Monitoring Option 1 requires a CO

CEMS with Appendix F requirements

(Appendix F requirements ensure the

data generated is reliable), an opacity

CEMS without Appendix F

requirements, and operating parameter

monitoring requirements for the MWI

and, if applicable, for the air pollution

control device. Because the use of

Appendix F is required under this

option, the CO CEMS would be used for

direct enforcement of the CO emission

limit. The opacity CEMS without

Appendix F requirements would simply

provide an indication of opacity and

would not be used for direct

enforcement of the opacity limit.

Routine opacity testing with Reference

Method 9 is included in Monitoring

Option 1 to compensate for not

including Appendix F requirements on

the opacity CEMS.

Monitoring Option 2 is the same as

Monitoring Option 1, except that it

would not include Appendix F

requirements for the CO CEMS, which

would reduce costs. Without Appendix

F requirements, the CO CEMS would

provide an indication of CO emissions

and would not be used for direct

enforcement of the CO emission limit.

Emission testing for CO is included in

Monitoring Option 2 to compensate for

excluding Appendix F requirements on

the CO CEMS. An opacity CEMS and

operating parameter monitoring would

be required as in Monitoring Option 1.

Monitoring Option 3 is the same as

Monitoring Option 2, except that,

instead of the more expensive CO

CEMS, stack emission testing for CO

would be required. An opacity CEMS

and operating parameter monitoring

would be required as in Monitoring

Options 1 and 2.

Monitoring Option 4 would require

no CEMS. Instead, it would rely on

manual emission test methods

(including more frequent Method 9

opacity tests) and operating parameter

monitoring.

For each of these monitoring options,

three emission testing options have been

developed. Emission testing Option A

would require initial and annual/skip

tests. With the annual/skip test

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. Emission testing Option A,
31750 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

under all four monitoring options,

would require an initial stack test for all

pollutants. Annual or skip emission

testing under Monitoring Options 1, 2,

and 3 would also require emission

testing of all pollutants. However,

annual or skip emission testing under

Monitoring Option 4 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).

Emission testing Option B would

require an initial emission test for all

pollutants, but would not require

annual emission tests. In lieu of annual

or skip emission testing, MWI

inspection/maintenance would be

required. This inspection/maintenance

would be required annually under

Monitoring Options 1 and 2; however, it

would be required quarterly under

Monitoring Options 3 and 4, where no

CO CEMS is required. The inspection/

maintenance could be done by in-house

personnel. With regard to any necessary

repairs arising from the inspection/

maintenance, the owner or operator of

the MWI would be required to contact

the State (or local, if delegated by the

State) air pollution control agency and

negotiate a date, within 10 operating

days following the date of the

inspection/maintenance, by which the

repairs must be completed.

Emission testing Option C would

permit substitute emission testing. A

substitute emission test is an emission

test conducted on another, but identical

MWI. An MWI would be required to

petition the State (or local, if delegated

by the State) air pollution control

agency for approval, however, and the

‘‘burden of proof’’ would be on the MWI

to demonstrate to the satisfaction of the

agency that the substitute emission test

is on an identical MWI. In addition, an

initial emission test for Hg would be

required; this test would ensure that

appropriate measures for managing the

mercury content of the waste are

utilized (e.g., material separation,

material purchasing, etc.). Inspection/

maintenance requirements would be the

same as under Emission Testing Option

B.

The most direct means of ensuring

compliance with emission limits

included in regulations 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 in

regulations to demonstrate and ensure

compliance on a continuous basis with

the regulations. Only when the impacts

of including such requirements are

considered unreasonable, does the EPA

consider other options.

For MWI, it appears that almost all of

the emission testing and monitoring

options under consideration cost more

than the emission control system that

would be installed to meet the emission

limits in the regulations; in some cases,

the emission testing and monitoring

requirements could cost twice as much

as the emission control system.

Consequently, the Agency is inclined to

include the emission testing and

monitoring requirements under

Monitoring Option 4 in the final

regulations to minimize costs. Where

the regulations are based on good

combustion and wet and/or dry

scrubbing systems, the EPA is inclined

to require Monitoring Option 4 with

Emission Testing Option A; where the

regulations are based, in part, on the use

of good combustion alone, the EPA is

inclined to require Monitoring Option 4

with Emission Testing Option B.

The appropriate choice of emission

testing and monitoring requirements (as

well as inspection/maintenance

requirements) is an area in which the

EPA specifically solicits comments.

Many of the MWI visited or inspected

by the EPA in the course of gathering

data and information often appeared

poorly maintained and operated.

Inadequate maintenance and/or

operation can cause even the best

equipment to perform poorly and result

in excess emissions. The inspection/

maintenance and operator training

requirements included in the final

regulations are expected to address this

problem in a satisfactory manner;

however, the EPA is interested in

whether others feel the inspection/

maintenance requirements and operator

training requirements should be

supplemented with more extensive

emission testing and/or monitoring

requirements.

In addition, CEMS vendors have

expressed concern with the costs

developed by EPA for the various CEMS

and operating parameter monitoring

requirements. In particular, they believe

the costs of CEMS are much lower than

those estimated by EPA. As mentioned,

a detailed breakdown of the EPA

estimates of the costs of these

requirements is available in the docket

as item IV–B–54. The EPA solicits

comments on these costs and if costs are

indeed much lower than estimated, EPA

may consider more comprehensive

monitoring requirements in the final

rule. Finally, even if the costs remain

similar to those previously estimated,

the EPA is considering more

comprehensive emission testing and

monitoring requirements (including

CEMS) for large MWI that burn medical

waste generated offsite (i.e., generated at

another location than that of the MWI).

Definition of Medical Waste

Section 129 of the Clean Air Act

directs the EPA to adopt regulations for

solid waste incineration units that

combust (1) municipal waste; (2)

hospital, medical, and infectious waste;

(3) commercial or industrial waste; and

(4) all other solid waste. The regulations

limiting air emissions from solid waste

incineration units combusting

municipal waste (otherwise known as

municipal waste combustor(s) or MWC)

were promulgated on December 19,

1995 (60 FR 65387). In developing

regulations to limit air emissions from

solid waste incineration units

combusting hospital, medical, and

infectious waste (otherwise known as

medical waste incinerator(s) or MWI),

medical waste was defined 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.

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’’ (SWDA). For the proposed air

emission standards and guidelines for

MWI, EPA adopted the definition of

‘‘medical waste’’ from solid waste

regulations codified in 40 CFR part 259,

subpart B because this definition was

‘‘established by the Administrator

pursuant to the [SWDA],’’ as amended

by the Medical Waste Tracking Act

(MWTA). However, 40 CFR part 259 has

since been withdrawn. Consequently,

there is no definition of medical waste

which has been ‘‘established by the

Administrator pursuant to the [SWDA],’’

and EPA now has the flexibility to

examine and consider other definitions

of medical waste. While EPA is inclined

to adopt a specific definition described

below, EPA is considering all of the

definitions discussed in this section as

well as the proposed definition and

solicits comment on the merits of each

definition discussed as well as other

definitions EPA should consider.

During the public comment period,

the majority of the comments on the

definition of medical waste stated that

the proposed definition was too broad

and that it should be narrowed. Several

commenters stated that this definition

would aggravate an already confusing

situation, where the public distinction

between the terms medical waste and

infectious waste has become blurred

and in most cases lost; these terms are

often used synonymously in public

discourse.
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31751

These commenters believed that a

broad definition of medical waste in the

regulations for MWI would have the

undesirable impact of fostering and

encouraging the use and adoption of

this definition in other areas and by

other regulatory authorities. They

suggested that as this definition

becomes more widespread and adopted

by others, healthcare facilities would

eventually be forced to handle most, if

not all, medical waste as infectious

waste—whether it was burned in an

incinerator or not.

These commenters stated the

proposed definition of medical waste,

because of the loss of public distinction

between this term and the term

infectious waste, and the resulting

impact of eventually forcing healthcare

facilities to treat most waste as

infectious waste, would lead to a

massive increase in the volume of

infectious waste. This increase would,

in turn, lead to a major increase in the

costs of disposal of waste from

hospitals, since most waste would have

to be handled as infectious waste.

These commenters stated that, as in

implementing the MWTA, healthcare

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 ‘‘healthcare

trash’’ waste stream, which has no

potential for infection and is treated and

handled as municipal waste. These

commenters urged EPA to narrow the

definition of medical waste used in the

MWI regulations to one of infectious

waste, analogous to the term ‘‘regulated

medical waste’’ adopted in regulations

resulting from the MWTA.

In most—if not all—cases, these

commenters indicated that, where

healthcare facilities operate medical

waste incinerators, they burn infectious

medical waste or a mixture of infectious

medical waste and noninfectious waste

(i.e., healthcare trash). These

commenters stated that there were very

few, if any, medical waste incinerators

operated by healthcare facilities that

burned only noninfectious waste or

healthcare trash.

Consequently, by defining medical

waste narrowly, in a manner consistent

with infectious or regulated medical

waste, and by applying the regulations

to incinerators that burn this waste or

any mixture of this waste and other

waste, the EPA could achieve the

objective, which is regulating air

pollution from medical waste

incinerators at healthcare facilities; this

objective would be achieved without

adding to the confusion or leading to the

serious impacts outlined above.

These commenters further stated the

proposed definition of medical waste

would subject MWC, which burn

general nonregulated and noninfectious

waste from hospitals, to the same

requirements as those proposed for

MWI. Consequently, even if healthcare

facilities were not eventually forced to

handle most waste as infectious waste

(because MWC that burn general

nonregulated and noninfectious waste

from hospitals would be subject to the

MWI regulations) this broad definition

would result in higher disposal costs for

healthcare facilities which send their

general nonregulated and noninfectious

waste to MWC for disposal.

Some commenters, on the other hand,

support the proposed broad definition

of medical waste. These commenters

pointed out that there is little difference

in the air emissions created by burning

infectious medical waste (e.g., regulated

medical waste or ‘‘red bag’’ waste) and

by burning noninfectious waste (e.g.,

nonregulated medical waste or

healthcare trash). As a result, the

regulations should apply to the burning

of all medical waste, as EPA proposed.

These commenters believe that EPA’s

use of the broad definition of medical

waste, solely for the purpose of defining

what type of incinerator the regulations

apply to, does not imply that more

waste or that all medical waste will be

considered infectious waste. Merely

requiring that incinerators that burn

medical waste must limit air pollution

will not require all healthcare facilities

to handle all their medical waste as

infectious waste.

In fact, these commenters indicated

that many healthcare facilities today

routinely separate their waste into two

types: infectious waste (‘‘red bag’’) and

noninfectious waste (‘‘black bag’’).

Numerous items of waste from

healthcare facilities are not, nor need

not be considered infectious waste. On

the other hand, many healthcare

facilities today do little to separate their

waste streams; most waste is handled

and treated as infectious waste. If waste

disposal costs were of paramount

concern to healthcare facilities, those

that do little separation today could

reduce their present waste disposal

costs by more carefully segregating their

waste into infectious and noninfectious

waste streams and properly disposing of

these two waste streams.

Finally, several commenters

questioned whether animal carcasses

and pathological waste should be

included in the definition of medical

waste. These commenters were

uncertain as to whether pathological

waste incinerators were to be regulated

as MWI or separately. These

commenters requested clarification of

this situation and urged EPA to regulate

pathological wastes separately from

medical waste.

Similarly, several commenters

questioned whether ‘‘out-of-date’’ or

‘‘off-spec’’ drugs, or radio-active type

medical wastes, should be included in

the definition of medical waste. These

commenters requested special treatment

for these types of wastes, similar to that

proposed for pathological wastes.

The EPA did not intend to add or

contribute to the confusion that

presently exists in the public discourse

regarding the distinction or lack of

distinction between the terms medical

waste, regulated medical waste, and

infectious medical waste. In fact, the

EPA would like to state very clearly that

numerous items within the medical

waste stream are noninfectious and

need not be treated as infectious. In fact,

the majority of items in the medical

waste stream are noninfectious, and in

terms of percentages, most authorities

conclude that only 10 to 15 percent of

the items in the medical waste stream

are infectious, or potentially infectious,

and warrant special treatment or

handling.

In considering the public comments,

an interesting and unanimous

agreement emerges, even if it is not

stated as such. All of the commenters

seem to agree that healthcare facilities

can be viewed as generating two waste

streams: an infectious medical waste

stream and a noninfectious healthcare

trash, or ‘‘municipal waste’’ type, waste

stream. The challenge for EPA,

therefore, is to reconcile the agreement

in this area with the requirement of the

Clean Air Act to develop regulations for

incinerators burning hospital, medical,

and infectious waste.

The Clean Air Act requires EPA to

develop regulations for the burning of

medical waste; but it also requires EPA

to develop regulations for the burning of

municipal waste. In fact, EPA adopted

regulations limiting air pollution from

the burning of municipal waste on

December 19, 1995 (60 FR 65387). As a

result, if healthcare facilities are viewed

as generating two types of waste

streams, an infectious waste stream and

a municipal waste stream, then the

burning of the municipal waste stream

is already covered by regulations.

The definition of municipal waste

included in the regulations covering the

burning of municipal waste states:

Municipal solid waste * * * means

household, commercial/retail, and/or

institutional waste * * * Commercial/retail

waste includes material discarded by stores,
31752 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

offices, restaurants * * * Institutional waste

includes materials discarded by schools,

nonmedical waste discarded by hospitals,

* * * and material discarded by other

similar establishments or facilities.

The regulations cover the burning of

municipal waste discarded from offices

and institutions. Hospitals are cited as

an example of an institution and clinics

and nursing homes are considered

‘‘similar establishment(s)’’. Offices

include doctors’ offices, dentists’

offices, etc. Consequently,

noninfectious, municipal-type waste

discarded from healthcare facilities is

considered part of the municipal waste

stream and is covered by the regulations

adopted for the burning of municipal

waste.

The remaining need, therefore, is to

regulate the burning of the infectious

waste stream discarded from healthcare

facilities, which can be achieved by

redefining medical waste in terms of

infectious or potentially infectious

materials. Thus, the EPA is inclined to

narrow the applicability of the proposed

regulations by adopting a definition of

medical waste that focuses on that

portion of the overall medical waste

stream that is generally considered

infectious or potentially infectious.

Given the confusion and number of

varying definitions of medical waste,

regulated medical waste, infectious

waste, etc., at the Federal and State

level, and within the healthcare

community, transportation sector, etc.,

EPA does not intend to add to this

confusion by creating another

definition. As a result, EPA is inclined

to adopt a definition of medical waste,

for the MWI regulations, from among

those already in use.

As mentioned, numerous definitions

are currently in use, such as the

definition of infectious waste created by

the U.S. Department of Transportation,

the definition of regulated medical

waste created by EPA, as well as other

definitions created by other regulatory

agencies and national associations, such

as the Occupational Safety and Health

Administration, the New York State

Department of Health, the American

Hospital Association, etc. While these

are just a few of the agencies or

associations that have developed

definitions of medical waste that are

currently in use, they are the ones most

often cited or suggested in the public

comments. Each of these definitions are

slightly different, but all focus on

infectious or potentially infectious

medical waste. These definitions are

discussed in more detail in document

number IV–B–25, available in the

Docket.

For the most part, infectious or

potentially infectious wastes are defined

through the use of categories or classes

of wastes. The classes of wastes most

commonly used include:

1. Cultures and stocks of infectious

agents;

2. Human pathological wastes;

3. Human blood and blood products;

4. Used sharps;

5. Animal wastes;

6. Isolation wastes; and

7. Unused sharps.

These seven waste classes are

commonly used by various agencies and

associations as the basis for defining

medical wastes. However, while the

classes of wastes included in two

different definitions may be identical,

the specific items included under each

class and the definitions for these items

may be very different. Each agency or

association has developed different

language to define each of these waste

classes in a way that best serves their

purposes. For example, some definitions

include intravenous (IV) bags under

class 3 wastes, while others do not.

It appears that adoption of any one of

these definitions or any definition at all

will be controversial. No uniform or

widespread agreement on a definition

exists, and for each commenter who

argued strongly for adoption of one

particular definition, another

commenter argued equally strongly for

adoption of a different one.

Of all these definitions, EPA is

inclined to adopt the New York State

Department of Health (NYSDOH)

definition, which is one of the more

recently developed definitions for use in

the MWI air pollution emission

regulations. This definition was

subjected to intense discussion,

consideration, and review within the

medical and healthcare community.

Because it was adopted fairly recently,

this definition also benefits from the

various controversies and discussions

generated by adoption of earlier

definitions by other agencies and

associations. Further, this definition

seems to be among the more

comprehensive ones in terms of

identifying and defining the various

classes of infectious or potentially

infectious medical waste mentioned

above.

The NYSDOH definition includes six

of the seven waste classes; isolation

wastes (class 6) are not listed as a

separate category. The definitions used

for waste classes 1, 2, 4, and 7 are

similar to those used by the MWTA

definition. As with the AHA definition,

the NYSDOH definition differs from the

MWTA definition in the specifics of

class 3 wastes. Class 3 waste under the

NYSDOH definition does not include

items caked with dried blood or IV bags.

These wastes are included in the

MWTA definition of class 3 waste. The

definitions for class 5 waste only

includes wastes from animals exposed

to infectious agents during research, the

production of biologicals, or the testing

of pharmaceuticals. Pathological waste

from veterinary facilities is excluded

from the MWTA definition. The

NYSDOH defines class 5 wastes as

wastes from animals known to be

contaminated with infectious agents or

from animals inoculated during

research, the production of biologicals,

or pharmaceutical testing. Unlike the

MWTA definition, the NYSDOH

definition seems to include some wastes

(from animals contaminated with

infectious agents) generated by general

veterinary practices. The specifics of

this definition are included in item IV–

J–078 in the docket).

Also, as stated at proposal, the EPA is

inclined to exclude crematories and

incinerators used solely for burning

pathological waste (human or animal

remains and tissues) from the medical

waste incinerator regulation. However,

MWI that burn animal and pathological

waste co-mingled with other classes of

medical waste would be subject to the

regulation. Because MWI that burn

mixtures of medical and pathological (or

animal) waste would be covered by the

regulation, it is necessary to include a

description of pathological and animal

waste in the definition of medical waste.

Human pathological waste and animal

waste are included in the NYSDOH

definition of medical waste.

