[Federal Register Volume 62, Number 178 (Monday, September 15, 1997)]
[Rules and Regulations]
[Pages 48348-48391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23835]
[[Page 48347]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 60
Standards of Performance for New Stationary Sources and Emission
Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
Incinerators; Final Rule
Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 /
Rules and Regulations
[[Page 48348]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 60
[AD-FRL-5878-8]
RIN 2060-AC62
Standards of Performance for New Stationary Sources and Emission
Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
Incinerators
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action promulgates new source performance standards (NSPS
or standards) and emission guidelines (EG or guidelines) to reduce air
emissions from hospital/medical/infectious waste incinerator(s) (HMIWI)
by adding subpart Ec, standards of performance for new HMIWI, and
subpart Ce, emission guidelines for existing HMIWI, to 40 CFR part 60.
The standards and guidelines implement sections 111 and 129 of the
Clean Air Act (CAA) as amended in 1990. The standards and guidelines
apply to units whose primary purpose is the combustion of hospital
waste and/or medical/infectious waste. Sources are required to achieve
emission levels reflecting the maximum degree of reduction in emissions
of air pollutants that the Administrator has determined is achievable,
taking into consideration the cost of achieving such emission
reduction, any nonair-quality health and environmental impacts, and
energy requirements. The promulgated standards and guidelines establish
emission limits for particulate matter (PM), opacity, sulfur dioxide
(SO2), hydrogen chloride (HCl), oxides of nitrogen
(NOX), carbon monoxide (CO), lead (Pb), cadmium (Cd),
mercury (Hg), dioxins and dibenzofurans (dioxins/furans), and fugitive
ash emissions. Some of the pollutants being regulated are considered to
be carcinogens and at sufficient concentrations can cause toxic effects
following exposure. The standards and guidelines also establish
requirements for HMIWI operator training/qualification, waste
management plans, and testing/monitoring of pollutants and operating
parameters. Additionally, the guidelines for existing HMIWI contain
equipment inspection requirements and the standards for new HMIWI
include siting requirements.
DATES: Effective Dates. The standards for new sources (Sec. 60.17 and
Secs. 60.50c through 60.58c) are effective as of March 16, 1998 and the
emission guidelines for existing sources (Sec. 60.30 and Secs. 60.30e
through 60.39e) are effective as of November 14, 1997. The
incorporation by reference of certain publications listed in the
regulations is approved by the Director of the Federal Register as of
March 16, 1998. See SUPPLEMENTARY INFORMATION for a discussion of the
schedule for judicial review.
Comments. Comments on the Information Collection Request (ICR)
document associated with the final standards for new sources are
requested, as discussed in section VI.B of this preamble. Comments on
the ICR document must be received on or before November 14, 1997. Refer
to Section VI.B for further information on this request for comment.
ADDRESSES: Comments. As noted above, comments on the ICR document
associated with the final standards for new sources are requested. See
section VI.B and the SUPPLEMENTARY INFORMATION section of this preamble
for further information on obtaining a copy of the ICR document and
addresses for submitting comments on the ICR document.
Background Information. The principal background information for
the final standards and guidelines includes a background information
document entitled ``Hospital/Medical/ Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b), which
contains a summary of all the public comments submitted regarding the
changes to the standards and guidelines that were discussed in the June
20, 1996 Federal Register document (61 FR 31736) and the EPA's response
to these comments. Background information documents which present the
economic and regulatory impacts of the standards and guidelines
entitled: (1) ``Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Analysis of Economic Impacts for Existing Sources'' (EPA-453/R-97-
007b); (2) ``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Analysis of
Economic Impacts for New Sources'' (EPA-453/R-97-008b); and (3)
``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Regulatory Impact
Analysis for New and Existing Facilities'' (EPA-453/R-97-009b) are
available. Also a document entitled ``Fact Sheet: New Hospital/Medical/
Infectious Waste Incinerators--Promulgated Subpart Ec Standards,''
which succinctly summarizes the final standards, and a document
entitled ``Fact Sheet: Existing Hospital/Medical/Infectious Waste
Incinerators--Promulgated Subpart Ce Emission Guidelines,'' which
succinctly summarizes the guidelines, are available. See SUPPLEMENTARY
INFORMATION for instructions and addresses for obtaining these
documents.
Docket. Docket No. A-91-61, which contains supporting information
used in developing the standards and guidelines, is available for
public inspection and copying between 8:00 a.m. and 4:00 p.m., Monday
through Friday except for Federal holidays at the following address:
U.S. Environmental Protection Agency, Air and Radiation Docket and
Information Center (Mail Code 6102), 401 M Street SW, Washington DC
20460 (phone: (202) 260-7548). The docket is located at the above
address in room M-1500, Waterside Mall (ground floor, central mall). A
reasonable fee may be charged for copying.
FOR FURTHER INFORMATION CONTACT: Mr. Rick Copland at (919) 541-5265,
Combustion Group, Emission Standards Division (MD-13), U. S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711 ([email protected]) or any of the EPA Regional Office
contacts listed in Table 1 below.
Table 1.--Contacts in EPA Regional Offices
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Region Contact Phone No.
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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
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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
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Examples of
Category regulated entities
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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-
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proposal, but merely a notice of supplemental information. However,
some commenters stated that the 1996 notice should be considered a re-
proposal. Upon consideration of these comments, EPA now considers the
1996 notice to have been a re-proposal. The 1996 notice included all of
the elements of a re-proposal, including: A new inventory of sources;
new subcategories; revised assessments of emissions and performance of
technology; new MACT floors; new regulatory options; revised cost,
environmental, and economic impacts; an indication of EPA's selection
of MACT; and a request for public comment. More importantly, virtually
every aspect of the 1995 proposal was changed significantly by the 1996
notice, making most of the analyses and conclusions from the 1995
notice irrelevant. Therefore, in today's final rule, HMIWI which
commenced construction after June 20, 1996 are considered new sources
subject to the NSPS under Subpart Ec, and HMIWI which commenced
construction on or before June 20, 1996 are considered existing sources
subject to the EG under subpart Ce.
The 1996 re-proposal served as a response to most comments on the
1995 proposed rule. Comments on miscellaneous issues that were not
addressed in the 1996 re-proposal notice are summarized and responded
to in ``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Summary of Public
Comments and Responses'' (EPA-453/R-97-006b). The 1996 re-proposal
notice discussed the reanalyses of new information that led to changes
in the 1995 proposed standards and guidelines. Presented below is a
brief summary of the reanalyses that occurred following the 1995
proposal and a discussion of the EPA's inclinations that were
introduced in the 1996 re-proposal.
Following the 1995 proposal, a number of comments were received
regarding the EPA's inventory of existing HMIWI. Most commenters felt
that the EPA's inventory was inadequate and should be updated. In
response to these concerns, the EPA compiled a new inventory of
existing HMIWI based on information received from the American Hospital
Association, State agencies, HMIWI vendors, commercial medical waste
disposal companies, and other stakeholders. After several revisions,
the final HMIWI inventory contained approximately 2,400 existing HMIWI.
The Agency also reanalyzed the HMIWI subcategories based on the new
information received after the 1995 proposal. In the 1996 re-proposal,
the Agency stated that it was inclined to subcategorize the new and
existing population of HMIWI into three subcategories based on waste
charging capacity: small (200 lb/hr), medium (>200 and
500 lb/hr) and large (>500 lb/hr). While these subcategories
were based on HMIWI size, they also reflect design differences among
HMIWI.
Directly related to the issue of subcategorizing HMIWI by size is
the question of how to determine HMIWI size in a manner that is
consistent, uniform, and applicable to all HMIWI covered under the
standards and guidelines. In the 1996 re-proposal, the EPA stated that
it was inclined to base HMIWI capacity on either: (1) Volumetric waste
burning capacity factors developed using the design heat release rate
of the HMIWI and the heat content of medical waste or (2) an
enforceable limit that would restrict waste charge rate.
At the time of the 1995 proposal, relatively few emission test
reports were available to the EPA from which to draw conclusions
regarding the performance capabilities of various air pollution control
systems. Many commenters believed that EPA misjudged the performance
capabilities of various air pollution control technologies, especially
the capabilities of wet scrubbing systems. Following the 1995 proposal,
a number of emission test reports were submitted to EPA. The EPA
reviewed the data contained in these emission test reports and, as a
result, EPA's conclusions regarding the performance capabilities of
various air pollution control technologies were revised and presented
in the 1996 re-proposal.
As discussed earlier, the new information submitted led to changes
to the HMIWI inventory, subcategories, and conclusions about the
performance of technology. Because these factors can influence the MACT
floors, a review of the MACT floors was conducted. The recalculated
MACT floors and the new conclusions regarding the performance
capabilities of air pollution control technologies led to new
conclusions regarding what technologies HMIWI would have to use to
achieve the MACT floors.
In the 1996 re-proposal, the EPA defined regulatory options more
stringent than the MACT floors for new and existing HMIWI and presented
the impacts of the regulatory options. After reviewing the emissions
reductions that could be achieved and the impacts of the regulatory
options, the EPA presented its inclinations as to which emission levels
the final MACT standards and guidelines might reflect. For new medium
and large HMIWI, the EPA stated that it was inclined to adopt emission
limits that could be achieved with good combustion followed by a high
efficiency wet scrubber and a DI/FF system with carbon (i.e., combined
dry/wet scrubber with carbon). The EPA stated that it was inclined to
adopt emission limits that could be achieved with good combustion and a
moderate efficiency wet scrubber for new small HMIWI and for medium
existing HMIWI. For large existing HMIWI, the EPA stated that it was
inclined to adopt emission limits that could be achieved with the use
of good combustion and a high efficiency wet scrubber. The EPA offered
no inclinations for the emission limits for small existing HMIWI.
Instead, the EPA discussed the regulatory options and impacts for small
existing HMIWI and solicited comments on which emission levels would be
suitable for the final guidelines.
Many comments were also received regarding the 1995 proposed
testing and monitoring requirements. Commenters noted that the proposed
4-hour test run was much longer than the more conventional test run of
about 1-hour. Commenters also noted that many hospitals and health care
facilities would normally not have sufficient waste on hand to
accommodate three, 4-hour test runs and the 1995 proposed emission
testing requirements would substantially increase the costs associated
with emission testing. In response to these comments, the EPA stated in
the 1996 re-proposal that it was inclined to adopt requirements that
EPA test methods be followed when performing emissions testing to
determine compliance. This requirement would ensure that compliance
testing follows the same procedures used to generate the emission data
upon which the emission limits in the regulation were based. In most
cases, three test runs of about 1 hour each would be necessary to
determine compliance. An exception to this requirement would be
emission testing to measure dioxin/furan emissions. The procedures
outlined in the EPA test method frequently lead to test runs longer
than 1 hour to ensure sufficient sample is gathered to accurately
measure dioxin/furan emissions.
Numerous comments were received on the 1995 proposed annual
emission testing requirements. While some commenters supported the
annual testing requirements, others felt that the proposed requirements
for inspections, monitoring, and operator training were sufficient and
much less expensive than
[[Page 48354]]
annual testing. Some commenters suggested that the annual emission test
requirement be replaced with a requirement for annual equipment
inspection and maintenance. Many of the commenters supportive of the
proposed inspection requirements, however, suggested that the
requirement for a ``third party'' inspection be deleted. Therefore, EPA
stated in the 1996 re-proposal that it was inclined to include
inspection and maintenance requirements wherever annual stack testing
is not required and that the inspection would not have to be conducted
by a third party.
To consider comments on the 1995 proposal regarding the frequency
of emission testing and the proposed inspection and monitoring
requirements, EPA presented a matrix of testing and monitoring options
and their associated costs in the 1996 re-proposal. The EPA noted that
almost all of the emission testing and monitoring options under
consideration cost more than the incinerator or emission control system
that would be installed to meet the emission limits in the regulations.
Consequently, the Agency stated that it was inclined to include
monitoring of operating parameters and routine Method 9 opacity tests
(instead of CO and opacity CEMS) in the final regulations to minimize
costs.
With regard to specific air pollution control device (APCD)
operating parameters to be monitored, the Agency stated that it was
inclined to require monitoring of the same parameters as outlined in
the 1995 proposal for dry scrubbers, and the following for wet
scrubbers: Scrubber exit temperature, scrubber liquor pH, scrubber
liquor flow rate, and energy input to the scrubber (e.g., pressure drop
or horsepower).
The EPA also stated in the 1996 re-proposal that it was inclined to
require initial and repeat stack testing (annual/skip testing) where
the regulations are based on good combustion and wet and/or dry
scrubbing systems; and initial stack testing and routine inspections
where the regulations are based on the use of good combustion alone.
With the annual/skip testing requirement, emission tests would be
required for the first 3 years. If these tests show that the facility
was in compliance each of these 3 years, then subsequent testing would
be done every third year. Under the inclinations presented in the 1996
re-proposal, annual or skip emission testing would only require
emission testing of a few key or critical pollutants (i.e., only those
necessary to gain a good indication that the air pollution control
system is operating properly).
A large number of comments were received on the 1995 proposed
definition of medical waste. The majority of the commenters stated that
the proposed definition of medical waste was too broad and should be
narrowed. The commenters believed that the proposed definition would be
adopted by other regulatory agencies, and as the definition became more
widespread, that it would eventually force all health care facilities
to handle most of their waste as if it were infectious. This would
result in an increase in the volume of medical waste requiring special
handling, which in turn would result in increased costs to dispose of
waste from health care facilities. These commenters stated that health
care facilities should be viewed as generating two waste streams: A
medical waste stream, which is usually defined by the potential for
disease transmission and requires special handling; and a noninfectious
waste or ``health care trash'' waste stream, which has no potential for
infection and is treated and handled as municipal waste. The commenters
urged EPA to narrow the definition of medical waste used in the HMIWI
regulations to one that includes only the infectious portion of the
waste stream.
In response to the comments concerning the 1995 proposed definition
of medical waste, the EPA stated in the 1996 re-proposal that it was
inclined to adopt a definition of medical waste that focuses on the
infectious or potentially infectious portion of the overall medical
waste stream. Given the confusion and number of varying definitions of
medical waste in use at the Federal, State and local levels, the EPA
stated that it was inclined to adopt a definition of medical waste for
the HMIWI regulations from among those definitions already in use.
Specifically, the EPA stated that it was inclined to adopt the New York
State Department of Health (NYSDOH) definition of medical waste.
In the 1996 re-proposal, the EPA also stated that it was inclined
to exclude crematories and incinerators used solely for burning
pathological waste (human or animal remains and tissues), incinerators
used solely for burning ``off-spec'' or ``out of date'' drugs or
pharmaceuticals, and incinerators used solely for burning radioactive-
type medical wastes from the HMIWI regulations. The EPA further stated
that it was inclined to adopt separate regulations for pyrolysis
treatment technologies and requested comment on the merits of continued
development of separate pyrolysis regulations.
F. Stakeholders and Public Involvement
Throughout the development of the standards and guidelines, EPA
conducted meetings with stakeholders to explain EPA conclusions and
solicit comments, data, and information. Numerous discussions were held
with governmental entities, industry representatives, and environmental
groups including, but not limited to, the following: the U.S.
Conference of Mayors; the National League of Cities; the National
Association of City and County Health Officials; the National
Association of Counties; the National Association of Public Hospitals;
the Department of Defense; the Department of Veterans Affairs; the
American Hospital Association; the Medical Waste Institute; the Sierra
Club; the Natural Resources Defense Council; vendors of pyrolysis
units, HMIWI, continuous emission monitoring systems, and air pollution
control technologies; and the general public.
The standards and guidelines being adopted today were first
proposed in the Federal Register on February 27, 1995 (60 FR 10654).
The preambles for the 1995 proposed standards and guidelines described
the rationale for the proposed standards and guidelines. Following the
1995 proposal, the EPA provided interested persons the opportunity to
comment through a written comment period and held a public hearing. The
public comment period lasted from February 27, 1995 to April 28, 1995
and all late comments were accepted. Over 700 comments were received
from private citizens, industry representatives, environmental groups,
and governmental entities. Several public meetings and meetings with
industry stakeholders were held following the 1995 proposal to discuss
EPA's assessment of new information submitted with comments, to gather
additional information, and to solicit further comments. As discussed
above in sections II.D and II.E, the comments and new information
received following the 1995 proposal led to numerous changes to the
standards and guidelines.
On June 20, 1996, EPA re-proposed the standards and guidelines in
the Federal Register. Following the 1996 re-proposal, the EPA held a
public meeting to review the contents of the re-proposal and to answer
questions so that interested parties could better prepare their written
comments. The comment period remained open from June 20, 1996 until
August 8, 1996. Again, late comments were accepted. Nearly 70 comments
were received. The comments received following the 1996 re-proposal
were carefully considered
[[Page 48355]]
and changes were made to the HMIWI standards and guidelines where
appropriate. Sections III, IV, and V of this preamble discuss the
responses to comments on the standards and guidelines that address the
major concerns of the commenters on the 1996 re-proposal.
III. Considerations in Developing the Final Standards and
Guidelines
Following the June 20, 1996 re-proposal, the EPA received numerous
comments concerning applicability of the standards and guidelines,
pollution prevention, and the testing and monitoring requirements.
Special consideration was given to these issues when developing the
final HMIWI standards and guidelines. This section discusses these
issues and changes, if any, that were made to the final HMIWI standards
and guidelines following the 1996 re-proposal. Additional discussion
and responses to specific concerns regarding these and other issues are
provided in ``Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b).
A. Applicability
A great deal of interest and discussion has taken place regarding
which incinerators should be subject to this rule and which should not.
All comments have been considered and the following sections present
EPA's final decisions.
1. Definition of Medical Waste
This section discusses the evolution of the definition of medical
waste used in determining the applicability of the HMIWI standards and
guidelines. In the 1996 re-proposal ``medical waste'' was the term used
to describe what is today called ``medical/infectious waste'' in the
final HMIWI standards and guidelines. Similarly, the term ``medical
waste incinerator'' or ``MWI'' was used to describe what is called
``hospital/medical/ infectious waste incinerator'' or ``HMIWI'' in the
standards and guidelines promulgated today.
Section 129 of the CAA directs the EPA to adopt regulations for
solid waste incineration units that combust ``hospital waste, medical
waste, and infectious waste.'' Section 129(g)(6) states that the term
``medical waste'' shall have the meaning ``established by the
Administrator pursuant to the Solid Waste Disposal Act.'' For the 1995
proposed air emission standards and guidelines for ``MWI,'' EPA adopted
the definition of ``medical waste'' from the solid waste regulations
codified in 40 CFR part 259, subpart B. As a result, medical waste was
defined broadly as any solid waste that is generated in the diagnosis,
treatment, or immunization of human beings or animals, in research
pertaining thereto, or in the production or testing of biologicals. The
broad definition of medical waste in the 1995 proposal was not intended
to be used to identify ``infectious'' or ``potentially infectious''
items in the health care waste stream. The EPA's only intention was to
define those items likely to be burned in an ``MWI'' for the sake of
defining and regulating the air emissions from incinerators used to
burn ``hospital waste, medical waste, and infectious waste.''
As discussed earlier, the majority of the comments on the 1995
proposed definition of medical waste stated that the proposed
definition was too broad and should be narrowed. Consequently, the 1996
re-proposal announced EPA's inclination to adopt an existing and more
narrow definition of medical waste for the purpose of regulating
``MWI.'' Specifically, the EPA stated that it was inclined to adopt the
definition of medical waste created by the New York State Department of
Health (NYSDOH). While inclined to adopt the NYSDOH definition, the EPA
stated in the 1996 re-proposal that it was also considering definitions
of medical waste adopted by other regulatory agencies and national
associations as well as the 1995 proposed definition. The EPA solicited
public comment on the merits of each definition as well as other
definitions EPA should consider.
Following the 1996 re-proposal, several commenters supported a
definition of medical waste that is limited to potentially infectious
materials and several commenters agreed that the NYSDOH definition of
medical waste is appropriate. Other commenters suggested that the EPA
Office of Solid Waste (OSW) definition of regulated medical waste (RMW)
is more appropriate than the NYSDOH definition because Congress
intended for EPA to use the Solid Waste Disposal Act (SWDA) definition.
On the other hand, several commenters argued that a broad
definition of medical waste is appropriate. The commenters stated that
anything burned in an incinerator at a health care facility should be
classified as medical waste and pointed out that the CAA requires EPA
to regulate emissions from solid waste incineration units ``combusting
hospital waste, medical waste and infectious waste.'' The commenters
contended that facilities operating onsite incinerators would use them
primarily for noninfectious waste, which produces emissions similar to
medical waste when burned.
The EPA has concluded that the Medical Waste Tracking Act (MWTA)
definition of regulated medical waste is the most appropriate
definition of medical/infectious waste for the final HMIWI standards
and guidelines. As noted in the proposal and re-proposal, the EPA
considered several definitions for purposes of these regulations (e.g.,
OSHA, NYSDOH, MWTA, AHA). Although the various definitions are not
identical, they cover many of the same materials. After considering the
comments received, the EPA today is promulgating the MWTA definition
under the co-authority of section 2002 of the SWDA, 42 U.S.C. 6912, and
sections 129 and 301 of the CAA, 42 U.S.C. 7429 and 7601.
The EPA believes the MWTA definition is the most appropriate
because it includes the materials of concern, and will lead to the
least confusion in the regulated community because it is a familiar
definition. In addition, the MWTA definition has undergone public
comment at the Federal level, during both the rulemaking under the
MWTA, as well as rulemaking on these regulations. The EPA emphasizes
that the MWTA definition being promulgated today is solely for purposes
of determining which incineration units are covered by the HMIWI
regulations under section 129 of the CAA. It is not for purposes of
determining applicability of SWDA requirements. THE MWTA definition,
however, does not include hospital waste; thus, EPA also is
promulgating today under authority of sections 129 and 301 of the CAA,
42 U.S.C. 7429 and 7601, a definition of hospital waste.
The MWTA differentiates between infectious and noninfectious
wastes. The MWTA definition of RMW includes seven classes of waste
which are very similar to the classes of infectious waste included in
the NYSDOH definition. However, the MWTA definition of RMW is broader
than the NYSDOH definition of medical waste because the MWTA definition
includes some items (e.g., intravenous bags) which may not be
infectious, but are aesthetically unpleasing. The MWTA definition does
not include hazardous waste; household waste; ash from incineration of
medical/infectious waste; human corpses, remains, and anatomical parts
intended for interment or cremation; or domestic sewage materials.
[[Page 48356]]
The EPA recognizes that the MWTA definition does not fully
encompass the terms ``hospital waste, medical waste, and infectious
waste.'' The MWTA definition, as well as other definitions considered
for the final HMIWI regulations, cover ``medical waste and infectious
waste,'' but do not cover ``hospital waste.'' Commenters are correct in
pointing out that the emissions from combustion of hospital waste are
very similar to emissions from the combustion of medical/infectious
waste. Therefore, the final HMIWI standards and guidelines contain
definitions for ``hospital'' and ``hospital waste'' and the definition
of ``medical/infectious waste'' (MWTA definition). The definitions of
``hospital'' and ``hospital waste'' will subject incinerators located
at hospitals to the final standards and guidelines, whether they burn
``infectious'' waste, ``noninfectious'' waste, or a combination.
Commenters on the 1995 proposed regulations stated there are very
few, if any, incinerators that are used by hospitals to burn only
noninfectious hospital trash. Consequently, this inclusion of
``hospital waste'' along with ``medical/infectious waste'' should:
minimize the concern about the overly broad definition of medical
waste; cover the same incinerators as envisioned in the 1995 proposal
and 1996 re-proposal, resulting in the same emission reductions without
imposing additional costs; and satisfy the CAA requirement to regulate
solid waste incinerators combusting ``hospital waste, medical waste,
and infectious waste.'' On the other hand, section 129 directs EPA to
develop regulations for four categories of solid waste incinerators.
Because municipal waste combustors (MWC), industrial/commercial waste
incinerators, and other solid waste incinerators sometimes burn small
amounts of hospital waste and/or medical/infectious waste, and because
these other categories are already or will be subject to section 129
regulations, the final HMIWI regulations focus on incinerators whose
primary purpose is the disposal of hospital waste and/or medical/
infectious waste in an effort to avoid duplicative requirements.
Combustors subject to subparts Ea, Eb, or Cb (the NSPS and EG for MWC
larger than 250 tons per day) have been excluded from coverage under
the HMIWI regulations. In addition, any incinerator which burns 10
percent or less by weight hospital waste and medical/infectious waste
is not subject to the final HMIWI standards and guidelines. This 10
percent provision is discussed further in section A.2 ``Co-fired
Combustors'' (below).
The primary purpose of the MWTA definition of medical waste as used
for the HMIWI standards and guidelines is to define items combusted in
an HMIWI, and not to define items which could transmit disease. Only a
small fraction of ``medical/infectious'' waste is truly ``infectious.''
The EPA believes that to add or remove specific items to or from the
MWTA definition, as suggested by some commenters, would create
additional regulatory confusion because the revised definition would
essentially become a new definition of medical waste if altered. Any
waste excluded from the MWTA definition is either covered now or will
be covered in the future by other solid waste incinerator regulations.
The final standards and guidelines will apply to hospital/medical/
infectious waste incinerators. It should be noted that the definition
of medical/infectious waste adopted for the HMIWI regulations is not
the government-wide Federal definition, or even the Agency-wide EPA
definition of infectious waste. The medical/infectious waste definition
contained in the final regulations promulgated today is for use in
determining applicability of the HMIWI standards and guidelines only.
It should also be noted that ``hospital waste'' is simply waste
generated at a hospital. Most of the waste generated at a hospital (85
to 90 percent or more) is simply municipal-type waste that may be
recycled or disposed without special treatment. The use of the term
``hospital waste'' in these regulations is for use in determining
applicability of the HMIWI standards and guidelines only.
2. Co-fired Combustors
In the 1996 re-proposal, the EPA provided no inclinations regarding
the applicability of the HMIWI regulations to combustors that co-fire
medical waste with other fuels or wastes. Some examples of units that
might be used to co-fire medical waste along with other fuels or wastes
include municipal waste combustors (MWC), boilers, and industrial/
commercial waste incinerators. During the public comment period
following the 1996 re-proposal, several comments were received
questioning the applicability of the HMIWI regulations to units that
co-fire medical waste with other fuels or wastes.
One commenter provided information on a circulating fluidized bed
combustor (CFBC) steam plant which co-fires coal and medical waste. The
commenter noted that traditional HMIWI burn materials with low sulfur
content and that the proposed SO2 emission limit was
arbitrarily set higher than actual HMIWI emissions. The commenter
requested that the SO2 emission limit be raised to 100 ppm
to accommodate the CFBC without affecting other incinerators that burn
medical waste.
Other commenters requested that ``potentially infectious'' medical
waste and ``off-spec'' or ``out-of-date'' pharmaceuticals be allowed to
be combusted in MWC along with municipal solid waste (MSW) without
subjecting MWC to the HMIWI rules. The commenters noted that MWC which
co-combust municipal and medical waste are regulated under the MWC
emission standards. The commenters recommended that an exclusion be
written into the final rule that will allow MWC combusting a minimal
amount of medical waste (up to 10 percent of the waste stream) to be
excluded from the HMIWI rule. The commenters suggested that, if EPA
feels that co-combustion of MSW and medical waste in a small MWC not
covered under the MWC standards is an environmental threat, that co-
combustion should not be allowed in MWC burning less than 40 tons per
day. Other commenters stated that small MWC not regulated under the MWC
standards should not be allowed to accept medical waste without
complying with the HMIWI regulations.
Other commenters requested that a ``de minimis'' quantity exemption
be allowed for facilities that incinerate insignificant quantities of
medical waste. Some commenters requested that clinical waste in the
amount of 5 to 10 percent of the total waste stream be allowed to be
disposed of in a pathological waste incinerator.
