10654 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 60

[AD-FRL–5150–9]

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: Proposed standards and

guidelines, and notice of public hearing.

SUMMARY: Today, EPA is proposing

standards and guidelines for new and

existing medical waste incinerators

(MWI’s) that will reduce air pollution

from MWI’s. Once implemented, these

standards and guidelines will protect

public health by reducing exposure to

air pollution.

This proposal would add subparts Ec

and Cc to 40 CFR part 60. Subpart Ec

would limit emissions from new and

modified MWI’s. The proposed

standards would implement sections

111(b) and 129 of the Clean Air Act

(Act) as amended in 1990, and would

require new MWI’s to control emissions

of air pollutants to levels that reflect the

degree of emission reduction based on

maximum achievable control

technology (MACT). In addition, this

notice includes proposed standards for

fugitive fly ash/bottom ash emissions,

MWI operator training and qualification,

siting, and permitting.

Subpart Cc would establish emission

guidelines and compliance schedules

for use by States in developing State

regulations to control emissions from

existing MWI’s. The proposed emission

guidelines implement sections 111(d)

and 129 of the Act, and would initiate

State action to develop State

regulations. These State regulations

would control air pollutant emissions

from existing MWI’s to levels that reflect

the degree of emission reduction based

on MACT. In addition, this notice

includes proposed guidelines for

fugitive fly ash/bottom ash emissions,

equipment inspections, training and

qualification of MWI operators and

permitting.

DATES: Comments. Comments must be

received on or before April 28, 1995.

Public Hearing. The EPA will hold at

least one public hearing in Washington,

D.C. in mid- to late-March 1995.

Additional hearings may also be held. A

Federal Register notice will be

published within the next 2 weeks to

announce the details of the hearing(s)

and to confirm the date(s) and

location(s) for the hearing(s).

ADDRESSES: Comments. Comments on

the proposal should be submitted (in

duplicate, if possible) to: 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.

Commenters wishing to submit

proprietary information for

consideration should clearly distinguish

such information from other comments,

and clearly label it ‘‘Confidential

Business Information.’’ Submissions

containing such proprietary information

should be sent directly to the following

address, and 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. EPA Confidential

Business Manager, 411 W. Chapel Hill

Street, Room 944, Durham, North

Carolina 27701. 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 by the

EPA, the submission may be made

available to the public without further

notice to the commenter.

Background Information Documents.

Two ‘‘Fact Sheets’’ are available that

succinctly summarize the proposed

standards and guidelines. The Fact

Sheets are suggested reading for persons

requiring an overview of the proposal.

The Fact Sheets can be obtained by (1)

calling Ms. Julia Latta at (919) 541–5578

or (2) accessing the EPA’s Technology

Transfer Network (TTN) electronic

bulletin board. See SUPPLEMENTARY

INFORMATION for instructions on

accessing the TTN (electronic bulletin

board). The background information

documents (BID’s) for the proposed

standards and guidelines may be

obtained from the docket; from the U.S.

EPA Library (MD–35), Research Triangle

Park, North Carolina 27711, telephone

number (919) 541–2777; or from the

National Technical Information

Services, 5285 Port Royal Road,

Springfield, Virginia 22161, telephone

number (703) 487–4650. See

SUPPLEMENTARY INFORMATION for a listing

of these documents.

Docket. Docket No. A–91–61,

containing supporting information used

in developing the proposed 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.

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. EPA,

Research Triangle Park, North Carolina

27711.

SUPPLEMENTARY INFORMATION:

Incineration is a common method of

medical waste disposal in the United

States and around the world. However,

while it is a very effective method of

medical waste treatment with regard to

rendering waste non-infectious,

incineration results in the production of

air pollutants. The EPA estimates that

there are about 3,700 MWI’s currently in

operation in the United States. While

these incinerators are small in size

relative to municipal waste combustors,

their large number makes MWI’s a

significant source of air pollution. The

EPA recently released a draft report

reassessing the health effects of

exposure to dioxin. In the draft report,

currently undergoing public review,

MWI’s are identified as a significant

source of dioxin emissions. In addition,

MWI’s emit substantial quantities of

hydrogen chloride (HCl), lead (Pb),

cadmium (Cd), and mercury (Hg).

Today’s proposed standards and

guidelines will result in greater than 95

percent reduction in air pollution from

MWI’s. Once implemented, these

standards and guidelines will protect

public health by reducing exposure to

air pollution.

The EPA, the Sierra Club, and the

Natural Resources Defense Council

(NRDC) have 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 requires the EPA

Administrator to sign a notice of

proposed rulemaking not later than

February 1, 1995 and a notice of final

rulemaking not later than April 15,

1996.

The EPA will hold at least one public

hearing to provide interested parties an

opportunity for oral presentation of

data, views, or arguments concerning

the proposal. Additional hearings may

also be held (see discussion of public

hearing above).

The EPA seeks full public

participation in arriving at its final

decisions and strongly encourages

comments on all aspects of this proposal

from all interested parties. Whenever

applicable, full supporting data and

detailed analysis should accompany all
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10655

comments to allow the EPA to

adequately respond to the comments.

The key documents used to develop

the proposed standards and guidelines

include:

1. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Industry

Profile Report for New and Existing

Facilities,’’ EPA–453/R–94–042a, July

1994;

2. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Process

Description Report for New and Existing

Facilities,’’ EPA–453/R–94–043a, July

1994;

3. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Control

Technology Performance Report for

New and Existing Facilities,’’ EPA–453/

R–94–044a, July 1994;

4. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Model Plant

Description and Cost Report for New

and Existing Facilities,’’ EPA–453/R–

94–045a, July 1994;

5. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines:

Environmental Impacts Report for New

and Existing Facilities,’’ EPA–453/R–

94–046a, July 1994;

6. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Analysis of

Economic Impacts for New Sources,’’

EPA–453/R–94–047a, July 1994 (see

also item 9 below);

7. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Analysis of

Economic Impacts for Existing

Sources,’’ EPA–453/R–94–048a, July

1994 (see also item 9 below);

8. ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Regulatory

Impact Analysis for New and Existing

Facilities, EPA–453/R–94–063a, July

1994 (see also item 9 below); and

9. B. Strong and S. Shoraka-Blair,

MRI, to R. Copland, EPA/ESD. January

30, 1995. Regulatory Impacts of the

Proposed New Source Performance

Standard (NSPS) and Emission

Guidelines (EG) for Medical Waste

Incinerators (MWI’s). Docket A–91–61,

II–B–108.

An electronic copy of the items listed

below are available from the EPA’s TTN

electronic bulletin board. The TTN is

accessible 24 hours per day, 7 days per

week, except Monday morning from

8:00 a.m. to 12:00 p.m. EST, when the

system is updated. The TTN contains 12

electronic bulletin boards, and

information relating to this proposal is

contained in the Clean Air Act

Amendments (CAAA) bulletin board.

Instructions for accessing the TTN can

be obtained by calling (919) 541–5384.

MWI Items in the Electronic Bulletin

Board (TTN/CAAA)

1. Fact Sheet—Proposed subpart Ec

Emission Standards for New MWI’s.

2. Fact Sheet—Proposed subpart Cc

Emission Guidelines for Existing MWI’s.

3. This Federal Register notice

(preamble).

4. Proposed subpart Ec Emission

Standards.

5. Proposed subpart Cc Emission

Guidelines.

Other technical documents, including

the key documents listed under the

SUPPLEMENTARY INFORMATION section, are

contained in Docket No. A–91–61.

The following outline is provided to

aid in locating information in this notice

(the preamble to the proposed standards

and guidelines):

I. Introduction

A. Overview of this Preamble

B. New Source Performance Standards

(NSPS)—General

C. NSPS Decision Scheme

D. Emission Guidelines—General Goals

E. Additional Requirements Under Section

129

II. Summary of the Standards and Guidelines

A. Source Category to be Regulated

B. Pollutants to be Regulated

C. Affected Facility and Designated Facility

D. Proposed Standards and Guidelines

E. Operator Training and Qualification

Requirements

F. Siting Requirements—New MWI’s

G. Inspection Requirements—Existing

MWI’s

H. Compliance and Performance Test

Methods and Monitoring Requirements

I. Reporting and Recordkeeping—New

MWI’s

J. Reporting and Recordkeeping—Existing

MWI’s

K. Compliance Times

L. Permit Requirements

III. Impacts of the Proposed Standards for

New MWI’s

A. Air Impacts

B. Water and Solid Waste Impacts

C. Energy Impacts

D. Control Cost Impacts

E. Economic Impacts

IV. Impacts of the Proposed Guidelines for

Existing MWI’s

A. Air Impacts

B. Water and Solid Waste Impacts

C. Energy Impacts

D. Control Cost Impacts

E. Economic Impacts

V. Rationale for the Proposed Standards and

Guidelines

A. Background

B. Selection of Source Category

C. Modification of Existing MWI’s

D. Selection of Pollutants

E. Selection of Affected and Designated

Facilities

F. Selection of Format for the Proposed

Standards and Emission Guidelines

G. Selection of Classes, Types, and Sizes

H. Performance of Technology

I. MACT Floor and MACT for New MWI’s

J. MACT Floor and MACT for Existing

MWI’s

K. Selection of Fugitive Fly Ash/Bottom

Ash Standards and Guidelines

L. Operator Training and Qualification

Requirements

M. Siting Requirements—New MWI’s

N. Inspection Requirements—Existing

MWI’s

O. Compliance and Performance Test

Methods and Monitoring Requirements

P. Reporting and Recordkeeping—New

MWI’s

Q. Reporting and Recordkeeping—Existing

MWI’s

R. Compliance Times

S. Permit Requirements

VI. Request for Comment

A. Procedure to Determine MACT

B. Alternatives to Onsite Incineration

C. Definition of Medical Waste

VII. Administrative Requirements

A. Public Hearing

B. Docket

C. Clean Air Act Procedural Requirements

D. Office of Management and Budget

Reviews

E. Regulatory Flexibility Act Compliance

I. Introduction

A. Overview of This Preamble

The 1990 Clean Air Act Amendments

reflect growing public concern about the

large volume of toxic air pollutants

released from numerous categories of

emission sources. Title III of the

Amendments specifically enumerated

189 hazardous air pollutants and

instructed EPA to protect public health

by reducing emissions of these

pollutants from the sources that release

them. The EPA’s standards are to be

issued in two phases. The first phase

standards are designed to bring all

sources up to the level of emissions

control achieved by those that are

already well-controlled, using pollution

prevention measures as well as ‘‘end-ofpipe’’ methods. The second phase

standards, due approximately a decade

later, are to require further emission

reductions in any case in which the first

phase measures were not by themselves

sufficient to fully protect the public

health.

In this context, the 1990 Amendments

singled out waste incineration for

special attention. Congress recognized

both a high level of public concern

about the incineration of municipal,

medical and other wastes, and a number

of special management concerns for

these types of sources. Consequently,

section 129 of the Act directs EPA to

apply the two-phase control approach of

Title III to various categories of waste

incinerators, including medical waste
10656 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

incinerators. Today’s action proposes

standards and guidelines for new and

existing MWI’s under section 129.

Current methods of medical waste

incineration cause the release of a wide

array of air pollutants, including several

pollutants of particular public health

concern. In September of 1994, EPA

released a review draft of a report

reassessing the health effects associated

with dioxin, which suggests that dioxin

exposure can result in a number of

cancer and noncancer health effects in

humans. In the report, MWI’s are

identified as the largest known source of

dioxin emissions, emitting more than

municipal waste combustors, hazardous

waste incinerators, and cement kilns.

Because of this, the reduction of dioxin

emissions from all sources is one of the

Administrator’s highest air quality

protection priorities. Consequently, the

development of MWI regulations has

received increased attention.

In addition to dioxin, MWI’s also emit

significant quantities of heavy metals

including lead, cadmium, and mercury.

Once again, MWI’s have been identified

as the largest known source of mercury

emissions, emitting more than

municipal waste combustors and coalfired electric utility boilers. The MWI’s

also emit nitrogen oxides (a contributor

to ozone smog), particulate matter,

sulfur dioxide, and other acid gases.

Several States, including New York,

California, and Texas, have adopted

relatively stringent regulations in the

past few years limiting emissions from

MWI’s. The implementation of these

regulations has brought about very large

reductions in MWI emissions and the

associated risk to public health in those

States. It has also significantly reshaped

how medical waste is managed in those

States. Many facilities have responded

to the State regulations by switching to

other medical waste treatment and

disposal options to avoid the high cost

of add-on air pollution control

equipment. The two most commonly

chosen alternatives have been off-site

contract disposal in larger, commercial

incinerators dedicated to medical waste,

and on-site treatment by other means

(e.g., steam autoclaving). Other

alternatives include chemical treatment

and microwave irradiation. The

availability of alternatives to onsite

incineration has mitigated the economic

impacts that might have been associated

with the State regulations.

Today EPA proposes nationally

applicable emission standards and

guidelines for MWI’s that build on the

experience of these leading States. Like

the State regulations, the standards and

guidelines proposed today are based on

the use of add-on air pollution control

systems.

These standards and guidelines will

implement the first phase requirements

of section 129, described above.

The commercial medical waste

disposal industry has indicated that

sufficient commercial medical waste

disposal capacity is available to handle

the amount of waste that would no

longer be treated onsite. In addition, as

mentioned earlier, onsite alternatives

are available for facilities that choose to

treat their medical waste onsite. In fact,

even in the absence of Federal

regulations, most facilities that generate

medical waste do not operate onsite

MWI’s. This indicates that there

currently are viable alternatives to

onsite incineration.

As described in detail below, section

129, like section 112, of the Clean Air

Act instructs the Agency to set

performance standards that challenge

industry to meet or exceed the pollution

control standards established by better

controlled similar facilities. In this way,

the overall state of environmental

practice is raised for large segments of

industry, a basic level of health

protection is provided to all

communities, situations in which

uncertainty about total risk and hazard

result in no protection for the exposed

public are avoided, and yet the cost of

pollution control to industry is

constrained to levels already absorbed

by similar operations. Eight years later,

in a second phase, EPA must evaluate

whether the residual public health risk

warrants additional control.

For new MWI’s, the proposed

emissions standards would reduce

nationwide emissions of dioxins/furans

by 99 percent; PM, CO, HCl, Pb, and Cd

by greater than 95 percent; and Hg by

92 percent. In addition, the standards

would achieve an emission reduction of

about 25 percent for SO2 and NOx.

Because wastewater, solid waste, and

energy requirements associated with

implementation of the proposed

standards are not significant, adverse

water, solid waste, or energy impacts are

not anticipated.

The nationwide annual costs

associated with the proposed standards

for new MWI’s will increase by

approximately $74.5 million/yr from the

regulatory baseline cost of $63.3

million/yr. This results in an increase in

the cost of waste incineration per unit

of waste treated of approximately $177/

Mg ($161/ton) compared to the

regulatory baseline cost of $150/Mg

($136/ton).

The results of the economic impacts

analyses for new MWI’s indicate that no

medical waste-generating industry

would need to be significantly

reconstructed (e.g., through closures or

consolidations) as a result of the

proposed standards. The market price

increase resulting from the standards is

relatively small for each industry. The

corresponding decreases in output,

employment, and revenue were also

low, never exceeding 0.05 percent.

With regard to existing MWI’s, an

estimated 3.4 million tons of waste are

produced annually by medical waste

generators in the United States. The

EPA believes that approximately 3,700

MWI’s are currently burning waste

generated at health care facilities. The

proposed guidelines for existing MWI’s

would reduce nationwide emissions of

dioxins/furans and Pb by 99 percent;

PM, CO, and HCl by 98 percent; Cd by

97 percent; and Hg by 94 percent. The

guidelines would also achieve an

overall emission reduction of 37 percent

for both SO2 and NOx. Because

wastewater, solid waste, and energy

requirements associated with

implementation of the proposed

guidelines are not significant, adverse

water, solid waste, or energy impacts are

not anticipated.

The nationwide annual costs

associated with the proposed guidelines

for existing MWI’s will increase by

approximately $351 million/yr from the

regulatory baseline cost of $265 million/

yr. This results in an increase in the cost

of waste incineration per unit of waste

treated of approximately $245/Mg

($222/ton) compared to the regulatory

baseline cost of $185/Mg ($168/ton).

The results of the economic impacts

analyses for existing MWI’s indicate that

no medical waste-generating industry

would need to be significantly

restructured (e.g., through closures or

consolidations) as a result of the

proposed emission guidelines. The

market price increase resulting from the

emission guidelines is relatively small

for each industry. The corresponding

decreases in output, employment, and

revenue were also low, never exceeding

1 percent.

Considering the benefits to be gained

from the reduction of air pollution from

MWI’s along with the availability of

alternative treatment methods and the

clear Congressional intent, these

proposed standards and guidelines are

considered reasonable.

This preamble will:

1. Summarize the important features

of the proposed standards and

guidelines;

2. Describe the environmental, energy,

and economic impacts of these

standards and guidelines;
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10657

3. Present a rationale for each of the

decisions made regarding the proposed

standards and guidelines;

4. Request public comment on

specific issues; and

5. Discuss administrative

requirements relevant to this action.

B. New Source Performance

Standards—General

The proposed new source

performance standards (NSPS, or

standard(s)) for MWI’s would

implement section 111(b) of the Act.

The NSPS are issued for categories of

sources that cause, or contribute

significantly to, air pollution that may

reasonably be anticipated to endanger

public health or welfare. They apply to

new stationary sources of emissions

(i.e., sources whose construction or

modification begins after a standard is

proposed). An NSPS requires these

sources to control emissions to the level

achievable by the best system of

continuous emission reduction,

considering costs and other impacts.

C. NSPS Decision Scheme

An NSPS is the end product of a

series of decisions related to certain key

elements for the source category being

considered for regulation. The elements

in this decision are generally the

following:

1. Source category to be regulated—

usually an emission source category, but

can be a process or group of processes

within an industry.

2. Affected facility—the pieces or

groups of equipment that comprise the

sources to which the standards will

apply.

3. Pollutants to be regulated—the

particular substances emitted by the

affected facility that the standards

control.

4. Best system of continuous emission

reduction—the technology on which the

standards will be based, i.e., application

of the best system of continuous

emission reduction that (taking into

consideration the cost of achieving such

emission reduction and any nonairquality health and environmental

impacts and energy requirements) the

Administrator determines has been

adequately demonstrated (section

111(a)(1)).

5. Format for the standards—the form

in which the standards are expressed,

i.e., as pollutant concentration emission

limits, as a percent reduction in

emissions, or as equipment or work

practice standards.

6. Actual standards—generally,

emission limits based on the level of

reduction that the best demonstrated

technology (BDT) can achieve. Only in

unusual cases do standards require that

a specific technology be used. In

general, the source owner or operator

may select any method for complying

with the standards.

7. Other considerations—(in addition

to emission limits) NSPS usually

include: standards for visible emissions,

modification provisions, monitoring

requirements, performance test methods

and compliance procedures, and

reporting and recordkeeping

requirements.

D. Emission Guidelines—General Goals

The Act requires the promulgation of

standards of performance under section

111(b) for categories of new sources that

may contribute to the endangerment of

public health or welfare. When

standards of performance are

promulgated under section 111(b) for a

designated pollutant, the Act requires

States under section 111(d) to submit

plans that: (1) establish emission

standards for this designated pollutant

from existing sources and (2) provide for

implementation and enforcement of

these emission standards. In most cases,

this means that control under section

111(d) is appropriate when the pollutant

may cause or contribute to

endangerment of public health or

welfare but is not known to be

‘‘hazardous’’ within the meaning of

section 112 and is not controlled under

sections 108 through 110 because, for

example, it is not emitted from

‘‘numerous or diverse’’ sources as

required by section 108.

As specified in 40 CFR part 60.23,

States are required to adopt and submit

to the Administrator a plan

implementing the section 111(d)

guidelines within 1 year after the

promulgation of the guidelines. The Act

further requires that the procedure for

State submission of a plan shall be

similar to the procedure for submission

of State implementation plans (SIP’s)

under section 110. The Act also

provides that the EPA shall prescribe a

plan according to procedures similar to

those in section 110(c) if a State fails to

submit a ‘‘satisfactory plan.’’

E. Additional Requirements Under

Section 129

The Amendments of 1990 added

section 129, which includes specific

requirements for solid waste

combustion units. Section 129 requires

the EPA, under § 111(b), to establish

new source performance standards

(NSPS) for new MWI’s and, under

§ 111(d), to establish emission

guidelines for existing MWI’s.

1. New Sources The NSPS must

specify numerical emission limitations

for the following: 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/furans (CDD/CDF). Section

129 also includes requirements for

operator training as well as siting

requirements for new MWI’s.

Section 129 requires that emission

standards reflect the maximum degree

of reduction in air emissions that the

Administrator, taking into consideration

the cost of achieving such emission

reduction, and any nonair-quality health

and environmental impacts and energy

requirements, determines is achievable.

This requirement is referred to as

maximum achievable control

technology (MACT). The degree of

reduction in emissions that is deemed

achievable for new MWI’s may not be

less stringent than the emissions control

that is achieved in practice by the best

controlled similar unit. This

requirement that the standards must be

no less stringent than certain levels of

emission control currently achieved is

referred to as the ‘‘MACT floor’’ for new

MWI’s.

For NSPS, the control technology

used to achieve the standards is not

specified. Only the emission limits

achievable by MACT are included in the

standards. Any control technology that

can comply with these emission limits

may be used.

2. Existing Sources Notwithstanding

the limitations of setting guidelines for

existing sources under section 111(d),

section 129 directs EPA to issue

guidelines for existing MWI’s that

specify numerical emission limitations

for the same pollutants listed above for

new MWI’s. Section 129 also includes

requirements for operator training.

Section 129 provides that the State

plan for existing MWI’s be at least as

protective as the guidelines.

Section 129 also provides that

emission guidelines for existing MWI’s

reflect MACT, as described above.

However, while the guidelines for

existing MWI’s may be less stringent

than the standards for new MWI’s, the

guidelines may be no less stringent than

the average emission limitation

achieved by the best performing 12

percent of units in the category. This

requirement that the guidelines must be

no less stringent than certain levels of

emission control currently achieved is

referred to as the ‘‘MACT floor’’ for

existing MWI’s.

For emission guidelines (EG), the

control technology used for compliance

is not specified. Only the emission

limits achievable by MACT are included

in the guidelines. Any control
10658 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

technology that can comply with these

emission limits may be used.

Under section 129, States are required

to submit to the Administrator a plan

implementing the emission guidelines

within 1 year after promulgation of the

guidelines. Section 129 also requires

that a State plan shall provide that each

unit subject to the guidelines shall be in

compliance with all requirements of the

proposed guidelines within 3 years after

the State plan is approved by the

Administrator but in no case later that

5 years after promulgation of these

guidelines. The compliance schedule in

today’s proposed emission guidelines

would supersede and is more

comprehensive than the compliance

schedule and timetable specified in

section 129.

The proposal requires that a State

plan shall provide that each source

subject to the guidelines shall be in

compliance with all requirements of the

guidelines within 1 year after the State

plan is approved by the Administrator.

The proposal allows two exceptions to

this compliance schedule: extensions

for facilities planning to install the

necessary air pollution equipment and

extensions under a petition process for

other reasons. State plans that include

such provisions may allow designated

facilities up to 3 years after the State

plan is approved by the Administrator

(but no more than 5 years after

promulgation of the guidelines) to

achieve compliance. The only exception

to these compliance times involves the

operator training and qualification

requirements and the maintenance

inspection requirement. The proposed

emission guidelines require that a State

plan provide that each designated

facility shall be in compliance with the

operator training and qualification

requirements and the maintenance

inspection requirements within 1 year

after the State plan is approved by the

Administrator.

Section 129 specifies that the EPA, in

reviewing State plans for any variation

from the emission guidelines, must

ensure that State plans and their

resulting MWI control requirements are

at least as protective as the EPA

emission guidelines, including

incorporation of the compliance

schedule requirements established by

the guidelines.

II. Summary of the Standards and

Guidelines

A. Source Category To Be Regulated

The proposed standards for new

MWI’s would limit emissions of air

pollutants from each MWI for which

construction is commenced after today’s

date, or for which modification is

commenced after the effective date of

the standards. The effective date of the

proposed standards is specified in the

Act as the date 6 months after

promulgation of the standards. The

proposed guidelines for existing MWI’s

would require States to develop

emission standards limiting emissions

of air pollutants from each MWI for

which construction was commenced on

or before today’s date. Changes made to

an existing MWI solely for the purpose

of complying with the emission

guidelines would not bring an existing

MWI under the NSPS for new MWI’s.

The proposed standards and

guidelines would require facilities that

employ technologies such as pyrolysis/

gasification in medical waste

destruction to meet the emission limits

and all other requirements in today’s

proposal. The pyrolysis/gasification

industry does not object to be covered

under today’s proposed MWI standards

and guidelines and believes that they

can meet and exceed the proposed

emission limitations. However, the

pyrolysis/gasification industry believes

that their process is unique enough to

warrant a separate category for the

purpose of regulations. The agency is

requesting comment on whether these

units should be regulated as MWI’s or

as a separate source category. Also,

comment is requested on the definitions

of medical waste incineration and

medical waste pyrolysis/gasification

that would differentiate these two

categories of waste destruction for the

purpose of regulation.

An MWI is defined as any device used

to burn medical waste, with or without

other fuels or types of waste, including

the heat recovery device, if one is

present. Medical waste is 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 production or

testing of biologicals. Biologicals refer to

preparations made from living

organisms and their products, including

vaccines, cultures, etc., intended for use

in diagnosing, treating, or immunizing

humans or animals or in research

pertaining thereto. Medical waste

includes materials such as sharps,

fabrics, plastics, paper, waste

chemicals/drugs that are not RCRA

hazardous waste, and pathological

waste. Medical waste does not include

household waste, hazardous waste, or

human and animal remains not

generated as medical waste.

Most MWI’s burn a diverse mixture of

medical waste (referred to in this

preamble as general medical waste), that

may include some pathological waste

(human and animal body parts and/or

tissue). However, larger amounts of

pathological waste require special

operating conditions for combustion.

Thus, some facilities maintain MWI’s

designed and operated to burn

pathological waste exclusively.

The proposed standards and

guidelines focus on regulating emissions

from general medical waste incinerators

and include very minor requirements

for pathological MWI’s. Under this

proposal, pathological MWI’s would

only be required to submit quarterly

reports of the amount and type of

materials charged to the incinerator.

Pathological MWI’s will be considered

in future regulatory action under section

129 in the source category of ‘‘other

solid waste incinerators.’’

B. Pollutants To Be Regulated

Section 129 of the Act requires the

EPA to establish numerical emission

limits for PM, opacity, CO, CDD/CDF,

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

pollutants to be regulated would be

reported as concentrations and are

corrected to 7 percent oxygen.

Particulate matter and metals (Pb, Cd,

and Hg) would be reported as

milligrams per dry standard cubic meter

(mg/dscm). For Hg, the proposed

standards and guidelines would also

establish an alternative percent

reduction requirement. Carbon

monoxide, HCl, SO2, and NOx would be

reported as parts per million by volume

(ppmv), dry basis. As an alternative, the

proposed standards and guidelines for

HCl would also establish a percent

reduction requirement. Emissions of

CDD/CDF would be reported in units of

total nanograms per dry standard cubic

meter (ng/dscm) or ng/dscm toxic

equivalency (TEQ). Measurements of

TEQ are determined by first measuring

the total concentration of CDD/CDF

congeners and adjusting the results to

account for the varying toxicity of each

congener. Opacity is reported on a

percentage basis. The proposed

standards and guidelines also establish

fly ash/bottom ash fugitive emission

limitations, reported on a percentage

basis.

C. Affected Facility and Designated

Facility

The affected facility to which the

proposed standards applies is each

individual MWI for which construction

is commenced after today’s date or for

which modification is commenced after

the effective date of these standards.

