[Federal Register Volume 62, Number 178 (Monday, September 15, 1997)]
[Rules and Regulations]
[Pages 48348-48391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23835]



[[Page 48347]]

_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 60



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

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

[[Page 48348]]



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 (Sec. 60.17 and 
Secs. 60.50c through 60.58c) are effective as of March 16, 1998 and the 
emission guidelines for existing sources (Sec. 60.30 and Secs. 60.30e 
through 60.39e) are effective as of November 14, 1997. The 
incorporation by reference of certain publications listed in the 
regulations is approved by the Director of the Federal Register as of 
March 16, 1998. See SUPPLEMENTARY INFORMATION for a discussion of the 
schedule for judicial review.
    Comments. Comments on the Information Collection Request (ICR) 
document associated with the final standards for new sources are 
requested, as discussed in section VI.B of this preamble. Comments on 
the ICR document must be received on or before November 14, 1997. Refer 
to Section VI.B for further information on this request for comment.

ADDRESSES: Comments. As noted above, comments on the ICR document 
associated with the final standards for new sources are requested. See 
section VI.B and the SUPPLEMENTARY INFORMATION section of this preamble 
for further information on obtaining a copy of the ICR document and 
addresses for submitting comments on the ICR document.
    Background Information. The principal background information for 
the final standards and guidelines includes a background information 
document entitled ``Hospital/Medical/ Infectious Waste Incinerators: 
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b), which 
contains a summary of all the public comments submitted regarding the 
changes to the standards and guidelines that were discussed in the June 
20, 1996 Federal Register document (61 FR 31736) and the EPA's response 
to these comments. Background information documents which present the 
economic and regulatory impacts of the standards and guidelines 
entitled: (1) ``Hospital/Medical/Infectious Waste Incinerators: 
Background Information for Promulgated Standards and Guidelines--
Analysis of Economic Impacts for Existing Sources'' (EPA-453/R-97-
007b); (2) ``Hospital/Medical/Infectious Waste Incinerators: Background 
Information for Promulgated Standards and Guidelines--Analysis of 
Economic Impacts for New Sources'' (EPA-453/R-97-008b); and (3) 
``Hospital/Medical/Infectious Waste Incinerators: Background 
Information for Promulgated Standards and Guidelines--Regulatory Impact 
Analysis for New and Existing Facilities'' (EPA-453/R-97-009b) are 
available. Also a document entitled ``Fact Sheet: New Hospital/Medical/
Infectious Waste Incinerators--Promulgated Subpart Ec Standards,'' 
which succinctly summarizes the final standards, and a document 
entitled ``Fact Sheet: Existing Hospital/Medical/Infectious Waste 
Incinerators--Promulgated Subpart Ce Emission Guidelines,'' which 
succinctly summarizes the guidelines, are available. See SUPPLEMENTARY 
INFORMATION for instructions and addresses for obtaining these 
documents.
    Docket. Docket No. A-91-61, which contains supporting information 
used in developing the standards and guidelines, is available for 
public inspection and copying between 8:00 a.m. and 4:00 p.m., Monday 
through Friday except for Federal holidays at the following address: 
U.S. Environmental Protection Agency, Air and Radiation Docket and 
Information Center (Mail Code 6102), 401 M Street SW, Washington DC 
20460 (phone: (202) 260-7548). The docket is located at the above 
address in room M-1500, Waterside Mall (ground floor, central mall). A 
reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: Mr. Rick Copland at (919) 541-5265, 
Combustion Group, Emission Standards Division (MD-13), U. S. 
Environmental Protection Agency, Research Triangle Park, North Carolina 
27711 ([email protected]) or any of the EPA Regional Office 
contacts listed in Table 1 below.

               Table 1.--Contacts in EPA Regional Offices               
------------------------------------------------------------------------
            Region                     Contact             Phone No.    
------------------------------------------------------------------------
I (Boston)....................  Susan Lancey.........     (617) 565-3587
II (New York).................  Christine DeRosa.....     (212) 637-4022
III (Philadelphia)............  James Topsale........     (215) 566-2190
IV (Atlanta)..................  Scott Davis..........     (404) 562-9127
V (Chicago)...................  Douglas Aburano (MI).     (312) 353-6960

[[Page 48349]]

                                                                        
                                Ryan Bahr (IN).......     (312) 353-4366
                                Scott Hamilton (OH)..     (312) 353-4775
                                Charles Hatten (WI)..     (312) 886-6031
                                Mark Palermo (IL)....     (312) 886-6082
                                Rick Tonielli (MN)...     (312) 886-6068
VI (Dallas)...................  Mick Cote............     (214) 665-7219
VII (Kansas City).............  Wayne Kaiser.........     (913) 551-7603
VIII (Denver).................  Meredith Bond........     (303) 312-6438
IX (San Francisco)............  Patricia Bowlin......     (415) 744-1188
X (Seattle)...................  Catherine Woo........     (206) 553-1814
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION:

Regulated Entities

    Entities potentially regulated by the standards and guidelines are 
those which operate hospital/medical/infectious waste incinerators. 
Regulated categories and entities include those listed in Table 2.

                      Table 2.--Regulated Entitiesa                     
------------------------------------------------------------------------
                                                         Examples of    
                     Category                        regulated entities 
------------------------------------------------------------------------
Industry..........................................  Hospitals, nursing  
                                                     homes, research    
                                                     laboratories, other
                                                     health care        
                                                     facilities,        
                                                     commercial waste   
                                                     disposal companies.
Federal Government................................  Armed services,     
                                                     public health      
                                                     service, Federal   
                                                     hospitals, other   
                                                     Federal health care
                                                     facilities.        
State/local/Tribal Government.....................  State/county/city   
                                                     hospitals and other
                                                     health care        
                                                     facilities.        
------------------------------------------------------------------------
a This table is not intended to be exhaustive, but rather provides a    
  guide for readers regarding entities likely to be regulated by the    
  standards or guidelines for HMIWI. This table lists the types of      
  entities that EPA is now aware could potentially be regulated. Other  
  types of entities not listed in the table could also be regulated. To 
  determine whether your facility is regulated by the standards or      
  guidelines for hospital/medical/ infectious waste incinerators, you   
  should carefully examine the applicability criteria in sections 60.50c
  and 60.51c of the promulgated standards, section 60.32e of the        
  promulgated guidelines, and in section III.A of today's notice. If you
  have questions regarding the applicability of the HMIWI standards and 
  guidelines to a particular entity, consult a person listed in the     
  preceding FOR FURTHER INFORMATION CONTACT section.                    

Documents Available Electronically

    This Federal Register document discusses: (1) The standards for new 
HMIWI, (2) the guidelines for existing HMIWI, and (3) a request for 
public comment on the ICR document. This preamble and regulatory text 
are available electronically via the Internet. Also available 
electronically are FACT SHEETS, which summarize the final standards and 
guidelines. They are suggested reading for persons requiring an 
overview of the standards and guidelines. Hard copies of the FACT 
SHEETS can also be obtained by calling Donna Collins at (919) 541-5578. 
The following five items are available electronically in file 
``MWIFINAL.ZIP'':
    1. ``Fact Sheet: New Hospital/Medical/Infectious Waste 
Incinerators--Promulgated Subpart Ec Standards.''
    2. ``Fact Sheet: Existing Hospital/Medical/Infectious Waste 
Incinerators--Promulgated Subpart Ce Emission Guidelines.''
    3. Federal Register document for this promulgation: ``Standards of 
Performance for New Stationary Sources and Emission Guidelines for 
Existing Sources: Hospital/Medical/Infectious Waste Incinerators'' 
(this document).
    4. ``Hospital/Medical/Infectious Waste Incinerators: Background 
Information for Promulgated Standards and Guidelines--Summary of Public 
Comments and Responses'' (EPA-453/R-97-006b).
    5. Information Collection Request document for these standards for 
new sources: ``Supporting Statement for ICR No. 1730.02--1997 Standards 
for New Hospital/Medical/Infectious Waste Incinerators (Subpart Ec).''
    The documents are available via the Internet at ``http://
www.epa.gov/ttn/oarpg/rules.html''. The documents are also available 
via the Internet through the Unified Air Toxics Website at ``http://
www.epa.gov/oar/oaqps/airtox/''.

Judicial Review

    Under section 307(b)(1) of the Clean Air Act, judicial review of 
the actions taken by this notice is available by filing a petition for 
review in the U.S. Court of Appeals for the District of Columbia 
Circuit within 60 days of today's publication of this rule. Under 
section 307(b)(2) of the Clean Air Act, the requirements that are in 
today's notice may not be challenged later in the civil or criminal 
proceedings brought by the EPA to enforce these requirements.

Preamble Outline

    The following outline is provided to aid in locating information in 
the introductory text (preamble) to the final standards and guidelines.

I. Acronyms, Abbreviations, and Measurement Units
    A. Acronyms
    B. Abbreviations and Measurement Units
II. Introduction
    A. Purpose of the Standards and Guidelines
    B. Implementation of the Emission Guidelines
    1. Implementation Activities
    2. Public Involvement
    C. Technical Basis of the Standards and Guidelines
    D. February 1995 Proposal
    E. June 1996 Re-proposal
    F. Stakeholders and Public Involvement
III. Considerations in Developing the Final Standards and Guidelines
    A. Applicability
    1. Definition of Medical Waste
    2. Co-fired Combustors
    3. Waste Types
    4. Cement Kilns
    B. Pyrolysis Units
    C. Waste Management Plans
    D. Testing, Monitoring, and Inspection
    E. Operator Training and Qualification
IV. Standards of Performance for New Sources
    A. Summary of the Standards
    B. Significant Issues and Changes

[[Page 48350]]

    1. Combined Dry/Wet Scrubbers
    2. Siting Analysis
    C. Selection of MACT
    D. Impacts of the Standards
V. Emission Guidelines for Existing Sources
    A. Summary of the Guidelines
    B. Significant Issues and Changes
    C. Selection of MACT
    D. Impacts of the Guidelines
VI. Administrative Requirements
    A. Docket
    B. Paperwork Reduction Act
    C. Executive Order 12866
    D. Unfunded Mandates Reform Act
    E. Executive Order 12875
    F. Regulatory Flexibility Act (RFA) and Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA)
    G. Submission to Congress and the General Accounting Office
    H. Clean Air Act Procedural Requirements

I. Acronyms, Abbreviations, and Measurement Units

    The following acronyms, abbreviations, and measurement units are 
provided to clarify the preamble to the final standards and guidelines.

A. Acronyms

APCD  air pollution control device
APTI  Air Pollution Training Institute
CAA  Clean Air Act
CAAA  Clean Air Act Amendments of 1990
CEMS  continuous emissions monitoring system(s)
CFBC  circulating fluidized bed combustor
CFR  Code of Federal Regulations
DI  dry injection
EPA  U.S. Environmental Protection Agency
EG  emission guidelines
FF  fabric filter
FR  Federal Register
HAP  hazardous air pollutant(s)
HMIWI  hospital/medical/infectious waste incinerator(s)
ICCR  Industrial Combustion Coordinated Rulemaking
ICR  information collection request
MACT  maximum achievable control technology
MSW  municipal solid waste
MWC  municipal waste combustor(s)
MWI  medical waste incinerator(s)
MWP  medical waste pyrolysis
MWTA  Medical Waste Tracking Act
NAPH  National Association of Public Hospitals
NSPS  new source performance standards
NSR  new source review
NYSDOH  New York State Department of Health
OAQPS  Office of Air Quality Planning and Standards
OMB  Office of Management and Budget
ORD  Office of Research and Development
PSD  prevention of significant deterioration
RCRA  Resource Conservation and Recovery Act
RFA  Regulatory Flexibility Act
RMW  regulated medical waste
SBA  Small Business Administration
SBREFA  Small Business Regulatory Enforcement Fairness Act
SMSA  standard metropolitan statistical area
SWDA  Solid Waste Disposal Act

B. Abbreviations and Measurement Units

bps=bits per second
Btu=British thermal units
Btu/yr=British thermal units per year
Cd=cadmium
CDD/CDF=dioxins/furans
CO=carbon monoxide
dioxins=polychlorinated dibenzo-p-dioxins
dscf=dry standard cubic feet (at 14.7 pounds per square inch, 68 deg.F)
dscm=dry standard cubic meters (at 14.7 pounds per square inch, 
68 deg.F)
 deg.F=degrees Fahrenheit
ft3=cubic feet
furans=polychlorinated dibenzofurans
g=gram (454 grams per pound)
g/yr=grams per year
gr=grains (7,000 grains per pound)
HCl=hydrogen chloride
Hg=mercury
m3=cubic meter (35.3 cubic feet per cubic meter)
mg=milligrams (10-3 grams)
Mg=megagram (1.1 tons per megagram)
Mg/yr=megagrams per year
MMm3=million cubic meters
MW=megawatt
MW-hr/yr=megawatt-hours per year
ng=nanogram (10-9 grams)
NOX=nitrogen oxides
Pb=lead
PM=particulate matter
ppmv=parts per million by volume
SO2=sulfur dioxide
TEQ basis=2,3,7,8-tetrachlorinated dibenzo-p-dioxin toxic equivalent 
based on the 1989 international toxic equivalency factors
tons/d=tons per day
total mass basis=total mass of tetra-through octa-chlorinated dibenzo-
p-dioxins and dibenzofurans

II. Introduction

A. Purpose of the Standards and Guidelines

    The 1990 Clean Air Act Amendments (CAAA) reflect growing public 
concern about the large volume of toxic air pollutants released from 
numerous categories of emission sources. Title III of the CAAA 
specifically enumerated 189 hazardous air pollutants (HAP) and 
instructed EPA to protect public health by reducing emissions of these 
pollutants from the sources that release them. The EPA's standards are 
to be issued in two phases. The first phase standards are designed to 
bring all sources up to the level of emissions control achieved by 
those that are already well-controlled. The second phase standards, due 
a few years later, are to require further emission reductions in any 
case in which the first phase measures were not by themselves 
sufficient to fully protect the public health.
    In this context, the CAAA singled out waste incineration for 
special attention. Congress recognized both a high level of public 
concern about the incineration of municipal, medical, and other solid 
wastes and a number of special management concerns for these types of 
sources. Consequently, section 129 of the CAA directs EPA to apply the 
two-phase control approach to various categories of solid waste 
incinerators, including hospital/ medical/infectious waste 
incinerator(s) (HMIWI). Today's action promulgates standards and 
guidelines for new and existing HMIWI under section 129. Current 
methods of medical waste incineration cause the release of a wide array 
of air pollutants, including several pollutants of particular public 
health concern.
    The EPA estimates that there are approximately 2,400 HMIWI 
operating in the United States, which combust approximately 767 
thousand Mg (846 thousand tons) of hospital waste and medical/
infectious waste annually. Emissions from HMIWI contain organics 
(dioxins/furans), particulates (PM), metals (Cd, Pb, and Hg), acid 
gases (HCl and SO2), and NOX. These pollutants 
can have adverse effects on both public health and welfare. Pollutants 
of principal concern to public health include dioxins/furans, PM, Pb, 
Cd, and Hg. Today's standards and guidelines are set forth as emission 
limits and will significantly reduce HMIWI emissions.
    Several States, including New York, California, and Texas, have 
adopted relatively stringent regulations in the past few years limiting 
emissions from HMIWI. The implementation of these regulations has 
brought about very large reductions in HMIWI emissions and the 
associated risk to public health in those States. Today EPA is 
promulgating nationally applicable emission standards and guidelines 
for HMIWI that build on the experience of these leading States. Like 
the State regulations, the standards and guidelines promulgated today 
are based on the use of add-on air pollution control systems. These 
standards and

[[Page 48351]]

guidelines implement the first phase requirements of section 129 
described above. As described in detail below, section 129, like 
section 112, of the CAA instructs the Agency to set performance 
standards that challenge industry to meet or exceed the pollution 
control standards established by better controlled similar facilities. 
In this way, the overall state of environmental practice is raised for 
large segments of industry, a basic level of health protection is 
provided to all communities, situations in which uncertainty about 
total risk and hazard result in no protection for the exposed public 
are avoided, and yet the cost of pollution control to industry is 
constrained to levels already absorbed by similar operations. Eight 
years later, in a second phase, EPA will evaluate whether the residual 
public health risk warrants additional control.
    The EPA's Office of Research and Development (ORD) is preparing a 
national inventory of dioxin emissions as part of its Dioxin 
Reassessment. This effort will include emission estimates for HMIWI. 
Since the effort is not yet complete, the results are not included in 
this package. The ORD is considering a very similar approach to that 
used in this rulemaking and anticipates generating similar emission 
estimates.