Section 129 requires the EPA to develop NSPS and EG for MWC, HMIWI,
industrial/commercial waste incinerators, and ``other'' solid waste
incinerators. The final NSPS and guidelines applicable to MWC with
capacities of greater than 40 tons/day were promulgated in December
1995, but have since been partially vacated and remanded. In this case,
it is not the EPA's intent for MWC to be dually covered under both the
MWC regulations and the HMIWI regulations. Therefore, combustors
subject to Subparts Ea, Eb, or Cb (the NSPS and EG for MWC larger than
250 tons/day) have been excluded from coverage under the HMIWI
regulations regardless of the amount of hospital waste or medical/
infectious waste combusted. As regulations are developed under Section
129 for the other categories of solid waste incinerators, EPA will make
clear which regulations apply to which incinerators. In some cases,
incinerators
[[Page 48357]]
may be subject to more than one regulation.
Commenters requesting that MWC, boilers, and other industrial
processes that co-fire medical waste be exempted from coverage under
the HMIWI regulations generally seem to agree that these units combust
no more than 10 percent hospital waste and/or medical/infectious waste.
Therefore, the final HMIWI NSPS and guidelines contain the provision
that any incinerator or industrial process that combusts less than or
equal to 10 percent hospital waste and medical/infectious waste (by
weight) is not subject to the HMIWI NSPS and guidelines provided that
the facility notifies the Administrator of an exemption claim and
maintains records of the amount of hospital waste, medical/ infectious
waste, and other fuels or wastes combusted.
As discussed in section A.3 ``Waste Types'' (below), ``off-spec''
or ``out-of-date'' drugs are not considered to be medical/infectious
waste as defined in the final HMIWI regulations and are not considered
to be hospital waste, unless disposed with the hospital's waste. ``Off-
spec'' or ``out-of-date'' drugs are viewed the same as other fuels or
wastes (e.g., municipal waste, coal, etc.) under HMIWI regulations.
Therefore, incinerators that combust waste pharmaceuticals (i.e.,
``off-spec'' or ``out-of-date'' drugs), and combust 10 percent or less
hospital waste and medical/infectious waste (by weight) are not subject
to the HMIWI regulations. However, any incinerator that combusts waste
pharmaceuticals along with more than 10 percent hospital waste and
medical/infectious waste is subject to the HMIWI regulations.
As also discussed in section A.3 ``Waste Types'' (below),
pathological waste, chemotherapeutic waste, and low-level radioactive
waste are considered ``excluded'' wastes. While these wastes sometimes
meet the definition of hospital waste or medical/infectious waste, they
are viewed the same as ``other'' fuels or wastes (e.g., municipal
waste, coal, etc.) when calculating the amount of hospital waste and
medical/infectious waste burned in a co-fired combustor. For example, a
combustor burning 90 percent pathological waste with 10 percent
hospital waste is a co-fired combustor, even if the pathological waste
meets the definition of medical/infectious waste. However, any
incinerator that combusts pathological, chemotherapeutic, and/or low-
level radioactive waste along with more than 10 percent of other
materials meeting the definition of hospital waste and/or medical/
infectious waste is subject to the HMIWI regulations.
While incinerators that burn 10 percent or less hospital waste and
medical/infectious waste are excluded from the HMIWI regulations, this
exclusion does not mean that EPA will not develop regulations which
will cover these units in the future. The NSPS and EG that were
recently remanded for MWC with capacities between 40 tons/day and 250
tons/day will be revised and repromulgated. Furthermore, the CAA
directs the EPA to develop regulations for all solid waste
incinerators, including MWC with capacities less than 40 tons/day. The
EPA has announced that regulations for other solid waste incinerators
will be developed by the year 2000. Thus, burning of hospital waste or
medical/infectious wastes in other solid waste incineration units will
be covered by regulations developed within the next few years.
Exclusion of incinerators that burn small amounts of hospital waste or
medical/infectious waste from the HMIWI regulation is only a temporary
deferment from regulation if these units are not presently regulated
under section 129.
3. Waste Types
In the 1996 re-proposal, the EPA stated that it was inclined to
exclude crematories and incinerators used solely for burning
pathological waste from coverage under the HMIWI regulations. The EPA
also stated that it was inclined to exclude incinerators used solely
for burning low-level radioactive waste or ``off-spec'' and ``out-of-
date'' pharmaceuticals. This section discusses the major public
comments received regarding exemption of specific wastes from the HMIWI
standards and guidelines.
Several commenters requested that crematories and incinerators used
solely for burning pathological waste be excluded from the HMIWI
regulation. One commenter questioned whether animal waste is to be
included, excluded, or partially excluded from the regulation. Another
commenter stated that there are no effective alternative disposal
options for pathological waste, especially for large domestic animal
carcasses (i.e., cows and horses). Several commenters also requested
that incinerators used to burn only ``off-spec'' and ``out-of-date''
drugs or low-level radioactive waste be excluded from the regulation.
One commenter stated that crematories and incinerators used to burn
drugs, low-level radioactive waste, and pathological waste are already
covered under other regulations, or will be covered under regulations
developed through EPA's Industrial Combustion Coordinated Rulemaking
(ICCR) project. Other commenters urged EPA to exclude units permitted
under section 3005 of the SWDA from the HMIWI rule. One commenter
argued that section 129 of the CAA statutorily prohibits EPA from
regulating in the HMIWI rule hazardous waste combustion units which are
to be regulated under the Resource Conservation and Recovery Act
(RCRA).
Pathological waste, low-level radioactive waste, and
chemotherapeutic waste are different from most hospital waste and
medical/infectious waste and are often burned in incinerators which
burn these wastes exclusively. While these wastes often times meet the
definition of hospital waste or medical/infectious waste, the
combustion of these materials warrants separate consideration.
Pathological waste, chemotherapeutic waste, and low-level radioactive
waste are considered ``excluded'' wastes, regardless of whether the
waste meets the definition of hospital waste or medical/infectious
waste in the HMIWI regulations. Consequently, in determining the amount
of hospital waste and medical/infectious waste burned in a co-fired
combustor, these ``excluded'' wastes are included in the calculation as
``other'' wastes (they do not count toward the 10 percent hospital
waste and medical/infectious waste), as discussed above in section A.2.
In addition, incinerators that are otherwise subject to the HMIWI
regulations are exempt during periods when only pathological waste,
low-level radioactive waste, and/or chemotherapeutic waste is burned.
These latter units must keep records of the periods of time when only
pathological, chemotherapeutic, and low-level radioactive wastes are
burned.
With regard to crematories, human remains intended for interment or
cremation are not hospital waste or medical/infectious waste.
Consequently, crematories are not subject to the HMIWI regulations
unless they burn waste that meets the definition of hospital waste or
medical/infectious waste.
While pathological incinerators, chemotherapeutic and low-level
radioactive waste incinerators, and crematories are excluded from the
final HMIWI standards and guidelines, this exclusion does not mean that
EPA will not develop regulations which will cover these incinerators in
the future. The CAA directs the EPA to develop regulations for all
solid waste incinerators. The EPA is developing separate regulations
which will cover these units as part of the ``other'' category of solid
waste incineration
[[Page 48358]]
units within the ICCR project. The EPA has announced that regulations
for other solid waste incinerators will be developed by the year 2000.
Thus, cremation and burning of pathological, chemotherapeutic, and low-
level radioactive wastes will be covered by regulations developed
within the next few years. Exclusion of crematories and incinerators
burning pathological, chemotherapeutic, and low-level radioactive waste
from the HMIWI regulation is only a temporary deferment.
Pharmaceutical wastes such as ``off-spec'' or ``out-of-date'' drugs
are not considered to be medical/infectious waste as defined in the
final HMIWI regulations. Also, pharmaceutical wastes are not considered
to be hospital waste unless generated at a hospital and disposed with
the hospital's waste. In the HMIWI regulations ``hospital waste'' is
defined as discards generated at a hospital, excluding human remains
and unused items returned to the manufacturer. Thus, ``out-of-date''
drugs returned by a hospital to a pharmaceutical company for disposal
are not considered hospital waste. Waste pharmaceuticals are viewed the
same as other fuels and wastes (e.g., municipal waste, coal, etc.)
under the HMIWI regulations. Therefore, incinerators that combust waste
pharmaceuticals, and combust 10 percent or less hospital waste and
medical/infectious waste (by weight) are not subject to the HMIWI
regulations. However, any incinerator that combusts waste
pharmaceuticals along with more than 10 percent hospital waste and
medical/infectious waste is subject to the HMIWI regulations.
Section 129(g)(1) of the CAA specifically exempts from the HMIWI
NSPS and guidelines solid waste incinerators required to have a permit
under section 3005 of the SWDA. To be consistent with section 129, the
final HMIWI standards and guidelines specifically exempt incinerators
permitted under section 3005 of the SWDA. In addition, the definition
of medical/infectious waste in the final regulations specifically
excludes hazardous waste identified or listed under the regulations in
40 CFR Part 261.
4. Cement Kilns
Some commenters pointed out that section 129 clearly addresses
incinerators, not cement kilns. Commenters stated that HMIWI and cement
kilns using medical waste as fuel are two completely different devices
and should not be confused with each other or regulated under the same
air emissions control standards. One commenter recommended that if EPA
concludes that Congress intended to regulate cement kilns under section
129, EPA should not impose emission limitations and other requirements
that were written for HMIWI on cement kilns.
The EPA disagrees with commenters that contend EPA has no authority
to regulate cement kilns under section 129. Section 129(a)(1)(A)
requires the Administrator to establish performance standards and other
requirements for each category of solid waste incineration units.
Congress specifically listed in section 129 various categories of solid
waste incineration units that EPA must regulate. Section 129(g)(1)
broadly defines solid waste incineration unit as ``a distinct operating
unit of any facility which combusts any solid waste material * * *''
(emphasis added). This definition clearly indicates Congress' intent to
regulate more than just incinerators because the definition sweeps
within its scope any facility that is combusting any solid waste
material.
Further evidence of EPA's authority to regulate cement kilns under
section 129 is presented in ``Hospital/Medical/Infectious Waste
Incinerators: Background Information for Promulgated Standards and
Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-97-
006b). However, the EPA does recognize that cement kilns are different
from HMIWI in size, design, and operation. Accordingly, the EPA is not
regulating cement kilns under this regulation, but instead, is
determining whether separate regulations under section 129 are
appropriate for cement kilns combusting solid waste materials.
B. Pyrolysis Units
In the 1996 re-proposal, the EPA stated that it was considering a
separate regulation for pyrolysis units that would look very similar to
the HMIWI regulation in that it would contain definitions, emissions
limitations, monitoring and testing requirements to demonstrate
compliance, and reporting and recordkeeping requirements. However, the
separate pyrolysis regulation would differ from the HMIWI regulations
in that some definitions would be different, the emission limitations
would, in many cases, be more stringent than the HMIWI regulations, and
the monitoring and testing requirements would reflect the operating
parameters that are unique to pyrolysis systems.
Following the 1996 re-proposal, several commenters encouraged EPA
to promulgate separate standards for medical waste pyrolysis (MWP)
units. One commenter noted that separate regulations would contain
emission limits more stringent than the HMIWI regulations and reflect
the unique features of pyrolysis units.
Other commenters suggested that EPA modify the 1995 proposed HMIWI
regulations to include pyrolysis units and defer the final promulgation
of separate pyrolysis regulations. The commenters stated that
variations in the operating characteristics among pyrolysis
technologies would make separate pyrolysis regulations unwieldy to
implement at this time. The commenters requested that EPA modify the
HMIWI regulations to provide flexibility if a specific operator
training, siting, performance verification, compliance verification,
monitoring, recordkeeping or reporting requirement does not directly
apply to a pyrolysis system.
Other commenters stated that pyrolysis units are similar to
conventional incinerators and requested that they be included under the
HMIWI regulations. The commenters stated that, if EPA regulates
pyrolysis units separately, that MACT floor levels should be based on
available test data, and the pyrolysis regulation should be issued
concurrently with the final HMIWI regulations.
The various arguments for and against developing separate
regulations for pyrolysis units lead to three options for developing
regulations for pyrolysis units: (1) Regulate pyrolysis under the
standards and guidelines being promulgated today; (2) exempt pyrolysis
units from the HMIWI regulations and simultaneously promulgate separate
regulations for pyrolysis units; and (3) exempt pyrolysis units from
the HMIWI regulation and defer the development of separate regulations.
Pyrolysis technology is different from conventional incineration.
Because air is generally not used in the pyrolysis treatment process,
the volume of exhaust gas produced from pyrolysis treatment is likely
to be far less than the volume of gas produced from the burning of
waste in an HMIWI. Although conventional combustion does not occur
during pyrolysis treatment, there are some emissions from the pyrolysis
process.
As discussed in the 1996 re-proposal, the EPA developed a draft
regulation for pyrolysis units. The 1996 re-proposal pointed out that
the draft regulatory text was incomplete and it included placeholders
and requests for information where such information was lacking. The
EPA requested
[[Page 48359]]
comments to help fill in the missing information.
Following the 1996 re-proposal, the EPA received information for
use in developing the separate pyrolysis regulation from vendors of
pyrolysis technology. As pointed out by one commenter and supported by
the information received from pyrolysis vendors, there are variations
in the operating characteristics among pyrolysis technologies that
would make separate regulations for pyrolysis units very difficult to
implement at this time. As a result, the EPA has concluded that
sufficient information is not available to develop a separate and
uniform regulation for pyrolysis technology that would contain
requirements that are technically feasible for all pyrolysis units.
Because separate regulations for pyrolysis technology cannot be
developed at this time, the EPA considered modifying the HMIWI
regulations to include pyrolysis units. However, nearly all aspects of
the HMIWI regulations would have to be altered to accommodate pyrolysis
units including the format of the emission limits, the operator
training requirements, siting requirements, the testing and monitoring
requirements, and the reporting and recordkeeping requirements.
Furthermore, the HMIWI subcategories and MACT floors would not be
appropriate for pyrolysis units. Due to variations in the operating
characteristics of pyrolysis technologies and the differences between
HMIWI and pyrolysis technologies, it is unclear how the HMIWI
regulations could be modified to feasibly cover pyrolysis technologies
as well as HMIWI.
Section 129 requires EPA to develop NSPS and EG for ``solid waste
incineration units * * * combusting hospital waste, medical waste, and
infectious waste.'' As discussed above, pyrolysis and conventional
incineration are not the same. Because regulations developed for HMIWI
are not appropriate for pyrolysis technologies, pyrolysis treatment
technologies have specifically been excluded from coverage under the
final HMIWI standards and guidelines. The EPA may consider these
devices in future regulatory development.
C. Waste Management Plans
During the public comment period following the 1996 re-proposal,
several commenters stated that the EPA standards for HMIWI are reliant
on pollution control and give little attention to pollution prevention.
The commenters stated that recycling and pollution prevention measures
could yield greater reductions in emissions than add-on controls alone.
Some commenters stated that Congress intended for EPA to use process
changes or substitution of materials to help eliminate emissions. Some
commenters stated that dioxin/furan, HCl, and Hg emissions could be
controlled through a pollution prevention program that reduces or
eliminates incineration of chlorinated materials and batteries. One
commenter requested that EPA suggest pollution prevention measures for
controlling Hg as well as other pollutant precursors (i.e., lead,
cadmium, chlorine, nitrogen, fluorine, and sulfur). The commenter
maintained that the economic impact of the HMIWI regulations could be
reduced significantly if EPA required medical facilities to institute
pollution prevention techniques.
The types of materials sent to an HMIWI vary from facility to
facility depending on facility operating practices, which are defined
by purchasing decisions, waste handling procedures, and other practices
that affect the types of materials incinerated.
In the February 1995 proposal, the EPA stated that it had no data
to indicate the effects of waste handling practices on emissions of
various pollutants and requested comments on the extent to which
operating practices could influence emissions. To evaluate the
effectiveness of waste segregation programs, the EPA specifically
solicited detailed descriptions of programs and results of performance
tests conducted to demonstrate pollutant emission levels from the HMIWI
prior to implementation of the program and subsequent to implementation
of the program. In addition, the EPA solicited comments on how such a
program could be incorporated into the HMIWI regulations.
Following the 1995 proposal, the EPA received no data to
conclusively indicate the effectiveness of waste segregation programs
in reducing emissions from HMIWI. Therefore, the final HMIWI standards
and guidelines are primarily based on air pollution controls rather
than pollution prevention. However, as discussed in the 1996 re-
proposal, EPA has included pollution prevention measurements in setting
the Hg emission limit for good combustion. To ensure that emissions of
Hg from facilities with good combustion controls meet the final
emission guidelines for Hg, EPA is requiring that these facilities
conduct a Hg emission test. If the facility fails the emission test,
the facility will need to implement Hg pollution prevention measures or
install an APCD to meet the emission limits.
The EPA has investigated the impacts on emissions of shifting the
waste composition from chlorinated plastics to non-chlorinated
polymers. However, the outcome of this investigation is inconclusive. A
number of studies have concluded that the chlorine content of the waste
is directly related to dioxin/furan emissions, while other studies
suggest there is no relationship between the chlorine content of the
waste and dioxin/furan emissions. At this point, the effectiveness of a
pollution prevention program directed at reducing dioxin/furan
emissions through shifting the waste composition from chlorinated
plastics to nonchlorinated polymers would be questionable.
A number of health care facilities have implemented waste
management measures to reduce the overall volume of waste. However, it
should be stressed that each health care facility is unique and site-
specific strategies must be developed that achieve the most efficient
results. Through the development of individual waste management
programs, health care facilities can achieve significant reductions in
their waste stream, reduce the volume of waste to be incinerated, and
thereby reduce the amount of air pollution emissions associated with
that waste. Therefore, the final HMIWI standards and guidelines require
that health care facilities which operate incinerators develop and
implement a waste management plan.
The waste management plan would identify both the feasibility and
the approach to separate certain components of solid waste from the
health care waste stream in order to reduce the amount of toxic
emissions from incinerated waste. The waste management plan may include
elements such as paper, cardboard, plastics, glass, battery, or metal
recycling; or purchasing recycled or recyclable products. A waste
management plan may include different goals or approaches for different
areas or departments of the facility and need not include new waste
management goals for every waste stream. It should identify, where
possible, reasonably available additional waste management measures,
taking into account the effectiveness of waste management measures
already in place, the costs of additional measures, the emission
reductions expected to be achieved, and any other environmental or
energy impacts they might have. A copy of the waste management plan
would be submitted to EPA along with the results of the initial
performance test demonstrating compliance with the emission limits. In
addition, the waste
[[Page 48360]]
management plan may be reviewed by the Joint Commission on
Accreditation of Health Care Organizations during the accreditation
process.
Health care facilities are encouraged to review and incorporate
into their waste management plans the waste minimization techniques
discussed in ``An Ounce of Prevention: Waste Reduction Strategies for
Health Care Facilities,'' which is published by the American Society
for Health Care Environmental Services of the American Hospital
Association. This document may be obtained by contacting AHA Services,
Inc., P.O. Box 92683, Chicago, Illinois 60675-2683, or by calling 800-
242-2626. The cost of the document is $50.00 plus $10.95 for shipping
and handling. The document is available for public inspection at EPA's
Air and Radiation Docket and Information Center (Docket A-91-61, item
IV-J-124). See the ADDRESSES section at the beginning of this preamble
for the location of the Docket. Note that because of copyright law,
this document may not be copied. This document was approved for
incorporation by reference by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
D. Testing, Monitoring, and Inspection
Section 129(c) of the CAA requires the EPA to include emissions
monitoring and testing requirements in the regulation. The purpose of
these requirements is to allow the EPA to determine whether a source is
operating in compliance with the regulations.
In the 1996 re-proposal, the EPA stated that it was inclined to
adopt requirements that EPA test methods be followed when performing
any emission testing required to determine compliance with the HMIWI
regulations. In most cases, three test runs of about 1 hour each would
be necessary to determine compliance. The EPA also stated in the 1996
re-proposal that it was inclined to include in-house inspection and
maintenance requirements wherever annual stack testing was not
required. To minimize costs, the EPA stated that it was inclined to
include requirements for monitoring of operating parameters and routine
Method 9 (stack opacity) testing in the final regulations instead of CO
and opacity continuous emissions monitoring systems (CEMS) for onsite
HMIWI. Where the regulations are based on wet and/or dry scrubbing
systems, the EPA stated that it was inclined to require initial and
repeat stack testing (annual/skip testing where annual testing is
required for the first 3 years and, if these tests show compliance,
subsequent testing would be done every third year). Where the
regulations are based, in part, on the use of good combustion alone,
the EPA stated that it was inclined to require initial stack testing
and routine inspections. The EPA solicited public comment on all of the
testing and monitoring inclinations presented in the 1996 re-proposal.
In addition, because some CEMS vendors questioned the CEMS and
parameter monitoring costs developed by EPA, the EPA solicited public
comment on the costs of CEMS and monitoring of operating parameters.
Several comments concerning the EPA's inclinations for monitoring
and testing were received following the 1996 re-proposal. One commenter
requested that EPA require CEMS for CO, HCl, SO2,
NOX, Hg, and PM. The commenter contended that CEMS for CO,
HCl, SO2, NOX, Hg, and PM would eliminate the
need for stack testing. The commenter stated that the only way to
ensure compliance at all times, as mandated by the CAA, is through the
continuous use of CEMS. One commenter stated that EPA should require
continuous monitoring of CO emissions from all HMIWI, continuous
opacity monitoring at large incinerators, and continuous monitoring of
HCl emissions from very large (>1000 lb/hr) incinerators. The commenter
indicated that continuous monitoring of CO and O2 is the
only way to ensure that good combustion is occurring. The commenter
concluded that CO and O2 ``process'' monitors should be
sufficient for HMIWI with capacities less than 500 lb/hr. The commenter
stated that EPA's inclination not to require continuous monitoring is
based on inaccurate CEMS costs.
A number of commenters supported EPA's inclination to determine
compliance using parameter monitoring and routine inspection and
maintenance rather than CEMS. One of the commenters supported
monitoring of operating parameters and routine Method 9 testing
combined with initial stack testing and annual inspections to ensure
compliance with the rule. Another commenter stated that an initial
stack test for the primary pollutants and regular inspection,
maintenance, and daily recording of operating parameters would be
appropriate. One commenter stated that monitoring of operating
parameters with no CEMS and substitute stack testing with annual
inspections would provide an excellent means to attain low emissions
for minimal costs for small HMIWI. Other commenters recommended
monitoring operating parameters and routine Method 9 testing with
initial stack testing and no repeat testing. Another commenter
suggested that an initial performance test and monitoring is sufficient
and that additional tests are not necessary especially given operator
training, inspections, and monitoring.
The most direct means of ensuring compliance with emission limits
is the use of CEMS. As a matter of policy, the first and foremost
option considered by EPA is to require the use of CEMS to demonstrate
continuous compliance with specific emission limits. Other options are
considered only when CEMS are not available or when the impacts of
including such requirements are considered unreasonable. When
monitoring options other than CEMS are considered, there is always a
tradeoff between the cost of the monitoring requirement and the quality
of the information collected with respect to determining actual
emissions. While monitoring of operations (operating parameters) cannot
provide a direct measurement of emissions, it is usually much less
expensive than CEMS, and the information provided can be used to ensure
that the incinerator and associated air pollution control equipment are
operating properly. This information provides EPA and the public with
assurance that the reductions envisioned by the regulations are being
achieved.
For the 1996 re-proposal, testing and monitoring costs were
developed for a range of options, and the Agency concluded that the
cost of CEMS were unreasonably high relative to the cost of the
incinerators and air pollution control systems needed for compliance.
Based on comments and information received as a result of the 1996 re-
proposal, the cost estimates for CEMS and parameter monitoring have
been revised. While the cost estimates for CEMS have been significantly
reduced and additional costs have been included for parameter
monitoring, it appears that the annual costs of monitoring requirements
which include CEMS are still quite high compared to the cost of the
incinerator and air pollution control device required to meet the
emission limits.
A large HMIWI costs approximately $120,000/yr to operate, while an
add-on APCD can cost from $150,000 to $300,000/yr to operate. The most
comprehensive monitoring option including CEMS for HCl and CO costs
about $95,000/yr. This option costs nearly as much to operate as the
incinerator itself and could represent as much as half the cost of the
APCD. In addition, the only emissions that are directly measured are
HCl and CO. Consequently, the most comprehensive
[[Page 48361]]
monitoring option that could be selected for large HMIWI is considered
unreasonable.
There are no direct measurements of dioxin/furan or toxic metals.
Particulate matter and Hg CEMS are currently under development but have
not been demonstrated in the United States to be capable of accurately
and reliably measuring PM or Hg emissions for use in determining
compliance with PM or Hg emission limits at this time. With regard to
SO2 and NOX, the emission limits in the final
regulations reflect uncontrolled emissions. Therefore, it is
unreasonable to impose a cost (of monitoring) where no emission
reduction benefit will be gained.
Looking at other options for large HMIWI, the only CEMS available
are CO/O2 and opacity. For a large HMIWI equipped with a
sophisticated APCD like a wet scrubber, dry scrubber, or combined dry/
wet scrubber, these CEMS provide very little information regarding the
pollutants that are of most concern to the public (i.e., dioxin/furan
and toxic metals). Consequently, because the APCD already represents a
substantial increase in the cost of incineration and because the more
comprehensive monitoring options do not provide much information
regarding the pollutants of most concern, the final monitoring and
testing requirements for HMIWI equipped with APCD reflect routine stack
testing coupled with continuous monitoring of operating parameters.
Where incinerators are not equipped with add-on air pollution
control (i.e., units utilizing good combustion alone), EPA agrees with
commenters that CO provides the best measure of good combustion.
However, regulations based on good combustion alone only apply to small
existing HMIWI meeting certain ``remote'' criteria (see section V.B).
For these small existing HMIWI using only good combustion, the
incinerator costs about $35,000/yr to operate and the air pollution
control costs about $10,000/yr to operate. Monitoring options including
CO CEMS for compliance are clearly unreasonable at about $54,000/yr
(five times the cost of the air pollution control). The monitoring
option which includes a CO ``process'' monitor costs about $17,000/yr
while the option that relies on operating parameters costs about
$10,000/yr. The EPA does not believe that the CO ``process'' monitor
provides enough additional information to justify the $7,000/yr
additional cost, especially considering that the air pollution control
only costs $10,000/yr. Consequently, where the regulations are based on
good combustion alone, the monitoring requirements consist of an
initial stack test coupled with continuous monitoring of operating
parameters and annual inspections.
The specific values for operating parameters are chosen by the
owner or operator and are established during the initial performance
test demonstrating compliance with the emission limits. After the
performance test, monitoring of the operating parameters is the only
way to determine, on a continuous basis, whether the source is
operating in compliance. Operation outside the bounds of an established
operating parameter is a violation of an operating parameter limit. In
addition, under certain conditions, operation outside the bounds of one
or more parameter limits constitutes a violation of a specific emission
limit. This latter provision was included in the 1995 proposed
regulations and is retained in the final regulations. The owner or
operator has the flexibility to choose the values for the operating
parameters and may conduct repeated performance tests to ``fine tune''
the operating parameter limits, if desired.
With regard to the testing requirements, annual testing is required
for the first 3 years. If these tests show that the facility is in
compliance each of these 3 years, then subsequent testing would be done
every third year. Initial testing includes testing for the following
pollutants: PM, CO, HCl, dioxin/furan, Pb, Cd, Hg, and opacity. The
annual/skip or ``repeat'' testing only includes testing for PM, CO,
HCl, and opacity. Where good combustion alone serves as the basis for
the emission limits, the Agency only requires facilities to perform an
initial compliance test for PM, CO, dioxin/furan, Hg, and opacity,
annual incinerator inspections, annual opacity testing, and parameter
monitoring (charge rate and secondary chamber temperature). Minimum
sampling times of 1 hour (4 hours for dioxin/furan) have been included
in the final regulations for all HMIWI.
