EPA
United States
Environmental Protection
Agency
Office of Air Quality
Planning and Standards
Research Triangle Park, NC 27711
EPA-453/R-97-006b
July 1997
Air
Hospital/Medical/Infectious
Waste Incinerators:
Background Information for
Promulgated Standards and
Guidelines -
Summary of Public Comments
and Responses
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EPA-453/R-97-006b
Hospital/Medical/Infectious Waste Incinerators:
Background Information for
Promulgated Standards and Guidelines -
Summary of Public Comments and Responses
Emission Standards Division
U. S. Environmental Protection Agency
Office of Air and Radiation
Office of Air Quality Planning and Standards
Research Triangle Park, North Carolina 27711
July 1997
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DISCLAIMER
This report is issued by the Office of Air Quality Planning and Standards, U. S.
Environmental Protection Agency. Mention of trade names and/or commercial products is not
intended to constitute endorsement or recommendation for use. Copies of this report are
available free of charge to Federal employees, current contractors and grantees, and non-profit
organizationsas supplies permitfrom the Library Services Office (MD-35), U. S.
Environmental Protection Agency, Research Triangle Park, North Carolina 27711 (919-541-
2777) or, for a nominal fee, from the National Technical Information Service, 5285 Port
Royal Road, Springfield, Virginia 22161 (703-487-4650).
u
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TABLE OF CONTENTS
I&ge
1.0 OVERVIEW 1-1
2.0 PUBLIC COMMENTS . . . 2-1
2.1 LIST OF COMMENTERS 2-1
2.2 ORGANIZATION OF COMMENT SUMMARIES 2-8
2.3 LIST OF ACRONYMS AND ABBREVIATIONS FOR UNITS OF
MEASURE 2-9
3.0 ANALYSIS OF NEW INFORMATION RECEIVED AFTER THE 1995
PROPOSAL 3-1.
3.1 MWI INVENTORY 3-1
3.2 SUBCATEGORIZATION 3-2
3.3 PERFORMANCE AND COST OF TECHNOLOGY 3-10
3.3.1 Good Combustion . . . 3-14
3.3.2 Wet Scrubbers 3-16
3.3.3 Dry Scrubbers 3-16
3.3.4 Combined Dry/Wet Scrubbers 3-17
3.4 MACT FLOOR 3-22
3.4.1 Existing MWI '. 3-23
3.4.2 New MWI 3-30
3.5 BASELINE EMISSIONS 3-36
3.6 OPERATOR TRAINING AND QUALIFICATION 3-41
3.7 TESTING, MONITORING, AND INSPECTION 3-49
3.8 APPLICABILITY . 3-70
3.8.1 Definition of Medical Waste . . 3-70
3.8.2 Municipal Waste Combustors, Cement Kilns, Boilers, and
Industrial/Commercial Waste Incinerators 3-79
3.8.3 Pathological, Drugs, Chemotherapy, Low-level
Radioactive, and Hazardous Wastes 3-88
3.8.4 MWI Built Following the 1995 Proposal 3-94
3.9 PYROLYSIS UNITS 3-97
3.10 ALTERNATIVE MEDICAL WASTE TREATMENT
TECHNOLOGIES 3-104
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TABLE OF CONTENTS (continued)
4.0 REGULATORY OPTIONS AND IMPACTS FOR EXISTING MWI 4-1
4.1 REGULATORY OPTIONS 4-1
4.2 NATIONAL ENVIRONMENTAL AND COST IMPACTS 4-6
4.2.1 Analytical Approach 4-6
4.2.2 Water and Solid Waste Impacts 4-8
4.2.3 Cost Impacts 4-9
4.3 ECONOMIC IMPACTS . 4-13
4.3.1 Industry-wide Economic Impacts 4-13
4.3.2 Facility-Specific Economic Impacts 4-14
5.0 REGULATORY OPTIONS AND IMPACTS FOR NEW MWI 5-1
5.1 REGULATORY OPTIONS 5-1
5.2 NATIONAL ENVIRONMENTAL AND COST IMPACTS 5-1
6.0 INCLINATIONS FOR THE FINAL RULE 6-1
6.1 REGULATORY OPTIONS 6-1
6.2 URBAN/RURAL CLASSIFICATION 6-5
6.3 OTHER INCLINATIONS 6-11
7.0 MISCELLANEOUS 7-1
7.1 SITING REQUIREMENTS 7-10
7.2 POLLUTION PREVENTION 7-13
7.3 FORMAT OF STANDARD 7-19
7.4 FUGITIVE EMISSIONS 7-32
APPENDIX A: REGULATORY OPTIONS AND IMPACTS OF THE STANDARDS
APPENDIX B: REGULATORY OPTIONS AND IMPACTS OF THE GUIDELINES
IV
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LIST OF TABLES
Table
2-1.
12-2.
LIST OF COMMFJSTTERS ON THE NEW SOURCE PERFORMANCE
STANDARDS AND EMISSION GUIDELINES FOR MEDICAL
WASTE INCINERATORS PRESENTED IN THE JUNE 1996
RE-PROPOSAL
LIST OF COMMENTERS ON THE NEW SOURCE PERFORMANCE
STANDARDS AND EMISSION GUIDELINES FOR MEDICAL
WASTE INCINERATORS IN THE FEBRUARY 1995 PROPOSAL . .
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VI
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1.0 OVERVIEW
On February 27, 1995, the Environmental Protection Agency (EPA) proposed
standards of performance for new medical waste incinerator(s) (MWI) and emission guidelines
for existing MWI under the authority of section 129 of the Clean Air Act (Act or CAA). The
new source performance standards (NSPS) and emission guidelines (EG) would reduce air
pollution from MWI. Public comments were requested on the 1995 proposal in the Federal
-Register. The EPA received a total of 724 letters commenting on the 1995 proposed standards
and guidelines during the public comment period following the 1995 proposed rule.
Comments were submitted by health care facilities that own and operate MWI, industry trade
associations, regulatory agencies, environmental groups, alternative medical waste treatment
-^technology vendors, MWI vendors, air pollution control technology vendors, and other
interested parties. The public comments received on the 1995 proposed standards and
guidelines are summarized in a document entitled "Medical Waste Incinerators- Summary of
Public Comments on the Proposed Standards and Guidelines" (Docket No. A-91-61, Item
No. IV-A-5).
Submitted in the comment letters was a wealth of new information that addressed every
aspect of the 1995 proposed standards and guidelines, including: the existing population of
MWI; 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 contained in the public comments
lead EPA to conclusions different from those at the 1995 proposal.
On June 20, 1996, EPA published a supplemental Federal Register notice (61 FR
31736). The purpose of the June 1996 notice was to: <1) announce the availability of the new
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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 MWI standards and guidelines, and (4) reopen the public comment period to solicit
comments on EPA's assessments and inclinations. As discussed further in section 3.8.4, EPA
now considers the June 1996 notice to be a re-proposal. Both terms "supplemental notice" and
"1996 re-proposal" are used throughout this document to refer to the June 1996 notice because
many commenters refer to the June 1996 notice as the "supplemental notice."
The June 20, 1996 re-proposal served as a response to most comments on the 1995
proposed rule. During the public comment period following the re-proposal, EPA received a
total of 68 comment letters which are summarized and responded to in this document.
Comments on miscellaneous issues from the 1995 proposal that were not addressed in the re-
proposal are also summarized and responded to in this document.
This summary of comments and responses serves as the basis for the revisions made to
the MWI standards and guidelines between the re-proposal and promulgation. The preamble
to the final standards and guidelines provides an abbreviated summary of the significant issues
and changes to the standards and guidelines that occurred following the re-proposal.
As discussed in section 3.8.1, the title of the standards and guidelines has been changed
for the promulgation in an attempt to clarify applicability and in response to public comments.
The 1995 proposed standards and guidelines and the provisions discussed in the re-proposal
applied to "medical waste incinerators" or "MWI." The final standards and guidelines apply
to "hospital/medical/mfectious waste incinerators" or "HMTWI." Medical waste incinerators
and HMIWI are essentially the same, and for all practical purposes, the two acronyms "MWI"
and "HMIWI" should be viewed as interchangeable. Both acronyms are used hi this document
because comments received following the re-proposal referred to "MWI." However, only the
acronym "HMIWI" is used throughout the preamble, fact sheets, and regulatory text to clarify
the applicability of the final standards and guidelines.
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2.0 PUBLIC COMMENTS
;2.1 LIST OF COMMENTERS
The public comment period following the June 20, 1996 re-proposal lasted from June
20, 1996 to August 8, 1996. Late comments received prior to December 31, 1996 were
accepted. A total of 68 letters commenting on the re-proposal were submitted by health care
facilities that own and operate MWI, industry trade associations, regulatory agencies,
environmental groups, alternative medical waste treatment technology vendors, MWI vendors,
air pollution control technology vendors, and other interested parties. These comments have
'been placed in the docket for this rulemaking (Docket A-91-61) under category IV-D,
beginning with item number IV-D-726 and continuing through item number IV-D-793.
Table 2-1 presents a listing of all persons submitting written comments on the re-proposalr
.their affiliations, and the recorded docket item number assigned to their correspondences.
The re-proposal served as a response to the majority of the comments received on the
MWI standards and guidelines proposed in February 1995. However, some miscellaneous
issues associated with the 1995 proposed MWI standards and guidelines were not addressed by
EPA in the re-proposal. Comments received following the 1995 proposal that pertain to issues
not addressed hi the re-proposal have been summarized in this document. These comments, as
well as all other comments received on the 1995 proposal, are available in Docket A-91-61
under category IV-D. Table 2-2 presents a listing of all persons submitting written comments
on the 1995 proposal that were not addressed hi the re-proposal, their affiliations, and the
^recorded docket item number assigned to their correspondences. Note that all comments from
the 1995 proposal have docket item numbers of IV-D-724 or less.
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TABLE 2-1. LIST OF COMMENTERS ON THE NEW SOURCE PERFORMANCE
STANDARDS AND EMISSION GUIDELINES FOR MEDICAL WASTE INCINERATORS
PRESENTED IN THE JUNE 1996 RE-PROPOSAL
Item No.
IV-D-726
W-D-727
IV-D-728
IV-D-729
IV-D-730'
IV-D-731
IV-D-732
IV-D-733
IV-D-734
IV-D-735
IV-D-736
IV-D-737
IV-D-738
IV-D-739
IV-D-740*
IV-D-741
IV-D-742
IV-D-743"
IV-D-744
Commenter and Affiliation
M. BeUes
Citizen of Rowlett, Texas
M. Owens
Eli Oily and Company
D. Sussman
Ogden Projects
T. White
Pharmaceutical Research and Manufacturers of America (PhARMA)
B. Lerner
BECO Engineering Company
J. Albers
American Animal Hospital Association
G. Byrns
Indian Health Service
J. Dow
American Red Cross
D. Gustafson
The Dow Chemical Company
J. Osborne
Empire International Corporation
D. Roberts
ADA Technologies
N. Mossholder
Bio-Oxidation, Inc.
G. Carpenter
American Association of Equine Practioners
L. Morris
Charleston Area Medical Center
B. Lerner
BECO Engineering Company
H. Marshall
Emcotek Corporation
O. Baker
National Incinerator, Inc.
B. Lemer
BECO Engineering Company
D. Marrack
Fort Bend Medical Clinic
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TABLE 2-1. (continued)
Item No.
IV-D-745
IV-D-746
IV-D-747
IV-D-748
IV-D-749
IV-D-750
IV-D-751
IV-D-752
IV-D-753
IV-D-754
IV-D-755
IV-D-756
IV-D-757
IV-D-758
IV-D-759
IV-D-760
IV-D-761
IV-D-762
IV-D-763
IV-D-764
Commenter and Affiliation
F. Hasselriis
Hasselriis Associates
M. Benoit
Cadence Environmental Energy, Inc.
C. Campbell
Cement Kiln Recycling Coalition
E. Munsell
Department of the Navy
M. Wax
Institute of Clean Air Companies
A. Man-
Scission Technologies
C. Collins
Wyoming Department of Environmental Quality
J. Gibson
Masuda, Funai, Eifert & Mitchell, Ltd.
M. Starck
Alyeska Pipeline Service Company
J. Tripp
Environmental Denfense Fund
H. Holley
Promina
J. Williams
Desert Citizens Against Pollution
C. Hill
Center for the Biology of Natural-Systems >
A. Martin
The Breast Cancer Fund
R. Menaul
Washington State Hospital Association
L. Spinar
South Dakota State University ,
S. Beck
Roatan Medical Services Corporation
M. Taitz
Sanitec
R. Jorgensen and L. Crawford
American Veterninary Medical Association
J. Seferiadis
Lightening Environmental Recovery Systems
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TABLE 2-1. (continued)
Item No.
IV-D-765
IV-D-766
IV-D-767
IV-D-768
IV-D-769
1V-D-770
IV-D-771
IV-D-772
IV-D-773
IV-D-774
P/-D-775
IV-D-776
IV-D-777
W-D-778
IV-D-779
IV-D-780
IV-D-781
IV-D-782
IV-D-783
IV-D-784
Commenter and Affiliation
J. Higgins
New York State Department of Environmental Conservation
R. Massey
Consumat Systems, Inc.
P. deFur
Virginia Commonwealth University Center for Environmental Studies
A. Szurgot
American Ref-Fuel
E. DuSold
Eli Lilly and Company
L. Thompson
Cornell University
R. Wiles
Environmental Working Group
J. Christensen
Citizen of Minneapolis, Minnesota
R. Sites
Ohio Hospital Association
E. Krisiunas
Spectrum
M. Zannes
Integrated Waste Services Association
W. Schmidt
National Wildlife Federation
M. Nelson
City Medical Waste Services
B. Hogan
Resource Environmental Systems, Inc.
R. Stryker
Integrated Environmental Systems
A. Johnston
Molten Metal Technology
M. Lynch
Browning-Ferris Industries
P. Mayberry
Association of the Nonwoven Fabrics Industry
R. Otis
American Plastics Council
R. Moskowitz
Medical Waste Institute
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TABLE 2-1. (continued)
Item No.
IV-D-785
IV-D-786
IV-D-787
IV-D-788
IV-D-789
IV-D-790
IV-D-791
IV-D-792
IV-D-793
Commenter and Affiliation
T. White
Pharmaceutical Research and Manufacturers of America
J. Pew
Natural Resources Defense Council
Fifty-two Groups
Various citizen and environmental groups
A. Lancaster
Association for Professionals in Infection Control and Epidemiology, Inc.
M. Clarke
Commonweal
P. Wfflging
American Health Care Association
B. Bateson
Vance IDS, Inc.
J. McLarney
American Hospital Association
L. Doucet
Doucet & Mainka, P.C.
"This commenter submitted three separate comment letters:
IV-D-730, IV-D-740, and IV-D-743.
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TABLE 2-2. LIST OF COMMENTERS ON THE NEW SOURCE PERFORMANCE
STANDARDS AND EMISSION GUIDELINES FOR MEDICAL WASTE
INCINERATORS PRESENTED IN THE FEBRUARY 1995 PROPOSAL
Item No.
IV-D-01
IV-D-04
IV-D-134
IV-D-252
IV-D-453
IV-D^54
IV-D-462
IV-D-490
IV-D-494
IV-D-498
IV-D-499/659"
IV-D-518/595'
IV-D-534
IV-D-535
IV-D-536
IV-D-547
IV-D-561
IV-D-562
IV-D-572
IV-D-573
Commenter and Affiliation
Robert Scott
City of Philadelphia, Department of Public Health, Environmental Protection
Division
D.A. Drum
Butler County Community College
H.L. Rhodes
Department of Environmental Protection
J.R. Osbourne
Empire International
LJ. Adrian
Sobering Laboratories
P.O. Mayberry
Association of the Nonwoven Fabrics Industry
N. Judge
Vanguard Research, Inc.
R.D. Fletcher
State of California, Air Resources Board
F.N. Hasselriis and J.W. Norton
ASME International and The American Society of Mechanical Engineers
D.S. White
Engineered Recovery Systems, Inc.
W. O'Sullivan
State of New Jersey, Department of Environmental Protection, Air Quality
Permitting Program
M. Fisher
Natural Resources Council of Maine
R. Gerard Highland
RGH Associates, Inc.
S. Romelczyk and R. Salcedo
Air Pollution Control District, County of San Diego
R.H. Colby and D.F. Theiler
State and Territorial Air Pollution Program Administrators and the Association of
Local Air Pollution Control Officials (STAPPA/ALAPCO)
R.L. Sites
Ohio Hospital Association
E.B. Wright
U.S. EPA, Region ffl
R.M. Baldiserotto and J.C. Garcia
Hofftnan-LaRoche, Inc.
K.B. Thaus
WMX Technologies, Inc.
T.X. White
Pharmaceutical Research and Manufacturers of America (PhRMA)
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TABLE 2-2. (continued)
Item No.
IV-D-598
IV-D-613
iy-D-619/679"
IV-D-627
IV-D-636
IV-D-637
IV-D-654
IV-D-663
IV-D-692
Commenter and Affiliation '
M. Lydell
WCA Hospital
M.E. Lynch
Browning-Ferris Industries
D. Driesen
Natural Resources Defense Council
R.S. Moskowitz
Medical Waste Institute
M. Babos
Merck & Co., Inc.
H. Bryan
American Hospital Association
A.M. Szurgot
American Ref-Fuel
R. Methier
Georgia Department of Natural Resources
DONLEE Technologies, Inc.
"This commenter submitted two separate
comment letters on the 1995 proposal.
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In some instances, commenters incorporated by reference their earlier comments on the
1995 proposal into their comments on the re-proposal. When this occurred, the appropriate
comments on the 1995 proposal were summarized and the docket item number of the
comments on the 1995 proposal along with the docket item number of the comments on the re-
proposal were used to reference the commenter. For example, commenter IV-D-769
incorporated their comments on the 1995 proposal, which were recorded as docket item IV-D-
557, into their comments on the re-proposal. Therefore, hi this document the statements of
commenter IV-D-769 are listed as "IV-D-769/557" to indicate that the comment summary was
developed using two separate comment letters from the same organization.
In other cases, commenters supported their comments by referencing comments
submitted by other commenters. In these instances the supporter's docket item number is
listed each time the supported docket item number is listed. For example, commenter IV-D-
762 supported the comments of commenter IV-D-784 in their entirety. Therefore, the
comments of IV-D-784 are listed as "IV-D-762/784 and IV-D-784" to reflect the support of
two separate commenters.
2.2 ORGANIZATION OF COMMENT SUMMARIES
Chapters 3.0 through 7.0 present a summary of the comments on the re-proposal (and
comments on the 1995 proposal not addressed by the re-proposal) along with EPA responses.
The comments are grouped by subject areas, and the organization of topics is similar to the
organization of the re-proposal.
Chapter 3.0 contains comments regarding EPA's analyses of the information received
following 1995 proposal of the MWINSPS and emission guidelines. These include comments
on the MWI inventory, EPA's conclusions regarding performance of control technologies,
selection of the maximum achievable control technology (MACT) floor, the selected size
categories and emission limits for MWI, the operator training and qualification requirements,
and the testing, monitoring, and inspection provisions. Chapter 3.0 also contains comments on
EPA's calculation of baseline emissions from MWI, applicability of the standards and
guidelines, pyrolysis technologies, and alternative medical waste treatment technologies.
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Chapters 4.0 and 5.0 summarize comments on the EPA's selection of regulatory
options for the emission guidelines for existing MWI and the NSPS for new MWI,
respectively. Chapters 4.0 and 5.0 also contain comments regarding EPA's calculations of the
environmental, energy, cost, and economic impacts of the regulatory options under
consideration for the NSPS and emission guidelines.
Chapter 6.0 contains comments related to the EPA's inclinations for the final HMIWI
standards and guidelines. These comments pertain to EPA's selection of the final MACT
standards and guidelines for all classifications of MWI and to the basis for the regulatory
options considered. The comments also address the issues associated with urban/rural
classification for small existing MWI.
Chapter 7.0 summarizes comments on the siting requirements for new MWI,
incorporation of pollution prevention techniques, format of the standards and guidelines, and
other miscellaneous issues.
Appendices A and B summarize the regulatory options considered for the final HMIWI
standards and guidelines, respectively. The appendices present the air, cost, nonair quality
environmental, energy, and economic impacts of the regulatory options considered for the
standards and guidelines.
2.3 LIST OF ACRONYMS AND ABBREVIATIONS FOR UNITS OF MEASURE
ACRONYMS
Act
Administrator
Agency
AHA
APCD
APTI
CAA
CARB
Cd
CDD/CDF
CEM
GEMS
CEP
CETRED
CFBC
Clean Air Act
EPA Administrator
EPA
American Hospital Association
air pollution control device(s)
Air Pollution Training Institute
Clean Air Act
California Air Resources Board
cadmium
dioxins/furans
continuous emissions monitor
continuous emissions monitoring system(s)
catalytic extraction processing
Combustion Emissions Technical Resource Document
circulating fluidized bed combustor
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CFR
CO
DEP
DI
dioxins
DoD
DOT
EG
EPA
ESP
EU
FF
FBCA
FR
ftirans
Hz
HAP
HC1
Hg
HMIWI
HWI
ITEQ
MACT
MWTA
MSW
MWC
MWI
MWP
N2
NAAQS
NESHAP
NH3
NOX
NRC
NSPS
NSR
NYSDOH
02
OAQPS
OSHA
Pb
PEWS
PM
PM-2.5
Code of Federal Regulations
carbon monoxide
Department of Environmental Protection
dry injection
polychlorinated dibenzo-p-dioxins
U.S. Department of Defense
U.S. Department of Transportation
emission guidelines
U.S. Environmental Protection Agency
electrostatic precipitator
European Union
fabric filter (baghouse)
fixed-bed carbon adsorber
Federal Register
polychlorinated dibenzofurans
hydrogen
hazardous air pollutant(s)
hydrogen chloride
mercury
hospital/medical/mfectious waste incinerator(s)
hazardous waste incinerator(s)
international toxic equivalents
maximum available control technology
Medical Waste Tracking Act
municipal solid waste
municipal waste combustor(s)
medical waste incinerator(s)
medical waste pyrolysis or medical waste pyrolysis unit
nitrogen
National Ambient Air Quality Standards
national emission standards for hazardous air pollutants
ammonia
nitrogen oxides
U.S. Nuclear Regulatory Commission
new source performance standards
new source review
New York State Department of Health
oxygen
Office of Air Quality Planning and Standards
Occupational Safety and Health Administration
lead
packed-bed wet scrubber
particulate matter
particulate matter (less than 2.5 microns)
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PM-10
PSD
PVA
PVC
RCRA
RMW
-SMSA
"SNCR
JSWDA
'TCLP
TEF
TEQ
VOC
WEP
paniculate matter (less than 10 microns)
prevention of significant deterioration
polyvinyl alcohol
polyvinyl chloride
quality assurance
Resource Conservation and Recovery Act
regulated medical waste
standard metropolitan statistical area
selective noncatalytic reduction
sulfur dioxide
Solid Waste Disposal Act
toxic characteristics leachate procedure
toxic equivalency factor
toxic equivalent quantity (e.g., 2,3,7,8- tetrachlorinated dibenzo-p-
dioxin toxic equivalent)
volatile organic compounds
wet electrostatic precipitator
^ABBREyiAITONS FOR UNITS OF MEASURE
Btu
dscf
..dscfm
dscm
-op
Jt3
gr
hr
Ib
mg
Mg
MMm3
MW
MW-hr/yr
ng
ppm
^ppmv
ppmdv
ton/yr
yr
British thermal unit
dry standard cubic foot (@ 14.7 psia, 68°F)
dry standard cubic foot.per minute (@ 14.7 psia, 68°F)
dry standard cubic meter (@ 14 psia, 68°F)
degrees Fahrenheit
cubic feet
grains
hour
pound
milligrams (10"3 grams)
megagram (106 grams)
million cubic meters
megawatt
megawatt-hours per year
nanogram (10~9 grams)
parts per million
parts per million by volume
parts per million by dry volume
tons per year
microgram (10"6 grams)
week
year
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3.0 ANALYSIS OF NEW INFORMATION RECEIVED AFTER THE 1995 PROPOSAL
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However, due to the large number of MWI across the nation, it is likely that small changes in
the MWI population will have no effect on the MACT floors and very little effect on the
nationwide impacts. Consequently, the current inventory is adequate to allow EPA to make
informed decisions hi developing the emission guidelines for existing sources as well as the
NSPS for new sources.
3.2 SUBCATEGORIZATION
: Eight commenters (IV-D-748, IV-D-759, IV-D-760, IV-D-763, IV-D-765,
IV-D-785, IV-D-790, and IV-D-792) supported the subcategories presented in the
supplemental notice. One commenter (IV-D-748) stated that the categorization of incinerators
in the supplemental notice follows what many States have implemented with their current MWI
regulations. Another commenter (W-D-760) pointed out that incinerator characteristics appear
to be more closely associated with size than with type. Another commenter (IV-D-792) stated
that there are sound technical justifications for such subcategorization.
Five commenters (TV-D-757, IV-D-761, IV-D-777, IV-D-786, andIV-D-789)
contended that EPA should not subcategorize MWI by size. The commenters argued that
subcategorization by size leads to a MACT floor for small units that is uncontrolled. Three
commenters (IV-D-761, IV-D-786, and IV-D-789) argued that small MWI are the worst
controlled and the highest emitters of dioxins and other pollutants. Because small MWI are
not as well controlled as large MWI, one commenter (IV-D-786) concluded that
subcategorizing by size amounts to subcategorizing by emission level. Two commenters
(IV-D-762/784 and IV-D-784) warned that subcategorization could create an economic
incentive to treat waste in small onsite incinerators with no pollution controls and will result hi
an increase in unregulated pollutants emitted from the MWI source category. One commenter
(IV-D-744) argued that setting different emission maxima for different MWI sizes and modes
of operation (batch, hitermittent, and continuous) was inappropriate and unjustified under the
CAA.
Response: Section 129 of the CAA states that the Administrator may distinguish
among classes, types, and sizes of units within a category in establishing the standards and
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guidelines. This concept of subcategorization is clearly authorized by the CAA and has been
used throughout EPA's history in developing regulations under the authority of the CAAs
In the 1995 proposal, EPA concluded that the MWI population should be divided into
three subcategories based on MWI design: (1) continuous MWI, (2) intermittent MWI, and
^(3) batch MWI. While these subcategories were based on differences in MWI design, they
salso roughly correlate with MWI size (capacity to burn medical waste). During the public
^comment period following the 1995 proposal, several commenters urged EPA to subcategorize
directly by MWI size because many States have implemented MWI regulations that
subcategorize by size and because incinerator characteristics are more closely related to MWI
size than to MWI type. Following the public comment period for the 1995 proposal, EPA
.examined State MWI regulations in an effort to determine where States may have found
distinct differences among MWI. Because the MACT floor for existing MWI is based on State
^regulatory emission limits, an examination of changes in the MACT floor with size provided
an indication of where States found enough difference in MWI to warrant different regulatory
.requirements. Significant differences in MACT floor levels were identified at 200 and
:500 Ib/hr.
As a result of comments on the 1996 reproposal, another assessment of subcategories
^has been conducted. This time, the number of existing units in the MWI inventory was
analyzed by size and by type. This approach showed that virtually all batch MWI are smaller
than 200 Ib/hr, while virtually all continuous MWI are larger tha»500 Ib/hr. These size
breaks coincide with the size breaks determined using the MACT floor approach discussed
above. Consequently, the three subcategories described in the 1996 reproposal remain the
same for the final standards and guidelines: small (<200 Ib/hr), medium (>200 to
-<500 Ib/hr), and large (>500 Ib/hr).
It is not appropriate for EPA to subcategorize by emission control alone, as one
^commenter has stated. However, it is appropriate to subcategorize where technical distinctions
^can be made among subcategories. Because the MACT floor for existing units reflects current
-regulatory practices, it is not surprising that there are different MACT floors for different
subcategories. Just as the CAA authorizes EPA to distinguish among classes, types, and sizes,
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many current Stale regulations tecognize the need to distinguish among classes, types, and
sizes in developing reguktory requirements rather than impose "one-size-fits-air regulatory
: .jisjr1!: ,
requirements. This is not the same as subcategorizing by emission level.
Finally, the MACT floor reflects the least stringent regulatory option allowed under the
CAA for each subcategory. The MACT floor is not an end in itself, but merely the starting
point in the regulatory analysis. The CAA requires EPA to examine regulatory options more
stringent than the MACT floor. The EPA must consider the cost, environmental, economic,
and energy impacts of these regulatory options and select one that reflects the maximum
reduction in emissions that EPA determines is achievable (i.e., MACT). Considerations such
as the air pollution control level associated with the MACT floor for each subcategory, total
air pollution emissions from each subcategory, and trends toward the use of smaller MWI are
taken into account in examining regulatory options more stringent than the MACT floor, not in
developing subcategories or calculating MACT floor emission levels.
Comment: One commenter (IV-D-744) contended that all MWI should operate
continuously because emissions measured during startup and shutdown exceed the emissions
measured during stable continuous operation. In the commenter1 s opinion, intermittent and
batch modes of operation are unacceptable. The commenter mentioned that coincineration of
municipal and medical waste would provide the needed continuous supply of waste to keep an
MWI in continuous operation. Another commenter (TV-D-789) remarked that no new batch
MWI should.be permitted due to .their,inferior, design. The commenter argued that intermittent
MWI are incapable of achieving good combustion because frequent recharging of waste upsets
the furnace temperature and oxygen content of the combustion gases. The commenter
recommended that EPA discourage the construction of new intermittent MWI. Other
commenters (IV-D-756 and IV-D-776) contended that small batch incinerators should be
regulated aggressively because they are a significant source of dioxin emissions.
Response: Because poor combustion and higher emissions can result from improper
startup and shutdown, EPA defines startup and shutdown under the final HMIWI regulations
as periods when no waste is burning. Incinerators are required to attain their minimum
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operating temperatures before waste combustion begins and maintain their operating
temperatures until waste combustion ends, avoiding periods of poor combustion. Ji
The methods of charging waste are the same for continuous and intermittent MWI.
r33oth continuous and intermittent MWI charge waste at frequent, regular intervals.
^Consequently, there is no reason to believe that one design is better than the other based on
charging practices. In fact, good combustion has been observed in test data for all three
fdesign types. There is no indication that any of the three designs is inferior to the others.
-Therefore, EPA disagrees with commenters who state that intermittent and batch MWI are not
capable of achieving good combustion. The MACT standards and guidelines specify emission
limits based on achievable levels of emission control. The final standards and guidelines do
not include specifications for a particular incinerator design or for specific air pollution control
equipment. Any combination of incinerator design and air pollution control that is capable of
^meeting the final standards and guidelines may be used. This provides the most flexibility to
the regulated community, encourages competition, and promotes the development of new -
technologies.
Comment: One commenter (IV-D-732) supported the concept of identifying a category
of small incinerators and recommends a new category of less than or equal to 100 Ib/hr be
^created and made exempt from the regulation. Another commenter (TV-D-742) stated that
there are a number of small MWI with wet scrubbers and pointed out that the smallest of these
MWI is rated at 100 Ib/hr. The commenter requested that the EPA change the small
subcategory to exclude MWI rated below 100 Ib/hr from the requirements of the emission
levels achievable with a wet scrubber, for both new and existing MWI.
Response: Subcategories must reflect differences in the incinerator, not merely hi the
air pollution control used by the incinerator. Subcategorization by emissions control is not
EPA's objective and is not appropriate. For the 1996 reproposal, the MACT floor for existing
*MWI was used as a surrogate to indicate where States found significant differences in MWI
^technology. When determining the appropriate size cutoffs for the MWI subcategories, size
categories that represent MWI with capacities of less than or equal to 100 Ib/hr were
considered. There appear to be distinct technical differences between MWI with capacities
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less than 200 Ib/hr and greater than 200 Ib/hr. However, there do not appear to be distinct
differences between MWI smaller than 100 Ib/hr compared to MWI between 100 and .
200 Ib/hr. Therefore, there is no justification for a subcategory for new incinerators less than
or equal to 100 Ib/hr.
Comment: One commenter (TV-D-735) proposed four subcategories: small
0^.200 Ib/hr), medium (201 to 500 Ib/hr), intermediate (501 to 1,500 Ib/hr), and large (over
1,500 to 2,000 Ib/hr). The large category proposed by the commenter was for commercial ;:,
MWI.
Response: When determining the appropriate size cutoffs for the MWI subcategories,
size categories that represent MWI with capacities of > 1,000 Ib/hr and > 2,000 Ib/hr were
considered. There was found to be little, if any, technical distinction between MWI in a
>500 Ib/hr category and MWI in a > 1,000 Ib/hr or > 2,000 Ib/hr category. Therefore, there
is no justification for a separate subcategory for MWI with capacities greater than 1,500 Ib/hr.
Comment: Five commenters (IV-D-751, IV-D-760, IV-D-781, IV-D-790, and
IV-D-792) requested that MWI size be determined using a Federally enforceable limit on
charge rate. One commenter (IV-D-751) noted that there are facilities whose quantity of waste
burned would qualify their incinerators as small units, however, the rated capacities of the
units would qualify them as medium or large units. The commenter explained that the
oversizing of these units would not cause emission problems and that the emissions should be
on the order of what is expected from smaller units. Another commenter (TV-D-735) stated
that some facilities will want a system through-put higher than its present requirements
demand. The commenter suggested rating a system's capacity and category by permitted
capacity and using a weigh-feed system to regulate the amount of waste fed per hour. One
commenter (IV-D-781) noted that determination of MWI size by a Federally enforceable limit,
as suggested in the 1996 reproposal, would reduce the burden on numerous States that rely on
permit conditions. The commenter suggested that the documented measurement requirements
necessary to demonstrate compliance include: (1) use of a weight scale to demonstrate
compliance with waste feed permit levels, (2) continuous monitoring in the primary and
secondary chambers, and (3) recorded monitoring results kept for 2 years. Two commenters
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(TV-D-790 and IV-D-792) requested that the Federally enforceable State operating permit
limits be recognized by the EPA for facilities having multiple MWI as well as for facilities
'electing to derate the capacities of their MWI in order to fall within the requirements of a
-'/different regulatory category.
Two commenters (TV-D-762/784 and IV-D-784) argued that because EPA is
^considering lenient standards for small MWI, allowing a unit to change its size based on a
^permit condition that limits throughput will result in a rule that does little to reduce MWI
Demissions. The commenters suggested that if EPA allows a source to classify itself as a small
unit based on its permitted throughput limitation, then EPA should impose a daily limit on the
amount of waste being burned. The commenters recommended that this limit be 500 Ib/d for
'small MWI. The commenters explained that this daily limit would prevent facilities from
= charging less than 200 Ib/hr for several hours per day into MWI with the capacity to burn
^larger amounts of waste per hour.
Response: The EPA recognizes that some facilities may have purchased an existing
MWI with capacity that exceeds their current waste disposal needs. These facilities may only
i burn a quantity of waste that would qualify their incinerators as small units, but may operate
MWI that would be classified as medium or large units based on rated capacity. To prevent
^facilities with excess waste charging capacity from being subjected to more stringent
regulations than necessary, the final HMIWI standards and guidelines allow facilities to change
their size designation by establishing an operating^arameter "maximum charge rate" during
their performance test to demonstrate compliance with the emission limits. This operating
parameter limit will allow facilities to base their HMIWI size on the amount of waste they
burn instead of on rated HMIWI capacity.
The final HMIWI guidelines do not require that the capacities of multiple existing units
-at one site be combined when determining MWI size. Facilities that operate multiple MWI
^may base the capacity of each individual MWI on the "maximum charge rate".
To prevent facilities from derating their MWI capacity through this operating parameter
tlimit, and then charging more waste than allowed, EPA considered the possibility of requiring
"facilities to install a lockout-feed system. While some States require MWI charging systems
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that wiU lock or prevent charging until the secondary chamber reaches a certain temperature,
there are no known State requirements for a lockout system that prevents over-charging-based
solely on the weight and/or frequency of charging. Therefore, in lieu of a lockout-feed system
to demonstrate compliance with the maximum charge rate, the final HMTWI standards and
guidelines require that facilities record the charge rate using an automatic system to document
the date, time, and weight of each charge.
As mentioned earlier, the MACT floor reflects the least stringent regulatory option
allowed under the CAA for each subcategory. One commenter's concern about "lenient"
requirements for small units refers to the MACT floor for small existing units, which can be
achieved with good combustion alone. However, the MACT floor is not an end in itself, but
merely the starting point in the regulatory analysis. The CAA requires EPA to examine
regulatory options more stringent than the MACT floor. The EPA must consider the cost,
environmental, economic, and energy impacts of these regulatory options and select one that
reflects the maximum reduction in emissions that EPA determines is achievable (i.e., MACT).
Considerations such as the air pollution control level associated with the MACT floor for each
subcategory, total air pollution emissions from each subcategory, and trends toward the use of
smaller MWI (in this case derating to escape requirements based on a scrubber) are taken into
account in examining regulatory options more stringent than the MACT floor, not in
developing subcategories, calculating MACT floor emission levels, or in this case deciding
how to determine MWI capacity.
Comment: Two commenters (TV-D-769/557 and IV-D-785) argued that it is not
acceptable for EPA to combine waste burning capacity of multiple units at a site to artificially
assign the total capacity as that of a single unit. The commenters noted that multiple units at
the same site may be designed to accomplish separate purposes. One unit may be designated
to bum pathological waste and another to burn highly infectious pharmaceutical research
waste. The commenters stated that EPA's concern that a facility would install several small
units to avoid the more stringent standards faced by a single large unit is invalid due to
economics. Three commenters (TV-D-762/784, IV-D-784, and IV-D-792) supported EPA's
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inclination to combine the waste burning capacity of multiple units at one location for the
purposes of determining MWI size. ;
Response: The EPA recognizes that some facilities operate multiple incinerators to
"accomplish separate purposes such as burning hazardous or low-level radioactive waste.
However, the inclination to combine capacity of multiple units would only have applied to
;vmultiple MWI, not to all incinerators at a particular facility. Nevertheless, further
^consideration has been given to the idea of combining the capacity of multiple units. Most
^existing MWI are located at hospitals, and most hospitals with incinerators have only one
MWI. Only large commercial facilities typically have more than one MWI and each one is
usually larger than 500 Ib/hr. Consequently, there does not appear to be much benefit in
combining the capacity of multiple units under the MWI emission guidelines for existing units.
On the other hand, those few facilities that might have installed more than one MWI in the
-past might be faced with more severe economic impacts than a comparable facility with one
ilarger MWI. In addition, the regulatory requirements for new MWI built in the future are
essentially the same, regardless of size. Consequently, there appears to be no need to combine
^capacity of multiple units. In the final regulations, size is determined on an individual unit
'. basis.
-* Comment: Two commenters (TV-D-762/784 and IV-D-784) noted that EPA has
calculated a volumetric waste burning capacity factor for batch units of 0.375 Ib/hr-ft3 based
on a 12-hour burn cycle and an average densily^fcmedical waste (^.5 Ib/ft3). The commenters
argued that batch units have an 8-hour burn cycle and the proper coefficient for estimating the
burning capacity is 0.563 Ib/hr-ft3.
Response: The volumetric waste burning capacity factor for batch units presented in
-the 1996 reproposal was based on a 12-hour burn cycle. A 12-hour burn cycle was used to
-account for a wide range of sizes of batch MWI. However, because most batch MWI are very
^mall and typically burn waste for about 8 hours, EPA agrees that the volumetric waste
<5burning capacity factor for batch units should be based on an 8-hour burn cycle. The
-volumetric waste burning capacity factor presented in the final HMIWI standards and
guidelines is 0.563 Ib/hr-ft3, based on an 8-hour batch burn cycle.
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3.3 PERFORMANCE AND COST OF TECHNOLOGY
Comment: One commenter (TV-D-745) submitted a statistical analysis of MWI
emissions test data that accounts for the variability of emissions at individual facilities over
time. The methodology used in the analysis was based on the Combustion Emissions
Technical Resource Document (CETRED) which was prepared to understand the variability of
emissions from hazardous waste incinerator(s) (HWI). The commenter stated that the emission
limitations should not be set so low that the facility would occasionally exhibit emission levels
which were out of compliance, in spite of normal operation. The commenter acknowledged
difficulties in conducting statistical analyses on such a small data set. However, based on the
statistical model, the commenter concluded that the MACT floors for lead (Pb) and cadmium
(Cd) could "presumably" be met by new installations with wet scrubbers and "surely" by
facilities with fabric filters. The commenter concluded that both wet and dry scrubbers could
meet the mercury (Hg) MACT floor and that MWI with wet scrubbers have "barely" met the
proposed dioxin MACT floor for new large units (0.6 ng/dscm TEQ), leaving no room for
variation. The commenter contended that a TEQ level of 2.3 ng/dscm would be more
reasonable for all sizes of MWI. The commenter pointed out that dry scrubbers cannot meet
the 15 ppm hydrogen chloride (HC1) limit shown in the 1996 "proposal" and argued that there
is no justification for setting the HC1 limit for new MWI below that accepted for municipal
waste combustors (25 ppm or 95 percent control). The commenter stated that activated carbon
injection would be necessary if the emission limits for Hg were reduced and for a TEQ
emission limit of 0.6 ng/dscm. The commenter argued that activated carbon injection would
be burdensome and unjustifiable for small and medium facilities. The commenter suggested
that States could require mercury control on a site-specific basis when modeling of emissions
indicates concentrations as high as 10 percent of acceptable health risk-based levels.
Response: The EPA's conclusions regarding performance of technology are based on a
review of available emission test data from MWI. As the commenter points out, the data set is
relatively small, making statistical analyses difficult. However, EPA's conclusions were
presented to air pollution control device vendors for their review. Wet scrubber vendors
indicated they routinely provide guarantees to their customers at levels comparable to the
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achievable emission levels EPA selected for wet scrubbers. Dry scrubber vendors indicated
they routinely provide guarantees to their ^customers at levels comparable to the achievable
emission levels EPA selected for dry scrubbers (with and without carbon injection). As
^discussed later in this section, EPA has concluded that combined dry/wet scrubbers with
-scarbon can achieve the emission levels of a wet scrubber and the emission levels of a dry
-scrubber with carbon. The commenter's concern that the emission limits should be set taking
|anto account variability so they are not set artificially low is well taken. This is EPA's goal.
jiHowever, the commenter's analysis does not appear to contradict EPA's conclusions. Instead,
the commenter appears to misunderstand EPA's conclusions.
Based on emissions test data, the EPA determined that MWI equipped with wet
-scrubbers could meet a dioxin/furan emission limit of 2.3 ng/dscm Toxic Equivalent Quantity
(TEQ) and that MWI with a combined dry/wet control system with carbon injection could
smeet a dioxin/furan emission limit of 0.6 ng/dscm TEQ. Thus, EPA did not conclude that
MWI with wet scrubbers could meet a dioxin/furan emission limit of 0.6 ng/dscm TEQ. The
EPA agrees with the commenter that carbon injection would be necessary to achieve
- 0.6 ng/dscm TEQ. The commenter also states that the MACT floors for Pb and Cd could
"presumably" be met with a wet scrubber, in spite of the data presented by the commenter
indicating some wet scrubbers were unable to meet the MACT floor emission level. It is
EPA's conclusion that the MAGT floor emission levels for Pb and Cd on new medium and
large MWI are not consistently achievable by^a-wet scrubber alonet With regard to HC1, again
EPA agrees with the commenter that a dry scrubber alone will have difficulty achieving
15 ppm. The 15 ppm value is based on a wet scrubber. As discussed elsewhere, EPA has
concluded that MACT for new medium and large MWI should be based on a combined
dry/wet scrubber with activated carbon. Regulatory analysis for new MWI. is discussed further
-in Section 5.
With regard to the commenters statement that the MWI HC1 limit should be no more
Astringent than the municipal waste combustor (MWC) HC1 limit, EPA disagrees. Municipal
waste combustors differ from MWI in size, design, baseline emissions, and available air
^pollution control technologies. Because of differences in the air pollution control technologies,
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the MACT floors and achievable emission levels are different for MWI and MWC. The MWI
NSPS and emission guidelines are to reflect the level of control currently achieved in practice
on MWI. Emissions test data indicates that MWI with wet scrubbers can achieve an HC1
emissions level of 15 ppm (or 99 percent reduction). Therefore, the HC1 emission limit for
new MWI is 15 ppm (or 99 percent reduction) instead of 25 ppm (or 95 percent reduction) as
required under the MWC standards and guidelines.
Comment: One commenter (TV-D-789) indicated that the same add-on controls used to
control nitrogen oxide (NOJ emissions from MWC could be used to control NOX emissions
from MWI. The commenter explained that NOX emissions could be reduced by minimizing
fuel NOX through pollution prevention, minimizing thermal NOX production through
combustion controls, and minimizing the remaining NOX formed via add-on controls. Two
commenters (TV-D-562 and IV-D-613) argued that the NOX limit is not achievable for the full
spectrum of medical waste streams; for example, those with high levels of nitrogen bearing
organic compounds. One commenter (TV-D-613) stated that the limit will be exceeded during
a 12-hour stack test.
Response: During combustion, NOX is formed through oxidation of fuel-bound
nitrogen (Nj) contained in the medical waste and oxidation of atmospheric N2 (from the
combustion air). Because the chemical composition of most waste items is unknown, it is
unlikely that health care facilities will be able to segregate nitrogen-containing wastes from
their waste stream to minimize fuel NOX formation.
Combustion modifications such as controlling temperature and combustion air flow can
be used to minimize fuel and thermal NOX formation. Most MWI are designed to operate with
staged combustion, which limits the combustion air and temperature in the primary chamber
and provides excess air and higher temperatures in the secondary chamber. The lower
temperatures in the primary chamber minimize formation of thermal NOX, and the substoichio-
metric levels of air limit the availability of oxygen (O2) for reaction with fuel-bound or
atmospheric N2 to form NOX. The higher temperatures and combustion air flows in the
secondary chamber allow for completion of the combustion processes initiated in the primary
chamber. The flame temperature in the secondary chamber of most MWI is sufficient to allow
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for combustion of volatile organics and oxidation of carbon monoxide (CO), but is maintained
well below 3000°F, which limits the fornjation of thermal NOX. The NOX emissions from
MWI are very low compared to NOX emissions from other combustion sources. The EPA does
; not know of any MWI that are operating with combustion modifications designed specifically
*for control of NOX formation. Therefore, the final HMIWI standards and guidelines do not
£require combustion modifications for NOX control.
Selective noncatalytic reduction (SNCR) add-on technology has been used to control
SNOX emissions from MWC by reducing NOX to N2 without the use of catalysts. Techniques
include Thermal DeNOx, which injects ammonia into the combustor as a reducing agent; the
NOXOUT process, which injects urea with chemical additives; and a two-stage
.urea/methanol injection process. Maximum emissions reduction occurs when the reducing
agents are injected into a gas stream within a narrow temperature range and the gas is
^maintained hi that range for a sufficient length of time. A discussion of SNCR NOX control
was presented in the proposal preamble for the MWC NSPS (59 FR 181 page 48228). The
use of SNCR at MWC results in NOX emission reductions of about 45 percent.
The EPA has some concerns about the applicability of SNCR to MWI. The SNCR
technology has never been applied to MWI, and several factors may complicate the use of
--SNCR and may reduce its performance level. The periodic charging of waste may cause
- corresponding temperature fluctuations, and the varying moisture and nonhomogeneous nature
of the waste burned. When the temperaturerrises*above the required injection temperature
window, the reducing agent is oxidized to NOX, and NOX emissions can increase. In the event
of low temperatures, unreacted ammonia (NH3) emissions can occur.
Furthermore, uncertainties exist regarding the injection pattern necessary to achieve
- adequate mixing and residence tune in the operating temperature window and in the design and
-^engineering work necessary to develop equipment that could be used in applications with much
^smaller gas flow rates than those for MWC. Consequently, SNCR is not considered a
^demonstrated control technology for MWI.
With the exception of dioxin/furan, the length of the stack testing requirements has
been changed to three 1-hour test runs (i.e., a 3 hourtest). However, because the NOX
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emission limits in the final standards and guidelines are not based on combustion modifications
or add-on NO, controls, testing for NOX is not required.
Comment: One commenter (IV-D-778) supplied information on an incinerator with an
innovative control device which includes a paniculate filter with ceramic collection elements.
The commenter stated that the predicted performance of this filter is 0.005 gr/dscf paniculate.
The commenter indicated that they would submit performance test results for the incinerator
and control device at a later date. The commenter suggested that, considering the performance
of the filter, the environmental impacts, and the cost ($400,000), the system described by the
commenter should be evaluated as if no switching to alternate methods of waste treatment
occurs. The commenter stated that they would communicate with personnel at EPA's Office
of Air Quality Planning and Standards (OAQPS) hi order to provide all necessary data for
establishment of new aix emission standards.
Response: By setting emission limitations rather than control equipment specifications,
the MWI regulations encourage and promote the development of new emission control
technologies that can meet the emission limits at lower costs. While EPA believes that new
technologies should be promoted and encouraged, the EPA relied on the performance and cost
data from commercially available technologies in developing the switching scenario. In the
event that innovative and low cost technologies become available, it is likely that a number of
new and existing MWI will choose not to switch to an alternative treatment technology.
However, EPA believes the switching scenario is still valid because it is based on technologies
that are proven and commercially available to the MWI source category. In any event,
switching is not a requirement, but merely a means to estimate the impacts of the EPA's
regulatory options.
3.3.1 Good Combustion
Comment: One commenter (IV-D-781) stated that EPA has drawn conclusions with
respect to achievable Hg emissions levels for good combustion based on limited data. The
commenter noted that EPA changed its conclusions regarding achievable Hg emission levels
because of high data points from emission tests after determining that common waste
management practices were not employed. The commenter requested that EPA require waste
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segregation practices, especially battery recovery operations, to ensure that good combustion
provides adequate control in practice. Other commenters (TV-D-762/784 and IV-D-784)*
.contended that the Hg emission levels stated in the supplemental notice to be achieved by good
^combustion are unrealistic. The commenters argued that unless the rule contains an
--enforceable requirement to ban sources of Hg from the incinerator, there is no reason to
ffoelieve all generators will be successful in removing Hg sources from their waste stream.
Response: Following the 1995 proposal, Facility A was retested in July 1995 to
^determine the effectiveness of a Hg waste segregation program to reduce Hg from Facility A's
waste stream. The retest results showed that Hg emissions from Facility A were reduced
significantly. Therefore, only runs from condition 4 (during condition 4 waste was being
burned from another hospital) and the retest at Facility A along with the other uncontrolled Hg
emission data were used to set the achievable emission levels for uncontrolled Hg emissions.
2The resulting emission limit developed from the new data set is 7.5 mg/dscm. The final
HMIWI guidelines include an emission limit at 7.5 mg/dscm for facilities meeting emission
limits associated with good combustion. Facilities complying with emission limits associated
-with good combustion must conduct an initial performance test (stack test) to demonstrate
--compliance with the Hg emission limit.
Facilities that are unable to meet the Hg emission limit may choose to remove sources
-of Hg (including batteries) in order to meet the emission limits or add the appropriate control
equipment. However, each health care facility is-unique with regard to waste segregation
practices, and every health care facility may not be able to remove all sources of Hg from their
waste stream. There is not enough available data to conclude that removal of specific
materials from a health care facility's waste stream will reduce incinerator emissions.
^Therefore, an outright ban on specific materials from the incinerator is not justified.
4However, the final HMIWI standards and guidelines require each facility to develop a waste
^reduction plan. The Hg stack test along with the waste reduction plan should be sufficient to
censure compliance with the Hg emission limit.
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3.3.2 Wet Scrubbers
Comment: One commenter (IV-D-792) stated that there is no basis for EPA's
conclusion that activated carbon can be readily injected into wet scrubbing systems without
operational problems. Another commenter (TV-D-789) noted that activated carbon has been
used with dry scrubbers and with wet scrubbers in Europe. The commenter provided some
literature on the use of activated carbon in Europe. Because activated carbon is relatively
inexpensive, the commenter suggested that it be required for all MWI.
* Response: In the 1996 reproposal, the EPA noted that there is a possibility that a fixed
activated carbon bed could be used with a wet scrubber for enhanced control of Hg and
dioxin/furan. However, the EPA did not conclude that activated carbon can be readily
injected into wet scrubbing systems without operational problems. As stated in the 1996
reproposal, there is no data upon which to assess the performance of wet scrubbers with
activated carbon and there are no known wet scrubbing systems that currently operate on an
MWI in the U.S. with activated carbon. Thus, the emission limits contained in the final
HMTWI standards and guidelines do not reflect the use of activated carbon in conjunction with
wet scrubbers.
3.3.3 Pry Scrubbers
Comment: One commenter (IV-D-735) requested that EPA lighten the dioxin/furan
limitations. The commenter stated that most tests and research studies of combustion units
directly link exhaust temperature as the true factor in dioxin/furan generation. The commenter
stated that Empire International has developed a dry injection/fabric filter (DI/FF) system that
operates in excess of 850°F, well above the 300° to 600°F window where dioxins form. The
commenter contended that this new DI/FF system will be doomed to additional capital and
operating costs before it goes into operation in January 1997 because EPA is dictating the use
of wet scrubbers. The commenter noted that there are safety hazards when handling carbon or
carbon/dry-reagent blends because the carbon particles can cause black lung-type symptoms if
accidental exposure occurs often enough over a period of time.
