48348 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 60

[AD–FRL–5878–8]

RIN 2060–AC62

Standards of Performance for New

Stationary Sources and Emission

Guidelines for Existing Sources:

Hospital/Medical/Infectious Waste

Incinerators

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This action promulgates new

source performance standards (NSPS or

standards) and emission guidelines (EG

or guidelines) to reduce air emissions

from hospital/medical/infectious waste

incinerator(s) (HMIWI) by adding

subpart Ec, standards of performance for

new HMIWI, and subpart Ce, emission

guidelines for existing HMIWI, to 40

CFR part 60. The standards and

guidelines implement sections 111 and

129 of the Clean Air Act (CAA) as

amended in 1990. The standards and

guidelines apply to units whose primary

purpose is the combustion of hospital

waste and/or medical/infectious waste.

Sources are required to achieve

emission levels reflecting the maximum

degree of reduction in emissions of air

pollutants that the Administrator has

determined is achievable, taking into

consideration the cost of achieving such

emission reduction, any nonair-quality

health and environmental impacts, and

energy requirements. The promulgated

standards and guidelines establish

emission limits for particulate matter

(PM), opacity, sulfur dioxide (SO2),

hydrogen chloride (HCl), oxides of

nitrogen (NOX), carbon monoxide (CO),

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

dioxins and dibenzofurans (dioxins/

furans), and fugitive ash emissions.

Some of the pollutants being regulated

are considered to be carcinogens and at

sufficient concentrations can cause toxic

effects following exposure. The

standards and guidelines also establish

requirements for HMIWI operator

training/qualification, waste

management plans, and testing/

monitoring of pollutants and operating

parameters. Additionally, the guidelines

for existing HMIWI contain equipment

inspection requirements and the

standards for new HMIWI include siting

requirements.

DATES: Effective Dates. The standards

for new sources (§ 60.17 and §§ 60.50c

through 60.58c) are effective as of March

16, 1998 and the emission guidelines for

existing sources (§ 60.30 and §§ 60.30e

through 60.39e) are effective as of

November 14, 1997. The incorporation

by reference of certain publications

listed in the regulations is approved by

the Director of the Federal Register as of

March 16, 1998. See SUPPLEMENTARY

INFORMATION for a discussion of the

schedule for judicial review.

Comments. Comments on the

Information Collection Request (ICR)

document associated with the final

standards for new sources are requested,

as discussed in section VI.B of this

preamble. Comments on the ICR

document must be received on or before

November 14, 1997. Refer to Section

VI.B for further information on this

request for comment.

ADDRESSES: Comments. As noted above,

comments on the ICR document

associated with the final standards for

new sources are requested. See section

VI.B and the SUPPLEMENTARY

INFORMATION section of this preamble for

further information on obtaining a copy

of the ICR document and addresses for

submitting comments on the ICR

document.

Background Information. The

principal background information for

the final standards and guidelines

includes a background information

document entitled ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b), which contains a summary

of all the public comments submitted

regarding the changes to the standards

and guidelines that were discussed in

the June 20, 1996 Federal Register

document (61 FR 31736) and the EPA’s

response to these comments.

Background information documents

which present the economic and

regulatory impacts of the standards and

guidelines entitled: (1) ‘‘Hospital/

Medical/Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Analysis of Economic

Impacts for Existing Sources’’ (EPA–

453/R–97–007b); (2) ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Analysis of Economic

Impacts for New Sources’’ (EPA–453/R–

97–008b); and (3) ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Regulatory Impact Analysis

for New and Existing Facilities’’ (EPA–

453/R–97–009b) are available. Also a

document entitled ‘‘Fact Sheet: New

Hospital/Medical/Infectious Waste

Incinerators—Promulgated Subpart Ec

Standards,’’ which succinctly

summarizes the final standards, and a

document entitled ‘‘Fact Sheet: Existing

Hospital/Medical/Infectious Waste

Incinerators—Promulgated Subpart Ce

Emission Guidelines,’’ which succinctly

summarizes the guidelines, are

available. See SUPPLEMENTARY

INFORMATION for instructions and

addresses for obtaining these

documents.

Docket. Docket No. A–91–61, which

contains supporting information used in

developing the standards and

guidelines, is available for public

inspection and copying between 8:00

a.m. and 4:00 p.m., Monday through

Friday except for Federal holidays at the

following address: U.S. Environmental

Protection Agency, Air and Radiation

Docket and Information Center (Mail

Code 6102), 401 M Street SW,

Washington DC 20460 (phone: (202)

260–7548). The docket is located at the

above address in room M–1500,

Waterside Mall (ground floor, central

mall). A reasonable fee may be charged

for copying.

FOR FURTHER INFORMATION CONTACT: Mr.

Rick Copland at (919) 541–5265,

Combustion Group, Emission Standards

Division (MD–13), U. S. Environmental

Protection Agency, Research Triangle

Park, North Carolina 27711

(copland.rick@epamail.epa.gov) or any

of the EPA Regional Office contacts

listed in Table 1 below.

TABLE 1.—CONTACTS IN EPA REGIONAL OFFICES

Region Contact Phone No.

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

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

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

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

V (Chicago) .............................................................................. Douglas Aburano (MI) ............................................................. (312) 353–6960
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48349

TABLE 1.—CONTACTS IN EPA REGIONAL OFFICES—Continued

Region Contact Phone No.

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

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

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

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

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

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

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

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

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

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

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by the standards and guidelines are those which operate hospital/medical/infectious

waste incinerators. Regulated categories and entities include those listed in Table 2.

TABLE 2.—REGULATED ENTITIESa

Category Examples of regulated entities

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

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

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

aThis table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the standards

or guidelines for HMIWI. This table lists the types of entities that EPA is now aware could potentially be regulated. Other types of entities not listed in the table could also be regulated. To determine whether your facility is regulated by the standards or guidelines for hospital/medical/ infectious waste incinerators, you should carefully examine the applicability criteria in sections 60.50c and 60.51c of the promulgated standards, section 60.32e of the promulgated guidelines, and in section III.A of today’s notice. If you have questions regarding the applicability of the HMIWI

standards and guidelines to a particular entity, consult a person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Documents Available Electronically

This Federal Register document

discusses: (1) The standards for new

HMIWI, (2) the guidelines for existing

HMIWI, and (3) a request for public

comment on the ICR document. This

preamble and regulatory text are

available electronically via the Internet.

Also available electronically are FACT

SHEETS, which summarize the final

standards and guidelines. They are

suggested reading for persons requiring

an overview of the standards and

guidelines. Hard copies of the FACT

SHEETS can also be obtained by calling

Donna Collins at (919) 541–5578. The

following five items are available

electronically in file ‘‘MWIFINAL.ZIP’’:

1. ‘‘Fact Sheet: New Hospital/

Medical/Infectious Waste Incinerators—

Promulgated Subpart Ec Standards.’’

2. ‘‘Fact Sheet: Existing Hospital/

Medical/Infectious Waste Incinerators—

Promulgated Subpart Ce Emission

Guidelines.’’

3. Federal Register document for this

promulgation: ‘‘Standards of

Performance for New Stationary Sources

and Emission Guidelines for Existing

Sources: Hospital/Medical/Infectious

Waste Incinerators’’ (this document).

4. ‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b).

5. Information Collection Request

document for these standards for new

sources: ‘‘Supporting Statement for ICR

No. 1730.02—1997 Standards for New

Hospital/Medical/Infectious Waste

Incinerators (Subpart Ec).’’

The documents are available via the

Internet at ‘‘http://www.epa.gov/ttn/

oarpg/rules.html’’. The documents are

also available via the Internet through

the Unified Air Toxics Website at

‘‘http://www.epa.gov/oar/oaqps/airtox/

’’.

Judicial Review

Under section 307(b)(1) of the Clean

Air Act, judicial review of the actions

taken by this notice is available by filing

a petition for review in the U.S. Court

of Appeals for the District of Columbia

Circuit within 60 days of today’s

publication of this rule. Under section

307(b)(2) of the Clean Air Act, the

requirements that are in today’s notice

may not be challenged later in the civil

or criminal proceedings brought by the

EPA to enforce these requirements.

Preamble Outline

The following outline is provided to

aid in locating information in the

introductory text (preamble) to the final

standards and guidelines.

I. Acronyms, Abbreviations, and

Measurement Units

A. Acronyms

B. Abbreviations and Measurement Units

II. Introduction

A. Purpose of the Standards and

Guidelines

B. Implementation of the Emission

Guidelines

1. Implementation Activities

2. Public Involvement

C. Technical Basis of the Standards and

Guidelines

D. February 1995 Proposal

E. June 1996 Re-proposal

F. Stakeholders and Public Involvement

III. Considerations in Developing the Final

Standards and Guidelines

A. Applicability

1. Definition of Medical Waste

2. Co-fired Combustors

3. Waste Types

4. Cement Kilns

B. Pyrolysis Units

C. Waste Management Plans

D. Testing, Monitoring, and Inspection

E. Operator Training and Qualification

IV. Standards of Performance for New

Sources

A. Summary of the Standards

B. Significant Issues and Changes
48350 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

1. Combined Dry/Wet Scrubbers

2. Siting Analysis

C. Selection of MACT

D. Impacts of the Standards

V. Emission Guidelines for Existing Sources

A. Summary of the Guidelines

B. Significant Issues and Changes

C. Selection of MACT

D. Impacts of the Guidelines

VI. Administrative Requirements

A. Docket

B. Paperwork Reduction Act

C. Executive Order 12866

D. Unfunded Mandates Reform Act

E. Executive Order 12875

F. Regulatory Flexibility Act (RFA) and

Small Business Regulatory Enforcement

Fairness Act of 1996 (SBREFA)

G. Submission to Congress and the General

Accounting Office

H. Clean Air Act Procedural Requirements

I. Acronyms, Abbreviations, and

Measurement Units

The following acronyms,

abbreviations, and measurement units

are provided to clarify the preamble to

the final standards and guidelines.

A. Acronyms

APCD air pollution control device

APTI Air Pollution Training Institute

CAA Clean Air Act

CAAA Clean Air Act Amendments of

1990

CEMS continuous emissions

monitoring system(s)

CFBC circulating fluidized bed

combustor

CFR Code of Federal Regulations

DI dry injection

EPA U.S. Environmental Protection

Agency

EG emission guidelines

FF fabric filter

FR Federal Register

HAP hazardous air pollutant(s)

HMIWI hospital/medical/infectious

waste incinerator(s)

ICCR Industrial Combustion

Coordinated Rulemaking

ICR information collection request

MACT maximum achievable control

technology

MSW municipal solid waste

MWC municipal waste combustor(s)

MWI medical waste incinerator(s)

MWP medical waste pyrolysis

MWTA Medical Waste Tracking Act

NAPH National Association of Public

Hospitals

NSPS new source performance

standards

NSR new source review

NYSDOH New York State Department

of Health

OAQPS Office of Air Quality Planning

and Standards

OMB Office of Management and

Budget

ORD Office of Research and

Development

PSD prevention of significant

deterioration

RCRA Resource Conservation and

Recovery Act

RFA Regulatory Flexibility Act

RMW regulated medical waste

SBA Small Business Administration

SBREFA Small Business Regulatory

Enforcement Fairness Act

SMSA standard metropolitan

statistical area

SWDA Solid Waste Disposal Act

B. Abbreviations and Measurement

Units

bps=bits per second

Btu=British thermal units

Btu/yr=British thermal units per year

Cd=cadmium

CDD/CDF=dioxins/furans

CO=carbon monoxide

dioxins=polychlorinated dibenzo-pdioxins

dscf=dry standard cubic feet (at 14.7

pounds per square inch, 68°F)

dscm=dry standard cubic meters (at 14.7

pounds per square inch, 68°F)

°F=degrees Fahrenheit

ft3=cubic feet

furans=polychlorinated dibenzofurans

g=gram (454 grams per pound)

g/yr=grams per year

gr=grains (7,000 grains per pound)

HCl=hydrogen chloride

Hg=mercury

m3=cubic meter (35.3 cubic feet per

cubic meter)

mg=milligrams (10-3 grams)

Mg=megagram (1.1 tons per megagram)

Mg/yr=megagrams per year

MMm3=million cubic meters

MW=megawatt

MW-hr/yr=megawatt-hours per year

ng=nanogram (10-9 grams)

NOX=nitrogen oxides

Pb=lead

PM=particulate matter

ppmv=parts per million by volume

SO2=sulfur dioxide

TEQ basis=2,3,7,8-tetrachlorinated

dibenzo-p-dioxin toxic equivalent

based on the 1989 international toxic

equivalency factors

tons/d=tons per day

total mass basis=total mass of tetrathrough octa-chlorinated dibenzo-pdioxins and dibenzofurans

II. Introduction

A. Purpose of the Standards and

Guidelines

The 1990 Clean Air Act Amendments

(CAAA) reflect growing public concern

about the large volume of toxic air

pollutants released from numerous

categories of emission sources. Title III

of the CAAA specifically enumerated

189 hazardous air pollutants (HAP) and

instructed EPA to protect public health

by reducing emissions of these

pollutants from the sources that release

them. The EPA’s standards are to be

issued in two phases. The first phase

standards are designed to bring all

sources up to the level of emissions

control achieved by those that are

already well-controlled. The second

phase standards, due a few years later,

are to require further emission

reductions in any case in which the first

phase measures were not by themselves

sufficient to fully protect the public

health.

In this context, the CAAA singled out

waste incineration for special attention.

Congress recognized both a high level of

public concern about the incineration of

municipal, medical, and other solid

wastes and a number of special

management concerns for these types of

sources. Consequently, section 129 of

the CAA directs EPA to apply the twophase control approach to various

categories of solid waste incinerators,

including hospital/ medical/infectious

waste incinerator(s) (HMIWI). Today’s

action promulgates standards and

guidelines for new and existing HMIWI

under section 129. Current methods of

medical waste incineration cause the

release of a wide array of air pollutants,

including several pollutants of

particular public health concern.

The EPA estimates that there are

approximately 2,400 HMIWI operating

in the United States, which combust

approximately 767 thousand Mg (846

thousand tons) of hospital waste and

medical/infectious waste annually.

Emissions from HMIWI contain organics

(dioxins/furans), particulates (PM),

metals (Cd, Pb, and Hg), acid gases (HCl

and SO2), and NOX. These pollutants

can have adverse effects on both public

health and welfare. Pollutants of

principal concern to public health

include dioxins/furans, PM, Pb, Cd, and

Hg. Today’s standards and guidelines

are set forth as emission limits and will

significantly reduce HMIWI emissions.

Several States, including New York,

California, and Texas, have adopted

relatively stringent regulations in the

past few years limiting emissions from

HMIWI. The implementation of these

regulations has brought about very large

reductions in HMIWI emissions and the

associated risk to public health in those

States. Today EPA is promulgating

nationally applicable emission

standards and guidelines for HMIWI

that build on the experience of these

leading States. Like the State

regulations, the standards and

guidelines promulgated today are based

on the use of add-on air pollution

control systems. These standards and
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48351

guidelines implement the first phase

requirements of section 129 described

above. As described in detail below,

section 129, like section 112, of the CAA

instructs the Agency to set performance

standards that challenge industry to

meet or exceed the pollution control

standards established by better

controlled similar facilities. In this way,

the overall state of environmental

practice is raised for large segments of

industry, a basic level of health

protection is provided to all

communities, situations in which

uncertainty about total risk and hazard

result in no protection for the exposed

public are avoided, and yet the cost of

pollution control to industry is

constrained to levels already absorbed

by similar operations. Eight years later,

in a second phase, EPA will evaluate

whether the residual public health risk

warrants additional control.

The EPA’s Office of Research and

Development (ORD) is preparing a

national inventory of dioxin emissions

as part of its Dioxin Reassessment. This

effort will include emission estimates

for HMIWI. Since the effort is not yet

complete, the results are not included in

this package. The ORD is considering a

very similar approach to that used in

this rulemaking and anticipates

generating similar emission estimates.

B. Implementation of the Emission

Guidelines

The subpart Ce emission guidelines

are unique in that, unlike the subpart Ec

NSPS, the guidelines are not direct

Federal requirements for HMIWI. The

subpart Ec NSPS are Federal

requirements that apply to all new

HMIWI units that commence

construction after June 20, 1996 or to

existing HMIWI units that commence

modification after March 16, 1998. The

subpart Ce emission guidelines require

States to develop section 111(d)/129

State plans to regulate existing HMIWI

built on or before June 20, 1996. These

State plans must be submitted to EPA

for approval and must be at least as

protective as the guidelines. Together,

40 CFR part 60, subpart B and subpart

Ce specify the content and the general

rules for adopting and submitting the

section 111(d)/129 State plans.

The CAA requires that each State

submit a State plan to EPA within 1 year

of EPA’s adoption of the guidelines.

State plans must contain specific

information and legal mechanisms

necessary to implement the guidelines.

The State must make available to the

public the State plan and provide

opportunity for discussion of the State

plan in a public hearing prior to

submittal to EPA. The State must submit

the final plan to EPA by September 15,

1998. The EPA then has 6 months to

approve or disapprove the State plan.

Plan approval or disapproval will be

published in the Federal Register. If a

State plan is disapproved, EPA will

state the reasons for disapproval in the

Federal Register. The State can respond

to EPA’s concerns and submit a revised

plan. If a State does not submit an

approvable State plan by September 15,

1999, EPA will adopt and implement a

Federal plan that applies to existing

HMIWI in the State.

1. Implementation Activities

The EPA is preparing an Enabling

Document to assist States with

implementing the HMIWI guidelines.

The EPA Regional Offices will mail hard

copies of the Enabling Document to

their State contacts. This document

should be publicly available in the next

few weeks. The public can access this

document electronically via the Internet

at ‘‘http://www.epa.gov/ttn/oarpg/

rules.html’’ or ‘‘http://www.epa.gov/

oar/oaqps/airtox/’.

In September 1997, EPA plans to

broadcast a telecourse to States, regions,

and the public on the HMIWI rule and

on implementation requirements. State

field offices will be notified of the

telecourse. The EPA’s distance learning

network telecourse schedule, as well as

a list of telecourse sites, is available at

http://134.67.104.12/html/apti/

aptc.htm.

Finally, EPA will host its annual Air

Toxics Workshop for EPA Regions and

States in Research Triangle Park in late

August 1997. A 1-hour session is

scheduled to provide States an overview

of the HMIWI rule and to discuss

implementation issues. The Air Toxics

Workshop provided for EPA Regions

and States is not open to the public.

Opportunities for public participation in

the implementation process are

discussed below.

2. Public Involvement

Public participation, under the

provision of the CAA, is an important

right and responsibility of citizens in

the State process of developing,

adopting, and implementing section

111(d)/ 129 State plans. As with State

Implementation Plans (SIP) for criteria

pollutants, EPA regulations in 40 CFR

part 60, subpart B, make it clear that

citizen input on section 111(d)/129

State plans is encouraged in order to

help define appropriate emission

standards and retrofit schedules. Under

Subpart B, some minimum public

participation requirements are as

follows:

a. Reasonable notice of one or more

public hearing(s) at least 30 days before

the hearing;

b. One or more public hearing(s) on

the section 111(d)/129 State plan (or

revision) conducted at location(s)

within the State, if requested;

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

prominently advertised in each region

affected;

d. Availability of draft section 111(d)/

129 State plan for public inspection in

at least one location in each region to

which it will apply;

e. Notice of hearing provided to EPA

Regional Administrator, local affected

agencies, and to other States affected;

f. Certification that the public hearing,

if held, was conducted in accordance

with Subpart B State procedures; and

g. Hearing records must be retained

for a minimum of 2 years; these records

must include the list of commenters,

their affiliation, summary of each

presentation and/or comments

submitted, and the State’s responses to

those comments.

C. Technical Basis of the Standards and

Guidelines

Section 129 requires the EPA to

develop numerical emission limitations

in the standards for new HMIWI and

guidelines for existing HMIWI for the

following: Particulate matter (PM),

opacity, sulfur dioxide (CO2), hydrogen

chloride (HCl), oxides of nitrogen

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

cadmium (Cd), mercury (Hg), and

dioxins and dibenzofurans (dioxin/

furan). Section 129 requires that the

standards and guidelines reflect the

maximum degree of reduction in

emissions of air pollutants, taking into

consideration the cost of achieving such

emission reduction, any nonair-quality

health and environmental impacts, and

energy requirements that the

Administrator determines are

achievable for a particular category of

sources. This control level is commonly

referred to as the ‘‘maximum achievable

control technology’’ or ‘‘MACT.’’

Section 129 also provides that standards

for new sources may not be less

stringent than the emissions control

achieved in practice by the best

controlled similar unit. This is

commonly referred to as the ‘‘MACT

floor’’ for new HMIWI. Additionally,

section 129 provides that the emission

limitations in the guidelines for existing

HMIWI may not be less stringent than

the average emission limitation

achieved by the best performing 12

percent of units in the category. This is

commonly referred to as the ‘‘MACT

floor’’ for existing HMIWI.
48352 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

The CAA requires EPA to evaluate

standards and guidelines more stringent

than the MACT floor, considering costs

and other impacts described above. If

EPA concludes that more stringent

standards and/or guidelines are

achievable considering costs and other

impacts, then the standards and/or

guidelines would be established at these

more stringent levels (i.e., MACT would

be more stringent than the MACT floor).

The EPA may establish NSPS or EG at

the MACT floor only if EPA concludes

that the costs and/or other impacts

associated with the more stringent

requirements are unreasonable. In no

case may EPA establish emission

limitations less stringent than the

MACT floor.

Technical data on the number and

size of HMIWI, control technologies in

use, permit emission limits, and

emission test data were used to

determine the MACT floors for new and

existing HMIWI and to define regulatory

options more stringent than the MACT

floors. The types of data EPA considered

in selecting final standards and

guidelines included emissions

information from literature and State

and local agencies; and emissions test

data provided by industry or gathered

during EPA’s HMIWI emissions test

program. Overall, the EPA used

performance test data from over 30

HMIWI to develop the standards and

guidelines.

In keeping with the Administrator’s

‘‘reinventing government’’ initiative,

several of the changes to the guidelines

and standards were made to streamline

the regulations and provide increased

flexibility while optimizing

environmental control by using

common sense initiatives. Examples of

these changes include the following: (1)

Reduced testing for HMIWI

demonstrating compliance with the

required emission levels; (2) narrowing

the definition of medical waste; (3)

clarification of siting requirements for

new HMIWI; (4) allowing HMIWI

operators to receive training and

qualification through a State-approved

training program; (5) requiring facilities

to develop a waste management plan

instead of banning materials from waste

streams; (6) revised text to clarify that

the emission limits do not apply during

periods when units are burning only

pathological, chemotherapeutic, and/or

low-level radioactive waste; (7)

exemption for plants firing small

amounts of hospital waste and/or

medical/infectious waste (10 percent or

less by weight); (8) allowing certain

records to be maintained in either

electronic or paper format without

duplication; and (9) establishing

emission limits for existing HMIWI that

may be met with either a wet or dry

scrubber. All of these changes are

discussed further in sections III, IV, and

V of this preamble and in ‘‘Hospital/

Medical/Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses (EPA–453/R–

97–006b). These changes improve the

effectiveness and efficiency of the

standards and guidelines without any

reduction in environmental protection.

D. February 1995 Proposal

On February 27, 1995 (60 FR 10654),

EPA published proposed NSPS and EG

for HMIWI. The 1995 proposal was the

result of several years of effort reviewing

available information in light of the

CAA requirements described above.

During the data-gathering phase of the

HMIWI project, it was difficult to get an

accurate count of the nationwide

HMIWI population. In addition, it was

difficult to find HMIWI with add-on air

pollution control systems in place.

Information from a few State surveys led

to an estimated population of 3,700

existing HMIWI.

The 1995 proposed standards and

guidelines contained HMIWI

subcategories that were determined

based on design differences among

different types of incinerators:

continuous, intermittent, and batch.

These three design types roughly

correlate to HMIWI size.

A few HMIWI with various levels of

combustion control (no add-on air

pollution control) were tested to

determine the performance of

combustion control in reducing HMIWI

emissions. One HMIWI equipped with a

wet scrubber (add-on control) was tested

to determine the performance

capabilities of wet scrubbing systems. A

few other HMIWI equipped with dry

scrubbing systems (add-on control) were

tested to determine the performance

capabilities of dry scrubbing systems.

These systems were considered typical

of air pollution control systems

available at the time, and the data

appeared to indicate that dry scrubbing

systems could achieve much lower

emissions than wet scrubbing systems.

As mentioned above, the MACT floor

for new HMIWI is to reflect the

emissions control achieved by the best

controlled similar unit. Dry scrubbing

systems were identified on at least one

HMIWI in each of the three

subcategories (continuous, intermittent,

and batch). Consequently, the MACT

floor emission levels for the 1995

proposed NSPS reflected the

performance capabilities of dry

scrubbing systems.

For existing HMIWI under the 1995

proposed emission guidelines, State

regulations and permits were used to

calculate the average emission

limitation achieved by the best

performing 12 percent of units. These

results were then compared with the

results of the emission tests on wet and

dry scrubbing systems. This comparison

led to the conclusion that the 1995

proposed MACT floor for existing

HMIWI would require the use of a dry

scrubbing system, even for small

existing batch HMIWI.

Following determination of the

HMIWI population, subcategories,

performance of technology, and MACT

floors, the CAA requires EPA to

consider standards and guidelines that

are more stringent than the floors.

However, because the MACT floors

calculated for the 1995 proposal were so

stringent, EPA was left with few options

to consider. Emission limits reflecting

the capability of dry scrubbing systems

with carbon were proposed for all sizes

and types of new and existing HMIWI.

A proposal is essentially a request for

public comment on the information

used, assumptions made, and

conclusions drawn from the evaluation

of available information. Following the

1995 proposal, more than 700 comment

letters were received, some including

new information and some indicating

that commenters were in the process of

gathering information for EPA to

consider. The large amount of new

information that was ultimately

submitted addressed every aspect of the

1995 proposed standards and

guidelines, including: the existing

population of HMIWI, HMIWI

subcategories, the performance

capabilities of air pollution control

systems, monitoring and testing,

operator training, alternative medical

waste treatment technologies, and the

definition of medical waste. In almost

every case, the new information led to

different conclusions, as outlined

below.

E. June 1996 Re-Proposal

On June 20, 1996, EPA published a

Federal Register document to: (1)

Announce the availability of the new

information received following the 1995

proposal, (2) review EPA’s assessment

of the new information, (3) provide

EPA’s inclinations as to how the new

information might change the final

standards and guidelines, and (4) solicit

comments on EPA’s assessments and

inclinations. In the June 20, 1996

Federal Register document, EPA

indicated that the notice was not a re-
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48353

proposal, but merely a notice of

supplemental information. However,

some commenters stated that the 1996

notice should be considered a reproposal. Upon consideration of these

comments, EPA now considers the 1996

notice to have been a re-proposal. The

1996 notice included all of the elements

of a re-proposal, including: A new

inventory of sources; new subcategories;

revised assessments of emissions and

performance of technology; new MACT

floors; new regulatory options; revised

cost, environmental, and economic

impacts; an indication of EPA’s

selection of MACT; and a request for

public comment. More importantly,

virtually every aspect of the 1995

proposal was changed significantly by

the 1996 notice, making most of the

analyses and conclusions from the 1995

notice irrelevant. Therefore, in today’s

final rule, HMIWI which commenced

construction after June 20, 1996 are

considered new sources subject to the

NSPS under Subpart Ec, and HMIWI

which commenced construction on or

before June 20, 1996 are considered

existing sources subject to the EG under

subpart Ce.

The 1996 re-proposal served as a

response to most comments on the 1995

proposed rule. Comments on

miscellaneous issues that were not

addressed in the 1996 re-proposal notice

are summarized and responded to in

‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). The 1996 re-proposal

notice discussed the reanalyses of new

information that led to changes in the

1995 proposed standards and

guidelines. Presented below is a brief

summary of the reanalyses that occurred

following the 1995 proposal and a

discussion of the EPA’s inclinations that

were introduced in the 1996 reproposal.

Following the 1995 proposal, a

number of comments were received

regarding the EPA’s inventory of

existing HMIWI. Most commenters felt

that the EPA’s inventory was inadequate

and should be updated. In response to

these concerns, the EPA compiled a new

inventory of existing HMIWI based on

information received from the American

Hospital Association, State agencies,

HMIWI vendors, commercial medical

waste disposal companies, and other

stakeholders. After several revisions, the

final HMIWI inventory contained

approximately 2,400 existing HMIWI.

The Agency also reanalyzed the

HMIWI subcategories based on the new

information received after the 1995

proposal. In the 1996 re-proposal, the

Agency stated that it was inclined to

subcategorize the new and existing

population of HMIWI into three

subcategories based on waste charging

capacity: small (≤200 lb/hr), medium

(>200 and ≤500 lb/hr) and large (>500

lb/hr). While these subcategories were

based on HMIWI size, they also reflect

design differences among HMIWI.

Directly related to the issue of

subcategorizing HMIWI by size is the

question of how to determine HMIWI

size in a manner that is consistent,

uniform, and applicable to all HMIWI

covered under the standards and

guidelines. In the 1996 re-proposal, the

EPA stated that it was inclined to base

HMIWI capacity on either: (1)

Volumetric waste burning capacity

factors developed using the design heat

release rate of the HMIWI and the heat

content of medical waste or (2) an

enforceable limit that would restrict

waste charge rate.

At the time of the 1995 proposal,

relatively few emission test reports were

available to the EPA from which to draw

conclusions regarding the performance

capabilities of various air pollution

control systems. Many commenters

believed that EPA misjudged the

performance capabilities of various air

pollution control technologies,

especially the capabilities of wet

scrubbing systems. Following the 1995

proposal, a number of emission test

reports were submitted to EPA. The EPA

reviewed the data contained in these

emission test reports and, as a result,

EPA’s conclusions regarding the

performance capabilities of various air

pollution control technologies were

revised and presented in the 1996 reproposal.

As discussed earlier, the new

information submitted led to changes to

the HMIWI inventory, subcategories,

and conclusions about the performance

of technology. Because these factors can

influence the MACT floors, a review of

the MACT floors was conducted. The

recalculated MACT floors and the new

conclusions regarding the performance

capabilities of air pollution control

technologies led to new conclusions

regarding what technologies HMIWI

would have to use to achieve the MACT

floors.

In the 1996 re-proposal, the EPA

defined regulatory options more

stringent than the MACT floors for new

and existing HMIWI and presented the

impacts of the regulatory options. After

reviewing the emissions reductions that

could be achieved and the impacts of

the regulatory options, the EPA

presented its inclinations as to which

emission levels the final MACT

standards and guidelines might reflect.