In addition, the EPA is inclined to

exclude from the regulation incinerators

used solely for burning ‘‘off-spec’’ or

‘‘out of date’’ drugs or pharmaceuticals,

as well as incinerators used solely for

burning radio-active type medical

wastes. In other words, as several

comments suggested, the EPA is

inclined to treat these wastes in a

manner similar to pathological waste.

While EPA is inclined to exclude

these types of wastes from the

regulation for MWI, this exclusion does

not mean that EPA will not develop

regulations which will cover these

wastes. The Clean Air Act clearly

directs the EPA to develop regulations

to cover burning of these wastes. Thus,

this inclination to exclude them is only

to temporarily defer regulation.

The Clean Air Act directs the EPA to

develop regulations for all solid waste

incinerators, and burning these wastes

will be covered by regulations

developed within the next few years.

The Clean Air Act also directs the EPA

to announce a schedule for development
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31753

of these other regulations, and the EPA

has announced these regulations will be

developed by the year 2000.

I. Pyrolysis Units

Incineration is only one of several

medical waste treatment technologies.

Other treatment technologies, such as

autoclaves, microwaves, and chemical

treatment, where there is clearly no

combustion occurring, are referred to in

this notice as ‘‘alternative technologies’’

and are discussed further in Section II.J.

These ‘‘alternative technologies’’ clearly

are not subject to MWI regulations. On

the other hand, some medical waste

treatment technologies employ plasma

or gasification processes (i.e., pyrolysis).

Because it appears that at least some

combustion is taking place in these

devices, EPA considered these pyrolysis

technologies covered by the proposed

MWI regulations.

Comments from the vendors of

pyrolysis technologies indicated they

believed they could easily meet the

emission limitations included in the

proposed MWI standards and

guidelines. However, they believed that

their processes are unique enough to

warrant a separate category for

regulation. The vendors were

particularly concerned that the

proposed compliance and monitoring

requirements for MWI do not apply to

pyrolysis technologies. The proposal,

therefore, requested comment on

whether pyrolysis units should be

regulated as MWI or as a separate source

category.

Numerous comments and suggestions

were received following proposal from

vendors of pyrolysis treatment

technologies. Based on these comments

and suggestions, a draft regulation for

pyrolysis treatment technologies has

been developed and is available in the

docket as item IV–B–56. This draft

regulatory text is incomplete at this

time. It includes placeholders and

requests for information where such

information is lacking. Comments are

requested to help EPA fill in this

missing information.

A separate regulation for pyrolysis

treatment technologies would look very

similar to the MWI regulation in that it

would contain definitions, emissions

limitations, monitoring and testing

requirements to demonstrate

compliance, and reporting and

recordkeeping requirements. It would

differ from the MWI regulations in that

some definitions would be different, the

emission limitations would, in many

cases, be more stringent than the MWI

regulations, and the monitoring and

testing requirements would reflect the

operating parameters that are unique to

pyrolysis systems.

The EPA is inclined to adopt separate

regulations for pyrolysis treatment

technologies. The EPA specifically

requests comment on the merits of

continued development of separate

regulations for pyrolysis systems. These

systems appear to be very different than

incinerators. Because they are emerging

technologies, however, the normal

process of determining a MACT floor

and MACT for these systems is not

possible at this time. In fact, because

they appear to be inherently clean

technologies, regulation of these

systems may not be warranted at this

time.

J. Alternative Medical Waste Treatment

Technologies

In the proposal, it was estimated that

many owners of existing onsite MWI

would discontinue use of their existing

MWI in favor of less expensive medical

waste disposal options to avoid the high

cost of add-on air pollution control

equipment. In addition, many facilities

that would have chosen to purchase a

new onsite MWI were estimated to be

likely to choose some other method of

waste disposal. This phenomenon was

labeled as ‘‘switching’’ in the proposal,

and it has already occurred in a few

States that have adopted stringent MWI

regulations in the past few years.

Next to onsite incineration, the two

most common methods of medical

waste disposal are (1) offsite contract

disposal, which usually involves larger,

commercial incinerators dedicated to

medical waste and (2) onsite alternative

medical waste treatment technologies,

which include steam autoclaving,

chemical treatment, and microwave

irradiation. Because the MWI regulation

may encourage switching and the use of

onsite alternatives, the possible impacts

of other waste disposal methods were

assessed. Although autoclaves, chemical

treatment systems, and microwave

systems are not covered by the MWI

standards and guidelines, commercial

medical waste incinerators would be

subject to the MWI standards and

guidelines.

Following proposal, new data on

commercial disposal facilities

throughout the U.S. were obtained.

Information on the costs of commercial

disposal for medical waste generators in

both urban and rural locations was

obtained. Also, information on the

environmental impacts of increased

transportation of medical waste was

developed. This new information

pertaining to commercial disposal was

factored into the economic and

environmental impacts analyses

presented in Sections III and IV of this

notice. The remainder of this section

will focus on information relating to

nonincineration alternative technologies

(i.e., autoclaves, chemical treatment,

microwave irradiation, etc.).

During the public comment period

following proposal, several concerns

were raised regarding the availability,

effectiveness, costs, and environmental

impacts of onsite alternative treatment

technologies. Concerns were also raised

regarding alternative technology

operator safety and State acceptance of

alternative technologies. Because of the

concerns raised during the public

comment period, the Agency has

examined the available information on

the effects that switching from onsite

incineration to alternative technologies

could have on medical waste generators

and the environment.

Following proposal, a great deal of

information on alternative technologies

was received. This information was

compiled and is presented in document

No. IV–B–43. The material presented in

document IV–B–43 should not be

considered an in-depth study of

alternative technologies. Instead, it is a

review of the available information.

Based on this information, there appears

to be no significant or substantial

adverse economic, environmental, or

health and safety issues associated with

the increased use of these

nonincineration alternative medical

waste treatment technologies.

The most widely used

nonincineration alternative technologies

are autoclaves, chemical treatment

systems, and microwave systems. In

autoclaves, the effects of heat from

saturated steam and increased pressure

are used to decontaminate the medical

waste. In chemical treatment systems,

an antimicrobial chemical, such as

sodium hypochlorite, chlorine dioxide,

or peracetic acid, is used to

decontaminate the waste. In microwave

technologies, medical waste is wetted

and heated to decontaminating

temperatures with microwave

irradiation.

Most alternative technologies are

equipped with a shredder or grinder

that is used to reduce the volume of the

waste by up to 80 percent and render

the waste unrecognizable. In some

alternative technologies, the waste is

compacted, and the waste volume is

reduced by 50 percent. With most

alternative technologies, the mass of the

waste is not reduced due to the

entrainment of liquids that are added

during treatment.

Because shredding or grinding

pathological and animal waste may

present aesthetically unacceptable
31754 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

results, most alternative technologies

are not suitable treatment methods for

these types of waste. Also, alternative

technologies are usually unable to

effectively treat chemotherapy,

hazardous, or low-level radioactive

wastes. The total waste stream at a

typical hospital contains less than 3

percent by weight of pathological,

animal, chemotherapy, hazardous, and

low level radioactive wastes. Facilities

using alternative technologies usually

package this portion of the waste and

send it to a commercial disposal facility.

The efficacy of autoclave, microwave,

and other thermal treatment

technologies depends primarily on the

treatment time and temperature. The

efficacy of chemical treatment systems

depends on the treatment time and the

chemical concentration. The most

widely used criteria for determining the

efficacy of an alternative technology in

decontaminating the waste was

developed by the State and Territorial

Association of Alternate Treatment

Technologies (STAATT). The STAATT

criteria recommends, as a safe and

satisfactory level of medical waste

treatment, the inactivation of vegetative

bacteria, fungi, lipophilic/hydrophilic

viruses, and mycobacteria at a 6 Log10

reduction or greater and the inactivation

of Bacillus subtilis or Bacillus

stearothermophilus at a 4 Log10 or

greater. Efficacy test reports indicate

that autoclave systems, chemical

treatment systems, and microwave

systems can meet and exceed the

STAATT efficacy criteria. Therefore, the

most widely used alternative treatment

technologies seem to be effective

methods of decontaminating medical

waste.

In most States, alternative

technologies must undergo an approval

or permitting process before they can be

installed in the State. As long as the

technology can demonstrate that it

meets the State’s efficacy requirements,

which are usually similar to, if not the

same as, the STAATT criteria, the

technology can be installed, unless the

State determines that the technology is

unacceptable for some other reason. The

State approval or permitting process

usually takes less than a year. Many

alternative technology vendors have

gained approval of their systems in a

number of States so that less time will

be required for review of the technology

by State regulatory agencies before the

system is installed.

There are some 20 vendors of

alternative technologies (i.e. autoclaves,

chemical treatment systems, and

microwave systems) that have a

considerable number of installations.

These vendors, when combined, have

about 150 years of experience in the

medical waste business. Some of these

vendors have more than 15 years of

experience alone. These vendors are

responsible for approximately 975

alternative technology installations,

which range in capacity from 12 to

8,000 pounds of medical waste treated

per hour. An additional 17 alternative

technology vendors were identified with

systems that are under development and

are expected to appear on the market in

the near future.

Alternative technologies seem to be

available, and many vendors have been

in the medical waste business for many

years. With the number of vendors that

have alternative technologies under

development, the alternatives industry

appears to be growing. Alternative

technology vendors claim they will be

able to meet any increased demand for

onsite alternative systems due to

switching.

The results from reports on the air

emissions from autoclaves show that

there are some emissions of volatile

organics from autoclaves. However, the

test reports also show that the emissions

of Pb, Cd, Hg, HCl, and PM from

autoclaves are insignificant when

compared to emissions of the same

pollutants from MWI. No information

on dioxin emissions from autoclaves

was available. The available data on the

air emissions from autoclaves shows

that these emissions are more organic

than the acid gas and metal emissions

from MWI. Furthermore, it appears that

on a pound of pollutant per pound of

waste basis, far less total emissions are

produced from treating medical waste in

an autoclave than from burning waste in

an MWI.

No data is available on the air

emissions from chemical treatment

systems and microwave systems.

However, some States require chemical

treatment systems to obtain air permits.

The emissions from microwave systems

are likely to be similar to those from an

autoclave since lower temperatures are

used during microwaving and the only

component added is water.

Based on the information received,

there does not appear to be any water

pollution from the liquid effluents of

autoclaves and chemical treatment

systems and no liquid effluent from

microwave treatment systems. The

results of Toxicity Characteristics

Leachate Procedure (TCLP) tests

conducted on waste treated in an

autoclave and a chemical treatment

system were far below the regulatory

threshold for metals and organics. Since

the only component added to waste that

is treated in a microwave system is

water, the TCLP tests conducted on

microwaved waste should produce

similar results to those of autoclaved

waste.

The annualized price per pound of

medical waste treatment with an

alternative technology is comparable to

the price per pound associated with

other methods of medical waste

treatment and disposal. For facilities

that wish to treat their medical waste

onsite with an alternative technology,

but do not have the capital to purchase

an alternative system, options for

leasing or renting an alternative

technology are available. According to

alternative technology vendors, leasing

onsite medical waste treatment

technologies is a common practice. Most

lease agreements are available either

through the alternative vendor directly

or through a third party leasing

company.

The results from a survey of hospitals

that are currently using autoclaves,

chemical treatment systems, and

microwave systems indicate that these

hospitals are pleased with the operation

of their alternative medical waste

treatment systems. The hospitals

indicated that problems with shredder

jams are rare and that odors are minimal

with the alternative systems. The

surveyed hospitals reported that the

alternative technologies are cost

effective and easy to operate. The

hospitals also indicated that the waste

treated in their alternative systems is

readily accepted at local landfills.

Further, the hospitals indicated that

they would recommend their alternative

technology as a method of medical

waste treatment.

The potential hazards associated with

medical waste treatment arise primarily

from the presence and handling of

infectious waste. Therefore, the

potential hazards of medical waste

treatment are similar for operators of all

medical waste treatment technologies,

including MWI. Few, if any, additional

hazards are associated with alternative

technologies that have not already been

associated with medical waste

incineration.

III. Regulatory Options and Impacts for

Existing MWI

As discussed earlier, the MACT

‘‘floor’’ defines the least stringent

emission guidelines the EPA may adopt

for existing MWI. However, as also

discussed earlier, the Clean Air Act

requires the EPA to examine alternative

emission guidelines (i.e., regulatory

options) more stringent than the MACT

floor. The EPA must consider the cost,

environmental, and energy impacts of

these regulatory options and select one

that reflects the maximum reduction in
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31755

emissions that EPA determines is

achievable (i.e., MACT).

At proposal, the EPA concluded all

existing MWI would need good

combustion and dry scrubbers to meet

the MACT floors for CO, PM, and HCl.

Consequently, EPA was left to consider

only two regulatory options for MACT.

The first regulatory option reflected the

floor (i.e., emission limitations

achievable with good combustion and

dry scrubbers). The second reflected

emission limitations achievable with

good combustion and dry scrubbers

with activated carbon injection. Based

on the cost, environmental, and energy

impacts of the second regulatory option

relative to the first option, EPA selected

the second option as MACT.

Consequently, EPA proposed emission

guidelines for existing MWI based on

the use of good combustion and dry

scrubbers with activated carbon

injection.

As discussed earlier in this notice,

EPA received numerous comments

containing substantial new information

following proposal. Based on this

information, new conclusions

concerning the MWI inventory, MWI

subcategories, performance of emission

control technologies, MACT floors, and

monitoring and testing options have

been reached. As a result, EPA now

believes there are several new regulatory

options that merit consideration in

selecting MACT for existing MWI. The

following sections summarize these new

regulatory options and the EPA’s initial

assessment of their merits.

A. Regulatory Options

As discussed earlier, new MACT floor

emission levels were developed for

small, medium, and large MWI. To

assess the impacts of regulatory options,

EPA must first consider what emission

control technology(s) existing MWI may

need to meet regulations based on these

floor emission limits. The floor for small

existing MWI appears to require good

combustion; add-on wet scrubbing

systems would not be necessary to meet

the MACT floor. For medium existing

MWI, the MACT floor appears to require

good combustion and a moderate

efficiency wet scrubber. The MACT

floor for large existing MWI appears to

require good combustion and a high

efficiency wet scrubber.

Having identified these control

technologies, the EPA is now able to

review the performance capabilities of

other emission control technologies and

identify those that are capable of

achieving even greater emission

reductions. This review enables EPA to

identify regulatory options more

stringent than the floor that could be

selected as MACT.

For small existing MWI, as mentioned

above, good combustion is the emission

control technology most MWI would

probably need to meet the MACT floor

emission levels. Therefore, this

technology serves as the basis for the

first regulatory option for the MACT

emission guidelines for small existing

MWI. Based on the performance

capabilities of various emission control

technologies, however, using low

efficiency wet scrubbing systems in

addition to good combustion could

achieve greater emission reductions.

This combination would achieve further

emission reductions in PM and dioxins,

as well as HCl, Pb, Hg, and Cd.

Therefore, these controls used together

are a possible option beyond the MACT

floor emission levels for small existing

MWI.

As discussed earlier in Section II.B.,

the availability of alternatives for the

treatment and disposal of medical waste

is generally more limited in rural areas

than in urban areas. Therefore, the

potential impact of MACT regulations

on small existing MWI may be greater in

rural than in urban areas. This concern

was expressed in many comments EPA

received following proposal. As also

discussed earlier in Section II.B., section

129 of the Clean Air Act permits EPA

to subcategorize the MACT emission

guidelines by class, consequently,

subcategorizing small existing MWI into

rural and urban classes was examined.

In terms of the MACT floor emission

limits, however, subcategorizing small

existing MWI into rural and urban

classes made no difference—the MACT

floor emission limits are the same. As a

result, for purposes of the MACT floor,

there is no merit to subcategorizing

small existing MWI into rural and urban

classes.

Although subcategorizing based on

location was rejected for purposes of the

MACT floor, it was considered again in

identifying regulatory options more

stringent than the MACT floor. Thus,

the regulatory option of MACT emission

guidelines for small existing MWI based

on the use of good combustion and low

efficiency wet scrubbing systems was

subdivided to create two options. The

first regulatory option beyond the

MACT floor is to base the MACT

guidelines for small existing MWI

located in rural areas on good

combustion only, as required by the

MACT floor, but to base MACT

guidelines for small existing MWI

located in urban areas on good

combustion and low efficiency wet

scrubbing systems. If this option were

selected as the basis for the final MACT

emission guidelines, the emission limits

for small existing MWI located in rural

areas would be different than the

emission limits for small existing MWI

located in urban areas.

As discussed in Section II.B., location,

by itself, is not a valid criterion for

subcategorization under the Clean Air

Act. In addition, use of location as

surrogate measure of the availability of

technology may not be a valid criterion

for subcategorization either. There may

be statutory limitations to this approach.

As a result, the previous discussion

regarding differences in regulatory

requirements based on the location of an

MWI may not be allowed under the

Clean Air Act, and EPA specifically

requests comment on the validity of this

approach. As discussed later in Section

V., one of the options EPA is

considering would reflect good

combustion and wet scrubbers on all

small existing MWI except where an

individual MWI could meet certain

‘‘criteria,’’ in which case the individual

MWI would be subject to emission

limits based on good combustion alone.

Consequently, in addition to seeking

comment on the validity of identifying

urban and rural MWI as separate

‘‘classes,’’ EPA also requests comment

on other criteria that could be used to

make distinctions in regulatory

requirements.

A third regulatory option is MACT

emission guidelines for small existing

MWI located in both rural and urban

areas based on good combustion and

low efficiency wet scrubbing systems. In

other words, no difference in the MACT

emission limits between small existing

MWI located in rural or urban areas

would exist. This third option would

achieve greater emission reductions

than the second option.

Beyond these three regulatory options

(i.e., the MACT floor option and the two

options more stringent than the floor), a

review of the performance capabilities

of various emission control technologies

readily identifies a fourth regulatory

option for small existing MWI. This

regulatory option is to base the MACT

emission guidelines for small existing

MWI on the use of good combustion and

moderate efficiency wet scrubbing

systems. This regulatory option would

further reduce PM emissions, however,

it would not achieve further reductions

in emissions of other pollutants. As

summarized earlier, moderate and high

efficiency wet scrubbing systems do not

appear to achieve greater emission

reductions of dioxins, acid gases (e.g.,

HCl), or the metals (i.e., Hg, Pb, or Cd)

than low efficiency wet scrubbing

systems.
31756 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

Option 4 could also be subdivided

into two options: (1) MACT emission

guidelines for small existing MWI in

rural areas based on good combustion

and low efficiency wet scrubbing

systems; and MACT guidelines for small

existing MWI in urban areas based on

good combustion and moderate

efficiency wet scrubbing systems and (2)

MACT emission guidelines for small

existing MWI in both rural and urban

areas based on good combustion and

moderate efficiency wet scrubbing

systems. However, the cost difference

between using a low efficiency wet

scrubbing system or a moderate

efficiency wet scrubbing system is not

as great as that between using a low

efficiency wet scrubbing system or not

using a wet scrubbing system at all.