The ``repeat'' testing requirements will ensure, on an ongoing
basis, that the APCD is operating properly, that no deterioration in
performance has occurred, and that no changes have been made to the
operating system or the type of waste burned. Where ``repeat'' testing
is not required, annual inspections, annual opacity testing, and
parameter monitoring will ensure that the HMIWI is in good working
order. However, cost considerations were the only reason for excluding
the repeat testing for units with good combustion alone. Good
combustion alone with its associated monitoring are provided in order
to minimize costs for a small number of incinerators in remote areas
where alternatives to incineration might be unavailable. Initial
testing for good combustion units includes testing for PM, CO, dioxin/
furan, Hg, and opacity. The Hg testing is required to ensure that units
are segregating Hg bearing wastes and meeting the Hg emission limit.
Rather than require third-party inspections, which could be
burdensome for small remote facilities, the final guidelines allow for
in-house equipment inspections. However, EPA plans to work with States
to give higher priority to these small remote facilities in terms of
enforcement inspections. Either the EPA or the State will inspect these
small remote facilities annually for the first three years after the
State plan is approved. Following the three-year period, these sources
will be placed on the regular enforcement inspection schedule.
E. Operator Training and Qualification
The final operator training and qualification requirements are
almost identical to those described in the 1996 re-proposal. The final
requirements provide flexibility by allowing State-approved training
and qualification programs. Where there are no State-approved programs,
the final regulations include minimum requirements for training and
qualification. The EPA has a training manual available through its Air
Pollution Training Institute (APTI). For further information, contact
APTI at (919) 541-2497. In addition, EPA plans to work with the
American Hospital Association to develop a correspondence course for
those facilities that may not have access to adequate training. As
discussed above, EPA plans to work with States to give higher priority
to the small remote units in terms of enforcement inspections,
including a review of operator training.
IV. Standards of Performance for New Sources
This section presents a summary of the final standards, including
identification of the source category and pollutants being regulated,
and presentation of the final emission limits and their associated
performance testing, monitoring, recordkeeping and reporting
requirements. This section discusses the most significant changes to
the standards presented in the June 20, 1996 Federal Register document.
Also discussed in this section is the rationale for the selection of
MACT and a summary of the impacts of the final standards.
A. Summary of the Standards
The final standards (subpart Ec) apply to each new HMIWI for which
[[Page 48362]]
construction commenced after June 20, 1996 or to an existing HMIWI for
which modification commenced after March 16, 1998. Hospital/medical/
infectious waste incinerators for which construction commenced on or
before June 20, 1996 are not covered under the subpart Ec standards;
they are considered existing sources and are subject to the guidelines
under subpart Ce (see section V of this notice).
A HMIWI is defined as any device that combusts any amount of
medical/infectious waste or hospital waste. The terms medical/
infectious waste and hospital waste are discussed in section III.A and
defined in Sec. 60.51c. An incinerator is not subject to subpart Ec
during periods when only pathological, low-level radioactive, or
chemotherapeutic waste (all defined in Sec. 60.51c) is burned provided
that the owner or operator keeps records of the periods of time when
only pathological, low-level radioactive, and/or chemotherapeutic waste
is burned. Any combustor required to have a permit under section 3005
of the SWDA is exempt from subpart Ec as are incinerators subject to
subpart Cb, Ea, or Eb. New incinerators, processing operations, or
boilers that co-fire medical/infectious waste or hospital waste with
other fuels or wastes and that combust 10 percent or less medical/
infectious waste and hospital waste by weight (on a calendar quarter
basis) are not subject to the emission limits under subpart Ec, but
must keep records of the amount of each fuel and waste fired.
The HMIWI source category is divided into three subcategories based
on waste burning capacity: Small (200 lb/hr), medium (>200
to 500 lb/hr), and large (>500 lb/hr). Waste burning capacity is
determined either by the maximum design capacity or by the ``maximum
charge rate'' established during the most recent performance test. In
other words, a source may change its size designation by establishing a
``maximum charge rate'' lower than its design capacity. For example, a
``medium'' unit with a design capacity of 250 lb/hr may establish a
maximum charge rate of 200 lb/hr and be considered a ``small'' unit for
purposes of the standards. Separate emission standards apply to each
subcategory of new HMIWI. A summary of the final emission limits for
new or modified HMIWI is presented in Table 3.
Table 3.--Summary of Promulgated Emission Limits for New HMIWI
----------------------------------------------------------------------------------------------------------------
Emission limits
Pollutant (test method) --------------------------------------------------------------------------
Small HMIWI Medium HMIWI Large HMIWI
----------------------------------------------------------------------------------------------------------------
Particulate matter (EPA Method 5 or 69 mg/dscm (0.03 gr/ 34 mg/dscm (0.015 gr/ 34 mg/dscm (0.015 gr/
Method 29). dscf). dscf). dscf).
Carbon monoxide (EPA Method 10 or 40 ppmv................ 40 ppmv................ 40 ppmv.
Method 10B).
Dioxins/furans (EPA Method 23)....... 125 ng/dscm total CDD/ 25 ng/dscm total CDD/ 25 ng/dscm total CDD/
CDF (55 gr/10\9\ dscf) CDF (11 gr/10 \9\ CDF (11 gr/10 \9\
or 2.3 ng/dscm TEQ dscf) or 0.6 ng/dscm dscf) or 0.6 ng/dscm
(1.0 gr/10 \9\ dscf). TEQ (0.26 gr/10 \9\ TEQ (0.26 gr/10 \9\
dscf). dscf).
Hydrogen chloride (EPA Method 26).... 15 ppmv or 99% 15 ppmv or 99% 15 ppmv or 99%
reduction. reduction. reduction.
Sulfur dioxide (testing not required) 55 ppmv................ 55 ppmv................ 55 ppmv.
Nitrogen oxides (testing not 250 ppmv............... 250 ppmv............... 250 ppmv.
required).
Lead (EPA Method 29)................. 1.2 mg/dscm (0.52 gr/10 0.07 mg/dscm (0.03 gr/ 0.07 mg/dscm (0.03 gr/
\3\ dscf) or 70% 10 \3\ dscf) or 98% 10 \3\ dscf) or 98%
reduction. reduction. reduction.
Cadmium (EPA Method 29).............. 0.16 mg/dscm (0.07 gr/ 0.04 mg/dscm (0.02 gr/ 0.04 mg/dscm (0.02 gr/
10 \3\ dscf) or 65% 10 \3\ dscf) or 90% 10 \3\ dscf) or 90%
reduction. reduction. reduction.
Mercury (EPA Method 29).............. 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/
10 \3\ dscf) or 85% 10 \3\ dscf) or 85% 10 \3\ dscf) or 85%
reduction. reduction. reduction.
----------------------------------------------------------------------------------------------------------------
In addition to the emission limits, new or modified large HMIWI are
subject to a 5 percent visible emission limit for fugitive emissions
generated during ash handling and all new or modified HMIWI are subject
to a 10 percent stack opacity limit. Performance tests for fugitive
emissions from ash handling must be conducted using EPA Reference
Method 22. Stack opacity must be determined using EPA Reference Method
9.
Table 4 summarizes the additional requirements for new or modified
HMIWI under the NSPS, including the operator training and qualification
requirements, siting requirements, compliance and performance testing
requirements, monitoring requirements, and reporting and recordkeeping
requirements. A summary of dates for compliance with the promulgated
standards for new HMIWI is presented in Table 5. These dates apply to
all new or modified HMIWI.
Table 4.--Summary of Additional Requirements Under the NSPS for New
HMIWI
------------------------------------------------------------------------
Additional requirements
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:
Complete HMIWI operator training course.
Qualify operators.
Maintain information regarding HMIWI operating procedures
and review annually.
Siting Requirements:
Prepare a siting analysis that considers air pollution
control alternatives that minimize, on a site-specific basis and to
the maximum extent practicable, potential risks to public health
and the environment.
[[Page 48363]]
Waste Management Plan:
Prepare a waste management plan that identifies the
feasibility and approach to separate certain components of a health
care waste stream.
Compliance and Performance Testing Requirements:
Conduct an initial performance test to determine compliance
with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and
opacity limit, and establish operating parameters.
Conduct annual performance tests to determine compliance
with the PM, CO, and HCl emission limits and opacity limit.
Facilities may conduct performance tests for PM, CO, and
HCl every third year if the previous three HMIWI performance tests
demonstrate that the facility is in compliance with the emission
limits for PM, CO, or HCl.
Perform annual fugitive testing (large HMIWI only).
Monitoring Requirements:
Install and maintain equipment to continuously monitor
operating parameters including secondary chamber temperature, waste
feed rate, bypass stack, and APCD operating parameters as
appropriate.
Obtain monitoring data at all times during HMIWI operation.
Reporting and Recordkeeping Requirements:
Maintain for 5 years records of results from initial
performance test and all subsequent performance tests, operating
parameters, any maintenance, the siting analysis, and operator
training and qualification.
Submit the results of the initial performance test and all
subsequent performance tests.
Submit reports on emission rates or operating parameters
that have not been recorded or that exceeded applicable limits.
Provide notification of intent to construct, construction
commencement date, planned initial start-up date, planned waste
type(s) to be combusted, the waste management plan, and
documentation resulting from the siting analysis.
------------------------------------------------------------------------
Note: This table depicts major provisions of the NSPS and does not
attempt to show all requirements. The regulatory text of Subpart Ec
should be relied upon for a full and comprehensive statement of the
requirements of the NSPS.
Table 5.--Compliance Times Under the NSPS for New HMIWI
------------------------------------------------------------------------
Requirement Compliance time
------------------------------------------------------------------------
Effective date............................... 6 months after
promulgation of NSPS.
Operator training and qualification On effective date or upon
requirements. initial start up,
whichever is later.
Initial compliance test...................... On effective date or
within 180 days of
initial start up,
whichever is later.
Performance test............................. Within 12 months
following initial
compliance test and
annually thereafter.
Facilities may conduct
performance tests every
third year if the
previous three
performance tests
demonstrate compliance
with the emission
limits.
Operator parameter monitoring................ Continuously, upon
completion of initial
compliance test.
Recordkeeping................................ Continuously, upon
completion of initial
compliance test.
Reporting.................................... Annually, upon completion
of initial compliance
test; semiannually, if
noncompliance.
------------------------------------------------------------------------
Note: This table depicts major provisions of the NSPS and does not
attempt to show all requirements. The regulatory text of Subpart Ec
should be relied upon for a full and comprehensive statement of the
requirements of the NSPS.
B. Significant Issues and Changes
The most significant changes to the standards made following the
June 20, 1996 Federal Register document are discussed below. Further
discussion of these changes as well as other comments and responses
regarding the NSPS are provided in ``Hospital/Medical/ Infectious Waste
Incinerators: Background Information for Promulgated Standards and
Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-97-
006b).
1. Combined Dry/Wet Scrubbers
As discussed in the 1996 re-proposal, the MACT floor for medium and
large HMIWI was based on emission limits achievable with good
combustion and a dry injection/fabric filter (DI/FF) combined with a
high efficiency wet scrubber (combined dry/wet system).
During the public comment period following the 1996 re-proposal,
several commenters questioned the basis for the MACT floors for new
medium and large HMIWI. The commenters contended that the revised MACT
floor emission levels were based on invalid test data and invalid
assumptions as to the applicability and technical feasibility of
combination dry/wet scrubbing systems. The commenters stated that the
combined dry/wet system is not proven technology. Some commenters
stated that the pollutant-by-pollutant approach used to determine the
MACT floor for new medium and large units resulted in a MACT floor that
can not be accomplished with any type of economic feasibility. Other
commenters stated that the costs of requiring a wet scrubber in
addition to a dry scrubber far outweigh the air pollution control
benefits.
The EPA recognizes that the pollutant-by-pollutant approach for
determining the MACT floor can, as it does in this case, cause the
overall cost of the regulation to increase. For example, the pollutant-
by-pollutant approach for the HMIWI regulation results in a MACT floor
for HCl based on a high efficiency wet scrubber, while the MACT floor
for other pollutants reflects the performance of a dry scrubber.
Compared to the dry scrubber alone, the addition of the wet scrubber
adds considerable cost to the regulation while achieving a relatively
small additional reduction in HCl. However, as mentioned later in this
notice, a spray dryer/fabric filter system with carbon injection could
be used instead of a combined dry/wet scrubber to achieve all of the
emission limits at a lower cost than the combined system. On the other
hand, EPA interprets section 129 of the CAA to require that the MACT
floor be determined in this manner, and EPA believes that Congress did
in fact intend that sources subject to regulations developed under
section 129 meet emission limits that are achieved by the
[[Page 48364]]
best controlled unit for each pollutant as long as the control systems
are compatible with each other. To EPA's knowledge, there is no
technical reason why these two air pollution control systems cannot be
combined (discussed later).
Section 129(a)(2) of the CAA specifies that ``the degree of
reduction in emissions that is deemed achievable for new units in a
category shall not be less stringent than the emissions control
achieved in practice by the best controlled similar unit, as determined
by the Administrator.'' This requirement identifies the least stringent
emissions standards that the EPA may adopt for new HMIWI (i.e., the
MACT floor).
At least one existing HMIWI in the medium subcategory is controlled
with a high efficiency wet scrubber and another is equipped with a DI/
FF system without carbon. The MACT floor for new medium HMIWI was based
on both of these technologies (i.e., a combined dry/wet scrubber
system) because the wet scrubber achieves the lowest dioxin, HCl, and
Hg emissions, but the DI/FF without carbon injection achieves the
lowest Pb and Cd emissions (note: as discussed elsewhere, the DI/FF
system with carbon injection achieves the same or lower dioxin and Hg
emissions as a wet scrubber). While no combined dry/wet scrubber
systems were identified on medium HMIWI, these systems are currently in
operation on large HMIWI. As discussed later, test data appear to
indicate that combining the two systems is technically feasible.
Similarly, the MACT floor for new large HMIWI was based on the emission
levels that are achievable with good combustion and a combined dry/wet
system with activated carbon.
The EPA does not agree that the MACT floors are to be based upon
one overall unit. Rather, the EPA believes that section 129 supports
its interpretation that it is legally permissible to set the MACT floor
pollutant-by-pollutant, as long as the various MACT floors do not
result in standards that are not achievable.
Section 129(a)(2) requires the EPA to establish technology based
emission standards that ``reflect the maximum degree of reduction in
emission of air pollutants listed under section (a)(4) that the
Administrator, taking into consideration the cost of achieving such
emission reduction and any nonair quality health and environmental
impacts and energy requirements, determines is achievable . . .''
Congress further specified in section 129(a)(2) the minimum reduction
that could satisfy this requirement (i.e., the MACT floor) for new
sources as ``the emission control that is achieved in practice by the
best controlled similar unit, as determined by the Administrator.''
This language does not expressly address whether the floor may be
established pollutant-by-pollutant. The ``emission control achieved by
the best controlled similar unit'' can be read either to mean emission
control as to a particular pollutant, or emission control that is
achieved by the unit as a whole. Nevertheless, the MACT floor reflects
the least stringent emission standards that EPA may adopt in accordance
with section 129(a)(2) regardless of costs.
Other statutory provisions are relevant, although they also do not
decisively address this issue. Section 129(a)(4) requires MACT
standards for, at a minimum, PM, opacity, SO2, HCl,
NOX, CO, Pb, Cd, Hg, and dioxin/furan emitted by HMIWI. This
provision certainly appears to direct maximum reduction of each
specified pollutant. Moreover, although the provisions do not state
whether there is to be a separate floor for each pollutant, the fact
that Congress singled out these pollutants suggests that the floor
level of control need not be limited by the performance of devices that
only control some of these pollutants well.
A more detailed discussion of the legal basis for this pollutant-
by-pollutant approach is contained in section 3.4.2 of ``Hospital/
Medical/Infectious Waste Incinerators: Background Information for
Promulgated Standards and Guidelines--Summary of Public Comments and
Responses'' (EPA-453/R-97-006b). Quantitative information about the
costs and air pollution control performance of both wet scrubbers and
dry scrubbers is summarized in the 1996 re-proposal (61 FR 31743). As
discussed in the 1996 re-proposal, detailed descriptions of costs and
air pollution control performance of these systems are available in
Docket A-91-61, items IV-B-30, IV-B-32, IV-B-48, and IV-B-49. See the
ADDRESSES section of this preamble for the location and telephone
number for the docket.
The EPA also notes that it followed this approach of setting the
MACT floors and MACT standards pollutant-by-pollutant in the proposed
MWC rules that were published on September 20, 1994 pursuant to section
129 and codified in 40 CFR part 60, Subparts Eb and Cb. Commenters on
that rule also expressed concerns about the achievability of the
resulting standards. The EPA notes that large MWC units (more than 250
tons/day capacity) are achieving the promulgated standards (in fact,
several combined systems were in operation at the time of
promulgation); thus, the approach of proposing MACT standards
pollutant-by-pollutant did not lead to unachievable or economically
infeasible standards in this case.
In response to commenters' concerns regarding the technical
feasibility of combined dry/wet systems, a review of the available data
documenting the performance of combined dry/wet scrubber systems was
conducted. Although limited emissions data are available for HMIWI with
combined dry/wet control systems, the available data indicate that the
MACT floor emission levels for new HMIWI are achievable and technically
feasible. The performance of dry scrubbers with activated carbon
injection and the performance of wet scrubbers is well documented. The
available data for combination dry/wet systems provide no indication of
operational or emissions problems that occur as a result of combining
dry and wet control systems. Finally, as mentioned in the 1996 re-
proposal, one existing HMIWI equipped with a spray dryer/fabric filter
system with carbon injection was tested during the EPA testing program,
and this test demonstrated that this scrubbing technology could be used
instead of a combined dry/wet scrubber to achieve all of the emission
limits.
2. Siting Analysis
Section 129 of the CAA states that performance standards for new
HMIWI must incorporate siting requirements that minimize, on a site-
specific basis and to the maximum extent practicable, potential risks
to public health or the environment. The Agency is directed by the CAA
to promulgate siting requirements that meet the minimum criteria
outlined in the CAA. In the 1995 proposal, the siting requirements were
patterned after the Prevention of Significant Deterioration (PSD)
requirements within the New Source Review (NSR) program. Additionally,
the originally proposed siting requirements included provisions for a
public meeting and the preparation of a comment/response document that
would be made available to the public.
Following the 1996 re-proposal, commenters requested that EPA do
away with the siting requirements because they will be costly and will
impede the permitting process. Other commenters requested that EPA
adopt siting requirements that are consistent with those that have been
developed and enacted by most of the State environmental agencies. The
commenters noted that States are equally concerned with minimizing
potential risks to the environment, and that most have taken
appropriate steps
[[Page 48365]]
in the development of their own siting criteria. The commenters
indicated that requiring siting analyses in addition to those required
by States and under the National Environmental Policy Act would be
duplicative and would not enhance environmental protection. Other
commenters supported the EPA's 1995 proposal to require an opportunity
for public comments and a hearing on siting decisions.
In reviewing the 1995 proposed siting requirements and the comments
received, the Agency is promulgating siting requirements as outlined in
the CAA. The siting requirements promulgated today require the
potential owner of an affected facility to prepare an analysis of the
impacts of the affected facility. The analysis must consider air
pollution control alternatives that minimize, on a site-specific basis,
to the maximum extent practicable, potential risks to public health or
the environment. In considering such alternatives, the analysis may
consider costs, energy impacts, non-air environmental impacts, or any
other factors related to the practicability of the alternatives.
Analyses of facility impacts prepared to comply with State, local, or
other Federal regulatory requirements may be used to satisfy the
requirements of this section, as long as they include the consideration
of air pollution control alternatives specified above. The owner or
operator of the affected facility must complete and submit the siting
requirements to EPA.
C. Selection of MACT
The EPA considered three regulatory options for adoption as the
final standard for new HMIWI. These regulatory options are discussed in
Appendix A of ``Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b). As
required by section 129(a)(2) of the CAA, the Administrator reviewed
the emissions reductions achievable with each regulatory option and the
cost, nonair quality environmental, and energy impacts of the
regulatory options. Based on this review, the Administrator determined
that the most cost-effective and achievable emission standards for
promulgation are based on emission limits achievable with good
combustion and a moderate efficiency wet scrubber for new small HMIWI,
and good combustion and a combined dry/wet control system with carbon
for new medium and large HMIWI. These final emissions standards reflect
the MACT floor emission levels for new small and large HMIWI, but are
more stringent than the MACT floor for new medium HMIWI.
The MACT floor for new small HMIWI was based on emission limits
achievable through use of good combustion and a moderate efficiency wet
scrubber. Consideration of the impact of this MACT floor indicates that
few new small HMIWI are likely to be constructed due to the substantial
increase in the cost of a new small HMIWI as a result of the moderate
efficiency wet scrubber and the availability of alternative means of
medical waste disposal.
One regulatory option more stringent than this MACT floor would
reflect the use of good combustion and a high efficiency wet scrubber.
Consideration of this option indicates that the nationwide impacts
would be negligible, primarily because few new small HMIWI would be
constructed (i.e., because of switching to alternative means of medical
waste disposal). Where a typical new small HMIWI was constructed,
however, the high efficiency wet scrubber would only reduce PM
emissions by a small amount and would increase air pollution control
costs by about 15 percent. As a result, the EPA established the MACT
emission limitations for small new HMIWI based on the use of good
combustion and a moderate efficiency wet scrubber (i.e., the MACT
floor).
The MACT floor for new medium HMIWI was based on emission limits
achievable through the use of good combustion and a combined dry/wet
control system without activated carbon. On a national basis, because
of switching to the use of alternative means of medical waste disposal,
the addition of activated carbon to the combined dry/wet system results
in negligible cost increase. For a typical new medium HMIWI, the
addition of carbon would reduce emissions of dioxin significantly and
would increase air pollution control costs by less than 4 percent. As a
result, the EPA established the MACT emission limitations for new
medium HMIWI based on good combustion and a combined dry/wet scrubber
system with activated carbon.
The MACT floor for new large HMIWI was based on emission limits
achievable through use of good combustion and a combined dry/wet
scrubber with activated carbon. There is no air pollution control
technology which could achieve lower emissions than this system.
Consequently, EPA established the MACT emission limitations for new
large HMIWI based on good combustion and a combined dry/wet scrubber
system with activated carbon (i.e., the MACT floor).
D. Impacts of the Standards
There are a number of alternatives to onsite incineration of
hospital waste and medical/infectious waste, including recycling or
direct landfilling of non-infectious waste, and off-site commercial
waste disposal or any of several waste disinfection technologies (e.g.,
steam autoclaving, microwave irradiation, macrowave irradiation,
chemical treatment, thermal treatment, and biological treatment) for
infectious waste. Many facilities that may have purchased an HMIWI in
the absence of the HMIWI standards may find it more cost effective to
dispose of their waste using one of these alternatives. As discussed in
the June 1996 re-proposal, while further study is warranted, there
appears to be no significant or substantial adverse economic,
environmental, or health and safety issues associated with the
increased use of the alternative waste treatment technologies.
In some cases, facilities that ``switch'' to alternative methods of
waste disposal may further decrease their waste disposal costs by
segregating their waste into infectious and noninfectious portions, and
recycling or landfilling (rather than treating) their noninfectious
waste. To account for facilities switching to alternative methods of
waste disposal, the impacts of the standards were developed based on
three compliance scenarios: no switching (scenario A), switching with
waste segregation (scenario B), and switching without waste segregation
(scenario C).
In the absence of the new standards, EPA projects that 85 new small
HMIWI, 90 new medium HMIWI, 60 new large HMIWI, and 10 new commercial
HMIWI would have been installed over the next five years. Scenario A
preserves this assumption and estimates the costs of the additional
control measures that would be required for these 245 new facilities to
meet the standards at $36.2 million annually. The EPA believes that
Scenario A is unrealistic and grossly overstates the national costs
associated with the standards. Under Scenarios B and C, no new small or
medium HMIWI are projected to be installed. Facilities that would have
installed these units are assumed to find alternate methods of waste
disposal. Under Scenario B, no new large HMIWI (other than commercial
units) are projected to be installed either. The EPA believes that the
total costs of the final standards for new sources in the fifth year
after
[[Page 48366]]
implementation will fall somewhere between the $12.1 million/yr
estimate for Scenario B and the $26.2 million/yr estimate for Scenario
C.
Table 6 presents baseline emissions (i.e., emissions in the absence
of the MACT emission standards) and the emissions that are expected to
occur under the final MACT standard. A range of emissions is presented
in Table 6 to account for the emissions that could occur under
switching scenarios B and C as a result of the NSPS. Table 6 also
presents the percent reduction in emissions achieved under the final
MACT standard for new HMIWI.
Table 6.--Baseline Emissions, Emissions in the Fifth Year After Implementation of the Final NSPS, and Emissions
Reduction
[Metric Units]
----------------------------------------------------------------------------------------------------------------
Emissions under the final Emissions reduction,
Pollutant, units Baseline NSPS percent
----------------------------------------------------------------------------------------------------------------
PM, Mg/yr............................... 28 2.1 to 4.1................. 85 to 92.
CO, Mg/yr............................... 14 6.5 to 14.................. 0 to 52.
CDD/CDF, g/yr........................... 47 5.9 to 12.................. 74 to 87.
TEQ CDD/CDF, g/yr....................... 1.1 0.14 to 0.28............... 74 to 87.
HCl, Mg/yr.............................. 64 1.5 to 3.1................. 95 to 98.
SO2, Mg/yr.............................. 28 14 to 28................... 0 to 52.
NOX, Mg/yr.............................. 130 65 to 130.................. 0 to 52.
Pb, Mg/yr............................... 0.39 0.031 to 0.06.............. 85 to 92.
Cd, Mg/yr............................... 0.051 4.6 x 10-3 to 8.9 x 10-3... 83 to 91.
Hg, Mg/yr............................... 0.21 0.056 to 0.12.............. 45 to 74.
----------------------------------------------------------------------------------------------------------------
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6.
As discussed further in Appendix A of ``Hospital/Medical/Infectious
Waste Incinerators: Background Information for Promulgated Standards
and Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-
97-006b), the EPA is not able to calculate a monetized value for most
of these emission reductions. However, using ``Benefit-Cost Analysis of
Selected NSPS for Particulate Matter'' as a basis, EPA has calculated a
monetized value for reductions in PM emissions using an estimate of
$6,075 (1993 dollars) per ton of PM. This yields annualized benefits of
PM reductions for the standards ranging from $157,300 to $170,000 (1993
dollars).
As a result of the MACT standards for new HMIWI, industries that
generate hospital waste and/or medical/infectious waste (i.e.,
hospitals, nursing homes, etc.) are expected to experience average
price increases in the range of 0.00 to 0.16 percent, depending on the
industry. These industries are expected to experience output and
employment impacts in the range of 0.00 to 0.21 percent. In addition,
the revenue impacts for these industries are expected to range from an
increase of 0.05 percent to a decrease of 0.05 percent as a result of
the standards. For hospitals, 0.03 percent is estimated as the price
increase necessary to recover annual control costs. The expected
average price increase for each hospital patient-day is expected to be
less than 35 cents. The average price impact for the commercial medical
waste incinerator industry is approximately a 4.1 percent increase in
price.
Facilities with onsite HMIWI that are currently uncontrolled may
experience impacts ranging from 0.03 to 1.70 percent, depending on the
industry. For many of these facilities, the economic impacts of
switching to an alternative method of waste disposal are much lower
than the economic impacts of choosing to install emission control
equipment. The decision to switch to an alternative method of waste
disposal should preclude facilities from experiencing a significant
economic impact. The impacts that would be incurred by medical/
infectious waste generators that currently use an offsite waste
incineration service range from 0.00 to 0.02 percent and are considered
negligible impacts.