Response: The commenter provides no justification for less stringent dioxin/furan
emission limits. The EPA agrees that there is some literature that relates dioxin/furan
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formation to exhaust gas temperature as well as to other factors such as the presence of a waste
vlieat recovery boiler. However, activatedjcarbon is highly effective at removing dioxin/furan
,sfrom exhaust gases. Activated carbon is widely used throughout the chemical industry and for
^.control of emissions from various types of incinerators. The proper use and handling of
^activated carbon will not cause serious health affects, unless as the commenter points out, there
^is repeated accidental exposure over a period of time.
~ Because standards and guidelines developed under section 129 are to reflect the
^performance capabilities of commercially available air pollution control technology, EPA must
assess available air pollution control technologies and draw conclusions regarding their
performance. This concept is often misunderstood and some assume that the regulations
require the use of specific technology. However, the control technology used to achieve the
..standards or guidelines is not specified in the regulations. The regulations only include
^specific air pollution emission limits that a source (i.e., an MWI) must achieve. The emission
limits specified in the standards and guidelines reflect the level of control achieved by current
technology and provide a target level of control for new technologies. Any control technology
-that can comply with the final emission limits may be used. The EPA does not dictate which
technologies must be used to comply with section 129 standards and guidelines.
Comment: One commenter (IV-D-766) pointed out that the emission levels presented
-rin Table 5 of the supplemental notice for dry scrubbers with carbon injection are achievable.
Response: Based on the emission test daiarfrom facilities with dry scrubbers, the EPA
agrees that the emission levels presented in Table 5 of the 1996 reproposal are achievable
using a dry scrubber with carbon.
3.3.4 Combined Dry/Wet Scrubbers
Comment: Four commenters (IV-D-741, IV-D-766, IV-D-790, and IV-D-792)
questioned the data on which EPA established achievable emission levels for combined dry/wet
^scrubber systems. One commenter (IV-D-741) noted that the data from the Hamot Medical
.Center report of May 15, 1990 is probably invalid for three reasons: (1) it was run on
"selected medical waste," not general hospital waste, (2) the exhaust flows are exceptionally
vlow for the burn rate claimed, and (3) the process data" and gas conditions have been
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"scrambled" among Tables 1, 2, 3 and 6 in a manner that causes the whole report to lose
credibility. Another commenter (TV-D-766) pointed out that the 1990 Hamot data used by
EPA to justify the combined dry/wet system is flawed and should not be used for regulatory
purposes. The commenter stated that EPA has data in its possession which shows negative
effects of combining wet/dry systems.
Two commenters (IV-D-790 and IV-D-792) contended that the revised emission levels
were based on invalid test data and invalid assumptions as to the applicability and feasibility of
combination dry/wet scrubbing systems. The commenters argued that combination dry/wet
systems are inappropriate for most medium MWI due to technical, spatial, and operational
limitations. One commenter (IV-D-792) stated that the flue gas flow rates and compositions
presented in the 1990 Hamot test report are very inconsistent with the incinerator feed rates
indicated in the report. Based on combustion calculations and indication in the 1990 Hamot
report that tests were run on "selected medical waste," the commenter argued that the waste
used during the 1990 Hamot testing was not representative of medical waste. The commenter
questioned the logic for the EPA to rely so heavily on the 1990 Hamot test data, which is
questionable, for justifying important assumptions as to the viability of a particular technology
or for justifying the selection of the MACT floor. The commenter noted that in developing the
1995 proposed regulations and through ongoing work leading to the supplemental notice that
EPA has continually made it clear that all submitted test data must to be reliable,
representative, and>well-documented. The commenter also noted that the EPA insisted on
receiving multiple test reports before even recognizing that wet scrubbers are capable of
meeting the originally proposed MACT floor levels. The commenter stated that EPA is being
inconsistent in relying on the 1990 Hamot test report to make important decisions. The
commenter also stated that the limited data on combined dry/wet systems indicates that
inherent process reactions typically occur which tend to cause operational difficulties,
emissions problems, and reliability problems. The commenter stated that salts, mercury, and
dioxin emissions tend to increase due to internal process reactions.
Response: EPA did not rely solely on the data from the 1990 Hamot test report in
drawing conclusions regarding the performance capabilities of combined dry/wet scrubbing
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systems. As discussed later, EPA concluded that the MACT floor for new large and medium
MWI reflects the performance of a combined dry/wet control system. After drawing thi|
initial conclusion, EPA questioned whether any units were equipped with such systems and
-whether there was any evidence suggesting negative effects of combining the two systems.
:: Based on the existence of the Hamot dry/wet system and the 1990 test report, EPA concluded
-°that such systems exist and EPA saw no negative effects of combining the systems.
' In response to concerns regarding the validity of the 1990 Hamot test data, the
^Pennsylvania Department of Environmental Protection was contacted to obtain additional
emissions test reports on the Hamot MWI. A test report was also obtained from an MWI
located at Boston University Medical Center, which is equipped with good combustion and a
DI/FF followed by a packed-bed wet scrubber. While much of the data documenting the
performance of combined dry/wet control systems was considered to be unacceptable, the
-acceptable data indicates that combined dry/wet control systems can achieve the MACT floor
emission limits for PM, HC1, Pb, and Cd. The only valid dioxin/furan data was found in the
Hamot 1993 test report, indicating dioxin/furan emissions of 178 ng/dscm. While this is
higher than the 25 ng/dscm emission limit reflecting a combined dry/wet system with carbon,
this unit is not injecting carbon. Of the two valid Hg test results (Hamot 1992 and Boston
- University), the test result from the MWI at Boston University indicated emissions of Hg
(0.859 mg/dscm) that were slightly higher than the Hg emission limit reflecting a combined
dry/wet system with carbon. Again, the Bostori'-University system? does not use carbon.
Carbon injection has been shown to be highly effective in reducing dioxin/furan and Hg when
used in conjunction with a DI/FF system. Consequently, it is expected that dioxin/furan and
Hg emissions would be reduced substantially if carbon was injected into these systems.
The negative effects to which one commenter has referred is assumed to involve
dioxin/furan emissions data for the MWI located at Boston University Medical Center. Upon
--review of the Boston University MWI test report, discrepancies were found between the
^dioxin/furan emissions data presented in the appendices of the report and in the report
summary tables. When converted to units of ng/dscm at 7 percent O2, the information
presented in the summary tables indicates a dioxin/fprari concentration of 5,182 ng/dscm (total
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basis). It is unclear how the testing company calculated the emission rates and concentrations
presented in the summary table from the data presented in the appendices. Upon recalculation
of the dioxin/furan emissions concentration from the data presented in the appendices, a
concentration of 17.1 ng/dscm (0.389 ng/dscm TEQ) corrected to 7 percent O2 was obtained.
Because the validity of the dioxin/furan concentration is questionable, there is little reason to
believe that the miscalculated dioxin/furan concentration of 5,182 ng/dscm (total basis) is
representative of the performance of combined dry/wet control systems or that the high
dioxin/furan concentration is the result of negative effects of combining dry and wet control
technologies.
While there is evidence that dioxin/furan formation can occur in air pollution control
devices (APCD) under certain conditions, there is no evidence to indicate that there is more
likelihood of dioxin/furan formation occurring when wet and dry control systems are
combined. The EPA emission test program demonstrated that activated carbon used in
conjunction with a dry scrubber will provide high and consistent dioxin/furan removal.
Activated carbon also reduces emissions of Hg. There is no indication that carbon injection
would be any less effective in a dry scrubber used in combination with a wet scrubber. It is
true that formation of salts can occur as a result of internal process reactions in combined
dry/wet control systems. However, performance test data for combined dry/wet control
technologies demonstrates very low emissions of particulate (PM). Therefore, the formation
of salts within the control system does not appear to cause emissions problems.
With regard to the comments concerning the use of "selected medical wastes," it is
common for health care facilities that operate MWI to burn a mixture of general (noninfectious
or black bag) medical waste and potentially infectious (red bag) medical waste. The 1992 and
1993 Hamot test reports indicate that testing was performed using a mixture of 50 percent red
bag and 50 percent general waste. The Boston University test report does not indicate the
composition of the waste. For all three test reports, there is no reason to believe that "selected
waste" was used or that "waste cutting" occurred.
Comment: One commenter (TV-D-779) contended that the financial, environmental,
and energy costs of requiring a wet scrubber in addition to a dry scrubber far outweigh the air
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pollution control benefits of a wet scrubber. The commenter argued that adding a wet
scrubber to a 2,000 Ib/hr system already equipped with a DI/FF system would cost *
^approximately $300,000 per year (not including capital) and would reduce HC1 emissions by
2.66 tons per year. The cost per ton of pollutant removed would be $112,800.
Response: Section 129(a)(2) of the CAA specifies that "the degree of reduction in
Emissions that is deemed achievable for new units hi a category shall not be less stringent than
^Ithe emissions control achieved in practice by the best controlled similar unit, as determined by
«the Administrator." This requirement, referred to as the MACT floor, identifies the least
stringent emissions standards that the EPA may adopt for new MWI. While costs are
considered when examining regulatory options more stringent than the MACT floor, costs are
not considered when determining the MACT floor emission levels. A detailed discussion of
how the MACT floor for new MWI was determined is provided in section 3.4.2.
^Comment: One commenter (W-D-792) contended that because a medium MWI with an
DI/FF has been identified, EPA has assumed that there would be no problems adding a wet
scrubber to it. The commenter stated that combined dry/wet systems are technically infeasible
-for medium MWI for the following reasons: (l)'DI/FF's installed on intermittent MWI are
7 subject to rapid deterioration due to temperature swings, condensation, and acid attacks during
^shutdown; (2) health care facilities that have medium MWI have insufficient space to
- accommodate a DI/FF; and (3) most facilities requiring medium MWI do not generate enough
medical waste or demand enough steam'to justify'mstallation of a waste heat recovery boiler as
required for MWI with DI/FF1 s or combined dry/wet systems.
Response: The EPA did not assume that there would be no technical or spatial
difficulties adding a wet scrubber to an existing DI/FF. The MACT emission levels for
^medium existing MWI are based on emission limits achievable with good combustion and
-either a DI/FF with carbon or a moderate efficiency wet scrubber. Thus, there is no need to
-add a wet scrubber to a medium existing MWI that operates a DI/FF.
As discussed in section 3.4.2, the MACT floor for new medium MWI is based on
emission levels achievable with a combined DI/FF and high efficiency wet scrubber. The
MACT floor reflects the least stringent regulatory option that the EPA may adopt for new
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medium units, regardless of cost, amount of waste generated, practicality of a waste heat
recovery boiler, or demand for steam. Several intermittent MWI operate with DI/FF's and
one intermittent MWI operates with a combined DI/FF and wet scrubber. It is expected that
spatial limitations will be accounted for hi the purchase and design of a new incinerator and
APCD system. In the event that housing for an old incineration system is not large enough to
accommodate a new system and its associated air pollution controls, the air pollution controls
may be placed outside of the incinerator housing. For these reasons, the EPA disagrees with
the commenter's opinion that it is technically infeasible for medium MWI to operate with
combined dry/wet control systems.
Comment: One commenter (IV-D-792) stated that MWI vendors will be extremely
reluctant to offering commercial guarantees to purchasers of MWI with dry/wet systems
because there is very little data to indicate the performance of such systems. The commenter
argued that this reluctance could result in the loss of the MWI incineration industry in the U.S.
which would have detrimental impacts on countless hospitals that rely on incineration.
Response: As discussed in section 3.4.2, the MACT floor is the least stringent
regulatory option that the EPA may consider for new MWI. The MACT floor from new
medium and large MWI reflects the use of a combined dry/wet scrubber system. Unless
negative effects (e.g., increased air emissions) can be attributed to combining dry and wet
control systems, the combined system represents the best controlled similar unit (i.e., the
MACT floor). As discussed earlier, the EPA has reviewed performance data for combined
dry/wet control systems at two separate facilities. The combined dry/wet control systems were
supplied to the two facilities by two separate vendors. The performance data do not show any
negative effects of combining dry and wet controls.
3.4 MACT FLOOR
Comment: One commenter (TV-D-769/557) contended that EPA has incorrectly
interpreted section 129 of the CAA mandating that a MACT floor may be adopted as a
standard only if levels of control beyond the floor are not achievable. The commenter argued
that EPA is not required to go beyond the floor.
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Response: Section 129 of the CAA states that standards "shall 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." Thus, section 129 requires EPA to
-examine regulatory options more stringent than the MACT floor, and to select the option that
isreflects the maximum reduction in emissions that EPA determines is achievable, considering
-scosts and other impacts.
3.4.1 Existing MWI
Comment: Two commenters (TV-D-790 and IV-D-792) concurred with the revised
'MACT floor emission levels for existing MWI. However, seven commenters (TV-D-744,
IV-D-757, IV-D-767, IV-D-769/557, IV-D-772, IV-D-780/500, ihd IV-D-782/454) argued
^that the MACT floor should be based on actual measurements rather than permit values. One
commenter (TV-D-744) stated that permit limits are not based on available technology and that
available technology is capable of reducing MWI emissions to levels below the permit limits.
The commenter recommended calculating the MACT floor for each pollutant based on
measured values and dropping plants that have no measured data for a pollutant from the
MACT floor calculation for that pollutant. One commenter (TV-D-757) noted that actual
emissions are well below the State emission limits. Two commenters (IV-D-786 and
IV-D-789) argued that the MACT floor for new; and existing units^calculated by EPA is much
less stringent than required by the CAA because the floor is based on local permits and
emission limits. The commenters also maintained that EPA should have only considered
12 percent of the units for which it had data instead of 12 percent of the entire MWI
population. The commenters stated that this flaw is exacerbated by EPA using data from
-poorly controlled units to fill in the gaps where there was no permit data. The commenters
^contended that EPA's calculation of the MACT floor does not comply with the CAA and cited
-several provisions from section 112 to support their arguments. The commenters requested
that EPA use the actual data that it has and can reasonably obtain to set the new MACT floors
for each pollutant. The commenters recommended the following as the MACT floors for all
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existing units: PM - 0.000683 gr/dscf, HC1 - 1 ppm, SO2 - 1 ppm, NOX - 42.27 ppmv, Hg -
3.347 /xg/dscm, Cd - 0.656 /ig/dscm, Pb -1.785 #g/dscm, CO - 0.171 ppm, and TEQ -
0.01198 ng/dscm. Another commenter (TV-D-754) endorsed the MACT floor calculations
submitted by commenter IV-D-789.
Response: The EPA believes that permit and State limitation data are appropriate to
use in determining the MACT floors for existing HMIWI sources. Section 129(a)(l)(A) and.
(C) state that performance standards and other requirements that are promulgated for HMIWI *.
are established under both sections 111 and 129 of the Act. Standards established for existing
HMIWI must be at least as stringent as the "average emission limitation achieved by the best
performing 12 percent of units in the category (excluding units which first meet lowest
achievable emissions rates 18 months before the date such standards are proposed or 30 months
before the date such standards are promulgated, whichever is later)." This is termed the
MACT floor. "Emission limitation," however, is not defined in either section 129 or section
111.
Congress did provide a definition for "emission limitation" in section 302(k), but did
not clearly indicate whether it intended for this definition to apply to standards promulgated
under sections 111 and/or 129. The starting point for analyzing whether MACT floors should
be based on permit terms and state regulations using the definition of emission limitation
provided in section 302(k) or on actual emission data is the "test" set forth in Chevron v.
IffiDlC, 467 U.S. 837 (1984). Under the Chevron test, the reviewing court will first ask
whether Congress has "directly spoken to the precise question at issue." Chevron. 467 U.S. at
842. If Congress has not "directly spoken to the precise question at issue," the court will
proceed to the second prong of the Chevron analysis, in which it must uphold the Agency's
interpretation if it is a "permissible construction" of the statute. £L at 843.
The EPA concludes from its analysis of the statutory language that Congress has not
clearly indicated which interpretation it intended. The EPA therefore does not believe that the
language of section 129 clearly requires it to use regulatory and permit data to set the MACT
floor, or clearly requires it to use actual data.
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For example, although the EPA could interpret the statute as requiring it to apply the
definition of emission limitation in section;302(k) to section 129(a)(2), that application would
result in a conflict with the language of section 11 l(h). Section 302(k) provides:
The terms "emission limitation" and "emission standard" mean a requirement
established by the State or the Administrator which limits the quantity, rate, or
concentration of emissions of air pollutants on a continuous basis, including any
requirement relating to the operation or maintenance of a source to assure
continuous emission reduction, and any design, equipment, work practice or
operational standard promulgated under this chapter.
42 U. S. C. § 7602(k) (emphasis added). Section 111 (h), however, provides:
For purposes of this section, if it is not feasible ... to prescribe or enforce a
standard of performance. . . . [the Administrator] may instead promulgate a
design, equipment, work practice, or operational standard, or combination
thereof, which reflects the best technological system of continuous emission
reduction which (taking into consideration the cost of achieving such emission
reduction, and any non-air quality health and environmental impact and energy
requirements) the Administrator determines has been adequately demonstrated.
42 U.S.C. § 7411(h)(l) (emphasis added). Since 1970, section lll(a)(l) has incorporated the
.following language in its definition of "standard of performance":
[A] standard for emissions of air pollutants which reflects the degree of
emission limitation achievable through the application of the best system of
emission reduction which (taking into account the cost of achieving such
reduction and any non-air quality health and environmental impact and energy
requirements) the Administrator determines has been adequately demonstrated.
See 42 U.S.C. § 7411(a)(l) (emphasis added). The 1977 Amendments of the Act amended the
definition of standard of performance to include a requirement that the Administrator also must
take into account "any non-air quality health and environmental impact and energy
requirements . . .." 42 U.S.C. § 7411(a)(l). Thus, since section lll(h) authorizes the EPA
to promulgate "a design, equipment, work practice, or operational standard" instead of a
performance standard, and section lll(a)(l) defines a performance standard in terms of
emission limitation achievable, one cannot unequivocally conclude that Congress intended for
'the definition of emission limitation provided in section 302(k) to apply to section 111. And
since HMIWI standards are promulgated under both sections 129 and 111, one cannot
unequivocally conclude that Congress intended for section 302(k) to apply to section 129.
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Moreover, such an interpretation is contrary to the interpretation that the EPA
consistently has given to a phrase in section lll(a)(l) that uses similar terminology. That
section states, "The term 'standard of performance1 means a standard for emissions of air
pollutants which reflects the degree of emission limitation achievable through the application
of the best system of emission reduction . . .." 42 U.S.C. § 7411(a)(l) (emphasis added).
The EPA also does not agree with the commenters who stated that Congress intended
for the EPA always to use actual emissions data to set the MACT floors when the data are
available. For some emission standards, using actual data to set the MACT floors may be
inappropriate based on the facts applicable to the standard being set. In some cases actual
emissions data may not be available. In other cases use of actual data may result in MACT
floors that no unit, nor any technology, can continuously meet. For example, the MACT
floors based on actual data that were submitted by commenters IV-D-786 and IV-D-789 are
not continuously achievable with any single unit or control technology.
Section 129(a)(2) requires MACT standards to be at least as stringent as the MACT
floor. Not only does the definition of "MACT" emphasize achievable~i.e., maximum
achievable control technology-but case law also requires standards promulgated under
section 111 to be achievable "under the range of relevant conditions which may affect the
emissions to be regulated " National Lime Ass'n v. EPA. 627 F.2d 416, 433 (D.C.C.
1980).
An achievable standard does not have to be one that is already routinely achieved in industry,
but it must be one that is capable of being met under most adverse conditions which reasonably
can be expected to recur and which are not or cannot be taken into account in determining the
'costs' of compliance." Li. at 431 n.46. Thus, the EPA concludes that Congress did not
intend for the EPA to always use actual emissions data to set MACT standards, because
Congress would not have intended for the EPA to promulgate standards that are at least as
stringent as the MACT floor, when the MACT floor itself is not achievable continuously.
In general, EPA believes that National Lime requires it to promulgate standards that are
achievable under the range of relevant operating conditions. This case is particularly
applicable here because Congress expressly stated in sections 129(a)(l)(A) and (C) that
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standards and other requirements for HMIWI are to be promulgated under both sections 111
and 129. Accordingly, EPA disagrees wfth the commenter that stated that the achievabiHty
requirements in National Lime do not apply to MACT floor determinations. Under the
icommenter's view, if a MACT floor was not achievable continuously due to, for example,
'- expected operating variability of the very units that were used to derive the MACT floor, EPA
"twould be required to set the standard for all units in the category at or more stringent than the
fefloor irrespective of the holding in National Lime. EPA does not believe that this is what
^Congress intended.
The EPA does agree that actual emission data routinely fall below the State and permit
emission limits. In choosing a technology to meet State and permit emission limits, facilities
must choose a technology that will achieve those limits on a continuous basis. Therefore, test
data will frequently be lower than permit/State emission limits. However, this does not mean
that the MACT floor must reflect the lower actual emission levels, particularly when these
levels are not routinely achieved in practice.
Although there are several similarities between sections 112 and 129, EPA does not
-agree that language from section 112 should be impliedly read into section 129, as raised by
Commenter IV-D-789. For example, section 129 simply states that the MACT floor must be
calculated based on the "best performing 12 percent of units in the category." Section 129
does not include the language in section 112(d)(3)(A) that requires the MACT floor for
existing sources in a category to be based on the best performing 12 percent of existing sources
"for which the Administrator has emissions information." [Emphasis added.] Since the
standards promulgated today are being promulgated under sections 129 and 111, EPA is not
expressing an opinion here as to what the language in section 112 requires. EPA does note,
"though, that since Congress did not include the phrase emphasized above in section 129, any
-reliance on that phrase by the commenter is misplaced. Similarly, reliance on the MACT floor
^determination under section 112 for categories with fewer than 30 sources, and other citations
^to section 112, are not appropriate given that today's standards are being promulgated under a
separate MACT section of the Act--i.e., section 129. Thus, EPA disagrees with the comment
that the MACT floor for HMIWI must be based only on units for which EPA has data.
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As the above discussion establishes, Congress has not "directly spoken to the precise
question at issue" [Chevron 467 U.S. 837 (1984)]--namely, whether it intended for the EPA to
apply the definition of section 302(k) to section 129 when setting MACT floors, or to use
actual emissions data when the data are available as some commenters have asserted. In the
HMIWI rulemaking, however, the EPA believed that only one of the two interpretations was
reasonable based on the data on hand-i.e., use of permits and regulatory data as the basis for
existing MACT floors. This is because EPA only had actual emissions data from
approximately one percent of the existing HMIWI (i.e., data from less than 30 sources).
Although EPA could use these data to characterize the performance of various technologies,
EPA could not conclude from the data whether they represented the performance achieved by
the best performing 12 percent of sources-i.e., EPA did not know if the data were
representative of the best performing sources in the category. Accordingly, EPA used
regulatory and permit data because the EPA could conclude from these data what the best
performing 12 percent of existing HMIWI were able to achieve.
In response to the comment that EPA did not know whether the sources actually were
achieving their permitted limits, this addresses the achievability of the limits, not whether or
not the limits themselves were appropriate for EPA to use when setting the MACT floors. The
EPA did not receive any comments that stated the permitted limits were not achievable and
thus, should not be considered because they were not "emissions limitations achieved by the
best performing 12 percent."
Moreover, the MACT floor is only the beginning point of EPA's regulatory analysis
because the EPA is required to consider regulatory options more stringent than the MACT
floor when determining the MACT emission guidelines. Actual performance test data were
used when considering regulatory options more stringent than the MACT floor. For example,
after EPA determined which technologies could be used to achieve the MACT floor emission
levels, the EPA considered the emissions levels that are routinely achievable with other
technologies as demonstrated by performance data from these technologies. Although the
MACT floor emission levels were based on permit data, the MACT guidelines reflect the
capabilities of current technology.
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Emissions data fromEPA1s test pix)giuniwere used to fill in the gaps where there were
no permit data. Most States have not established permit limits for several of the pollutants to
* ° ' -"": iil^nuu-V".'. ' -SpftL,' ..-';-?.*': '.**- *
be regulated under the MA'Cl* emission gulde1nie₯J~ Therefore, there was not a sufficient
number of permit limits to represent 12 percent of the existing MWI population for some
^pollutants. For example, when establishing the Hg MACT floor for large MWI, permit limits
- >, ,- .-.;.i,.i, .-. ._ .. .-, ./ ,, .....stes .._ .. ,-. , , .,
*were not available to represent 12 percent of the existing large MWI population. Therefore,
*data that reflects uncontrolled emissions from Hg were used to represent the remaining
%12 percent of MWI for which there were no permit limits. Using this methodology, the Hg
MACT floor for large existing units was determined to be 6.61 mg/dscm. Although the
MACT floor for Hg was 6.61 mg/dscm, the PM limit (0.021 gr/dscf) requires the use of a
'high efficiency wet scrubber. Therefore, the Hg emission limit was set at 0.55 mg/dscm, the
emission limit associated with a high efficiency wet scrubber. Similar methodology was used
-in determining the MACT floor for other pollutants for which there were insufficient permit
data. However, as was the case for Hg, use of the high test data did not affect the MACT
level of emissions control because the control necessary to achieve the PM limit met or
exceeded the level of control necessary to achieve other emission limits. Even though
-uncontrolled data were used to calculate the MACT floor for some pollutants, the MACT
- guidelines reflect the capabilities of current technology and are not less stringent than the CAA
requires.
Comment: One commenter (W-D-785)"stated that the procedure used to standardize
the 708 available permit limits contains errors and faulty assumptions. The commenter noted
that exhaust was assumed to be at 14 percent O2 for all calculations and that slight differences
in percent O2 could result in significant differences in emissions. The commenter also noted
0.9 dscfm/lb/batch was assumed for all batch MWI and 3.16 dscfm/lb/hr was assumed for
other MWI. The commenter stated that exhaust flow rate is a critical factor in determining
-emissions and therefore, it is not appropriate to use one factor for all batch units. The
-'Tsommenter also argued that the HC1 percent reduction used to determine the MACT floor
Should be based on that which is actually achieved per unit, not one value per category. The
commenter requested that EPA reevaluate the MACT floor using actual data.
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Response: Over 700 MWI permits were received from State and local agencies. In
.order to use these data to calculate the MACT floors, certain assumptions had to be made to
convert mass emission limitations to concentration-based emission limitations. The permit
information did not contain information on O2 concentrations, uncontrolled emission levels,
and flow rates; therefore simplifying assumptions had to be developed. These assumptions
required using information obtained from EPA's test data on typical O2 concentrations,
uncontrolled emission levels, and typical flow rates. As discussed above it would be
impossible to reevaluate the MACT floor using actual data because facility-specific data
typically were not included in the permit or in many cases testing was not required.
Comment: Two commenters (IV-D-762/784 and IV-D-784) argued that failure to
calculate MACT floor emission levels for HC1, SO2, Pb, Cd, Hg, and dioxin is misleading and
does not quantify the environmental impact of the actual emissions of these pollutants from
each of the subcategories.
Response: The MACT floor is not a measure of actual emissions. It is a measure of
the level of air pollution control currently used by a relatively small fraction of MWI. The
purpose of the MACT floor is to establish the least stringent regulatory option that EPA may
consider. Separate calculations of baseline emissions are developed to characterize the
emissions of each pollutant from MWI.
3.4.2 New MWI
Comment: Three commenters (IV-D-741, IV-D-748, and IV-D-766) disagreed with
the revised MACT floor for new MWI. One commenter (TV-D-741) argued that the MACT
floor for medium units is being set based on theory, and not on practice, which is what the
CAA requires. The commenter contended that the MACT floor for new MWI has been made
artificially more stringent by sophistry beyond the CAA's intentions. Another commenter
(TV-D-748) contended that the MACT floor for new incinerators poses an unreasonable burden
on the regulated community. The commenter, and another commenter (IV-D-766), argued
that the combined dry/wet system is not proven technology. The commenters recommended
that EPA base the emission limits on control equipment that is in actual operation in the United
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States. The commenters requested that EPA choose emission limits that may be met with
either a dry or wet scrubber system.
One commenter (IV-D-744) indicated that the 1989 to 1992 inclusive, uncorrected data
-= for the Hamot Medical Center facility should not be used in the MACT floor calculation
-because of the way the emission concentrations were calculated. The commenter stated that
^revised correctly calculated values for Hamot stack emissions are available from the State of
^Pennsylvania and should be used in the MACT floor calculation.
One commenter (IV-D-735) indicated that a MACT floor based on nine pollutant
constituents (pollutant by pollutant) cannot be accomplished with any type of economic
feasibility. The commenter stated that each MWI system is its own entity with operating
parameters and special conditions intrinsic to its location, type of waste feedstocks, operating
hours, air pollution control, and feed systems. The commenter recommended that EPA revise
-its formula for establishing the nine emission limits to the following: (1) review test data and
confirm that no "waste cutting" occurred, (2) ensure that the tested units are representative of
the four U.S. regions (east coast, midwest, mountain, and west coast) and contain similar
control technology, (3) determine the nine units for eacfi pollutant constituent, and (4) use the
- average of the nine pollutant constituents found in the nine unit's permit limits to set the
emission limits. The commenter explained that this methodology would allow reasonable
limits that do not require a combination of scrubbing systems.
One commenter (TV-D-779) questioned-whether there are any combined dry/wet
systems that achieve in practice the revised MACT floor emission levels announced in the
supplemental notice. The commenter stated that units with good combustion and a DI/FF with
carbon injection can meet all of the limits in the supplemental notice with the exception of
HC1. The commenter stated that the DI/FF system reduces dioxins more effectively than the
^dry/wet configuration. The commenter argued that the DI/FF system with carbon is
achievable and reflects the best controlled similar unit, and therefore should represent the
:MACT floor.
Response: 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
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the emissions control achieved hi practice by the best controlled similar unit, as determined by
the Administrator." This requirement, referred to as the MACT floor, identifies the least
stringent emissions standards that the EPA may adopt for new MWI.
As discussed in the 1996 reproposal, the EPA has determined that the MACT floor
emission levels for new medium MWI may be achieved using good combustion and a
combination of two control technologies, a DI/FF and a high efficiency wet scrubber. At least
one existing MWI 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 is based on
both of these technologies (i.e., a.combined dry/wet scrubber system) because the wet
scrubber achieves the lowest dioxin/furan, HC1, and Hg emissions, but the DI/FF without
carbon injection achieves the lowest Pb and Cd emissions. While no combined dry/wet
scrubber systems were identified on medium MWI, these systems are currently in operation on
large MWI. Similarly, the MACT floor for new large MWI is based on the emission levels
that are achievable with good combustion and a combination of two control technologies, the
high efficiency wet scrubber and the DI/FF system with activated carbon.
The EPA does not agree that the MACT floors are to be based upon one overall unit.
Rather, as discussed below, the EPA believes that section 129 supports the interpretation that it
is legally permissible for the EPA 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 hi emission 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 . . .." 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
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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. ^
Other statutory provisions are relevant, although they also do not decisively address this
issue. Section 129(a)(4) requires MACT standards for, at minimum, PM, opacity, suliur
'-dioxide, hydrogen chloride, oxides of nitrogen, carbon monoxide, lead, cadmium, mercury,
^and dioxins and dibenzofurans emitted by MWI. 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.
The recommended approach of commenter IV-D-735 has been reviewed in light of
section 129 and the discussion above. With regard to the commenter's first point, all data is
reviewed as much as possible to ensure no "waste cutting" has occurred. As discussed in
Section 3.3, air pollution control vendors agree with EPA's conclusions regarding the
performance capabilities of wet scrubbers and the performance capabilities of dry scrubbers
with carbon. The EPA's conclusions regarding the performance capabilities of combined
dry/wet systems were discussed earlier. With regard to the commenter's second point, iiiere is
-no justification for a distinction in incinerator technology by geographic location. For
purposes of calculating the MACT floor, subcategories must reflect differences in the
incinerator, not in it's location or it's air pollution control. Finally^, with regard to the
commenter1 s third and fourth points, the MACT floor for new units is to be based on the best
controlled unit, not on the average of nine units.
Only limited emissions data is available for MWI with combined dry/wet control
systems. However, the available data indicate that the MACT floor emission levels for new
^MWI are achievable and technically feasible. The performance of dry scrubbers with activated
"carbon injection and the performance of wet scrubbers is well documented, and there is no
-evidence that combining the two systems is technically infeasible.
Comment: One commenter (TV-D-786) stated that EPA based the MACT floor for
new units on permit data and assumptions about the performance of certain control
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technologies (i.e., on assumptions about what the technology attached to the unit with the most
stringent permit can achieve). The commenter requested that EPA comply with the CAA and
set standards for new MWI based on the actual performance of the best controlled unit for each
category instead of permit limits. The commenter and another commenter, (TV-D-789),
recommended that a fabric filter be used for all new MWI to ensure paniculate control. The
commenters recommended the following as the MACT floor for new units: PM-0.0006 gr/
dscf, HC1--1 ppm, SO2-1 ppm, NOx-39.53 ppmv, Hg-1.84 //g/dscm, Cd-0.414 Atg/dscm,
Pb--1.2 ^g/dscm, CO--0 ppm, and TEQ--0.0078 ng/dscm.
Response: As discussed elsewhere, section 129(a)(2) requires MACT standards to be at
least as stringent as the MACT floor. Not only does the definition of "MACT" emphasize
achievable--!, e., maximum achievable control technology-but case law also requires standards
promulgated under section 111 to be achievable "under the range of relevant conditions which
may affect the emissions to be regulated . . .." National Lime Ass'n v. EPA. 627 F.2d 416,
433 (D.C.C. 1980). An achievable standard does not have to be one that is already routinely
achieved in industry, but it must be one that is capable of being met under most adverse
conditions which reasonably can be expected to recur and which are not or cannot be taken
into account in determining the 'costs' of compliance." The MACT floor presented by the
commenter is not continuously achievable.
The MACT floors calculated by EPA for new units are based on actual performance
data and not permit limits. All valid data from dry scrubbing systems was used to determine
the performance capabilities of dry scrubbing systems. All valid data from wet scrubbing
systems was used to determine the performance capabilities of wet scrubbing systems. When
determining the MACT floors, the best controlled unit in each subcategory was identified for
each pollutant (based on the air pollution control technology in place and EPA's conclusions
regarding the performance capability of the air pollution control system). In accordance with
section 129, the MACT floors are based on the performance of the emission control
technologies for the best controlled similar units.
Comment: One commenter (TV-D-740/743) provided information on the performance
and costs of dry/wet control systems installed on MWI at King's College Hospital in London
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and at King George's Hospital in Goodmayes. The commenter stated that there are only slight
differences between British testing protocols and EPA methods. Consequently, the commenter
stated that consistent results may be obtained by either the British testing protocols or EPA
testing methods. Another commenter (IV-D-744) stated that all appropriate stack emission
^values from American designed and fabricated MWI wherever they are sited in the world
^should be applicable for the MACT determination. The commenter recommended including
^measurements made at the U.S. built facilities at King George's Hospital in Goodmayes and
"Eastbourne in the United Kingdom. The commenter stated that the methods used to determine
the emissions from the MWI located outside of the U.S. are similar to the U.S. testing
methods. The commenter suggested that the emission limits for new MWI should be at least
as stringent as the current European Union (EU) Standards and that all MWI should be
required to meet the EU standards within 10 years.
Response: Although not precluded from using foreign data, the EPA has chosen to rely
on performance and permit data from domestic MWI. It is difficult to compare European
performance data to U.S. performance data due to differences in test methods, quality
assurance procedures, arid emissions test reporting arid documentation methods. For this
reason, the data from European plants submitted by commenter IV-D-740/743 were not used
in selecting the MACT floor emission levels and NSPS emission limits.
The EPA disagrees with the commenter who recommends that all MWI should be
required to meet the EU standards. There are differences betweeri^the EPA and EU standards
with regard to regulatory flexibility, compliance, and test methods used to measure emissions.
These factors must be considered when comparing the respective emission requirements.
Comment: Two commenters (TV-D-790 and IV-D-792) stated that dry/wet systems are
-only offered by a single vendor that has patent restrictions and requires the Use of proprietary
compounds. The commenters stated that endorsement of the dry/wet system may be contrary
no Federal regulations prohibiting special favoritism. One commenter (IV-D-792) noted that
*the dry/wet system process parameters are patented, a proprietary compound is injected into
the flue gas, and that various system components are fabricated using special alloys and
proprietary materials. The commenter stated that the only vendor of the dry/wet system is
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affiliated with an incinerator vendor. The commenter contended that the relationship between
the incinerator and dry/wet system vendor would be an obvious problem for other incinerator
vendors with respect to the procurement of competitively-priced combination wet scrubber and
DI/FF systems.
Response: The performance of MWI with combined dry/wet control technologies
located at two separate facilities was reviewed. One of the MWI was equipped with a
combined dry/wet scrubber system manufactured by the vendor to which the commenters .are
referring. The other MWI was equipped with a dry injection system manufactured by one
vendor, a fabric filter manufactured by a separate vendor, and a packed-bed wet scrubber
(PBWS) manufacturer by yet another vendor. The performance of the two combined dry/wet
control systems was comparable, as is discussed in more detail in section 3.4.2. Thus, data
indicate that conventional dry scrubbers can be used in conjunction with conventional wet
scrubbers.
Comment: One commenter (TV-D-742) requested that the MACT floor for all new
MWI rated below 100 Ib/hr be good combustion alone.
Response: As discussed in Section 3.2 above, a _<_100 Ib/hr subcategory was not
created for the emission standards because there appears to be no apparent technical distinction
between MWI with capacities of j<.100 Ib/hr and MWI with capacities of _<200 Ib/hr.
Therefore, new MWI with capacities below 100 Ib/hr are subject to the same emission limits
as MWI in the _
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not operate at the proper temperature and accordingly does not use good combustion. The
commenters argued that the use of State permit emission limits in the baseline emissions
calculations is inappropriate where States do not regulate certain pollutants or exempt small
MWI from permitting requirements. The commenters stated that the high data point that drove
rthe Hg emission limit up at the 1995 proposal is representative of Hg emissions that could
"occur at facilities that do not segregate Hg from their waste stream. The commenters
^explained that unless the final rule contains an enforceable requirement to ban Hg from MWI,
=there is no reason to believe that all generators will be successful at removing Hg from their
waste stream. Accordingly, the commenters advised that EPA should not calculate MWI Hg
emissions based on 7.5 mg/dscm, unless EPA will require add-on controls capable of
achieving this limit or ensure that Hg-containing substances are not charged into the
incinerator.
Response: In presenting the environmental impacts in the 1996 reproposal, space
limitations dictated that only total air emissions from each regulatory option were presented.
To include a breakdown by subcategory for all the regulatory options would have required an
additional 18 tables; therefore, it was decided that only a summary of the annual emissions,
not broken out by MWI subcategory, would be included. For persons interested in further
detail on air impacts (including emissions by subcategory), a reference of the memorandum
documenting the procedures and the results was included in the June Federal Register notice.
This reference is located in Air Docket No. A-91-61 as item No. IV-B-51. In addition, a
breakdown of the baseline emissions by subcategory was provided to the commenter in a
meeting on July 9, 1996 in Washington, D.C.
Contrary to the commenter's contention, startup and shutdown operations were
included in the estimate of baseline emissions for small MWI. While there is no data available
(and none was supplied by the commenter) to determine if startup and shutdown emissions are
"higher or lower than during steady-state operation, emissions were assumed to continue at the
same rate throughout the combustion cycle. On the other hand, because poor combustion and
higher emissions can result from improper startup and shutdown, the final regulations define
startup and shutdown as periods when no waste is burning. Incinerators are required to attain
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their minimum operating temperatures before waste combustion begins and maintain their
operating temperatures until waste combustion ends, avoiding periods of poor combustion.
In developing the baseline emissions from the existing MWI inventory, the type of
emission control on each MWI was estimated based on (1) the average PM emission rate for
the different types of emission controls and (2) the PM limit to which the MWI is subject. For
example, the average PM emission rate for intermittent and continuous MWI with 1/4-second
combustion control was estimated from test data to be 0.30 gr/dscf. All continuous and
intermittent MWI with PM emission limits greater than or equal to 0.30 gr/dscf were assumed
to be equipped with 1/4-second combustion control only. Consequently, State permits and
regulations were not used directly in estimating baseline emissions. State permits and
regulations were used to estimate the level of air pollution control likely to be present at each
MWI. Once the level of air pollution control was determined, actual emissions data were used
to estimate the baseline emissions.
In the example mentioned above, the acid gas and metals emissions were assumed to be
uncontrolled. Uncontrolled emission data for all facilities was averaged to determine
uncontrolled emission rates. For the purpose of calculating baseline emission rates, the high
Hg data points were included hi the baseline calculation. However, for the purpose of
estimating future emission levels, Hg emission rates were determined excluding the high Hg
emission levels. As discussed in section 3.3.1, Hg stack testing and a waste reduction plan
will be required to ensure compliance with the Hg emission limit.
Comment: One commenter (IV-D-767) stated that FJPA has adjusted the dioxin
emission rate downward based on conditions assumed to occur hi the burner. Specifically, the
commenter stated that gas residence times and temperatures were assumed instead of being
based on empirical measurements. The commenter noted that the assumption of longer
residence time increases the destruction of dioxin/furan, and lowers the dioxin/furan emission
rate. The commenter stated that the assumed operating conditions were obtained from
operating specifications provided by MWI manufacturers or incinerator operators.
Response: Only a small number of MWI nationwide have been tested for dioxin/furan,
therefore a number of assumptions had to be made in estimating the nationwide dioxin/furan
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emissions from MWI. In estimating nationwide emissions, the Agency began with a data base
of existing MWI. This data base contained the name, location, size, identification as ;
commercial or noncommercial, and in some cases the associated control level. Actual control
-information was used where available, but where it was unavailable, estimates were necessary.
"'When emission control system type was unknown, it was estimated based on (1) the average
%PM emission rates from the different types of emission controls and (2) the PM limit to which
%he MWI is subject. For example, the average PM emission rate for intermittent and
continuous MWI with 1/4-second residence tune in the secondary chamber was estimated from
available test data to be 0.30 gr/dscf. Thus, any MWI with an emission limit greater than 0.30
was assumed to have 1/4-second combustion system. Based on information collected during
the EPA sponsored testing program, a correlation was seen between the residence time and the
associated dioxin/furan emissions. Based on this correlation, dioxin/furan emission rates were
associated with various levels of residence time. Using this information, dioxin/furan emission
rates were assigned for each MWI.
The Agency agrees that in many cases the gas residence tune, and thus the associated
level of control has been estimated. However, the Agency believes that in light of the lack of
available information, the estimates of gas residence time using PM emission limits are
sufficient to develop baseline emission estimates.
Comment: Two commenters (TV-D-756 and IV-D-776) contended that EPA has
underestimated the dioxin emissions. The commenters stated that prior to its 1990 MWI
rulemaking, the California Air Resources Board (CARB) reported that 127 MWI emitted
16 grams (CA TEQ) of dioxin during incineration of 20,000 tons of medical waste, or
approximately 4 micrograms of CA TEQ per pound of waste incinerated. The commenters
-stated that this factor (4 //g/lb waste) provides 0.125 grams of CA TEQ per year from a
diverse group of MWI. Using this approximation, the commenters concluded that the
~2,400 MWI identified by EPA should emit approximately 300 grams CA TEQ of dioxin per
^year instead of 150 TEQ. The commenters cited the EPA estimates that 500,000 tons or
* 3.36 million tons of medical waste is burned annually. Based on California's experience,
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these commenters concluded that 500,000 tons of waste could produce 4,000 grams of CA
TEQ and 3.36 million tons would produce over 22,000 grams of CA TEQ.
Response: There are several reasons for the differences in the EPA estimates of TEQ
and the GARB estimates of CA TEQ. First, current EPA TEQ and 1990 CA TEQ are not the
same because the toxic equivalency factors (TEF's) applied to different dioxin/furan isomers in
developing the 1990 CA TEQ estimates are different than the current EPA TEF's.
Second, the 500,000 tons/yr and 3.36 million tons/yr estimates cited by the commenter
are 1994 estimates of the amount of infectious and total (infectious and noninfectious) waste,
respectively, generated by the entire health care industry. These estimates represent the waste
generated by approximately 682,400 facilities including hospitals, nursing homes, clinics,
laboratories, blood banks, industry health units, rescue operations, and so on. Not all of these
facilities operate MWI. Thus, the 500,000 and 3.36 million tons/yr estimates do not represent
the amount of waste burned by the health care industry in 1994. The current estimate of the
amount of total (infectious and noninfectious) waste burned by health care facilities with MWI,
which was used in determining the baseline TEQ emissions, is 846,000 tons/yr.
Third, the 0.125 grams per year estimate is very dependent upon the size and type of
MWI used to develop that estimate. Approximately 53 percent of the medical waste burned in
California in 1990 was burned in controlled MWI, and the remaining 47 percent was burned in
uncontrolled MWI. The ratio of the waste burned in controlled and uncontrolled MWI in the
current EPA inventory is different than for the waste burned in MWI in California in 1990.
This is partly because a number of States have adopted regulations that require controls for
MWI since 1990. Around 67 percent of the waste burned in MWI in the EPA inventory is
burned in controlled MWI, which results in a lower estimate of 150 grams of TEQ per year.
Also, 16 grams per 20,000 tons of waste equals 0.4 micrograms per pound instead of
4 micrograms per pound. Using this ratio, 400 grams CA TEQ would be associated with
500,000 tons of waste and 2,700 grams CA TEQ would be associated with 3.36 million tons
of waste, instead of 4,000 and 22,000, respectively. Nevertheless, for the reasons discussed
above, the estimates of 1990 CA TEQ are not necessarily applicable to current levels of TEQ
from the nationwide MWI population.
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3.6 OPERATOR TRAINING AND QUALIFICATION
Comment: Six commenters (TV-D-760, IV-D-765, IV-D-769/557, IV-D-781, ;
IV-D-785, and IV-D-792) supported EPA's acceptance of a State-approved operator training
and qualification program. One commenter (TV-D-760) maintained that States should be given
?the responsibility with a clear directive to consider in-house (onsite) programs for approval.
^ Three commenters (TV-D-748, IV-D-790, and IV-D-792) supported the proposed
previsions to the operator training and qualification requirements. The revised operator training
^requirements would allow operators to be trained through a State-approved program or by
completing a training course with 24 hours of instruction, passing an examination, and
receiving a handbook. The revised requirements would also allow operators to be easily
accessible (or on call) while the incinerator is operating. One commenter (TV-D-748)
requested that EPA finalize the operator training requirements described in the supplemental
^notice.
Response: Operator training may be obtained through a State-approved program or by
completing and passing a training course with (1) 24 hours of classroom instruction, (2) an
-examination designed and administered by the course instructor, and (3) reference material
^distributed to the attendees covering course topics. Thus, in-house operator training may be
^conducted if it meets these minimum criteria.
The revised operator training and qualification requirements described in the 1996
reproposal are nearly the same as the operator training requirements adopted for the final
HMIWI rule. As indicated in the 1996 reproposal, the final operator training requirements
allow qualified MWI operators to be easily accessible or on call. However, the final operator
training requirements now include the additional stipulation that a qualified operator must be
^onsite within 1 hour of the time when a problem with the MWI occurs that can potentially
-result in a violation of either an emission or operational standard in the NSPS or EG, as
-^applicable.
Comment: One commenter (TV-D-735) agreed with the base training requirements
-(24 hours of class, 4 hours hands-on, an exam, and handbook). However, the commenter and
- another commenter (IV-D-769/557) requested that training be limited to the particular type of
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incinerator and air pollution control equipment that the operator will be working with instead
of all types of incinerators and control devices.
Response: The 1995 proposed operator training requirements required that MWI
operators receive instruction on the operation of various MWI and APCD design types.
However, in response to comments received on the 1995 proposed operator training
requirements, the revised operator training requirements limit operator training to the specific
type of incinerator, air pollution controls, and monitoring equipment to be used by the
operator.
Comment: One commenter (TV-D-735) indicated that most operators will not be
capable of calibrating GEMS. The commenter also indicated that MWI operators should not
have access to the controls where operating parameters could be altered and, for properly
designed incinerators, should not need to make any adjustments. The commenter argued that
the maintenance of qualification is an excessive requirement and recommended deleting all
3-year requirements and requiring only an annual review of the regulations and necessary
paperwork.
Response: The operator training course is to include a discussion of methods of
monitoring pollutants, including CEMS and monitoring of MWI and APCD operating
parameters. When applicable, the operator training class is also to discuss equipment
calibration procedures. This does not imply that MWI operators will be trained or expected to
calibrate GEMS and all MWI or APCD operating parameters. For some MWI, there may be
some equipment that MWI operators must calibrate. Thus, when applicable, the procedures
for calibration of this equipment are to be covered in the operator training course.
Maintenance of qualification is necessary to ensure that qualified operators are kept up-
to-date and their memory refreshed on MWI operating procedures. To maintain qualification,
MWI operators may fulfill the qualification requirements of a State-approved operator training
and qualification program which could require only an annual review of the regulations and
paperwork. However, if there is no State-approved operator training and qualification
program, MWI operators are to maintain qualification by completing and passing an annual
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review course of at least 4 hours covering regulations, incinerator operation, inspection and
maintenance, responses to upset conditions, and operating problems. ;
Comment: One commenter (TV-D-782/454) stated that training requirements imposed
-rby regulations implementing Section 609 of the CAA should be used as a model for the
^operator training program. The commenter noted that these regulations allow facilities the
^flexibility to choose between on-the-job training or onsite training involving instructors,
4videos, or a hands-on demonstration. The commenter stated that section 609 regulations list
fthe subjects to be covered in training, but not the number of hours for training. The
commenter stated that the operating manual supplied by the manufacturer and used by the
operators should be sufficient for use as a site-specific operating manual. Another commenter
(TV-D-769/557) remarked that mandatory hours for classroom and hands-on training are
unnecessary. The commenter suggested that the regulation specify"only basic requirements as
iwell as provide more flexibility to hospitals, facilities, and States to implement the operator
training and qualification requirements.
Response: Section 609 of the CAA contains requirements for programs used to train
-automobile air conditioner service technicians. Section 609 allows training programs to
-provide on-the-job training, videos, or a hands-on demonstration, and lists the subjects to be
^covered without specifying the number of hours for training. However, all training programs
under Section 609 must be approved by EPA. The MWI operator training requirements do not
include the provision that MWI operator training-programs be approved by the EPA. The
MWI operator training requirements allow for State-approved training programs or completion
of a training course with: (1) 24 hours of classroom instruction, (2) an examination designed
and administered by the course instructor, and (3) reference material distributed to the
-attendees covering course topics. Under the MWI operator training requirements, States may
^decide to allow on-the-job training without specifying the number of hours for training. The
^operating manual supplied by the manufacturer may be used as the site-specific operating
smanual if it contains all of the documentation listed under the operator training and
qualification requirements in the final HMIWI regulation.
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Comment: One commenter (TV-D-760) stated that there should not be a fixed number
of hours of classroom instruction or for the annual review because some MWI are more -
complex than others. The commenter recommended establishing a passing grade for the end-
of-course examination.
Response: The MWI operator training requirements require 24 hours of classroom
instruction and an annual review course for maintenance of qualification that is a minimum of
4 hours hi length. The EPA believes that these rninimum requirements provide necessary and,
sufficient time to tram MWI operators. State-approved MWI operator training programs may
have different requirements for the hours of instruction and review. Some State-approved
programs may not require a fixed number of hours of instruction or review. However, hi
States where there are no State-approved operator training programs, MWI operators must
receive training through a program that includes a minimum of 24 hours of instruction and 4
hours of annual review. Although not required, training courses that exceed 24 hours of
instruction and 4 hours of annual review are not discouraged by EPA, especially for operators
of more complex MWI.
The EPA does not develop the end-of-course examinations; therefore, it is not
reasonable for the EPA to establish a passing grade for end-of-course examinations. Each
operator training program that develops an end-of-course examination is responsible for
determining what grade is acceptable for MWI operators to pass the course.
Comment: Two commenters (TV-D-769/557 and IV-D-785) stated that operators with
more than 12 months of experience should not be required to take the initial training class.
One commenter (TV-D-785) suggested that only one qualified operator should be required to
observe and qualify new operators because some facilities may not have more than one
operator. The commenter supported EPA's determination to allow a trained and qualified
operator to be easily accessible instead of onsite at all times while the MWI is in operation.
Response: Some MWI operators with more than 12 months experience, while skilled
in MWI operation and maintenance, may not fully understand basic combustion principles,
environmental concerns, monitoring, factors affecting performance of air pollution control
equipment, regulations, the new recordkeepuig requirements, or other subjects discussed hi the
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operator training class. Therefore, it is necessary for experienced MWI operators to complete
the training course. Two qualified operators are required to observe and qualify new operators
to ensure that the new operator follows proper procedures. Having two qualified operators
; serves as a check and prevents only one qualified operator from demonstrating improper
-procedures. Facilities that have only one qualified operator may have a qualified operator
*from another facility or from the operator training program to observe qualification of new
^operators. The revised requirements allow operators to be easily accessible (or on call) while
^the incinerator is operating. The qualified operator must arrive onsite within 1 hour from the
time a problem with the MWI occurs.