Consequently, at this point, to limit the

number of regulatory options under

consideration, the EPA has chosen not

to further subdivide this regulatory

option.

Reviewing the performance

capabilities of emission control

technologies identifies a fifth regulatory

option for small existing MWI. This

option is to base the MACT emission

guidelines for small existing MWI on

the use of good combustion and high

efficiency wet scrubbing systems. This

would further reduce PM emissions, but

as outlined above, would not further

reduce emissions of other air pollutants

such as dioxins, acid gases (e.g., HCl),

or the metals (i.e., Pb, Hg, Cd).

A sixth regulatory option for small

existing MWI also is apparent. This

option is to base the MACT emission

guidelines for small existing MWI on

the use of good combustion and dry

scrubbing systems with activated carbon

injection. This possibility would further

reduce emissions of Pb, Cd, and dioxins,

but would not further reduce emissions

of other air pollutants. Dry scrubbing

systems, however, generally cost about

one and a half times what highefficiency wet scrubbing systems cost to

operate annually, and the overall

difference in the emissions control

performance between the two systems is

relatively small. Therefore, at this point,

to limit the total number of regulatory

options under consideration, the EPA

has chosen not to include this sixth

regulatory option for small existing

MWI.

For medium existing MWI, as

discussed earlier, the use of good

combustion and moderate efficiency wet

scrubbing systems appears to be

necessary to meet the MACT floor

emission limits. This option, therefore,

is the first regulatory option for medium

existing MWI. The second regulatory

option is to base the emission guidelines

on good combustion and high efficiency

wet scrubbing systems.

Finally, for large existing MWI, as

discussed earlier, the use of good

combustion and high efficiency wet

scrubbing systems appears to be

necessary to meet the MACT floor

emission limits. Thus, the EPA is not

inclined at this point to consider other

regulatory options for large existing

MWI.

As mentioned above, a review of the

performance capabilities of emission

control technologies indicates that dry

scrubbing systems can reduce emissions

of some pollutants (i.e., Pb, Cd, and

dioxins) greater than high-efficiency wet

scrubbing systems. Additional

regulatory options for both medium and

large existing MWI could be structured,

therefore, around the use of dry

scrubbing systems. However, as also

mentioned above, the cost of these

systems is much higher than that of

high-efficiency wet scrubbing systems

and the overall difference in emission

control performance is relatively small.

For existing MWI already equipped with

wet scrubbers, replacing a wet scrubber

with a dry scrubber would be

exorbitantly expensive. As a result, at

this point, the EPA has chosen not to

develop additional regulatory options

for medium and large existing MWI

based on the use of dry scrubbing

systems to keep the total number of

regulatory options under consideration

to a manageable number.

The regulatory options outlined above

are compiled in Table 13. This table

summarizes the technology basis for the

regulatory options for the various MACT

emission guidelines the EPA believes

merit consideration as MACT for

existing MWI. This table is constructed

only to organize and structure an

analysis of the cost, environmental, and

energy impacts associated with the

various MACT emission guidelines in

order to consider these impacts in

selecting MACT for existing MWI. In

reviewing this table, therefore, there are

several important points to keep in

mind.

TABLE 13.—LEVEL OF AIR POLLUTION CONTROL ASSOCIATED WITH EACH REGULATORY OPTION FOR EXISTING MWI

MWI size

Regulatory options

1 2 3 4 5 6

Small ≤200 lb/hr ... Good combustion Good combustion

on rural; Good

combustion and

low efficiency

wet scrubber on

urban.

Good combustion

and low efficiency wet

scrubber.

Good combustion

and moderate

efficiency wet

scrubber.

Good combustion

and moderate

efficiency wet

scrubber.

Good combustion

and high efficiency wet

scrubber.

Medium 201–500

lb/hr.

Good combustion

and moderate

efficiency wet

scrubber.

Good combustion

and moderate

efficiency wet

scrubber.

Good combustion

and moderate

efficiency wet

scubber.

Good combustion

and moderate

efficiency wet

scrubber.

Good combustion

and high efficiency wet

scrubber.

Good combustion

and high efficiency wet

scrubber.

Large 500 lb/hr ..... Good combustion

and high efficiency wet

scrubber.

Good combustion

and high efficiency wet

scrubber.

Good combustion

and high efficiency wet

scubber.

Good combustion

and high efficiency wet

scrubber.

Good combustion

and high efficiency wet

scrubber.

Good combustion

and high efficiency wet

scrubber.

First, the MACT emission guidelines

for existing MWI will not include

requirements to use a specific emission

control system or technology; the MACT

emission guidelines will only include

emission limits, which may be met by

any means or by using any control

system or technology the owner or

operator of the MWI decides to use to

meet these emission limits. Second, to

the extent possible (i.e., within the

constraints imposed by Section 129 of

the Clean Air Act), the EPA plans to

adopt emission limits in the MACT

emission guidelines that can be met

through the use of several emission

control systems or technologies.

Consequently, where not constrained by
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31757

the Clean Air Act, the actual emission

limits associated with some of the

regulatory options shown in Table 13

have been selected at a level designed

to encourage or permit the use of both

wet and dry scrubbing control systems,

as outlined below.

The emission limits associated with

each of the regulatory options for small,

medium, and large existing MWI are

presented in Table 14.

TABLE 14.—EMISSION LIMITATIONS ASSOCIATED WITH EACH REGULATORY OPTION FOR SMALL, MEDIUM, AND LARGE

EXISTING MWI

Pollutant,

units

Regulatory options Small MWI’s Medium

MWI’s

Large

MWI’s

1 2 (rural) 2 (urban) 3 4 and 5 6 1–4 5 and 6 1–6

PM, gr/dscf ... 0.086 0.086 0.05 ......... 0.05 ......... 0.03 ......... 0.015 ....... 0.03 ......... 0.015 ....... 0.015.

CO, ppmdv ... 40 40 40 ............ 40 ............ 40 ............ 40 ............ 40 ............ 40 ............ 40.

CDD/CDF,

ng/dscm.

800 800 125 .......... 125 .......... 125 .......... 125 .......... 125 .......... 125 .......... 125.

TEQ CDD/

CDF, ng/

dscm.

15 15 2.3 ........... 2.3 ........... 2.3 ........... 2.3 ........... 2.3 ........... 2.3 ........... 2.3.

HCI, ppmdv 3,100 3,100 100 or

93%.

100 or

93%.

100 or

93%.

100 or

93%.

100 or

93%.

100 or

93%.

100 or

93%.

SO2, ppmdv 55 55 55 ............ 55 ............ 55 ............ 55 ............ 55 ............ 55 ............ 55.

NOx, ppmdv 250 250 250 .......... 250 .......... 250 .......... 250 .......... 250 .......... 250 .......... 250.

Pb, mg/dscm 10 10 1.2 or 70% 1.2 or 70% 1.2 or 70% 1.2 or 70% 1.2 or 70% 1.2 or 70% 1.2 or

70%.

Cd, mg/dscm 4 4 0.16 or

65%.

0.16 or

65%.

0.16 or

65%.

0.16 or

65%.

0.16 or

65%.

0.16 or

65%.

0.16 or

65%.

HG, mg/dscm 7.5 7.5 0.55 or

85%.

0.55 or

85%.

0.55 or

85%.

0.55 or

85%.

0.55 or

85%.

0.55 or

85%.

0.55 or

85%.

Regulatory Option 1 in Table 14

reflects the performance of the emission

control system or technology needed to

meet the MACT floor. For small existing

MWI, Regulatory Option 1 reflects

emission limits based on good

combustion. For medium existing MWI,

Regulatory Option 1 reflects emission

limits based on good combustion and

moderate efficiency wet scrubbers,

except for HCl (discussed below). For

large existing MWI, Regulatory Option 1

reflects emission limits based on good

combustion and high efficiency wet

scrubbers, except for HCl (discussed

below).

Dry scrubbers with activated carbon

injection can achieve the emission

limits associated with moderate or high

efficiency wet scrubbers, with the

exception of HCl. While dry scrubbers

cannot reduce HCl emissions to the

same levels as wet scrubbers, dry

scrubbers can achieve the MACT floor

emission level for HCl. Consequently,

Regulatory Option 1 reflects the HCl

emission limit achievable with a dry

scrubber for both medium and large

existing MWI. Both technologies (wet or

dry scrubber) are capable of achieving

the emission limits shown for

Regulatory Option 1.

Regulatory Option 2 is the same as

Regulatory Option 1 for medium and

large existing MWI. Small existing MWI

located in urban areas would be

required to meet emission limits

associated with good combustion and

low efficiency wet scrubbers. Small

existing MWI located in rural areas

would remain subject to the same

emission limits as Regulatory Option 1

(based on good combustion). Regulatory

Option 3 would establish emission

limits for all small existing MWI (urban

and rural) based on good combustion

and low efficiency wet scrubbers.

Regulatory Option 4 would establish

emission limits for all small existing

MWI based on good combustion and

moderate efficiency wet scrubbers.

Requirements for medium and large

existing MWI would remain the same

under Regulatory Options 1, 2, 3, and 4.

As discussed above, HCl emission limits

in all cases would allow the use of dry

scrubbers.

Regulatory Option 5 would establish

emission limits for small existing MWI

based on good combustion and

moderate efficiency wet scrubbers;

medium existing MWI based on good

combustion and high efficiency wet

scrubbers; and large existing MWI based

on good combustion and high efficiency

wet scrubbers. The sixth and final

regulatory option would require all

existing MWI to meet emission

limitations associated with good

combustion and high efficiency wet

scrubbers. As discussed above, the HCl

emission limit under Regulatory

Options 5 and 6 would allow the use of

dry scrubbing systems.

B. National Environmental and Cost

Impacts

This section presents a summary of

the air, water, solid waste, energy, and

cost impacts of the six regulatory

options described above for existing

MWI. Economic impacts are discussed

in Section III.C. All impacts are

nationwide impacts resulting from the

implementation of the emission

guidelines on existing MWI.

1. Analytical Approach

As discussed at proposal and within

this notice, healthcare facilities may

choose from among a number of

alternatives for treatment and disposal

of their medical wastes; however, these

alternatives are generally more limited

for healthcare facilities located in rural

areas than for those in urban areas. In

fact, as stated at proposal, most

estimates are that less than half of

hospitals today currently operate onsite

medical waste incinerators. The clear

trend over the past several years has

been for more and more hospitals to

turn to the use of alternative onsite

medical waste treatment technologies or

commercial offsite treatment and

disposal services. Consequently, even

fewer hospitals are now likely to operate

onsite medical waste incinerators.

More than half of existing hospitals

today, therefore, have chosen to use

other means of treatment and disposal

of their medical waste than operation of

an onsite incinerator. This is a clear
31758 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

indication that alternatives to the use of

onsite incinerators exist and that they

are readily available in many cases.

(Although as mentioned above, these

alternatives—particularly the

availability and competitive cost of

offsite commercial treatment and

disposal services—tend to be more

limited in rural areas than in urban

areas). For other healthcare facilities,

such as nursing homes, outpatient

clinics, doctors and dentists offices, etc.,

only very few facilities currently operate

onsite medical waste incinerators.

Therefore, for these types of healthcare

facilities, the percentage of such

facilities using alternative means of

treatment and disposal of medical

waste—particularly commercial

treatment and disposal services—is

much higher, probably higher than 95

percent. This high percentage is further

confirmation of the availability of

alternatives to onsite incinerators for the

treatment and disposal of medical

waste.

A very likely reaction and outcome

associated with the adoption of MACT

emission guidelines for existing MWI,

therefore, is an increase in the use of

these alternatives by healthcare facilities

for treatment and disposal of medical

waste. The EPA’s objective is not to

encourage the use of alternatives or to

discourage the continued use of onsite

medical waste incinerators; the EPA’s

objective is to adopt MACT emission

guidelines for existing MWI that fulfill

the requirements of Section 129 of the

Clean Air Act. In doing so, however, one

outcome associated with adoption of

these MACT emission guidelines is

likely to be an increase in the use of

alternatives and a decrease in the

continued use of onsite medical waste

incinerators. Consequently, EPA should

acknowledge and incorporate this

outcome into the analyses of the cost,

environmental, and energy impacts

associated with the MACT emission

guidelines.

In these analyses of the cost,

environmental, and energy impacts, the

selection of an alternative form of

medical waste treatment and disposal

by a healthcare facility, rather than the

operation of an onsite medical waste

incinerator and purchase the emission

control technology necessary to meet

the MACT emission limits, is referred to

as ‘‘switching’’. Switching was

incorporated in the analyses at proposal

and was the basis for the conclusion at

proposal that adoption of the proposed

MACT emission guidelines could lead

to as many as 80 percent of healthcare

facilities with MWI to choose an

alternative means of medical waste

treatment and disposal over continued

operation of their MWI. Although

switching was not EPA’s objective, it

was a potential outcome of the

regulations that EPA believed should be

acknowledged, considered, and

discussed at proposal.

Switching has also been incorporated

into the new analyses of the cost,

environmental, and energy impacts

associated with the six new regulatory

options. The new analyses, however,

incorporate three scenarios; one

scenario that ignores switching and two

scenarios that consider switching.

Scenario A assumes that each existing

MWI remains in operation and complies

with the appropriate regulatory option

(i.e., no switching). This scenario results

in the highest costs because it assumes

no existing MWI will switch to a less

expensive waste disposal method. This

scenario is clearly unrealistic and

grossly overstates the national costs

associated with MACT emission

guidelines. It should not be viewed as

representative or even close to

representative of the impacts associated

with the MACT emission guidelines.

This scenario is so misleading that the

EPA considered not including it in the

analysis; some may take it out of context

and use it as representative, when it is

in no way representative of the impacts

of the MACT emission guidelines. The

EPA finally decided to include this

scenario in the analysis only because

some may ask ‘‘what if * * *?’’ and the

EPA wanted to be in a position to

answer such questions.

Switching Scenarios B and C are

much more realistic and more

representative of the cost,

environmental, and energy impacts

associated with the MACT emission

guidelines for existing MWI. Only these

scenarios merit serious review and

consideration in gauging the potential

impacts associated with the MACT

emission guidelines. Both Scenarios B

and C assume switching occurs when

the cost associated with purchasing and

installing the air pollution control

technology or system necessary to

comply with the MACT emission

guideline (i.e., a regulatory option) is

greater than the cost of choosing an

alternative means of treatment and

disposal.

The difference in Scenarios B and C

is the assumption of how much

separation of the medical waste stream

into an infectious medical waste stream

and a noninfectious medical waste

stream currently occurs at healthcare

facilities that today operate a medical

waste incinerator. Some have stated

that, for the most part, hospitals that are

currently operating onsite medical

waste incinerators practice little

separation of medical waste into

infectious and noninfectious waste;

generally all the waste at the facility is

incinerated.

Based on estimates in the literature

that only 10 to 15 percent of medical

waste is potentially infectious and the

remaining 85 to 90 percent is

noninfectious, Scenario B assumes that

only 15 percent of the waste currently

being burned at a healthcare facility

operating an onsite medical waste

incinerator is potentially infectious

medical waste. The 85 percent

noninfectious waste is municipal waste

that needs no special handling,

treatment, transportation, or disposal. It

can be sent to a municipal landfill or

municipal combustor for disposal. Thus,

under Scenario B, when choosing an

alternative to continued operation of an

onsite medical waste incinerator, in

response to adoption of MACT emission

guidelines, a healthcare facility need

only choose an alternative form of

medical waste treatment and disposal

for 15 percent of the waste stream

currently burned onsite and may send

the remaining 85 percent to a municipal

landfill. In other words, if a hospital is

burning 100 pounds of waste, Scenario

B assumes 85 pounds are noninfectious

and 15 pounds are potentially

infectious. This scenario results in the

lowest costs because 85 percent of the

waste is disposed at the relatively

inexpensive cost of municipal waste

disposal.

On the other hand, it is unlikely that

all healthcare facilities that currently

operate an MWI will be able to or will

decide to segregate the waste stream

currently being burned in their

incinerator. If a hospital is already

separating medical waste into infectious

and noninfectious waste streams, for

example, this hospital would be unable

to separate the waste stream any further.

In other words, if a hospital is burning

100 pounds of waste, Scenario C

assumes all 100 pounds are potentially

infectious. Scenario C, therefore,

assumes that all medical waste being

burned at a healthcare facility currently

operating a medical waste incinerator is

potentially infectious medical waste and

must be treated and disposed of

accordingly. As a result, Scenario C

leads to higher costs than Scenario B.

For the purposes of determining

impacts of the emission guidelines

under switching Scenarios B and C, the

MWI inventory was separated into

commercial (offsite) incinerators and

onsite incinerators used to burn

healthcare waste. The commercial

incinerators were not subjected to the

switching analyses under Scenarios B

and C because switching to an
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31759

alternative method of waste disposal

(e.g., commercial disposal) is not

feasible for commercial facilities. An

assumption was made that commercial

facilities would add on the control

associated with the emission guidelines.

Only the onsite MWI in the inventory

were subject to the switching analyses

under Scenarios B and C.

Scenarios B and C represent the likely

range of impacts associated with the

MACT emission guidelines for existing

MWI. The actual impacts of a MACT

emission guideline (i.e., a regulatory

option) is most likely to fall somewhere

within the range represented by

Scenarios B and C.

2. Air Impacts

As outlined above, the impacts

associated with six MACT emission

guidelines or regulatory options, under

three scenarios reflecting switching,

have been assessed. Baseline emissions

(i.e., emissions today in the absence of

adoption of the MACT emission

guidelines) and emissions under each

MACT emission guideline or regulatory

option are summarized in Tables 15, 16,

and 17. Emissions under Scenario A (no

switching) are summarized in Table 15;

emissions under Scenario B (switching

with waste separation) are summarized

in Table 16; and emissions under

Scenario C (switching without waste

separation) are summarized in Table 17.