The option of switching to an alternative method of waste disposal
will be an attractive option for many facilities that are considering
the purchase of a new HMIWI and should preclude facilities from
experiencing a significant economic impact. However, two types of HMIWI
operators may not be able to switch to an alternative: commercial HMIWI
operators, because their line of business is commercial incineration;
and onsite HMIWI that burn a small amount of waste and are located far
away from an urban area, because they may not have access to other
methods of waste disposal. However only a few, if any, of the projected
10 new commercial HMIWI over the next 5 years, and at the most, only a
few of the projected 85 new small onsite HMIWI over the next 5 years
are likely to be significantly impacted by the regulation (under all
three regulatory options). A ``significant impact'' does not
necessarily imply a facility closure or the need to cancel plans to
open up or expand a facility. For example, operators of small, remote
onsite HMIWI may still have switching opportunities. As the commercial
incineration industry continues to grow (with additional impetus being
provided by the EG and NSPS), it is possible that services will be
extended to remote, isolated areas that are currently not served.
Onsite autoclaving is another possible treatment alternative. If a
facility had planned to invest in a new HMIWI, it stands to reason that
an onsite alternative technology of comparable cost would be
affordable.
The economic impact analysis examines possible economic impacts
that may occur in industries that will be directly affected by this
regulation. Therefore, the analysis includes an examination of
industries that generate hospital waste or medical/infectious waste or
dispose of such waste. Secondary impacts such as subsequent impacts on
APCD vendors and HMIWI vendors are not estimated due to data
limitations. Air pollution control device vendors are expected to
experience an increase in demand for their products due to the
regulation. This regulation is also expected to increase demand for
commercial HMIWI services. However, due to economies of scale, this
regulation is expected to shift demand from smaller incinerators to
larger incinerators. Therefore, small HMIWI vendors potentially may be
adversely affected by the regulation. Lack of data on the above effects
prevent
[[Page 48367]]
quantification of the economic impacts on these secondary sectors.
No increase in the total national usage of natural gas for
combustion controls is expected to result from the final HMIWI
standards. The total national usage of electrical energy for the
operation of add-on control devices as a result of the final MACT
standards is expected to increase by less than 9,800 megawatt hours per
year (MW-hr/yr) (33.4 billion British thermal units per year [10\9\
Btu/yr]). As discussed in the 1996 re-proposal, compared to the amount
of energy used by health care facilities such as hospitals
(approximately 2,460 MMm \3\/yr of natural gas and 23.2 million MW-hr/
yr of electricity), the increase in energy usage that results from
implementation of the HMIWI emission standards is insignificant.
Less than 43,600 Mg/yr (48,000 tons/yr) of additional solid waste
is expected to result from the adoption of the final MACT standards. As
discussed in the 1996 re-proposal, compared to municipal waste, which
is disposed in landfills at an annual rate of over 91 million Mg/yr
(100 million tons/yr), the increase in solid waste from the
implementation of the final HMIWI standards is insignificant.
Less than 3.3 million gallons of additional wastewater would be
generated in the fifth year by HMIWI as a result of the final NSPS.
This amount is the equivalent of wastewater produced annually by one
small hospital. Therefore, when considering the wastewater produced
annually at health care facilities nationwide, the increase in
wastewater resulting from the implementation of the MACT emission
standards for new HMIWI is insignificant.
V. Emission Guidelines for Existing Sources
This section presents a summary of the final emission guidelines,
including identification of the source category and pollutants being
regulated, and presentation of the final emission limits and their
associated performance testing, monitoring, recordkeeping and reporting
requirements. This section discusses the most significant changes to
the guidelines presented in the June 20, 1996 Federal Register
document. Also discussed in this section is the rationale for the
selection of MACT and a summary of the impacts of the final guidelines.
A. Summary of the Guidelines
The final guidelines (subpart Ce) apply to each existing HMIWI for
which construction commenced on or before June 20, 1996. Hospital/
medical/infectious waste incinerators for which construction commenced
after June 20, 1996 or modification commenced after March 16, 1998 are
not subject to the final subpart Ce guidelines; they are considered new
sources and are subject to the standards under subpart Ec (see section
IV of this document).
A HMIWI is defined as any device that combusts any amount of
medical/infectious waste or hospital waste. The terms ``medical/
infectious waste'' and ``hospital waste'' are discussed in section
III.A and defined in Sec. 60.51c. An incinerator is not subject to
subpart Ce during periods when only pathological, low-level
radioactive, or chemotherapeutic waste (all defined in Sec. 60.51c) is
burned provided that the owner or operator keeps records of the periods
of time when only pathological, low-level radioactive, or
chemotherapeutic waste is burned. Any unit required to have a permit
under section 3005 of the Solid Waste Disposal Act is exempt from
subpart Ce as are incinerators subject to subpart Cb, Ea, or Eb.
Existing incinerators, processing operations, or boilers that co-fire
hospital waste and/or medical/infectious waste with other fuels or
wastes and combust 10 percent or less medical/infectious waste and
hospital waste by weight (on a calendar quarter basis) are not subject
to the emission limitations but must keep records of the amounts of
each fuel and waste burned.
The HMIWI source category is divided into three subcategories based
on waste burning capacity: small (200 lb/hr), medium (>200
to 500 lb/hr), and large (>500 lb/hr). Waste burning capacity is
determined either by the maximum design capacity or by the ``maximum
charge rate'' established during the most recent performance test. In
other words, a source may change its size designation by establishing a
``maximum charge rate'' lower than its design capacity. For example, a
``medium'' unit with a design capacity of 250 lb/hr may establish a
maximum charge rate of 200 lb/hr and be considered a ``small'' unit for
purposes of the emission guidelines. Separate emission guidelines apply
to each subcategory of existing HMIWI. A summary of the final emission
limits for existing HMIWI is presented in Table 7. In addition to the
emission limits presented in Table 7, all HMIWI are subject to a 10
percent stack opacity limitation. Stack opacity will be determined
using EPA Reference Method 9.
Table 7.--Summary of Promulgated Emission Limits for Existing HMIWI
----------------------------------------------------------------------------------------------------------------
Emission limits
Pollutant (test method) --------------------------------------------------------------------------
Small HMIWI Medium HMIWI Large HMIWI
----------------------------------------------------------------------------------------------------------------
Particulate matter (EPA Method 5 or 115 mg/dscm (0.05 gr/ 69 mg/dscm (0.03 gr/ 34 mg/dscm (0.015 gr/
Method 29). dscf). dscf). dscf).
Carbon monoxide (EPA Method 10 or 40 ppmv................ 40 ppmv................ 40 ppmv.
Method 10B).
Dioxins/furans (EPA Method 23)....... 125 ng/dscm total CDD/ 125 ng/dscm total CDD/ 125 ng/dscm total CDD/
CDF (55 gr/109 dscf) CDF (55 gr/109 dscf) CDF (55 gr/109 dscf).
or 2.3 ng/dscm TEQ or 2.3 ng/dscm TEQ or 2.3 ng/dscm TEQ
(1.0 gr/109 dscf). (1.0 gr/109 dscf). (1.0 gr/109 dscf).
Hydrogen chloride (EPA Method 26).... 100 ppmv or 93% 100 ppmv or 93% 100 ppmv or 93%
reduction. reduction. reduction
Sulfur dioxide (testing not required) 55 ppmv................ 55 ppmv................ 55 ppmv.
Nitrogen oxides (testing not 250 ppmv............... 250 ppmv............... 250 ppmv.
required).
Lead (EPA Method 29)................. 1.2 mg/dscm (0.52 gr/ 1.2 mg/dscm (0.52 gr/ 1.2 mg/dscm (0.52 gr/
103 dscf) or 70% 103 dscf) or 70% 103 dscf) or 70%
reduction. reduction. reduction.
Cadmium (EPA Method 29).............. 0.16 mg/dscm (0.07 gr/ 0.16 mg/dscm (0.07 gr/ 0.16 mg/dscm (0.07 gr/
103 dscf) or 65% 103 dscf) or 65% 103 dscf) or 65%
reduction. reduction. reduction.
[[Page 48368]]
Mercury (EPA Method 29).............. 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/ 0.55 mg/dscm (0.24 gr/
103 dscf) or 85% 103 dscf) or 85% 103 dscf) or 85%
reduction. reduction. reduction.
----------------------------------------------------------------------------------------------------------------
The emission limits for small existing HMIWI presented in Table 7
are more stringent than the MACT floor emission limits for small
existing HMIWI. However, the final HMIWI guidelines contain alternative
emission limits which are based on the MACT floor for small existing
HMIWI that meet certain ``rural criteria.'' The ``rural criteria''
stipulates that an HMIWI is allowed to meet alternative emission limits
if it is located at least 50 miles from the nearest Standard
Metropolitan Statistical Area (SMSA) boundary and burns no more than
2,000 pounds of hospital waste and medical/infectious waste per week.
The SMSA is defined by the Office of Management and Budget (OMB). For
purposes of these emission guidelines, the list of areas comprising
each SMSA as of June 30, 1993 will be used to determine whether a small
HMIWI meets the ``rural criteria.'' The list of areas comprising each
SMSA is presented in OMB Bulletin No. 93-17 entitled ``Revised
Statistical Definitions for Metropolitan Areas.'' This document may be
obtained by contacting the National Technical Information Services,
5285 Port Royal Road, Springfield, Virginia 22161, or by calling (703)
487-4650 and requesting document No. PB 93-192-664. This document is
available for public inspection and copying at EPA's Air and Radiation
Docket and Information Center (Docket A-91-61, item IV-J-125). See the
ADDRESSES section at the beginning of this preamble for the telephone
number and location of the Docket. This document has been approved for
incorporation by reference by the Director of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The emission limits
that correspond with these alternative guidelines for rural HMIWI are
presented in Table 8. For further discussion of the ``rural criteria''
and rationale for the alternative emission limits for small existing
HMIWI in rural areas, see section V.B ``Significant Issues and
Changes'' (below).
Table 8.--Summary of Alternative Emission Limits for Small Existing
HMIWI That Meet the Rural Criteria
------------------------------------------------------------------------
Pollutant (Performance test method) Emission limits
------------------------------------------------------------------------
Particulate matter (EPA Method 5)...... 197 mg/dscm (0.086 gr/dscf).
Carbon monoxide (EPA Method 10 of 10B). 40 ppmv.
Dioxins/furans (EPA Method 23)......... 800 ng/dscm total CDD/CDF (350
gr/10 \9\ dscf) or 15 ng/dscm
TEQ (6.6 gr/10 \9\ dscf).
Hydrogen chloride (testing not 3,100 ppmv.
required).
Sulfur dioxide (testing not required).. 55 ppmv.
Nitrogen oxides (testing not required). 250 ppmv.
Lead (testing not required)............ 10 mg/dscm (4.4 gr/10 \3\
dscf).
Cadmium (testing not required)......... 4 mg/dscm (1.7 gr/10 \3\ dscf).
Mercury (EPA Method 29)................ 7.5 mg/dscm (3.3 gr/10 \3\
dscf).
------------------------------------------------------------------------
Table 9 summarizes the additional requirements for existing HMIWI
under the emission guidelines, including the operator training and
qualification requirements, inspection requirements, compliance and
performance testing requirements, monitoring requirements, and
reporting and recordkeeping requirements. Table 10 summarizes the
additional requirements under the emission guidelines for small
existing HMIWI that meet the rural criteria. With the exception of the
compliance and performance testing requirements and the inspection
requirements, existing HMIWI that meet the small rural criteria are to
comply with the same additional requirements as all other existing
HMIWI. A summary of dates for compliance with the promulgated
guidelines for existing HMIWI is presented in Table 11. These dates
apply to all existing HMIWI.
Table 9.--Summary of Additional Requirements Under the Emission
Guidelines for Existing HMIWI
------------------------------------------------------------------------
Additional requirements
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:
Complete HMIWI operator training course.
Qualify operators.
Maintain information regarding HMIWI operating procedures
and review annually.
Waste Management Plan:
Prepare a waste management plan that identifies the
feasibility and approach to separate certain components of a health
care waste stream.
Compliance and Performance Testing Requirements:
Conduct an initial performance test to determine compliance
with the PM, CO, CDD/CDF, HCl, Pb, Cd, and Hg emission limits and
opacity limit, and establish operating parameters.
Conduct annual performance tests to determine compliance
with the PM, CO, and HCl emission limits and opacity limit.
Facilities may conduct performance tests for PM, CO, and
HCl every third year if the previous three performance tests
demonstrate that the facility is in compliance with the emission
limits for PM, CO, and HCl.
[[Page 48369]]
Monitoring Requirements:
Install and maintain equipment to continuously monitor
operating parameters including secondary chamber temperature, waste
feed rate, bypass stack, and APCD operating parameters as
appropriate.
Obtain monitoring data at all times during HMIWI operation.
Reporting and Recordkeeping Requirements:
Maintain for 5 years records of results from the initial
performance test and all subsequent performance tests, operating
parameters, and operator training and qualification.
Submit the results of the initial performance test and all
subsequent performance tests.
Submit reports on emission rates or operating parameters
that have not been recorded or which exceeded applicable limits.
------------------------------------------------------------------------
Note: This table depicts the major provisions of the emission guidelines
and does not attempt to show all requirements. The regulatory text of
Subpart Ce should be relied upon for a full and comprehensive
statement of the requirements of the final guidelines.
Table 10.--Summary of Additional Requirements Under the Emission
Guidelines for Existing HMIWI that Meet the Rural Criteria
------------------------------------------------------------------------
Additional requirements
-------------------------------------------------------------------------
Operator Training and Qualification Requirements:
Complete HMIWI operator training course.
Qualify operators.
Maintain information regarding HMIWI operating procedures
and review annually.
Inspection Requirements:
Provide for an annual equipment inspection of the
designated facility.
Waste Management Plan:
Prepare a waste management plan that identifies the
feasibility and approach to separate certain components of a health
care waste stream.
Compliance and Performance Testing Requirements:
Conduct an initial performance test to determine compliance
with the PM, CO, CDD/CDF, and Hg emission limits and opacity limit,
and establish operating parameters.
Conduct annual tests to determine compliance with the
opacity limit.
Monitoring Requirements:
Install and maintain equipment to continuously monitor
operating parameters including secondary chamber temperature, waste
feed rate, bypass stack, and APCD operating parameters as
appropriate.
Obtain monitoring data at all times during HMIWI operation.
Reporting and Recordkeeping Requirements:
Maintain for 5 years records of results from the initial
performance test and all subsequent performance tests, operating
parameters, inspections, any maintenance, and operator training and
qualification.
Submit the results of the initial performance test and all
subsequent performance tests.
Submit reports on emission rates or operating parameters
that have not been recorded or which exceeded applicable limits.
------------------------------------------------------------------------
Note: This table depicts the major provisions of the emission guidelines
and does not attempt to show all requirements. The regulatory text of
Subpart Ce should be relied upon for a full and comprehensive
statement of the requirements of the final guidelines.
Table 11.--Compliance Times Under the Emission Guidelines for Existing
HMIWI
------------------------------------------------------------------------
Requirement Compliance time
------------------------------------------------------------------------
State Plan submittal........................... Within 1 year after
promulgation of EPA
emission guidelines.
Operator training and qualification Within 1 year after EPA
requirements. approval of State
Plan.
Inspection requirements........................ Within 1 year after EPA
approval of State
Plan.
Initial compliance test........................ Within 1 year after EPA
approval of State plan
or up to 3 years after
EPA approval of State
plan if the source is
granted an extension.
Repeat performance test........................ Within 12 months
following initial
compliance test and
annually thereafter.
Parameter monitoring........................... Continuously, upon
completion of initial
compliance test.
Recordkeeping.................................. Continuously, upon
completion of initial
compliance test.
Reporting...................................... Annually, upon
completion of initial
compliance test;
semiannually, if
noncompliance.
------------------------------------------------------------------------
B. Significant Issues and Changes
This section discusses the most significant changes to the
guidelines made following the June 20, 1996 Federal Register document.
Further discussion of these changes as well as other comments and
responses regarding the emission guidelines are provided in ``Hospital/
Medical/Infectious Waste Incinerators: Background Information for
Promulgated Standards and Guidelines--Summary of Public Comments and
Responses'' (EPA-453/R-97-006b).
As discussed in the 1996 re-proposal, the MACT floor for small
existing HMIWI was based on emission limits achievable through use of
good combustion alone (i.e., without add-on control). The EPA presented
regulatory options more stringent than the MACT floor for small
existing HMIWI in the 1996 re-proposal and stated that it had no
inclination as to which regulatory
[[Page 48370]]
option might be selected for the final emission guidelines for small
HMIWI. The EPA solicited public comment on the available regulatory
options for the guidelines for small existing HMIWI.
During the public comment period, the EPA received several comments
containing suggestions for the final emission guidelines for small
existing HMIWI. A number of commenters requested that the emission
guidelines for small existing HMIWI be based on the MACT floor. Other
commenters requested that the guidelines for small HMIWI require small
HMIWI in urban locations to meet emission guidelines more stringent
than the MACT floor and allow small HMIWI in rural locations to meet
the MACT floor emission limits. These commenters noted that cost-
effective alternatives to onsite incineration may not be available to
facilities operating small HMIWI in rural locations and that emission
limits based on wet scrubbers would cause these facilities financial
hardship. Other commenters contended that emission limits for small
incinerators consistent with no more than good combustion would result
in largely uncontrolled emissions, and would encourage medium-sized
units to change their size designation to small by burning less waste
per hour while operating more hours per day. These commenters stated
that there are cost-effective alternatives to incineration and
requested that small existing HMIWI be subject to emission limits
consistent with wet scrubbers.
Guidelines for small existing HMIWI based on the use of good
combustion and low efficiency wet scrubbing could cause the cost of
waste disposal to more than double for facilities that install the
equipment necessary to meet the emission guidelines. Even guidelines
based on the MACT floor (good combustion alone) would cause a
significant increase in costs for such facilities. The EPA's cost
projections show that the costs of retrofitting small existing HMIWI to
meet the MACT floor would be about $18 million annually, while the cost
of going beyond the floor (guidelines based on low efficiency wet
scrubbers) for the estimated 1,025 small HMIWI that do not meet the
``remote'' criteria (discussed later) would be an additional $47
million. However, as noted by commenters and observed by States that
have implemented stringent HMIWI regulations, there are a number of
cost-effective alternatives to onsite incineration for most facilities
that operate small HMIWI. Therefore, many health care facilities
operating small HMIWI could switch to alternative means of waste
disposal if the emission guidelines are based on the use of good
combustion and low efficiency wet scrubbing. In fact, EPA's modeling
projects that most existing facilities, except those meeting the
``remote'' criteria, would find it more economical to switch to
alternative means of waste disposal than to retrofit their small
incinerators even to meet the MACT floor, and virtually all such
facilities would switch rather than retrofit small incinerators with
low efficiency wet scrubbers. Under the switching scenario, the costs
for non-``remote'' small facilities range from $6 to $13 million for
guidelines based on the MACT floor, and from $6 to $20 million for
guidelines based on low efficiency wet scrubbers. In addition, by
making the guidelines for small existing HMIWI only slightly less
stringent than those for medium existing HMIWI (the guidelines for
small existing HMIWI are based on good combustion and low efficiency
wet scrubbers, while those for medium existing HMIWI are based on good
combustion and moderate efficiency wet scrubbers), the selected option
removes any strong incentive for medium existing facilities to
reclassify themselves as small in order to escape more stringent
guidelines. The result is that, under the selected option, most medium
existing facilities will also switch to alternative means of waste
disposal. Unlike the small facilities, most of these medium HMIWI would
have found it economical to continue operating if they could have
reclassified themselves as small and been required to meet emission
limits based on good combustion alone. Thus, most of the emission
reduction benefits from going beyond the MACT floor for small existing
HMIWI actually come from these medium HMIWI that switch to alternative
waste disposal rather than operating as small units subject to emission
limits based on good combustion alone (the MACT floor). The additional
costs to this group under the switching scenario of going beyond the
floor range from $4 to $30 million annually.
While EPA's objective is to adopt MACT emission guidelines that
fulfill the requirements of section 129 of the CAA, and not to cause
the shutdown of most existing small and medium HMIWI, the EPA believes
that the replacement of poorly controlled incinerators with cost
effective alternatives that significantly reduce toxic emissions is an
appropriate outcome. From a national perspective, guidelines for small
existing HMIWI based on good combustion and low efficiency wet
scrubbing (and the switching to alternative waste disposal options that
EPA believes will result) will minimize emissions of PM, dioxin, acid
gases, and metals from small and medium existing HMIWI at a relatively
low cost due to the availability of alternative means of waste
treatment. As a result, the final emission guidelines for small HMIWI
are based on emission limits achievable through the use of good
combustion and low efficiency wet scrubbers. These emission limits are
more stringent than the MACT floor for small HMIWI.
As some commenters have pointed out, alternative means of medical
waste treatment may not be available at a reasonable cost to some
facilities that operate small HMIWI in rural or remote locations.
Facilities that operate small HMIWI in remote locations could be faced
with adverse impacts if required to meet emission limits associated
with good combustion and low efficiency wet scrubbing. Therefore, the
final emission guidelines subcategorize facilities for purposes of
establishing MACT standards based on the location of the facility and
the amount of waste burned. The EPA established MACT standards at the
respective MACT floors for facilities that meet certain ``rural
criteria;'' which are achievable through the use of good combustion
alone. The EPA set MACT standards for all other small HMIWI more
stringent than the MACT floors.
The basis for this subcategorization approach is found in section
129(a)(2), which states: ``The Administrator may distinguish among
classes, types * * * and sizes of units within a category in
establishing such standards.'' This language gives EPA broad discretion
to distinguish among units in a category in establishing subcategories,
including establishing subcategories based on a unit's location. See
Davis County Solid Waste Management & Energy Recovery Special Services
District v. EPA, 101 F.3d 1395, 1405 n.11 (D.C. Cir. 1996), amended 108
F.3d 1454 (D.C. Cir. 1997). As discussed above, the EPA believed it was
appropriate to subcategorize for purposes of establishing MACT
standards, where all MACT standards were at least as stringent as the
respective MACT floors.
In the 1996 re-proposal, the EPA discussed the option of adopting
emission guidelines with criteria for small existing HMIWI located in
rural areas to meet requirements--on a case by case basis--based on the
use of good combustion alone. The EPA solicited public comment on this
option and on what criteria could be associated with this option to
determine if a facility may be faced with cost impacts that warrant
special consideration with regard to the emission guidelines.
[[Page 48371]]
Following the 1996 re-proposal, the EPA received several comments
regarding possible ``rural criteria'' that may be used if the final
guidelines allow rural HMIWI to meet less stringent emission limits.
Some commenters suggested that rural criteria be based on distance from
a SMSA or population density. Other commenters recommended a weekly
limit on amount of waste burned in the small HMIWI and a requirement
that no more than 10 percent of the waste burned in the small HMIWI is
from an outside facility. Other commenters suggested that facilities
operating small rural HMIWI should be required to demonstrate that no
alternatives to onsite incineration are available at a reasonable cost.
Finally, other commenters suggested considering ambient air quality,
good engineering practice stack height, and risk analysis as part of
the rural criteria.
The purpose of the rural criteria is to further define those
facilities operating small HMIWI in remote areas that may have fewer
cost-effective options for waste disposal; in which case, emission
guidelines based on wet scrubbers could cause financial hardship. It is
difficult to determine precisely which HMIWI have limited waste
disposal options, and it is difficult to establish a universal set of
criteria that could quantify ``hardship.'' All of the suggestions
submitted by commenters with regard to the rural criteria for small
HMIWI were considered. However, many of the suggestions would be very
difficult to define or implement. Consequently, the rural criteria
examined focused on (1) distance from a SMSA, and (2) amount of waste
burned per week. The combination of small size, distance from an SMSA,
and small amount of waste burned are the most likely indications that
commercial services are not available for a reasonable cost.
Distance criteria ranging from 25 to 150 miles from an SMSA in
conjunction with weekly waste burning limits ranging from 500 to 3,300
lb/wk were examined to determine the appropriate rural criteria. The
final ``rural criteria'' selected for small existing HMIWI stipulates
that: (1) The facility must be located at least 50 miles from the
nearest SMSA boundary and (2) the HMIWI operated by the facility may
not be used to burn more than 2,000 lb/wk. The 2,000 pound per week
criterion was suggested by commenters; focuses the option for less
stringent requirements on the smallest HMIWI; and reflects a sufficient
quantity of waste to ensure that commercial services are available. The
50 mile criterion added to the 2,000 lb/wk criterion provides the less
stringent requirements for less than 10 percent of small HMIWI (over 90
percent of small HMIWI would remain subject to guidelines based on wet
scrubbers). It is very likely that commercial services are available
within 50 miles of an SMSA, regardless of the amount of waste to be
picked up.
Small units with good combustion alone are not left
``uncontrolled.'' Good combustion reduces emissions of PM, CO, and
dioxin/furan, and these units remain subject to operator training
requirements. Small HMIWI operating with good combustion alone are also
required to reduce Hg emissions through pollution prevention. The
guidelines also include requirements for routine inspection and
maintenance to ensure good combustion. Based on EPA's assessment of
costs and other impacts, these less stringent requirements will,
themselves, raise the cost of incineration such that alternatives, if
available, are likely to be less expensive. In other words, where
alternatives are available, guidelines based on good combustion alone
are likely to result in switching. Under the MACT guidelines, less than
one percent of the waste burned in existing HMIWI will be burned in
small rural HMIWI with good combustion controls alone. The final
guidelines result in substantial reductions in emissions from the HMIWI
source category as a whole. The promulgated emission guidelines for
small HMIWI are consistent with section 129 because they reflect the
maximum degree of reduction in emissions that can be achieved by small
existing HMIWI while avoiding detrimental cost impacts to facilities
operating small ``remote'' HMIWI.
C. Selection of MACT
The EPA considered six regulatory options for adoption as the final
guidelines for existing HMIWI. These regulatory options are discussed
in Appendix B of ``Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-97-006b). As
required by section 129(a)(2) of the CAA, the Administrator reviewed
the emissions reductions achievable with each regulatory option and the
cost, nonair quality environmental, and energy impacts of the
regulatory options. Based on this review, the Administrator determined
that the most cost effective and achievable emission guidelines for
promulgation are based on emission levels achievable with good
combustion and a low efficiency wet scrubber for most small existing
HMIWI; good combustion and a moderate efficiency wet scrubber for
medium existing HMIWI; and good combustion and a high efficiency wet
scrubber for large existing HMIWI. The promulgated emission guidelines
allow small HMIWI that meet certain ``rural criteria'' to meet emission
limits achievable with good combustion alone.
The EPA concluded that MACT for most small units should reflect
emission limits achievable with good combustion and a low efficiency
wet scrubber because the reductions in emissions are substantial, while
the cost and economic impacts for most small HMIWI appear minimal.
Compared to emission limits achievable with good combustion and low
efficiency wet scrubbers, emission limits based on the use of good
combustion and moderate or high efficiency wet scrubbers would increase
the capital control costs for facilities operating small HMIWI by 15 to
42 percent and would only slightly decrease the emissions of PM from
small HMIWI. As a result, good combustion and moderate or high
efficiency wet scrubbers were not further considered in the selection
of MACT for small HMIWI.