Comment: Five commenters (TV-D-762/784, IV-D-781, IV-D-784, IV-D-786, and
IV-D-789) stated that all MWI operators should be trained to operate the equipment under all
conditions and be able to respond quickly to unusual or emergency situations. The
^-commenters disagreed with EPA's inclination to allow an MWI to be operated without a
trained and qualified operator at the facility at all tunes that waste is charging. One
"commenter (W-D-781) stated that operator training should be required within 1 year of
-promulgation of the regulation.
Another commenter (TV-D-637) stated that defining "operation" as the "period during
-%hich the MWI combustion air blowers are operating" is excessive. This commenter
recommended that MWI operators be on duty from the tune when the MWI is first started until
1 hour after the last charge of waste instead-Of the entire time wheli the combustion air blowers
are operating.
Response: Several commenters on the 1995 proposed rule and one of the above
commenters have suggested that the requirement for a trained and qualified operator to be on
" duty during times when the combustion air blowers are operating is unnecessary and
^-unwarranted for environmental protection. Therefore, the final operator training and
-^qualification requirements allow trained and qualified MWI operators to be easily accessible or
^on call at all times while the MWI is operating. The trained and qualified operator may
^operate the MWI directly or be the direct supervisor of individuals that charge waste, remove
-ash, etc. from the MWI. The final operator training requirements include the provision that
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the trained and qualified MWI operator must be onsite within 1 hour from the time a problem
with the MWI occurs. This provision was included to ensure that the MWI operator will
respond to unusual or emergency situations in a timely manner. The final standards and
guidelines require that MWI be operated by a fully trained and qualified operator 1 year after
approval of the State's Section 111 (d)/129 Plan, instead of 1 year after promulgation of the
regulation. There may be no State-approved operator training programs in a particular State
until the lll(d)/129 Plan is developed and approved. Therefore, it is more feasible for ...
operator training and qualification to be conducted after the lll(d)/129 Plan is approved.
Comment: One commenter (IV-D-01) suggested additional requirements for MWI
operators. The commenter stated that an operator should be present until all fuel in the
primary chamber is consumed and the unit is secured and that direct observations of complete
burnout in the primary chamber must supplement automated shutdown procedures. The
commenter stated that evidence of burnout might include a cooled state in the primary
chamber, the absence of smoke and flame, and the absence of emissions from the entire
process. The commenter also suggested that the secondary combustion chamber must be above
the statutory lower temperature limit whenever the primary chamber is combusting waste. The
commenter noted that an operator cannot assume the chart recorders are operating properly and
that the operators senses should supplement the chart readings.
Response: Under the 1995 proposed MWI operator training requirements, the operator
would have to be on-duty and at the facility for the entire time while the combustion air
blowers are operating. Many commenters on the 1995 proposed operator training
requirements stated that the amount of time that the operator was required to be present was
excessive. Requiring that an operator be present until all fuel in the primary chamber is
consumed and the unit is cooled and requiring that direct observations of complete burnout in
the primary chamber supplement automated shutdown procedures may also be excessive. For
example, consider requiring a trained operator to be present during the entire batch burn cycle.
The complete batch burn cycle (including cooldown) normally takes 1 or 2 days, depending on
the size of the unit and the amount of waste charged. This would require a trained operator to
be present between 6 and 24 hours to observe complete burnout of the fuel in the primary
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chamber. Therefore, EPA believes that to require an MWI operator to be present until all fuel
in the primary chamber is consumed and until the unit is secured would be overly burdensome.
Under the final regulations, "startup" and "shutdown" are defined as periods when no waste is
^burning. Incinerators are required to attain their minimum operating temperatures before
-waste combustion begins and maintain their operating temperatures until waste combustion
^ends. Instead of requiring a trained and qualified operator to be present at all times when
fwaste is burning, the final HMIWI standards and guidelines require that an MWI operator be
^easily accessible or on call. The trained and qualified MWI operator must be onsite within 1
hour from the time when a problem with the MWI occurs.
Comment: One commenter (EV-D-732) stated that the most practical means of training
MWI operators in remote locations is through a self-paced correspondence course. The
commenter stated that most remote facilities will not be able to afford the travel and per diem
^osts necessary to send housekeeping staff to a training course in a major city. The commenter
indicated that the experience requirements may also present logistical problems.
Response: If self-paced correspondence courses are approved by the State for MWI
operator training, then they will be available to rural facilities in that State. Trained MWI
-operators may obtain qualification if they have 6 months experience as an MWI operator,
-*6 months experience as the direct supervisor of a qualified operator, or if they complete two
burn cycles under the supervision of two qualified operators. Completion of two burn cycles
under the observation of two trained and qualified operators does nbt require any prior MWI
operator experience.
Comment: Two commenters (TV-D-762/784 and TV-D-784) suggested that
qualification be obtained by completing an approved training course, completing at least two
^burn cycles on the facility's incinerator under the observation of two qualified operators, and
>'6 months of experience as an MWI operator.
Response: Under the MWI standards and guidelines, MWI are to be operated by a
drained and qualified operator. Qualification may be obtained by completion of the operator
training course and either 6 months experience as an MWI operator, 6 months experience as a
direct supervisor of a qualified MWI operator, or completion of at least two burn cycles under
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the observation of two qualified operators. New MWI operators may not be able to gain
6.months experience before it is necessary that they must operate an MWI without the -
supervision of a qualified operator. For example, a small facility with no qualified operators
may send a new operator for training and qualify that individual under the supervision of two
outside qualified operators. However, if this individual was required to gain 6 months
experience as an MWI operator before qualification, then there would be no qualified operator
at the facility to operate the MWI while this individual gains 6 months of experience. -
Therefore, EPA does not believe that operators should be required to obtain qualification by
completing two burn cycles on the facility's incinerator under the observation of two qualified
operators and 6 months of experience as an MWI operator. The EPA believes that completing
two burn cycles on the facility's incinerator under the observation of two qualified operators or
6 months of experience as an MWI operator is sufficient for qualification.
Comment: Two commenters (TV-D-786 and IV-D-789) stated that, EPA should propose
a more rigorous, uniform national program for certification of operators. The commenters
noted that operators cannot learn much about chemistry, fluid dynamics, waste composition,
regulations, engineering, ash toxicity, and emissions controls in 24 hours. The commenters
also noted that there is potential for conflicts of interest involving vendor training personnel
who are involved with exam preparation and certification procedures. The commenters
suggested that there should be no connection between those who administer the training course
and those who design and.administer the tests.
Response: The MWI operator training requirements allow for operator training to be
obtained through a State-approved training program or by completing a course with
(1) 24 hours of classroom instruction, (2) an examination designed and administered by the
course instructor, and (3) reference material distributed to the attendees covering the course
topics. Operators of MWI have the option of completing a State-approved program or a
course that meets the three national requirements above. It is not necessary for MWI operators
to be highly skilled in chemistry, fluid dynamics, waste composition, regulations, engineering,
ash toxicity, and emissions controls to operate MWI and respond to upset conditions. State-
approved programs or 24 hours of classroom instruction will provide an acceptable level of
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training. It is not feasible to have two different groups of training personnel to administer the
training course and to design and administer the test. The end-of-course test should be b(ased
on the material covered in the course, and the course material should be based on the type of
-MWI and APCD the operators taking the course will operate. The group that administers the
^course should design a test that is representative of the material covered in the course. There
^ris no real advantage to be gained by vendor training personnel who improperly administer a
%training course or exam. Therefore, the final operator training and qualification requirements
*do not contain any provisions to prevent MWI vendor personnel from training MWI operators
and administering exams.
Comment: One commenter (TV-D-747) suggested that operator training requirements
for cement kilns (if regulated) would have to be different than for MWI. Another commenter
(IV-D-613) suggested that pathological MWI operators should have to meet operator training
-and qualification requirements.
Response: Incinerators used to burn strictly pathological waste are not covered by the
MWI standards and guidelines, and therefore are exempt from the MWI operator training and
-qualification requirements. Similarly, cement kilns arenot covered by the MWI standards and
-guidelines, and therefore are exempt from the MWI operator training and qualification
requirements.
3.7 TESTING, MONITORING, AND INSPECTION
Comment: One commenter (TV-D-149y''Stated that EPA should require continuous
monitoring of CO emissions from all MWI, continuous opacity monitoring at large
incinerators, and continuous monitoring of HC1 emissions from very large (> 1,000 Ib/hr)
incinerators. The commenter stated that Appendix F requirements are only necessary for large
-y(500 to 1,000 Ib/hr) and very large (> 1,000 Ib/hr) MWI. The commenter argued that EPA
-cannot promulgate limits based on good combustion without providing a regulatory mechanism
^-for confirming the use of good combustion. 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 MWI with
capacities less than 500 Ib/hr. The commenter stated that the EPA should build safety margins
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into allowed operating parameter ranges to account for the indirectness of parameter
monitoring if EPA decides to use this technique. The commenter recommended that HC1
monitors be required for MWI with capacities greater than 1,000 Ib/hr due to the high chlorine
concentrations in the feed. The commenter stated that EPA's inclination not to require
continuous monitoring is based on inaccurate GEMS costs. The commenter argued that actual
capital and annual costs for continuous monitoring systems are much lower than EPA
estimates. The commenter also argued that EPA has underestimated some of the costs
associated with parameter monitoring. The commenter provided cost data to support their
opinion.
Another commenter (TV-D-726) advised that third party testing and GEMS with
Appendix F requirements be required to ensure an on-going commitment to proper incinerator
operation. The commenter contended that small uncontrolled units are typically operated
improperly resulting in high emissions. Another commenter (IV-D-774) suggested that GEMS
should be required for small units to provide incentive for accountability. Three other
commenters (TV-D-762/784, IV-D-781, and IV-D-784) stated that the MWI regulation should
require GEMS for CO and O2 (no Appendix F) as well as operating parameter monitoring on
all units to ensure continuous compliance with good combustion. The commenters noted that
GEMS can be successfully operated over a period of time with reliable results and at a
reasonable cost.
Another commenter (TV-D-765) warned that using parameter monitoring and routine
inspection instead of GEMS will create problems with incinerators located in urban areas,
where short term emission exceedances may be harmful to the public. The commenter argued
that GEMS would identify exceedances and enable appropriate actions to be taken to mitigate
them. The commenter requested that, at a minimum, large MWI should be required to install
GEMS. Two commenters (IV-D-786 and IV-D-789) suggested that two facilities could share
mobile (trailer-mounted) GEMS, alternating usage at half the cost. The commenters also
suggested shorter (1-hour) averaging times for GEMS.
One commenter (TV-D-748) stated that the testing and monitoring requirements
described in the supplemental notice are much more acceptable than the annual stack testing
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and continuous monitoring requirements in the 1995 proposed rule. The commenter
recommended that EPA adopt the supplemental notice's testing and monitoring inclinations for
the final rule. Two commenters (TV-D-769/557 and IV-D-785) supported EPA's inclination to
-determine compliance using parameter monitoring and routine inspection and maintenance
-rather than GEMS. One of the commenters (TV-D-785) supported monitoring option 4
-^combined with emissions testing option B to ensure compliance with the rule.
One commenter (TV-D-755) stated that their facility owns a barely 4-year old 750 Ib/hr
1VMWI with a high efficiency wet scrubber. This commenter stated that the guidelines may
force the MWI to shut down because of the costs associated with the testing and monitoring
requirements. The commenter requested that EPA exempt all onsite MWI from the more
comprehensive and expensive emissions testing and monitoring requirements including CEMS.
The commenter argued that an initial stack test for the primary pollutants would verify
-^equipment performance and regular inspection, maintenance, and daily recording of operating
parameters would suffice.
One commenter (TV-D-760) stated that monitoring option 4 (operating parameters with
-no CEMS) with emission testing option C (substitute testing) for small MWI provides an
- excellent means to attain low emissions for minimal costs. Three other commenters
- (TV-D-766, IV-D-790, and IV-D-792) recommended monitoring option 4 with testing option B
(initial stack test, no repeat test).
Response: Section 129(c) of the CAA requires the EPA toinclude monitoring and
testing requirements in regulations developed under section 129. The purpose of these
requirements is to allow the EPA to determine whether a source is operating in compliance
with the regulations. 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
tof 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
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emissions. While monitoring of operations (operating parameters) cannot usually provide a
direct and continuous measurement of emissions, they are much less expensive than CEMS,
and the information they provide 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.
In the 1996 reproposal, testing and monitoring costs were developed for a range of
options, and the Agency concluded that the cost of CEMS were unreasonably high relative to
the cost of the incinerators and air pollution control systems needed for compliance. Based on
comments and information received as a result of the 1996 reproposal, the cost estimates for
CEMS and parameter monitoring have been revised. While the cost estimates for CEMS have
been significantly reduced and additional costs have been included for parameter monitoring, it
appears that the annual costs of monitoring requirements which include CEMS are still quite
high compared to the cost of the incinerator and APCD required to meet the emission limits.
A large MWI costs approximately $120,000/yr to operate and add-on APCD can cost
from $140,000 to $300,000/yr to operate. The most comprehensive monitoring option
including CEMS for HC1 and CO costs about $95,000/yr. This option costs nearly as much as
the incinerator itself and could represent as much as half the cost of the air pollution control.
In addition, the only emissions that are directly measured are HC1 and CO. There are no
direct measurements of dioxin/furan or toxic metals (CEMS for PM and toxic metals are
discussed below). .Consequently, this option is considered unreasonable. Looking at other
options for large MWI, the only CEMS included are CO and opacity. For a large MWI
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 MWI equipped with APCD
reflect routine stack testing coupled with continuous monitoring of operating parameters.
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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 MWI meeting certain "remote" criteria (discussed elsewhere). For
-these small existing MWI 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 "indicator"
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 "indicator" 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
vgood combustion alone, the monitoring requirements consist of an initial stack test coupled
with continuous monitoring of operating parameters and routine inspection/maintenance.
Comment: One commenter (TV-D-572) suggested that the definition for maximum
- paiticulate matter control device inlet temperature is too'restrictive. The commenter suggested
that the NSPS should reflect the range of temperature demonstrated during a compliance stack
~ test. The commenter suggested that the definition should be for the "average" paiticulate
matter control device inlet temperature. Another commenter (TV-D-453) suggested that the
maximum paiticulate matter control device inlet temperature be defined as the temperature of
the exhaust at the discharge of a quench system or heat recovery device prior to an air
pollution control device.
Response: The Agency is requiring monitoring at the inlet to the fabric filter system,
-instead of at the boiler or a heat exchanger, to provide the most accurate indication of
'^temperature in the fabric filter system. Increased fabric filter inlet temperatures can lead to
increased dioxin/furan emissions. The purpose of the maximum temperature requirement and
wthe purpose of all of the maximum and minimum operating parameter limits is to ensure that
the MWI and air pollution control equipment are operating as they were during the latest
performance test demonstrating compliance with the emission limits. The operating
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parameters are established and "maximum" or "minimum" to provide enforceable boundaries
in their operation. Operating outside the bounds of the maximum or minimum parameters may
lead to increased air emissions.
The EPA acknowledges concern about using an "average" temperature to define the
"maximum" temperature because temperature, like any operating parameter, varies with time.
To account for this variability, an adjustment factor of 10 percent has been added to all
"maximum" and "minimum" operating parameters. "Maximum" parameters are established at
110 percent of the lowest 3-hour average parameter, and "minimum" parameters are
established at 90 percent of the highest 3-hour average parameter.
Operation outside of established parameters will be a direct violation of those operating
parameters. In addition, operating outside the bounds of two or more parameters
simultaneously (as specified in the final rule) will constitute a violation of specific emission
limits. For example, operating above the maximum charge rate and below the minimum
secondary chamber temperature simultaneously will constitute a violation of the CO emission
limit.
Operators have the flexibility to choose the values for the operating parameters during
the performance test. Because the parameters are "maximum" and "minimum" the operator
also has the flexibility to operate as far as necessary on one side of each parameter.
Performance tests may be repeated at any tune to establish new values for the operating
parameters. If two or more parameters are exceeded so as to constitute a violation of a
specific emission limit, the operator may conduct a performance test within 30 days to
demonstrate that the combination of parameters in not a violation of that emission limit. The
final provision for operating parameter monitoring provides flexibility to the MWI
owner/operator while providing enforceable provisions for EPA.
Comment: One commenter (IV-D-786) requested that EPA require CEMS for CO,
HC1, SO2, NOX, Hg, and PM. The commenter noted that emissions from individual
incinerators may vary over time and that annual stack testing only gives a snapshot, which is
carefully orchestrated, of the MWI actual performance over time. The commenter stated that
the law requires EPA to determine that all MWI are in compliance at all times. The
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commenter contended that CEMS for CO, HC1, SO2, NOX, Hg, and PM would eliminate the
need for stack testing, which is not adequately responsive to the CAA which mandates that
EPA determine whether a source is operating in compliance. The commenter stated that the
:only way to ensure compliance at all times is through the continuous use of CEMS, instead of
"through inspection and maintenance requirements where testing is not required or monitoring
~of process parameters only. The commenter stated that the only instance in which EPA could
-be justified in requiring periodic stack testing in lieu of CEMS is where CEMS for a particular
^pollutant are not available (e.g., dioxin).
Response: As discussed above, EPA considers the costs of HC1 and CO CEMS to be
unreasonably high relative to the cost of the MWI and air pollution control costs associated
with the MWI regulation. The EPA disagrees with the commenter1 s contention that CEMS
must be required unless they are unavailable. With regard to SO2 and NOX, the emission limits
-in the final regulations reflect uncontrolled emissions. Consequently, it seems unreasonable to
impose monitoring requirements in a technology-based regulation where the facility operator
" has no control over the emissions and where the emission limit is not likely ever to be
"-exceeded. In addition, PM and Hg CEMS are currently "under development. At this time,
they have not been demonstrated to be capable of accurately and reliably measuring PM or Hg
Demissions for use in determining compliance with PM or Hg emission limits. Continuous
monitoring of operating parameters provides and adequate assurance of continuous
compliance.
Comment: Two commenters (TV-D-786 and IV-D-789) recommended that the final
rule require at least annual stack testing of all pollutants not continuously monitored. The
commenters also suggested that all compliance tests be conducted simultaneously so that one
^device's performance is not optimized at another's expense.
One commenter (IV-D-735) suggested that, in addition to an initial test, there could be
another confirmation test after 1 year's operation, after which, retesting could be required if
any system has more than three failures within a given calendar year. The commenter stated
"that tests and reports cost as much as $20,000 when completed and submitted.
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Another commenter (TV-D-769/557) suggested that an initial performance test and
monitoring is sufficient. The commenter stated that additional tests are not necessary .,
especially given operator training, inspections, and monitoring. The commenter argued that if
a facility monitors and is able to achieve compliance with its site-specific permit conditions
and does not make any changes to the operating system or the type of waste burned, additional
annual testing would not be necessary.
One commenter (TV-D-748) requested that EPA define what repeat testing entails. The
commenter stated that repeat testing should not be required more often than every 5 years.
Another commenter (TV-D-785) recommended that an initial stack test be conducted to
determine compliance and to establish site-specific permit conditions. Provided that a facility
achieves compliance with its permit conditions, the commenter argued that annual testing is
unnecessary. The commenter noted that this testing strategy is consistent with the
requirements of State air programs and Resource Conservation and Recovery Act (RCRA)
programs. The commenter supported the revision of the length of test runs to 1 hour.
Two other commenters (TV-D-762/784 and IV-D-784) requested that testing option A
(initial and annual/skip stack testing) be required for all MWI and that no substitute stack
testing should be allowed. The commenters noted that substitute stack testing and annual
inspection/maintenance requirements are not an adequate substitute for repeat testing because
problems such as a breakdown in a facility's Hg waste separation program would not be
detected. One commenter (W-D-781) stated that because waste segregation practices have an
effect on air emissions, EPA should require initial performance tests that include metals. One
commenter (IV-D-726) argued that substitute stack testing is unacceptable because it fails to
identify MWI operators that do not commit the necessary attention to the proper operation of
the MWI. Another commenter (TV-D-755) requested that substitute emissions testing be
allowed even though it is unlikely that many facilities will have identical incinerator/scrubber
systems.
Response: The final HQVflWI standards and guidelines require annual/skip testing for
facilities installing or operating an add-on APCD to meet the emission limits. Annual testing
is required for the first 3 years. If these tests show that the facility is in compliance each of
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these 3 years, then subsequent testing would be done every third year. Initial testing includes
testing for the following pollutants: PM, CO, HC1, dioxin/furan, Pb, Cd, Hg, and opacity.
The annual/skip or "repeat" testing only includes testing for PM, CO, HC1, 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 weight and secondary chamber temperature).
The "repeat" testing requirements will ensure, on an on-going 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. The Agency believes
testing at least every 3 years provides less burden than an annual testing requirement while at
the same time does not allow the MWI to operate for an extended period without testing. The
?choice of 3-year testing as opposed to annual or 5-year reflects EPA's balancing of costs with
"quality of information gathered (in this case, timely determinations of compliance). Where
""repeat" testing is not required, annual inspections, annual opacity testing, and parameter
* monitoring will ensure that the MWI is in good working order. However, cost considerations
the only reason for excluding the repeat testing for units with good combustion alone.
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 testSng 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.
The EPA agrees with the commenter that stated that substitute stack testing is
-unacceptable. Waste stream compositions vary from health care facility to health care facility.
""Therefore, substitute stack testing would be unreliable for waste-related pollutants. The final
^HMIWI standards and guidelines require that all facilities conduct an initial performance test.
Facilities are required to continuously monitor several MWI and APCD operating
^parameters. All operating parameters must remain within the specific operating values
established during the initial performance test. Maximums for operating parameters are
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defined as the "110 percent of the lowest 3-hour average" and minimums are defined as the
"90.percent of the highest 3-hour average." Thus, facilities will not be able to manipulate
MWI and APCD operating parameters to achieve low emissions of some pollutants while
causing high emissions of other pollutants without violating the operating parameter
limitations. Because maximum and minimum operating parameters do not allow for
optimizing emissions of one pollutant over another, it is not required that all performance tests
be conducted simultaneously.
Comment: One commenter (TV-D-781) indicated that continuous monitoring of CO is
essential to guarantee efficient combustion in all sizes of incinerators. However, the
commenter warned that EPA's proposed CO limit of 40 ppmv for 4 hours average is too low
to guarantee 100 percent compliance. The commenter suggested that EPA require a higher
limit or establish a goal of percent of tune in compliance. The commenter stated that they will
submit CO monitoring data to support their opinions under a separate cover.
Response: As discussed above, EPA is not requiring CO GEMS for monitoring of CO
emissions. However, the Agency has reviewed its conclusions on the averaging time necessary
to meet the 40 ppmdv CO emission limit for MWI operating CO GEMS. Provisions in the
final regulation have been included that allow 12-hour rolling averaging for determining
compliance with the CO limit when a GEMS is used. Based on GEMS data, the Agency
believes that a 40 ppmdv emission limit can be achieved with a 12-hour rolling average.
Comment: One commenter (IV-D-736) supplied information on the development of a
continuous monitor for Hg. The commenter noted that what is lacking in the development of
Hg monitors is the debugging that customarily occurs through years of industrial use. Because
the Hg monitor technology is relatively new, the commenter noted that the MWI community is
likely to offer some reticence to accept a ruling that requires continuous Hg monitors. The
commenter stated that the regulated community would experience a learning curve similar to
that experienced when continuous monitors for SO2 and NOX were first required, if Hg
monitors are required.
Response: The EPA appreciates the information submitted by the commenter regarding
the Hg GEMS. While GEMS do exist for Hg, their performance history is not fully
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documented. Mercury monitors continue to be evaluated by the EPA. There is no
requirement for Hg GEMS in this rulemaking; however, States are free to impose such f
requirements if they choose.
Comment: Three commenters (TV-D-735, IV-D-790, and IV-D-792) contended that
-total dioxin instead of TEQ is a more reasonable testing approach because there are technical
^difficulties with testing resolution at the TEQ levels the EPA is considering. Another
^tommenter (TV-D-766) questioned the accuracy of Method 23 in measuring low concentrations
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air pollution control system. The opacity emission limit in the final HMIWI standards and
guidelines is 10 percent.
Comment: One commenter (IV-D-637) argued that opacity monitoring for wet
scrubbers does not make sense. Another commenter (TV-D-494) suggested that an exhaust gas
reheat or other suitable means should be required in order to enable an opacity monitor to
operate reliably on a continuous basis following a wet scrubber.
Response: The Agency agrees with the commenter that opacity GEMS are
inappropriate for wet scrubbers. Continuous emission monitoring systems for opacity are not
required in the final standards and guidelines. However, manual Method 9 is applicable for
determining opacity emissions from wet scrubbers. Method 9 certification entails training on
determining opacity readings from steam plumes. Opacity readings can be taken as the steam
plume dissipates or if the plume is detached hi the area between the plume and the stack.
Comment: One commenter (TV-D-732) stated that the requirement of having three
separate test runs of 1 hour each is not feasible for many remote sites because of the limited
quantities of medical waste generated at these facilities. The commenter stated that most
remote health care facilities would have to rely on testing by a third party. The commenter
indicated that the cost of flying a private testing firm to remote locations such as the Pribilof
Islands in the Bering Sea off the coast of Alaska is cost-prohibitive. The commenter
recommended that small remote MWI be exempted from the testing requirements.
Response: Facilities that operate small existing incinerators in remote locations have
been given special consideration with regard to emission limitations. As discussed in
section 6.2, small existing MWI that meet certain rural criteria are allowed to meet emission
limits associated with good combustion alone instead of emission limits associated with good
combustion and wet scrubbers. Furthermore, as discussed in section 3.8.2, the final HMIWI
! !'! '" " ' 'I '':'.*
standards and guidelines focus on incinerators whose primary purpose is the disposal of
1;.: ' ' ,
hospital waste and medical/infectious waste. Any incinerator or combustion device that burns
10 percent or less by weight hospital waste and medical/infectious waste is not subject to the
emission limits provided that the facility keeps records of the amount and types of wastes
bumed. Finally, any facility may apply for special monitoring, testing, and compliance
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provisions provided the facility can demonstrate to EPA's satisfaction that the incinerator is in
compliance with the emission limits. Given the less stringent emission limits for small rural
facilities, the 10 percent by weight provision which may exclude these units from the MWI
emission limits, and the ability to apply for special compliance provisions, the final standards
-«and guidelines do not exempt facilities combusting small amounts of waste in remote areas
^sfrom the testing requirements.
Comment: Four commenters (IV-D-769/557, IV-D-777, IV-D-782/454, and
sTV-D-785) agreed that the third party inspection requirements should be deleted. One
commenter (TV-D-777) requested that required inspections be conducted pursuant to a
standardized set of requirements to promote uniformity throughout the industry. Another
commenter (TV-D-735) pointed out that annual or biannual inspection is reasonable. The
commenter stated that the 10 day requirement for corrective action is too stringent due to parts
^availability and shipping, especially in rural areas. The commenter suggested increasing the
"time allowance for corrective action to at least 30 to 60 days.
Response: During the public comment period following the 1995 proposal of the MWI
'Standards and guidelines, several commenters who were'supportive of the inspection
^requirements suggested that the requirement for a "third party" inspection be deleted. These
^commenters stated that in-house personnel are more familiar with the details and operating
intricacies with their equipment and that liability concerns could arise from injury or damage
caused by the "third party" inspection requirement. Therefore, the-requirement for a "third
party" to conduct inspections has been deleted from the final HMIWI standards and guidelines.
The final inspection requirements contain a minimum list of equipment that is to be inspected
to promote uniformity of inspections throughout the industry. Facilities are to complete
-repairs within 10 operating days following an equipment inspection, unless the owner or
"operator of the facility establishes a date in agreement with the State enforcement agency
-whereby all necessary repairs are to be completed. This does not mean that all repairs are to
^be completed within 10 days following an inspection. Instead, facilities and State agency
- personnel are allowed to determine the most suitable date for repairs to be completed.
Comment: One commenter (TV-D-561) suggested that the inspections include waste heat
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boiler systems because failure of the boilers could lead to stack bypass events in order to avoid
damage to the control equipment.
Response: The inspection requirements have been modified to include inspection of a
waste heat boiler, if the units are so equipped.
Comment: One commenter (IV-D-572) stated that section 60.57c(b)(2)(i) should state
"opacity and stack concentration of CO adjusted to 7 percent oxygen as determined by CEM"
instead of "emission rates of CO and opacity as determined by the GEMS." The commenter
stated that there is no such thing as opacity emission rate and that extra equipment would be
necessary to convert continuously monitored CO concentrations to emission rates.
Response: The final standards and guidelines do not require the use of GEMS for
opacity and CO. However, facilities that choose to use CO, opacity, or other GEMS are
required to maintain records of data collected using these devices. The commenter is correct
in that there is no such thing as opacity emission rate. It was not EPA's intention to require
additional equipment to convert CO concentrations to emission rates. The wording of the
regulatory text has been changed to clarify these points.
Comment: Two commenters (TV-D-627 and IV-D-636) suggested that the rule should
allow electronic recording and storage of data.
Response: A provision is contained within the final reporting and recordkeeping
requirements that allows records to be maintained onsite in either paper copy or computer-
readable format.
Comment: One commenter (TV-D-613) suggested that a feasible alternative to the
mandated weigh cell system for measuring sorbent flow is a simple calibrated screw feeder.
Another commenter (TV-D-572) cautioned that there may not be equipment to accurately
measure sorbent flow as required in the rule. The commenter recommended that the EPA
allow alternatives and suggested that a typical feed hopper could be used.
Response: The EPA recognizes that it is more difficult to measure the flow rate of
a dry powder material than of a liquid. The final standards and guidelines have been revised
to require that a device "or method" be used to determine the amount of sorbent used each
hour. Facilities using automatic sorbent feed devices will need to calibrate the equipment
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periodically as recommended by the manufacturer and maintain records of calibration for 5
years. -. v
Comment: One commenter (IV-D-735) stated that the need for CEMS equipment as
,part of initial testing should not be dictated as new combustion technologies operate at
^temperatures that are too hot for probes and other devices. The commenter requested that all
^initial testing be done with portable field equipment as is done now. The commenter suggested
iihat CEMS requirements be left to the discretion of the States. The commenter stated that
tCEMS cost from $85,000 to $140,000 depending on the type of sampling system used, probe
style, and ancillary equipment required by various agencies. The commenter noted that the
supplemental notice states that CEMS may be required for large MWI that burn medical waste
generated offsite. The commenter questioned if CEMS will be required for health care
facilities that share an MWI or for facilities that have an MWI located some distance from the
^facility. The commenter requested that if it is EPA's intent to require CEMS for commercial
units only, that it be clearly stated as such.
Response: The Agency is not dictating that initial performance testing be conducted
rusing CEMS. The regulatory text contains the required EPA manual methods for each air
-pollutant to be tested. However, facilities may opt to test for CO using a CEMS system.
-Ouring the EPA sponsored testing program, several of the CO tests were performed using CO
CEMS. These CEMS were equipped with high temperature probes. As mentioned above, the
final regulation does not contain requirements "for CEMS. "^
Comment: One commenter (TV-D-777) requested a statement clarifying that CEMS
data will not be used to determine compliance or for direct enforcement purposes. The
commenter stated CEM is a valuable tool for indicating conditions in control equipment which
rmay need to be investigated. However, the commenter explained that CEMS data may not
-provide conclusive determinations which necessarily indicate a violation. The commenter
^stated that using CEMS data for enforcement purposes would be a disincentive for facilities to
ilnstall CEMS where it may not be necessary to do so.
Response: As discussed above, the EPA is not requiring CEMS for determining
compliance with the emission limits. However, the Agency cannot guarantee that State or
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local agencies will not require the use of CEMS for the purposes of direct enforcement. The
Agency has developed quality assurance procedures (40 CFR 60 appendix F) for the purpose
of certifying CEMS for continuous compliance. The appendix F requirements include annual
relative accuracy test audits and quarterly cylinder gas audits that ensure that CEMS are
operating to performance specifications and are acceptable for enforcement purposes.
Comment: One commenter (TV-D-785) questioned the value of the information
provided by monitoring the exit temperature and energy input for a wet scrubber. The
commenter advised that monitoring scrubber liquid pH and flow rate would provide the critical
information on whether the equipment is operating properly.
Response: Monitoring the scrubber exit temperature is important to ensure Hg
revolatilization hi not occurring after capture in a wet scrubbing system. To ensure continued
PM removal in a wet scrubber, one of two parameters are required to be monitored: pressure
drop across the scrubber or energy input to the wet scrubber. Typical venturi scrubbers use a
variable throat to maintain a relatively constant pressure drop across the system. Monitoring
the pressure drop across the system provides an indication that the PM removal system is
operating properly. Other systems have a relatively low pressure drop across the system but
use subcooUng to remove PM from the exhaust gas. Pressure drop across the system is an
inappropriate indicator of performance for these systems, however, energy input to the
scrubber is an appropriate parameter to indicate PM removal efficiency.
Comment: One commenter (IV-D-735) stated that continuous compliance and
continuous monitoring are the same. The commenter questioned why two sets of paperwork
are necessary for the same basic cause. The commenter stated that continuous compliance and
continuous monitoring could be combined, but not with the present requirements. The
commenter contended that a double standard is associated with the compliance guidelines. The
commenter stated that a unit must meet a specified emission standard, and that the guidelines
state that the facility must operate within the tested emission levels that were achieved hi the
initial testing. The commenter argued that this violates statistical control practices and quality
assurance (QA) protocols. The commenter stated that EPA has suggested the initial testing
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actually be three testing groups (now $60,000 worth of testing, not $20,000) where the mean
is utilized to establish the emission limits.; 'I
Response: Continuous monitoring is required to ensure continuous compliance with the
-regulations. They are not two sets of requirements. In the case of this regulation, monitoring
".of operating parameters is required instead of monitoring of emissions. During the initial
- rstack test which measures emissions directly, limits are established for certain operating
parameters (temperatures, flow rates, feed rates, etc.). Following the initial stack test, the
-operating parameters must be monitored continuously to demonstrate that the incinerator and
associated air pollution control are operating as they did when the MWI demonstrated
compliance with the emission limits through the stack test. The operating parameter limits
include appropriate averaging times and are established hi such a way that it should not be
burdensome to operate within them. With regard to stack testing, EPA regulations have
"always required (and many State regulations require) that sources demonstrate compliance by
measuring emissions using a minimum of three test runs and taking the average. This is how
the emissions data were collected to establish the emission limits.
Comment: One commenter (TV-D-572) requested clarification on the ability of a
facility to retest an incinerator if it fails the initial compliance test for any of the parameters.
Response: A facility must retest the incinerator if it fails to meet the emission limits
during the initial performance test. Under the final standards and guidelines, sources are given
specific deadlines by which they must demonstrate compliance with the emission limits. If the
source fails a performance test for a pollutant, the performance test for that pollutant must be
repeated before this compliance deadline. If the MWI fails its initial performance test and
continues to operate after the compliance deadline established under the NSPS or the section
~lll(d)/129 plan, then the MWI would be considered to have continuous emission violations,
mnless a second performance test has demonstrated compliance with emissions and operational
requirements. Normally, EPA does not require source shutdown if it fails an initial
-performance test. However, an EPA or State enforcement action for identified continuous
emissions violations may lead to a source shutdown requirement.
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Comment: One commenter (TV-D-735) agreed that record keeping is advisable, while
a 3-year record keeping period would be more amiable than a 5-year period. The commenter
stated that it is not necessary for a facility to send in a letter every quarter if no exceedances
occur within that quarter. The commenter argued that if a facility is in exceedance, that
reporting is proper and a letter for the following quarter stating compliance would be
acceptable. Other commenters (TV-D-252, IV-D-453, and IV-D-782/454) suggested a shorter
than 5-year record retention period be adopted in the final rule. One commenter (TV-D-252)
suggested a 3-year record retention period. The commenter also suggested removing the
requirement for notification if the incinerator is in compliance with standards. The commenter
expressed concern that recordkeeping requirements may violate the Fifth Amendment rights of
the owner/operator. Other commenters (TV-D-453, IV-D-535, and IV-D-782/454) suggested
requiring quarterly reports only if there is an exceedance and that CEM data should be
sufficient to confirm compliance. These and other commenters (TV-D-534, and IV-D-547)
claimed that the reporting and recordkeeping requirements are excessive and unnecessary.
Response: Reporting and recordkeeping are necessary to document continuous
compliance with the MWI standards and guidelines. The 1995 proposed MWI standards and
guidelines contained 5-year and "life of the facility" recordkeeping requirements. The "life, of
the facility" recordkeeping requirements have been modified, and the final HMIWI standards
and guidelines now require that facilities maintain these records for a period of 5 years. The
EPA statute of limitation is 5 years for emission violations; therefore, it is useful for EPA
regulations to cover this time frame with respect to maintenance of compliance related records
and documents. A 3-year time frame in the regulation will be to the financial advantage of
violating sources because EPA's economic benefit penalty calculation would account for only
3 years of violations, as compared to 5. Because of limited EPA/State resources, violations
may not be discovered until after a 2- or 3-year period. The Agency believes that maintenance
of records for 5 years is necessary to ensure that facility personnel are operating and
maintaining the MWI and air pollution control equipment properly.
Under the final reporting requirements, facilities are required to submit semiannual
reports on exceedances of emissions or operating parameters and on periods emissions data or
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operating parameters are not obtained. These semiannual reports are to be submitted no later
than 60 days following the reporting period. If no exceedances occur within a year, theibwner
of the affected facility is to be submit a letter stating so. The Agency believes that a letter
stating that no exceedances have occurred is necessary in order for delegated authorities (in
-most cases State agencies) to maintain complete records on each facility. Semiannual reporting
provides assurance that facilities report emission or operating parameter exceedances in a
timely manner and will not operate for extended periods of time in violation of the standards
and guidelines. Section 114 of the CAA gives EPA the authority to require sources subject to
regulations under the CAA to maintain records and submit reports to ensure compliance with
the regulations.
Comment: One commenter (IV-D-636) explained that there is no need for quarterly
reports of waste incinerated by pathological incinerators.
Response: Incinerators used solely for the purpose of burning pathological waste are
not subject to the MWI standards and guidelines. Therefore, the 1995 proposed reporting and
recordkeeping requirements for pathological MWI have been deleted from the MWI standards
and guidelines. Owners or operators of pathological incinerators are required to keep records
of the amount and type of waste burned but are not required to submit reports under the final
HMTWI regulations.
Comment: Two commenters (TV-D-663 and IV-D-536) suggested that the reporting
and recordkeeping requirements be modified to correspond to Sta(§' agency requirements. One
commenter (TV-D-663) noted that requiring information such as the statement of intent to
construct, date of commencement of construction, the anticipated date of initial startup, the
types of waste to be combusted, all siting documentation, and letters from the State approving
construction and operation, to be submitted to the delegated authority are redundant and
confusing. The commenter assumed that the State is the delegated authority and that the letter
of approval for construction and operation is a permit issued by the State or local agency, and
"that the other information noted above should be sent to the State as part of the permit
application or be included in the permit. One commenter (TV-D-536) suggested that all
State/local agencies do not issue approval letters.
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Response: The EPA has not developed reporting and recordkeeping requirements for
MWI that correspond to current State agency requirements because State requirements vary.
The reporting and recordkeeping requirements developed by EPA are pursuant to 40 CFR part
60, subpart A~General Provisions. Initial notification reports such as a statement of intent to
construct, date of commencement of construction, the anticipated date of initial startup, the
types of waste to be combusted, and siting documentation are necessary for the EPA or
delegated authority to determine what sources are subject to the NSPS. The Agency agrees
that requiring letters from the State approving construction and operation to be submitted to the
delegated authority (in most cases the State) would be redundant. Therefore, this requirement
has been deleted from the final HMIWI standards.
Comment: One commenter (TV-D-534) questioned if recordkeeping and reporting must
be continuous. The commenter stated that continuous recordkeeping and reporting would
require multipen recording on a strip chart. The commenter recommended continual data
logging once every 15 minutes, with immediate logging of exceedances. The commenter
noted that with continuous logging the monthly report is likely to amount to 500 pages. The
commenter warned that reporting could constitute a severe paper work burden for a small
source, and a severe reading and storage burden for many budget constrained regulatory
agencies. Another commenter (TV-D-636) suggested that in section 60.57c(d), the EPA should
identify where quarterly reports are to be submitted.
Response: Operating parameters (temperatures, flow rates, feed rates, etc) that can be
recorded continuously must be recorded continuously and the results averaged over the
specified averaging time to demonstrate compliance with operating parameter limits. This will
most likely be done electronically by computer, with very few paper records to store. The
owner or operator is to submit results of performance tests and reports containing information
on emission rates or operating parameters that were not recorded or that exceed the applicable
limits semiannually. If no exceedances occur and all parameters are monitored within a
reporting period, the owner or operator of the facility is to submit a letter stating so annually.
In no case is the owner or operator expected to submit all daily records of monitored data and
operating parameters. Therefore, EPA disagrees with the commenter1 s contention that the
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reporting and recordkeeping requirements are a severe paperwork burden for small sources and
are a severe reading and storage burden for regulatory agencies. v$
Reports are to be submitted to the delegated authority (most likely a State agency) that
Is responsible for implementing the MWI standards and guidelines. However, because the
"delegated authority will not be determined until after implementation plans have been reviewed
by the Administrator, the reporting and recordkeeping requirements contain no reference to
whom is to receive the reports. Until the State air pollution control agency has accepted
delegation of the NSPS requirements and received approval of its section lll(d)/129 plan,
MWI compliance reports should be submitted to the appropriate EPA regional office.
Comment: Two commenters (IV-D-786 and IV-D-789) stated that EPA should set
strict requirements for recordkeeping and reporting of GEMS data., including a requirement
that CEMS data be continuously telemetered and instantaneously transmitted to regulatory
authorities and the public via the Internet. The commenters requested that amounts of
activated carbon and other reagents be reported. The commenters suggested that operators be
required to report exceedances within a few days of occurrence. Another commenter
(TV-D-619/679) suggested that similar to reporting activated carbon amounts, the EPA should
require reporting of the amount of reagents such as alkaline absorbents that are used. The
commenter also suggested that violations should be reported within days, not at the end of 30
days.
Response: As discussed elsewhere, the final standards ancfguidelines do not include
requirements for CEMS. Amounts of activated carbon and other reagents used in air pollution
control devices, along with MWI and APCD operating parameters, must be recorded. The
data must be compiled and reports must be submitted on a semiannual basis. More frequent
reporting would be unnecessarily burdensome. Records must be kept for 5 years.
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3.8 APPLICABILITY
Comment: One commenter (TV-D-786) stated that EPA should broaden the definition
of the MWI source category to include all medical waste treatment technologies, including
alternatives to incineration. The commenter indicated that section 112 authorizes EPA to
regulate treatment of medical waste, whether or not sources combust waste. The commenter
argued that all medical waste treatment technologies should meet the same emission limits.
Another commenter (TV-D-04) stated that the proposed rule should make it easier to get
approval for a state of the art incinerator than for an alternative technology and landfilling.
The commenter stated that the proposed rule does not place enough emphasis on penalizing
systems that do not destroy medical waste safely.
Response: The Clean Air Act Amendments of 1990 added section 129, which includes
specific requirements for solid waste combustion units. Section 129 requires EPA to establish
NSPS for new MWI under section lll(b) and to establish emission guidelines for existing
MWI under section 11 l(d). Thus, the MWI standards and guidelines are to be established
pursuant to sections 129 and 111, and not section 112. In fact, section 129(h)(2) precludes
EPA from establishing regulations under section 112 for solid waste incineration units subject
to regulations under section 129. Section 129 is specific to solid waste combustion units and
does not require EPA to establish NSPS and emission guidelines for all medical waste
treatment technologies. Section 129 does not require EPA to penalize systems that do not
destroy medical waste. The first commenter is correct in stating that EPA has the authority
under section 112 to regulate hazardous air pollutant(s) (HAP) from alternative medical waste
treatment technologies. Nonincineration medical waste treatment technologies are not on the
current list of source categories for which section 112 standards are being developed.
However, in future project planning, EPA may consider emission standards for other medical
waste treatment technologies under section 112.
3.8.1 Definition of Medical Waste
Comment: Eight commenters (IV-D-731, IV-D-732, IV-D-733, IV-D-738, IV-D-739,
IV-D-740/743, IV-D-769/557, and IV-D-785) supported a definition of medical waste that is
limited to "infectious and potentially infections materials" as suggested in the 1996 reproposal.
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Seven commenters (IV-D-760, IV-D-763, IV-D-765, IV-D-788, IV-D-768, IV-D-769/557,
and IV-D-785) agreed that the New YorkState Department of Health (NYSDOH) definifion of
medical waste is appropriate.
One commenter (TV-D-748) agreed that EPA has taken the appropriate path in choosing
"an existing and narrower definition of medical waste. However, this commenter stated that the
definition used for EPA's now withdrawn Standards for the Tracking and Management of
'Medical Waste under the Medical Waste Tracking Act (MWTA) is more appropriate than the
"NYSDOH definition. The commenter stated that the NYSDOH definition is their second
choice. Another commenter (TV-D-732) concurred with the definition of medical waste
adopted by the EPA hi the MWTA but questioned the purpose of excluding dried blood from
the definition. The commenter stated that certain pathogens such as hepatitis B can survive for
weeks in dried blood.
Six commenters (TV-D-762/784, IV-D-772, IV-D-774, IV-D-781, IV-D-784, and
IV-D-786) argued that a broad definition of medical waste is appropriate. Three commenters
(IV-D-772, IV-D-774, and IV-D-786) stated that anything burned in an incinerator at a health
care facility should be classified as medical waste. Three commenters (TV-D-762/784,
IV-D-784, and IV-D-786) pointed out that the CAA requires EPA to regulate emissions from
solid waste incineration units "combusting hospital waste, medical waste and infectious waste."
One commenter (TV-D-774) contended that facilities that operate onsite incinerators use them
primarily for noninfectious waste, which produces emissions similar to medical waste when
burned. One commenter (IV-D-786) stated that noninfectious waste from health care facilities
will be burned in small MWC or MWI without any controls if EPA does not include this waste
in the regulation. The commenter argued that noninfectious medical waste contains the same
amount of polyvinyl chloride (PVC) as infectious medical waste, and will therefore produce
the same dioxin emissions when burned. Two commenters (TV-D-762/784 and IV-D-784)
noted that hospital waste will have the same emissions profile when burned whether the waste
Ms contaminated with microorganisms or is essentially sterile; therefore it is capricious to define
medical waste incinerator based on the infectious nature of the waste it combusts. The
commenters stated that EPA's intention to define MWI as those units that burn only infectious
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waste will prolong the use of small incinerators because some facilities will segregate their
.i1 ': , ".'" '' ' ,
.waste and burn their noninfectious waste which is unregulated. The commenters suggested
adopting a broad definition of medical waste and including a sentence stating that the definition
was developed, not to consider the infectious nature of the waste, but to determine those solid
waste combustors that are subject to the MWI emission standards. The commenters stated that
narrowing the definition to focus on potentially infectious waste is a violation of section 129.
One commenter (IV-D-786) stated that the CAA requires EPA to regulate incinerators,
not waste streams. The commenter argued that it was the intent of Congress for EPA to use
the definition of medical waste from the Solid Waste Disposal Act (SWDA) because Congress
did not give EPA the authority to define medical waste under the CAA. The commenter stated
that EPA can not create the authority to define medical waste by withdrawing its definition of
medical waste under the SWDA. One commenter (TV-D-781) stated that the NYSDOH
definition has not been established by the Administrator of EPA under the SWDA, has never
been subjected to Congressional debate or public comment outside of New York State, and is
not authorized by Section 129.
Three commenters (TV-D-737, IV-D-759, and IV-D-782/454) argued that use of the
NYSDOH definition is inappropriate. One commenter (IV-D-737) stated the New York
definition excludes materials which could transmit disease such as items that contain significant
quantities of dried blood or body fluids. The commenter contended that, if not included in the
definition, these wastes will be incorporated into the municipal solid waste stream, exposing
housekeeping and waste management personnel to potentially harmful materials. Another
commenter (IV-D-782/454) mentioned that the definition covers materials that have little or no
potential for infection. The commenter recommended that EPA adopt a narrow definition that
includes only sharps and microbiological waste (cultures and stocks).
Response: 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 solid waste regulations codified in 40 CFR part 259, subpart B because
this definition was "established by the Administrator pursuant to the [SWDA]," as amended by
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the MWTA. 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 "i
research pertaining thereto, or in the production or testing of biologicals. The 1995 proposed
broad definition of medical waste 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 MWI and
-regulating the air emissions from MWI.
The EPA pointed out in the 1996 reproposal that most noninfectious waste from health
care could be considered "municipal type waste," which would be regulated under other
categories of solid waste incinerators listed in section 129. Consequently, the 1996 reproposal
announced EPA's inclination to adopt an existing and more narrow definition of medical waste
for the purpose of regulating MWI. The EPA indicated that it was inclined to adopt the
definition of medical waste created by the NYSDOH. While inclined to adopt the NYSDOH
definition, the EPA stated in the 1996 reproposal 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
discussed in the 1996 reproposal as well as other definitions EPA should consider.
Following publication of the 1996 reproposal, 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 HMTWI 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 undergonhg public comment at
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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 promulgated 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
first defines medical waste broadly as any solid waste that is generated hi the diagnosis,
treatment, or immunization of human beings or animals, in research pertaining thereto, or in
the production or testing of biologicals. The MWTA definition of RMW, which is the
definition of "medical/infectious waste" used for the final HMIWI regulations, is a more
narrow subset of the MWTA definition of medical waste. Seven classes of waste are included
under the MWTA definition of RMW: (1) cultures and stocks of infectious agents, (2) human
pathological wastes, (3) human blood and blood products, (4) used sharps, (5) animal wastes,
(6) isolation wastes, and (7) unused sharps. These classes of RMW are very similar to the
classes of infectious waste included in the NYSDOH definition of medical waste. 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.
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
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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 bum "infectious" waste, "noninfectious" waste, or a combination.
Commenters on the 1995 proposed MWI regulations stated there are very few, if any,
MWI that are used by hospitals to bum 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 reproposal, resulting hi 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, 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. Any incinerator which burns 10 percent by weight or less of
hospital waste and medical/infectious waste is not subject to the final HMIWI standards and
guidelines. This 10 percent provision is discussed further below.
As mentioned earlier, the purpose of defining the waste streams is only to determine
which incinerators are subject the HMIWI regulations. Different regulatory definitions of
medical waste may be necessary to accomplish separate purposes such as worker safety,
transportation of medical waste, or regulating the air emissions from incineration of medical
waste. The purpose of the MWTA definition of medical waste as used in the HMIWI
regulations is not to define which items are potentially infectious, but to define
"medical/infectious waste" in order to limit air emissions from incineration of this waste, as
required by section 129 of the CAA. As evidenced by the many comments on this issue, there
is disagreement, even within the medical community, about which items in the health care
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waste stream should be viewed as "infectious." This debate will not, and need not, be settled
by EPA's HMIWI regulation. Other definitions of "medical" waste and "infectious" waste
may be appropriate for other purposes such as infection control and worker safety. The
definition of medical/infectious waste included in the HMIWI regulations should not be viewed
as the Federal definition or even as the EPA agency-wide definition of medical waste.
Comment: Two commenters (TV-D-735 and lV-D-76ti) agreed that the NYSDOH
definition of medical waste is more appropriate than the proposed definition, but had specific
questions regarding the NYSDOH definition. One commenter (TV-D-735) questioned if
blood-stained linens and bandages would be included in the definition. The commenter
recommended that regulated medical waste generated by in-home health care and out-of-date
and off-spec drugs be included in the definition. One commenter (TV-D-760) recommended
that the NYSDOH guideline that "Sharps as defined in subcategory 4 must be treated and
destroyed (rendered unrecognizable) before they can be disposed of in a landfill" not be
included in any of the regulatory material for the MWI standards and guidelines. The
commenter stated that it is not necessary to require the destruction of sharps before disposal in
a landfill because some facilities are able to arrange for immediate burial of incinerator ash
containing recognizable needles. The commenter also requested that the EPA definition
include only the italicized sections found on pages two through six of "Managing Regulated
Medical Waste" (Docket item IV-J-78). The commenter also suggested that the definitions of
"treatment" and "infectious agents" given on page six be included.
Response: As discussed above, the MWTA definition of medical waste, rather than the
NYSDOH definition has been included in the final HMIWI standards and guidelines. The
primary purpose of the MWTA definition of medical waste as used for the final HMIWI
standards and guidelines is to define items combusted in an MWI, and not to define items
which could transmit disease. Items that are saturated with blood or caked with dried blood
are included under the MWTA definition. Medical waste generated by in-home health care
and out-of-date or off-spec drugs are not covered under the MWTA definition. Furthermore,
the MWTA definition does not include hazardous waste; household waste; ash from
incineration of medical/infectious waste; human corpses, remains, and anatomical parts
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intended for interment or cremation; or domestic sewage materials. To add or remove specific
items to or from the MWTA definition would create additional regulatory confusion because
the revised definition would essentially become a new definition of medical waste if altered.