TABLE 15.—BASELINE EMISSIONS COMPARED WITH EMISSIONS AFTER IMPLEMENTATION OF THE EMISSION GUIDELINES

[Scenario A]

[Metric Units]

Pollutant, units Baseline

Regulatory options

1 2 3 4 5 6

PM, Mg/yr ................................................................ 940 190 160 140 120 110 100

CO, Mg/yr ................................................................ 460 120 120 120 120 120 120

CDD/CDF, g/yr ........................................................ 7,200 420 360 300 300 300 300

TEQ CDD/CDF, g/yr ............................................... 150 9.4 8.2 7.1 7.1 7.1 7.1

HCl, Mg/yr ............................................................... 5,700 880 490 86 86 86 86

SO2 Mg/yr ................................................................ 250 250 250 250 250 250 250

NOX, Mg/yr .............................................................. 1,200 1,200 1,200 1,200 1,200 1,200 1,200

Pb, Mg/yr ................................................................. 11 3.3 2.7 2.1 2.1 2.1 2.1

Cd, Mg/yr ................................................................. 1.2 0.42 0.36 0.29 0.29 0.29 0.29

Hg, Mg/yr ................................................................. 15 1.4 1.2 1.1 1.1 1.1 1.1

To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6

TABLE 16.—BASELINE EMISSIONS COMPARED WITH EMISSIONS AFTER IMPLEMENTATION OF THE EMISSION GUIDELINES

[Scenario B]

[Metric Units]

Pollutant, units Baseline

Regulatory options

1 2 3 4 5 6

PM, Mg/yr ................................................................ 940 91 78 67 67 65 65

CO, Mg/yr ................................................................ 460 83 83 82 82 81 81

CDD/CDF, g/yr ........................................................ 7,200 240 220 210 210 200 200

TEQ CDD/CDF, g/yr ............................................... 150 5.5 5.1 4.8 4.8 4.7 4.7

HCl, Mg/yr ............................................................... 5,700 310 180 77 77 77 77

SO2, Mg/yr ............................................................... 250 180 170 170 170 170 170

NOX, Mg/yr .............................................................. 1,200 830 820 810 810 810 810

Pb, Mg/yr ................................................................. 11 1.7 1.5 1.3 1.3 1.3 1.3

Cd, Mg/yr ................................................................. 1.2 0.23 0.20 0.18 0.18 0.18 0.18

Hg, Mg/yr ................................................................. 15 0.87 0.81 0.76 0.76 0.75 0.75

To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6

TABLE 17.—BASELINE EMISSIONS COMPARED WITH EMISSIONS AFTER IMPLEMENTATION OF THE EMISSION GUIDELINES

[Scenario C]

[Metric Units]

Pollutant, units Baseline

Regulatory options

1 2 3 4 5 6

PM, Mg/yr ................................................................ 940 170 140 110 110 100 100

CO, Mg/yr ................................................................ 460 120 120 120 120 120 120

CDD/CDF, g/yr ........................................................ 7,200 400 350 300 300 300 300

TEQ CDD/CDF, g/yr ............................................... 150 9.0 8.0 7.1 7.1 7.1 7.1

HCl, Mg/yr ............................................................... 5,700 740 410 86 86 86 86

SO2, Mg/yr ............................................................... 250 250 250 250 250 250 250

NOX, Mg/yr .............................................................. 1,200 1,200 1,200 1,200 1,200 1,200 1,200

Pb, Mg/yr ................................................................. 11 3.1 2.6 2.1 2.1 2.1 2.1

Cd, Mg/yr ................................................................. 1.2 0.40 0.34 0.29 0.29 0.29 0.29

Hg, Mg/yr ................................................................. 15 1.3 1.2 1.1 1.1 1.1 1.1

To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6.
31760 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

As discussed in previous sections,

new information has led to new

conclusions about the MWI inventory,

performance of technology, and control

levels associated with each existing

MWI. As a result, revised estimates of

annual baseline emissions and

emissions under each regulatory option

are significantly lower than estimates

developed at proposal. There are two

primary reasons for the lower emission

estimates. First, existing MWI are

equipped with better emission control

than was assumed at proposal. Second,

many more MWI were assumed to exist

at proposal than in the current

inventory.

3. Water and Solid Waste Impacts

Estimates of wastewater impacts were

developed for only Regulatory Option 6,

Scenario A, which reflects all existing

MWI equipped with wet scrubbers in

the absence of switching. Assessing

these impacts under Scenario A without

any consideration of the effect of

switching grossly overstates the

magnitude of these impacts. Under

Scenarios B and C more than half of the

existing MWI are expected to switch,

resulting in significantly lower impacts.

This approach of estimating and

summarizing impacts under Scenario A,

at this point, was taken as a matter of

expediency to share new information

and provide an opportunity for public

comment.

Under Scenario A and Regulatory

Option 6, 198 million gallons of

additional wastewater would be

generated annually by existing MWI as

a result of the MACT emission

guideline. This amount is the equivalent

of wastewater produced annually by

four large hospitals. Therefore, when

considering the wastewater produced

annually at healthcare facilities

nationwide, the increase in wastewater

resulting from the implementation of

the MACT emission guidelines for

existing MWI is insignificant.

With regard to solid waste impacts,

about 767 million Mg (846 million tons)

of medical waste are burned annually in

existing MWI producing about 76,700

Mg/yr (84,600 tons/yr) of solid waste

(bottom ash) disposed of in landfills. To

estimate the solid waste impacts for the

MACT emission guidelines, impacts

were developed only for Regulatory

Option 6, Scenario B. This option is

associated with the most switching and

the most separation of waste for

disposal in municipal landfills and,

thus, produces the greatest estimated

impact.

Under Regulatory Option 6, Scenario

B, 210,000 Mg/yr (231,000 tons/yr) of

additional solid waste would result

from the adoption of the MACT

emission guideline. Compared to

municipal waste, which is disposed in

landfills at an annual rate of over 91

million Mg/yr (100 million tons/yr), this

increase from the implementation of the

MACT emission guideline for existing

MWI is insignificant.

4. Energy Impacts

The emission control technologies

used by existing MWI to comply with

the MACT emission limits consume

energy. Estimates of energy impact were

developed for Regulatory Option 6,

Scenario A. Under Scenarios B and C,

which include switching, it is not clear

whether overall national energy

consumption would increase, decrease,

or remain the same. Alternatives to

incineration require energy to operate,

however, information is not available to

estimate whether these alternatives use

more or less energy than MWI.

The energy impacts associated with

the MACT emission guidelines could

include additional auxiliary fuel

(natural gas) for combustion controls

and additional electrical energy for

operation of the add-on control devices,

such as wet scrubbers and dry

scrubbers. Regulatory Option 6,

Scenario A, could increase total national

usage of natural gas for combustion

controls by about 16.6 million cubic

meters per year (MMm3/yr) (586 million

cubic feet per year [106 ft3/yr]). Total

national usage of electrical energy for

the operation of add-on control devices

could increase by about 259,000

megawatt hours per year (MW-hr/yr)

(883 billion British thermal units per

year [109 Btu/yr]). Once again,

compared to the amount of energy used

by healthcare facilities such as hospitals

(approximately 2,460 MMm3/yr of

natural gas and 23.2 million MW-hr/yr

of electricity) the increase in energy

usage that results from implementation

of the MACT emission guideline for

existing MWI is insignificant.

5. Cost Impacts

The cost impacts on individual

healthcare facilities that currently

operate an MWI vary depending on the

MACT emission guideline or regulatory

option; the actual cost to purchase and

install any additional air pollution

control equipment; the cost of

alternative means of treatment and

disposal where they are located; and

other factors, such as liability issues

related to disposal and State and local

medical waste treatment and disposal

requirements. In general, facilities with

smaller MWI will have a greater

incentive to use alternative means of

treatment and disposal because their

onsite incineration cost (per pound of

waste burned) will be higher.

Large healthcare facilities with larger

amounts of waste to be treated or

healthcare facilities that serve as

regional treatment centers for waste

generated at other healthcare facilities

in the area may have some cost

advantages compared to smaller

facilities. Due to economies of scale,

their cost of burning waste may be lower

(i.e., dollars per pound burned), and

they may have already installed some

air pollution control equipment. These

facilities may only have to upgrade this

equipment to comply with the MACT

emission guideline rather than purchase

and install a complete air pollution

control system.

Table 18 contains the estimated

increase in national annual costs

associated with each of the MACT

emission guidelines or regulatory

options under Scenario A (no

switching), Scenario B (switching with

separation of waste), and Scenario C

(switching with no separation of waste).

As discussed earlier, Scenario A is

unrealistic and grossly overstates the

national cost impacts. The costs

associated with the MACT emission

guidelines under Scenarios B and C

represent the likely range of national

cost impacts, and only these costs merit

serious consideration and review.

TABLE 18.—COSTS OF THE REGULATORY OPTIONS OF THE EMISSION GUIDELINES [SCENARIOS A, B, AND C]

[Million $year]

Scenario

Regulatory options

1 2 3 4 5 6

A ............................................................................................................................ 120 145 173 181 190 201

B ............................................................................................................................ 57.0 57.1 57.4 57.4 57.7 57.7

C ............................................................................................................................ 108 113 118 119 122 123
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31761

The nationwide annual costs

presented in Table 18, excluding

Scenario A, range from $57 million/yr

for Regulatory Option 1 and Scenario B

to $123 million/yr for Regulatory Option

6 and Scenario C. These nationwide

annual costs are significantly lower than

the $351 million/yr estimated for the

proposed emission guidelines. The

primary reason for the difference in the

proposed and the current nationwide

annual cost estimates is the greater level

of emissions control found at existing

MWI than was assumed at proposal. The

costs of upgrading from the current level

of control now known to be on existing

MWI are far less than the costs of

upgrading from the mere 1⁄4 sec

combustion controls assumed to be on

most MWI at proposal. Also, the annual

cost of the MACT emission levels

discussed in this notice is significantly

less than the proposed MACT emission

level (DI/FF with activated carbon).

Another reason for the difference is that

the number of MWI assumed to exist at

proposal was much greater than the

number of MWI in the current

inventory. For example, the cost

estimates at proposal were based on an

estimated 3,700 MWI; currently, there

are approximately 2,400 MWI in the

inventory.

C. Economic Impacts

Section III.B.1 described assumptions

pertaining to three analysis scenarios:

no switching, switching with waste

segregation, and switching with no

waste segregation. Section III.B.5

presented annual cost estimates that

have been developed for each of the six

regulatory options. This section

incorporates these assumptions and cost

data to estimate potential economic

impacts that might result from

implementation of these regulatory

options.

The goal of the economic impact

analysis is to estimate the market

response of affected industries to the

emission guidelines and to identify any

adverse impacts that may occur as a

result of the regulation. Industries that

operate onsite waste incinerators

(hospitals, nursing homes, research labs,

and commercial waste incinerators) and

those that utilize offsite medical waste

incinerators (hospitals, nursing homes,

medical/dental laboratories, funeral

homes, physicians’ offices, dentist

offices, outpatient care, freestanding

blood banks, fire and rescue operations,

and correctional facilities) will

potentially be affected by the regulation.

Industrywide impacts, including

changes in market price, output or

production, revenues, and employment

for the affected industries are estimated

for each regulatory option assuming the

three switching scenarios. Facilityspecific impacts are estimated for

hospitals of varying sizes, ownerships,

and operating characteristics; nursing

homes; commercial research labs; and

commercial waste incineration based on

engineering model plant cost estimates

under each of the three switching

scenarios.

1. Analytical Approach

The analytical approach to estimate

industrywide and facility specific

economic impacts and evaluate the

economic feasibility of switching are

briefly described. For a more detailed

description refer to docket item IV–A–

8. Prices are stated at 1993 levels.

The average price changes anticipated

to occur in each industry sector for each

of the regulatory options are estimated

by comparing the annual control cost

estimates to annual revenues for each

affected industry. This calculation

provides an indication of the magnitude

of a price change that would occur for

each industry sector to fully recover its

annual control costs. The resulting costto-revenue ratio represents the price

increase necessary on average for firms

in the industry to recover the increased

cost of environmental controls. Percent

changes in output or production are

estimated using the price impact

estimate and a high and low estimate of

the price elasticity of demand. Resulting

changes in revenues are estimated based

upon the estimated changes in price and

output for an industry. Employment or

labor market impacts result from

decreases in the output for an industry

and are assumed to be proportional to

the estimated decrease in output for

each industry.

Facility-specific economic impacts are

estimated by using model plant

information under the three switching

scenarios. The assumption of no

switching (Scenario A) represents the

highest cost and economic impact

scenario for most affected industries,

while the assumption of switching with

waste segregation (Scenario B)

represents the lowest cost and economic

impact scenario for most of the affected

industries. As previously stated, EPA

considers Scenario A to be an unlikely

scenario; therefore, the economic

impacts presented under Scenarios B

and C should be regarded as the impacts

most likely to occur.

2. Industry-Wide Economic Impacts

Industry-wide impacts include

estimates of the change in market price

for the services provided by the affected

industries, the change in market output

or production, the change in industry

revenue, and the impact on affected

labor markets in terms of full time

equivalent workers lost. These impacts

are summarized in Tables 19 and 20.

TABLE 19.—MEDICAL WASTE INCINERATION INDUSTRY-WIDE PRICE IMPACTS—EXISTING SOURCES PERCENT INCREASE a

[In percent]

Industry

Range for regulatory options 1–6

Scenario A

No switching

Scenario B

Switching with

waste segregation

Scenario C

Switching with

no waste segregation

Hospitals ....................................................................................................................................... 0.03–0.05 0.01 0.02–0.03

Nursing homes ............................................................................................................................. 0.03–0.04 0.01 0.02–0.03

Laboratories:

Research ............................................................................................................................... 0.08–0.13 0.04 0.07–0.08

Medical/dental ....................................................................................................................... 0 0 0

Funeral homes ............................................................................................................................. 0 0 0

Physicians’ offices ........................................................................................................................ 0 0 0

Dentists’ offices and clinics .......................................................................................................... 0 0 0

Outpatient care ............................................................................................................................. 0 0 0

Freestanding blood banks ............................................................................................................ 0 0 0

Fire and rescue operations .......................................................................................................... 0 0 0

Correctional facilities .................................................................................................................... 0 0 0
31762 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

TABLE 19.—MEDICAL WASTE INCINERATION INDUSTRY-WIDE PRICE IMPACTS—EXISTING SOURCES PERCENT INCREASE a—

Continued

[In percent]

Industry

Range for regulatory options 1–6

Scenario A

No switching

Scenario B

Switching with

waste segregation

Scenario C

Switching with

no waste segregation

Commercial incineration ............................................................................................................... 2.6 2.6 2.6

aThe price increase percentages reported represent the price increase necessary to recover annualized emission control costs for each industry.

TABLE 20.—MEDICAL WASTE INCINERATION INDUSTRY-WIDE OUTPUT, EMPLOYMENT AND REVENUE IMPACTS—EXISTING

SOURCES

Industry

Range for regulatory options 1–6

Scenario A

No switching

Scenario B

Switching with

waste segregation

Scenario C

Switching with

no waste segregation

Hospitals:

Output decrease (%) ............................................................................................................. 0–0.02 0 0–0.01

Employment decrease (FTE’s) ............................................................................................. 0–647 0–174 0–388

Revenue increase or (decrease) (%) .................................................................................... 0.02–0.05 0.01 0.02–0.03

Nursing homes:

Output decrease (%) ............................................................................................................. 0.01–0.03 0–0.01 0.01–0.02

Employment decrease (FTE’s) ............................................................................................. 139–484 63–130 126–290

Revenue increase or (decrease) (%) .................................................................................... 0.01–0.03 0–0.01 0.01–0.02

Laboratories:

Research:

Output decrease (%) ...................................................................................................... 0.08–0.18 0.04–0.05 0.07–0.11

Employment decrease (FTE’s) ...................................................................................... 124–281 56–76 112–169

Revenue increase or (decrease) (%) ............................................................................ (0.04)–0 (0.01)–0 (0.03)–0

Medical/dental:

Output decrease (%) ...................................................................................................... 0 0 0

Employment decrease (FTE’s) ...................................................................................... 2–3 2–3 2–3

Revenue increase or (decrease) (%) ............................................................................ 0 0 0

Funeral homes:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Physicians’ offices:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0–1 0–1 0–1

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Dentists’ offices and clinics:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 1 1 1

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Outpatient care:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0–1 0–1 0–1

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Freestanding blood banks:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Fire and rescue operations:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Correctional facilities:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Output decreases and full time equivalents (FTE’s) employment losses as a result of the regulation are shown in this table. Revenue increases

and decreases are presented with decreases noted in brackets.
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31763

As shown in Table 19, industries that

generate medical waste (i.e., hospitals,

nursing homes, etc.) are expected to

experience average price increases in

the range of 0.00 to 0.13 percent,

depending on the industry, regulatory

option, and scenario. Table 20 shows

that these industries are expected to

experience output and employment

impacts in the range of 0.00 to 0.18

percent. In addition, the revenue

impacts for these industries are

expected to range from an increase of

0.05 percent to a decrease of 0.04

percent. An increase in industry

revenue is expected in cases where the

price elasticity of demand for an

industry’s product is less than one. A

price elasticity of less than one indicates

that the percentage decrease in output

will be less than the percentage increase

in price. Since total revenue is a product

of price and output, a less than

proportional change in output compared

to price means that total revenue should

increase.

The following example illustrates

how the above price impacts could be

interpreted for the hospital industry.

Table 19 shows that for hospitals, 0.03

percent is estimated as the price

increase necessary to recover annual

control costs assuming Regulatory

Option 6, the most stringent regulatory

option, and Scenario C, switching with

no waste segregation. This change in

price can be expressed in terms of the

increased cost of hospitalization due to

the regulation. The 1993 estimate of

adjusted patient days nationwide totals

304,500,000 days. This estimate of

adjusted patient-days is based on a

combined estimate of in-patient and

out-patient days at hospitals.

Calculating the ratio of annual control

cost ($86,167,082) to the number of

adjusted patient days provides an

estimate of $0.28/day. Therefore, the

average price increase that an individual

would experience for each hospital

patient-day is expected to equal 28

cents.

Table 19 also shows that the average

price impact for the commercial medical

waste incinerator industry is

approximately a 2.6 percent increase in

price. Cost and economic impact

estimates are the same for the

commercial MWI industry regardless of

the regulatory option analyzed because

all six regulatory options specify

identical regulatory requirements for

large MWI. Average industrywide

output, employment, and revenue

impacts were not estimated for this

sector because data such as price

elasticity estimates and employment

levels were not available.