B. Implementation of the Emission Guidelines

    The subpart Ce emission guidelines are unique in that, unlike the 
subpart Ec NSPS, the guidelines are not direct Federal requirements for 
HMIWI. The subpart Ec NSPS are Federal requirements that apply to all 
new HMIWI units that commence construction after June 20, 1996 or to 
existing HMIWI units that commence modification after March 16, 1998. 
The subpart Ce emission guidelines require States to develop section 
111(d)/129 State plans to regulate existing HMIWI built on or before 
June 20, 1996. These State plans must be submitted to EPA for approval 
and must be at least as protective as the guidelines. Together, 40 CFR 
part 60, subpart B and subpart Ce specify the content and the general 
rules for adopting and submitting the section 111(d)/129 State plans.
    The CAA requires that each State submit a State plan to EPA within 
1 year of EPA's adoption of the guidelines. State plans must contain 
specific information and legal mechanisms necessary to implement the 
guidelines. The State must make available to the public the State plan 
and provide opportunity for discussion of the State plan in a public 
hearing prior to submittal to EPA. The State must submit the final plan 
to EPA by September 15, 1998. The EPA then has 6 months to approve or 
disapprove the State plan. Plan approval or disapproval will be 
published in the Federal Register. If a State plan is disapproved, EPA 
will state the reasons for disapproval in the Federal Register. The 
State can respond to EPA's concerns and submit a revised plan. If a 
State does not submit an approvable State plan by September 15, 1999, 
EPA will adopt and implement a Federal plan that applies to existing 
HMIWI in the State.
1. Implementation Activities
    The EPA is preparing an Enabling Document to assist States with 
implementing the HMIWI guidelines. The EPA Regional Offices will mail 
hard copies of the Enabling Document to their State contacts. This 
document should be publicly available in the next few weeks. The public 
can access this document electronically via the Internet at ``http://
www.epa.gov/ttn/oarpg/rules.html'' or ``http://www.epa.gov/oar/oaqps/
airtox/'.
    In September 1997, EPA plans to broadcast a telecourse to States, 
regions, and the public on the HMIWI rule and on implementation 
requirements. State field offices will be notified of the telecourse. 
The EPA's distance learning network telecourse schedule, as well as a 
list of telecourse sites, is available at http://134.67.104.12/html/
apti/aptc.htm.
    Finally, EPA will host its annual Air Toxics Workshop for EPA 
Regions and States in Research Triangle Park in late August 1997. A 1-
hour session is scheduled to provide States an overview of the HMIWI 
rule and to discuss implementation issues. The Air Toxics Workshop 
provided for EPA Regions and States is not open to the public. 
Opportunities for public participation in the implementation process 
are discussed below.
2. Public Involvement
    Public participation, under the provision of the CAA, is an 
important right and responsibility of citizens in the State process of 
developing, adopting, and implementing section 111(d)/ 129 State plans. 
As with State Implementation Plans (SIP) for criteria pollutants, EPA 
regulations in 40 CFR part 60, subpart B, make it clear that citizen 
input on section 111(d)/129 State plans is encouraged in order to help 
define appropriate emission standards and retrofit schedules. Under 
Subpart B, some minimum public participation requirements are as 
follows:
    a. Reasonable notice of one or more public hearing(s) at least 30 
days before the hearing;
    b. One or more public hearing(s) on the section 111(d)/129 State 
plan (or revision) conducted at location(s) within the State, if 
requested;
    c. Date, time, and place of hearing(s) prominently advertised in 
each region affected;
    d. Availability of draft section 111(d)/129 State plan for public 
inspection in at least one location in each region to which it will 
apply;
    e. Notice of hearing provided to EPA Regional Administrator, local 
affected agencies, and to other States affected;
    f. Certification that the public hearing, if held, was conducted in 
accordance with Subpart B State procedures; and
    g. Hearing records must be retained for a minimum of 2 years; these 
records must include the list of commenters, their affiliation, summary 
of each presentation and/or comments submitted, and the State's 
responses to those comments.

C. Technical Basis of the Standards and Guidelines

    Section 129 requires the EPA to develop numerical emission 
limitations in the standards for new HMIWI and guidelines for existing 
HMIWI for the following: Particulate matter (PM), opacity, sulfur 
dioxide (CO2), hydrogen chloride (HCl), oxides of nitrogen 
(NOX), carbon monoxide (CO), lead (Pb), cadmium (Cd), 
mercury (Hg), and dioxins and dibenzofurans (dioxin/furan). Section 129 
requires that the standards and guidelines reflect the maximum degree 
of reduction in emissions of air pollutants, taking into consideration 
the cost of achieving such emission reduction, any nonair-quality 
health and environmental impacts, and energy requirements that the 
Administrator determines are achievable for a particular category of 
sources. This control level is commonly referred to as the ``maximum 
achievable control technology'' or ``MACT.'' Section 129 also provides 
that standards for new sources may not be less stringent than the 
emissions control achieved in practice by the best controlled similar 
unit. This is commonly referred to as the ``MACT floor'' for new HMIWI. 
Additionally, section 129 provides that the emission limitations in the 
guidelines for existing HMIWI may not be less stringent than the 
average emission limitation achieved by the best performing 12 percent 
of units in the category. This is commonly referred to as the ``MACT 
floor'' for existing HMIWI.

[[Page 48352]]

    The CAA requires EPA to evaluate standards and guidelines more 
stringent than the MACT floor, considering costs and other impacts 
described above. If EPA concludes that more stringent standards and/or 
guidelines are achievable considering costs and other impacts, then the 
standards and/or guidelines would be established at these more 
stringent levels (i.e., MACT would be more stringent than the MACT 
floor). The EPA may establish NSPS or EG at the MACT floor only if EPA 
concludes that the costs and/or other impacts associated with the more 
stringent requirements are unreasonable. In no case may EPA establish 
emission limitations less stringent than the MACT floor.
    Technical data on the number and size of HMIWI, control 
technologies in use, permit emission limits, and emission test data 
were used to determine the MACT floors for new and existing HMIWI and 
to define regulatory options more stringent than the MACT floors. The 
types of data EPA considered in selecting final standards and 
guidelines included emissions information from literature and State and 
local agencies; and emissions test data provided by industry or 
gathered during EPA's HMIWI emissions test program. Overall, the EPA 
used performance test data from over 30 HMIWI to develop the standards 
and guidelines.
    In keeping with the Administrator's ``reinventing government'' 
initiative, several of the changes to the guidelines and standards were 
made to streamline the regulations and provide increased flexibility 
while optimizing environmental control by using common sense 
initiatives. Examples of these changes include the following: (1) 
Reduced testing for HMIWI demonstrating compliance with the required 
emission levels; (2) narrowing the definition of medical waste; (3) 
clarification of siting requirements for new HMIWI; (4) allowing HMIWI 
operators to receive training and qualification through a State-
approved training program; (5) requiring facilities to develop a waste 
management plan instead of banning materials from waste streams; (6) 
revised text to clarify that the emission limits do not apply during 
periods when units are burning only pathological, chemotherapeutic, 
and/or low-level radioactive waste; (7) exemption for plants firing 
small amounts of hospital waste and/or medical/infectious waste (10 
percent or less by weight); (8) allowing certain records to be 
maintained in either electronic or paper format without duplication; 
and (9) establishing emission limits for existing HMIWI that may be met 
with either a wet or dry scrubber. All of these changes are discussed 
further in sections III, IV, and V of this preamble and in ``Hospital/
Medical/Infectious Waste Incinerators: Background Information for 
Promulgated Standards and Guidelines--Summary of Public Comments and 
Responses (EPA-453/R-97-006b). These changes improve the effectiveness 
and efficiency of the standards and guidelines without any reduction in 
environmental protection.

D. February 1995 Proposal

    On February 27, 1995 (60 FR 10654), EPA published proposed NSPS and 
EG for HMIWI. The 1995 proposal was the result of several years of 
effort reviewing available information in light of the CAA requirements 
described above.
    During the data-gathering phase of the HMIWI project, it was 
difficult to get an accurate count of the nationwide HMIWI population. 
In addition, it was difficult to find HMIWI with add-on air pollution 
control systems in place. Information from a few State surveys led to 
an estimated population of 3,700 existing HMIWI.
    The 1995 proposed standards and guidelines contained HMIWI 
subcategories that were determined based on design differences among 
different types of incinerators: continuous, intermittent, and batch. 
These three design types roughly correlate to HMIWI size.
    A few HMIWI with various levels of combustion control (no add-on 
air pollution control) were tested to determine the performance of 
combustion control in reducing HMIWI emissions. One HMIWI equipped with 
a wet scrubber (add-on control) was tested to determine the performance 
capabilities of wet scrubbing systems. A few other HMIWI equipped with 
dry scrubbing systems (add-on control) were tested to determine the 
performance capabilities of dry scrubbing systems. These systems were 
considered typical of air pollution control systems available at the 
time, and the data appeared to indicate that dry scrubbing systems 
could achieve much lower emissions than wet scrubbing systems.
    As mentioned above, the MACT floor for new HMIWI is to reflect the 
emissions control achieved by the best controlled similar unit. Dry 
scrubbing systems were identified on at least one HMIWI in each of the 
three subcategories (continuous, intermittent, and batch). 
Consequently, the MACT floor emission levels for the 1995 proposed NSPS 
reflected the performance capabilities of dry scrubbing systems.
    For existing HMIWI under the 1995 proposed emission guidelines, 
State regulations and permits were used to calculate the average 
emission limitation achieved by the best performing 12 percent of 
units. These results were then compared with the results of the 
emission tests on wet and dry scrubbing systems. This comparison led to 
the conclusion that the 1995 proposed MACT floor for existing HMIWI 
would require the use of a dry scrubbing system, even for small 
existing batch HMIWI.
    Following determination of the HMIWI population, subcategories, 
performance of technology, and MACT floors, the CAA requires EPA to 
consider standards and guidelines that are more stringent than the 
floors. However, because the MACT floors calculated for the 1995 
proposal were so stringent, EPA was left with few options to consider. 
Emission limits reflecting the capability of dry scrubbing systems with 
carbon were proposed for all sizes and types of new and existing HMIWI.
    A proposal is essentially a request for public comment on the 
information used, assumptions made, and conclusions drawn from the 
evaluation of available information. Following the 1995 proposal, more 
than 700 comment letters were received, some including new information 
and some indicating that commenters were in the process of gathering 
information for EPA to consider. The large amount of new information 
that was ultimately submitted addressed every aspect of the 1995 
proposed standards and guidelines, including: the existing population 
of HMIWI, HMIWI subcategories, the performance capabilities of air 
pollution control systems, monitoring and testing, operator training, 
alternative medical waste treatment technologies, and the definition of 
medical waste. In almost every case, the new information led to 
different conclusions, as outlined below.

E. June 1996 Re-Proposal

    On June 20, 1996, EPA published a Federal Register document to: (1) 
Announce the availability of the new information received following the 
1995 proposal, (2) review EPA's assessment of the new information, (3) 
provide EPA's inclinations as to how the new information might change 
the final standards and guidelines, and (4) solicit comments on EPA's 
assessments and inclinations. In the June 20, 1996 Federal Register 
document, EPA indicated that the notice was not a re-

[[Page 48353]]

proposal, but merely a notice of supplemental information. However, 
some commenters stated that the 1996 notice should be considered a re-
proposal. Upon consideration of these comments, EPA now considers the 
1996 notice to have been a re-proposal. The 1996 notice included all of 
the elements of a re-proposal, including: A new inventory of sources; 
new subcategories; revised assessments of emissions and performance of 
technology; new MACT floors; new regulatory options; revised cost, 
environmental, and economic impacts; an indication of EPA's selection 
of MACT; and a request for public comment. More importantly, virtually 
every aspect of the 1995 proposal was changed significantly by the 1996 
notice, making most of the analyses and conclusions from the 1995 
notice irrelevant. Therefore, in today's final rule, HMIWI which 
commenced construction after June 20, 1996 are considered new sources 
subject to the NSPS under Subpart Ec, and HMIWI which commenced 
construction on or before June 20, 1996 are considered existing sources 
subject to the EG under subpart Ce.
    The 1996 re-proposal served as a response to most comments on the 
1995 proposed rule. Comments on miscellaneous issues that were not 
addressed in the 1996 re-proposal notice are summarized and responded 
to in ``Hospital/Medical/Infectious Waste Incinerators: Background 
Information for Promulgated Standards and Guidelines--Summary of Public 
Comments and Responses'' (EPA-453/R-97-006b). The 1996 re-proposal 
notice discussed the reanalyses of new information that led to changes 
in the 1995 proposed standards and guidelines. Presented below is a 
brief summary of the reanalyses that occurred following the 1995 
proposal and a discussion of the EPA's inclinations that were 
introduced in the 1996 re-proposal.
    Following the 1995 proposal, a number of comments were received 
regarding the EPA's inventory of existing HMIWI. Most commenters felt 
that the EPA's inventory was inadequate and should be updated. In 
response to these concerns, the EPA compiled a new inventory of 
existing HMIWI based on information received from the American Hospital 
Association, State agencies, HMIWI vendors, commercial medical waste 
disposal companies, and other stakeholders. After several revisions, 
the final HMIWI inventory contained approximately 2,400 existing HMIWI.
    The Agency also reanalyzed the HMIWI subcategories based on the new 
information received after the 1995 proposal. In the 1996 re-proposal, 
the Agency stated that it was inclined to subcategorize the new and 
existing population of HMIWI into three subcategories based on waste 
charging capacity: small (200 lb/hr), medium (>200 and 
500 lb/hr) and large (>500 lb/hr). While these subcategories 
were based on HMIWI size, they also reflect design differences among 
HMIWI.
    Directly related to the issue of subcategorizing HMIWI by size is 
the question of how to determine HMIWI size in a manner that is 
consistent, uniform, and applicable to all HMIWI covered under the 
standards and guidelines. In the 1996 re-proposal, the EPA stated that 
it was inclined to base HMIWI capacity on either: (1) Volumetric waste 
burning capacity factors developed using the design heat release rate 
of the HMIWI and the heat content of medical waste or (2) an 
enforceable limit that would restrict waste charge rate.
    At the time of the 1995 proposal, relatively few emission test 
reports were available to the EPA from which to draw conclusions 
regarding the performance capabilities of various air pollution control 
systems. Many commenters believed that EPA misjudged the performance 
capabilities of various air pollution control technologies, especially 
the capabilities of wet scrubbing systems. Following the 1995 proposal, 
a number of emission test reports were submitted to EPA. The EPA 
reviewed the data contained in these emission test reports and, as a 
result, EPA's conclusions regarding the performance capabilities of 
various air pollution control technologies were revised and presented 
in the 1996 re-proposal.
    As discussed earlier, the new information submitted led to changes 
to the HMIWI inventory, subcategories, and conclusions about the 
performance of technology. Because these factors can influence the MACT 
floors, a review of the MACT floors was conducted. The recalculated 
MACT floors and the new conclusions regarding the performance 
capabilities of air pollution control technologies led to new 
conclusions regarding what technologies HMIWI would have to use to 
achieve the MACT floors.
    In the 1996 re-proposal, the EPA defined regulatory options more 
stringent than the MACT floors for new and existing HMIWI and presented 
the impacts of the regulatory options. After reviewing the emissions 
reductions that could be achieved and the impacts of the regulatory 
options, the EPA presented its inclinations as to which emission levels 
the final MACT standards and guidelines might reflect. For new medium 
and large HMIWI, the EPA stated that it was inclined to adopt emission 
limits that could be achieved with good combustion followed by a high 
efficiency wet scrubber and a DI/FF system with carbon (i.e., combined 
dry/wet scrubber with carbon). The EPA stated that it was inclined to 
adopt emission limits that could be achieved with good combustion and a 
moderate efficiency wet scrubber for new small HMIWI and for medium 
existing HMIWI. For large existing HMIWI, the EPA stated that it was 
inclined to adopt emission limits that could be achieved with the use 
of good combustion and a high efficiency wet scrubber. The EPA offered 
no inclinations for the emission limits for small existing HMIWI. 
Instead, the EPA discussed the regulatory options and impacts for small 
existing HMIWI and solicited comments on which emission levels would be 
suitable for the final guidelines.
    Many comments were also received regarding the 1995 proposed 
testing and monitoring requirements. Commenters noted that the proposed 
4-hour test run was much longer than the more conventional test run of 
about 1-hour. Commenters also noted that many hospitals and health care 
facilities would normally not have sufficient waste on hand to 
accommodate three, 4-hour test runs and the 1995 proposed emission 
testing requirements would substantially increase the costs associated 
with emission testing. In response to these comments, the EPA stated in 
the 1996 re-proposal that it was inclined to adopt requirements that 
EPA test methods be followed when performing emissions testing to 
determine compliance. This requirement would ensure that compliance 
testing follows the same procedures used to generate the emission data 
upon which the emission limits in the regulation were based. In most 
cases, three test runs of about 1 hour each would be necessary to 
determine compliance. An exception to this requirement would be 
emission testing to measure dioxin/furan emissions. The procedures 
outlined in the EPA test method frequently lead to test runs longer 
than 1 hour to ensure sufficient sample is gathered to accurately 
measure dioxin/furan emissions.
    Numerous comments were received on the 1995 proposed annual 
emission testing requirements. While some commenters supported the 
annual testing requirements, others felt that the proposed requirements 
for inspections, monitoring, and operator training were sufficient and 
much less expensive than

[[Page 48354]]

annual testing. Some commenters suggested that the annual emission test 
requirement be replaced with a requirement for annual equipment 
inspection and maintenance. Many of the commenters supportive of the 
proposed inspection requirements, however, suggested that the 
requirement for a ``third party'' inspection be deleted. Therefore, EPA 
stated in the 1996 re-proposal that it was inclined to include 
inspection and maintenance requirements wherever annual stack testing 
is not required and that the inspection would not have to be conducted 
by a third party.
    To consider comments on the 1995 proposal regarding the frequency 
of emission testing and the proposed inspection and monitoring 
requirements, EPA presented a matrix of testing and monitoring options 
and their associated costs in the 1996 re-proposal. The EPA noted that 
almost all of the emission testing and monitoring options under 
consideration cost more than the incinerator or emission control system 
that would be installed to meet the emission limits in the regulations. 
Consequently, the Agency stated that it was inclined to include 
monitoring of operating parameters and routine Method 9 opacity tests 
(instead of CO and opacity CEMS) in the final regulations to minimize 
costs.
    With regard to specific air pollution control device (APCD) 
operating parameters to be monitored, the Agency stated that it was 
inclined to require monitoring of the same parameters as outlined in 
the 1995 proposal for dry scrubbers, and the following for wet 
scrubbers: Scrubber exit temperature, scrubber liquor pH, scrubber 
liquor flow rate, and energy input to the scrubber (e.g., pressure drop 
or horsepower).
    The EPA also stated in the 1996 re-proposal that it was inclined to 
require initial and repeat stack testing (annual/skip testing) where 
the regulations are based on good combustion and wet and/or dry 
scrubbing systems; and initial stack testing and routine inspections 
where the regulations are based on the use of good combustion alone. 
With the annual/skip testing requirement, emission tests would be 
required for the first 3 years. If these tests show that the facility 
was in compliance each of these 3 years, then subsequent testing would 
be done every third year. Under the inclinations presented in the 1996 
re-proposal, annual or skip emission testing would only require 
emission testing of a few key or critical pollutants (i.e., only those 
necessary to gain a good indication that the air pollution control 
system is operating properly).
    A large number of comments were received on the 1995 proposed 
definition of medical waste. The majority of the commenters stated that 
the proposed definition of medical waste was too broad and should be 
narrowed. The commenters believed that the proposed definition would be 
adopted by other regulatory agencies, and as the definition became more 
widespread, that it would eventually force all health care facilities 
to handle most of their waste as if it were infectious. This would 
result in an increase in the volume of medical waste requiring special 
handling, which in turn would result in increased costs to dispose of 
waste from health care facilities. These commenters stated that health 
care facilities should be viewed as generating two waste streams: A 
medical waste stream, which is usually defined by the potential for 
disease transmission and requires special handling; and a noninfectious 
waste or ``health care trash'' waste stream, which has no potential for 
infection and is treated and handled as municipal waste. The commenters 
urged EPA to narrow the definition of medical waste used in the HMIWI 
regulations to one that includes only the infectious portion of the 
waste stream.
    In response to the comments concerning the 1995 proposed definition 
of medical waste, the EPA stated in the 1996 re-proposal that it was 
inclined to adopt a definition of medical waste that focuses on the 
infectious or potentially infectious portion of the overall medical 
waste stream. Given the confusion and number of varying definitions of 
medical waste in use at the Federal, State and local levels, the EPA 
stated that it was inclined to adopt a definition of medical waste for 
the HMIWI regulations from among those definitions already in use. 
Specifically, the EPA stated that it was inclined to adopt the New York 
State Department of Health (NYSDOH) definition of medical waste.
    In the 1996 re-proposal, the EPA also stated that it was inclined 
to exclude crematories and incinerators used solely for burning 
pathological waste (human or animal remains and tissues), incinerators 
used solely for burning ``off-spec'' or ``out of date'' drugs or 
pharmaceuticals, and incinerators used solely for burning radioactive-
type medical wastes from the HMIWI regulations. The EPA further stated 
that it was inclined to adopt separate regulations for pyrolysis 
treatment technologies and requested comment on the merits of continued 
development of separate pyrolysis regulations.

