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

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## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** September 15, 1997
- **Citation:** 62 FR 48348

## Text

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 Guidel

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-23835. Public record. Not legal advice.