3. Facility-Specific Economic Impacts

Facility-specific impacts were also

estimated for the affected industries.

These estimates, presented in Tables 21

and 22, were calculated for the three

switching scenarios. A cost as a percent

of revenue ratio was calculated to

provide an indication of the magnitude

of the impact of the regulation on an

uncontrolled facility in each industry

sector. This calculation was then

compared to the industrywide price

impact to determine if the facility’s

impacts differ significantly from the

average industrywide impacts (i.e., if

there is greater than a 1 percent

difference).

TABLE 21.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING NO SWITCHING AND ONSITE

INCINERATION—EXISTING SOURCES ANNUALIZED CONTROL COST AS A PERCENT OF REVENUE/BUDGET

[In percent]

Industry

Scenario A—No switching

Option

1 2 3 4 5 6

Hospitals—Short-term, excluding psychiatric:

Federal Government:

Small:

Urban ......................................................................................................................... 0.09 0.37 0.37 0.41 0.41 0.46

Rural .......................................................................................................................... 0.09 0.09 0.37 0.41 0.41 0.46

Medium .......................................................................................................................... 0.20 0.20 0.20 0.20 0.22 0.22

Large ............................................................................................................................. 0.13 0.13 0.13 0.13 0.13 0.13

State Government:

Small:

Urban ......................................................................................................................... 0.20 0.80 0.80 0.87 0.87 0.99

Rural .......................................................................................................................... 0.20 0.20 0.80 0.87 0.87 0.99

Medium .......................................................................................................................... 0.21 0.21 0.21 0.21 0.23 0.23

Large ............................................................................................................................. 0.07 0.07 0.07 0.07 0.07 0.07

Local Government:

Small:

Urban ......................................................................................................................... 0.31 1.24 1.24 1.36 1.36 1.53

Rural .......................................................................................................................... 0.31 0.31 1.24 1.36 1.36 1.53

Medium .......................................................................................................................... 0.32 0.32 0.32 0.32 0.36 0.36

Large ............................................................................................................................. 0.10 0.10 0.10 0.10 0.10 0.10

Not-for-profit:

Small:

Urban ......................................................................................................................... 0.21 0.84 0.84 0.92 0.92 1.04

Rural .......................................................................................................................... 0.21 0.21 0.84 0.92 0.92 1.04

Medium .......................................................................................................................... 0.23 0.23 0.23 0.23 0.26 0.26

Large ............................................................................................................................. 0.11 0.11 0.11 0.11 0.11 0.11

For-profit:

Small:

Urban ......................................................................................................................... 0.23 0.95 0.95 1.04 1.04 1.18

Rural .......................................................................................................................... 0.23 0.23 0.95 1.04 1.04 1.18

Medium .......................................................................................................................... 0.25 0.25 0.25 0.25 0.25 0.28

Large ............................................................................................................................. 0.14 0.14 0.14 0.14 0.14 0.14
31764 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

TABLE 21.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING NO SWITCHING AND ONSITE

INCINERATION—EXISTING SOURCES ANNUALIZED CONTROL COST AS A PERCENT OF REVENUE/BUDGET—Continued

[In percent]

Industry

Scenario A—No switching

Option

1 2 3 4 5 6

Hospitals—Psychiatric, short-term and long-term:

Small:

Urban ......................................................................................................................... 0.32 1.30 1.30 1.43 1.43 1.62

Rural .......................................................................................................................... 0.32 0.31 1.30 1.43 1.43 1.62

Medium .......................................................................................................................... 0.57 0.57 0.57 0.57 0.64 0.64

Large ............................................................................................................................. 0.46 0.46 0.46 0.46 0.46 0.46

Nursing homes:

Tax-paying:

Urban ......................................................................................................................... 0.35 1.41 1.41 1.55 1.55 1.75

Rural .......................................................................................................................... 0.35 0.35 1.41 1.55 1.55 1.75

Tax-exempt:

Urban ......................................................................................................................... 0.36 1.45 1.45 1.59 1.59 1.79

Rural .......................................................................................................................... 0.36 0.36 1.45 1.59 1.59 1.79

Commercial research labs:

Tax-paying ..................................................................................................................... 0.40 0.40 0.40 0.40 0.46 0.46

Tax-exempt .................................................................................................................... 0.40 0.40 0.40 0.40 0.46 0.46

Commercial incineration facilities ..................................................................................... 8.02 8.02 8.02 8.02 8.02 8.02

TABLE 22.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING SWITCHING FROM ONSITE INCINERATION

TO COMMERCIAL DISPOSAL ALTERNATIVES—ALTERNATIVE WASTE DISPOSAL COST AS A PERCENT OF REVENUE/BUDGET

[In percent]

Industry

Scenario B

Switching with

waste segregation

Scenario C

Switching

without waste

segregation

Hospitals—Short-term, excluding psychiatric:

Federal Government:

Small:

Urban ................................................................................................................................................................ 0.03 0.10

Rural .................................................................................................................................................................. 0.03 0.17

Medium:

Urban ................................................................................................................................................................ 0.05 0.17

Rural .................................................................................................................................................................. 0.05 0.27

Large:

Urban ................................................................................................................................................................ 0.08 0.29

Rural .................................................................................................................................................................. 0.09 0.47

State Government:

Small:

Urban ................................................................................................................................................................ 0.06 0.22

Rural .................................................................................................................................................................. 0.06 0.36

Medium:

Urban ................................................................................................................................................................ 0.05 0.18

Rural .................................................................................................................................................................. 0.05 0.29

Large:

Urban ................................................................................................................................................................ 0.05 0.16

Rural .................................................................................................................................................................. 0.05 0.27

Local Government:

Small:

Urban ................................................................................................................................................................ 0.09 0.34

Rural .................................................................................................................................................................. 0.10 0.56

Medium:

Urban ................................................................................................................................................................ 0.07 0.27

Rural .................................................................................................................................................................. 0.08 0.44

Large:

Urban ................................................................................................................................................................ 0.06 0.22

Rural .................................................................................................................................................................. 0.06 0.36

Not-for-profit:

Small:

Urban ................................................................................................................................................................ 0.06 0.23

Rural .................................................................................................................................................................. 0.07 0.38

Medium:

Urban ................................................................................................................................................................ 0.05 0.20

Rural .................................................................................................................................................................. 0.06 0.32
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31765

TABLE 22.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING SWITCHING FROM ONSITE INCINERATION

TO COMMERCIAL DISPOSAL ALTERNATIVES—ALTERNATIVE WASTE DISPOSAL COST AS A PERCENT OF REVENUE/

BUDGET—Continued

[In percent]

Industry

Scenario B

Switching with

waste segregation

Scenario C

Switching

without waste

segregation

Large:

Urban ................................................................................................................................................................ 0.07 0.25

Rural .................................................................................................................................................................. 0.07 0.41

For-profit:

Small:

Urban ................................................................................................................................................................ 0.07 0.26

Rural .................................................................................................................................................................. 0.08 0.43

Medium:

Urban ................................................................................................................................................................ 0.06 0.21

Rural .................................................................................................................................................................. 0.06 0.34

Large:

Urban ................................................................................................................................................................ 0.09 0.32

Rural .................................................................................................................................................................. 0.09 0.52

Hospitals—Psychiatric, short-term and long-term:

Small:

Urban ................................................................................................................................................................ 0.10 0.36

Rural .................................................................................................................................................................. 0.11 0.59

Medium:

Urban ................................................................................................................................................................ 0.13 0.48

Rural .................................................................................................................................................................. 0.14 0.78

Large:

Urban ................................................................................................................................................................ 0.29 1.05

Rural .................................................................................................................................................................. 0.31 1.70

Nursing homes:

Tax-paying:

Urban ................................................................................................................................................................ 0.11 0.39

Rural .................................................................................................................................................................. 0.11 0.64

Tax-exempt:

Urban ................................................................................................................................................................ 0.11 0.40

Rural .................................................................................................................................................................. 0.12 0.65

Commercial research labs:

Tax-paying:

Urban ................................................................................................................................................................ 0.09 0.34

Rural .................................................................................................................................................................. 0.10 0.56

Tax-exempt:

Urban ................................................................................................................................................................ 0.09 0.34

Rural .................................................................................................................................................................. 0.10 0.56

Tables 21 and 22 show that facilities

with onsite MWI that are currently

uncontrolled may experience impacts

ranging from 0.03 to 1.79 percent,

depending on the industry, regulatory

option, and scenario. A comparison of

the economic impacts expected to occur

under the three switching scenarios,

presented in Tables 21 and 22, indicates

that the option of switching will be

attractive to some facilities currently

operating an onsite incinerator. For

many of the uncontrolled model

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

should preclude any facilities from

experiencing a significant economic

impact. These results support EPA’s

assertion that implementation of the

regulation will likely result in either

Scenarios B or C and that the costs and

economic impacts of Scenario A are

unlikely to occur.

Table 23 shows the impacts that

would be incurred by medical waste

generators that currently use an offsite

medical waste incineration service.

These impacts range from 0.00 to 0.02

percent and are considered negligible

impacts. These results indicate that the

incremental cost for the vast majority of

medical waste generators are expected

to be small.

TABLE 23.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS FOR

FIRMS THAT UTILIZE OFFSITE

WASTE INCINERATION—EXISTING

SOURCES INCREMENTAL ANNUAL

COST AS A PERCENT OF REVENUE/

BUDGET

[In percent]

Industry

Incremental

annual cost as

a percent of

revenue

Hospitals:

<50 Beds ....................... 0–0.01

50–99 Beds ................... 0–0.01

100–299 Beds ............... 0–0.01

300 + Beds .................... 0–0.01

Nursing homes:

0–19 Employees:

Tax-paying ..................... 0

Tax-exempt .................... 0
31766 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

TABLE 23.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS FOR

FIRMS THAT UTILIZE OFFSITE

WASTE INCINERATION—EXISTING

SOURCES INCREMENTAL ANNUAL

COST AS A PERCENT OF REVENUE/

BUDGET—Continued

[In percent]

Industry

Incremental

annual cost as

a percent of

revenue

20–99 Employees:

Tax-paying ..................... 0

Tax-exempt .................... 0

100 + Employees:

Tax-exempt .................... 0

Tax-paying ..................... 0

Commercial research labs:

Tax-paying:

0–19 Employees ............ 0

20–99 Employees .......... 0

100 + Employees .......... 0

Tax-exempt ....................... 0

Outpatient care clinics:

Physicians’ clinics (Amb.

Care)

Tax-paying ..................... 0

Tax-exempt .................... 0

Freestanding kidney dialysis facilities:

Tax-paying ..................... 0

Tax-exempt .................... 0–0.01

Physicians’ offices ................ 0

Dentists’ offices and clinics:

Offices ............................ 0

Clinics ............................ ........................

Tax-paying ................. 0

Tax-exempt ................ 0

Medical & dental labs:

Medical .......................... 0–0.01

Dental ............................ 0–0.01

Freestanding blood banks .... 0–0.02

Funeral homes ...................... 0

Fire & Rescue ....................... 0

Corrections:

Federal Government ...... 0

State Government ......... 0

Local Government ......... 0

Table 22 also presents price impact

estimates for the commercial medical

waste incinerator sector. The analysis

shows that uncontrolled medical waste

incinerators required to meet any of the

regulatory options would need to

increase their prices by approximately 8

percent in order to recoup their control

costs. Several factors indicate that it is

unlikely these particular facilities

would be able to increase the price of

their service by 8 percent.

An examination of the MWI inventory

indicates that a majority of facilities the

commercial MWI sector have already

implemented controls that would enable

them to meet the requirements of any of

the six regulatory options. Only a small

number of facilities in this sector would

be ‘‘uncontrolled’’ in the baseline and

would, therefore, incur the majority of

the costs estimated for this sector. This

distribution suggests that commercial

MWI that must install emission control

equipment will not be able to freely

increase their prices due to competition

from already controlled commercial

MWI. As indicated in the industrywide

impact calculations, the average

industrywide price increase is expected

to be approximately 3 percent.

Therefore, commercial MWI having to

incur regulatory costs will most likely

be forced to absorb some portion of their

cost increase instead of passing the

increase to their customers.

Another factor indicating the likely

possibility that these commercial MWI

would be required to absorb some

portion of their cost increases is based

on model plant capacity information.

Many MWI are operating below full

capacity, indicating that medical waste

incinerator operators with excess

capacity will act as a competitive force

to keep incineration prices from rising.

One advantage that commercial MWI

operators will experience due to the

regulation will be increasing demand for

commercial incineration service. Table

22 presents impact information under

the assumption that some facilities with

onsite incinerators will choose to switch

to a lower cost alternative for medical

waste disposal rather than install

emission control equipment to meet the

requirements of the regulation. Some

facilities will probably choose one of

these lower cost options, which in many

cases may be to switch to commercial

incineration. If implementation of the

regulation will have such an effect,

demand for commercial incineration

should increase and commercial MWI

operators should be able to offset some

of their absorbed cost increases due to

increased demands for their service.

Another consideration regarding the

current state of the commercial MWI

industry is that the small number of

uncontrolled commercial MWI may

currently be enjoying a cost advantage

compared to the majority of controlled

firms in the industry. Commercial MWI

facilities that currently operate with

emission control equipment presumably

operate at a higher cost per unit than

uncontrolled facilities. If the majority of

the facilities in this industry are

controlled and are able to charge prices

that enable them to recapture their costs

and earn reasonable profits, then

uncontrolled facilities that are probably

operating at a lower cost are likely to be

enjoying profits exceeding the levels

earned by the controlled facilities in the

industry.

Based on these explanations, EPA

estimates that the price of commercial

incineration is likely to increase by an

average of approximately 2.6 percent.

Some uncontrolled facilities in this

industry may need to absorb some of

their cost increases due to

implementation of this regulation.

However, due to factors such as

increased demand for commercial

incineration and possible cost

advantages currently enjoyed by these

facilities, the cost of the regulation

should be achievable.

This economic impact section

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

medical waste or dispose medical waste.

Secondary impacts such as subsequent

impacts on air pollution device vendors

and MWI vendors are not estimated due

to data limitations. Air pollution 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 MWI services. However,

due to economies of scale, this

regulation is expected to shift demand

from smaller incinerators to larger

incinerators. Therefore, small MWI

vendors may be adversely affected by

the regulation. Lack of data on the above

effects prevents quantification of the

economic impacts on these secondary

sectors.

IV. Regulatory Options and Impacts for

New MWI

As discussed earlier, the MACT

‘‘floor’’ defines the least stringent

emission standards the EPA may adopt

for new MWI. However, as also

discussed earlier, the Clean Air Act

requires EPA to examine alternative

emission standards (i.e., regulatory

options) more stringent than the MACT

floor. The EPA must consider the cost,

environmental, and energy impacts of

these regulatory options and select one

that reflects the maximum reduction in

emissions that EPA determines is

achievable (i.e., MACT).

At proposal, the EPA concluded all

new MWI would need good combustion

and dry scrubbers to meet the MACT

floors for CO, PM, and HCl.

Consequently, EPA was left to consider

only two regulatory options for MACT.

The first regulatory option reflected the

floor (i.e., emission limitations

achievable with good combustion and

dry scrubbers). The second reflected

emission limitations achievable with

good combustion and dry scrubbers

with activated carbon injection. Based

on the cost, environmental, and energy

impacts of the second regulatory option
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31767

relative to the first option, EPA selected

the second option as MACT.

Consequently, EPA proposed emission

standards for new MWI based on the use

of good combustion and dry scrubbers

with activated carbon injection.

As discussed earlier in this notice,

EPA received numerous comments

containing substantial new information

following the proposal. Based on this

new information, new conclusions

concerning the MWI inventory, MWI

subcategories, performance of emission

control technologies, MACT floors, and

monitoring and testing options have

been reached. As a result, EPA now

believes there are several new regulatory

options that merit consideration in

selecting MACT for new MWI. The

following sections summarize these new

regulatory options and the EPA’s initial

assessment of their merits.

A. Regulatory Options

As discussed earlier, new MACT floor

emission levels were developed for

small, medium, and large MWI. To

assess the impacts of regulatory options,

EPA must first consider what emission

control technology(s) new MWI may

need to meet regulations based on these

floor emission limits. The floor for small

new MWI appears to require good

combustion and moderate efficiency wet

scrubbers. For medium new MWI, the

MACT floor appears to require good

combustion and a combined wet/dry

scrubbing system without activated

carbon injection. The MACT floor for

large new MWI appears to require good

combustion and a combined wet/dry

scrubbing system with activated carbon

injection.

Having identified these control

technologies, the EPA is now able to

review the performance capabilities of

other control technologies and to

identify those technologies capable of

achieving even greater emission

reductions. This review enables EPA to

identify regulatory options more

stringent than the floor that could be

selected as MACT.

For small new MWI, as mentioned

above, good combustion and a moderate

efficiency wet scrubber system are the

emission control technologies most

MWI would probably need to meet the

MACT floor emission levels. Therefore,

these technologies serve as the basis for

the first regulatory option for the MACT

emission standards for small new MWI.

A review of the performance capabilities

of various emission control technologies

summarized earlier readily identifies a

second option for small new MWI. This

option is to base the MACT emission

standards for small new MWI on the use

of good combustion and high efficiency

wet scrubbing systems. This would

achieve further reductions in PM

emissions, but it would not further

reduce other pollutants. As summarized

earlier, high efficiency wet scrubbing

systems do not appear to achieve greater

reductions in emissions of dioxins, acid

gases (e.g., HCl), or metals (i.e., Hg, Pb,

or Cd) than do moderate efficiency wet

scrubbing systems.

Reviewing the performance

capabilities of emission control

technologies also identifies a third

option for small new MWI. This

regulatory option is to base the MACT

emission standards for small new MWI

on the use of good combustion and a

combined dry/wet scrubbing system

with activated carbon injection. This

alternative would further reduce

emissions of Pb, Cd, and dioxins, but

would not further reduce emissions of

other air pollutants. The combined

system, however, generally costs about

two and a half times what highefficiency wet scrubbing systems cost to

operate annually, and the overall

difference in the emissions control

performance between the two systems is

relatively small. As a result, at this

point, to limit and manage the total

number of regulatory options under

consideration, the EPA has chosen not

to include this third regulatory option

for small new MWI.

For medium new MWI, as discussed

earlier, the use of good combustion and

a combined wet/dry scrubbing system

without activated carbon injection

appears to be necessary to meet the

MACT floor emission limits. Therefore,

this option is the first regulatory option

for medium new MWI. The second

regulatory option is to base the emission

standards for medium new MWI on

good combustion and a combined wet/

dry scrubbing system with activated

carbon injection.