For new medium and large HMIWI, the

EPA stated that it was inclined to adopt

emission limits that could be achieved

with good combustion followed by a

high efficiency wet scrubber and a DI/

FF system with carbon (i.e., combined

dry/wet scrubber with carbon). The EPA

stated that it was inclined to adopt

emission limits that could be achieved

with good combustion and a moderate

efficiency wet scrubber for new small

HMIWI and for medium existing

HMIWI. For large existing HMIWI, the

EPA stated that it was inclined to adopt

emission limits that could be achieved

with the use of good combustion and a

high efficiency wet scrubber. The EPA

offered no inclinations for the emission

limits for small existing HMIWI.

Instead, the EPA discussed the

regulatory options and impacts for small

existing HMIWI and solicited comments

on which emission levels would be

suitable for the final guidelines.

Many comments were also received

regarding the 1995 proposed testing and

monitoring requirements. Commenters

noted that the proposed 4-hour test run

was much longer than the more

conventional test run of about 1-hour.

Commenters also noted that many

hospitals and health care facilities

would normally not have sufficient

waste on hand to accommodate three, 4-

hour test runs and the 1995 proposed

emission testing requirements would

substantially increase the costs

associated with emission testing. In

response to these comments, the EPA

stated in the 1996 re-proposal that it

was inclined to adopt requirements that

EPA test methods be followed when

performing emissions testing to

determine compliance. This

requirement would ensure that

compliance testing follows the same

procedures used to generate the

emission data upon which the emission

limits in the regulation were based. In

most cases, three test runs of about 1

hour each would be necessary to

determine compliance. An exception to

this requirement would be emission

testing to measure dioxin/furan

emissions. The procedures outlined in

the EPA test method frequently lead to

test runs longer than 1 hour to ensure

sufficient sample is gathered to

accurately measure dioxin/furan

emissions.

Numerous comments were received

on the 1995 proposed annual emission

testing requirements. While some

commenters supported the annual

testing requirements, others felt that the

proposed requirements for inspections,

monitoring, and operator training were

sufficient and much less expensive than
48354 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

annual testing. Some commenters

suggested that the annual emission test

requirement be replaced with a

requirement for annual equipment

inspection and maintenance. Many of

the commenters supportive of the

proposed inspection requirements,

however, suggested that the requirement

for a ‘‘third party’’ inspection be

deleted. Therefore, EPA stated in the

1996 re-proposal that it was inclined to

include inspection and maintenance

requirements wherever annual stack

testing is not required and that the

inspection would not have to be

conducted by a third party.

To consider comments on the 1995

proposal regarding the frequency of

emission testing and the proposed

inspection and monitoring

requirements, EPA presented a matrix of

testing and monitoring options and their

associated costs in the 1996 re-proposal.

The EPA noted that almost all of the

emission testing and monitoring options

under consideration cost more than the

incinerator or emission control system

that would be installed to meet the

emission limits in the regulations.

Consequently, the Agency stated that it

was inclined to include monitoring of

operating parameters and routine

Method 9 opacity tests (instead of CO

and opacity CEMS) in the final

regulations to minimize costs.

With regard to specific air pollution

control device (APCD) operating

parameters to be monitored, the Agency

stated that it was inclined to require

monitoring of the same parameters as

outlined in the 1995 proposal for dry

scrubbers, and the following for wet

scrubbers: Scrubber exit temperature,

scrubber liquor pH, scrubber liquor flow

rate, and energy input to the scrubber

(e.g., pressure drop or horsepower).

The EPA also stated in the 1996 reproposal that it was inclined to require

initial and repeat stack testing (annual/

skip testing) where the regulations are

based on good combustion and wet and/

or dry scrubbing systems; and initial

stack testing and routine inspections

where the regulations are based on the

use of good combustion alone. With the

annual/skip testing requirement,

emission tests would be required for the

first 3 years. If these tests show that the

facility was in compliance each of these

3 years, then subsequent testing would

be done every third year. Under the

inclinations presented in the 1996 reproposal, annual or skip emission

testing would only require emission

testing of a few key or critical pollutants

(i.e., only those necessary to gain a good

indication that the air pollution control

system is operating properly).

A large number of comments were

received on the 1995 proposed

definition of medical waste. The

majority of the commenters stated that

the proposed definition of medical

waste was too broad and should be

narrowed. The commenters believed

that the proposed definition would be

adopted by other regulatory agencies,

and as the definition became more

widespread, that it would eventually

force all health care facilities to handle

most of their waste as if it were

infectious. This would result in an

increase in the volume of medical waste

requiring special handling, which in

turn would result in increased costs to

dispose of waste from health care

facilities. These commenters stated that

health care facilities should be viewed

as generating two waste streams: A

medical waste stream, which is usually

defined by the potential for disease

transmission and requires special

handling; and a noninfectious waste or

‘‘health care trash’’ waste stream, which

has no potential for infection and is

treated and handled as municipal waste.

The commenters urged EPA to narrow

the definition of medical waste used in

the HMIWI regulations to one that

includes only the infectious portion of

the waste stream.

In response to the comments

concerning the 1995 proposed

definition of medical waste, the EPA

stated in the 1996 re-proposal that it

was inclined to adopt a definition of

medical waste that focuses on the

infectious or potentially infectious

portion of the overall medical waste

stream. Given the confusion and

number of varying definitions of

medical waste in use at the Federal,

State and local levels, the EPA stated

that it was inclined to adopt a definition

of medical waste for the HMIWI

regulations from among those

definitions already in use. Specifically,

the EPA stated that it was inclined to

adopt the New York State Department of

Health (NYSDOH) definition of medical

waste.

In the 1996 re-proposal, the EPA also

stated that it was inclined to exclude

crematories and incinerators used solely

for burning pathological waste (human

or animal remains and tissues),

incinerators used solely for burning

‘‘off-spec’’ or ‘‘out of date’’ drugs or

pharmaceuticals, and incinerators used

solely for burning radioactive-type

medical wastes from the HMIWI

regulations. The EPA further stated that

it was inclined to adopt separate

regulations for pyrolysis treatment

technologies and requested comment on

the merits of continued development of

separate pyrolysis regulations.

F. Stakeholders and Public Involvement

Throughout the development of the

standards and guidelines, EPA

conducted meetings with stakeholders

to explain EPA conclusions and solicit

comments, data, and information.

Numerous discussions were held with

governmental entities, industry

representatives, and environmental

groups including, but not limited to, the

following: the U.S. Conference of

Mayors; the National League of Cities;

the National Association of City and

County Health Officials; the National

Association of Counties; the National

Association of Public Hospitals; the

Department of Defense; the Department

of Veterans Affairs; the American

Hospital Association; the Medical Waste

Institute; the Sierra Club; the Natural

Resources Defense Council; vendors of

pyrolysis units, HMIWI, continuous

emission monitoring systems, and air

pollution control technologies; and the

general public.

The standards and guidelines being

adopted today were first proposed in the

Federal Register on February 27, 1995

(60 FR 10654). The preambles for the

1995 proposed standards and guidelines

described the rationale for the proposed

standards and guidelines. Following the

1995 proposal, the EPA provided

interested persons the opportunity to

comment through a written comment

period and held a public hearing. The

public comment period lasted from

February 27, 1995 to April 28, 1995 and

all late comments were accepted. Over

700 comments were received from

private citizens, industry

representatives, environmental groups,

and governmental entities. Several

public meetings and meetings with

industry stakeholders were held

following the 1995 proposal to discuss

EPA’s assessment of new information

submitted with comments, to gather

additional information, and to solicit

further comments. As discussed above

in sections II.D and II.E, the comments

and new information received following

the 1995 proposal led to numerous

changes to the standards and guidelines.

On June 20, 1996, EPA re-proposed

the standards and guidelines in the

Federal Register. Following the 1996 reproposal, the EPA held a public meeting

to review the contents of the re-proposal

and to answer questions so that

interested parties could better prepare

their written comments. The comment

period remained open from June 20,

1996 until August 8, 1996. Again, late

comments were accepted. Nearly 70

comments were received. The

comments received following the 1996

re-proposal were carefully considered
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48355

and changes were made to the HMIWI

standards and guidelines where

appropriate. Sections III, IV, and V of

this preamble discuss the responses to

comments on the standards and

guidelines that address the major

concerns of the commenters on the 1996

re-proposal.

III. Considerations in Developing the

Final Standards and Guidelines

Following the June 20, 1996 reproposal, the EPA received numerous

comments concerning applicability of

the standards and guidelines, pollution

prevention, and the testing and

monitoring requirements. Special

consideration was given to these issues

when developing the final HMIWI

standards and guidelines. This section

discusses these issues and changes, if

any, that were made to the final HMIWI

standards and guidelines following the

1996 re-proposal. Additional discussion

and responses to specific concerns

regarding these and other issues are

provided in ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b).

A. Applicability

A great deal of interest and discussion

has taken place regarding which

incinerators should be subject to this

rule and which should not. All

comments have been considered and the

following sections present EPA’s final

decisions.

1. Definition of Medical Waste

This section discusses the evolution

of the definition of medical waste used

in determining the applicability of the

HMIWI standards and guidelines. In the

1996 re-proposal ‘‘medical waste’’ was

the term used to describe what is today

called ‘‘medical/infectious waste’’ in the

final HMIWI standards and guidelines.

Similarly, the term ‘‘medical waste

incinerator’’ or ‘‘MWI’’ was used to

describe what is called ‘‘hospital/

medical/ infectious waste incinerator’’

or ‘‘HMIWI’’ in the standards and

guidelines promulgated today.

Section 129 of the CAA directs the

EPA to adopt regulations for solid waste

incineration units that combust

‘‘hospital waste, medical waste, and

infectious waste.’’ Section 129(g)(6)

states that the term ‘‘medical waste’’

shall have the meaning ‘‘established by

the Administrator pursuant to the Solid

Waste Disposal Act.’’ For the 1995

proposed air emission standards and

guidelines for ‘‘MWI,’’ EPA adopted the

definition of ‘‘medical waste’’ from the

solid waste regulations codified in 40

CFR part 259, subpart B. As a result,

medical waste was defined broadly as

any solid waste that is generated in the

diagnosis, treatment, or immunization

of human beings or animals, in research

pertaining thereto, or in the production

or testing of biologicals. The broad

definition of medical waste in the 1995

proposal was not intended to be used to

identify ‘‘infectious’’ or ‘‘potentially

infectious’’ items in the health care

waste stream. The EPA’s only intention

was to define those items likely to be

burned in an ‘‘MWI’’ for the sake of

defining and regulating the air

emissions from incinerators used to

burn ‘‘hospital waste, medical waste,

and infectious waste.’’

As discussed earlier, the majority of

the comments on the 1995 proposed

definition of medical waste stated that

the proposed definition was too broad

and should be narrowed. Consequently,

the 1996 re-proposal announced EPA’s

inclination to adopt an existing and

more narrow definition of medical

waste for the purpose of regulating

‘‘MWI.’’ Specifically, the EPA stated

that it was inclined to adopt the

definition of medical waste created by

the New York State Department of

Health (NYSDOH). While inclined to

adopt the NYSDOH definition, the EPA

stated in the 1996 re-proposal that it

was also considering definitions of

medical waste adopted by other

regulatory agencies and national

associations as well as the 1995

proposed definition. The EPA solicited

public comment on the merits of each

definition as well as other definitions

EPA should consider.

Following the 1996 re-proposal,

several commenters supported a

definition of medical waste that is

limited to potentially infectious

materials and several commenters

agreed that the NYSDOH definition of

medical waste is appropriate. Other

commenters suggested that the EPA

Office of Solid Waste (OSW) definition

of regulated medical waste (RMW) is

more appropriate than the NYSDOH

definition because Congress intended

for EPA to use the Solid Waste Disposal

Act (SWDA) definition.

On the other hand, several

commenters argued that a broad

definition of medical waste is

appropriate. The commenters stated that

anything burned in an incinerator at a

health care facility should be classified

as medical waste and pointed out that

the CAA requires EPA to regulate

emissions from solid waste incineration

units ‘‘combusting hospital waste,

medical waste and infectious waste.’’

The commenters contended that

facilities operating onsite incinerators

would use them primarily for

noninfectious waste, which produces

emissions similar to medical waste

when burned.

The EPA has concluded that the

Medical Waste Tracking Act (MWTA)

definition of regulated medical waste is

the most appropriate definition of

medical/infectious waste for the final

HMIWI standards and guidelines. As

noted in the proposal and re-proposal,

the EPA considered several definitions

for purposes of these regulations (e.g.,

OSHA, NYSDOH, MWTA, AHA).

Although the various definitions are not

identical, they cover many of the same

materials. After considering the

comments received, the EPA today is

promulgating the MWTA definition

under the co-authority of section 2002

of the SWDA, 42 U.S.C. 6912, and

sections 129 and 301 of the CAA, 42

U.S.C. 7429 and 7601.

The EPA believes the MWTA

definition is the most appropriate

because it includes the materials of

concern, and will lead to the least

confusion in the regulated community

because it is a familiar definition. In

addition, the MWTA definition has

undergone public comment at the

Federal level, during both the

rulemaking under the MWTA, as well as

rulemaking on these regulations. The

EPA emphasizes that the MWTA

definition being promulgated today is

solely for purposes of determining

which incineration units are covered by

the HMIWI regulations under section

129 of the CAA. It is not for purposes

of determining applicability of SWDA

requirements. THE MWTA definition,

however, does not include hospital

waste; thus, EPA also is promulgating

today under authority of sections 129

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

7601, a definition of hospital waste.

The MWTA differentiates between

infectious and noninfectious wastes.

The MWTA definition of RMW includes

seven classes of waste which are very

similar to the classes of infectious waste

included in the NYSDOH definition.

However, the MWTA definition of RMW

is broader than the NYSDOH definition

of medical waste because the MWTA

definition includes some items (e.g.,

intravenous bags) which may not be

infectious, but are aesthetically

unpleasing. The MWTA definition does

not include hazardous waste; household

waste; ash from incineration of medical/

infectious waste; human corpses,

remains, and anatomical parts intended

for interment or cremation; or domestic

sewage materials.
48356 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

The EPA recognizes that the MWTA

definition does not fully encompass the

terms ‘‘hospital waste, medical waste,

and infectious waste.’’ The MWTA

definition, as well as other definitions

considered for the final HMIWI

regulations, cover ‘‘medical waste and

infectious waste,’’ but do not cover

‘‘hospital waste.’’ Commenters are

correct in pointing out that the

emissions from combustion of hospital

waste are very similar to emissions from

the combustion of medical/infectious

waste. Therefore, the final HMIWI

standards and guidelines contain

definitions for ‘‘hospital’’ and ‘‘hospital

waste’’ and the definition of ‘‘medical/

infectious waste’’ (MWTA definition).

The definitions of ‘‘hospital’’ and

‘‘hospital waste’’ will subject

incinerators located at hospitals to the

final standards and guidelines, whether

they burn ‘‘infectious’’ waste,

‘‘noninfectious’’ waste, or a

combination.

Commenters on the 1995 proposed

regulations stated there are very few, if

any, incinerators that are used by

hospitals to burn only noninfectious

hospital trash. Consequently, this

inclusion of ‘‘hospital waste’’ along with

‘‘medical/infectious waste’’ should:

minimize the concern about the overly

broad definition of medical waste; cover

the same incinerators as envisioned in

the 1995 proposal and 1996 re-proposal,

resulting in the same emission

reductions without imposing additional

costs; and satisfy the CAA requirement

to regulate solid waste incinerators

combusting ‘‘hospital waste, medical

waste, and infectious waste.’’ On the

other hand, section 129 directs EPA to

develop regulations for four categories

of solid waste incinerators. Because

municipal waste combustors (MWC),

industrial/commercial waste

incinerators, and other solid waste

incinerators sometimes burn small

amounts of hospital waste and/or

medical/infectious waste, and because

these other categories are already or will

be subject to section 129 regulations, the

final HMIWI regulations focus on

incinerators whose primary purpose is

the disposal of hospital waste and/or

medical/infectious waste in an effort to

avoid duplicative requirements.

Combustors subject to subparts Ea, Eb,

or Cb (the NSPS and EG for MWC larger

than 250 tons per day) have been

excluded from coverage under the

HMIWI regulations. In addition, any

incinerator which burns 10 percent or

less by weight hospital waste and

medical/infectious waste is not subject

to the final HMIWI standards and

guidelines. This 10 percent provision is

discussed further in section A.2 ‘‘Cofired Combustors’’ (below).

The primary purpose of the MWTA

definition of medical waste as used for

the HMIWI standards and guidelines is

to define items combusted in an HMIWI,

and not to define items which could

transmit disease. Only a small fraction

of ‘‘medical/infectious’’ waste is truly

‘‘infectious.’’ The EPA believes that to

add or remove specific items to or from

the MWTA definition, as suggested by

some commenters, would create

additional regulatory confusion because

the revised definition would essentially

become a new definition of medical

waste if altered. Any waste excluded

from the MWTA definition is either

covered now or will be covered in the

future by other solid waste incinerator

regulations.

The final standards and guidelines

will apply to hospital/medical/

infectious waste incinerators. It should

be noted that the definition of medical/

infectious waste adopted for the HMIWI

regulations is not the government-wide

Federal definition, or even the Agencywide EPA definition of infectious waste.

The medical/infectious waste definition

contained in the final regulations

promulgated today is for use in

determining applicability of the HMIWI

standards and guidelines only. It should

also be noted that ‘‘hospital waste’’ is

simply waste generated at a hospital.

Most of the waste generated at a hospital

(85 to 90 percent or more) is simply

municipal-type waste that may be

recycled or disposed without special

treatment. The use of the term ‘‘hospital

waste’’ in these regulations is for use in

determining applicability of the HMIWI

standards and guidelines only.

2. Co-fired Combustors

In the 1996 re-proposal, the EPA

provided no inclinations regarding the

applicability of the HMIWI regulations

to combustors that co-fire medical waste

with other fuels or wastes. Some

examples of units that might be used to

co-fire medical waste along with other

fuels or wastes include municipal waste

combustors (MWC), boilers, and

industrial/commercial waste

incinerators. During the public

comment period following the 1996 reproposal, several comments were

received questioning the applicability of

the HMIWI regulations to units that cofire medical waste with other fuels or

wastes.

One commenter provided information

on a circulating fluidized bed combustor

(CFBC) steam plant which co-fires coal

and medical waste. The commenter

noted that traditional HMIWI burn

materials with low sulfur content and

that the proposed SO2 emission limit

was arbitrarily set higher than actual

HMIWI emissions. The commenter

requested that the SO2 emission limit be

raised to 100 ppm to accommodate the

CFBC without affecting other

incinerators that burn medical waste.

Other commenters requested that

‘‘potentially infectious’’ medical waste

and ‘‘off-spec’’ or ‘‘out-of-date’’

pharmaceuticals be allowed to be

combusted in MWC along with

municipal solid waste (MSW) without

subjecting MWC to the HMIWI rules.

The commenters noted that MWC which

co-combust municipal and medical

waste are regulated under the MWC

emission standards. The commenters

recommended that an exclusion be

written into the final rule that will allow

MWC combusting a minimal amount of

medical waste (up to 10 percent of the

waste stream) to be excluded from the

HMIWI rule. The commenters suggested

that, if EPA feels that co-combustion of

MSW and medical waste in a small

MWC not covered under the MWC

standards is an environmental threat,

that co-combustion should not be

allowed in MWC burning less than 40

tons per day. Other commenters stated

that small MWC not regulated under the

MWC standards should not be allowed

to accept medical waste without

complying with the HMIWI regulations.

Other commenters requested that a

‘‘de minimis’’ quantity exemption be

allowed for facilities that incinerate

insignificant quantities of medical

waste. Some commenters requested that

clinical waste in the amount of 5 to 10

percent of the total waste stream be

allowed to be disposed of in a

pathological waste incinerator.

Section 129 requires the EPA to

develop NSPS and EG for MWC,

HMIWI, industrial/commercial waste

incinerators, and ‘‘other’’ solid waste

incinerators. The final NSPS and

guidelines applicable to MWC with

capacities of greater than 40 tons/day

were promulgated in December 1995,

but have since been partially vacated

and remanded. In this case, it is not the

EPA’s intent for MWC to be dually

covered under both the MWC

regulations and the HMIWI regulations.

Therefore, combustors subject to

Subparts Ea, Eb, or Cb (the NSPS and

EG for MWC larger than 250 tons/day)

have been excluded from coverage

under the HMIWI regulations regardless

of the amount of hospital waste or

medical/infectious waste combusted. As

regulations are developed under Section

129 for the other categories of solid

waste incinerators, EPA will make clear

which regulations apply to which

incinerators. In some cases, incinerators
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may be subject to more than one

regulation.

Commenters requesting that MWC,

boilers, and other industrial processes

that co-fire medical waste be exempted

from coverage under the HMIWI

regulations generally seem to agree that

these units combust no more than 10

percent hospital waste and/or medical/

infectious waste. Therefore, the final

HMIWI NSPS and guidelines contain

the provision that any incinerator or

industrial process that combusts less

than or equal to 10 percent hospital

waste and medical/infectious waste (by

weight) is not subject to the HMIWI

NSPS and guidelines provided that the

facility notifies the Administrator of an

exemption claim and maintains records

of the amount of hospital waste,

medical/ infectious waste, and other

fuels or wastes combusted.

As discussed in section A.3 ‘‘Waste

Types’’ (below), ‘‘off-spec’’ or ‘‘out-ofdate’’ drugs are not considered to be

medical/infectious waste as defined in

the final HMIWI regulations and are not

considered to be hospital waste, unless

disposed with the hospital’s waste.

‘‘Off-spec’’ or ‘‘out-of-date’’ drugs are

viewed the same as other fuels or wastes

(e.g., municipal waste, coal, etc.) under

HMIWI regulations. Therefore,

incinerators that combust waste

pharmaceuticals (i.e., ‘‘off-spec’’ or

‘‘out-of-date’’ drugs), and combust 10

percent or less hospital waste and

medical/infectious waste (by weight) are

not subject to the HMIWI regulations.

However, any incinerator that combusts

waste pharmaceuticals along with more

than 10 percent hospital waste and

medical/infectious waste is subject to

the HMIWI regulations.

As also discussed in section A.3

‘‘Waste Types’’ (below), pathological

waste, chemotherapeutic waste, and

low-level radioactive waste are

considered ‘‘excluded’’ wastes. While

these wastes sometimes meet the

definition of hospital waste or medical/

infectious waste, they are viewed the

same as ‘‘other’’ fuels or wastes (e.g.,

municipal waste, coal, etc.) when

calculating the amount of hospital waste

and medical/infectious waste burned in

a co-fired combustor. For example, a

combustor burning 90 percent

pathological waste with 10 percent

hospital waste is a co-fired combustor,

even if the pathological waste meets the

definition of medical/infectious waste.

However, any incinerator that combusts

pathological, chemotherapeutic, and/or

low-level radioactive waste along with

more than 10 percent of other materials

meeting the definition of hospital waste

and/or medical/infectious waste is

subject to the HMIWI regulations.

While incinerators that burn 10

percent or less hospital waste and

medical/infectious waste are excluded

from the HMIWI regulations, this

exclusion does not mean that EPA will

not develop regulations which will

cover these units in the future. The

NSPS and EG that were recently

remanded for MWC with capacities

between 40 tons/day and 250 tons/day

will be revised and repromulgated.

Furthermore, the CAA directs the EPA

to develop regulations for all solid waste

incinerators, including MWC with

capacities less than 40 tons/day. The

EPA has announced that regulations for

other solid waste incinerators will be

developed by the year 2000. Thus,

burning of hospital waste or medical/

infectious wastes in other solid waste

incineration units will be covered by

regulations developed within the next

few years. Exclusion of incinerators that

burn small amounts of hospital waste or

medical/infectious waste from the

HMIWI regulation is only a temporary

deferment from regulation if these units

are not presently regulated under

section 129.

3. Waste Types

In the 1996 re-proposal, the EPA

stated that it was inclined to exclude

crematories and incinerators used solely

for burning pathological waste from

coverage under the HMIWI regulations.

The EPA also stated that it was inclined

to exclude incinerators used solely for

burning low-level radioactive waste or

‘‘off-spec’’ and ‘‘out-of-date’’

pharmaceuticals. This section discusses

the major public comments received

regarding exemption of specific wastes

from the HMIWI standards and

guidelines.

Several commenters requested that

crematories and incinerators used solely

for burning pathological waste be

excluded from the HMIWI regulation.

One commenter questioned whether

animal waste is to be included,

excluded, or partially excluded from the

regulation. Another commenter stated

that there are no effective alternative

disposal options for pathological waste,

especially for large domestic animal

carcasses (i.e., cows and horses). Several

commenters also requested that

incinerators used to burn only ‘‘offspec’’ and ‘‘out-of-date’’ drugs or lowlevel radioactive waste be excluded

from the regulation. One commenter

stated that crematories and incinerators

used to burn drugs, low-level

radioactive waste, and pathological

waste are already covered under other

regulations, or will be covered under

regulations developed through EPA’s

Industrial Combustion Coordinated

Rulemaking (ICCR) project. Other

commenters urged EPA to exclude units

permitted under section 3005 of the

SWDA from the HMIWI rule. One

commenter argued that section 129 of

the CAA statutorily prohibits EPA from

regulating in the HMIWI rule hazardous

waste combustion units which are to be

regulated under the Resource

Conservation and Recovery Act (RCRA).

Pathological waste, low-level

radioactive waste, and

chemotherapeutic waste are different

from most hospital waste and medical/

infectious waste and are often burned in

incinerators which burn these wastes

exclusively. While these wastes often

times meet the definition of hospital

waste or medical/infectious waste, the

combustion of these materials warrants

separate consideration. Pathological

waste, chemotherapeutic waste, and

low-level radioactive waste are

considered ‘‘excluded’’ wastes,

regardless of whether the waste meets

the definition of hospital waste or

medical/infectious waste in the HMIWI

regulations. Consequently, in

determining the amount of hospital

waste and medical/infectious waste

burned in a co-fired combustor, these

‘‘excluded’’ wastes are included in the

calculation as ‘‘other’’ wastes (they do

not count toward the 10 percent

hospital waste and medical/infectious

waste), as discussed above in section

A.2. In addition, incinerators that are

otherwise subject to the HMIWI

regulations are exempt during periods

when only pathological waste, low-level

radioactive waste, and/or

chemotherapeutic waste is burned.

These latter units must keep records of

the periods of time when only

pathological, chemotherapeutic, and

low-level radioactive wastes are burned.

With regard to crematories, human

remains intended for interment or

cremation are not hospital waste or

medical/infectious waste. Consequently,

crematories are not subject to the

HMIWI regulations unless they burn

waste that meets the definition of

hospital waste or medical/infectious

waste.

While pathological incinerators,

chemotherapeutic and low-level

radioactive waste incinerators, and

crematories are excluded from the final

HMIWI standards and guidelines, this

exclusion does not mean that EPA will

not develop regulations which will

cover these incinerators in the future.

The CAA directs the EPA to develop

regulations for all solid waste

incinerators. The EPA is developing

separate regulations which will cover

these units as part of the ‘‘other’’

category of solid waste incineration
48358 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

units within the ICCR project. The EPA

has announced that regulations for other

solid waste incinerators will be

developed by the year 2000. Thus,

cremation and burning of pathological,

chemotherapeutic, and low-level

radioactive wastes will be covered by

regulations developed within the next

few years. Exclusion of crematories and

incinerators burning pathological,

chemotherapeutic, and low-level

radioactive waste from the HMIWI

regulation is only a temporary

deferment.

Pharmaceutical wastes such as ‘‘offspec’’ or ‘‘out-of-date’’ drugs are not

considered to be medical/infectious

waste as defined in the final HMIWI

regulations. Also, pharmaceutical

wastes are not considered to be hospital

waste unless generated at a hospital and

disposed with the hospital’s waste. In

the HMIWI regulations ‘‘hospital waste’’

is defined as discards generated at a

hospital, excluding human remains and

unused items returned to the

manufacturer. Thus, ‘‘out-of-date’’ drugs

returned by a hospital to a

pharmaceutical company for disposal

are not considered hospital waste.

Waste pharmaceuticals are viewed the

same as other fuels and wastes (e.g.,

municipal waste, coal, etc.) under the

HMIWI regulations. Therefore,

incinerators that combust waste

pharmaceuticals, and combust 10

percent or less hospital waste and

medical/infectious waste (by weight) are

not subject to the HMIWI regulations.

However, any incinerator that combusts

waste pharmaceuticals along with more

than 10 percent hospital waste and

medical/infectious waste is subject to

the HMIWI regulations.

Section 129(g)(1) of the CAA

specifically exempts from the HMIWI

NSPS and guidelines solid waste

incinerators required to have a permit

under section 3005 of the SWDA. To be

consistent with section 129, the final

HMIWI standards and guidelines

specifically exempt incinerators

permitted under section 3005 of the

SWDA. In addition, the definition of

medical/infectious waste in the final

regulations specifically excludes

hazardous waste identified or listed

under the regulations in 40 CFR Part

261.

4. Cement Kilns

Some commenters pointed out that

section 129 clearly addresses

incinerators, not cement kilns.

Commenters stated that HMIWI and

cement kilns using medical waste as

fuel are two completely different

devices and should not be confused

with each other or regulated under the

same air emissions control standards.

One commenter recommended that if

EPA concludes that Congress intended

to regulate cement kilns under section

129, EPA should not impose emission

limitations and other requirements that

were written for HMIWI on cement

kilns.

The EPA disagrees with commenters

that contend EPA has no authority to

regulate cement kilns under section 129.

Section 129(a)(1)(A) requires the

Administrator to establish performance

standards and other requirements for

each category of solid waste

incineration units. Congress specifically

listed in section 129 various categories

of solid waste incineration units that

EPA must regulate. Section 129(g)(1)

broadly defines solid waste incineration

unit as ‘‘a distinct operating unit of any

facility which combusts any solid waste

material * * *’’ (emphasis added). This

definition clearly indicates Congress’

intent to regulate more than just

incinerators because the definition

sweeps within its scope any facility that

is combusting any solid waste material.

Further evidence of EPA’s authority to

regulate cement kilns under section 129

is presented in ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). However, the EPA does

recognize that cement kilns are different

from HMIWI in size, design, and

operation. Accordingly, the EPA is not

regulating cement kilns under this

regulation, but instead, is determining

whether separate regulations under

section 129 are appropriate for cement

kilns combusting solid waste materials.

B. Pyrolysis Units

In the 1996 re-proposal, the EPA

stated that it was considering a separate

regulation for pyrolysis units that would

look very similar to the HMIWI

regulation in that it would contain

definitions, emissions limitations,

monitoring and testing requirements to

demonstrate compliance, and reporting

and recordkeeping requirements.