The effective date of the proposed

standards is specified in the Act as the

date 6 months after promulgation of the

standards.
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10659

The designated facility to which the

proposed emission guidelines apply is

each individual MWI for which

construction is commenced on or before

today’s date.

D. Proposed Standards and Guidelines

Table 1 lists the emission limitations

under the proposed standards and

guidelines, Tables 2 and 3 list other

requirements of the proposed standards

and guidelines, and Tables 4 and 5 list

the compliance times for the proposed

standards and guidelines.

TABLE 1.—SUMMARY OF PROPOSED EMISSION LIMITS FOR NEW AND EXISTING MEDICAL WASTE INCINERATORS

Pollutant Emissions limits

Particulate matter ...................................... 30 mg/dscm (0.013 gr/dscf) 12-hour average.

Opacity ...................................................... 5 percent 6-minute average.

Carbon monoxide ...................................... 50 ppmv 12-hour average.

Dioxins/furans ............................................ 80 ng/dscm total CDD/CDF (35 gr/10 9 dscf) or 1.9 ng/dscm TEQ (0.83 gr/10 9 dscf) 12-hour average.

Hydrogen chloride ..................................... 42 ppmv or 97% reduction 9-hour average.

Sulfur dioxide ............................................. 45 ppmv 12-hour average.

Nitrogen oxides ......................................... 210 ppmv 12-hour average.

Lead ........................................................... 0.10 mg/dscm (44 gr/10 6 dscf) 12-hour average.

Cadmium ................................................... 0.05 mg/dscm (22 gr/10 9 dscf) 12-hour average.

Mercury ...................................................... 0.47 mg/dscm (210 gr/10 6 dscf) or 85% reduction 12-hour average.

NOTE: Tables 1 through 5 depict the major provisions of the proposed standards and guidelines and do not attempt to show all requirements.

The full text of Subparts Ec and Cc should be relied upon for a full and comprehensive statement of the requirements of the proposed standards

and guidelines.

TABLE 2.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE NSPS FOR NEW MEDICAL WASTE INCINERATORS

Additional Requirements

Operator Training and Qualification Requirements:

• Complete MWI operator training course.

• Qualify operators.

• Develop a site-specific operating manual and update annually.

Siting Requirements:

• Prepare a siting analysis.

• Conduct a public meeting at which comment is accepted on the siting analysis.

• Prepare responses to the comments and make them available to the public.

• Include in the initial notification to construct the results of siting analysis and a letter from the State air pollution control office approving

the construction and operation of the affected facility.

Compliance and Performance Testing Requirements:

• Conduct an initial and annual performance test to determine compliance with the emission limitations for all pollutants and to establish

operating parameters.

• Facilities may conduct performance tests for CDD/CDF, PM, Cd, Pb, and Hg every third year if the previous three MWI performance

tests demonstrate that the facility is in compliance with the emission limits.

Continuously monitor emissions and measure and record operating parameters.

• Perform monthly fugitive testing.

Monitoring Requirements:

• Install and maintain equipment to continuously monitor emissions/operating parameters as appropriate.

• Obtain monitoring data at all times during MWI operation.

Reporting and Recordkeeping Requirements:

• Maintain for 5 years records of results from initial performance test and all subsequent performance tests, operating parameters, and any

maintenance.

• Maintain for the life of the incinerator records of siting analysis and operator training and qualification.

• Submit the results of the initial performance test and all subsequent performance tests.

• Submit, within 30 days following the end of the quarter of occurrence, reports on emission rates or operating parameters that have not

been recorded or that exceeded applicable limits.

• Provide notification of intent to construct, of planned initial start-up date, and of planned waste type(s) to be combusted.

NOTE: Tables 1 and 2 depict the major provisions of the NSPS and do not attempt to show all requirements. The regulatory text of Subpart Ec

should be relied upon for a full and comprehensive statement of the requirements of the proposed NSPS.

TABLE 3.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE EG FOR EXISTING MEDICAL WASTE INCINERATORS

Additional Requirements

Operator Training and Qualification Requirements:

• Complete MWI operator training course.

• Qualify operators.

• Develop a site-specific operating manual and update annually.

Inspection Requirements:

• Provide for an annual equipment inspection by an MWI service technician not employed by the owner or operator of the affected facility

until source demonstrates compliance with emission limits.

Compliance and Performance Testing Requirements:

• Conduct an initial and annual performance test to determine compliance with the emission limitations for all pollutants and to establish

operating parameters.
10660 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

TABLE 3.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE EG FOR EXISTING MEDICAL WASTE INCINERATORS—

Continued

Additional Requirements

• Facilities may conduct performance tests for CDD/CDF, PM, Cd, Pb, and Hg every third year if the previous three performance tests

demonstrate that the facility is in compliance with the emission limits.

• Continuously monitor emissions and measure and record operating parameters.

• Perform monthly fugitive testing.

Monitoring Requirements:

• Install and maintain equipment to continuously monitor emissions/operating parameters as appropriate.

• Obtain monitoring data at all times during MWI operation.

Reporting and Recordkeeping Requirements:

• Maintain for 5 years records of: results from initial performance test and all subsequent performance tests, operating parameters, annual

inspections, and any maintenance.

• Maintain for the life of the incinerator records of operator training and qualification.

• Submit the results of the initial performance test and all subsequent performance tests.

• Submit, within 30 days following the end of the quarter of occurrence, reports on emission rates or operating parameters that have not

been recorded or which exceeded applicable limits.

NOTE: Tables 1 and 3 depict the major provisions of the emission guidelines (EG) and do not attempt to show all requirements. The regulatory

text of Subpart Cc should be relied upon for a full and comprehensive statement of the requirements of the proposed guidelines.

TABLE 4.—COMPLIANCE TIMES FOR NEW MWI’S NEW SOURCE PERFORMANCE STANDARDS

Requirement Compliance Time

Effective date ............................................. 6 months after promulgation of NSPS.

Operator training and qualification requirements.On effective date or upon initial start up, whichever is later.

Initial compliance test ................................ On effective date or within 180 days of initial start up, whichever is later.

Performance test ....................................... Within 12 months following initial compliance test and annually thereafter.

CEMS and parameter monitoring ............. Continuously, upon completion of initial compliance test.

Recordkeeping .......................................... Continuously, upon completion of initial compliance test.

Reporting ................................................... Quarterly, upon completion of initial compliance test.

TABLE 5.—COMPLIANCE TIMES FOR EXISTING MWI’S EMISSION GUIDELINES

Requirement Compliance Time

State Plan submittal .................................. Within 1 year after promulgation of EPA emission guidelines.

Effective date ............................................. Within 1 year after EPA approval of State Plan.

Operator training and qualification requirements.Within 1 year after EPA approval of State Plan.

Recordkeeping .......................................... Continuously, upon completion of initial compliance test.

Initial compliance test ................................ Within 1 year after EPA approval of State plan or up to 3 years after EPA approval of State plan if

the source is granted an extension.

Performance test ....................................... Within 12 months following initial compliance test and annually thereafter.

CEMS and parameter monitoring ............. Continuously, upon completion of initial compliance test.

Inspection requirements ............................ Within 1 year after EPA approval of State Plan.

Reporting ................................................... Quarterly, upon completion of initial compliance test.

A brief discussion of the emission

limitations is presented below. Further

discussion of the additional

requirements can be found in sections

II.E through II.L of this section.

1. Numerical Emission Limits

The numerical emission limits in this

section are corrected to 7 percent O2.

Particulate Matter—The proposed

emission limitation for PM for both new

and existing MWI’s is 30 milligrams per

dry standard cubic meter (mg/dscm).

Opacity—The proposed emission

limitation for stack opacity for both new

and existing MWI’s is 5 percent (6-

minute average).

Carbon Monoxide—The proposed

emission limitation for CO for both new

and existing MWI’s is 50 parts per

million by volume (ppmv), dry basis.

Dioxins/Furans—The proposed

emission limitation for CDD/CDF for

both new and existing MWI’s is 80 ng/

dscm total CDD/CDF or 1.9 ng/dscm

TEQ. This limit would be measured as

total tetra- through octa-chlorinated

dibenzo-p-dioxins and dibenzofurans as

determined by Reference Method 23 and

converted to TEQ’s using the toxic

equivalency factors (TEF’s) shown in

Table 6.

TABLE 6.—TOXIC EQUIVALENCY

FACTORS

CDD/CDF congener

Toxic

equivalency factor

2,3,7,8-tetrachlorinated dibenzo-pdioxin ......................................... 1

1,2,3,7,8-pentachlorinated

dibenzo-p-dioxin ........................ 0.5

1,2,3,4,7,8-hexachlorinated

dibenzo-p-dioxin ........................ 0.1

1,2,3,7,8,9-hexachlorinated

dibenzo-p-dioxin ........................ 0.1

1,2,3,6,7,8-hexachlorinated

dibenzo-p-dioxin ........................ 0.1

1,2,3,4,6,7,8-heptachlorinated

dibenzo-p-dioxin ........................ 0.01

octachlorinated dibenzo-p-dioxin .. 0.001
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10661

TABLE 6.—TOXIC EQUIVALENCY

FACTORS—Continued

CDD/CDF congener

Toxic

equivalency factor

2,3,7,8-tetrachlorinated

dibenzofuran ............................. 0.1

2,3,4,7,8-pentachlorinated

dibenzofuran ............................. 0.5

1,2,3,7,8-pentachlorinated

dibenzofuran ............................. 0.05

1,2,3,4,7,8-hexachlorinated

dibenzofuran ............................. 0.1

1,2,3,6,7,8-hexachlorinated

dibenzofuran ............................. 0.1

1,2,3,7,8,9-hexachlorinated

dibenzofuran ............................. 0.1

2,3,4,6,7,8-hexachlorinated

dibenzofuran ............................. 0.1

1,2,3,4,6,7,8-heptachlorinated

dibenzofuran ............................. 0.01

1,2,3,4,7,8,9-heptachlorinated

dibenzofuran ............................. 0.01

octachlorinated dibenzofuran ....... 0.001

Hydrogen Chloride—The proposed

emission limitation for HCl for both new

and existing MWI’s is 42 ppmv, dry

basis (or 97-percent reduction).

Sulfur Dioxide—The proposed

emission limitation for SO2 for both new

and existing MWI’s is 45 ppmv, dry

basis.

Nitrogen Oxides—The proposed

emission limitation for NOX for both

new and existing MWI’s is 210 ppmv,

dry basis.

Lead—The proposed emission

limitation for Pb for both new and

existing MWI’s is 0.10 mg/dscm.

Cadmium—The proposed emission

limitation for Cd for both new and

existing MWI’s is 0.05 mg/dscm.

Mercury—The proposed emission

limitation for Hg for both new and

existing MWI’s is 0.47 mg/dscm (or 85-

percent reduction).

2. Fly Ash/Bottom Ash Emissions

The proposed standards and

guidelines would establish a limit of

zero percent opacity of fly ash or bottom

ash from any fly ash or bottom ash

storage or handling area within the

facility’s property boundary.

E. Operator Training and Qualification

Requirements

The proposed standards and

guidelines include operator training and

qualification requirements for each MWI

operator. For new MWI’s, these

requirements would become effective

six months after promulgation of the

NSPS. For existing MWI’s, these

requirements would become effective

one year after approval of the State plan.

An acceptable training course would

provide the operator with a minimum

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. To be

qualified, an operator must complete the

training course and have either a

minimum level of experience or satisfy

comparable or more stringent criteria

that are established by a national

professional organization. The proposed

standards and guidelines also would

require that the owner or operator of the

facility develop and annually update a

site-specific operating manual. The

manual would summarize State

emissions regulations, operating

procedures, and reporting and

recordkeeping requirements in

accordance with the proposed standards

and guidelines.

F. Siting Requirements—New MWI’s

Site selection criteria are being

proposed for MWI’s that commence

construction after the date of

promulgation of this rule. The proposed

siting requirements would address the

impact of the facility on ambient air

quality, visibility, soils, vegetation, and

other factors that may be relevant in

determining that the benefits of the

proposed facility significantly outweigh

the environmental and social costs

imposed as a result of its location and

construction. A document presenting

the results of the analyses would be

prepared and submitted to EPA, State,

and local officials and would be made

available to the public. Provisions for a

public meeting and the preparation of a

comment and response document are

also included in the proposed siting

requirements.

G. Inspection Requirements—Existing

MWI’s

The proposed emission guidelines

include a requirement for an initial

equipment inspection of the designated

facility. These requirements would

become effective 1 year after the EPA

approval of the State plan. The

inspection must be performed by an

MWI service technician not employed

by the owner or operator of the

designated facility. The proposed

guidelines provide minimum

requirements for inspection of the

designated facility. Following the initial

inspection and until compliance with

the emission limitations has been

demonstrated, facilities are required to

conduct annual inspections of the MWI.

H. Compliance and Performance Test

Methods and Monitoring Requirements

Testing and monitoring requirements

are proposed to demonstrate compliance

with the emission limits. The proposed

standards and guidelines require that

the owner or operator of the facility: (1)

conduct initial and annual performance

tests to demonstrate compliance with

the emission limits and (2) demonstrate

continuous compliance with the

emission limits following the initial

performance test.

The initial and annual performance

tests would be conducted using the

following EPA-approved methods:

1. Method 1 would be used to select

the sampling site and number of

traverse points;

2. Method 3 or 3A would be used for

gas composition analysis, including

measurement of oxygen;

3. Method 5 or Method 29 would be

used to measure PM emissions;

4. A continuous emissions monitoring

system (CEMS) would be used to

measure opacity;

5. A CEMS would be used to measure

CO emissions;

6. Method 23 would be used to

measure CDD/CDF emissions;

7. Method 26 would be used to

measure HCl emissions;

8. Method 29 would be used to

measure Pb, Cd, and Hg emissions; and

9. Method 9 would be used to

measure opacity of fugitive emissions.

The proposed standards and

guidelines include provisions for less

frequent testing if the facility

consistently demonstrates compliance.

These provisions are described in detail

in section V of this preamble. Following

the initial performance test, the owners

or operators must demonstrate

continuous compliance with the limits

by monitoring the output of a CEMS,

where a CEMS is required, and by

monitoring site-specific operating

parameters where a CEMS is not

required. Facilities are required to:

1. Demonstrate continuous

compliance with the CO emission limit

based on the output from the CO CEMS;

2. Demonstrate continuous

compliance with the opacity emission

limit based on the output from the

opacity CEMS; and

3. Demonstrate compliance with the

fugitive emission limit by conducting a

performance test using Method 9 at least

once per calendar month when ash is

removed from the incinerator and when

ash is removed from the air pollution

control device (APCD).

In addition, facilities equipped with a

dry scrubber followed by a fabric filter

are required to demonstrate compliance

in the following ways:
10662 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

1. Demonstrate compliance with the

Hg emission limit by continuously

monitoring the Hg sorbent flow rate

(typically activated carbon) and

continuously measuring the weight and

time of each load of waste charged to

the incinerator. The minimum Hg

sorbent flow rate, the maximum charge

weight, and the maximum hourly charge

rate are to be established during the

initial performance test to determine

compliance with the Hg emission limit.

Operation of the facility below the

minimum sorbent flow rate, or above

the maximum charge weight or

maximum hourly charge rate would

constitute a violation of the Hg emission

limit.

2. Demonstrate compliance with the

CDD/CDF emission limit by

continuously monitoring the CDD/CDF

sorbent flow rate (typically activated

carbon) and the temperature measured

at the inlet to the PM control device.

The minimum CDD/CDF sorbent flow

rate and the maximum PM control

device inlet temperature are to be

established during the initial

performance test to determine

compliance with the CDD/CDF emission

limit. Operation of the facility below the

minimum sorbent flow rate or above the

maximum PM control device inlet

temperature would constitute a

violation of the CDD/CDF emission

limit.

3. Demonstrate compliance with the

HCl emission limit by continuously

monitoring the HCl sorbent flow rate

(typically hydrated lime) and

continuously measuring the weight and

time of each load of waste charged to

the incinerator. The minimum HCl

sorbent flow rate, the maximum charge

weight, and the maximum hourly charge

rate are to be established during the

initial performance test to demonstrate

compliance with the emission limit for

HCl. Operation of the facility below the

minimum sorbent flow rate, or above

the maximum charge weight or

maximum hourly charge rate would

constitute a violation of the HCl

emission limit.

The proposed standards and

guidelines require the owner or operator

of an MWI using a control device other

than a dry scrubber followed by a fabric

filter to petition the Administrator for

other site-specific operating parameters

to demonstrate continuous compliance

with the emission limits for CDD/CDF,

Hg, HCl, and/or opacity. These

parameters would be established during

the initial performance test for these

pollutants and would be continuously

monitored to demonstrate compliance

with the emission limits. As discussed

in section VI, the EPA requests

comment on appropriate parameters for

wet scrubbers and for other control

systems that may be used to control

emissions from MWI’s.

I. Reporting and Recordkeeping—New

MWI’s

The proposed standards would

require owners of affected facilities (i.e.,

new or modified MWI’s) to submit

notifications concerning construction

and initial startup of the affected

facility. Owners and operators are also

required to maintain thorough records

documenting the results of the initial

and annual performance tests, records

demonstrating continuous monitoring of

site-specific operating parameters, and

CEMS output data and quality assurance

determinations. These records must be

kept on file for at least 5 years.

Additional records must be kept on

file for the life of the affected facility.

These records are required to document

compliance with the siting requirements

and the operator training and

qualification requirements. The records

to be maintained include all

documentation produced as a result of

the siting requirements and records of

the names of the persons who have

completed the operator training

requirements, the names of the persons

who have been qualified as MWI

operators, and the names of the persons

who have completed review of the sitespecific MWI operating manual. All

records must also include dates

associated with operator training and

qualification, and dates associated with

review of the operating manual.

Under the proposed standards,

owners or operators of affected facilities

are required to submit the results of the

initial performance test and all

subsequent performance tests. Also,

reports on emission rates or operating

parameters that have not been obtained

or that exceed applicable limits must be

submitted within 30 days after the end

of the quarter of occurrence. If no

exceedances occur during a quarter, the

owner of the affected facility would be

required to submit a letter stating so. All

reports submitted to comply with the

requirements of the proposed standards

must be signed by the facilities manager.

J. Reporting and Recordkeeping—

Existing MWI’s

The proposed emission guidelines

would require owners of designated

facilities (i.e., existing MWI’s) to

maintain thorough records documenting

the results of the initial and annual

performance tests, records

demonstrating continuous monitoring of

site-specific operating parameters,

CEMS output data and quality assurance

determinations, and records of the

initial and annual inspections. These

records must be kept on file for at least

5 years.

Additional records must be kept on

file for the life of the designated facility.

These records are required to document

compliance with the operator training

and qualification requirements and

include records of the names of the

persons who have completed the

operator training requirements, the

names of the persons who have been

qualified as MWI operators, and the

names of the persons who have

completed review of the site-specific

MWI operating manual. All records

must also include dates associated with

operator training and qualification, and

dates associated with review of the

operating manual.

Under the proposed emission

guidelines owners or operators are

required to submit the results of the

initial and annual maintenance

inspections and the results of the initial

performance test and all subsequent

performance tests. Additionally, reports

of data on emission rates or operating

parameters that have not been obtained

or that exceed applicable limits must be

submitted within 30 days after the end

of the quarter of occurrence. If no

exceedances occur during a quarter, the

owner of the designated facility would

be required to submit a letter stating so.

All reports submitted to comply with

the requirements of the proposed

emission guidelines must be signed by

the facilities manager.

K. Compliance Times

1. New MWI’s

The effective date of the standards for

new MWI’s is the date 6 months after

promulgation of the standards.

2. Existing MWI’s

In accordance with the proposed

guidelines, for approval, a State plan

must require that designated facilities

comply with all requirements of the

guidelines within 1 year after EPA

approval of the State plan. The proposal

allows two exceptions to this

compliance schedule. First, State plans

may allow facilities that are planning to

install the necessary air pollution

control equipment up to three years

after EPA approval of the State plan to

comply, provided the State plan

specifies that the facility submit

measurable and legally enforceable

incremental steps of progress that will

be taken to comply with the State plan.

Second, State plans may include

provisions for a petition process through

which designated facilities could
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10663

request an extension for other reasons.

The proposed guidelines specify

minimum requirements to be included

in State plans with such provisions. If

an extension is granted, compliance

must be required within 3 years after

EPA approval of the State plan.

Regardless of the status of the State

plans, all designated facilities must be

in compliance within 5 years after

promulgation of the emission

guidelines. The proposed emission

guidelines require the EPA to develop,

implement, and enforce a plan for any

State that has not submitted an

approvable plan within 2 years after

promulgation of the emission

guidelines.

The proposed emission guidelines

also require that, for approval, a State

plan provide that each designated

facility must be in compliance with the

operator training and qualification

requirements and the inspection

requirements within 1 year after EPA

approval of the State plan. No extension

is available for training, qualification, or

inspection.

L. Permit Requirements

The proposed standards and

guidelines include a requirement that

facilities operate pursuant to permits

issued under the EPA-approved State

operating permit program. Permits

would be required beginning 36 months

after the date of promulgation of the

standards and guidelines, or on the

effective date of an EPA-approved

operating permit program in the State in

which the facility is located, whichever

date is later. The operating permit

programs are developed under Title V of

the Act and the implementing

regulations under 40 CFR part 70.

III. Impacts of the Proposed Standards

for New MWI’s

This section presents a description of

the air, water, solid waste, energy,

control cost, and economic impacts of

today’s proposed standards for new

MWI’s. All of the impacts presented are

nationwide impacts that are expected to

result from the implementation of the

NSPS in the fifth year after adoption. As

discussed below, it is expected that as

many as 80 percent of the projected

number of new MWI’s will not be

constructed to avoid the increased costs

associated with installation of control

equipment. Therefore, impacts are

presented assuming 80 percent of

projected new MWI’s are not

constructed, with the waste being

disposed of by other means (i.e., the

‘‘switching scenario’’).

Based on historic sales to date, in the

absence of regulation, an estimated 700

new MWI’s are expected to be installed

over the next 5 years. However, onsite

incineration is only one of several

medical waste treatment and disposal

options. For some MWI’s, the

equipment necessary to comply with the

proposed regulations will make onsite

incineration more expensive than other

waste treatment and disposal options.

Consequently, many facilities that

would have chosen onsite incineration

are likely to consider less expensive

methods of treatment and disposal. The

EPA expects that as many as 80 percent

of the projected number of new MWI’s

will not be constructed if the standards

are promulgated as proposed. This is

referred to in this notice as the

‘‘switching scenario’’ because of the

expectation that potential owners of

MWI’s will switch to another method of

waste treatment and disposal.

Recent experience at the State level

confirms that switching to lower cost

alternatives is a likely impact of the

implementation of MWI regulations that

require add-on air pollution control. For

example, recent regulations adopted by

the State of New York require the use of

add-on acid gas scrubber systems. As a

result, the State estimates that as many

as 90 percent of previously existing

MWI’s in New York have ceased

operation. New York’s regulations are

similar to the proposed EPA standards

in that they require the use of add-on air

pollution control systems or use of an

alternative waste disposal approach.

While these State regulations have

increased the cost of waste disposal, it

appears that the availability of

alternatives to onsite incineration has

mitigated the economic impacts that

might have been associated with the

State regulations.

One concern that has recently been

raised related to switching away from

onsite incineration is the availability of

alternatives to onsite incineration. Two

common alternatives are offsite contract

disposal (most commonly commercial

medical waste incineration) and onsite

autoclaving (steam treatment). Other

less common alternatives include onsite

chemical treatment and onsite

microwave irradiation. The commercial

medical waste disposal industry

believes that there presently exists

sufficient offsite capacity to treat the

waste that would no longer be treated

onsite. In addition, autoclaves and other

onsite waste disposal options are

available. In fact, even today in the

absence of Federal regulations, most

facilities that generate medical waste do

not operate onsite MWI’s. This indicates

that there currently are viable

alternatives to onsite incineration.

A second concern regrading a shift

away from onsite incineration is the

increased transportation and handling

of untreated medical waste. However,

the Department of Transportation (DOT)

has promulgated regulations (49 CFR

parts 171, 172, and 173) that address the

safe transportation and handling of

medical waste. The DOT regulations

include provisions for packaging and

labeling of medical waste. Also, the

Occupational Safety and Health

Administration (OSHA) promulgated

regulations on December 5, 1991 (29

CFR part 1910) that address

occupational exposure to bloodborne

pathogens. Using a combination of

engineering and work practice controls,

personal protective clothing and

equipment, training, medical follow-up

of exposure incidents, vaccinations

(where appropriate) and other

provisions, the OSHA regulations

minimize or eliminate health risk as a

result of occupational exposure to

bloodborne pathogens. The Agency

believes these DOT and OSHA

regulations will provide sufficient

protection from potential increases in

exposure to these wastes.

A. Air Impacts

As discussed earlier, impacts are

presented assuming the more likely

‘‘switching scenario.’’ Baseline

emissions and emissions under the

proposed NSPS based on the switching

scenario are presented in Tables 7a and

7b.

TABLE 7a.—BASELINE EMISSIONS

COMPARED WITH EMISSIONS AFTER

NSPS (WITH SWITCHING)

[Metric Units]

Pollutant Units Baseline

After

NSPS

with

switching

PM ........... Mg/yr ... 1,670 81.7

CO ........... Mg/yr ... 1,630 61.7

CDD/CDF kg/yr .... 21.7 0.032

HCl .......... Mg/yr ... 10,000 230

SO2 .......... Mg/yr ... 192 144

NOX ......... Mg/yr ... 1,240 944

Pb ............ Mg/yr ... 19.2 0.29

Cd ............ Mg/yr ... 1.38 0.042

Hg ............ Mg/yr ... 14.5 1.10
10664 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

TABLE 7b.—BASELINE EMISSIONS

COMPARED WITH EMISSIONS AFTER

NSPS (WITH SWITCHING)

[English Units]

Pollutant Units Baseline

After

NSPS with

switching

PM .... Tons/yr ... 1,850 90.0

CO .... Tons/yr ... 1,790 68.0

CDD/

CDF.

Lb/yr ....... 47.9 0.070

HCl .... Tons/yr ... 11,100 254

SO2 ... Tons/yr ... 212 159

NOX .. Tons/yr ... 1,370 1,040

Pb ..... Tons/yr ... 21.2 0.32

Cd ..... Tons/yr ... 1.52 0.046

Hg ..... Tons/yr ... 16.0 1.21

The proposed standards would reduce

nationwide emissions of PM by 1,590

megagrams per year (Mg/yr) (1,750 tons

per year (tons/yr)) from estimated

emission levels under the typical

existing control or the ‘‘regulatory

baseline’’ of 1,670 Mg/yr (1,850 tons/yr).

This reduction represents a decrease of

about 95 percent from baseline PM

emission levels in the absence of the

proposed standards.

Nationwide emissions of CO would be

reduced by 1,570 Mg/yr (1,730 tons/yr)

from estimated emission levels under

the regulatory baseline of 1,630 Mg/yr

(1,790 tons/yr). This reduction equates

to an overall control level of about 96

percent for CO emissions.

As a result of today’s proposal,

nationwide emissions of CDD/CDF

would be reduced by 21.70 kilograms

per year (kg/yr) (47.8 pounds per year

(lb/yr)) from estimated emission levels

under the regulatory baseline of 21.73

kg/yr (47.9 lb/yr). The CDD/CDF

emissions would be reduced by over 99

percent from the regulatory baseline.

The proposed standards would reduce

nationwide emissions of HCl by 9,820

Mg/yr (10,800 tons/yr) from estimated

emission levels under the regulatory

baseline of 10,000 Mg/yr (11,100 tons/

yr). This reduction represents a decrease

of about 98 percent in HCl emissions.