F. Stakeholders and Public Involvement

    Throughout the development of the standards and guidelines, EPA 
conducted meetings with stakeholders to explain EPA conclusions and 
solicit comments, data, and information. Numerous discussions were held 
with governmental entities, industry representatives, and environmental 
groups including, but not limited to, the following: the U.S. 
Conference of Mayors; the National League of Cities; the National 
Association of City and County Health Officials; the National 
Association of Counties; the National Association of Public Hospitals; 
the Department of Defense; the Department of Veterans Affairs; the 
American Hospital Association; the Medical Waste Institute; the Sierra 
Club; the Natural Resources Defense Council; vendors of pyrolysis 
units, HMIWI, continuous emission monitoring systems, and air pollution 
control technologies; and the general public.
    The standards and guidelines being adopted today were first 
proposed in the Federal Register on February 27, 1995 (60 FR 10654). 
The preambles for the 1995 proposed standards and guidelines described 
the rationale for the proposed standards and guidelines. Following the 
1995 proposal, the EPA provided interested persons the opportunity to 
comment through a written comment period and held a public hearing. The 
public comment period lasted from February 27, 1995 to April 28, 1995 
and all late comments were accepted. Over 700 comments were received 
from private citizens, industry representatives, environmental groups, 
and governmental entities. Several public meetings and meetings with 
industry stakeholders were held following the 1995 proposal to discuss 
EPA's assessment of new information submitted with comments, to gather 
additional information, and to solicit further comments. As discussed 
above in sections II.D and II.E, the comments and new information 
received following the 1995 proposal led to numerous changes to the 
standards and guidelines.
    On June 20, 1996, EPA re-proposed the standards and guidelines in 
the Federal Register. Following the 1996 re-proposal, the EPA held a 
public meeting to review the contents of the re-proposal and to answer 
questions so that interested parties could better prepare their written 
comments. The comment period remained open from June 20, 1996 until 
August 8, 1996. Again, late comments were accepted. Nearly 70 comments 
were received. The comments received following the 1996 re-proposal 
were carefully considered

[[Page 48355]]

and changes were made to the HMIWI standards and guidelines where 
appropriate. Sections III, IV, and V of this preamble discuss the 
responses to comments on the standards and guidelines that address the 
major concerns of the commenters on the 1996 re-proposal.

III. Considerations in Developing the Final Standards and 
Guidelines

    Following the June 20, 1996 re-proposal, the EPA received numerous 
comments concerning applicability of the standards and guidelines, 
pollution prevention, and the testing and monitoring requirements. 
Special consideration was given to these issues when developing the 
final HMIWI standards and guidelines. This section discusses these 
issues and changes, if any, that were made to the final HMIWI standards 
and guidelines following the 1996 re-proposal. Additional discussion 
and responses to specific concerns regarding these and other issues are 
provided in ``Hospital/Medical/Infectious Waste Incinerators: 
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b).

A. Applicability

    A great deal of interest and discussion has taken place regarding 
which incinerators should be subject to this rule and which should not. 
All comments have been considered and the following sections present 
EPA's final decisions.
1. Definition of Medical Waste
    This section discusses the evolution of the definition of medical 
waste used in determining the applicability of the HMIWI standards and 
guidelines. In the 1996 re-proposal ``medical waste'' was the term used 
to describe what is today called ``medical/infectious waste'' in the 
final HMIWI standards and guidelines. Similarly, the term ``medical 
waste incinerator'' or ``MWI'' was used to describe what is called 
``hospital/medical/ infectious waste incinerator'' or ``HMIWI'' in the 
standards and guidelines promulgated today.
    Section 129 of the CAA directs the EPA to adopt regulations for 
solid waste incineration units that combust ``hospital waste, medical 
waste, and infectious waste.'' Section 129(g)(6) states that the term 
``medical waste'' shall have the meaning ``established by the 
Administrator pursuant to the Solid Waste Disposal Act.'' For the 1995 
proposed air emission standards and guidelines for ``MWI,'' EPA adopted 
the definition of ``medical waste'' from the solid waste regulations 
codified in 40 CFR part 259, subpart B. As a result, medical waste was 
defined broadly as any solid waste that is generated in the diagnosis, 
treatment, or immunization of human beings or animals, in research 
pertaining thereto, or in the production or testing of biologicals. The 
broad definition of medical waste in the 1995 proposal was not intended 
to be used to identify ``infectious'' or ``potentially infectious'' 
items in the health care waste stream. The EPA's only intention was to 
define those items likely to be burned in an ``MWI'' for the sake of 
defining and regulating the air emissions from incinerators used to 
burn ``hospital waste, medical waste, and infectious waste.''
    As discussed earlier, the majority of the comments on the 1995 
proposed definition of medical waste stated that the proposed 
definition was too broad and should be narrowed. Consequently, the 1996 
re-proposal announced EPA's inclination to adopt an existing and more 
narrow definition of medical waste for the purpose of regulating 
``MWI.'' Specifically, the EPA stated that it was inclined to adopt the 
definition of medical waste created by the New York State Department of 
Health (NYSDOH). While inclined to adopt the NYSDOH definition, the EPA 
stated in the 1996 re-proposal that it was also considering definitions 
of medical waste adopted by other regulatory agencies and national 
associations as well as the 1995 proposed definition. The EPA solicited 
public comment on the merits of each definition as well as other 
definitions EPA should consider.
    Following the 1996 re-proposal, several commenters supported a 
definition of medical waste that is limited to potentially infectious 
materials and several commenters agreed that the NYSDOH definition of 
medical waste is appropriate. Other commenters suggested that the EPA 
Office of Solid Waste (OSW) definition of regulated medical waste (RMW) 
is more appropriate than the NYSDOH definition because Congress 
intended for EPA to use the Solid Waste Disposal Act (SWDA) definition.
    On the other hand, several commenters argued that a broad 
definition of medical waste is appropriate. The commenters stated that 
anything burned in an incinerator at a health care facility should be 
classified as medical waste and pointed out that the CAA requires EPA 
to regulate emissions from solid waste incineration units ``combusting 
hospital waste, medical waste and infectious waste.'' The commenters 
contended that facilities operating onsite incinerators would use them 
primarily for noninfectious waste, which produces emissions similar to 
medical waste when burned.
    The EPA has concluded that the Medical Waste Tracking Act (MWTA) 
definition of regulated medical waste is the most appropriate 
definition of medical/infectious waste for the final HMIWI standards 
and guidelines. As noted in the proposal and re-proposal, the EPA 
considered several definitions for purposes of these regulations (e.g., 
OSHA, NYSDOH, MWTA, AHA). Although the various definitions are not 
identical, they cover many of the same materials. After considering the 
comments received, the EPA today is promulgating the MWTA definition 
under the co-authority of section 2002 of the SWDA, 42 U.S.C. 6912, and 
sections 129 and 301 of the CAA, 42 U.S.C. 7429 and 7601.
    The EPA believes the MWTA definition is the most appropriate 
because it includes the materials of concern, and will lead to the 
least confusion in the regulated community because it is a familiar 
definition. In addition, the MWTA definition has undergone public 
comment at the Federal level, during both the rulemaking under the 
MWTA, as well as rulemaking on these regulations. The EPA emphasizes 
that the MWTA definition being promulgated today is solely for purposes 
of determining which incineration units are covered by the HMIWI 
regulations under section 129 of the CAA. It is not for purposes of 
determining applicability of SWDA requirements. THE MWTA definition, 
however, does not include hospital waste; thus, EPA also is 
promulgating today under authority of sections 129 and 301 of the CAA, 
42 U.S.C. 7429 and 7601, a definition of hospital waste.
    The MWTA differentiates between infectious and noninfectious 
wastes. The MWTA definition of RMW includes seven classes of waste 
which are very similar to the classes of infectious waste included in 
the NYSDOH definition. However, the MWTA definition of RMW is broader 
than the NYSDOH definition of medical waste because the MWTA definition 
includes some items (e.g., intravenous bags) which may not be 
infectious, but are aesthetically unpleasing. The MWTA definition does 
not include hazardous waste; household waste; ash from incineration of 
medical/infectious waste; human corpses, remains, and anatomical parts 
intended for interment or cremation; or domestic sewage materials.

[[Page 48356]]

    The EPA recognizes that the MWTA definition does not fully 
encompass the terms ``hospital waste, medical waste, and infectious 
waste.'' The MWTA definition, as well as other definitions considered 
for the final HMIWI regulations, cover ``medical waste and infectious 
waste,'' but do not cover ``hospital waste.'' Commenters are correct in 
pointing out that the emissions from combustion of hospital waste are 
very similar to emissions from the combustion of medical/infectious 
waste. Therefore, the final HMIWI standards and guidelines contain 
definitions for ``hospital'' and ``hospital waste'' and the definition 
of ``medical/infectious waste'' (MWTA definition). The definitions of 
``hospital'' and ``hospital waste'' will subject incinerators located 
at hospitals to the final standards and guidelines, whether they burn 
``infectious'' waste, ``noninfectious'' waste, or a combination.
    Commenters on the 1995 proposed regulations stated there are very 
few, if any, incinerators that are used by hospitals to burn only 
noninfectious hospital trash. Consequently, this inclusion of 
``hospital waste'' along with ``medical/infectious waste'' should: 
minimize the concern about the overly broad definition of medical 
waste; cover the same incinerators as envisioned in the 1995 proposal 
and 1996 re-proposal, resulting in the same emission reductions without 
imposing additional costs; and satisfy the CAA requirement to regulate 
solid waste incinerators combusting ``hospital waste, medical waste, 
and infectious waste.'' On the other hand, section 129 directs EPA to 
develop regulations for four categories of solid waste incinerators. 
Because municipal waste combustors (MWC), industrial/commercial waste 
incinerators, and other solid waste incinerators sometimes burn small 
amounts of hospital waste and/or medical/infectious waste, and because 
these other categories are already or will be subject to section 129 
regulations, the final HMIWI regulations focus on incinerators whose 
primary purpose is the disposal of hospital waste and/or medical/
infectious waste in an effort to avoid duplicative requirements. 
Combustors subject to subparts Ea, Eb, or Cb (the NSPS and EG for MWC 
larger than 250 tons per day) have been excluded from coverage under 
the HMIWI regulations. In addition, any incinerator which burns 10 
percent or less by weight hospital waste and medical/infectious waste 
is not subject to the final HMIWI standards and guidelines. This 10 
percent provision is discussed further in section A.2 ``Co-fired 
Combustors'' (below).
    The primary purpose of the MWTA definition of medical waste as used 
for the HMIWI standards and guidelines is to define items combusted in 
an HMIWI, and not to define items which could transmit disease. Only a 
small fraction of ``medical/infectious'' waste is truly ``infectious.'' 
The EPA believes that to add or remove specific items to or from the 
MWTA definition, as suggested by some commenters, would create 
additional regulatory confusion because the revised definition would 
essentially become a new definition of medical waste if altered. Any 
waste excluded from the MWTA definition is either covered now or will 
be covered in the future by other solid waste incinerator regulations.
    The final standards and guidelines will apply to hospital/medical/
infectious waste incinerators. It should be noted that the definition 
of medical/infectious waste adopted for the HMIWI regulations is not 
the government-wide Federal definition, or even the Agency-wide EPA 
definition of infectious waste. The medical/infectious waste definition 
contained in the final regulations promulgated today is for use in 
determining applicability of the HMIWI standards and guidelines only. 
It should also be noted that ``hospital waste'' is simply waste 
generated at a hospital. Most of the waste generated at a hospital (85 
to 90 percent or more) is simply municipal-type waste that may be 
recycled or disposed without special treatment. The use of the term 
``hospital waste'' in these regulations is for use in determining 
applicability of the HMIWI standards and guidelines only.
2. Co-fired Combustors
    In the 1996 re-proposal, the EPA provided no inclinations regarding 
the applicability of the HMIWI regulations to combustors that co-fire 
medical waste with other fuels or wastes. Some examples of units that 
might be used to co-fire medical waste along with other fuels or wastes 
include municipal waste combustors (MWC), boilers, and industrial/
commercial waste incinerators. During the public comment period 
following the 1996 re-proposal, several comments were received 
questioning the applicability of the HMIWI regulations to units that 
co-fire medical waste with other fuels or wastes.
    One commenter provided information on a circulating fluidized bed 
combustor (CFBC) steam plant which co-fires coal and medical waste. The 
commenter noted that traditional HMIWI burn materials with low sulfur 
content and that the proposed SO2 emission limit was 
arbitrarily set higher than actual HMIWI emissions. The commenter 
requested that the SO2 emission limit be raised to 100 ppm 
to accommodate the CFBC without affecting other incinerators that burn 
medical waste.
    Other commenters requested that ``potentially infectious'' medical 
waste and ``off-spec'' or ``out-of-date'' pharmaceuticals be allowed to 
be combusted in MWC along with municipal solid waste (MSW) without 
subjecting MWC to the HMIWI rules. The commenters noted that MWC which 
co-combust municipal and medical waste are regulated under the MWC 
emission standards. The commenters recommended that an exclusion be 
written into the final rule that will allow MWC combusting a minimal 
amount of medical waste (up to 10 percent of the waste stream) to be 
excluded from the HMIWI rule. The commenters suggested that, if EPA 
feels that co-combustion of MSW and medical waste in a small MWC not 
covered under the MWC standards is an environmental threat, that co-
combustion should not be allowed in MWC burning less than 40 tons per 
day. Other commenters stated that small MWC not regulated under the MWC 
standards should not be allowed to accept medical waste without 
complying with the HMIWI regulations.
    Other commenters requested that a ``de minimis'' quantity exemption 
be allowed for facilities that incinerate insignificant quantities of 
medical waste. Some commenters requested that clinical waste in the 
amount of 5 to 10 percent of the total waste stream be allowed to be 
disposed of in a pathological waste incinerator.
    Section 129 requires the EPA to develop NSPS and EG for MWC, HMIWI, 
industrial/commercial waste incinerators, and ``other'' solid waste 
incinerators. The final NSPS and guidelines applicable to MWC with 
capacities of greater than 40 tons/day were promulgated in December 
1995, but have since been partially vacated and remanded. In this case, 
it is not the EPA's intent for MWC to be dually covered under both the 
MWC regulations and the HMIWI regulations. Therefore, combustors 
subject to Subparts Ea, Eb, or Cb (the NSPS and EG for MWC larger than 
250 tons/day) have been excluded from coverage under the HMIWI 
regulations regardless of the amount of hospital waste or medical/
infectious waste combusted. As regulations are developed under Section 
129 for the other categories of solid waste incinerators, EPA will make 
clear which regulations apply to which incinerators. In some cases, 
incinerators