These "excluded" wastes are either covered now or will be covered in the future by other solid
waste incinerator regulations. Provisions for the treatment of sharps before landfilling are not
necessary to define the items that are likely to be combusted in an MWI.
As mentioned earlier, the purpose of the MWTA definition of medical waste, as used
for the final HMIWI standards and guidelines, is not to determine what items in the health care
waste stream are infectious and require treatment before disposal. The purpose of the MWTA
definition of medical waste as used hi the HMIWI regulations is to define "medical/infectious
waste" in order to limit air emissions from incineration of this waste, as required by section
129 of the CAA. Therefore definitions of "treatment" and "infectious agents" are not
necessary for the final HMIWI regulations. As also mentioned earlier, the debate over which
items in the health care waste stream are infectious and require treatment will not, and need
not, be settled by EPA's HMIWI regulation. Definitions of "medical" waste and "infectious"
waste, other than the MWTA definition may be appropriate for other purposes such as
infectious waste transportation and worker safety. Therefore, the definition of
medical/infectious waste included in the HMIWI regulations should not be viewed as the.
Federal definition or even as the EPA agency-wide definition of medical waste.
Comment: Four commenters (IV-D-759, IV-D-762/784, IV-D-784, and IV-D-792)
stated that it is more appropriate to define medical waste incinerator than the medical waste
itself. Two commenters (TV-D-762/784 and IV-D-784) stated that EPA is capable of defining
medical waste incinerator without entering into a debate over the definition of medical waste.
The commenters noted that the staff of EPA's Air and Radiation Office do not have the
appropriate expertise to identify substances that need to be treated as regulated medical waste.
The commenters stated that EPA could define medical waste incinerator as follows: "A
medical waste incinerator is any incinerator that accepts waste generated during the diagnosis
or treatment of a human or animal, including but not limited to, incinerators that are located at
hospitals, veterinary clinics, and nursing homes." One commenter (TV-D-739) encouraged
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EPA to recognize in the final MWI rule that hospitals using incinerators will generally burn
most of their waste. The commenter recommended that EPA avoid defining or using the term
"medical waste" for the purposes of the rule, and instead to allow for combustion of hospital
waste. The commenter suggested using the term "health care waste incinerator." One
commenter (TV-D-534) suggests that nonmedical waste should be referred to as institutional
waste, not municipal waste.
Two commenters (TV-D-790 and IV-D-792) agree that the NYSDOH definition is
superior to the original, broad definition. However, the commenters recommended that EPA
avoid adopting a specific definition of medical waste because any definition will be
problematic.
Response: The EPA agrees with commenters that any definition of medical waste will
be controversial and that it would be better to define medical waste incinerator than to define
medical waste. The EPA attempted to define medical waste incinerator without defining
medical waste following the 1995 proposal and again following the 1996 reproposal.
Unfortunately, there appears to be no way to distinguish MWI from other types of combustors
without defining the types of materials burned in MWI (i.e., defining medical waste). The
definition of medical waste incinerator suggested by commenter IV-D-784 was considered.
The scope of the definition mentioned by the commenter is similar to the scope of the proposed
definitions of medical waste and medical waste incinerator. As such, the suggested definition
promotes the same misunderstanding that all waste from health care is somehow dangerous
when, in fact, most health care waste is no more dangerous than municipal waste. For
purposes of regulating air emissions from HMIWI under section 129, the EPA is not
attempting to identify substances that need to be treated as regulated medical waste; rather, an
existing definition of medical waste has been selected for the HMTWI regulations. As
discussed earlier, the final HMIWI standards and guidelines contain the MWTA definition of
medical waste along with definitions for "hospital," "hospital waste," and "hospital/
medical/infectious waste incinerator." The final standards and guidelines will apply to
"hospital/medical/infectious waste incinerators".
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Comment: Three commenters (TV-D-790, IV-D-792, and IV-D-759), suggested that
"EPA reference the applicability of the regulations to the medical waste definitions of the*State
or locality where the MWI is installed.
Response: Federal regulations developed under the CAA are to establish uniform
national standards and guidelines. Definitions of medical waste may vary greatly from one
State or locality to another. Some States may have different definitions of medical waste to
accomplish different purposes such as regulations for occupational safety or transportation.
"Determining the applicability of the MWI regulations based on each State's unique definition
would be contrary to the CAA's goal of uniform national standards and guidelines.
Comment: One commenter (TV-D-792) suggested that if EPA adopts a definition of
medical waste that the definition should become the Agency standard applicable to all EPA
regulations. Another commenter (IV-D-748) stated that a long term solution to the problem of
proliferating medical waste definitions would be to develop a standard federal regulatory
definition of medical waste which would be adopted by all entities of the Federal government.
Response: As discussed above, the final HMIWI standards and guidelines include the
MWTA definition of medical waste. The EPA believes that the MWTA definition of medical
waste is appropriate to define the types of waste that are likely to be burned in an MWI.
However, the MWTA definition of medical waste may not be appropriate to replace the
medical waste definitions contained in other Federal regulations concerning medical waste
handling, worker safety, transportation, and disposal. Such a definition would have to be
made overly broad to encompass concerns in all of these areas, and EPA does not have the
authority to develop a definition for the Federal government. Therefore, the definition of
medical waste developed for the final HMIWI standards and guidelines should not be viewed
as the Federal definition or the EPA agency-wide definition. It's only purpose in this instance
is to determine which incinerators are subject to the final HMTWI regulations.
3.8.2 Municipal Waste Combustors, Cement Kilns, Boilers, and
Industrial/Commercial Waste Incinerators
Comment: Two commenters (TV-D-728 and IV-D-775) requested that "potentially
infectious" medical waste be allowed to be combusted in MWC along with municipal solid
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waste (MSW) without being subjected to the MWI rules. The commenters stated that the
combustion characteristics and emissions from burning medical waste are similar to those from
burning MSW. The commenters noted that research has proven that co-combustion of
municipal and medical waste provides complete destruction of all pathogens. The commenters
stated that the database used to develop the standards for MWC included units that co-combust
municipal and medical waste. The commenters stated that MWC co-combust less than
10 percent medical waste. The commenters stated that MWC co-combust "off-spec" and
"out-of-date" Pharmaceuticals with MSW routinely. The commenters maintained that these
materials should not fall into the infectious waste category and that they should not require
different standards if they are combusted in small percentages in an MWC. 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. The commenters suggested that
MWC combusting less than 10 percent "potentially infectious" medical waste be subject to the
MWC rule and not to both the MWC and MWI rules.
Another commenter (TV-D-768) agreed with EPA's proposed definition of medical
waste that would exclude MWC that burn Pharmaceuticals, treated (autoclaved or microwaved)
medical waste, and noninfectious hospital waste from the MWI rule. The commenter
recommended that even if the definition of medical waste is revised before promulgation that
EPA should include a clause that exempts MWC covered under the MWC rule from the MWI
rule. The commenter recommended that an exclusion be written into the final rule that will
allow MWC that combust a minimal amount of medical waste (10 percent of the waste stream)
to be excluded from the MWI rule.
Two commenters (TV-D-762/784 and IV-D-784) stated that small MWC which are not
regulated under the MWC standards should not be allowed to accept medical waste without
complying with the MWI standards. The commenters questioned whether the emissions
profiles formed by burning noninfectious health care trash and municipal waste are similar.
The commenters stated that one would logically assume that health care trash with its higher
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plastic content and exotic constituents will produce an emissions profile with higher levels of
HC1, Hg, and other hazardous air pollutants.
Response: Section 129 requires the EPA to develop NSPS and emission guidelines for
*MWI and MWC. The final NSPS and guidelines applicable to MWC with capacities of
-^greater than 40 tons per day ("large" MWC) were promulgated in December 1995, but have
- since been partially vacated and remanded. Emission standards and guidelines for MWC with
^capacities of less than 40 tons per day ("small" MWC) are scheduled to be developed by the
*EPA in the next few years. It is not the EPA's intent for MWC to be dually covered under
both the MWC regulations and the HMIWI regulations. Therefore MWC subject to Subparts
Ea, Eb, or Cb are exempted completely from the HMIWI standards and guidelines.
Commenters requesting that MWC and other industrial processes that co-fire medical
waste be exempted from coverage under the MWI regulations generally seem to agree that
£these units combust no more than 10 percent medical waste. Therefore, the final HMIWI
NSPS and guidelines contain the provision that any incinerator that combusts 10 percent by
weight or less of hospital waste and medical/infectious waste is not subject to the HMIWI
»NSPS and guidelines, provided that these facilities notify the Administrator of an exemption
claim and keep records of the weight of hospital waste, medical/infectious waste, and other
^fuels combusted.
As discussed later in section 3.8.3, pharmaceutical wastes such as "off-spec" or
"out-of-date" drugs are not considered to be medical/infectious waite. Also, pharmaceutical
wastes are not considered to be hospital waste unless generated at a hospital and disposed of
with the hospital's waste. In the final 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. "Off-spec" or "out-of-date" drugs sent to an
1MWC from a hospital are considered to be hospital waste. Nevertheless, incinerators
"(including MWC) that combust waste Pharmaceuticals, and combust 10 percent by weight or
less of hospital waste and medical/infectious waste (by weight) are not subject to the HMIWI
regulations provided that these facilities keep records of the weight and types of wastes
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burned. Any incinerator that combusts waste Pharmaceuticals along with more than 10 percent
hospital waste and medical/infectious waste is subject to the HMIWI regulations, unless they
are expressly excluded in the regulations (e.g., cement kilns and incinerators combusting
pathological waste are excluded, as discussed later in this section and in section 3.8.4,
respectively).
As also discussed later in section 3.8.3, 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 MWC that burn 10 percent by weight or less of 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 incinerators in the future.
The NSPS and emission guidelines that were recently vacated and 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 and MWC with capacities less than 40 tons/day
will be developed by the year 2000 as part of its Industrial Combustion Coordinated
Rulemaking project. Thus, burning of medical wastes in MWC not covered by this rule or
Subparts Ea, Cb, or Eb will be covered by regulations developed within the next few years.
Exclusion of those MWC that burn small amounts of medical waste from the HMIWI
regulation is only a temporary deferment.
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Comment: Two commenters (TV-D-746 and IV-D-747) requested that the term
"medical waste incinerator" be redefined to exclude cement kilns and other industrial sources.
The commenters pointed out that section 129 clearly addresses incinerators, not cement kilns
and legislative history supports the difference between an incinerator and a kiln. The
^commenters stated that MWI 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
Remissions control standards. The commenters supplied process information and emissions data
"to support their positions. The commenters stated that the EPA did not consider cement kilns
in its energy and air quality impact analysis. The commenters suggested that the EPA should
consider cement kilns in its analysis if it plans to include them under this rule. The
commenters noted that if cement kilns are regulated, fossil fuels will replace medical waste as
a fuel. The commenters suggested that the energy conservation impacts be considered. One
*commenter (IV-D-746) suggested that EPA state that an industrial furnace using medical waste
as part of a manufacturing process is not within the scope of the medical waste incinerator
definition.
One commenter (IV-D-747) recommended that if the 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 MWI on cement kilns. The
commenter argued that EPA would have to gather technical and economic data on cement kilns
before subjecting kilns to emission limits developed for MWI. "The" commenter noted that
cement kilns operate with much higher temperatures (3000 °F), longer residence times (6 to
10 seconds), and greater turbulence (100,000 Reynolds number) than incinerators. The
commenter noted that cement kilns, which are typically 180 to 260 feet in length and 10 to
15 feet in diameter, are much larger than incinerators because they are built to handle much
""larger volumes of raw material and gas. The commenter stated that only 5 percent of a kiln's
^otal input is waste fuel. The commenter stated that cement kilns have a gas volume average
-of 120,000 to 130,000 dscfm, which is about four to five times the gas flow of an incinerator.
"The commenter stated that this difference should be accounted for when considering mass
emission rate standards. The commenter stated that the fact that cement kilns are producing a
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product restricts the kilns' ability to use the same APCD as an incinerator. The commenter
noted that the inlet grain loading to the APCD is two to three times higher than that of an
incinerator due to the nature of the cement manufacturing process. As a result, the commenter
concluded that the outlet grain loading for a kiln will be two to three times greater than an
incinerator APCD with the same collection efficiency.
Response: The EPA does not agree with the commenters that stated EPA has no
authority to regulate cement kilns and other industrial devices that combust hospital, medical,
and infectious waste, or any other solid waste material, Section 129(a)(l)(A) requires the
Administrator to establish performance standards and other requirements pursuant to section
111 and section 129 of the Act for each category of solid waste incineration units. 42 U.S.C
§ 7429(a)(l)(A). Whereas section 112(c) of the Act requires EPA to determine major and area
sources of the 189 hazardous air pollutants (HAPs) listed in section 112(b), Congress
specifically listed in section 129 various categories of solid waste incineration units that EPA .
must regulate, including solid waste incineration units combustion municipal solid waste
[sections 129(a)(l)(B) and (C)], solid waste incineration units combusting hospital waste,
medical waste, and infectious waste [section (a)(l)(C)], solid waste incineration units
combusting commercial or industrial waste [section 129(a)(l)(D)], and "other categories of
solid waste incineration units[,]" which are to be defined by EPA. 42 U.S.C. § 7429(a)(l).
Section 129(g)(l) of the Act broadly defines a solid waste incineration unit ("SWIU")
as "a distinct operating unit of any facility which combusts any solid waste material from
commercial or industrial establishments or the general public...." 42 U.S.C. § 7429(g)(l)
(emphasis added). This definition clearly indicates Congress' intent to regulate more than just
incinerators as some commenters contended, because the definition sweeps within its scope any
.facility that is combusting any solid waste material. Additionally, the legislative history
indicates Congress' intent to regulate more than incinerators. In its early stages, section 129
was intended to regulate only municipal waste combustors. Later drafts of the section
broadened the scope of coverage to medical waste incinerators, and then other categories of
solid waste incineraiiojQ units, not other incinerators. Moreover, Congress added to section
129 the broad definition of solid waste incineration units, as noted above.
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That Congress intended to sweep broadly and regulate numerous facilities that combust
solid waste materials, and not just incinerators, is further evidenced by the fact that section 129
expressly excludes from the definition of SWIU certain enumerated units, including
"incinerators or other units required to have a permit under section 3005 of the Solid Waste
-Disposal Act" [i.e., RCRA]. 42 U.S.C. § 7429(g)(l) (emphasis added). If Congress intended
=*for EPA to regulate only incinerators under section 129, there would have been no need to
^include the phrase "or other units" with RCRA permits. Section 129 expressly exempts from
-coverage the following facilities:
(A) materials recovery facilities (including primary and secondary smelters) which
combust waste for the primary purpose of recovering metals, (B) qualifying small
power production facilities, as defined in section 769(17)(C) of Title 16, qualifying
cogeneration facilities as defined in 769(18)(B) of Title 16, which burn homogeneous
waste (such as units which burn tires or used oil, but not including refuse-derived fuel)
for the production of electric energy or in the case of qualifying cogeneration facilities
which bum homogenous waste for the production of electric energy (such as heat)
which are used for industrial, commercial, heating or cooling purposes, or (C) air
curtain incinerators provided that such incinerators only burn wood wastes, yard wastes
and clean lumber and that such air curtain incinerators comply with opacity limitations
to be established by the Administrator by rule. ^
42 U.S.C. § 7429(g)(l). Not only are these exclusions written in terms of facilities (not just
-.incinerators) exempted from coverage under section 129, but the fact that Congress expressly
* excluded smelters and small power production facilities indicates Congress intended for EPA
.to regulate units that are not labeled incinerators. .Moreover, the fact that only certain units
are listed indicates an intent to have EPA regulate all others Accordingly, with the exception
of those solid waste incineration units that are expressly excluded from regulation by section
129(g)(l), Congress intended EPA to establish regulations for aU SWIU's combusting solid
waste under section 129. This includes cement kilns and other industrial processes that
^combust solid waste materials, including hospital, medical, and infectious waste.
The EPA, however, does recognize that cement kilns are different from MWI 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, including hospital, medical,
and infectious waste, as well as municipal solid waste.
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Comment: Three commenters (W-D-753, W-D-790, and IV-D-792) requested that a
"de minimus" quantity exemption be allowed for facilities that incinerate an insignificant
quantity of medical waste. Two commenters (W-D-790 and IV-D-792) 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. One commenter (W-D-753) stated that their company,
which is located in Alaska and provides onsite medical services, burned only 143 pounds of
medical waste in 10 separate solid waste incinerators in 1995. The commenter pointed out that
this represents less than 0.1 percent of total waste burned. The commenter provided a cost per
pound analysis of their medical waste disposal options: (1) install wet scrubbers at each
incinerator ($2,875/lb), (2) ship all medical waste to one company incinerator with the proper
controls ($288/lb), and (3) ship waste out of state to an EPA approved disposal facility
($25/lb). The commenter proposed that EPA use a 200 pound per facility per year exemption
for facilities that operate solid waste incinerators.
Response: Commenters requesting that MWC and other industrial processes that co-
fire medical waste be exempted from coverage under the MWI regulations generally seem to
agree that these units combust no more than 10 percent medical waste. Therefore, the final
EGMTWI NSPS and guidelines contain the provision that any incinerator or industrial process
that combusts 10 percent by weight or less of hospital waste and medical/infectious waste is
not subject to the final HMIWI NSPS and guidelines provided that the facility notifies the
Administrator of an exemption claim and keeps records of the weights of hospital waste,
medical/infectious waste, and other fuels burned. This 10 percent exemption should provide
the necessary relief for the commenter who suggested a 200 Ib/yr exemption, so a separate
exemption in terms of pounds per year is not included in the final regulations.
For purposes of determining applicability of the small quantity (10 percent by weight or
less of hospital waste and medical/infectious waste) exemption to incinerators burning mixtures
of pathological waste with other fuels, pathlogical waste is viewed the same as "other" fuels or
wastes (e.g., municipal waste, coal, etc.), even if it meets the definition of jospital waste or
medical/infectious waste. For example, an incinerator burning 89 percent municipal waste,
2 percent pathological waste (meeting the definition of medical/infectious waste), and
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9 percent medical/infectious waste would not be covered under the HMIWI regulations. On
the other hand an incinerator that combusts 6 percent medical/infectious waste, 6 percent
hospital waste, 12 percent pathological waste, and 76 percent municipal waste would be
^covered under the HMIWI regulations because this unit is combusting more than 10 percent
--waste that is considered hospital waste or medical/infectious waste.
The final HMIWI regulations state that combustors are not subject to the NSPS and EG
^during periods when only pathological, low-level radioactive, and/or chemotherapeutic waste
is burned. Application of the co-fired combustor provision to incinerators co-firing low-level
radioactive and chemotherapeutic waste along with other fuels is similar to applicability of the
co-fired combustor provision for incinerators co-firing pathological waste with other fuels.
Incinerators that co-fire 10 percent by weight or less of material that is considered to be
hospital waste and/or medical/infectious waste under the HMIWI Definitions (for purposes of
-calculating the 10 percent, radioactive, pathological, and chemotherapeutic wastes and
considered "other" fuels), are not subject to the HMIWI regulations provided that these
-.facilities notify the Administrator of an exemption claim and maintain records of the amounts
and types of wastes burned.
Comment: One commenter (IV-D-692) provided data on circulating fluidized bed
...:combustors. The commenter stated that a circulating fluidized bed combustor (CFBC) steam
plant which co-fires coal and medical waste will easily be able to meet the proposed emission
limits for all pollutants except for SO2 and CO.
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less of hospital waste and medical/infectious waste are not covered provided that these
facilities notify the Administrator of an exemption claim and maintain records of the weight of
hospital waste, medical/infectious waste, and other fuels burned. Boilers burning more than
10 percent by weight hospital waste and medical/infectious waste remain subject to the
HMIWI regulations. Alternative compliance methods may be approved on a case-by-case
basis which should solve the SO2 problem. The facility would have to show that the SO2 from
the combustion of waste is less than the emission limit in the regulation. The SO2 contribution
from coal or other fuels is not regulated under the final standards and guidelines.
Comment: One commenter (TV-D-746) recommended that industrial and commercial
incinerators, hazardous waste incinerators, and incinerators regulated by section 3005 of the
Solid Waste Disposal Act be exempt from this rule because they are already regulated, or will
be regulated in the near future.
Response: As discussed above, the final HMIWI standards and guidelines contain
exemptions for incinerators and industrial processes that bum 10 percent by weight or less of
hospital waste and medical/infectious waste, provided that these facilities notify the
Administrator of an exemption claim and maintain records of the weights of hospital waste,
medical/infectious waste, and other fuels burned. Thus, industrial and commercial
incinerators that do not have a permit under section 3005 of the SWDA are covered under the
HMIWI standards and guidelines, unless they burn 10 percent by weight or less hospital waste
and medical/infectious waste. As discussed below, 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 Part 261.
3.8.3 Pathological, Drugs, Chemotherapy, Low-level Radioactive, and Hazardous Wastes
Comment: Nine commenters (IV-D-731, IV-D-738, IV-D-760, IV-D-763, IV-D-765,
IV-D-766, IV-D-770, IV-D-790, and IV-D-792) requested that crematories and incinerators
used solely for burning pathological waste be excluded from the MWI regulation as suggested
in the notice. One commenter (IV-D-760) stated that it is unclear in the present discussion as
to whether NYSDOH Class 5-Animal waste is to be included, excluded, or partially excluded
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from the regulation. One commenter (IV-D-770) stated that there are no effective alternative
disposal options for pathological waste, especially for large domestic animal carcasses (i
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While crematoria and pathological waste incinerators may be excluded from the
regulation for HMIWI, 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 has announced that regulations for other
solid waste incinerators will be developed by the year 2000. Thus, burning of pathological
wastes will be covered by regulations developed within the next few years. Exclusion of
crematories and pathological waste incinerators from the HMIWI regulation is only a . . , ..
temporary deferment.
Comment: One commenter (TV-D-760) requested that drugs, pharmaceutical, and
radioactive wastes be excluded from these regulations. Five commenters (TV-D-763,
IV-D-766, IV-D-781, IV-D-790, and IV-D-792) agreed with EPA's inclination to exclude
incinerators that burn only Pharmaceuticals or radioactive waste from the regulation. One
commenter (TV-D-792) stated that incineration of such waste types is already covered under
other regulations, or will be covered under regulations developed through EPA's industrial
combustion coordinated rulemaking procedures. Other commenters (IV-D-769/557 and
IV-D-785) agreed with EPA's inclination to exclude Pharmaceuticals from the definition of
medical waste and to exclude incinerators that burn only Pharmaceuticals.
One commenter (TV-D-744) argued the MWI regulations must apply to all systems
using thermal oxidation (incineration) as a treatment modality for medical waste. The
commenter argued that medical waste containing radioactive materials must not only comply
with all the Nuclear Regulatory Commission's (NRC's) applicable regulations but, in addition,
all those regulations for MWI promulgated by EPA and other appropriate agencies (State and
other) that are applicable. The commenter concluded that there should be no exceptions.
Response: Pharmaceutical wastes such as "off-spec" or "out-of-date" drugs are not
,' '"! ' i"i', . * '
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 final HMIWI regulations "hospital waste" is
defined as discards generated at a hospital, excluding human remains and unused items
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returned to the manufacturer. Thus, "out-of-date" drugs returned by a hospital to a
pharmaceutical company for disposal are not considered hospital waste. ,
Radioactive waste is different from most hospital waste and medical/infectious waste
and is often burned in incinerators which burn this waste exclusively. While radioactive waste
may meet the definition of hospital waste or medical/infectious waste, the combustion of this
material warrants separate consideration. Therefore, incinerators that burn only low-level
^radioactive waste alone or in combination with pathological or chemotherapeutical waste are
-exempt from the final HMIWI standards and guidelines.
Furthermore, incinerators that combust waste Pharmaceuticals or low-level radioactive
waste, and combust 10 percent by weight or less of hospital waste and medical/infectious
waste are not subject to the HMIWI regulations provided that these facilities keep records of
the weight and types of wastes burned. Any incinerator that combusts waste Pharmaceuticals
-or low-level radioactive waste along with more than 10 percent by weight ^hospital waste and
medical/infectious waste is subject to the HMIWI regulations.
While pharmaceutical and low-level radioactive waste incinerators are excluded from
the regulation for HMIWI, 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 has announced that regulations for other
solid waste incinerators will be developed by the year 2000. Thus, burning of pharmaceutical
j
and low-level radioactive wastes will be covered by regulations developed within the next few
years. Exclusion of pharmaceutical and low-level radioactive waste incinerators from the
HMIWI regulation is only a temporary deferment. Although the burning of low-level
radioactive waste is not covered under the HMIWI regulations, NRC regulations pertaining to
"the disposal of low-level radioactive waste continue to apply.
Comment: One commenter (TV-D-734) stated that EPA drafted the proposed MWI rule
"without any exclusion for RCRA-regulated hazardous waste combustion units. The commenter
^argued that section 129 of the CAA statutorily prohibits EPA from regulating RCRA
^hazardous waste combustion units in the MWI rule. The commenter stated that the final rule
-for MWC has an exclusion for all units that have a permit under section 3005 of the SWDA.
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The commenter and another commenter (TV-D-769/557) urged EPA to exclude units permitted
under section 3005 of the SWDA from the MWI rule.
Response: Section 129(g)(l) 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 Part 261.
Comment: One commenter (TV-D-786) stated that EPA has provided no rationale for
excluding crematoria or units burning solely radioactive waste.
Response: Human remains are excluded from the definitions of "hospital waste" and
"medical/infectious waste," as are most animal remains and tissue. Consequently, all human
crematoria and most animal crematoria are excluded from the final HMIWI standards and
guidelines. As discussed previously, 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. Therefore, incinerators used solely for the
purpose of burning low-level radioactive waste are excluded from the HMIWI regulations.
The NRC regulates the disposal of radioactive materials; therefore, exclusion of radioactive
waste incinerators from the HMIWI regulations does not mean that low-level radioactive waste
will be disposed of improperly.
While crematoria and low-level radioactive waste incinerators are excluded from the
regulation for HMIWI, 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 has announced that regulations for other
solid waste incinerators will be developed by the year 2000. Thus, crematoria and incinerators
burning low-level radioactive wastes will be covered by regulations developed within the next
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few years. Exclusion of crematoria and low-level radioactive waste incinerators from the
HMIWI regulation is only a temporary deferment.
Comment: Two commenters (TV-D-769/557 and IV-D-785) stated that the switching
scenario is not possible for pharmaceutical research operations because of the need to retain
'control of low-level radioactive waste and returned drugs. One commenter (TV-D-769/557)
-stated that landfill space for low-level radioactive waste has been eliminated.
Response: As discussed above, incinerators used solely for burning radioactive-type
-'waste are excluded from the HMIWI regulations. The final HMIWI regulations also contain
an exemption for incinerators that burn 10 percent by weight or less of hospital waste and
medical/infectious waste. Incinerators that burn mixtures of "off-spec" or "out-of-date" drugs
or low-level radioactive waste commingled with more than 10 percent by weight hospital waste
and medical/infectious waste are covered under the HMIWI regulation. Low-level radioactive
;?waste does not count towards the 10 percent hospital waste and medical/infectious waste even
if it meets the definition of hospital waste or medical/infectious waste.
As discussed previously, returned or "off-spec" drugs alone 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. '
Facilities that must retain control of low-level radioactive wastes and returned drugs
and who combust hospital waste or medical/infectious waste have at least two options. These
facilities may operate their incinerators to combust only their low-level radioactive waste and
returned drugs, without being covered under the HMIWI regulations, and may use offsite
-disposal or an onsite alternative treatment technology to treat their hospital waste and
medical/infectious waste. These facilities may also co-mingle their low-level radioactive waste
and returned drugs with medical waste and operate their incinerator under coverage of the
HMIWI regulations. Each individual facility must consider its options and select the waste
disposal method that is most appropriate for that particular facility.
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3.8.4 MWT Built Following the 1995 Proposal
Comment: One commenter (IV-D-739) stated that they were issued a permit in March,
1995 to install a new MWI with the controls necessary to meet the EPA emission limits as
proposed in 1995; however, the emission limits for new MWI presented in the supplemental
notice are more stringent that the 1995 proposed emission limits. The commenter suggested
that a provision be included in the final regulations that would allow MWI installed between
the dates of the 1995 proposal and promulgation to meet the 1995 proposed emission limits.
The commenter stated that precedent for this provision has been established previously in the
Industrial-Commercial-Institutional Steam Generating Units NSPS and in the
Perchloroethylene Dry Cleaning Facilities NESHAP. The commenter stated that it is unfair
and unjustifiable to require MWI that were designed and permitted to meet EPA's original
limits to meet more stringent limits which may or may not be incorporated into the final
regulations. The commenter suggested that EPA include the following languageif the changes
described in the supplemental notice are incorporated into the final MWI rule:
"The applicability date for the standards adopted today are February 27, 1995.
The standards include emission standards for medical waste incinerators built
between February 27, 1995 and today, and a stricter standard for medical waste
incinerators built after today. The emissions standards for medical waste
incinerators constructed between February 27, 1995 and today are: [reference:
Proposed MACT Floor Emissions Levels for New MWI, February, 1995
(batch, intermittent, and continuous)]. The emission standards for medical
waste incinerators constructed after today are [Revised MACT Floor Emission
Levels for New MWI]."
Another commenter (IV-D-748) applied for a permit to construct an MWI in February,
1994. However, the commenter did not receive the permit until June 6, 1995, which caused
the MWI to be classified as a new incinerator under the 1995 proposed standards. The
commenter stated that the facility changed the control device to meet the 1995 proposed
emission limits. The commenter noted that the MACT floor in the 1995 proposed rule has
been reevaluated and the supplemental notice presents new emission limits based on different
control technology and the final rule is still 12 months from promulgation. The commenter
estimated that it will cost the facility an additional 1 to 1.5 million dollars to comply with the
emission limits in the supplemental notice. The commenter stated that, in the past, EPA has
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provided special consideration to owners of sources that were constructed based on a proposed
rule, only to have the final rule include more stringent requirements. The commenter argued
that facilities which commenced construction with intentions of meeting the 1995 proposed
emission limits should not be penalized if the final rule becomes more stringent. The
commenter recommended that incinerators commencing construction or reconstruction between
the 1995 proposal date and the supplemental notice date should be regulated as existing
? sources. The commenter suggested that a fair solution would be to move the date at which a
facility is considered new to the supplemental notice date (June 20, 1996) or to define new
incinerators as those that had not applied for a permit to construct prior to the February 27,
1995 proposal date.
Another commenter (IV-D-779) was issued the authority to construct two 1,000 Ib/hr
MWI with a DI/FF with carbon on March 7, 1996. The commenter stated that these MWI
"were constructed in accordance with the 1995 proposed MWI rule. The commenter noted that
the standards presented in the supplemental notice are more stringent than the 1995 proposed
standards. The commenter requested that, if the standards from the supplemental notice are
promulgated, that EPA change the date for which facilities are considered to be new to the
supplemental notice date (June 20, 1996). The commenter stated that the intent behind
requiring a facility that commences construction after a rule is proposed, but prior to
promulgation of the final rule, to comply with the rule is to impose the requirements of the
final rule on a facility that has notice of what the final rule is to entail. The commenter noted
that facilities had no notice of the standards that would be announced in the supplemental
notice. Therefore, the commenter explained that, if the standards announced in the
supplemental notice are adopted as the final rule, the notice must be considered a new
proposed rule, and only those facilities commencing construction after the date of the notice
should be considered new facilities for the purposes of the final rule. The commenter stated
that any MWI constructed before the supplemental notice date should be considered as existing
"MWI. Alternatively, in accordance with section 112(i)(2) of the CAA, the commenter stated
that EPA could provide a 3-year grace period for compliance for units constructed between
February 27, 1995 and June 20, 1996.
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One commenter (IV-D-741) stated that if the regulations for new MWI apply to all
incinerators whose construction commenced after February 27, 1995, the tightening of the
MWI regulations creates a "moving target" for the affected facilities. The commenter stated
that facilities may have been provided with a guaranteed compliance with the original draft
regulations, and now are confronted with added systems components such as carbon injection.
Two commenters (TV-D-790 and IV-D-792) recommended that EPA include special
provisions for MWI installed between the dates of the 1995 proposed regulations and the final
regulations so that they are only required to meet the 1995 proposed emission limits. One
commenter (EV-D-792) noted that such provisions have been included in the final rules for
Industrial-Commercial-Institutional Steam Generating Units and Perchloroethylene Dry
Cleaning Facilities.
One commenter (TV-D-782/454) argued that the significant changes in the 1996
proposed standard compared with the 1995 proposal make the 1996 supplemental notice a
reproposal rather than a "Reopening of the Comment Period." The commenter stated that
sources constructed after the proposal and before the supplemental notice lacked sufficient
notice regarding the requirements of the standard. The commenter requested that EPA issue a
..1'! ' .. . ' »( .'' , . . , . .'
clarification or correction with the final rule stating that only sources built after June 20, 1996
1111J! '' ' ' , ' .iii1,', , ' "
are new sources. The commenter also stated that if the final rule is appreciably different, then
the final rule date should be used for new source determination. Furthermore, the commenter
requested that EPA provide MWI owners the maximum amount of time allowable to comply
and impose requirements that are no more stringent than the minimum the CAA requires.
Response: The initial purpose of the June 1996 notice was to announces the availability
of new information, review EPA's assessment of the new information, provide EPA's
inclination as to how the new information might change the final standards and guidelines, and
solicit comments on EPA's assessments and inclinations. In addition, the June 1996 notice
served not only as a review of new information and request for comment, but also as a
response to comments on the 1995 proposed rule. The June 1996 notice included: a new
inventory of sources; new subcategories; revised assessments of emissions and performance of
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technology; new MAGT floors; new regulatory options; revised cost, and environmental and
economic impacts. ,
The Agency agrees with the commenter that asserted that the June 1996 notice
contained significant changes compared with the 1995 proposal, making most of the analysis
and conclusions from the 1995 proposal irrelevant. Upon further consideration, EPA now
considered the June 1996 notice to have been a reproposal. Therefore, units who commenced
construction on or before June 20, 1996 are considered existing sources subject to the EG
under.Subpart Ce.
Because MWI built between the dates of the 1995 proposal and the 1996 notice are
allowed to comply with the emission guidelines, and are not required to comply with the
NSPS, the EPA does not believe that it is necessary for these units to be granted a 3-year grace
_Af\
period for compliance.
"3.9 PYROLYSIS UNITS
Comment: One commenter (IV-D-737) encouraged EPA to promulgate separate
standards for medical waste pyrolysis (MWP) units. The commenter contended that, if EPA
were to defer regulating MWP, implementation of the MWP technology would be slowed
significantly because States would regulate MWP units as MWI. The commenter explained
that since current State MWI regulations do not apply to MWP, permitting of new installations
would be very slow and dispersion modeling and emissions testing would be required, making
the economics of the pyrolysis process much less favorable.
Referring to Docket Item IV-B-56 in Docket Number A-91-61, "Standards of
Performance for Medical Waste Pyrolysis Units," the commenter stated that MWP technology
will have no trouble complying with the emission limits listed in Table 1.
The commenter stated that some MWP technology is completely controlled by
computer and does not require an operator. The commenter expressed concern that if operator
training requirements are incorporated into the MWP standards that States might interpret the
requirements to mean that an operator must be present when an MWP is in operation.
The commenter also expressed concern that siting requirements for small MWI may
preclude an appropriate site for pyrolysis technology. The commenter contended that a
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requirement for public notice and the opportunity to request a public hearing concerning a
CAA permit is sufficient to ensure protection of the public. The commenter encouraged EPA
not to impose siting requirements which would create additional burdens to the implementation
of the MWP technology.
The commenter supported the use of MWP emissions test data from an identical unit in
lieu of performing an emissions test at each installation.
The commenter offered definitions of the following: fixed bed carbon adsorber
(FBCA), allowable tolerances, identical, maximum FBCA life, minimum wet electrostatic
precipitator corona power, packed bed wet scrubber, shutdown, wet electrostatic precipitator
(WEP), and compliance measurement.
The commenter advised that section 60.55(d) item (3) on page 14 of Docket Item IV-B-
56 should read "Minimum pressure drop across the sorbent injection nozzle of the PBWS."
The commenter stated that the parameter of interest is the sorbent flow, which is related to the
pressure drop across the nozzle. The commenter stated that the pressure drop across the
PBWS is not critical to compliance in this particular type of scrubber.
One commenter (TV-D-791) contended that the emission limits hi the draft pyrolysis
regulation are set for incineration and oxidation. The commenter stated that measuring
,"",i|i ' ' ' '
concentration would lead to false impressions of the true emissions. The commenter noted that
one MWP technology has no added air and has a gas stream that is highly concentrated and
low in volume. The commenter stated that the 500 Ib/hr MWP has an average gas flow rate of
3 cubic meters per minute. The commenter requested that the regulations be written in
measurable and identifiable quantities that allow for true comparisons between all forms of
potential air emission sources. Another commenter (IV-D-535) stated that a mass emissions
standards woukf be more appropriate for pyrolysis units and would also provide a better gauge
of the emissions control for incineration units.
One commenter (TV-D-783) requested that EPA clarify that combustion, which occurs
in the presence of oxygen, is different from pyrolysis, which occurs in the absence of oxygen.
Two commenters (TV-D-765 and IV-D-780/500) agreed with EPA's inclination to
develop a separate regulation for medical waste pyrolysis units. One commenter (IV-D-765)
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stated that while at least some combustion is taking place, the pyrolysis process is unique and
warrants separate regulation. One commenter (TV-D-780/500) stated that separate regulations
for pyrolysis units would be more stringent than the MWI regulations and would reflect the
unique process, operating, and monitoring features of pyrolysis units.
One commenter (IV-D-752) stated that EPA is correct in (1) recognizing that pyrolysis
-differs from medical waste incineration, (2) anticipating the emergence of pyrolysis systems,
and (3) recognizing that identification of MACT for pyrolysis is premature or impossible. The
- commenter, along with another commenter (IV-D-764), suggested that EPA modify slightly
the 1995 proposed MWI regulations to include pyrolysis units and defer the final promulgation
of the draft pyrolysis regulation. 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 stated that modifying the MWI
regulations to include pyrolysis units would eliminate the uncertainty that could inhibit and
delay the development of pyrolysis technologies. The commenters requested that EPA modify
the MWI regulations to provide flexibility if a specific operator training, siting, performance
; verification, compliance verification, monitoring, record keeping or reporting requirement
does not directly apply to a pyrolysis system. The commenters recommended that the MWI
regulations allow for adjustments of the requirements listed above by State environmental
authorities when necessary to fit the operating characteristics of a pyrolysis system. One
commenter (TV-D-764) suggested that EPA review the following report: A Regulatory
Overview of Plasma Technology. A Report of the Plasma Technology Subgroup of the
Interstate Technology and Regulatory Cooperation Working Group, June 1996. This report
presents the findings of a group of State regulators, industry, public representatives, federal
agencies, and other professional organizations who have studied alternative thermal treatment
technologies. The study supports the issues raised by the commenter.
Two commenters (TV-D-790 and IV-D-792) stated that pyrolysis units are similar to
- conventional incinerators, and that most State agencies regulate them under MWI 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
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concurrently with the final MWI regulations. Another commenter (IV-D-741) argued that
while it is true that the bottom ash from pyrolysis may be as "clean" as bottom ash from
incineration, the exhaust gases are no cleaner in many respects than the exhaust gases from the
primary chamber of an incinerator. The commenter noted that pyrolysis exhaust gases contain
breakdown products from the destructive distillation of chlorinated plastics, such as HC1,
dioxins, furans, and, in addition, contain a great deal of hydrocarbon vapors, liquids, and tars
that would have been destroyed in the secondary chamber of a conventional incinerator. The
commenter contended that if taken to the same temperature range (1500° to 1700°F) the
exhaust gases from pyrolysis would probably contain the same volatile metals as incinerator
exhaust. The commenter stated that an announcement that regulation of pyrolysis will be
delayed will create incentive for switching to this technology, which has never been
scientifically proven to be "clean" with regard to air emissions. Another commenter
(TV-D-766) stated that pyrolysis units should be included under the incinerator regulations.
The commenter noted that pyrolysis involves combustion type reactions. The commenter
stated that pyrolysis technology was unsuccessfully attempted for use with municipal solid
waste.
Response: The EPA acknowledges the various arguments for and against developing
separate regulations for pyrolysis units. The Agency recognizes three options for developing
regulations for pyrolysis units: (1) regulate pyrolysis under the standards and guidelines being
promulgated for HMIWI; (2) exempt pyrolysis units from the HMIWI regulations and
simultaneously promulgate separate regulations for pyrolysis units; and (3) exempt pyrolysis
units from the MWI regulation and defer the development of separate regulations.
The EPA believes that 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 MWI. Although conventional combustion does not occur
during pyrolysis treatment, there are some emissions from the pyrolysis process. Therefore, at
the 1995 proposal, the EPA considered pyrolysis units to be covered under the 1995 proposed
regulations.
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Following the 1995 proposal, comments from the vendors of pyrolysis technologies
indicated that they believed they could easily meet the emission limitations included in th>
1995 proposed standards and guidelines. However, they believed that their processes were
unique enough to warrant a separate category for regulation. The vendors were particularly
-concerned that the 1995 proposed compliance and monitoring requirements for MWI do not
;apply to pyrolysis technologies.
Therefore, in the 1996 reproposal, the EPA stated that it was considering separate
-regulations for pyrolysis units that would look very similar to the MWI 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 MWI regulations in that some definitions
would be different, the emission limitations would, in many cases, be more stringent than the
^MWI regulations, and the monitoring and testing requirements would reflect the operating
parameters that are unique to pyrolysis systems.
The EPA developed a draft regulation for pyrolysis units. The EPA noted, in the 1996
reproposal, that the draft regulatory text was incomplete" and that it included placeholders and
requests for information where such information is lacking. The EPA requested comments to
^ help EPA fill in the missing information.
Following the 1996 reproposal, 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 EPA 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 can not be developed at this time,
the EPA considered modifying the MWI regulations to include pyrolysis units. However,
nearly all aspects of the MWI regulations would have to be altered to accommodate pyrolysis
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units including the format of the emission limits, the operator training requirements, siting
1 I.. , . . ' . ;
requirements, the testing and monitoring requirements, and the reporting and recordkeeping
requirements. Furthermore, the MWI 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 MWI and pyrolysis technologies, it is unclear how
the MWI regulations could be modified to feasibly cover pyrolysis technologies as well as
MWI.
Section 129 requires EPA to develop NSPS and emission guidelines 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 MWI are not appropriate for pyrolysis technologies, pyrolysis
treatment technologies have specifically been excluded from coverage under the final HMIWI
standards and guidelines. Future project planning may include regulation of pyrolysis units.
Comment: One commenter (IV-D-780/500) requested that EPA recognize catalytic
extraction processing (CEP) as an alternative technology. The commenter noted that State
environmental authorities have recognized CEP as a noncombustive technology. The
commenter supported EPA's recognition of technologies which are different from combustion
and thus are not within the source category regulated under the MWI rule. The commenter
stated that the patented technology, CEP, recycles hazardous and nonhazardous wastes into
commodity products like syngas (H2/CO), ceramics, and metals that have economic value and
may be used for manufacturing processes. Therefore, the commenter concluded that CEP fits
into a source category that includes environmentally sound recycling technologies. Another
commenter (IV-D-750) described a technology that involves thermal decomposition of wastes
at temperatures in excess of 10,000°F. The commenter requested that this technology be
considered an alternative technology.
Response: As discussed above, the EPA agrees that pyrolysis treatment technologies l
are different from MWI in design and operation. Because of the inherent differences between
MWI and pyrolysis treatment technologies, the EPA agrees that pyrolysis units do not belong
within the source category regulated under the MWI standards and guidelines. In the final
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HMIWI regulations, the EPA has defined "pyrolysis" and specifically exempted pyrolysis
treatment technologies from coverage.
The MWI standards and guidelines do not classify medical waste treatment technologies
as either MWI or alternative treatment technologies for purposes of determining applicability.
Alternative medical waste treatment technologies are not specifically defined under the MWI
~ standards and guidelines. As defined in the final HMIWI standards and guidelines^
""pyrolysis" means the endothermic gasification of hospital waste and/or medical/infectious
-waste using external energy. "Hospital/medical/infectious waste incinerator" is defined as any
device that combusts any amount of medical/infectious or hospital waste. If a medical waste
treatment technology falls under the definition of HMIWI, then it is covered under the final
HMIWI standards and guidelines. If a medical waste treatment technology does not fall under
the definition of HMIWI, then it is not covered under the final HMIWI standards and
? guidelines.
Comment: One commenter (TV-D-462) proposed a definition for pyrolysis to
separate alternative thermal processes from incineration. The commenter's suggested definition
was "An endothermic process that uses external energy to convert organic medical waste
~ materials into carbon and simple combustible gases." The commenter suggested that the
definition of incineration be changed to "An exothermic process that uses combustion as the
energy source to convert organic medical waste materials to ash and noncombustible gases."
Two commenters (IV-D-498, TV-D-627) suggested that medical waste pyrolysis treatment
systems be defined as "a medical waste treatment process or system consisting of one or more
reaction chambers. The first reaction chamber functions in a pyrolysis mode whereby the
medical waste is heated in an endothermic process powered by external energy to gasify
organic matter. The external heating may be augmented by controlled pyrolysis wherein a
:Timited quantity of oxidant is introduced to promote gasification of elemental carbon to carbon
-monoxide." One commenter (TV-D-535) suggested that pyrolysis be defined as the
"transformation of a substance into one or more other substances by heat alone, i.e., without
oxidation.
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Response: As discussed above, the EPA agrees that pyrolysis treatment technologies
are different from MWI in design and operation. Due to the differences between MWI and
pyrolysis treatment technologies, a separate definition of "pyrolysis" has been included in the
final HMIWI standards and guidelines and pyrolysis units have been excluded form coverage
under the MWI regulations. In the final HMIWI regulations, pyrolysis is defined as "the
endothermic gasification of hospital waste and/or medical/infectious waste using external
energy."
3.10 ALTERNATIVE MEDICAL WASTE TREATMENT TECHNOLOGIES
Comment: Three commenters (IV-D-741, IV-D-782/454, and IV-D-793) disagreed
with the statement that alternative technologies produce "no significant or substantial adverse
economic, environmental, health or safety issues associated with their increased use." Four
commenters (TV-D-789, IV-D-790, IV-D-792, and IV-D-793) stated that EPA has not fully
evaluated the economic, environmental, health and safety issues, and impacts of alternative
technologies. One commenter (TV-D-741) requested that EPA consider the study published by
Roger Olson that compares an incinerator to steam decontamination and grinding. Another
commenter (TV-D-782/454) stated that alternatives may have a more significant impact on the
environment than incineration because alternatives do not reduce the waste volume as much as
incinerators. The commenter also questioned the fate of spent chemicals and issues of worker
exposure to chemicals. One commenter (TV-D-789) noted that autoclaves are often vented
inside a building. The commenter stated that autoclave operators could inhale volatile organic
emissions from autoclaves and that EPA has not considered worker safety. One commenter
(IV-D-793) remarked that EPA's conclusions about alternative technologies disregard data,
reports, and information, that indicate that there are reasons for concerns about the
environmental, economic, health, and safety impacts of alternative technologies. The
commenter stated that they provided several reports on alternative technologies in their
comments on the 1995 proposed MWI rule. The commenter stated that the information on
which EPA based its conclusions was furnished primarily from vendors, developers, and
promoters of alternative technologies. The commenter noted that vendor-provided information
has a tendency to be selective and biased. The commenter stated that EPA should not be
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publishing a blanket endorsement and an implied approval of all such technologies hi the
supplemental notice.
One commenter (IV-D-730) included a letter and an article discussing the potential
environmental impacts of onsite alternative treatment technologies and commercial hauling.
~The author of the article concluded that the increased use of alternative methods of waste
disposal as a result of the MACT standards will increase air pollution. The letter questioned
-the fate of chemicals that are placed in autoclaves and microwaves. The author of the letter
stated that chemicals contained in medical waste are likely to be emitted into the atmosphere
when heated in an autoclave or microwave. The letter also contended that aerosolized
pathogens will be displaced into the atmosphere as waste is fed to preshredders.
One commenter (TV-D-735) contended that the use of onsite alternative technologies
will add a quantity of emissions comparable to the emissions reduction achieved due to
- switching. The commenter also stated that amounts of select emissions may increase due to
diesel transit vehicles hauling waste to treatment facilities. Another commenter (TV-D-766)
recommended that EPA compare the emissions from alternative technologies with incineration,
on a total basis, in order to provide the public with a true basis for switching or not switching.
Another commenter (TV-D-744) stated that the EPA should recognize that several alternative
technologies emit HAP. The commenter requested that the emissions from alternative
technologies be brought under regulatory restrictions so the emissions from alternatives will
pose no greater risk to the public than those from a MWI under the1 new MACT standards.
Two commenters (TV-D-762/784 and IV-D-784) agreed with the statement that
alternative technologies produce "no significant or substantial adverse economic,
environmental, health or safety issues associated with their increased use." The commenters
argued that alternative technologies are competitive, environmentally preferable, and readily
available. The commenters also noted that many alternative technologies are equipped with
automated material handling features which may reduce the risk of occupational exposure to
"infectious agents. Another commenter (TV-D-761) stated that there are alternatives sized and
priced to meet the needs of almost all medical waste generators. The commenter stated that
many alternative technologies may be installed in a very short amount of time with minimal
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site preparation. The commenter also stated that alternatives have been proven to be
efficacious in sterilizing or disinfecting medical waste. Another commenter (IV-D-762/784)
stated that there are sufficient numbers of cost effective and environmentally compatible
alternatives to allow EPA to promulgate environmentally effective regulations without
adversely affecting facilities with incinerators.
One commenter (IV-D-757) stated that autoclaving is a dioxin-free alternative to
incineration. The commenter stated that autoclaving is cheaper than highly controlled
incineration and is available to rural generators; hence, standards more stringent than MACT
should be considered.
Response: The EPA reviewed the available information on alternative technologies,
including the information submitted in comments on the 1995 proposed MWI rule. The
information available on alternative technologies included efficacy test reports, testing of liquid
effluents, limited autoclave air emissions data, toxic characteristics leachate procedure (TCLP)
tests, reports comparing the environmental aspects of alternative technologies to those of well-
controlled MWI (including the Roger Olson publication), studies conducted by States, surveys,
and information from vendors. Because there have been few concerns regarding the
environmental impacts of alternative technologies in the past, a great deal of the information
available on alternative technologies is vendor-derived. To gain information that is not
vendor-derived, and based on actual experiences with alternative technologies, surveys of State
agencies and users of alternative technologies were conducted.
All of the information discussed above was compiled in a report on alternative
technologies that was not intended to be an in-depth study, but merely a review of the
available information. The EPA's primary objective is to develop standards to limit the
emissions from MWI and not to conduct an in-depth study to determine if there are any
operational problems with alternative technologies. There are negative aspects associated with
all medical waste treatment technologies, including incineration. The air emissions from
uncontrolled incineration pose a significant threat to the environment. The question before
EPA is whether alternative treatment technologies pose a greater threat to the environment than
the emissions from uncontrolled MWI.
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Only a few limited scientific studies have been conducted to measure the environmental
impacts of alternative technologies. Most reports, such as the Roger Olson publication,
compare the environmental impacts of autoclaves to those of well-controlled incinerators.
Together these reports discuss air emissions, energy impacts, leachate potentials, and
transportation impacts. It is more likely that uncontrolled MWI will switch to alternative
technologies in response to the MWI rule than MWI that are well-controlled. Therefore, most
of the reports do not contain useful comparisons. However, the data specific to autoclaving
from each report was reviewed, and when necessary, the data were compared to similar data
from uncontrolled incineration. These reports show that there are some air emissions, energy
requirements, leachate potentials, risks, and transportation requirements associated with
alternative technologies as there are with many other technologies and activities that occur in
an industrial society. However, the reports do not demonstrate any substantial energy,
-environmental, or health and safety impacts that would cause alternative technologies to
become a significant environmental threat if their use was increased in response to the
decreased use of poorly controlled MWI.
Alternative technologies are only capable of reducing the volume of the waste they treat
"by 50 to 80 percent, instead of 90 percent by incineration. For facilities that switch to
alternatives from incineration, an additional 10 to 40 percent of the waste treated may be
landfilled. As with municipal waste that is landfilled, there is potential for leachate and
landfill gas from waste treated with alternative technologies. According to the TCLP tests and
data submitted by commenters regarding medical waste that is treated in autoclaves and
chemical treatment systems, leachate is below the regulatory thresholds. In a report
published by the EPA ("Report to Congress on Flow Control and Municipal Solid Waste,"
March 1995) the EPA finds that extensive and stringent regulations are in place for landfills
for the purpose of protecting human health and the environment. For example, the
environmental impacts for landfills are addressed through Subtitle D (i.e., all new landfills
must have double liners). The EPA has also promulgated NSPS (40 CFR 60, subpart WWW)
and emission guidelines (40 CFR 60, subpart Cc) for landfills under section 111 (b) and (d) of
the CAA to control emissions of total nonmethane organic compounds from landfills.