However, the separate pyrolysis

regulation would differ from the HMIWI

regulations in that some definitions

would be different, the emission

limitations would, in many cases, be

more stringent than the HMIWI

regulations, and the monitoring and

testing requirements would reflect the

operating parameters that are unique to

pyrolysis systems.

Following the 1996 re-proposal,

several commenters encouraged EPA to

promulgate separate standards for

medical waste pyrolysis (MWP) units.

One commenter noted that separate

regulations would contain emission

limits more stringent than the HMIWI

regulations and reflect the unique

features of pyrolysis units.

Other commenters suggested that EPA

modify the 1995 proposed HMIWI

regulations to include pyrolysis units

and defer the final promulgation of

separate pyrolysis regulations. The

commenters stated that variations in the

operating characteristics among

pyrolysis technologies would make

separate pyrolysis regulations unwieldy

to implement at this time. The

commenters requested that EPA modify

the HMIWI regulations to provide

flexibility if a specific operator training,

siting, performance verification,

compliance verification, monitoring,

recordkeeping or reporting requirement

does not directly apply to a pyrolysis

system.

Other commenters stated that

pyrolysis units are similar to

conventional incinerators and requested

that they be included under the HMIWI

regulations. The commenters stated that,

if EPA regulates pyrolysis units

separately, that MACT floor levels

should be based on available test data,

and the pyrolysis regulation should be

issued concurrently with the final

HMIWI regulations.

The various arguments for and against

developing separate regulations for

pyrolysis units lead to three options for

developing regulations for pyrolysis

units: (1) Regulate pyrolysis under the

standards and guidelines being

promulgated today; (2) exempt pyrolysis

units from the HMIWI regulations and

simultaneously promulgate separate

regulations for pyrolysis units; and (3)

exempt pyrolysis units from the HMIWI

regulation and defer the development of

separate regulations.

Pyrolysis technology is different from

conventional incineration. Because air

is generally not used in the pyrolysis

treatment process, the volume of

exhaust gas produced from pyrolysis

treatment is likely to be far less than the

volume of gas produced from the

burning of waste in an HMIWI.

Although conventional combustion does

not occur during pyrolysis treatment,

there are some emissions from the

pyrolysis process.

As discussed in the 1996 re-proposal,

the EPA developed a draft regulation for

pyrolysis units. The 1996 re-proposal

pointed out that the draft regulatory text

was incomplete and it included

placeholders and requests for

information where such information

was lacking. The EPA requested
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48359

comments to help fill in the missing

information.

Following the 1996 re-proposal, the

EPA received information for use in

developing the separate pyrolysis

regulation from vendors of pyrolysis

technology. As pointed out by one

commenter and supported by the

information received from pyrolysis

vendors, there are variations in the

operating characteristics among

pyrolysis technologies that would make

separate regulations for pyrolysis units

very difficult to implement at this time.

As a result, the EPA has concluded that

sufficient information is not available to

develop a separate and uniform

regulation for pyrolysis technology that

would contain requirements that are

technically feasible for all pyrolysis

units.

Because separate regulations for

pyrolysis technology cannot be

developed at this time, the EPA

considered modifying the HMIWI

regulations to include pyrolysis units.

However, nearly all aspects of the

HMIWI regulations would have to be

altered to accommodate pyrolysis units

including the format of the emission

limits, the operator training

requirements, siting requirements, the

testing and monitoring requirements,

and the reporting and recordkeeping

requirements. Furthermore, the HMIWI

subcategories and MACT floors would

not be appropriate for pyrolysis units.

Due to variations in the operating

characteristics of pyrolysis technologies

and the differences between HMIWI and

pyrolysis technologies, it is unclear how

the HMIWI regulations could be

modified to feasibly cover pyrolysis

technologies as well as HMIWI.

Section 129 requires EPA to develop

NSPS and EG for ‘‘solid waste

incineration units * * * combusting

hospital waste, medical waste, and

infectious waste.’’ As discussed above,

pyrolysis and conventional incineration

are not the same. Because regulations

developed for HMIWI are not

appropriate for pyrolysis technologies,

pyrolysis treatment technologies have

specifically been excluded from

coverage under the final HMIWI

standards and guidelines. The EPA may

consider these devices in future

regulatory development.

C. Waste Management Plans

During the public comment period

following the 1996 re-proposal, several

commenters stated that the EPA

standards for HMIWI are reliant on

pollution control and give little

attention to pollution prevention. The

commenters stated that recycling and

pollution prevention measures could

yield greater reductions in emissions

than add-on controls alone. Some

commenters stated that Congress

intended for EPA to use process changes

or substitution of materials to help

eliminate emissions. Some commenters

stated that dioxin/furan, HCl, and Hg

emissions could be controlled through a

pollution prevention program that

reduces or eliminates incineration of

chlorinated materials and batteries. One

commenter requested that EPA suggest

pollution prevention measures for

controlling Hg as well as other pollutant

precursors (i.e., lead, cadmium,

chlorine, nitrogen, fluorine, and sulfur).

The commenter maintained that the

economic impact of the HMIWI

regulations could be reduced

significantly if EPA required medical

facilities to institute pollution

prevention techniques.

The types of materials sent to an

HMIWI vary from facility to facility

depending on facility operating

practices, which are defined by

purchasing decisions, waste handling

procedures, and other practices that

affect the types of materials incinerated.

In the February 1995 proposal, the

EPA stated that it had no data to

indicate the effects of waste handling

practices on emissions of various

pollutants and requested comments on

the extent to which operating practices

could influence emissions. To evaluate

the effectiveness of waste segregation

programs, the EPA specifically solicited

detailed descriptions of programs and

results of performance tests conducted

to demonstrate pollutant emission levels

from the HMIWI prior to

implementation of the program and

subsequent to implementation of the

program. In addition, the EPA solicited

comments on how such a program could

be incorporated into the HMIWI

regulations.

Following the 1995 proposal, the EPA

received no data to conclusively

indicate the effectiveness of waste

segregation programs in reducing

emissions from HMIWI. Therefore, the

final HMIWI standards and guidelines

are primarily based on air pollution

controls rather than pollution

prevention. However, as discussed in

the 1996 re-proposal, EPA has included

pollution prevention measurements in

setting the Hg emission limit for good

combustion. To ensure that emissions of

Hg from facilities with good combustion

controls meet the final emission

guidelines for Hg, EPA is requiring that

these facilities conduct a Hg emission

test. If the facility fails the emission test,

the facility will need to implement Hg

pollution prevention measures or install

an APCD to meet the emission limits.

The EPA has investigated the impacts

on emissions of shifting the waste

composition from chlorinated plastics to

non-chlorinated polymers. However, the

outcome of this investigation is

inconclusive. A number of studies have

concluded that the chlorine content of

the waste is directly related to dioxin/

furan emissions, while other studies

suggest there is no relationship between

the chlorine content of the waste and

dioxin/furan emissions. At this point,

the effectiveness of a pollution

prevention program directed at reducing

dioxin/furan emissions through shifting

the waste composition from chlorinated

plastics to nonchlorinated polymers

would be questionable.

A number of health care facilities

have implemented waste management

measures to reduce the overall volume

of waste. However, it should be stressed

that each health care facility is unique

and site-specific strategies must be

developed that achieve the most

efficient results. Through the

development of individual waste

management programs, health care

facilities can achieve significant

reductions in their waste stream, reduce

the volume of waste to be incinerated,

and thereby reduce the amount of air

pollution emissions associated with that

waste. Therefore, the final HMIWI

standards and guidelines require that

health care facilities which operate

incinerators develop and implement a

waste management plan.

The waste management plan would

identify both the feasibility and the

approach to separate certain

components of solid waste from the

health care waste stream in order to

reduce the amount of toxic emissions

from incinerated waste. The waste

management plan may include elements

such as paper, cardboard, plastics, glass,

battery, or metal recycling; or

purchasing recycled or recyclable

products. A waste management plan

may include different goals or

approaches for different areas or

departments of the facility and need not

include new waste management goals

for every waste stream. It should

identify, where possible, reasonably

available additional waste management

measures, taking into account the

effectiveness of waste management

measures already in place, the costs of

additional measures, the emission

reductions expected to be achieved, and

any other environmental or energy

impacts they might have. A copy of the

waste management plan would be

submitted to EPA along with the results

of the initial performance test

demonstrating compliance with the

emission limits. In addition, the waste
48360 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

management plan may be reviewed by

the Joint Commission on Accreditation

of Health Care Organizations during the

accreditation process.

Health care facilities are encouraged

to review and incorporate into their

waste management plans the waste

minimization techniques discussed in

‘‘An Ounce of Prevention: Waste

Reduction Strategies for Health Care

Facilities,’’ which is published by the

American Society for Health Care

Environmental Services of the American

Hospital Association. This document

may be obtained by contacting AHA

Services, Inc., P.O. Box 92683, Chicago,

Illinois 60675–2683, or by calling 800–

242–2626. The cost of the document is

$50.00 plus $10.95 for shipping and

handling. The document is available for

public inspection at EPA’s Air and

Radiation Docket and Information

Center (Docket A–91–61, item IV–J–

124). See the ADDRESSES section at the

beginning of this preamble for the

location of the Docket. Note that

because of copyright law, this document

may not be copied. This document was

approved for incorporation by reference

by the Director of the Federal Register

in accordance with 5 U.S.C. 552(a) and

1 CFR part 51.

D. Testing, Monitoring, and Inspection

Section 129(c) of the CAA requires the

EPA to include emissions monitoring

and testing requirements in the

regulation. The purpose of these

requirements is to allow the EPA to

determine whether a source is operating

in compliance with the regulations.

In the 1996 re-proposal, the EPA

stated that it was inclined to adopt

requirements that EPA test methods be

followed when performing any emission

testing required to determine

compliance with the HMIWI

regulations. In most cases, three test

runs of about 1 hour each would be

necessary to determine compliance. The

EPA also stated in the 1996 re-proposal

that it was inclined to include in-house

inspection and maintenance

requirements wherever annual stack

testing was not required. To minimize

costs, the EPA stated that it was

inclined to include requirements for

monitoring of operating parameters and

routine Method 9 (stack opacity) testing

in the final regulations instead of CO

and opacity continuous emissions

monitoring systems (CEMS) for onsite

HMIWI. Where the regulations are based

on wet and/or dry scrubbing systems,

the EPA stated that it was inclined to

require initial and repeat stack testing

(annual/skip testing where annual

testing is required for the first 3 years

and, if these tests show compliance,

subsequent testing would be done every

third year). Where the regulations are

based, in part, on the use of good

combustion alone, the EPA stated that it

was inclined to require initial stack

testing and routine inspections. The

EPA solicited public comment on all of

the testing and monitoring inclinations

presented in the 1996 re-proposal. In

addition, because some CEMS vendors

questioned the CEMS and parameter

monitoring costs developed by EPA, the

EPA solicited public comment on the

costs of CEMS and monitoring of

operating parameters.

Several comments concerning the

EPA’s inclinations for monitoring and

testing were received following the 1996

re-proposal. One commenter requested

that EPA require CEMS for CO, HCl,

SO2, NOX, Hg, and PM. The commenter

contended that CEMS for CO, HCl, SO2,

NOX, Hg, and PM would eliminate the

need for stack testing. The commenter

stated that the only way to ensure

compliance at all times, as mandated by

the CAA, is through the continuous use

of CEMS. One commenter stated that

EPA should require continuous

monitoring of CO emissions from all

HMIWI, continuous opacity monitoring

at large incinerators, and continuous

monitoring of HCl emissions from very

large (>1000 lb/hr) incinerators. The

commenter indicated that continuous

monitoring of CO and O2 is the only

way to ensure that good combustion is

occurring. The commenter concluded

that CO and O2 ‘‘process’’ monitors

should be sufficient for HMIWI with

capacities less than 500 lb/hr. The

commenter stated that EPA’s inclination

not to require continuous monitoring is

based on inaccurate CEMS costs.

A number of commenters supported

EPA’s inclination to determine

compliance using parameter monitoring

and routine inspection and maintenance

rather than CEMS. One of the

commenters supported monitoring of

operating parameters and routine

Method 9 testing combined with initial

stack testing and annual inspections to

ensure compliance with the rule.

Another commenter stated that an

initial stack test for the primary

pollutants and regular inspection,

maintenance, and daily recording of

operating parameters would be

appropriate. One commenter stated that

monitoring of operating parameters with

no CEMS and substitute stack testing

with annual inspections would provide

an excellent means to attain low

emissions for minimal costs for small

HMIWI. Other commenters

recommended monitoring operating

parameters and routine Method 9 testing

with initial stack testing and no repeat

testing. Another commenter suggested

that an initial performance test and

monitoring is sufficient and that

additional tests are not necessary

especially given operator training,

inspections, and monitoring.

The most direct means of ensuring

compliance with emission limits is the

use of CEMS. As a matter of policy, the

first and foremost option considered by

EPA is to require the use of CEMS to

demonstrate continuous compliance

with specific emission limits. Other

options are considered only when

CEMS are not available or when the

impacts of including such requirements

are considered unreasonable. When

monitoring options other than CEMS are

considered, there is always a tradeoff

between the cost of the monitoring

requirement and the quality of the

information collected with respect to

determining actual emissions. While

monitoring of operations (operating

parameters) cannot provide a direct

measurement of emissions, it is usually

much less expensive than CEMS, and

the information provided can be used to

ensure that the incinerator and

associated air pollution control

equipment are operating properly. This

information provides EPA and the

public with assurance that the

reductions envisioned by the

regulations are being achieved.

For the 1996 re-proposal, testing and

monitoring costs were developed for a

range of options, and the Agency

concluded that the cost of CEMS were

unreasonably high relative to the cost of

the incinerators and air pollution

control systems needed for compliance.

Based on comments and information

received as a result of the 1996 reproposal, the cost estimates for CEMS

and parameter monitoring have been

revised. While the cost estimates for

CEMS have been significantly reduced

and additional costs have been included

for parameter monitoring, it appears that

the annual costs of monitoring

requirements which include CEMS are

still quite high compared to the cost of

the incinerator and air pollution control

device required to meet the emission

limits.

A large HMIWI costs approximately

$120,000/yr to operate, while an add-on

APCD can cost from $150,000 to

$300,000/yr to operate. The most

comprehensive monitoring option

including CEMS for HCl and CO costs

about $95,000/yr. This option costs

nearly as much to operate as the

incinerator itself and could represent as

much as half the cost of the APCD. In

addition, the only emissions that are

directly measured are HCl and CO.

Consequently, the most comprehensive
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48361

monitoring option that could be selected

for large HMIWI is considered

unreasonable.

There are no direct measurements of

dioxin/furan or toxic metals. Particulate

matter and Hg CEMS are currently

under development but have not been

demonstrated in the United States to be

capable of accurately and reliably

measuring PM or Hg emissions for use

in determining compliance with PM or

Hg emission limits at this time. With

regard to SO2 and NOX, the emission

limits in the final regulations reflect

uncontrolled emissions. Therefore, it is

unreasonable to impose a cost (of

monitoring) where no emission

reduction benefit will be gained.

Looking at other options for large

HMIWI, the only CEMS available are

CO/O2 and opacity. For a large HMIWI

equipped with a sophisticated APCD

like a wet scrubber, dry scrubber, or

combined dry/wet scrubber, these

CEMS provide very little information

regarding the pollutants that are of most

concern to the public (i.e., dioxin/furan

and toxic metals). Consequently,

because the APCD already represents a

substantial increase in the cost of

incineration and because the more

comprehensive monitoring options do

not provide much information regarding

the pollutants of most concern, the final

monitoring and testing requirements for

HMIWI equipped with APCD reflect

routine stack testing coupled with

continuous monitoring of operating

parameters.

Where incinerators are not equipped

with add-on air pollution control (i.e.,

units utilizing good combustion alone),

EPA agrees with commenters that CO

provides the best measure of good

combustion. However, regulations based

on good combustion alone only apply to

small existing HMIWI meeting certain

‘‘remote’’ criteria (see section V.B). For

these small existing HMIWI using only

good combustion, the incinerator costs

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

pollution control costs about $10,000/yr

to operate. Monitoring options

including CO CEMS for compliance are

clearly unreasonable at about $54,000/yr

(five times the cost of the air pollution

control). The monitoring option which

includes a CO ‘‘process’’ monitor costs

about $17,000/yr while the option that

relies on operating parameters costs

about $10,000/yr. The EPA does not

believe that the CO ‘‘process’’ monitor

provides enough additional information

to justify the $7,000/yr additional cost,

especially considering that the air

pollution control only costs $10,000/yr.

Consequently, where the regulations are

based on good combustion alone, the

monitoring requirements consist of an

initial stack test coupled with

continuous monitoring of operating

parameters and annual inspections.

The specific values for operating

parameters are chosen by the owner or

operator and are established during the

initial performance test demonstrating

compliance with the emission limits.

After the performance test, monitoring

of the operating parameters is the only

way to determine, on a continuous

basis, whether the source is operating in

compliance. Operation outside the

bounds of an established operating

parameter is a violation of an operating

parameter limit. In addition, under

certain conditions, operation outside the

bounds of one or more parameter limits

constitutes a violation of a specific

emission limit. This latter provision was

included in the 1995 proposed

regulations and is retained in the final

regulations. The owner or operator has

the flexibility to choose the values for

the operating parameters and may

conduct repeated performance tests to

‘‘fine tune’’ the operating parameter

limits, if desired.

With regard to the testing

requirements, annual testing is required

for the first 3 years. If these tests show

that the facility is in compliance each of

these 3 years, then subsequent testing

would be done every third year. Initial

testing includes testing for the following

pollutants: PM, CO, HCl, dioxin/furan,

Pb, Cd, Hg, and opacity. The annual/

skip or ‘‘repeat’’ testing only includes

testing for PM, CO, HCl, and opacity.

Where good combustion alone serves as

the basis for the emission limits, the

Agency only requires facilities to

perform an initial compliance test for

PM, CO, dioxin/furan, Hg, and opacity,

annual incinerator inspections, annual

opacity testing, and parameter

monitoring (charge rate and secondary

chamber temperature). Minimum

sampling times of 1 hour (4 hours for

dioxin/furan) have been included in the

final regulations for all HMIWI.

The ‘‘repeat’’ testing requirements

will ensure, on an ongoing basis, that

the APCD is operating properly, that no

deterioration in performance has

occurred, and that no changes have been

made to the operating system or the type

of waste burned. Where ‘‘repeat’’ testing

is not required, annual inspections,

annual opacity testing, and parameter

monitoring will ensure that the HMIWI

is in good working order. However, cost

considerations were the only reason for

excluding the repeat testing for units

with good combustion alone. Good

combustion alone with its associated

monitoring are provided in order to

minimize costs for a small number of

incinerators in remote areas where

alternatives to incineration might be

unavailable. Initial testing for good

combustion units includes testing for

PM, CO, dioxin/furan, Hg, and opacity.

The Hg testing is required to ensure that

units are segregating Hg bearing wastes

and meeting the Hg emission limit.

Rather than require third-party

inspections, which could be

burdensome for small remote facilities,

the final guidelines allow for in-house

equipment inspections. However, EPA

plans to work with States to give higher

priority to these small remote facilities

in terms of enforcement inspections.

Either the EPA or the State will inspect

these small remote facilities annually

for the first three years after the State

plan is approved. Following the threeyear period, these sources will be placed

on the regular enforcement inspection

schedule.

E. Operator Training and Qualification

The final operator training and

qualification requirements are almost

identical to those described in the 1996

re-proposal. The final requirements

provide flexibility by allowing Stateapproved training and qualification

programs. Where there are no Stateapproved programs, the final regulations

include minimum requirements for

training and qualification. The EPA has

a training manual available through its

Air Pollution Training Institute (APTI).

For further information, contact APTI at

(919) 541–2497. In addition, EPA plans

to work with the American Hospital

Association to develop a

correspondence course for those

facilities that may not have access to

adequate training. As discussed above,

EPA plans to work with States to give

higher priority to the small remote units

in terms of enforcement inspections,

including a review of operator training.

IV. Standards of Performance for New

Sources

This section presents a summary of

the final standards, including

identification of the source category and

pollutants being regulated, and

presentation of the final emission limits

and their associated performance

testing, monitoring, recordkeeping and

reporting requirements. This section

discusses the most significant changes

to the standards presented in the June

20, 1996 Federal Register document.

Also discussed in this section is the

rationale for the selection of MACT and

a summary of the impacts of the final

standards.

A. Summary of the Standards

The final standards (subpart Ec) apply

to each new HMIWI for which
48362 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

construction commenced after June 20,

1996 or to an existing HMIWI for which

modification commenced after March

16, 1998. Hospital/medical/infectious

waste incinerators for which

construction commenced on or before

June 20, 1996 are not covered under the

subpart Ec standards; they are

considered existing sources and are

subject to the guidelines under subpart

Ce (see section V of this notice).

A HMIWI is defined as any device

that combusts any amount of medical/

infectious waste or hospital waste. The

terms medical/ infectious waste and

hospital waste are discussed in section

III.A and defined in § 60.51c. An

incinerator is not subject to subpart Ec

during periods when only pathological,

low-level radioactive, or

chemotherapeutic waste (all defined in

§ 60.51c) is burned provided that the

owner or operator keeps records of the

periods of time when only pathological,

low-level radioactive, and/or

chemotherapeutic waste is burned. Any

combustor required to have a permit

under section 3005 of the SWDA is

exempt from subpart Ec as are

incinerators subject to subpart Cb, Ea, or

Eb. New incinerators, processing

operations, or boilers that co-fire

medical/infectious waste or hospital

waste with other fuels or wastes and

that combust 10 percent or less medical/

infectious waste and hospital waste by

weight (on a calendar quarter basis) are

not subject to the emission limits under

subpart Ec, but must keep records of the

amount of each fuel and waste fired.

The HMIWI source category is

divided into three subcategories based

on waste burning capacity: Small (≤200

lb/hr), medium (>200 to 500 lb/hr), and

large (>500 lb/hr). Waste burning

capacity is determined either by the

maximum design capacity or by the

‘‘maximum charge rate’’ established

during the most recent performance test.

In other words, a source may change its

size designation by establishing a

‘‘maximum charge rate’’ lower than its

design capacity. For example, a

‘‘medium’’ unit with a design capacity

of 250 lb/hr may establish a maximum

charge rate of 200 lb/hr and be

considered a ‘‘small’’ unit for purposes

of the standards. Separate emission

standards apply to each subcategory of

new HMIWI. A summary of the final

emission limits for new or modified

HMIWI is presented in Table 3.

TABLE 3.—SUMMARY OF PROMULGATED EMISSION LIMITS FOR NEW HMIWI

Pollutant (test method)

Emission limits

Small HMIWI Medium HMIWI Large HMIWI

Particulate matter (EPA Method 5

or Method 29).

69 mg/dscm (0.03 gr/dscf) ............ 34 mg/dscm (0.015 gr/dscf) .......... 34 mg/dscm (0.015 gr/dscf).

Carbon monoxide (EPA Method

10 or Method 10B).

40 ppmv ........................................ 40 ppmv ........................................ 40 ppmv.

Dioxins/furans (EPA Method 23) .. 125 ng/dscm total CDD/CDF (55

gr/109 dscf) or 2.3 ng/dscm

TEQ (1.0 gr/10 9 dscf).

25 ng/dscm total CDD/CDF (11

gr/10 9 dscf) or 0.6 ng/dscm

TEQ (0.26 gr/10 9 dscf).

25 ng/dscm total CDD/CDF (11

gr/10 9 dscf) or 0.6 ng/dscm

TEQ (0.26 gr/10 9 dscf).

Hydrogen chloride (EPA Method

26).

15 ppmv or 99% reduction ........... 15 ppmv or 99% reduction ........... 15 ppmv or 99% reduction.

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

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

Lead (EPA Method 29) ................. 1.2 mg/dscm (0.52 gr/10 3 dscf) or

70% reduction.

0.07 mg/dscm (0.03 gr/10 3 dscf)

or 98% reduction.

0.07 mg/dscm (0.03 gr/10 3 dscf)

or 98% reduction.

Cadmium (EPA Method 29) .......... 0.16 mg/dscm (0.07 gr/10 3 dscf)

or 65% reduction.

0.04 mg/dscm (0.02 gr/10 3 dscf)

or 90% reduction.

0.04 mg/dscm (0.02 gr/10 3 dscf)

or 90% reduction.

Mercury (EPA Method 29) ............ 0.55 mg/dscm (0.24 gr/10 3 dscf)

or 85% reduction.

0.55 mg/dscm (0.24 gr/10 3 dscf)

or 85% reduction.

0.55 mg/dscm (0.24 gr/10 3 dscf)

or 85% reduction.

In addition to the emission limits,

new or modified large HMIWI are

subject to a 5 percent visible emission

limit for fugitive emissions generated

during ash handling and all new or

modified HMIWI are subject to a 10

percent stack opacity limit. Performance

tests for fugitive emissions from ash

handling must be conducted using EPA

Reference Method 22. Stack opacity

must be determined using EPA

Reference Method 9.

Table 4 summarizes the additional

requirements for new or modified

HMIWI under the NSPS, including the

operator training and qualification

requirements, siting requirements,

compliance and performance testing

requirements, monitoring requirements,

and reporting and recordkeeping

requirements. A summary of dates for

compliance with the promulgated

standards for new HMIWI is presented

in Table 5. These dates apply to all new

or modified HMIWI.

TABLE 4.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE NSPS FOR NEW HMIWI

Additional requirements

Operator Training and Qualification Requirements:

• Complete HMIWI operator training course.

• Qualify operators.

• Maintain information regarding HMIWI operating procedures and review annually.

Siting Requirements:

• Prepare a siting analysis that considers air pollution control alternatives that minimize, on a site-specific basis and to the maximum extent

practicable, potential risks to public health and the environment.
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48363

TABLE 4.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE NSPS FOR NEW HMIWI—Continued

Additional requirements

Waste Management Plan:

• Prepare a waste management plan that identifies the feasibility and approach to separate certain components of a health care waste

stream.

Compliance and Performance Testing Requirements:

• Conduct an initial performance test to determine compliance with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and opacity limit, and establish operating parameters.

• Conduct annual performance tests to determine compliance with the PM, CO, and HCl emission limits and opacity limit.

• Facilities may conduct performance tests for PM, CO, and HCl every third year if the previous three HMIWI performance tests demonstrate that the facility is in compliance with the emission limits for PM, CO, or HCl.

• Perform annual fugitive testing (large HMIWI only).

Monitoring Requirements:

• Install and maintain equipment to continuously monitor operating parameters including secondary chamber temperature, waste feed rate,

bypass stack, and APCD operating parameters as appropriate.

• Obtain monitoring data at all times during HMIWI operation.

Reporting and Recordkeeping Requirements:

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

maintenance, the siting analysis, and operator training and qualification.

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

• Submit reports on emission rates or operating parameters that have not been recorded or that exceeded applicable limits.

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

combusted, the waste management plan, and documentation resulting from the siting analysis.

NOTE: This table depicts major provisions of the NSPS and does not attempt to show all requirements. The regulatory text of Subpart Ec

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

TABLE 5.—COMPLIANCE TIMES UNDER THE NSPS FOR NEW HMIWI

Requirement Compliance time

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

Operator training and qualification 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. Facilities may conduct performance tests every third year if the previous three performance tests demonstrate compliance with the emission limits.

Operator parameter monitoring ... Continuously, upon completion of initial compliance test.

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

Reporting ..................................... Annually, upon completion of initial compliance test; semiannually, if noncompliance.

NOTE: This table depicts major provisions of the NSPS and does not attempt to show all requirements. The regulatory text of Subpart Ec

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

B. Significant Issues and Changes

The most significant changes to the

standards made following the June 20,

1996 Federal Register document are

discussed below. Further discussion of

these changes as well as other

comments and responses regarding the

NSPS are provided in ‘‘Hospital/

Medical/ Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b).

1. Combined Dry/Wet Scrubbers

As discussed in the 1996 re-proposal,

the MACT floor for medium and large

HMIWI was based on emission limits

achievable with good combustion and a

dry injection/fabric filter (DI/FF)

combined with a high efficiency wet

scrubber (combined dry/wet system).

During the public comment period

following the 1996 re-proposal, several

commenters questioned the basis for the

MACT floors for new medium and large

HMIWI. The commenters contended

that the revised MACT floor emission

levels were based on invalid test data

and invalid assumptions as to the

applicability and technical feasibility of

combination dry/wet scrubbing systems.

The commenters stated that the

combined dry/wet system is not proven

technology. Some commenters stated

that the pollutant-by-pollutant approach

used to determine the MACT floor for

new medium and large units resulted in

a MACT floor that can not be

accomplished with any type of

economic feasibility. Other commenters

stated that the costs of requiring a wet

scrubber in addition to a dry scrubber

far outweigh the air pollution control

benefits.

The EPA recognizes that the

pollutant-by-pollutant approach for

determining the MACT floor can, as it

does in this case, cause the overall cost

of the regulation to increase. For

example, the pollutant-by-pollutant

approach for the HMIWI regulation

results in a MACT floor for HCl based

on a high efficiency wet scrubber, while

the MACT floor for other pollutants

reflects the performance of a dry

scrubber. Compared to the dry scrubber

alone, the addition of the wet scrubber

adds considerable cost to the regulation

while achieving a relatively small

additional reduction in HCl. However,

as mentioned later in this notice, a spray

dryer/fabric filter system with carbon

injection could be used instead of a

combined dry/wet scrubber to achieve

all of the emission limits at a lower cost

than the combined system. On the other

hand, EPA interprets section 129 of the

CAA to require that the MACT floor be

determined in this manner, and EPA

believes that Congress did in fact intend

that sources subject to regulations

developed under section 129 meet

emission limits that are achieved by the
48364 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

best controlled unit for each pollutant as

long as the control systems are

compatible with each other. To EPA’s

knowledge, there is no technical reason

why these two air pollution control

systems cannot be combined (discussed

later).

Section 129(a)(2) of the CAA specifies

that ‘‘the degree of reduction in

emissions that is deemed achievable for

new units in a category shall not be less

stringent than the emissions control

achieved in practice by the best

controlled similar unit, as determined

by the Administrator.’’ This requirement

identifies the least stringent emissions

standards that the EPA may adopt for

new HMIWI (i.e., the MACT floor).

At least one existing HMIWI in the

medium subcategory is controlled with

a high efficiency wet scrubber and

another is equipped with a DI/FF

system without carbon. The MACT floor

for new medium HMIWI was based on

both of these technologies (i.e., a

combined dry/wet scrubber system)

because the wet scrubber achieves the

lowest dioxin, HCl, and Hg emissions,

but the DI/FF without carbon injection

achieves the lowest Pb and Cd

emissions (note: as discussed elsewhere,

the DI/FF system with carbon injection

achieves the same or lower dioxin and

Hg emissions as a wet scrubber). While

no combined dry/wet scrubber systems

were identified on medium HMIWI,

these systems are currently in operation

on large HMIWI. As discussed later, test

data appear to indicate that combining

the two systems is technically feasible.