Finally, for large new MWI, as

discussed earlier, the use of good

combustion and a combined wet/dry

scrubbing system with activated carbon

injection appears necessary to meet the

MACT floor emission limits. Because no

other air pollution control technologies

have been identified that can achieve

more stringent emission limits, the EPA

is not inclined at this point to consider

other regulatory options for large new

MWI.

The regulatory options outlined above

are combined in Table 24. This table

summarizes the technology basis for the

regulatory options for the various MACT

standards the EPA believes merit

consideration as MACT for new MWI.

This table is constructed only to

organize and structure an analysis of the

cost, environmental, and energy impacts

associated with the various MACT

standards in order to consider these

impacts in selecting MACT for new

MWI. As mentioned earlier, the MACT

standards for new MWI will not include

requirements to use a specific emission

control system or technology; the MACT

standards will only include emission

limits, which may be met by any means

or by using any control system or

technology the owner or operator of the

MWI decides to use to meet these

emission limits.

TABLE 24.—LEVEL OF AIR POLLUTION CONTROL ASSOCIATED WITH EACH REGULATORY OPTION FOR NEW MWI

MWI size

Regulatory options

1 2 3

Small ≤200 lb/hr ......... Good combustion and moderate efficiency wet scrubber.Good combustion and moderate efficiency wet scrubber.Good combustion and high efficiency

wet scrubber.

Medium 201–500 lb/hr Good combustion, dry injection/fabric

filter system, and high efficiency

wet scrubber.

Good combustion, dry injection/fabric

filter system with carbon, and high

efficiency wet scrubber.

Good combustion, dry injection/fabric

filter system with carbon, and high

efficiency wet scrubber.

Large >500 lb/hr ......... Good combustion, dry injection/fabric

filter system with carbon, and high

efficiency wet scrubber.

Good combustion, dry injection/fabric

filter system with carbon, and high

efficiency wet scrubber.

Good combustion, dry injection/fabric

filter system with carbon, and high

efficency wet scrubber.

The emission limits associated with

each of the regulatory options for small,

medium, and large new MWI are

presented in Table 25.
31768 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

TABLE 25.—EMISSION LIMITATIONS ASSOCIATED WITH EACH REGULATORY OPTION FOR SMALL, MEDIUM, AND LARGE

NEW MWI

1 and 2 3 1 2 and 3 1–3

PM, gr/dscf ........................................................................................ 0.03 ............. 0.015 ........... 0.015 ........... 0.015 ........... 0.015

CO, ppmdv ........................................................................................ 40 ................ 40 ................ 40 ................ 40 ................ 40

CDD/CDF, ng/dscm .......................................................................... 125 .............. 125 .............. 125 .............. 25 ................ 25

TEQ CDD/CDF, ng/dscm .................................................................. 2.3 ............... 2.3 ............... 2.3 ............... 0.6 ............... 0.6

HCl, ppmdv ....................................................................................... 15 or 99% ... 15 or 99% ... 15 or 99% ... 15 or 99% ... 15 or 99%

SO2, ppmdv ...................................................................................... 55 ................ 55 ................ 55 ................ 55 ................ 55

NOx, ppmdv ...................................................................................... 250 .............. 250 .............. 250 .............. 250 .............. 250

Pb, mg/dscm ..................................................................................... 1.2 or 70% 1.2 or 70% 0.07 or 98% 0.07 or 98% 0.07 or 98%

Cd, mg/dscm ..................................................................................... 0.16 or 65% 0.16 or 65% 0.04 or 90% 0.04 or 90% 0.04 or 90%

Hg, mg/dscm ..................................................................................... 0.55 or 85% 0.55 or 85% 0.55 or 85% 0.55 or 85% 0.55 or 85%

Regulatory Option 1 in Table 25

reflects the performance of the emission

control system or technology needed to

meet the MACT floor. For small new

MWI, Regulatory Option 1 reflects

emission limits based on good

combustion and moderate efficiency wet

scrubbers. For medium new MWI,

Regulatory Option 1 reflects emission

limits based on good combustion and a

combined wet/dry scrubbing system

without carbon. For large new MWI,

Regulatory Option 1 reflects emission

limits based on good combustion and a

combined wet/dry scrubbing system

with activated carbon injection.

Regulatory Option 1 does not reflect

the most stringent emission limits

achievable for all subcategories.

Consequently, the Clean Air Act

requires EPA to examine the costs and

other impacts of regulatory options

more stringent than Regulatory

Option 1. Each regulatory option

examined reflects slightly more

stringent emission standards.

Regulatory Option 2 is the same as

Regulatory Option 1 for small and large

MWI. Medium MWI would be required

to meet emission limits associated with

good combustion and a combined wet/

dry scrubbing system with activated

carbon injection. Regulatory Option 3

would establish emission limits for

small MWI based on good combustion

and high efficiency wet scrubbers.

Requirements for medium and large

MWI would remain the same under

Regulatory Option 3 as under

Regulatory Option 2.

B. National Environmental and Cost

Impacts

This section presents a summary of

the air, water, solid waste, energy, and

cost impacts of the three regulatory

options for new MWI. Economic

impacts are discussed in Section IV.C.

All impacts are nationwide resulting

from the implementation of the new

source performance standards for new

MWI.

1. Analytical Approach

As discussed at proposal and within

this notice, healthcare facilities may

choose from among a number of

alternatives for treatment and disposal

of their medical wastes; however, these

alternatives are generally more limited

for healthcare facilities located in rural

areas than for those located in urban

areas. In fact, as stated at proposal, most

estimates are that less than half of

hospitals today currently operate onsite

medical waste incinerators. The clear

trend over the past several years has

been for more and more hospitals to

turn to the use of alternative onsite

medical waste treatment technologies or

commercial offsite treatment and

disposal services. Consequently, even

fewer hospitals are now likely to operate

onsite medical waste incinerators.

More than half of existing hospitals

today, therefore, have chosen to use

other means of treatment and disposal

of their medical waste than operation of

an onsite incinerator. This is a clear

indication that alternatives to the use of

onsite incinerators exist and that they

are readily available in many cases

(although as mentioned above, these

alternatives—particularly the

availability and competitive cost of

offsite commercial treatment and

disposal services—tend to be more

limited in rural areas than in urban

areas). For other healthcare facilities,

such as nursing homes, outpatient

clinics, doctors and dentists offices, etc.,

only very few facilities currently operate

onsite medical waste incinerators.

Therefore, for these types of healthcare

facilities, the percentage of such

facilities using alternative means of

treatment and disposal of medical

waste—particularly commercial

treatment and disposal services—is

much higher, probably higher than 95

percent. This high percentage is further

confirmation of the availability of

alternatives to onsite incinerators for the

treatment and disposal of medical

waste.

A very likely reaction and outcome

associated with the adoption of MACT

standards for new MWI, therefore, is an

increase in the use of these alternatives

by healthcare facilities for treatment and

disposal of medical waste. The EPA’s

objective is not to encourage the use of

alternatives or to discourage the use of

onsite medical waste incinerators; EPA’s

objective is to adopt MACT emission

standards for new MWI that fulfill the

requirements of Section 129 of the Clean

Air Act. In doing so, however, one

outcome associated with adoption of

these MACT standards is likely to be an

increase in the use of alternatives and a

decrease in the use of onsite medical

waste incinerators. Consequently, EPA

should acknowledge and incorporate

this outcome into the analyses of the

cost, environmental, and energy impacts

associated with the MACT emission

standards.

In these analyses of the cost,

environmental, and energy impacts, the

selection of an alternative form of

medical waste treatment and disposal

by a healthcare facility, rather than the

purchase of an onsite medical waste

incinerator and the emission control

technology necessary to meet the MACT

emission limits, is referred to as

‘‘switching’’. Switching was

incorporated in the analyses at proposal

and was the basis for the conclusion at

proposal that adoption of the proposed

MACT emission standards could lead to

as many as 80 percent of healthcare

facilities to choose an alternative means

of medical waste treatment and disposal

over the purchase of an MWI. Although

switching was not EPA’s objective, it

was a potential outcome of the

regulations that EPA believed should be
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31769

acknowledged, considered, and

discussed at proposal.

Switching has also been incorporated

into the new analyses of the cost,

environmental, and energy impacts

associated with the three new regulatory

options. The new analyses, however,

incorporate three scenarios: one

scenario that ignores switching and two

scenarios that consider switching.

Scenario A assumes that each new MWI

will be installed and will comply with

the appropriate regulatory option (i.e.,

no switching). This scenario results in

the highest costs because it assumes no

potential new MWI owner will switch to

a less expensive waste disposal method.

This scenario is clearly unrealistic and

grossly overstates the national costs

associated with MACT emission

standards. It should not be viewed as

representative or even close to

representative of the impacts associated

with the MACT emission standards.

This scenario is so misleading that EPA

considered not including it in the

analysis; some may take it out of context

and use it as representative, when it is

in no way representative of the impacts

of the MACT emission standards. The

EPA finally decided to include this

scenario in the analysis only because

some may ask ‘‘what if * * *?’’ and the

EPA wanted to be in a position to

answer such questions.

Switching Scenarios B and C are

much more realistic and more

representative of the cost,

environmental, and energy impacts

associated with the MACT emission

standards for new MWI. Only these

scenarios merit serious review and

consideration in gauging the potential

impacts associated with the MACT

emission standards. Both Scenarios B

and C assume switching occurs when

the cost associated with purchasing and

installing the air pollution control

technology or system necessary to

comply with the MACT emission

standard (i.e., a regulatory option) is

greater than the cost of choosing an

alternative means of treatment and

disposal.

The difference in Scenarios B and C

is the assumption of how much

separation of the medical waste stream

into an infectious medical waste stream

and a noninfectious medical waste

stream currently occurs at healthcare

facilities that today operate a medical

waste incinerator. Some have stated

that, for the most part, hospitals that are

currently operating onsite medical

waste incinerators practice little

separation of medical waste into

infectious and noninfectious waste;

generally all the medical waste at the

facility is incinerated.

Based on estimates in the literature

that only 10 to 15 percent of medical

waste is potentially infectious and the

remaining 85 to 90 percent is

noninfectious, Scenario B assumes that

only 15 percent of the waste currently

being burned at a healthcare facility

operating an onsite medical waste

incinerator is potentially infectious

medical waste. The 85 percent

noninfectious waste is municipal waste

that needs no special handling,

treatment, transportation, or disposal. It

can be sent to a municipal landfill or

municipal combustor for disposal. Thus,

under Scenario B, when choosing an

alternative to an onsite medical waste

incinerator, in response to adoption of

MACT emission standards, a healthcare

facility need only chose an alternative

form of medical waste treatment and

disposal for 15 percent of the waste

stream currently burned onsite and may

send the remaining 85 percent to a

municipal landfill. In other words, if a

hospital plans to burn 100 pounds of

waste, Scenario B assumes 85 pounds

are noninfectious and 15 pounds are

potentially infectious. This scenario

results in the lowest costs because 85

percent of the waste is disposed at the

relatively inexpensive cost of municipal

waste disposal.

On the other hand, it is unlikely that

all healthcare facilities that consider

purchasing an MWI will be able to or

will decide to segregate the waste

stream to be burned in the incinerator.

If a hospital already separates medical

waste into infectious and noninfectious

waste streams, for example, this hospital

would be unable to separate the waste

stream any further. In other words, if a

hospital plans to burn 100 pounds of

waste, Scenario C assumes all 100

pounds are potentially infectious.

Scenario C, therefore, assumes that all

medical waste to be burned at a

healthcare facility that purchases a

medical waste incinerator is potentially

infectious medical waste and must be

treated and disposed of accordingly. As

a result, Scenario C leads to higher costs

than Scenario B.

For the purposes of determining

impacts of the emission standards under

switching Scenarios B and C, new

commercial (offsite) incinerators and

onsite incinerators used to burn

healthcare waste were treated

separately. The commercial incinerators

were not subjected to the switching

analyses under Scenarios B and C

because switching to an alternative

method of waste disposal (e.g.,

commercial disposal) is not feasible for

commercial facilities. An assumption

was made that commercial facilities

would add on the control associated

with the emission standards. Only the

new onsite MWI were subject to the

switching analyses under Scenarios B

and C. On the other hand, a commercial

waste disposal company does have the

option of purchasing an alternative

technology (e.g., autoclave or

microwave) rather than installing a new

MWI. Consequently, while switching

was not included in this analysis for

commercial MWI, it is an option that

could result in lower costs.

Scenarios B and C represent the likely

range of impacts associated with the

MACT emission standards for new

MWI. The actual impacts of a MACT

emission standard (i.e., a regulatory

option) is most likely to fall somewhere

within the range represented by

Scenarios B and C.

2. Air Impacts

As outlined above, the impacts

associated with three MACT emission

standards or regulatory options, under

three scenarios reflecting switching,

have been assessed. Baseline emissions

(i.e., emissions in the absence of

adoption of the MACT emission

standards) and emissions under each

MACT emission standard or regulatory

option are summarized in Tables 26, 27,

and 28. Emissions under Scenario A (no

switching) are summarized in Table 26;

emissions under Scenario B (switching

with waste separation) are summarized

in Table 27; and emissions under

Scenario C (switching without waste

separation) are summarized in Table 28.

TABLE 26.—BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE FIFTH YEAR AFTER IMPLEMENTATION OF THE NSPS

[Scenario A]

[Metric Units]

Pollutant, units Baseline

Regulatory Options

1 2 3

PM, Mg/yr ............................................................................................................... 28 2.7 2.7 2.3
31770 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

TABLE 26.—BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE FIFTH YEAR AFTER IMPLEMENTATION OF THE

NSPS—Continued

[Scenario A]

[Metric Units]

Pollutant, units Baseline

Regulatory Options

1 2 3

CO, Mg/yr ............................................................................................................... 14 14 14 14

CDD/CDF, g/yr ....................................................................................................... 47 12 7.2 7.2

TEQ CDD/CDF, g/yr ............................................................................................... 1.1 0.28 0.17 0.17

HC1, Mg/yr ............................................................................................................. 64 3.1 3.1 3.1

SO2, Mg/yr .............................................................................................................. 28 28 28 28

NOx, Mg/yr .............................................................................................................. 130 130 130 130

Pb, Mg/yr ................................................................................................................ 0.39 0.02 0.02 0.02

Cd, Mg/yr ................................................................................................................ 0.001 3.5 x 10¥3 3.5 x 10¥3 3.5 x 10¥3

Hg, Mg/yr ................................................................................................................ 0.21 0.12 0.12 0.12

To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6.

TABLE 27.—BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE FIFTH YEAR AFTER IMPLEMENTATION OF THE

EMISSION GUIDELINES

[Scenario B]

[Metric Units]

Pollutant, units Baseline

Regulatory options

1 2 3

PM, Mg/yr ............................................................................................................................. 28 2.1 2.1 2.1

CO, Mg/yr ............................................................................................................................. 14 6.5 6.5 6.5

CDD/CDF, g/yr ..................................................................................................................... 47 5.9 5.9 5.9

TEQ CDD/CDF, g/yr ............................................................................................................. 1.1 0.14 0.14 0.14

HC1, Mg/yr ........................................................................................................................... 64 1.5 1.5 1.5

SO2, Mg/yr ............................................................................................................................ 28 14 14 14

NOx, Mg/yr ............................................................................................................................ 130 65 65 65

Pb, Mg/yr .............................................................................................................................. 0.39 0.031 0.031 0.031

Cd, Mg/yr .............................................................................................................................. 0.051 4.6×10¥3 4.6×10¥3 4.6×10¥3

Hg, Mg/yr .............................................................................................................................. 0.21 0.056 0.056 0.056

To convert Mg/yr to ton/yr, multiply by 1.1 To convert g/yr to lb/yr, divide by 453.6.

TABLE 28.—BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE FIFTH YEAR AFTER IMPLEMENTATION OF THE

NSPS

[Scenario C]

[Metric Units]

Pollutant, units Baseline

Regulatory options

1 2 3

PM, Mg/yr ............................................................................................................................. 28 4.1 4.1 4.1

CO, Mg/yr ............................................................................................................................. 14 14 14 14

CDD/CDF, g/yr ..................................................................................................................... 47 12 12 12

TEQ CDD/CDF, g/yr ............................................................................................................. 1.1 0.28 0.28 0.28

HC1, Mg/yr ........................................................................................................................... 64 3.1 3.1 3.1

SO2, Mg/yr ............................................................................................................................ 28 28 28 28

NOx, Mg/yr ............................................................................................................................ 130 130 130 130

Pb, Mg/yr .............................................................................................................................. 0.39 0.06 0.06 0.06

Cd, Mg/yr .............................................................................................................................. 0.051 8.9×10¥3 8.9×10¥3 8.9×10¥3

Hg, Mg/yr .............................................................................................................................. 0.21 0.12 0.12 0.12

To convert Mg/yr to ton/yr, multiply by 1.1 To convert g/yr to lb/yr, divide by 453.6.

As discussed in previous sections,

new information has led to new

conclusions about the MWI inventory,

performance of technology, and control

levels associated with each new MWI.

As a result, revised estimates of annual

baseline emissions and emissions under

each regulatory option are significantly

lower than estimates developed at

proposal. There are two primary reasons

for the lower emission estimates. First,

a greater level of emission control is

expected at new MWI than was assumed

at proposal. Second, more MWI were

projected to be built at proposal than

current estimates.

3. Water and Solid Waste Impacts

Estimates of wastewater impacts were

developed for only Regulatory Option 3,

Scenario A, which reflects all new MWI

equipped with wet scrubbers in the
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31771

absence of switching. Assessing these

impacts under Scenario A without any

consideration of the effect of switching

grossly overstates the magnitude of

these impacts. Under Scenarios B and C

more than half of the new MWI are

expected not to be built, resulting in

significantly lower impacts. This

approach of estimating and

summarizing impacts under Scenario A,

at this point, was taken as a matter of

expediency to share new information

and provide an opportunity for public

comment.

Under Regulatory Option 3, Scenario

A, 3.3 million gallons of additional

wastewater would be generated in the

fifth year by MWI as a result of the

NSPS. This amount is the equivalent of

wastewater produced annually by one

small hospital. Therefore, when

considering the wastewater produced

annually at healthcare facilities

nationwide, the increase in wastewater

resulting from the implementation of

the MACT emission standards for new

MWI is insignificant.