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Additionally, a landfills NESHAP is scheduled to be developed by the year 2000. Thus, when
compared to the amount of municipal waste that is landfilled, its associated emissions and
leachate, and the controls that are or will be in place at landfills, the additional treated medical
waste that is landfilled will cause only minimal impacts.
The available data indicates that there are some air emissions from autoclaves that
consist primarily of volatile organic compounds (VOC) and include formaldehyde. Metals are
emitted from autoclaves in significantly lower concentrations and mass per pound of waste
treated than from MWI. No information on dioxin/furan emissions from autoclaves is
available. Based on the emissions data available for autoclaves, it appears that per pound of
waste treated, autoclaves produce a much smaller volume of emissions than MWI.
Furthermore, the emissions from autoclaves are different than those from incineration in that
they contain mostly organic compounds instead of acid gases and metals. The air emissions
from microwaves and chemical treatment systems have not yet been quantified. It is expected
that emissions from microwaves will be similar to those from autoclaves due to the similarities
in the treatment temperatures. The EPA has no reason to believe that the emissions from
alternative technologies would cause a greater air impact than the continued use of
uncontrolled MWI.
Emissions characteristic of diesel trucks are different than the emissions from MWI.
To dispose of medical waste, an uncontrolled onsite MWI emits more HC1, dioxin/furan, PM,
Pb, Cd, and Hg than a diesel truck. However, an increase in the use of diesel transit vehicles
could slightly increase the emissions of CO and NOX associated with medical waste treatment
and disposal. Compared to the number of diesel trucks currently in use across the nation and
their emissions, the increased use of trucks to haul medical waste and the associated increase in
NOX and CO emissions is not expected to cause an adverse impact, especially given the
reduction in HC1, dioxin/furan, PM, Pb, Cd, and Hg emissions that would be achieved by
transporting waste to a controlled MWI for disposal.
As with any medical waste treatment technology, worker safety issues also exist with
alternative treatment technologies. The primary worker safety issues for operators of all
medical waste treatment technologies, including incinerators, are concerned with the presence
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and handling of potentially infectious medical waste. This is the arena of the Occupational
Safety and Health Administration (OSHA). Limits on the concentrations of air contaminants
have been developed by OSHA to prevent occupational overexposure to VOC and other
chemicals that may be emitted into a worker's surroundings. Alternative technologies are
subject to these OSHA worker safety requirements.
There may be some negative operational and environmental aspects associated with
"alternative treatment technologies (as there are with any waste treatment technologies).
"However, further study is necessary to quantify the exact impacts of alternative technologies.
There does not appear to be any substantial evidence in the available information to indicate
that any adverse economic, environmental, or health and safety impacts, will result from the
increased use of alternative technologies. Based on the information available, it appears that
several alternative technologies are effective in destroying the pathogens found in medical
"waste, pose minimal threat to the environment, are priced comparably to other medical waste
disposal methods, pose few additional safety hazards if operated properly, are available, and
are satisfactory to users. These conclusions regarding alternative treatment technologies are
not and were never intended to be an endorsement of all such technologies, but are merely
conclusions based on the available information.
Section 129 of the CAA requires EPA to develop emission standards and guidelines for
new and existing MWI. The MWI regulations could cause the increased use of alternative
treatment technologies as a result of the decreased use of poorly controlled MWI. While there
currently does not appear to be any environmental impacts associated with the increased use of
alternative treatment technologies that would change the course of the MWI regulations, this
does not mean that alternative treatment technologies will not become the subject of regulatory
scrutiny in the future. However, for now, the greater environmental threat and the more
pressing issue is the regulation of MWI.
Comment: One commenter (TV-D-735) questioned if utilities for shredding or
grinding, labor, and hauling costs were added into the calculation of the operational costs for
alternatives. The commenter argued that, with the limitations on alternatives, medical
facilities would need an onsite incinerator to treat pathological, chemotherapeutic, liquid,
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shaips, and animal wastes. The commenter stated that most medical facilities do not have
room for multiple systems, but do have room for a single incinerator that will cleanly handle
all of their waste types while reducing material mass shipped to a landfill by over 95 percent.
Another commenter (TV-D-760) stated that transport of pathogenic materials from rural
facilities is not feasible because of adverse public reaction and cost. The commenter also
indicated that it is not cost effective for facilities to operate an onsite alternative and an MWI
for their pathological waste.
Response: All costs associated with alternative treatment technologies, including labor,
hauling, disposal of waste not treatable, and utilities for shredding, were accounted for in the
calculation of the operational costs for each technology. Facilities that choose alternative
technologies that cannot treat pathological, chemotherapeutic, or other wastes may either
choose to ship this waste offsite or burn it onsite. Pathological incinerators and incinerators
used solely for low-level radioactive medical wastes and/or chemotherapeutic waste are not
covered under the MWI rule. Therefore, facilities that switch may continue to burn their
pathological and chemotherapeutic waste in an existing onsite incinerator. The EPA is not
suggesting that all facilities with alternative technologies should install an incinerator or use an
existing incinerator to dispose of waste not treatable with an alternative technology. For some
rural facilities, offsite transport of waste not treatable with an alternative technology may not
be economically feasible. This is one reason that rural generators have been given special
consideration with regard to the HMIWI emission limits. Each affected health care facility
must consider their economic, spatial, and locational constraints when selecting a waste
disposal method. Facilities have several waste disposal options which include onsite
incineration, offsite disposal, and onsite alternative treatment technologies. Each individual
facility must select the waste disposal method that is most appropriate for that particular
facility.
Comment: One commenter (IV-D-735) stated that the majority of commercial
treatment facilities employ incineration and few use microwave or autoclave technologies. The
commenter questioned why EPA has not discussed incineration with hospitals that use it and
collected data on why they prefer MWI over alternatives. The commenter argued that within
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the medical industry the preferred method for sterilization, mass reduction, and disposal of
regulated medical waste is through the process of incineration. The commenter argued that the
information on alternative technologies collected from surveys of eight hospitals and nine
states was not comprehensive and showed no real conclusive evidence that alternatives are
superior to MWI. The commenter stated that facilities that operated an MWI prior to
switching to an alternative technology probably had an out-of-date and poorly maintained
""MWI. The commenter stated that newer MWI have been unproved to address the
^inadequacies of the older systems. The commenter stated that the cost of new incineration
technology is comparable to or less than the costs of alternatives.
Response: The EPA did not survey facilities that operate MWI to obtain information
on alternative treatment technologies because information on the experience of actual users of
alternative technologies was of interest. The intention behind the surveys was to gather
information on alternative technologies from their users, and not to compare alternative
technologies to MWI or to determine which technology is superior. Indeed, most of the
facilities indicating in the surveys that they operated incinerators prior to installing an
alternative technology closed their MWI because it was old and out-of-date or because of
upcoming MWI regulations. The EPA agrees that incineration technology has unproved over
the years and that the costs of new incineration technology are comparable to the costs of some
alternative technologies. This is one reason why the economic impacts of switching to an
onsite alternative technology are not excessive. The EPA's objective is not to encourage the
use of alternative technologies or to discourage the use of MWI. The EPA's objective is to
adopt MACT standards and guidelines that fulfill the requirements of Section 129 of the CAA.
Comment: Two commenters (TV-D-769/557 and IV-D-785) indicated that commercial
incineration capacity does not exist to treat the increased volume of medical waste generated if
80 percent of the current onsite incineration operations shut down.
Response: Owners or operators of facilities that close their MWI in response to the
TVIWI standards and guidelines may choose to contract with a commercial disposal company for
treatment of their infectious waste or to purchase an onsite alternative treatment technology. It
is not likely that all of the waste that is currently burned by facilities who will switch in
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response to the HMIWI regulations will be sent to commercial disposal companies. A number
of facilities that switch may purchase onsite alternative treatment technologies instead of
contracting with a commercial hauler. Also, many facilities currently burn a mixture of
infectious waste and noninfectious municipal-type waste. The cost of disposing of infectious
waste is considerably higher than the cost of disposing of municipal waste. Facilities that
switch to offsite disposal are likely to lower costs by recycling or by sending their
noninfectious waste to a nearby landfill or municipal waste incinerator instead of to a
commercial medical waste treatment facility. Given the availability of onsite alternative
treatment technologies, the fact that many facilities that will switch are currently burning
noninfectious waste that may be landfilled, and the fact that representatives of the commercial
medical waste disposal industry have indicated that their industry is operating at very low
capacity, EPA concludes that there is sufficient treatment capacity to dispose of the infectious
waste from facilities that close their MWI in response to the final HMIWI regulations.
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4.0 REGULATORY OPTIONS AND IMPACTS FOR EXISTING MWI
*4.1 REGULATORY OPTIONS
Comment: One commenteir (IV-D-789) pointed out that there is a fourth scenario
(Scenario D) that is not described in the supplemental notice. The commenter stated that
scenario D involves EPA including appropriate onsite waste prevention, segregation, and
management practices as part of the emission control technologies recommended by each
^regulatory option, and a resulting reduction hi the quantity and toxicity of waste burned onsite,
"reduced environmental impacts, and reduced costs to the facility. The commenter noted that
this scenario has been happening in New York City, starting with the New York City Medical
"Waste Management Plan.
Response: The commenter appears to be confusing "regulatory options" with
?"scenarios." Each regulatory option describes the elements of a potential regulation. The
primary elements of a regulatory option include emission limitations, compliance provisions,
and reporting and recordkeeping requirements. The emission limitations in the MWI
regulatory options are based primarily on air pollution control technologies, but (if sufficient
information had been available) could also have been based on waste prevention, segregation,
and management practices. Scenarios, on the other hand, are not requirements or suggestions,
Taut are an attempt to estimate the industry response to a regulatory option so that the cost,
-economic, and environmental impacts of a regulatory option can be assessed.
One likely industry response to the MWI standards and guidelines is the increased use
-*bf alternatives to onsite incineration. Scenarios A, B, and C (switching scenarios) reflect
"different industry responses to regulations. Scenario A reflects all MWI continuing operation
and installing air pollution control with no waste separation. Because of the costs associated
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with this scenario and the cost savings that can occur from waste segregation and/or switching
to other methods of waste disposal, Scenario A is considered to be highly unlikely. Scenarios
B and C reflect a combination of switching to other waste disposal methods and waste
segregation. The scenario reflecting the most waste segregation (Scenario B) results in the
lowest cost impacts. Once again, this is not a requirement, but it does show that facilities can
reduce costs by minimizing the amount of waste to be disposed.
As discussed in more detail in section 7.2, the EPA has no data to conclusively indicate
the effectiveness of waste segregation programs in reducing the emissions from MWI.
Therefore, the regulatory options examined for the final HMIWI regulations are based
primarily on air pollution controls rather than specific pollution prevention techniques.
However, the EPA agrees that many facilities may be able to prevent some MWI emissions by
separating their waste and instituting pollution prevention techniques. For this reason, the
final HMIWI standards and guidelines contain a provision that requires facilities to develop a
waste reduction plan.
Comment: One commenter (TV-D-726) stated that the MACT floor emission levels for
small existing MWI cannot be met with good combustion based on a comparison of Tables 3
and 7 from the supplemental notice. This commenter concluded that the MACT floor for
small units should be based on a low efficiency wet scrubbing system based on the values in
Tables 4 and 7 in the supplemental notice.
Response: Table 7 in the 1996 re-proposal, which presents the revised MACT floors
for existing MWI, indicates that the PM MACT floor for small existing MWI is 0.086 gr/dscf.
Tables 3 and 4 in the 1996 re-proposal indicate that the achievable PM emission levels for
good combustion control and low efficiency wet or dry scrubbers are 0.25 gr/dscf and
0.05 gr/dscf, respectively. The commenter is correct in recognizing that, based on comparison
of Tables 3 and 7, the MACT floor emission levels for small existing MWl appear to be
unachievable with good combustion alone and appear to be achievable with a low efficiency
wet scrubber. However, as discussed hi the 1996 re-proposal, contrary to the available data,
MWI manufacturers have indicated that they routinely guarantee achieving 0.08 gr/dscf with
good combustion. Therefore, based on the experience of MWI manufacturers, the EPA has
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concluded that the MACT floor for small MWI would require the use of good combustion
practices and that add-on scrubbers would not be needed.
Comment: Another commenter (IV-D-789) recommended that the guidelines for small
existing MWI be based, at a minimum, on high efficiency wet scrubbers with addition of
-alkaline and carbon reagents. The commenter recommended that a fabric filter or electrostatic
precipitator (ESP) be required for medium and large existing MWI to ensure control of
=particulate matter.
Response: When examining regulatory options more stringent than the MACT floor
for small existing MWI, the EPA considered the possibility of basing the emission limits on
high efficiency wet scrubbers. After reviewing the costs associated with high efficiency wet
scrubbers, the emissions reduction that could be achieved (PM only), and the availability of
f.
alternatives to onsite incineration, the EPA concluded that emission limits based on low
^efficiency wet scrubbers were suitable for most small existing MWI. The,EPA concluded that
emission limits based on good combustion alone are suitable for small existing MWI in rural
areas that do not have reasonably available alternatives to onsite incineration. The addition of
-carbon was not considered in the examination of regulatory options more stringent than the
- MACT floor because there is no data with which to determine the performance of wet
^scrubbers with carbon and the EPA knows of no wet scrubbers that operate with carbon in the
--United States.
When developing regulatory options more stringent than the MACT floor for medium
and large existing MWI, the EPA considered the possibility of basing emission limits
exclusively on wet scrubbers or exclusively on DI/FF's with activated carbon injection. The
EPA did not consider the use of ESP's because DI/FF's are more commonly used on MWI for
:PM control than are ESP's. Basing emission limits exclusively on wet scrubbers would reduce
emissions of HC1, but would preclude the use of dry scrubbers. Basing the emission limits
- exclusively on dry scrubbers with carbon would further reduce emissions of Pb, Cd, and
^oxin/furan, but would preclude the use of wet scrubbers. For existing MWI already
"equipped with wet scrubbers or dry scrubbers, replacing one system with the other would be
exorbitantly expensive, and the overall difference in the emissions control performance
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between the two systems is relatively small. As a result, the EPA chose not to develop
additional regulatory options for medium and large existing MWI beyond what could be
achieved with either a wet scrubber or a dry scrubber.
Comment: One commenter (TV-D-741) remarked that the regulatory options have been
intentionally adjusted back to the MACT floor, from what is achievable, to enable dry
scrubbers to compete in the market. The commenter stated that this is inconsistent with the
1 ': Vi ' ' '
approach used to determine the 1995 proposed MACT floor.
Response: The CAA specifies in section 129 that the degree of reduction in emissions
that is deemed achievable for existing MWI shall not be less stringent than the average
emission limitation achieved by the best performing 12 percent of units in a category; this
requirement is referred to as the "MACT floor" for existing MWI. Based on conclusions
drawn in the 1995 proposal regarding performance of technology, it was determined that all
existing MWI would need good combustion and dry scrubbers to meet the MACT floor
emission limits. Based on information available at the time of the 1995 proposal, it appeared
that wet scrubbers would be unable to meet the 1995 proposed MACT floor emission limits.
New information submitted following the 1995 proposal led to changes in the MWI
inventory, subcategories, and performance of technology. Because these factors can influence
the MACT floors, a review of the MACT floors was conducted. It was determined that good
combustion and wet or dry scrubbers could be used to meet the revised MACT floor emission
limits. Guidelines more stringent than the MACT floor could have be based on wet, dry, or
combined dry/wet scrubber systems. The performance capabilities of wet and dry control
technologies are similar. Guidelines based only on wet, dry, or combined dry/wet systems
were not chosen to prevent facilities that currently operate any of these technologies from the
unnecessary expense of removing one control technology and retrofitting another control
technology or adding an additional control technology that achieves similar control. Because
the costs of dry scrubbing systems are considerably higher than the costs of wet scrubbing
- l'?i ' "' ' " ' ' . I"1- " '. ' ' .! i' .... '
systems, impact analyses for the MACT floor and regulatory options more stringent than the
,h " ' ''Ij,* , ' '' | ' »,''',' , ',, i, ' ''!' "'
MACT floor were based on use of wet scrubbers. However, the emission limits for the final
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HMIWI guidelines Tiave been set so that either a wet, dry, or combined dry/wet control
technology may be used.
Comment: One commenter (TV-D-757) stated that EPA raised the proposed TEQ
Demission limit from 0.6 ng/dscm to 2.3 ng/dscm to facilitate the use of wet scrubbers. The
~
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Impacts. The CAA requires the EPA to develop emissions standards and guidelines for MWI,
not for alternative treatment technologies. As required by the CAA, the numerical emission
limits for MWI are based on the performance of MWI control technologies and not on the
performance or cost of alternative treatment technologies.
4.2 NATIONAL ENVIRONMENTAL AND COST IMPACTS
4.2.1 Analytical Approach
Comment: Two commenters (IV-D-762/784 and IV-D-784) suggested that EPA has
overestimated the number of small uncontrolled units that will switch to an alternative to onsite
incineration as a result of this rulemaking. The commenters noted that many of these sources
have performed their own switching analysis in response to solicitations from the alternatives
industry and have chosen not to switch. The commenters argued that if good combustion is
chosen as the MACT floor, then fewer small units will switch. Therefore, the commenters
concluded the reduction in environmental loading projected for regulatory option 1 is
overstated.
Response: The fact that many small sources have performed their own switching
analysis in response to solicitations from the alternatives industry and have not chosen to
switch may not be a good indication of their evaluation after implementation of the final
HMIWI regulations. After implementation of the HMIWI regulations small MWI will need to
perform approximately $41,000 worth of emissions testing, implement operator training
requirements, and perform periodic incinerator inspections. These.costs are in addition to any
costs that facilities operating small MWI must incur to ensure that their MWI is operating with
good combustion. These additional costs, which currently are not incurred, will result in a
number of small MWI switching to alternatives to onsite incineration. Therefore, EPA does
not believe that the reduction in environmental loading projected for regulatory option 1 has
been overstated.
Comment: One commenter (TV-D-735) stated that the switching scenarios utilized for
comparative and emission reduction calculations do not appear to be based on realistic details
or the preferred operating methods existing in medical waste institutions. Instead, the
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commenter charged that the switching scenarios are based on supposition, leaps-of-faith, and a
bias against MWI. . ._£.
Response: The EPA's objective is not to encourage the use of alternative technologies
-or to discourage the use of MWI. The EPA's objective is to adopt MACT standards and
guidelines that fulfill the requirements of section 129 of the CAA. While many health care
-^facilities may prefer to use MWI to dispose of their waste, the costs associated with the use of
3MWI technology will increase as a result of the MWI regulations. Therefore, one outcome
^associated with the adoption of the MACT emission guidelines is likely to be an increase in the
use of alternatives to incineration, and a decrease in the use of onsite MWI. Consequently, the
EPA has acknowledged and incorporated this outcome into the cost, environmental, and
energy impact analyses.
Comment: One commenter (IV-D-782/454) stated that ifis unclear how the impacts of
^increased transportation of medical waste were factored into the economic and environmental
impacts analyses. The commenter noted that increased transportation requires more diesel
.trucks with heavier loads that emit many of the same combustion-related pollutants emitted
-from MWI.
Response: In response to concerns about the impacts of increased transportation, the
.eair emission impacts of hauling and off site incineration of medical waste were reviewed by
ZEPA. It was determined that a diesel truck would have to travel thousands of miles before
emitting more dioxin/furan, PM, Pb, Cd, and Hg than an uncontrolled onsite MWI.
Consequently, it was determined that the increased use of diesel trucks to haul medical waste
would not cause a significant, substantial, or adverse air emissions impact. The costs of
commercial hauling and disposal were factored into the cost impacts under the switching
scenarios.
Comment: Two commenters (IV-D-762/784 and IV-D-784) indicated that health care
facilities are experienced at waste segregation and that waste segregation is feasible for all
thealth care facilities. The commenters requested that EPA adopt Scenario B for its
^environmental and economic impacts analyses.
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Response: The EPA agrees that many health care facilities are segregating their waste
and that others may choose to segregate their waste in the future. The degree of waste
segregation is dependent upon individual facilities. Therefore, the EPA developed three
scenarios to represent a range of environmental, cost, and energy impacts that accounts for
varying degrees of waste segregation among facilities. The goal hi developing the three
switching scenarios was not for EPA to determine if it should require facilities to implement
waste segregation practices, but to consider the possible outcomes of the MWI regulations by
taking into account the varying degrees of waste segregation that facilities currently practice.
4.2.2 Water and Solid Waste Impacts
Comment: Two commenters (TV-D-769/557 and IV-D-785) contended that the solid
waste impacts analysis for existing MWI is flawed. The commenters stated that if 846 million
tons of medical waste are burned annually in MWI that each of the 2,400 MWI must be
burning over 80,000 pounds per hour. The commenters also questioned \yhether the 231,000
tons per year of additional waste as a result of regulatory option 6, scenario B, represents
85 percent of the total medical waste currently burned in MWI. Another commenter
(IV-D-756) questioned the 846 million tons of medical waste per year figure and stated that the
total production of municipal waste is only 207 million tons per year.
Response: With regard to the amount of solid waste burned annually in MWI, the
commenters are correct in recognizing the 846 million tons is an unrealistic estimate. The
1996 re-proposal should have stated that there are 846 thousand tons of solid waste burned
annually in MWI instead of 846 million tons. The 231,000 tons of additional solid waste
that would result each year under regulatory option 6, scenario B, does not represent
85 percent of the solid waste currently burned in MWI for two reasons. First, all MWI do not
switch under option 6, scenario B. Facilities that do not switch are likely to continue burning
the same amount of waste as they were burning prior to the MWI guidelines. Because it was
assumed that facilities continuing to operate MWI under the guidelines would not segregate
their waste, no solid waste impacts were associated with the facilities that do not switch. Also,
commercial MWI currently burn about 47 percent of the total waste burned in MWI annually.
Waste segregation is not feasible for commercial facilities. Therefore, no solid waste impacts
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due to waste segregation were associated with the portion of the total waste stream burned in
commercial MWI annually. The estimate; of 231,000 tons/yr of additional solid waste that
would be landfilled represents 85 percent of the waste stream (the noninfectious portion) from
'facilities that switch only, and does not include the amount of ash that would have been created
from burning this waste instead of landfilling it directly.
4.2.3 Cost Impacts
Comment: Two commenters (TV-D-769/557 and IV-D-785) argued that the cost
-analysis is flawed and that the actual cost of the proposed rule is unreasonable. The
commenters argued that the EPA should estimate cost impacts based on scenario A and in
terms of cost per ton of pollutant removed. Using the baseline emissions and costs of the
regulatory options under scenario A, the commenters estimated that the cost of the rule ranges
from $18,338 to $26,804 per ton of pollutant removed. The commenters noted that the cost
rises to approximately $8 million per ton for Hg and $770 billion to $1.2 trillion per ton for
"TEQ.
Response: For technology-based NSPS and emission guidelines, the MACT floor,
which is the least stringent regulatory option that the EPA may select regardless of cost, is
determined first. Once the MACT floor is determined, the EPA is required to examine
3 regulatory options more stringent than the floor along with their associated costs and
environmental impacts to determine MACT. While the EPA has the liberty of determining
whether the costs for regulatory options beyohd'the MACT floor~afe unreasonable for the
emissions reduction achieved, the CAA requires EPA to develop a regulation that is at least as
stringent as the MACT floor regardless of cost. Thus, even a cost/ton estimate that appears to
be unreasonably high would have no effect on MACT standards and guidelines that remain at
~the MACT floor.
Cost per ton estimates are useful if the benefits (e.g., reduced negative health effects,
reduced damage to vegetation and materials, etc.) of a reduction in emissions of a pollutant
^ can be quantified. Benefit estimates ($ saved/ton pollutant removed) have not been developed
"for most pollutants covered under the MWI NSPS and guidelines. Therefore, cost per ton
" estimates have little meaning for the MWI standards and guidelines.
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The costs associated with scenario A are not likely to occur. Fewer than half the
hospitals in the U.S. currently operate their own incinerator and the trend is away from onsite
incineration. Because of the availability and relatively low cost of other methods of waste
disposal, the cost and environmental impacts associated with scenarios B and C are much more
likely to occur.
Comment: One commenter (IV-D-785) stated that the purpose of a cost assessment for
a proposed rule is not to guess what businesses will or will not do in response to a rule (switch
or continue to incinerate onsite), but to document how much it will cost the impacted
community to comply with it. The commenter stated that scenario A should not be
disregarded.
Response: One very likely outcome of the adoption of the MACT emission guidelines
for existing MWI is the increased use of alternatives to onsite incineration. This trend of
switching from onsite incineration to other alternatives has been observed in States that have
adopted strict MWI regulations. The EPA cannot ignore switching when developing estimates
of the impacts of the MACT emission guidelines because switching is a likely outcome.
Consequently, EPA has acknowledged and incorporated this outcome into the analyses of the
cost, environmental, and energy impacts associated with the MACT emission guidelines. The
EPA has also determined the impacts associated with the emission guidelines without
incorporating the switching analysis under scenario A. While EPA believes that scenario A is
highly.unlikely,-theimpacts under scenario A have been considered.
Comment: One commenter (IV-D-781) contended that the cost analyses understate or
ignore the cost savings that will accrue to facilities that decide to cease operating an onsite
incinerator. The commenter stated that these positive cost impacts include energy and water
costs, equipment maintenance and repair, operator training, personnel and related overhead
cost savings. The commenter explained that by understating positive cost impacts of the
various regulatory options that EPA's analysis fails to reflect the cost savings that may result
from the regulations. Two other commenters (TV-D-762/784 and IV-D-784) recommended
that EPA revise its cost estimates, even if these revisions result in the conclusion that the
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imposition of strict emission standards actually saves the health care industry money as a result
of switching.
Response: Some facilities, particularly those operating the smallest MWI located in
-areas where there are several alternative waste disposal options available, may actually
experience a cost savings as a result of the HMIWI standards and guidelines if they are
-currently not using the lowest cost waste disposal option available. The facility may have
^chosen a slightly more expensive option (i.e., their on-site MWI) for reasons other than cost
^(e.g., liability concerns or concerns about the potential for commercial disposal costs to
increase in the future). Facilities operating MWI will likely reassess their waste disposal
options when faced with increased costs imposed by the requirements of the final HMIWI
regulations. This is taken into account in the "switching scenarios." As discussed elsewhere,
scenario A (no switching) is highly unlikely because of the availability of other waste disposal
^-options. Scenarios B and C, which show much lower cost impacts because of switching, are
^much more likely to occur. However, it is not expected that there will be nationwide cost
-savings associated with the final HMIWI regulations. Facilities may not opt for the lowest
^ cost alternative disposal method for reasons described ab*bve. Many facilities will still have to
-- finish paying for the MWI if it was recently purchased. Consequently, EPA believes the cost
..analysis presented in scenarios B and C reflect the most likely costs associated with the final
HMIWI regulations.
Comment: One commenter (IV-D-785)'stated that the cos$analysis did not account for
the burden on the pharmaceutical industry, which must maintain its own incinerators. The
commenter stated that the cost impact analysis did not include the costs of CEMS, annual stack
testing, annual certifications, and annual inspections. The commenter cautioned that the costs
«of CEMS received from CEM manufacturers may be unrealistically low. The commenter also
-stated that the EPA did not consider the costs associated with packaging of medical waste for
^hauling. Another commenter (IV-D-769/557) suggested that the cost analysis should include
%the increased cost due to packaging medical waste for shipment per Department of
^Transportation (DOT) standards.
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Response: The cost analysis under scenario A, the no switching scenario, accounts for
the financial burden on the pharmaceutical industry. The capital and annual costs of air
pollution controls, annual inspection costs, and annual stack testing costs were incorporated
into the cost impact analyses. Because GEMS are not required for compliance with the final
HMIWI regulations, CEMS costs, including annual certifications, were not included in the
final cost analysis. Packaging costs were included in the costs for off site transportation.
Comment: Two commenters (TV-D-790 and IV-D-792) recommended that the cost
impact analyses be revised to include and consider rapidly escalating off site disposal rates,
increased general waste disposal costs, annualized system and equipment owning and operating
costs, cost comparisons of different control options, and cost comparisons of alternative
treatment technologies. The commenters suggested that cost analyses tables should be
provided for net capital cost requirements, present worth values, total annualized costs, and
unit costs for each scenario and option. The commenters argued the current tables (in the
supplemental notice) are not useful for enabling proper comparisons and decisions.
Response: The level of detail that can be incorporated into a nationwide cost impacts
analysis is limited because the true costs of the MWI regulations are facility-specific. The
EPA has no information that indicates that offsite disposal costs are rapidly escalating or that
general waste disposal costs will increase. In fact, the EPA has reason to believe, because of
excess commercial disposal capacity, that the cost of offsite disposal has remained constant or
decreased. For analysis of the cost impacts under scenarios B andjC, the EPA compared the
costs of the different control options (i.e., regulatory options) including the annualized
equipment owning and operating costs to the costs of alternative treatment technologies.
1 .i1'1 . '
Capital and annual costs were presented as nationwide impacts for each regulatory option and
scenario in Docket item IV-B-50. Present worth values and unit costs were not included in the
nationwide cost analysis because they are facility-specific and unknown. The current tables
represent the nationwide impacts, which are of use to the EPA for making the comparisons and
decisions necessary to establish nationwide MWI standards and guidelines.
Comment: One commenter (TV-D-782/454) stated that EPA's analysis of the economic
impacts of installing certain control technologies compares the relationship between cost and
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the charge rate (Ib/hr) of the MWI. The commenter stated that the relationship between cost
and MWI charge rate is not a meaningful'comparison. The commenter requested that the
analysis of economic impacts of installing control technologies be based, at least in part, on the
location of the facility (urban or rural).
Response: The cost of an add-on control device is dependent on MWI size. Larger
control devices are needed for larger MWI to accommodate higher exhaust gas flow rates.
Similarly, smaller control devices are needed for smaller MWI. The annual cost to operate a
control device is likely to be similar for identical control devices regardless of urban or rural
location.
4.3 ECONOMIC IMPACTS
4.3.1 Industry-wide Economic Impacts
Comment: One commenter (IV-D-782/454) stated that the EPA should not simply look
at the revenues of health care facilities to determine the impacts of the MWI rule. The
commenter stated that EPA should also consider the costs of operating health care facilities.
The commenter noted that the health care industry is undergoing a major restructuring due to
economic pressures. The commenter stated that it is unreasonable for EPA to assume that a
health care facility can absorb the costs of this rule. The commenter contended that health
care facilities will have to pass the costs of the MWI rulemaking onto patients.
Response: The approach used by the EPA to estimate the industry-wide impact of the
MWI rule for health care facilities estimates the price increase and the output, employment,
and revenue impacts that may result for the health care industries (hospitals, nursing homes,
laboratories, funeral homes, physician's offices, dentist offices, and other health care facilities)
as a result of this regulation. Thus, the industry-wide approach does reflect the possibility that
health care facilities may pass on increased emission control costs to patients. Under all
scenarios and regulatory options evaluated, the price increases expected to occur for the health
care industry after consideration of the increased cost of emission controls range from no price
increase to a price increase of 0.13 percent on an annual basis.
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4.3.2 Facility-Specific Economic Impacts
Comment: One commenter (TV-D-748) stated that EPA has understated the economic
impacts of the proposed rules on the U.S. Department of Defense (DoD) medical operations.
The commenter stated that: (1) increased revenues are not available to DoD MWI operators,
(2) installing controls on DoD incinerators or switching to alternate means of medical waste
disposal are both expensive, (3) incremental costs on DoD medical waste generators is
expected to be large, (4) the increased cost of switching to contract disposal is exacerbated by
the expected rise in contract costs, and (5) the economic impact of the anticipated closure of
small DoD MWI will be great. The commenter stated that the DoD may have to discontinue
use of 40 of the 41 MWI (14 Army, 23 Air Force, and 4 Navy) that it currently operates due
to increased regulatory costs. The commenter stated that replacing the DoD MWI with
autoclaves would cost approximately $10.24 million and contract disposal would cost
approximately $2.9 million per year for the entire DoD. The commenter stated that the DoD
does not operate hospitals for profit and is unable to pass the increased costs on to customers.
The commenter recommended that EPA revise the economic analysis and reevaluate the
proposed regulations in light of the increased DoD operating costs and the expected benefits
that are intended to be derived from the proposed regulation. The commenter requested that
EPA extend the currently proposed compliance schedule to allow DoD facilities to program the
funding for any increased costs within the Federal budget cycle.
.Response: The DoD concerns appear to be no different than concerns raised by the rest
of the affected industry. Finding resources for projects is a concern to all industry sectors.
While installing controls can be expensive, it appears that alternative waste disposal methods
are available at a reasonable cost (there is no evidence to suggest that contract disposal costs
will rise substantially). Many hospitals operate on a not-for-profit basis. It is not clear from
the comment why DoD incinerators will face adverse economic impacts. For the most part,
the regulations have been established at the MACT floor, the least cost regulations allowed
under the CAA. Facilities have been on notice since February 1995 that these regulations are
under development, and final compliance for existing units will not be required before the year
2000. This should allow adequate time to program funding into the Federal budget cycle.
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The DoD, as a department of the Federal government, has an annual budget to cover
capital and annual expenditures. Although DoD can not pass on increased costs to patients,
increased costs of medical waste disposal can be considered in the budgetary process. The
economic analysis did not focus specifically on the costs of the regulation to the DoD.
However, the impacts of the rule to Federal hospitals, some of which are operated by the
DoD, was evaluated. Individual small (urban and rural), medium, and large Federally
-operated hospitals are expected to experience increases in the emissions control costs as a
result of the regulation that range from 0.03 to 0.47 percent of the annual budget of the
hospital. The size of the cost as a percent of the budget estimate varies according to the
regulatory scenario (add-on controls versus switching to an alternative method of waste
disposal) evaluated, the size of the hospital, and the regulatory options assumed. The emission
guidelines are not requiring the use of add-on controls, or the use of autoclaves, or the use of
off site incineration, but rather are requiring firms operating MWI to comply with emission
limits. The DoD will have the opportunity to choose the least costly alternative to comply with
the emission limits established in the emission guidelines.
In comments, DoD contends that 40 of 41 existing MWI operated by DoD will cease
operation as a result of the regulation, that the purchase of autoclaves will cost $10.24 million
(capital cost), and that contract disposal will cost $2.9 million annually. The relevant costs of
the regulation to consider in determining the magnitude of economic impacts are the
annualized costs of add-on controls or the annualized costs of alternative methods of disposal
such as the use of autoclaves or offsite incineration in excess of current annual expenditures to
operate MWI. The DoD can reasonably be expected to choose the least costly alternative.
Annualized costs include annual operation and maintenance expenses and annual capital
recovery for capital equipment or annual expenditures for offsite waste disposal. Capital costs
such as the cost of purchasing autoclaves are not directly comparable to an annual budget for
DoD hospitals since capital equipment has a useful life greater than 1 year and benefit periods
..extend beyond the current budget year. For example, hypothetically assume the DoD expends
$1.5 million annually to operate MWI and that this expenditure will become zero if the MWI
are no longer operated. Further assume that the least cost regulatory alternative is offsite
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;!'!;, ": It I I, «-.'
waste disposal that costs $2.9 million per year (the DoD estimate). For the regulatory
alternative of offsite waste disposal, the relevant regulatory costs to consider amount to $1.4
million annually ($2.9 million minus $1.5 million). Using this approach, the EPA estimates
that the annualized costs of this regulation for each Federal hospital will range from 0.03 to
0.47 percent of the annual budget of the hospital. Within this range of impacts, DoD can be
expected to choose the least cost method of waste disposal.
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5.0 REGULATORY OPTIONS AND IMPACTS FOR NEW MWI
5.1 REGULATORY OPTIONS
Comment: One commenter (TV-D-735) contended that, by naming technologies in the
supplemental notice, EPA is dictating the use of a DI/FF with activated carbon in combination
with a wet scrubber system. The commenter stated that many State environmental agencies
will interpret this to mean the dry/wet technology is the only option.
Response: The EPA has based the MACT emission standards on a, DI/FF with a wet
scrubber and activated carbon injection. However, the final standards do not include explicit
-requirements for the use of a combined dry/wet scrubber with carbon injection. The standards
include emission limits based on the combined dry/wet system with carbon, which may be met
by any means or with any control technology. The EPA is not dictating the use of a combined
-dry/wet scrubber with activated carbon.
5.2 NATIONAL ENVIRONMENTAL AND COST IMPACTS
Comment: One commenter (TV-D-735) stated that facilities with new MWI and
DI/FF/Wet scrubber systems or alternative treatment technologies that use water would face
financial hardships because they would have to shut down during periods of drought. The
commenter argued that many water-starved States will not take kindly to being told that in
order to maintain the option of MWI that they must use a precious resource (i.e., water) in
order to operate.
Response: As discussed earlier, the combined dry/wet scrubbing system reflects the
MACT floor, the least burdensome regulatory option EPA may consider in developing
regulations for MWI. In estimating the impacts of such a regulatory option, EPA has
concluded that many facilities that might have installed an incinerator are likely to decide to
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use other waste disposal methods, simply because of the cost of the air pollution control
device. Lack of water my be another factor which influences a facility's choice of waste
disposal. There appear to be a number of alternative waste disposal options, some of which do
not require water.
While the standards are based on the performance capabilities of combined dry/wet
scrubbers, the EPA is not dictating their use. Any MWI that can meet the emission limits may
be used. While this may be a fine point (most commenters would agree that only a combined
dry/wet system can achieve all of the emission limits hi the final standards on a routine basis),
the establishment of emission limits rather than control technology requirements does leave the
door open for the development of new technologies which might be able to meet the emission
limits without the use of water.
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\;;«i.-fe. -:
6.0 INCLINATIONS FOR THE FINAL RULE
'6.1 REGULATORY OPTIONS
Comment: One commenter (TV-D-742) requested that the MACT floor for new and
existing units with capacities of less than 100 Ib/hr be good combustion alone. The commenter
explained that to go beyond the MACT floor for MWI rated below 100 Ib/hr would produce
minimal environmental benefit with terrible economic impacts for the owners and
manufacturers of these MWI. The commenter stated that small rural hospitals would be forced
to pay considerably more for waste disposal if they were forced to install a wet scrubber or
>choose commercial hauling. The commenter stated that small MWI vendors may go out of
^business because it is unlikely that there will be customers for very small incinerators with wet
scrubbers. The commenter stated that the wet scrubbers currently sell for about five times the
splice of the incinerator. Another commenter (TV-D-732) mentioned that if extremely small
(i.e., less than 100 Ib/hr) MWI must be included in the guidelines, then the only regulatory
options that are feasible are regulatory options T and 2^4^The~comn1[enter argued that regulatory
options 3 through 6 are not feasible with existing technology and staffing resources at remote
health care facilities.
One commenter (TV-D-782/454) concluded, based on costs, that the MACT floor
should be the emission guideline for small existing facilities. The commenter indicated that
the cost of waste disposal at small facilities would more than double if wet scrubbers are
required and there would be little environmental benefit. Another commenter (TV-D-751)
-requested that the guidelines for small MWI be based on regulatory option 2. The commenter
", = - "" '-';-'^'"""''.'.., ',-. ' - ".- > . £.''.'.t^ytfrar'-'.
noted that the commercial waste disposal options for medical facilities in Wyoming are located
out of State. The' commenter indicated that while 'these'^fflffleMat companies will^service
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remote locations, the costs are burdensome for small facilities. The commenter stated that the
majority of the MWI in Wyoming are used to incinerate 20 to 200 pounds of medical waste,
with over 50 percent of the units incinerating less than 100 pounds per hour. Another
commenter (TV-b-760) suggested that adoption of regulatory option 4 will place an
unjustifiable burden upon small rural generators who have no other cost effective alternatives.
i,, ' ' " ' " , 'iii1" '" ' i. , ' '
One commenter (IV-D-749) contended that emission limits for small incinerators
consistent with no more than good combustion would result in largely uncontrolled emissions
from units that are probably the dirtiest. The commenter requested that small existing MWI be
subject to emission limits consistent with wet scrubbers. The commenter noted that the current
limits for small MWI are different than the limits for small MWC. The commenter argued
that, while differences exist in the design of small MWI and small MWC, EPA should make
the emission limits consistent for both MWI and MWC. Another commenter (IV-D-774)
contended that the use of good combustion as a criteria for controlling emissions from small
MWI is inappropriate because small MWI generate the most pollution. The commenter argued
that small incinerators are more likely to have inappropriately trained operators, inappropriate
feeding of waste, inappropriate management of ash and other problems.
Three other commenters (TV-D-757, IV-D-761, and IV-D-786) indicated that there are
cost effective alternatives to onsite incineration in small MWI and that small MWI should not
be allowed to operate without air pollution controls. One commenter (IV-D-786) argued that
if small MWI cannot improve their emission levels that they should shut down and the waste
they burn should be disposed of in a way that will not create such health risk.
Two commenters (TV-D-762/784 and IV-D-784) included data from a study that
compares the emissions from several smaller onsite incinerators to the emissions from one
large regional incinerator. The regional incinerator shows lower emissions than the combined
environmental loading of the smaller onsite incinerators.
One commenter (IV-D-748) argued that regulatory option 1 is the most reasonable
choice for all sizes of incinerators. The commenter requested that HP A establish the MACT
floor based on regulatory option 1. Another commenter (TV-D-792) recommended that the
MACT floor emission limits for existing MWI be adopted for the final regulations.
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One commenter (IV-D-759) noted that original baseline estimates were wrong for the
number of MWI, the volumes of pollutants emitted, and the quality of present emissions"
^controls. The commenter remarked that the new baseline allows EPA to not go beyond the
MACT floor.
One commenter (IV-D-781) stated that it would be unjustifiable for EPA not to look
beyond the MACT floor given that small incremental costs will yield significant emissions
: reductions as the MACT moves from regulatory options 1 to 5. Two other commenters
(TV-D-762/784 and IV-D-784) argued that the marginal increase in costs and the emissions
reductions achieved in going from regulatory option 1 to 3 suggests that EPA should require
all incinerators to install APCD.
One commenter (TV-D-726) concluded that the emission guidelines should be based on
regulatory option 6 since scenario B is the most likely outcome and the difference in the
relative cost impacts under scenario B is negligible.
Response: The EPA acknowledges that few small new MWI are likely to be
constructed in the future because of the costs associated with a small MWI equipped with a
"scrubber. However, as discussed elsewhere, there is no technical justification for a
subcategory of units smaller than 100 Ib/hr, and the MACT floor for small new units reflects
-emissions achievable with a wet scrubber. Consequently, EPA has no authority to establish
emission limits for small new units based on good combustion alone.
With regard to small existing MWI,'the MACT floor reflects the emissions achievable
with good combustion alone. As discussed elsewhere, EPA must consider regulations more
stringent than the MACT floor. Based on an examination of the costs, emission reductions,
and economic impacts of guidelines based on wet scrubbers for small existing units, EPA has
concluded that MACT for most small units should reflect emissions achievable with good
combustion and a low efficiency wet scrubber. The reductions in emissions are substantial,
while the cost and economic impacts for most small MWI appear minimal. On the other hand,
there may be MWI located in remote areas with fewer options for waste disposal. In these
'cases, MACT based on a wet scrubber could result in adverse impacts. It is difficult to
determine precisely which MWI have limited waste disposal options, and it is difficult to
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establish a universal set of criteria that could quantify "hardship." Consequently, as discussed
below, the criteria examined have focused on (1) distance from a Standard Metropolitan
Statistical Area (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.
With regard to concerns about emissions from small units with good combustion alone
and associated health concerns, these units are not left "uncontrolled." Good combustion
reduces emissions of PM, CO, and dioxin/furan, and these units remain subject to operator
training requirements. The guidelines also include requirements for routine inspection and
maintenance to ensure good combustion. It is not clear that these units will pose a health
threat to the surrounding community. Based on EPA's assessment of costs and other impacts,
MACT for small existing units allows for good combustion alone in some cases. As
mentioned elsewhere, EPA is to examine the residual risk associated with this source category
following adoption of the standards and guidelines to determine if there is any remaining risk.
If there is unacceptable residual risk, EPA may adopt more stringent guidelines in the future.
In the meantime, the final standards and guidelines result in substantial reductions in emissions
from the MWI source category as a whole.
With regard to the comment implying that guidelines for small MWI should be
comparable with emission limits for small MWC, it should be pointed out that a "small" MWC
of 50 tons per day capacity is vastly different than a "small" MWI of less than 1 ton per day.
As discussed elsewhere, there is no need for the MWC and MWI regulations to establish the
same emission limits. Each category is examined separately, and emission limits will be
established based on MACT for each subcategory.
Comment: One commenter (IV-D-760) argued that the MACT floor for small new
MWI should be the same as the MACT floor for small existing MWI. The commenter stated
that the cost of a moderate efficiency wet scrubber will discourage replacement of small
existing MWI. The commenter stated that this demonstrates a weakness in the law (CAA)
because limits for new units are based on maximum available technology rather than the end
result. The commenter stated that the reduction in the total emissions by the inclusion of
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scrubbers comes at an excessively high cost per unit of total mass excluded from the
environment. The commenter requested that this issue be developed further and brought to the
; attention of Congress.
Response: Section 129 of the CAA specifies that the degree of reduction in emissions
-that is deemed achievable for existing MWI shall not be less stringent than the average
- emission limitation achieved by the best performing 12 percent of units in a category; this
requirement is referred to as the MACT floor for existing MWI. Section 129 also specifies
that the degree of reduction in emissions that is deemed achievable for new MWI shall not be
less stringent than the emissions control achieved by the best-controlled similar unit; this
requirement is referred to as the MACT floor for new MWI. The average emission limitation
achieved by the best performing 12 percent of existing small MWI is achievable with good
combustion. Small existing MWI that are equipped with moderate efficiency wet scrubbers
have been identified. Therefore, as required by the CAA, the MACT floor for small existing
MWI is based on good combustion alone and the MACT floor for small new MWI is based on
moderate efficiency wet scrubbing systems. Congress intended for EPA to examine existing
*units separately from new units as evidenced by the statement: "Emissions standards for
^-existing units in a category may be less stringent than standards for new units in the same
^category ..." (section 129(a)(2)).
6.2 URBAN/RURAL CLASSIFICATION
Comment: Six commenters (IV-D-732, W-D-735, TV-D-748, IV-D-782/454,
IV-D-790, and IV-D-792) supported EPA's efforts to adopt less restrictive emission limits for
MWI located in rural areas. One commenter (TV-D-732) stated that tribal governments
operate a number of small hospitals and ambulatory care centers that are not serviced by major
roads. Therefore, the commenter concluded that it is inconceivable that these facilities will be
able to make use of commercial hauling services at a reasonable cost. One commenter
(TV-D-735) argued that a small urban/rural classification would be reasonable for existing and
-new MWI because contract services, excess water utilities, and timely system repair services
may not be readily available to rural sites. The commenter recommended considering
population density, distance from population centers;~industrial complex of the region, and
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VIP , ''W wnr
geographical hardship as criteria for defining urban or rural. Another commenter (IV-D-748)
recommended that EPA exempt small MWI located in rural locations from regulation under
this rule because their waste disposal options are limited. In lieu of an outright exemption, the
commenter recommended that EPA establish less stringent regulatory compliance options for
small existing MWI in remote locations.
One commenter (TV-D-782/454) stated that EPA has the authority to give special
consideration to rural MWI since the standards may not be achievable considering the costs for
these facilities.
One commenter (IV-D-781) supported the goal of regulatory option 2 but did not
believe that EPA has the authority to subcategorize based on location. The commenter stated
that there are few facilities in the nation that are located outside of reasonable access to
alternative disposal options, either onsite or offsite. The commenter suggested the following
guidelines for a facility to demonstrate economic necessity to comply with, the good
combustion guidelines alone: (1) no alternative offsite disposal is available at a reasonable
cost. This could be determined by location of more than 150 miles from an SMSA and from
service quotes from commercial services that show annualized costs that exceed a certain
percent of revenue such that the cost would create economic hardship for the facility; (2) no
alternative onsite technology is available at a reasonable cost. This could be determined by
comparing annualized cost as a percent of revenue; (3) the commenter believes that rather than
allowing such facilities to run high-emitting incinerators, that EPA should consider a shipping
subsidy.
Other commenters (TV-D-762/784 and IV-D-784) argued that EPA should require air
pollution controls for all MWI because numerous alternatives to onsite incineration are
available. Nevertheless, the commenters suggested some criteria for defining remotely located
small MWI that would be allowed to meet the MACT floor: (1) the small MWI must be more
than 150 miles from an SMSA, (2) the small MWI burns less than 2,000 Ib/wk, and (3) the
facility does not accept more than 10 percent of the total waste burned from offsite generators.
The commenters suggested that State pollution control authorities should be vested with the
discretion to require small remote facilities to meet emission limits more stringent than the
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MACT floor if the State determines that the facility has alternatives to onsite incineration. The
commenters stated that small remote facilities should be required to ensure good combusltion
practices, monitor CO, record and submit the State reports documenting amount of waste
processed, comply with the operator training requirements, conduct performance tests, and
renew their exemption on a periodic basis (i.e., continually investigate alternatives to onsite
incineration).
Another commenter (TV-D-760) argued that there is no need to define urban and rural
-locations. However, if EPA decides to regulate on the basis of location, the commenter
recommended using ambient air quality as a proxy. The commenter also recommended SMS A
if ambient air quality cannot be used. Another commenter (TV-D-765) disagreed with less
stringent requirements for small MWI in rural areas. The commenter argued the emissions
from small MWI are the same regardless of location. The commenter recommended that if
EPA decides to give special .consideration to small rural MWI, it be done pn a case-by-case
basis with proper documentation of unavailability and/or the cost of alternatives. The
commenter recommended establishing a set criteria to permit small rural MWI to comply with
.Jess stringent requirements.
Another commenter (TV-D-786) argued that EPA should not create special lenient
-standards for rural incinerators. The commenter stated that no examples of rural facilities that
cannot afford to ship waste offsite have been offered. The commenter stated that humans
could be directly exposed to emissions from MWI regardless of rufal location and that rural
MWI are likely to be located near farming areas where food is grown and livestock are raised.
The commenter noted that humans could consume these MWI emissions, especially Hg and
dioxin, in their food. The commenter stated that, if there is a health care facility that could
not remain in business if it has to ship its waste offsite, EPA should consider some "hardship"
criteria or a shipping subsidy.
Another commenter (IV-D-726) argued that rural MWI with cost-effective alternatives
M;o onsite incineration should be regulated consistently with urban MWI. The commenter
explained that the cost impacts for rural MWI to meet the same requirements as urban MWI
are minimal and that the emissions from rural units are potentially high.
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Response: The MACT floor for small existing HMIWI is 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 including guidelines based on scrubbing systems. 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. However, 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
medical waste disposal if the emission guidelines are based on the use of good combustion and
low efficiency wet scrubbing. However, it should be noted that EPA's objective is not to
encourage the use of alternatives to incineration or to discourage the use of onsite HMIWI;
EPA's objective is to adopt MACT emission guidelines for existing HMIWI that fulfill the
requirements of Section 129 of the CAA.
Commenters have pointed out that 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 rural 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 allow facilities that meet
certain "rural criteria" to meet emission limits achievable through the use of good combustion
1 , -S ' '!'' ' ' , i ' .' ;i"ii . ' i , ' ',
alone (i.e., the MACT floor emission limits).
Commenters suggested that rural criteria be based on distance from an 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.
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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." The Agency
does not want to develop a criteria that will unduly burden State and local agencies to make
""^"hardship" determinations on the approximately 600 small rural MWI. Consequently, the
rural criteria examined for use in regulatory option 2 focused on (1) distance from an 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 hi conjunction with
-weekly waste burning limits ranging from 500 to 3,300 Ib/wk were examined to determine the
appropriate rural criteria. Suggestions by commenters, and factors such as likelihood that
commercial services are available and number of HMIWI meeting the criteria, were considered
'in evaluating the criteria. Rural criteria based on a distance of 50 miles from an SMSA and a
"2,000 pound per week waste charging limit were selected for a number of reasons. The 2,000
"pound per week criterion was suggested by commenters; focuses the option for less stringent
requirements on the smallest HMEWI; and reflects a sufficient quantity of waste to ensure that
commercial services are available. The 50 mile criterion added to the 2,000 Ib/wk criterion
provides the less stringent requirements for less than 10 percent of small HMTWI (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.
All of the suggestions submitted by commenters with regard to the rural criteria for
small HMIWI were considered. However, many of the suggestions such as economic
necessity, ambient air quality, good engineering practice, and risk analysis as part of the rural
criteria would be very difficult to define or implement. The final "rural criteria" for small
existing HMIWI stipulates that: (1) the facility must be located 50 miles from the nearest
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SMS A and (2) the HMIWI operated by the facility may not be used to burn more than 2,000
Ib/wk. This criteria is based on suggestions by commenters, analysis of the size and location
of small HMTWI relative to SMSA's, and an analysis of the costs and emissions taking into
consideration the possibility of medium units becoming small through a Federally enforceable
limit on charge rate.