The MACT floor for medium existing HMIWI appears to require the use
of good combustion and a moderate efficiency wet scrubber. One
regulatory option more stringent than this MACT floor would reflect the
use of good combustion and a high efficiency wet scrubber. On a
nationwide basis, while this more stringent option would result in a
relatively small cost increase, it would also result in only a small
decrease in PM emissions. For a typical facility operating a medium
HMIWI that installed or upgraded an existing wet scrubber to a high
efficiency wet scrubber, air pollution control costs would increase by
about 15 to 25 percent. As a result, EPA concluded that the MACT
emission limitations for medium existing HMIWI based on the use of good
combustion and a moderate efficiency wet scrubber (i.e., the MACT
floor) are the most cost effective and achievable. These emission
limitations could also be achieved using a dry scrubber with activated
carbon.
The MACT floor for large existing HMIWI appears to require the use
of good combustion and a high efficiency wet scrubber. Regulatory
options more stringent than this MACT floor were not considered for
large HMIWI for the reasons discussed below. As a result, EPA concluded
that MACT emission limitations for large existing HMIWI based on the
use of good combustion and a high efficiency wet scrubber (i.e., the
MACT floor) are the most cost
[[Page 48372]]
effective and achievable. These emission limitations could also be
achieved using a dry scrubber with activated carbon.
The MACT emission limitations for medium and large existing HMIWI
were structured so that either a dry scrubber or a wet scrubber could
be used to achieve the emission limits. The emission limitations were
not based on the use of dry scrubbers exclusively or wet scrubbers
exclusively because a dry scrubber typically costs much more than a wet
scrubber, and a dry scrubber with activated carbon would result in only
a very small additional reduction in dioxin, Pb, and Cd emissions.
Furthermore, for existing HMIWI already equipped with wet scrubbers,
replacing a wet scrubber with a dry scrubber would be extremely
expensive. Similarly, for existing HMIWI already equipped with dry
scrubbers, replacing the dry scrubber with a wet scrubber would be
extremely expensive. Guidelines based on the use of combined dry/wet
scrubbing systems were not considered for medium and large existing
HMIWI because such control systems are very expensive and result in
only small additional reductions in emissions.
D. Impacts of the Guidelines
There are a number of alternatives to onsite incineration of
hospital waste and medical/infectious waste, including recycling or
direct landfilling of non-infectious waste, and off-site commercial
waste disposal or any of several waste disinfection technologies (e.g.,
steam autoclaving, microwave irradiation, macrowave irradiation,
chemical treatment, thermal treatment, and biological treatment) for
infectious waste. Many facilities that currently operate onsite HMIWI
may find it more cost effective to dispose of their waste using one of
these alternatives. As discussed in the June 1996 re-proposal, while
further study is warranted, there appears to be no significant or
substantial adverse economic, environmental, or health and safety
issues associated with the increased use of the alternative waste
treatment technologies.
In some cases, facilities that ``switch'' to alternative methods of
waste disposal may further decrease their waste disposal costs by
segregating their waste into infectious and noninfectious portions, and
recycling or landfilling (rather than treating) their noninfectious
waste. To account for facilities switching to alternative methods of
waste disposal, the impacts of the guidelines were developed based on
three compliance scenarios: no switching (scenario A), switching with
waste segregation (scenario B), and switching without waste segregation
(scenario C).
The EPA estimates that there are approximately 1,139 existing small
HMIWI, 692 existing medium HMIWI, 463 existing large HMIWI, and 79
existing commercial HMIWI in operation today. Scenario A preserves this
assumption and estimates the costs of the additional control measures
that would be required for these 2,373 existing facilities to meet the
guidelines at $172 million annually. The EPA believes that Scenario A
is unrealistic and grossly overstates the national costs associated
with the guidelines. Under Scenarios B and C, 93 to 100 percent of
existing small ``non-remote'' HMIWI, 60 to 95 percent of existing
medium HMIWI, and as many as 35 percent of existing large HMIWI are
expected to cease operation. All 79 commercial units and 114 small
units meeting the ``remote'' criteria are assumed to remain in
operation. Facilities that cease operation are assumed to find
alternate methods of waste disposal. The EPA believes that the total
costs of the final guidelines for existing sources will fall somewhere
between the $59 million/yr estimate for Scenario B and the $120
million/yr estimate for Scenario C.
Table 12 presents baseline emissions (i.e., emissions in the
absence of the MACT emission guidelines) and the range of emissions
that are expected to occur under the final MACT guidelines. A range of
emissions is presented in Table 12 to account for the emissions that
could occur under switching scenarios B and C as a result of the
guidelines. Table 12 also presents the percent reduction in emissions
achieved under the final MACT guidelines for existing HMIWI.
Table 12.--Baseline Emissions, Emissions After Implementation of the Final Emission Guidelines, and Emissions
Reduction
[Metric Units]
----------------------------------------------------------------------------------------------------------------
Emissions under the final Emissions reduction,
Pollutant, units Baseline emission guidelines percent
----------------------------------------------------------------------------------------------------------------
PM, Mg/yr............................... 940 72 to 120.................. 88 to 92.
CO, Mg/yr............................... 460 82 to 120.................. 75 to 82.
CDD/CDF, g/yr........................... 7,200 210 to 310................. 96 to 97.
TEQ CDD/CDF, g/yr....................... 150 5 to 7..................... 95 to 97.
HCl, Mg/yr.............................. 5,700 130 to 140................. 98.
SO2, Mg/yr.............................. 250 170 to 250................. 0 to 30.
NOX, Mg/yr.............................. 1,200 810 to 1,200............... 0 to 30.
Pb, Mg/yr............................... 11 1.4 to 2.2................. 80 to 87.
Cd, Mg/yr............................... 1.2 0.19 to 0.30............... 75 to 84.
Hg, Mg/yr............................... 15 0.8 to 1.1................. 93 to 95.
----------------------------------------------------------------------------------------------------------------
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to lb/yr, divide by 453.6.
As discussed further in Appendix B of ``Hospital/Medical/Infectious
Waste Incinerators: Background Information for Promulgated Standards
and Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-
97-006b), the EPA is not able to calculate a monetized value for most
of these emission reductions. However, using ``Benefit-Cost Analysis of
Selected NSPS for Particulate Matter'' as a basis, EPA has calculated a
monetized value for reductions in PM emissions using an estimate of
$6,075 (1993 dollars) per ton of PM. This yields annualized benefits of
PM reductions for the guidelines ranging from $5.5 million to $5.8
million (1993 dollars).
As a result of the MACT guidelines for existing HMIWI, industries
that generate hospital waste and/or medical/infectious waste (i.e.,
hospitals, nursing homes, etc.) are expected to experience average
price increases in the range of 0.00 to 0.14 percent, depending on the
[[Page 48373]]
industry. These industries are expected to experience output and
employment impacts in the range of 0.00 to 0.18 percent. In addition,
the revenue impacts for these industries are expected to range from an
increase of 0.05 percent to a decrease of 0.04 percent as a result of
the guidelines. For hospitals, 0.03 percent is the estimated price
increase necessary to recover annual control costs. The expected
average price increase for each hospital patient-day is expected to be
less than 30 cents. The average price impact for the commercial HMIWI
industry is approximately a 2.6 percent increase in price.
Facilities with onsite HMIWI that are currently uncontrolled may
experience impacts ranging from 0.03 to 1.83 percent, depending on the
industry. For many of these facilities, the economic impacts of
switching to an alternative method of waste disposal are much lower
than the economic impacts of choosing to install emission control
equipment. The decision to switch to an alternative method of waste
disposal should preclude any facilities from experiencing a significant
economic impact. The impacts that would be incurred by medical/
infectious waste generators that currently use an offsite waste
incineration service range from 0.00 to 0.02 percent and are considered
negligible impacts.
The option of switching to an alternative method of waste disposal
will be an attractive option for many facilities that currently operate
onsite HMIWI and should preclude most facilities from experiencing a
significant economic impact. However, two types of HMIWI operators may
not be able to switch to an alternative: commercial HMIWI operators,
because their line of business is commercial incineration; and small,
rural, remote HMIWI, which may not have access to alternative waste
disposal methods. For commercial HMIWI operators, only three of the 59
facilities operating the 79 commercial HMIWI in the HMIWI inventory
were found to be significantly impacted by the regulation. As discussed
in ``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Analysis of
Economic Impacts for Existing Sources'' (EPA-453/R-97-007b), commercial
HMIWI are considered to be significantly impacted if the price impact
(i.e., the price increase that would be necessary to recover compliance
costs) on an individual facility exceeds the market price increase
(2.62 percent) by more than 2 percentage points (i.e., above 4.6
percent). Price increases at these three facilities are calculated as
9.58 percent, 11.13 percent, and 18.36 percent. These facilities may
not have to raise their prices this much to remain profitable, since
they are completely uncontrolled in the baseline and therefore may
currently enjoy a cost advantage over their competitors (most of which
are at least partially controlled in the baseline). Also, demand may
increase as a result of switching away from onsite incineration. In
this latter case, increased revenues (which could offset control costs)
may result in one of two ways: either by allowing a larger increase in
price, or by providing an increase in the amount of waste coming to the
facility (i.e., increased capacity utilization). Impacts are not
significant for small, rural, remote HMIWI operators because the final
guidelines allow good combustion alone where alternatives to onsite
incineration might be unavailable.
The economic impact analysis examines possible economic impacts
that may occur in industries that will be directly affected by this
regulation. Therefore, the analysis includes an examination of
industries that generate hospital waste or medical/infectious waste or
dispose of such waste. Secondary impacts such as subsequent impacts on
air pollution device vendors and HMIWI vendors are not estimated due to
data limitations. Air pollution control device vendors are expected to
experience an increase in demand for their products due to the
regulation. This regulation is also expected to increase demand for
commercial HMIWI services. However, due to economies of scale, this
regulation is expected to shift demand from smaller incinerators to
larger incinerators. Therefore, small HMIWI vendors potentially may be
adversely affected by the regulation. Lack of data on the above effects
prevent quantification of the economic impacts on these secondary
sectors.
The total national usage of natural gas for HMIWI combustion
controls is expected to increase by less than 16.6 million cubic meters
per year (MMm3/yr) (586 million cubic feet per year
[106 ft3/yr]). The total national usage of
electrical energy for the operation of add-on control devices as a
result of the final MACT guidelines is expected to increase by less
than 259,000 megawatt hours per year (MW-hr/yr) (883 billion British
thermal units per year [109 Btu/yr]). As discussed in the
1996 re-proposal, compared to the amount of energy used by health care
facilities such as hospitals (approximately 2,460 MMm3/yr of
natural gas and 23.2 million MW-hr/yr of electricity) the increase in
energy usage that results from implementation of the HMIWI emission
guidelines is insignificant.
Less than 211,000 Mg/yr (233,000 tons/yr) of additional solid waste
is expected to result from the adoption of the final MACT guidelines.
As discussed in the 1996 re-proposal, compared to municipal waste,
which is disposed in landfills at an annual rate of over 91 million Mg/
yr (100 million tons/yr), the increase in solid waste from the
implementation of the final HMIWI guidelines is insignificant.
Less than 198 million gallons of additional wastewater would be
generated by HMIWI as a result of the final emission guidelines. This
amount is the equivalent of wastewater produced annually by four large
hospitals. Therefore, when considering the wastewater produced annually
at health care facilities nationwide, the increase in wastewater
resulting from the implementation of the MACT emission guidelines for
existing HMIWI is insignificant.
VI. Administrative Requirements
This section addresses the following administrative requirements:
Docket, Paperwork Reduction Act, Executive Orders 12866 and 12875,
Unfunded Mandates Reform Act, Regulatory Flexibility Act, Small
Business Regulatory Enforcement Fairness Act, and Clean Air Act
Procedural Requirements.
A. Docket
The docket is an organized and complete file of all the information
considered in the development of this rulemaking. The principal
purposes of the docket are: (1) To allow interested parties to identify
and locate documents so that they can effectively participate in the
rulemaking process; and (2) to serve as the record in case of judicial
review, except for interagency review material. The docket number for
this rulemaking is A-91-61. Information on how to obtain documents from
the docket was provided in the ADDRESSES section at the beginning of
this preamble.
B. Paperwork Reduction Act
The information collection requirements in this rule have been
submitted for approval to OMB under the Paperwork Reduction Act. An
Information Collection Request (ICR) document has been prepared by EPA
(ICR No. 1730.02) and a copy may be obtained from Sandy Farmer, OPPE
Regulatory Information Division; U. S. Environmental Protection Agency
(2136); 401 M St., S.W.; Washington, DC 20460 or by calling (202) 260-
2740.
[[Page 48374]]
This ICR document is also available electronically via the Internet.
See the SUPPLEMENTARY INFORMATION section of this preamble for
information on accessing this document via the Internet.
The information required to be collected by this rule is necessary
to identify the regulated entities who are subject to the rule and to
ensure their compliance with the rule. The recordkeeping and reporting
requirements are mandatory and are being established under authority of
sections 114 and 129(c) of the CAA. All information submitted as part
of a report to the Agency for which a claim of confidentiality is made
will be safeguarded according to the Agency policies set forth in Title
40, Chapter 1, part 2, subpart B--Confidentiality of Business
Information (see 40 CFR Part 2; 41 FR 36902, September 1, 1976, amended
by 43 FR 39999, September 28, 1978; 43 FR 42251, September 28, 1978; 44
FR 17674, March 23, 1979).
The Agency predicts that somewhere between 2 and 14 new HMIWI will
be constructed each year after implementation of the NSPS. The total
annual reporting and recordkeeping burden summarized in the ICR
document for this collection averaged over the first 3 years of the
NSPS application to new HMIWI is estimated to be about 14,106 person
hours per year if 14 new HMIWI are constructed each year. This burden
estimate includes the time needed to review instructions, search
existing data sources, gather and maintain the data needed, and
complete and review the collection of information. Efforts were made to
reduce the burden on facilities installing new HMIWI by allowing them
to: (1) Monitor operating parameters rather than continuously monitor
emissions using CEMS; (2) test emissions once every 3 years instead of
annually if they demonstrate that they consistently meet the emissions
requirements; (3) retest emissions of PM, CO, and HCl rather than
emissions of all pollutants; and (4) submit reports semiannually (or
annually if no exceedances occur) rather than quarterly as was
originally proposed.
Comments on the ICR document are requested, including the Agency's
need for the information presented in this ICR document, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden. Send comments on the ICR to the Director,
OPE Regulatory Information Division; U. S. Environmental Protection
Agency (2136); 401 M St. S.W.; Washington, DC 20460; and to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th St. N.W.; Washington, DC 20503; marked ``Attention: Desk
Officer for EPA.'' Include the ICR number in any correspondence. Since
the OMB is required to make a decision concerning the ICR between 30
and 60 days after today's request for comment, a comment to OMB is best
assured of having its full effect if OMB receives it by October 15,
1997. The EPA will publish a response to OMB and public comments on the
information collection requirements contained in this document in a
subsequent Federal Register document.
C. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the EPA
must determine whether a regulatory action is ``significant,'' and
therefore, subject to OMB review and the requirements of the Executive
Order. The Order defines ``significant'' regulatory action as one that
is likely to lead to a rule that may:
1. Have an annual effect on the economy of $100 million or more, or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local or Tribal governments or communities;
2. Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
3. Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
4. Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, the EPA considers
these promulgated standards and guidelines to be ``significant.'' As
such, this action was submitted to OMB for review. Changes made in
response to OMB suggestions or recommendations are documented in the
public docket for this rulemaking.
Also, in accordance with the provisions of the Executive Order
regarding ``significant regulatory actions,'' EPA has prepared
assessments of the costs and benefits of the rule and of ``potentially
effective and reasonably feasible alternatives.'' These assessments are
contained in four documents: ``Hospital/Medical/Infectious Waste
Incinerators: Background Information for Promulgated Standards and
Guidelines--Analysis of Economic Impacts for Existing Sources'' (EPA-
453/R-97-007b), ``Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Analysis of Economic Impacts for New Sources'' (EPA-453/R-97-008b),
``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Regulatory Impact
Analysis for New and Existing Sources'' (EPA-453/R-07-009b), and
Appendices A and B of ``Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and Guidelines--
Summary of Public Comments and Responses'' (EPA-453/R-970-006b). The
selected options for both the New Source Performance Standards and the
Emissions Guidelines are identified as regulatory option 2 in these
documents. Several other options, both more and less stringent than the
selections options, are also analyzed. A summary of these analyses is
included below in Section VI.D.2 of this preamble.
D. Unfunded Mandates Reform Act
Under section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, the EPA
must prepare a statement to accompany any rule where the estimated
costs to State, local, or Tribal governments, or to the private sector,
will be $100 million or more in any 1 year. Section 203 requires the
EPA to establish a plan for informing and advising any small
governments that may be significantly impacted by the rule. Under
section 205(a), the EPA must select the ``least costly, most cost-
effective or least burdensome alternative that achieves the objectives
of the rule'' and is consistent with statutory requirements. The EPA
has complied with section 205 of the Unfunded Mandates Act, by
promulgating a rule that is the most cost-effective alternative for
regulation of these sources that meets the statutory requirements under
the Clean Air Act.
The unfunded mandates statement under section 202 must include: (1)
A citation of the statutory authority under which the rule is proposed,
(2) an assessment of the costs and benefits of the rule including the
effect of the mandate on health, safety and the environment, and the
Federal resources available to defray the costs, (3) where feasible,
estimates of future compliance costs and disproportionate impacts upon
particular geographic or social segments of the nation or industry, (4)
where relevant, an estimate of the effect on the national economy, and
(5) a description of the EPA's consultation with State, local, and
Tribal officials.
[[Page 48375]]
Since this rule is estimated to impose costs to the private sector
and government entities in excess of $100 million per year, it is
considered a significant regulatory action. Therefore, EPA has prepared
the following statement with respect to Sections 202 through 205 of the
Unfunded Mandates Act.
1. Statutory Authority
This rule establishes emission guidelines for existing HMIWI and
standards of performance for new HMIWI pursuant to sections 111 and 129
of the CAA. Section 129(a)(2) requires the Administrator to promulgate
standards for new solid waste incinerator units and emission guidelines
for existing units that ``reflect the maximum degree of reduction in
emissions of air pollutants listed under section (a)(4) that the
Administrator, taking into consideration the cost of achieving such
emission reduction, and any non-air quality health and environmental
impacts and energy requirements, determines is achievable for new or
existing units in each category. The Administrator may distinguish
among classes, types, and sizes of units within a category in
establishing such standards . . .'' This is commonly referred to as
maximum achievable control technology, or MACT. Section 129(a)(2)
further defines a minimum level of stringency that can be considered
for MACT standards--commonly referred to as the MACT floor--which for
new units, is the level of control achieved by the best controlled
similar unit, and for existing units, is the level of control achieved
by the average of the best performing 12 percent of units in the
category.
Control technologies and their performance are discussed in the
June 1996 re-proposal (61 FR 31736, June 20, 1996). For the promulgated
standards and guidelines, EPA divided the HMIWI population into three
size categories which reflect technical differences in HMIWI design:
small (200 lb/hr), medium (>200 to 500 lb/hr),
and large (>500 lb/hr). The EPA considered emission reduction, costs,
and energy impacts, as required by the statutory language of section
111 of the CAA, in selecting the promulgated MACT standards and
guidelines. The promulgated standards and guidelines achieve a
significant reduction in HMIWI emissions as outlined in sections IV.D
and V.D and in section 2 ``Social Costs and Benefits'' (below). The
cost impacts of the standards and guidelines are presented in section 2
``Social Costs and Benefits'' (below). Consultations with the public
entities and affected industries as required by the Unfunded Mandates
Act are described in section 4, ``Consultation with Government
Officials'' (below). The energy impacts are discussed in sections IV.D
and V.D of this notice. Regarding EPA's compliance with section 205(a),
the EPA considered a reasonable number of alternatives which are
discussed in section 2.b, ``Regulatory Alternatives Considered''
(below).
2. Social Costs and Benefits
This assessment of the costs and benefits to State, local, and
Tribal governments of the NSPS and guidelines is based on the
regulatory impact analysis (EPA-453/R-97-009b). Measuring the social
costs of the rule requires identification of the affected entities by
ownership (public or private), consideration of regulatory
alternatives, calculation of the regulatory compliance costs for each
affected entity, and assessment of the market implications of the
additional pollution control costs. Calculating the social benefits of
the NSPS and guidelines requires estimating the anticipated reductions
in emissions at HMIWI due to regulation, identification of the harmful
effects of exposure to HMIWI emissions, and valuing the expected
reductions in these damages to society.
a. Affected Entities. Approximately 2,400 HMIWI are estimated to be
in operation in this country, and this inventory estimate was used to
estimate the cost of the EG to affected entities. While the inventory
distinguishes the size of HMIWI and indicates whether the HMIWI are
located at commercial waste disposal facilities, other information is
not precisely known such as the types of entities (hospitals,
laboratories, nursing homes, and other) and ownership characteristics
(public versus private) of entities operating onsite HMIWI. However,
the majority of directly affected entities are not likely to be owned
or operated by State, local, or Tribal governments. This statement is
based upon the ownership characteristics of these industries rather
than the ownership characteristics of the portion of these industries
operating HMIWI. Approximately 26.5 percent of the 6,500 hospitals
operating in this country are designated to have affiliations with
State and local governments. The remaining 73.5 percent have private
ownership; are designated nongovernment, not-for-profit; or have
Federal government affiliations. Nearly 20,900 nursing homes and 4,200
commercial research labs operate in the United States. Of these nursing
homes and research labs, approximately 28.4 and 8.2 percent,
respectively are tax exempt and may have government affiliations or be
nonprofit organizations. Finally, 59 commercial HMIWI operate in this
country, and these facilities are predominately privately owned. Since
the number of HMIWI operating is only a fraction of the total number of
hospitals, laboratories, nursing homes, and other entities in existence
in this country, only a fraction of these entities will be directly
impacted by the HMIWI regulations. Other firms generating hospital,
medical, and infectious waste and sending the waste offsite for
disposal will be indirectly affected by the regulation to the extent
waste disposal fees increase. The above affected entity information is
equally relevant to the NSPS since no additional information is known
about the types of entities or ownership characteristics expected for
new HMIWI.
b. Regulatory Alternatives Considered. Under section 205 of the
Unfunded Mandates Act, the EPA must identify and consider a reasonable
number of regulatory options before promulgating a rule for which a
budgetary impact statement must be prepared. The Agency must select
from those alternatives the least costly, most cost-effective, or least
burdensome alternative that achieves the objectives of the rule, unless
the EPA explains why this alternative is not selected or the selection
of this alternative is inconsistent with the law.
The two broad categories of regulatory standards available include
design standards and emission standards. Design standards specify the
type of control equipment polluters must install, whereas emission
standards specify the maximum quantity of a given pollutant that any
one polluter may release.
Design standards offer the least flexible approach considered in
this analysis. Owners of HMIWI would have to install the specified
control equipment regardless of the additional emission reductions
achieved or the relative cost of alternative means of emission
reductions.
Emission standards allow greater flexibility in the methods used to
reduce emissions. Owners of HMIWI are free to meet the emission limit
in the manner that is least costly to them. Consequently, for a given
level of emission reductions, emission standards are generally less
costly than design standards. Furthermore, emission standards give
owners of HMIWI an incentive to develop more effective means of
controlling emissions. In addition, the CAA requires the
[[Page 48376]]
Administrator to promulgate emission standards unless such standards
are not feasible. Since emission standards for HMIWI are feasible, the
EPA is barred from promulgating design standards for HMIWI.
Even though emission standards generally result in a more efficient
allocation of costs than design standards, uniform emission standards
can be more costly than necessary. Uniform emission standards require
the same level of emission control of every discharger. Because
marginal control costs differ for plants of different sizes, different
technologies, different levels of product recovery (i.e., in the
chemical industry), and different levels of baseline control, an
effective solution can be reached if standards are carefully tailored
to the special characteristics of each discharger. This type of
standard is referred to as a differentiated standard.
In formulating the regulatory options for HMIWI, EPA divided the
HMIWI population into three size categories: small (200 lb/
hr), medium (>200 to 500 lb/hr), and large (>500 lb/hr). A
number of regulatory options were considered for each size
classification. The regulatory options for the three selected size
classifications did not specify a particular control technology;
rather, they specified emission limits that facilities would be
required to meet.
A detailed discussion of the regulatory options considered for the
final standards and guidelines is presented in Appendices A and B of
``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Summary of Public
Comments and Responses'' (EPA-453/R-97-006b). For the most part, the
final standards and guidelines reflect the MACT floor, the least
stringent regulatory option EPA may adopt for the final rule. In two
cases (medium new units and small existing units), MACT was selected at
a level more stringent than the MACT floor. A description of EPA's
decision regarding medium new units is presented in section IV.C of
this notice, and a description of EPA's decision regarding small
existing units is presented in sections V.B and V.C of this notice. The
EPA believes that the final standards and guidelines reflect the least
costly, most cost-effective, and least burdensome regulatory option
that achieves the objectives of the rule.
c. Social Cost and Benefits. The regulatory impact analysis,
including the Agency's assessment of costs and environmental benefits,
is detailed in the ``Medical Waste Incinerators--Background Information
for Proposed Standards and Guidelines: Regulatory Impact Analysis for
New and Existing Facilities,'' (EPA 453/R-94-063a). The regulatory
impact assessment document has been updated for the final rule and is
entitled ``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Regulatory Impact
Analysis for New and Existing Facilities'' (EPA-453/R-97-009b).
Estimates of the costs and benefits of the various regulatory options
considered are discussed in the revised regulatory impact analysis
document and in Appendices A and B of ``Hospital/Medical/Infectious
Waste Incinerators: Background Information for Promulgated Standards
and Guidelines--Summary of Public Comments and Responses'' (EPA-453/R-
97-006b). Quantitative estimates of the costs, impacts, and benefits
associated with the final NSPS and EG are presented in sections IV.D
and V.D of this notice. These estimates are summarized below.
Total costs for the selected options are estimated to range from
$71 million per year under Scenario B, which assumes switching and
substantial additional waste segregations, to $146 million per year
under Scenario C, which assumes switching but little opportunity for
additional waste segregations. As a point of reference, EPA also
calculated the costs under Scenario A, in which all existing HMIWI
install retrofit technology and all new HMIWI projected to be built
over the next 5 years install control technology to comply with the
guidelines and standards. Under Scenario A, the total costs are
estimated to be $210 million per year. The EPA does not believe
Scenario A represents a realistic outcome, given the availability of
alternative waste disposal options that would be cheaper than
installing control technology for many facilities. Thus, EPA believes
the actual costs will fall within the range estimated for Scenarios B
and C.
Implementation of the NSPS and EG for HMIWI is expected to reduce
emissions of HAP, dioxin/furan, and criteria air pollutants. Reduction
in a variety of HAP including Cd, HCl, Pb, and Hg is expected as a
result of the regulation. Dioxin/furan emissions are also expected to
be reduced. In addition, decreases in the following criteria air
pollutants are anticipated: PM, SO2, CO, and NOX.
Table 6 in section IV.D gives a quantitative estimate of the emissions
reductions expected from the NSPS, and Table 12 in section V.D gives a
quantitative estimate of the emissions reductions expected from the EG.
Air quality benefits resulting from the air quality improvements
resulting from this regulation include a reduction in adverse health
effects associated with inhalation of the above pollutants as well as
improved welfare effects such as improved visibility and crop yields.
While the Agency believes that the health and environmental
benefits of this rule are quite significant, the EPA is not currently
able to quantitatively evaluate all human and environmental benefits
associated with the rule's air quality improvements, and is even more
limited in its ability to assign monetary values to these benefit
categories. Categories that are not evaluated include several health
and welfare endpoints (categories), as well as entire pollutant
categories. Consequently, the discussion of benefits included in the
Regulatory Impact Analysis and summarized here is primarily
qualitative.