With regard to solid waste impacts,

about 88,800 Mg (97,900 tons) of

medical waste would be burned in the

fifth year in new MWI in the absence of

Federal regulations, producing about

8,880 Mg/yr (9,790 tons/yr) of solid

waste (bottom ash) disposed of in

landfills. To determine the solid waste

impacts for the NSPS, impacts were

developed for Regulatory Option 3,

Scenario B. This option is associated

with the most switching and the most

separation of waste for disposal in

municipal landfills and thus, produces

the greatest estimated impact.

Under Regulatory Option 3, Scenario

B, 43,600 Mg/yr (48,000 tons/yr) of

additional solid waste would result

from the adoption of the NSPS.

However, 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 MWI standards is insignificant.

4. Energy Impacts

The emission control technologies

used by new MWI to comply with the

MACT emission limits consume energy.

Estimates of energy impact were

developed for Regulatory Option 3,

Scenario A. Under Scenarios B and C,

which include switching, it is not clear

whether overall national energy

consumption would increase, decrease,

or remain the same. Alternatives to

incineration require energy to operate;

however, information is not available to

estimate whether these alternatives use

more or less energy than MWI.

The energy impacts associated with

the MACT emission standards could

include additional auxiliary fuel

(natural gas) for combustion controls

and additional electrical energy for

operation of the add-on control devices,

such as wet scrubbers and dry

scrubbers. It was assumed that all new

MWI would be installed with

combustion controls in the absence of

the NSPS in order to meet State

regulations for new MWI. Therefore,

there is no increase in the total national

usage of natural gas for combustion

controls under Regulatory Option 3,

Scenario A. Total national usage of

electrical energy for the operation of

add-on control devices would increase

by about 9,800 megawatt hours per year

(MW-hr/yr) (33.4 billion British thermal

units per year (109 Btu/yr)). Once again,

compared to the amount of energy used

by health care facilities such as

hospitals (approximately 2,460 MMm3/

yr of natural gas and 23.2 million MWhr/yr of electricity) the increase in

energy usage that results from

implementation of the MWI emission

standards is insignificant.

5. Cost Impacts

The cost impacts on individual

healthcare facilities that consider

purchasing an MWI vary depending on

the MACT emission standard or

regulatory option; the actual cost to

purchase and install any additional air

pollution control equipment; the cost of

alternative means of treatment and

disposal where they are located; and

other factors, such as liability issues

related to disposal and State and local

medical waste treatment and disposal

requirements. In general, facilities

considering purchasing smaller MWI

will have a greater incentive to use

alternative means of treatment and

disposal because their onsite

incineration cost (per pound of waste

burned) will be higher.

Large healthcare facilities with larger

amounts of waste to be treated or

healthcare facilities that serve as

regional treatment centers for waste

generated at other healthcare facilities

in the area may have some cost

advantages compared to smaller

facilities. Due to economies of scale,

their cost of burning waste may be lower

(i.e., dollars per pound burned), even

after purchasing and installing a

complete air pollution control system to

comply with the emission standards.

Table 29 contains the estimated

increase in national annual costs

associated with each of the MACT

emission standards or regulatory

options under Scenario A (no

switching), Scenario B (switching with

separation of waste), and Scenario C

(switching with no separation of waste).

As discussed earlier, Scenario A is

unrealistic and grossly overstates the

national cost impacts. The costs

associated with the MACT emission

standards under Scenarios B and C

represent the likely range of national

cost impacts and only these costs merit

serious consideration and review.

TABLE 29.—COSTS OF THE

REGULATORY OPTIONS OF THE NSPS

[Scenarios A, B, and C]

[Million $/year]

Scenario

Regulatory options

1 2 3

A ........................ 32.3 32.8 33.7

B ........................ 10.8 10.8 10.8

C ........................ 24.0 24.0 24.0

The nationwide annual costs

presented in Table 29, excluding

Scenario A, range from $10.8 million/yr

for the regulatory options under

Scenario B to $24.0 million/yr for the

regulatory options under Scenario C.

These nationwide annual costs are

significantly lower than the $74.5

million/yr estimated for the proposed

emission standards. The difference in

the proposed and the current

nationwide annual cost estimates can be

attributed to the difference in the

number of new MWI that were

predicted to be installed at proposal and

the current estimate of the number of

new MWI. For example, at proposal it

was estimated that approximately 700

new MWI would be installed by the fifth

year after adoption of the emission

standards. It is now estimated that

approximately 235 new MWI will be

installed by the fifth year after adoption

of the standards.

C. Economic Impacts

Section IV.B.1 described assumptions

pertaining to three analysis scenarios:

no switching, switching with waste

segregation, and switching with no

waste segregation. Section IV.B.5

presented annual cost estimates that

have been developed for each of the six

regulatory options. This section

incorporates these assumptions and cost

data to estimate potential economic

impacts that might result from

implementation of these regulatory

options.

The goal of the economic impact

analysis is to estimate the market

response of affected industries to the

emission guidelines and to identify any

adverse impacts that may occur as a

result of the regulation. Industries that
31772 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

operate onsite waste incinerators

(hospitals, nursing homes, research labs,

and commercial waste incinerators) and

those that utilize offsite medical waste

incinerators (hospitals, nursing homes,

medical/dental laboratories, funeral

homes, physicians’ offices, dentist

offices, outpatient care, freestanding

blood banks, fire and rescue operations,

and correctional facilities) will

potentially be affected by the regulation.

Industrywide impacts, including

changes in market price, output or

production, revenues, and employment

for the affected industries, are estimated

for each regulatory option assuming the

three switching scenarios. Facilityspecific impacts are estimated for

hospitals of varying sizes, ownerships,

and operating characteristics; nursing

homes; commercial research labs; and

commercial waste incineration based on

engineering model plant cost estimates

under each of the three switching

scenarios.

1. Analytical Approach

The analytical approach to estimate

industrywide and facility specific

economic impacts and evaluate the

economic feasibility of switching are

briefly described. For a more detailed

description refer to docket item IV–A–

9. Prices are stated at 1993 levels.

Economic impacts for new MWI are

calculated under several assumptions.

First, the costs that are used to estimate

the economic impacts of the NSPS

include control costs from both the EG

and NSPS. This approach is used to

account for market adjustments (e.g.,

price, etc.) that would have had to occur

under implementation of the EG first.

This approach allows for the

establishment of a future baseline

scenario. Second, due to lack of

information, revenue data for each of

the affected industries were not adjusted

for growth during the 5 year time

period.

The average price changes anticipated

to occur in each industry sector for each

of the regulatory options are estimated

by comparing the annual control cost

estimates to annual revenues for each

affected industry. This calculation

provides an indication of the magnitude

of a price change that would occur for

each industry sector to fully recover its

annual control costs. The resulting costto-revenue ratio represents the price

increase necessary on average for firms

in the industry to recover the increased

cost of environmental controls. Percent

changes in output or production are

estimated using the price impact

estimate and a high and low estimate of

the price elasticity of demand. Resulting

changes in revenues are estimated based

upon the estimated changes in price and

output for an industry. Employment or

labor market impacts result from

decreases in the output for an industry

and are assumed to be proportional to

the estimated decrease in output for

each industry.

Facility-specific economic impacts are

estimated by using model plant

information under the three switching

scenarios. The assumption of no

switching (Scenario A) represents the

highest cost and economic impact

scenario for most affected industries,

while the assumption of switching with

waste segregation (Scenario B)

represents the lowest cost and economic

impact scenario for most of the affected

industries. As previously stated, EPA

considers Scenario A to be an unlikely

scenario; therefore, the economic

impacts presented under Scenarios B

and C should be regarded as the impacts

most likely to occur.

2. Industry-Wide Economic Impacts

Industry-wide impacts include

estimates of the change in market price

for the services provided by the affected

industries, the change in market output

or production, the change in industry

revenue, and the impact on affected

labor markets in terms of full time

equivalent workers lost. These impacts

are summarized in Tables 30 and 31.

TABLE 30.—MEDICAL WASTE INCINERATION INDUSTRY-WIDE PRICE IMPACTS—NEW SOURCES PERCENT INCREASE

[Percent]a

Industry

Range for regulatory options 1–6

Scenario A

No switching

Scenario B

Switching with

waste segregation

Scenario C

Switching with

no waste segregation

Hospitals ......................................................................................................................................... 0.05 0.01 0.03

Nursing homes ............................................................................................................................... 0.05 0.01 0.03

Laboratories:

Research ................................................................................................................................. 0.15–0.16 0.04 0.09

Medical/dental ......................................................................................................................... ...................... 0 0

Funeral homes ............................................................................................................................... 0 0 0

Physicians’ offices .......................................................................................................................... 0 0 0

Dentists’ offices and clinics ............................................................................................................ 0 0 0

Outpatient care ............................................................................................................................... 0 0 0

Freestanding blood banks .............................................................................................................. 0.01 0.01 0.01

Fire and rescue operations ............................................................................................................ 0 0 0

Correctional facilities ...................................................................................................................... 0 0 0

Commercial incineration ................................................................................................................. 3.8 3.8 3.8

aThe price increase percentages reported represent the price increase necessary to recover annualized emission control costs for each industry.
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31773

TABLE 31.—MEDICAL WASTE INCINERATION INDUSTRY-WIDE OUTPUT, EMPLOYMENT AND REVENUE IMPACTS—NEW

SOURCES

Industry

Range for regulatory options 1–6

Scenario A

No switching

Scenario B

Switching with

waste segregation

Scenario C

Switching with

no waste segregation

Hospitals:

Output decrease (%) ............................................................................................................. 0–0.02 0–0.01 0–0.01

Employment decrease (FTE’s) ............................................................................................. 0–767 0–200 0–457

Revenue increase or (decrease) (%) .................................................................................... 0.02–0.05 0.01 0.02–0.03

Nursing homes:

Output decrease (%) ............................................................................................................. 0.02–0.04 0.01 0.01–0.02

Employment decrease (FTE’s) ............................................................................................. 260–574 74–150 168–342

Revenue increase or (decrease) (%) .................................................................................... 0.03–0.04 0–0.01 0.01–0.02

Laboratories:

Research:

Output decrease (%) ............................................................................................................. 0.15–0.21 0.04–0.06 0.09–0.13

Employment decrease (FTE’s) ............................................................................................. 231–333 65–87 149–199

Revenue increase or (decrease) (%) .................................................................................... (0.05)–0 (0.01)–0 (0.03)–0

Medical/dental:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 3–5 3–5 3–5

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Funeral homes:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Physicians’ offices:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0–2 0–2 0–2

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Dentists’ offices and clinics:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 1–2 1–2 1–2

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Outpatient care:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0–1 0–1 0–1

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Freestanding blood banks:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0–0.01 0–0.01 0–0.01

Fire and rescue operations:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Correctional facilities:

Output decrease (%) ............................................................................................................. 0 0 0

Employment decrease (FTE’s) ............................................................................................. 0 0 0

Revenue increase or (decrease) (%) .................................................................................... 0 0 0

Output decreases and full time equivalents (FTE’s) employment losses as a result of the regulation are shown in this table. Revenue increases

and decreases are presented with decreases noted in brackets.

As shown in Table 30, industries that

generate medical 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, regulatory

option, and scenario. Table 31 shows

that 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. An increase in industry

revenue is expected in cases where the

price elasticity of demand for an

industry’s product is less than one. A

price elasticity of less than one indicates

that the percentage decrease in output

will be less than the percentage increase

in price. Since total revenue is a product

of price and output, a less than

proportional change in output compared

to price means that total revenue should

increase.

The following example illustrates

how the above price impacts could be

interpreted for the hospital industry.

Table 30 shows that for hospitals, 0.03

percent is estimated as the price

increase necessary to recover annual

control costs assuming Regulatory

Option 3, the most stringent regulatory

option, and Scenario C, switching with

no waste segregation. This change in

price can be expressed in terms of the

increased cost of hospitalization due to

the regulation. The 1993 estimate of

adjusted patient days nationwide totals

304,500,000 days. This estimate of

adjusted patient-days is based on a
31774 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

combined estimate of in-patient and

out-patient days at hospitals. The total

annual control cost for the EG and NSPS

for hospitals required to comply with

regulatory option 3 is estimated as

$101,652,807. Assuming that the ratio of

adjusted patient-days to revenue does

not significantly change over time, the

expected average price increase for each

hospital patient-day is expected to equal

33 cents.

Table 30 also shows that the average

price impact for the commercial medical

waste incinerator industry is

approximately a 3.8 percent increase in

price. Cost and economic impact

estimates are the same for the

commercial MWI industry regardless of

the regulatory option analyzed because

all three regulatory options specify

identical regulatory requirements for

large MWI. Average industrywide

output, employment, and revenue

impacts were not estimated for this

sector because data such as price

elasticity estimates and employment

levels were not available.

3. Facility-Specific Economic Impacts

Facility-specific impacts were also

estimated for the affected industries.

These estimates, presented in Tables 32

and 33, were calculated for the three

switching scenarios. A cost as a percent

of revenue ratio was calculated to

provide an indication of the magnitude

of the impact of the regulation on an

uncontrolled facility in each industry

sector. This calculation was then

compared to the industrywide price

impact to determine if the facility’s

impacts differ significantly from the

average industrywide impacts (i.e., if

there is greater than a 1 percent

difference).

TABLE 32.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING NO SWITCHING AND ONSITE

INCINERATION—NEW SOURCES ANNUALIZED CONTROL COST AS A PERCENT OF REVENUE BUDGET

[Percent]

Industry Option 1 Option 2 Option 3

Hospitals—Short term, excluding psychiatric:

Federal Government

Small

Urban ............................................................................................................................................................. 0.36 0.36 0.41

Rural .............................................................................................................................................................. 0.36 0.36 0.41

Medium ............................................................................................................................................................. 0.33 0.49 0.49

Large ................................................................................................................................................................. 0.16 0.16 0.16

State Government

Small

Urban ............................................................................................................................................................. 0.76 0.76 0.88

Rural 0.76 0.76 0.88

Medium ............................................................................................................................................................. 0.35 0.51 0.51

Large ................................................................................................................................................................. 0.09 0.09 0.09

Local Government

Small

Urban ............................................................................................................................................................. 1.18 1.18 1.36

Rural .............................................................................................................................................................. 1.18 1.18 1.36

Medium ............................................................................................................................................................. 0.53 0.78 0.78

Large ................................................................................................................................................................. 0.12 0.12 0.12

Not-for-profit

Small

Urban ............................................................................................................................................................. 0.80 0.80 0.93

Rural .............................................................................................................................................................. 0.80 0.80 0.93

Medium ............................................................................................................................................................. 0.39 0.58 0.58

Large ................................................................................................................................................................. 0.14 0.14 0.14

For-profit

Small

Urban ............................................................................................................................................................. 0.91 0.91 1.04

Rural .............................................................................................................................................................. 0.91 0.91 1.04

Medium ............................................................................................................................................................. 0.41 0.61 0.61

Large ................................................................................................................................................................. 0.17 0.17 0.17

Hospitals—Psychiatric, short term and long term:

Small

Urban ............................................................................................................................................................. 1.25 1.25 1.44

Rural .............................................................................................................................................................. 1.25 1.25 1.44

Medium ............................................................................................................................................................. 0.95 1.40 1.40

Large ................................................................................................................................................................. 0.56 0.56 0.56

Nursing Homes:

Tax-Paying

Urban ............................................................................................................................................................. 1.35 1.35 1.56

Rural .............................................................................................................................................................. 1.35 1.35 1.56

Tax-exempt

Urban ............................................................................................................................................................. 1.39 1.39 1.59

Rural .............................................................................................................................................................. 1.39 1.39 1.59

Commercial research labs:

Tax-paying ..................................................................................................................................................... 0.68 1.00 1.00

Tax-exempt ................................................................................................................................................... 0.68 1.00 1.00

Commercial Incineration Facilities ....................................................................................................................... 11.82 11.82 11.82
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31775

TABLE 33.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING SWITCHING FROM ONSITE INCINERATION

TO COMMERCIAL DISPOSAL ALTERNATIVES ALTERNATIVE WASTE DISPOSAL COST AS A PERCENT OF REVENUE BUDGET

[Percent]

Industry

Scenario B

Switching with

waste segregation

Scenario C

Switching

without waste

segregation

Hospitals—Short-term, excluding psychiatric:

Federal Government:

Small

Urban ................................................................................................................................................................ 0.03 0.10

Rural .................................................................................................................................................................. 0.03 0.17

Medium

Urban ................................................................................................................................................................ 0.05 0.17

Rural .................................................................................................................................................................. 0.05 0.27

Large

Urban ................................................................................................................................................................ 0.08 0.29

Rural .................................................................................................................................................................. 0.09 0.47

State Government:

Small

Urban ................................................................................................................................................................ 0.06 0.22

Rural .................................................................................................................................................................. 0.06 0.36

Medium

Urban ................................................................................................................................................................ 0.05 0.18

Rural .................................................................................................................................................................. 0.05 0.29

Large

Urban ................................................................................................................................................................ 0.05 0.16

Rural .................................................................................................................................................................. 0.05 0.27

Local Government:

Small

Urban ................................................................................................................................................................ 0.09 0.34

Rural .................................................................................................................................................................. 0.10 0.56

Medium

Urban ................................................................................................................................................................ 0.07 0.27

Rural .................................................................................................................................................................. 0.08 0.44

Large

Urban ................................................................................................................................................................ 0.06 0.22

Rural .................................................................................................................................................................. 0.06 0.36

Not-for-profit:

Small

Urban ................................................................................................................................................................ 0.06 0.23

Rural .................................................................................................................................................................. 0.07 0.38

Medium

Urban ................................................................................................................................................................ 0.05 0.20

Rural .................................................................................................................................................................. 0.06 0.32

Large

Urban ................................................................................................................................................................ 0.07 0.25

Rural .................................................................................................................................................................. 0.07 0.41

For-profit:

Small

Urban ................................................................................................................................................................ 0.07 0.26

Rural .................................................................................................................................................................. 0.08 0.43

Medium

Urban ................................................................................................................................................................ 0.06 0.21

Rural .................................................................................................................................................................. 0.06 0.34

Large

Urban ................................................................................................................................................................ 0.09 0.32

Rural .................................................................................................................................................................. 0.09 0.52

Hospitals—Psychiatric, short-term and long-term:

Small

Urban ................................................................................................................................................................ 0.10 0.36

Rural .................................................................................................................................................................. 0.11 0.59

Medium

Urban ................................................................................................................................................................ 0.13 0.48

Rural .................................................................................................................................................................. 0.14 0.78

Large

Urban ................................................................................................................................................................ 0.29 1.05

Rural .................................................................................................................................................................. 0.31 1.70

Nursing homes:

Tax-paying

Urban ................................................................................................................................................................ 0.11 0.39

Rural .................................................................................................................................................................. 0.11 0.64

Tax-exempt

Urban ................................................................................................................................................................ 0.11 0.40
31776 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

TABLE 33.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS ASSUMING SWITCHING FROM ONSITE INCINERATION

TO COMMERCIAL DISPOSAL ALTERNATIVES ALTERNATIVE WASTE DISPOSAL COST AS A PERCENT OF REVENUE BUDGET—Continued

[Percent]

Industry

Scenario B

Switching with

waste segregation

Scenario C

Switching

without waste

segregation

Rural .................................................................................................................................................................. 0.12 0.65

Commercial research labs:

Tax-paying

Urban ................................................................................................................................................................ 0.09 0.34

Rural .................................................................................................................................................................. 0.10 0.56

Tax-exempt

Urban ................................................................................................................................................................ 0.09 0.34

Rural .................................................................................................................................................................. 0.10 0.56

Tables 32 and 33 show that facilities

with onsite MWI that are currently

uncontrolled may experience impacts

ranging from 0.03 to 1.59 percent,

depending on the industry, regulatory

option, and scenario. A comparison of

the economic impacts expected to occur

under the three switching scenarios,

presented in Tables 32 and 33, indicates

that the option of switching will be

attractive to some facilities that might

have considered operating an onsite

incinerator in the absence of this

regulation. 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 medical waste

disposal should preclude any facilities

from experiencing a significant

economic impact. These results support

EPA’s assertion that implementation of

the regulation will likely result in either

Scenarios B or C and that the costs and

economic impacts of Scenario A are

unlikely to occur.