Subcategorization, while authorized by the CAA, must be based on technical
distinctions between subcategories. For HMIWI, technical distinctions among incinerator
types occur at 200 Ib/hr and 500 Ib/hr. Subcategorization by location prior to determining the
MACT floor is not appropriate under the CAA. On the other hand, in developing the final
regulations, cost and economic impact considerations are taken into account in determining
MACT, as long as MACT is no less stringent than the MACT floor. In this case, cost and
economic impacts may be different based on the location of the HMIWI. 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." 42 U.S.C. § 7429(a)(2). This language gives EPA broad discretion to distinguish
among units in a category in establishing subcategories, including establishing subcategories
based on unit's location. See Davis County Solid Waste Management & Recovery Special
Services District v. EPA. 101 F.3d 1395, 1405 n.ll D.C. Cir. 196) amended 108 F.3d 1454
(D.C. CIR. 1997). The EPA believes it is appropriate to subcategorize for purposes of
establishing MACT standards, where all MACT standards were at least as stringent as the
respective MACT floors. Consequently, EPA has established guidelines based on one level of
control for most small existing units, while establishing separate guidelines for certain small
existing remote units where the economic impacts of the requirements might be severe. This is
not the same as subcategorizing by location.
Facilities meeting the rural criteria are required to implement operator training, a waste
reduction plan, monitor operating parameters (waste feed rate and secondary chamber
temperature), perform an initial compliance test (PM, CO, dioxin/furan, and Hg), annual
opacity testing, annual inspections, and reporting and recordkeeping. The Agency believes
that these requirements will ensure good combustion practices on an ongoing basis.
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Based on EPA's assessment of the costs and other impacts, the less stringent
requirements based on good combustion alone will themselves raise the cost of incineration
such that alternatives, if available, are likely to be less expensive than continued onsite
incineration. In other words, where alternatives are available, guidelines based on good
'"combustion alone are likely to result in switching. Therefore, while the less stringent
requirements apply to about 100 small HMIWI, it is expected that only those with no other
"waste disposal options will continue operating their incinerator.
6.3 OTHER INCLINATIONS
Comment: One commenter (IV-D-769/557) agreed that consideration of wet scrubbing
systems as an emission control technology that is appropriate for MWI is a significant
improvement in the development of NSPS and guidelines under section 129. However, the
commenter was unclear if EPA's inclinations for the standards have a valid legal or technical
*basis. The commenter noted that the determination of whether a regulatory option is
"achievable is focused on a cost evaluation and the switching scenarios. The commenter argued
that the MWI standards should be based on technologies that are achieved by the best
^performing 12 percent, and not on the cost evaluation that the proposed MACT standards are
'* achievable if facilities close and use other alternatives.
Response: The CAA specifies in section 129 that the degree of reduction in emissions
that is deemed achievable for existing MWI may not be less stringent than the average
emission limitation achieved by the best performing 12 percent of units in each category. This
requirement is referred to as the "MACT floor" for existing MWI. The MACT floor, which
defines the least stringent emission guidelines EPA may adopt, is only the starting point of the
MACT analysis. The CAA requires EPA to examine alternative emission guidelines
(i.e., regulatory options) more stringent than the MACT floor. When examining regulatory
options more stringent than the MACT floor, the EPA must consider the cost, environmental,
and energy impacts of these regulatory options and select one that reflects the maximum
reduction in emissions that EPA determines is achievable (i.e., MACT). Thus, while the
MACT floor is the least stringent regulatory option that the EPA can adopt regardless of cost,
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the EPA must consider costs when examining regulatory options more stringent than the
MACT floor.
One likely outcome associated with the adoption of MACT emission guidelines for
existing MWI is the increased use of alternatives to onsite incineration, which has been
referred to as "switching." The MACT floor is the least stringent regulatory option that the
EPA can adopt regardless of the availability of alternatives to onsite incineration. However, in
the analysis of the regulatory options more stringent than the MACT floor, the EPA must
consider the increased use of alternatives to onsite incineration. The analyses of the cost,
environmental, and energy impacts of the six regulatory options for existing MWI incorporated
three scenarios; one that ignored switching, and two that considered switching.
Because the MACT floor reflects the least stringent regulatory option that the EPA may
adopt for new or existing units regardless of costs or switching, the MACT emission standards
and guidelines are at least as stringent as the best performing 12 percent of MWI in each
category, and thus, meet or exceed the MACT floor.
Comment: One commenter (TV-D-735) requested that the emission limits for existing
MWI reside at the MACT floor. The commenter contended that this would allow for easy
retrofitting and save the affected facilities the cost of tear-out and disposal of the existing units
and the increased capital for new MWI, alternative technologies, or offsite contracting.
Response: The final MACT emission limits for existing small MWI that meet certain
rural criteria, medium MWI, and large MWI remain at the MACT floor emission level.
However, the MACT emission limits for small MWI that do not meet the rural criteria are
more stringent than the MACT floor for small MWI. After considering the costs and
environmental impacts of the regulatory options for small MWI, the EPA decided that
emission limits associated with low efficiency wet scrubbers are achievable.for small MWI that
'!:'; ' ' "!" ". '":" . 'll!l ' ' ' ' '' ', ' ' ' ""' ;
do not meet the rural criteria. The EPA believes that the regulatory options that it has selected
for each MWI subcategory achieve a significant reduction in emissions and satisfy the
requirements of the CAA without subjecting the regulated community to unnecessary costs.
Comment: Two commenters (TV-D-756 and IV-D-776) stated that EPA's MWI rule is
inconsistent with its findings on the MWC and HWI rules. The commenters noted that the
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dioxin limits for the MWC and HWI rules are 10 times lower than the dioxin limits for the
MWI rule. Another commenter (TV-D-780/500) suggested that the standard should be -
consistent with that of MWC since the same control equipment is available to and used by both
types of incinerators. Another commenter (IV-D-789) suggested that the emission standards
"for MWI be no less stringent than those required for municipal or hazardous waste incinerators
since the combustion control methods and emission control devices are largely the same.
Response: Medical waste incinerators, HWI, and MWC are similar in some respects,
but are part of separate source categories. For the development of NSPS and emission
guidelines, available data are examined to determine what emissions control is achievable for
each source category. Municipal waste combustors and HWI differ from MWI hi size, design,
baseline emissions, and available air pollution control technologies. Because of differences in
the air pollution control technologies, the MACT floors and achievable emission levels are
^different for MWI, HWI, and MWC. The CAA requires the MWI NSPS and emission
guidelines to reflect the level of control currently achieved in practice on MWI. There is no
requirement or need for the final HMIWI, MWC, and HWI emission limits to be the same.
Comment: One commenter (IV-D-785) stated that the CAA does not permit EPA to
^assign MACT standards based on both emission limits and control technology. The
^commenter argued that EPA is inappropriately prescribing a dry scrubber followed by a fabric
filter with carbon injection as MACT for dioxin/furan. The commenter noted that carbon
injection and fabric filters will generate a potentially dioxin contaminated waste stream.
The commenter also stated that: Hg emissions are better controlled by pollution
prevention; EPA has not proven that the proposed Hg levels are based on the top 12 percent of
the best controlled sources; and EPA's assumption that the best controlled sources should have
Tig sorbent injection and fabric filter technology is inappropriate.
The commenter noted that an EPA document entitled "Guidance on Setting Permit
Conditions and Reporting Trial Burn Results" is currently used to develop site-specific
operating permits for HWI. The commenter stated that adoption of a similar program for
MWI would be more beneficial to EPA in achieving its goals than a mandate of dry scrubbers
and fabric filters.
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Response: The commenter is correct in noting that the EPA is not permitted under the
CAA to prescribe specific control technologies. Indeed, the EPA is not prescribing or
mandating any particular technology for MWI. Section 129 standards and guidelines are
technology-based and are to reflect the performance of available control technologies. While
the MACT standards and guidelines are based on the performance of available emissions
control technologies, they do not contain explicit requirements for the use of any one control
technology. Instead, the standards and guidelines contain emission limits that may be met with
any control technology or by any means that a regulated facility chooses.
For the most part, add-on air pollution control technologies that remove pollutants after
combustion serve as the basis for the emission limits. Add-on air pollution control devices can
achieve greater reductions in Hg (and other) emissions than pollution prevention alone. Not
only is carbon highly effective at removing dioxin/furan and Hg from incinerator exhaust gas,
:but studies indicate that once adsorbed onto the carbon, these pollutants do not off-gas or
leach. Consequently, the fly ash can be landfilled (either in a municipal landfill or hazardous
waste landfill), without posing a future threat to the environment.
With regard to the comment suggesting site specific operating permits, the CAA
requires EPA to establish national emissions standards and guidelines for all MWI. The
standards and guidelines are not to be site-specific.
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7.0 MISCELLANEOUS
Comment: One commenter (IV-D-726) stated that MWI in air pollution nonattainment
areas should be held to a standard which accepts higher costs as a justification.
Response: As required by the CAA, Section 129 emission standards and guidelines are
technology-based and do not distinguish between sources located in attainment or
non-attainment areas. The NSPS and guidelines are intended to reduce emissions on a
^nationwide basis. States are free to require facilities located in nonattainment areas to meet
ntnore stringent emission standards if the State believes more stringent requirements are
-necessary. Furthermore, major new facilities that are located in nonattainment areas are
required to undergo new source review (NSR).
% Comment: Two commenters (TV-D-727 and IV-D-729) requested a 60-day extension
sof the comment period. Another commenter (IV-D-773) requested a 30-day extension of the
comment period.
Response: Requests for extensions of the public -comment?period were denied.
However, late comments were considered until December 31, 1996.
Comment: One commenter (TV-D-732) requested that the final rule contain a provision
to grant a 5-year deferment to remote health care programs on a case-by-case basis. The
commenter stated that the deferment should be limited to those facilities where there are no
-reasonable alternatives to onsite incineration.
Response: Under Section 129, States are required to submit to the Administrator a
plan implementing the emission guidelines within 1 year after promulgation of the guidelines.
^Section 129 also requires that a State plan provide that each unit subject to the guidelines be in
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, compliance with the guidelines within 3 years after the State plan is approved by the EPA but
in no case later than 5 years after promulgation of the emission guidelines.
The final emission guidelines require that a State plan provide that each source subject
to the emission guidelines be in compliance with the guidelines within 1 year after approval of
the State plan. However, there are exceptions to this compliance schedule. First, State plans
may allow facilities that are planning to install the necessary air pollution control equipment up
to 3 years after EPA approval of the State plan (but not later than 5 years after promulgation
of the guidelines) to comply with the guidelines. Second, State plans may include provisions
allowing facilities to petition the State for extensions for compliance. If an extension is
granted, compliance shall be required within 3 years after EPA approval of the State plan but
not later than 5 years after promulgation of the emission guidelines.
The EPA believes that 1 year after EPA approval of a State plan (approximately
,2 years after promulgation of the guidelines) is sufficient time for facilities; to comply with the
emission guidelines. However, the above compliance schedule allows facilities that petition
and receive extensions from States up to 5 years after promulgation to comply with the
emission guidelines. Therefore, EPA does not believe that it is necessary for the guidelines
that contain a provision to grant a 5-year deferment to remote health care programs.
Comment: One commenter (TV-D-735) submitted articles and news clippings that,
according to the commenter, indicate a bias against incinerators by EPA management. The
commenter mentioned a moratorium on MWI that was enacted in Florida by Ms. Browner.
Based on conversations with regulatory officers of the Florida Department of Environmental
Protection (DEP), the commenter concluded that the moratorium was enacted for political
instead of scientific reasons. The commenter noted that officials from the Florida DEP found
that alternative technologies were "not working out" during the moratorium and that prices for
commercial medical waste hauling increased.
Response: It is certainly better for the environment to avoid generating waste, where
possible, than to have to dispose of it. Items that can be safely reused are often better for the
environment than disposables. Recycling materials is usually better for the environment than
direct disposal. However, EPA recognizes that there are wastes which must be produced and
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which are neither reusable nor recyclable. For these wastes, landfilling and incineration are
.two acceptable methods of disposal. While there are many items in a hospital's waste stream
<;that can be recycled, many items cannot and should not be reused or recycled. The EPA has
no particular bias against incinerators. The final regulations for HMIWI reflect EPA's
determination of maximum achievable control technology, as specified by the CAA.
Comment: Two commenters (TV-D-790 and IV-D-792) agreed with EPA's revised
-dioxin estimate of 150 grams per year. The commenters requested that EPA publicize the
lower dioxin emissions estimate to the same degree as the original estimate was publicized.
Another commenter (TV-D-735) contended that EPA incorrectly assumed that MWI are the
only major sources of PM, CO, HC1, Pb, Cd, and Hg in the nation. The commenter argued
that MWI are a minuscule source of emissions such as dioxin/furan and that the EPA has not
re-addressed this issue in the supplemental notice.
Response: As presented in the 1996 re-proposal, EPA's estimates of national
dioxin/furan emissions from MWI are much lower than the estimates calculated for the 1995
.proposal, based on new and better information provided by commenters on the 1995 proposal.
These lower numbers were published in the Federal Register on June 20, 1996 with a separate
^section dedicated to "baseline emissions." The final rule also shows the lower estimates of
^dioxin/furan from MWI. While MWI are no longer seen as "the" significant source of
dioxin/furan emissions in the U.S., they remain as one of several significant sources of
dioxin/furan emissions.
The EPA never meant to imply that MWI are the only major source of PM, CO, HC1,
Pb, Cd, and Hg in the nation. On the other hand, MWI are not a "minuscule" source of
emissions.
Comment: One commenter (IV-D-536) suggested that subparts EC and Eb should be
-consistent in regards to the critical temperature for dioxin/furan formation. The commenter
noted that subpart Eb focuses on temperatures over 450 °F, while subpart EC focuses on
.temperatures over 300°F.
Response: There is some literature that relates dioxin/furan formation to exhaust gas
temperature as well as to other factors such as the presence!ofa waste heat recovery boiler.
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The literature presents a range of temperatures at which dioxin/furan formation has been
observed. While dioxin/furan formation has been observed at temperatures over 300 °F with
MWI and at temperatures over 450 °F with MWC, no definitive conclusions have been made
regarding a specific temperature or range of temperatures at which dioxin/furan formation can
occur with combustors in general. There is no mention of a critical temperature at which
dioxin/furan formation may occur in the final HMIWI standards and guidelines. Facilities are
required to establish operating temperatures during an initial performance test which
demonstrates compliance with the dioxin/furan emission limit. Once the operating
temperatures are established, facilities are required monitor the temperatures and remain within
10 percent of the set point established during performance testing.
Comment: One commenter (TV-D-748) stated that the U.S. Army has been exploring
the possibility of obtaining portable field incinerators for world-wide use. The commenter
stated that these field incinerators would treat waste generated by medical units in the field,
where waste treatment and disposal is a significant problem due to remote locations and
climatic conditions. The commenter stated that, in order for the field incinerators to be used
for military operations, training must be conducted on proper mobile MWI setup and
operation. The commenter requested that a training exemption for portable military MWI be
included in 40 CFR part 60, subpart EC. The commenter stated that it is necessary for mobile
units to be light-weight, compact, and easy to operate; therefore it would not be practical to
include air pollution control devices.
Response: As discussed elsewhere, the final standards and guidelines focus on
incinerators whose primary purpose is the disposal of hospital and/or medical/infectious waste.
'!,.;'i ';. : " ii '." , . '.. !
Any incinerator that burns less than 10 percent by weight hospital waste and medical/infectious
waste is not subject to the final standards and guidelines. This provision should provide
sufficient relief for portable military units, especially considering they are only used in the
U.S. for training purposes. Other wastes could be burned for training purposes.
Comment: Two commenters (TV-D-769/557 and IV-D-785) stated that failure to
»; ' , .-' , ' ' . . ' ,
publish the regulatory language for the 1996 proposed rule in the Federal Register will limit
the extent and quality of public comment, to the detriment of the rulemaking process.
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Response: The June 20, 1996 re-proposal clearly presented EPA's new conclusions on
subcategories, MACT, monitoring requirements, performance testing requirement, and *
-operator training/certification requirements. In addition, EPA did include inclinations to give
the regulated community a general idea of the tentative decisions made. The Agency believes
'this information was sufficient to allow the public to formulate quality comments on the 1996
-re-proposal.
Comment: One commenter (TV-D-789) noted that in the 1995 proposal, it seemed to
be a clear requirement for MWI to optimize reagent injection rates (e.g., activated carbon and
lime). The commenter noted that such language is not included in the MACT standards and
guidelines discussed in the supplemental notice. The commenter suggested that EPA define
good operating practices and include performance criteria for operating practices in the MACT
standards and guidelines. The commenter stated that good operating practices, which involve
-optimizing control device parameters (e.g., reagent injection rates, scrubber residence tune,
"flue gas temperatures, etc.), are not expensive when compared to equipment replacement. The
commenter included data that demonstrates the effects of altering control device operating
parameters on emissions.
* Response: The 1996 re-proposal did specify operating parameters for wet scrubbers
and refereed to the parameters for dry scrubbers discussed in the 1995 proposal. Requirements
for specific MWI and APCD operating parameters are included in the final HMIWI standards
and guidelines such as dioxin/furan sorbent flow rate, hourly charge rate, secondary chamber
temperature, and liquor flow rate.
Operating parameters were included in the 1995 proposed regulations, not to optimize
operating practices, but to ensure that units are operated within the same operating parameters
that were used to demonstrate compliance with the emission limits during performance testing.
"The operating parameters included in the final rule are for the same purpose.
Comment: One commenter (IV-D-619/679) suggested that the rule should state that
using different reagents on a stack test than the "typical" ones is a violation of the CAA.
Response: It is unclear if the commenter is referring to reagents used hi control
devices or to reagents used hi emissions testing so this comment has been responded to in two
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ways. If the commenter is referring to reagents used in control devices, use of reagents other
than the "typical" ones are allowed during performance tests. Facilities are allowed to use any
method, control device, or reagent available as long as the facility can meet the applicable
emission limits. However, facilities are not allowed to use one reagent to demonstrate
compliance with the emission limits and then substitute a different reagent during normal
operation when no performance tests are being conducted. In addition to other operating
parameters, the final HMIWI standards and guidelines require recordkeeping and reporting of
the amount and type of sorbent used in dry scrubbers and of the flow rate and pH of wet
scrubber liquor Facilities that change reagents used in wet scrubbers are likely to alter the pH
of the scrubber liquor and be in violation of a wet scrubber operating parameter.
The EPA Reference Methods for stack testing contain specific requirements for
solutions of reagents and chemicals that must be used when collecting samples of stack gas.
The final standards and guidelines require that emissions testing be conducted according to the
EPA Reference Methods. Use of solutions other than those required by the EPA Reference
Methods could result in invalid emissions data; therefore, a repeat performance test may be
necessary.
Comment: Five commenters (TV-D-756, IV-D-758, IV-D-772, IV-D-776 and
IV-D-787) requested that EPA set human health based standards for both existing and new
incinerators under the CAA. Two commenters (TV-D-758 and IV-D-787) concluded that the
dioxin limit should be zero because some of the health effects of dioxin were found to occur at
or near levels to which people m the general population are currently exposed. One
commenter (IV-D-758) remarked that human health based standards are also needed for lead,
cadmium, mercury, and other particulates. Another commenter (TV-D-787) remarked that
MWI should be eliminated because control technologies cannot achieve zero dioxin emissions
and alternatives to incineration are available.
Response: The CAA requires the EPA to develop NSPS and emission guidelines for
new and existing MWI. As required by section 129 of the CAA, the NSPS and emission
guidelines are technology-based standards, and not health-based standards. For NSPS and
emission guidelines, MACT is determined and emission limits are developed based on MACT.
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A zero dioxin limit is not achievable based on the MACT or on current technology. The CAA
-gives EPA the authority to determine the MACT, but does not give EPA the authority tov
eliminate sources if the MACT does not achieve zero emissions. It is recognized that there are
health concerns associated with dioxin/furan and Hg. The final emission standards and
guidelines will significantly reduce dioxin/furan and Hg emissions. Within 5 years of
* implementation of these rules, the CAA requires EPA to conduct an analysis to examine
^residual risk.
Comment: Two commenters (TV-D-758 and IV-D-772) stated that the data obtained
from industry used to establish the MACT standards should be peer reviewed.
Response: The data received from industry that was used to establish MACT was
reviewed within EPA and was made available for public review and comment. There has been
no evidence provided that EPA's conclusions regarding the data used to establish MACT are
^'incorrect. There is no need to establish another level of review at this time.
Comment: One commenter (TV-D-134) requested that EPA clarify whether delegation
of the State standards for existing facilities will follow an approval process under Section 111
-or Section 112. The commenter recommended that approval of State rules for MWI emission
^guidelines fall under the Section 111 process. Two other commenters (IV-D-490 and
*IV-D-536) questioned whether the NSPS delegation and approval of State standards will follow
the process under section 111 or 112. One commenter (TV-D-536) suggested that the NSPS
delegation and approval of State standards should fall under Section 111.
Response: Section lll(d) has been included in the CAA since 1970 and requires EPA
to establish procedures for submitting State Plans for implementing emission guidelines.
Section 129, added in 1990, specifically addresses solid waste combustion, including
"units combusting hospital waste, medical waste and infectious waste" (section 129(a)(l)(C)).
It further states, "Performance standards under this section and section 111 for solid waste
incineration units shall include guidelines promulgated pursuant to section lll(d) [italics
added] and this section applicable to existing units" (129(b)(l)). Thus, the EPA and States
must follow the section lll(d) process.
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Section 129 supersedes some aspects of section lll(d). It requires EPA to establish
emission guidelines for medical waste incinerators and States to develop State Plans for...
implementing those emission guidelines. Section 129 also requires that State Plans be at least
as protective as the emission guideline.
Subpart B of 40 CFR part 60 contains the procedures for adoption and submittal of
: ,*'! ' . '" - ' > ' '. , :.: . ;".'- , ; , '.':' ; .' :.' ;
section Ill(d)/l29 State Plans. On December 19, 1995, EPA revised subpart B to allow the
applicable subparts, for example, the emission guidelines promulgated under section 129, to
specify requirements that would supersede the otherwise binding generic requirements of
subpart B.
Comment: Two commenters (TV-D-499/659 and IV-D-535) suggested that regional
.offices should be able to delegate to State and local agencies the authority to review, establish,
and approve control alternatives to a dry scrubber/fabric filter. One commenter (IV-D-535)
suggested that when new emission reduction techniques are proposed, they are more efficiently
and expeditiousiy handled at a local level where the equipment is actually being installed. The
commenter stated that if operating parameters had to be determined by EPA, this would
complicate and delay permit evaluations. Another commenter (IV-D-663) suggested that
States should be able to petition for delegation of siting requirements and establishment of
operating parameters for alternative control techniques. The commenter requested that EPA
provide guidance on the criteria to be met by State and local agencies that seek to obtain
delegated authority in these areas.
Response: The final HMIWI standards and guidelines delegate to States authority over
the siting requirements. However, the Administrator retains the authority to establish
operating parameters for alternative controls. The Agency has included minimum or
maximum operating parameters for the most common MWI control devices. However, due to
the development of new technologies additional operating parameters will need to be
developed. In this case, the Agency will review operating parameters submitted by petitioners
which could then be available to other MWI units with the same technology. In addition,
operation of an MWI outside maximum or minimum operating parameters, under certain
conditions, is considered a violation of the applicable emission limit. The EPA believes any
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judgements in setting minimum or maximum operating parameters that will be linked to
^violations of the emissions limits should be retained by the Administrator. *
Comment: One commenter (IV-D-786) noted that some MWI stacks are located near
fresh air intake vents for hospitals. The commenter requested that EPA require existing and
sources to retrofit or relocate to avoid indoor air impacts.
Response: The CAA requires the EPA to develop NSPS and emission guidelines for
and existing MWI. As required by section 129 of the CAA, the NSPS and emission
guidelines are technology-based standards, and not health-based standards. For NSPS and
emission guidelines, emission limits are developed based on MACT and will result in
substantial emissions reductions from MWI. This should minimize any indoor air emissions
from units located near indoor air intakes. In addition, section 129 states that performance
standards for new MWI 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 believes that this will require new MWI to consider stack location
when siting new MWI.
Comment: One commenter (IV-D-786) stated that the statute forbids running an MWI
^without meeting the emission limitations in the NSPS from the date of the 1995 proposal
onwards. The commenter stated that to the extent that section 60.52 of the 1995 proposed rule
(governing start-up dates) is inconsistent with the statutory requirements, it is illegal. Addition
of a section that states that no new MWI may emit pollutants untiPafter completion of the
performance test would make this consistent with the statute.
Response: Section 129(f)(l) states that the effective date of the NSPS is to be the date
6 months after promulgation. While any incinerator built after the date of proposal (or in this
case re-proposal) is considered a "new source," a proposal is only a notice and request for
- comment on the NSPS. Section 129(f)(3) goes on to state that after, the effective date of the
regulations, it is unlawful to operate an incinerator in violation of the regulations. There is no
'Acquirement in the statute which forbids operating without meeting the standards from the date
of proposal, and there is nothing in the statute that forbids emissions until after completion of a
performance test. New units must be given tune after initial startup to get the systems
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operating properly before attempting to demonstrate compliance. It also takes time to schedule
testing, conduct testing, and receive test results. New sources have 6 months after startup to
demonstrate compliance.
Comment: One commenter (TV-D-453) requests that non-major facilities be exempt
from Title V of the CAA.
Response: Section 129(e) of the CAA requires each solid waste combustor to operate
pursuant to a permit issued under Title V of the CAA. Therefore, the Agency has included in
the final standards and guidelines that each incinerator subject to the regulations obtain an
operating permit issued under Title V regardless of facility size. The EPA has no authority to
exempt "nonmajor" HMIWI from title V.
Comment: One commenter (TV-D-572) stated that you can not mix flyash with bottom
ash because some States consider flyash hazardous.
Response: Facilities equipped with dry scrubbers followed by fabric filters typically
mix their flyash and bottom ash prior to disposal. After mixing the flyash and bottom ash,
facilities perform a TCLP test. If the mixture of flyash and bottom ash passes the test, the
waste is then disposed of in a municipal landfill. In most cases, the mixture of flyash and
i vi . ',':. ' ':,',:
bottom ash passes the TCLP test. However, if facilities are not allowed to mix the flyash and
bottom ash, the bottom ash typically passes the TCLP test while the flyash typically does not.
Most States allow the mixing of flyash and bottom ash prior to TCLP testing. Nevertheless, as
the commenter pointed out, some States do not allow mixing of flyash and bottom ash. To
account for this, the higher cost to dispose of flyash as hazardous waste rather than municipal
waste was incorporated into the revised cost impact calculations following the 1996 re-
proposal. However, the final HMIWI NSPS and guidelines do not require facilities operating
fabric filters to mix flyash and bottom ash.
' ' Wi '.'' , . . -. ' ..' ;
7.1 SITING REQUIREMENTS
Comment: One commenter (IV-D-735) argued that a national forum requirement for
],; ' . " ' '.;' ' ' ' - ," , ' ' > ,.' is;.;, '"' : ..i : ' ' , ;
siting would unacceptably delay the permitting process. The commenter requested that EPA
do away with the siting requirements because they will be costly and will impede the
I I ' ' ., & ' ' : ' ' ' . ' : t
permitting process. The commenter suggested leaving States to decide what would be rational.
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Two commenters (IV-D-790 and IV-D-792) requested that EPA adopt siting
-requirements that are consistent with those that have been developed and enacted by mosit 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
:^in the development of their own siting criteria. One commenter (TV-D-792) stated that the
~ 1995 proposed siting requirements (which included siting approval consistent with Prevention
-*of Significant Deterioration (PSD) procedures and risk assessments) were exceedingly onerous
and costly. The commenter argued that the EPA did not duly consider the comparative costs
and benefits of other siting options as required by the CAA.
One commenter (TV-D-748) stated that the analyses required for the 1995 proposed
siting document for new MWI are already required for Federal facilities under the National
Environmental Policy Act. The commenter stated that, in addition, many states require similar
^analyses before new incineration units are permitted. The commenter stated that requiring
additional studies under the 1995 proposed rule would be duplicative and would not enhance
environmental protection. The commenter estimated that the costs to develop an additional
-environmental impacts document are from $30,000 to $100,000 per facility. The commenter
Recommended that the final rule clearly state that any environmental analyses conducted to
fulfill the requirements of existing Federal or State regulations which meet EPA's criteria will
satisfy the 1995 proposed siting requirements.
One commenter (TV-D-766) requested that EPA base siting'of new MWI on the
regulatory review approach mentioned as the first approach in the 1995 proposal.
One commenter (TV-D-780/500) suggested that siting analysis should examine impacts
on all media. The commenter warned that shifting risks from one medium to another or from
one population to another must be avoided. The commenter supported the public participation
" requirements of the third approach discussed in the 1995 proposal. The commenter also
suggested that the public be informed of alternate technologies.
One commenter (TV-D-786) supported the EPA's 1995 proposal to require an
opportunity for public comments and a hearing on siting decisions. The commenter requested
that the final rule require that the public meeting occur at least 90 days after the siting analysis
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is made public to allow the public time to prepare for the hearing. The commenter indicated
that public participation will be more fruitful in terms of environmental results if EPA requires
analysis of environmental effects of alternative sites and alternative technologies.
Response: Section 129 of the CAA states that performance standards for MWI 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 PSD
requirements within the NSR program. The 1995 proposed siting requirements required a
comprehensive air quality analyses in regard to National Ambient Air Quality Standards
(NAAQS) and PSD increments. An impacts analysis, which studies the potential effect of air,
solid waste, and water pollution on visibility, soils, and vegetation was also required.
Additionally, the 1995 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. In the 1995 proposal, the siting information required above would be submitted to
EPA sufficiently in advance of the intent to commence construction of the facility.
Construction would be allowed to commence only after approval by EPA and the appropriate
State/local agency.
In reviewing the 1995 proposed siting requirements and the comments received, the
Agency is promulgating siting requirements as outlined in the CAA. The promulgated siting
requirements require the potential owner of an affected facility to 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. Analyses of facility impacts prepared to comply with State,
local, or Federal regulatory requirements may be used to satisfy the siting requirements, as
long as they include the consideration of air pollution control alternatives discussed above.
This requirement, outlined in the final regulation, requires the owner or operator to examine
alternative that minimize the impacts of the new source.
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Any source subject to the final HMIWI NSPS will be required to obtain a permit under
£-40 CFR 70 (Operating Permit Program). Although not required in the siting analysis, a'|>ublic
"hearing is required under 40 CFR 70.7(h). The source is required to give notice to the general
"public of an upcoming public hearing. There must be at least 30 days for public comment on
"the permit.
7.2 POLLUTION PREVENTION
Comment: Four commenters (TV-D-756, IV-D-757, IV-D-758, and IV-D-776) stated
that the EPA standards for MWI are reliant on pollution control and give little attention to
pollution prevention. These commenters suggested that EPA focus on pollution prevention
instead of pollution control because controls are unable to completely eliminate emissions.
Another commenter (TV-D-771) encouraged the EPA to adopt emission guidelines and NSPS
based first and foremost on pollution prevention. The commenter contended that, if required
"'by the EPA, waste management practices at medical facilities would significantly reduce the
overall emissions of toxic chemicals such as dioxin/furan and Hg. Other commenters
"(IV-D-756 and IV-D-776) argued that Congress intended for EPA to use process changes or
substitution of materials to help eliminate dioxin/furan and Hg from air emissions. The
*:
^commenters stated that Congress granted the Administrator the authority to prohibit the
releases of these highly toxic pollutants and to establish ways in which to remove the pollutants
and their precursors from waste streams in §112 of the CAA. The commenters argued that the
only way to stop the formation of dioxin/furanls to stop1 feeding PVC and chlorinated
materials to the incinerator. The commenters also stated that the source of Cd emitted from
MWI is the dye in the red bags. The commenters stated that another color of bag should be
selected to reduce Cd emissions, The commenters stated that pollution prevention or activated
carbon injection is the best method for controlling Hg. Another commenter (TV-D-776) stated
'that air toxics emitted from MWI have been a serious threat to the Great Lakes ecosystem for
years. This commenter contended that the EPA is required by law to incorporate pollution
prevention measures such as source reduction and recycling into the proposed MWI
regulations. Another commenter (IV-D-780/500) recommended that the EPA add the
requirement that the owner/operator of a MWI recycle medical wastes whenever
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technologically and economically feasible. The commenter contended that recycling and
pollution prevention measures will yield greater reductions in emissions than just add on..,
controls alone.
Response: The types of materials sent to an MWI 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
III1,i», ' , ' ' : ; ' " ' ' " ' ' , ' ' "
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 MWI
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
MWI regulations.
Following the 1995 proposal, the EPA received no data to conclusively indicate the
effectiveness of waste segregation programs in reducing emissions from MWI. Therefore, the
final HMIWI standards and guidelines are primarily based on air pollution controls rather than
pollution prevention. However, hi developing the emission limits in the June 20, 1996 re-
proposal EPA included pollution prevention measurements in setting emission limits for good
combustion.
In 1990, EPA conducted an emissions test at Borgess Medical Center in Kalamazoo,
Michigan, that included testing for Hg at the inlet and outlet of the dry lime injection/fabric
filter system. These tests showed that Hg emissions measured at the inlet to the DI/FF system
were extremely high compared to similar measurements made at other facilities. A subsequent
test conducted in September 1991 also showed elevated levels of Hg at the inlet to the DI/FF
system. After reviewing the Hg emission results at the inlet to the DI/FF system, Borgess
Medical Center implemented several Hg waste reduction practices including a battery
collection program, a fluorescent lamp collection program, a Hg spill response collection
protocol, and collection of polyvinyl alcohol (PVA) fixative samples. After these practices
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were implemented, EPA returned to Borgess in July 1995 to conduct emission testing at the
-iinlet to the DI/FF to determine the impact of these practices on Hg emissions. The 1995. test
showed much lower levels of Hg than the previous tests. However, the emissions were not
^reduced to zero. Instead, they were reduced to levels comparable to other facilities.
In the development of 1995 proposed emission limits for uncontrolled MWI, the
-achievable emission levels were driven by the high Hg emission levels at Borgess. Following
%the 1995 retest, the achievable Hg emission levels were developed using only the Borgess test
runs in which waste was being burned from another hospital, the runs conducted during the
1995 retest, and data from other facilities. The results of this study translated into
significantly lower achievable emission levels for Hg from uncontrolled MWI. The results of
the 1995 Hg emission test at Borgess were similar to the average emission rates from other
MWI tested during the EPA testing program, which indicates that the pollution prevention
-^measures implemented at Borgess are commonly implemented in other health care facilities.
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
itest. If the facility fails the emission test, the facility will need to implement Hg pollution
^prevention measures to meet the emission limits or install an APCD.
A number of commenters requested that EPA include in the final regulation additional
pollution prevention requirements. 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. Therefore, EPA is requiring that health care facilities
implement waste management programs whenever technologically and economically feasible.
The EPA agrees that the red bags used to collect infectious waste at health care
-^facilities may contain cadmium-based pigments. Some States require that infectious waste be
placed in labeled leakproof receptacles, preferable red in color. The EPA believes that health
scare facilities should examine the option of switching to another color or type of bag that does
not contain cadmium but believes banning red bags could result hi increased incidents of
infectious waste being mislabeled and ending up in the7municipal waste stream.
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il" I
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
"ll.ii . . ', ' ',-, .'-. ; > ' "::
the waste is directly related to dioxin/furan emissions, while other studies suggest there is no
' ii'! ' ' ' " ' . '.: .':. i ' ' ' '':"!l
relationship between the chlorine content of the waste and dioxin/furan emissions. At this
1 ' 'ii*: . ..<,-. . ..','." ' ' ' '", ' ''',.; .'
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.
Comment: One commenter (IV-D-767) requested that the EPA use the MWI
rulemaking as an opportunity to phase out MWI and promote pollution prevention through the
use of alternative technologies that reduce, reuse, and recycle waste materials.
!,, |'"it' " .i1
Response: The CAA requires the EPA to develop NSPS and emission guidelines for
new and existing MWI. As required by section 129 of the CAA, the NSP$ and emission
guidelines are technology-based standards. The CAA gives EPA the authority to determine
MACT, but does not give EPA the authority to eliminate or phase out sources. The EPA
believes that the promulgation of the emissions limits in today's standards and guidelines along
with requiring waste management measures will significantly reduce air emissions from
medical waste incinerators.
Comment: One commenter (TV-D-789) maintained that the economic impact of the
MWI regulations could be reduced significantly if EPA requires medical facilities to institute
pollution prevention techniques. The commenter stated that there is a direct correlation
between the amount of pollutant in the waste stream and emissions. The commenter stated that
New Jersey has indicated that pollution prevention measures could amount to a
95 percent reduction in mercury emissions. The commenter requested that EPA suggest
pollution prevention measures for controlling mercury as well as other pollutant precursors
(i.e., lead, cadmium, chlorine, nitrogen, fluorine, and sulfur). The commenter argued that
percent reduction options should not be part of the standards and guidelines because they will
allow increased emissions during times of high levels of pollutant precursors hi the waste and
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discourage pollution prevention efforts. Another commenter (TV-D-780/500) stated that the
-assue of mercury spikes can be resolved through recycling. K
Response: The MACT standards and guidelines specify emission limits that are based
-on the achievable level of emissions control. However, the final HMIWI standards and
- guidelines do not include specifications for a particular incinerator design or for specific
control equipment. The regulations are designed to encourage and promote the use of any
""technology or technique capable of meeting the final emission limitations. The EPA believes
that any technology or technique capable of meeting the emission limits should be allowed in
order to give the regulated community a number of options with which to meet the final
HMIWI standards. The EPA agrees that waste reduction can result hi a significantly lower
economic impact. Furthermore, the EPA also agrees with the commenter in that there is a
relationship between the amount of pollutant in the waste stream and the emission levels for
&some pollutants (see the previous discussion on Borgess Medical Center). Therefore, EPA is
including waste management requirements in the final standards and guidelines.
The EPA disagrees with the statement that percent reduction should not be part of the
standards and guidelines because high levels of pollution precursors will be eliminated with
pollution prevention. As determined during the EPA-sponsored testing program, percent
reduction options are necessary for HC1, Pb, Cd, and Hg due to the inherent variability in the
waste stream and the inability of an air pollution control device to consistently achieve a
specific emission limit during periods of unusually high "inlet concentrations (otherwise known
as "spikes"). The percent reduction option ensures that a well-operated unit with a well-
operated control device is not penalized if a numerical emission limit is beyond the control
capability of the control device during a "spike" in emissions. While pollution prevention
efforts may reduce the incidence of "spikes," there is no evidence to conclude that pollution
-prevention will eliminate them.
Comment: One commenter (IV-D-735) contended that EPA has not investigated the
- effects of mercury waste reduction and shifting the waste composition from chlorinated plastics
to non-chlorinated polymers on HC1 emissions.
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Response: As discussed above, EPA has performed an emissions test on a health care
facility that has implemented a mercury waste reduction program. The outcome of this Jtesting
program has resulted in EPA setting lower mercury emission limits from facilities meeting
emissions limits associated with good combustion. The EPA agrees that reduction hi the
amount of chlorinated plastics will reduce the emissions of HC1. However, the regulatory
requirements of the final regulation will require much more stringent limits than those
achievable through pollution prevention alone. Where emission limits for acid gases reflect
1 . j , ' "!" , . . ,,,,; i, . ; . . ., .)
good combustion alone (i.e., APCD are not required), pollution prevention should be able to
reduce HC1 emissions. However, the HC1 emission limits for MWI with good combustion are
not based on a chlorine waste management program because no emissions data from such a
program are available on which to establish an "achievable" emission limit.
Comment: One commenter (TV-D-786) recommended that EPA ban incineration of
batteries and all other identified sources of mercury. The commenter also,contended the final
rule should presumptively ban incineration of chlorinated materials to reduce dioxin and HC1
emissions, absent a showing that no substitute for the material exists and no superior
alternative for recycling exists. The commenter recommended that EPA require that MWI
have permit requirements to maximize pollution prevention and recycling. The commenter
also recommended that EPA ban the incineration of identifiable recyclable materials and
require maximum achievable reductions of at least 25 percent of medical waste going to
incineration. The commenter suggested that the total volume of waste, including infectious
waste, should be reduced by 40 percent. The commenter contended that these percentage
reductions are modest because hospitals can probably reduce their waste by as much as
97 percent.
Response: The final regulations include requirements that health care facilities with
incinerators prepare a waste management plan. 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. With regards to banning of batteries, and maximum achievable reductions of
waste volume, the EPA believes that there are no universal waste reduction practices that can
be implemented at all health care facilities. However, through the development of individual
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waste management programs, health care facilities can achieve significant reductions in Bieir *
--waste stream and reduce the volume of waste to be incinerator."' "w-^ *-- ^" 4.i»* «£.- 3%!^
The EPA has investigated the impacts of shifting the waste composition from
^chlorinated plastics to nonchlorinated polymers on emissions, However',flhe 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
emission through shifting the waste composition from chlorinated plastics to nonchlorinated
polymers would be questionable. The EPA expects that each facility will examine the
feasibility of reducing the amount of waste and the types of products, including chlorinated
plastics.
T7.3 FORMAT OF STANDARD
Comment: Two commenters (TV-D-786 and IV-D-789) urged EPA to gather data and
establish a MACT standard for PM-10 (or PM-2.5). The commenters provided data on the
<"PM-10 emissions from two facilities.
Response: The Agency appreciates the comments and information provided for setting
emission limits for PM-10 and PM-2.5. However, the Agency believes that the majority of
PM emitted from MWI is fine paniculate (PM-10 and PM-2.5). Therefore, the MACT
te[}
emission limits for total PM represent the maximum emission reductions achievable from PM-
10 and PM-2.5. Consequently, separate standards for PM-10 and PM-2.5 are unnecessary.
Comment: Two commenters (TV-D-786 and IV-D-789) argued that EPA should
eliminate the percent reduction alternatives for Hg, Pb, Cd, and HC1 because they guarantee
that almost every facility will not use pollution prevention, appropriate technology, and good
"operating practice to produce the maximum achievable emission reductions. Another
commenter (TV-D-780/500) suggested that percent reduction is inappropriate for Hg. The
"commenter argued that the percent reduction allows for increased emissions during times of
high pollutant precursors.
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Response;: The composition of the waste burned in an MWI is not uniform; as a result,
the concentration levels of waste-related pollutants such as Pb, Cd, Hg, and HC1 from an
MWI varies. On occasion, however, a momentary rise or "spike" in the concentration level of
a waste-related pollutant may occur; while a wet scrubbing or dry scrubbing system can reduce
this concentration level considerably, the system can not necessarily reduce it to the numerical
concentration levels specified in the MWI standards and guidelines. An achievable standard
must be capable of being met under the most adverse conditions which reasonably can be
expected to recur. For this reason, conclusions regarding achievable emission levels associated
with the use of wet or dry scrubbing systems for waste-related pollutants must include a
percent reduction component to accurately reflect the performance capabilities of wet and dry
scrubbing systems. The percent reduction option ensures that a well-operated unit with a well-
operated control device is not penalized if a numerical emission limit is beyond the control
capability of the control device during periods of unusually high inlet concentrations. While
pollution prevention may reduce the incidence of "spikes," EPA has no specific data to
indicate the effects of pollution prevention measures on MWI emissions following wet
scrubbers or dry scrubbers. Therefore, the EPA cannot establish emission limits for MWI
equipped with scrubbers based on pollution prevention measures or conclude that "spikes" will
not occur if pollution prevention measures are instituted.
Comment: Three commenters (TVXD-741, IV-D-748, and IV-D-780/500)
recommended that EPA express the dioxin/furan emission concentration standard in the form
of TEQ. One commenter (TV-D-741) stated that most of the regulated community understands
toxic equivalency if it is based on a consistent international standard such as ITEQ 1989/DB-5
data. The commenter stated that a total dioxin limit can be very ambiguous and must be
carefully defined, as to which isomers it includes and excludes. The commenter contended
that failures to comply which are brought about solely by minutely-toxic and non-toxic
isomers, could well result in unwanted litigation. Another commenter (IV-D-748) stated that
most State and Federal regulations express dioxin/furan concentrations in TEQ and that stack
emission test services are used to working on a TEQ basis. Another commenter
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(IV-D-500/626) suggested that the EPA require use of the TEQ basis in that TEQ provides a
-nnore meaningful and appropriate picture of dioxin/furan emissions. !l
Three commenters (W-Dr735, IV-D-790, and IV-D-792) argued that total dioxin
^instead of TEQ is a more reasonable testing approach because there are technical difficulties
-r with testing resolution at the TEQ levels the EPA is considering.
Response: In the 1996 re-proposal EPA presented a dual format for the dioxin/furan
^-emission limit (total mass or TEQ). The majority of the comments received on the basis for
the dioxin/furan emission limits indicated that the TEQ basis is preferable over the total mass
basis. Conversely, some commenters stated that they prefer emission limits for dioxin/furan
on a total mass basis. However, no commenters offered outright objections to the dual
dioxin/furan format. In EPA's opinion, either the TEQ or total mass format is acceptable for
reporting of dioxin/furan emissions. Both TEQ and total mass format are related and there is
^no indication that either format is superior to the other. Therefore, due to the lack of
consensus among commenters, the EPA is promulgating the final HMTWI dioxin/furanf
-standards and guidelines in the dual format (total and TEQ). A discussion of the testing
: resolution for low levels of dioxin/furan was provided in section 3.7.
* Comment: Three commenters (IV-D-134, IV-D-536, and IV-D-627) suggested
Previsions to the definition of malfunction. The first suggested that a definition of malfunction
with a limit to the duration and frequency of malfunctions be added to the rule. The second
(TV-D-536) suggested that "malfunction" be defined so operatorsifo riot confuse malfunction
with poor operation and maintenance of the facility. The third (IV-D-627) suggested that the
EPA's definition of malfunction should allow facilities to continue operating in the event of a
malfunction, as long as the facility is able to comply with the emission limits.
Response: The emission limits contained in the standards and guidelines apply at all
"tunes except during startup, shutdown, and malfunction provided that no waste is charged into
the incinerator during startup, shutdown, or malfunction. (Startup in a batch unit allows for
^charging of waste to the incinerator provided the waste is not ignited.) Malfunction has been
defined as 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
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that are caused by poor maintenance or careless operation are not considered as malfunction.
L , nl.,.,' I . ' ' i :" ' :
Although the standards and guidelines do not apply during periods of malfunction, the Agency
has include requirements that the owner or operator put forth a good faith effort to maintain,
as applicable, all minimum or maximum operating parameters. Owners and operators are
required to report any malfunctions and the duration and cause of all malfunctions. In
addition, if a facility could meet all applicable emission limits and operating parameters, the
Agency does not believe this condition represents malfunction. Only if there is an incident
that would result in a facility being out of compliance with their operating parameters or
emission limits would this constitute a malfunction. Facilities are to record operating
" '
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and the corrective action taken to prevent further use of the bypass stack. Use of the bypass
^tack during a performance test invalidates the performance test. 1
Comment: One commenter (IV-D-613) stated that the 1995 proposed definition for
"facilities manager does not accommodate differences in corporate structure and management of
^-medical waste facilities. The commenter recommended that the final definition include "the
owner's or operator's representative responsible for the management of the medical waste
-incineration facility."
Response: The definition of facilities manager has been changed to read "the
individual in charge of purchasing, maintaining, and operating the HMTWI, 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."
Comment: One commenter (TV-D-627) proposed a definition for a batch MWI as "an
incinerator designed or operated hi a manner such that neither waste charging nor ash removal
occurs during combustion". This commenter also proposed a definition for an intermittent unit
as "a medical waste incinerator that is designed or operated in a manner to allow waste
charging, but not ash removal, during combustion". Another commenter (TV-D-637)
"contended that an intermittent MWI is one "that is operated on a less than 24 hour per day
^basis but which is not operated on a batch basis."
One commenter (TV-D-572) suggested adding the words "and operated" after
"designed" in the definition for batch MWI. Otherwise batch designed incinerators modified to
burn intermittently or continuously, or intermittent designed incinerators modified to bum
continuously would be regulated as batch units.
Response: While the 1995 proposed regulations made distinctions by incinerator type
(continuous, intermittent, and batch), the final regulations provide separate regulatory
requirements by size (small, medium, and large). The terms "continuous," "intermittent," and
"batch" are defined in the final regulations only for the purpose of determining maximum
-waste burning capacity (size). Continuous and intermittent MWI use the same formula to
determine size, while a separate formula is provided for batch units. Whether a continuous
unit operates continuously or intermittently does not affect its regulatory requirements.
7-23
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Whether an intermittent unit operates intermittently or continuously also does not affect its
regulatory requirements. It is highly unlikely that a continuous or intermittent unit would be.
operated in a batch mode. It would be terribly inefficient. It is also unlikely that a batch unit
could be modified to operate continuously or intermittently. If such a modification occurred,
the unit would effectively be reclassified (considered "re-designed"). Consequently, there is
no need to define the incinerator types as the commenters recommend.
Comment: One commenter (TV-D-627) stated that the 1995 proposed definition of
pathological MWI would allow the uncontrolled burning of inappropriate materials. The
commenter staled that the 1995 proposed definition of a pathological MWI as "a MWI that
burns only pathological waste, the bags/containers used to collect and transport the waste, and
animal bedding (if applicable)" would allow burning of bags and containers that result in
harmful emissions. Another commenter (IV-D-613) stated that the definition of pathological
MWI allows combustion of waste material included in animal bedding that should be
controlled under the MWI standards. The commenter suggested that the final regulations make
t! . . ' ' , ':;" ' .'.''V' 1;: ' ' ' ".','' l1'.1
clear that animal bedding does not include plastic tubing and other medical devices that can
contribute to metals or dioxin/furan air emissions.
Response: While incinerators that burn pathological waste have been excluded from
coverage the final HMIWI standards and guidelines, this exclusion does not mean that EPA
will not develop regulations which will cover these units in the future. The CAA directs the
EPA to develop regulations for all solid waste incinerators. The EPA has announced that
regulations for other solid waste incinerators will be developed by the year 2000. Thus,
burning of pathological wastes, their containers, and animal bedding will be covered by
regulations developed within the next few years. Exclusion of pathological incinerators from
the final HMIWI regulation is only a temporary deferment.
Comment: Two commenters (IV-D-572, IV-D-637) argued that the definition for
combustion air blower is too restrictive and does not allow for secondary combustion chambers
or air blowers. The first (TV-D-572) suggested the definition be revised to include "or
secondary". The second (TV-D-637) suggested that the definition of combustion air blower
should include the blowers responsible for delivering air to all combustion chambers.
7-24
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Response:'The definition of combustion air blower was used in the 1995 proposed
-MWI regulations in conjunction with the definition of MWI operation. Generally, an MWI k
"burning waste when the primary combustion air blowers are operating. Therefore, the 1995
proposed definition of combustion air blowers referred to the air blowers in the primary
chamber. This is not to say that there are no combustion air blowers used to deliver air to the
secondary chamber. Nevertheless, the definition of combustion air blower has been eliminated
from the final HMIWI standards and guidelines and the definition of operation has been
changed. In the final HMIWI regulations, "operation" is defined as the period during which
the waste is combusted in the incinerator excluding periods of startup and shutdown.
Comment: One commenter (IV-D-534) requested that the definition for continuous
sorbent flow rate be revised. The commenter suggested that during startup, shutdown,
maintaining hot standby, or generating steam on auxiliary fuel and while not incinerating waste
should not be considered operation and should not necessitate the use of sorbent. The
commenter suggested that the definition of "incinerator operation" be considered and a new
phrase, "hot standby," should be added to the proposed regulation. During "hot standby", an
-incinerator would not be operating, as defined in the regulation, but would be required to meet
'emission standards.
r" One commenter (TV-D-499/659) stated that the 1995 proposed definition for shutdown
in Subpart EC may allow operators to shut the primary air blowers down without checking the
burning status of waste in the primary chamber. The commenteHfiiggested adding the
following text to avoid misinterpretation by the operators and uncontrolled releases of air
contaminants. "Shutdown means the period of time between the shutoff of the MWI
combustion air blowers and the shutdown of all systems. The combustion air blowers shall not
be shut-off until the waste in the primary chamber has cooled to below 300?F."
Response: The 1995 proposed definition of shutdown has been modified. In the final
HMIWI standards and guidelines, shutdown is defined as the period of time after all waste in
-"the primary has been combusted (not less than 2 hours after the last charge for continuous
;=units, not less than 4 hours after the last charge for intermittent units, and not less than 5 hours
after completion of the high-air phase for batch units). Time requirements after the last charge
7-25
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of waste were jincluded in the definition of shutdown to ensure that all maximum and minimum
operating parameters and emission limits are achieved while waste is burning down in the
primary chamber. A temperature was not specified in the definition of shutdown to indicate
when burnout has occurred because limited available data indicated a large difference in the
times required for MWI to cool to various temperatures. Furthermore, some facilities may not
completely cool their MWI (e.g., continuous units) between periods of operation.