Nationwide emissions of SO2 and

NOX would be reduced by 48.1 Mg/yr

(53.0 tons/yr) and 300 Mg/yr (331 tons/

yr), respectively, from estimated

emission levels under the regulatory

baseline of 192 Mg/yr (212 tons/yr) for

SO2 and 1,240 Mg/yr (1,370 tons/yr) for

NOX. These reductions equate to an

overall emissions decrease of about 25

percent for SO2 and about 24 percent for

NOX.

As a result of today’s proposal, the

nationwide emissions of Pb, Cd, and Hg

would be reduced by 18.9 Mg/yr (20.9

tons/yr), 1.34 Mg/yr (1.47 tons/yr), and

13.4 Mg/yr (14.8 tons/yr), respectively,

from estimated emission levels under

the regulatory baseline of 19.2 Mg/yr

(21.2 tons/yr) for Pb, 1.38 Mg/yr (1.52

tons/yr) for Cd, and 14.5 Mg/yr (16.0

tons/yr) for Hg. These reductions equate

to overall control levels of about 98

percent for Pb, 97 percent for Cd, and

92 percent for Hg.

B. Water and Solid Waste Impacts

Under the proposed NSPS, no

significant water pollution impacts are

projected because the emission control

technologies on which the emission

limits are based do not produce a

wastewater stream. However, to the

extent that wet scrubber systems could

be used to comply with the proposed

emission limitations, water pollution

impacts could be more significant. As

discussed in section VI of this preamble,

the Agency solicits information

regarding water pollution impacts

associated with the use of wet scrubber

systems.

With regard to solid waste impacts,

about 421,000 Mg (464,000 tons) of

medical waste are projected to be

burned annually in new MWI’s in the

fifth year after adoption of the NSPS in

the absence of Federal regulations (i.e.,

at the regulatory baseline). This quantity

of waste burned would result in about

42,100 Mg/yr (46,400 tons/yr) of solid

waste (bottom ash) disposed of in

landfills. The addition of acid gas

control using dry lime injection, and

CDD/CDF and Hg control using

activated carbon injection, would

increase the quantity of solid waste for

final disposal by adding baghouse ash to

the amount of bottom ash already

generated under the regulatory baseline.

In addition, switching to onsite

alternatives to incineration will result in

an increase in solid waste for final

disposal because the nonincineration

treatment methods do not reduce the

volume of waste as much as

incineration.

Under the switching scenario, the

amount of solid waste ultimately sent to

landfills would increase by about

135,000 Mg/yr (149,000 tons/yr). This

includes the increase in ash from the air

pollution control devices (APCD’s) and

the increase in waste that is treated and

landfilled without being incinerated.

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. Therefore, no adverse

solid waste impacts are anticipated

under the proposed standards.

C. Energy Impacts

The emission control technologies

upon which the emission limits are

based would require additional energy

consumption for all new MWI’s. Under

the switching scenario, it is not clear

whether energy consumption will

increase, decrease, or remain the same.

Alternatives to incineration require

energy to operate. However, information

is not available to estimate whether

alternatives use more or less energy than

MWI’s. It is expected that the increase

in energy consumption resulting from

the switching scenario will be less than

the increase under the no-switching

scenario.

The estimates of energy impacts

assuming all new MWI’s are constructed

and install air pollution control (noswitching scenario) include additional

auxiliary fuel (natural gas) for

combustion controls and additional

electrical energy for operation of the

add-on control devices. In the fifth year

after adoption, the proposed standards

would increase total national usage of

natural gas by about 25 million cubic

meters per year (MMm3/yr) (895 million

cubic feet per year (106 ft3/yr))

compared to fuel consumption

determined from the regulatory

baseline. Total national usage of

electrical energy would increase by

about 41,400 megawatt hours per year

(MW-hr/yr) (141 billion British thermal

units per year (109 Btu/yr)) of electricity

compared to electrical energy

consumption determined from the

regulatory baseline.

D. Control Cost Impacts

The control cost impacts on

individual facilities will vary depending

on the cost of compliance with the

regulation; the cost of alternative

treatment and disposal methods; and

other factors such as proximity to an

offsite contract disposal facility, liability

issues related to the transportation and

final disposal of the waste, and State

and local medical waste treatment and

disposal requirements. In general,

facilities requiring a smaller waste

treatment capacity will have a greater

incentive to use a less expensive

treatment and disposal option because

their onsite incineration cost (per ton of

waste burned) will be higher. Facilities

with larger amounts of waste to be

treated may have some cost advantages

if they use lower cost alternatives, but

these advantages are not as significant

due to economies of scale.

Under the switching scenario, the

nationwide annual costs associated with

the NSPS will increase by about 74.5

million/yr (from a baseline cost of 63.3
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10665

million/yr). The nationwide annualized

cost of waste disposal per unit of

medical waste treated would increase by

$177/Mg ($161/ton) from the estimated

nationwide annualized cost of $150/Mg

($136/ton) under the regulatory

baseline.

E. Economic Impacts

The goal of the economic impact

analysis was to estimate the market

response to the NSPS and to determine

whether there would be adverse impacts

associated with the proposed standards.

The proposed standards would affect

five major industry sectors (hospitals,

nursing homes, veterinary facilities,

commercial research laboratories, and

commercial medical waste incineration

facilities) within which some facilities

operate an onsite MWI. In addition, the

proposed standards would affect a

number of other industry sectors in

which facilities do not typically operate

an onsite MWI (e.g., blood banks). The

economic impact analysis for new

MWI’s examined each of these sectors as

a whole to determine industrywide

impacts.

To assess the industrywide impacts of

control costs, the market price increase

resulting from the proposed standards

was estimated for each regulated

industry. The market price increases,

presented in Table 8, may be thought of

as an average price increase across each

industry required to recover control

costs within each industry. Table 8

reflects the more likely switching

scenario. For example, under the

switching scenario, the hospital

industry would have to raise prices by

an average of about 0.03 percent (over

current revenues of about $224 billion/

yr) to cover the increased cost of waste

disposal. This table shows that the price

increase is relatively small for each

industry. This result is mainly due to

the projection that most facilities do not

(or will not, within the next 5 years after

adoption of the standards) operate an

onsite incinerator.

TABLE 8.—MARKET PRICE INCREASES

IN THE MAJOR INDUSTRY SECTORS

UNDER THE NSPS—SWITCHING

SCENARIO

Industry

Price increase,

percent

Hospitals ..................................... 0.03

Nursing Homes ........................... 0.01

Veterinary Facilities .................... 0.01

Commercial Research Laboratories ....................................... 0.03

Physicians’ Offices ..................... 0

Dentists’ Offices .......................... 0

Freestanding Bloodbanks ........... 0.02

TABLE 8.—MARKET PRICE INCREASES

IN THE MAJOR INDUSTRY SECTORS

UNDER THE NSPS—SWITCHING

SCENARIO—Continued

Industry

Price increase,

percent

Commercial Medical Waste Incineration Facilities ................. a N/A

a Industrywide impacts were not calculated

for commercial medical waste incineration facilities because estimates of the change in demand for commercial medical waste incineration were not available. However, this industry is expected to be able to recoup all control

cost increases through price increases.

Output, employment, and revenue

impacts were also estimated. As a result

of the low market price increases and/

or relatively inelastic demand, the

corresponding decreases in output,

employment, and revenue were also

low, never exceeding 0.05 percent under

the more likely switching scenario. This

result implies that no medical wastegenerating industry would need to be

significantly reconstructed (e.g., through

closures or consolidations) as a result of

the proposed standards.

IV. Impacts of the Proposed Guidelines

for Existing MWI’s

This section presents a description of

the air, water, solid waste, energy,

control cost, and economic impacts of

today’s proposed guidelines. All

impacts are nationwide impacts that are

expected to result from the

implementation of the emission

guidelines. As discussed below, it is

expected that as many as 80 percent of

existing facilities currently using onsite

incineration will switch to an

alternative method of treatment and

disposal to avoid the increased cost of

installing air pollution control

equipment. Therefore, impacts are

presented assuming 80 percent of

existing facilities using onsite MWI’s

will switch to a lower cost alternative

treatment and disposal methods (i.e.,

the ‘‘switching scenario’’).

Onsite incineration is only one of

several medical waste treatment and

disposal options, and for some MWI’s,

the cost of the equipment necessary to

comply with the proposed emission

guidelines will make onsite incineration

more expensive than other treatment

and disposal options. Consequently,

many facilities that currently operate

onsite MWI’s are likely to switch to a

less expensive method of treatment and

disposal. The EPA expects that as many

as 80 percent of the existing facilities

currently using onsite MWI’s will

switch to a lower cost alternative

method of treatment and disposal if the

guidelines are promulgated as proposed.

This is referred to in this notice as the

‘‘switching scenario’’ because of the

expectation that owners of MWI’s will

switch to another method of waste

treatment and disposal.

Recent experience at the State level

confirms that switching to lower cost

alternatives is a likely impact of the

implementation of MWI regulations that

require add-on air pollution control. For

example, recent regulations adopted by

the State of New York require the use of

add-on acid gas scrubber systems. As a

result, the State estimates that as many

as 90 percent of previously existing

MWI’s in New York have ceased

operation. New York’s regulations are

similar to the proposed EPA guidelines

in that they require the use of add-on air

pollution control systems or use of an

alternative waste disposal approach.

While these State regulations have

increased the cost of waste disposal, it

appears that the availability of

alternatives to onsite incineration has

mitigated the economic impacts that

might have been associated with the

State regulations.

One concern that has recently been

raised related to switching away from

onsite incineration is the availability of

alternatives to onsite incineration. Two

common alternatives are offsite contract

disposal (most commonly commercial

medical waste incineration) and onsite

autoclaving (steam treatment). Other

less common alternatives include onsite

chemical treatment and onsite

microwave irradiation. The commercial

medical waste disposal industry

believes that there presently exists

sufficient offsite capacity to treat the

waste that would no longer be treated

onsite. In addition, autoclaves and other

onsite waste disposal options are

available. In fact, even today in the

absence of Federal regulation, most

facilities that generate medical waste do

not operate onsite MWI’s. This indicates

that there currently are viable

alternatives to onsite incineration.

A second concern regarding a shift

away from onsite incineration is the

increased transportation and handling

of untreated medical waste. However,

the Department of Transportation (DOT)

has promulgated regulations (49 CFR

parts 171, 172, and 173) that address the

safe transportation and handling of

medical waste. The DOT regulations

include provisions for packaging and

labeling of medical waste. Also, the

Occupational Safety and Health

Administration (OSHA) has

promulgated regulations on December 5,

1991 (29 CFR part 1910) that address

occupational exposure to bloodborne
10666 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

pathogens. Using a combination of

engineering and work practice controls,

personal protective clothing and

equipment, training, medical follow-up

of exposure incidents, vaccinations

(where appropriate) and other

provisions, the OSHA regulations

minimize or eliminate health risk as a

result of occupational exposure to

bloodborne pathogens. The EPA

believes these DOT and OSHA

regulations will provide sufficient

protection from potential increases in

exposure to those wastes.

A. Air Impacts

As discussed earlier, impacts are

presented assuming the more likely

‘‘switching scenario.’’ Baseline

emissions and emissions under the

proposed EG based on the switching

scenario are presented in Tables 9a and

9b.

TABLE 9a.—BASELINE EMISSIONS

COMPARED WITH EMISSIONS AFTER

IMPLEMENTATION OF THE EMISSION

GUIDELINES (WITH SWITCHING)

[Metric Units]

Pollutant Units Baseline

After EG

with

switching

PM ....... Mg/yr ... 11,300 272

CO ....... Mg/yr ... 13,100 207

CDD/

CDF.

kg/yr .... 285 0.11

HC1 ..... Mg/yr ... 41,200 777

SO2 ...... Mg/yr ... 766 479

Nox ...... Mg/yr ... 5,040 3,160

Pb ........ Mg/yr ... 77.5 0.97

Cd ........ Mg/yr ... 5.62 0.14

Hg ........ Mg/yr ... 58.6 3.67

TABLE 9b.—BASELINE EMISSIONS

COMPARED WITH EMISSIONS AFTER

IMPLEMENTATION OF THE EMISSION

GUIDELINES (WITH SWITCHING)

[English Units]

Pollutant Units Baseline

After EG

with

switching

PM .... Tons/yr ... 12,400 300

CO .... Tons/yr ... 14,500 228

CDD/

CDF.

Lb/yr ....... 628 0.23

HC1 .. Tons/yr ... 45,400 857

SO2 ... Tons/yr ... 844 528

NOx ... Tons/yr ... 5,560 3,490

Pb ..... Tons/yr ... 85.5 1.07

Cd ..... Tons/yr ... 6.20 0.16

Hg ..... Tons/yr ... 64.6 4.05

The proposed guidelines would

reduce nationwide emissions of PM by

11,000 megagrams per year (Mg/yr)

(12,100 tons per year (tons/yr)) from the

estimated emission levels under the

typical existing control or the

‘‘regulatory baseline’’ of 11,300 Mg/yr

(12,400 tons/yr). This reduction

represents an overall decrease of about

98 percent of baseline PM emission

levels in the absence of the proposed

emission guidelines.

Nationwide emissions of CO would be

reduced by 12,900 Mg/yr (14,200 tons/

yr) from the estimated emission levels

under the regulatory baseline of 13,100

Mg/yr (14,500 tons/yr). This reduction

represents an overall control level of

about 98 percent for CO emissions.

The proposed guidelines would

reduce nationwide emissions of

dioxins/furans by 284.8 kilograms per

year (kg/yr) (627.9 pounds per year (lb/

yr)) from the estimated emission levels

under the regulatory baseline of 284.9

kg/yr (628.1 lb/yr). Dioxin/furan

emissions would be reduced by over 99

percent from the regulatory baseline.

Nationwide emissions of HCl would

be reduced by 40,400 Mg/yr (44,600

tons/yr) from the estimated emission

levels under the regulatory baseline of

41,200 Mg/yr (45,400 tons/yr). This

reduction represents a decrease of about

98 percent in HCl emissions from the

regulatory baseline.

Nationwide emissions of SO2 and

NOX would be reduced by 287 Mg/yr

(316 tons/yr) and 1,880 Mg/yr (2,070

tons/yr), respectively, from the

estimated emission levels under the

regulatory baseline of 766 Mg/yr (844

tons/yr) for SO2 and 5,040 Mg/yr (5,560

tons/yr) for NOX. These reductions

equate to an overall emissions decrease

of about 37 percent for both SO2 and

NOX.

As a result of today’s proposal,

nationwide emissions of Pb, Cd, and Hg

would be reduced by 76.6 Mg/yr (84.4

tons/yr), 5.48 Mg/yr (6.04 tons/yr), and

54.9 Mg/yr (60.5 tons/yr), respectively,

from the estimated emission levels

under the regulatory baseline of 77.5

Mg/yr (85.5 tons/yr) for Pb, 5.62 Mg/yr

(6.20 tons/yr) for Cd, and 58.6 Mg/yr

(64.6 tons/yr) for Hg. These reductions

equate to overall control levels of about

99 percent for Pb, 97 percent for Cd, and

94 percent for Hg.

B. Water and Solid Waste Impacts

Under the proposed guidelines, no

significant water pollution impacts are

projected because the emission control

technologies upon which the emission

limits are based do not produce a

wastewater stream. However, to the

extent that wet scrubber systems could

be used to comply with the proposed

emission limitations, water pollution

impacts could be more significant. As

discussed in section VI of this notice,

the Agency solicits information

regarding water pollution impacts

associated with the use of wet scrubber

systems.

With regard to solid waste impacts,

about 1.43 million Mg (1.58 million

tons) of medical waste are burned

annually in existing MWI’s producing

about 143,000 Mg/yr (158,000 tons/yr)

of solid waste (bottom ash) disposed of

in landfills. The addition of acid gas

control using dry lime injection, and

CDD/CDF and Hg control using

activated carbon injection, would

increase the quantity of solid waste for

final disposal by adding baghouse ash to

the amount of bottom ash already

generated under the regulatory baseline.

In addition, switching to onsite

alternatives to incineration would result

in an increase in solid waste for final

disposal because the nonincineration

treatment methods do not reduce the

volume of waste as much as

incineration.

Under the switching scenario, the

amount of solid waste ultimately sent to

landfills would increase by about

631,000 Mg/yr (696,000 tons/yr). This

quantity includes the increase in ash

from the APCD’s and the increase in

waste that is treated and landfilled

without being incinerated. Compared to

municipal waste, which is disposed in

landfills at a rate of over 91 million Mg/

yr (100 million tons/yr), the increase in

solid waste from the implementation of

the MWI emissions guidelines is

insignificant. Therefore, no adverse

solid waste impacts are anticipated

under the proposed guidelines.

C. Energy Impacts

The emission control technologies

upon which the emission limits are

based would require additional energy

consumption for all existing MWI’s.

Under the switching scenario, it is not

clear whether energy consumption will

increase, decrease, or remain the same.

Alternatives to incineration require

energy to operate. However, information

is not available to estimate whether

alternatives use more or less energy than

MWI’s. It is expected that the increase

in energy consumption resulting from

the switching scenario will be less than

the increase under the no-switching

scenario.

The estimates of energy impacts

assuming all existing MWI’s install air

pollution control (no-switching

scenario) include additional auxiliary

fuel for combustion controls and

additional electrical energy for

operation of the add-on control devices.

The proposed guidelines would increase

total national usage of natural gas for

combustion controls by about 100

million cubic meters per year (MMm3/
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10667

yr) (3,490 million cubic feet per year

(106 ft3/yr)) compared to fuel

consumption determined from the

regulatory baseline. Total national usage

of electrical energy for the operation of

add-on control devices would increase

by about 175,000 megawatt hours per

year (MW-hr/yr) (599 billion British

thermal units per year (109 Btu/yr)) of

electricity compared to energy

consumption determined from the

regulatory baseline.

D. Control Cost Impacts

The control cost impacts on

individual facilities will vary depending

on the cost of compliance with the

guidelines; the cost of alternative

treatment and disposal methods; and

other factors such as proximity to an

offsite contract disposal facility, liability

issues related to the transportation and

final disposal of the waste, and State

and local medical waste treatment and

disposal requirements. In general,

facilities requiring a smaller waste

treatment capacity will have a greater

incentive to use a less expensive

treatment and disposal option because

their onsite incineration cost (per ton of

waste burned) will be higher. Facilities

with larger amounts of waste to be

treated may have some cost advantages

if they use a lower cost alternative, but

these advantages are not as significant

due to economies of scale.

Under the switching scenario, the

nationwide annual costs associated with

the proposed emission guidelines will

increase by about $351 million/yr. The

nationwide annual cost of waste

disposal per unit of medical waste

treated would increase by $245/Mg

($222/ton) to a total cost of $430/Mg

($390/ton) from the estimated

nationwide annualized cost of $185/Mg

($168/ton) under the regulatory

baseline.

E. Economic Impacts

The goal of the economic impact

analysis was to estimate the market

response to the emission guidelines and

determine whether there would be

adverse impacts associated with the

proposed guidelines. The proposed

guidelines would affect five major

industry sectors (hospitals, nursing

homes, veterinary facilities, commercial

research laboratories, and commercial

medical waste incineration facilities)

within which some facilities operate an

onsite MWI. In addition, the proposed

guidelines would affect a number of

other industry sectors in which facilities

do not typically operate an onsite MWI

(e.g., bloodbanks). The economic impact

analysis for existing MWI’s examined

each of these sectors as a whole to

determine industry wide impacts.

To assess the industrywide impacts of

control costs, the market price increase

resulting from the proposed guidelines

was estimated for each regulated

industry. The market price increases,

presented in Table 10, may be thought

of as an average price increase across

each industry required to recover

control costs within each industry.

Table 10 reflects the more likely

switching scenario. For example, under

the switching scenario, the hospital

industry would have to raise prices by

an average of about 0.1 percent (over

current revenues of about $224 billion/

year) to cover the increased cost of

waste disposal. This table shows that

the price increase is relatively small for

each industry. This result is mainly due

to the fact that the majority of the

facilities in each industry sector do not

operate an onsite incinerator.

TABLE 10.—MARKET PRICE INCREASED IN THE MAJOR INDUSTRY

SECTORS UNDER THE EMISSION

GUIDELINES—SWITCHING SCENARIO

Industry

Price increase,

percent

Hospitals ..................................... 0.1

Nursing Homes ........................... 0.1

Veterinary Facilities .................... 0.6

Commercial Research Laboratories ....................................... 0.4

Physicians’ Offices ..................... 0

Dentists’ Offices .......................... 0

Freestanding Bloodbanks ........... 0.1

Commercial Medical Waste Incineration Facilities ................. 9 N/A

9 Industrywide impacts were not calculated

for commercial medical waste incineration facilities because estimates of the change in demand for commercial medical waste incineration were not available. However, this industry is expected to be able to recoup all control

cost increases through price increases.

Output, employment, and revenue

impacts were also estimated. As a result

of the low market price increases and/

or relatively inelastic demand, the

corresponding decreases in output,

employment, and revenue were also

low, never exceeding 1 percent under

the more likely switching scenario. This

result implies that no medical wastegenerating industry would need to be

significantly restructured (e.g., through

closures or consolidations) as a result of

the proposed emission guidelines.

V. Rationale for the Proposed

Standards and Guidelines

A. Background

An estimated 3.4 million tons of

waste are produced annually by medical

waste generators in the United States.

Hospitals are the single largest generator

of medical waste, producing over 70

percent of the annual total.

Approximately 5,000 MWI’s are

believed to exist nationwide (3,700

burning general medical waste and

1,300 burning pathological waste). Over

60 percent of these MWI’s are found at

hospitals. Medical waste incinerators

are also found at commercial medical

waste disposal facilities, research

laboratories, nursing homes, and

veterinary facilities. Based on historic

sales data, an estimated 700 new MWI’s

will be installed over the next 5 years.

Medical waste incinerators are subject

to State and local regulations that vary

widely both in format and scope. A

survey in April 1990 showed that in 38

States, regulations or permit guidelines

specific to MWI’s were either in place

or were in the planning stages. The

remainder of the States regulate MWI’s

under general incinerator requirements,

which typically are less stringent that

those specific to MWI’s. The most

common State requirements for MWI’s

are limits for PM, HCl, and secondary

chamber temperature and residence

time. Some States also regulate metals,

CDD/CDF, and CO. About one third of

the States require operator training.

On November 1, 1988, the Medical

Waste Tracking Act (MWTA) was signed

by Congress. The MWTA required EPA

to establish a 2-year demonstration

program to track medical waste from its

origin to its disposal. In early 1989, EPA

established this program in 40 CFR 259.

The program was in effect from June 22,

1989, to June 22, 1991, and applied to

the States of New York, New Jersey,

Connecticut, and Rhode Island, and to

Puerto Rico. The MWTA required EPA

to prepare a series of Reports to

Congress on medical waste and the

demonstration program. Now that the

demonstration program has concluded,

Congress will decide if a medical waste

tracking program should be

implemented nationwide.

The current air emissions standards

development effort for MWI’s was

initiated in 1989. The data-gathering

effort was designed to take advantage of

information gathered under the auspices

of the MWTA. Also, in 1989, an MWI

operator training course and manual

were developed with recommendations

on the proper operation and

maintenance of MWI’s.

The Amendments of 1990 added

section 129 to the Act. Section 129

specifically addresses development of

standards for MWI’s. Section 129

requires EPA to establish an NSPS for

new MWI’s and emission guidelines for

existing MWI’s that combust hospital
10668 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

waste, medical waste, and infectious

waste. The standards and guidelines

must specify numerical emission

limitations for the following: PM,

opacity, SO2, HCl, NOX, CO, Pb, Cd, Hg,

and CDD/CDF. Section 129 also

includes requirements for operator

training as well as siting requirements

for new MWI’s.

The standards and guidelines must

reflect MACT ‘‘* * * the maximum

degree of reduction in emissions of air

pollutants * * * that the Administrator,

taking into consideration the cost of

achieving such emission reduction, any

nonair quality health and environmental

impacts and energy requirements,

determines is achievable * * *’’ Section

129 states that ‘‘The degree of reduction

in emissions that is deemed achievable

for new units in a category shall not be

less stringent than the emissions control

that is achieved in practice by the bestcontrolled similar unit * * *’’ Also

section 129 requires that ‘‘Emissions

standards for existing units in a category

may be less stringent than standards for

new units in the same category but shall

not be less stringent than the average

emissions limitation achieved by the

best performing 12 percent of units in

the category * * *’’ The standards and

guidelines must be no less stringent

than these levels of emission control

currently achieved. These levels are

referred to as the MACT floor.

B. Selection of Source Category

Section 129 of the Act directs the EPA

to issue standards and guidelines

pursuant to section 111 for solid waste

incineration units combusting hospital

waste, medical waste, and infectious

waste (i.e., MWI’s). An MWI is defined

as any device that burns medical waste,

with or without other types of waste

(e.g., municipal solid waste [MSW]) and

with or without heat recovery.

Medical waste is defined pursuant to

the Solid Waste Disposal Act as codified

in 40 CFR 259 subpart B 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. Medical waste consists of,

but is not limited to, the following types

of materials:

1. Sharps (e.g., hypodermic and

suture needles, scalpel blades, syringes,

pipettes, vials, other types of broken or

unbroken glassware, etc.);

2. Fabrics (e.g., gauze, garments,

bandages, swabs, etc.);

3. Plastics (e.g., trash bags, sharps

containers, IV bags, tubes, specimen

cups, etc.);

4. Paper (e.g., disposable gowns,

sheets, etc.; premoistened towels; paper

towels; etc.);

5. Waste chemicals/drugs that are not

RCRA hazardous waste (e.g., lab

chemicals, leftover and out-of-date

drugs, disinfectants, etc.); and

6. Pathological waste (e.g., human and

animal body parts and tissue).

Medical waste does not include any

hazardous waste identified or listed

under 40 CFR 261, or any household

waste as defined in 40 CFR 261.4(b)(1).

On the other hand, mixtures of medical

waste with hazardous waste or

household waste would be considered

medical waste for the purposes of these

proposed standards and guidelines. The

definition of household waste includes

waste generated at single and multiple

residences. Nursing homes or retirement

homes with a health care facility could

be considered multiple residences. For

the purpose of the proposed standards

and guidelines, the definition of

medical waste includes waste materials

that meet the definition of medical

waste and are generated by retirement

homes/nursing homes.

Medical waste also does not include

human and animal remains that are not

generated as medical waste. A device

that burns solely human or animal

remains (and the caskets or containers

carrying the remains, or the bedding

included with the animal remains) for

the purpose of cremation is not an MWI

and, therefore, is not subject to the

requirements of the standards and

guidelines. For example, a facility that

burns the remains of animals that have

been euthanized at animal shelters and

animal hospitals is not an MWI because

the remains are not considered medical

waste. On the other hand, a facility that

burns human and/or animal remains

that are generated as medical waste or

a facility that burns general medical

waste in addition to human and/or

animal remains is an MWI and is subject

to the standards and guidelines. For

example, a facility that burns the

remains of research laboratory rats is an

MWI because the remains are

considered medical waste (they are

generated in research pertaining to the

diagnosis, treatment, or immunization

of human beings or animals or in the

production or testing of biologicals).

The range of waste types included in

this definition is broader than that

defined in the now expired Medical

Waste Tracking Act (40 CFR part 259) as

Regulated Medical Waste. Regulated

Medical Waste consisted of seven

categories of medical waste based on

potential for infection or aesthetic

concerns. The definition of medical

waste in this proposal classifies medical

waste more broadly based on materials’

composition. Consequently, the

estimated amount of waste generated by

medical waste generators (3.4 million

tons/yr) and the estimated amount of

waste burned in medical waste

incinerators (1.8 million tons/yr) is

greater than the Medical Waste Tracking

Act estimated amount of Regulated

Medical Waste generated (922,000 tons/

yr). It has been suggested that EPA’s

definition of medical waste in this

proposal is inappropriate. The EPA

specifically requests comment on the

definition of medical waste as applied

to the regulation of medical waste

incinerators.