[[Page 48357]]

may be subject to more than one regulation.
    Commenters requesting that MWC, boilers, and other industrial 
processes that co-fire medical waste be exempted from coverage under 
the HMIWI regulations generally seem to agree that these units combust 
no more than 10 percent hospital waste and/or medical/infectious waste. 
Therefore, the final HMIWI NSPS and guidelines contain the provision 
that any incinerator or industrial process that combusts less than or 
equal to 10 percent hospital waste and medical/infectious waste (by 
weight) is not subject to the HMIWI NSPS and guidelines provided that 
the facility notifies the Administrator of an exemption claim and 
maintains records of the amount of hospital waste, medical/ infectious 
waste, and other fuels or wastes combusted.
    As discussed in section A.3 ``Waste Types'' (below), ``off-spec'' 
or ``out-of-date'' drugs are not considered to be medical/infectious 
waste as defined in the final HMIWI regulations and are not considered 
to be hospital waste, unless disposed with the hospital's waste. ``Off-
spec'' or ``out-of-date'' drugs are viewed the same as other fuels or 
wastes (e.g., municipal waste, coal, etc.) under HMIWI regulations. 
Therefore, incinerators that combust waste pharmaceuticals (i.e., 
``off-spec'' or ``out-of-date'' drugs), and combust 10 percent or less 
hospital waste and medical/infectious waste (by weight) are not subject 
to the HMIWI regulations. However, any incinerator that combusts waste 
pharmaceuticals along with more than 10 percent hospital waste and 
medical/infectious waste is subject to the HMIWI regulations.
    As also discussed in section A.3 ``Waste Types'' (below), 
pathological waste, chemotherapeutic waste, and low-level radioactive 
waste are considered ``excluded'' wastes. While these wastes sometimes 
meet the definition of hospital waste or medical/infectious waste, they 
are viewed the same as ``other'' fuels or wastes (e.g., municipal 
waste, coal, etc.) when calculating the amount of hospital waste and 
medical/infectious waste burned in a co-fired combustor. For example, a 
combustor burning 90 percent pathological waste with 10 percent 
hospital waste is a co-fired combustor, even if the pathological waste 
meets the definition of medical/infectious waste. However, any 
incinerator that combusts pathological, chemotherapeutic, and/or low-
level radioactive waste along with more than 10 percent of other 
materials meeting the definition of hospital waste and/or medical/
infectious waste is subject to the HMIWI regulations.
    While incinerators that burn 10 percent or less hospital waste and 
medical/infectious waste are excluded from the HMIWI regulations, this 
exclusion does not mean that EPA will not develop regulations which 
will cover these units in the future. The NSPS and EG that were 
recently remanded for MWC with capacities between 40 tons/day and 250 
tons/day will be revised and repromulgated. Furthermore, the CAA 
directs the EPA to develop regulations for all solid waste 
incinerators, including MWC with capacities less than 40 tons/day. The 
EPA has announced that regulations for other solid waste incinerators 
will be developed by the year 2000. Thus, burning of hospital waste or 
medical/infectious wastes in other solid waste incineration units will 
be covered by regulations developed within the next few years. 
Exclusion of incinerators that burn small amounts of hospital waste or 
medical/infectious waste from the HMIWI regulation is only a temporary 
deferment from regulation if these units are not presently regulated 
under section 129.
3. Waste Types
    In the 1996 re-proposal, the EPA stated that it was inclined to 
exclude crematories and incinerators used solely for burning 
pathological waste from coverage under the HMIWI regulations. The EPA 
also stated that it was inclined to exclude incinerators used solely 
for burning low-level radioactive waste or ``off-spec'' and ``out-of-
date'' pharmaceuticals. This section discusses the major public 
comments received regarding exemption of specific wastes from the HMIWI 
standards and guidelines.
    Several commenters requested that crematories and incinerators used 
solely for burning pathological waste be excluded from the HMIWI 
regulation. One commenter questioned whether animal waste is to be 
included, excluded, or partially excluded from the regulation. Another 
commenter stated that there are no effective alternative disposal 
options for pathological waste, especially for large domestic animal 
carcasses (i.e., cows and horses). Several commenters also requested 
that incinerators used to burn only ``off-spec'' and ``out-of-date'' 
drugs or low-level radioactive waste be excluded from the regulation. 
One commenter stated that crematories and incinerators used to burn 
drugs, low-level radioactive waste, and pathological waste are already 
covered under other regulations, or will be covered under regulations 
developed through EPA's Industrial Combustion Coordinated Rulemaking 
(ICCR) project. Other commenters urged EPA to exclude units permitted 
under section 3005 of the SWDA from the HMIWI rule. One commenter 
argued that section 129 of the CAA statutorily prohibits EPA from 
regulating in the HMIWI rule hazardous waste combustion units which are 
to be regulated under the Resource Conservation and Recovery Act 
(RCRA).
    Pathological waste, low-level radioactive waste, and 
chemotherapeutic waste are different from most hospital waste and 
medical/infectious waste and are often burned in incinerators which 
burn these wastes exclusively. While these wastes often times meet the 
definition of hospital waste or medical/infectious waste, the 
combustion of these materials warrants separate consideration. 
Pathological waste, chemotherapeutic waste, and low-level radioactive 
waste are considered ``excluded'' wastes, regardless of whether the 
waste meets the definition of hospital waste or medical/infectious 
waste in the HMIWI regulations. Consequently, in determining the amount 
of hospital waste and medical/infectious waste burned in a co-fired 
combustor, these ``excluded'' wastes are included in the calculation as 
``other'' wastes (they do not count toward the 10 percent hospital 
waste and medical/infectious waste), as discussed above in section A.2. 
In addition, incinerators that are otherwise subject to the HMIWI 
regulations are exempt during periods when only pathological waste, 
low-level radioactive waste, and/or chemotherapeutic waste is burned. 
These latter units must keep records of the periods of time when only 
pathological, chemotherapeutic, and low-level radioactive wastes are 
burned.
    With regard to crematories, human remains intended for interment or 
cremation are not hospital waste or medical/infectious waste. 
Consequently, crematories are not subject to the HMIWI regulations 
unless they burn waste that meets the definition of hospital waste or 
medical/infectious waste.
    While pathological incinerators, chemotherapeutic and low-level 
radioactive waste incinerators, and crematories are excluded from the 
final HMIWI standards and guidelines, this exclusion does not mean that 
EPA will not develop regulations which will cover these incinerators in 
the future. The CAA directs the EPA to develop regulations for all 
solid waste incinerators. The EPA is developing separate regulations 
which will cover these units as part of the ``other'' category of solid 
waste incineration

[[Page 48358]]

units within the ICCR project. The EPA has announced that regulations 
for other solid waste incinerators will be developed by the year 2000. 
Thus, cremation and burning of pathological, chemotherapeutic, and low-
level radioactive wastes will be covered by regulations developed 
within the next few years. Exclusion of crematories and incinerators 
burning pathological, chemotherapeutic, and low-level radioactive waste 
from the HMIWI regulation is only a temporary deferment.
    Pharmaceutical wastes such as ``off-spec'' or ``out-of-date'' drugs 
are not considered to be medical/infectious waste as defined in the 
final HMIWI regulations. Also, pharmaceutical wastes are not considered 
to be hospital waste unless generated at a hospital and disposed with 
the hospital's waste. In the HMIWI regulations ``hospital waste'' is 
defined as discards generated at a hospital, excluding human remains 
and unused items returned to the manufacturer. Thus, ``out-of-date'' 
drugs returned by a hospital to a pharmaceutical company for disposal 
are not considered hospital waste. Waste pharmaceuticals are viewed the 
same as other fuels and wastes (e.g., municipal waste, coal, etc.) 
under the HMIWI regulations. Therefore, incinerators that combust waste 
pharmaceuticals, and combust 10 percent or less hospital waste and 
medical/infectious waste (by weight) are not subject to the HMIWI 
regulations. However, any incinerator that combusts waste 
pharmaceuticals along with more than 10 percent hospital waste and 
medical/infectious waste is subject to the HMIWI regulations.
    Section 129(g)(1) of the CAA specifically exempts from the HMIWI 
NSPS and guidelines solid waste incinerators required to have a permit 
under section 3005 of the SWDA. To be consistent with section 129, the 
final HMIWI standards and guidelines specifically exempt incinerators 
permitted under section 3005 of the SWDA. In addition, the definition 
of medical/infectious waste in the final regulations specifically 
excludes hazardous waste identified or listed under the regulations in 
40 CFR Part 261.
4. Cement Kilns
    Some commenters pointed out that section 129 clearly addresses 
incinerators, not cement kilns. Commenters stated that HMIWI and cement 
kilns using medical waste as fuel are two completely different devices 
and should not be confused with each other or regulated under the same 
air emissions control standards. One commenter recommended that if EPA 
concludes that Congress intended to regulate cement kilns under section 
129, EPA should not impose emission limitations and other requirements 
that were written for HMIWI on cement kilns.
    The EPA disagrees with commenters that contend EPA has no authority 
to regulate cement kilns under section 129. Section 129(a)(1)(A) 
requires the Administrator to establish performance standards and other 
requirements for each category of solid waste incineration units. 
Congress specifically listed in section 129 various categories of solid 
waste incineration units that EPA must regulate. Section 129(g)(1) 
broadly defines solid waste incineration unit as ``a distinct operating 
unit of any facility which combusts any solid waste material * * *'' 
(emphasis added). This definition clearly indicates Congress' intent to 
regulate more than just incinerators because the definition sweeps 
within its scope any facility that is combusting any solid waste 
material.
    Further evidence of EPA's authority to regulate cement kilns under 
section 129 is presented in ``Hospital/Medical/Infectious Waste 
Incinerators: Background Information for Promulgated Standards and 
Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-97-
006b). However, the EPA does recognize that cement kilns are different 
from HMIWI in size, design, and operation. Accordingly, the EPA is not 
regulating cement kilns under this regulation, but instead, is 
determining whether separate regulations under section 129 are 
appropriate for cement kilns combusting solid waste materials.

B. Pyrolysis Units

    In the 1996 re-proposal, the EPA stated that it was considering a 
separate regulation for pyrolysis units that would look very similar to 
the HMIWI regulation in that it would contain definitions, emissions 
limitations, monitoring and testing requirements to demonstrate 
compliance, and reporting and recordkeeping requirements. However, the 
separate pyrolysis regulation would differ from the HMIWI regulations 
in that some definitions would be different, the emission limitations 
would, in many cases, be more stringent than the HMIWI regulations, and 
the monitoring and testing requirements would reflect the operating 
parameters that are unique to pyrolysis systems.
    Following the 1996 re-proposal, several commenters encouraged EPA 
to promulgate separate standards for medical waste pyrolysis (MWP) 
units. One commenter noted that separate regulations would contain 
emission limits more stringent than the HMIWI regulations and reflect 
the unique features of pyrolysis units.
    Other commenters suggested that EPA modify the 1995 proposed HMIWI 
regulations to include pyrolysis units and defer the final promulgation 
of separate pyrolysis regulations. The commenters stated that 
variations in the operating characteristics among pyrolysis 
technologies would make separate pyrolysis regulations unwieldy to 
implement at this time. The commenters requested that EPA modify the 
HMIWI regulations to provide flexibility if a specific operator 
training, siting, performance verification, compliance verification, 
monitoring, recordkeeping or reporting requirement does not directly 
apply to a pyrolysis system.
    Other commenters stated that pyrolysis units are similar to 
conventional incinerators and requested that they be included under the 
HMIWI regulations. The commenters stated that, if EPA regulates 
pyrolysis units separately, that MACT floor levels should be based on 
available test data, and the pyrolysis regulation should be issued 
concurrently with the final HMIWI regulations.
    The various arguments for and against developing separate 
regulations for pyrolysis units lead to three options for developing 
regulations for pyrolysis units: (1) Regulate pyrolysis under the 
standards and guidelines being promulgated today; (2) exempt pyrolysis 
units from the HMIWI regulations and simultaneously promulgate separate 
regulations for pyrolysis units; and (3) exempt pyrolysis units from 
the HMIWI regulation and defer the development of separate regulations.
    Pyrolysis technology is different from conventional incineration. 
Because air is generally not used in the pyrolysis treatment process, 
the volume of exhaust gas produced from pyrolysis treatment is likely 
to be far less than the volume of gas produced from the burning of 
waste in an HMIWI. Although conventional combustion does not occur 
during pyrolysis treatment, there are some emissions from the pyrolysis 
process.
    As discussed in the 1996 re-proposal, the EPA developed a draft 
regulation for pyrolysis units. The 1996 re-proposal pointed out that 
the draft regulatory text was incomplete and it included placeholders 
and requests for information where such information was lacking. The 
EPA requested

[[Page 48359]]

comments to help fill in the missing information.
    Following the 1996 re-proposal, the EPA received information for 
use in developing the separate pyrolysis regulation from vendors of 
pyrolysis technology. As pointed out by one commenter and supported by 
the information received from pyrolysis vendors, there are variations 
in the operating characteristics among pyrolysis technologies that 
would make separate regulations for pyrolysis units very difficult to 
implement at this time. As a result, the EPA has concluded that 
sufficient information is not available to develop a separate and 
uniform regulation for pyrolysis technology that would contain 
requirements that are technically feasible for all pyrolysis units.
    Because separate regulations for pyrolysis technology cannot be 
developed at this time, the EPA considered modifying the HMIWI 
regulations to include pyrolysis units. However, nearly all aspects of 
the HMIWI regulations would have to be altered to accommodate pyrolysis 
units including the format of the emission limits, the operator 
training requirements, siting requirements, the testing and monitoring 
requirements, and the reporting and recordkeeping requirements. 
Furthermore, the HMIWI subcategories and MACT floors would not be 
appropriate for pyrolysis units. Due to variations in the operating 
characteristics of pyrolysis technologies and the differences between 
HMIWI and pyrolysis technologies, it is unclear how the HMIWI 
regulations could be modified to feasibly cover pyrolysis technologies 
as well as HMIWI.
    Section 129 requires EPA to develop NSPS and EG for ``solid waste 
incineration units * * * combusting hospital waste, medical waste, and 
infectious waste.'' As discussed above, pyrolysis and conventional 
incineration are not the same. Because regulations developed for HMIWI 
are not appropriate for pyrolysis technologies, pyrolysis treatment 
technologies have specifically been excluded from coverage under the 
final HMIWI standards and guidelines. The EPA may consider these 
devices in future regulatory development.

C. Waste Management Plans

    During the public comment period following the 1996 re-proposal, 
several commenters stated that the EPA standards for HMIWI are reliant 
on pollution control and give little attention to pollution prevention. 
The commenters stated that recycling and pollution prevention measures 
could yield greater reductions in emissions than add-on controls alone. 
Some commenters stated that Congress intended for EPA to use process 
changes or substitution of materials to help eliminate emissions. Some 
commenters stated that dioxin/furan, HCl, and Hg emissions could be 
controlled through a pollution prevention program that reduces or 
eliminates incineration of chlorinated materials and batteries. One 
commenter requested that EPA suggest pollution prevention measures for 
controlling Hg as well as other pollutant precursors (i.e., lead, 
cadmium, chlorine, nitrogen, fluorine, and sulfur). The commenter 
maintained that the economic impact of the HMIWI regulations could be 
reduced significantly if EPA required medical facilities to institute 
pollution prevention techniques.
    The types of materials sent to an HMIWI vary from facility to 
facility depending on facility operating practices, which are defined 
by purchasing decisions, waste handling procedures, and other practices 
that affect the types of materials incinerated.
    In the February 1995 proposal, the EPA stated that it had no data 
to indicate the effects of waste handling practices on emissions of 
various pollutants and requested comments on the extent to which 
operating practices could influence emissions. To evaluate the 
effectiveness of waste segregation programs, the EPA specifically 
solicited detailed descriptions of programs and results of performance 
tests conducted to demonstrate pollutant emission levels from the HMIWI 
prior to implementation of the program and subsequent to implementation 
of the program. In addition, the EPA solicited comments on how such a 
program could be incorporated into the HMIWI regulations.
    Following the 1995 proposal, the EPA received no data to 
conclusively indicate the effectiveness of waste segregation programs 
in reducing emissions from HMIWI. Therefore, the final HMIWI standards 
and guidelines are primarily based on air pollution controls rather 
than pollution prevention. However, as discussed in the 1996 re-
proposal, EPA has included pollution prevention measurements in setting 
the Hg emission limit for good combustion. To ensure that emissions of 
Hg from facilities with good combustion controls meet the final 
emission guidelines for Hg, EPA is requiring that these facilities 
conduct a Hg emission test. If the facility fails the emission test, 
the facility will need to implement Hg pollution prevention measures or 
install an APCD to meet the emission limits.
    The EPA has investigated the impacts on emissions of shifting the 
waste composition from chlorinated plastics to non-chlorinated 
polymers. However, the outcome of this investigation is inconclusive. A 
number of studies have concluded that the chlorine content of the waste 
is directly related to dioxin/furan emissions, while other studies 
suggest there is no relationship between the chlorine content of the 
waste and dioxin/furan emissions. At this point, the effectiveness of a 
pollution prevention program directed at reducing dioxin/furan 
emissions through shifting the waste composition from chlorinated 
plastics to nonchlorinated polymers would be questionable.
    A number of health care facilities have implemented waste 
management measures to reduce the overall volume of waste. However, it 
should be stressed that each health care facility is unique and site-
specific strategies must be developed that achieve the most efficient 
results. Through the development of individual waste management 
programs, health care facilities can achieve significant reductions in 
their waste stream, reduce the volume of waste to be incinerated, and 
thereby reduce the amount of air pollution emissions associated with 
that waste. Therefore, the final HMIWI standards and guidelines require 
that health care facilities which operate incinerators develop and 
implement a waste management plan.
    The waste management plan would identify both the feasibility and 
the approach to separate certain components of solid waste from the 
health care waste stream in order to reduce the amount of toxic 
emissions from incinerated waste. The waste management plan may include 
elements such as paper, cardboard, plastics, glass, battery, or metal 
recycling; or purchasing recycled or recyclable products. A waste 
management plan may include different goals or approaches for different 
areas or departments of the facility and need not include new waste 
management goals for every waste stream. It should identify, where 
possible, reasonably available additional waste management measures, 
taking into account the effectiveness of waste management measures 
already in place, the costs of additional measures, the emission 
reductions expected to be achieved, and any other environmental or 
energy impacts they might have. A copy of the waste management plan 
would be submitted to EPA along with the results of the initial 
performance test demonstrating compliance with the emission limits. In 
addition, the waste

[[Page 48360]]

management plan may be reviewed by the Joint Commission on 
Accreditation of Health Care Organizations during the accreditation 
process.
    Health care facilities are encouraged to review and incorporate 
into their waste management plans the waste minimization techniques 
discussed in ``An Ounce of Prevention: Waste Reduction Strategies for 
Health Care Facilities,'' which is published by the American Society 
for Health Care Environmental Services of the American Hospital 
Association. This document may be obtained by contacting AHA Services, 
Inc., P.O. Box 92683, Chicago, Illinois 60675-2683, or by calling 800-
242-2626. The cost of the document is $50.00 plus $10.95 for shipping 
and handling. The document is available for public inspection at EPA's 
Air and Radiation Docket and Information Center (Docket A-91-61, item 
IV-J-124). See the ADDRESSES section at the beginning of this preamble 
for the location of the Docket. Note that because of copyright law, 
this document may not be copied. This document was approved for 
incorporation by reference by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