Under the final standards and guidelines, facilities are required to meet the emission
limits at all times except during startup, shutdown, and malfunction, provided that no waste is
charged during startup, shutdown, or malfunction. Thus, facilities are no longer required to
meet the emission limitations at all times while the combustion air blowers are operating as
was proposed in 1995. Because hot standby occurs after shutdown and prior to the next
startup when no waste is being charged into the system, the emission limitations do not apply
during hot standby and sorbent is not required. Hot standby was not specifically defined in the
final standards and guidelines because this period corresponds to startup and shutdown which
are defined in the final regulation.
,;; ' , -, «,! ' . ' .": . " ' '
Comment: Two commenters (TV-D-572, IV-D-627) suggested revisions to the
definition of minimum sorbent flow rate. The first (TV-D-572) suggested that the basis for
flowrate measurement should be every 4 hours for both sorbents, so as to avoid confusion and
added expense during monitoring. The second (IV-D-627) stated that the definition for
1 . ' !''''i'!ijji,i i ' ' ' ' ' " " ' ! '' ll"'" ' ' '' ' ,|i! " ' |!i ' ' , ,
minimum sorbept flow is inappropriate and will increase the cost p.f medical waste incineration
without providing a concurrent benefit to the environment. The commenter suggested that the
performance test be used to establish a ratio of sorbent to amount of waste charged.
Response: The 1995 proposed definitions of minimum sorbent flow rate for
', !i:l|i ' ' ' !' ,|' ' " ' , ,1 I, li
dioxin/furan, Hg, and HC1 have been revised for the final standards and guidelines. Each
definition specifies that the minimum sorbent flow rate is 90 percent of the highest hourly
average sorbent flow rate (taken, at a minimum, once every hour) measured during the most
. ' ., 'i'tiii'i ' '"' ' .' ' : 1; ' . . '''. >' . " *' '!!
recent performance test demonstrating compliance with the applicable emission limits. Thus,
all definitions are worded consistently and require the same hourly basis for flow measurement
to minimize expense and confusion. Performance tests are used to establish the facility-
":>" Si:1]
7-26
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specific sorbent flow rate. Alternative methods of monitoring are allowed under the General
Provisions. However, any alternative methods of monitoring must be approved by the '-',-
Administrator.
Comment: One commenter (TV-D-613) stated that the definitions related to compliance
and performance testing and monitoring give confusing or insufficient guidance to operators.
These definitions include: "batch MWI," "combustion air blower," "dry scrubber," "fabric
"filter," "maximum charge weight," "maximum paniculate matter control device inlet
temperature," "maximum hourly charge weight," and "minimum HC1 sorbent flow rate."
Response: In the final HMIWI standards, "batch HMTWT is defined as an HMTWI
that is designed such that waste charging nor ash removal can occur during combustion. "Dry
scrubber" is defined as 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
"baghbuse" is defined as an add-on air pollution control system that removes PM and
nonvaporous metals emissions by passing flue gas through filter bags. These definitions are
.\
^essentially the same as the 1995 proposed definitions of"batch MWI," "dry scrubber," and
^'fabric filter." The definition of "combustion air blower" has been eliminated from the final
"HMTWT standards and guidelines.
In the final standards, a definition of "maximum fabric filter inlet temperature" replaces
the 1995 proposed definition of "maximum particulate matter control device inlet
temperature." "Maximum fabric filter inlet temperature" is defined as 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
rwith the dioxin/furan emission limit.
The final standards contain a definition of "maximum charge rate" which replaces the
1995 proposed definitions of "maximum charge weight" and "maximum hourly charge rate."
"Maximum charge rate" is defined as: (1) for continuous and intermittent MWI, 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 MWI, 110 percent
7-27
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of the lowest daily charge rate measured during the most recent performance test
demonstrating compliance with all applicable emission limits.
The 1995 proposed definition of "minimum HC1 sorbent flow rate" has been revised
for the final standards. In the final standards, "minimum HC1 sorbent flow rate" is defined as
90 percent of the highest 3-hour average HC1 sorbent flow rate (taken, at a minimum, once
every hour) measured during the most recent performance test demonstrating compliance with
the HC1 emission limit.
The definitions of "fabric filter," "dry scrubber," "minimum HC1 sorbent flow rate,"
and "maximum fabric filter inlet temperature" are necessary to specify control device operating
parameters when dry scrubbers are used. The revised definitions of "minimum HC1 sorbent
flow rate" and "maximum fabric filter inlet temperature" were written to provide specific
guidance to MWI operators and personnel involved in determining control device operating
parameters.
The definitions of "batch MWI" and "maximum charge rate" are used in determining
the rate at which waste may be charged into the MWI. For batch MWI, the maximum charge
rate is determined by the lowest amount of waste charged to the MWI during the most recent
performance test.
Comment: One commenter (TV-D-572) contended that the definition for maximum
charge weight is unnecessarily restrictive and should be eliminated or applied only to units that
receive one charge, such as batch units, in which case the maximum charge is equal to the
charging rate. Another commenter (TV-D-627) proposed a definition of maximum charge
weight. The suggested definition is "the maximum charge weight measured during the most
recent performance test demonstrating compliance with either the HC1 emission limit or the Hg
emission limit. For batch or intermittent medical waste incinerators, the maximum charge
weight means the total weight of the entire charge as measured during the most recent
performance test." Another commenter (TV-D-637) suggested that the 1995 proposed
definition for maximum charge weight is inconsistent with standard technology and should be
defined as the "average hourly charge weight measured during successful compliance testing."
7-28
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Response: The final standards contain a definition of "maximum charge rate" which
-replaces the 1995 proposed definitions of "maximum charge weight" and "maximum hourly
charge rate." "Maximum charge rate" is defined as: (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. The purpose
of a maximum charge rate is to prevent facilities from over charging their incinerators, which
could lead to exceedances of emission or operating parameter limitations. The Agency does
not agree that such a limitation on the amount of waste charged to an MWI is overly restrictive
or inconsistent with current technology.
Comment: One commenter (IV-D-637) suggested that the definition for dioxin/furan
should be expanded to incorporate "total equivalent (TEQ) dioxins" in view of the fact that
such terminology is included in the emissions standard and throughout the text of the 1995
proposed regulations.
Response: The definition of "dioxins/furans" contained in the final HMIWI standards
^is the same as the 1995 proposed definition. The purpose of the "Definitions" section of the
"MWI regulatory text is to define terminology that is not defined elsewhere in the regulatory
text. Toxic equivalency and the methods for determining toxic equivalency are discussed in
detail hi §60.56c "Compliance and performance testing." Thus, inclusion of toxic equivalency
in the definition of dioxins/furans was not necessary.
Comment: One commenter (TV-D-572) suggested that the definition of startup be
modified to read "and the first charge of medical waste to the unit." Another commenter
(TV-D-627) suggested that the definition of startup may be appropriate for a batch or
intermittent incinerator, however, continuous feed units use the Btu value in the waste to reach
operating conditions and, therefore, must charge waste to the primary chamber during startup.
"This commenter suggested allowing continuous feed incinerators to charge waste during the
startup period as necessary to achieve required operating conditions under their State permits.
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Two commenters (TV-D-518/595, IV-D-619/679) stated that the rule should apply
during periods of startup and shutdown.
Response: In the final HMIWI standards, "startup" is defined as the period of time
between activation of the system and the first charge to the unit. For batch MWI, "startup" is
defined as the period of time between activation of the system and ignition of the waste.
The emissions limitations and operating parameter limitations contained in the standards
apply upon the first charge of waste for continuous and intermittent units. Continuous units
Which charge waste to reach operating conditions run the risk of violating the minimum
secondary chamber temperature limit. The secondary chamber temperature is to be recorded
every minute and averaged over a 3-hour period for determining compliance with the
minimum secondary chamber temperature limit. Thus, continuous units which charge waste to
reach operating temperatures may possibly be able to comply with the minimum secondary
chamber temperature limit because it is averaged over a 3-hour period. Because many
continuous MWI achieve proper operating conditions prior to charging waste, the Agency does
riot believe that it is necessary to modify the definition of startup to accommodate those
continuous MWJ that charge waste to meet the specified operating conditions. The final
standards require attainment of operating temperatures before waste charging to prevent poor
combustion. As suggested by commenter IV-D-627 earlier, high emissions can occur during
startup before the secondary chamber has reached its proper operating temperature. Operation
before the incinerator has reached this temperature could result in increased emissions of PM
and volatiles. Because the final regulations do not allow burning of waste during periods of
startup and shutdown, the emission limits and operating parameter limits do not apply during
startup and shutdown.
Comment: Several commenters requested clarification to the modification provisions
of the rule. One commenter (TV-D-627) suggested that EPA clarify that even major
modifications will not prompt new source review as long as the unit's capacity does not
change. Another commenter (IV-D-637) suggested that the definition of modification be
revised so that a modification occurs when its cost is greater than 50 percent of a replacement
unit. Commenter (TV-D-561) stated that the final rule should exempt a unit that has been
7-30
JllSii'I j
:S,,;;:;, ,r :';.lit!,<
-------
modified to no longer burn medical waste only if a Federally enforceable permit prohibits such
activity.
Response: Section 60.32e of the Emission Guidelines specifies that physical or
operation changes made to an existing unit solely for the purpose of complying with the
emission guidelines is not considered a modification and will not result in the unit becoming
subject to the requirements of the NSPS. The Agency believes that this provision clearly
allows modification of an existing MWI to meet the requirements of the emission guidelines
without being subject the NSPS requirements.
Modification or modified MWI was specified in the 1995 proposal because section 129
of the CAA defines this term. That definition of "modified solid waste incineration unit"
under section 129 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. Because this term has been
specified in section 129 of the CAA, no change*will be made to the definition in the final
regulation.
The final standards and guidelines apply to any incinerator burning hospital waste
and/or medical/infectious waste. In addition, the standards and guidelines exempt incinerators
during periods when only low-level radioactive, pathological, and/or chemotherapeutic waste
"is burned. Finally, any co-fired combustor is not subject to the standards and guidelines
provided it burns less than 10 percent hospital waste and/or medical/infectious waste.
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7.4 FUGITIVE EMISSIONS
Comment: One commenter (TV-D-784) questioned the basis for the 1995 proposed
0 percent opacity standard for control of ash. The commenter noted that MACT floors for
fugitive emissions for each subcategory have not been calculated, technology assessments with
regard to achievable emission limits and costs have not been performed, and the economic
impacts have not been assessed. The commenter requested that the EPA adopt a 5 percent
opacity standard for fugitive emissions from ash management operations and requests that EPA
require annual instead of monthly testing of the ash management system. Another commenter
(IV-D-782/454) stated that EPA has not explained why it is "appropriate" to set an emissions
limit of 0 percent opacity for fugitive emissions of fly ash/bottom ash and believes this
requirement is unnecessary. Another commenter (IV-D-04) questioned the inclusion of
fugitive fly ash/bottom ash as a regulated pollutant. This commenter argued that road and
household dust are bigger problems than fugitive fly ash and bottom ash.
Two commenters (IV-D-636 and IV-D-572) argued that 6 percent opacity for ash
handling is inappropriate and unachievable. One commenter (TV-D-572) stated that many ash
handling systems are not automatic, thereby requiring transferring of ash from one container to
another, whicji generates some dust. One commenter (Ty-D-636) stated that even wet ash
handling systems will produce small amounts of visible emissions. The commenter also
argued that the requirement that opacity be checked on a monthly basis is unnecessary and
overly burdensome, especially if there is no certified opacity reader onsite. The commenter
suggested that a qualitative standard based on opacity that states that the ash and solids from
the air pollution control equipment be managed in a manner to prevent release, disposal or
discharge or processing residuals into the air, water, or onto land.
Five commenters (TV-D-531, IV-D-572, IV-D-627, IV-D-636, and IV-D-654) stated
that monthly testing for opacity of fugitives is unnecessary. One commenter (IV-D-572)
suggested reducing testing to once every 12 months or eliminating testing.
One commenter (TV-D-735) suggested eliminating the 0 percent fugitive emissions
.,;!' , , » a:,,! , I , ' ' ; i . ' i , / ' ;
statement. The commenter stated that some systems do not tolerate wetting ash prior to
7-32
*;..
-------
extraction because the moisture content could affect emissions and refractory life, slow
operations, and plug equipment.
Another commenter (TV-D-654) argued that a zero visible emissions is unrealistic, and
that a better approach to control fugitive emissions would be to establish best management
-practices for ash handling. Another commenter (TV-D-785) explained that it would be more
efficient and effective for facilities to propose ash handling procedures to minimize emissions
of the ash.
Response: Section 129 of the CAA requires EPA to develop NSPS that specify
numerical emission limitations for the following: PM, opacity, CO, dioxin/furan, HC1, SO2,
NOX, Pb, Cd, and Hg. Airborne fugitive emissions may be created during removal of bottom
ash from the primary chamber of an MWI and during removal of fly ash that is collected from
fabric filter control devices. Bottom ash and flyash consist primarily of PM, which is one of
the nine pollutants to be regulated under the MWI NSPS. Fly ash consists of an alkaline
sorbent (e.g. hydrated lime), activated carbon (if used), and the pollutants removed from the
exhaust gas by the sorbent, carbon, and fabric filter.
The 1995 proposed 0 percent opacity standard for control of fugitive emissions from
ash handling was based on facilities employing measures to minimize or eliminate fugitive
emissions such as wetting or covering dry ash, providing covers for dry ash containers,
providing wind screens for outdoor sites, or using an automatic ash removal system. Since the
1995 proposal, the EPA has developed new MWI subcategories and has reassessed the MACT
floors and achievable emissions levels for fugitive emissions for each category.
The MACT floors for fugitive emissions from small, medium, and large existing MWI
as well as small and medium new MWI reflect no control of fugitive emissions. With regard
to regulatory options more stringent than the MACT floor, the EPA considered adopting work
practices for these units or a 5 percent visible emissions limit for fugitive emissions from ash
handling based on what is achievable with an automatic ash removal system. As noted by the
commenters, many MWI rely on manual ash removal which can lead to fugitive emissions. A
water spray could be used to minimize the fugitive emissions generated during manual ash
removal. However, the EPA recognizes that some MWI do not tolerate wetting of ash prior to
7-33
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extraction. Several MWI manufacturers discourage spraying water into the primary chamber
Of an MWI because the moisture could cause damage to the refractory and plug equipment.
, : - , '" ,'",:, " .''>?', '',,',,,,;
Other practices that could be used to minimize fugitive emissions include the use of wind
screens for outdoor sites, decreasing the number of ash transfers from container to container,
and storing dry ash in a covered container. However, there are no universally accepted
practices for reducing fugitive emissions generated during ash handling at most existing MWI.
Furthermore, most existing MWI do not have automatic ash removal systems. It would be
infeasible for existing MWI to retrofit an automatic ash removal system due to cost, technical
difficulty, and spatial limitations. Because there are no universal work practices and automatic
ash removal systems are costly to retrofit, the fugitive emission limits have been removed from
the final HMIWI standards and guidelines for all MWI size categories except for new large
MWI.
The MACT floor for fugitive emissions for new large MWI is based on an automatic
ash removal system (i.e., a wet sump). Large MWI with automatic ash removal systems are
, 'I:'" ' " ' ' II, ,; , ,1, || 'I ' ' , / ' ', t
similar in design to small modular municipal waste combustors. The municipal waste
combustor standards and guidelines promulgated on December 19, 1995 included a 5 percent
visible emissions limit for fugitive emissions. Because the ash removal technology is similar,
the final HMIWI standards include a visible emissions limit for fugitive emissions from new
large MWI of 5 percent as measured by EPA Reference Method 22. The final standards
include an exemption from the fugitive ash visible emissions limit for maintenance and repair
activities, because these necessary activities may require opening of an enclosure that could
generate short-term visible emissions. Performance tests are to be conducted annually using
EPA Reference Method 22 to determine compliance with the fugitive emission limit for new
large MWI.
Comment: Seven commenters (TV-D-561, IV-D-573, IV-D-636, IV-D-637, IV-D-654,
IV-D-785/573, and IV-D-769/557) stated that Method 9 is inappropriate for establishing
emissions from ash handling. One commenter (IV-D-636) stated that Method 9 is meant to be
administered outdoors with sunlight behind the reader and while looking at a plume from a
stack. The commenter noted that most ash handling systems are located at ground level and
7-34
I:
ill ill
'"!'''''"; 1, i!'11:';,I!1!"i"flfi
-------
either in a building or under cover. The commenter argued that compliance cannot be
accurately determined from opacity readings at these conditions. Another commenter
(IV-D-561) noted that Method 9 is intended for a stationary source with visible emission
discharges through a stack(s). The commenter remarked that Method 22 appears to be a more
appropriate test method. Another commenter (IV-D-572) stated that EPA has no approved
methodology for determination of opacity hi an enclosed structure. The commenter contended
that since ash handling is event-based rather than a continuous process hi many instances, that
a 6-minute block, using Method 9 for opacity is inappropriate. The commenter stated that a
more meaningful standard might be based on Method 22. One commenter (IV-D-572)
indicated that 5 percent opacity based on a 6-minute average is achievable.
Response: As discussed above, the final HMIWI standards and guidelines do not
contain fugitive emission limits, except for new large MWI. New large MWI are to meet a
5 percent visible emission limit for fugitives based on the performance of an automatic ash
removal system. In response to comments stating that Method 9 is inappropriate for
establishing the emissions from ash handling, the EPA has chosen Method 22 as the method
for determining compliance with the fugitive emissions limit for new large MWI. Method 22
tests are to be conducted annually. The average duration of the visible emissions is to be
calculated from three 1-hour observation periods. The 5 percent visible emissions limit allows
for visible emissions during 9 minutes of the 3-hour observation period. The fugitive ash
emission limit applies only to visible emissions discharged from a building or enclosure that
houses an MWI, and not to the visible emissions inside the building or enclosure. The fugitive
ash emission limit does not apply during periods when maintenance and repair activities are
underway.
Comment: One commenter (IV-D-613) suggested that the EPA clarify that enclosed
buildings dedicated to flyash solidification are not subject to flyash rules. Another commenter
(TV-D-735) stated that operators must already take precautions when removing ash to meet
OSHA regulations.
Response: The EPA recognizes that MWI operators must take precautions when
removing ash from MWI to meet OSHA regulations that limit employee exposure to
7-35
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particulates. These OSHA regulations apply inside of buildings. It was the EPA's original
intent that the fugitive ash emissions limit apply to external ash emissions which could be
emitted into the atmosphere only. Therefore, if ash handling and storage equipment is
enclosed inside a building or other enclosure, the fugitive ash emission limit would apply to
yisible emissions discharged from the building or enclosure, not visible emissions inside the
building or enclosure. The final rule has been revised to clarify this point.
7-36
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Appendix A
Regulatory Options and Impacts of the Standards
-------
THIS PAGE INTENTIONALLY LEFT BLANK
-------
REGULATORY OPTIONS AND IMPACTS OF THE STANDARDS
This Appendix presents the regulatory options considered for the final emission
standards for new HMIWI. This section also discusses the air, cost, non-air quality
environmental, energy, and economic impacts of the regulatory options considered for the final
emission standards. Estimates of these impacts have been revised since publication in the June
~20, 1996 re-proposal as a result of changes in testing and monitoring costs, inclusion of
operator training costs, and inclusion of increased flyash disposal costs.
1. Regulatory Options
Table A-l summarizes the technology basis for the regulatory options for the various
MACT standards the EPA considered for new HMIWI. The regulatory options presented in
Table A-l are identical to those presented in the June 20, 1996 re-proposal. Regulatory option
"1 represents the MACT floor. This table was constructed only to organize and structure the
analyses of the cost, environmental, and energy impacts associated with the various regulatory
options for the MACT standards. The MACT standards for new HMIWI do not include
requirements to use a specific emission control system or technology; the MACT standards
*only include emission limits, which may be met by any means or by using any control system
"or technology the owner or operator of the HMIWI decides to use to meet the emission limits.
The emission limits associated with each of the regulatory options for small, medium, and
large new HMIWI are presented in Table A-2. ~~
A-l
-------
"'".if
IF; i
i;,"';1;; , f ;; ,i n ""iij"!
TABLE A-l. LEVEL OF AIR POLLUTION CONTROL ASSOCIATED
:::,WITH EACH REGULATORY OPTION FOR NEW HMIWI
MWIsize
Small
.£200 Ib/hr
Medium
201-500 Ib/hr
Large
> 500 Ib/hr
Regulatory options
1
Good combustion and
moderate efficiency wet
scrubber
Good combustion, dry
injection/fabric filter
system, and high efficiency
wet scrubber
Good combustion, dry
injection/fabric filter
system with carbon, and
high efficiency wet
scrubber
2
Good combustion and
moderate efficiency wet
scrubber
Good combustion, dry
injection/fabric filter
system with carbon, and
high efficiency wet
scrubber
Good combustion, dry
injection/fabric filter
system with carbon, and
high efficiency wet
scrubber
3
Good combustion and
high efficiency wet
scrubber
Good combustion, dry
injection/fabric filter
system with carbon, and
high efficiency wet
scrubber
Good combustion, dry
injection/fabric filter
system with carbon, and
high efficiency wet
scrubber
TABLE A-2. EMISSION LIMITATIONS ASSOCIATED WITH EACH
REGULATORY OPTION FOR SMALL. MEDIUM, AND LARGE NEW HMIWI
Pollutant, units
PM, gr/dscf
CO, ppmdv
CDD/CDF,
ng/dscm
TEQ CDD/CDF,
ng/dscm
HC1, ppmdv
SO,, ppmdv
NO,, ppmdv
Pb, mg/dscm
Cd, mg/dscm
Hg, mg/dscm
Regulatory options
Small HMIWI
1 and 2
0.03
40
125
2.3
15 or 99%
55
250
1.2 or 70%
0.16 or 65%
0.55 or 85%
3
0.015
40
125
2.3
15 or 99%
55 ,
250
1.2 or 70%
0.16 or 65%
0.55 or 85%
Medium HMIWI
1
0.015
40
125
2.3
15 or 99%
55
250
0.07 or 98%
0.04 or 90%
0.55 or 85%
2 and 3
0.015
40
25
0.6
15 or 99%
55
250
0.07 or 98%
0.04 or 90%
0.55 or 85%
Large
HMIWI
1-3
0.015
40
25
0.6
15 or 99%
55
250
0.07 or 98%
0.04 or 90%
0.55 or 85%
A-2
-------
Regulatory option 1 in Table A-2 reflects the performance of the emission control
"system needed to meet the MACT floor. Regulatory option 1 does not reflect the most v
stringent emission limits achievable for all subcategories. The EPA is required by the CAA to
examine the costs and other impacts of regulatory options more stringent than regulatory
option 1. Thus, regulatory options 2 and 3 reflect slightly more stringent emission standards.
2. Impacts of the Regulatory Options
A summary of the air, water, solid waste, energy, cost, and economic impacts of the
three regulatory options for new HMIWI was presented in the 1996 re-proposal. (61 FR
31736, June 20, 1996). Following the 1996 re-proposal, some commenters suggested that the
testing an monitoring costs used to develop the cost impact estimates presented in the
supplemental notice were inaccurate. As a result, the costs of emissions testing and
monitoring were revised following the 1996 re-proposal. The impacts of the standards were
"revised based on the updated testing and monitoring costs, inclusion of operator training costs,
and inclusion of increased flyash disposal costs. This section presents a summary of the air,
- water, solid waste, and energy impacts, and the revised cost and economic impacts of the three
-regulatory options for new HMIWI. All impacts are nationwide resulting from the
implementation of the new source performance standards for new HMIWI in the fifth year
*after adoption of the NSPS.
a. Analytical Approach. The same analytical approach used to estimate the impacts
presented in the 1996 re-proposal was used to revise the impact estimates presented hi this
section; however, the revised testing and monitoring costs were substituted, the operator
training costs were included, and the increased flyash disposal costs were included. This
analytical approach was discussed at length hi the June 20, 1996 re-proposal and is described
briefly below.
In the analyses of the cost, environmental, and energy impacts, the selection of an
alternative form of medical waste treatment and disposal by a health care facility, rather than
the purchase of an onsite HMIWI and the emission control technology necessary to meet the
MACT emission limits, is referred to as "switching". The impact analyses incorporate three
scenarios: one scenario that ignores switching (scenario A) and two scenarios that consider
A-3
-------
Switching (scenarios B and C). Scenario A assumes that each new HMIWI will be installed
and will comply with the appropriate regulatory option (i.e., no switching). This scenario
results in the highest costs because it assumes no potential new HMIWI owner will switch to a
less expensive waste disposal method. This scenario is unrealistic and overstates the national
costs associated with MACT emission standards.
Switching scenarios B and C are much more realistic and more representative of the
cost, environmental, and energy impacts associated with the MACT emission standards for
new HMIWI. Only these scenarios merit serious review and consideration in gauging the
potential impacts associated with the MACT emission standards. Both scenarios B and C
assume switching occurs when the cost associated with installing the air pollution control
technology or system necessary to comply with a regulatory option is greater than the cost of
choosing an alternative means of treatment and disposal. The difference in scenarios B and C
is the assumption of how much separation of the medical waste stream into infectious and
noninfectious portions occurs at health care facilities that currently operate HMIWI.
Based on estimates in literature that only 10 to 15 percent of medical waste is
potentially infectious and the remaining 85 to 90 percent is noninfectious, scenario B assumes
that only 15 percent of the waste currently being burned at a health care facility operating an
onsite HMIWI is potentially infectious medical waste. The remaining 85 percent noninfectious
waste needs no special handling and can be recycled or sent to a municipal landfill or
municipal waste combustor for disposal. Thus, under scenario B, when choosing an
alternative to an onsite HMIWI in response to adoption of MACT emission standards, a health
care facility need only chose an alternative form of medical waste treatment for 15 percent of
the waste stream currently burned onsite and may send the remaining 85 percent to a municipal
landfill. This scenario results in the lowest costs because 85 percent of the waste is disposed at
the relatively inexpensive cost of municipal waste disposal.
On the other hand, if a hospital already separates medical waste into infectious and
, '!' " ' > .11,1 II , , " . ''''I . '' »" ' ! ' '" , 'r '" JI'|Jl'. , ,!' I' ' , ,1 I, ' ,1 ' '! I ",,B
noninfectious waste streams, this hospital would be unable to separate the waste stream any
further. Scenario C, therefore, assumes that all medical waste to be burned at a health care
A-4
-------
facility that purchases an HMIWI is potentially infectious medical waste and must be treated
,;.and disposed of accordingly. As a result, scenario C leads to higher costs than scenario B.
New commercial incinerators were not subjected to the switching analyses under
scenarios B and C. An assumption was made that commercial facilities would add on the
-control associated with the emission standards. Only the new onsite HMIWI were subject to
the switching analyses under scenarios B and C.
Scenarios B and C represent the likely range of impacts associated with the MACT
emission standards for new HMIWI. The actual impacts of a regulatory option are most likely
to fall somewhere within the range represented by scenarios B and C.
b. Air Impacts. As outlined above, the impacts associated with the three regulatory
options for new HMIWI, under three scenarios reflecting switching, have been assessed. The
air impacts associated with the standards for new HMIWI are the same as those presented hi
the 1996 re-proposal. Baseline emissions (i.e., emissions in the absence of adoption of the
MACT emission standards) and emissions under each regulatory option are summarized in
Tables A-3, A-4, and A-5. Emissions under scenario A (no switching) are summarized in
Table A-3; emissions under scenario B (switching with waste separation) are summarized in
iTable A-4; and emissions under scenario C (switching without waste separation) are
-Summarized in Table A-5.
c. Cost Impacts The cost impacts on individual health care facilities that consider
purchasing an HMIWI vary depending on the regulatory option; the actual cost to purchase
and install any additional air pollution control equipment; the cost of alternative means of
treatment and disposal where they are located; and other factors, such as liability issues related
to disposal and State and local medical waste treatment and disposal requirements. In general,
facilities considering purchasing smaller HMIWI will have a greater incentive to use
alternative means of treatment and disposal because their onsite incineration cost (per pound of
waste burned) will be higher.
Large health care facilities with larger amounts of waste to be treated or health care
facilities that serve as regional treatment centers for waste generated at other health care
facilities in the area may have some cost advantages compared to smaller facilities. Due to
A-5
-------
economies of scale, their cost of burning waste may be lower (i.e., dollars per pound burned),
even after purchasing and installing a complete air pollution control system to comply with the
emission standards.
Table A-6 contains the estimated increase in national annual costs associated with each
of the regulatory options under scenario A (no switching), scenario B (switching with
separation of waste), and scenario C (switching with no separation of waste) in the fifth year
after implementation of the NSPS. Table A-7 presents the number of small, medium, and
"'r !.,.' ; i ::'i " . '"." ',: - ' ' ,' ' : : ,' i ": ;i;,""; ' '." " '. ' '" , ' , . '
large new MWI that do not switch under each of the regulatory options for scenarios B and C.
As discussed earlier, scenario A is unrealistic and grossly overstates the national cost impacts.
The costs associated with the MACT emission standards under scenarios B and C represent the
likely range of national cost impacts and only these costs merit serious consideration and
review.
The nationwide annual costs presented in Table A-6, excluding scenario A, range from
$12.1 miUion/yr for the regulatory options under scenario B to $26.2 million/yr for the
regulatory options under scenario C. The nationwide annual costs remain the same for all
three regulatory options under scenarios B and C because all potential owners of new HMIWI
i,.-', . ' : , ' ii-ii ' __. " ' ' i ' ' ' M1 ' : ' "' . '
(with the exception of HMIWI classified as large units for which there is only one regulatory
option) are expected to switch to alternative methods of medical waste treatment.
A-6
-------
TABLE A-3. BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE
FIFTH YEAR AFTER IMPLEMENTATION OF THE NSPS (SCENARIO A) ~
(Metric Units)
Pollutant, units
PM, Mg/yr
CO, Mg/yr
CDD/CDF, g/yr
TEQ CDD/CDF, g/yr
HC1, Mg/yr
SO,, Mg/yr
NOT, Mg/yr
Pb, Mg/yr
Cd, Mg/yr
Hg, Mg/yr
Baseline
28
14
47
- 1.1
64
28
130
0.39
0.051
0.21
Regulatory options
1
2.7
14
12
0.28
3.1
28
130
0.02
3.5 x 10'3
0.12
' 2
2.7
14
7.2
0.17
3.1
28
130
0.02
3.5 x 10'3
0.12
3
2.3
14
7.2
0.17
3.1
28
130
0.02
3.5 x 10'3
0.12
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to Ib/yr, divide by 453.6.
TABLE A-4. BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE
FIFTH YEAR AFTER IMPLEMENTATION OF THE NSPS (SCENARIO B)
(Metric Units)
Pollutant, units
PM, Mg/yr
CO, Mg/yr
CDD/CDF, g/yr
TEQ CDD/CDF, g/yr
HC1, Mg/yr
SO,, Mg/yr
NO« Mg/yr
Pb, Mg/yr
Cd, Mg/yr
Hg, Mg/yr
Baseline
28
14
47
1.1
64
28
130
0.39
0.051
0.21
Regulatory options
1
2.1
6.5
5.9
0.14
1.5
14
65
0.031
4.6 x 10'3
0.056
"2
2.1
6.5
5.9
0.14
1.5
14
65
0.031
4.6 x 10'3
0.056
3
2.1
6.5
5.9
0.14
1.5
14
65
0.031
4.6 x 10'3
0.056
A-7
-------
I1!"1
14 ' '' it'':
TABLE A-5. BASELINE EMISSIONS COMPARED WITH EMISSIONS IN THE
FIFTH YEAR AFTER IMPLEMENTATION OF THE NSPS (SCENARIO C)
(Metric Units)
Pollutant, units
PM, Mg/yr
CO, Mg/yr
CDD/CDF, g/yr
TEQ CDD/CDF, g/yr
HC1, Mg/yr
SO,, Mg/yr
NOT, Mg/yr
Pb, Mg/yr
Cd, Mg/yr
Hg, Mg/yr
Baseline
28
14
47
1.1
64
28
130
0.39
0.051
0.21
Regulatory options
1
4.1
14
12
0.28
3.1
28
130
0.06
8.9 x 10'3
0.12
2
4.1
14
12
0.28
3.1
28
130
0.06
8.9 x ID'3
0.12
3
4.1
14
12
0.28
3.1
28
130
0.06
8.9 x 10'3
0.12
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to Ib/yr, divide by 453.6.
TABLE A-6. COSTS OF THE REGULATORY OPTIONS IN THE FIFTH YEAR
AFTER IMPLEMENTATION OF THE NSPS (SCENARIOS A, B, AND C)
(million $/yr)
Scenario
A
B
C
Regulatory options
1
36.2
12.1
26.2
2
36.7
12.1
26.2
3
37.6
12.1
26.2
A-8
-------
TABLE A-7. NUMBER OF NEW MWI'S THAT DO NOT SWITCH
MWIType
Total
Regulatory Option
1
2
3
Scenario B
Small
Medium
Large
Commercial
Total
85
90
60
10
245
0
0
0
10
10
0
0
0
10
10
0
0
0
10
10
Scenario C
Small
Medium
Large
Commercial
Total
85
90
60
10
245
0
0
60
10
70
0
0
60
10
70
0
0
60
10
70
A-9
-------
i',.: Jii s!fe!,J'::
;"_: ^c^Jj^cr-'.
d. Water and Solid Waste Impacts. Es
«»"* MMW mmmmftTiim***ln^,..^ i::l.
for only regulatory option Jpscenario
were developed
with wet
scrubbers in the absence of switching. Assessing these impacts under scenario A without any
''iSiRyfc
magnitude of these impacts.
consideration of the effect of switching grossly overstates
Under scenarios B and C more than haf
' ' ...... '' ' '
resulting in significantly, tower impacts^
........... '" - . . r.
Under regulatory option 3 , scenario A, 3.3 million
would be generated hi the fifth year by EDMOhvt^'W'irirauiit'
equivalent of wastewater produced annually by one small hospital. Therefore, when
expected not to be built,
of additional wastewater
NSPS. This amount is the
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
111111 *K*~H~»«IK*«P>T^^ ...I;,,. '»- ti n,, ,
HMIWI is insignificant.
With regard to solid waste impacts, about 88,800 Mg (97,900 tons) of medical waste
would be burned in the fifth year in new HMIWI in the absence of Federal regulations,
producing about 8,880 Mg/yr (9,790 tons/yr) of solid waste (bottom ash) disposed of in
landfills. To determine the solid waste impacts for the NSPS, impacts were developed for
regulatory option 3, scenario B. This option is associated with the most switching and the
most separation of waste for disposal in municipal landfills and thus, produces the greatest
estimated impact.
Under regulatory option 3, scenario B, 43,600 Mg/yr (48,000 tons/yr) of additional
solid waste would result from the adoption of the NSPS. However, 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 HMIWI standards is
insignificant.
e. Energy Impacts. The emission coatf6rfec^inoI6jgli!« useSWnew HMIWI to comply
F " 3-5;; "»?*'»&..,.,' -v,;,,.; " >" .,.*,'
with the MACT emission limits consume energy. Estimates of energy impact were developed
, ii!i" i"".1,,: iwi^iriy::^ " '
for regulatory option 3, scenario A. Under scenarios B £aa'C, which include switching, it is
- s«^
not clear whether overall national energy consumption would increase, decrease, or remain the
A-lO
-------
same. Alternatives to incineration require energy to operate; however, information is not
^available to estimate whether these alternatives use more or less energy than HMIWI.
The energy impacts associated with the MACT emission standards could include
additional auxiliary fuel (natural gas) for combustion controls and additional electrical energy
for operation of the add-on control devices, such as wet scrubbers and dry scrubbers. It was
-assumed that all new HMIWI would be installed with combustion controls in the absence of
the NSPS hi order to meet State regulations for new HMIWI. Therefore, there would be no
increase in the total national usage of natural gas for combustion controls under regulatory
option 3, scenario A. Total national usage of electrical energy for the operation of add-on
control devices would increase by about 9,800 megawatt hours per year (MW-hr/yr)
(33.4 billion British thermal units per year (109 Btu/yr)). Compared to the amount of energy
used by health care facilities such as hospitals (approximately 2,460 MMnrYyr 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.
f. Economic Impacts. The goal of the economic impact analysis is to estimate the
market response of affected industries to the NSPS and to identify any adverse impacts that
*may occur as a result of the regulation. Industries that operate onsite waste incinerators (e.g.,
-"hospitals, nursing homes, research labs, and commercial waste incinerators) and those
industries that utilize offsite incinerators (e.g., hospitals, nursing homes, medical/dental
laboratories, funeral homes, physicians offices, dentist offices, outpatient care, freestanding
blood banks, fire and rescue operations, and correctional facilities) will potentially be affected
by the regulation. Industry-wide impacts, including changes in market price, output or
production, revenues, and employment for the affected industries, are estimated for each
regulatory option assuming the three switching scenarios. Facility-specific impacts are
estimated for hospitals of varying sizes, ownership, and operating characteristics; nursing
homes; commercial research labs; and commercial waste incineration based on engineering
model plant cost estimates under each of the three switching scenarios.
A-ll
-------
(i) Analytical approach
The analytical approach used to estimate industry-wide and facility-specific economic
impacts and to evaluate the economic feasibility of substitution is briefly described. For a
more detailed description of the methodology used to estimate economic impacts, refer to the
document "Medical Waste Incinerators - Background Information for Proposed Standards and
Guidelines: Analysis of Economic Impacts for New Sources" (EPA-453/R-94-047a). A
revised analysis (using the same methodology with revised costs) is presented in
"Hospital/Medical/Infectious Waste Incinerators: Background Information for Promulgated
Standards and Guidelines - Analysis of Economic Impacts for New Sources" (EPA-453/R-97-
008b). Prices are stated in 1993 dollars.
Economic impacts for new HMTWI are calculated under two assumptions. First, the
costs used to estimate the economic impacts of these MACT emission standards include control
costs from both the emission guidelines (EG) for existing HMIWI and the emission standards
for new sources. This approach is used to account for market adjustments (e.g., price
impacts) that would first occur after implementation of the EG. This approach allows for the
establishment of a future baseline scenario. Second, due to lack of information, revenue data
for each of the affected industries were not adjusted for growth during the five-year time
frame. , ,," . , , . ' '.,/ "
The average price changes that are anticipated to occur in each industry sector for each
of the regulatory options are estimated by comparing the annual control cost estimates to
annual revenues for each affected industry. This calculation provides an indication of the
magnitude of a price change that would occur in order for each industry sector to fully recover
its annual control costs. The resulting ratio of cost-to-revenue represents the average price
increase necessary for firms in the industry to recover the increased cost of environmental
controls. Percent changes in output or production are estimated using the price impact
estimate and a high and low estimate of the price elasticity of demand for output from that
industry sector. Resulting changes in revenues are estimated based upon the estimated changes
in price and output for an industry. Employment losses or labor market impacts result from
A-12
-------
decreases in the output for an industry and are assumed to be proportional to the estimated
-decrease in output for each industry. - £
Facility-specific economic impacts are estimated by using model plant information
under the three switching scenarios. The assumption of no switching (scenario A) will
-^represent the highest cost and economic impact scenario for most of the affected industries
while the assumption of switching with waste segregation (scenario B) will represent the lowest
=*cost and economic impact scenario for most of the affected industries. As previously stated,
EPA considers scenario A to be an unlikely scenario so the economic impacts presented under
scenarios B and C should be regarded as the most realistic estimates.
(ii) Industry-Wide Economic Impacts
Industry-wide impacts include estimates of the change in market price for the services
provided by the affected industries, the change in market output or'production, the change in
-^industry revenue, and the impact on affected labor markets in terms of number of jobs lost.
"These impacts are summarized in Tables A-8 and A-9.
A-13
-------
TABLE A-8. HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATION
INDUSTRY-WIDE PRICE IMPACTS - NEW AND EXISTING SOURCES
PERCENT INCREASE (%)a
Industry
Hospitals
Nursing homes
Laboratories:
Research
Medical/dental
Funeral homes
Physicians offices
Dentists offices
and clinics
Outpatient care
Freestanding blood
banks
Fire and rescue
operations
Correctional
facilities
Commercial
incineration
Range for regulatory options 1-3
Scenario A
no switching
0.05
0.05
0.15-0.160
0
0
0
0
0.01
0
0
4.1
Scenario B
switching with
waste segregation
0.02
0.02
0.050
0
0
0
0
0.01
0
0
4.1
Scenario C
switching with no
waste segregation
0.03
0.03
0.100
0
0
0
0
0.01
0
0
4.1
i I i;
The price increase percentages reported represent the price increase necessary to
recover annualized emission control costs for each industry.
A-14
-------
TABLE A-9. HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATION
INDUSTRY-WIDE OUTPUT, EMPLOYMENT AND REVENUE IMPACTS -
NEW AND EXISTING SOURCES
Industry
Hospitals
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Nursing homes
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Laboratories:
Research
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Medical/dental
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Funeral homes
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Physicians offices
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Dentists offices and clinics
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Outpatient care
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Freestanding blood banks
Output decrease (%)
Employment loss
Revenue increase or (decrease)
(%)
Fire and rescue operations
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Correctional facilities
Output decrease (%)
Employment loss
Revenue increase or (decrease) (%)
Range for regulatory options 1-6
Scenario A
no switching
0-0.02
0-772
0.03-0.05
0.02-0.04
269-578
0.02-0.04
0.15-0.21
239-336
(0.05)-0
0
3-6
0
0
0
0
0
0-2
0
0
1-2
0
0
0-2
0
0
0
0-0.01
0
0
0
0
0
0
Scenario B
switching with waste
segregation
0-0.01
0-231
0.01-0.02
0.01
84-172
0.01
0.05-0.06
74-100
(0.02)-0
0
3-6
0
0
0
0
0
0-2
0
0
1-2
0
0
0-2
0
0
0
0-0.01
0
0
0
0
0
0
Scenario C
switching with no
waste segregation
0-0.01
0-489
0.02-0.03
0.01-0.02
179-366
0.01-0.02
0.10-0.13
158-213
(0.03)-0
0
3-6
0
0
0
0
0
0-2
0
0
1-2
0
0
0-2
0
,0
0
0-0.01
0
0
0
0
0
0
A-15
-------
'i'!1 II i I"1 ,,.'' '..I'l'MM'l
"Hl!!|! ' T I,""!'1:,,'!!'" ill"1"! i!r' Ml iri'lii
As can be seen in Table A-8, industries that generate hospital waste and/or
medical/infectipus waste (i.e., hospitals, nursing homes, etc.) are expected to experience^
average price increases in the range of 0 to 0.16 percent, depending on the industry, regulatory
option, and scenario analyzed. Table A-8 shows that these industries are expected to
experience output and employment impacts in the range of 0 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. An increase in industry revenue is expected to occur in cases
where the price elasticity of demand for an industry's product is inelastic or between 0 and -1.
Such a price elasticity indicates that output changes are hot very responsive to a change in
price, specifically that the percentage decrease in output will be less than the percentage
increase in price. Since revenue is a product of price and output, a less than proportional
change in output compared to price means that total revenue should increase.
The following example illustrates how the above price impacts could be interpreted for
, ' i ' ' , ' ' T ' , . . ' , ' ' 'II
the hospital industry. The estimated average industry-wide price increase for hospitals under
regulatory option 3 for the NSPS coupled with regulatory option 6 for the EG (the most
stringent regulatory options) and scenario C, switching with no waste segregation, is 0.03
percent as shown in Table A-8. This can be expressed in terms of the increased cost of
hospitalization due to the regulation. Total nationwide adjusted patient days at hospitals in
1993 were an estimated 304.5 million days. ("Adjusted" patient days include both in-patient
days and the in-patient day equivalent of out-patient visits.) The total annualized control cost
under regulatory option 3 (NSPS), regulatory option 6 (EG), and scenario C for the hospital
industry is $108.8 million, or $0.36 per adjusted patient day. This means that the average
price increase that an individual would experience for each hospital patient-day is expected to
equal 36 cents.
Table A-8 also shows that the average price impact for the commercial HMIWI
industry is approximately a 4.1 percent increase in price. Cost and economic impact estimates
are the same for the commercial HMIWI industry regardless of the regulatory option analyzed
because all three regulatory options specify identical regulatory requirements. Average
A-16
I;
'" * ,
.MS",: :;,;,""fir 7,;ii!v!i? ?
-------
industry-wide output, employment, and revenue impacts were not estimated for this sector
because data such as price elasticity estimatesiand .employment levels were not available:?
(iii) Facility-Specific Impacts
Facility-specific impacts were also estimated for the affected industries. These
estimates, presented in Tables A-lOa and A-lOb, were calculated for the three switching
scenarios. A cost as a percent of revenue/budget ratio was calculated to provide an indication
of the magnitude of the impact of the regulation on an uncontrolled facility in each industry
sector. This calculation was then compared to the industry-wide price impact to determine if
the facility's impacts differ significantly from the average industry-wide impacts. A
determination of significanceimplying that the facility price increase may not be achievable
is made for all but commercial HMIWI operators if the facility price increase exceeds the
average industry-wide, or "market" price increase by more than 1 percentage point. For
-commercial HMIWI operators, the facility price increase is considered significant if it exceeds
^the market price increase by more than 2 percentage points. More pricing latitude is given to
commercial HMIWI operators for two reasons: (1) commercial incineration is not subject to
the same institutional pricing constraints as the health care sector, and (2) commercial
incineration fees could actually get a boost from the regulation as a result of switching from
4pnsite incineration and an increase in the demand for commercial incineration services. Where
significance is found, the impact on net income (earnings) of absorbing control costs is
estimated and evaluated.
For industries other than commercial incineration, Tables A-lOa and A-lOb show that
facilities with onsite HMIWI that are currently uncontrolled may experience impacts ranging
from 0.03 to 1.70 percent, depending on the industry, regulatory option, and scenario
analyzed. For commercial incineration the cost to revenue/budget ratio is 19.35 percent. A
comparison of the facility-specific economic impacts expected to occur under the three
switching scenarios, presented hi Tables 10-9a and A-lOb, to the anticipated market price
increases indicates the impacts for facilities that operate onsite HMIWI are generally
insignificant. For many of the uncontrolled model facilities, the economic impacts from
A-17
-------
: n I:.1"
'
'ft! , ',: ' 1; ' - ''.: : '" . ) . !' -i,;' '. ' ' , ,.'. '> ' , *.
TABLE A-lOa. HOSPITAL/MEDIC AL/INFECTIOUS WASTE INCINERATION
PER FACILITY IMPACTS ASSUMING NO SWITCHING AND QNSITE
INCINERATIPN - NEW SOURCES CONTROL COST AS ^
A PERCENT OF REVENUE/BUDGET (%)
Industry
Hospitals - Short term, excluding psychiatric:
Federal Government:
Small
Urban
Rural
Medium
Large
State Government:
Small
Urban
Rural
Medium
Large
Local Government:
Small
Urban
Rural
Medium
Large
Not-for-profit:
Small
Urban
Rural
Medium
Large
For-profit:
Small
Urban
Rural
Medium
Large
Hospitals - Psychiatric, short term and long term:
Small
Urban
Rural
Medium
Large
Option 1
0.37
0.37
0.37
0.18
0.78
0.78
0.39
0.10
1.22
1.22
0.59
0.13
0.83
0.83
0.43
0.15
0.93
0.93
0.46
0.19
1.28
1.28
1.06
0.64
Option 2
0.37
0.37
0.38
0.18
0.78
0.78
0.40
0.10
1.22
1.22
0.16
0.13
0.83
0.83
0.45
0.15
0.93
0.93
0.48
0.19
1.28
1.28
1.10
0.64
Option 3
0.42
0.42
0.38
0.18
0.90
0.90
0.40
0.10
1.40
1.40
0.61
0.13
0.95
0.95
0.45
0.15
1.07
1.07
0.48
0.19
1.47
1.47
1.10
0.64
A-18
-------
TABLE A-lOa. (continued)
Industry
Nursing Homes:
Tax-Paying
Urban
Rural
Tax-exempt
Urban
Rural
Commercial research labs:
Tax-paying
Tax-exempt
Commercial Incineration Facilities"
Option 1
1.39
1.39
1.42
1.42
0.75
0.75
19.35
Option 2
1.39
1.39
1.42
1.42
0.78
0.78
19.35
Option 3
1.59
1.59
1.63
1.63
0.78
0.78
19.35
This cost to revenue ratio reflects the cost to new HMIW
I that would otherwise have been completely uncontrolled.
A-19
-------
TABLE A-lOb. HOSPITAIVMEDICAL/INFECTIOUS WASTE INCINERATION
PER FACILITY IMPACTS ASSUMING SWITCHING FROM ONSITE INCINERATION
TO COMMERCIAL DISPOSAL ALTERNATIVES - NEW SOURCES ALTERNATIVE
WASTE DISPOSAL COST AS A PERCENT OF REVENUE/BUDGET (%)
Industry
Hospitals - Short term, excluding psychiatric:
Federal Government:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
State Government:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Local Government:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Not-for-profit:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
For-profit:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Scenario B -
switching with waste
segregation
0.03
0.03
0.05
0.05
0.08
0.11
0.06
0.08
0.05
0.07
0.05
0.06
0.09
0.13
0.07
0.10
0.06
0.08
0.06
0.09
0.05
0.08
0.07
0.10
0.07
0.10
0.06
0.08
0.09
0.12
Scenario C -
switching without
waste segregation
0.10
0.17
0.17
0.27
0.29
0.47
0.22
0.36
0.18
0.29
0.16
0.27
0.34
0.56
0.27
0.44
0.22
0.36
0.23
0.38
0.20
0.32
0.25
0.41
0.26
0.43
0.21
0.34
0.32
0.52
A-20
-------
TABLE A-lOb. (continued)
Industry
Hospitals - Psychiatric, short term and long term:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Nursing Homes:
Tax-Paying - Urban
Rural
Tax-exempt - Urban
Rural
Commercial research labs:
Tax-Paying - Urban
Rural
Tax-exempt - Urban
Rural
Scenario B -
switching with waste
segregation
0.10
0.14
0.13
0.19
0.29
0.40
0.11
0.15
0.11
0.15
0.09
0.13
0.09
0.13
Scenario C -
switching without
waste segregation
0.36
0.59
0.48
0.78
1.05
1.70
0.39
0.64
0.40
0.65
0.34
0.56
0.34
0.56
A-21
-------
switching to an alternative method of waste disposal are much lower than the economic
impacts from installing emission control equipment. These results indicate that the option of
switching to a lower cost alternative for waste disposal will be an attractive option for some
facilities currently using an onsite HMIWI. The decision to switch to an alternative method of
-
-------
TABLE A-l 1. HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATION PER
FACILITY IMPACTS FOR FIRMS THAT UTILIZE OFFSITE INCINERATION -
NEW SOURCES INCREMENTAL ANNUAL COST AS A PERCENT OF
REVENUE/BUDGET (%)
Industry
Hospitals
<50 Beds
50-99 Beds
100-299 Beds
300+ Beds
Nursing Homes
0-19 Employees
Tax-paying
Tax-exempt
20-99 Employees
Tax-paying
Tax-exempt
100+ Employees
Tax-exempt
Tax-paying
Commercial Research Labs
Tax-paying
0-19 Employees
20-99 Employees
100+ Employees
Tax-exempt
Outpatient Care Clinics
Physicians' clinics (Amb. Care)
Tax-paying
Tax-exempt
Freestanding kidney dialysis facilities
Tax-paying
Tax-exempt
Physicians offices
Dentists offices and clinics
Offices
Clinics
Tax-paying
Tax-exempt
Medical & dental Labs
Medical
Dental
Freestanding blood banks
Funeral Homes
Fire & Rescue
Corrections
Federal Government
State Government
Local Government
Incremental annual cost as a percent of revenue
0-0.02
0-0.01
0-0.01
0-0.01
0
0-0.1
0-0.01
0-0.01
0-0.1
., °-°-1
0
0
0-0.1
0-0.1
0-0.01
0-0.01
0-0.01
0-0.01
0
0
0
0
0-0.01
0-0.02
0.01-0.03
0
0
0
0
0
A-23
-------
|''!f! i, ;.::1 ' 'if'," ff|! !':
This economic impact section examines possible economic impacts that may occur in
industries that will be directly affected by this regulation. Therefore, the analysis includes an
."",,' , . :;;;,: ; , ,«'!."'.... :>'.!,,":; , .;;,;: v",":.. ' : ' : j' " :." .;:,'$£
examination of industries that generate medical waste or dispose medical waste. Secondary
impacts, such as subsequent impacts on air pollution device vendors and HMIWI vendors, are
not estimated due to data limitations. Air pollution device vendors are expected to experience
an increase in demand for their products due to the regulation. This regulation is also expected
''!]'" ; j:1";" :' , IN ' ' " - i __^__ ' , , ' ...','.',' '(; ", ' ' '",,;'' ; , " ''' , :» , ;V ;
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.
'V1, '":| , i ,:}(j :; ;, ,'...'''. :'"' ' " . , .' : ' ;,-;i' ! ' j':':- " ; .1 :!" . : :*',-
Therefore, small HMIWI vendors potentially may be adversely affected by the regulation.