Similarly, the MACT floor for new large

HMIWI was based on the emission

levels that are achievable with good

combustion and a combined dry/wet

system with activated carbon.

The EPA does not agree that the

MACT floors are to be based upon one

overall unit. Rather, the EPA believes

that section 129 supports its

interpretation that it is legally

permissible to set the MACT floor

pollutant-by-pollutant, as long as the

various MACT floors do not result in

standards that are not achievable.

Section 129(a)(2) requires the EPA to

establish technology based emission

standards that ‘‘reflect the maximum

degree of reduction in emission of air

pollutants listed under section (a)(4)

that the Administrator, taking into

consideration the cost of achieving such

emission reduction and any nonair

quality health and environmental

impacts and energy requirements,

determines is achievable . . .’’ Congress

further specified in section 129(a)(2) the

minimum reduction that could satisfy

this requirement (i.e., the MACT floor)

for new sources as ‘‘the emission control

that is achieved in practice by the best

controlled similar unit, as determined

by the Administrator.’’ This language

does not expressly address whether the

floor may be established pollutant-bypollutant. The ‘‘emission control

achieved by the best controlled similar

unit’’ can be read either to mean

emission control as to a particular

pollutant, or emission control that is

achieved by the unit as a whole.

Nevertheless, the MACT floor reflects

the least stringent emission standards

that EPA may adopt in accordance with

section 129(a)(2) regardless of costs.

Other statutory provisions are

relevant, although they also do not

decisively address this issue. Section

129(a)(4) requires MACT standards for,

at a minimum, PM, opacity, SO2, HCl,

NOX, CO, Pb, Cd, Hg, and dioxin/furan

emitted by HMIWI. This provision

certainly appears to direct maximum

reduction of each specified pollutant.

Moreover, although the provisions do

not state whether there is to be a

separate floor for each pollutant, the fact

that Congress singled out these

pollutants suggests that the floor level of

control need not be limited by the

performance of devices that only control

some of these pollutants well.

A more detailed discussion of the

legal basis for this pollutant-bypollutant approach is contained in

section 3.4.2 of ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). Quantitative information

about the costs and air pollution control

performance of both wet scrubbers and

dry scrubbers is summarized in the 1996

re-proposal (61 FR 31743). As discussed

in the 1996 re-proposal, detailed

descriptions of costs and air pollution

control performance of these systems

are available in Docket A–91–61, items

IV–B–30, IV–B–32, IV–B–48, and IV–B–

49. See the ADDRESSES section of this

preamble for the location and telephone

number for the docket.

The EPA also notes that it followed

this approach of setting the MACT

floors and MACT standards pollutantby-pollutant in the proposed MWC rules

that were published on September 20,

1994 pursuant to section 129 and

codified in 40 CFR part 60, Subparts Eb

and Cb. Commenters on that rule also

expressed concerns about the

achievability of the resulting standards.

The EPA notes that large MWC units

(more than 250 tons/day capacity) are

achieving the promulgated standards (in

fact, several combined systems were in

operation at the time of promulgation);

thus, the approach of proposing MACT

standards pollutant-by-pollutant did not

lead to unachievable or economically

infeasible standards in this case.

In response to commenters’ concerns

regarding the technical feasibility of

combined dry/wet systems, a review of

the available data documenting the

performance of combined dry/wet

scrubber systems was conducted.

Although limited emissions data are

available for HMIWI with combined

dry/wet control systems, the available

data indicate that the MACT floor

emission levels for new HMIWI are

achievable and technically feasible. The

performance of dry scrubbers with

activated carbon injection and the

performance of wet scrubbers is well

documented. The available data for

combination dry/wet systems provide

no indication of operational or

emissions problems that occur as a

result of combining dry and wet control

systems. Finally, as mentioned in the

1996 re-proposal, one existing HMIWI

equipped with a spray dryer/fabric filter

system with carbon injection was tested

during the EPA testing program, and

this test demonstrated that this

scrubbing technology could be used

instead of a combined dry/wet scrubber

to achieve all of the emission limits.

2. Siting Analysis

Section 129 of the CAA states that

performance standards for new HMIWI

must incorporate siting requirements

that minimize, on a site-specific basis

and to the maximum extent practicable,

potential risks to public health or the

environment. The Agency is directed by

the CAA to promulgate siting

requirements that meet the minimum

criteria outlined in the CAA. In the 1995

proposal, the siting requirements were

patterned after the Prevention of

Significant Deterioration (PSD)

requirements within the New Source

Review (NSR) program. Additionally,

the originally proposed siting

requirements included provisions for a

public meeting and the preparation of a

comment/response document that

would be made available to the public.

Following the 1996 re-proposal,

commenters requested that EPA do

away with the siting requirements

because they will be costly and will

impede the permitting process. Other

commenters requested that EPA adopt

siting requirements that are consistent

with those that have been developed

and enacted by most of the State

environmental agencies. The

commenters noted that States are

equally concerned with minimizing

potential risks to the environment, and

that most have taken appropriate steps
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48365

in the development of their own siting

criteria. The commenters indicated that

requiring siting analyses in addition to

those required by States and under the

National Environmental Policy Act

would be duplicative and would not

enhance environmental protection.

Other commenters supported the EPA’s

1995 proposal to require an opportunity

for public comments and a hearing on

siting decisions.

In reviewing the 1995 proposed siting

requirements and the comments

received, the Agency is promulgating

siting requirements as outlined in the

CAA. The siting requirements

promulgated today require the potential

owner of an affected facility to prepare

an analysis of the impacts of the affected

facility. The analysis must consider air

pollution control alternatives that

minimize, on a site-specific basis, to the

maximum extent practicable, potential

risks to public health or the

environment. In considering such

alternatives, the analysis may consider

costs, energy impacts, non-air

environmental impacts, or any other

factors related to the practicability of the

alternatives. Analyses of facility impacts

prepared to comply with State, local, or

other Federal regulatory requirements

may be used to satisfy the requirements

of this section, as long as they include

the consideration of air pollution

control alternatives specified above. The

owner or operator of the affected facility

must complete and submit the siting

requirements to EPA.

C. Selection of MACT

The EPA considered three regulatory

options for adoption as the final

standard for new HMIWI. These

regulatory options are discussed in

Appendix A of ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). As required by section

129(a)(2) of the CAA, the Administrator

reviewed the emissions reductions

achievable with each regulatory option

and the cost, nonair quality

environmental, and energy impacts of

the regulatory options. Based on this

review, the Administrator determined

that the most cost-effective and

achievable emission standards for

promulgation are based on emission

limits achievable with good combustion

and a moderate efficiency wet scrubber

for new small HMIWI, and good

combustion and a combined dry/wet

control system with carbon for new

medium and large HMIWI. These final

emissions standards reflect the MACT

floor emission levels for new small and

large HMIWI, but are more stringent

than the MACT floor for new medium

HMIWI.

The MACT floor for new small

HMIWI was based on emission limits

achievable through use of good

combustion and a moderate efficiency

wet scrubber. Consideration of the

impact of this MACT floor indicates that

few new small HMIWI are likely to be

constructed due to the substantial

increase in the cost of a new small

HMIWI as a result of the moderate

efficiency wet scrubber and the

availability of alternative means of

medical waste disposal.

One regulatory option more stringent

than this MACT floor would reflect the

use of good combustion and a high

efficiency wet scrubber. Consideration

of this option indicates that the

nationwide impacts would be

negligible, primarily because few new

small HMIWI would be constructed (i.e.,

because of switching to alternative

means of medical waste disposal).

Where a typical new small HMIWI was

constructed, however, the high

efficiency wet scrubber would only

reduce PM emissions by a small amount

and would increase air pollution control

costs by about 15 percent. As a result,

the EPA established the MACT emission

limitations for small new HMIWI based

on the use of good combustion and a

moderate efficiency wet scrubber (i.e.,

the MACT floor).

The MACT floor for new medium

HMIWI was based on emission limits

achievable through the use of good

combustion and a combined dry/wet

control system without activated

carbon. On a national basis, because of

switching to the use of alternative

means of medical waste disposal, the

addition of activated carbon to the

combined dry/wet system results in

negligible cost increase. For a typical

new medium HMIWI, the addition of

carbon would reduce emissions of

dioxin significantly and would increase

air pollution control costs by less than

4 percent. As a result, the EPA

established the MACT emission

limitations for new medium HMIWI

based on good combustion and a

combined dry/wet scrubber system with

activated carbon.

The MACT floor for new large HMIWI

was based on emission limits achievable

through use of good combustion and a

combined dry/wet scrubber with

activated carbon. There is no air

pollution control technology which

could achieve lower emissions than this

system. Consequently, EPA established

the MACT emission limitations for new

large HMIWI based on good combustion

and a combined dry/wet scrubber

system with activated carbon (i.e., the

MACT floor).

D. Impacts of the Standards

There are a number of alternatives to

onsite incineration of hospital waste

and medical/infectious waste, including

recycling or direct landfilling of noninfectious waste, and off-site

commercial waste disposal or any of

several waste disinfection technologies

(e.g., steam autoclaving, microwave

irradiation, macrowave irradiation,

chemical treatment, thermal treatment,

and biological treatment) for infectious

waste. Many facilities that may have

purchased an HMIWI in the absence of

the HMIWI standards may find it more

cost effective to dispose of their waste

using one of these alternatives. As

discussed in the June 1996 re-proposal,

while further study is warranted, there

appears to be no significant or

substantial adverse economic,

environmental, or health and safety

issues associated with the increased use

of the alternative waste treatment

technologies.

In some cases, facilities that ‘‘switch’’

to alternative methods of waste disposal

may further decrease their waste

disposal costs by segregating their waste

into infectious and noninfectious

portions, and recycling or landfilling

(rather than treating) their noninfectious

waste. To account for facilities

switching to alternative methods of

waste disposal, the impacts of the

standards were developed based on

three compliance scenarios: no

switching (scenario A), switching with

waste segregation (scenario B), and

switching without waste segregation

(scenario C).

In the absence of the new standards,

EPA projects that 85 new small HMIWI,

90 new medium HMIWI, 60 new large

HMIWI, and 10 new commercial HMIWI

would have been installed over the next

five years. Scenario A preserves this

assumption and estimates the costs of

the additional control measures that

would be required for these 245 new

facilities to meet the standards at $36.2

million annually. The EPA believes that

Scenario A is unrealistic and grossly

overstates the national costs associated

with the standards. Under Scenarios B

and C, no new small or medium HMIWI

are projected to be installed. Facilities

that would have installed these units are

assumed to find alternate methods of

waste disposal. Under Scenario B, no

new large HMIWI (other than

commercial units) are projected to be

installed either. The EPA believes that

the total costs of the final standards for

new sources in the fifth year after
48366 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

implementation will fall somewhere

between the $12.1 million/yr estimate

for Scenario B and the $26.2 million/yr

estimate for Scenario C.

Table 6 presents baseline emissions

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

MACT emission standards) and the

emissions that are expected to occur

under the final MACT standard. A range

of emissions is presented in Table 6 to

account for the emissions that could

occur under switching scenarios B and

C as a result of the NSPS. Table 6 also

presents the percent reduction in

emissions achieved under the final

MACT standard for new HMIWI.

TABLE 6.—BASELINE EMISSIONS, EMISSIONS IN THE FIFTH YEAR AFTER IMPLEMENTATION OF THE FINAL NSPS, AND

EMISSIONS REDUCTION

[Metric Units]

Pollutant, units Baseline Emissions under the final NSPS

Emissions

reduction,

percent

PM, Mg/yr ....................................................................... 28 2.1 to 4.1 ........................................................................ 85 to 92.

CO, Mg/yr ....................................................................... 14 6.5 to 14 ......................................................................... 0 to 52.

CDD/CDF, g/yr ................................................................ 47 5.9 to 12 ......................................................................... 74 to 87.

TEQ CDD/CDF, g/yr ....................................................... 1.1 0.14 to 0.28 .................................................................... 74 to 87.

HCl, Mg/yr ....................................................................... 64 1.5 to 3.1 ........................................................................ 95 to 98.

SO2, Mg/yr ...................................................................... 28 14 to 28 .......................................................................... 0 to 52.

NOX, Mg/yr ..................................................................... 130 65 to 130 ........................................................................ 0 to 52.

Pb, Mg/yr ........................................................................ 0.39 0.031 to 0.06 .................................................................. 85 to 92.

Cd, Mg/yr ........................................................................ 0.051 4.6×10¥3 to 8.9×10¥3 .................................................... 83 to 91.

Hg, Mg/yr ........................................................................ 0.21 0.056 to 0.12 .................................................................. 45 to 74.

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

As discussed further in Appendix A

of ‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b), the EPA is not able to

calculate a monetized value for most of

these emission reductions. However,

using ‘‘Benefit-Cost Analysis of Selected

NSPS for Particulate Matter’’ as a basis,

EPA has calculated a monetized value

for reductions in PM emissions using an

estimate of $6,075 (1993 dollars) per ton

of PM. This yields annualized benefits

of PM reductions for the standards

ranging from $157,300 to $170,000

(1993 dollars).

As a result of the MACT standards for

new HMIWI, industries that generate

hospital waste and/or medical/

infectious waste (i.e., hospitals, nursing

homes, etc.) are expected to experience

average price increases in the range of

0.00 to 0.16 percent, depending on the

industry. These industries are expected

to experience output and employment

impacts in the range of 0.00 to 0.21

percent. In addition, the revenue

impacts for these industries are

expected to range from an increase of

0.05 percent to a decrease of 0.05

percent as a result of the standards. For

hospitals, 0.03 percent is estimated as

the price increase necessary to recover

annual control costs. The expected

average price increase for each hospital

patient-day is expected to be less than

35 cents. The average price impact for

the commercial medical waste

incinerator industry is approximately a

4.1 percent increase in price.

Facilities with onsite HMIWI that are

currently uncontrolled may experience

impacts ranging from 0.03 to 1.70

percent, depending on the industry. For

many of these facilities, the economic

impacts of switching to an alternative

method of waste disposal are much

lower than the economic impacts of

choosing to install emission control

equipment. The decision to switch to an

alternative method of waste disposal

should preclude facilities from

experiencing a significant economic

impact. The impacts that would be

incurred by medical/infectious waste

generators that currently use an offsite

waste incineration service range from

0.00 to 0.02 percent and are considered

negligible impacts.

The option of switching to an

alternative method of waste disposal

will be an attractive option for many

facilities that are considering the

purchase of a new HMIWI and should

preclude facilities from experiencing a

significant economic impact. However,

two types of HMIWI operators may not

be able to switch to an alternative:

commercial HMIWI operators, because

their line of business is commercial

incineration; and onsite HMIWI that

burn a small amount of waste and are

located far away from an urban area,

because they may not have access to

other methods of waste disposal.

However only a few, if any, of the

projected 10 new commercial HMIWI

over the next 5 years, and at the most,

only a few of the projected 85 new small

onsite HMIWI over the next 5 years are

likely to be significantly impacted by

the regulation (under all three

regulatory options). A ‘‘significant

impact’’ does not necessarily imply a

facility closure or the need to cancel

plans to open up or expand a facility.

For example, operators of small, remote

onsite HMIWI may still have switching

opportunities. As the commercial

incineration industry continues to grow

(with additional impetus being provided

by the EG and NSPS), it is possible that

services will be extended to remote,

isolated areas that are currently not

served. Onsite autoclaving is another

possible treatment alternative. If a

facility had planned to invest in a new

HMIWI, it stands to reason that an

onsite alternative technology of

comparable cost would be affordable.

The economic impact analysis

examines possible economic impacts

that may occur in industries that will be

directly affected by this regulation.

Therefore, the analysis includes an

examination of industries that generate

hospital waste or medical/infectious

waste or dispose of such waste.

Secondary impacts such as subsequent

impacts on APCD vendors and HMIWI

vendors are not estimated due to data

limitations. Air pollution control device

vendors are expected to experience an

increase in demand for their products

due to the regulation. This regulation is

also expected to increase demand for

commercial HMIWI services. However,

due to economies of scale, this

regulation is expected to shift demand

from smaller incinerators to larger

incinerators. Therefore, small HMIWI

vendors potentially may be adversely

affected by the regulation. Lack of data

on the above effects prevent
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48367

quantification of the economic impacts

on these secondary sectors.

No increase in the total national usage

of natural gas for combustion controls is

expected to result from the final HMIWI

standards. The total national usage of

electrical energy for the operation of

add-on control devices as a result of the

final MACT standards is expected to

increase by less than 9,800 megawatt

hours per year (MW-hr/yr) (33.4 billion

British thermal units per year [109 Btu/

yr]). As discussed in the 1996 reproposal, compared to the amount of

energy used by health care facilities

such as hospitals (approximately 2,460

MMm 3/yr of natural gas and 23.2

million MW-hr/yr of electricity), the

increase in energy usage that results

from implementation of the HMIWI

emission standards is insignificant.

Less than 43,600 Mg/yr (48,000 tons/

yr) of additional solid waste is expected

to result from the adoption of the final

MACT standards. As discussed in the

1996 re-proposal, compared to

municipal waste, which is disposed in

landfills at an annual rate of over 91

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

increase in solid waste from the

implementation of the final HMIWI

standards is insignificant.

Less than 3.3 million gallons of

additional wastewater would be

generated in the fifth year by HMIWI as

a result of the final NSPS. This amount

is the equivalent of wastewater

produced annually by one small

hospital. Therefore, when considering

the wastewater produced annually at

health care facilities nationwide, the

increase in wastewater resulting from

the implementation of the MACT

emission standards for new HMIWI is

insignificant.

V. Emission Guidelines for Existing

Sources

This section presents a summary of

the final emission guidelines, including

identification of the source category and

pollutants being regulated, and

presentation of the final emission limits

and their associated performance

testing, monitoring, recordkeeping and

reporting requirements. This section

discusses the most significant changes

to the guidelines presented in the June

20, 1996 Federal Register document.

Also discussed in this section is the

rationale for the selection of MACT and

a summary of the impacts of the final

guidelines.

A. Summary of the Guidelines

The final guidelines (subpart Ce)

apply to each existing HMIWI for which

construction commenced on or before

June 20, 1996. Hospital/medical/

infectious waste incinerators for which

construction commenced after June 20,

1996 or modification commenced after

March 16, 1998 are not subject to the

final subpart Ce guidelines; they are

considered new sources and are subject

to the standards under subpart Ec (see

section IV of this document).

A HMIWI is defined as any device

that combusts any amount of medical/

infectious waste or hospital waste. The

terms ‘‘medical/ infectious waste’’ and

‘‘hospital waste’’ are discussed in

section III.A and defined in § 60.51c. An

incinerator is not subject to subpart Ce

during periods when only pathological,

low-level radioactive, or

chemotherapeutic waste (all defined in

§ 60.51c) is burned provided that the

owner or operator keeps records of the

periods of time when only pathological,

low-level radioactive, or

chemotherapeutic waste is burned. Any

unit required to have a permit under

section 3005 of the Solid Waste Disposal

Act is exempt from subpart Ce as are

incinerators subject to subpart Cb, Ea, or

Eb. Existing incinerators, processing

operations, or boilers that co-fire

hospital waste and/or medical/

infectious waste with other fuels or

wastes and combust 10 percent or less

medical/infectious waste and hospital

waste by weight (on a calendar quarter

basis) are not subject to the emission

limitations but must keep records of the

amounts of each fuel and waste burned.

The HMIWI source category is

divided into three subcategories based

on waste burning capacity: small (≤200

lb/hr), medium (>200 to 500 lb/hr), and

large (>500 lb/hr). Waste burning

capacity is determined either by the

maximum design capacity or by the

‘‘maximum charge rate’’ established

during the most recent performance test.

In other words, a source may change its

size designation by establishing a

‘‘maximum charge rate’’ lower than its

design capacity. For example, a

‘‘medium’’ unit with a design capacity

of 250 lb/hr may establish a maximum

charge rate of 200 lb/hr and be

considered a ‘‘small’’ unit for purposes

of the emission guidelines. Separate

emission guidelines apply to each

subcategory of existing HMIWI. A

summary of the final emission limits for

existing HMIWI is presented in Table 7.

In addition to the emission limits

presented in Table 7, all HMIWI are

subject to a 10 percent stack opacity

limitation. Stack opacity will be

determined using EPA Reference

Method 9.

TABLE 7.—SUMMARY OF PROMULGATED EMISSION LIMITS FOR EXISTING HMIWI

Pollutant (test method)

Emission limits

Small HMIWI Medium HMIWI Large HMIWI

Particulate matter (EPA Method 5

or Method 29).

115 mg/dscm (0.05 gr/dscf) .......... 69 mg/dscm (0.03 gr/dscf) ............ 34 mg/dscm (0.015 gr/dscf).

Carbon monoxide (EPA Method

10 or Method 10B).

40 ppmv ........................................ 40 ppmv ........................................ 40 ppmv.

Dioxins/furans (EPA Method 23) .. 125 ng/dscm total CDD/CDF (55

gr/109 dscf) or 2.3 ng/dscm

TEQ (1.0 gr/109 dscf).

125 ng/dscm total CDD/CDF (55

gr/109 dscf) or 2.3 ng/dscm

TEQ (1.0 gr/109 dscf).

125 ng/dscm total CDD/CDF (55

gr/109 dscf). or 2.3 ng/dscm

TEQ (1.0 gr/109 dscf).

Hydrogen chloride (EPA Method

26).

100 ppmv or 93% reduction ......... 100 ppmv or 93% reduction ......... 100 ppmv or 93% reduction

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

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

Lead (EPA Method 29) ................. 1.2 mg/dscm (0.52 gr/103 dscf) or

70% reduction.

1.2 mg/dscm (0.52 gr/103 dscf) or

70% reduction.

1.2 mg/dscm (0.52 gr/103 dscf) or

70% reduction.

Cadmium (EPA Method 29) .......... 0.16 mg/dscm (0.07 gr/103 dscf)

or 65% reduction.

0.16 mg/dscm (0.07 gr/103 dscf)

or 65% reduction.

0.16 mg/dscm (0.07 gr/103 dscf)

or 65% reduction.
48368 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

TABLE 7.—SUMMARY OF PROMULGATED EMISSION LIMITS FOR EXISTING HMIWI—Continued

Pollutant (test method)

Emission limits

Small HMIWI Medium HMIWI Large HMIWI

Mercury (EPA Method 29) ............ 0.55 mg/dscm (0.24 gr/103 dscf)

or 85% reduction.

0.55 mg/dscm (0.24 gr/103 dscf)

or 85% reduction.

0.55 mg/dscm (0.24 gr/103 dscf)

or 85% reduction.

The emission limits for small existing

HMIWI presented in Table 7 are more

stringent than the MACT floor emission

limits for small existing HMIWI.

However, the final HMIWI guidelines

contain alternative emission limits

which are based on the MACT floor for

small existing HMIWI that meet certain

‘‘rural criteria.’’ The ‘‘rural criteria’’

stipulates that an HMIWI is allowed to

meet alternative emission limits if it is

located at least 50 miles from the

nearest Standard Metropolitan

Statistical Area (SMSA) boundary and

burns no more than 2,000 pounds of

hospital waste and medical/infectious

waste per week. The SMSA is defined

by the Office of Management and

Budget (OMB). For purposes of these

emission guidelines, the list of areas

comprising each SMSA as of June 30,

1993 will be used to determine whether

a small HMIWI meets the ‘‘rural

criteria.’’ The list of areas comprising

each SMSA is presented in OMB

Bulletin No. 93–17 entitled ‘‘Revised

Statistical Definitions for Metropolitan

Areas.’’ This document may be obtained

by contacting the National Technical

Information Services, 5285 Port Royal

Road, Springfield, Virginia 22161, or by

calling (703) 487–4650 and requesting

document No. PB 93–192–664. This

document is available for public

inspection and copying at EPA’s Air and

Radiation Docket and Information

Center (Docket A–91–61, item IV–J–

125). See the ADDRESSES section at the

beginning of this preamble for the

telephone number and location of the

Docket. This document has been

approved for incorporation by reference

by the Director of the Federal Register

in accordance with 5 U.S.C. 552(a) and

1 CFR part 51. The emission limits that

correspond with these alternative

guidelines for rural HMIWI are

presented in Table 8. For further

discussion of the ‘‘rural criteria’’ and

rationale for the alternative emission

limits for small existing HMIWI in rural

areas, see section V.B ‘‘Significant

Issues and Changes’’ (below).

TABLE 8.—SUMMARY OF ALTERNATIVE EMISSION LIMITS FOR SMALL EXISTING HMIWI THAT MEET THE RURAL CRITERIA

Pollutant (Performance test method) Emission limits

Particulate matter (EPA Method 5) .......................................................... 197 mg/dscm (0.086 gr/dscf).

Carbon monoxide (EPA Method 10 of 10B) ............................................ 40 ppmv.

Dioxins/furans (EPA Method 23) .............................................................. 800 ng/dscm total CDD/CDF (350 gr/10 9 dscf) or 15 ng/dscm TEQ

(6.6 gr/10 9 dscf).

Hydrogen chloride (testing not required) .................................................. 3,100 ppmv.

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

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

Lead (testing not required) ....................................................................... 10 mg/dscm (4.4 gr/10 3 dscf).

Cadmium (testing not required) ................................................................ 4 mg/dscm (1.7 gr/10 3 dscf).

Mercury (EPA Method 29) ........................................................................ 7.5 mg/dscm (3.3 gr/10 3 dscf).

Table 9 summarizes the additional

requirements for existing HMIWI under

the emission guidelines, including the

operator training and qualification

requirements, inspection requirements,

compliance and performance testing

requirements, monitoring requirements,

and reporting and recordkeeping

requirements. Table 10 summarizes the

additional requirements under the

emission guidelines for small existing

HMIWI that meet the rural criteria. With

the exception of the compliance and

performance testing requirements and

the inspection requirements, existing

HMIWI that meet the small rural criteria

are to comply with the same additional

requirements as all other existing

HMIWI. A summary of dates for

compliance with the promulgated

guidelines for existing HMIWI is

presented in Table 11. These dates

apply to all existing HMIWI.

TABLE 9.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE EMISSION GUIDELINES FOR EXISTING HMIWI

Additional requirements

Operator Training and Qualification Requirements:

• Complete HMIWI operator training course.

• Qualify operators.

• Maintain information regarding HMIWI operating procedures and review annually.

Waste Management Plan:

• Prepare a waste management plan that identifies the feasibility and approach to separate certain components of a health care waste

stream.

Compliance and Performance Testing Requirements:

• Conduct an initial performance test to determine compliance with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and opacity limit, and establish operating parameters.

• Conduct annual performance tests to determine compliance with the PM, CO, and HCl emission limits and opacity limit.

• Facilities may conduct performance tests for PM, CO, and HCl every third year if the previous three performance tests demonstrate that

the facility is in compliance with the emission limits for PM, CO, and HCl.
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48369

TABLE 9.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE EMISSION GUIDELINES FOR EXISTING HMIWI—

Continued

Additional requirements

Monitoring Requirements:

• Install and maintain equipment to continuously monitor operating parameters including secondary chamber temperature, waste feed rate,

bypass stack, and APCD operating parameters as appropriate.

• Obtain monitoring data at all times during HMIWI operation.

Reporting and Recordkeeping Requirements:

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

operator training and qualification.

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

• Submit reports on emission rates or operating parameters that have not been recorded or which exceeded applicable limits.

NOTE: This table depicts the major provisions of the emission guidelines and does not attempt to show all requirements. The regulatory text of

Subpart Ce should be relied upon for a full and comprehensive statement of the requirements of the final guidelines.

TABLE 10.—SUMMARY OF ADDITIONAL REQUIREMENTS UNDER THE EMISSION GUIDELINES FOR EXISTING HMIWI THAT

MEET THE RURAL CRITERIA

Additional requirements

Operator Training and Qualification Requirements:

• Complete HMIWI operator training course.

• Qualify operators.

• Maintain information regarding HMIWI operating procedures and review annually.

Inspection Requirements:

• Provide for an annual equipment inspection of the designated facility.

Waste Management Plan:

• Prepare a waste management plan that identifies the feasibility and approach to separate certain components of a health care waste

stream.

Compliance and Performance Testing Requirements:

• Conduct an initial performance test to determine compliance with the PM, CO, CDD/CDF, and Hg emission limits and opacity limit, and

establish operating parameters.

• Conduct annual tests to determine compliance with the opacity limit.

Monitoring Requirements:

• Install and maintain equipment to continuously monitor operating parameters including secondary chamber temperature, waste feed rate,

bypass stack, and APCD operating parameters as appropriate.

• Obtain monitoring data at all times during HMIWI operation.

Reporting and Recordkeeping Requirements:

• Maintain for 5 years records of results from the initial performance test and all subsequent performance tests, operating parameters, inspections, any maintenance, and operator training and qualification.

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

• Submit reports on emission rates or operating parameters that have not been recorded or which exceeded applicable limits.

NOTE: This table depicts the major provisions of the emission guidelines and does not attempt to show all requirements. The regulatory text of

Subpart Ce should be relied upon for a full and comprehensive statement of the requirements of the final guidelines.

TABLE 11.—COMPLIANCE TIMES UNDER THE EMISSION GUIDELINES FOR EXISTING HMIWI

Requirement Compliance time

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

Operator training and qualification

requirements.

Within 1 year after EPA approval of State Plan.

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

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

source is granted an extension.

Repeat performance test ................. Within 12 months following initial compliance test and annually thereafter.

Parameter monitoring ....................... Continuously, upon completion of initial compliance test.

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

Reporting .......................................... Annually, upon completion of initial compliance test; semiannually, if noncompliance.

B. Significant Issues and Changes

This section discusses the most

significant changes to the guidelines

made following the June 20, 1996

Federal Register document. Further

discussion of these changes as well as

other comments and responses

regarding the emission guidelines are

provided in ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b).

As discussed in the 1996 re-proposal,

the MACT floor for small existing

HMIWI was based on emission limits

achievable through use of good

combustion alone (i.e., without add-on

control). The EPA presented regulatory

options more stringent than the MACT

floor for small existing HMIWI in the

1996 re-proposal and stated that it had

no inclination as to which regulatory
48370 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

option might be selected for the final

emission guidelines for small HMIWI.

The EPA solicited public comment on

the available regulatory options for the

guidelines for small existing HMIWI.

During the public comment period,

the EPA received several comments

containing suggestions for the final

emission guidelines for small existing

HMIWI. A number of commenters

requested that the emission guidelines

for small existing HMIWI be based on

the MACT floor. Other commenters

requested that the guidelines for small

HMIWI require small HMIWI in urban

locations to meet emission guidelines

more stringent than the MACT floor and

allow small HMIWI in rural locations to

meet the MACT floor emission limits.