However, monetized benefits were calculated for PM emissions
reductions. These benefits were estimated using a valuation of $6075/
ton, based on analyses of PM emissions reductions benefits from other
rules that are discussed in the EPA document, ``Benefit-Cost Analysis
of Selected NSPS for Particulate Matter.'' Total PM emissions reduction
benefits from this rule are estimated to range from $5.5 million under
Scenario B to $5.8 million under Scenario C. Thus net monetized costs
(after subtracting out monetized benefits) are estimated to range from
$65 million under Scenario B to $140 million under Scenario C. Although
the monetized benefits associated with PM emission reductions are
compared to the estimated annualized emission control costs of the
regulation, EPA notes that, because most categories of emissions
reductions cannot be monetized, the monetized benefits and therefore
the net benefits are understated (in this case annualized costs exceed
the monetized benefits so net costs are overstated) for the regulation.
A qualitative discussion of the pollutants that do not have a
monetary benefit value shows the significance of other benefits
achieved by the rule. Emission reductions of Cd, Pb, HCl, and Hg are
expected to occur as a result of the HMIWI rule. Health effects
associated with exposures to Cd and Pb include probable carcinogenic
effects. Respiratory effects are associated with exposure to Cd, HCl,
and Hg. The HAP emitted from HMIWI facilities have also been associated
with effects on the central nervous system, neurological system,
gastrointestinal system, mucous membranes, and kidneys.
Reduction in emission of dioxin/furan are expected as a result of
the HMIWI
[[Page 48377]]
rule. Exposure to dioxin/furan has been linked to reproductive and
developmental effects, changes in hormone levels, and chloracne. Toxic
Equivalent Quantity, or TEQ, has been developed as a measure of the
toxicity of dioxin/furan. The TEQ measures the more chlorinated
compounds of dioxin/furan and thus provides a better indicator of the
part of dioxin/furan that has been linked to the toxic effects
associated with dioxin/furan. Unfortunately, quantitative relationships
between the toxic effects and exposure to dioxin/furan have not been
developed. Therefore, quantitative estimates of the health effects of
dioxin/furan emission reductions are not estimated.
Emission reductions are also anticipated for criteria air
pollutants. The health effects associated with exposure to PM include
premature mortality as well as morbidity. The morbidity effects of PM
exposure have been measured in terms of increased hospital and
emergency room visits, days of restricted activity or work loss,
increased respiratory symptoms, and reductions in lung function. The
welfare effects of PM exposure include increased soiling and visibility
degradation. Sulfur dioxide has been associated with respiratory
symptoms and pulmonary function changes in exercising asthmatics and
may also be associated with respiratory symptoms in nonasthmatics. In
addition to the effects on human health, SO2 has also been
linked to adverse welfare effects, such as materials damage, visibility
degradation, and crop and forestry damage. Carbon monoxide affects the
oxygen-carrying capacity of hemoglobin and, at current ambient
concentrations, has been related to adverse health effects among
persons with cardiovascular and chronic respiratory disease. Both
congestive heart failure and angina pectoris have been related to CO
exposure. Nitrogen oxides have also been shown to have an adverse
impact on both human health and welfare. The effects associated with
NOX include respiratory illness, damages to materials,
crops, and forests, and visibility degradation.
3. Effects on the National Economy
The Unfunded Mandates Act requires that the EPA estimate ``the
effect'' of this rule
On the national economy, such as the effect on productivity,
economic growth, full employment, creation of productive jobs, and
international competitiveness of the U.S. goods and services, if and
to the extent that the EPA in its sole discretion determines that
accurate estimates are reasonably feasible and that such effect is
relevant and material.
As stated in the Unfunded Mandates Act, such macroeconomic effects
tend to be measurable, in nationwide econometric models, only if the
economic impact of the regulation reaches 0.25 to 0.5 percent of gross
domestic product (in the range of $15 billion to $30 billion). A
regulation with a smaller aggregate effect is highly unlikely to have
any measurable impact in macroeconomic terms unless it is highly
focused on a particular geographic region or economic sector. Because
the economic impact of the HMIWI regulation is less than $1.5 billion,
no estimate of this rule's effect on the national economy has been
conducted.
4. Consultation with Government Officials
The Unfunded Mandates Act requires that the EPA describe the extent
of the EPA's consultation with affected State, local, and Tribal
officials, summarize the officials' comments or concerns, and summarize
the EPA's response to those comments or concerns. In addition, section
203 of the Unfunded Mandates Act requires that the EPA develop a plan
for informing and advising small governments that may be significantly
or uniquely impacted by a proposal.
Throughout the development of these rules (pre-proposal through
pre-promulgation phases), the EPA consulted with representatives of
affected State and local governments, including the U.S. Conference of
Mayors, the National Governors Association, the National League of
Cities, and the National Association of Counties, to inform them of the
1995 proposed rule and determine their concerns. The EPA also consulted
with representatives from other entities affected by the 1995 proposed
rule, such as the National Association of Public Hospitals, the
American Hospital Association, the Sierra Club, and the Natural
Resources Defense Council.
As part of EPA's consultation efforts in this rulemaking, the EPA
mailed a copy of the draft regulatory package for the February 1995
proposed HMIWI standards and guidelines to each of the associations
mentioned above and to several State and local governments. The EPA
also mailed a copy of the February 1995 draft regulatory package to
many other associations and stakeholders. At least 60 draft regulatory
packages were delivered to government agencies, associations, and
stakeholders. Interested parties who were not sent a draft regulatory
package were mailed an announcement of the 1995 proposed HMIWI
regulations, information on where to obtain a copy of the proposal, and
notice of a public meeting held to discuss the proposal and answer any
questions to allow stakeholders to better formulate their written
comments.
Following the 1995 proposal and prior to the June 1996 re-proposal,
the EPA held several public meetings to discuss changes in the HMIWI
regulations and to allow opportunity for additional public input. Prior
to each meeting, a notice of the meeting and the topics to be discussed
was delivered to over 300 stakeholders and government officials.
Additionally, many meetings were held with smaller expert groups (e.g.,
environmental groups, STAPPA/ALAPCO, NAPH, etc.) to discuss specific
issues and allow for additional comment. With these efforts, the EPA
believes that every affected State and local government, association,
and stakeholder, was made aware of the HMIWI rulemaking, provided with
the necessary information, and given ample opportunity for input.
Following the 1995 proposal and the 1996 re-proposal, comment
letters were received from State, local, and Tribal governments.
Additional comments were expressed by State, local, and Tribal
governments in meetings held during the course of the rulemaking. Many
of the commenters suggested that EPA consider ``tiering'' the standards
and guidelines using HMIWI size categories most often used by State
environmental agencies. For the most part, these commenters supported
the size categories presented in the 1996 re-proposal. Other commenters
expressed concern about the lack of medical waste disposal options for
facilities in rural locations and suggested that the Agency consider
location when developing the standards and guidelines. Many of the
commenters requested that the originally proposed broad definition of
medical waste be narrowed for the final HMIWI regulations. Some
commenters requested that the EPA exclude crematories and incinerators
used solely to burn pathological waste from the HMIWI regulations.
Also, several commenters requested that the EPA revise the 1995
proposed operator training requirements to allow State-approved
programs and onsite operator training.
The EPA has incorporated the suggestions of State, local, and
Tribal governments as well as suggestions from other stakeholders into
the standards and guidelines being promulgated today. As a result of
consultations with affected entities, the final HMIWI standards and
guidelines: (1) Subcategorize HMIWI based on the size
[[Page 48378]]
categories and technical distinctions most often used by States; (2)
allow existing facilities that meet certain rural criteria and operate
small HMIWI (200 lb/hr) to meet less stringent emission
limits; (3) define HMIWI through use of a narrow definition of medical
waste which recognizes that most hospital waste is not infectious and
can be recycled or disposed of as municipal-type waste; (4) exclude
crematories and pathological incinerators; (5) allow for HMIWI operator
training and qualification to be obtained through a State-approved
program, which may allow facilities to provide training onsite; and (6)
focus the regulations on incineration units whose primary purpose is
disposal of hospital waste and/or medical/infectious waste by providing
an exemption for units burning 10 percent or less hospital waste and
medical/infectious waste.
Documentation of the EPA's consideration of comments on the 1995
proposal is provided in the 1996 re-proposal notice. Documentation of
EPA's consideration of comments on the 1996 re-proposal is provided in
``Hospital/Medical/Infectious Waste Incinerators: Background
Information for Promulgated Standards and Guidelines--Summary of Public
Comments and Responses'' (EPA-453/R-97-006b). Refer to the
SUPPLEMENTARY INFORMATION and ADDRESSES sections of this preamble for
information on how to acquire copies of these documents.
As discussed in section VI.F, the number of small entities that are
significantly affected by the HMIWI regulation is not expected to be
substantial. The full analysis of potential regulatory impacts on small
organizations, small governments, and small businesses is included in
the economic impact assessment in the docket and is listed at the
beginning of today's document under SUPPLEMENTARY INFORMATION. Because
the number of small entities that are likely to experience significant
economic impacts as a result of the HMIWI regulation is not expected to
be substantial, no plan to inform and advise small governments is
required under section 203 of the Unfunded Mandates Act. However, as
described above, the EPA has communicated and consulted with small
governments and businesses that will be affected by the standards and
guidelines, keeping them informed about the content of this
promulgation.
E. Executive Order 12875
To reduce the burden of Federal regulations on States and small
governments, the President issued Executive Order 12875 on October 26,
1993, entitled ``Enhancing the Intergovernmental Partnership.'' Under
Executive Order 12875, the EPA is required to consult with
representatives of affected State, local, and Tribal governments, and
keep these affected parties informed about the content and effect of
the promulgated standards and emission guidelines. Section II.F of this
notice provides a brief account of the actions that the EPA has taken
to communicate and consult with the affected parties. Because this
regulatory action imposes costs to the private sector and government
entities in excess of $100 million per year, the EPA pursued
consultations, the preparation of an unfunded mandates statement, and
other requirements of the Unfunded Mandates Reform Act. The
requirements of the Unfunded Mandates Reform Act were met for this
rulemaking as presented under VI.D of this notice and also fulfill the
requirements of Executive Order 12875.
F. Regulatory Flexibility Act (RFA) and Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA)
Section 605 of the Regulatory Flexibility Act (RFA) requires
Federal agencies to give special consideration to the impacts of
regulations on small entities, which are small businesses, small
organizations, and small governments. The major purpose of the RFA is
to keep paperwork and regulatory requirements from getting out of
proportion to the scale of the entities being regulated without
compromising the objectives of, in this case, the CAA.
The President signed the Small Business Regulatory Enforcement
Fairness Act (SBREFA) into law on March 29, 1996. The SBREFA amended
the RFA to strengthen the RFA's analytical and procedural requirements.
The SBREFA also made other changes to agency regulatory practices as
they affect small entities.
Finally, SBREFA established a new mechanism for expedited
Congressional review of virtually all agency rules.
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. The
Administrator also has determined that the EG and NSPS for HMIWI will
not have a significant economic impact on a substantial number of small
entities.
The U.S. Small Business Administration (SBA) definitions pertaining
to business size are either specified by number of employees or sales
revenue. For analysis of the regulations being promulgated today, the
EPA considers a small business or small organization to be one with
gross annual revenue less than $5 million or one with less than 500
employees. The EPA considers a small government to be one that serves a
population less than 50,000. Three types of small ``entities'' are
impacted by the regulation: small businesses, small nonprofit
organizations, and small governmental jurisdictions. Examples of
impacted businesses include for-profit hospitals and tax-paying nursing
homes. Examples of impacted nonprofit organizations include not-for-
profit hospitals and, in many cases, tax-exempt nursing homes. Examples
of impacted governmental jurisdictions include those (e.g.,
municipalities, counties, States) that operate hospitals and probably
some tax-exempt nursing homes. For a description of EPA's outreach
efforts to these small entities and the general public, see section
II.F of this preamble.
In accordance with the RFA as amended by the SBREFA and current EPA
Guidance, an analysis of impacts of the EG and NSPS on small
``entities'' `` including small businesses, small nonprofit
organizations, and small governmental jurisdictions `` was performed.
The economic impact analysis indicates that neither the EG nor the NSPS
will have a ``significant economic impact on a substantial number of
small entities'' under any regulatory option. Impacts are not
significant for the vast majority of medical waste generators that send
their waste offsite to be treated and disposed. Impacts are also not
significant for the great majority of HMIWI operators that would have
the opportunity to switch to an alternative method of medical waste
treatment and disposal if control costs are prohibitive. Some
significant impacts were found for commercial HMIWI operators and for
small onsite HMIWI operators that are remote from an urban area. These
facilities might not have the opportunity to switch to an alternative
medical waste treatment and disposal method `` commercial HMIWI
operators because medical waste incineration is their line of business,
and small, remote HMIWI because they may not have access to commercial
incineration services. However, the number of such facilities that are
both significantly impacted under the regulatory option selected for
promulgation and ``small'' would be, at the most, only a few, and would
therefore not be substantial.
[[Page 48379]]
G. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedures Act,
as added by the SBREFA of 1996, the EPA submitted a report containing
this rule and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the General
Accounting Office prior to publication of the rule in today's Federal
Register. This rule is a ``major rule'' as defined by 5 U.S.C. 804(2).
H. Clean Air Act Procedural Requirements
The following procedural requirements of the CAA are addressed:
Administrative listing, periodic review, external participation, and
economic impact assessment.
1. Administrator Listing--Sections 111 and 129 of the Clean Air Act
Section 129 of the 1990 Amendments to the CAA directs the
Administrator to promulgate standards for new HMIWI and guidelines for
existing HMIWI. Section 129(a) states that the standards and guidelines
are promulgated under both sections 129 and 111 of the Clean Air Act.
2. Periodic Review--Sections 111 and 129 of the Clean Air Act
Sections 111 and 129 of the CAA require that the standards and
guidelines be reviewed not later than 5 years following the initial
promulgation. At that time and at 5-year intervals thereafter, the
Administrator shall review the standards and guidelines and revise them
if necessary. This review will include an assessment of such factors as
the need for integration with other programs, the existence of
alternative methods, enforceability, improvements in emission control
technology, and reporting requirements.
3. External Participation
In accordance with section 117 of the CAA, publication of this
promulgation was preceded by consultation with appropriate advisory
committees, independent experts, and Federal departments and agencies.
See section II.F of this preamble for a discussion of EPA's
consultation efforts.
4. Economic Impact Assessment
Section 317A of the CAA requires the EPA to prepare an economic
impact assessment for any standards or guidelines promulgated under
section 111(b) of the CAA. An economic impact assessment was prepared
for the promulgated standards and guidelines. In the manner described
in the sections of this preamble regarding the impacts of and rationale
for the promulgated standards and guidelines, the EPA considered all
aspects of the economic impact assessment in promulgating the standards
and guidelines. The economic impact assessment is included in the list
of key technical documents at the beginning of today's notice under
SUPPLEMENTARY INFORMATION.
List of Subjects in 40 CFR Part 60
Environmental protection, Air pollution control, Intergovernmental
relations, Incorporation by reference, Reporting and recordkeeping
requirements.
Dated: August 15, 1997.
Carol M. Browner,
Administrator.
Part 60, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:
PART 60--STANDARDS OF PERFORMANCE FOR NEW STATIONARY SOURCES
1. The authority citation for part 60 is revised to read as
follows:
Authority: 42 U.S.C. 7401, 7411, 7413, 7414, 7416, 7429, 7601
and 7602.
Subpart A--[Amended]
2. Section 60.17. is amended by removing from paragraph (b)(1) the
reference ``60.244(f)(2)''; and by adding new paragraphs (k) and (l) to
read as follows:
Sec. 60.17 Incorporation by reference.
* * * * *
(k) This material is available for purchase from the American
Hospital Association (AHA) Service, Inc., Post Office Box 92683,
Chicago, Illinois 60675-2683. You may inspect a copy at EPA's Air and
Radiation Docket and Information Center (Docket A-91-61, Item IV-J-
124), Room M-1500, 401 M Street SW, Washington, DC.
(1) An Ounce of Prevention: Waste Reduction Strategies for Health
Care Facilities. American Society for Health Care Environmental
Services of the American Hospital Association. Chicago, Illinois. 1993.
AHA Catalog No. 057007. ISBN 0-87258-673-5. IBR approved for
Sec. 60.35e and Sec. 60.55c.
(l) This material is available for purchase from the National
Technical Information Services, 5285 Port Royal Road, Springfield,
Virginia 22161. You may inspect a copy at EPA's Air and Radiation
Docket and Information Center (Docket A-91-61, Item IV-J-125), Room M-
1500, 401 M Street SW, Washington, DC.
(1) OMB Bulletin No. 93-17: Revised Statistical Definitions for
Metropolitan Areas. Office of Management and Budget, June 30, 1993.
NTIS No. PB 93-192-664. IBR approved for Sec. 60.31e.
3. Section 60.30 is revised to read as follows:
Sec. 60.30 Scope.
The following subparts contain emission guidelines and compliance
times for the control of certain designated pollutants in accordance
with section 111(d) and section 129 of the Clean Air Act and subpart B
of this part.
(a) Subpart Ca--[Reserved]
(b) Subpart Cb--Municipal Waste Combustors.
(c) Subpart Cc--Municipal Solid Waste Landfills.
(d) Subpart Cd--Sulfuric Acid Production Plants.
(e) Subpart Ce--Hospital/Medical/Infectious Waste Incinerators.
4. Part 60 is amended by adding a new subpart Ce to read as
follows:
Subpart Ce--Emission Guidelines and Compliance Times for Hospital/
Medical/Infectious Waste Incinerators
Sec.
60.30e Scope.
60.31e Definitions.
60.32e Designated facilities.
60.33e Emission guidelines.
60.34e Operator training and qualification guidelines.
60.35e Waste management guidelines.
60.36e Inspection guidelines.
60.37e Compliance, performance testing, and monitoring guidelines.
60.38e Reporting and recordkeeping guidelines.
60.39e Compliance times.
Table 1 to Subpart Ce--Emission Limits for Small, Medium, and Large
HMIWI
Table 2 to Subpart Ce--Emission Limits for Small HMIWI which meet
the criteria under Sec. 60.33e(b)
Subpart Ce--Emission Guidelines and Compliance Times for Hospital/
Medical/Infectious Waste Incinerators
Sec. 60.30e Scope.
This subpart contains emission guidelines and compliance times for
the control of certain designated pollutants from hospital/medical/
infectious waste incinerator(s) (HMIWI) in accordance with sections 111
and 129 of the Clean Air Act and subpart B of this part. The provisions
in these emission guidelines supersede the provisions of Sec. 60.24(f)
of subpart B of this part.
Sec. 60.31e Definitions.
Terms used but not defined in this subpart have the meaning given
them in the Clean Air Act and in subparts A, B, and Ec of this part.
[[Page 48380]]
Standard Metropolitan Statistical Area or SMSA means any areas
listed in OMB Bulletin No. 93-17 entitled ``Revised Statistical
Definitions for Metropolitan Areas'' dated June 30, 1993 (incorporated
by reference, see Sec. 60.17).
Sec. 60.32e Designated facilities.
(a) Except as provided in paragraphs (b) through (h) of this
section, the designated facility to which the guidelines apply is each
individual HMIWI for which construction was commenced on or before June
20, 1996.
(b) A combustor is not subject to this subpart during periods when
only pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste (all defined in Sec. 60.51c) is burned, provided
the owner or operator of the combustor:
(1) Notifies the Administrator of an exemption claim; and
(2) Keeps records on a calendar quarter basis of the periods of
time when only pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste is burned.
(c) Any co-fired combustor (defined in Sec. 60.51c) is not subject
to this subpart if the owner or operator of the co-fired combustor:
(1) Notifies the Administrator of an exemption claim;
(2) Provides an estimate of the relative weight of hospital waste,
medical/infectious waste, and other fuels and/or wastes to be
combusted; and
(3) Keeps records on a calendar quarter basis of the weight of
hospital waste and medical/infectious waste combusted, and the weight
of all other fuels and wastes combusted at the co-fired combustor.
(d) Any combustor required to have a permit under Section 3005 of
the Solid Waste Disposal Act is not subject to this subpart.
(e) Any combustor which meets the applicability requirements under
subpart Cb, Ea, or Eb of this part (standards or guidelines for certain
municipal waste combustors) is not subject to this subpart.
(f) Any pyrolysis unit (defined in Sec. 60.51c) is not subject to
this subpart.
(g) Cement kilns firing hospital waste and/or medical/infectious
waste are not subject to this subpart.
(h) Physical or operational changes made to an existing HMIWI unit
solely for the purpose of complying with emission guidelines under this
subpart are not considered a modification and do not result in an
existing HMIWI unit becoming subject to the provisions of subpart Ec
(see Sec. 60.50c).
(i) Beginning September 15, 2000, or on the effective date of an
EPA approved operating permit program under Clean Air Act title V and
the implementing regulations under 40 CFR part 70 in the State in which
the unit is located, whichever date is later, designated facilities
subject to this subpart shall operate pursuant to a permit issued under
the EPA-approved operating permit program.
Sec. 60.33e Emission guidelines.
(a) For approval, a State plan shall include the requirements for
emission limits at least as protective as those requirements listed in
Table 1 of this subpart, except as provided for in paragraph (b) of
this section.
(b) For approval, a State plan shall include the requirements for
emission limits at least as protective as those requirements listed in
Table 2 of this subpart for any small HMIWI which is located more than
50 miles from the boundary of the nearest Standard Metropolitan
Statistical Area (defined in Sec. 60.31e) and which burns less than
2,000 pounds per week of hospital waste and medical/infectious waste.
The 2,000 lb/week limitation does not apply during performance tests.
(c) For approval, a State plan shall include the requirements for
stack opacity at least as protective as Sec. 60.52c(b) of subpart Ec of
this part.
Sec. 60.34e Operator training and qualification guidelines.
For approval, a State plan shall include the requirements for
operator training and qualification at least as protective as those
requirements listed in Sec. 60.53c of subpart Ec of this part. The
State plan shall require compliance with these requirements according
to the schedule specified in Sec. 60.39e(e).
Sec. 60.35e Waste management guidelines.
For approval, a State plan shall include the requirements for a
waste management plan at least as protective as those requirements
listed in Sec. 60.55c of subpart Ec of this part.
Sec. 60.36e Inspection guidelines.
(a) For approval, a State plan shall require that each small HMIWI
subject to the emission limits under Sec. 60.33e(b) undergo an initial
equipment inspection that is at least as protective as the following
within 1 year following approval of the State plan:
(1) At a minimum, an inspection shall include the following:
(i) Inspect all burners, pilot assemblies, and pilot sensing
devices for proper operation; clean pilot flame sensor, as necessary;
(ii) Ensure proper adjustment of primary and secondary chamber
combustion air, and adjust as necessary;
(iii) Inspect hinges and door latches, and lubricate as necessary;
(iv) Inspect dampers, fans, and blowers for proper operation;
(v) Inspect HMIWI door and door gaskets for proper sealing;
(vi) Inspect motors for proper operation;
(vii) Inspect primary chamber refractory lining; clean and repair/
replace lining as necessary;
(viii) Inspect incinerator shell for corrosion and/or hot spots;
(ix) Inspect secondary/tertiary chamber and stack, clean as
necessary;
(x) Inspect mechanical loader, including limit switches, for proper
operation, if applicable;
(xi) Visually inspect waste bed (grates), and repair/seal, as
appropriate;
(xii) For the burn cycle that follows the inspection, document that
the incinerator is operating properly and make any necessary
adjustments;
(xiii) Inspect air pollution control device(s) for proper
operation, if applicable;
(xiv) Inspect waste heat boiler systems to ensure proper operation,
if applicable;
(xv) Inspect bypass stack components;
(xvi) Ensure proper calibration of thermocouples, sorbent feed
systems and any other monitoring equipment; and
(xvii) Generally observe that the equipment is maintained in good
operating condition.
(2) Within 10 operating days following an equipment inspection all
necessary repairs shall be completed unless the owner or operator
obtains written approval from the State agency establishing a date
whereby all necessary repairs of the designated facility shall be
completed.
(b) For approval, a State plan shall require that each small HMIWI
subject to the emission limits under Sec. 60.33e(b) undergo an
equipment inspection annually (no more than 12 months following the
previous annual equipment inspection), as outlined in paragraphs (a)(1)
and (a)(2) of this section.
Sec. 60.37e Compliance, performance testing, and monitoring
guidelines.
(a) Except as provided in paragraph (b) of this section, for
approval, a State plan shall include the requirements for compliance
and performance testing listed in Sec. 60.56c of subpart Ec of this
part, excluding the fugitive emissions testing requirements under
Sec. 60.56c(b)(12) and (c)(3).
(b) For approval, a State plan shall require any small HMIWI
subject to the emission limits under Sec. 60.33e(b) to
[[Page 48381]]
meet the following compliance and performance testing requirements:
(1) Conduct the performance testing requirements in Sec. 60.56c(a),
(b)(1) through (b)(9), (b)(11) (Hg only), and (c)(1) of subpart Ec of
this part. The 2,000 lb/week limitation under Sec. 60.33e(b) does not
apply during performance tests.
(2) Establish maximum charge rate and minimum secondary chamber
temperature as site-specific operating parameters during the initial
performance test to determine compliance with applicable emission
limits.
(3) Following the date on which the initial performance test is
completed or is required to be completed under Sec. 60.8, whichever
date comes first, ensure that the designated facility does not operate
above the maximum charge rate or below the minimum secondary chamber
temperature measured as 3-hour rolling averages (calculated each hour
as the average of the previous 3 operating hours) at all times except
during periods of startup, shutdown and malfunction. Operating
parameter limits do not apply during performance tests. Operation above
the maximum charge rate or below the minimum secondary chamber
temperature shall constitute a violation of the established operating
parameter(s).
(4) Except as provided in paragraph (b)(5) of this section,
operation of the designated facility above the maximum charge rate and
below the minimum secondary chamber temperature (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the PM, CO, and dioxin/furan emission limits.
(5) The owner or operator of a designated facility may conduct a
repeat performance test within 30 days of violation of applicable
operating parameter(s) to demonstrate that the designated facility is
not in violation of the applicable emission limit(s). Repeat
performance tests conducted pursuant to this paragraph must be
conducted using the identical operating parameters that indicated a
violation under paragraph (b)(4) of this section.
(c) For approval, a State plan shall include the requirements for
monitoring listed in Sec. 60.57c of subpart Ec of this part, except as
provided for under paragraph (d) of this section.
(d) For approval, a State plan shall include requirements for any
small HMIWI subject to the emission limits under Sec. 60.33e(b) to meet
the following monitoring requirements:
(1) Install, calibrate (to manufacturers' specifications),
maintain, and operate a device for measuring and recording the
temperature of the secondary chamber on a continuous basis, the output
of which shall be recorded, at a minimum, once every minute throughout
operation.
(2) Install, calibrate (to manufacturers' specifications),
maintain, and operate a device which automatically measures and records
the date, time, and weight of each charge fed into the HMIWI.
(3) The owner or operator of a designated facility shall obtain
monitoring data at all times during HMIWI operation except during
periods of monitoring equipment malfunction, calibration, or repair. At
a minimum, valid monitoring data shall be obtained for 75 percent of
the operating hours per day and for 90 percent of the operating hours
per calendar quarter that the designated facility is combusting
hospital waste and/or medical/infectious waste.
Sec. 60.38e Reporting and recordkeeping guidelines.
(a) For approval, a State plan shall include the reporting and
recordkeeping requirements listed in Sec. 60.58c(b), (c), (d), (e), and
(f) of subpart Ec of this part, excluding Sec. 60.58c(b)(2)(ii)
(fugitive emissions) and (b)(7) (siting).