, , :' ' ''"I]'1!,], . . ' t . '" . - ; ' i ," i' ' . ' ' " , i. ! ' "' "i ',' W ' : ';
Lack of data on the above effects prevent quantification of the economic impacts on these
secondary sectors.
g. Benefits Analysis. Implementation of the NSPS for HMIWI is expected to reduce
emissions of hazardous air pollutants, dioxin/furan, and criteria air pollutants. Reduction in a
variety of HAP including Cd, HC1, 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. 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. A qualitative discussion of the health and welfare benefits of the HMIWI
rule follows. The quantitative assessment of the benefits associated with the rule is limited to
the monetized value of PM emission reductions. Although the monetized benefits associated
With PM emission reductions are compared to the estimated annualized emission control costs
of the regulation, the EPA recognizes that the monetized benefits and therefore the net benefits
A-24
ilffill;'1, :
! is .! .«::; it''
-------
are understated (in this case annualized costs exceed the monetized benefits so net costs are
overstated) for the regulation.
(i) Qualitative Discussion of Benefits
Emission reductions of Cd, Pb, HC1, and Hg are expected to occur as a result of the
HMIWINSPS. Health effects associated with exposures to Cd and Pb include probable
carcinogenic effects. Respiratory effects are associated with exposure to Cd, HG1, 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 NSPS.
Exposure to dioxin/furan has been linked to reproductive and developmental effects, changes
in hormone levels, and chloracne. Toxic Equivalent Quantity (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
Blinked 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 hi non-asthmatics. 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
A-25
-------
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
,,'i ' ,,,''" , , . ' i! ' ''ii ,'" ,!'ii,' , i'" ','''.',' '' '''i ,,'"'.' '!7I ' , "!'', 'ii: -
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.
1 "' , , , , ' I |j'!,?|l , | ' .1 | i, , ,/';'
(ii) Quantitative Assessment of Benefits
Concentration-response functions have been developed for the majority of the health
and welfare effects mentioned above. In these functions, a quantitative relationship between a
specific health or welfare endpoint and exposure is established. Exposure, however, is
generally measured by models in terms of ambient concentration of a pollutant. To do this,
facility-specific information is needed to determine how changes in control technologies will
impact pollutant concentrations in the ambient air. Because such data are not available to
model changes in ambient air concentrations, a direct application of these concentration-
iresponse functions to the present analysis is not possible.
However, an approximation of the magnitude of these effects can be obtained using the
results of existing studies that have evaluated the health and welfare effects of reductions hi
pollutant concentrations. A review of available studies reveals one study of PM benefits that
can be used to estimate benefits of PM reductions from the HMTWI rule. Specifically, a study
of the benefits and costs of selected new source performance standards for paniculate matter is
particularly useful to develop quantitative benefit estimates for the PM emission reductions.
Two more recent PM studies, "The Benefits and Costs of the Clean Air Act, 1970 to 1990"
and "Regulatory Impact Analysis for Proposed Paniculate Matter National Ambient Air
Quality Standard" (1996) are expected to update these values. Since they are both currently in
draft form, they were not able to be used as of the completion of this analysis. Unfortunately,
no studies are representative or available to approximate the benefits associated with the SO2,
CO, and NOX emission reductions.
The selected study of PM benefits considered a diverse set of sources located in over
600 counties in the United States to develop estimates of the benefits per ton of PM reduced.
The benefit categories considered in this analysis included mortality, morbidity, household
:,:! " »!
A-26
-------
soiling, and materials damage. The national weighted average (weighted by emissions
reduced) of benefit per ton values estimated for 1995 was $6,075 (1993 dollars). Although
wide variations exist in the amount of benefits obtained across different areas (depending on
the exposed population, geographic and meteorological conditions, and the ambient
concentrations of PM), this analysis assumes that the weighted value of $6,075 per ton is
representative on average.
Tables A-12 and A-13 summarize the annualized emission control costs, the monetized
benefits and net benefits (costs) associated with regulatory options under scenarios B and C of
theNSPS.
A-27
-------
TABLE A-12. MONETIZED COSTS, BENEFITS, AND NET BENEFITS FOR
HMIWI REGULATORY OPTIONS - NSPS
(thousands of 1993 dollars)
Reg Option 1
Reg Option 2
Reg Option 3
Scenario B
Monetized
benefits, $a
171
171
171
Total annualized
costs, $
12,132
12,132
12,132
Net benefits (costs),
$
(11,961)
(11,961)
(11,961)
'Only the benefits from PM emission reductions have been monetized.
TABLE A-13. MONETIZED COSTS, BENEFITS, AND NET BENEFITS FOR
HMIWI REGULATORY OPTIONS - NSPS
(thousands of 1993 dollars)
Reg Option 1
Reg Option 2
Reg Option 3
Scenario C
Monetized
benefits,
$a
157
157
157
Total annualized
costs, $
26,224
26,224
26,224
Net benefits (costs),
$
(26,067)
(26,067)
(26,067)
"Only the benefits from PM emission reductions have been monetized.
A-28
-------
Appendix B
Regulatory Options and Impacts of the Guidelines
-------
THIS PAGE INTENTIONALLY LEFT BLANK
-------
REGULATORY OPTIONS AND IMPACTS OF THE GUIDELINES
*;,
This Appendix presents the regulatory options considered for the final emission
guidelines for existing HMIWI. This section also discusses the air, cost, nonair quality
environmental, energy, and economic impacts of the regulatory options considered for the final
emission guidelines. Estimates of these impacts have been revised since publication in the
*7une 20, 1996 notice as a result of modifications to the testing and monitoring costs, inclusion
of operator training costs, and consideration of larger HMIWI possibly being classified as
small HMIWI through permit limit.
1. Regulatory Options
Table B-l summarizes the technology basis for the regulatory options for the various
MACT standards the EPA considered for existing HMIWI. These regulatory options are
almost identical to those presented in the June 20, 1996 notice. Only regulatory option 2 has
changed, as discussed below. Regulatory option 1 represents the MACT floor. Table B-l was
constructed only to organize and structure the analyses of the cost, environmental, and energy
"impacts associated with the various regulatory options for the MACT guidelines. The MACT
"guidelines for existing HMIWI do not include requirements to use a specific emission control
^system or technology; the MACT guidelines only include emission limits, which may be met
by any means or by using any control system or technology the owner or operator of the
HMIWI decides to use to meet the emission limits. Where not constrained by the CAA, the
actual emission limits associated with some of the regulatory options shown in Table B-l have
been selected at a level designed to permit the use of either a wet scrubbing system or a dry
scrubbing system. The emission limits associated with each of the regulatory options for
small, medium, and large existing HMIWI are presented in Table B-2.
B-l
-------
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B-3
-------
Regulatory option 1 in Table B-2 reflects the performance of the emission control
system or technology needed to meet the MACT floor. Regulatory option 1 does not reflect
- , , ' ..rr i" .,'.. ' i ;. " i,, ',«,-.' . " " '-'"' i : ' "' . ' I" ': £:'.'.; ;.r i£ '.'
the most stringent emission limits achievable for all subcategories. The EPA is required by the
CAA to examine the costs and other impacts of regulatory options more stringent than
regulatory option 1. Thus, regulatory options 2 through 6 reflect slightly more stringent
emission guidelines.
As mentioned above, only regulatory option 2 has changed since re-proposal. In the
1996 re-proposal, regulatory option 2 reflected the use of good combustion alone at all small
rural facilities (i.e., those located outside of an SMSA). However, "rural criteria" has been
included in the revised regulatory option 2 which allows only those small HMlWI that are
located more than 50 miles from an SMSA and combust less than 2,000 pounds of waste per
week (Ib/wk) to meet emission limits associated with good combustion alone. As a result,
regulatory option 2 has been refined in order to determine the impacts of the guidelines if only
those units that meet the rural criteria, rather than all small HMIWI located outside of an
SMSA, are allowed to meet emission limits based on the use of good combustion alone.
The purpose of the rural criteria included in regulatory option 2 is to further define
those facilities operating small HMIWI hi remote areas that may have fewer cost effective
options for waste disposal; in which case, emission guidelines based on wet scrubbers could
'/; ; ..' "in ' , ., , - ./. ; :,;.','' f,i" ;,':, i'!;-1.: ; :''";
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
:. ; . ,5.,] ' . ;, ; ' .;,' ' .,".,.;. /r ; *'\ , ;. .: : /, ,; ,y\
quantify "hardship." Consequently, the rural criteria examined for use in regulatory option 2
'. '. i.i'!! . ' ' ' '"" .' '! . 'i " - ' "" ' ; ' i-1' > L,! .':' ' : ' " '' ,>. ";
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 Ib/wk were examined to determine the
appropriate rural criteria. Suggestions by commenters, and factors such as likelihood that
commercial services are available and number of HWIWI meeting the criteria, were
considered in evaluating the criteria. Rural criteria based on a distance of 50 miles from an
B-4
-------
-SMSA and a 2,000 Ib/wk waste charging limit-were selected for a number of reasons.
2,000 Ib/wk criterion was suggested by commenters; focuses the option for less stringent
requirements on the smallest HMTWI; and reflects a sufficient quantity of waste to ensure that
^commercial services are available. The 50 mile criterion added to the 2,000 Ib/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 hauled.
2. Impacts of the Regulatory Options
A summary of the air, water, solid waste, energy, cost, and economic impacts of the
six regulatory options for existing HMIWI was presented in the 1996 re-proposal. (61 FR
31736, June 20, 1996). Following the 1996 re-proposal, some commenters suggested that the
testing an monitoring costs used to develop the cost impact estimates presented in the 1996 re-
_iproposal were inaccurate. As a result, the costs of emissions testing and monitoring were
.revised following the 1996 re-proposal. The impacts of the guidelines were revised based on
*the updated testing and monitoring costs and inclusion of operator training costs. In addition,
$he impact analyses were changed to reflect the possibility of larger units becoming "small" by
permit limit. This section presents a summary of the revised air, water, solid waste, energy,
cost, and economic impacts of the six regulatory options for existing HMIWI. All impacts are
nationwide resulting from the implementation of the emission guidelines for existing HMIWI.
a. Analytical Approach. The same analytical approach used to estimate the impacts
presented in the 1996 re-proposal was used to revise the impact estimates presented in this
-section; however, the revised testing and monitoring costs were substituted and operator
training costs were included. Also, the impacts that could occur if medium units become small
by permit limit were estimated and it was assumed that the small units in the HMIWI
inventory meeting the "rural" criteria would not have alternative waste disposal options
available. The analytical approach used to determine the impacts was discussed at length in
the June 20, 1996 re-proposal and is briefly described below.
B-5
-------
In the analyses of the cost, environmental, and energy impacts, the selection of an
alternative form" of medical waste treatment and disposal by a health care facility, rather than
"- '- ,!l, , ' /: ,?..: ...'.'' ''' M ''. . -.iAi 'fl^W.*,,:!,1^ .
the purchase of an onsite HMIWI and the emission control technology necessary to meet the
i ' ' , . '",,11111 - " , ' 'I" ',,:!' ,::", i i ' ! , ,',' " ' ," ,1 , ," ' ' ,ii
MACT emission limits, is referred to as "switching". The impact analyses incorporate three
".?' ,1 ,;, >-i:i !", " ' : , i-ii , '.''' :!'""' ; ,, i, i ,;>,( , "; l; 'i ' ;, , ; . ' ,l yi" \ ,<
scenarios: one scenario that ignores switching (scenario A) and two scenarios that consider
Switching (scenarios B and C). Scenario A assumes that each existing HMIWI will be installed
and will comply with the appropriate regulatory option (i.e., no switching). This scenario
.' ; ,. . . ,T:'|:!I ,, ... , , H . ,'.: . . - ,. ₯:;' ' . '-.? ,.-' ,".. ?t, ,< -|
results in the highest costs because it assumes no potential existing HMIWI owner will switch
to a less expensive waste disposal method. This scenario is unrealistic and overstates the
national costs associated with MACT emission guidelines.
Switching scenarios B and C are much more realistic and more representative of the
cost, environmental, and energy impacts associated with the MACT emission guidelines for
existing HMIWI. Only these scenarios merit serious review and consideration in gauging the
potential impacts associated with the MACT emission guidelines. Both scenarios B and C
assume switching occurs when the cost associated with installing the air pollution control
technology or system necessary to comply with a regulatory option is greater than the cost of
choosing an alternative means of treatment and disposal. The difference in scenarios B and C
is the assumption of how much separation of the medical waste stream into infectious and
noninfectious portions occurs at health care facilities that currently operate HMIWI.
Based on estimates in literature that only 10 to 15 percent of medical waste is
potentially infectious and the remaining 85 to 90 percent is noninfectious, scenario B assumes
that only 15 percent of the waste currently being burned at a health care facility operating an
onsite HMEWI is potentially infectious medical waste. The remaining 85 percent noninfectious
Waste needs no special handling and can be recycled or sent to a municipal landfill or
municipal waste combustor for disposal. Thus, under scenario B, when choosing an
alternative to an onsite HMIWI in response to adoption of MACT emission guidelines, a health
> ; _ J1S ;.'.. .'".,; j ;i :,:l F ..;:. i -, .- " ' .M. ,p;, ;.,.. -,. ?'., .': /.;,;,.«
care facility need only chose an alternative form of medical waste treatment for 15 percent of
,'': ' « ' , if1'!!""1 , . '!. .:\ - ,"l;"; " ' f-11 ' '. ' : ".'' ' I":1"*' : " ,. ''. ..,' '' '''.<', :" v«- '' 'f''1 i''!:!!
the waste stream currently burned onsite and may send the remaining 85 percent to a municipal
iK'iii
!! I
B-6
;lli ' I! ' /'Sill r, ; '!: LI >>:;i .< ». iliill,, "i It . j . i .'i'liii; ! ,n 11'1 " ',;* ..E M,',', , '!
B i'11!1 "i,;,., ! ,!l '/
i. ;:,; i ',;",.'r: .ijiiu, liiii!!,, JiE'ij: : I
-------
landfill. This scenario results in the lowest costs because 85 percent of the waste is disposed at
the relatively inexpensive cost of municipal waste disposal. *
On the other hand, if a hospital already separates medical waste into infectious and
noninfectious waste streams, this hospital would be unable to separate the waste stream any
"further. Scenario C, therefore, assumes that all medical waste to be burned at a health care
-facility is potentially infectious medical waste and must be treated and disposed of accordingly.
As a result, scenario C leads to higher costs than scenario B.
Existing commercial incinerators were not subjected to the switching analyses under
scenarios B and C. An assumption was made that commercial facilities would add on the
control associated with the emission guidelines. Only the existing onsite HMIWI were subject
to the switching analyses under scenarios B and C. Also, small units meeting the "rural"
criteria were not subjected to the switching analysis, assuming that alternatives to onsite
incineration are unavailable.
Scenarios B and C represent the likely range of impacts associated with the MACT
emission guidelines for existing HMIWI. The actual impacts of a regulatory option is most
^likely to fall somewhere within the range represented by"scenarios B and C.
b. Air Impacts. As outlined above, the impacts associated with the six regulatory
^options for existing HMIWI, under three scenarios reflecting switching, have been assessed.
'Baseline emissions (i.e., emissions in the absence of adoption of the MACT emission
guidelines) and emissions under each regulatory option are summarized in Tables B-3, B-4,
and B-5. Emissions under scenario A (no switching) are summarized in Table B-3; emissions
under scenario B (switching with waste separation) are summarized in Table B-4; and
emissions under scenario C (switching without waste separation) are summarized hi Table B-5.
B-7
-------
TABLE B-3. BASELINE EMISSIONS COMPARED WITH EMISSIONS
. AFTER IMPLEMENTATION OF THE EMISSION GUIDELINES (SCENARIO A)
(Metric Units)
Pollutant, units
PM, Mg/yr
CO, Mg/yr
CDD/CDF, g/yr
TEQ CDD/CDF,
g/yr
HC1, Mg/yr
SO,, Mg/yr
NO,, Mg/yr
Pb, Mg/yr
Cd, Mg/yr
Hg, Mg/yr
Baseline
940
460
7,200
150
5,700
250
1,200
11
1.2
15
Regulatory options
1
320
120
620
13
2,300
250
1,200
5.5
0.65
2.0
2
150
120
310
7.2
140
250
1,200
2.2
0.30
1.1
3
140
120
300
7.1
86
250
1,200
2.1
0.29
1.1
4
120
120
300
7.1
86
250
1,200
2.1
0.29
1.1
5
110
120
300
7.1
86
250
1,200
2.1
0.29
1.1
6
100
120
300
7.1
86
250
1,200
2.1
0.29
1.1
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to Ib/yr, divide by 453.6.
TABLE B-4. BASELINE EMISSIONS COMPARED WITH EMISSIONS
AFTER IMPLEMENTATION OF THE EMISSION GUIDELINES (SCENARIO B)
(Metric Units)
Pollutant, units
PM, Mg/yr
CO, Mg/yr
CDD/CDF, g/yr
TEQ CDD/CDF,
g/yr
HC1, Mg/yr
SO,, Mg/yr
NO., Mg/yr
Pb, Mg/yr
Cd, Mg/yr
Hg, Mg/yr
Baseline
940
460
7,200
150
5,700
250
1,200
11
1.2
15
Regulatory options
1
190
90
390
8.5
1,200
190
890
3.2
0.39
1.3
2
72
82
210
4.9
130
170
810
1.4
0.19
0.78
3
68
82
200
4.8
77
170
810
1.3
0.18
0.75
4
67
82
200
4.8
77
170
810
1.3
0.18
0.75
5
66
81
200
4.7
77
170
810
1.3
0.18
0.75
6
65
81
200
4.7
77
170
810
1.3
0.18
0.75
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to Ib/yr, divide by 453.6.
B-8
-------
TABLE B-5. BASELINE EMISSIONS COMPARED WITH EMISSIONS
AFTER IMPLEMENTATION OF THE EMISSION GUIDELINES (SCENARIO C)
(Metric Units)
Pollutant, units
PM, Mg/yr
CO, Mg/yr
CDD/CDF, g/yr
TEQ CDD/CDF,
g/yr
HC1, Mg/yr
SO,, Mg/yr
NO,, Mg/yr
Pb, Mg/yr
Cd, Mg/yr
Hg, Mg/yr
Baseline
940
460
7,200
150
5,700
250
1,200
11
1.2
15
Regulatory options
1
310
120
600
13
2,100
250
1,200
5.2
6.62
1.9
2
120
120
310
7.2
140
250
1,200
2.2
0.30
1.1
3
110
120
300
7.1
86
250
1,200
2.1
0.29
1.1
4
110
120
300
7.1
86
250
1,200
2.1
0.29
"1.1
5
100 .
120
300
7.1
86
250
1,200
2.1
0.29
1.1
6
100
120
300
7.1
86
250
1,200
2.1
0.29
1.1
To convert Mg/yr to ton/yr, multiply by 1.1. To convert g/yr to Ib/yr, divide by 453.6.
B-9
-------
si!;:1
;" T I
; il'l h"
c. Cost Impacts. The cost impacts on individual health care facilities that currently
operate an HMIWI vary depending on the regulatory option; the actual cost to purchase and
i; 'i'jwi ,h ... , ' i !',' i|;. ....* i , , . ', - ;, 'I,, ' ., ," ,' .. . ' '. ,' ' i,
install any additional air pollution control equipment; the cost of alternative means of treatment
and disposal where they are located; and other factors, such as liability issues related to
disposal and State and local medical waste treatment and disposal requirements. In general,
facilities with smaller HMIWI will have a greater incentive to use alternative means of
treatment and disposal because their onsite incineration cost (per pound of waste burned) will
iii ij'i , r1 , , , .' ' r, ' '" , i . i ., , .
be higher.
Large health care facilities with larger amounts of waste to be treated or health care
facilities that serve as regional treatment centers for waste generated at other health care
facilities in the area may have some cost advantages compared to smaller facilities. Due to
economies of scale, their cost of burning waste may be lower (i.e., dollars per pound burned),
and they may have already installed some air pollution control equipment. These facilities
may only have to upgrade this equipment to comply with the MACT emission guideline rather
than purchase and install a complete air pollution control system.
Table B-6 contains the estimated increase in national annual costs associated with each
of the regulatory options under scenario A (no switching), scenario B (switching with
separation of waste), and scenario C (switching with no separation of waste). Table B-7
presents the number of small, medium, and large existing MWI that do not switch under each
of the regulatory options for scenarios B and C. As discussed earlier, scenario A is unrealistic
and grossly overstates the national cost impacts. The costs associated with the MACT
emission guidelines under scenarios B and C represent the likely range of national cost
impacts, and only these costs merit serious consideration and review. The nationwide annual
costs presented in Table B-6, excluding scenario A, range from $55.2 milliqn/yr for regulatory
option 1 and scenario B to $131 million/yr for regulatory option 6 and scenario C.
B-10
-------
TABLE B-6. COSTS OF THE REGULATORY OPTIONS FOR THE EMISSION
GUIDELINES (SCENARIOS A, B, AND C)
(MILLION $/YEAR)
Scenario
A
B
C
Regulatory options
1
85.2
55.2
82.2
2
172
59.2
120
3
111
64.2
125
4
185
65.0
126
5
194
65.2
129
6
205
66.3
131
TABLE B-7. NUMBER OF EXISTING MWI'S THAT DO NOT SWITCH
MWI type
Total
Regulatory Option
1
2
3
4
5
6
Scenario B
Small
rural remote
non-rural remote
Medium
Large
Commercial
Total
1,139
114
1,025
692
463
79
2,373
164
114
50
483
198
79
924
114
114
0
38
198
79
429
114
114
0
' fc
38
198
79
429
114
114
0
38
198
79
429
114
114
0
. 2
198
79
393
114
114
0
2
198
79
393
Scenario C
Small
rural remote
non-rural remote
Medium
Large
Commercial
Total
1,139
114
1,025
692
463
79
2,373
708
114
594
692
463
79
1,942
189
114
75
279
463
79
1,010
189
114
75
279
463
79
1,010
. / -f
-~170
114
56
279
463
79
991
170
114
56
232
463
79
- 944
135
1-14
21
232
463
79
909
B-ll
-------
d. Water and Solid Waste Impacts. Estimates of wastewater impacts were developed
for only regulatory option 6, scenario A, which reflects all existing HMIWI equipped with wet
scrubbers in the absence of switching. Assessing these impacts under scenario A without any
consideration of the effect of switching grossly overstates the magnitude of these impacts.
Under scenarios B and C more than half of the existing HMIWI are expected to switch,
resulting in significantly lower impacts.
Under scenario A and regulatory option 6, 198 million gallons of additional wastewater
would be generated annually by existing HMIWI as a result of the MACT emission guideline.
This amount is the equivalent of wastewater produced annually by four large hospitals.
Therefore, when considering the wastewater produced annually at health care facilities
,i ' ' i'l'f! - ," , 'I', ' :.:' ' ' ' '. ., " . ?"; ''.' ^ ,' -
nationwide, the increase in wastewater resulting from the implementation of the MACT
';: "'f|. ; r; r :' / , : , v. . ,"":' -::,. ;> '.:
emission guidelines for existing HMIWI is insignificant.
With regard to solid waste impacts, about 767 thousand Mg (846 thousand tons) of
medical waste are burned annually in existing HMIWI producing about 76,700 Mg/yr
» : , i I.mull i : ,','.. ' ' - 'i'1 'i ' ' ' ' , "
(84,600 tons/yr) of solid waste (bottom ash) disposed of in landfills. To estimate the solid
waste impacts for the MACT emission guidelines, impacts were developed only for regulatory
option 6, scenario B. This option is associated with the most switching and the most
separation of waste for disposal in municipal landfills and, thus, produces the greatest
estimated impact.
Under regulatory option 6, scenario B, 211,000 Mg/yr (233,000 tons/yr) of additional
" solid waste wou|(i result from the adoption of the MACT emission guideline. Compared to
municipal waste, which is disposed in landfills at an annual rate of over 91 million Mg/yr
(100 million tons/yr), this increase from the implementation of the MACT emission guideline
for existing HMIWI is insignificant.
e. Energy Impacts. The emission control technologies used by existing HMIWI to
comply with the MACT emission limits consume energy. Estimates of energy impact were
developed for regulatory option 6, scenario A. Under scenarios B and C, which include
switching, it is not clear whether overall national energy consumption would increase,
decrease, or remain the same. Alternatives to incineration require energy to operate, however,
B-12
-------
information is not available to estimate whether these alternatives use more or less energy than
HMIWI.
The energy impacts associated with the MACT emission guidelines could include
additional auxiliary fuel (natural gas) for combustion controls and additional electrical energy
for operation of the add-on control devices, such as wet scrubbers and dry scrubbers.
^Regulatory option 6, scenario A, could increase total national usage of natural gas for
combustion controls by about 16.6 million cubic meters per year (MMnrYyr) (586 million
cubic feet per year [106 fP/yr]). Total national usage of electrical energy for the operation of
add-on control devices could increase by about 259,000 megawatt hours per year (MW-hr/yr)
(883 billion British thermal units per year [109 Btu/yr]). Once again, compared to the amount
of energy used by health care facilities such as hospitals (approximately 2,460 MMnrYyr of
natural gas and 23.2 million MW-hr/yr of electricity) the increase in energy usage that results
'from implementation of the MACT emission guideline for existing HMIWI is insignificant.
f. Economic Impacts. The goal of the economic impact analysis is to estimate the
.market response of affected industries to the emission guidelines and to identify any adverse
impacts that may occur as a result of the regulation. Industries that operate onsite waste
incinerators (e.g., hospitals, nursing homes, research labs, and commercial waste incinerators)
.and those industries that utilize offsite incinerators (e.g., hospitals, nursing homes,
medical/dental laboratories, funeral homes, physicians offices, dentist offices, outpatient care,
freestanding blood banks, fire and rescue operations, and correctional facilities) will
potentially be affected by the regulation. Industry-wide impacts, including changes in market
price, output or production, revenues, and employment for the affected industries, are
estimated for each regulatory option assuming the three switching scenarios. Facility-specific
impacts are estimated for hospitals of varying sizes, ownership, and operating characteristics;
nursing homes; and commercial research labs based on engineering model plant cost estimates
under each of the three switching scenarios. Facility-specific impacts are estimated for
commercial incineration based upon facility-specific engineering cost estimates.
B-13
-------
"
(i) Analytical approach
The analytical approach used to estimate industry-wide and facility-specific economic
impacts and to evaluate the economic feasibility of substitution is briefly described. For a
more detailed description of the methodology used to estimate economic impacts, refer to the
document "Medical Waste Incinerators - Background Information for Proposed Standards and
Guidelines: Analysis of Economic Impacts for Existing Sources" (EPA-453/R-94-048a). A
revised analysis (using the same methodology with revised costs) is presented 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). Prices are stated in 1993 dollars.
i,, < ' ' '! i|i| ,' ',.' ,1 :",', i ... , .1 .iij
The average price changes that are anticipated to occur in each industry sector for each
of the regulatory options are estimated by comparing the annual control cost estimates to
annual revenues for each affected industry. This calculation provides an indication of the
magnitude of a price change that would occur in order for each industry sector to fully recover
its annual control costs. The resulting ratio of cost-to-revenue represents the average price
',,1 ,, i! , "i. ' i. ' , ',, , ,,| ,, ' ,' ' ' if. 'i i ' ' ' , ' '":' i, , ,'!, ' i i !»
increase necessary for firms in the industry to recover the increased cost of environmental
"!' '" V " "1'i J ! " " ' - '".''. ' ' , ' " " I '' ' ". "" ' " '"! 'i ' ! ' ':' " I " , 'ti
controls. Percent changes in output or production are estimated using the price impact
,, ' ' ' it " ' '""' ' ".'' " '' ' ''"'' ',,,", ' '. j" ''. '. i,,'1',,;" ',' '; ; ,"' -.. , ...;.' " , Jf
estimate and a high and low estimate of the price elasticity of demand for output from that
industry sector. Resulting changes in revenues are estimated based upon the estimated changes
in price and output for an industry. Employment losses or labor market impacts result from
decreases in the output for an industry and are assumed to be proportional to the estimated
1; 'j ' i,,ii ' , J . - . , , ' . -. i a ,t ,l; II-
decrease in output for each industry.
Facility-specific economic impacts are estimated by using model plant information
....... , ; : ' . ; ' «l / .-":.: ., ' - ' r:V. ,i:." ,"; i'V,' '-,.,'.' <: ..... ' , ' ;n:\,tf
under the three switching scenarios. The assumption of no switching (scenario A) will
'.. :,' ' "'v : :::!|!:; " . '" " . - . ', '- : 1;: ; V" > ' ' .'':;" . ' , ".:"".. ," ;l,. , '-'! ' 1; " n
represent the highest cost and economic impact scenario for most of the affected industries
"i ' ".' ; 'at " ' , , ''"'"" : .' . ; : , ' - / .'' ' .li!:1""1 ' i ' , ' : ' ,. " ': i"' ill
while the assumption of switching with waste segregation (scenario B) will represent the lowest
cost and economic impact scenario for most of the affected industries. As previously stated,
EPA considers scenario A to be an unlikely scenario so the economic impacts presented under
scenarios B and C should be regarded as the most realistic estimates.
fit
B-14
-------
(ii) Industry-wide economic impacts
Industry-wide impacts include estimates of the change in market price for the services
provided by the affected industries, the change in market output or production, the change in
industry revenue, and impact on affected labor markets in terms of employment losses or
-workers lost. These impacts are summarized in Tables B-8 and B-9.
As can be seen in Table B-8, industries that generate hospital waste and/or
medical/infectious waste and operate onsite incinerators (i.e., hospitals, nursing homes, etc.)
are expected to experience average price increases in the range of 0 to 0.14 percent, depending
on the industry, regulatory option, and scenario analyzed. Table B-9 shows that these
industries are expected to experience output and employment impacts in the range of 0 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. An increase in industry revenue is
- expected to occur in cases where the price elasticity of demand for an industry's product is
inelastic or between 0 and -1. Such a price elasticity indicates that output changes are not very
responsive to a change in price, specifically that the percentage decrease in output will be less
than the percentage increase in price. Since revenue is a product of price and output, a less
"than proportional change in output compared to price means that total revenue should increase.
The following example illustrates how the above price impacts could be interpreted for
the hospital industry. Table B-8 shows that for hospitals, 0.03 percent is estimated as the price
increase necessary to recover annual control costs assuming regulafBry option 6 (the most
stringent regulatory option) and scenario C, switching with no waste segregation. This change
in price can be expressed in terms of the increased cost of hospitalization due to the regulation.
Total nationwide adjusted patient days at hospitals in 1993 were an estimated 304.5 million
days. ("Adjusted" patient-days include both in-patient days and the in-patient equivalent of
out-patient days at hospitals.) The total annualized control cost under regulatory option 6,
scenario C for the hospital industry is $92.2 million, or $.30 per adjusted patient day. This
Tneans the average price increase that an individual would experience for each hospital patient-
day is expected to equal 30 cents.
B-15
-------
TABLE B-8.
SOURCES
Industry
Hospitals
Nursing homes
Laboratories:
Research
Medical/dental
Funeral homes
Physicians offices
Dentists offices and
clinics
Outpatient care
Freestanding blood
banks
Fire and rescue
operations
Correctional facilities
Commercial
incineration
Range for regulatory options !$, ..
Scenario A
no switching
0.02-0.05
0.02-0.05
0.05-0.14
0
0
0
0
0
0
0
0
2.6
Scenario B
switching with
waste segregation
0.01
0.01
0.03-0.04
0
0
0
0
0
0
0
0
2.6
Scenario C
switching with no
waste segregation
0.02-0.03
0.02-0.03
0.05-0.09
0
0
0
0
0
0
0
0
2.6
* The price increase percentages reported represent the
control costs for each industry.
price increase necessary to recover annualized emission
B-16
-------
TABLE B-9. HOSPITAL/MEDICAL/INFECTIOUS WASTE
INCINERATION INDUSTRY-WIDE OUTPUT, EMPLOYMENT AND REVENUE
IMPACTS - EXISTING SOURCES
Industry
Hospitals
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Nursing homes
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Laboratories:
Research
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Medical/dental
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Funeral homes
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Physicians offices
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Dentists offices and clinics
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Outpatient care
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Freestanding blood banks
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Fire and rescue operations
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Correctional facilities
Output decrease (%)
Employment loss (# of jobs)
Revenue increase or (decrease) (%)
Range for regulatory options 1-6
Scenario A
no switching
0-0.02
0-660
0.01-0.05
0.01-0.03
97-494
0.01-O.03
0.05-0.18
87-287
(0.04)-0
0
2-4
0
0
0
0
0
0-1
0
0
1
0
0
0-1
0
0
0
0
0
0
0
0
0
0
Scenario B
switching with
waste segregation
0-0.01
0-202
0.01
0-0.01
61-151
0-0.01
0.03-0.06
54-88
(0.01)-0
0
2-4
0
0
0
0
0
0-1
0
0
1
0
0
0-1
0
0
0
0
0
0
0
0
0
0
Scenario C
switching with no
waste segregation
0-0.01
0-415
0.01-0.03
0.01-0.02
94-310
0.01-0.02
0.05-0.11
83-180
(0.03)-0
0
2-4
0
0
0
0
0
0-1
0
0
1
0
0
0-1
0
0
0
0
0
0
0
0
0
0
B-17
-------
;:>', >;;
Table B-8 also shows that the average price impact for the commercial HMIWI
industry is approximately a 2.6 percent increase in price. Cost and economic impact estimates
are the same for the commercial HMIWI industry regardless of the regulatory option analyzed
because all six regulatory options specify identical regulatory requirements. Average industry-
wide output, employment, and revenue impacts were not estimated for this sector because data
>such as price elasticity estimates and employment levels were not available.
(iii) Facility-specific impacts
Facility-specific impacts were also estimated for the affected industries. The facility
specific price increase is the price increase necessary for an individual facility to fully recover
control costs and it is calculated as the ratio of model facility annualized control costs to
annual revenue^ These estimates, presented in Tables B-lOa and B-lOb, were calculated for
the three switching scenarios. A cost as a percent of revenue/budget ratio was calculated to
provide an indication of the magnitude of the impact of the regulation on an uncontrolled
facility in each industry sector. The facility-specific cost to revenue/budget ratio was
11 i:" : ' - HI . :,, , " .. . ' /-"'; : ; ' . . .:
compared to the industry-wide price impact to determine if the facility's impacts differ
Significantly from the average industry-wide impacts. This calculation was then compared to
/' ,M ' '. ' ' . . .'.',.'' V ' " , , ' ":
the industry-wide price impact to determine if the facility's impacts differ significantly from
the average industry-wide impacts. A determination of significanceimplying that the facility
price increase may not be achievableis made for all but commercial HMIWI operators if the
facility price increase exceeds the average industry-wide, or "market" price increase by more
than one percentage point. For commercial HMIWI operators, the facility price increase is
considered significant if it exceeds the market price increase by more than two percentage
points. More pricing latitude is given to commercial HMIWI operators for two reasons: (1)
commercial incineration is not subject to the same institutional pricing constraints as the health
care sector, and (2) commercial incineration fees could actually get a boost from the regulation
as a result of switching from onsite incineration and an increase in the demand for commercial
incineration services. Where significance is found, the impact on net income (earnings) of
absorbing control costs is estimated and evaluated.
B-18
-------
TABLE B-lOa. HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATION PER
FACILITY IMPACTS ASSUMING NO SWITCHING AND ONSITE INCINERATION -
EXISTING SOURCES ANNUALIZED CONTROL COST AS A PERCENT OF"
REVENUE/BUDGET (%)
Industry
Hospitals - Short term, excluding psychiatric:
Federal Government:
Small
Urban and rural, not remote or 2 2000 Ibs./week
Rural, remote and < 2000 Ibs./week
Medium
Large
State Government:
Small
Urban and rural, not remote or 2 2000 Ibs./week
Rural, remote and < 2000 Ibs./week
Medium
Large
Local Government:
Small
Urban and rural, not remote or 2 2000 Ibs./week
Rural, remote and < 2000 Ibs./week
Medium
Large
Not-for-profit:
Small
Urban and rural, not remote or £ 2000 Ibs./week
Rural, remote and < 2000 Ibs./week
Medium
Large
For-profit:
Small
Urban and rural, not remote or 2. 2000 Ibs./week
Rural
Medium
Large
Hospitals - Psychiatric, short term and long term:
Small
Urban and rural, not remote or 2 2000 Ibs./week
Rural, remote and < 2000 Ibs./week
Medium
Large
Nursing Homes:
Tax-Paying
Urban and rural, not remote or a 2000 Ibs./week
Rural, remote and < 2000 Ibs./week
Tax-exempt
Urban
Rural
Scenario A - no switching
Option
1
0.11
0.11
0.20
0.13
0.23
0.23
0.21
0.07
0.36
0.36
0.32
0.10
0.25
0.25
0.24
0.11
0.28
0.28
0.25
0.14
0.38
0.38
0.58
0.47
0.41
0.41
0.42
0.42
Option
2
0.38
0.11
0.20
0.13
0.82
0.23
0.21
0.07
1.27
0.36
0.32
0.10
0.86
0.25
0.24
0.11
0.97
0.28
0.25
0.14
1.34
0.38
0.58
0.47
1.45
0.41
1.49
0.42
Option
3
0.38
0.38
0.20
0.13
0.82
0.82
0.21
0.07
1.27
1.27
0.32
0.10
0.86
0.86
0.24
0.11
0.97
0.97
0.25
0.14
1.34
1.34
0.58
0.47
1.45
1.45
1.49
1.49
Option
4
0.42
0.42
0.20
0.13
0.89
0.89
0.21
0.07
1.39
1.39
0.32
.010
0.94
0.94
0.24
0.11
1.06
1.06
0.25
0.14
1.46
1.46
0.58
0.47
1.59
1.59
1.62
1.62
Option
5
0.42
0.42
0.23
0.13
0.89
0.89
0.24
0.07
1.39
1.39
0.36
0.10
0.94
0.94
0.27
0.11
1.06
1.06
0.28
0.14
1.46
1.46
0.66
0.47
1.59
1.59
1.62
1.62
Option
6
0.47
0.47
0.23
0.13
1.01
1.01
0.24
0.07
1.57
1.57
0.36
0.10
1.06
1.06
0.28
0.11
1.20
1.20
0.28
0.14
1.65
1.65
0.66
0.47
1.79
1.79
1.83
1.83
B-19
-------
TABLE B-lOa. (continued)
Industry
Commercial research labs:
Tax-paying
Tax-exempt
Commercial Incineration Facilities"
Scenario A - no switching
Option
1
0.41
0.41
0-
18.36
Option
2
0.41
0.41
0-
18.36
Option
3
0.41
0.41
0-
18.36
Option
4
0.47
0.47
0-
18.36
Option
5
0.47
0.47
0-
20.69
Option
6
0.47
0.47
0-
20.69
commercial incinerators. Only three of these facilities are
"This is the range of impacts for all 59 facilities operating
anticipated to experience cost to revenue/budget ratios exceeding the significance criteria of 4.6 percent.
B-20
-------
TABLE B-lOb. HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATION PER
FACILITY IMPACTS ASSUMING SWITCHING FROM ONSITE INCINERATION TO
COMMERCIAL DISPOSAL ALTERNATIVES - EXISTING SOURCES ALTERNATIVE
WASTE DISPOSAL COST AS A PERCENT OF REVENUE/BUDGET (%)
Industry
Hospitals - Short term, excluding psychiatric:
Federal Government:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
State Government:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Local Government:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Not-for-profit:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Por-profit:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Hospitals - Psychiatric, short term and long term:
Small - Urban
Rural
Medium - Urban
Rural
Large - Urban
Rural
Scenario B -
switching with
waste segregation
0.03
0.04
0.05
0.06
0.08
0.11
0.06
0.08
0.05
0.07
0.05
0.06
0.09
0.13
0.07
0.08
0.06
0.08
0.06
0.09
0.05
0.08
0.07
0.10
0.07
0.10
0.06
0.08
0.09
0.12
0.10
0.14
0.13
0.19
0.29
0.40
Scenario C -
switching without
waste segregation
0.10
0.17
0.17
0.27
0.29
0.47
0.22
0.36
0.18
0.29
0.16
0.27
0.34
0.56
0.27
0.44
0.22
0.36
0.23
0.38
0.20
0.32
0.25
0.41
0.26
0.43
0.21
0.34
0.32
0.52
0.36
0.59
0.48
0.78
1.05
1.70
B-21
-------
v t;
'" ' tar
i I IS'"!-
TABLE B-10b. (continued)
Industry
Nursing Homes:
Tax-Paying- Urban
Rural
Tax-exempt- Urban
Rural
Commercial research labs:
Tax-Paying - Urban
Rural
Tax-exempt- Urban
Rural
Scenario B -
switching with
waste segregation
0.11
0.15
0.11
0.15
0.09
0.13
0.09
0.13
Scenario C -
switching without
waste segregation
0.39
0.64
0.40
0.65
0.34
0.56
0.34
0.56
B-22
-------
Excluding commercial incineration, Tables B-lOa and B-lOb show that facilities with
onsite HMIWI that are currently uncontrolled may experience impacts ranging from
0.03 percent to 1.83 percent, depending on the industry, regulatory option, and scenario
analyzed. Commercial incinerator impacts range from 0 to 20.69 percent. A comparison of
-the facility-specific economic impacts expected to occur under the three switching scenarios to
-market price increases indicates that the impacts for facilities that operate onsite HMIWI are
^generally insignificant. Either the cost of controls or the cost of switching to an alternative
waste treatment and disposal method could be recovered with a price increase that does not
significantly exceed the market price increase. For many firms currently operating onsite
HMIWI the option of switching will be attractive because the economic impacts of switching
to an alternative method of waste disposal are much lower than the economic impacts from
installing emission control equipment for facilities that are currently uncontrolled.
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 (defined as more than 50 miles away from an SMSA and burning
-less than 2,000 pounds of waste per week), which may not have access to waste hauling and/or
^commercial incineration services. For commercial HMIWI operators, three of the 59 facilities
^operating the 79 commercial HMIWI in the HMIWI inventory were found to be significantly
impacted by the regulation (under all six regulatory options). These facilities may not have to
shut down, since they are completely uncontrolled in the baseline 'arid therefore may currently
enjoy a cost advantage over their competitors (most of which are at least partially controlled in
the baseline), and that the regulation will bring aboutdue to switching away from onsite
incinerationan increase in the demand for commercial incineration services. Impacts are not
significant for small, rural, remote HMIWI operators under regulatory options 1 and 2. Under
regulatory options 3 through 6, on the other hand, some of these facilities are significantly
Tmpacted and might therefore have to shut down.
B-23
-------
Table B-l 1 shows the impacts that would be incurred by medical waste generators that
hi!" , i i. ' ,i, inn . ni T . , 1,1 < < , i,
currently use an pffsite waste incineration service. These impacts range from 0 to 0.02 percent
and are considered negligible impacts. These results indicate that the incremental costs for the
vast majority of medical waste generators are expected to be small.
," : ' !; ' ' 'I';! ' !': >; , ' ; . ,' ""V ' " " . :l '". ' '[' .' ' ' .'' ' ' ' ' ; ':
This economic impact analysis examines hidustries that are directly impacted by the
regulation, namely industries that generate or treat medical waste. Secondary impacts such as
those on air pollution device vendors and HMIWI vendors were not evaluated due to data
limitations. However, it can be said that air pollution device vendors are expected to
experience an increase hi demand for their products due to the regulation. The regulation is
"'''/ , «" . , 7"!] ; !>'; ; : ,, ': * .' .',:. , *,.' ' , > . I'..' il Mi;
also expected to mcrease the demand for commercial HMIWI services. Due to economies of
scale, however, there is likely to be a demand shift from smaller incinerators to larger
incinerators. Therefore, vendors of small HMIWI potentially may be adversely affected by the
regulation.
B-24
-------
TABLE B-l 1. HOSPITAL/MEDICAL/INFECTIOUS WASTE INCINERATION
PER FACILITY IMPACTS FOR FIRMS THAT UTILIZE OFFSITE WASTE
INCINERATION - EXISTING SOURCES INCREMENTAL ANNUAL COST AS A
PERCENT OF REVENUE/BUDGET (%)
Industry
Hospitals
<50 Beds
50-99 Beds
100-299 Beds
300+ Beds
Nursing Homes
0-19 Employees
Tax-paying
Tax-exempt
20-99 Employees
Tax-paying
Tax-exempt
100+ Employees
Tax-exempt
Tax-paying
Commercial Research Labs
Tax-paying
0-19 Employees
20-99 Employees
100+ Employees
Tax-exempt
Outpatient Care Clinics
Physicians clinics (Amb. Care)
Tax-paying
Tax-exempt
Freestanding kidney dialysis facilities
Tax-paying
Tax-exempt
Physicians offices
Dentists offices and clinics
Offices
Clinics
Tax-paying
Tax-exempt
Medical & dental Labs
Medical
Dental
Freestanding blood banks
Funeral Homes
Fire & Rescue
Corrections
Federal Government
State Government
Local Government
Incremental annual cost as a percent of revenue
0-0.01
0-0.01
0-0.01
0-0.01
0
0
0
0
0
0
0
0
0
0
0
o
0
0-0.01
0
0
0
s o
0-0.01
0-0.01
0-0.02
0
0
0
0
0
B-25
-------
g. Benefits Analysis. Implementation of the emission guidelines for HMIWI is
expected to reduce emissions of hazardous air pollutants, dioxin/furan, and criteria air
pollutants. Reduction in a variety of HAP including Cd, HC1, Pb, and Hg is expected as a
result of the regulation. Dioxin/furan emissions are also expected to be reduced. In addition,
decreases in thefollbwing criteria air pollutants are anticipated: PM, SO2, CO, and NOX. 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 unproved visibility and crop yields.
While the Agency believes that the health and environmental benefits of this rule are
I, : , a n ° J : i , ...,. . . ! ; '. ' . v
quite significant, the EPA is not currently able to quantitatively evaluate all human and
'; :' . ll " .'/: - ;. ' " ' :'. '::' < !' -; , -^i"
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. A qualitative discussion of the health and welfare benefits of the HMIWI
rule follows. The quantitative assessment of the benefits associated with the rule is limited to
the monetized value of PM emission reductions. Although the monetized benefits associated
'>;1" j ,.'" '" H ',,,., '.> ; : , ; , . ls.' <.: V! '; r; ' ':, ." '.'" ' ., '.":,;,
with PM emission reductions are compared to the estimated annualized emission control costs
I:;;, ' ' ' "V;;! '" :. '. "',:. ; ' > " > . ,;, " : ,;;, ;,;;> ": , * '., , , .''.''. ; /..r1'
of the regulation, the EPA recognizes that 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.
(i) Qualitative discussion of benefits
''/' ' « :P.I. : ' " "' ' " ' ,'' : !' ! '.!.!'' , ' " ,, , " ': "^ ' ' ' i :> ' " ' , ' . '
Emissipn reductions of Cd, Pb, HC1, and Hg are expected to occur as a result of the
HMIWI guidelines. Health effects associated with exposures to Cd and Pb include probable
carcinogenic effects. Respiratory effects are associated with exposure to Cd, HC1, 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
guidelines Exposure to dioxin/furan has been linked to reproductive and developmental
Jilt
II
B-26
-------
effects, changes in hormone levels, and chloracne. Toxic Equivalent Quantity (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 non-asthmatics. 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.
(ii) Quantitative assessment of benefits
Concentration-response functions have been developed for the majority of the health
and welfare effects mentioned above. In these functions, a quantitative relationship between a
specific health or welfare end point and exposure is established. Exposure, however, is
generally measured by models in terms of ambient concentration of a pollutant. To do this,
facility-specific information is needed to determine how changes in control technologies will
B-27
-------
:." "A: ' ' '.:>'. .'''.
in 1 '"' '
impact pollutant concentrations in the ambient air. Because such data are not available to
model changes in ambient air concentrations, a direct application of these concentration-
i ' 'I'iii , !- " iii ' ii"; ' ' ,!" '" ' '., ' i
response functions to the present analysis is not possible.
However* an approximation of the magnitude of these effects can be obtained using the
results of existing studies that have evaluated the health and welfare effects of reductions in
pollutant concentrations. A review of available studies reveals one study of PM benefits that
can be used to estimate benefits of PM reductions from the HMIWI rule. Specifically, a study
of the benefits and costs of selected new source performance standards for paniculate matter is
particularly useful to develop quantitative benefit estimates for the PM emission reductions.
Two more recent PM studies, "The Benefits and Costs of the Clean Air Act, 1970 to 1990"
and "Regulatory Impact Analysis for Proposed Particulate Matter National Ambient Air
Quality Standard" (1996) are expected to update these values. Since they are both currently in
draft form, they were not able to be used as of the completion of this analysis. Unfortunately,
no studies are representative or available to approximate the benefits associated with the SO2,
CO, and NOX emission reductions.
The selected study of PM benefits considered a diverse set of sources located in over
600 counties in the United States to develop estimates of the benefits per ton of PM reduced.
The benefit categories considered in this analysis included mortality, morbidity, household
soiling, and materials damage. The national weighted average (weighted by emissions
reduced) of benefit per ton .values estimated for 1995 was $6,075 (1993 dollars). Although
wide variations exist in the amount of benefits obtained across different areas (depending on
the exposed population, geographic and meteorological conditions, and the ambient
concentrations of PM), this analysis assumes that the weighted value of $6,075 per ton is
:» , , ' II . ' ."',',., '::' ' ' '' ' 'I*,',
representative on average. .
Tables B 12 and B-13 summarize the annualized emission control costs, the monetized
j1 V , IN! ' ' >'' " .'';. - ' ..': .; :; '4 .",?'..-,; ,v '''., ' ;> ' .'. '["*
benefits and net benefits (costs) associated with regulatory options under scenarios B and C of
the emission guidelines.
/!' ' f'j
sis V>
B-28
-------
TABLE B-12. MONETIZED COSTS, BENEFITS, AND NET BENEFITS FOR
HMIWI REGULATORY OPTIONS - EMISSION GUIDELINES
(thousands of 1993 dollars)
Reg Option 1
Reg Option 2
Reg Option 3
Reg Option 4
Reg Option 5
Reg Option 6
Scenario B
Monetized benefits,
$a
5,000
5,814
5,838
5,844
5,856
5,856
Total annualized
costs, $
55,205
59,155
64,201
64,961
65,213
66,327
Net benefits (costs),
$
(50,205)
(50,342)
(58,363)
(59,117)
(59,358)
(60,471)
"Only the benefits from PM emission reductions have been monetized.
TABLE B-13. MONETIZED COSTS, BENEFITS, AND NET BENEFITS FOR
HMIWI REGULATORY OPTIONS - EMISSION GUIDELINES
(thousands of 1993 dollars)
Reg Option 1
Reg Option 2
Reg Option 3
Reg Option 4
Reg Option 5
Reg Option 6
Scenario C
Monetized benefits,
$a
4,234
5,510
5,534
5,559
5,601
5,607
Total
annualized
costs, $
82,184
119,727
124,773
126,394
129,290
130,737
Net benefits (costs),
$
(77,950)
(114,217)
(119,239)
(120,835)
(123,689)
(125,130)
B-29
-------
,st r:
TfflS PAGE INTENTIONALLY LEFT BLANK
B-30
-------
TECHNICAL REPORT DATA
(Please read Instructions on reverse before completing)
1. REPORT NO.
EPA-453/R-97-006b
3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
Hospital/Medical/Infectious Waste Incinerators:
Background Information for Promulgated Standards and
Guidelines - Summary of Public Comments and Responses
5. REPORT DATE
July 1997
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
8. PERFORMING ORGANIZATION REPORT NO.
9. PERFORMING ORGANIZATION NAME AND ADDRESS
Emission Standards Division (Mail Drop 13)
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
68-D6-0012
12. SPONSORING AGENCY NAME AND ADDRESS
Director
Office of Air Quality Planning and Standards
Office of Air and Radiation
U. S. Environmental Protection Agency
Research Triangle Park, NC 27711
13. TYPE OF REPORT AND PERIOD COVERED
Final
14. SPONSORING AGENCY CODE
EPA/200/04
15. SUPPLEMENTARY NOTES
Published in conjunction with promulgated air emission standards and guidelines for
hospital/medical/infectious waste incinerators
16. ABSTRACT
This report presents a summary of public comments regarding development of air emission
standards and guidelines for new and existing hospital/medicayinfectious waste incinerators
(HMIWI) and EPA's responses to those comments.
17.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b. IDENTIFIERS/OPEN ENDED TERMS
c. COSATI Field/Group
Air Pollution
Pollution Control
Standards of Performance
Emission Guidelines
Medical Waste Incinerators
Hospital/Medical/Infectious Waste Incinerators
Air Pollution Control
Solid Waste
Medical Waste
Incineration
Hospital Waste
Infectious Waste
18. DISTRIBUTION STATEMENT
Release Unlimited
19. SECURITY CLASS (Report)
Unclassified
21. NO. OF PAGES
266
20. SECURITY CLASS (Page)
Unclassified
22. PRICE
EPA Form 2220-1 (Rev. 4-77) PREVIOUS EDITION IS OBSOLETE
J:\dms\480001\trd
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