Most MWI’s burn a diverse mixture of

medical waste (referred to in this

preamble as general medical waste),

which may include some pathological

waste (human and animal body parts

and/or tissue). Most of the materials that

make up the general medical waste

stream burn readily, and given the

proper conditions, will continue to burn

once they are ignited. Metal and glass

sharps do not burn but also do not

greatly impede combustion of other

materials. Pathological waste has a very

high moisture content and will not

support self-sustained combustion but

will burn if adequate heat is applied to

drive off excess moisture. As a result,

larger amounts of pathological waste

require special operating conditions for

combustion. Thus, some facilities

maintain MWI’s designed and operated

to burn pathological waste exclusively.

Because of differences in waste

composition and the combustion

process, uncontrolled emissions from

pathological MWI’s contain significantly

lower levels of the pollutants of concern

for this source category than

uncontrolled emissions from general

medical waste incinerators. General

medical waste typically contains more

metals and chlorine than does

pathological waste, resulting in higher

emissions of metals and HCl from

general medical waste incinerators than

from pathological incinerators. For

example, typical uncontrolled Hg

emissions are about 3.1 mg/dscm for

general medical waste incinerators and

about 0.05 mg/dscm for pathological

MWI’s. Overall pollutant emissions

from pathological MWI’s represent less

than 3 percent of the uncontrolled

nationwide emissions from MWI’s

burning general medical waste.

Additionally, onsite alternatives to

incineration are available for the

treatment of general medical waste,

while most of these technologies are not

applicable to the treatment of purely

pathological waste. As a result,

pathological MWI’s are more likely to
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10669

face adverse economic impacts

associated with installation of pollution

control equipment, while general

medical waste incinerators could use

available alternatives to incineration.

For these reasons, the proposed

standards and guidelines focus on

regulating emissions from general

medical waste incinerators and include

very minor requirements for

pathological MWI’s. Under the proposed

standards and guidelines, pathological

MWI’s would only be required to submit

quarterly reports of the amount and type

of materials charged to the incinerator.

Finally, in addition to developing

standards and guidelines for medical

waste incinerators, section 129 of the

Act directs the EPA to develop

standards and guidelines for municipal

waste incinerators, commercial or

industrial waste incinerators, and other

categories of solid waste incinerators.

The Agency intends to consider

pathological incinerators (along with

crematory incinerators) when evaluating

the category of other solid waste

incinerators for regulation.

C. Modification of Existing MWI’s

Previously, the terms ‘‘modification’’

and ‘‘reconstruction’’ were defined

under sections 60.14 and 60.15 of

subpart A of part 60. Section 129 of the

Act has specified a new definition of

‘‘modified’’ that combines and revises

the previous definitions of

‘‘modification’’ and ‘‘reconstruction.’’

Specifically, ‘‘modified’’ refers to:

(1) modifications for which the

* * * cumulative costs of the

modifications, over the life of the unit,

exceed 50 per centum of the original

cost of the construction and installation

of the unit (not including the cost of any

land purchased in connection with such

construction or installation) updated to

current costs * * *

or (2) modification involving

* * * a physical change in or change

in the method of operation of the unit

which increases the amount of any air

pollutant emitted by the unit for which

standards have been established under

[section 129] or sections 111 * * *.

A special provision has been included

in the proposed NSPS and emission

guidelines to address certain

modifications to existing facilities. This

provision states that if an existing MWI

is modified for the purpose of meeting

the requirements of the proposed

guidelines for existing MWI’s or State

regulations developed to implement

these guidelines, then the MWI would

not be considered a ‘‘modified’’ MWI

and would not be subject to the NSPS

(40 CFR part 60, subpart Ec).

On the other hand, if the existing

facility is modified in ways not required

to meet the emission guidelines, then

the facility could be considered a

‘‘modified’’ MWI and could become

subject to the NSPS. For example, if an

existing pathological MWI, which was

not originally designed to accommodate

general medical waste, begins burning

general medical waste, then that MWI

may be considered a modified MWI and,

as a result, will be subject to the NSPS.

D. Selection of Pollutants

Section 129 of the Act requires that

the standards and guidelines

promulgated under sections 111 and

129 and applicable to all solid waste

incineration units shall specify

numerical emission limitations for the

following substances or mixtures: PM

(total and fine), opacity, SO2, HCl, NOX,

CO, Pb, Cd, Hg, and CDD/CDF. For this

reason, the MWI standards and

guidelines specify numerical emission

limits for these pollutants.

E. Selection of Affected and Designated

Facilities

As required by section 129 of the Act,

the affected facility to which the

proposed new source performance

standards apply is each individual MWI

for which construction is commenced

after today’s date or for which

modification is commenced after the

effective date of these standards. The

designated facility to which the

proposed emission guidelines apply is

each existing MWI for which

construction commenced on or before

today’s date. A facility that burns both

municipal waste and medical waste

could be subject to both the municipal

waste combustor standards and

guidelines and the medical waste

incinerator standards and guidelines.

F. Selection of Format for the Proposed

Standards and Emission Guidelines

The format selected for the proposed

standards and guidelines is a

combination of emission limitations and

percent reductions to ensure control of

emissions. The specific format of the

proposed standards and guidelines and

the reasons for selection are discussed

below.

As required by section 129 of the Act,

the proposed standards and guidelines

would establish numerical emission

limitations for PM, CO, CDD/CDF, HCl,

SO2, NOX, Pb, Cd, and Hg. For the

purpose of regulating PM and metals

(Pb, Cd, and Hg) the format selected is

a numerical concentration limit in units

of mg/dscm corrected to 7 percent

oxygen. For the purpose of regulating

Hg an alternative percent reduction is

also proposed. The numerical Hg

emission limit reflects the emission

level that can be achieved based on a

fabric filter (FF) system with activated

carbon injection. Emissions of Hg can be

highly variable and depend on the Hg

input level. In cases where Hg levels are

temporarily elevated due to variability

in the waste feed, the numerical

emission limit may not be consistently

achievable. However, the control device

is capable of achieving 85 percent

reduction of elevated Hg levels.

Under the proposed standards and

guidelines, CDD/CDF emissions are

measured in units of total ng/dscm or

ng/dscm toxic equivalency (TEQ). To

arrive at the TEQ, measured emissions

of each tetra- through octa-CDD and

CDF congener are multiplied by the

corresponding toxic equivalency factor

(TEF) specified in the standards and

guidelines (see Table 6). The products

are then added to obtain the total

concentration of CDD/CDF emitted in

terms of TEQ.

For CO, SO2, NOX, and HCl, the

proposed standards and guidelines are

volume concentrations corrected to 7

percent oxygen. For HCl, an alternative

percent reduction is also proposed. A

percent reduction is generally

appropriate for acid gases emissions

from MWI’s. However, in cases where

inlet levels are very low and the

specified percent reduction would

result in concentrations below the

specified volume concentration (42

ppmv, which is a 97 percent reduction

from typical uncontrolled emissions),

these percent reductions may not be

achievable. Therefore, the proposed HCl

emission limits would require either a

97 percent reduction or a 42 ppmv HCl

outlet concentration, which is based on

reduction from typical uncontrolled

emission levels, whichever is less

stringent. An alternative percent

reduction is not proposed for emissions

of SO2 because at the low inlet levels

associated with medical waste, EPA

emission test data shows that acid gases

controls are not effective in reducing

SO2 emissions and as a result, SO2

limits are based on uncontrolled

emissions.

Under the proposed standards and

guidelines, emission limits for Hg and

HCl include stack concentrations as

well as percent reductions. The EPA is

requesting comments on the

appropriateness of including a percent

reduction along with a stack

concentration limit in the standards and

guidelines for these two pollutants.

G. Selection of Classes, Types, and Sizes

Section 129 states that the

Administrator may distinguish among
10670 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

classes, types, and sizes of units within

a category in establishing the standards

and guidelines. In other words, EPA

may subcategorize the MWI source

category in establishing standards and

guidelines. After reviewing the

population of MWI’s, the EPA believes

that, for the purpose of regulatory

development and of determining MACT,

the MWI population should be divided

into three subcategories: (1) continuous

MWI’s, (2) intermittent MWI’s, and (3)

batch MWI’s. These three subcategories

are based on differences in the design of

the MWI’s as discussed in the following

paragraphs.

In each of the design systems,

sequential combustion operations

typically are carried out in two separate

chambers: primary and secondary. In

the primary chamber, the waste is

loaded and ignited, the volatile organic

components driven off, and the

nonvolatile materials combusted to ash.

The volatile organic components

released from the primary chamber are

combusted in the secondary chamber.

Newer MWI’s are typically designed

with 1-second (1-sec) residence time

secondary chambers; older MWI’s were

designed with smaller, 0.25-second

(0.25 sec) residence time secondary

chambers.

While there are similarities in the

three design types of MWI’s, there are

also key design differences that make

each type unique. The primary

differences between the three design

types of MWI’s are the methods of

charging waste to and removing ash

from the primary chamber. These

differences cause variations in the way

the waste is burned and in the pollutant

emission profile for each MWI design

type.

Continuous units, which are the

largest of the three types, have

mechanical ram feeders and continuous

ash removal systems. These features

allow the unit to operate 24 hours per

day for many days at a time. Continuous

MWI’s achieve steady-state operation in

the beginning of their operating cycle

and maintain this mode of operation

throughout the remainder of the cycle.

Waste is charged and ash is removed

simultaneously (i.e., on a continuous

basis). During operation, waste is

burned at the same rate as it is charged

into the unit, and pollutant emission

rates and primary and secondary

chamber temperatures tend to be

relatively constant.

Most intermittent MWI’s also have

mechanical ram feeders that charge

waste into the primary chamber at about

5- to 10-minute intervals. However,

because there is no means for ash

removal during the burning phase of the

operating cycle, the unit can only be

operated for a limited number of hours

before the accumulation of ash in the

primary chamber requires the unit to be

shut down for ash removal. Intermittent

units, which are usually much smaller

than continuous units, typically operate

on a daily burn cycle of 10 to 14 hours.

While these units tend to approach

steady-state operation during the middle

of their operating cycle, waste is

normally being charged faster than it is

being burned. Primary chamber

temperatures tend to climb throughout

the operating cycle until waste is no

longer charged into the unit. Because

there is a significant accumulation of

unburned material in the primary

chamber at the end of the charging

period, these units are designed with a

burndown/cooldown phase. Generally,

pollutant emissions continue through

this phase, which can continue for

several hours after charging has ceased.

The batch operating cycle consists of

three phases: low-air, high-air, and

cooldown. All of the waste to be burned

during a complete cycle is loaded into

the primary chamber before the unit

begins operation. Once the unit is filled

with waste and the burning cycle

begins, the charging door is not opened

again until the cycle is complete and the

unit is cool. This cycle normally takes

1 or 2 days, depending on the size of the

unit and the amount of waste charged.

During the low-air phase, temperatures

in the primary chamber rise slowly

because combustion is occurring only

on the surface of the waste pile and

because combustion air is restricted.

When the high-air phase begins, the

temperatures climb more rapidly, more

volatiles are exposed to the flame front,

and the combustion process quickens.

Batch MWI’s tend to approach steadystate operation at the end of the low-air

phase, when the primary chamber

temperature reaches the design

operating range. Pollutant emission

rates also tend to increase in the second

half of the low-air phase, then level off,

and continue steadily during the highair and cooldown phases. Pollutant

concentrations during the high-air phase

of batch MWI’s are similar to

concentrations during the charging

period for continuous and intermittent

units.

The differences in typical hours of

operation, discussed above, affect the

potential for total emissions (on a mass

basis) from each MWI type. Continuous

MWI’s, which can accommodate waste

charging for an unrestricted length of

time, will have the greatest potential

emissions because waste burning and

subsequent emissions can occur

continuously. Intermittent MWI’s,

designed to accept waste charges at

periodic intervals for between 8 and 14

hours, will be limited in potential

emissions by periods of shutdown

required to remove ash from the

incinerator. The hours of operation,

limited by the time required to remove

ash, result in less potential emissions

from intermittent MWI’s than from

continuous MWI’s. Batch MWI’s are

designed to burn only one load of waste

at a time. The operating cycle normally

takes 1 or 2 days, depending on the size

of the unit and the amount of waste

charged. Potential emissions from batch

MWI’s are lower than continuous and

intermittent MWI’s because of the

significant difference in the total

amount of waste burned over a given

period of time.

Typical uncontrolled emission levels

for each of the three subcategories are

presented in Tables 11a and 11b. Table

11a shows uncontrolled emissions from

new MWI’s, while Table 11b shows

uncontrolled emissions from existing

MWI’s. These emission levels reflect

concentrations when the MWI is

operating at steady-state conditions,

which include the high-air phase for the

batch MWI and the charging period for

continuous and intermittent MWI’s. As

noted elsewhere, the EPA specifically

solicits comment on the determination

to distinguish between continuous,

intermittent, and batch units.

TABLE 11a.—TYPICAL UNCONTROLLED EMISSIONS FROM NEW MWI’S

Pollutant Continuous Intermittent Batch

PM, mg/dscm ..................................................................................................................................... 300 300 300

CO, ppmv ........................................................................................................................................... 300 300 300

CDD/CDF, ng/dscm ........................................................................................................................... 6,600 6,600 6,600

HCI, ppmv .......................................................................................................................................... 1,400 1,400 1,400

SO2, ppmv .......................................................................................................................................... 16 16 16

NOX, ppmv ......................................................................................................................................... 140 140 140
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10671

TABLE 11a.—TYPICAL UNCONTROLLED EMISSIONS FROM NEW MWI’S—Continued

Pollutant Continuous Intermittent Batch

Pb, mg/dscm ...................................................................................................................................... 4.2 4.2 4.2

Cd, mg/dscm ...................................................................................................................................... 0.29 0.29 0.29

Hg, mg/dscm ...................................................................................................................................... 3.1 3.1 3.1

TABLE 11b.—TYPICAL UNCONTROLLED EMISSIONS FROM EXISTING MWI’S

Pollutant Continuous

(0.25-sec)

Continuous

(1-sec) Intermittent Batch

PM, mg/dscm ........................................................................................................... 570 300 570 570

CO, ppmv ................................................................................................................. 690 300 690 690

CDD/CDF, ng/dscm .................................................................................................. 25,000 6,600 25,000 25,000

HCI, ppmv ................................................................................................................ 1,400 1,400 1,400 1,400

SO2, ppmv ................................................................................................................ 16 16 16 16

NOX, ppmv ............................................................................................................... 140 140 140 140

Pb, mg/dscm ............................................................................................................ 4.2 4.2 4.2 4.2

Cd, mg/dscm ............................................................................................................ 0.29 0.29 0.29 0.29

Hg, mg/dscm ............................................................................................................ 3.1 3.1 3.1 3.1

One specific approach which EPA is

considering and on which EPA requests

comment is that of further

subcategorizing batch and intermittent

MWI’s by size or capacity to burn

medical waste. Some have suggested, for

example, that EPA examine alternatives,

such as subcategorizing these categories

into incinerators with capacities of 50

pounds per hour or less, 100 pounds per

hour or less, 200 pounds per hour or

less, etc. A number of States have

already established subcategories based

on size which exempt the smallest

incinerators or impose less stringent

requirements on such incinerators.

Current State regulations, therefore, may

provide a basis for further

subcategorizing the categories of batch

and intermittent MWI’s.

To fully consider subcategorization by

size within the batch and intermittent

categories, however, a mechanism must

be available to accurately and

consistently determine the capacity of

an MWI. Only if such a mechanism

exists, will enforcement personnel, as

well as owners and operators of MWI’s,

be assured that MWI’s are subject to a

consistent set of requirements.

The EPA believes this may be a

serious problem. It appears there is no

common or widely used mechanism or

‘‘standard’’ within the MWI industry for

sizing or determining the capacity of an

incinerator to burn medical waste. As a

result, it seems that one vendor’s 50

pound per hour capacity incinerator can

be another vendor’s 100 pound per hour

capacity incinerator. It also appears the

same vendor may sell one customer a 50

pound per hour capacity MWI and then

sell another customer the same

incinerator as a 100 pound per hour

MWI. The EPA believes that a

manufacturer’s or vendor’s ‘‘nameplate

capacity’’ is not an accurate and reliable

means for determining the size or

capacity of an MWI.

The EPA recognizes that the

composition of medical waste changes

across generators, over time, and in

response to changes in waste handling

or recycling practices in a way that may

affect the amount of medical waste a

specific incinerator is able to burn. For

the purposes of enforcing regulations

that may vary by size or capacity, a

common mechanism or ‘‘standard’’ to

measure or determine the capacity of

MWI’s is necessary.

Consequently, EPA specifically

requests comments on a mechanism or

‘‘standard’’ for accurately and

consistently determining the capacity of

MWI’s in the enforcement of whatever

regulation might be adopted. For

example, the comments might outline

the mechanisms or approaches used by

States to ensure all MWI’s of the same

capacity are subject to the same

requirements. Or, the comments may

offer alternative measures of capacity

that serve as a better basis for

identifying small intermittent and/or

small batch MWI’s. Finally, the

manufacturers may choose to develop a

voluntary approach providing a

consistent measure of rated capacity.

H. Performance of Technology

Medical waste incinerator emissions

are mixtures of pollutants including

acid gases (HCl and SO2), NOX, CO, PM,

CDD/CDF, and metals (Pb, Cd, and Hg).

There are basically two approaches to

controlling these emissions: combustion

control and add-on air pollution control.

These approaches will be discussed in

sections 1. and 2. below.

The first approach, combustion

control, can be broken down into three

levels that are based on the flue gas

residence time in the secondary

chamber. These three levels are 0.25-sec

combustion, 1-sec combustion, and 2-

sec combustion.

The second approach can be further

broken down into various add-on

control systems, including wet systems,

fabric filter systems without activated

carbon injection, and fabric filter

systems with activated carbon injection.

The control of NOX will also be

discussed under add-on control

systems.

One additional area that has been

suggested for consideration is waste

segregation. This topic will be discussed

in paragraph 3. of this section.

1. Combustion Control

Combustion control includes the

proper design, construction, operation,

and maintenance of an MWI to destroy

or prevent the formation of air

pollutants prior to their release to the

atmosphere. Test data indicate that as

secondary chamber residence time and

temperature increase, emissions

decrease. Combustion control is most

effective in reducing CDD/CDF, PM, and

CO emissions.

The 0.25-sec combustion level

includes a minimum secondary

chamber temperature of 927 °C (1700 °F)

and a 0.25-sec secondary chamber

residence time. These combustion

conditions are typical of older MWI’s.

The 1-sec combustion level includes a

minimum secondary chamber

temperature of 927°C (1700°F) and

residence time of 1-sec. These

combustion conditions are typical of

newer MWI’s. Compared to 0.25-sec

combustion, 1-sec combustion will

achieve substantial reductions in CDD/

CDF and CO emissions, and will
10672 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

provide some control of PM, but will

not reduce emissions of acid gases (HCl

and SO2), NOX, or metals (Pb, Cd, and

Hg).

The 2-sec combustion level includes a

minimum secondary chamber

temperature of 1800°F and residence

time of 2-sec. These combustion

conditions will provide additional

control of CDD/CDF, CO, and PM, but

will not reduce emissions of acid gases

(HCl and SO2), NOX, or metals (Pb, Cd,

and Hg). The 2-sec combustion

conditions are considered to be the best

level of combustion control that is

applied to MWI’s.

2. Add-On Control

Add-on control refers to various addon air pollution control systems used in

addition to 2-sec combustion to capture

pollutants as they leave the incinerator.

Add-on controls include wet systems,

fabric filter systems without activated

carbon injection, and fabric filter

systems with activated carbon injection.

Because Pb and Cd are associated with

PM in the flue gas and are removed by

PM control devices, these three

pollutants are considered as a group

when evaluating MACT. Similarly, SO2

and HCl are considered together because

generally, they are both reduced using

acid gas controls.

a. Wet systems. Wet systems include

scrubbing systems such as a venturi

scrubber (VS) or a venturi scrubber

followed by a packed-bed absorber (VS/

PB). Compared to combustion control,

wet systems achieve substantial

reductions in HCl emissions, provide

some control of Pb and Cd, and further

reduce PM and CDD/CDF emissions, but

do not add to the control of NOX, CO,

or Hg. However, at the low SO2 levels

associated with MWI’s, wet systems are

not, in EPA’s experience, effective in

reducing SO2 emissions. As discussed

in section VI, EPA requests comment on

the performance and costs of wet

scrubber systems.

b. Fabric filter systems without carbon

injection. Fabric filter systems include a

fabric filter followed by a packed bed

absorber (FF/PB), dry sorbent injection

followed by a fabric filter (DI/FF), or a

spray dryer followed by a fabric filter

(SD/FF). The SD/FF and the DI/FF

systems have the same performance

based on EPA MWI test data. The fabric

filter alone was not examined because

wet systems achieve greater overall

emission reduction at a lower cost.

Compared to wet systems, fabric filter

systems generally provide additional

control of PM, Pb, and Cd, but do not

add to the control of acid gases, NOX,

CO, or Hg. The performance of the three

fabric filter systems in reducing CDD/

CDF emissions varies significantly.

Compared to combustion control, the

DI/FF and SD/FF systems provide no

additional control of CDD/CDF, while

formation of CDD/CDF is a potential

problem with the FF/PB system.

Formation of CDD/CDF occurs when

there is intimate contact between a gas

stream containing CDD/CDF precursors

and fly ash, which acts as a catalyst for

CDD/CDF formation. The optimum

temperature window for fly ash

catalyzed CDD/CDF formation is

between 300° and 600°F. The formation

of CDD/CDF is minimized when using

combustion control or wet systems

because these options provide: (1) rapid

cooling of the gas stream through the

temperature window; and/or (2) quick

dispersion (or removal in the case of wet

systems) of CDD/CDF precursors and fly

ash. In DI/FF and SD/FF systems, the

presence of an acid gas sorbent (lime,

for example) also limits the formation of

CDD/CDF. The fabric filter in a FF/PB

system, on the other hand, can provide

those conditions conducive to CDD/CDF

formation. In fact, test data have shown

CDD/CDF formation in the FF/PB

system.

c. Fabric filter systems with carbon

injection. Data from a DI/FF system and

a SD/FF system show that the injection

of activated carbon upstream of the

fabric filter results in significant

reductions in CDD/CDF and Hg

emissions, compared to wet systems and

FF systems without carbon. Because no

data are available from a FF/PB system

with carbon injection, and because

CDD/CDF formation occurred in a FF/

PB system, it is not known exactly what

CDD/CDF emission reductions can be

achieved with this system. However, it

is expected that the injection of carbon

will improve the performance of a FF/

PB system in reducing CDD/CDF

emissions.

d. Nitrogen oxides control. During

combustion, NOX is formed through

oxidation of fuel-bound nitrogen (N2)

contained in the medical waste and

oxidation of atmospheric N2 (from the

combustion air). Selective noncatalytic

reduction (SNCR) add-on technology

has been used to control NOX emissions

from municipal waste combustors

(MWC’s) by reducing NOX to N2 without

the use of catalysts. Techniques include

Thermal DeNOXTM, which injects

ammonia into the combustor as a

reducing agent; the NOXOUTTM process,

which injects urea with chemical

additives; and a two-stage urea/

methanol injection process. Maximum

emissions reduction occurs when the

reducing agents are injected into a gas

stream within a narrow temperature

range and the gas is maintained in that

range for a sufficient length of time.

A discussion of SNCR NOX control

was presented in the recent proposal

preamble for the MWC NSPS (59 FR 181

page 48228). The use of SNCR at MWC’s

results in NOX emission reductions of

about 45 percent.

There are some concerns about the

applicability of SNCR to MWI’s. The

SNCR technology has never been

applied to MWI’s, and several factors

may complicate the use of SNCR and

may reduce its performance level. The

periodic charging of waste may cause

corresponding temperature fluctuations,

and the varying moisture and

nonhomogeneous nature of the waste

burned. When the temperature rises

above the required injection

temperature window, the reducing agent

is oxidized to NOX, and NOX emissions

can increase. In the event of low

temperatures, unreacted ammonia (NH3)

emissions can occur.

Furthermore, uncertainties exist

regarding the injection pattern necessary

to achieve adequate mixing and

residence time in the operating

temperature window and in the design

and engineering work necessary to

develop equipment that could be used

in applications with much smaller gas

flow rates than those for MWC’s.

Consequently, SNCR is not considered a

demonstrated control technology for

MWI’s.

Although SNCR is not considered a

demonstrated control technology for

MWI’s, the EPA specifically solicits

comments on the technical feasibility of

applying NOX control to MWI’s.

Specifically, the EPA solicits

information on the performance,

including control device inlet and outlet

emissions data, costs, applicability, and

operating experience associated with

specific NOX control technologies for

MWI’s.

3. Waste segregation. One area that

has been suggested for consideration is

waste segregation. It has been suggested

that removal of batteries would reduce

Hg emissions and that removal of

chlorinated plastics would result in

reductions in HCl and CDD/CDF. The

EPA data indicate that these emissions

vary from facility to facility which could

be a result of differences in the amount

of Hg and chlorine found in the waste

stream. The types of materials that are

sent to the incinerator will vary from

facility to facility depending on facility

operating practices, which are defined

by purchasing decisions, waste handling

procedures, and other practices that

affect the types of materials incinerated.

The EPA has no data on the effect of

waste handling practices on emissions
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10673

of various pollutants and is requesting

comments on the extent to which

operating practices could influence

emissions. To evaluate the effectiveness

of waste segregation programs, the EPA

is specifically soliciting detailed

descriptions of the programs and results

of performance tests conducted to

demonstrate pollutant emission levels

from the MWI prior to implementation

of the program and subsequent to

implementation of the program. This

information is critical to a thorough

evaluation of the effectiveness of the

program. In addition, the EPA solicits

comments on how such a program could

be incorporated into the MWI

regulations. Whenever information is

submitted relative to Hg emissions, the

EPA requests that, if available, Hg

emissions data be broken out by various

species emitted (for example mercury

chloride or elemental mercury).

I. MACT Floor and MACT for New

MWI’s

Section 129 of the Clean Air Act

requires that emission standards reflect

MACT. According to section 129, the

degree of reduction in emissions that is

deemed achievable for new MWI’s may

not be less stringent than the emissions

control that is achieved in practice by

the best controlled similar unit. As a

result, the emission limits selected to

reflect MACT for new MWI’s must, at a

minimum, be as stringent as the

emission levels achieved by the best

controlled similar unit. This minimum

performance level is known as the

MACT floor. Beyond the MACT floor, in

determining what performance level

should be adopted in the standards as

MACT, the Administrator is to consider

the costs, any nonair-quality health and

environmental impacts and energy

requirements associated with such

emission limits.

The basis for MACT determinations

are presented for each subcategory in

paragraphs I1, I2, and I3 of this section.

The EPA solicits comments on whether

test data are available from MWI’s that

are achieving better control than the

systems used as the basis for the MACT

determinations. If submitting Hg data,

EPA specifically requests that, if

available, Hg emission data be broken

down by various species emitted (for

example, mercury chloride and

elemental mercury).

While the paragraphs that follow

focus on specific control technologies in

determining the MACT floor and MACT

for new MWI’s, the standards do not

require the use of any specific

technology. The Agency’s assessment of

the performance of specific technologies

is used to develop emission limitations,

which appear in the regulation. Any

control technology that can comply with

the emission limitations may be used.

1. MACT Floor and MACT for New

Continuous MWI’s

As discussed in section VI, the

discussion that follows is based in part

on limited test data on wet scrubber

systems. The EPA requests comment on

the performance and costs of wet

scrubber systems.