These commenters noted that costeffective alternatives to onsite

incineration may not be available to

facilities operating small HMIWI in

rural locations and that emission limits

based on wet scrubbers would cause

these facilities financial hardship. Other

commenters contended that emission

limits for small incinerators consistent

with no more than good combustion

would result in largely uncontrolled

emissions, and would encourage

medium-sized units to change their size

designation to small by burning less

waste per hour while operating more

hours per day. These commenters stated

that there are cost-effective alternatives

to incineration and requested that small

existing HMIWI be subject to emission

limits consistent with wet scrubbers.

Guidelines for small existing HMIWI

based on the use of good combustion

and low efficiency wet scrubbing could

cause the cost of waste disposal to more

than double for facilities that install the

equipment necessary to meet the

emission guidelines. Even guidelines

based on the MACT floor (good

combustion alone) would cause a

significant increase in costs for such

facilities. The EPA’s cost projections

show that the costs of retrofitting small

existing HMIWI to meet the MACT floor

would be about $18 million annually,

while the cost of going beyond the floor

(guidelines based on low efficiency wet

scrubbers) for the estimated 1,025 small

HMIWI that do not meet the ‘‘remote’’

criteria (discussed later) would be an

additional $47 million. However, as

noted by commenters and observed by

States that have implemented stringent

HMIWI regulations, there are a number

of cost-effective alternatives to onsite

incineration for most facilities that

operate small HMIWI. Therefore, many

health care facilities operating small

HMIWI could switch to alternative

means of waste disposal if the emission

guidelines are based on the use of good

combustion and low efficiency wet

scrubbing. In fact, EPA’s modeling

projects that most existing facilities,

except those meeting the ‘‘remote’’

criteria, would find it more economical

to switch to alternative means of waste

disposal than to retrofit their small

incinerators even to meet the MACT

floor, and virtually all such facilities

would switch rather than retrofit small

incinerators with low efficiency wet

scrubbers. Under the switching

scenario, the costs for non-‘‘remote’’

small facilities range from $6 to $13

million for guidelines based on the

MACT floor, and from $6 to $20 million

for guidelines based on low efficiency

wet scrubbers. In addition, by making

the guidelines for small existing HMIWI

only slightly less stringent than those

for medium existing HMIWI (the

guidelines for small existing HMIWI are

based on good combustion and low

efficiency wet scrubbers, while those for

medium existing HMIWI are based on

good combustion and moderate

efficiency wet scrubbers), the selected

option removes any strong incentive for

medium existing facilities to reclassify

themselves as small in order to escape

more stringent guidelines. The result is

that, under the selected option, most

medium existing facilities will also

switch to alternative means of waste

disposal. Unlike the small facilities,

most of these medium HMIWI would

have found it economical to continue

operating if they could have reclassified

themselves as small and been required

to meet emission limits based on good

combustion alone. Thus, most of the

emission reduction benefits from going

beyond the MACT floor for small

existing HMIWI actually come from

these medium HMIWI that switch to

alternative waste disposal rather than

operating as small units subject to

emission limits based on good

combustion alone (the MACT floor). The

additional costs to this group under the

switching scenario of going beyond the

floor range from $4 to $30 million

annually.

While EPA’s objective is to adopt

MACT emission guidelines that fulfill

the requirements of section 129 of the

CAA, and not to cause the shutdown of

most existing small and medium

HMIWI, the EPA believes that the

replacement of poorly controlled

incinerators with cost effective

alternatives that significantly reduce

toxic emissions is an appropriate

outcome. From a national perspective,

guidelines for small existing HMIWI

based on good combustion and low

efficiency wet scrubbing (and the

switching to alternative waste disposal

options that EPA believes will result)

will minimize emissions of PM, dioxin,

acid gases, and metals from small and

medium existing HMIWI at a relatively

low cost due to the availability of

alternative means of waste treatment. As

a result, the final emission guidelines

for small HMIWI are based on emission

limits achievable through the use of

good combustion and low efficiency wet

scrubbers. These emission limits are

more stringent than the MACT floor for

small HMIWI.

As some commenters have pointed

out, alternative means of medical waste

treatment may not be available at a

reasonable cost to some facilities that

operate small HMIWI in rural or remote

locations. Facilities that operate small

HMIWI in remote locations could be

faced with adverse impacts if required

to meet emission limits associated with

good combustion and low efficiency wet

scrubbing. Therefore, the final emission

guidelines subcategorize facilities for

purposes of establishing MACT

standards based on the location of the

facility and the amount of waste burned.

The EPA established MACT standards at

the respective MACT floors for facilities

that meet certain ‘‘rural criteria;’’ which

are achievable through the use of good

combustion alone. The EPA set MACT

standards for all other small HMIWI

more stringent than the MACT floors.

The basis for this subcategorization

approach is found in section 129(a)(2),

which states: ‘‘The Administrator may

distinguish among classes, types * * *

and sizes of units within a category in

establishing such standards.’’ This

language gives EPA broad discretion to

distinguish among units in a category in

establishing subcategories, including

establishing subcategories based on a

unit’s location. See Davis County Solid

Waste Management & Energy Recovery

Special Services District v. EPA, 101

F.3d 1395, 1405 n.11 (D.C. Cir. 1996),

amended 108 F.3d 1454 (D.C. Cir. 1997).

As discussed above, the EPA believed it

was appropriate to subcategorize for

purposes of establishing MACT

standards, where all MACT standards

were at least as stringent as the

respective MACT floors.

In the 1996 re-proposal, the EPA

discussed the option of adopting

emission guidelines with criteria for

small existing HMIWI located in rural

areas to meet requirements—on a case

by case basis—based on the use of good

combustion alone. The EPA solicited

public comment on this option and on

what criteria could be associated with

this option to determine if a facility may

be faced with cost impacts that warrant

special consideration with regard to the

emission guidelines.
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48371

Following the 1996 re-proposal, the

EPA received several comments

regarding possible ‘‘rural criteria’’ that

may be used if the final guidelines allow

rural HMIWI to meet less stringent

emission limits. Some commenters

suggested that rural criteria be based on

distance from a SMSA or population

density. Other commenters

recommended a weekly limit on amount

of waste burned in the small HMIWI

and a requirement that no more than 10

percent of the waste burned in the small

HMIWI is from an outside facility. Other

commenters suggested that facilities

operating small rural HMIWI should be

required to demonstrate that no

alternatives to onsite incineration are

available at a reasonable cost. Finally,

other commenters suggested considering

ambient air quality, good engineering

practice stack height, and risk analysis

as part of the rural criteria.

The purpose of the rural criteria is to

further define those facilities operating

small HMIWI in remote areas that may

have fewer cost-effective options for

waste disposal; in which case, emission

guidelines based on wet scrubbers could

cause financial hardship. It is difficult

to determine precisely which HMIWI

have limited waste disposal options,

and it is difficult to establish a universal

set of criteria that could quantify

‘‘hardship.’’ All of the suggestions

submitted by commenters with regard to

the rural criteria for small HMIWI were

considered. However, many of the

suggestions would be very difficult to

define or implement. Consequently, the

rural criteria examined focused on (1)

distance from a SMSA, and (2) amount

of waste burned per week. The

combination of small size, distance from

an SMSA, and small amount of waste

burned are the most likely indications

that commercial services are not

available for a reasonable cost.

Distance criteria ranging from 25 to

150 miles from an SMSA in conjunction

with weekly waste burning limits

ranging from 500 to 3,300 lb/wk were

examined to determine the appropriate

rural criteria. The final ‘‘rural criteria’’

selected for small existing HMIWI

stipulates that: (1) The facility must be

located at least 50 miles from the

nearest SMSA boundary and (2) the

HMIWI operated by the facility may not

be used to burn more than 2,000 lb/wk.

The 2,000 pound per week criterion was

suggested by commenters; focuses the

option for less stringent requirements on

the smallest HMIWI; and reflects a

sufficient quantity of waste to ensure

that commercial services are available.

The 50 mile criterion added to the 2,000

lb/wk criterion provides the less

stringent requirements for less than 10

percent of small HMIWI (over 90

percent of small HMIWI would remain

subject to guidelines based on wet

scrubbers). It is very likely that

commercial services are available

within 50 miles of an SMSA, regardless

of the amount of waste to be picked up.

Small units with good combustion

alone are not left ‘‘uncontrolled.’’ Good

combustion reduces emissions of PM,

CO, and dioxin/furan, and these units

remain subject to operator training

requirements. Small HMIWI operating

with good combustion alone are also

required to reduce Hg emissions

through pollution prevention. The

guidelines also include requirements for

routine inspection and maintenance to

ensure good combustion. Based on

EPA’s assessment of costs and other

impacts, these less stringent

requirements will, themselves, raise the

cost of incineration such that

alternatives, if available, are likely to be

less expensive. In other words, where

alternatives are available, guidelines

based on good combustion alone are

likely to result in switching. Under the

MACT guidelines, less than one percent

of the waste burned in existing HMIWI

will be burned in small rural HMIWI

with good combustion controls alone.

The final guidelines result in substantial

reductions in emissions from the

HMIWI source category as a whole. The

promulgated emission guidelines for

small HMIWI are consistent with

section 129 because they reflect the

maximum degree of reduction in

emissions that can be achieved by small

existing HMIWI while avoiding

detrimental cost impacts to facilities

operating small ‘‘remote’’ HMIWI.

C. Selection of MACT

The EPA considered six regulatory

options for adoption as the final

guidelines for existing HMIWI. These

regulatory options are discussed in

Appendix B of ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). As required by section

129(a)(2) of the CAA, the Administrator

reviewed the emissions reductions

achievable with each regulatory option

and the cost, nonair quality

environmental, and energy impacts of

the regulatory options. Based on this

review, the Administrator determined

that the most cost effective and

achievable emission guidelines for

promulgation are based on emission

levels achievable with good combustion

and a low efficiency wet scrubber for

most small existing HMIWI; good

combustion and a moderate efficiency

wet scrubber for medium existing

HMIWI; and good combustion and a

high efficiency wet scrubber for large

existing HMIWI. The promulgated

emission guidelines allow small HMIWI

that meet certain ‘‘rural criteria’’ to meet

emission limits achievable with good

combustion alone.

The EPA concluded that MACT for

most small units should reflect emission

limits achievable with good combustion

and a low efficiency wet scrubber

because the reductions in emissions are

substantial, while the cost and

economic impacts for most small

HMIWI appear minimal. Compared to

emission limits achievable with good

combustion and low efficiency wet

scrubbers, emission limits based on the

use of good combustion and moderate or

high efficiency wet scrubbers would

increase the capital control costs for

facilities operating small HMIWI by 15

to 42 percent and would only slightly

decrease the emissions of PM from

small HMIWI. As a result, good

combustion and moderate or high

efficiency wet scrubbers were not

further considered in the selection of

MACT for small HMIWI.

The MACT floor for medium existing

HMIWI appears to require the use of

good combustion and a moderate

efficiency wet scrubber. One regulatory

option more stringent than this MACT

floor would reflect the use of good

combustion and a high efficiency wet

scrubber. On a nationwide basis, while

this more stringent option would result

in a relatively small cost increase, it

would also result in only a small

decrease in PM emissions. For a typical

facility operating a medium HMIWI that

installed or upgraded an existing wet

scrubber to a high efficiency wet

scrubber, air pollution control costs

would increase by about 15 to 25

percent. As a result, EPA concluded that

the MACT emission limitations for

medium existing HMIWI based on the

use of good combustion and a moderate

efficiency wet scrubber (i.e., the MACT

floor) are the most cost effective and

achievable. These emission limitations

could also be achieved using a dry

scrubber with activated carbon.

The MACT floor for large existing

HMIWI appears to require the use of

good combustion and a high efficiency

wet scrubber. Regulatory options more

stringent than this MACT floor were not

considered for large HMIWI for the

reasons discussed below. As a result,

EPA concluded that MACT emission

limitations for large existing HMIWI

based on the use of good combustion

and a high efficiency wet scrubber (i.e.,

the MACT floor) are the most cost
48372 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

effective and achievable. These

emission limitations could also be

achieved using a dry scrubber with

activated carbon.

The MACT emission limitations for

medium and large existing HMIWI were

structured so that either a dry scrubber

or a wet scrubber could be used to

achieve the emission limits. The

emission limitations were not based on

the use of dry scrubbers exclusively or

wet scrubbers exclusively because a dry

scrubber typically costs much more than

a wet scrubber, and a dry scrubber with

activated carbon would result in only a

very small additional reduction in

dioxin, Pb, and Cd emissions.

Furthermore, for existing HMIWI

already equipped with wet scrubbers,

replacing a wet scrubber with a dry

scrubber would be extremely expensive.

Similarly, for existing HMIWI already

equipped with dry scrubbers, replacing

the dry scrubber with a wet scrubber

would be extremely expensive.

Guidelines based on the use of

combined dry/wet scrubbing systems

were not considered for medium and

large existing HMIWI because such

control systems are very expensive and

result in only small additional

reductions in emissions.

D. Impacts of the Guidelines

There are a number of alternatives to

onsite incineration of hospital waste

and medical/infectious waste, including

recycling or direct landfilling of noninfectious waste, and off-site

commercial waste disposal or any of

several waste disinfection technologies

(e.g., steam autoclaving, microwave

irradiation, macrowave irradiation,

chemical treatment, thermal treatment,

and biological treatment) for infectious

waste. Many facilities that currently

operate onsite HMIWI may find it more

cost effective to dispose of their waste

using one of these alternatives. As

discussed in the June 1996 re-proposal,

while further study is warranted, there

appears to be no significant or

substantial adverse economic,

environmental, or health and safety

issues associated with the increased use

of the alternative waste treatment

technologies.

In some cases, facilities that ‘‘switch’’

to alternative methods of waste disposal

may further decrease their waste

disposal costs by segregating their waste

into infectious and noninfectious

portions, and recycling or landfilling

(rather than treating) their noninfectious

waste. To account for facilities

switching to alternative methods of

waste disposal, the impacts of the

guidelines were developed based on

three compliance scenarios: no

switching (scenario A), switching with

waste segregation (scenario B), and

switching without waste segregation

(scenario C).

The EPA estimates that there are

approximately 1,139 existing small

HMIWI, 692 existing medium HMIWI,

463 existing large HMIWI, and 79

existing commercial HMIWI in

operation today. Scenario A preserves

this assumption and estimates the costs

of the additional control measures that

would be required for these 2,373

existing facilities to meet the guidelines

at $172 million annually. The EPA

believes that Scenario A is unrealistic

and grossly overstates the national costs

associated with the guidelines. Under

Scenarios B and C, 93 to 100 percent of

existing small ‘‘non-remote’’ HMIWI, 60

to 95 percent of existing medium

HMIWI, and as many as 35 percent of

existing large HMIWI are expected to

cease operation. All 79 commercial

units and 114 small units meeting the

‘‘remote’’ criteria are assumed to remain

in operation. Facilities that cease

operation are assumed to find alternate

methods of waste disposal. The EPA

believes that the total costs of the final

guidelines for existing sources will fall

somewhere between the $59 million/yr

estimate for Scenario B and the $120

million/yr estimate for Scenario C.

Table 12 presents baseline emissions

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

MACT emission guidelines) and the

range of emissions that are expected to

occur under the final MACT guidelines.

A range of emissions is presented in

Table 12 to account for the emissions

that could occur under switching

scenarios B and C as a result of the

guidelines. Table 12 also presents the

percent reduction in emissions achieved

under the final MACT guidelines for

existing HMIWI.

TABLE 12.—BASELINE EMISSIONS, EMISSIONS AFTER IMPLEMENTATION OF THE FINAL EMISSION GUIDELINES, AND

EMISSIONS REDUCTION

[Metric Units]

Pollutant, units Baseline Emissions under the final emission guidelines

Emissions

reduction,

percent

PM, Mg/yr ....................................................................... 940 72 to 120 ........................................................................ 88 to 92.

CO, Mg/yr ....................................................................... 460 82 to 120 ........................................................................ 75 to 82.

CDD/CDF, g/yr ................................................................ 7,200 210 to 310 ...................................................................... 96 to 97.

TEQ CDD/CDF, g/yr ....................................................... 150 5 to 7 .............................................................................. 95 to 97.

HCl, Mg/yr ....................................................................... 5,700 130 to 140 ...................................................................... 98.

SO2, Mg/yr ...................................................................... 250 170 to 250 ...................................................................... 0 to 30.

NOX, Mg/yr ..................................................................... 1,200 810 to 1,200 ................................................................... 0 to 30.

Pb, Mg/yr ........................................................................ 11 1.4 to 2.2 ........................................................................ 80 to 87.

Cd, Mg/yr ........................................................................ 1.2 0.19 to 0.30 .................................................................... 75 to 84.

Hg, Mg/yr ........................................................................ 15 0.8 to 1.1 ........................................................................ 93 to 95.

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

As discussed further in Appendix B of

‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b), the EPA is not able to

calculate a monetized value for most of

these emission reductions. However,

using ‘‘Benefit-Cost Analysis of Selected

NSPS for Particulate Matter’’ as a basis,

EPA has calculated a monetized value

for reductions in PM emissions using an

estimate of $6,075 (1993 dollars) per ton

of PM. This yields annualized benefits

of PM reductions for the guidelines

ranging from $5.5 million to $5.8

million (1993 dollars).

As a result of the MACT guidelines

for existing HMIWI, industries that

generate hospital waste and/or medical/

infectious waste (i.e., hospitals, nursing

homes, etc.) are expected to experience

average price increases in the range of

0.00 to 0.14 percent, depending on the
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48373

industry. These industries are expected

to experience output and employment

impacts in the range of 0.00 to 0.18

percent. In addition, the revenue

impacts for these industries are

expected to range from an increase of

0.05 percent to a decrease of 0.04

percent as a result of the guidelines. For

hospitals, 0.03 percent is the estimated

price increase necessary to recover

annual control costs. The expected

average price increase for each hospital

patient-day is expected to be less than

30 cents. The average price impact for

the commercial HMIWI industry is

approximately a 2.6 percent increase in

price.

Facilities with onsite HMIWI that are

currently uncontrolled may experience

impacts ranging from 0.03 to 1.83

percent, depending on the industry. For

many of these facilities, the economic

impacts of switching to an alternative

method of waste disposal are much

lower than the economic impacts of

choosing to install emission control

equipment. The decision to switch to an

alternative method of waste disposal

should preclude any facilities from

experiencing a significant economic

impact. The impacts that would be

incurred by medical/infectious waste

generators that currently use an offsite

waste incineration service range from

0.00 to 0.02 percent and are considered

negligible impacts.

The option of switching to an

alternative method of waste disposal

will be an attractive option for many

facilities that currently operate onsite

HMIWI and should preclude most

facilities from experiencing a significant

economic impact. However, two types

of HMIWI operators may not be able to

switch to an alternative: commercial

HMIWI operators, because their line of

business is commercial incineration;

and small, rural, remote HMIWI, which

may not have access to alternative waste

disposal methods. For commercial

HMIWI operators, only three of the 59

facilities operating the 79 commercial

HMIWI in the HMIWI inventory were

found to be significantly impacted by

the regulation. As discussed in

‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Analysis of Economic

Impacts for Existing Sources’’ (EPA–

453/R–97–007b), commercial HMIWI

are considered to be significantly

impacted if the price impact (i.e., the

price increase that would be necessary

to recover compliance costs) on an

individual facility exceeds the market

price increase (2.62 percent) by more

than 2 percentage points (i.e., above 4.6

percent). Price increases at these three

facilities are calculated as 9.58 percent,

11.13 percent, and 18.36 percent. These

facilities may not have to raise their

prices this much to remain profitable,

since they are completely uncontrolled

in the baseline and therefore may

currently enjoy a cost advantage over

their competitors (most of which are at

least partially controlled in the

baseline). Also, demand may increase as

a result of switching away from onsite

incineration. In this latter case,

increased revenues (which could offset

control costs) may result in one of two

ways: either by allowing a larger

increase in price, or by providing an

increase in the amount of waste coming

to the facility (i.e., increased capacity

utilization). Impacts are not significant

for small, rural, remote HMIWI

operators because the final guidelines

allow good combustion alone where

alternatives to onsite incineration might

be unavailable.

The economic impact analysis

examines possible economic impacts

that may occur in industries that will be

directly affected by this regulation.

Therefore, the analysis includes an

examination of industries that generate

hospital waste or medical/infectious

waste or dispose of such waste.

Secondary impacts such as subsequent

impacts on air pollution device vendors

and HMIWI vendors are not estimated

due to data limitations. Air pollution

control device vendors are expected to

experience an increase in demand for

their products due to the regulation.

This regulation is also expected to

increase demand for commercial HMIWI

services. However, due to economies of

scale, this regulation is expected to shift

demand from smaller incinerators to

larger incinerators. Therefore, small

HMIWI vendors potentially may be

adversely affected by the regulation.

Lack of data on the above effects prevent

quantification of the economic impacts

on these secondary sectors.

The total national usage of natural gas

for HMIWI combustion controls is

expected to increase by less than 16.6

million cubic meters per year (MMm3/

yr) (586 million cubic feet per year [106

ft3/yr]). The total national usage of

electrical energy for the operation of

add-on control devices as a result of the

final MACT guidelines is expected to

increase by less than 259,000 megawatt

hours per year (MW-hr/yr) (883 billion

British thermal units per year [109 Btu/

yr]). As discussed in the 1996 reproposal, compared to the amount of

energy used by health care facilities

such as hospitals (approximately 2,460

MMm3/yr of natural gas and 23.2

million MW-hr/yr of electricity) the

increase in energy usage that results

from implementation of the HMIWI

emission guidelines is insignificant.

Less than 211,000 Mg/yr (233,000

tons/yr) of additional solid waste is

expected to result from the adoption of

the final MACT guidelines. As

discussed in the 1996 re-proposal,

compared to municipal waste, which is

disposed in landfills at an annual rate of

over 91 million Mg/yr (100 million tons/

yr), the increase in solid waste from the

implementation of the final HMIWI

guidelines is insignificant.

Less than 198 million gallons of

additional wastewater would be

generated by HMIWI as a result of the

final emission guidelines. This amount

is the equivalent of wastewater

produced annually by four large

hospitals. Therefore, when considering

the wastewater produced annually at

health care facilities nationwide, the

increase in wastewater resulting from

the implementation of the MACT

emission guidelines for existing HMIWI

is insignificant.

VI. Administrative Requirements

This section addresses the following

administrative requirements: Docket,

Paperwork Reduction Act, Executive

Orders 12866 and 12875, Unfunded

Mandates Reform Act, Regulatory

Flexibility Act, Small Business

Regulatory Enforcement Fairness Act,

and Clean Air Act Procedural

Requirements.

A. Docket

The docket is an organized and

complete file of all the information

considered in the development of this

rulemaking. 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. The docket number for this

rulemaking is A–91–61. Information on

how to obtain documents from the

docket was provided in the ADDRESSES

section at the beginning of this

preamble.

B. Paperwork Reduction Act

The information collection

requirements in this rule have been

submitted for approval to OMB under

the Paperwork Reduction Act. An

Information Collection Request (ICR)

document has been prepared by EPA

(ICR No. 1730.02) and a copy may be

obtained from Sandy Farmer, OPPE

Regulatory Information Division; U. S.

Environmental Protection Agency

(2136); 401 M St., S.W.; Washington, DC

20460 or by calling (202) 260–2740.
48374 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

This ICR document is also available

electronically via the Internet. See the

SUPPLEMENTARY INFORMATION section of

this preamble for information on

accessing this document via the

Internet.

The information required to be

collected by this rule is necessary to

identify the regulated entities who are

subject to the rule and to ensure their

compliance with the rule. The

recordkeeping and reporting

requirements are mandatory and are

being established under authority of

sections 114 and 129(c) of the CAA. All

information submitted as part of a report

to the Agency for which a claim of

confidentiality is made will be

safeguarded according to the Agency

policies set forth in Title 40, Chapter 1,

part 2, subpart B—Confidentiality of

Business Information (see 40 CFR Part 2;

41 FR 36902, September 1, 1976,

amended by 43 FR 39999, September

28, 1978; 43 FR 42251, September 28,

1978; 44 FR 17674, March 23, 1979).

The Agency predicts that somewhere

between 2 and 14 new HMIWI will be

constructed each year after

implementation of the NSPS. The total

annual reporting and recordkeeping

burden summarized in the ICR

document for this collection averaged

over the first 3 years of the NSPS

application to new HMIWI is estimated

to be about 14,106 person hours per year

if 14 new HMIWI are constructed each

year. This burden estimate includes the

time needed to review instructions,

search existing data sources, gather and

maintain the data needed, and complete

and review the collection of

information. Efforts were made to

reduce the burden on facilities installing

new HMIWI by allowing them to: (1)

Monitor operating parameters rather

than continuously monitor emissions

using CEMS; (2) test emissions once

every 3 years instead of annually if they

demonstrate that they consistently meet

the emissions requirements; (3) retest

emissions of PM, CO, and HCl rather

than emissions of all pollutants; and (4)

submit reports semiannually (or

annually if no exceedances occur) rather

than quarterly as was originally

proposed.

Comments on the ICR document are

requested, including the Agency’s need

for the information presented in this ICR

document, the accuracy of the provided

burden estimates, and any suggested

methods for minimizing respondent

burden. Send comments on the ICR to

the Director, OPE Regulatory

Information Division; U. S.

Environmental Protection Agency

(2136); 401 M St. S.W.; Washington, DC

20460; and to the Office of Information

and Regulatory Affairs, Office of

Management and Budget, 725 17th St.

N.W.; Washington, DC 20503; marked

‘‘Attention: Desk Officer for EPA.’’

Include the ICR number in any

correspondence. Since the OMB is

required to make a decision concerning

the ICR between 30 and 60 days after

today’s request for comment, a comment

to OMB is best assured of having its full

effect if OMB receives it by October 15,

1997. The EPA will publish a response

to OMB and public comments on the

information collection requirements

contained in this document in a

subsequent Federal Register document.

C. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the EPA must

determine whether a regulatory action is

‘‘significant,’’ and therefore, subject to

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, or

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, the EPA considers these

promulgated standards and guidelines

to be ‘‘significant.’’ As such, this action

was submitted to OMB for review.

Changes made in response to OMB

suggestions or recommendations are

documented in the public docket for

this rulemaking.

Also, in accordance with the

provisions of the Executive Order

regarding ‘‘significant regulatory

actions,’’ EPA has prepared assessments

of the costs and benefits of the rule and

of ‘‘potentially effective and reasonably

feasible alternatives.’’ These

assessments are contained in four

documents: ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Analysis of Economic

Impacts for Existing Sources’’ (EPA–

453/R–97–007b), ‘‘Hospital/Medical/

Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Analysis of Economic

Impacts for New Sources’’ (EPA–453/R–

97–008b), ‘‘Hospital/Medical/Infectious

Waste Incinerators: Background

Information for Promulgated Standards

and Guidelines—Regulatory Impact

Analysis for New and Existing Sources’’

(EPA–453/R–07-009b), and Appendices

A and B of ‘‘Hospital/Medical/Infectious

Waste Incinerators: Background

Information for Promulgated Standards

and Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–970–006b). The selected options for

both the New Source Performance

Standards and the Emissions Guidelines

are identified as regulatory option 2 in

these documents. Several other options,

both more and less stringent than the

selections options, are also analyzed. A

summary of these analyses is included

below in Section VI.D.2 of this

preamble.

D. Unfunded Mandates Reform Act

Under section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, the EPA

must prepare a statement to accompany

any rule where the estimated costs to

State, local, or Tribal governments, or to

the private sector, will be $100 million

or more in any 1 year. Section 203

requires the EPA to establish a plan for

informing and advising any small

governments that may be significantly

impacted by the rule. Under section

205(a), the EPA must select the ‘‘least

costly, most cost-effective or least

burdensome alternative that achieves

the objectives of the rule’’ and is

consistent with statutory requirements.

The EPA has complied with section 205

of the Unfunded Mandates Act, by

promulgating a rule that is the most

cost-effective alternative for regulation

of these sources that meets the statutory

requirements under the Clean Air Act.

The unfunded mandates statement

under section 202 must include: (1) A

citation of the statutory authority under

which the rule is proposed, (2) an

assessment of the costs and benefits of

the rule including the effect of the

mandate on health, safety and the

environment, and the Federal resources

available to defray the costs, (3) where

feasible, estimates of future compliance

costs and disproportionate impacts

upon particular geographic or social

segments of the nation or industry, (4)

where relevant, an estimate of the effect

on the national economy, and (5) a

description of the EPA’s consultation

with State, local, and Tribal officials.
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48375

Since this rule is estimated to impose

costs to the private sector and

government entities in excess of $100

million per year, it is considered a

significant regulatory action. Therefore,

EPA has prepared the following

statement with respect to Sections 202

through 205 of the Unfunded Mandates

Act.

1. Statutory Authority

This rule establishes emission

guidelines for existing HMIWI and

standards of performance for new

HMIWI pursuant to sections 111 and

129 of the CAA. Section 129(a)(2)

requires the Administrator to

promulgate standards for new solid

waste incinerator units and emission

guidelines for existing units that ‘‘reflect

the maximum degree of reduction in

emissions of air pollutants listed under

section (a)(4) that the Administrator,

taking into consideration the cost of

achieving such emission reduction, and

any non-air quality health and

environmental impacts and energy

requirements, determines is achievable

for new or existing units in each

category. The Administrator may

distinguish among classes, types, and

sizes of units within a category in

establishing such standards . . .’’ This

is commonly referred to as maximum

achievable control technology, or

MACT. Section 129(a)(2) further defines

a minimum level of stringency that can

be considered for MACT standards—

commonly referred to as the MACT

floor—which for new units, is the level

of control achieved by the best

controlled similar unit, and for existing

units, is the level of control achieved by

the average of the best performing 12

percent of units in the category.

Control technologies and their

performance are discussed in the June

1996 re-proposal (61 FR 31736, June 20,

1996). For the promulgated standards

and guidelines, EPA divided the HMIWI

population into three size categories

which reflect technical differences in

HMIWI design: small (≤200 lb/hr),

medium (>200 to ≤500 lb/hr), and large

(>500 lb/hr). The EPA considered

emission reduction, costs, and energy

impacts, as required by the statutory

language of section 111 of the CAA, in

selecting the promulgated MACT

standards and guidelines. The

promulgated standards and guidelines

achieve a significant reduction in

HMIWI emissions as outlined in

sections IV.D and V.D and in section 2

‘‘Social Costs and Benefits’’ (below).

The cost impacts of the standards and

guidelines are presented in section 2

‘‘Social Costs and Benefits’’ (below).

Consultations with the public entities

and affected industries as required by

the Unfunded Mandates Act are

described in section 4, ‘‘Consultation

with Government Officials’’ (below).