D. Testing, Monitoring, and Inspection

    Section 129(c) of the CAA requires the EPA to include emissions 
monitoring and testing requirements in the regulation. The purpose of 
these requirements is to allow the EPA to determine whether a source is 
operating in compliance with the regulations.
    In the 1996 re-proposal, the EPA stated that it was inclined to 
adopt requirements that EPA test methods be followed when performing 
any emission testing required to determine compliance with the HMIWI 
regulations. In most cases, three test runs of about 1 hour each would 
be necessary to determine compliance. The EPA also stated in the 1996 
re-proposal that it was inclined to include in-house inspection and 
maintenance requirements wherever annual stack testing was not 
required. To minimize costs, the EPA stated that it was inclined to 
include requirements for monitoring of operating parameters and routine 
Method 9 (stack opacity) testing in the final regulations instead of CO 
and opacity continuous emissions monitoring systems (CEMS) for onsite 
HMIWI. Where the regulations are based on wet and/or dry scrubbing 
systems, the EPA stated that it was inclined to require initial and 
repeat stack testing (annual/skip testing where annual testing is 
required for the first 3 years and, if these tests show compliance, 
subsequent testing would be done every third year). Where the 
regulations are based, in part, on the use of good combustion alone, 
the EPA stated that it was inclined to require initial stack testing 
and routine inspections. The EPA solicited public comment on all of the 
testing and monitoring inclinations presented in the 1996 re-proposal. 
In addition, because some CEMS vendors questioned the CEMS and 
parameter monitoring costs developed by EPA, the EPA solicited public 
comment on the costs of CEMS and monitoring of operating parameters.
    Several comments concerning the EPA's inclinations for monitoring 
and testing were received following the 1996 re-proposal. One commenter 
requested that EPA require CEMS for CO, HCl, SO2, 
NOX, Hg, and PM. The commenter contended that CEMS for CO, 
HCl, SO2, NOX, Hg, and PM would eliminate the 
need for stack testing. The commenter stated that the only way to 
ensure compliance at all times, as mandated by the CAA, is through the 
continuous use of CEMS. One commenter stated that EPA should require 
continuous monitoring of CO emissions from all HMIWI, continuous 
opacity monitoring at large incinerators, and continuous monitoring of 
HCl emissions from very large (>1000 lb/hr) incinerators. The commenter 
indicated that continuous monitoring of CO and O2 is the 
only way to ensure that good combustion is occurring. The commenter 
concluded that CO and O2 ``process'' monitors should be 
sufficient for HMIWI with capacities less than 500 lb/hr. The commenter 
stated that EPA's inclination not to require continuous monitoring is 
based on inaccurate CEMS costs.
    A number of commenters supported EPA's inclination to determine 
compliance using parameter monitoring and routine inspection and 
maintenance rather than CEMS. One of the commenters supported 
monitoring of operating parameters and routine Method 9 testing 
combined with initial stack testing and annual inspections to ensure 
compliance with the rule. Another commenter stated that an initial 
stack test for the primary pollutants and regular inspection, 
maintenance, and daily recording of operating parameters would be 
appropriate. One commenter stated that monitoring of operating 
parameters with no CEMS and substitute stack testing with annual 
inspections would provide an excellent means to attain low emissions 
for minimal costs for small HMIWI. Other commenters recommended 
monitoring operating parameters and routine Method 9 testing with 
initial stack testing and no repeat testing. Another commenter 
suggested that an initial performance test and monitoring is sufficient 
and that additional tests are not necessary especially given operator 
training, inspections, and monitoring.
    The most direct means of ensuring compliance with emission limits 
is the use of CEMS. As a matter of policy, the first and foremost 
option considered by EPA is to require the use of CEMS to demonstrate 
continuous compliance with specific emission limits. Other options are 
considered only when CEMS are not available or when the impacts of 
including such requirements are considered unreasonable. When 
monitoring options other than CEMS are considered, there is always a 
tradeoff between the cost of the monitoring requirement and the quality 
of the information collected with respect to determining actual 
emissions. While monitoring of operations (operating parameters) cannot 
provide a direct measurement of emissions, it is usually much less 
expensive than CEMS, and the information provided can be used to ensure 
that the incinerator and associated air pollution control equipment are 
operating properly. This information provides EPA and the public with 
assurance that the reductions envisioned by the regulations are being 
achieved.
    For the 1996 re-proposal, testing and monitoring costs were 
developed for a range of options, and the Agency concluded that the 
cost of CEMS were unreasonably high relative to the cost of the 
incinerators and air pollution control systems needed for compliance. 
Based on comments and information received as a result of the 1996 re-
proposal, the cost estimates for CEMS and parameter monitoring have 
been revised. While the cost estimates for CEMS have been significantly 
reduced and additional costs have been included for parameter 
monitoring, it appears that the annual costs of monitoring requirements 
which include CEMS are still quite high compared to the cost of the 
incinerator and air pollution control device required to meet the 
emission limits.
    A large HMIWI costs approximately $120,000/yr to operate, while an 
add-on APCD can cost from $150,000 to $300,000/yr to operate. The most 
comprehensive monitoring option including CEMS for HCl and CO costs 
about $95,000/yr. This option costs nearly as much to operate as the 
incinerator itself and could represent as much as half the cost of the 
APCD. In addition, the only emissions that are directly measured are 
HCl and CO. Consequently, the most comprehensive

[[Page 48361]]

monitoring option that could be selected for large HMIWI is considered 
unreasonable.
    There are no direct measurements of dioxin/furan or toxic metals. 
Particulate matter and Hg CEMS are currently under development but have 
not been demonstrated in the United States to be capable of accurately 
and reliably measuring PM or Hg emissions for use in determining 
compliance with PM or Hg emission limits at this time. With regard to 
SO2 and NOX, the emission limits in the final 
regulations reflect uncontrolled emissions. Therefore, it is 
unreasonable to impose a cost (of monitoring) where no emission 
reduction benefit will be gained.
    Looking at other options for large HMIWI, the only CEMS available 
are CO/O2 and opacity. For a large HMIWI equipped with a 
sophisticated APCD like a wet scrubber, dry scrubber, or combined dry/
wet scrubber, these CEMS provide very little information regarding the 
pollutants that are of most concern to the public (i.e., dioxin/furan 
and toxic metals). Consequently, because the APCD already represents a 
substantial increase in the cost of incineration and because the more 
comprehensive monitoring options do not provide much information 
regarding the pollutants of most concern, the final monitoring and 
testing requirements for HMIWI equipped with APCD reflect routine stack 
testing coupled with continuous monitoring of operating parameters.
    Where incinerators are not equipped with add-on air pollution 
control (i.e., units utilizing good combustion alone), EPA agrees with 
commenters that CO provides the best measure of good combustion. 
However, regulations based on good combustion alone only apply to small 
existing HMIWI meeting certain ``remote'' criteria (see section V.B). 
For these small existing HMIWI using only good combustion, the 
incinerator costs about $35,000/yr to operate and the air pollution 
control costs about $10,000/yr to operate. Monitoring options including 
CO CEMS for compliance are clearly unreasonable at about $54,000/yr 
(five times the cost of the air pollution control). The monitoring 
option which includes a CO ``process'' monitor costs about $17,000/yr 
while the option that relies on operating parameters costs about 
$10,000/yr. The EPA does not believe that the CO ``process'' monitor 
provides enough additional information to justify the $7,000/yr 
additional cost, especially considering that the air pollution control 
only costs $10,000/yr. Consequently, where the regulations are based on 
good combustion alone, the monitoring requirements consist of an 
initial stack test coupled with continuous monitoring of operating 
parameters and annual inspections.
    The specific values for operating parameters are chosen by the 
owner or operator and are established during the initial performance 
test demonstrating compliance with the emission limits. After the 
performance test, monitoring of the operating parameters is the only 
way to determine, on a continuous basis, whether the source is 
operating in compliance. Operation outside the bounds of an established 
operating parameter is a violation of an operating parameter limit. In 
addition, under certain conditions, operation outside the bounds of one 
or more parameter limits constitutes a violation of a specific emission 
limit. This latter provision was included in the 1995 proposed 
regulations and is retained in the final regulations. The owner or 
operator has the flexibility to choose the values for the operating 
parameters and may conduct repeated performance tests to ``fine tune'' 
the operating parameter limits, if desired.
    With regard to the testing requirements, annual testing is required 
for the first 3 years. If these tests show that the facility is in 
compliance each of these 3 years, then subsequent testing would be done 
every third year. Initial testing includes testing for the following 
pollutants: PM, CO, HCl, dioxin/furan, Pb, Cd, Hg, and opacity. The 
annual/skip or ``repeat'' testing only includes testing for PM, CO, 
HCl, and opacity. Where good combustion alone serves as the basis for 
the emission limits, the Agency only requires facilities to perform an 
initial compliance test for PM, CO, dioxin/furan, Hg, and opacity, 
annual incinerator inspections, annual opacity testing, and parameter 
monitoring (charge rate and secondary chamber temperature). Minimum 
sampling times of 1 hour (4 hours for dioxin/furan) have been included 
in the final regulations for all HMIWI.
    The ``repeat'' testing requirements will ensure, on an ongoing 
basis, that the APCD is operating properly, that no deterioration in 
performance has occurred, and that no changes have been made to the 
operating system or the type of waste burned. Where ``repeat'' testing 
is not required, annual inspections, annual opacity testing, and 
parameter monitoring will ensure that the HMIWI is in good working 
order. However, cost considerations were the only reason for excluding 
the repeat testing for units with good combustion alone. Good 
combustion alone with its associated monitoring are provided in order 
to minimize costs for a small number of incinerators in remote areas 
where alternatives to incineration might be unavailable. Initial 
testing for good combustion units includes testing for PM, CO, dioxin/
furan, Hg, and opacity. The Hg testing is required to ensure that units 
are segregating Hg bearing wastes and meeting the Hg emission limit.
    Rather than require third-party inspections, which could be 
burdensome for small remote facilities, the final guidelines allow for 
in-house equipment inspections. However, EPA plans to work with States 
to give higher priority to these small remote facilities in terms of 
enforcement inspections. Either the EPA or the State will inspect these 
small remote facilities annually for the first three years after the 
State plan is approved. Following the three-year period, these sources 
will be placed on the regular enforcement inspection schedule.

E. Operator Training and Qualification

    The final operator training and qualification requirements are 
almost identical to those described in the 1996 re-proposal. The final 
requirements provide flexibility by allowing State-approved training 
and qualification programs. Where there are no State-approved programs, 
the final regulations include minimum requirements for training and 
qualification. The EPA has a training manual available through its Air 
Pollution Training Institute (APTI). For further information, contact 
APTI at (919) 541-2497. In addition, EPA plans to work with the 
American Hospital Association to develop a correspondence course for 
those facilities that may not have access to adequate training. As 
discussed above, EPA plans to work with States to give higher priority 
to the small remote units in terms of enforcement inspections, 
including a review of operator training.

IV. Standards of Performance for New Sources

    This section presents a summary of the final standards, including 
identification of the source category and pollutants being regulated, 
and presentation of the final emission limits and their associated 
performance testing, monitoring, recordkeeping and reporting 
requirements. This section discusses the most significant changes to 
the standards presented in the June 20, 1996 Federal Register document. 
Also discussed in this section is the rationale for the selection of 
MACT and a summary of the impacts of the final standards.

A. Summary of the Standards

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

[[Page 48362]]

construction commenced after June 20, 1996 or to an existing HMIWI for 
which modification commenced after March 16, 1998. Hospital/medical/
infectious waste incinerators for which construction commenced on or 
before June 20, 1996 are not covered under the subpart Ec standards; 
they are considered existing sources and are subject to the guidelines 
under subpart Ce (see section V of this notice).
    A HMIWI is defined as any device that combusts any amount of 
medical/infectious waste or hospital waste. The terms medical/ 
infectious waste and hospital waste are discussed in section III.A and 
defined in Sec. 60.51c. An incinerator is not subject to subpart Ec 
during periods when only pathological, low-level radioactive, or 
chemotherapeutic waste (all defined in Sec. 60.51c) is burned provided 
that the owner or operator keeps records of the periods of time when 
only pathological, low-level radioactive, and/or chemotherapeutic waste 
is burned. Any combustor required to have a permit under section 3005 
of the SWDA is exempt from subpart Ec as are incinerators subject to 
subpart Cb, Ea, or Eb. New incinerators, processing operations, or 
boilers that co-fire medical/infectious waste or hospital waste with 
other fuels or wastes and that combust 10 percent or less medical/
infectious waste and hospital waste by weight (on a calendar quarter 
basis) are not subject to the emission limits under subpart Ec, but 
must keep records of the amount of each fuel and waste fired.
    The HMIWI source category is divided into three subcategories based 
on waste burning capacity: Small (200 lb/hr), medium (>200 
to 500 lb/hr), and large (>500 lb/hr). Waste burning capacity is 
determined either by the maximum design capacity or by the ``maximum 
charge rate'' established during the most recent performance test. In 
other words, a source may change its size designation by establishing a 
``maximum charge rate'' lower than its design capacity. For example, a 
``medium'' unit with a design capacity of 250 lb/hr may establish a 
maximum charge rate of 200 lb/hr and be considered a ``small'' unit for 
purposes of the standards. Separate emission standards apply to each 
subcategory of new HMIWI. A summary of the final emission limits for 
new or modified HMIWI is presented in Table 3.

                         Table 3.--Summary of Promulgated Emission Limits for New HMIWI                         
----------------------------------------------------------------------------------------------------------------
                                                                    Emission limits                             
       Pollutant (test method)        --------------------------------------------------------------------------
                                             Small HMIWI              Medium HMIWI             Large HMIWI      
----------------------------------------------------------------------------------------------------------------
Particulate matter (EPA Method 5 or    69 mg/dscm (0.03 gr/     34 mg/dscm (0.015 gr/    34 mg/dscm (0.015 gr/  
 Method 29).                            dscf).                   dscf).                   dscf).                
Carbon monoxide (EPA Method 10 or      40 ppmv................  40 ppmv................  40 ppmv.               
 Method 10B).                                                                                                   
Dioxins/furans (EPA Method 23).......  125 ng/dscm total CDD/   25 ng/dscm total CDD/    25 ng/dscm total CDD/  
                                        CDF (55 gr/10\9\ dscf)   CDF (11 gr/10 \9\        CDF (11 gr/10 \9\     
                                        or 2.3 ng/dscm TEQ       dscf) or 0.6 ng/dscm     dscf) or 0.6 ng/dscm  
                                        (1.0 gr/10 \9\ dscf).    TEQ (0.26 gr/10 \9\      TEQ (0.26 gr/10 \9\   
                                                                 dscf).                   dscf).                
Hydrogen chloride (EPA Method 26)....  15 ppmv or 99%           15 ppmv or 99%           15 ppmv or 99%         
                                        reduction.               reduction.               reduction.            
Sulfur dioxide (testing not required)  55 ppmv................  55 ppmv................  55 ppmv.               
Nitrogen oxides (testing not           250 ppmv...............  250 ppmv...............  250 ppmv.              
 required).                                                                                                     
Lead (EPA Method 29).................  1.2 mg/dscm (0.52 gr/10  0.07 mg/dscm (0.03 gr/   0.07 mg/dscm (0.03 gr/ 
                                        \3\ dscf) or 70%         10 \3\ dscf) or 98%      10 \3\ dscf) or 98%   
                                        reduction.               reduction.               reduction.            
Cadmium (EPA Method 29)..............  0.16 mg/dscm (0.07 gr/   0.04 mg/dscm (0.02 gr/   0.04 mg/dscm (0.02 gr/ 
                                        10 \3\ dscf) or 65%      10 \3\ dscf) or 90%      10 \3\ dscf) or 90%   
                                        reduction.               reduction.               reduction.            
Mercury (EPA Method 29)..............  0.55 mg/dscm (0.24 gr/   0.55 mg/dscm (0.24 gr/   0.55 mg/dscm (0.24 gr/ 
                                        10 \3\ dscf) or 85%      10 \3\ dscf) or 85%      10 \3\ dscf) or 85%   
                                        reduction.               reduction.               reduction.            
----------------------------------------------------------------------------------------------------------------

    In addition to the emission limits, new or modified large HMIWI are 
subject to a 5 percent visible emission limit for fugitive emissions 
generated during ash handling and all new or modified HMIWI are subject 
to a 10 percent stack opacity limit. Performance tests for fugitive 
emissions from ash handling must be conducted using EPA Reference 
Method 22. Stack opacity must be determined using EPA Reference Method 
9.
    Table 4 summarizes the additional requirements for new or modified 
HMIWI under the NSPS, including the operator training and qualification 
requirements, siting requirements, compliance and performance testing 
requirements, monitoring requirements, and reporting and recordkeeping 
requirements. A summary of dates for compliance with the promulgated 
standards for new HMIWI is presented in Table 5. These dates apply to 
all new or modified HMIWI.