(b) For approval, a State plan shall require the owner or operator
of each small HMIWI subject to the emission limits under Sec. 60.33e(b)
to:
(1) Maintain records of the annual equipment inspections, any
required maintenance, and any repairs not completed within 10 days of
an inspection or the timeframe established by the State regulatory
agency; and
(2) Submit an annual report containing information recorded under
paragraph (b)(1) of this section no later than 60 days following the
year in which data were collected. Subsequent reports shall be sent no
later than 12 calendar months following the previous report (once the
unit is subject to permitting requirements under Title V of the Act,
the owner or operator must submit these reports semiannually). The
report shall be signed by the facilities manager.
Sec. 60.39e Compliance times.
(a) Not later than September 15, 1998, each State in which a
designated facility is operating shall submit to the Administrator a
plan to implement and enforce the emission guidelines.
(b) Except as provided in paragraphs (c) and (d) of this section,
State plans shall provide that designated facilities comply with all
requirements of the State plan on or before the date 1 year after EPA
approval of the State plan, regardless of whether a designated facility
is identified in the State plan inventory required by Sec. 60.25(a) of
subpart B of this part.
(c) State plans that specify measurable and enforceable incremental
steps of progress towards compliance for designated facilities planning
to install the necessary air pollution control equipment may allow
compliance on or before the date 3 years after EPA approval of the
State plan (but not later than the September 16, 2002. Suggested
measurable and enforceable activities to be included in State plans
are:
(1) Date for submitting a petition for site specific operating
parameters under Sec. 60.56c(i) of subpart Ec of this part.
(2) Date for obtaining services of an architectural and engineering
firm regarding the air pollution control device(s);
(3) Date for obtaining design drawings of the air pollution control
device(s);
(4) Date for ordering the air pollution control device(s);
(5) Date for obtaining the major components of the air pollution
control device(s);
(6) Date for initiation of site preparation for installation of the
air pollution control device(s);
(7) Date for initiation of installation of the air pollution
control device(s);
(8) Date for initial startup of the air pollution control
device(s); and
(9) Date for initial compliance test(s) of the air pollution
control device(s).
(d) State plans that include provisions allowing designated
facilities to petition the State for extensions beyond the compliance
times required in paragraph (b) of this section shall:
(1) Require that the designated facility requesting an extension
submit the following information in time to allow the State adequate
time to grant or deny the extension within 1 year after EPA approval of
the State plan:
(i) Documentation of the analyses undertaken to support the need
for an extension, including an explanation of why up to 3 years after
EPA approval of the State plan is sufficient time to comply with the
State plan while 1 year after EPA approval of the State plan is not
sufficient. The documentation shall also include an evaluation of the
option to transport the waste offsite to a commercial medical waste
treatment and disposal facility on a temporary or permanent basis; and
(ii) Documentation of measurable and enforceable incremental steps
of progress to be taken towards compliance with the emission
guidelines.
(2) Include procedures for granting or denying the extension; and
(3) If an extension is granted, require compliance with the
emission
[[Page 48382]]
guidelines on or before the date 3 years after EPA approval of the
State plan (but not later than September 16, 2002.
(e) For approval, a State plan shall require compliance with
Sec. 60.34e--Operator training and qualification guidelines and
Sec. 60.36e--Inspection guidelines by the date 1 year after EPA
approval of a State plan.
(f) The Administrator shall develop, implement, and enforce a plan
for existing HMIWI located in any State that has not submitted an
approvable plan within date 2 years after September 15, 1997. Such
plans shall ensure that each designated facility is in compliance with
the provisions of this subpart no later than date 5 years after
September 15, 1997.
Table 1 to Subpart Ce.--Emission Limits for Small, Medium, and Large HMIWI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emission limits
-------------------------------------------------------------------------------------
Pollutant Units (7 percent oxygen, dry HMIWI size
basis) -------------------------------------------------------------------------------------
Small Medium Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter.................. Milligrams per dry standard 115 (0.05)............. 69 (0.03)............. 34 (0.015).
cubic meter (grains per dry
standard cubic foot).
Carbon monoxide..................... Parts per million by volume. 40..................... 40.................... 40.
Dioxins/furans...................... Nanograms per dry standard 125 (55) or 2.3 (1.0).. 125 (55) or 2.3 (1.0). 125 (55) or 2.3 (1.0).
cubic meter total dioxins/
furans (grains per billion
dry standard cubic feet) or
nanograms per dry standard
cubic meter TEQ (grains per
billion dry standard cubic
feet).
Hydrogen chloride................... Parts per million by volume 100 or 93%............. 100 or 93%............ 100 or 93%.
or percent reduction.
Sulfur dioxide...................... Parts per million by volume. 55..................... 55.................... 55.
Nitrogen oxides..................... Parts per million by volume. 250.................... 250................... 250.
Lead................................ Milligrams per dry standard 1.2 (0.52) or 70%...... 1.2 (0.52) or 70%..... 1.2 (0.52) or 70%.
cubic meter (grains per
thousand dry standard cubic
feet) or percent reduction.
Cadmium............................. Milligrams per dry standard 0.16 (0.07) or 65%..... 0.16 (0.07) or 65%....
cubic meter (grains per
thousand dry standard cubic
feet) or percent reduction.
Mercury............................. Milligrams per dry standard 0.55 (0.24) or 85%..... 0.55 (0.24) or 85%.... 0.55 (0.24) or 85%.
cubic meter (grains per
thousand dry standard cubic
feet) or percent reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2 to Subpart Ce.--Emissions Limits for Small HMIWI Which Meet the
Criteria Under Sec. 60.33e(b)
------------------------------------------------------------------------
Units (7 percent HMIWI emission
Pollutant oxygen, dry basis) limits
------------------------------------------------------------------------
Particulate matter............ Milligrams per dry 197 (0.086).
standard cubic meter
(grains per dry
standard cubic foot).
Carbon monoxide............... Parts per million by 40.
volume.
Dioxins/furans................ nanograms per dry 800 (350) or 15
standard cubic meter (6.6).
total dioxins/furans
(grains per billion
dry standard cubic
feet) or nanograms
per dry standard
cubic meter TEQ
(grains per billion
dry standard cubic
feet).
Hydrogen chloride............. Parts per million by 3100.
volume.
Sulfur dioxide................ Parts per million by 55.
volume.
Nitrogen oxides............... Parts per million by 250.
volume.
Lead.......................... Milligrams per dry 10 (4.4).
standard cubic meter
(grains per thousand
dry standard cubic
feet).
Cadmium....................... Milligrams per dry 4 (1.7).
standard cubic meter
(grains per thousand
dry standard cubic
feet).
Mercury....................... Milligrams per dry 7.5 (3.3).
standard cubic meter
(grains per
thousands dry
standard cubic feet).
------------------------------------------------------------------------
5. Part 60 is amended by adding a new subpart Ec to read as
follows:
Subpart Ec--Standards of Performance for Hospital/Medical/Infectious
Waste Incinerators for Which Construction Is Commenced After June 20,
1996
60.50c Applicability and delegation of authority.
60.51c Definitions.
60.52c Emission limits.
60.53c Operator training and qualification requirements.
60.54c Siting requirements.
60.55c Waste management plan.
60.56c Compliance and performance testing.
60.57c Monitoring requirements.
60.58c Reporting and recordkeeping requirements.
Table 1 to Subpart Ec--Emission Limits for Small, Medium, and Large
HMIWI
Table 2 to Subpart Ec--Toxic Equivalency Factors
Table 3 to Subpart Ec--Operating Parameters to be Monitored and
Minimum Measurement and Recording Frequencies
Subpart Ec--Standards of Performance for Hospital/Medical/
Infectious Waste Incinerators for Which Construction Is Commenced
After June 20, 1996
Sec. 60.50c Applicability and delegation of authority.
(a) Except as provided in paragraphs (b) through (h) of this
section, the affected facility to which this subpart applies is each
individual hospital/medical/infectious waste incinerator (HMIWI) for
which construction is
[[Page 48383]]
commenced after June 20, 1996 or for which modification is commenced
after March 16, 1998.
(b) A combustor is not subject to this subpart during periods when
only pathological waste, low-level radioactive waste, and/or
chemotherapeutic waste (all defined in Sec. 60.51c) is burned, provided
the owner or operator of the combustor:
(1) Notifies the Administrator of an exemption claim; and
(2) Keeps records on a calendar quarter basis of the periods of
time when only pathological waste, low-level radioactivewaste and/or
chemotherapeutic waste is burned.
(c) Any co-fired combustor (defined in Sec. 60.51c) is not subject
to this subpart if the owner or operator of the co-fired combustor:
(1) Notifies the Administrator of an exemption claim;
(2) Provides an estimate of the relative amounts of hospital waste,
medical/infectious waste, and other fuels and wastes to be combusted;
and
(3) Keeps records on a calendar quarter basis of the weight of
hospital waste and medical/infectious waste combusted, and the weight
of all other fuels and wastes combusted at the co-fired combustor.
(d) Any combustor required to have a permit under section 3005 of
the Solid Waste Disposal Act is not subject to this subpart.
(e) Any combustor which meets the applicability requirements under
subpart Cb, Ea, or Eb of this part (standards or guidelines for certain
municipal waste combustors) is not subject to this subpart.
(f) Any pyrolysis unit (defined in Sec. 60.51c) is not subject to
this subpart.
(g) Cement kilns firing hospital waste and/or medical/infectious
waste are not subject to this subpart.
(h) Physical or operational changes made to an existing HMIWI
solely for the purpose of complying with emission guidelines under
subpart Ce are not considered a modification and do not result in an
existing HMIWI becoming subject to this subpart.
(i) In delegating implementation and enforcement authority to a
State under section 111(c) of the Clean Air Act, the following
authorities shall be retained by the Administrator and not transferred
to a State:
(1) The requirements of Sec. 60.56c(i) establishing operating
parameters when using controls other than those listed in
Sec. 60.56c(d).
(2) Alternative methods of demonstrating compliance under
Sec. 60.8.
(j) Affected facilities subject to this subpart are not subject to
the requirements of 40 CFR part 64.
(k) The requirements of this subpart shall become effective March
16, 1998
(l) Beginning September 15, 2000, or on the effective date of an
EPA-approved operating permit program under Clean Air Act title V and
the implementing regulations under 40 CFR part 70 in the State in which
the unit is located, whichever date is later, affected facilities
subject to this subpart shall operate pursuant to a permit issued under
the EPA approved State operating permit program.
Sec. 60.51c Definitions.
Batch HMIWI means an HMIWI that is designed such that neither waste
charging nor ash removal can occur during combustion.
Biologicals means preparations made from living organisms and their
products, including vaccines, cultures, etc., intended for use in
diagnosing, immunizing, or treating humans or animals or in research
pertaining thereto.
Blood Products means any product derived from human blood,
including but not limited to blood plasma, platelets, red or white
blood corpuscles, and other derived licensed products, such as
interferon, etc.
Body Fluids means liquid emanating or derived from humans and
limited to blood; dialysate; amniotic, cerebrospinal, synovial,
pleural, peritoneal and pericardial fluids; and semen and vaginal
secretions.
Bypass stack means a device used for discharging combustion gases
to avoid severe damage to the air pollution control device or other
equipment.
Chemotherapeutic waste means waste material resulting from the
production or use of antineoplastic agents used for the purpose of
stopping or reversing the growth of malignant cells.
Co-fired combustor means a unit combusting hospital waste and/or
medical/infectious waste with other fuels or wastes (e.g., coal,
municipal solid waste) and subject to an enforceable requirement
limiting the unit to combusting a fuel feed stream, 10 percent or less
of the weight of which is comprised, in aggregate, of hospital waste
and medical/infectious waste as measured on a calendar quarter basis.
For purposes of this definition, pathological waste, chemotherapeutic
waste, and low-level radioactive waste are considered ``other'' wastes
when calculating the percentage of hospital waste and medical/
infectious waste combusted.
Continuous emission monitoring system or CEMS means a monitoring
system for continuously measuring and recording the emissions of a
pollutant from an affected facility.
Continuous HMIWI means an HMIWI that is designed to allow waste
charging and ash removal during combustion.
Dioxins/furans means the combined emissions of tetra-through octa-
chlorinated dibenzo-para-dioxins and dibenzofurans, as measured by EPA
Reference Method 23.
Dry scrubber means an add-on air pollution control system that
injects dry alkaline sorbent (dry injection) or sprays an alkaline
sorbent (spray dryer) to react with and neutralize acid gases in the
HMIWI exhaust stream forming a dry powder material.
Fabric filter or baghouse means an add-on air pollution control
system that removes particulate matter (PM) and nonvaporous metals
emissions by passing flue gas through filter bags.
Facilities manager means the individual in charge of purchasing,
maintaining, and operating the HMIWI or the owner's or operator's
representative responsible for the management of the HMIWI. Alternative
titles may include director of facilities or vice president of support
services.
High-air phase means the stage of the batch operating cycle when
the primary chamber reaches and maintains maximum operating
temperatures.
Hospital means any facility which has an organized medical staff,
maintains at least six inpatient beds, and where the primary function
of the institution is to provide diagnostic and therapeutic patient
services and continuous nursing care primarily to human inpatients who
are not related and who stay on average in excess of 24 hours per
admission. This definition does not include facilities maintained for
the sole purpose of providing nursing or convalescent care to human
patients who generally are not acutely ill but who require continuing
medical supervision.
Hospital/medical/infectious waste incinerator or HMIWI or HMIWI
unit means any device that combusts any amount of hospital waste and/
or medical/infectious waste.
Hospital/medical/infectious waste incinerator operator or HMIWI
operator means any person who operates, controls or supervises the
day-to-day operation of an HMIWI.
Hospital waste means discards generated at a hospital, except
unused items returned to the manufacturer. The definition of hospital
waste does not include human corpses, remains, and anatomical parts
that are intended for interment or cremation.
Infectious agent means any organism (such as a virus or bacteria)
that is
[[Page 48384]]
capable of being communicated by invasion and multiplication in body
tissues and capable of causing disease or adverse health impacts in
humans.
Intermittent HMIWI means an HMIWI that is designed to allow waste
charging, but not ash removal, during combustion.
Large HMIWI means:
(1) Except as provided in (2);
(i) An HMIWI whose maximum design waste burning capacity is more
than 500 pounds per hour; or
(ii) A continuous or intermittent HMIWI whose maximum charge rate
is more than 500 pounds per hour; or
(iii) A batch HMIWI whose maximum charge rate is more than 4,000
pounds per day.
(2) The following are not large HMIWI:
(i) A continuous or intermittent HMIWI whose maximum charge rate is
less than or equal to 500 pounds per hour; or
(ii) A batch HMIWI whose maximum charge rate is less than or equal
to 4,000 pounds per day.
Low-level radioactive waste means waste material which contains
radioactive nuclides emitting primarily beta or gamma radiation, or
both, in concentrations or quantities that exceed applicable federal or
State standards for unrestricted release. Low-level radioactive waste
is not high-level radioactive waste, spent nuclear fuel, or by-product
material as defined by the Atomic Energy Act of 1954 (42 U.S.C.
2014(e)(2)).
Malfunction means any sudden, infrequent, and not reasonably
preventable failure of air pollution control equipment, process
equipment, or a process to operate in a normal or usual manner.
Failures that are caused, in part, by poor maintenance or careless
operation are not malfunctions. During periods of malfunction the
operator shall operate within established parameters as much as
possible, and monitoring of all applicable operating parameters shall
continue until all waste has been combusted or until the malfunction
ceases, whichever comes first.
Maximum charge rate means:
(1) For continuous and intermittent HMIWI, 110 percent of the
lowest 3-hour average charge rate measured during the most recent
performance test demonstrating compliance with all applicable emission
limits.
(2) For batch HMIWI, 110 percent of the lowest daily charge rate
measured during the most recent performance test demonstrating
compliance with all applicable emission limits.
Maximum design waste burning capacity means:
(1) For intermittent and continuous HMIWI,
C=PV x 15,000/8,500
Where:
C=HMIWI capacity, lb/hr
PV=primary chamber volume, ft\3\
15,000=primary chamber heat release rate factor, Btu/ft\3\/hr
8,500=standard waste heating value, Btu/lb;
(2) For batch HMIWI,
C=PV x 4.5/8
Where:
C=HMIWI capacity, lb/hr
PV=primary chamber volume, ft\3\
4.5=waste density, lb/ft\3\
8=typical hours of operation of a batch HMIWI, hours.
Maximum fabric filter inlet temperature means 110 percent of the
lowest 3-hour average temperature at the inlet to the fabric filter
(taken, at a minimum, once every minute) measured during the most
recent performance test demonstrating compliance with the dioxin/furan
emission limit.
Maximum flue gas temperature means 110 percent of the lowest 3-hour
average temperature at the outlet from the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the mercury (Hg) emission limit.
Medical/infectious waste means any waste generated in the
diagnosis, treatment, or immunization of human beings or animals, in
research pertaining thereto, or in the production or testing of
biologicals that is listed in paragraphs (1) through (7) of this
definition. The definition of medical/infectious waste does not include
hazardous waste identified or listed under the regulations in part 261
of this chapter; household waste, as defined in Sec. 261.4(b)(1) of
this chapter; ash from incineration of medical/infectious waste, once
the incineration process has been completed; human corpses, remains,
and anatomical parts that are intended for interment mation; and
domestic sewage materials identified in Sec. 261.4(a)(1) of this
chapter.
(1) Cultures and stocks of infectious agents and associated
biologicals, including: cultures from medical and pathological
laboratories; cultures and stocks of infectious agents from research
and industrial laboratories; wastes from the production of biologicals;
discarded live and attenuated vaccines; and culture dishes and devices
used to transfer, inoculate, and mix cultures.
(2) Human pathological waste, including tissues, organs, and body
parts and body fluids that are removed during surgery or autopsy, or
other medical procedures, and specimens of body fluids and their
containers.
(3) Human blood and blood products including:
(i) Liquid waste human blood;
(ii) Products of blood;
(iii) Items saturated and/or dripping with human blood; or
(iv) Items that were saturated and/or dripping with human blood
that are now caked with dried human blood; including serum, plasma, and
other blood components, and their containers, which were used or
intended for use in either patient care, testing and laboratory
analysis or the development of pharmaceuticals. Intravenous bags are
also include in this category.
(4) Sharps that have been used in animal or human patient care or
treatment or in medical, research, or industrial laboratories,
including hypodermic needles, syringes (with or without the attached
needle), pasteur pipettes, scalpel blades, blood vials, needles with
attached tubing, and culture dishes (regardless of presence of
infectious agents). Also included are other types of broken or unbroken
glassware that were in contact with infectious agents, such as used
slides and cover slips.
(5) Animal waste including contaminated animal carcasses, body
parts, and bedding of animals that were known to have been exposed to
infectious agents during research (including research in veterinary
hospitals), production of biologicals or testing of pharmaceuticals.
(6) Isolation wastes including biological waste and discarded
materials contaminated with blood, excretions, exudates, or secretions
from humans who are isolated to protect others from certain highly
communicable diseases, or isolated animals known to be infected with
highly communicable diseases.
(7) Unused sharps including the following unused, discarded sharps:
hypodermic needles, suture needles, syringes, and scalpel blades.
Medium HMIWI means:
(1) Except as provided in paragraph (2);
(i) An HMIWI whose maximum design waste burning capacity is more
than 200 pounds per hour but less than or equal to 500 pounds per hour;
or
(ii) A continuous or intermittent HMIWI whose maximum charge rate
is more than 200 pounds per hour but less than or equal to 500 pounds
per hour; or
(iii) A batch HMIWI whose maximum charge rate is more than 1,600
pounds per day but less than or equal to 4,000 pounds per day.
[[Page 48385]]
(2) The following are not medium HMIWI:
(i) A continuous or intermittent HMIWI whose maximum charge rate is
less than or equal to 200 pounds per hour or more than 500 pounds per
hour; or
(ii) A batch HMIWI whose maximum charge rate is more than 4,000
pounds per day or less than or equal to 1,600 pounds per day.
Minimum dioxin/furan sorbent flow rate means 90 percent of the
highest 3-hour average dioxin/furan sorbent flow rate (taken, at a
minimum, once every hour) measured during the most recent performance
test demonstrating compliance with the dioxin/furan emission limit.
Minimum Hg sorbent flow rate means 90 percent of the highest 3-hour
average Hg sorbent flow rate (taken, at a minimum, once every hour)
measured during the most recent performance test demonstrating
compliance with the Hg emission limit.
Minimum hydrogen chloride (HCl) sorbent flow rate means 90 percent
of the highest 3-hour average HCl sorbent flow rate (taken, at a
minimum, once every hour) measured during the most recent performance
test demonstrating compliance with the HCl emission limit.
Minimum horsepower or amperage means 90 percent of the highest 3-
hour average horsepower or amperage to the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the applicable emission limits.
Minimum pressure drop across the wet scrubber means 90 percent of
the highest 3-hour average pressure drop across the wet scrubber PM
control device (taken, at a minimum, once every minute) measured during
the most recent performance test demonstrating compliance with the PM
emission limit.
Minimum scrubber liquor flow rate means 90 percent of the highest
3-hour average liquor flow rate at the inlet to the wet scrubber
(taken, at a minimum, once every minute) measured during the most
recent performance test demonstrating compliance with all applicable
emission limits.
Minimum scrubber liquor pH means 90 percent of the highest 3-hour
average liquor pH at the inlet to the wet scrubber (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the HCl emission limit.
Minimum secondary chamber temperature means 90 percent of the
highest 3-hour average secondary chamber temperature (taken, at a
minimum, once every minute) measured during the most recent performance
test demonstrating compliance with the PM, CO, or dioxin/furan emission
limits.
Modification or Modified HMIWI means any change to an HMIWI unit
after the effective date of these standards such that:
(1) The cumulative costs of the modifications, over the life of the
unit, exceed 50 per centum of the original cost of the construction and
installation of the unit (not including the cost of any land purchased
in connection with such construction or installation) updated to
current costs, or
(2) The change involves a physical change in or change in the
method of operation of the unit which increases the amount of any air
pollutant emitted by the unit for which standards have been established
under section 129 or section 111.
Operating day means a 24-hour period between 12:00 midnight and the
following midnight during which any amount of hospital waste or
medical/infectious waste is combusted at any time in the HMIWI.
Operation means the period during which waste is combusted in the
incinerator excluding periods of startup or shutdown.
Particulate matter or PM means the total particulate matter emitted
from an HMIWI as measured by EPA Reference Method 5 or EPA Reference
Method 29.
Pathological waste means waste material consisting of only human or
animal remains, anatomical parts, and/or tissue, the bags/containers
used to collect and transport the waste material, and animal bedding
(if applicable).
Primary chamber means the chamber in an HMIWI that receives waste
material, in which the waste is ignited, and from which ash is removed.
Pyrolysis means the endothermic gasification of hospital waste and/
or medical/infectious waste using external energy.
Secondary chamber means a component of the HMIWI that receives
combustion gases from the primary chamber and in which the combustion
process is completed.
Shutdown means the period of time after all waste has been
combusted in the primary chamber. For continuous HMIWI, shutdown shall
commence no less than 2 hours after the last charge to the incinerator.
For intermittent HMIWI, shutdown shall commence no less than 4 hours
after the last charge to the incinerator. For batch HMIWI, shutdown
shall commence no less than 5 hours after the high-air phase of
combustion has been completed.
Small HMIWI means:
(1) Except as provided in (2);
(i) An HMIWI whose maximum design waste burning capacity is less
than or equal to 200 pounds per hour; or
(ii) A continuous or intermittent HMIWI whose maximum charge rate
is less than or equal to 200 pounds per hour; or
(iii) A batch HMIWI whose maximum charge rate is less than or equal
to 1,600 pounds per day.
(2) The following are not small HMIWI:
(i) A continuous or intermittent HMIWI whose maximum charge rate is
more than 200 pounds per hour;
(ii) A batch HMIWI whose maximum charge rate is more than 1,600
pounds per day.
Standard conditions means a temperature of 20 deg. C and a pressure
of 101.3 kilopascals.
Startup means the period of time between the activation of the
system and the first charge to the unit. For batch HMIWI, startup means
the period of time between activation of the system and ignition of the
waste.
Wet scrubber means an add-on air pollution control device that
utilizes an alkaline scrubbing liquor to collect particulate matter
(including nonvaporous metals and condensed organics) and/or to absorb
and neutralize acid gases.
Sec. 60.52c Emission limits.
(a) On and after the date on which the initial performance test is
completed or is required to be completed under Sec. 60.8, whichever
date comes first, no owner or operator of an affected facility shall
cause to be discharged into the atmosphere from that affected facility
any gases that contain stack emissions in excess of the limits
presented in Table 1 of this subpart.
(b) On and after the date on which the initial performance test is
completed or is required to be completed under Sec. 60.8, whichever
date comes first, no owner or operator of an affected facility shall
cause to be discharged into the atmosphere from the stack of that
affected facility any gases that exhibit greater than 10 percent
opacity (6-minute block average).
(c) On and after the date on which the initial performance test is
completed or is required to be completed under Sec. 60.8, whichever
date comes first, no owner or operator of an affected facility
utilizing a large HMIWI shall cause to be discharged into the
atmosphere visible emissions of combustion ash from an ash conveying
system (including conveyor transfer points) in excess of 5 percent of
the observation period (i.e., 9 minutes per 3-hour period), as
[[Page 48386]]
determined by EPA Reference Method 22, except as provided in paragraphs
(d) and (e) of this section.
(d) The emission limit specified in paragraph (c) of this section
does not cover visible emissions discharged inside buildings or
enclosures of ash conveying systems; however, the emission limit does
cover visible emissions discharged to the atmosphere from buildings or
enclosures of ash conveying systems.
(e) The provisions specified in paragraph (c) of this section do
not apply during maintenance and repair of ash conveying systems.
Maintenance and/or repair shall not exceed 10 operating days per
calendar quarter unless the owner or operator obtains written approval
from the State agency establishing a date whereby all necessary
maintenance and repairs of ash conveying systems shall be completed.
Sec. 60.53c Operator training and qualification requirements.
(a) No owner or operator of an affected facility shall allow the
affected facility to operate at any time unless a fully trained and
qualified HMIWI operator is accessible, either at the facility or
available within 1 hour. The trained and qualified HMIWI operator may
operate the HMIWI directly or be the direct supervisor of one or more
HMIWI operators.
(b) Operator training and qualification shall be obtained through a
State-approved program or by completing the requirements included in
paragraphs (c) through (g) of this section.
(c) Training shall be obtained by completing an HMIWI operator
training course that includes, at a minimum, the following provisions:
(1) 24 hours of training on the following subjects:
(i) Environmental concerns, including pathogen destruction and
types of emissions;
(ii) Basic combustion principles, including products of combustion;
(iii) Operation of the type of incinerator to be used by the
operator, including proper startup, waste charging, and shutdown
procedures;
(iv) Combustion controls and monitoring;
(v) Operation of air pollution control equipment and factors
affecting performance (if applicable);
(vi) Methods to monitor pollutants (continuous emission monitoring
systems and monitoring of HMIWI and air pollution control device
operating parameters) and equipment calibration procedures (where
applicable);
(vii) Inspection and maintenance of the HMIWI, air pollution
control devices, and continuous emission monitoring systems;
(viii) Actions to correct malfunctions or conditions that may lead
to malfunction;
(ix) Bottom and fly ash characteristics and handling procedures;
(x) Applicable Federal, State, and local regulations;
(xi) Work safety procedures;
(xii) Pre-startup inspections; and
(xiii) Recordkeeping requirements.
(2) An examination designed and administered by the instructor.
(3) Reference material distributed to the attendees covering the
course topics.