The energy impacts are discussed in

sections IV.D and V.D of this notice.

Regarding EPA’s compliance with

section 205(a), the EPA considered a

reasonable number of alternatives which

are discussed in section 2.b, ‘‘Regulatory

Alternatives Considered’’ (below).

2. Social Costs and Benefits

This assessment of the costs and

benefits to State, local, and Tribal

governments of the NSPS and

guidelines is based on the regulatory

impact analysis (EPA–453/R–97–009b).

Measuring the social costs of the rule

requires identification of the affected

entities by ownership (public or

private), consideration of regulatory

alternatives, calculation of the

regulatory compliance costs for each

affected entity, and assessment of the

market implications of the additional

pollution control costs. Calculating the

social benefits of the NSPS and

guidelines requires estimating the

anticipated reductions in emissions at

HMIWI due to regulation, identification

of the harmful effects of exposure to

HMIWI emissions, and valuing the

expected reductions in these damages to

society.

a. Affected Entities. Approximately

2,400 HMIWI are estimated to be in

operation in this country, and this

inventory estimate was used to estimate

the cost of the EG to affected entities.

While the inventory distinguishes the

size of HMIWI and indicates whether

the HMIWI are located at commercial

waste disposal facilities, other

information is not precisely known such

as the types of entities (hospitals,

laboratories, nursing homes, and other)

and ownership characteristics (public

versus private) of entities operating

onsite HMIWI. However, the majority of

directly affected entities are not likely to

be owned or operated by State, local, or

Tribal governments. This statement is

based upon the ownership

characteristics of these industries rather

than the ownership characteristics of

the portion of these industries operating

HMIWI. Approximately 26.5 percent of

the 6,500 hospitals operating in this

country are designated to have

affiliations with State and local

governments. The remaining 73.5

percent have private ownership; are

designated nongovernment, not-forprofit; or have Federal government

affiliations. Nearly 20,900 nursing

homes and 4,200 commercial research

labs operate in the United States. Of

these nursing homes and research labs,

approximately 28.4 and 8.2 percent,

respectively are tax exempt and may

have government affiliations or be

nonprofit organizations. Finally, 59

commercial HMIWI operate in this

country, and these facilities are

predominately privately owned. Since

the number of HMIWI operating is only

a fraction of the total number of

hospitals, laboratories, nursing homes,

and other entities in existence in this

country, only a fraction of these entities

will be directly impacted by the HMIWI

regulations. Other firms generating

hospital, medical, and infectious waste

and sending the waste offsite for

disposal will be indirectly affected by

the regulation to the extent waste

disposal fees increase. The above

affected entity information is equally

relevant to the NSPS since no additional

information is known about the types of

entities or ownership characteristics

expected for new HMIWI.

b. Regulatory Alternatives Considered.

Under section 205 of the Unfunded

Mandates Act, the EPA must identify

and consider a reasonable number of

regulatory options before promulgating

a rule for which a budgetary impact

statement must be prepared. The

Agency must select from those

alternatives the least costly, most costeffective, or least burdensome

alternative that achieves the objectives

of the rule, unless the EPA explains why

this alternative is not selected or the

selection of this alternative is

inconsistent with the law.

The two broad categories of regulatory

standards available include design

standards and emission standards.

Design standards specify the type of

control equipment polluters must

install, whereas emission standards

specify the maximum quantity of a

given pollutant that any one polluter

may release.

Design standards offer the least

flexible approach considered in this

analysis. Owners of HMIWI would have

to install the specified control

equipment regardless of the additional

emission reductions achieved or the

relative cost of alternative means of

emission reductions.

Emission standards allow greater

flexibility in the methods used to reduce

emissions. Owners of HMIWI are free to

meet the emission limit in the manner

that is least costly to them.

Consequently, for a given level of

emission reductions, emission standards

are generally less costly than design

standards. Furthermore, emission

standards give owners of HMIWI an

incentive to develop more effective

means of controlling emissions. In

addition, the CAA requires the
48376 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

Administrator to promulgate emission

standards unless such standards are not

feasible. Since emission standards for

HMIWI are feasible, the EPA is barred

from promulgating design standards for

HMIWI.

Even though emission standards

generally result in a more efficient

allocation of costs than design

standards, uniform emission standards

can be more costly than necessary.

Uniform emission standards require the

same level of emission control of every

discharger. Because marginal control

costs differ for plants of different sizes,

different technologies, different levels of

product recovery (i.e., in the chemical

industry), and different levels of

baseline control, an effective solution

can be reached if standards are carefully

tailored to the special characteristics of

each discharger. This type of standard is

referred to as a differentiated standard.

In formulating the regulatory options

for HMIWI, EPA divided the HMIWI

population into three size categories:

small (≤200 lb/hr), medium (>200 to

≤500 lb/hr), and large (>500 lb/hr). A

number of regulatory options were

considered for each size classification.

The regulatory options for the three

selected size classifications did not

specify a particular control technology;

rather, they specified emission limits

that facilities would be required to meet.

A detailed discussion of the

regulatory options considered for the

final standards and guidelines is

presented in Appendices A and B of

‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). For the most part, the final

standards and guidelines reflect the

MACT floor, the least stringent

regulatory option EPA may adopt for the

final rule. In two cases (medium new

units and small existing units), MACT

was selected at a level more stringent

than the MACT floor. A description of

EPA’s decision regarding medium new

units is presented in section IV.C of this

notice, and a description of EPA’s

decision regarding small existing units

is presented in sections V.B and V.C of

this notice. The EPA believes that the

final standards and guidelines reflect

the least costly, most cost-effective, and

least burdensome regulatory option that

achieves the objectives of the rule.

c. Social Cost and Benefits. The

regulatory impact analysis, including

the Agency’s assessment of costs and

environmental benefits, is detailed in

the ‘‘Medical Waste Incinerators—

Background Information for Proposed

Standards and Guidelines: Regulatory

Impact Analysis for New and Existing

Facilities,’’ (EPA 453/R–94–063a). The

regulatory impact assessment document

has been updated for the final rule and

is entitled ‘‘Hospital/Medical/Infectious

Waste Incinerators: Background

Information for Promulgated Standards

and Guidelines—Regulatory Impact

Analysis for New and Existing

Facilities’’ (EPA–453/R–97–009b).

Estimates of the costs and benefits of the

various regulatory options considered

are discussed in the revised regulatory

impact analysis document and in

Appendices A and B of ‘‘Hospital/

Medical/Infectious Waste Incinerators:

Background Information for

Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). Quantitative estimates of

the costs, impacts, and benefits

associated with the final NSPS and EG

are presented in sections IV.D and V.D

of this notice. These estimates are

summarized below.

Total costs for the selected options are

estimated to range from $71 million per

year under Scenario B, which assumes

switching and substantial additional

waste segregations, to $146 million per

year under Scenario C, which assumes

switching but little opportunity for

additional waste segregations. As a

point of reference, EPA also calculated

the costs under Scenario A, in which all

existing HMIWI install retrofit

technology and all new HMIWI

projected to be built over the next 5

years install control technology to

comply with the guidelines and

standards. Under Scenario A, the total

costs are estimated to be $210 million

per year. The EPA does not believe

Scenario A represents a realistic

outcome, given the availability of

alternative waste disposal options that

would be cheaper than installing control

technology for many facilities. Thus,

EPA believes the actual costs will fall

within the range estimated for Scenarios

B and C.

Implementation of the NSPS and EG

for HMIWI is expected to reduce

emissions of HAP, dioxin/furan, and

criteria air pollutants. Reduction in a

variety of HAP including Cd, HCl, Pb,

and Hg is expected as a result of the

regulation. Dioxin/furan emissions are

also expected to be reduced. In addition,

decreases in the following criteria air

pollutants are anticipated: PM, SO2, CO,

and NOX. Table 6 in section IV.D gives

a quantitative estimate of the emissions

reductions expected from the NSPS, and

Table 12 in section V.D gives a

quantitative estimate of the emissions

reductions expected from the EG. Air

quality benefits resulting from the air

quality improvements resulting from

this regulation include a reduction in

adverse health effects associated with

inhalation of the above pollutants as

well as improved welfare effects such as

improved visibility and crop yields.

While the Agency believes that the

health and environmental benefits of

this rule are quite significant, the EPA

is not currently able to quantitatively

evaluate all human and environmental

benefits associated with the rule’s air

quality improvements, and is even more

limited in its ability to assign monetary

values to these benefit categories.

Categories that are not evaluated

include several health and welfare

endpoints (categories), as well as entire

pollutant categories. Consequently, the

discussion of benefits included in the

Regulatory Impact Analysis and

summarized here is primarily

qualitative.

However, monetized benefits were

calculated for PM emissions reductions.

These benefits were estimated using a

valuation of $6075/ton, based on

analyses of PM emissions reductions

benefits from other rules that are

discussed in the EPA document,

‘‘Benefit-Cost Analysis of Selected NSPS

for Particulate Matter.’’ Total PM

emissions reduction benefits from this

rule are estimated to range from $5.5

million under Scenario B to $5.8 million

under Scenario C. Thus net monetized

costs (after subtracting out monetized

benefits) are estimated to range from $65

million under Scenario B to $140

million under Scenario C. Although the

monetized benefits associated with PM

emission reductions are compared to the

estimated annualized emission control

costs of the regulation, EPA notes that,

because most categories of emissions

reductions cannot be monetized, the

monetized benefits and therefore the net

benefits are understated (in this case

annualized costs exceed the monetized

benefits so net costs are overstated) for

the regulation.

A qualitative discussion of the

pollutants that do not have a monetary

benefit value shows the significance of

other benefits achieved by the rule.

Emission reductions of Cd, Pb, HCl, and

Hg are expected to occur as a result of

the HMIWI rule. Health effects

associated with exposures to Cd and Pb

include probable carcinogenic effects.

Respiratory effects are associated with

exposure to Cd, HCl, and Hg. The HAP

emitted from HMIWI facilities have also

been associated with effects on the

central nervous system, neurological

system, gastrointestinal system, mucous

membranes, and kidneys.

Reduction in emission of dioxin/furan

are expected as a result of the HMIWI
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48377

rule. Exposure to dioxin/furan has been

linked to reproductive and

developmental effects, changes in

hormone levels, and chloracne. Toxic

Equivalent Quantity, or TEQ, has been

developed as a measure of the toxicity

of dioxin/furan. The TEQ measures the

more chlorinated compounds of dioxin/

furan and thus provides a better

indicator of the part of dioxin/furan that

has been linked to the toxic effects

associated with dioxin/furan.

Unfortunately, quantitative

relationships between the toxic effects

and exposure to dioxin/furan have not

been developed. Therefore, quantitative

estimates of the health effects of dioxin/

furan emission reductions are not

estimated.

Emission reductions are also

anticipated for criteria air pollutants.

The health effects associated with

exposure to PM include premature

mortality as well as morbidity. The

morbidity effects of PM exposure have

been measured in terms of increased

hospital and emergency room visits,

days of restricted activity or work loss,

increased respiratory symptoms, and

reductions in lung function. The welfare

effects of PM exposure include

increased soiling and visibility

degradation. Sulfur dioxide has been

associated with respiratory symptoms

and pulmonary function changes in

exercising asthmatics and may also be

associated with respiratory symptoms in

nonasthmatics. In addition to the effects

on human health, SO2 has also been

linked to adverse welfare effects, such

as materials damage, visibility

degradation, and crop and forestry

damage. Carbon monoxide affects the

oxygen-carrying capacity of hemoglobin

and, at current ambient concentrations,

has been related to adverse health

effects among persons with

cardiovascular and chronic respiratory

disease. Both congestive heart failure

and angina pectoris have been related to

CO exposure. Nitrogen oxides have also

been shown to have an adverse impact

on both human health and welfare. The

effects associated with NOX include

respiratory illness, damages to

materials, crops, and forests, and

visibility degradation.

3. Effects on the National Economy

The Unfunded Mandates Act requires

that the EPA estimate ‘‘the effect’’ of this

rule

On the national economy, such as the

effect on productivity, economic growth, full

employment, creation of productive jobs, and

international competitiveness of the U.S.

goods and services, if and to the extent that

the EPA in its sole discretion determines that

accurate estimates are reasonably feasible

and that such effect is relevant and material.

As stated in the Unfunded Mandates

Act, such macroeconomic effects tend to

be measurable, in nationwide

econometric models, only if the

economic impact of the regulation

reaches 0.25 to 0.5 percent of gross

domestic product (in the range of $15

billion to $30 billion). A regulation with

a smaller aggregate effect is highly

unlikely to have any measurable impact

in macroeconomic terms unless it is

highly focused on a particular

geographic region or economic sector.

Because the economic impact of the

HMIWI regulation is less than $1.5

billion, no estimate of this rule’s effect

on the national economy has been

conducted.

4. Consultation with Government

Officials

The Unfunded Mandates Act requires

that the EPA describe the extent of the

EPA’s consultation with affected State,

local, and Tribal officials, summarize

the officials’ comments or concerns, and

summarize the EPA’s response to those

comments or concerns. In addition,

section 203 of the Unfunded Mandates

Act requires that the EPA develop a

plan for informing and advising small

governments that may be significantly

or uniquely impacted by a proposal.

Throughout the development of these

rules (pre-proposal through prepromulgation phases), the EPA

consulted with representatives of

affected State and local governments,

including the U.S. Conference of

Mayors, the National Governors

Association, the National League of

Cities, and the National Association of

Counties, to inform them of the 1995

proposed rule and determine their

concerns. The EPA also consulted with

representatives from other entities

affected by the 1995 proposed rule, such

as the National Association of Public

Hospitals, the American Hospital

Association, the Sierra Club, and the

Natural Resources Defense Council.

As part of EPA’s consultation efforts

in this rulemaking, the EPA mailed a

copy of the draft regulatory package for

the February 1995 proposed HMIWI

standards and guidelines to each of the

associations mentioned above and to

several State and local governments.

The EPA also mailed a copy of the

February 1995 draft regulatory package

to many other associations and

stakeholders. At least 60 draft regulatory

packages were delivered to government

agencies, associations, and stakeholders.

Interested parties who were not sent a

draft regulatory package were mailed an

announcement of the 1995 proposed

HMIWI regulations, information on

where to obtain a copy of the proposal,

and notice of a public meeting held to

discuss the proposal and answer any

questions to allow stakeholders to better

formulate their written comments.

Following the 1995 proposal and

prior to the June 1996 re-proposal, the

EPA held several public meetings to

discuss changes in the HMIWI

regulations and to allow opportunity for

additional public input. Prior to each

meeting, a notice of the meeting and the

topics to be discussed was delivered to

over 300 stakeholders and government

officials. Additionally, many meetings

were held with smaller expert groups

(e.g., environmental groups, STAPPA/

ALAPCO, NAPH, etc.) to discuss

specific issues and allow for additional

comment. With these efforts, the EPA

believes that every affected State and

local government, association, and

stakeholder, was made aware of the

HMIWI rulemaking, provided with the

necessary information, and given ample

opportunity for input.

Following the 1995 proposal and the

1996 re-proposal, comment letters were

received from State, local, and Tribal

governments. Additional comments

were expressed by State, local, and

Tribal governments in meetings held

during the course of the rulemaking.

Many of the commenters suggested that

EPA consider ‘‘tiering’’ the standards

and guidelines using HMIWI size

categories most often used by State

environmental agencies. For the most

part, these commenters supported the

size categories presented in the 1996 reproposal. Other commenters expressed

concern about the lack of medical waste

disposal options for facilities in rural

locations and suggested that the Agency

consider location when developing the

standards and guidelines. Many of the

commenters requested that the

originally proposed broad definition of

medical waste be narrowed for the final

HMIWI regulations. Some commenters

requested that the EPA exclude

crematories and incinerators used solely

to burn pathological waste from the

HMIWI regulations. Also, several

commenters requested that the EPA

revise the 1995 proposed operator

training requirements to allow Stateapproved programs and onsite operator

training.

The EPA has incorporated the

suggestions of State, local, and Tribal

governments as well as suggestions from

other stakeholders into the standards

and guidelines being promulgated

today. As a result of consultations with

affected entities, the final HMIWI

standards and guidelines: (1)

Subcategorize HMIWI based on the size
48378 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

categories and technical distinctions

most often used by States; (2) allow

existing facilities that meet certain rural

criteria and operate small HMIWI (≤200

lb/hr) to meet less stringent emission

limits; (3) define HMIWI through use of

a narrow definition of medical waste

which recognizes that most hospital

waste is not infectious and can be

recycled or disposed of as municipaltype waste; (4) exclude crematories and

pathological incinerators; (5) allow for

HMIWI operator training and

qualification to be obtained through a

State-approved program, which may

allow facilities to provide training

onsite; and (6) focus the regulations on

incineration units whose primary

purpose is disposal of hospital waste

and/or medical/infectious waste by

providing an exemption for units

burning 10 percent or less hospital

waste and medical/infectious waste.

Documentation of the EPA’s

consideration of comments on the 1995

proposal is provided in the 1996 reproposal notice. Documentation of

EPA’s consideration of comments on the

1996 re-proposal is provided in

‘‘Hospital/Medical/Infectious Waste

Incinerators: Background Information

for Promulgated Standards and

Guidelines—Summary of Public

Comments and Responses’’ (EPA–453/

R–97–006b). Refer to the

SUPPLEMENTARY INFORMATION and

ADDRESSES sections of this preamble for

information on how to acquire copies of

these documents.

As discussed in section VI.F, the

number of small entities that are

significantly affected by the HMIWI

regulation is not expected to be

substantial. The full analysis of

potential regulatory impacts on small

organizations, small governments, and

small businesses is included in the

economic impact assessment in the

docket and is listed at the beginning of

today’s document under SUPPLEMENTARY

INFORMATION. Because the number of

small entities that are likely to

experience significant economic

impacts as a result of the HMIWI

regulation is not expected to be

substantial, no plan to inform and

advise small governments is required

under section 203 of the Unfunded

Mandates Act. However, as described

above, the EPA has communicated and

consulted with small governments and

businesses that will be affected by the

standards and guidelines, keeping them

informed about the content of this

promulgation.

E. Executive Order 12875

To reduce the burden of Federal

regulations on States and small

governments, the President issued

Executive Order 12875 on October 26,

1993, entitled ‘‘Enhancing the

Intergovernmental Partnership.’’ 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 promulgated standards and

emission guidelines. Section II.F of this

notice provides a brief account of the

actions that the EPA has taken to

communicate and consult with the

affected parties. Because this regulatory

action imposes costs to the private

sector and government entities in excess

of $100 million per year, the EPA

pursued consultations, the preparation

of an unfunded mandates statement,

and other requirements of the Unfunded

Mandates Reform Act. The requirements

of the Unfunded Mandates Reform Act

were met for this rulemaking as

presented under VI.D of this notice and

also fulfill the requirements of

Executive Order 12875.

F. Regulatory Flexibility Act (RFA) and

Small Business Regulatory Enforcement

Fairness Act of 1996 (SBREFA)

Section 605 of the Regulatory

Flexibility Act (RFA) requires Federal

agencies to give special consideration to

the impacts 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 CAA.

The President signed the Small

Business Regulatory Enforcement

Fairness Act (SBREFA) into law on

March 29, 1996. The SBREFA amended

the RFA to strengthen the RFA’s

analytical and procedural requirements.

The SBREFA also made other changes to

agency regulatory practices as they

affect small entities.

Finally, SBREFA established a new

mechanism for expedited Congressional

review of virtually all agency rules.

EPA has determined that it is not

necessary to prepare a regulatory

flexibility analysis in connection with

this final rule. The Administrator also

has determined that the EG and NSPS

for HMIWI will not have a significant

economic impact on a substantial

number of small entities.

The U.S. Small Business

Administration (SBA) definitions

pertaining to business size are either

specified by number of employees or

sales revenue. For analysis of the

regulations being promulgated today,

the EPA considers a small business or

small organization to be one with gross

annual revenue less than $5 million or

one with less than 500 employees. The

EPA considers a small government to be

one that serves a population less than

50,000. Three types of small ‘‘entities’’

are impacted by the regulation: small

businesses, small nonprofit

organizations, and small governmental

jurisdictions. Examples of impacted

businesses include for-profit hospitals

and tax-paying nursing homes.

Examples of impacted nonprofit

organizations include not-for-profit

hospitals and, in many cases, taxexempt nursing homes. Examples of

impacted governmental jurisdictions

include those (e.g., municipalities,

counties, States) that operate hospitals

and probably some tax-exempt nursing

homes. For a description of EPA’s

outreach efforts to these small entities

and the general public, see section II.F

of this preamble.

In accordance with the RFA as

amended by the SBREFA and current

EPA Guidance, an analysis of impacts of

the EG and NSPS on small ‘‘entities’’ ‘‘

including small businesses, small

nonprofit organizations, and small

governmental jurisdictions ‘‘ was

performed. The economic impact

analysis indicates that neither the EG

nor the NSPS will have a ‘‘significant

economic impact on a substantial

number of small entities’’ under any

regulatory option. Impacts are not

significant for the vast majority of

medical waste generators that send their

waste offsite to be treated and disposed.

Impacts are also not significant for the

great majority of HMIWI operators that

would have the opportunity to switch to

an alternative method of medical waste

treatment and disposal if control costs

are prohibitive. Some significant

impacts were found for commercial

HMIWI operators and for small onsite

HMIWI operators that are remote from

an urban area. These facilities might not

have the opportunity to switch to an

alternative medical waste treatment and

disposal method ‘‘ commercial HMIWI

operators because medical waste

incineration is their line of business,

and small, remote HMIWI because they

may not have access to commercial

incineration services. However, the

number of such facilities that are both

significantly impacted under the

regulatory option selected for

promulgation and ‘‘small’’ would be, at

the most, only a few, and would

therefore not be substantial.
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48379

G. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedures Act, as

added by the SBREFA of 1996, the EPA

submitted a report containing this rule

and other required information to the

U.S. Senate, the U.S. House of

Representatives, and the Comptroller

General of the General Accounting

Office prior to publication of the rule in

today’s Federal Register. This rule is a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

H. Clean Air Act Procedural

Requirements

The following procedural

requirements of the CAA are addressed:

Administrative listing, periodic review,

external participation, and economic

impact assessment.

1. Administrator Listing—Sections 111

and 129 of the Clean Air Act

Section 129 of the 1990 Amendments

to the CAA directs the Administrator to

promulgate standards for new HMIWI

and guidelines for existing HMIWI.

Section 129(a) states that the standards

and guidelines are promulgated under

both sections 129 and 111 of the Clean

Air Act.

2. Periodic Review—Sections 111 and

129 of the Clean Air Act

Sections 111 and 129 of the CAA

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 shall

review the standards and guidelines and

revise them 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

In accordance with section 117 of the

CAA, publication of this promulgation

was preceded by consultation with

appropriate advisory committees,

independent experts, and Federal

departments and agencies. See section

II.F of this preamble for a discussion of

EPA’s consultation efforts.

4. Economic Impact Assessment

Section 317A of the CAA requires the

EPA to prepare an economic impact

assessment for any standards or

guidelines promulgated under section

111(b) of the CAA. An economic impact

assessment was prepared for the

promulgated standards and guidelines.

In the manner described in the sections

of this preamble regarding the impacts

of and rationale for the promulgated

standards and guidelines, the EPA

considered all aspects of the economic

impact assessment in promulgating the

standards and guidelines. The economic

impact assessment is included in the list

of key technical documents at the

beginning of today’s notice under

SUPPLEMENTARY INFORMATION.

List of Subjects in 40 CFR Part 60

Environmental protection, Air

pollution control, Intergovernmental

relations, Incorporation by reference,

Reporting and recordkeeping

requirements.

Dated: August 15, 1997.

Carol M. Browner,

Administrator.

Part 60, chapter I, title 40 of the Code

of Federal Regulations is amended as

follows:

PART 60—STANDARDS OF

PERFORMANCE FOR NEW

STATIONARY SOURCES

1. The authority citation for part 60 is

revised to read as follows:

Authority: 42 U.S.C. 7401, 7411, 7413,

7414, 7416, 7429, 7601 and 7602.

Subpart A—[Amended]

2. Section 60.17. is amended by

removing from paragraph (b)(1) the

reference ‘‘60.244(f)(2)’’; and by adding

new paragraphs (k) and (l) to read as

follows:

§ 60.17 Incorporation by reference.

* * * * *

(k) This material is available for

purchase from the American Hospital

Association (AHA) Service, Inc., Post

Office Box 92683, Chicago, Illinois

60675–2683. You may inspect a copy at

EPA’s Air and Radiation Docket and

Information Center (Docket A–91–61,

Item IV–J–124), Room M–1500, 401 M

Street SW, Washington, DC.

(1) An Ounce of Prevention: Waste

Reduction Strategies for Health Care

Facilities. American Society for Health

Care Environmental Services of the

American Hospital Association.

Chicago, Illinois. 1993. AHA Catalog

No. 057007. ISBN 0–87258–673–5. IBR

approved for § 60.35e and § 60.55c.

(l) This material is available for

purchase from the National Technical

Information Services, 5285 Port Royal

Road, Springfield, Virginia 22161. You

may inspect a copy at EPA’s Air and

Radiation Docket and Information

Center (Docket A–91–61, Item IV–J–

125), Room M–1500, 401 M Street SW,

Washington, DC.

(1) OMB Bulletin No. 93–17: Revised

Statistical Definitions for Metropolitan

Areas. Office of Management and

Budget, June 30, 1993. NTIS No. PB 93–

192–664. IBR approved for § 60.31e.

3. Section 60.30 is revised to read as

follows:

§ 60.30 Scope.

The following subparts contain

emission guidelines and compliance

times for the control of certain

designated pollutants in accordance

with section 111(d) and section 129 of

the Clean Air Act and subpart B of this

part.

(a) Subpart Ca—[Reserved]

(b) Subpart Cb—Municipal Waste

Combustors.

(c) Subpart Cc—Municipal Solid

Waste Landfills.

(d) Subpart Cd—Sulfuric Acid

Production Plants.

(e) Subpart Ce—Hospital/Medical/

Infectious Waste Incinerators.

4. Part 60 is amended by adding a

new subpart Ce to read as follows:

Subpart Ce—Emission Guidelines and

Compliance Times for Hospital/Medical/

Infectious Waste Incinerators

Sec.

60.30e Scope.

60.31e Definitions.

60.32e Designated facilities.

60.33e Emission guidelines.

60.34e Operator training and qualification

guidelines.

60.35e Waste management guidelines.

60.36e Inspection guidelines.

60.37e Compliance, performance testing,

and monitoring guidelines.

60.38e Reporting and recordkeeping

guidelines.

60.39e Compliance times.

Table 1 to Subpart Ce—Emission Limits for

Small, Medium, and Large HMIWI

Table 2 to Subpart Ce—Emission Limits for

Small HMIWI which meet the criteria

under § 60.33e(b)

Subpart Ce—Emission Guidelines and

Compliance Times for Hospital/

Medical/Infectious Waste Incinerators

§ 60.30e Scope.

This subpart contains emission

guidelines and compliance times for the

control of certain designated pollutants

from hospital/medical/infectious waste

incinerator(s) (HMIWI) in accordance

with sections 111 and 129 of the Clean

Air Act and subpart B of this part. The

provisions in these emission guidelines

supersede the provisions of § 60.24(f) of

subpart B of this part.

§ 60.31e Definitions.

Terms used but not defined in this

subpart have the meaning given them in

the Clean Air Act and in subparts A, B,

and Ec of this part.
48380 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

Standard Metropolitan Statistical

Area or SMSA means any areas listed in

OMB Bulletin No. 93–17 entitled

‘‘Revised Statistical Definitions for

Metropolitan Areas’’ dated June 30,

1993 (incorporated by reference, see

§ 60.17).

§ 60.32e Designated facilities.

(a) Except as provided in paragraphs

(b) through (h) of this section, the

designated facility to which the

guidelines apply is each individual

HMIWI for which construction was

commenced on or before June 20, 1996.

(b) A combustor is not subject to this

subpart during periods when only

pathological waste, low-level

radioactive waste, and/or

chemotherapeutic waste (all defined in

§ 60.51c) is burned, provided the owner

or operator of the combustor:

(1) Notifies the Administrator of an

exemption claim; and

(2) Keeps records on a calendar

quarter basis of the periods of time

when only pathological waste, low-level

radioactive waste, and/or

chemotherapeutic waste is burned.

(c) Any co-fired combustor (defined in

§ 60.51c) is not subject to this subpart if

the owner or operator of the co-fired

combustor:

(1) Notifies the Administrator of an

exemption claim;

(2) Provides an estimate of the relative

weight of hospital waste, medical/

infectious waste, and other fuels and/or

wastes to be combusted; and

(3) Keeps records on a calendar

quarter basis of the weight of hospital

waste and medical/infectious waste

combusted, and the weight of all other

fuels and wastes combusted at the cofired combustor.

(d) Any combustor required to have a

permit under Section 3005 of the Solid

Waste Disposal Act is not subject to this

subpart.

(e) Any combustor which meets the

applicability requirements under

subpart Cb, Ea, or Eb of this part

(standards or guidelines for certain

municipal waste combustors) is not

subject to this subpart.

(f) Any pyrolysis unit (defined in

§ 60.51c) is not subject to this subpart.

(g) Cement kilns firing hospital waste

and/or medical/infectious waste are not

subject to this subpart.

(h) Physical or operational changes

made to an existing HMIWI unit solely

for the purpose of complying with

emission guidelines under this subpart

are not considered a modification and

do not result in an existing HMIWI unit

becoming subject to the provisions of

subpart Ec (see § 60.50c).

(i) Beginning September 15, 2000, or

on the effective date of an EPA

approved operating permit program

under Clean Air Act title V and the

implementing regulations under 40 CFR

part 70 in the State in which the unit

is located, whichever date is later,

designated facilities subject to this

subpart shall operate pursuant to a

permit issued under the EPA-approved

operating permit program.

§ 60.33e Emission guidelines.

(a) For approval, a State plan shall

include the requirements for emission

limits at least as protective as those

requirements listed in Table 1 of this

subpart, except as provided for in

paragraph (b) of this section.

(b) For approval, a State plan shall

include the requirements for emission

limits at least as protective as those

requirements listed in Table 2 of this

subpart for any small HMIWI which is

located more than 50 miles from the

boundary of the nearest Standard

Metropolitan Statistical Area (defined in

§ 60.31e) and which burns less than

2,000 pounds per week of hospital

waste and medical/infectious waste.

The 2,000 lb/week limitation does not

apply during performance tests.

(c) For approval, a State plan shall

include the requirements for stack

opacity at least as protective as

§ 60.52c(b) of subpart Ec of this part.

§ 60.34e Operator training and

qualification guidelines.