   Table 4.--Summary of Additional Requirements Under the NSPS for New  
                                  HMIWI                                 
------------------------------------------------------------------------
                         Additional requirements                        
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:                       
     Complete HMIWI operator training course.                   
     Qualify operators.                                         
     Maintain information regarding HMIWI operating procedures  
     and review annually.                                               
Siting Requirements:                                                    
     Prepare a siting analysis that considers air pollution     
     control alternatives that minimize, on a site-specific basis and to
     the maximum extent practicable, potential risks to public health   
     and the environment.                                               

[[Page 48363]]

                                                                        
Waste Management Plan:                                                  
     Prepare a waste management plan that identifies the        
     feasibility and approach to separate certain components of a health
     care waste stream.                                                 
Compliance and Performance Testing Requirements:                        
     Conduct an initial performance test to determine compliance
     with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and  
     opacity limit, and establish operating parameters.                 
     Conduct annual performance tests to determine compliance   
     with the PM, CO, and HCl emission limits and opacity limit.        
     Facilities may conduct performance tests for PM, CO, and   
     HCl every third year if the previous three HMIWI performance tests 
     demonstrate that the facility is in compliance with the emission   
     limits for PM, CO, or HCl.                                         
     Perform annual fugitive testing (large HMIWI only).        
Monitoring Requirements:                                                
     Install and maintain equipment to continuously monitor     
     operating parameters including secondary chamber temperature, waste
     feed rate, bypass stack, and APCD operating parameters as          
     appropriate.                                                       
     Obtain monitoring data at all times during HMIWI operation.
Reporting and Recordkeeping Requirements:                               
     Maintain for 5 years records of results from initial       
     performance test and all subsequent performance tests, operating   
     parameters, any maintenance, the siting analysis, and operator     
     training and qualification.                                        
     Submit the results of the initial performance test and all 
     subsequent performance tests.                                      
     Submit reports on emission rates or operating parameters   
     that have not been recorded or that exceeded applicable limits.    
     Provide notification of intent to construct, construction  
     commencement date, planned initial start-up date, planned waste    
     type(s) to be combusted, the waste management plan, and            
     documentation resulting from the siting analysis.                  
------------------------------------------------------------------------
Note: This table depicts major provisions of the NSPS and does not      
  attempt to show all requirements. The regulatory text of Subpart Ec   
  should be relied upon for a full and comprehensive statement of the   
  requirements of the NSPS.                                             


         Table 5.--Compliance Times Under the NSPS for New HMIWI        
------------------------------------------------------------------------
                 Requirement                        Compliance time     
------------------------------------------------------------------------
Effective date...............................  6 months after           
                                                promulgation of NSPS.   
Operator training and qualification            On effective date or upon
 requirements.                                  initial start up,       
                                                whichever is later.     
Initial compliance test......................  On effective date or     
                                                within 180 days of      
                                                initial start up,       
                                                whichever is later.     
Performance test.............................  Within 12 months         
                                                following initial       
                                                compliance test and     
                                                annually thereafter.    
                                                Facilities may conduct  
                                                performance tests every 
                                                third year if the       
                                                previous three          
                                                performance tests       
                                                demonstrate compliance  
                                                with the emission       
                                                limits.                 
Operator parameter monitoring................  Continuously, upon       
                                                completion of initial   
                                                compliance test.        
Recordkeeping................................  Continuously, upon       
                                                completion of initial   
                                                compliance test.        
Reporting....................................  Annually, upon completion
                                                of initial compliance   
                                                test; semiannually, if  
                                                noncompliance.          
------------------------------------------------------------------------
Note: This table depicts major provisions of the NSPS and does not      
  attempt to show all requirements. The regulatory text of Subpart Ec   
  should be relied upon for a full and comprehensive statement of the   
  requirements of the NSPS.                                             

B. Significant Issues and Changes

    The most significant changes to the standards made following the 
June 20, 1996 Federal Register document are discussed below. Further 
discussion of these changes as well as other comments and responses 
regarding the NSPS are provided in ``Hospital/Medical/ Infectious Waste 
Incinerators: Background Information for Promulgated Standards and 
Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-97-
006b).
1. Combined Dry/Wet Scrubbers
    As discussed in the 1996 re-proposal, the MACT floor for medium and 
large HMIWI was based on emission limits achievable with good 
combustion and a dry injection/fabric filter (DI/FF) combined with a 
high efficiency wet scrubber (combined dry/wet system).
    During the public comment period following the 1996 re-proposal, 
several commenters questioned the basis for the MACT floors for new 
medium and large HMIWI. The commenters contended that the revised MACT 
floor emission levels were based on invalid test data and invalid 
assumptions as to the applicability and technical feasibility of 
combination dry/wet scrubbing systems. The commenters stated that the 
combined dry/wet system is not proven technology. Some commenters 
stated that the pollutant-by-pollutant approach used to determine the 
MACT floor for new medium and large units resulted in a MACT floor that 
can not be accomplished with any type of economic feasibility. Other 
commenters stated that the costs of requiring a wet scrubber in 
addition to a dry scrubber far outweigh the air pollution control 
benefits.
    The EPA recognizes that the pollutant-by-pollutant approach for 
determining the MACT floor can, as it does in this case, cause the 
overall cost of the regulation to increase. For example, the pollutant-
by-pollutant approach for the HMIWI regulation results in a MACT floor 
for HCl based on a high efficiency wet scrubber, while the MACT floor 
for other pollutants reflects the performance of a dry scrubber. 
Compared to the dry scrubber alone, the addition of the wet scrubber 
adds considerable cost to the regulation while achieving a relatively 
small additional reduction in HCl. However, as mentioned later in this 
notice, a spray dryer/fabric filter system with carbon injection could 
be used instead of a combined dry/wet scrubber to achieve all of the 
emission limits at a lower cost than the combined system. On the other 
hand, EPA interprets section 129 of the CAA to require that the MACT 
floor be determined in this manner, and EPA believes that Congress did 
in fact intend that sources subject to regulations developed under 
section 129 meet emission limits that are achieved by the

[[Page 48364]]

best controlled unit for each pollutant as long as the control systems 
are compatible with each other. To EPA's knowledge, there is no 
technical reason why these two air pollution control systems cannot be 
combined (discussed later).
    Section 129(a)(2) of the CAA specifies that ``the degree of 
reduction in emissions that is deemed achievable for new units in a 
category shall not be less stringent than the emissions control 
achieved in practice by the best controlled similar unit, as determined 
by the Administrator.'' This requirement identifies the least stringent 
emissions standards that the EPA may adopt for new HMIWI (i.e., the 
MACT floor).
    At least one existing HMIWI in the medium subcategory is controlled 
with a high efficiency wet scrubber and another is equipped with a DI/
FF system without carbon. The MACT floor for new medium HMIWI was based 
on both of these technologies (i.e., a combined dry/wet scrubber 
system) because the wet scrubber achieves the lowest dioxin, HCl, and 
Hg emissions, but the DI/FF without carbon injection achieves the 
lowest Pb and Cd emissions (note: as discussed elsewhere, the DI/FF 
system with carbon injection achieves the same or lower dioxin and Hg 
emissions as a wet scrubber). While no combined dry/wet scrubber 
systems were identified on medium HMIWI, these systems are currently in 
operation on large HMIWI. As discussed later, test data appear to 
indicate that combining the two systems is technically feasible. 
Similarly, the MACT floor for new large HMIWI was based on the emission 
levels that are achievable with good combustion and a combined dry/wet 
system with activated carbon.
    The EPA does not agree that the MACT floors are to be based upon 
one overall unit. Rather, the EPA believes that section 129 supports 
its interpretation that it is legally permissible to set the MACT floor 
pollutant-by-pollutant, as long as the various MACT floors do not 
result in standards that are not achievable.
    Section 129(a)(2) requires the EPA to establish technology based 
emission standards that ``reflect the maximum degree of reduction in 
emission of air pollutants listed under section (a)(4) that the 
Administrator, taking into consideration the cost of achieving such 
emission reduction and any nonair quality health and environmental 
impacts and energy requirements, determines is achievable . . .'' 
Congress further specified in section 129(a)(2) the minimum reduction 
that could satisfy this requirement (i.e., the MACT floor) for new 
sources as ``the emission control that is achieved in practice by the 
best controlled similar unit, as determined by the Administrator.'' 
This language does not expressly address whether the floor may be 
established pollutant-by-pollutant. The ``emission control achieved by 
the best controlled similar unit'' can be read either to mean emission 
control as to a particular pollutant, or emission control that is 
achieved by the unit as a whole. Nevertheless, the MACT floor reflects 
the least stringent emission standards that EPA may adopt in accordance 
with section 129(a)(2) regardless of costs.
    Other statutory provisions are relevant, although they also do not 
decisively address this issue. Section 129(a)(4) requires MACT 
standards for, at a minimum, PM, opacity, SO2, HCl, 
NOX, CO, Pb, Cd, Hg, and dioxin/furan emitted by HMIWI. This 
provision certainly appears to direct maximum reduction of each 
specified pollutant. Moreover, although the provisions do not state 
whether there is to be a separate floor for each pollutant, the fact 
that Congress singled out these pollutants suggests that the floor 
level of control need not be limited by the performance of devices that 
only control some of these pollutants well.
    A more detailed discussion of the legal basis for this pollutant-
by-pollutant approach is contained in section 3.4.2 of ``Hospital/
Medical/Infectious Waste Incinerators: Background Information for 
Promulgated Standards and Guidelines--Summary of Public Comments and 
Responses'' (EPA-453/R-97-006b). Quantitative information about the 
costs and air pollution control performance of both wet scrubbers and 
dry scrubbers is summarized in the 1996 re-proposal (61 FR 31743). As 
discussed in the 1996 re-proposal, detailed descriptions of costs and 
air pollution control performance of these systems are available in 
Docket A-91-61, items IV-B-30, IV-B-32, IV-B-48, and IV-B-49. See the 
ADDRESSES section of this preamble for the location and telephone 
number for the docket.
    The EPA also notes that it followed this approach of setting the 
MACT floors and MACT standards pollutant-by-pollutant in the proposed 
MWC rules that were published on September 20, 1994 pursuant to section 
129 and codified in 40 CFR part 60, Subparts Eb and Cb. Commenters on 
that rule also expressed concerns about the achievability of the 
resulting standards. The EPA notes that large MWC units (more than 250 
tons/day capacity) are achieving the promulgated standards (in fact, 
several combined systems were in operation at the time of 
promulgation); thus, the approach of proposing MACT standards 
pollutant-by-pollutant did not lead to unachievable or economically 
infeasible standards in this case.
    In response to commenters' concerns regarding the technical 
feasibility of combined dry/wet systems, a review of the available data 
documenting the performance of combined dry/wet scrubber systems was 
conducted. Although limited emissions data are available for HMIWI with 
combined dry/wet control systems, the available data indicate that the 
MACT floor emission levels for new HMIWI are achievable and technically 
feasible. The performance of dry scrubbers with activated carbon 
injection and the performance of wet scrubbers is well documented. The 
available data for combination dry/wet systems provide no indication of 
operational or emissions problems that occur as a result of combining 
dry and wet control systems. Finally, as mentioned in the 1996 re-
proposal, one existing HMIWI equipped with a spray dryer/fabric filter 
system with carbon injection was tested during the EPA testing program, 
and this test demonstrated that this scrubbing technology could be used 
instead of a combined dry/wet scrubber to achieve all of the emission 
limits.
2. Siting Analysis
    Section 129 of the CAA states that performance standards for new 
HMIWI must incorporate siting requirements that minimize, on a site-
specific basis and to the maximum extent practicable, potential risks 
to public health or the environment. The Agency is directed by the CAA 
to promulgate siting requirements that meet the minimum criteria 
outlined in the CAA. In the 1995 proposal, the siting requirements were 
patterned after the Prevention of Significant Deterioration (PSD) 
requirements within the New Source Review (NSR) program. Additionally, 
the originally proposed siting requirements included provisions for a 
public meeting and the preparation of a comment/response document that 
would be made available to the public.
    Following the 1996 re-proposal, commenters requested that EPA do 
away with the siting requirements because they will be costly and will 
impede the permitting process. Other commenters requested that EPA 
adopt siting requirements that are consistent with those that have been 
developed and enacted by most of the State environmental agencies. The 
commenters noted that States are equally concerned with minimizing 
potential risks to the environment, and that most have taken 
appropriate steps

[[Page 48365]]

in the development of their own siting criteria. The commenters 
indicated that requiring siting analyses in addition to those required 
by States and under the National Environmental Policy Act would be 
duplicative and would not enhance environmental protection. Other 
commenters supported the EPA's 1995 proposal to require an opportunity 
for public comments and a hearing on siting decisions.
    In reviewing the 1995 proposed siting requirements and the comments 
received, the Agency is promulgating siting requirements as outlined in 
the CAA. The siting requirements promulgated today require the 
potential owner of an affected facility to prepare an analysis of the 
impacts of the affected facility. The analysis must consider air 
pollution control alternatives that minimize, on a site-specific basis, 
to the maximum extent practicable, potential risks to public health or 
the environment. In considering such alternatives, the analysis may 
consider costs, energy impacts, non-air environmental impacts, or any 
other factors related to the practicability of the alternatives. 
Analyses of facility impacts prepared to comply with State, local, or 
other Federal regulatory requirements may be used to satisfy the 
requirements of this section, as long as they include the consideration 
of air pollution control alternatives specified above. The owner or 
operator of the affected facility must complete and submit the siting 
requirements to EPA.

C. Selection of MACT

    The EPA considered three regulatory options for adoption as the 
final standard for new HMIWI. These regulatory options are discussed in 
Appendix A of ``Hospital/Medical/Infectious Waste Incinerators: 
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b). As 
required by section 129(a)(2) of the CAA, the Administrator reviewed 
the emissions reductions achievable with each regulatory option and the 
cost, nonair quality environmental, and energy impacts of the 
regulatory options. Based on this review, the Administrator determined 
that the most cost-effective and achievable emission standards for 
promulgation are based on emission limits achievable with good 
combustion and a moderate efficiency wet scrubber for new small HMIWI, 
and good combustion and a combined dry/wet control system with carbon 
for new medium and large HMIWI. These final emissions standards reflect 
the MACT floor emission levels for new small and large HMIWI, but are 
more stringent than the MACT floor for new medium HMIWI.
    The MACT floor for new small HMIWI was based on emission limits 
achievable through use of good combustion and a moderate efficiency wet 
scrubber. Consideration of the impact of this MACT floor indicates that 
few new small HMIWI are likely to be constructed due to the substantial 
increase in the cost of a new small HMIWI as a result of the moderate 
efficiency wet scrubber and the availability of alternative means of 
medical waste disposal.
    One regulatory option more stringent than this MACT floor would 
reflect the use of good combustion and a high efficiency wet scrubber. 
Consideration of this option indicates that the nationwide impacts 
would be negligible, primarily because few new small HMIWI would be 
constructed (i.e., because of switching to alternative means of medical 
waste disposal). Where a typical new small HMIWI was constructed, 
however, the high efficiency wet scrubber would only reduce PM 
emissions by a small amount and would increase air pollution control 
costs by about 15 percent. As a result, the EPA established the MACT 
emission limitations for small new HMIWI based on the use of good 
combustion and a moderate efficiency wet scrubber (i.e., the MACT 
floor).
    The MACT floor for new medium HMIWI was based on emission limits 
achievable through the use of good combustion and a combined dry/wet 
control system without activated carbon. On a national basis, because 
of switching to the use of alternative means of medical waste disposal, 
the addition of activated carbon to the combined dry/wet system results 
in negligible cost increase. For a typical new medium HMIWI, the 
addition of carbon would reduce emissions of dioxin significantly and 
would increase air pollution control costs by less than 4 percent. As a 
result, the EPA established the MACT emission limitations for new 
medium HMIWI based on good combustion and a combined dry/wet scrubber 
system with activated carbon.
    The MACT floor for new large HMIWI was based on emission limits 
achievable through use of good combustion and a combined dry/wet 
scrubber with activated carbon. There is no air pollution control 
technology which could achieve lower emissions than this system. 
Consequently, EPA established the MACT emission limitations for new 
large HMIWI based on good combustion and a combined dry/wet scrubber 
system with activated carbon (i.e., the MACT floor).

D. Impacts of the Standards

    There are a number of alternatives to onsite incineration of 
hospital waste and medical/infectious waste, including recycling or 
direct landfilling of non-infectious waste, and off-site commercial 
waste disposal or any of several waste disinfection technologies (e.g., 
steam autoclaving, microwave irradiation, macrowave irradiation, 
chemical treatment, thermal treatment, and biological treatment) for 
infectious waste. Many facilities that may have purchased an HMIWI in 
the absence of the HMIWI standards may find it more cost effective to 
dispose of their waste using one of these alternatives. As discussed in 
the June 1996 re-proposal, while further study is warranted, there 
appears to be no significant or substantial adverse economic, 
environmental, or health and safety issues associated with the 
increased use of the alternative waste treatment technologies.
    In some cases, facilities that ``switch'' to alternative methods of 
waste disposal may further decrease their waste disposal costs by 
segregating their waste into infectious and noninfectious portions, and 
recycling or landfilling (rather than treating) their noninfectious 
waste. To account for facilities switching to alternative methods of 
waste disposal, the impacts of the standards were developed based on 
three compliance scenarios: no switching (scenario A), switching with 
waste segregation (scenario B), and switching without waste segregation 
(scenario C).
    In the absence of the new standards, EPA projects that 85 new small 
HMIWI, 90 new medium HMIWI, 60 new large HMIWI, and 10 new commercial 
HMIWI would have been installed over the next five years. Scenario A 
preserves this assumption and estimates the costs of the additional 
control measures that would be required for these 245 new facilities to 
meet the standards at $36.2 million annually. The EPA believes that 
Scenario A is unrealistic and grossly overstates the national costs 
associated with the standards. Under Scenarios B and C, no new small or 
medium HMIWI are projected to be installed. Facilities that would have 
installed these units are assumed to find alternate methods of waste 
disposal. Under Scenario B, no new large HMIWI (other than commercial 
units) are projected to be installed either. The EPA believes that the 
total costs of the final standards for new sources in the fifth year 
after

[[Page 48366]]

implementation will fall somewhere between the $12.1 million/yr 
estimate for Scenario B and the $26.2 million/yr estimate for Scenario 
C.
    Table 6 presents baseline emissions (i.e., emissions in the absence 
of the MACT emission standards) and the emissions that are expected to 
occur under the final MACT standard. A range of emissions is presented 
in Table 6 to account for the emissions that could occur under 
switching scenarios B and C as a result of the NSPS. Table 6 also 
presents the percent reduction in emissions achieved under the final 
MACT standard for new HMIWI.