(d) Qualification shall be obtained by:
(1) Completion of a training course that satisfies the criteria
under paragraph (c) of this section; and
(2) Either 6 months experience as an HMIWI operator, 6 months
experience as a direct supervisor of an HMIWI operator, or completion
of at least two burn cycles under the observation of two qualified
HMIWI operators.
(e) Qualification is valid from the date on which the examination
is passed or the completion of the required experience, whichever is
later.
(f) To maintain qualification, the trained and qualified HMIWI
operator shall complete and pass an annual review or refresher course
of at least 4 hours covering, at a minimum, the following:
(1) Update of regulations;
(2) Incinerator operation, including startup and shutdown
procedures;
(3) Inspection and maintenance;
(4) Responses to malfunctions or conditions that may lead to
malfunction; and
(5) Discussion of operating problems encountered by attendees.
(g) A lapsed qualification shall be renewed by one of the following
methods:
(1) For a lapse of less than 3 years, the HMIWI operator shall
complete and pass a standard annual refresher course described in
paragraph (f) of this section.
(2) For a lapse of 3 years or more, the HMIWI operator shall
complete and pass a training course with the minimum criteria described
in paragraph (c) of this section.
(h) The owner or operator of an affected facility shall maintain
documentation at the facility that address the following:
(1) Summary of the applicable standards under this subpart;
(2) Description of basic combustion theory applicable to an HMIWI;
(3) Procedures for receiving, handling, and charging waste;
(4) HMIWI startup, shutdown, and malfunction procedures;
(5) Procedures for maintaining proper combustion air supply levels;
(6) Procedures for operating the HMIWI and associated air pollution
control systems within the standards established under this subpart;
(7) Procedures for responding to periodic malfunction or conditions
that may lead to malfunction;
(8) Procedures for monitoring HMIWI emissions;
(9) Reporting and recordkeeping procedures; and
(10) Procedures for handling ash.
(i) The owner or operator of an affected facility shall establish a
program for reviewing the information listed in paragraph (h) of this
section annually with each HMIWI operator (defined in Sec. 60.51c).
(1) The initial review of the information listed in paragraph (h)
of this section shall be conducted within 6 months after the effective
date of this subpart or prior to assumption of responsibilities
affecting HMIWI operation, whichever date is later.
(2) Subsequent reviews of the information listed in paragraph (h)
of this section shall be conducted annually.
(j) The information listed in paragraph (h) of this section shall
be kept in a readily accessible location for all HMIWI operators. This
information, along with records of training shall be available for
inspection by the EPA or its delegated enforcement agent upon request.
Sec. 60.54c Siting requirements.
(a) The owner or operator of an affected facility for which
construction is commenced after September 15, 1997 shall prepare an
analysis of the impacts of the affected facility. The analysis shall
consider air pollution control alternatives that minimize, on a site-
specific basis, to the maximum extent practicable, potential risks to
public health or the environment. In considering such alternatives, the
analysis may consider costs, energy impacts, non-air environmental
impacts, or any other factors related to the practicability of the
alternatives.
(b) Analyses of facility impacts prepared to comply with State,
local, or other Federal regulatory requirements may be used to satisfy
the requirements of this section, as long as they include the
consideration of air pollution control alternatives specified in
paragraph (a) of this section.
(c) The owner or operator of the affected facility shall complete
and submit the siting requirements of this section as required under
Sec. 60.58c(a)(1)(iii).
[[Page 48387]]
Sec. 60.55c Waste management plan.
The owner or operator of an affected facility shall prepare a waste
management plan. The waste management plan shall identify both the
feasibility and the approach to separate certain components of solid
waste from the health care waste stream in order to reduce the amount
of toxic emissions from incinerated waste. A waste management plan may
include, but is not limited to, elements such as paper, cardboard,
plastics, glass, battery, or metal recycling; or purchasing recycled or
recyclable products. A waste management plan may include different
goals or approaches for different areas or departments of the facility
and need not include new waste management goals for every waste stream.
It should identify, where possible, reasonably available additional
waste management measures, taking into account the effectiveness of
waste management measures already in place, the costs of additional
measures, the emission reductions expected to be achieved, and any
other environmental or energy impacts they might have. The American
Hospital Association publication entitled ``An Ounce of Prevention:
Waste Reduction Strategies for Health Care Facilities'' (incorporated
by reference, see Sec. 60.17) shall be considered in the development of
the waste management plan.
Sec. 60.56c Compliance and performance testing.
(a) The emission limits under this subpart apply at all times
except during periods of startup, shutdown, or malfunction, provided
that no hospital waste or medical/infectious waste is charged to the
affected facility during startup, shutdown, or malfunction.
(b) The owner or operator of an affected facility shall conduct an
initial performance test as required under Sec. 60.8 to determine
compliance with the emission limits using the procedures and test
methods listed in paragraphs (b)(1) through (b)(12) of this section.
The use of the bypass stack during a performance test shall invalidate
the performance test.
(1) All performance tests shall consist of a minimum of three test
runs conducted under representative operating conditions.
(2) The minimum sample time shall be 1 hour per test run unless
otherwise indicated.
(3) EPA Reference Method 1 of appendix A of this part shall be used
to select the sampling location and number of traverse points.
(4) EPA Reference Method 3 or 3A of appendix A of this part shall
be used for gas composition analysis, including measurement of oxygen
concentration. EPA Reference Method 3 or 3A of appendix A of this part
shall be used simultaneously with each reference method.
(5) The pollutant concentrations shall be adjusted to 7 percent
oxygen using the following equation:
Cadj=Cmeas (20.9--7)/(20.9--%O2)
where:
Cadj=pollutant concentration adjusted to 7 percent oxygen;
Cmeas=pollutant concentration measured on a dry basis
(20.9--7)=20.9 percent oxygen--7 percent oxygen (defined oxygen
correction basis);
20.9=oxygen concentration in air, percent; and
%O2=oxygen concentration measured on a dry basis, percent.
(6) EPA Reference Method 5 or 29 of appendix A of this part shall
be used to measure the particulate matter emissions.
(7) EPA Reference Method 9 of appendix A of this part shall be used
to measure stack opacity.
(8) EPA Reference Method 10 or 10B of appendix A of this part shall
be used to measure the CO emissions.
(9) EPA Reference Method 23 of appendix A of this part shall be
used to measure total dioxin/furan emissions. The minimum sample time
shall be 4 hours per test run. If the affected facility has selected
the toxic equivalency standards for dioxin/furans, under Sec. 60.52c,
the following procedures shall be used to determine compliance:
(i) Measure the concentration of each dioxin/furan tetra-through
octa-congener emitted using EPA Reference Method 23.
(ii) For each dioxin/furan congener measured in accordance with
paragraph (b)(9)(i) of this section, multiply the congener
concentration by its corresponding toxic equivalency factor specified
in Table 2 of this subpart.
(iii) Sum the products calculated in accordance with paragraph
(b)(9)(ii) of this section to obtain the total concentration of
dioxins/furans emitted in terms of toxic equivalency.
(10) EPA Reference Method 26 of appendix A of this part shall be
used to measure HCl emissions. If the affected facility has selected
the percentage reduction standards for HCl under Sec. 60.52c, the
percentage reduction in HCl emissions (%RHCl) is computed
using the following formula:
[GRAPHIC] [TIFF OMITTED] TR15SE97.000
Where:
%RHCl=percentage reduction of HCl emissions achieved;
Ei=HCl emission concentration measured at the control device
inlet, corrected to 7 percent oxygen (dry basis); and
Eo=HCl emission concentration measured at the control device
outlet, corrected to 7 percent oxygen (dry basis).
(11) EPA Reference Method 29 of appendix A of this part shall be
used to measure Pb, Cd, and Hg emissions. If the affected facility has
selected the percentage reduction standards for metals under
Sec. 60.52c, the percentage reduction in emissions (%Rmetal)
is computed using the following formula:
[GRAPHIC] [TIFF OMITTED] TR15SE97.001
Where:
%Rmetal=percentage reduction of metal emission (Pb, Cd, or
Hg) achieved;
Ei=metal emission concentration (Pb, Cd, or Hg) measured at
the control device inlet, corrected to 7 percent oxygen (dry basis);
and
Eo=metal emission concentration (Pb, Cd, or Hg) measured at
the control device outlet, corrected to 7 percent oxygen (dry basis).
(12) The EPA Reference Method 22 of appendix A of this part shall
be used to determine compliance with the fugitive ash emission limit
under Sec. 60.52c(c). The minimum observation time shall be a series of
three 1-hour observations.
(c) Following the date on which the initial performance test is
completed or is required to be completed under Sec. 60.8, whichever
date comes first, the owner or operator of an affected facility shall:
(1) Determine compliance with the opacity limit by conducting an
annual performance test (no more than 12 months following the previous
performance test) using the applicable procedures and test methods
listed in paragraph (b) of this section.
(2) Determine compliance with the PM, CO, and HCl emission limits
by conducting an annual performance test (no more than 12 months
following the previous performance test) using the applicable
procedures and test methods listed in paragraph (b) of this section. If
all three performance tests over a 3-year period indicate compliance
with the emission limit for a pollutant (PM, CO, or HCl), the owner or
operator may forego a performance test for that pollutant for the
subsequent 2 years. At a minimum, a performance test for PM, CO, and
HCl shall be conducted every third year (no more than 36 months
following the previous performance test). If a performance test
conducted
[[Page 48388]]
every third year indicates compliance with the emission limit for a
pollutant (PM, CO, or HCl), the owner or operator may forego a
performance test for that pollutant for an additional 2 years. If any
performance test indicates noncompliance with the respective emission
limit, a performance test for that pollutant shall be conducted
annually until all annual performance tests over a 3-year period
indicate compliance with the emission limit. The use of the bypass
stack during a performance test shall invalidate the performance test.
(3) For large HMIWI, determine compliance with the visible emission
limits for fugitive emissions from flyash/bottom ash storage and
handling by conducting a performance test using EPA Reference Method 22
on an annual basis (no more than 12 months following the previous
performance test).
(4) Facilities using a CEMS to demonstrate compliance with any of
the emission limits under Sec. 60.52c shall:
(i) Determine compliance with the appropriate emission limit(s)
using a 12-hour rolling average, calculated each hour as the average of
the previous 12 operating hours (not including startup, shutdown, or
malfunction).
(ii) Operate all CEMS in accordance with the applicable procedures
under appendices B and F of this part.
(d) The owner or operator of an affected facility equipped with a
dry scrubber followed by a fabric filter, a wet scrubber, or a dry
scrubber followed by a fabric filter and wet scrubber shall:
(1) Establish the appropriate maximum and minimum operating
parameters, indicated in Table 3 of this subpart for each control
system, as site specific operating parameters during the initial
performance test to determine compliance with the emission limits; and
(2) Following the date on which the initial performance test is
completed or is required to be completed under Sec. 60.8, whichever
date comes first, ensure that the affected facility does not operate
above any of the applicable maximum operating parameters or below any
of the applicable minimum operating parameters listed in Table 3 of
this subpart and measured as 3-hour rolling averages (calculated each
hour as the average of the previous 3 operating hours) at all times
except during periods of startup, shutdown and malfunction. Operating
parameter limits do not apply during performance tests. Operation above
the established maximum or below the established minimum operating
parameter(s) shall constitute a violation of established operating
parameter(s).
(e) Except as provided in paragraph (h) of this section, for
affected facilities equipped with a dry scrubber followed by a fabric
filter:
(1) Operation of the affected facility above the maximum charge
rate and below the minimum secondary chamber temperature (each measured
on a 3-hour rolling average) simultaneously shall constitute a
violation of the CO emission limit.
(2) Operation of the affected facility above the maximum fabric
filter inlet temperature, above the maximum charge rate, and below the
minimum dioxin/furan sorbent flow rate (each measured on a 3-hour
rolling average) simultaneously shall constitute a violation of the
dioxin/furan emission limit.
(3) Operation of the affected facility above the maximum charge
rate and below the minimum HCl sorbent flow rate (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the HCl emission limit.
(4) Operation of the affected facility above the maximum charge
rate and below the minimum Hg sorbent flow rate (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the Hg emission limit.
(5) Use of the bypass stack (except during startup, shutdown, or
malfunction) shall constitute a violation of the PM, dioxin/furan, HCl,
Pb, Cd and Hg emission limits.
(f) Except as provided in paragraph (h) of this section, for
affected facilities equipped with a wet scrubber:
(1) Operation of the affected facility above the maximum charge
rate and below the minimum pressure drop across the wet scrubber or
below the minimum horsepower or amperage to the system (each measured
on a 3-hour rolling average) simultaneously shall constitute a
violation of the PM emission limit.
(2) Operation of the affected facility above the maximum charge
rate and below the minimum secondary chamber temperature (each measured
on a 3-hour rolling average) simultaneously shall constitute a
violation of the CO emission limit.
(3) Operation of the affected facility above the maximum charge
rate, below the minimum secondary chamber temperature, and below the
minimum scrubber liquor flow rate (each measured on a 3-hour rolling
average) simultaneously shall constitute a violation of the dioxin/
furan emission limit.
(4) Operation of the affected facility above the maximum charge
rate and below the minimum scrubber liquor pH (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the HCl emission limit.
(5) Operation of the affected facility above the maximum flue gas
temperature and above the maximum charge rate (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the Hg emission limit.
(6) Use of the bypass stack (except during startup, shutdown, or
malfunction) shall constitute a violation of the PM, dioxin/furan, HCl,
Pb, Cd and Hg emission limits.
(g) Except as provided in paragraph (h) of this section, for
affected facilities equipped with a dry scrubber followed by a fabric
filter and a wet scrubber:
(1) Operation of the affected facility above the maximum charge
rate and below the minimum secondary chamber temperature (each measured
on a 3-hour rolling average) simultaneously shall constitute a
violation of the CO emission limit.
(2) Operation of the affected facility above the maximum fabric
filter inlet temperature, above the maximum charge rate, and below the
minimum dioxin/furan sorbent flow rate (each measured on a 3-hour
rolling average) simultaneously shall constitute a violation of the
dioxin/furan emission limit.
(3) Operation of the affected facility above the maximum charge
rate and below the minimum scrubber liquor pH (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the HCl emission limit.
(4) Operation of the affected facility above the maximum charge
rate and below the minimum Hg sorbent flow rate (each measured on a 3-
hour rolling average) simultaneously shall constitute a violation of
the Hg emission limit.
(5) Use of the bypass stack (except during startup, shutdown, or
malfunction) shall constitute a violation of the PM, dioxin/furan, HCl,
Pb, Cd and Hg emission limits.
(h) The owner or operator of an affected facility may conduct a
repeat performance test within 30 days of violation of applicable
operating parameter(s) to demonstrate that the affected facility is not
in violation of the applicable emission limit(s). Repeat performance
tests conducted pursuant to this paragraph shall be conducted using the
identical operating parameters that indicated a violation under
paragraph (e), (f), or (g) of this section.
(i) The owner or operator of an affected facility using an air
pollution control device other than a dry scrubber followed by a fabric
filter, a wet
[[Page 48389]]
scrubber, or a dry scrubber followed by a fabric filter and a wet
scrubber to comply with the emission limits under Sec. 60.52c shall
petition the Administrator for other site-specific operating parameters
to be established during the initial performance test and continuously
monitored thereafter. The owner or operator shall not conduct the
initial performance test until after the petition has been approved by
the Administrator.
(j) The owner or operator of an affected facility may conduct a
repeat performance test at any time to establish new values for the
operating parameters. The Administrator may request a repeat
performance test at any time.
Sec. 60.57c Monitoring requirements.
(a) The owner or operator of an affected facility shall install,
calibrate (to manufacturers' specifications), maintain, and operate
devices (or establish methods) for monitoring the applicable maximum
and minimum operating parameters listed in Table 3 of this subpart such
that these devices (or methods) measure and record values for these
operating parameters at the frequencies indicated in Table 3 of this
subpart at all times except during periods of startup and shutdown.
(b) The owner or operator of an affected facility shall install,
calibrate (to manufacturers' specifications), maintain, and operate a
device or method for measuring the use of the bypass stack including
date, time, and duration.
(c) The owner or operator of an affected facility using something
other than a dry scrubber followed by a fabric filter, a wet scrubber,
or a dry scrubber followed by a fabric filter and a wet scrubber to
comply with the emission limits under Sec. 60.52c shall install,
calibrate (to the manufacturers' specifications), maintain, and operate
the equipment necessary to monitor the site-specific operating
parameters developed pursuant to Sec. 60.56c(i).
(d) The owner or operator of an affected facility shall obtain
monitoring data at all times during HMIWI operation except during
periods of monitoring equipment malfunction, calibration, or repair. At
a minimum, valid monitoring data shall be obtained for 75 percent of
the operating hours per day and for 90 percent of the operating days
per calendar quarter that the affected facility is combusting hospital
waste and/or medical/infectious waste.
Sec. 60.58c Reporting and recordkeeping requirements.
(a) The owner or operator of an affected facility shall submit
notifications, as provided by Sec. 60.7. In addition, the owner or
operator shall submit the following information:
(1) Prior to commencement of construction;
(i) A statement of intent to construct;
(ii) The anticipated date of commencement of construction; and
(iii) All documentation produced as a result of the siting
requirements of Sec. 60.54c.
(2) Prior to initial startup;
(i) The type(s) of waste to be combusted;
(ii) The maximum design waste burning capacity;
(iii) The anticipated maximum charge rate; and
(iv) If applicable, the petition for site-specific operating
parameters under Sec. 60.56c(i).
(b) The owner or operator of an affected facility shall maintain
the following information (as applicable) for a period of at least 5
years:
(1) Calendar date of each record;
(2) Records of the following data:
(i) Concentrations of any pollutant listed in Sec. 60.52c or
measurements of opacity as determined by the continuous emission
monitoring system (if applicable);
(ii) Results of fugitive emissions (by EPA Reference Method 22)
tests, if applicable;
(iii) HMIWI charge dates, times, and weights and hourly charge
rates;
(iv) Fabric filter inlet temperatures during each minute of
operation, as applicable;
(v) Amount and type of dioxin/furan sorbent used during each hour
of operation, as applicable;
(vi) Amount and type of Hg sorbent used during each hour of
operation, as applicable;
(vii) Amount and type of HCl sorbent used during each hour of
operation, as applicable;
(viii) Secondary chamber temperatures recorded during each minute
of operation;
(ix) Liquor flow rate to the wet scrubber inlet during each minute
of operation, as applicable;
(x) Horsepower or amperage to the wet scrubber during each minute
of operation, as applicable;
(xi) Pressure drop across the wet scrubber system during each
minute of operation, as applicable,
(xii) Temperature at the outlet from the wet scrubber during each
minute of operation, as applicable;
(xiii) pH at the inlet to the wet scrubber during each minute of
operation, as applicable,
(xiv) Records indicating use of the bypass stack, including dates,
times, and durations, and
(xv) For affected facilities complying with Secs. 60.56c(i) and
60.57c(c), the owner or operator shall maintain all operating parameter
data collected.
(3) Identification of calendar days for which data on emission
rates or operating parameters specified under paragraph (b)(2) of this
section have not been obtained, with an identification of the emission
rates or operating parameters not measured, reasons for not obtaining
the data, and a description of corrective actions taken.
(4) Identification of calendar days, times and durations of
malfunctions, a description of the malfunction and the corrective
action taken.
(5) Identification of calendar days for which data on emission
rates or operating parameters specified under paragraph (b)(2) of this
section exceeded the applicable limits, with a description of the
exceedances, reasons for such exceedances, and a description of
corrective actions taken.
(6) The results of the initial, annual, and any subsequent
performance tests conducted to determine compliance with the emission
limits and/or to establish operating parameters, as applicable.
(7) All documentation produced as a result of the siting
requirements of Sec. 60.54c;
(8) Records showing the names of HMIWI operators who have completed
review of the information in Sec. 60.53c(h) as required by
Sec. 60.53c(i), including the date of the initial review and all
subsequent annual reviews;
(9) Records showing the names of the HMIWI operators who have
completed the operator training requirements, including documentation
of training and the dates of the training;
(10) Records showing the names of the HMIWI operators who have met
the criteria for qualification under Sec. 60.53c and the dates of their
qualification; and
(11) Records of calibration of any monitoring devices as required
under Sec. 60.57c(a), (b), and (c).
(c) The owner or operator of an affected facility shall submit the
information specified in paragraphs (c)(1) through (c)(3) of this
section no later than 60 days following the initial performance test.
All reports shall be signed by the facilities manager.
(1) The initial performance test data as recorded under
Sec. 60.56c(b)(1) through (b)(12), as applicable.
(2) The values for the site-specific operating parameters
established pursuant to Sec. 60.56c(d) or (i), as applicable.
(3) The waste management plan as specified in Sec. 60.55c.
[[Page 48390]]
(d) An annual report shall be submitted 1 year following the
submission of the information in paragraph (c) of this section and
subsequent reports shall be submitted no more than 12 months following
the previous report (once the unit is subject to permitting
requirements under Title V of the Clean Air Act, the owner or operator
of an affected facility must submit these reports semiannually). The
annual report shall include the information specified in paragraphs
(d)(1) through (d)(8) of this section. All reports shall be signed by
the facilities manager.
(1) The values for the site-specific operating parameters
established pursuant to Sec. 60.56c(d) or (i), as applicable.
(2) The highest maximum operating parameter and the lowest minimum
operating parameter, as applicable, for each operating parameter
recorded for the calendar year being reported, pursuant to
Sec. 60.56c(d) or (i), as applicable.
(3) The highest maximum operating parameter and the lowest minimum
operating parameter, as applicable for each operating parameter
recorded pursuant to Sec. 60.56c(d) or (i) for the calendar year
preceding the year being reported, in order to provide the
Administrator with a summary of the performance of the affected
facility over a 2-year period.
(4) Any information recorded under paragraphs (b)(3) through (b)(5)
of this section for the calendar year being reported.
(5) Any information recorded under paragraphs (b)(3) through (b)(5)
of this section for the calendar year preceding the year being
reported, in order to provide the Administrator with a summary of the
performance of the affected facility over a 2-year period.
(6) If a performance test was conducted during the reporting
period, the results of that test.
(7) If no exceedances or malfunctions were reported under
paragraphs (b)(3) through (b)(5) of this section for the calendar year
being reported, a statement that no exceedances occurred during the
reporting period.
(8) Any use of the bypass stack, the duration, reason for
malfunction, and corrective action taken.
(e) The owner or operator of an affected facility shall submit
semiannual reports containing any information recorded under paragraphs
(b)(3) through (b)(5) of this section no later than 60 days following
the reporting period. The first semiannual reporting period ends 6
months following the submission of information in paragraph (c) of this
section. Subsequent reports shall be submitted no later than 6 calendar
months following the previous report. All reports shall be signed by
the facilities manager.
(f) All records specified under paragraph (b) of this section shall
be maintained onsite in either paper copy or computer-readable format,
unless an alternative format is approved by the Administrator.
Table 1 to Subpart Ec.--Emission Limits for Small, Medium, and Large HMIWI
--------------------------------------------------------------------------------------------------------------------------------------------------------
Emission limits
-------------------------------------------------------------------------------------
Pollutant Units (7 percent oxygen, dry HMIWI size
basis) -------------------------------------------------------------------------------------
Small Medium Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter.................. Milligrams per dry standard 69 (0.03).............. 34 (0.015)............ 34 (0.015).
cubic meter (grains per dry
standard cubic foot).
Carbon monoxide..................... Parts per million by volume. 40..................... 40.................... 40.
Dioxins/furans...................... Nanograms per dry standard 125 (55) or 2.3 (1.0).. 25 (11) or 0.6 (0.26). 25 (11) or 0.6 (0.26).
cubic meter total dioxins/
furans (grains per billion
dry standard cubic feet) or
nanograms per dry standard
cubic meter total dioxins/
furans TEQ (grains per
billion dry standard cubic
feet).
Hydrogen chloride................... Parts per million or percent 15 or 99%.............. 15 or 99%............. 15 or 99%.
reduction.
Sulfur dioxide...................... Parts per million by volume. 55..................... 55.................... 55.
Nitrogen oxides..................... Parts per million by volume. 250.................... 250................... 250.
Lead................................ Milligrams per dry standard 1.2 (0.52) or 70%...... 0.07 (0.03) or 98%.... 0.07 (0.03) or 98%.
cubic meter (grains per
thousand dry standard cubic
feet) or percent reduction.
Cadmium............................. Milligrams per dry standard 0.16 (0.07) or 65%..... 0.04 (0.02) or 90%.... 0.04 (0.02) or 90%.
cubic meter (grains per
thousand dry standard cubic
feet) or percent reduction.
Mercury............................. Milligrams per dry standard 0.55 (0.24) or 85%..... 0.55 (0.24) or 85%.... 0.55 (0.24) or 85%.
cubic meter (grains per
thousand dry standard cubic
feet) or percent reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2 To Supbart Ec.--Toxic Equivalency Factors
------------------------------------------------------------------------
Toxic
Dioxin/furan congener equivalency
factor
------------------------------------------------------------------------
2,3,7,8-tetrachlorinated dibenzo-p-dioxin................. 1
1,2,3,7,8-pentachlorinated dibenzo-p-dioxin............... 0.5
1,2,3,4,7,8-hexachlorinated dibenzo-p-dioxin.............. 0.1
1,2,3,7,8,9-hexachlorinated dibenzo-p-dioxin.............. 0.1
1,2,3,6,7,8-hexachlorinated dibenzo-p-dioxin.............. 0.1
1,2,3,4,6,7,8-heptachlorinated dibenzo-p-dioxin........... 0.01
octachlorinated dibenzo-p-dioxin.......................... 0.001
2,3,7,8-tetrachlorinated dibenzofuran..................... 0.1
2,3,4,7,8-pentachlorinated dibenzofuran................... 0.5
1,2,3,7,8-pentachlorinated dibenzofuran................... 0.05
[[Page 48391]]
1,2,3,4,7,8-hexachlorinated dibenzofuran.................. 0.1
1,2,3,6,7,8-hexachlorinated dibenzofuran.................. 0.1
1,2,3,7,8,9-hexachlorinated dibenzofuran.................. 0.1
2,3,4,6,7,8-hexachlorinated dibenzofuran.................. 0.1
1,2,3,4,6,7,8-heptachlorinated dibenzofuran............... 0.01
1,2,3,4,7,8,9-heptachlorinated dibenzofuran............... 0.01
Octachlorinated dibenzofuran.............................. 0.001
------------------------------------------------------------------------
Table 3 to Subpart Ec.--Operating Parameters to be Monitored and Minimum Measurement and Recording Frequencies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Minimum frequency Control system
--------------------------------------------------------------------------------------------------------------
Dry scrubber
Operating parameters to be monitored Dry scrubber followed by
Data measurement Data recording followed by Wet scrubber fabric
fabric filter and
filter wet scrubber
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum operating parameters:
Maximum charge rate.................. Continuous....................... 1 x hour........................
Maximum fabric filter inlet Continuous....................... 1 x minute...................... ............
temperature.
Maximum flue gas temperature......... Continuous....................... 1 x minute......................
Minimum operating parameters:
Minimum secondary chamber temperature Continuous....................... 1 x minute......................
Minimum dioxin/furan sorbent flow Hourly........................... 1 x hour........................ ............
rate.
Minimum HCI sorbent flow rate........ Hourly........................... 1 x hour........................ ............
Minimum mercury (Hg) sorbent flow Hourly........................... 1 x hour........................ ............
rate.
Minimum pressure drop across the wet Continuous....................... 1 x minute...................... ............
scrubber or minimum horsepower or
amperage to wet scrubber.
Minimum scrubber liquor flow rate.... Continuous....................... 1 x minute...................... ............
Minimum scrubber liquor pH........... Continuous....................... 1 x minute...................... ............
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 97-23835 Filed 9-12-97; 8:45 am]
BILLING CODE 6560-50-P