The MACT floor for continuous

MWI’s consists of the emission levels

that are achievable with DI/FF with

carbon injection. The MACT floor is

based on these emission levels because

DI/FF with carbon injection achieves

the lowest emission levels for all

pollutants, and it is used to control

emissions from at least one existing

continuous MWI. While the lowest

emission levels for most of the

pollutants are achieved by several

different control technologies (including

DI/FF with carbon injection), the lowest

Hg and CDD/CDF emission levels for

continuous MWI’s are achieved only

with DI/FF with carbon injection.

Because the MACT floor is the most

effective level of control for continuous

units, there are no alternatives beyond

the MACT floor to consider. The level

of emission control achieved by a DI/FF

system with carbon injection is

considered MACT for continuous

MWI’s.

As discussed earlier, NOX control has

not been demonstrated on MWI’s and

acid gas controls are not effective in

reducing SO2 emissions from MWI’s.

Therefore, MACT reflects no control of

NOX and SO2. However, because the Act

requires EPA to set numerical emission

limits for NOX and SO2, the limits are

proposed at 210 ppmv for NOX and 45

ppmv for SO2, the highest uncontrolled

NOX and SO2 emission rates measured

during the EPA test program. The EPA

specifically solicits comments on the

emission limits of 45 ppmv set for SO2

and 210 ppmv set for NOX and whether

these levels accurately reflect

uncontrolled emissions of NOX and SO2

at MWI’s.

2. MACT Floor and MACT for New

Intermittent MWI’s

As discussed in section VI, the

discussion that follows is based in part

on limited test data on wet scrubber

systems. The EPA requests comment on

the performance and costs of wet

scrubber systems.

The MACT floor for intermittent

MWI’s is based on the emission levels

that are achievable with a combination

of two control technologies. The VS/PB

and DI/FF without carbon injection

technologies are each used to control

emissions from at least one intermittent

MWI. The MACT floor is based on both

of these technologies because VS/PB

achieves the lowest CDD/CDF

emissions, but DI/FF without carbon

injection achieves the lowest PM, Pb,

and Cd emissions. The MACT floor

emission levels for the other pollutants

can be achieved with either technology.

Therefore, one way to achieve all of the

MACT floor emission levels for

intermittent MWI’s would be to use a

combination of both VS/PB and DI/FF

without carbon injection.

Another approach, which is less

complex and less costly than the above

combination of controls, could also be

used to achieve the MACT floor

emission levels. As noted in the

discussion of the MACT floor for

continuous MWI’s, the CDD/CDF

emission levels achievable with the DI/

FF with carbon injection are even lower

than those achievable with the VS/PB

system. Even though this technology is

not known to be used with existing

intermittent MWI’s, it could achieve

better performance for a much lower

cost than the combination of controls

described above, and therefore the

MACT floor for new intermittent MWI’s

is based on these emission levels.

Because the MACT floor is the most

effective level of control for intermittent

units, there are no alternatives beyond

the MACT floor to consider. The level

of emission control achieved by a DI/FF

system with carbon injection is

considered MACT for intermittent

MWI’s.

As discussed earlier, NOX control has

not been demonstrated on MWI’s and

acid gas controls are not effective in

reducing SO2 emissions from MWI’s.

Therefore, MACT reflects no control of

NOX and SO2. However, because the Act

requires EPA to set numerical emission

limits for NOX and SO2, the limits are

proposed at 210 ppmv for NOX and 45

ppmv for SO2, the highest uncontrolled

NOX and SO2 emission rates measured

during the EPA test program. The EPA

specifically solicits comments on the

emission limits of 45 ppmv set for SO2

and 210 ppmv set for NOX and whether

these levels accurately reflect

uncontrolled emissions of NOX and SO2

at MWI’s.

3. MACT Floor and MACT for New

Batch MWI’s

As discussed in section VI, the

discussion that follows is based in part

on limited test data on wet scrubber

systems. The EPA requests comment on

the performance and costs of wet

scrubber systems.
10674 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

Like the MACT floor for intermittent

MWI’s, the MACT floor for new batch

MWI’s consists of the emission levels

that are achieved with a combination of

two control technologies. The 2-sec

combustion control is used to control

emissions from many existing batch

MWI’s, and FF/PB is used to control

emissions from at least one batch MWI;

no other add-on control technologies

have been identified on batch units. The

FF/PB achieves lower PM, Pb, Cd, and

HCl emissions than 2-sec combustion

control, but because CDD/CDF

formation can occur in a FF/PB system,

2-sec combustion control alone achieves

lower CDD/CDF emissions. Equivalent

emission levels for other pollutants are

achieved with both technologies. The

MACT floor for all pollutants can be

achieved with the use of another

technology: DI/FF without carbon

injection. Except for CDD/CDF, this

technology achieves the same emission

levels as FF/PB, and the CDD/CDF

emissions are the same as those for 2-

sec combustion control alone.

Therefore, the MACT floor for new

batch MWI’s consists of the emission

levels that are achievable with DI/FF

without carbon injection.

Unlike continuous and intermittent

MWI’s, there is a level of control more

effective than the MACT floor for batch

MWI’s. This level of control is achieved

by adding carbon to the DI/FF system.

The result is further reduction in CDD/

CDF emissions along with significant Hg

control. The incremental national

annual cost of this option is about

$740,000, or about $170/ton of waste

burned nationwide. The national annual

costs increase by only about 3 percent.

Therefore, the level of control achieved

by the DI/FF system with carbon

injection is considered MACT for batch

MWI’s.

As discussed earlier, NOX control has

not been demonstrated on MWI’s and

acid gas controls are not effective in

reducing SO2 emissions from MWI’s.

Therefore, MACT reflects no control of

NOX and SO2. However, because the Act

requires EPA to set numerical emission

limits for NOX and SO2, the limits are

proposed at 210 ppmv for NOX and 45

ppmv for SO2, the highest uncontrolled

NOX and SO2 emission rates measured

during the EPA test program. The EPA

specifically solicits comments on the

emission limits of 45 ppmv set for SO2

and 210 ppmv set for NOX and whether

these levels accurately reflect

uncontrolled emissions of NOX and SO2

at MWI’s.

J. MACT Floor and MACT for Existing

MWI’s

1. MACT Floor for Existing MWI’s

Section 129 of the Act requires that

emission guidelines reflect MACT.

According to section 129, the degree of

reduction in emissions that is deemed

achievable for existing MWI’s must not

be less stringent than the average

emission limitation achieved by the best

performing 12 percent of units in the

category. In setting MACT standards,

the EPA must establish the MACT floor

for a source category because the Act

specifies that each standard must be at

least as stringent as the floor for the

relevant source category. For the MWI

source category, the EPA did not have

sufficient emissions data to determine

the MACT floor. Data was only available

from 7 MWI facilities (8 emissions

tests), to represent 3,700 existing MWI’s.

As a result, the EPA examined air

quality permits and State regulations to

determine the emission limitations

achieved by the best-performing 12

percent of units in each subcategory.

Emission limitations were determined

for the estimated total MWI population

by examining air quality permits where

available and by assuming that the

estimated population of MWI’s for

which permits were not available are

subject to emission limitations specified

by State regulations. It was assumed that

all MWI’s are either achieving their

permit limits or are achieving their State

regulatory emission limits.

For each subcategory, the emission

limitations for each pollutant were

ranked from most stringent to least

stringent and the MACT floors for each

pollutant were determined by averaging

the emission limitations of the top 12

percent of units in that subcategory. In

some cases, the number of MWI’s

subject to specific emission limitations

did not comprise 12 percent of the

population in a subcategory. Where this

occurred, numerical emission limits

were established for the MACT floor by

including uncontrolled emission values

for the additional number of MWI’s

necessary to make up 12 percent of the

existing population.

The MACT floors define the

minimum level of emissions control.

Beyond these levels, in determining

what performance levels should be

adopted in the guidelines as MACT, the

Administrator is to consider the costs,

any nonair-quality health and

environmental impacts, and energy

requirements associated with such

emission limits.

An estimated 338 continuous, 3,018

intermittent, and 336 batch MWI’s exist

nationwide. For each of these

subcategories, the MACT floor emission

levels for each pollutant are calculated

as the averages of the emission

limitations reported by the top 12

percent of units in that subcategory. The

top 12 percent of units in each

subcategory is represented by the 41

continuous, 363 intermittent, and 41

batch MWI’s with the most stringent

permit or state regulation limitations.

The MACT floor emission levels for

each pollutant in each subcategory are

presented in Table 12.

TABLE 12.—MACT FLOOR EMISSION LEVELS FOR EXISTING MWI’S

Pollutant

MWI type

Continuous Intermittent Batch

PM, mg/dscm ................................................................................................................................................. 46 69 69

CO, ppmv ....................................................................................................................................................... 76 90 91

CDD/CDF, ng/dscm ....................................................................................................................................... 1,619 12,906 14,606

HC1, ppmv ..................................................................................................................................................... 43 115 911

SO2, ppmv ...................................................................................................................................................... 284 414 1,166

NOX, ppmv ..................................................................................................................................................... 257 216 220

Pb, mg/dscm .................................................................................................................................................. 8.7 11.8 23.1

Cd, mg/dscm .................................................................................................................................................. 0.56 1.8 3.4

Hg, mg/dscm .................................................................................................................................................. 4.0 15.6 18.5
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10675

As noted above, EPA is also

considering further subcategorizing

batch and intermittent MWI’s by size or

capacity to burn medical waste.

Specifically, some have suggested EPA

consider alternatives, such as

subcategorizing these categories into

incinerators with capacities of 50

pounds per hour or less, 100 pounds per

hour or less, 200 pounds per hour or

less, etc. A number of States have

regulations which exempt the smallest

medical waste incinerators or impose

less stringent requirements on such

incinerators.

Subcategorization of the batch and

intermittent MWI categories could find

that the MACT floor for small

intermittent and/or small batch

incinerators is less stringent than the

MACT floor for larger incinerators in

these categories. The MACT floor for

small intermittent and/or small batch

MWI’s within these categories, for

example, could be much less stringent

than the MACT floor of 69 mg/dscm

identified above for both batch and

intermittent incinerators.

2. MACT for Existing Continuous MWI’s

As discussed in section VI, the

discussion that follows is based on

limited test data on wet scrubber

systems. The EPA requests comment on

the performance and costs of wet

scrubber systems. Also, while the

paragraphs that follow focus on specific

control technologies in determining

MACT for existing continuous MWI’s,

the guidelines do not require the use of

any specific technology. The Agency’s

assessment of the performance of

specific technologies is used to develop

emission limitations, which appear in

the guidelines. Any control technology

that can comply with the emission

limitations may be used.

a. MACT for PM, Pb, and Cd.

Uncontrolled PM emissions typically

are 570 mg/dscm for MWI’s with 0.25-

sec combustion and 300 mg/dscm for

MWI’s with 1-sec combustion. The

MACT floor for PM is 46 mg/dscm. A

fabric filter system is necessary to meet

the MACT floor level. The FF system is

capable of achieving PM emission levels

of as low as 30 mg/dscm.

Typical uncontrolled Pb and Cd

emission are 4.2 mg/dscm and 0.29 mg/

dscm, respectively. The MACT floors for

Pb and Cd are 8.65 mg/dscm and 0.56

mg/dscm, respectively. Although no

control is necessary to achieve the

MACT floor levels for Pb and Cd, the

fabric filter system that would be

needed to meet the MACT floor

emission level for PM, would reduce Pb

and Cd emissions to 0.10 mg/dscm and

0.05 mg/dscm, respectively. Because

this system is already necessary to meet

the MACT floor level for PM, there is no

cost associated with reducing emissions

of Pb and Cd from the uncontrolled

MACT floor levels to the level of control

achieved by the FF system. Additional

control beyond the FF system has not

been demonstrated for any of these

pollutants. As a result, the proposed

MACT for PM, Pb, and Cd for

continuous MWI’s are the levels

achievable with the FF system: 30 mg/

dscm for PM, 0.10 mg/dscm for Pb, and

0.05 mg/dscm for Cd.

b. MACT for Carbon Monoxide.

Typical uncontrolled emissions of CO at

continuous MWI’s are 690 ppmv for

units with 0.25-sec combustion and 300

ppmv for units with 1-sec combustion.

As discussed earlier, the MACT floor for

CO is 76 ppmv. Two-second combustion

control is necessary to meet the MACT

floor level for CO and is capable of

achieving CO levels as low as 50 ppmv

at no additional cost. Further reduction

of CO emissions has not been

demonstrated. Therefore, the proposed

MACT for CO is 50 ppmv, the level

achievable by 2-sec combustion.

c. MACT for Dioxins and Furans.

Typical uncontrolled emissions of

dioxins and furans (CDD/CDF) are

25,000 ng/dscm for MWI’s with 0.25-sec

combustion and 6,600 ng/dscm for

MWI’s with 1-sec combustion. The

MACT floor for CDD/CDF is 1,619 ng/

dscm. Two-second combustion control

is necessary to meet the MACT floor

level for CDD/CDF and is capable of

achieving CDD/CDF levels of 1,500 ng/

dscm, at no additional cost.

As discussed earlier, an FF system is

needed to achieve the MACT floor for

PM. Control of CDD/CDF beyond the

level of emissions achievable with 2-sec

combustion control can be attained

either by adding a wet system or by

injecting activated carbon into the FF

system. Although the wet system is

capable of reducing CDD/CDF

emissions, the less expensive approach

would be to inject carbon into the FF

system because the FF system is already

needed to meet the MACT floor level for

PM. By injecting carbon into the FF

system, CDD/CDF emissions could be

reduced to about 80 ng/dscm and Hg

emissions could substantially be

reduced. The nationwide incremental

annual cost of carbon injection is about

$9.4 million/yr, or about $12/ton of

waste burned in continuous MWI’s.

This incremental cost represents an

increase of only about 5.8 percent over

the cost of the FF system without carbon

injection. As a result, MACT for CDD/

CDF is the level of control achievable

with an FF system with carbon

injection, 80 ng/dscm total CDD/CDF, or

1.9 ng/dscm TEQ. To arrive at the TEQ,

measured emissions of each tetrathrough octa- CDD and CDF congener

are multiplied by the corresponding

toxic equivalency factor (TEF) specified

in § 60.36c of the proposed emission

guidelines. The products are then added

to obtain the concentration of CDD/CDF

emitted in terms of TEQ.

d. MACT for Mercury. Typical

uncontrolled Hg emissions are 3.1 mg/

dscm. The MACT floor for Hg is 4.04

mg/dscm. No control of Hg is necessary

to meet the MACT floor emission level.

The only control system capable of

consistently reducing Hg emissions is

the FF system with carbon injection,

which can achieve emissions of 0.47

mg/dscm Hg or 85 percent reduction

from uncontrolled emissions. The FF

system without carbon injection is

necessary to meet the MACT floor for

PM and the injection of carbon is

necessary to meet the proposed MACT

emission level for CDD/CDF. As

mentioned above in the discussion on

CDD/CDF, the nationwide incremental

annual cost of injecting carbon is about

$9.4 million/yr, or about $12/ton of

waste burned. This additional cost

represents an increase of only about 5.8

percent over the cost of the FF system

without carbon injection. Therefore, the

proposed MACT for Hg is 0.47 mg/dscm

or 85 percent reduction.

e. MACT for acid gases (HCl and SO2).

Typical uncontrolled emissions of HCl

and SO2 from continuous MWI’s are

1,400 ppmv for HCl and 16 ppmv for

SO2. In general, acid gases controls are

capable of reducing emissions of both

HCl and SO2. However, in EPA’s

experience, acid gases controls are not

effective in reducing emissions of SO2

from MWI’s because of the low SO2 inlet

levels associated with the incineration

of medical waste. The emissions of HCl

from MWI’s, on the other hand, are

reduced by acid gas controls. As

discussed earlier, the MACT floor for

HCl is 43 ppmv. A reduction of 97

percent from uncontrolled levels is

necessary to achieve the MACT floor for

HCl. Wet systems and FF systems are

each capable of reducing HCl emissions

to 42 ppmv or by 97 percent from

uncontrolled levels. Therefore, MACT

for HCl is 42 ppmv or 97 percent

reduction.

Typical uncontrolled emissions of

SO2 are 16 ppmv, but can range as high

as 45 ppmv. The MACT floor for SO2 is

284 ppmv, and can be achieved at

uncontrolled levels. Consequently, the

MACT floor requires no control of SO2.

As discussed earlier, acid gas controls

are not effective in reducing SO2

emissions from MWI’s. Therefore,

MACT also reflects no control of SO2.
10676 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

However, because the Act requires the

EPA to set a numerical emission limit

for SO2, the limit is proposed at 45

ppmv, the highest SO2 emission rate

measured during the EPA test program.

The EPA specifically solicits comments

on the emission limit of 45 ppmv set for

SO2 and whether this level accurately

reflects uncontrolled emissions of SO2

at MWI’s.

f. MACT for Nitrogen Oxides. Typical

uncontrolled emissions of NOX are 140

ppmv but range as high as 210 ppmv.

The MACT floor for NOX is 257 ppmv,

and can be achieved at uncontrolled

levels. As discussed earlier, NOX control

has not been demonstrated on MWI’s.

Therefore, MACT also reflects no

control of NOX. However, because the

Act requires the EPA to establish a

numerical emission limit for NOX, the

limit is proposed as 210 ppmv, the

highest NOX emission rate measured

during the EPA test program. The EPA

specifically solicits comments on the

emission limit of 210 ppmv set for NOX

and whether this level accurately

reflects uncontrolled emissions of NOX

at MWI’s.

3. MACT for Existing Intermittent

MWI’s

As discussed in section VI, the

discussion that follows is based on

limited test data on wet scrubber

systems. The EPA requests comment on

the performance and costs of wet

scrubber systems. Also, while the

paragraphs that follow focus on specific

control technologies in determining

MACT for existing intermittent MWI’s,

the guidelines do not require the use of

any specific technology. The Agency’s

assessment of the performance of

specific technologies is used to develop

emission limitations, which appear in

the guidelines. Any control technology

that can comply with the emission

limitations may be used.

a. MACT for PM, Pb, and Cd. Typical

uncontrolled emissions of PM from

intermittent MWI’s are about 570 mg/

dscm. The MACT floor for PM

emissions from intermittent MWI’s is 69

mg/dscm. A fabric filter system is

necessary to meet the MACT floor level.

In fact, the FF system can reduce PM

emissions even further, to 30 mg/dscm,

at no additional cost.

Uncontrolled emissions of Pb and Cd

are 4.2 mg/dscm and 0.29 mg/dscm,

respectively. The MACT floors for Pb

and Cd are 11.78 mg/dscm and 1.76 mg/

dscm, respectively. Although no control

is necessary to achieve the MACT floor

levels for Pb and Cd, the FF system

necessary to meet the MACT floor level

for PM would also reduce emissions of

Pb and Cd to 0.10 mg/dscm and 0.05

mg/dscm, respectively. Because this

system is already necessary to meet the

MACT floor level for PM, there is no

cost associated with reducing emissions

of Pb and Cd from the uncontrolled

MACT floor levels to the level of control

achieved by the FF system. Further

reduction of Pb and Cd has not been

demonstrated. Therefore, the proposed

MACT for intermittent MWI’s is the

level of control achievable with the FF

system: 30 mg/dscm for PM, 0.10 mg/

dscm for Pb, and 0.05 mg/dscm for Cd.

b. MACT for Carbon Monoxide.

Typical uncontrolled emissions of CO at

intermittent MWI’s are about 690 ppmv.

The MACT floor is 90 ppmv. Twosecond combustion control is necessary

to meet the MACT floor level and is

capable of achieving CO levels as low as

50 ppmv at no additional cost. Further

reduction of CO emissions has not been

demonstrated. Therefore, the proposed

MACT for CO is 50 ppmv, the level

achievable with 2-sec combustion.

c. MACT for Dioxins and Furans.

Uncontrolled levels of dioxins and

furans (CDD/CDF) are typically about

25,000 ng/dscm. The MACT floor for

CDD/CDF is 12,906 ng/dscm. Onesecond combustion control is necessary

to achieve the MACT floor emission

level and is capable of reducing CDD/

CDF emissions to 7,000 ng/dscm.

However, 2-second combustion control

is already needed to achieve the MACT

floor emission level for CO and would

reduce CDD/CDF emissions even

further, to about 1,500 ng/dscm, at no

additional cost.

The level of control associated with

the FF system is already needed to meet

the MACT floor for PM. Further

reduction in CDD/CDF emissions

beyond the level of emissions

achievable with 2-sec combustion

control can be attained either by adding

a wet system or by injecting carbon into

the FF system. Although the wet system

is capable of reducing CDD/CDF

emissions, the less expensive approach

would be to inject carbon into the FF

system that is already needed to meet

the MACT floor level for PM. An FF

system with carbon injection can reduce

CDD/CDF emissions to about 80 ng/

dscm and can substantially reduce Hg

emissions. The nationwide incremental

annual cost of carbon injection is about

$24.4 million/yr, or about $31/ton of

waste burned in intermittent MWI’s.

This incremental cost represents an

increase of only about 3.6 percent over

the cost of the FF system without carbon

injection. As a result, MACT for CDD/

CDF is the level of control achievable

with an FF system with carbon

injection, 80 ng/dscm total CDD/CDF, or

1.9 ng/dscm TEQ.

d. MACT for Mercury. Typical

uncontrolled Hg emissions are about 3.1

mg/dscm. The MACT floor for Hg is

15.56 mg/dscm, and can be achieved at

uncontrolled levels. The only control

system capable of consistently reducing

Hg emissions is the FF system with

activated carbon injection, which can

achieve emissions of 0.47 mg/dscm Hg

or 85 percent reduction from

uncontrolled emissions. The FF system

without carbon injection is necessary to

meet the MACT floor emission level for

PM and the injection of carbon is

necessary to meet the proposed MACT

emission level for CDD/CDF. As

mentioned above in the discussion on

CDD/CDF, the nationwide incremental

annual cost of injecting carbon is about

$24.4 million, or about $31/ton of waste

burned. This additional cost represents

an increase of only about 3.6 percent

over the cost of the FF system without

carbon injection. Therefore, the

proposed MACT for Hg is 0.47 mg/dscm

or 85 percent reduction.

e. MACT for Acid Gases (HCl and

SO2). Uncontrolled levels of HCl and

SO2 from MWI’s are 1,400 ppmv and 16

ppmv, respectively. As discussed

previously, acid gases controls are not

effective in reducing emissions of SO2

from MWI’s. The MACT floor for HCl is

115 ppmv and requires a reduction of 92

percent from uncontrolled levels. Wet

systems and FF systems are each

capable of reducing HCl emissions to 42

ppmv or by 97 percent from

uncontrolled levels. The FF system is

already needed to meet the MACT floor

emission levels for PM. The costs

associated with reducing emissions of

HCl from the MACT floor level (92

percent reduction) to the level of control

achievable with the FF system (97

percent reduction) include costs for

additional lime and ash disposal costs.

These additional costs are negligible

compared to the total cost of the system.

Therefore, the proposed MACT for HCl

is 42 ppmv or 97 percent reduction.

The MACT floor for SO2 is 414 ppmv

and can be achieved at uncontrolled

emission levels. As discussed earlier, no

controls have been demonstrated to

consistently reduce SO2 emissions from

MWI’s. Therefore, the proposed MACT

for SO2 is also based on uncontrolled

emissions. Analyses of test data from

MWI’s show that typical uncontrolled

emissions of SO2 are about 16 ppmv, but

can range as high as 45 ppmv. Because

the Act requires the EPA to set

numerical emission limit for SO2,

MACT for SO2 is set at 45 ppmv, the

highest SO2 emission rate measured

during the EPA test program. The EPA

specifically solicits comments on the

emission limit of 45 ppmv set for SO2
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10677

and whether this level accurately

reflects uncontrolled emissions of SO2

at MWI’s.

f. MACT for Nitrogen Oxides. Typical

uncontrolled emissions of NOX are 140

ppmv but range as high as 210 ppmv.

The MACT floor for NOX is 216 ppmv

and requires no control of NOX. As

discussed earlier, NOX control has not

been demonstrated on MWI’s.

Therefore, MACT is also based on no

control. However, because the Act

requires the EPA to set a numerical

emission limit for NOX, the NOX limit

is proposed to be 210 ppmv, the highest

uncontrolled NOX level measured

during the EPA test program. The EPA

specifically solicits comments on the

emission limit of 210 ppmv set for NOX

and whether this level accurately

reflects uncontrolled emissions of NOX

at MWI’s.

4. MACT for Existing Batch MWI’s

As discussed in section VI, the

discussion that follows is based on

limited test data on wet scrubber

systems. The EPA requests comment on

the performance and costs of wet

scrubber systems. Also, while the

paragraphs that follow focus on specific

control technologies in determining

MACT for existing batch MWI’s, the

guidelines do not require the use of any

specific technology. The Agency’s

assessment of the performance of

specific technologies is used to develop

emission limitations, which appear in

the guidelines. Any control technology

that can comply with the emission

limitations may be used.

a. MACT for PM, Pb, and Cd. Typical

uncontrolled PM emissions from batch

MWI’s are about 570 mg/dscm. The

MACT floor for PM emissions from

batch MWI’s is 69 mg/dscm. A fabric

filter system is necessary to meet the

MACT floor level. In fact, the FF system

can reduce PM emissions even further,

to 30 mg/dscm, at no additional cost.

Uncontrolled emissions of Pb and Cd

from batch MWI’s are about 4.2 mg/

dscm and 0.29 mg/dscm, respectively.

The MACT floor emission levels for Pb

and Cd are 23.10 mg/dscm and 3.44 mg/

dscm, respectively. Although no control

is necessary to achieve the MACT floor

levels for Pb and Cd, the FF system

necessary to meet the MACT floor level

for PM would also reduce emissions of

Pb and Cd to 0.10 mg/dscm and 0.05

mg/dscm, respectively. Because this

system is already necessary to meet the

MACT floor level for PM, there is no

cost associated with reducing emissions

of Pb and Cd from the uncontrolled

MACT floor levels to the level of control

achieved by the FF system. Further

reduction of Pb and Cd has not been

demonstrated. Therefore, the proposed

MACT for batch MWI’s is the level of

control achievable with the FF system:

30 mg/dscm for PM, 0.10 mg/dscm for

Pb, and 0.05 mg/dscm for Cd.

b. MACT for Carbon Monoxide.

Typical uncontrolled emissions of CO at

batch MWI’s are about 690 ppmv. The

MACT floor is 91 ppmv. Two-second

combustion control is necessary to meet

the MACT floor level and is capable of

achieving CO levels as low as 50 ppmv

at no additional cost. Further reduction

of CO emissions has not been

demonstrated. Therefore, the proposed

MACT for CO is 50 ppmv, the level

achievable with 2-sec combustion.

c. MACT for Dioxins and Furans.

Uncontrolled levels of dioxins and

furans (CDD/CDF) are typically about

25,000 ng/dscm. The MACT floor for

CDD/CDF is 14,606 ng/dscm. Onesecond combustion control is necessary

to achieve the MACT floor emission

level and is capable of reducing CDD/

CDF emissions to 7,000 ng/dscm.

However, 2-second combustion control

is already needed to achieve the MACT

floor emission level for CO and would

reduce CDD/CDF emissions even

further, to about 1,500 ng/dscm, at no

additional cost.