 Table 6.--Baseline Emissions, Emissions in the Fifth Year After Implementation of the Final NSPS, and Emissions
                                                    Reduction                                                   
                                                 [Metric Units]                                                 
----------------------------------------------------------------------------------------------------------------
                                                         Emissions under the final      Emissions  reduction,   
            Pollutant, units                Baseline                NSPS                       percent          
----------------------------------------------------------------------------------------------------------------
PM, Mg/yr...............................        28      2.1 to 4.1.................  85 to 92.                  
CO, Mg/yr...............................        14      6.5 to 14..................  0 to 52.                   
CDD/CDF, g/yr...........................        47      5.9 to 12..................  74 to 87.                  
TEQ CDD/CDF, g/yr.......................         1.1    0.14 to 0.28...............  74 to 87.                  
HCl, Mg/yr..............................        64      1.5 to 3.1.................  95 to 98.                  
SO2, Mg/yr..............................        28      14 to 28...................  0 to 52.                   
NOX, Mg/yr..............................       130      65 to 130..................  0 to 52.                   
Pb, Mg/yr...............................         0.39   0.031 to 0.06..............  85 to 92.                  
Cd, Mg/yr...............................         0.051  4.6 x 10-3 to 8.9 x 10-3...  83 to 91.                  
Hg, Mg/yr...............................         0.21   0.056 to 0.12..............  45 to 74.                  
----------------------------------------------------------------------------------------------------------------
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6.                         

    As discussed further in Appendix A of ``Hospital/Medical/Infectious 
Waste Incinerators: Background Information for Promulgated Standards 
and Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-
97-006b), the EPA is not able to calculate a monetized value for most 
of these emission reductions. However, using ``Benefit-Cost Analysis of 
Selected NSPS for Particulate Matter'' as a basis, EPA has calculated a 
monetized value for reductions in PM emissions using an estimate of 
$6,075 (1993 dollars) per ton of PM. This yields annualized benefits of 
PM reductions for the standards ranging from $157,300 to $170,000 (1993 
dollars).
    As a result of the MACT standards for new HMIWI, industries that 
generate hospital waste and/or medical/infectious waste (i.e., 
hospitals, nursing homes, etc.) are expected to experience average 
price increases in the range of 0.00 to 0.16 percent, depending on the 
industry. These industries are expected to experience output and 
employment impacts in the range of 0.00 to 0.21 percent. In addition, 
the revenue impacts for these industries are expected to range from an 
increase of 0.05 percent to a decrease of 0.05 percent as a result of 
the standards. For hospitals, 0.03 percent is estimated as the price 
increase necessary to recover annual control costs. The expected 
average price increase for each hospital patient-day is expected to be 
less than 35 cents. The average price impact for the commercial medical 
waste incinerator industry is approximately a 4.1 percent increase in 
price.
    Facilities with onsite HMIWI that are currently uncontrolled may 
experience impacts ranging from 0.03 to 1.70 percent, depending on the 
industry. For many of these facilities, the economic impacts of 
switching to an alternative method of waste disposal are much lower 
than the economic impacts of choosing to install emission control 
equipment. The decision to switch to an alternative method of waste 
disposal should preclude facilities from experiencing a significant 
economic impact. The impacts that would be incurred by medical/
infectious waste generators that currently use an offsite waste 
incineration service range from 0.00 to 0.02 percent and are considered 
negligible impacts.
    The option of switching to an alternative method of waste disposal 
will be an attractive option for many facilities that are considering 
the purchase of a new HMIWI and should preclude facilities from 
experiencing a significant economic impact. However, two types of HMIWI 
operators may not be able to switch to an alternative: commercial HMIWI 
operators, because their line of business is commercial incineration; 
and onsite HMIWI that burn a small amount of waste and are located far 
away from an urban area, because they may not have access to other 
methods of waste disposal. However only a few, if any, of the projected 
10 new commercial HMIWI over the next 5 years, and at the most, only a 
few of the projected 85 new small onsite HMIWI over the next 5 years 
are likely to be significantly impacted by the regulation (under all 
three regulatory options). A ``significant impact'' does not 
necessarily imply a facility closure or the need to cancel plans to 
open up or expand a facility. For example, operators of small, remote 
onsite HMIWI may still have switching opportunities. As the commercial 
incineration industry continues to grow (with additional impetus being 
provided by the EG and NSPS), it is possible that services will be 
extended to remote, isolated areas that are currently not served. 
Onsite autoclaving is another possible treatment alternative. If a 
facility had planned to invest in a new HMIWI, it stands to reason that 
an onsite alternative technology of comparable cost would be 
affordable.
    The economic impact analysis examines possible economic impacts 
that may occur in industries that will be directly affected by this 
regulation. Therefore, the analysis includes an examination of 
industries that generate hospital waste or medical/infectious waste or 
dispose of such waste. Secondary impacts such as subsequent impacts on 
APCD vendors and HMIWI vendors are not estimated due to data 
limitations. Air pollution control device vendors are expected to 
experience an increase in demand for their products due to the 
regulation. This regulation is also expected to increase demand for 
commercial HMIWI services. However, due to economies of scale, this 
regulation is expected to shift demand from smaller incinerators to 
larger incinerators. Therefore, small HMIWI vendors potentially may be 
adversely affected by the regulation. Lack of data on the above effects 
prevent

[[Page 48367]]

quantification of the economic impacts on these secondary sectors.
    No increase in the total national usage of natural gas for 
combustion controls is expected to result from the final HMIWI 
standards. The total national usage of electrical energy for the 
operation of add-on control devices as a result of the final MACT 
standards is expected to increase by less than 9,800 megawatt hours per 
year (MW-hr/yr) (33.4 billion British thermal units per year [10\9\ 
Btu/yr]). As discussed in the 1996 re-proposal, compared to the amount 
of energy used by health care facilities such as hospitals 
(approximately 2,460 MMm \3\/yr of natural gas and 23.2 million MW-hr/
yr of electricity), the increase in energy usage that results from 
implementation of the HMIWI emission standards is insignificant.
    Less than 43,600 Mg/yr (48,000 tons/yr) of additional solid waste 
is expected to result from the adoption of the final MACT standards. As 
discussed in the 1996 re-proposal, compared to municipal waste, which 
is disposed in landfills at an annual rate of over 91 million Mg/yr 
(100 million tons/yr), the increase in solid waste from the 
implementation of the final HMIWI standards is insignificant.
    Less than 3.3 million gallons of additional wastewater would be 
generated in the fifth year by HMIWI as a result of the final NSPS. 
This amount is the equivalent of wastewater produced annually by one 
small hospital. Therefore, when considering the wastewater produced 
annually at health care facilities nationwide, the increase in 
wastewater resulting from the implementation of the MACT emission 
standards for new HMIWI is insignificant.

V. Emission Guidelines for Existing Sources

    This section presents a summary of the final emission guidelines, 
including identification of the source category and pollutants being 
regulated, and presentation of the final emission limits and their 
associated performance testing, monitoring, recordkeeping and reporting 
requirements. This section discusses the most significant changes to 
the guidelines presented in the June 20, 1996 Federal Register 
document. Also discussed in this section is the rationale for the 
selection of MACT and a summary of the impacts of the final guidelines.

A. Summary of the Guidelines

    The final guidelines (subpart Ce) apply to each existing HMIWI for 
which construction commenced on or before June 20, 1996. Hospital/
medical/infectious waste incinerators for which construction commenced 
after June 20, 1996 or modification commenced after March 16, 1998 are 
not subject to the final subpart Ce guidelines; they are considered new 
sources and are subject to the standards under subpart Ec (see section 
IV of this document).
    A HMIWI is defined as any device that combusts any amount of 
medical/infectious waste or hospital waste. The terms ``medical/ 
infectious waste'' and ``hospital waste'' are discussed in section 
III.A and defined in Sec. 60.51c. An incinerator is not subject to 
subpart Ce during periods when only pathological, low-level 
radioactive, or chemotherapeutic waste (all defined in Sec. 60.51c) is 
burned provided that the owner or operator keeps records of the periods 
of time when only pathological, low-level radioactive, or 
chemotherapeutic waste is burned. Any unit required to have a permit 
under section 3005 of the Solid Waste Disposal Act is exempt from 
subpart Ce as are incinerators subject to subpart Cb, Ea, or Eb. 
Existing incinerators, processing operations, or boilers that co-fire 
hospital waste and/or medical/infectious waste with other fuels or 
wastes and combust 10 percent or less medical/infectious waste and 
hospital waste by weight (on a calendar quarter basis) are not subject 
to the emission limitations but must keep records of the amounts of 
each fuel and waste burned.
    The HMIWI source category is divided into three subcategories based 
on waste burning capacity: small (200 lb/hr), medium (>200 
to 500 lb/hr), and large (>500 lb/hr). Waste burning capacity is 
determined either by the maximum design capacity or by the ``maximum 
charge rate'' established during the most recent performance test. In 
other words, a source may change its size designation by establishing a 
``maximum charge rate'' lower than its design capacity. For example, a 
``medium'' unit with a design capacity of 250 lb/hr may establish a 
maximum charge rate of 200 lb/hr and be considered a ``small'' unit for 
purposes of the emission guidelines. Separate emission guidelines apply 
to each subcategory of existing HMIWI. A summary of the final emission 
limits for existing HMIWI is presented in Table 7. In addition to the 
emission limits presented in Table 7, all HMIWI are subject to a 10 
percent stack opacity limitation. Stack opacity will be determined 
using EPA Reference Method 9.

                       Table 7.--Summary of Promulgated Emission Limits for Existing HMIWI                      
----------------------------------------------------------------------------------------------------------------
                                                                    Emission limits                             
       Pollutant (test method)        --------------------------------------------------------------------------
                                             Small HMIWI              Medium HMIWI             Large HMIWI      
----------------------------------------------------------------------------------------------------------------
Particulate matter (EPA Method 5 or    115 mg/dscm (0.05 gr/    69 mg/dscm (0.03 gr/     34 mg/dscm (0.015 gr/  
 Method 29).                            dscf).                   dscf).                   dscf).                
Carbon monoxide (EPA Method 10 or      40 ppmv................  40 ppmv................  40 ppmv.               
 Method 10B).                                                                                                   
Dioxins/furans (EPA Method 23).......  125 ng/dscm total CDD/   125 ng/dscm total CDD/   125 ng/dscm total CDD/ 
                                        CDF (55 gr/109 dscf)     CDF (55 gr/109 dscf)     CDF (55 gr/109 dscf). 
                                        or 2.3 ng/dscm TEQ       or 2.3 ng/dscm TEQ       or 2.3 ng/dscm TEQ    
                                        (1.0 gr/109 dscf).       (1.0 gr/109 dscf).       (1.0 gr/109 dscf).    
Hydrogen chloride (EPA Method 26)....  100 ppmv or 93%          100 ppmv or 93%          100 ppmv or 93%        
                                        reduction.               reduction.               reduction             
Sulfur dioxide (testing not required)  55 ppmv................  55 ppmv................  55 ppmv.               
Nitrogen oxides (testing not           250 ppmv...............  250 ppmv...............  250 ppmv.              
 required).                                                                                                     
Lead (EPA Method 29).................  1.2 mg/dscm (0.52 gr/    1.2 mg/dscm (0.52 gr/    1.2 mg/dscm (0.52 gr/  
                                        103 dscf) or 70%         103 dscf) or 70%         103 dscf) or 70%      
                                        reduction.               reduction.               reduction.            
Cadmium (EPA Method 29)..............  0.16 mg/dscm (0.07 gr/   0.16 mg/dscm (0.07 gr/   0.16 mg/dscm (0.07 gr/ 
                                        103 dscf) or 65%         103 dscf) or 65%         103 dscf) or 65%      
                                        reduction.               reduction.               reduction.            

[[Page 48368]]

                                                                                                                
Mercury (EPA Method 29)..............  0.55 mg/dscm (0.24 gr/   0.55 mg/dscm (0.24 gr/   0.55 mg/dscm (0.24 gr/ 
                                        103 dscf) or 85%         103 dscf) or 85%         103 dscf) or 85%      
                                        reduction.               reduction.               reduction.            
----------------------------------------------------------------------------------------------------------------

    The emission limits for small existing HMIWI presented in Table 7 
are more stringent than the MACT floor emission limits for small 
existing HMIWI. However, the final HMIWI guidelines contain alternative 
emission limits which are based on the MACT floor for small existing 
HMIWI that meet certain ``rural criteria.'' The ``rural criteria'' 
stipulates that an HMIWI is allowed to meet alternative emission limits 
if it is located at least 50 miles from the nearest Standard 
Metropolitan Statistical Area (SMSA) boundary and burns no more than 
2,000 pounds of hospital waste and medical/infectious waste per week. 
The SMSA is defined by the Office of Management and Budget (OMB). For 
purposes of these emission guidelines, the list of areas comprising 
each SMSA as of June 30, 1993 will be used to determine whether a small 
HMIWI meets the ``rural criteria.'' The list of areas comprising each 
SMSA is presented in OMB Bulletin No. 93-17 entitled ``Revised 
Statistical Definitions for Metropolitan Areas.'' This document may be 
obtained by contacting the National Technical Information Services, 
5285 Port Royal Road, Springfield, Virginia 22161, or by calling (703) 
487-4650 and requesting document No. PB 93-192-664. This document is 
available for public inspection and copying at EPA's Air and Radiation 
Docket and Information Center (Docket A-91-61, item IV-J-125). See the 
ADDRESSES section at the beginning of this preamble for the telephone 
number and location of the Docket. This document has been approved for 
incorporation by reference by the Director of the Federal Register in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The emission limits 
that correspond with these alternative guidelines for rural HMIWI are 
presented in Table 8. For further discussion of the ``rural criteria'' 
and rationale for the alternative emission limits for small existing 
HMIWI in rural areas, see section V.B ``Significant Issues and 
Changes'' (below).

   Table 8.--Summary of Alternative Emission Limits for Small Existing  
                   HMIWI That Meet the Rural Criteria                   
------------------------------------------------------------------------
  Pollutant (Performance test method)            Emission limits        
------------------------------------------------------------------------
Particulate matter (EPA Method 5)......  197 mg/dscm (0.086 gr/dscf).   
Carbon monoxide (EPA Method 10 of 10B).  40 ppmv.                       
Dioxins/furans (EPA Method 23).........  800 ng/dscm total CDD/CDF (350 
                                          gr/10 \9\ dscf) or 15 ng/dscm 
                                          TEQ (6.6 gr/10 \9\ dscf).     
Hydrogen chloride (testing not           3,100 ppmv.                    
 required).                                                             
Sulfur dioxide (testing not required)..  55 ppmv.                       
Nitrogen oxides (testing not required).  250 ppmv.                      
Lead (testing not required)............  10 mg/dscm (4.4 gr/10 \3\      
                                          dscf).                        
Cadmium (testing not required).........  4 mg/dscm (1.7 gr/10 \3\ dscf).
Mercury (EPA Method 29)................  7.5 mg/dscm (3.3 gr/10 \3\     
                                          dscf).                        
------------------------------------------------------------------------

    Table 9 summarizes the additional requirements for existing HMIWI 
under the emission guidelines, including the operator training and 
qualification requirements, inspection requirements, compliance and 
performance testing requirements, monitoring requirements, and 
reporting and recordkeeping requirements. Table 10 summarizes the 
additional requirements under the emission guidelines for small 
existing HMIWI that meet the rural criteria. With the exception of the 
compliance and performance testing requirements and the inspection 
requirements, existing HMIWI that meet the small rural criteria are to 
comply with the same additional requirements as all other existing 
HMIWI. A summary of dates for compliance with the promulgated 
guidelines for existing HMIWI is presented in Table 11. These dates 
apply to all existing HMIWI.

     Table 9.--Summary of Additional Requirements Under the Emission    
                      Guidelines for Existing HMIWI                     
------------------------------------------------------------------------
                         Additional requirements                        
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:                       
     Complete HMIWI operator training course.                   
     Qualify operators.                                         
     Maintain information regarding HMIWI operating procedures  
     and review annually.                                               
Waste Management Plan:                                                  
     Prepare a waste management plan that identifies the        
     feasibility and approach to separate certain components of a health
     care waste stream.                                                 
Compliance and Performance Testing Requirements:                        
     Conduct an initial performance test to determine compliance
     with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and  
     opacity limit, and establish operating parameters.                 
     Conduct annual performance tests to determine compliance   
     with the PM, CO, and HCl emission limits and opacity limit.        
     Facilities may conduct performance tests for PM, CO, and   
     HCl every third year if the previous three performance tests       
     demonstrate that the facility is in compliance with the emission   
     limits for PM, CO, and HCl.                                        

[[Page 48369]]

                                                                        
Monitoring Requirements:                                                
     Install and maintain equipment to continuously monitor     
     operating parameters including secondary chamber temperature, waste
     feed rate, bypass stack, and APCD operating parameters as          
     appropriate.                                                       
     Obtain monitoring data at all times during HMIWI operation.
Reporting and Recordkeeping Requirements:                               
     Maintain for 5 years records of results from the initial   
     performance test and all subsequent performance tests, operating   
     parameters, and operator training and qualification.               
     Submit the results of the initial performance test and all 
     subsequent performance tests.                                      
     Submit reports on emission rates or operating parameters   
     that have not been recorded or which exceeded applicable limits.   
------------------------------------------------------------------------
Note: This table depicts the major provisions of the emission guidelines
  and does not attempt to show all requirements. The regulatory text of 
  Subpart Ce should be relied upon for a full and comprehensive         
  statement of the requirements of the final guidelines.                