For approval, a State plan shall

include the requirements for operator

training and qualification at least as

protective as those requirements listed

in § 60.53c of subpart Ec of this part.

The State plan shall require compliance

with these requirements according to

the schedule specified in § 60.39e(e).

§ 60.35e Waste management guidelines.

For approval, a State plan shall

include the requirements for a waste

management plan at least as protective

as those requirements listed in § 60.55c

of subpart Ec of this part.

§ 60.36e Inspection guidelines.

(a) For approval, a State plan shall

require that each small HMIWI subject

to the emission limits under § 60.33e(b)

undergo an initial equipment inspection

that is at least as protective as the

following within 1 year following

approval of the State plan:

(1) At a minimum, an inspection shall

include the following:

(i) Inspect all burners, pilot

assemblies, and pilot sensing devices for

proper operation; clean pilot flame

sensor, as necessary;

(ii) Ensure proper adjustment of

primary and secondary chamber

combustion air, and adjust as necessary;

(iii) Inspect hinges and door latches,

and lubricate as necessary;

(iv) Inspect dampers, fans, and

blowers for proper operation;

(v) Inspect HMIWI door and door

gaskets for proper sealing;

(vi) Inspect motors for proper

operation;

(vii) Inspect primary chamber

refractory lining; clean and repair/

replace lining as necessary;

(viii) Inspect incinerator shell for

corrosion and/or hot spots;

(ix) Inspect secondary/tertiary

chamber and stack, clean as necessary;

(x) Inspect mechanical loader,

including limit switches, for proper

operation, if applicable;

(xi) Visually inspect waste bed

(grates), and repair/seal, as appropriate;

(xii) For the burn cycle that follows

the inspection, document that the

incinerator is operating properly and

make any necessary adjustments;

(xiii) Inspect air pollution control

device(s) for proper operation, if

applicable;

(xiv) Inspect waste heat boiler systems

to ensure proper operation, if

applicable;

(xv) Inspect bypass stack components;

(xvi) Ensure proper calibration of

thermocouples, sorbent feed systems

and any other monitoring equipment;

and

(xvii) Generally observe that the

equipment is maintained in good

operating condition.

(2) Within 10 operating days

following an equipment inspection all

necessary repairs shall be completed

unless the owner or operator obtains

written approval from the State agency

establishing a date whereby all

necessary repairs of the designated

facility shall be completed.

(b) For approval, a State plan shall

require that each small HMIWI subject

to the emission limits under § 60.33e(b)

undergo an equipment inspection

annually (no more than 12 months

following the previous annual

equipment inspection), as outlined in

paragraphs (a)(1) and (a)(2) of this

section.

§ 60.37e Compliance, performance testing,

and monitoring guidelines.

(a) Except as provided in paragraph

(b) of this section, for approval, a State

plan shall include the requirements for

compliance and performance testing

listed in § 60.56c of subpart Ec of this

part, excluding the fugitive emissions

testing requirements under

§ 60.56c(b)(12) and (c)(3).

(b) For approval, a State plan shall

require any small HMIWI subject to the

emission limits under § 60.33e(b) to
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48381

meet the following compliance and

performance testing requirements:

(1) Conduct the performance testing

requirements in § 60.56c(a), (b)(1)

through (b)(9), (b)(11) (Hg only), and

(c)(1) of subpart Ec of this part. The

2,000 lb/week limitation under

§ 60.33e(b) does not apply during

performance tests.

(2) Establish maximum charge rate

and minimum secondary chamber

temperature as site-specific operating

parameters during the initial

performance test to determine

compliance with applicable emission

limits.

(3) Following the date on which the

initial performance test is completed or

is required to be completed under

§ 60.8, whichever date comes first,

ensure that the designated facility does

not operate above the maximum charge

rate or below the minimum secondary

chamber temperature measured as 3-

hour rolling averages (calculated each

hour as the average of the previous 3

operating hours) at all times except

during periods of startup, shutdown and

malfunction. Operating parameter limits

do not apply during performance tests.

Operation above the maximum charge

rate or below the minimum secondary

chamber temperature shall constitute a

violation of the established operating

parameter(s).

(4) Except as provided in paragraph

(b)(5) of this section, operation of the

designated facility above the maximum

charge rate and below the minimum

secondary chamber temperature (each

measured on a 3-hour rolling average)

simultaneously shall constitute a

violation of the PM, CO, and dioxin/

furan emission limits.

(5) The owner or operator of a

designated facility may conduct a repeat

performance test within 30 days of

violation of applicable operating

parameter(s) to demonstrate that the

designated facility is not in violation of

the applicable emission limit(s). Repeat

performance tests conducted pursuant

to this paragraph must be conducted

using the identical operating parameters

that indicated a violation under

paragraph (b)(4) of this section.

(c) For approval, a State plan shall

include the requirements for monitoring

listed in § 60.57c of subpart Ec of this

part, except as provided for under

paragraph (d) of this section.

(d) For approval, a State plan shall

include requirements for any small

HMIWI subject to the emission limits

under § 60.33e(b) to meet the following

monitoring requirements:

(1) Install, calibrate (to manufacturers’

specifications), maintain, and operate a

device for measuring and recording the

temperature of the secondary chamber

on a continuous basis, the output of

which shall be recorded, at a minimum,

once every minute throughout

operation.

(2) Install, calibrate (to manufacturers’

specifications), maintain, and operate a

device which automatically measures

and records the date, time, and weight

of each charge fed into the HMIWI.

(3) The owner or operator of a

designated facility shall obtain

monitoring data at all times during

HMIWI operation except during periods

of monitoring equipment malfunction,

calibration, or repair. At a minimum,

valid monitoring data shall be obtained

for 75 percent of the operating hours per

day and for 90 percent of the operating

hours per calendar quarter that the

designated facility is combusting

hospital waste and/or medical/

infectious waste.

§ 60.38e Reporting and recordkeeping

guidelines.

(a) For approval, a State plan shall

include the reporting and recordkeeping

requirements listed in § 60.58c(b), (c),

(d), (e), and (f) of subpart Ec of this part,

excluding § 60.58c(b)(2)(ii) (fugitive

emissions) and (b)(7) (siting).

(b) For approval, a State plan shall

require the owner or operator of each

small HMIWI subject to the emission

limits under § 60.33e(b) to:

(1) Maintain records of the annual

equipment inspections, any required

maintenance, and any repairs not

completed within 10 days of an

inspection or the timeframe established

by the State regulatory agency; and

(2) Submit an annual report

containing information recorded under

paragraph (b)(1) of this section no later

than 60 days following the year in

which data were collected. Subsequent

reports shall be sent no later than 12

calendar months following the previous

report (once the unit is subject to

permitting requirements under Title V

of the Act, the owner or operator must

submit these reports semiannually). The

report shall be signed by the facilities

manager.

§ 60.39e Compliance times.

(a) Not later than September 15, 1998,

each State in which a designated facility

is operating shall submit to the

Administrator a plan to implement and

enforce the emission guidelines.

(b) Except as provided in paragraphs

(c) and (d) of this section, State plans

shall provide that designated facilities

comply with all requirements of the

State plan on or before the date 1 year

after EPA approval of the State plan,

regardless of whether a designated

facility is identified in the State plan

inventory required by § 60.25(a) of

subpart B of this part.

(c) State plans that specify measurable

and enforceable incremental steps of

progress towards compliance for

designated facilities planning to install

the necessary air pollution control

equipment may allow compliance on or

before the date 3 years after EPA

approval of the State plan (but not later

than the September 16, 2002. Suggested

measurable and enforceable activities to

be included in State plans are:

(1) Date for submitting a petition for

site specific operating parameters under

§ 60.56c(i) of subpart Ec of this part.

(2) Date for obtaining services of an

architectural and engineering firm

regarding the air pollution control

device(s);

(3) Date for obtaining design drawings

of the air pollution control device(s);

(4) Date for ordering the air pollution

control device(s);

(5) Date for obtaining the major

components of the air pollution control

device(s);

(6) Date for initiation of site

preparation for installation of the air

pollution control device(s);

(7) Date for initiation of installation of

the air pollution control device(s);

(8) Date for initial startup of the air

pollution control device(s); and

(9) Date for initial compliance test(s)

of the air pollution control device(s).

(d) State plans that include provisions

allowing designated facilities to petition

the State for extensions beyond the

compliance times required in paragraph

(b) of this section shall:

(1) Require that the designated facility

requesting an extension submit the

following information in time to allow

the State adequate time to grant or deny

the extension within 1 year after EPA

approval of the State plan:

(i) 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 1 year

after EPA approval of the State plan is

not sufficient. The documentation shall

also include an evaluation of the option

to transport the waste offsite to a

commercial medical waste treatment

and disposal facility on a temporary or

permanent basis; and

(ii) Documentation of measurable and

enforceable incremental steps of

progress to be taken towards compliance

with the emission guidelines.

(2) Include procedures for granting or

denying the extension; and

(3) If an extension is granted, require

compliance with the emission
48382 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

guidelines on or before the date 3 years

after EPA approval of the State plan (but

not later than September 16, 2002.

(e) For approval, a State plan shall

require compliance with § 60.34e—

Operator training and qualification

guidelines and § 60.36e—Inspection

guidelines by the date 1 year after EPA

approval of a State plan.

(f) The Administrator shall develop,

implement, and enforce a plan for

existing HMIWI located in any State that

has not submitted an approvable plan

within date 2 years after September 15,

1997. Such plans shall ensure that each

designated facility is in compliance

with the provisions of this subpart no

later than date 5 years after September

15, 1997.

TABLE 1 TO SUBPART CE.—EMISSION LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI

Pollutant Units (7 percent oxygen, dry basis)

Emission limits

HMIWI size

Small Medium Large

Particulate matter ....... Milligrams per dry standard cubic meter

(grains per dry standard cubic foot).

115 (0.05) .................. 69 (0.03) .................... 34 (0.015).

Carbon monoxide ....... Parts per million by volume .......................... 40 .............................. 40 .............................. 40.

Dioxins/furans ............. Nanograms per dry standard cubic meter

total dioxins/furans (grains per billion dry

standard cubic feet) or nanograms per dry

standard cubic meter TEQ (grains per billion dry standard cubic feet).

125 (55) or 2.3 (1.0) .. 125 (55) or 2.3 (1.0) .. 125 (55) or 2.3 (1.0).

Hydrogen chloride ...... Parts per million by volume or percent reduction.100 or 93% ................ 100 or 93% ................ 100 or 93%.

Sulfur dioxide .............. Parts per million by volume .......................... 55 .............................. 55 .............................. 55.

Nitrogen oxides .......... Parts per million by volume .......................... 250 ............................ 250 ............................ 250.

Lead ............................ Milligrams per dry standard cubic meter

(grains per thousand dry standard cubic

feet) or percent reduction.

1.2 (0.52) or 70% ...... 1.2 (0.52) or 70% ...... 1.2 (0.52) or 70%.

Cadmium .................... Milligrams per dry standard cubic meter

(grains per thousand dry standard cubic

feet) or percent reduction.

0.16 (0.07) or 65% .... 0.16 (0.07) or 65%..

Mercury ....................... Milligrams per dry standard cubic meter

(grains per thousand dry standard cubic

feet) or percent reduction.

0.55 (0.24) or 85% .... 0.55 (0.24) or 85% .... 0.55 (0.24) or 85%.

TABLE 2 TO SUBPART CE.—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER § 60.33E(B)

Pollutant Units (7 percent oxygen, dry basis) HMIWI emission limits

Particulate matter ....................................... Milligrams per dry standard cubic meter (grains per dry standard cubic foot) ............ 197 (0.086).

Carbon monoxide ...................................... Parts per million by volume .......................................................................................... 40.

Dioxins/furans ............................................ nanograms per dry standard cubic meter total dioxins/furans (grains per billion dry

standard cubic feet) or nanograms per dry standard cubic meter TEQ (grains per

billion dry standard cubic feet).

800 (350) or

15 (6.6).

Hydrogen chloride ...................................... Parts per million by volume .......................................................................................... 3100.

Sulfur dioxide ............................................. Parts per million by volume .......................................................................................... 55.

Nitrogen oxides .......................................... Parts per million by volume .......................................................................................... 250.

Lead ........................................................... Milligrams per dry standard cubic meter (grains per thousand dry standard cubic

feet).

10 (4.4).

Cadmium .................................................... Milligrams per dry standard cubic meter (grains per thousand dry standard cubic

feet).

4 (1.7).

Mercury ...................................................... Milligrams per dry standard cubic meter (grains per thousands dry standard cubic

feet).

7.5 (3.3).

5. Part 60 is amended by adding a

new subpart Ec to read as follows:

Subpart Ec—Standards of Performance for

Hospital/Medical/Infectious Waste

Incinerators for Which Construction Is

Commenced After June 20, 1996

60.50c Applicability and delegation of

authority.

60.51c Definitions.

60.52c Emission limits.

60.53c Operator training and qualification

requirements.

60.54c Siting requirements.

60.55c Waste management plan.

60.56c Compliance and performance

testing.

60.57c Monitoring requirements.

60.58c Reporting and recordkeeping

requirements.

Table 1 to Subpart Ec—Emission Limits for

Small, Medium, and Large HMIWI

Table 2 to Subpart Ec—Toxic Equivalency

Factors

Table 3 to Subpart Ec—Operating Parameters

to be Monitored and Minimum

Measurement and Recording Frequencies

Subpart Ec—Standards of

Performance for Hospital/Medical/

Infectious Waste Incinerators for

Which Construction Is Commenced

After June 20, 1996

§ 60.50c Applicability and delegation of

authority.

(a) Except as provided in paragraphs

(b) through (h) of this section, the

affected facility to which this subpart

applies is each individual hospital/

medical/infectious waste incinerator

(HMIWI) for which construction is
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48383

commenced after June 20, 1996 or for

which modification is commenced after

March 16, 1998.

(b) A combustor is not subject to this

subpart during periods when only

pathological waste, low-level

radioactive waste, and/or

chemotherapeutic waste (all defined in

§ 60.51c) is burned, provided the owner

or operator of the combustor:

(1) Notifies the Administrator of an

exemption claim; and

(2) Keeps records on a calendar

quarter basis of the periods of time

when only pathological waste, low-level

radioactivewaste and/or

chemotherapeutic waste is burned.

(c) Any co-fired combustor (defined in

§ 60.51c) is not subject to this subpart if

the owner or operator of the co-fired

combustor:

(1) Notifies the Administrator of an

exemption claim;

(2) Provides an estimate of the relative

amounts of hospital waste, medical/

infectious waste, and other fuels and

wastes to be combusted; and

(3) Keeps records on a calendar

quarter basis of the weight of hospital

waste and medical/infectious waste

combusted, and the weight of all other

fuels and wastes combusted at the cofired combustor.

(d) Any combustor required to have a

permit under section 3005 of the Solid

Waste Disposal Act is not subject to this

subpart.

(e) Any combustor which meets the

applicability requirements under

subpart Cb, Ea, or Eb of this part

(standards or guidelines for certain

municipal waste combustors) is not

subject to this subpart.

(f) Any pyrolysis unit (defined in

§ 60.51c) is not subject to this subpart.

(g) Cement kilns firing hospital waste

and/or medical/infectious waste are not

subject to this subpart.

(h) Physical or operational changes

made to an existing HMIWI solely for

the purpose of complying with emission

guidelines under subpart Ce are not

considered a modification and do not

result in an existing HMIWI becoming

subject to this subpart.

(i) In delegating implementation and

enforcement authority to a State under

section 111(c) of the Clean Air Act, the

following authorities shall be retained

by the Administrator and not transferred

to a State:

(1) The requirements of § 60.56c(i)

establishing operating parameters when

using controls other than those listed in

§ 60.56c(d).

(2) Alternative methods of

demonstrating compliance under § 60.8.

(j) Affected facilities subject to this

subpart are not subject to the

requirements of 40 CFR part 64.

(k) The requirements of this subpart

shall become effective March 16, 1998

(l) Beginning September 15, 2000, or

on the effective date of an EPAapproved operating permit program

under Clean Air Act title V and the

implementing regulations under 40 CFR

part 70 in the State in which the unit

is located, whichever date is later,

affected facilities subject to this subpart

shall operate pursuant to a permit

issued under the EPA approved State

operating permit program.

§ 60.51c Definitions.

Batch HMIWI means an HMIWI that is

designed such that neither waste

charging nor ash removal can occur

during combustion.

Biologicals means preparations made

from living organisms and their

products, including vaccines, cultures,

etc., intended for use in diagnosing,

immunizing, or treating humans or

animals or in research pertaining

thereto.

Blood Products means any product

derived from human blood, including

but not limited to blood plasma,

platelets, red or white blood corpuscles,

and other derived licensed products,

such as interferon, etc.

Body Fluids means liquid emanating

or derived from humans and limited to

blood; dialysate; amniotic,

cerebrospinal, synovial, pleural,

peritoneal and pericardial fluids; and

semen and vaginal secretions.

Bypass stack means a device used for

discharging combustion gases to avoid

severe damage to the air pollution

control device or other equipment.

Chemotherapeutic waste means waste

material resulting from the production

or use of antineoplastic agents used for

the purpose of stopping or reversing the

growth of malignant cells.

Co-fired combustor means a unit

combusting hospital waste and/or

medical/infectious waste with other

fuels or wastes (e.g., coal, municipal

solid waste) and subject to an

enforceable requirement limiting the

unit to combusting a fuel feed stream,

10 percent or less of the weight of which

is comprised, in aggregate, of hospital

waste and medical/infectious waste as

measured on a calendar quarter basis.

For purposes of this definition,

pathological waste, chemotherapeutic

waste, and low-level radioactive waste

are considered ‘‘other’’ wastes when

calculating the percentage of hospital

waste and medical/infectious waste

combusted.

Continuous emission monitoring

system or CEMS means a monitoring

system for continuously measuring and

recording the emissions of a pollutant

from an affected facility.

Continuous HMIWI means an HMIWI

that is designed to allow waste charging

and ash removal during combustion.

Dioxins/furans means the combined

emissions of tetra-through octachlorinated dibenzo-para-dioxins and

dibenzofurans, as measured by EPA

Reference Method 23.

Dry scrubber means an add-on air

pollution control system that injects dry

alkaline sorbent (dry injection) or sprays

an alkaline sorbent (spray dryer) to react

with and neutralize acid gases in the

HMIWI exhaust stream forming a dry

powder material.

Fabric filter or baghouse means an

add-on air pollution control system that

removes particulate matter (PM) and

nonvaporous metals emissions by

passing flue gas through filter bags.

Facilities manager means the

individual in charge of purchasing,

maintaining, and operating the HMIWI

or the owner’s or operator’s

representative responsible for the

management of the HMIWI. Alternative

titles may include director of facilities

or vice president of support services.

High-air phase means the stage of the

batch operating cycle when the primary

chamber reaches and maintains

maximum operating temperatures.

Hospital means any facility which has

an organized medical staff, maintains at

least six inpatient beds, and where the

primary function of the institution is to

provide diagnostic and therapeutic

patient services and continuous nursing

care primarily to human inpatients who

are not related and who stay on average

in excess of 24 hours per admission.

This definition does not include

facilities maintained for the sole

purpose of providing nursing or

convalescent care to human patients

who generally are not acutely ill but

who require continuing medical

supervision.

Hospital/medical/infectious waste

incinerator or HMIWI or HMIWI unit

means any device that combusts any

amount of hospital waste and/or

medical/infectious waste.

Hospital/medical/infectious waste

incinerator operator or HMIWI operator

means any person who operates,

controls or supervises the day-to-day

operation of an HMIWI.

Hospital waste means discards

generated at a hospital, except unused

items returned to the manufacturer. The

definition of hospital waste does not

include human corpses, remains, and

anatomical parts that are intended for

interment or cremation.

Infectious agent means any organism

(such as a virus or bacteria) that is
48384 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

capable of being communicated by

invasion and multiplication in body

tissues and capable of causing disease or

adverse health impacts in humans.

Intermittent HMIWI means an HMIWI

that is designed to allow waste charging,

but not ash removal, during combustion.

Large HMIWI means:

(1) Except as provided in (2);

(i) An HMIWI whose maximum

design waste burning capacity is more

than 500 pounds per hour; or

(ii) A continuous or intermittent

HMIWI whose maximum charge rate is

more than 500 pounds per hour; or

(iii) A batch HMIWI whose maximum

charge rate is more than 4,000 pounds

per day.

(2) The following are not large

HMIWI:

(i) A continuous or intermittent

HMIWI whose maximum charge rate is

less than or equal to 500 pounds per

hour; or

(ii) A batch HMIWI whose maximum

charge rate is less than or equal to 4,000

pounds per day.

Low-level radioactive waste means

waste material which contains

radioactive nuclides emitting primarily

beta or gamma radiation, or both, in

concentrations or quantities that exceed

applicable federal or State standards for

unrestricted release. Low-level

radioactive waste is not high-level

radioactive waste, spent nuclear fuel, or

by-product material as defined by the

Atomic Energy Act of 1954 (42 U.S.C.

2014(e)(2)).

Malfunction means any sudden,

infrequent, and not reasonably

preventable failure of air pollution

control equipment, process equipment,

or a process to operate in a normal or

usual manner. Failures that are caused,

in part, by poor maintenance or careless

operation are not malfunctions. During

periods of malfunction the operator

shall operate within established

parameters as much as possible, and

monitoring of all applicable operating

parameters shall continue until all

waste has been combusted or until the

malfunction ceases, whichever comes

first.

Maximum charge rate means:

(1) For continuous and intermittent

HMIWI, 110 percent of the lowest 3-

hour average charge rate measured

during the most recent performance test

demonstrating compliance with all

applicable emission limits.

(2) For batch HMIWI, 110 percent of

the lowest daily charge rate measured

during the most recent performance test

demonstrating compliance with all

applicable emission limits.

Maximum design waste burning

capacity means:

(1) For intermittent and continuous

HMIWI,

C=PV x 15,000/8,500

Where:

C=HMIWI capacity, lb/hr

PV=primary chamber volume, ft3

15,000=primary chamber heat release

rate factor, Btu/ft3/hr

8,500=standard waste heating value,

Btu/lb;

(2) For batch HMIWI,

C=PV x 4.5/8

Where:

C=HMIWI capacity, lb/hr

PV=primary chamber volume, ft3

4.5=waste density, lb/ft3

8=typical hours of operation of a batch

HMIWI, hours.

Maximum fabric filter inlet

temperature means 110 percent of the

lowest 3-hour average temperature at

the inlet to the fabric filter (taken, at a

minimum, once every minute) measured

during the most recent performance test

demonstrating compliance with the

dioxin/furan emission limit.

Maximum flue gas temperature means

110 percent of the lowest 3-hour average

temperature at the outlet from the wet

scrubber (taken, at a minimum, once

every minute) measured during the most

recent performance test demonstrating

compliance with the mercury (Hg)

emission limit.

Medical/infectious waste means any

waste generated in the diagnosis,

treatment, or immunization of human

beings or animals, in research pertaining

thereto, or in the production or testing

of biologicals that is listed in paragraphs

(1) through (7) of this definition. The

definition of medical/infectious waste

does not include hazardous waste

identified or listed under the regulations

in part 261 of this chapter; household

waste, as defined in § 261.4(b)(1) of this

chapter; ash from incineration of

medical/infectious waste, once the

incineration process has been

completed; human corpses, remains,

and anatomical parts that are intended

for interment mation; and domestic

sewage materials identified in

§ 261.4(a)(1) of this chapter.

(1) Cultures and stocks of infectious

agents and associated biologicals,

including: cultures from medical and

pathological laboratories; cultures and

stocks of infectious agents from research

and industrial laboratories; wastes from

the production of biologicals; discarded

live and attenuated vaccines; and

culture dishes and devices used to

transfer, inoculate, and mix cultures.

(2) Human pathological waste,

including tissues, organs, and body

parts and body fluids that are removed

during surgery or autopsy, or other

medical procedures, and specimens of

body fluids and their containers.

(3) Human blood and blood products

including:

(i) Liquid waste human blood;

(ii) Products of blood;

(iii) Items saturated and/or dripping

with human blood; or

(iv) Items that were saturated and/or

dripping with human blood that are

now caked with dried human blood;

including serum, plasma, and other

blood components, and their containers,

which were used or intended for use in

either patient care, testing and

laboratory analysis or the development

of pharmaceuticals. Intravenous bags are

also include in this category.

(4) Sharps that have been used in

animal or human patient care or

treatment or in medical, research, or

industrial laboratories, including

hypodermic needles, syringes (with or

without the attached needle), pasteur

pipettes, scalpel blades, blood vials,

needles with attached tubing, and

culture dishes (regardless of presence of

infectious agents). Also included are

other types of broken or unbroken

glassware that were in contact with

infectious agents, such as used slides

and cover slips.

(5) Animal waste including

contaminated animal carcasses, body

parts, and bedding of animals that were

known to have been exposed to

infectious agents during research

(including research in veterinary

hospitals), production of biologicals or

testing of pharmaceuticals.

(6) Isolation wastes including

biological waste and discarded materials

contaminated with blood, excretions,

exudates, or secretions from humans

who are isolated to protect others from

certain highly communicable diseases,

or isolated animals known to be infected

with highly communicable diseases.

(7) Unused sharps including the

following unused, discarded sharps:

hypodermic needles, suture needles,

syringes, and scalpel blades.

Medium HMIWI means:

(1) Except as provided in paragraph

(2);

(i) An HMIWI whose maximum

design waste burning capacity is more

than 200 pounds per hour but less than

or equal to 500 pounds per hour; or

(ii) A continuous or intermittent

HMIWI whose maximum charge rate is

more than 200 pounds per hour but less

than or equal to 500 pounds per hour;

or

(iii) A batch HMIWI whose maximum

charge rate is more than 1,600 pounds

per day but less than or equal to 4,000

pounds per day.
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48385

(2) The following are not medium

HMIWI:

(i) A continuous or intermittent

HMIWI whose maximum charge rate is

less than or equal to 200 pounds per

hour or more than 500 pounds per hour;

or

(ii) A batch HMIWI whose maximum

charge rate is more than 4,000 pounds

per day or less than or equal to 1,600

pounds per day.

Minimum dioxin/furan sorbent flow

rate means 90 percent of the highest 3-

hour average dioxin/furan sorbent flow

rate (taken, at a minimum, once every

hour) measured during the most recent

performance test demonstrating

compliance with the dioxin/furan

emission limit.

Minimum Hg sorbent flow rate means

90 percent of the highest 3-hour average

Hg sorbent flow rate (taken, at a

minimum, once every hour) measured

during the most recent performance test

demonstrating compliance with the Hg

emission limit.

Minimum hydrogen chloride (HCl)

sorbent flow rate means 90 percent of

the highest 3-hour average HCl sorbent

flow rate (taken, at a minimum, once

every hour) measured during the most

recent performance test demonstrating

compliance with the HCl emission limit.

Minimum horsepower or amperage

means 90 percent of the highest 3-hour

average horsepower or amperage to the

wet scrubber (taken, at a minimum,

once every minute) measured during the

most recent performance test

demonstrating compliance with the

applicable emission limits.

Minimum pressure drop across the

wet scrubber means 90 percent of the

highest 3-hour average pressure drop

across the wet scrubber PM control

device (taken, at a minimum, once every

minute) measured during the most

recent performance test demonstrating

compliance with the PM emission limit.

Minimum scrubber liquor flow rate

means 90 percent of the highest 3-hour

average liquor flow rate at the inlet to

the wet scrubber (taken, at a minimum,

once every minute) measured during the

most recent performance test

demonstrating compliance with all

applicable emission limits.

Minimum scrubber liquor pH means

90 percent of the highest 3-hour average

liquor pH at the inlet to the wet

scrubber (taken, at a minimum, once

every minute) measured during the most

recent performance test demonstrating

compliance with the HCl emission limit.

Minimum secondary chamber

temperature means 90 percent of the

highest 3-hour average secondary

chamber temperature (taken, at a

minimum, once every minute) measured

during the most recent performance test

demonstrating compliance with the PM,

CO, or dioxin/furan emission limits.

Modification or Modified HMIWI

means any change to an HMIWI unit

after the effective date of these

standards such that:

(1) 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) The change involves 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

section 111.

Operating day means a 24-hour

period between 12:00 midnight and the

following midnight during which any

amount of hospital waste or medical/

infectious waste is combusted at any

time in the HMIWI.

Operation means the period during

which waste is combusted in the

incinerator excluding periods of startup

or shutdown.

Particulate matter or PM means the

total particulate matter emitted from an

HMIWI as measured by EPA Reference

Method 5 or EPA Reference Method 29.

Pathological waste means waste

material consisting of only human or

animal remains, anatomical parts, and/

or tissue, the bags/containers used to

collect and transport the waste material,

and animal bedding (if applicable).

Primary chamber means the chamber

in an HMIWI that receives waste

material, in which the waste is ignited,

and from which ash is removed.

Pyrolysis means the endothermic

gasification of hospital waste and/or

medical/infectious waste using external

energy.

Secondary chamber means a

component of the HMIWI that receives

combustion gases from the primary

chamber and in which the combustion

process is completed.

Shutdown means the period of time

after all waste has been combusted in

the primary chamber. For continuous

HMIWI, shutdown shall commence no

less than 2 hours after the last charge to

the incinerator. For intermittent HMIWI,

shutdown shall commence no less than

4 hours after the last charge to the

incinerator. For batch HMIWI,

shutdown shall commence no less than

5 hours after the high-air phase of

combustion has been completed.

Small HMIWI means:

(1) Except as provided in (2);

(i) An HMIWI whose maximum

design waste burning capacity is less

than or equal to 200 pounds per hour;

or

(ii) A continuous or intermittent

HMIWI whose maximum charge rate is

less than or equal to 200 pounds per

hour; or

(iii) A batch HMIWI whose maximum

charge rate is less than or equal to 1,600

pounds per day.

(2) The following are not small

HMIWI:

(i) A continuous or intermittent

HMIWI whose maximum charge rate is

more than 200 pounds per hour;

(ii) A batch HMIWI whose maximum

charge rate is more than 1,600 pounds

per day.

Standard conditions means a

temperature of 20° C and a pressure of

101.3 kilopascals.

Startup means the period of time

between the activation of the system

and the first charge to the unit. For

batch HMIWI, startup means the period

of time between activation of the system

and ignition of the waste.

Wet scrubber means an add-on air

pollution control device that utilizes an

alkaline scrubbing liquor to collect

particulate matter (including

nonvaporous metals and condensed

organics) and/or to absorb and

neutralize acid gases.

§ 60.52c Emission limits.

(a) On and after the date on which the

initial performance test is completed or

is required to be completed under

§ 60.8, whichever date comes first, no

owner or operator of an affected facility

shall cause to be discharged into the

atmosphere from that affected facility

any gases that contain stack emissions

in excess of the limits presented in

Table 1 of this subpart.