The level of control associated with

the FF system is already needed to meet

the MACT floor for PM. Further

reduction in CDD/CDF emissions

beyond the level of emissions

achievable with 2-sec combustion

control can be attained either by adding

a wet system or by injecting carbon into

the FF system. Although the wet system

is capable of reducing CDD/CDF

emissions, the less expensive approach

would be to inject carbon into the FF

system that is already needed to meet

the MACT floor level for PM. An FF

system with carbon injection can reduce

CDD/CDF emissions to about 80 ng/

dscm and can substantially reduce Hg

emissions. The nationwide incremental

annual cost of carbon injection is about

$1.5 million/yr, or about $170/ton of

waste burned in batch MWI’s. This

incremental cost represents an increase

of only about 2.7 percent over the cost

of the FF system without carbon

injection. As a result, MACT for CDD/

CDF is the level of control achievable

with an FF system with carbon

injection, 80 ng/dscm, or 1.9 ng/dscm

TEQ.

d. MACT for Mercury. Typical

uncontrolled Hg emissions are about 3.1

mg/dscm. The MACT floor for Hg is

18.54 mg/dscm, and can be achieved at

uncontrolled levels. The only control

system capable of consistently reducing

Hg emissions is the FF system with

carbon injection, which can achieve

emissions of 0.47 mg/dscm Hg or 85

percent reduction from uncontrolled

emissions. The FF system without

carbon injection is necessary to meet the

MACT floor emission level for PM and

the injection of carbon is necessary to

meet the proposed MACT emission

level for CDD/CDF. As mentioned above

in the discussion on CDD/CDF, the

nationwide incremental annual cost of

injecting carbon is about $1.5 million/

yr, or about $170/ton of waste burned.

This additional cost represents an

increase of only about 2.7 percent over

the cost of the FF system without carbon

injection. Therefore, the proposed

MACT for Hg is 0.47 mg/dscm or 85

percent reduction.

e. MACT for Acid Gases (HCl and

SO2). Uncontrolled levels of HCl and

SO2 from MWI’s are 1,400 ppmv and 16

ppmv, respectively. As discussed

earlier, acid gases controls are not

effective in reducing emissions of SO2

from MWI’s. The MACT floor for HCl is

911 ppmv and requires a reduction of 35

percent from uncontrolled levels. Wet

systems and FF systems are each

capable of reducing HCl emissions to 42

ppmv or by 97 percent from

uncontrolled levels. The FF system is

already needed to meet the MACT floor

emission levels for PM. The costs

associated with reducing emissions of

HCl from the MACT floor level (35

percent reduction) to the level of control

achievable with the FF system (97

percent reduction) include costs for

additional lime and ash disposal costs.

These additional costs are negligible

compared to the total cost of the system.

Therefore, the proposed MACT for HCl

is 42 ppmv or 97 percent reduction.

The MACT floor for SO2 is 1,166

ppmv and can be achieved at

uncontrolled emission levels. As

discussed earlier, no controls have been

demonstrated to consistently reduce

SO2 emissions from MWI’s. Therefore,

the proposed MACT for SO2 is also

based on uncontrolled emissions.

Analyses of test data from MWI’s show

that typical uncontrolled emissions of

SO2 are about 16 ppmv, but can range

as high as 45 ppmv. Because the Act

requires the EPA to set numerical

emission limit for SO2, MACT for SO2

is set at 45 ppmv, the highest SO2

emission rate measured during the EPA

test program. The EPA specifically

solicits comments on the emission limit

of 45 ppmv set for SO2 and whether this

level accurately reflects uncontrolled

emissions of SO2 at MWI’s.

f. MACT for Nitrogen Oxides. Typical

uncontrolled emissions of NOX are 140

ppmv but range as high as 210 ppmv.

The MACT floor for NOX is 220 ppmv

and can be achieved at uncontrolled
10678 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

emission levels. As discussed earlier,

NOX control has not been demonstrated

on MWI’s. Therefore, MACT is also

based on no control. However, because

the Act requires the EPA to set a

numerical emission limit for NOX, the

NOX limit is proposed to be 210 ppmv,

the highest uncontrolled NOX level

measured during the EPA test program.

The EPA specifically solicits comments

on the emission limit of 210 ppmv set

for NOX and whether this level

accurately reflects uncontrolled

emissions of NOX at MWI’s.

K. Selection of Fugitive Fly Ash/Bottom

Ash Standards and Guidelines

Combusting medical waste in an

incinerator creates noncombustible ash

in the primary chamber of the

incinerator. This ‘‘bottom’’ ash is

removed from the primary chamber

either periodically (intermittent and

batch MWI’s) or continuously

(continuous MWI’s). While removing

ash, airborne fugitive emissions may be

created.

Another potential source of fugitive

emissions from MWI’s is the collected

fly ash that is removed from the exhaust

gas stream by fabric filters. Facilities

that use fabric filters as part of an air

pollution control system must remove

the collected fly ash periodically.

Fugitive emissions of this fly ash can

occur during the removal and disposal

process.

While there is a potential for fugitive

emissions from MWI’s, precautions can

be taken that virtually eliminate these

emissions. The proposed 0 percent

opacity limit can be achieved by

employing measures such as wetting or

covering the dry ash, providing covers

for ash containers, and providing wind

screens around outdoor sites. The

following sections describe the different

types of MWI operations that may

release fugitive emissions.

1. Continuous MWI’s. For an MWI to

operate continuously, the combustor

must be designed so that accumulated

bottom ash can be removed while the

unit operates. All designs incorporate a

stepped, solid grate with internal ash

rams or a moving hearth to move ash

toward the discharge point at the end of

the primary chamber opposite the waste

charging door. At the discharge point,

the ash falls off the hearth into a wet

sump or a dry collection hopper.

Because these units either quench the

bottom ash (in a wet sump) or confine

the ash in a close-fitting hopper (dry

collection), there is virtually no

potential for fugitive emissions during

normal operation. With the wet sump

arrangement, there are no fugitive

emissions when the ash is conveyed to

the disposal container, usually a

dumpster. With dry ash, the transfer

from the collection hopper to the

dumpster may be a source of fugitive

emissions, but normal precautions such

as covering the ash or wetting it down

can effectively eliminate fugitive

emissions.

2. Intermittent and Batch MWI’s.

Intermittent and batch MWI’s are

allowed to cool before the bottom ash is

removed, usually on a daily basis. Few

of these units use any automated

mechanism to assist in the removal of

bottom ash. The ash is simply shoveled

or raked from the primary chamber

manually through the ash door.

Some larger units have an ash ram

that is used to push bottom ash toward

the ash door. With this type of system,

the ash may be allowed to fall from the

primary chamber into a collection bin as

the ram pushes it out of the unit.

Mechanical rams are usually somewhat

ineffective at removing the ash because

the ram face is considerably narrower

than the primary chamber. Ash that is

not in the path of the ram must be raked

or shoveled out manually.

Removing the bottom ash from these

MWI’s is a potential source of fugitive

emissions. Applying a water spray to

the ash as it is removed from the MWI,

reducing the distance the ash falls or is

conveyed, and providing wind screens

for outdoor sites are ways in which

fugitive emissions may be eliminated.

3. Collected Fly Ash from Control

Devices. Facilities utilizing fabric filters

as part of their air pollution control

system must use precautions to avoid

fugitive emissions resulting from the

removal of collected fly ash from the

fabric filter collection hopper. In most

cases, the collection hopper discharges

from the bottom directly into a disposal

bin. By including a flexible ‘‘sleeve’’ to

connect the collection hopper to the

disposal bin (often a 55-gallon drum)

and a close-fitting cover over the

disposal bin, fugitive emissions can be

eliminated. Likewise, a wind screen

around this operation is helpful for

outdoor installations. Once the disposal

bin is filled, it should be sealed for

transport to the ultimate disposal site. If

the disposal bin is emptied onsite into

a dumpster, the transfer must be

performed in a manner to avoid creating

fugitive emissions. Wetting the fly ash

in the disposal bin prior to dumping it

or performing the transfer in a covered

enclosure are effective ways to eliminate

fugitive emissions.

L. Operator Training and Qualification

Requirements

Section 129 of the Act requires the

EPA to develop and promote a model

program for the training and

qualification of MWI operators. Section

129 specifies that ‘‘any person with

control over processes affecting

emissions from a unit * * *’’ must

successfully complete an acceptable

training program. For new MWI’s, the

proposed standards require that an

affected facility be operated by a trained

and qualified operator or by an

individual under the direct supervision

of a trained and qualified operator. For

existing MWI’s, the proposed emission

guidelines would require that 1 year

after approval of the State plan,

designated facilities be operated by a

trained and qualified operator or by an

individual under the direct supervision

of a trained and qualified operator. The

3-year option for complying with all

other requirements of the emission

guidelines is not provided for the

training and qualification requirements.

The accelerated compliance schedule

proposed for the operator training and

qualification requirements will assist in

preparing the operators to properly

operate the MWI and associated air

pollution control equipment before the

initial compliance test.

The proposed standards and

guidelines also would require that each

owner or operator of an MWI develop

and update, on an annual basis, a sitespecific operating manual to be

reviewed by all qualified operators

annually. The standards and guidelines

include minimum criteria for the

training course, the qualification

program, and the contents of the

manual.

1. Training Requirements

The owner or operator of an MWI

would be responsible for ensuring that

one or more operators receive training

by an instructor not employed by the

owner or operator that provides, at a

minimum, the following: (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 classroom training would be

required to cover, at a minimum, the

following subjects:

1. Environmental concerns, including

pathogen destruction and types of

emissions;

2. Basic combustion principles,

including products of combustion;

3. Types of incinerator designs and

components of MWI’s;

4. Incinerator operation, including

startup and shutdown procedures;

5. Combustion controls and

monitoring;
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10679

6. Types of air pollution control

equipment;

7. Operation of air pollution control

equipment and factors affecting

performance;

8. Methods to monitor pollutants

(CEM’s) and equipment calibration

procedures;

9. Inspection and maintenance of the

MWI, APCD, and CEM’s;

10. Actions to correct malfunctions or

upsets;

11. Bottom and fly ash characteristics

and handling procedures;

12. Applicable Federal, State, and

local regulations; and

13. Work safety procedures.

Hands-on training would be required

on either an intermittent or continuous

MWI that is similar, but not necessarily

identical, to the unit(s) that the

operator(s) would be operating. The

MWI used in hands-on training also

must have an APCD. Material to be

covered during the hands-on training

must include: (1) prestartup inspections,

(2) proper startup, waste charging, and

shutdown procedures; (3) monitoring

operating conditions (visually and with

automated equipment), (4) responses to

upset conditions, and (5) recordkeeping.

The instruction also must identify

differences between the MWI used for

the hands-on training and other types of

MWI’s (i.e., batch, intermittent, and

continuous) and APCD’s (i.e., wet

scrubbers and dry scrubbers).

An examination would be required for

the operator to demonstrate an

understanding of the material presented.

A handbook covering the subjects

discussed during the course would give

the operator a reference to supplement

more detailed literature from the

manufacturer that is specific for the

equipment being operated at the facility.

2. Qualification Procedures

The owner or operator of an MWI

would be responsible for ensuring that

one or more operators at the facility are

qualified. Under the proposed standards

and guidelines, operators would be

qualified by one of two methods,

designated option 1 and option 2.

a. Option 1. To be qualified under

option 1, operators would be required to

complete a training course that satisfies

the criteria described above and have

one of the following levels of

experience: (1) at least 6 months

experience (1,040 hours) as an MWI

operator, (2) at least 6 months

experience as the direct supervisor of

MWI operators, or (3) experience

performing a minimum of two burn

cycles under the observation of two

qualified operators. The experience

must be on either the MWI at the

operator’s facility or an MWI of the

same type (i.e., batch, intermittent, or

continuous).

Qualification would be valid from the

date the training examination is passed

or the date on which the experience

requirements are met, whichever is

later. The owner or operator of the MWI

would be required to demonstrate to

enforcement personnel that the operator

has the necessary training and

experience.

To maintain qualification, the

operator would be required to complete

an annual review or refresher course

administered by an instructor not

employed by the owner or operator and

pass the examination administered by

the instructor at the end of the course.

An acceptable review course would

provide at least 4 hours of classroom

training and cover, at a minimum, the

following subjects: (1) update of

regulations; (2) incinerator operation,

including startup and shutdown

procedures; (3) inspection and

maintenance; (4) responses to upset

conditions; and (5) discussion of

operating problems encountered by the

attendees.

A lapsed qualification may be

renewed by one of two methods,

depending on the length of the lapse.

For a lapse of less than 3 years, the

operator would be required to complete

and pass a standard review course, as

described above in this section. For a

lapse of 3 years or more, the operator

would be required to complete and pass

a training course that meets the criteria

described earlier.

b. Option 2. Option 2 would allow

qualification by national professional

organizations. The same initial and

annual training described under option

1 would be required. National

organizations would be able to specify

criteria that are at least as stringent as

those under option 1. Qualification

programs developed by national

organizations also would specify

procedures to maintain and renew

qualifications.

3. Operating Manual

The proposed standards and

guidelines also would require that each

owner or operator of an MWI develop

and update, on an annual basis, a sitespecific operating manual to be

reviewed by all qualified operators

annually. The manual would summarize

State regulations, operating procedures,

and reporting and recordkeeping

requirements in accordance with the

proposed standards and guidelines.

4. Request for Comments

The EPA solicits comments on

whether and to what extent EPA should

allow States or certain specific national

professional organizations (e.g., the

American Hospital Association or the

American Society of Mechanical

Engineers) to pre-approve training

courses and qualification programs that

meet the above criteria. Commenters

should identify by name any national

organizations that they believe should

be granted this authority.

An advantage of allowing States or

national organizations to preapprove

courses is that the burden of

demonstrating that the course is in

compliance with the criteria would be

removed from the owner or operator. An

additional advantage of allowing

national organizations to pre-approve

courses is that the training would be

valid in all States, whereas a Stateapproved course would only be valid in

the State that approved it. As a result,

all operators in a company with

facilities in several States could take the

same course, and operators would not

need to take another training course if

they move from one State to another.

M. Siting Requirements—New MWI’s

Section 129 of the Act states that

performance standards for MWI’s must

incorporate siting requirements that

minimize, on a site-specific basis and to

the maximum extent practicable,

potential risks to public health or the

environment. In accordance with

section 129, site selection criteria are

being proposed for MWI’s that

commence construction after the date of

promulgation of this rule. The siting

requirements would not apply to

existing or modified MWI’s.

1. Options Considered for Siting

Requirements

The EPA considered three approaches

in the development of proposed siting

requirements. These approaches are

summarized below.

The first approach would be a

regulatory review approach. Under this

approach, the MWI owner/operator

would prepare a document listing all

current Federal, State, and local

regulatory requirements and permit

conditions that apply to the proposed

MWI, along with a discussion of the

equipment, construction practices,

operating practices, and other

conditions used to comply with each

requirement. The document would be

submitted to the EPA and to State and

local officials and would be made

available to the public. This approach

also includes provisions for a public
10680 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

meeting and the preparation of a

comment/response document that

would be made available to the public.

This approach addresses relevant siting

issues and would not require duplicate

analyses of health or environmental

impacts that may already be required

under other authorities (e.g., New

Source Review (NSR) air permits;

National Pollution Discharge

Elimination System [NPDES] water

discharge permits; stormwater permits;

wetland permits; State solid waste

permits; or local zoning permits).

The second approach would require

that an environmental assessment (EA)

be conducted, patterned after

requirements under the National

Environmental Policy Act (NEPA). This

approach would require an examination

of impacts in all media (i.e., air, water,

solid waste, energy, and land use). Also,

a description of alternatives to the

proposed project, including alternative

sites, technologies, or designs necessary

to determine a finding of no significant

impact (FNSI) would be required. The

EA and the description of alternatives to

the proposed project would be

documented and submitted to the EPA

and to State and local officials and

would be made available to the public.

The third approach sets forth general

siting requirements patterned after the

Prevention of Significant Deterioration

(PSD) requirements within the New

Source Review (NSR) program. This

approach requires comprehensive air

quality analyses in regard to National

Ambient Air Quality Standards

(NAAQS) and PSD increments. An

impacts analysis, which studies the

potential effect of air, solid waste, and

water pollution on visibility, soils, and

vegetation also would be required. This

approach also includes provisions for a

public meeting and the preparation of a

comment/response document that

would be made available to the public.

2. Proposed Siting Requirements

The third approach is being proposed

as the basis for the siting requirements

for MWI’s. Under the proposed

approach, MWI owners would be

required to conduct analyses of the

impacts of the proposed facility on

ambient air quality, visibility, soils, and

vegetation. A document presenting the

results of the analyses would be

prepared and submitted to the EPA and

State and local officials. This document

would also be made available to the

public. The proposed siting

requirements include provisions for a

public meeting (chaired by EPA or a

delegated enforcement agency) where

comments on the proposed MWI siting

analyses would be accepted. At least 30

days prior to the public meeting, the

owner of the affected facility is required

to announce the public meeting in

newspapers of general circulation that

serve the communities located within

the area where the affected facility is to

be located. The public meeting would

be conducted in the county in which the

affected facility is to be located and

would be scheduled to occur 30 days or

more after making the siting analyses

available to the public. A comment/

response document, summarizing and

responding to the comments received at

the public meeting, would then be

prepared and would be made available

to attendees of the public meeting, the

State air pollution control board, and

the EPA.

The siting requirements would apply

to any MWI that commences

construction after the date of

promulgation of this rule. The siting

requirements would not apply to

existing or modified MWI’s. The siting

information required above would be

submitted to EPA sufficiently in

advance of the intent to commence

construction of the facility. Construction

would be allowed to commence only

after approval by EPA and the

appropriate State/local agency. The

Agency invites comments regarding the

proposed siting requirements, including

suggestions of alternative approaches.

N. Inspection Requirements—Existing

MWI’s

The proposed emission guidelines

include a requirement for an initial

equipment inspection of the designated

facility. The purpose of the equipment

inspection is to ensure that the MWI is

in good working order until emission

control equipment is installed and

compliance with emission limits is

demonstrated. A poorly maintained

MWI will likely have higher emissions

than a well-maintained MWI.

These requirements would become

effective 1 year after approval of the

State plan. Installation of air pollution

control equipment may take up to 3

years (as discussed elsewhere in today’s

notice). Until the time that the source

demonstrates compliance with the

emission limits, the facility would be

required to perform the equipment

inspection annually. The inspection

service would have to be performed by

an MWI service technician not

employed by the owner or operator of

the designated facility.

The minimum requirements for an

inspection include:

1. Inspecting all burners, pilot

assemblies, and pilot sensing devices for

proper operation and cleaning as

necessary;

2. Adjusting primary and secondary

chamber combustion air;

3. Inspecting hinges and door latches;

4. Inspecting dampers, fans, and

blowers for proper operation;

5. Inspecting door and door gaskets

for proper sealing;

6. Inspecting motors for proper

operation;

7. Inspecting primary chamber

refractory lining and cleaning/repairing

as necessary;

8. Inspecting incinerator shell for

corrosion and/or hot spots;

9. Inspecting secondary/tertiary

chamber and stack and cleaning as

necessary;

10. Inspecting mechanical loader, if

applicable;

11. Visually inspecting waste bed, as

appropriate;

12. Test burning the incinerator with

typical waste to make any necessary

adjustments;

13. Inspecting air pollution control

devices for proper operation, if

applicable; and

14. Generally ensuring that the

equipment is maintained in proper

operating condition.

If any problems that affect emissions

are uncovered during the inspection, the

owner or operator of the designated

facility would be required to take

corrective action within 10 operating

days. All records of any inspection

services and any subsequent

maintenance services would have to be

maintained at the facility for a period of

at least 5 years.

O. Compliance and Performance Test

Methods and Monitoring Requirements

Section 129(c) of the Act requires the

Administrator to promulgate regulations

that include monitoring requirements as

necessary to protect public health and

the environment. The regulations must

also include provisions for

recordkeeping and reporting of such

monitoring. This section discusses the

proposed requirements to satisfy section

129(c).

As discussed in section VI, the

requirements of the proposed standards

and guidelines are based primarily on

the use of dry scrubber systems to

comply with the proposed emission

limitations. As a result, the proposed

testing and monitoring requirements

discussed below are structured around

the use of dry scrubber systems. To

accommodate MWI’s using an APCD

other than a dry scrubber system, the

proposed standards and guidelines

include provisions for petitioning the

Administrator to allow monitoring of

alternative operating parameters to

demonstrate continuous compliance
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10681

with the emission limits. Petitions for

alternative operating parameter

monitoring would be approved on a

case-by-case basis. This procedure could

become an awkward and lengthy one.

To the extent that wet scrubber systems

could be used to comply with the

proposed emission limitations, the

Agency is soliciting information from

wet scrubber vendors regarding the

operation of wet scrubber systems.

Specifically, the Agency solicits

information on a set of operating

parameters that could be included as a

means of demonstrating continuous

compliance with the emission

limitations for PM, CDD/CDF, HCl,

opacity, and metals, including

information on how the proposed

parameters to be monitored would be

established. The EPA envisions the final

standards and guidelines would be

structured in such a way to provide

specific operating parameter monitoring

requirements for wet scrubber systems

as well as for dry scrubber systems

directly in the regulation. To

accommodate MWI’s using an APCD

other than a dry scrubber system or a

wet scrubber system, provisions would

be included for petitioning the

Administrator to allow monitoring of

alternative operating parameters to

demonstrate continuous compliance

with the emission limits.

The performance testing and

monitoring requirements included in

the proposed standards and guidelines

would apply to all MWI’s subject to the

standards and guidelines. As stated in

the part 60 general provisions (40 CFR

60.8), performance tests must, unless

otherwise specified in the regulation,

consist of three separate valid runs

using the applicable test method, and

the arithmetic mean of the three runs

shall be used to determine compliance.

All emission limits for MWI’s are

corrected to 7 percent oxygen (dry

basis).

Testing and monitoring requirements

are proposed to demonstrate compliance

with the emission limits. The proposed

standards and guidelines require that

the owner or operator of an MWI

conduct initial and annual performance

tests to demonstrate compliance with

the emission limits. Also, following the

initial performance test, the owner or

operator of each MWI is required to

demonstrate continuous compliance

with the emission limits.

1. Initial and Annual Performance

Testing

To demonstrate initial compliance

with the emission limits for each

pollutant, all facilities must conduct an

initial performance test. Except as noted

below, the minimum sample time for

each test run would be 4 hours. This

minimum time is required to allow

enough sample to be collected and to

account for the heterogeneity of medical

waste. The following test methods and

procedures would be used to measure

pollutant emissions.

Particulate Matter—The performance

test for PM would be conducted in

accordance with Method 5. Method 1

would be used to determine the number

and location of sampling points. Method

3 or 3A would be used simultaneously

with each Method 5 run for flue gas

analysis.

Opacity—A CEMS would be used to

measure opacity;

Carbon Monoxide—A CEMS would be

used to measure CO emissions;

Dioxins/Furans—Method 23 would be

used to measure dioxin/furan emissions;

Hydrogen Chloride—Method 26

would be used to measure HCl

emissions;

Metals (lead, cadmium, and

mercury)—The performance test to

determine compliance with the

emission limits for Pb, Cd, and Hg

would be conducted in accordance with

Method 29. Method 3 or 3A would be

used simultaneously with each Method

5 run for flue gas analysis.

Fugitive emissions—Method 9 would

be used to measure the opacity of

fugitive emissions.

Following the initial performance

tests for all pollutants, subsequent

annual performance tests would be

required to demonstrate compliance

with the emission limits. The test

methods and procedures used for the

annual testing are identical to those

proposed for the initial tests.

Under the proposed standards and

guidelines, if three consecutive annual

compliance tests indicate compliance

with the emission limit for a pollutant,

the owner of the MWI would be allowed

to wait 3 years before retesting for that

pollutant. If the next test conducted in

the third year shows compliance with

the emission limit for the pollutant,

then the facility could again wait 3 years

to test for that pollutant. If

noncompliance with the emission limit

for the pollutant occurs, corrective

action would be required and the

annual testing requirement would

resume until 3 consecutive years of

compliance with the emission limit is

demonstrated. At a minimum,

performance tests for all pollutants must

be conducted once every 3 years (no

more than 36 months following the date

of the previous performance test). This

provision is included to minimize costs

while still retaining periodic testing to

ensure compliance.

2. Methods to Demonstrate Continuous

Compliance

Following the initial performance test,

the owners or operators of MWI’s are

required to demonstrate continuous

compliance with the emission

limitations. Section 702(b) of the Clean

Air Act Amendments of 1990 added

section 114(a)(3) to the Act, which

states:

The Administrator shall in the case of any

person which is the owner or operator of a

major stationary source, and may, in the case

of any other person, require enhanced

monitoring and submission of compliance

certifications. Compliance certifications shall

include (A) identification of the applicable

requirement that is the basis of the

certification, (B) the method used for

determining the compliance status of the

source, (C) the compliance status, (D)

whether compliance is continuous or

intermittent, (E) such other facts as the

Administrator may require. Compliance

certifications and monitoring data shall be

subject to subsection (c) of this section.

Submission of a compliance certification

shall in no way limit the Administrator’s

authorities to investigate or otherwise

implement this Act.

Section 114(a)(3) requires enhanced

monitoring and compliance

certifications of all major stationary

sources. The annual compliance

certifications must state whether

compliance has been continuous or

intermittent. Enhanced monitoring shall

be capable of detecting deviations from

each applicable emissions limitation or

standard with sufficient

representativeness, accuracy, precision,

reliability, frequency, and timeliness to

determine if compliance is continuous

during a reporting period. The

monitoring requirements in these

proposed standards and guidelines

satisfy the requirements of enhanced

monitoring, except as noted below.

The most direct means of ensuring

compliance with the emission limits on

a continuous basis is the use of a CEMS

to measure emissions of each pollutant.

However, a CEMS for specific pollutants

is not always available because of

technology constraints. Where a CEMS

for specific pollutants is not available,

the next best option is to use a CEMS

to measure surrogate pollutants whose

emission profiles closely parallel those

of the pollutants of concern. Continuous

emissions monitoring systems for

surrogate pollutants are also not always

available. Where a CEMS is not

available for surrogate pollutants, the

next best option is to monitor MWI and/

or APCD operating parameters that

affect emissions of the pollutants of

concern.

Where a CEMS is not available and a

correlation has been demonstrated
10682 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

between MWI and/or APCD operating

parameters and emissions, the proposed

standards and guidelines include MWI

and/or APCD operating parameters to be

monitored. Maximum or, in some cases,

minimum values for these parameters

are established during the initial

performance test to demonstrate

compliance with the emission limits.

Once these values are established, a

facility operating outside of these values

is considered to be in violation of the

emission limits. The following

paragraphs discuss methods available to

demonstrate continuous compliance

with emission limits for each pollutant.

a. HCl, CO, Opacity. Continuous

emission monitoring systems measuring

HCl, CO, and opacity are available to

determine continuous compliance with

the emission limits for these pollutants.

Opacity and CO CEMS’s are widely

used. On the other hand, a CEMS for

HCl is not widely used and has not been

commercially proven to be

economically and technically feasible

for MWI’s. Also, Federal performance

specifications for a HCl CEMS have not

been established to date. The EPA test

data from facilities equipped with a dry

scrubber system followed by a fabric

filter show a direct relationship between

HCl sorbent (lime) flow rate and HCl

removal efficiency. A decrease in the

sorbent flow rate results in a decrease in

HCl removal efficiency and therefore

higher HCl emissions. Also, for a given

amount of chlorine content in the waste

stream, the amount of waste charged to

the incinerator could be directly related

to the amount of HCl emitted. An

increase in the amount of waste charged

would result in higher HCl emissions.

For facilities equipped with a dry

scrubber followed by a fabric filter, the

minimum HCl sorbent flow rate, the

maximum charge weight, and the

maximum hourly charge rate would be

established during the initial

performance test for HCl and would be

monitored to demonstrate continuous

compliance with the emission limit for

HCl.