    Table 10.--Summary of Additional Requirements Under the Emission    
       Guidelines for Existing HMIWI that Meet the Rural Criteria       
------------------------------------------------------------------------
                         Additional requirements                        
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:                       
     Complete HMIWI operator training course.                   
     Qualify operators.                                         
     Maintain information regarding HMIWI operating procedures  
     and review annually.                                               
Inspection Requirements:                                                
     Provide for an annual equipment inspection of the          
     designated facility.                                               
Waste Management Plan:                                                  
     Prepare a waste management plan that identifies the        
     feasibility and approach to separate certain components of a health
     care waste stream.                                                 
Compliance and Performance Testing Requirements:                        
     Conduct an initial performance test to determine compliance
     with the PM, CO, CDD/CDF, and Hg emission limits and opacity limit,
     and establish operating parameters.                                
     Conduct annual tests to determine compliance with the      
     opacity limit.                                                     
Monitoring Requirements:                                                
     Install and maintain equipment to continuously monitor     
     operating parameters including secondary chamber temperature, waste
     feed rate, bypass stack, and APCD operating parameters as          
     appropriate.                                                       
     Obtain monitoring data at all times during HMIWI operation.
Reporting and Recordkeeping Requirements:                               
     Maintain for 5 years records of results from the initial   
     performance test and all subsequent performance tests, operating   
     parameters, inspections, any maintenance, and operator training and
     qualification.                                                     
     Submit the results of the initial performance test and all 
     subsequent performance tests.                                      
     Submit reports on emission rates or operating parameters   
     that have not been recorded or which exceeded applicable limits.   
------------------------------------------------------------------------
Note: This table depicts the major provisions of the emission guidelines
  and does not attempt to show all requirements. The regulatory text of 
  Subpart Ce should be relied upon for a full and comprehensive         
  statement of the requirements of the final guidelines.                


 Table 11.--Compliance Times Under the Emission Guidelines for Existing 
                                  HMIWI                                 
------------------------------------------------------------------------
                  Requirement                        Compliance time    
------------------------------------------------------------------------
State Plan submittal...........................  Within 1 year after    
                                                  promulgation of EPA   
                                                  emission guidelines.  
Operator training and qualification              Within 1 year after EPA
 requirements.                                    approval of State     
                                                  Plan.                 
Inspection requirements........................  Within 1 year after EPA
                                                  approval of State     
                                                  Plan.                 
Initial compliance test........................  Within 1 year after EPA
                                                  approval of State plan
                                                  or up to 3 years after
                                                  EPA approval of State 
                                                  plan if the source is 
                                                  granted an extension. 
Repeat performance test........................  Within 12 months       
                                                  following initial     
                                                  compliance test and   
                                                  annually thereafter.  
Parameter monitoring...........................  Continuously, upon     
                                                  completion of initial 
                                                  compliance test.      
Recordkeeping..................................  Continuously, upon     
                                                  completion of initial 
                                                  compliance test.      
Reporting......................................  Annually, upon         
                                                  completion of initial 
                                                  compliance test;      
                                                  semiannually, if      
                                                  noncompliance.        
------------------------------------------------------------------------

B. Significant Issues and Changes

    This section discusses the most significant changes to the 
guidelines made following the June 20, 1996 Federal Register document. 
Further discussion of these changes as well as other comments and 
responses regarding the emission guidelines are provided in ``Hospital/
Medical/Infectious Waste Incinerators: Background Information for 
Promulgated Standards and Guidelines--Summary of Public Comments and 
Responses'' (EPA-453/R-97-006b).
    As discussed in the 1996 re-proposal, the MACT floor for small 
existing HMIWI was based on emission limits achievable through use of 
good combustion alone (i.e., without add-on control). The EPA presented 
regulatory options more stringent than the MACT floor for small 
existing HMIWI in the 1996 re-proposal and stated that it had no 
inclination as to which regulatory

[[Page 48370]]

option might be selected for the final emission guidelines for small 
HMIWI. The EPA solicited public comment on the available regulatory 
options for the guidelines for small existing HMIWI.
    During the public comment period, the EPA received several comments 
containing suggestions for the final emission guidelines for small 
existing HMIWI. A number of commenters requested that the emission 
guidelines for small existing HMIWI be based on the MACT floor. Other 
commenters requested that the guidelines for small HMIWI require small 
HMIWI in urban locations to meet emission guidelines more stringent 
than the MACT floor and allow small HMIWI in rural locations to meet 
the MACT floor emission limits. These commenters noted that cost-
effective alternatives to onsite incineration may not be available to 
facilities operating small HMIWI in rural locations and that emission 
limits based on wet scrubbers would cause these facilities financial 
hardship. Other commenters contended that emission limits for small 
incinerators consistent with no more than good combustion would result 
in largely uncontrolled emissions, and would encourage medium-sized 
units to change their size designation to small by burning less waste 
per hour while operating more hours per day. These commenters stated 
that there are cost-effective alternatives to incineration and 
requested that small existing HMIWI be subject to emission limits 
consistent with wet scrubbers.
    Guidelines for small existing HMIWI based on the use of good 
combustion and low efficiency wet scrubbing could cause the cost of 
waste disposal to more than double for facilities that install the 
equipment necessary to meet the emission guidelines. Even guidelines 
based on the MACT floor (good combustion alone) would cause a 
significant increase in costs for such facilities. The EPA's cost 
projections show that the costs of retrofitting small existing HMIWI to 
meet the MACT floor would be about $18 million annually, while the cost 
of going beyond the floor (guidelines based on low efficiency wet 
scrubbers) for the estimated 1,025 small HMIWI that do not meet the 
``remote'' criteria (discussed later) would be an additional $47 
million. However, as noted by commenters and observed by States that 
have implemented stringent HMIWI regulations, there are a number of 
cost-effective alternatives to onsite incineration for most facilities 
that operate small HMIWI. Therefore, many health care facilities 
operating small HMIWI could switch to alternative means of waste 
disposal if the emission guidelines are based on the use of good 
combustion and low efficiency wet scrubbing. In fact, EPA's modeling 
projects that most existing facilities, except those meeting the 
``remote'' criteria, would find it more economical to switch to 
alternative means of waste disposal than to retrofit their small 
incinerators even to meet the MACT floor, and virtually all such 
facilities would switch rather than retrofit small incinerators with 
low efficiency wet scrubbers. Under the switching scenario, the costs 
for non-``remote'' small facilities range from $6 to $13 million for 
guidelines based on the MACT floor, and from $6 to $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.

[[Page 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

[[Page 48372]]

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 non-infectious waste, and off-site commercial 
waste disposal or any of several waste disinfection technologies (e.g., 
steam autoclaving, microwave irradiation, macrowave irradiation, 
chemical treatment, thermal treatment, and biological treatment) for 
infectious waste. Many facilities that 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]                                                 
----------------------------------------------------------------------------------------------------------------
                                                         Emissions under the final      Emissions  reduction,   
            Pollutant, units                Baseline        emission guidelines                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

[[Page 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 re-proposal, 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.

[[Page 48374]]

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.

[[Page 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-for-profit; 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 cost-effective, 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

[[Page 48376]]

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

[[Page 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 
pre-promulgation 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 re-proposal. 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 State-approved 
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

[[Page 48378]]

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 municipal-type 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 re-proposal 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, tax-exempt 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.

[[Page 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:


Sec. 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 
Sec. 60.35e and Sec. 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 Sec. 60.31e.
    3. Section 60.30 is revised to read as follows:


Sec. 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 Sec. 60.33e(b)

Subpart Ce--Emission Guidelines and Compliance Times for Hospital/
Medical/Infectious Waste Incinerators


Sec. 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 Sec. 60.24(f) 
of subpart B of this part.


Sec. 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.

[[Page 48380]]

    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 Sec. 60.17).


Sec. 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 Sec. 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 Sec. 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 co-fired 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 Sec. 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 Sec. 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.


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


Sec. 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 Sec. 60.53c of subpart Ec of this part. The 
State plan shall require compliance with these requirements according 
to the schedule specified in Sec. 60.39e(e).


Sec. 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 Sec. 60.55c of subpart Ec of this part.


Sec. 60.36e  Inspection guidelines.

    (a) For approval, a State plan shall require that each small HMIWI 
subject to the emission limits under Sec. 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 Sec. 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.


Sec. 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 Sec. 60.56c of subpart Ec of this 
part, excluding the fugitive emissions testing requirements under 
Sec. 60.56c(b)(12) and (c)(3).
    (b) For approval, a State plan shall require any small HMIWI 
subject to the emission limits under Sec. 60.33e(b) to

[[Page 48381]]

meet the following compliance and performance testing requirements:
    (1) Conduct the performance testing requirements in Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.


Sec. 60.38e  Reporting and recordkeeping guidelines.

    (a) For approval, a State plan shall include the reporting and 
recordkeeping requirements listed in Sec. 60.58c(b), (c), (d), (e), and 
(f) of subpart Ec of this part, excluding Sec. 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 Sec. 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.


Sec. 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 Sec. 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 Sec. 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

[[Page 48382]]

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 
Sec. 60.34e--Operator training and qualification guidelines and 
Sec. 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                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Emission limits                                  
                                                                   -------------------------------------------------------------------------------------
              Pollutant               Units (7 percent oxygen, dry                                       HMIWI size                                     
                                                 basis)            -------------------------------------------------------------------------------------
                                                                             Small                   Medium                         Large               
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter..................  Milligrams per dry standard   115 (0.05).............  69 (0.03).............  34 (0.015).                        
                                       cubic meter (grains per dry                                                                                      
                                       standard cubic foot).                                                                                            
Carbon monoxide.....................  Parts per million by volume.  40.....................  40....................  40.                                
Dioxins/furans......................  Nanograms per dry standard    125 (55) or 2.3 (1.0)..  125 (55) or 2.3 (1.0).  125 (55) or 2.3 (1.0).             
                                       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).                                                                                                           
Hydrogen chloride...................  Parts per million by volume   100 or 93%.............  100 or 93%............  100 or 93%.                        
                                       or percent reduction.                                                                                            
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   1.2 (0.52) or 70%......  1.2 (0.52) or 70%.....  1.2 (0.52) or 70%.                 
                                       cubic meter (grains per                                                                                          
                                       thousand dry standard cubic                                                                                      
                                       feet) or percent reduction.                                                                                      
Cadmium.............................  Milligrams per dry standard   0.16 (0.07) or 65%.....  0.16 (0.07) or 65%....                                     
                                       cubic meter (grains per                                                                                          
                                       thousand dry standard cubic                                                                                      
                                       feet) or percent reduction.                                                                                      
Mercury.............................  Milligrams per dry standard   0.55 (0.24) or 85%.....  0.55 (0.24) or 85%....  0.55 (0.24) or 85%.                
                                       cubic meter (grains per                                                                                          
                                       thousand dry standard cubic                                                                                      
                                       feet) or percent reduction.                                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------


 Table 2 to Subpart Ce.--Emissions Limits for Small HMIWI Which Meet the
                     Criteria Under Sec.  60.33e(b)                     
------------------------------------------------------------------------
                                   Units (7 percent      HMIWI emission 
           Pollutant              oxygen, dry basis)         limits     
------------------------------------------------------------------------
Particulate matter............  Milligrams per dry     197 (0.086).     
                                 standard cubic meter                   
                                 (grains per dry                        
                                 standard cubic foot).                  
Carbon monoxide...............  Parts per million by   40.              
                                 volume.                                
Dioxins/furans................  nanograms per dry      800 (350) or 15  
                                 standard cubic meter   (6.6).          
                                 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).                                 
Hydrogen chloride.............  Parts per million by   3100.            
                                 volume.                                
Sulfur dioxide................  Parts per million by   55.              
                                 volume.                                
Nitrogen oxides...............  Parts per million by   250.             
                                 volume.                                
Lead..........................  Milligrams per dry     10 (4.4).        
                                 standard cubic meter                   
                                 (grains per thousand                   
                                 dry standard cubic                     
                                 feet).                                 
Cadmium.......................  Milligrams per dry     4 (1.7).         
                                 standard cubic meter                   
                                 (grains per thousand                   
                                 dry standard cubic                     
                                 feet).                                 
Mercury.......................  Milligrams per dry     7.5 (3.3).       
                                 standard cubic meter                   
                                 (grains per                            
                                 thousands dry                          
                                 standard cubic feet).                  
------------------------------------------------------------------------

    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


Sec. 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

[[Page 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 Sec. 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 Sec. 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 co-fired 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 Sec. 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 Sec. 60.56c(i) establishing operating 
parameters when using controls other than those listed in 
Sec. 60.56c(d).
    (2) Alternative methods of demonstrating compliance under 
Sec. 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 
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, affected facilities 
subject to this subpart shall operate pursuant to a permit issued under 
the EPA approved State operating permit program.


Sec. 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 octa-
chlorinated 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

[[Page 48384]]

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, ft\3\
15,000=primary chamber heat release rate factor, Btu/ft\3\/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, ft\3\
4.5=waste density, lb/ft\3\
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 Sec. 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 Sec. 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.

[[Page 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 deg. 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.


Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 48386]]

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.


Sec. 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 
State-approved 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 Sec. 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.


Sec. 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 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.
    (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 
Sec. 60.58c(a)(1)(iii).

[[Page 48387]]

Sec. 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 Sec. 60.17) shall be considered in the development of 
the waste management plan.


Sec. 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 Sec. 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 Sec. 60.52c, 
the following procedures shall be used to determine compliance:
    (i) Measure the concentration of each dioxin/furan tetra-through 
octa-congener 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 Sec. 60.52c, the 
percentage reduction in HCl emissions (%RHCl) is computed 
using the following formula:
[GRAPHIC] [TIFF OMITTED] TR15SE97.000

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 
Sec. 60.52c, the percentage reduction in emissions (%Rmetal) 
is computed using the following formula:
[GRAPHIC] [TIFF OMITTED] TR15SE97.001

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 Sec. 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 Sec. 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

[[Page 48388]]

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 Sec. 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 Sec. 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

[[Page 48389]]

scrubber, or a dry scrubber followed by a fabric filter and a wet 
scrubber to comply with the emission limits under Sec. 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.


Sec. 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 Sec. 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 Sec. 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.


Sec. 60.58c  Reporting and recordkeeping requirements.

    (a) The owner or operator of an affected facility shall submit 
notifications, as provided by Sec. 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 Sec. 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 site-specific operating 
parameters under Sec. 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 Sec. 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 Secs. 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 Sec. 60.54c;
    (8) Records showing the names of HMIWI operators who have completed 
review of the information in Sec. 60.53c(h) as required by 
Sec. 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 Sec. 60.53c and the dates of their 
qualification; and
    (11) Records of calibration of any monitoring devices as required 
under Sec. 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 
Sec. 60.56c(b)(1) through (b)(12), as applicable.
    (2) The values for the site-specific operating parameters 
established pursuant to Sec. 60.56c(d) or (i), as applicable.
    (3) The waste management plan as specified in Sec. 60.55c.

[[Page 48390]]

    (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 Sec. 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 
Sec. 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 Sec. 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                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Emission limits                                  
                                                                   -------------------------------------------------------------------------------------
              Pollutant               Units (7 percent oxygen, dry                                       HMIWI size                                     
                                                 basis)            -------------------------------------------------------------------------------------
                                                                             Small                   Medium                         Large               
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter..................  Milligrams per dry standard   69 (0.03)..............  34 (0.015)............  34 (0.015).                        
                                       cubic meter (grains per dry                                                                                      
                                       standard cubic foot).                                                                                            
Carbon monoxide.....................  Parts per million by volume.  40.....................  40....................  40.                                
Dioxins/furans......................  Nanograms per dry standard    125 (55) or 2.3 (1.0)..  25 (11) or 0.6 (0.26).  25 (11) or 0.6 (0.26).             
                                       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).                                                                                                           
Hydrogen chloride...................  Parts per million or percent  15 or 99%..............  15 or 99%.............  15 or 99%.                         
                                       reduction.                                                                                                       
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   1.2 (0.52) or 70%......  0.07 (0.03) or 98%....  0.07 (0.03) or 98%.                
                                       cubic meter (grains per                                                                                          
                                       thousand dry standard cubic                                                                                      
                                       feet) or percent reduction.                                                                                      
Cadmium.............................  Milligrams per dry standard   0.16 (0.07) or 65%.....  0.04 (0.02) or 90%....  0.04 (0.02) or 90%.                
                                       cubic meter (grains per                                                                                          
                                       thousand dry standard cubic                                                                                      
                                       feet) or percent reduction.                                                                                      
Mercury.............................  Milligrams per dry standard   0.55 (0.24) or 85%.....  0.55 (0.24) or 85%....  0.55 (0.24) or 85%.                
                                       cubic meter (grains per                                                                                          
                                       thousand dry standard cubic                                                                                      
                                       feet) or percent reduction.                                                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------


            Table 2 To Supbart Ec.--Toxic Equivalency Factors           
------------------------------------------------------------------------
                                                                Toxic   
                   Dioxin/furan congener                     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 

[[Page 48391]]

                                                                        
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                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Minimum frequency                                        Control system             
                                          --------------------------------------------------------------------------------------------------------------
                                                                                                                                            Dry scrubber
   Operating parameters to be monitored                                                                         Dry scrubber                 followed by
                                                    Data measurement                   Data recording            followed by  Wet scrubber     fabric   
                                                                                                                   fabric                    filter and 
                                                                                                                   filter                   wet scrubber
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum operating parameters:                                                                                                                           
    Maximum charge rate..................  Continuous.......................  1 x hour........................                     
    Maximum fabric filter inlet            Continuous.......................  1 x minute......................         ............       
     temperature.                                                                                                                                       
    Maximum flue gas temperature.........  Continuous.......................  1 x minute......................                            
Minimum operating parameters:                                                                                                                           
    Minimum secondary chamber temperature  Continuous.......................  1 x minute......................                     
    Minimum dioxin/furan sorbent flow      Hourly...........................  1 x hour........................         ............       
     rate.                                                                                                                                              
    Minimum HCI sorbent flow rate........  Hourly...........................  1 x hour........................         ............       
    Minimum mercury (Hg) sorbent flow      Hourly...........................  1 x hour........................         ............       
     rate.                                                                                                                                              
    Minimum pressure drop across the wet   Continuous.......................  1 x minute......................  ............              
     scrubber or minimum horsepower or                                                                                                                  
     amperage to wet scrubber.                                                                                                                          
    Minimum scrubber liquor flow rate....  Continuous.......................  1 x minute......................  ............              
    Minimum scrubber liquor pH...........  Continuous.......................  1 x minute......................  ............              
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 97-23835 Filed 9-12-97; 8:45 am]
BILLING CODE 6560-50-P