(b) On and after the date on which the

initial performance test is completed or

is required to be completed under

§ 60.8, whichever date comes first, no

owner or operator of an affected facility

shall cause to be discharged into the

atmosphere from the stack of that

affected facility any gases that exhibit

greater than 10 percent opacity (6-

minute block average).

(c) On and after the date on which the

initial performance test is completed or

is required to be completed under

§ 60.8, whichever date comes first, no

owner or operator of an affected facility

utilizing a large HMIWI shall cause to be

discharged into the atmosphere visible

emissions of combustion ash from an

ash conveying system (including

conveyor transfer points) in excess of 5

percent of the observation period (i.e., 9

minutes per 3-hour period), as
48386 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

determined by EPA Reference Method

22, except as provided in paragraphs (d)

and (e) of this section.

(d) The emission limit specified in

paragraph (c) of this section does not

cover visible emissions discharged

inside buildings or enclosures of ash

conveying systems; however, the

emission limit does cover visible

emissions discharged to the atmosphere

from buildings or enclosures of ash

conveying systems.

(e) The provisions specified in

paragraph (c) of this section do not

apply during maintenance and repair of

ash conveying systems. Maintenance

and/or repair shall not exceed 10

operating days per calendar quarter

unless the owner or operator obtains

written approval from the State agency

establishing a date whereby all

necessary maintenance and repairs of

ash conveying systems shall be

completed.

§ 60.53c Operator training and

qualification requirements.

(a) No owner or operator of an

affected facility shall allow the affected

facility to operate at any time unless a

fully trained and qualified HMIWI

operator is accessible, either at the

facility or available within 1 hour. The

trained and qualified HMIWI operator

may operate the HMIWI directly or be

the direct supervisor of one or more

HMIWI operators.

(b) Operator training and qualification

shall be obtained through a Stateapproved program or by completing the

requirements included in paragraphs (c)

through (g) of this section.

(c) Training shall be obtained by

completing an HMIWI operator training

course that includes, at a minimum, the

following provisions:

(1) 24 hours of training on the

following subjects:

(i) Environmental concerns, including

pathogen destruction and types of

emissions;

(ii) Basic combustion principles,

including products of combustion;

(iii) Operation of the type of

incinerator to be used by the operator,

including proper startup, waste

charging, and shutdown procedures;

(iv) Combustion controls and

monitoring;

(v) Operation of air pollution control

equipment and factors affecting

performance (if applicable);

(vi) Methods to monitor pollutants

(continuous emission monitoring

systems and monitoring of HMIWI and

air pollution control device operating

parameters) and equipment calibration

procedures (where applicable);

(vii) Inspection and maintenance of

the HMIWI, air pollution control

devices, and continuous emission

monitoring systems;

(viii) Actions to correct malfunctions

or conditions that may lead to

malfunction;

(ix) Bottom and fly ash characteristics

and handling procedures;

(x) Applicable Federal, State, and

local regulations;

(xi) Work safety procedures;

(xii) Pre-startup inspections; and

(xiii) Recordkeeping requirements.

(2) An examination designed and

administered by the instructor.

(3) Reference material distributed to

the attendees covering the course topics.

(d) Qualification shall be obtained by:

(1) Completion of a training course

that satisfies the criteria under

paragraph (c) of this section; and

(2) Either 6 months experience as an

HMIWI operator, 6 months experience

as a direct supervisor of an HMIWI

operator, or completion of at least two

burn cycles under the observation of

two qualified HMIWI operators.

(e) Qualification is valid from the date

on which the examination is passed or

the completion of the required

experience, whichever is later.

(f) To maintain qualification, the

trained and qualified HMIWI operator

shall complete and pass an annual

review or refresher course of at least 4

hours covering, at a minimum, the

following:

(1) Update of regulations;

(2) Incinerator operation, including

startup and shutdown procedures;

(3) Inspection and maintenance;

(4) Responses to malfunctions or

conditions that may lead to

malfunction; and

(5) Discussion of operating problems

encountered by attendees.

(g) A lapsed qualification shall be

renewed by one of the following

methods:

(1) For a lapse of less than 3 years, the

HMIWI operator shall complete and

pass a standard annual refresher course

described in paragraph (f) of this

section.

(2) For a lapse of 3 years or more, the

HMIWI operator shall complete and

pass a training course with the

minimum criteria described in

paragraph (c) of this section.

(h) The owner or operator of an

affected facility shall maintain

documentation at the facility that

address the following:

(1) Summary of the applicable

standards under this subpart;

(2) Description of basic combustion

theory applicable to an HMIWI;

(3) Procedures for receiving, handling,

and charging waste;

(4) HMIWI startup, shutdown, and

malfunction procedures;

(5) Procedures for maintaining proper

combustion air supply levels;

(6) Procedures for operating the

HMIWI and associated air pollution

control systems within the standards

established under this subpart;

(7) Procedures for responding to

periodic malfunction or conditions that

may lead to malfunction;

(8) Procedures for monitoring HMIWI

emissions;

(9) Reporting and recordkeeping

procedures; and

(10) Procedures for handling ash.

(i) The owner or operator of an

affected facility shall establish a

program for reviewing the information

listed in paragraph (h) of this section

annually with each HMIWI operator

(defined in § 60.51c).

(1) The initial review of the

information listed in paragraph (h) of

this section shall be conducted within 6

months after the effective date of this

subpart or prior to assumption of

responsibilities affecting HMIWI

operation, whichever date is later.

(2) Subsequent reviews of the

information listed in paragraph (h) of

this section shall be conducted

annually.

(j) The information listed in paragraph

(h) of this section shall be kept in a

readily accessible location for all

HMIWI operators. This information,

along with records of training shall be

available for inspection by the EPA or

its delegated enforcement agent upon

request.

§ 60.54c Siting requirements.

(a) The owner or operator of an

affected facility for which construction

is commenced after September 15, 1997

shall prepare an analysis of the impacts

of the affected facility. The analysis

shall consider air pollution control

alternatives that minimize, on a sitespecific basis, to the maximum extent

practicable, potential risks to public

health or the environment. In

considering such alternatives, the

analysis may consider costs, energy

impacts, non-air environmental impacts,

or any other factors related to the

practicability of the alternatives.

(b) Analyses of facility impacts

prepared to comply with State, local, or

other Federal regulatory requirements

may be used to satisfy the requirements

of this section, as long as they include

the consideration of air pollution

control alternatives specified in

paragraph (a) of this section.

(c) The owner or operator of the

affected facility shall complete and

submit the siting requirements of this

section as required under

§ 60.58c(a)(1)(iii).
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48387

§ 60.55c Waste management plan.

The owner or operator of an affected

facility shall prepare a waste

management plan. The waste

management plan shall identify both the

feasibility and the approach to separate

certain components of solid waste from

the health care waste stream in order to

reduce the amount of toxic emissions

from incinerated waste. A waste

management plan may include, but is

not limited to, elements such as paper,

cardboard, plastics, glass, battery, or

metal recycling; or purchasing recycled

or recyclable products. A waste

management plan may include different

goals or approaches for different areas or

departments of the facility and need not

include new waste management goals

for every waste stream. It should

identify, where possible, reasonably

available additional waste management

measures, taking into account the

effectiveness of waste management

measures already in place, the costs of

additional measures, the emission

reductions expected to be achieved, and

any other environmental or energy

impacts they might have. The American

Hospital Association publication

entitled ‘‘An Ounce of Prevention:

Waste Reduction Strategies for Health

Care Facilities’’ (incorporated by

reference, see § 60.17) shall be

considered in the development of the

waste management plan.

§ 60.56c Compliance and performance

testing.

(a) The emission limits under this

subpart apply at all times except during

periods of startup, shutdown, or

malfunction, provided that no hospital

waste or medical/infectious waste is

charged to the affected facility during

startup, shutdown, or malfunction.

(b) The owner or operator of an

affected facility shall conduct an initial

performance test as required under

§ 60.8 to determine compliance with the

emission limits using the procedures

and test methods listed in paragraphs

(b)(1) through (b)(12) of this section. The

use of the bypass stack during a

performance test shall invalidate the

performance test.

(1) All performance tests shall consist

of a minimum of three test runs

conducted under representative

operating conditions.

(2) The minimum sample time shall

be 1 hour per test run unless otherwise

indicated.

(3) EPA Reference Method 1 of

appendix A of this part shall be used to

select the sampling location and number

of traverse points.

(4) EPA Reference Method 3 or 3A of

appendix A of this part shall be used for

gas composition analysis, including

measurement of oxygen concentration.

EPA Reference Method 3 or 3A of

appendix A of this part shall be used

simultaneously with each reference

method.

(5) The pollutant concentrations shall

be adjusted to 7 percent oxygen using

the following equation:

Cadj=Cmeas (20.9—7)/(20.9—%O2) where:

Cadj=pollutant concentration adjusted to

7 percent oxygen;

Cmeas=pollutant concentration measured

on a dry basis (20.9—7)=20.9

percent oxygen—7 percent oxygen

(defined oxygen correction basis);

20.9=oxygen concentration in air,

percent; and

%O2=oxygen concentration measured

on a dry basis, percent.

(6) EPA Reference Method 5 or 29 of

appendix A of this part shall be used to

measure the particulate matter

emissions.

(7) EPA Reference Method 9 of

appendix A of this part shall be used to

measure stack opacity.

(8) EPA Reference Method 10 or 10B

of appendix A of this part shall be used

to measure the CO emissions.

(9) EPA Reference Method 23 of

appendix A of this part shall be used to

measure total dioxin/furan emissions.

The minimum sample time shall be 4

hours per test run. If the affected facility

has selected the toxic equivalency

standards for dioxin/furans, under

§ 60.52c, the following procedures shall

be used to determine compliance:

(i) Measure the concentration of each

dioxin/furan tetra-through octacongener emitted using EPA Reference

Method 23.

(ii) For each dioxin/furan congener

measured in accordance with paragraph

(b)(9)(i) of this section, multiply the

congener concentration by its

corresponding toxic equivalency factor

specified in Table 2 of this subpart.

(iii) Sum the products calculated in

accordance with paragraph (b)(9)(ii) of

this section to obtain the total

concentration of dioxins/furans emitted

in terms of toxic equivalency.

(10) EPA Reference Method 26 of

appendix A of this part shall be used to

measure HCl emissions. If the affected

facility has selected the percentage

reduction standards for HCl under

§ 60.52c, the percentage reduction in

HCl emissions (%RHCl) is computed

using the following formula:

%R

E E

E HCl

i o

i

( ) =  −



 



 ×100

Where:

%RHCl=percentage reduction of HCl

emissions achieved;

Ei=HCl emission concentration

measured at the control device

inlet, corrected to 7 percent oxygen

(dry basis); and

Eo=HCl emission concentration

measured at the control device

outlet, corrected to 7 percent

oxygen (dry basis).

(11) EPA Reference Method 29 of

appendix A of this part shall be used to

measure Pb, Cd, and Hg emissions. If

the affected facility has selected the

percentage reduction standards for

metals under § 60.52c, the percentage

reduction in emissions (%Rmetal) is

computed using the following formula:

%R

E E

E metal

i o

i

( ) =  −



 



 ×100

Where:

%Rmetal=percentage reduction of metal

emission (Pb, Cd, or Hg) achieved;

Ei=metal emission concentration (Pb,

Cd, or Hg) measured at the control

device inlet, corrected to 7 percent

oxygen (dry basis); and

Eo=metal emission concentration (Pb,

Cd, or Hg) measured at the control

device outlet, corrected to 7 percent

oxygen (dry basis).

(12) The EPA Reference Method 22 of

appendix A of this part shall be used to

determine compliance with the fugitive

ash emission limit under § 60.52c(c).

The minimum observation time shall be

a series of three 1-hour observations.

(c) Following the date on which the

initial performance test is completed or

is required to be completed under

§ 60.8, whichever date comes first, the

owner or operator of an affected facility

shall:

(1) Determine compliance with the

opacity limit by conducting an annual

performance test (no more than 12

months following the previous

performance test) using the applicable

procedures and test methods listed in

paragraph (b) of this section.

(2) Determine compliance with the

PM, CO, and HCl emission limits by

conducting an annual performance test

(no more than 12 months following the

previous performance test) using the

applicable procedures and test methods

listed in paragraph (b) of this section. If

all three performance tests over a 3-year

period indicate compliance with the

emission limit for a pollutant (PM, CO,

or HCl), the owner or operator may

forego a performance test for that

pollutant for the subsequent 2 years. At

a minimum, a performance test for PM,

CO, and HCl shall be conducted every

third year (no more than 36 months

following the previous performance

test). If a performance test conducted
48388 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

every third year indicates compliance

with the emission limit for a pollutant

(PM, CO, or HCl), the owner or operator

may forego a performance test for that

pollutant for an additional 2 years. If

any performance test indicates

noncompliance with the respective

emission limit, a performance test for

that pollutant shall be conducted

annually until all annual performance

tests over a 3-year period indicate

compliance with the emission limit. The

use of the bypass stack during a

performance test shall invalidate the

performance test.

(3) For large HMIWI, determine

compliance with the visible emission

limits for fugitive emissions from

flyash/bottom ash storage and handling

by conducting a performance test using

EPA Reference Method 22 on an annual

basis (no more than 12 months

following the previous performance

test).

(4) Facilities using a CEMS to

demonstrate compliance with any of the

emission limits under § 60.52c shall:

(i) Determine compliance with the

appropriate emission limit(s) using a 12-

hour rolling average, calculated each

hour as the average of the previous 12

operating hours (not including startup,

shutdown, or malfunction).

(ii) Operate all CEMS in accordance

with the applicable procedures under

appendices B and F of this part.

(d) The owner or operator of an

affected facility equipped with a dry

scrubber followed by a fabric filter, a

wet scrubber, or a dry scrubber followed

by a fabric filter and wet scrubber shall:

(1) Establish the appropriate

maximum and minimum operating

parameters, indicated in Table 3 of this

subpart for each control system, as site

specific operating parameters during the

initial performance test to determine

compliance with the emission limits;

and

(2) Following the date on which the

initial performance test is completed or

is required to be completed under

§ 60.8, whichever date comes first,

ensure that the affected facility does not

operate above any of the applicable

maximum operating parameters or

below any of the applicable minimum

operating parameters listed in Table 3 of

this subpart and measured as 3-hour

rolling averages (calculated each hour as

the average of the previous 3 operating

hours) at all times except during periods

of startup, shutdown and malfunction.

Operating parameter limits do not apply

during performance tests. Operation

above the established maximum or

below the established minimum

operating parameter(s) shall constitute a

violation of established operating

parameter(s).

(e) Except as provided in paragraph

(h) of this section, for affected facilities

equipped with a dry scrubber followed

by a fabric filter:

(1) Operation of the affected facility

above the maximum charge rate and

below the minimum secondary chamber

temperature (each measured on a 3-hour

rolling average) simultaneously shall

constitute a violation of the CO

emission limit.

(2) Operation of the affected facility

above the maximum fabric filter inlet

temperature, above the maximum

charge rate, and below the minimum

dioxin/furan sorbent flow rate (each

measured on a 3-hour rolling average)

simultaneously shall constitute a

violation of the dioxin/furan emission

limit.

(3) Operation of the affected facility

above the maximum charge rate and

below the minimum HCl sorbent flow

rate (each measured on a 3-hour rolling

average) simultaneously shall constitute

a violation of the HCl emission limit.

(4) Operation of the affected facility

above the maximum charge rate and

below the minimum Hg sorbent flow

rate (each measured on a 3-hour rolling

average) simultaneously shall constitute

a violation of the Hg emission limit.

(5) Use of the bypass stack (except

during startup, shutdown, or

malfunction) shall constitute a violation

of the PM, dioxin/furan, HCl, Pb, Cd

and Hg emission limits.

(f) Except as provided in paragraph

(h) of this section, for affected facilities

equipped with a wet scrubber:

(1) Operation of the affected facility

above the maximum charge rate and

below the minimum pressure drop

across the wet scrubber or below the

minimum horsepower or amperage to

the system (each measured on a 3-hour

rolling average) simultaneously shall

constitute a violation of the PM

emission limit.

(2) Operation of the affected facility

above the maximum charge rate and

below the minimum secondary chamber

temperature (each measured on a 3-hour

rolling average) simultaneously shall

constitute a violation of the CO

emission limit.

(3) Operation of the affected facility

above the maximum charge rate, below

the minimum secondary chamber

temperature, and below the minimum

scrubber liquor flow rate (each

measured on a 3-hour rolling average)

simultaneously shall constitute a

violation of the dioxin/furan emission

limit.

(4) Operation of the affected facility

above the maximum charge rate and

below the minimum scrubber liquor pH

(each measured on a 3-hour rolling

average) simultaneously shall constitute

a violation of the HCl emission limit.

(5) Operation of the affected facility

above the maximum flue gas

temperature and above the maximum

charge rate (each measured on a 3-hour

rolling average) simultaneously shall

constitute a violation of the Hg emission

limit.

(6) Use of the bypass stack (except

during startup, shutdown, or

malfunction) shall constitute a violation

of the PM, dioxin/furan, HCl, Pb, Cd

and Hg emission limits.

(g) Except as provided in paragraph

(h) of this section, for affected facilities

equipped with a dry scrubber followed

by a fabric filter and a wet scrubber:

(1) Operation of the affected facility

above the maximum charge rate and

below the minimum secondary chamber

temperature (each measured on a 3-hour

rolling average) simultaneously shall

constitute a violation of the CO

emission limit.

(2) Operation of the affected facility

above the maximum fabric filter inlet

temperature, above the maximum

charge rate, and below the minimum

dioxin/furan sorbent flow rate (each

measured on a 3-hour rolling average)

simultaneously shall constitute a

violation of the dioxin/furan emission

limit.

(3) Operation of the affected facility

above the maximum charge rate and

below the minimum scrubber liquor pH

(each measured on a 3-hour rolling

average) simultaneously shall constitute

a violation of the HCl emission limit.

(4) Operation of the affected facility

above the maximum charge rate and

below the minimum Hg sorbent flow

rate (each measured on a 3-hour rolling

average) simultaneously shall constitute

a violation of the Hg emission limit.

(5) Use of the bypass stack (except

during startup, shutdown, or

malfunction) shall constitute a violation

of the PM, dioxin/furan, HCl, Pb, Cd

and Hg emission limits.

(h) The owner or operator of an

affected facility may conduct a repeat

performance test within 30 days of

violation of applicable operating

parameter(s) to demonstrate that the

affected facility is not in violation of the

applicable emission limit(s). Repeat

performance tests conducted pursuant

to this paragraph shall be conducted

using the identical operating parameters

that indicated a violation under

paragraph (e), (f), or (g) of this section.

(i) The owner or operator of an

affected facility using an air pollution

control device other than a dry scrubber

followed by a fabric filter, a wet
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48389

scrubber, or a dry scrubber followed by

a fabric filter and a wet scrubber to

comply with the emission limits under

§ 60.52c shall petition the Administrator

for other site-specific operating

parameters to be established during the

initial performance test and

continuously monitored thereafter. The

owner or operator shall not conduct the

initial performance test until after the

petition has been approved by the

Administrator.

(j) The owner or operator of an

affected facility may conduct a repeat

performance test at any time to establish

new values for the operating parameters.

The Administrator may request a repeat

performance test at any time.

§ 60.57c Monitoring requirements.

(a) The owner or operator of an

affected facility shall install, calibrate

(to manufacturers’ specifications),

maintain, and operate devices (or

establish methods) for monitoring the

applicable maximum and minimum

operating parameters listed in Table 3 of

this subpart such that these devices (or

methods) measure and record values for

these operating parameters at the

frequencies indicated in Table 3 of this

subpart at all times except during

periods of startup and shutdown.

(b) The owner or operator of an

affected facility shall install, calibrate

(to manufacturers’ specifications),

maintain, and operate a device or

method for measuring the use of the

bypass stack including date, time, and

duration.

(c) The owner or operator of an

affected facility using something other

than a dry scrubber followed by a fabric

filter, a wet scrubber, or a dry scrubber

followed by a fabric filter and a wet

scrubber to comply with the emission

limits under § 60.52c shall install,

calibrate (to the manufacturers’

specifications), maintain, and operate

the equipment necessary to monitor the

site-specific operating parameters

developed pursuant to § 60.56c(i).

(d) The owner or operator of an

affected facility shall obtain monitoring

data at all times during HMIWI

operation except during periods of

monitoring equipment malfunction,

calibration, or repair. At a minimum,

valid monitoring data shall be obtained

for 75 percent of the operating hours per

day and for 90 percent of the operating

days per calendar quarter that the

affected facility is combusting hospital

waste and/or medical/infectious waste.

§ 60.58c Reporting and recordkeeping

requirements.

(a) The owner or operator of an

affected facility shall submit

notifications, as provided by § 60.7. In

addition, the owner or operator shall

submit the following information:

(1) Prior to commencement of

construction;

(i) A statement of intent to construct;

(ii) The anticipated date of

commencement of construction; and

(iii) All documentation produced as a

result of the siting requirements of

§ 60.54c.

(2) Prior to initial startup;

(i) The type(s) of waste to be

combusted;

(ii) The maximum design waste

burning capacity;

(iii) The anticipated maximum charge

rate; and

(iv) If applicable, the petition for sitespecific operating parameters under

§ 60.56c(i).

(b) The owner or operator of an

affected facility shall maintain the

following information (as applicable) for

a period of at least 5 years:

(1) Calendar date of each record;

(2) Records of the following data:

(i) Concentrations of any pollutant

listed in § 60.52c or measurements of

opacity as determined by the

continuous emission monitoring system

(if applicable);

(ii) Results of fugitive emissions (by

EPA Reference Method 22) tests, if

applicable;

(iii) HMIWI charge dates, times, and

weights and hourly charge rates;

(iv) Fabric filter inlet temperatures

during each minute of operation, as

applicable;

(v) Amount and type of dioxin/furan

sorbent used during each hour of

operation, as applicable;

(vi) Amount and type of Hg sorbent

used during each hour of operation, as

applicable;

(vii) Amount and type of HCl sorbent

used during each hour of operation, as

applicable;

(viii) Secondary chamber

temperatures recorded during each

minute of operation;

(ix) Liquor flow rate to the wet

scrubber inlet during each minute of

operation, as applicable;

(x) Horsepower or amperage to the

wet scrubber during each minute of

operation, as applicable;

(xi) Pressure drop across the wet

scrubber system during each minute of

operation, as applicable,

(xii) Temperature at the outlet from

the wet scrubber during each minute of

operation, as applicable;

(xiii) pH at the inlet to the wet

scrubber during each minute of

operation, as applicable,

(xiv) Records indicating use of the

bypass stack, including dates, times,

and durations, and

(xv) For affected facilities complying

with §§ 60.56c(i) and 60.57c(c), the

owner or operator shall maintain all

operating parameter data collected.

(3) Identification of calendar days for

which data on emission rates or

operating parameters specified under

paragraph (b)(2) of this section have not

been obtained, with an identification of

the emission rates or operating

parameters not measured, reasons for

not obtaining the data, and a description

of corrective actions taken.

(4) Identification of calendar days,

times and durations of malfunctions, a

description of the malfunction and the

corrective action taken.

(5) Identification of calendar days for

which data on emission rates or

operating parameters specified under

paragraph (b)(2) of this section exceeded

the applicable limits, with a description

of the exceedances, reasons for such

exceedances, and a description of

corrective actions taken.

(6) The results of the initial, annual,

and any subsequent performance tests

conducted to determine compliance

with the emission limits and/or to

establish operating parameters, as

applicable.

(7) All documentation produced as a

result of the siting requirements of

§ 60.54c;

(8) Records showing the names of

HMIWI operators who have completed

review of the information in § 60.53c(h)

as required by § 60.53c(i), including the

date of the initial review and all

subsequent annual reviews;

(9) Records showing the names of the

HMIWI operators who have completed

the operator training requirements,

including documentation of training

and the dates of the training;

(10) Records showing the names of

the HMIWI operators who have met the

criteria for qualification under § 60.53c

and the dates of their qualification; and

(11) Records of calibration of any

monitoring devices as required under

§ 60.57c(a), (b), and (c).

(c) The owner or operator of an

affected facility shall submit the

information specified in paragraphs

(c)(1) through (c)(3) of this section no

later than 60 days following the initial

performance test. All reports shall be

signed by the facilities manager.

(1) The initial performance test data

as recorded under § 60.56c(b)(1) through

(b)(12), as applicable.

(2) The values for the site-specific

operating parameters established

pursuant to § 60.56c(d) or (i), as

applicable.

(3) The waste management plan as

specified in § 60.55c.
48390 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

(d) An annual report shall be

submitted 1 year following the

submission of the information in

paragraph (c) of this section and

subsequent reports shall be submitted

no more than 12 months following the

previous report (once the unit is subject

to permitting requirements under Title

V of the Clean Air Act, the owner or

operator of an affected facility must

submit these reports semiannually). The

annual report shall include the

information specified in paragraphs

(d)(1) through (d)(8) of this section. All

reports shall be signed by the facilities

manager.

(1) The values for the site-specific

operating parameters established

pursuant to § 60.56c(d) or (i), as

applicable.

(2) The highest maximum operating

parameter and the lowest minimum

operating parameter, as applicable, for

each operating parameter recorded for

the calendar year being reported,

pursuant to § 60.56c(d) or (i), as

applicable.

(3) The highest maximum operating

parameter and the lowest minimum

operating parameter, as applicable for

each operating parameter recorded

pursuant to § 60.56c(d) or (i) for the

calendar year preceding the year being

reported, in order to provide the

Administrator with a summary of the

performance of the affected facility over

a 2-year period.

(4) Any information recorded under

paragraphs (b)(3) through (b)(5) of this

section for the calendar year being

reported.

(5) Any information recorded under

paragraphs (b)(3) through (b)(5) of this

section for the calendar year preceding

the year being reported, in order to

provide the Administrator with a

summary of the performance of the

affected facility over a 2-year period.

(6) If a performance test was

conducted during the reporting period,

the results of that test.

(7) If no exceedances or malfunctions

were reported under paragraphs (b)(3)

through (b)(5) of this section for the

calendar year being reported, a

statement that no exceedances occurred

during the reporting period.

(8) Any use of the bypass stack, the

duration, reason for malfunction, and

corrective action taken.

(e) The owner or operator of an

affected facility shall submit semiannual

reports containing any information

recorded under paragraphs (b)(3)

through (b)(5) of this section no later

than 60 days following the reporting

period. The first semiannual reporting

period ends 6 months following the

submission of information in paragraph

(c) of this section. Subsequent reports

shall be submitted no later than 6

calendar months following the previous

report. All reports shall be signed by the

facilities manager.

(f) All records specified under

paragraph (b) of this section shall be

maintained onsite in either paper copy

or computer-readable format, unless an

alternative format is approved by the

Administrator.

TABLE 1 TO SUBPART EC.—EMISSION LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI

Pollutant Units (7 percent oxygen, dry basis)

Emission limits

HMIWI size

Small Medium Large

Particulate matter ....... Milligrams per dry standard cubic meter

(grains per dry standard cubic foot).

69 (0.03) .................... 34 (0.015) .................. 34 (0.015).

Carbon monoxide ....... Parts per million by volume .......................... 40 .............................. 40 .............................. 40.

Dioxins/furans ............. Nanograms per dry standard cubic meter

total dioxins/furans (grains per billion dry

standard cubic feet) or nanograms per dry

standard cubic meter total dioxins/furans

TEQ (grains per billion dry standard cubic

feet).

125 (55) or 2.3 (1.0) .. 25 (11) or 0.6 (0.26) .. 25 (11) or 0.6 (0.26).

Hydrogen chloride ...... Parts per million or percent reduction ........... 15 or 99% .................. 15 or 99% .................. 15 or 99%.

Sulfur dioxide .............. Parts per million by volume .......................... 55 .............................. 55 .............................. 55.

Nitrogen oxides .......... Parts per million by volume .......................... 250 ............................ 250 ............................ 250.

Lead ............................ Milligrams per dry standard cubic meter

(grains per thousand dry standard cubic

feet) or percent reduction.

1.2 (0.52) or 70% ...... 0.07 (0.03) or 98% .... 0.07 (0.03) or 98%.

Cadmium .................... Milligrams per dry standard cubic meter

(grains per thousand dry standard cubic

feet) or percent reduction.

0.16 (0.07) or 65% .... 0.04 (0.02) or 90% .... 0.04 (0.02) or 90%.

Mercury ....................... Milligrams per dry standard cubic meter

(grains per thousand dry standard cubic

feet) or percent reduction.

0.55 (0.24) or 85% .... 0.55 (0.24) or 85% .... 0.55 (0.24) or 85%.

TABLE 2 TO SUPBART EC.—TOXIC EQUIVALENCY FACTORS

Dioxin/furan congener Toxic equivalency factor

2,3,7,8-tetrachlorinated dibenzo-p-dioxin ............................................................................................................................................... 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

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
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48391

TABLE 2 TO SUPBART EC.—TOXIC EQUIVALENCY FACTORS—Continued

Dioxin/furan congener Toxic equivalency factor

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

TABLE 3 TO SUBPART EC.—OPERATING PARAMETERS TO BE MONITORED AND MINIMUM MEASUREMENT AND RECORDING

FREQUENCIES

Operating parameters to be monitored

Minimum frequency Control system

Data measurement Data recording

Dry scrubber followed

by fabric filter

Wet scrubber

Dry scrubber followed

by fabric filter and wet

scrubber

Maximum operating parameters:

Maximum charge rate .......................................................... Continuous ....... 1×hour .............. ✔ ✔ ✔

Maximum fabric filter inlet temperature ............................... Continuous ....... 1×minute ........... ✔ .................... ✔

Maximum flue gas temperature ........................................... Continuous ....... 1×minute ........... ✔ ✔

Minimum operating parameters:

Minimum secondary chamber temperature ......................... Continuous ....... 1×minute ........... ✔ ✔ ✔

Minimum dioxin/furan sorbent flow rate .............................. Hourly ............... 1×hour .............. ✔ .................... ✔

Minimum HCI sorbent flow rate ........................................... Hourly ............... 1×hour .............. ✔ .................... ✔

Minimum mercury (Hg) sorbent flow rate ............................ Hourly ............... 1×hour .............. ✔ .................... ✔

Minimum pressure drop across the wet scrubber or minimum horsepower or amperage to wet scrubber.Continuous ....... 1×minute ........... .................... ✔ ✔

Minimum scrubber liquor flow rate ...................................... Continuous ....... 1×minute ........... .................... ✔ ✔

Minimum scrubber liquor pH ............................................... Continuous ....... 1×minute ........... .................... ✔ ✔

[FR Doc. 97–23835 Filed 9–12–97; 8:45 am]

BILLING CODE 6560–50–P