While the proposed standards and

guidelines do not require a CEMS for

monitoring HCl emissions, the EPA

specifically solicits further information

on the availability, reliability, accuracy,

status of development, and costs for

continuous HCl monitors.

b. Dioxins and Furans. Currently

CDD/CDF emissions cannot be

measured using a CEMS. While CO is

occasionally mentioned as a surrogate

for CDD/CDF emissions, it is not a

precise indicator of CDD/CDF

emissions. However, good combustion

conditions minimize CDD/CDF

formation and lower CO emissions

indicate that good combustion is

occurring. Therefore, continuous

compliance with the emission limit for

CO based on the CO CEMS output

would ensure good combustion

conditions and minimized CDD/CDF

formation.

As discussed elsewhere, the proposed

standards and guidelines for CDD/CDF

are based on add-on air pollution

control, which reduces CDD/CDF

emissions even more than good

combustion. Air pollution control

system operating parameters have been

correlated with CDD/CDF emissions.

For MWI’s using a dry scrubber system

followed by a fabric filter, the operating

parameters correlated with CDD/CDF

emissions are CDD/CDF sorbent flow

rate and temperature measured at the

inlet to the PM control device. The EPA

test data on a DI/FF system with carbon

injection show a direct relationship

between carbon flow rate and CDD/CDF

removal efficiency. A decrease in the

sorbent flow rate results in a decrease in

CDD/CDF removal efficiency and

therefore higher CDD/CDF emissions. It

has been shown that the optimum

temperature window for fly ash

catalyzed CDD/CDF formation is

between 300° and 600°F. Available data

indicate that cooling flue gases and

operating the PM control device below

the temperature window where

formation may occur minimizes

formation of CDD/CDF in the flue gas.

A minimum value for the CDD/CDF

sorbent flow rate and a maximum value

for the temperature measured at the

inlet to the PM control device would be

established during the initial

performance test for CDD/CDF and

would be monitored to demonstrate

continuous compliance with the

emission limit for CDD/CDF.

c. Mercury. Mercury emissions cannot

be measured using a CEMS. The EPA

test data from facilities equipped with a

dry scrubber followed by a fabric filter

show a direct relationship between Hg

sorbent (activated carbon) flow rate and

Hg removal efficiency. A decrease in the

sorbent flow rate results in a decrease in

Hg removal efficiency and therefore

higher Hg emissions. Also, depending

on the presence of Hg in the waste

stream, the amount of waste charged

could be directly related to the amount

of Hg emitted. An increase in the

amount of waste charged could result in

higher Hg emissions. For facilities

equipped with a dry scrubber followed

by a fabric filter, the minimum Hg

sorbent flow rate, the maximum charge

weight, and the maximum hourly charge

rate would be established during the

initial performance test for Hg and

monitored to demonstrate continuous

compliance with the emission limit for

Hg.

While the proposed standards and

guidelines do not require a CEMS for

monitoring Hg emissions, the EPA

specifically solicits further information

on the availability, reliability, accuracy,

status of development, and costs for

continuous Hg monitors. The EPA is

requesting data that could be used to

determine whether Hg monitors

measure all Hg or just certain species of

Hg and if only certain species of Hg are

measured, how such a monitor could be

used in determining compliance with

the Hg emission limit.

d. PM, Pb, and Cd. Particulate matter,

Pb, and Cd emissions cannot currently

be measured using a CEMS. The EPA

has not, to date, identified surrogate

pollutants or MWI/APCD operating

parameters that could be monitored to

measure compliance. The Agency is

currently working to develop applicable

MWI/APCD operating parameters for

lead, cadmium, and PM that are

sufficiently representative, accurate,

precise, reliable, frequent, and timely to

determine whether a deviation from the

proposed emission limits has occurred,

thus enabling owners and operators to

certify whether compliance with the

proposed emission limits is continuous

or intermittent. The Agency will include

operating parameters for the pollutants

lead, cadmium, and PM in the final rule.

Today the Agency is requesting

comment on appropriate operating

parameters for lead, cadmium, and PM

that will satisfy the requirements of

enhanced monitoring and also requests

any associated supporting data.

e. SO2 and NOX. No monitoring

requirements are proposed for SO2 and

NOX because the emission limits are

based on uncontrolled emission levels.

f. Fugitive Emissions. Continuous

compliance with the emission limits for

fugitive emissions would be

demonstrated by conducting a

performance test using Method 9 at least

once per month when bottom ash is

removed from the incinerator and when

fly ash is removed from the add-on air

pollution control device.

g. Other Air Pollution Control

Systems. To accommodate MWI’s using

an APCD other than a dry scrubber

followed by a fabric filter, provisions are

included in the standards and

guidelines for petitioning the

Administrator to allow monitoring of

alternative operating parameters to

demonstrate continuous compliance

with the emission limits for CDD/CDF,

Hg, HCl, and/or opacity. The petition

must include a discussion illustrating

the relationship between the alternative

operating parameters and emissions of
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10683

CDD/CDF, Hg, HCl, and/or opacity. The

petition must also describe by what

means and how often the parameters

would be monitored and must specify

the recommended minimum/maximum

values of the parameters that are not to

be exceeded. Petitions for alternative

operating parameter monitoring would

be approved on a case-by-case basis.

3. Continuous Compliance

Requirements

To demonstrate continuous

compliance following the initial

performance test, facilities are required

to:

a. Demonstrate compliance with the

CO emission limit based on the output

from the CO CEMS;

b. Demonstrate compliance with the

opacity emission limit based on the

output from the opacity CEMS; and

c. Demonstrate compliance with the

fugitive emission limit by conducting a

performance test using Method 9 at least

once per calendar month when ash is

removed from the incinerator and when

ash is removed from the APCD.

In addition, facilities equipped with a

dry scrubber followed by a fabric filter

are required to:

d. Demonstrate compliance with the

Hg emission limit by continuously

monitoring the Hg sorbent flow rate, the

charge weight, and the hourly charge

rate. The minimum Hg sorbent flow

rate, the maximum charge weight, and

the maximum hourly charge rate are to

be established during the initial

performance test to determine

compliance with the Hg emission limit.

Operation of the MWI below the

minimum sorbent flow rate, or above

the maximum charge weight or

maximum hourly charge rate would

constitute a violation of the Hg emission

limit.

e. Demonstrate compliance with the

CDD/CDF emission limit by

continuously monitoring the CDD/CDF

sorbent flow rate and the temperature

measured at the inlet to the PM control

device. The minimum CDD/CDF sorbent

flow rate and the maximum PM control

device inlet temperature are to be

established during the initial

performance test to determine

compliance with the CDD/CDF emission

limit. Operation of the MWI below the

minimum sorbent flow rate or above the

maximum PM control device inlet

temperature would constitute a

violation of the CDD/CDF emission

limit.

f. Demonstrate compliance with the

HCl emission limit by continuously

monitoring the HCl sorbent flow rate

and continuously measuring the weight

and time of each load of waste charged

to the incinerator. The minimum HCl

sorbent flow rate, the maximum charge

weight, and the maximum hourly charge

rate are to be established during the

initial performance test to demonstrate

compliance with the emission limit for

HCl. Operation of the MWI below the

minimum sorbent flow rate, or above

the maximum charge weight or

maximum hourly charge rate would

constitute a violation of the HCl

emission limit.

The proposed standards and

guidelines require the owner or operator

of an MWI using a control device other

than a dry scrubber followed by a fabric

filter to petition the Administrator for

other site-specific operating parameters

to demonstrate continuous compliance

with the emission limits for CDD/CDF,

Hg, HCl, and/or opacity. These

parameters would be established during

the initial performance test for these

pollutants and would be continuously

monitored to demonstrate compliance

with the emission limits.

P. Reporting and Recordkeeping—New

MWI’s

The proposed standards would

require owners of affected facilities to

submit notifications concerning

construction and initial startup of the

affected facility. The information to be

submitted includes: (1) a statement of

intent to construct along with the date

of commencement of construction, (2)

the anticipated date of startup, (3) a

statement of the type of waste to be

burned, (4) the letter from the State air

pollution agency approving the

construction and operation of the

affected facility, and (5) all

documentation produced as a result of

the siting requirements.

The proposed standards also require

that the owner or operator of an affected

facility maintain the following

information for a period of at least 5

years: (1) the results of the initial,

annual, and any subsequent

performance tests; (2) data

demonstrating continuous monitoring of

site-specific operating parameters; (3)

CEMS output data; and (4) results of

CEMS quality assurance determinations.

Additional records must be kept on

file for the life of the facility. These

records include: (1) all documentation

produced as a result of the siting

requirements, (2) the letter from the

State air pollution agency approving the

construction and operation of the

affected facility, (3) records showing the

names of the persons who have

completed the requirements for MWI

operator training and dates of training

(along with documentation of the

training program completed), (4) records

showing the names of those who have

completed review of the site-specific

MWI operating manual and dates of

review, and (5) records showing the

names of the qualified MWI operators

and dates of qualification.

The proposed standards require that

certain documentation be submitted to

the Administrator. Owners or operators

are required to submit the results of the

initial performance test and all

subsequent performance tests. Also,

reports on emission rates or operating

parameters that have not been obtained

or that exceed applicable limits must be

submitted within 30 days after the end

of the quarter of occurrence. If no

exceedances occur during a quarter, the

owner of the affected facility is required

to submit a letter stating so. All reports

submitted to comply with the

requirements of the proposed standards

must be signed by the facilities

manager—the individual responsible for

purchasing, maintaining, and, in many

cases, operating the MWI. This

individual is likely to have different

titles at different facilities, for example,

director of facilities or vice president of

support services.

The reporting and recordkeeping

requirements in the proposed standards

are necessary to inform enforcement

personnel of the compliance status of

new MWI’s. In addition, they would

provide the data and information

necessary to ensure continued

compliance of these MWI’s with the

proposed standards. At the same time,

these requirements would not impose

an unreasonable burden on MWI owners

or operators.

Q. Reporting and Recordkeeping—

Existing MWI’s

The proposed emission guidelines

would require owners or operators of

MWI’s to maintain the following

information for a period of at least 5

years: (1) the results of the initial and

annual performance tests, (2) data

demonstrating continuous monitoring of

site-specific operating parameters, (3)

CEMS output data, (4) results of CEMS

quality assurance determinations, and

(5) results of the initial and annual

inspections.

Additional records must be kept on

file for the life of the facility. These

records include: (1) records showing the

names of the persons who have

completed the requirements for MWI

operator training and dates of training

(along with documentation that the

training program was completed), (2)

records showing the names of those who

have completed review of the sitespecific MWI operating manual and

dates of review, and (3) records showing
10684 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

the names of the qualified MWI

operators and dates of qualification.

Under the proposed emission

guidelines owners or operators are

required to submit the results of the

initial maintenance inspection and any

subsequent inspections completed prior

to demonstrating initial compliance

with the emission limits. This

documentation must include a

discussion of any repairs performed in

response to the inspection and when the

repairs occurred. Additionally, MWI

owners or operators are required to

submit to the Administrator the results

of the initial performance test and all

subsequent performance tests. Also,

reports on emission rates or operating

parameters that have not been obtained

or that exceed applicable limits must be

submitted within 30 days after the end

of the quarter of occurrence. If no

exceedances occur during a quarter, the

owner of the designated facility is

required to submit a letter stating so. All

reports submitted to comply with the

requirements of the emission guidelines

must be signed by the facilities

manager—the individual responsible for

purchasing, maintaining, and, in many

cases, operating the MWI. This

individual is likely to have different

titles at different facilities, for example,

director of facilities or vice president of

support services.

The reporting and recordkeeping

requirements in the proposed guidelines

are necessary to inform enforcement

personnel of the compliance status of

existing MWI’s. In addition, they would

provide the data and information

necessary to ensure continued

compliance of these MWI’s with the

proposed guidelines. At the same time,

these requirements would not impose

an unreasonable burden on MWI owners

or operators.

R. Compliance Times

1. New MWI’s

As stated in section 129, the effective

date of standards for new MWI’s is to be

the date 6 months after promulgation of

the standards. Consequently, while any

MWI for which construction is

commenced after today’s date will be

subject to the standards, they will not be

subject to the standards until the

effective date of the standards.

2. Existing MWI’s

Under section 129, States are required

to submit to the Administrator a plan

implementing the emission guidelines

within 1 year after promulgation of the

guidelines. Section 129 also requires

that a State plan shall provide that each

unit subject to the guidelines shall be in

compliance with all requirements of the

proposed guidelines within 3 years after

the State plan is approved by the EPA

but in no case later than 5 years after

promulgation of the emission

guidelines. The compliance schedule in

today’s proposal would supersede and

is more comprehensive than the

compliance schedule specified in

section 129.

The proposal requires that a State

plan shall provide that each source

subject to the emission guidelines shall

be in compliance with all requirements

of the guidelines within 1 year after EPA

approval of the State plan. The proposal

allows two exceptions to this

compliance schedule. First, State plans

may allow facilities that are planning to

install the necessary air pollution

control equipment up to three years

after EPA approval of the State plan (but

not later than 5 years after promulgation

of the guidelines) to comply if the State

plan specifies that the facility submit

measurable and legally enforceable

incremental steps of progress towards

compliance. Suggested incremental

steps of progress to be included in the

State plans are specified in the emission

guidelines.

Second, State plans may include

provisions allowing designated facilities

to petition the State for extensions for

compliance. Under the proposed

emission guidelines, State plans that

include such provisions must require

that the designated facility requesting an

extension submit information to assist

the State in deciding whether to grant or

deny the extension. The schedule for

submittal of this information must allow

the State sufficient time to grant or deny

the extension within one year after EPA

approval of the State plan.

This information must include

documentation of the analyses

undertaken to support the need for an

extension, including an explanation of

why up to 3 years after EPA approval of

the State plan is sufficient time to

comply with the State plan while one

year after EPA approval of the State plan

is not sufficient time to comply. The

documentation must also include an

evaluation of the option to send the

waste offsite to a commercial medical

waste treatment and disposal facility,

either in the interim, while the facility

is taking steps towards achieving

compliance, or on a permanent basis.

State plans that allow extensions must

also include procedures for granting or

denying an extension. Under the

proposed guidelines, if an extension is

granted, compliance shall be required

within 3 years after EPA approval of the

State plan, but not later than 5 years

after the date of promulgation of the

emission guidelines.

While the EPA expects that States will

grant extensions for facilities planning

to install the necessary air pollution

control equipment, the Agency does not

expect many extensions will be granted

for facilities planning to switch to an

alternative method of treatment and

disposal. Alternatives to onsite

incineration include either offsite

contract treatment and disposal or

onsite alternative treatment

technologies, such as autoclaves.

It is expected that facilities choosing

to switch to an alternative could do so

within the 1 year following EPA

approval of the State plan. The

commercial waste disposal industry has

indicated that sufficient excess capacity

currently exists to handle the amount of

waste that would no longer be treated

onsite and that commercial facilities are

located such that most areas could be

served by this excess capacity. Also,

they have indicated that short term

contracts are available.

As a result, if a facility chooses to

install an alternative onsite treatment

technology and the installation takes

longer than the time allowed for

compliance, offsite contract disposal

could be used as a temporary means of

compliance while the alternative

technology is installed and made

operational. The provision for

extensions is included only to address

cases where absolutely no other options

are available and is not intended to

allow up to three years for any facility

that requests an extension.

Regardless of the status of the State

plans, all designated facilities must be

in compliance within 5 years after

promulgation of the emission

guidelines. To ensure that each

designated facility is in compliance

with the provisions of the emission

guidelines within 5 years, the EPA will

develop, implement, and enforce a plan

for any State that has not submitted an

approvable plan within 2 years after

promulgation of the emission

guidelines.

The proposed emission guidelines

also require that, for approval, a State

plan provide that each designated

facility must be in compliance with the

operator training and qualification

requirements and the inspection

requirements within 1 year after EPA

approval of the State plan. The rationale

for not granting extensions for these

requirements is presented in sections

V.L and V.N.

S. Permit Requirements

Section 129 of the Act requires MWI’s

subject to the standards and guidelines
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10685

to be operated pursuant to a permit

issued under the EPA-approved State

operating permit program. In

accordance with section 129, under the

proposed standards and guidelines, a

permit would be required on the date 36

months after the date of promulgation,

or on the effective date of an EPAapproved operating permit program in

the State in which the facility is located,

whichever date is later. The operating

permit programs are developed under

Title V of the Act and the implementing

regulations under 40 CFR part 70.

VI. Request for Comment

This section is included in this notice

to request public comment on certain

issues raised during the development of

these proposed standards and

guidelines. As mentioned at the

beginning of this notice, the EPA seeks

full public participation in arriving at its

final decisions and strongly encourages

comments on all aspects of this proposal

from all interested parties.

A. Procedure To Determine MACT

Section 129 of the Act establishes

specific criteria that must be analyzed in

developing standards and guidelines for

solid waste combustion units. 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. The details of how

this process was applied to the MWI

source category are described in section

V.

In the process of developing the

proposed standards and guidelines, the

EPA met with representatives from

environmental groups, States, MWI and

air pollution control equipment

vendors, commercial waste disposal

companies, and trade associations that

represent owners or operators of MWI’s

to discuss the proposed standards and

guidelines. During these discussions,

various groups have called into question

some of the conclusions reached in

developing the proposed standards and

guidelines.

Specifically, questions were raised

about: (1) appropriate methods for

subcategorizing the source category, (2)

information and assumptions used in

determining the MACT floor, (3)

conclusions drawn regarding the

performance of air pollution control

technology, and (4) decisions made

regarding MACT for MWI’s. This section

describes the regulatory development

process in general terms and requests

public comments on the information

used and assumptions made in drawing

conclusions. Following proposal, a

reassessment of the four criteria listed

above will be made that may result in

the establishment of standards and

guidelines that are different from this

proposal.

1. Subcategorization

Section 129 of the Act enables EPA to

distinguish among classes, types, and

sizes within categories of new and

existing sources in establishing

standards and guidelines. The Agency

has determined that subcategorizing the

source category by type of unit is

appropriate because of distinct technical

differences among three types of MWI’s.

Therefore, three subcategories based on

MWI type have been identified for the

purpose of regulating MWI’s: batch,

intermittent, and continuous. While

these subcategories were selected

because of technical differences

between the three types of units, as

described in section V.G, they also

generally follow differences in size

within the source category. Typically,

continuous units are large capacity

MWI’s and batch units are small

capacity MWI’s. Intermittent units tend

to fall between the continuous and

batch units in size. The EPA specifically

solicits comment on its determination to

distinguish between continuous,

intermittent, and batch units.

It has been suggested that

subcategories could have been

identified according to size or capacity:

small capacity, medium capacity, and

large capacity, or that EPA might

establish a subcategory of small

intermittent and/or small batch MWI’s

in addition to establishing subcategories

on the basis of continuous, intermittent,

and batch units. Such a distinction by

size, or tiering, is currently used by

many State air pollution control

agencies. Current State regulations,

therefore, may provide a basis for

subcategorization by size in establishing

the standards and guidelines. The

Agency is considering subcategorization

by size and specifically solicits

comment on the basis for

subcategorization by size.

The EPA recognizes that there may be

a relatively large number of very small

incinerators within the categories of

batch and intermittent. If so, further

subcategorizing batch and intermittent

incinerators by size or capacity could

provide an alternative for consideration

which might significantly reduce the

cost of today’s proposed standards and

guidelines. If the MACT floor is less

stringent for small intermittent and or

small batch MWI’s, the EPA could

consider less stringent requirements for

these incinerators. Also, if these

incinerators contribute little to total

national medical waste incineration

capacity, adoption of less stringent

requirements for them could result in

little loss in the environmental benefits

associated with today’s proposal. This

alternative, therefore, could have

substantial merit and the EPA requests

comment on such an approach.

To fully consider subcategorization by

size, however, a mechanism must be

available to accurately and consistently

determine the capacity of an MWI. Only

if such a mechanism exists, will

enforcement personnel, as well as

owners and operators of MWI’s, be

assured that MWI’s are subject to a

consistent set of requirements.

The EPA believes this may be a

serious problem. It appears there is no

common or widely used mechanism or

‘‘standard’’ within the MWI industry for

sizing or determining the capacity of an

incinerator to burn medical waste. As a

result, it seems that one vendor’s 50

pound per hour capacity incinerator can

be another vendor’s 100 pound per hour

capacity incinerator. It also appears the

same vendor may sell one customer a 50

pound per hour capacity MWI and then

sell another customer the same

incinerator as a 100 pound per hour

MWI. The EPA believes that a

manufacturer’s or vendor’s ‘‘nameplate

capacity’’ is not an accurate and reliable

means for determining the size or

capacity of an MWI.

The EPA recognizes that the

composition of medical waste changes

across generators, over time, and in

response to changes in waste handling

or recycling practices in a way that may

affect the amount of medical waste a

specific incinerator is able to burn. For

the purposes of enforcing regulations

that may vary by size or capacity, a

common mechanism or ‘‘standard’’ to

measure or determine the capacity of

MWI’s is necessary.

Consequently, EPA specifically

requests comments on a mechanism or

‘‘standard’’ for accurately and

consistently determining the capacity of

MWI’s in the enforcement of whatever

regulation might be adopted. For

example, the comments might outline

the mechanisms or approaches used by

States to ensure all MWI’s of the same

capacity are subject to the same

requirements. Or, the comments may

offer alternative measures of capacity

that serve as a better basis for

identifying small intermittent and/or

small batch MWI’s. Finally, the
10686 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

manufacturers may choose to develop a

voluntary approach providing a

consistent measure of rated capacity.

It has also been suggested that

subcategories could be identified

according to the geographic location of

the MWI. Facilities located in isolated,

rural areas may be different than

facilities located in urban areas based on

their economic environment. For

example, alternatives to onsite

incineration (e.g., commercial medical

waste treatment services) may be more

limited and/or more expensive in

isolated locations. The Agency

specifically solicits comment on the

advantages and disadvantages of

subcategorizing by geographic location.

2. MACT Floor

The MACT floor refers to the

minimum level of control required by

the Act. For new units, the standards

must not be less stringent than the

emissions control that is achieved in

practice by the best controlled similar

unit. The MACT floors for the proposed

standards were determined by

evaluating the performance of control

technologies and identifying MWI’s that

currently use what is considered to be

the best control technology for each

pollutant within each subcategory, as

described in section V.I. Comments are

requested on the Agency’s conclusions

regarding the MACT floors for new

MWI’s in each subcategory.

For existing units, the guidelines must

not be less stringent than the average

emission limitation achieved by the best

performing 12 percent of units. The

MACT floors for the proposed

guidelines were determined by

examining emission limitations found

in air quality permits and State

regulations, as described in section V.J.

Because of widely varying formats used

from State to State to regulate MWI’s,

many assumptions are necessary to

standardize the regulations to a common

basis. As a result, State regulations are

subject to different interpretations

depending on the assumptions made in

standardizing them for comparison.

Comments are requested on the basis for

the Agency’s conclusions on the MACT

floors for existing MWI’s in each

subcategory.

Subcategorization based on size rather

than, or in addition to, MWI type (as

discussed above) could result in

different MACT floors. For example, the

MACT floor level for particulate matter

emissions for a subcategory including

small intermittent and/or small batch

MWI’s may be much less stringent than

the 69 mg/dscm MACT floor identified

above for intermittent and batch MWI’s.

If the MACT floors are found to be

significantly different than those under

today’s proposal, the Agency will

determine if MACT levels more

stringent than the MACT floors are

achievable considering cost, any nonair

quality health and environmental

impacts, and energy requirements. The

MACT floors will be reassessed

following proposal.

3. Performance of Technology

While the standards and guidelines

are required to reflect MACT, the

Agency establishes emission limitations,

rather than equipment specifications, to

encourage competition and further the

development of technology. Individual

facilities have the flexibility of selecting

the method of control used to comply

with the established pollutant emission

limitations. The benefits of this

approach include increased competition

among vendors of control devices,

further development and refinement of

control technologies, and lower costs, as

competing control device vendors strive

to meet or exceed the required

performance levels at lower costs than

their competitors. Competition among

vendors of air pollution control

equipment will ensure that the benefits

of emission reduction are realized at the

lowest possible costs to MWI users and

to society.

In developing the proposed standards

and guidelines, the EPA concluded that

dry scrubbers are the only technology

capable of achieving the MACT floor

levels. Consequently, the proposed

emission limitations have been

established at levels reflecting dry

scrubber performance. Once again, this

does not mean that MWI’s are required

to use dry scrubbers. Any technology

that can achieve the emission

limitations may be used. On the other

hand, the EPA conclusion about the

performance capabilities of wet

scrubbers is based on emissions data

from only one MWI facility using a wet

scrubber system. Vendors of wet

scrubber systems believe that the wet

scrubber tested by EPA is not reflective

of current wet scrubber technology.

They believe that current wet scrubber

technologies are not only capable of

achieving the MACT floor levels, but

may also be capable of achieving the

proposed emission limitations for all

pollutants. As a result, while the

preamble assumes the use of a dry

scrubber system to comply with the

proposed emission limits, it appears

that high efficiency wet scrubber

systems as well as dry scrubber systems

may be capable of achieving the

proposed emission limits.

In addition, vendors of wet scrubber

systems believe that wet scrubber

systems are able to achieve the proposed

emission limitations at about half the

estimated total annual costs of dry

scrubber systems. Wet scrubber vendors

also claim that wet scrubber systems

currently not capable of complying with

the proposed emission limitations could

be retrofitted to do so at a reasonable

cost. Users of MWI’s that have already

installed less efficient wet scrubber

systems to comply with State and/or

local regulations may be able to upgrade

their existing wet scrubber system to

comply with the proposed emission

limits. The Agency is interested in this

alternative in part because a number of

facilities have installed wet scrubber

controls in recent years in an effort to

meet State standards. If the alternative

is not available, these facilities may

have to remove their wet scrubbers and

replace them with more expensive dry

scrubbers. The Agency is interested in

data on the number of facilities that

have installed wet scrubbers and the

likely cost of replacing the wet

scrubbers with dry scrubber technology.

While upgrading an existing wet

scrubber system may result in lower

total annual costs than installing a new

dry scrubber system, most facilities may

still find that alternative disposal

options, such as offsite contract disposal

or onsite autoclaving, are less

expensive. Consequently, the EPA

believes that the use of wet scrubber

systems to comply with the proposed

standards and guidelines will have

essentially the same impact on shifts

away from onsite incineration as the use

of dry scrubber systems. In fact, the use

of any add-on control system will

increase the costs of onsite incineration

such that alternatives to onsite

incineration become more economical.

Because the issue of wet scrubber

performance is important to MWI users,

EPA specifically solicits further

information on wet scrubber systems.

The EPA is requesting emissions data

that could be used to evaluate the

performance of wet scrubber systems

and to determine the capability of these

systems in achieving the MACT floor

levels and/or the proposed emission

limitations. Sufficient data are available

on emissions of CO, opacity, NOX, SO2,

and HCl for use in developing the

proposed standards and guidelines. The

Agency specifically solicits data on PM,

Pb, Cd, Hg, and CDD/CDF emissions.

If new data on wet scrubber

performance shows that wet scrubbers

are capable of achieving the MACT floor

levels, then EPA would have to review

the decision to base the emission

limitations on dry scrubbers by

examining the additional costs and

emission reductions achieved by dry
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10687

scrubbers relative to wet scrubbers. In

this case, the EPA may conclude that

the additional costs associated with dry

scrubber limits are unreasonable relative

to the emission reductions achieved. On

the other hand, if new data on wet

scrubber performance shows that wet

scrubbers are capable of achieving the

proposed emission limitations, then it is

likely that the emission limitations will

remain unchanged. In this case, the

emission limitations would reflect the

use of either wet scrubbers or dry

scrubbers.

The performance of air pollution

control equipment can best be

established when both APCD inlet and

APCD outlet concentration data are

measured and compared. Several

pollutants are waste related. The EPA

test program identified significant

variations in the uncontrolled

concentrations of these pollutants from

source to source, which could be a

result of differences in the types and

amounts of various materials included

in the waste stream. Therefore, the

Agency solicits APCD inlet

concentration data, to the extent

available, wherever outlet concentration

data are provided.