Table 34 shows the impacts that

would be incurred by medical waste

generators that currently use an offsite

medical waste incineration service.

These impacts range from 0.00 to 0.02

percent and are considered negligible

impacts. These results indicate that the

incremental cost for the vast majority of

medical waste generators are expected

to be small.

TABLE 34.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS FOR

FIRMS THAT UTILIZE OFFSITE

WASTE INCINERATION—NEW

SOURCES INCREMENTAL ANNUAL

COST AS A PERCENT OF REVENUE/

BUDGET

[Percent]

Industry

Incremental

annual cost

as a percent of revenue

Hospitals:

<50 Beds ........................... 0–0.01

50–99 Beds ....................... 0–0.01

100–299 Beds ................... 0–0.01

300 + Beds ........................ 0–0.01

Nursing homes:

0–19 Employees

Tax-paying ......................... 0

Tax-exempt ........................ 0

20–99 Employees

Tax-paying ......................... 0–0.01

Tax-exempt ........................ 0–0.01

100 + Employees

Tax-paying ......................... 0

Tax-exempt ........................ 0

Commercial research labs:

Tax-paying

0–19 Employees ................ 0

20–99 Employees .............. 0

100 + Employees .............. 0

Tax-exempt ........................ 0

Outpatient care clinics:

Physicians’ clinics (Amb.

Care)

Tax-paying ......................... 0–0.01

Tax-exempt ........................ 0–0.01

Freestanding kidney dialysis facilities

Tax-paying ......................... 0–0.01

Tax-exempt ........................ 0–0.01

Physicians’ offices .................... 0

Dentists’ offices and clinics:

Offices ................................ 0

Clinics

Tax-paying ......................... 0

Tax-exempt ........................ 0

Medical & dental labs:

Medical .............................. 0–0.01

TABLE 34.—MEDICAL WASTE INCINERATION PER FACILITY IMPACTS FOR

FIRMS THAT UTILIZE OFFSITE

WASTE INCINERATION—NEW

SOURCES INCREMENTAL ANNUAL

COST AS A PERCENT OF REVENUE/

BUDGET—Continued

[Percent]

Industry

Incremental

annual cost

as a percent of revenue

Dental ................................ 0–0.01

Freestanding blood banks ........ 0.01–0.02

Funeral homes .......................... 0

Fire & Rescue ........................... 0

Corrections:

Federal Government .......... 0

State Government ............. 0

Local Government ............. 0

Table 33 also presents price impact

estimates for the commercial medical

waste incinerator sector. The analysis

shows that a new medical waste

incinerator required to meet any of the

regulatory options would need to

increase its prices by approximately

11.82 percent in order to recoup its

control costs. The large difference

between the facility-specific price

increase compared to the industry-wide

price increase (3.8 percent) for this

industry suggests that it is unlikely that

a new commercial MWI would be able

to increase the price of its service by

11.82 percent.

Although a ‘‘switching’’ analysis was

not developed for the commercial MWI

sector, recent trends in the medical

waste treatment and disposal industry

suggest that the concept of switching

may also be applicable to the

commercial MWI sector. A company in

this industry that might have decided to

open a new incinerator may reconsider

the option of opening an alternative
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31777

technology, such as autoclaving. These

alternative technologies will seem more

attractive from a cost perspective due to

the requirements that regulation places

on new MWI. Therefore, some

companies in this industry will have an

incentive to choose to open an

alternative treatment unit, such as an

autoclave unit. Some companies in the

medical waste treatment and disposal

industry have already begun to make

these ‘‘switching’’ decisions. Since

companies in this industry have

demonstrated the ability to operate

various types of medical waste

treatment and disposal units, the option

of ‘‘switching’’ should be seen as a

viable alternative for commercial MWI

operators.

This economic impact section

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

medical waste or dispose medical waste.

Secondary impacts such as subsequent

impacts on air pollution device vendors

and MWI vendors are not estimated due

to data limitations. Air pollution 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 MWI services. However,

due to economies of scale, this

regulation is expected to shift demand

from smaller incinerators to larger

incinerators. Therefore, small MWI

vendors may be adversely affected by

the regulation. Lack of data on the above

effects prevents quantification of the

economic impacts on these secondary

sectors.

V. Inclinations for Final Rule

At various points throughout this

notice, EPA has indicated

‘‘inclinations’’ regarding the final

regulations for MWI, based on the new

information and revised analyses now

available. For example, as discussed in

Section II of this notice, EPA is inclined

to: subcategorize MWI by size rather

than by type, where judged appropriate

in the final regulations; adopt the

NYSDOH definition of medical waste

for the purpose of determining what

incinerators the final regulations apply

to; determine compliance with the final

regulations using parameter monitoring

and routine inspection/maintenance

rather than CEMS; defer to the States the

judgement of what constitutes an

acceptable operator training program;

and develop a separate regulation for

medical waste ‘‘pyrolysis’’ units. In this

final section, EPA inclinations regarding

the regulatory options outlined earlier

are discussed.

A note of caution should be observed

and kept in mind by the reader,

however, with regard to these EPA

inclinations. These ‘‘inclinations’’

should not be viewed as final or, for that

matter, even tentative EPA decisions.

All options discussed in this notice and

any additional options which may arise

from further public comment will be

considered in developing the final

standards and guidelines for MWI. The

primary purpose of these inclinations is

to solicit public comment.

It is also important to reiterate some

additional points. First, as mentioned

earlier, all of the information and

analyses reviewed in this notice,

particularly the discussions below with

their focus on air pollution control

technology, are often misunderstood

and lead some to assume that the final

regulations will require the use of a

specific air pollution control

technology—this is not the case. The

final regulations must be based upon the

performance capabilities of air pollution

control technology; as a result, EPA

assesses air pollution control

technologies and draws conclusions

regarding their performance capabilities.

These conclusions regarding

performance capabilities take the form

of emission limits which could be

achieved through the use of the various

air pollution control technologies. This

approach permits EPA to identify and

consider the different options for the

regulations, in terms of emission limits.

The final regulations will not require

use of any specific air pollution control

technology. The final regulations will

include emission limits (i.e.,

concentration levels in the gases

released to the atmosphere) for specific

air pollutants (e.g., hydrogen chloride,

lead, etc.) that an MWI must achieve.

The decision on how to meet these

emission limits is left to the MWI owner

or operator; an owner or operator may

select any equipment or any means

available to comply with these emission

limits.

Second, as also mentioned earlier,

Section 129 of the Clean Air Act directs

EPA to develop regulations for MWI

which are based on maximum

achievable control technology (MACT).

Section 129 defines MACT as the

maximum reduction in emissions which

is achievable, considering cost,

environmental, and energy impacts.

Section 129 also states, however, that

for new MWI MACT can be no less

stringent than the best similar MWI and

for existing MWI MACT can be no less

stringent than the best 12 percent of

existing MWI. These minimum

stringency requirements for the

standards (new MWI) and the guidelines

(existing MWI) are referred to as the

MACT ‘‘floors.’’ The emission limits in

the final regulations can be no less

stringent than the MACT floor emission

limits.

Finally, the MACT floors are only the

starting point for determining MACT.

Since MACT is the maximum reduction

in air pollution emissions that is

achievable, considering cost,

environmental, and energy impacts, if

more stringent emission limits than the

MACT floor are achievable, EPA must

identify these more stringent emission

limits and consider them in selecting

the MACT emission limits for the final

regulations.

A. New MWI

As discussed in Section IV, the MACT

floor for large new MWI appears to

require the 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 is inclined

to establish emission limitations for

large new MWI based on good

combustion and a combined dry/wet

scrubber system with activated carbon

(i.e., the MACT floor).

For medium new MWI, the MACT

floor appears to require the use of good

combustion and a combined dry/wet

scrubber system without activated

carbon. In this case, one regulatory

option more stringent than the MACT

floor would reflect the addition of

activated carbon to the combined dry/

wet scrubber system. On a national

basis, because of switching to the use of

alternative means of medical waste

disposal, the addition of activated

carbon results in a negligible cost

increase. Where a typical medium new

MWI was constructed, the addition of

activated carbon would reduce

emissions of dioxin and would increase

air pollution control costs by less than

4 percent. As a result, EPA is inclined

to establish emission limitations for

medium new MWI based on good

combustion and a combined dry/wet

scrubber system with activated carbon

(i.e., more stringent than the MACT

floor).

For small new MWI, four small

existing MWI have been identified

which currently operate with good

combustion and moderate efficiency wet

scrubbers; therefore, the MACT floor

appears to require the use of good

combustion and a moderate efficiency

wet scrubber. Consideration of the

impact of this MACT floor indicates that

few new small MWI are likely to be
31778 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules

constructed due to the substantial

increase in the cost of a new small MWI

as a result of the moderate efficiency

wet scrubber and the availability of

switching to an 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 MWI would be constructed (i.e.,

because of switching to alternative

means of medical waste disposal).

Where a typical new small MWI 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,

EPA is inclined to establish emission

limitations for small new MWI based on

the use of good combustion and a

moderate efficiency wet scrubber (i.e.,

the MACT floor).

B. Existing MWI

As discussed in Section III, the MACT

floor for large existing MWI appears to

require the use of good combustion and

a high efficiency wet scrubber. One

regulatory option more stringent than

this MACT floor is the use of dry

scrubbers with activated carbon.

However, a dry scrubber typically costs

much more than a high efficiency wet

scrubber, and a dry scrubber with

activated carbon would result in only a

very small additional reduction in

dioxin, Pb, and Cd emissions. For large

existing MWI already equipped with

wet scrubbers, replacing a wet scrubber

with a dry scrubber would be

exorbitantly expensive. As a result, EPA

is inclined to establish emission

limitations for large existing MWI based

on the use of good combustion and a

high efficiency wet scrubber (i.e., the

MACT floor). As discussed in Section

III, these emission limitations could also

be achieved using a dry scrubber with

activated carbon.

For medium existing MWI, the MACT

floor appears to require the use of good

combustion and a moderate efficiency

wet scrubber. One regulatory option

more stringent than this MACT floor

would reflect the use of good

combustion and a high efficiency wet

scrubber. On a nation-wide basis, while

this more stringent option would result

in a relatively small cost increase, it

would also result in only a small

decrease in PM emissions. For a typical

medium MWI that installed or upgraded

an existing wet scrubber to a high

efficiency wet scrubber, air pollution

control costs would increase by about

15 to 25 percent. As a result, EPA is

inclined to establish emission

limitations for medium existing MWI

based on the use of good combustion

and a moderate efficiency wet scrubber

(i.e., the MACT floor). As mentioned

above and in Section III, these emission

limitations could also be achieved using

a dry scrubber with activated carbon.

For small existing MWI, the MACT

floor appears to require the use of good

combustion; add-on air pollution

control would not be needed to meet the

MACT floor. One regulatory option

more stringent than this MACT floor

would reflect the use of good

combustion and a low efficiency wet

scrubber. Consideration of this option,

as well as other options outlined below,

is the subject of the remainder of this

section. At this point, EPA has no

inclination, but solicits comment on the

options available.

If the guidelines for small existing

MWI were established based on the use

of good combustion and wet scrubbing,

the analysis indicates that almost all

healthcare facilities operating small

MWI would switch to the use of

alternative means of medical waste

disposal. From a national perspective,

this would minimize emissions of PM,

dioxin, acid gases, and metals from

small existing MWI at a relatively low

cost because of switching. For most

healthcare facilities using small existing

MWI, the cost of switching to the use of

alternative means of medical waste

disposal would be negligible. On this

basis, one might argue that EPA should

establish emission guidelines for small

existing MWI based on the use of good

combustion and wet scrubbers.

On the other hand, if a healthcare

facility chooses to install a wet

scrubbing system on its small existing

MWI, the cost of waste disposal at this

facility would more than double and the

emission reduction achieved would be

relatively small. The wet scrubber-based

option would effectively preclude

continued use of the MWI, whereas

guidelines based on the use of good

combustion alone would permit many

healthcare facilities with small MWI to

continue to use these MWI, preserving

incineration as a viable medical waste

disposal option for these healthcare

facilities. On this basis, one might argue

that EPA should establish emission

guidelines for small existing MWI based

on the use of good combustion alone.

As mentioned earlier in this notice,

some commenters expressed concern

about the availability and/or the cost of

alternative means of medical waste

disposal to healthcare facilities located

in remote or rural locations. In this case,

the conclusion that costs would be

negligible because of switching would

be incorrect, and such a facility could be

faced with adverse impacts. The

availability and/or cost of alternative

means of medical waste disposal in

urban areas, however, does not appear

to be an issue. Competition among

commercial medical waste disposal

services, formation of healthcare

facilities into groups for the purpose of

leading commercial disposal services to

bid for waste disposal contracts, as well

as other forms of cooperation among

healthcare facilities in urban areas

appears to ensure that alternative means

of medical waste disposal are readily

available at reasonable costs to

healthcare facilities in urban areas.

This consideration of the potential

difference in the availability and/or cost

of alternative means of medical waste

disposal to healthcare facilities located

in rural or urban areas leads to

additional regulatory options. Small

existing MWI could be subcategorized

into those located in urban areas and

those located in rural areas.

As mentioned, the MACT floor for

small existing MWI only appears to

require the use of good combustion; it

does not appear to require the use of

good combustion and a wet scrubber.

The guideline for small existing MWI

located in urban areas could be based on

the use of good combustion and a low

efficiency wet scrubber (i.e, beyond the

MACT floor). The guideline for small

existing MWI located in rural areas,

however, could be based on the use of

good combustion alone (i.e., the MACT

floor). On the other hand, the guideline

for small existing MWI located in rural

areas could be based on the use of good

combustion and low efficiency wet

scrubbers (i.e., beyond the MACT floor),

but permit—on a case by case basis—a

healthcare facility which met certain

criteria to comply with a guideline

based on the use of good combustion

alone (i.e., the MACT floor).

These options of differing

requirements for small existing MWI in

urban and rural areas were examined in

a broad sense under Regulatory Option

2, which would establish emission

limitations based on good combustion

alone in rural areas, but establish

emission limitations based on good

combustion and wet scrubbers in urban

areas. The difference between these two

options is that the second option would

establish a set of criteria (much more

comprehensive than simply ‘‘rural

location’’) to permit a small existing

MWI in a rural location to comply with

requirements based on the use of good

combustion alone.
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Proposed Rules 31779

The attractiveness of this second

option is that it would appear to

minimize emissions from small existing

MWI (urban or rural) while providing

relief—on a case by case basis—for

those few small MWI located in rural

areas where the impacts of compliance

might be particularly severe due to the

limited availability of alternative means

of medical waste disposal. The EPA,

therefore, solicits comment on the

following options:

(1) Guidelines for small existing MWI

located in both urban and rural areas

based on the use of good combustion

alone;

(2) Guidelines for small existing MWI

located in urban areas based on the use

of good combustion and wet scrubbing,

and guidelines for small existing MWI

located in rural areas based on the use

of good combustion alone;

(3) Guidelines for small existing MWI

located in urban and rural areas based

on the use of good combustion and wet

scrubbers, but with the guidelines

permitting small existing MWI located

in rural areas to meet requirements

based on the use of good combustion

alone, provided these MWI meet certain

criteria; and

(4) Guidelines for small existing MWI

in both urban and rural areas based on

the use of good combustion and wet

scrubbers.

As mentioned above, EPA has no

inclination with regard to the guidelines

for small existing MWI. Each of the

options outlined above merits serious

consideration. Since the option outlined

above with criteria for small existing

MWI located in rural areas to meet

requirements—on a case by case basis—

based on the use of good combustion

alone would seem to achieve the

environmental benefits, but avoid the

cost impacts, of the most stringent

option, EPA specifically solicits

comment on what the criteria associated

with this option might be.

For example, these criteria might

include: location with respect to an

Metropolitan Statistical Area [MSA]

(i.e., either outside an MSA or more

than a specified number of miles from

an MSA); location with respect to a

commercial waste disposal company or

a vendor of alternative treatment

technology; some other measure of the

lack of alternative disposal options;

some measure of economic impact of

switching waste disposal methods or

some other reason why switching would

not be possible; etc. The criteria could

also be structured to allow good

combustion alone only where a

healthcare facility generates less than

some very small amount of medical

waste on a daily or weekly basis.

List of Subjects in 40 CFR Part 60

Air pollution control, New source

performance standards, Emission

guidelines, Medical waste incinerators.

Dated: June 12, 1996.

Mary D. Nichols,

Assistant Administrator for Air and

Radiation.

[FR Doc. 96–15585 Filed 6–19–96; 8:45 am]

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