Additionally, the Agency solicits

comments on the technical feasibility of

injecting activated carbon into wet

scrubber systems to control CDD/CDF

and Hg emissions. Specifically, the

Agency is requesting information on

whether carbon injection is necessary to

reduce CDD/CDF and Hg using wet

scrubbers and if so, what problems are

associated with the injection of carbon

into a wet system or what other means

of using the carbon adsorption

mechanism are available to reduce

emissions of these pollutants. If carbon

injection is not necessary to reduce

emissions of CDD/CDF and Hg, the EPA

is soliciting information on what wet

scrubber mechanisms reduce emissions

of CDD/CDF and Hg. The EPA

specifically requests that, if available,

Hg emissions data be broken down by

various species emitted (e.g., Hg

chloride versus elemental Hg).

In addition to performance data, the

EPA is requesting information on the

costs associated with the installation of

new higher efficiency wet scrubber

systems and with the retrofit of existing

wet scrubber systems to achieve the

same performance capabilities of the

higher efficiency wet scrubber systems.

The Agency also solicits information on

the performance and cost of dry

scrubber systems, as well as information

on whether there are technical

limitations associated with the

application of air pollution control

systems to various sizes and types of

MWI’s.

There is some concern about the

impacts on other media from the use of

wet scrubber systems—specifically, the

fate of metals transferred from the stack

gas to the scrubber water with

subsequent disposal to a sewer system.

Wastewater pretreatment may be

necessary to remove these metals. As a

result, the Agency is soliciting

information on pretreatment techniques

that are, or could be, used to remove

metals from the scrubber effluent prior

to discharge to a sewer system and on

the costs associated with these

techniques. The additional costs of

scrubber effluent pretreatment may

increase the total annual costs

associated with wet scrubber systems to

a level that is more comparable to the

use of a dry scrubber system. Because

the Act directs the Agency to consider

all media in developing regulations, the

final standards and guidelines may

include requirements that address the

pretreatment of MWI wastewater to

ensure that water quality is not

compromised.

4. Determining MACT for MWI’s

While section 129 of the Act requires

that the standards and guidelines be no

less stringent than the MACT floor, it

does provide EPA with the authority to

establish emission limitations that are

more restrictive than the MACT floor. In

deciding whether the standards and

guidelines should be more restrictive

than the MACT floor, section 129

requires the Administrator to consider

the cost, any nonair quality health and

environmental impacts, and energy

requirements associated with the more

restrictive standards and guidelines.

As described in section V of this

notice, EPA has concluded that dry

scrubbers are the only technology

available to meet the MACT floor.

Furthermore, dry scrubbers achieve

substantially lower emissions than the

MACT floor for little, if any, additional

cost. Consequently, EPA was faced with

two options: (1) propose more restrictive

emission limitations that reflect the

performance of the technology needed

to meet the MACT floor (i.e., scrubber

limits); or (2) propose less restrictive

emission limitations that reflect the

MACT floor (i.e., floor limits). On one

hand, there is essentially no cost

associated with the scrubber limits

relative to the floor limits because the

dry scrubber would be installed to meet

the floor limits. On the other hand, the

installation of a dry scrubber will result

in the lower emissions associated with

a dry scrubber. Therefore, it can be

argued that there is also no

environmental benefit associated with

the more restrictive emission limits.

The EPA specifically requests

comment on the advantages and

disadvantages of MACT floor-based

emission limits versus dry scrubberbased emission limits. The Agency has

chosen the more restrictive dry

scrubber-based emission limits for the

following reasons. First, as discussed

above, the EPA believes that a dry

scrubber is the only technology capable

of meeting the MACT floor. In addition,

activated carbon can be injected into a

dry scrubber to further reduce dioxin

and Hg emissions for a relatively small

cost. Other technologies have not been

identified that are able to incorporate

carbon injection for dioxin and Hg

removal. Incineration of medical waste

has been identified as the largest known

source of dioxin and Hg emissions. The

additional reduction of dioxin and Hg

emissions achieved by the injection of

activated carbon is discussed earlier in

this preamble. The EPA believes that the

benefits of activated carbon injection

outweigh the costs.

Secondly, by setting emission

limitations rather than control

equipment specifications, EPA

encourages and promotes the

development of new emission control

technologies that can meet the emission

limits at lower costs. If the Agency

proposes the MACT floor emission

limits, it will promote new technologies

that are only capable of meeting the

floor. In this case, the use of new

technologies capable of meeting the

MACT floor may result in higher

emissions than current technologies

(i.e., dry scrubbers). The Agency

believes that new technologies should

be promoted and encouraged, but that

the dry scrubber based emission limits

are the more appropriate target for these

new technologies. Therefore, today’s

proposal has set dry scrubber emission

limits as the target for new technologies.

The Agency specifically requests

comment on the appropriate target

emission limits for developing

technologies.

As noted above, however, vendors of

wet scrubbers believe that current wet

scrubber technologies are not only

capable of achieving the MACT floor

levels, but may also be capable of

achieving more stringent control levels.

If EPA receives additional data that

confirms this level of performance, then

EPA would have to review the decision

to base the emission limits on dry

scrubbers. Thus, EPA would consider

the potential incremental emission

reductions and the potential gains from

technology development with the
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differential retrofit costs of these two

alternative control technologies.

In addition, as noted above, EPA is

considering further subcategorization by

size. If EPA decides to establish a

subcategory of ‘‘very small MWI’s’’ in

the final rule, it is possible that one or

more additional control approaches (in

addition to fabric filters) would be able

to achieve (or exceed) the MACT floor

levels for this subcategory. The Agency

would then undertake a careful review

of the alternative control approaches

available for this category of ‘‘very small

MWI’s’’ by considering the incremental

emission reductions of the more

stringent control options with the

differences in retrofit cost across

alternatives.

The Agency requests comment on the

appropriate emission limits under these

alternative options.

B. Alternatives to Onsite Incineration

As discussed in sections III and IV of

this notice, in evaluating costs

associated with MACT for each MWI, it

was determined that many facilities

would have the option of using an

alternative method of treatment and

disposal that would be less expensive

than onsite incineration under the

proposed standards and guidelines. The

most common alternatives to onsite

incineration are offsite contract disposal

(most commonly commercial medical

waste incineration) and onsite

autoclaving. While data are available to

estimate costs for these two alternatives

and to estimate emissions from

commercial medical waste incineration,

data are not available to quantify

emissions or energy requirements from

onsite autoclaving of medical waste.

The EPA solicits emissions data, energy

use data, and cost information on the

use of autoclaves and other

nonincineration methods to treat and

dispose of medical waste.

Several concerns related to the use of

alternatives to onsite incineration have

been raised. One concern is the ability

of alternative technology manufacturers

to meet the increased demand for

installations. Also, questions have been

raised about the general stability in the

alternative technology marketplace.

Specifically, questions have been raised

about whether vendors of alternative

technologies will be able to service the

equipment that has been installed over

the life of that equipment. To respond

to these concerns, the EPA solicits

information on the number of

companies that currently manufacture

alternatives to onsite incineration, the

number of U.S. installations, the

number of installations the individual

companies are capable of on an annual

basis, and the number of years the

individual companies have been in

business.

Concerns about environmental

impacts associated with the use of these

alternatives have also been raised.

Specifically, questions have been raised

about air and water pollution impacts.

As discussed earlier, data are not

available to quantify air emissions from

the use of alternative technologies. Data

are also not available to quantify other

environmental impacts resulting from

the use of alternatives. In addition to air

emissions data (requested earlier), the

EPA solicits data related to other media

impacts, including water pollution

impacts, resulting from the use of

alternative technologies.

C. Definition of Medical Waste

As discussed above, the definition of

medical waste included in today’s

proposed regulations is very broad.

Medical waste is any solid waste

generated in the treatment, diagnosis, or

immunization of humans or animals, or

research pertaining thereto, or in the

production or testing of biologicals.

Section 129 of the Clean Air Act

directs the EPA to adopt regulations for

solid waste incineration units burning

medical waste. This section also states

that ‘‘* * * ‘‘solid waste’’ and ‘‘medical

waste’’ shall have the meanings

established by the Administrator

pursuant to the Solid Waste Disposal

Act.’’

The Solid Waste Disposal Act was

amended extensively and, for all

practical purposes replaced, by the

Resource Conservation and Recovery

Act (RCRA) in 1976. The RCRA, in turn,

was amended in 1984 and, as it pertains

to medical waste, was amended again in

1988 by the Medical Waste Tracking Act

(MWTA). The MWTA included a

definition of medical waste, which was

added to the RCRA. In implementing

the amendments to the RCRA, this

statutory definition of medical waste

was adopted by the Administrator. The

definition of medical waste included in

today’s proposal, therefore, is in EPA’s

opinion the definition of this term

established by the Administrator

pursuant to the Solid Waste Disposal

Act.

As mentioned above, some have

suggested the definition of medical

waste included in today’s proposal is

inappropriate and the EPA requests

comment on this definition. It appears

the basis for this suggestion stems from

the following concern. If the impact of

today’s regulation is as widespread as

the EPA believes, in terms of the large

number of medical waste generators

who may decide to switch from the use

of onsite incineration to the use of

alternative waste disposal techniques,

there may not be enough medical waste

disposal capacity currently available to

safely and properly dispose of this

medical waste.

To reduce the amount of medical

waste covered by today’s proposed

regulations, some have suggested that

the EPA narrow the definition of

medical waste. Various definitions have

been offered, such as ‘‘regulated medical

waste’’ (a term used by the EPA in

implementing the MWTA amendments

to the RCRA), ‘‘red bag medical waste’’,

‘‘infectious medical waste’’, etc. These

wastes are included under the broad

definition of medical waste, but are

generally viewed as constituting only

about 15 to 20 percent of the total

quantity of medical waste. If today’s

proposal covered only these types of

medical wastes, as opposed to all types

of medical wastes, the amount of

medical waste which might be

displaced from onsite incineration at

medical waste generators to alternative

waste disposal techniques would be

much less and, as a result, more easily

handled by these alternative techniques.

It appears to the EPA, however, that

there are several reasons to believe there

is or would be sufficient capacity

available to safely and properly treat

and dispose of all the medical waste

that might be displaced from onsite

incineration at medical waste generators

as a result of today’s proposed

regulations. Since this issue concerns

medical waste presently being treated

by onsite medical waste incinerators at

medical waste generators, it concerns

existing incinerators, not new

incinerators. Thus, the focus of this

issue is today’s proposed emission

guidelines, not the proposed new source

performance standards.

Today’s proposed emission guidelines

provide time for medical waste

generators currently using onsite

medical waste incinerators to consider

alternatives for treating and disposing of

their medical waste. The guidelines will

not be adopted by the EPA for at least

1 year (the EPA is under Court Order to

adopt final regulations by April 15,

1996). States are provided 1 year by the

Clean Air Act to adopt plans for

implementing the guidelines and to

submit these plans to the EPA for

approval. The Act then provides EPA

180 days to review and approve these

State plans. Finally, today’s proposed

guidelines provide 1 year following EPA

approval of the State plan for existing

medical waste incinerators to comply

with the proposed emission limits.

Medical waste generators currently

operating onsite incinerators, therefore,
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10689

have about 31⁄2 years from today’s date

to consider how to treat and dispose of

their medical waste in the future. In

addition, today’s proposed emission

guidelines include provisions to permit

an extension of up to 3 years following

EPA approval of the state plan for

individual medical waste generators

currently operating medical waste

incinerators to comply with the

proposed emission limits.

Consequently, where circumstances

dictate the need for additional time,

medical waste generators currently

operating medical waste incinerators

could have up to 51⁄2 years from today’s

date to consider how to treat and

dispose of their medical waste.

Turning to the alternatives, the EPA

believes medical waste generators

currently operating medical waste

incinerators have three choices to

consider. These are: (1) continued

operation of their onsite incinerator and

compliance with the proposed emission

limits; (2) installation of an alternative

medical waste treatment technology

onsite, such as autoclaving,

microwaving, macrowaving, chemical

treatment, etc.; or (3) contracting with a

commercial medical waste disposal

service for offsite treatment and disposal

of medical waste.

As discussed above, the EPA believes

many medical waste generators

currently operating onsite medical

waste incinerators will select the second

or third choice in response to today’s

proposed emission guidelines. With

regard to the second choice, installation

of an alternative medical waste

treatment technology onsite, several

manufacturers and vendors of autoclave,

microwave, macrowave, and chemical

treatment systems have indicated

informally that 31⁄2 to 51⁄2 years is more

than enough time to purchase and

install one of these alternative treatment

systems. In fact, some manufacturers

and vendors have indicated informally

that they could supply their equipment

within months for installation.

These informal comments have led

the EPA to conclude that today’s

proposed emission guidelines provide

ample time for medical waste generators

currently operating onsite medical

waste incinerators, who may select the

second choice, to purchase and install

the appropriate equipment. The EPA,

however, specifically requests

manufacturers and vendors of these

alternative treatment systems to

comment formally on the time necessary

for a medical waste generator to obtain

the necessary permits to install and

operate their systems, the time

necessary to obtain and install their

systems, and their ability to respond to

increased orders for their systems over

the next 3 to 6 years, as a result of

today’s proposal.

Based on a survey of current practices

regarding landfill disposal of medical

waste, the EPA believes that medical

waste may be disposed of in most

landfills provided it has been properly

treated to destroy infectious agents and

is not recognizable as medical waste. It

appears the first criteria is met through

the use of these alternative treatment

systems. The second criteria is met by

grinding and/or shredding the waste,

which is common practice where these

alternative treatment systems are in

operation today. If this belief is correct,

it would seem clear that there is more

than enough landfill capacity available

in the United States for disposal of

medical waste treated by these

alternative waste treatment disposal

systems.

With regard to the third choice,

contracting with a commercial medical

waste disposal service, representatives

and operators of these services have

indicated informally that their industry

is currently operating at very low

capacity. They have indicated

informally that the industry currently

treats and disposes of about 20 percent

of the medical waste generated in the

United States and that the industry has

the capacity today to treat and dispose

of possibly as much as 40 percent of the

medical waste generated. Finally, given

the time frame of 31⁄2 to 51⁄2 years

provided in the proposed emission

guidelines for medical waste generators

currently operating medical waste

incinerators to decide how to dispose of

their medical waste in the future, the

commercial medical waste disposal

industry has indicated informally that

sufficient additional capacity could be

permitted, constructed, and brought on

line by the industry to service all those

medical waste generators who may

select this third choice.

It appears, therefore, the commercial

medical waste disposal industry has a

great deal of capacity today and could

add substantial capacity in the near

future to meet any increase in the need

for their services which may result. The

EPA, however, specifically requests that

the representatives and operators of

commercial medical waste disposal

services comment formally on the

capacity within their industry today to

dispose of medical waste, the current

utilization of this capacity, and their

ability to permit, construct, and bring on

line major additions to this capacity in

the next 3 to 6 years.

Finally, while not related to questions

of the capacity of alternatives to treat

and dispose of medical waste displaced

by medical waste generators which

currently use onsite medical waste

incinerators, there are other reasons

EPA believes all medical waste should

be covered by today’s proposed

regulations. The suggestions to narrow

the applicability of today’s proposal

would basically narrow the proposal to

cover ’’red bag’’ medical wastes. Testing

during the EPA test program to examine

differences in emissions between redbag medical waste and general medical

waste showed no significant difference

in emissions of air pollutants, such as

hydrogen chloride (HCl), dioxins, lead,

mercury, etc.

The EPA believes, therefore, that there

is no significant difference between redbag medical waste and general medical

waste in emissions of those air

pollutants which section 129 of the

Clean Air Act directs the EPA to

regulate. In addition, there appears to be

no significant difference in the

applicability, performance, or cost of

various technologies to reduce these

emissions from medical waste

incinerators burning red-bag medical

waste or general medical waste. There

is, therefore, no compelling reason EPA

sees for narrowing the definition of

medical waste included in today’s

proposed regulations.

VII. Administrative Requirements

A. Public Hearing

The EPA will hold at least one public

hearing to provide interested parties an

opportunity for oral presentation of

data, views, or arguments concerning

the proposal. Additional hearings may

also be held. A Federal Register

document will be published within the

next 2 weeks to announce the details of

the heading(s). At the public hearing(s),

the proposed standards and guidelines

will be discussed in accordance with

section 307(d)(5). Oral presentations

will be limited to 15 minutes each. Any

member of the public may file a written

statement before, during, or within 30

days after the hearing. Written

statements should be mailed to the Air

and Radiation Docket and Information

Center at the address given in the

ADDRESSES section of this preamble.

A verbatim transcript of the hearing

and written statements will be available

for public inspection and copying

during normal working hours at the

EPA’s Air and Radiation Docket and

Information Center in Washington, DC

(see ADDRESSES section of this

preamble).

B. Docket

The docket is an organized and

complete file of all the information
10690 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules

submitted to or otherwise considered in

the development of the proposed

standards and guidelines. The principal

purposes of the docket are: (1) to allow

interested parties to identify and locate

documents so that they can effectively

participate in the rulemaking process,

and (2) to serve as the record in case of

judicial review (except for interagency

review material [section 307(d)(7)(A)]).

The docket number for this rulemaking

is A–91–61.

C. Clean Air Act Procedural

Requirements

1. Administrator Listing—Section 111;

Section 129 of the Act

Section 129 of the Act calls for the

Administrator to promulgate standards

for new MWI’s and guidelines for

existing MWI’s pursuant to section 111

and 129.

2. Periodic Review—Section 111 and

Section 129 of the Act

Section 111 and section 129 of the Act

require that the standards and

guidelines be reviewed not later than 5

years following the initial promulgation.

At that time and at 5-year intervals

thereafter, the Administrator is to

review the standards and guidelines and

make revisions if necessary. This review

will include an assessment of such

factors as the need for integration with

other programs, the existence of

alternative methods, enforceability,

improvements in emission control

technology, and reporting requirements.

3. External Participation—Section 117

of the Act

In accordance with section 117 of the

Act, publication of this proposal was

preceded by consultation with

appropriate advisory committees,

independent experts, and Federal

departments and agencies. The

Administrator welcomes comments on

all aspects of the proposal, including

economic and technological issues.

4. Economic Impact Assessment—

Section 317 of the Act

Section 317 of the Act requires the

EPA to prepare an economic impact

assessment for any emission standards

and guidelines promulgated under

section 111 of the Act. An economic

impact assessment was prepared for the

proposed standards and guidelines. In

the manner described above under the

discussions of the impacts of, and

rationale for, the proposed standards

and guidelines, the EPA considered all

aspects of the assessment in proposing

the standards and guidelines. The

economic impact assessment is

included in the docket listed at the

beginning of today’s notice under

SUPPLEMENTARY INFORMATION.

D. Office of Management and Budget

Reviews

1. Paperwork Reduction Act (PRA)

The information collection

requirements in this proposed rule have

been submitted for approval to the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq. An

Information Collection Request (ICR)

document has been prepared by the EPA

(ICR No. 1730.01) and a copy may be

obtained from Sandy Farmer,

Information Policy Branch (2136); U. S.

Environmental Protection Agency, 401

M Street, SW., Washington, DC 20460 or

by calling (202) 260–2740.

This collection of information is

estimated to have an average annual

reporting burden of 0.01 person years

per pathological MWI and an average of

about 2.4 person years for MWI’s

burning general medical waste. This

includes time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Send comments regarding the burden

estimate or any other aspect of this

collection of information, including

suggestions for reducing this burden to

Chief, Information Policy Branch (2136),

U.S. Environmental Protection Agency,

401 M Street, SW., Washington, DC

20460; and to the Office of Information

and Regulatory Affairs, Office of

Management and Budget, Washington,

DC 20503, marked ‘‘Attention: Desk

Officer for the EPA.’’ The final rule will

respond to any OMB or public

comments on the information collection

requirements contained in this proposal.

2. Executive Order 12866 Review

Under Executive Order (E.O.) 12866,

the EPA must determine whether the

proposed regulatory action is

‘‘significant’’ and therefore, subject to

the Office of Management and Budget

(OMB) review and the requirements of

the Executive Order. The Order defines

‘‘significant’’ regulatory action as one

that is likely to lead to a rule that may:

(1) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety in

State, local, or tribal governments or

communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees

or loan programs or the rights and

obligations of recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

Pursuant to the terms of Executive

Order 12866, it has been determined

that the proposed standards and

guidelines are ‘‘significant’’ because the

annual effect on the economy will

exceed $100 million. As such, this

action was submitted to OMB for

review. Changes made in response to

OMB suggestions or recommendations

are documented in the public record.

3. Executive Order 12875

Under Executive Order 12875, the

EPA is required to consult with

representatives of affected State, local,

and tribal governments, and keep these

affected parties informed about the

content and effect of the proposed

standards and guidelines. The following

discussion provides a brief summary of

the content, need for, and cost of the

proposed standards and guidelines, as

well as the actions that the EPA has

taken to communicate and consult with

the affected parties.

a. Summary of the Proposed Standards

and Guidelines

The proposed standards and

guidelines would establish emission

limitations for new and existing MWI’s.

The proposed standards and guidelines

do not specify which type of air

pollution control equipment must be

used at MWI’s to meet the proposed

emission limitations. However, the EPA

expects that, to meet the proposed

emission limitations, most MWI’s would

use dry scrubbing systems (DI/FF) with

activated carbon injection for dioxins/

furans, metals, and acid gas control.

Refer to section II of this preamble for

a more detailed discussion of the

proposed standards and guidelines.

b. Need for the Proposed Standards and

Guidelines

Under the Act Amendments of 1990,

section 129 includes a schedule that

requires the EPA to develop standards

and guidelines for MWI’s by November

1992. The EPA did not comply with that

schedule and is now under court order

to propose the standards and guidelines

by February 1, 1995 and promulgate the

standards and guidelines by April 15,

1996. As required by section 129, the

proposed standards and guidelines

would establish emission limitations for

PM, opacity, CO, CDD/CDF, HCl, SO2,

NOX, Pb, Cd, and Hg. See section I of
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10691

this preamble for further discussion of

the regulatory history and general goals

of the proposed standards and

guidelines.

c. Cost of the Proposal

The nationwide annual costs

associated with the proposed standards

for new MWI’s would increase by

approximately $74.5 million/yr from the

regulatory baseline cost of $63.3

million/yr. The cost of compliance with

the proposed standards for an

individual facility will vary depending

on the method chosen to comply with

the proposed emission limitations. Of

the projected number of new MWI’s,

some will be constructed with air

pollution control equipment to comply

with the proposed emission limitations.

However, as discussed in Section III of

this preamble, the EPA expects that, to

avoid the increased costs associated

with the installation of control

equipment, as many as 80 percent of the

projected number of new MWI’s will not

be constructed. Instead, these facilities

are likely to consider less expensive

methods of treatment and disposal.

Under the proposed standards, the

average annualized cost of incineration

for a typical small MWI would be about

$326 thousand per year. The two most

common alternatives to onsite

incineration include offsite contract

disposal and onsite steam sterilization.

Instead of installing an MWI with air

pollution control equipment, the facility

may choose to use offsite contract

disposal at an estimated average

annualized cost of $98.8 thousand per

year, or onsite steam sterilization at an

estimated average annualized cost of

$65.6 thousand per year. Either of these

alternatives is considerably less

expensive than onsite incineration

under the proposed standards.

Under the proposed standards, the

average annualized cost of incineration

for a typical large MWI would be about

$520 thousand per year. The cost to

dispose of the same amount of waste

using offsite contract disposal is

estimated at about $1.01 million per

year, which is considerably higher than

the costs of onsite incineration. Onsite

steam sterilization of the same amount

of waste would cost about $158

thousand per year. Instead of installing

an MWI with air pollution control

equipment, the facility may choose to

use onsite steam sterilization at a much

lower cost. A more complete summary

of the cost and economic impacts of the

proposed standards are presented in

Section III of this preamble.

The nationwide annual costs

associated with the proposed guidelines

for existing MWI’s would increase by

approximately $351 million/yr from the

regulatory baseline cost of $265 million/

yr. As with new MWI’s, the cost of

compliance with the proposed

guidelines for an individual facility will

vary depending on the method chosen

to comply with the proposed emission

limitations. Some facilities may choose

to keep their incinerator and install air

pollution control equipment to comply

with the proposed emission limitations.

However, as discussed in Section IV of

this preamble, the EPA expects that as

many as 80 percent of existing facilities

currently using onsite incineration will

switch to an alterative method of

treatment and disposal to avoid the

increased cost of installing air pollution

control equipment.

For a typical small MWI, the

installation of control equipment would

increase the average annualized cost of

incineration to about $329 thousand per

year. Instead of installing air pollution

control equipment, the facility may

choose to use offsite contract disposal at

an estimated average annualized cost of

$98.8 thousand per year, or onsite steam

sterilization at an estimated average

annualized cost of $65.6 thousand per

year. The costs for either of these

alternatives is considerably less than the

costs for installing control equipment to

meet the proposed emission limitations.

The average annualized cost of

incineration for a typical large MWI

would increase to about $533 thousand

per year. The cost to dispose of the same

amount of waste using offsite contract

disposal is estimated at about $1.01

million per year, which is substantially

higher than the estimated costs of onsite

incineration. Onsite steam sterilization

of the same amount of waste would cost

about $158 thousand per year. Instead of

installing air pollution control

equipment to meet the proposed

emission limitations, the facility may

choose to use onsite steam sterilization

at a much lower cost. A more complete

summary of the cost and economic

impacts of the proposed guidelines are

presented in Section IV of this

preamble.

d. Communication With Affected Parties

As previously mentioned, Executive

Order 12875 requires the EPA to consult

with representatives of affected State,

local, and tribal governments, and prior

to promulgation of final standards,

summarize concerns of the

governmental entities and respond to

their comments. The EPA has already

initiated consultations with numerous

governmental entities including, but not

limited to, the U.S. Conference of

Mayors, the National Association of City

and County Health Officials, the

National Association of Counties, the

National Association of Public

Hospitals, and the National Governors

Association. These groups have been

informed of the content of the proposal

and the estimated impacts. In drafting

the proposal, the EPA has considered

the concerns expressed by these groups,

and discussions with these groups will

continue following proposal. The EPA

awaits comments from these groups on

the proposal and will respond to their

comments.

E. Regulatory Flexibility Act

Compliance

The Regulatory Flexibility Act (RFA)

(5 U.S.C. 601 et seq.) requires Federal

agencies to give special consideration to

the impact of regulations on small

entities, which are small businesses,

small organizations, and small

governments. The major purpose of the

RFA is to keep paperwork and

regulatory requirements from getting out

of proportion to the scale of the entities

being regulated, without compromising

the objectives of, in this case, the Act.

If a regulation is likely to have a

significant economic impact on a

substantial number of small entities, the

EPA may give special consideration to

those small entities when analyzing

regulatory alternatives and drafting the

regulation. In the case of the proposed

standards and guidelines, the results of

the economic analysis indicate that the

standards and guidelines will not have

a significant impact on a substantial

number of small entities. Less than 20

percent of ‘‘small’’ government

jurisdictions are expected to be

significantly impacted. In addition,

although some small medical waste

generators would be significantly

impacted by the regulation’s control

requirements, the majority of these

impacts could be avoided by switching

to less expensive alternatives for

medical waste disposal. Therefore, it is

expected that the number of facilities

that are significantly impacted will not

be ‘‘substantial.’’

List of Subjects in 40 CFR Part 60

Air Pollution control, Incorporation

by reference, Intergovernmental

relations, Medical waste, Reporting and

recordkeeping.

Dated: February 1, 1995.

Carol M. Browner,

Administrator.

[FR Doc. 95–3045 Filed 2–24–95; 8:45 am]

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