Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Hospital/Medical/Infectious Waste Incinerators, 51368-51415 [E9-22928]
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 60
[EPA–HQ–OAR–2006–0534; FRL–8959–9]
RIN 2060–A004
Standards of Performance for New
Stationary Sources and Emissions
Guidelines for Existing Sources:
Hospital/Medical/Infectious Waste
Incinerators
CPrice-Sewell on DSKJ8SOYB1PROD with RULES2
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: On September 15, 1997, EPA
adopted new source performance
standards (NSPS) and emissions
guidelines (EG) for hospital/medical/
infectious waste incinerators (HMIWI).
The NSPS and EG were established
under Sections 111 and 129 of the Clean
Air Act (CAA or Act). In a response to
a suit filed by the Sierra Club and the
Natural Resources Defense Council
(Sierra Club), the U.S. Court of Appeals
for the District of Columbia Circuit (the
Court) remanded the HMIWI regulations
on March 2, 1999, for further
explanation of EPA’s reasoning in
determining the minimum regulatory
‘‘floors’’ for new and existing HMIWI.
The HMIWI regulations were not
vacated and were fully implemented by
September 2002. On February 6, 2007,
we published our proposed response to
the Court’s remand. Following recent
court decisions and receipt of public
comments regarding the proposal, we
re-assessed our response to the remand,
and on December 1, 2008, we published
another proposed response and solicited
public comments. This action
promulgates our response to the Court’s
remand and also satisfies the CAA
Section 129(a)(5) requirement to
conduct a review of the standards every
5 years.
DATES: The amendments to 40 CFR
60.32e, 60.33e, 60.36e, 60.37e, 60.38e,
60.39e, Table 1A and 1B to subpart Ce,
and Tables 2A and 2B to subpart Ce are
effective as of December 7, 2009. The
amendments to 40 CFR 60.17, 60.50c,
60.51c, 60.52c, 60.55c, 60.56c, 60.57c,
60.58c, and Tables 1A and 1B to subpart
Ec are effective as of April 6, 2010. The
incorporation by reference of certain
publications listed in the regulations is
approved by the Director of the Federal
Register as of April 6, 2010.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OAR–2006–0534 and
Legacy Docket ID No. A–91–61. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., confidential business information
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through https://
www.regulations.gov or in hard copy at
the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the EPA Docket Center is
(202) 566–1742.
FOR FURTHER INFORMATION CONTACT: Mr.
Ketan D. Patel, Natural Resources and
Commerce Group, Sector Policies and
Programs Division (E143–03),
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711; telephone number: (919) 541–
9736; fax number: (919) 541–3470; email address: patel.ketan@epa.gov.
SUPPLEMENTARY INFORMATION:
Organization of This Document. The
following outline is provided to aid in
locating information in this preamble.
I. General Information
A. Does the Final Action Apply to Me?
B. Where Can I Get a Copy of This
Document?
C. Judicial Review
II. Background
III. Summary of the Final Rule and Changes
Since Proposal
A. Remand Response
B. Clean Air Act Section 129(a)(5) 5-Year
Review Response
C. Other Amendments
D. Implementation Schedule for Existing
Hospital/Medical/Infectious Waste
Incinerators
E. Changes to the Applicability Date of the
1997 New Source Performance Standards
F. Startup, Shutdown, and Malfunction
Exemption
IV. Summary of Major Comments and
Responses
A. Applicability
B. Subcategorization
C. MACT Floor Approach
D. Emissions Limits
E. Monitoring
F. Emissions Testing
G. Alternatives to On-Site Incineration
H. Medical Waste Segregation
I. Startup, Shutdown, and Malfunction
J. Economic Impacts
V. Impacts of the Final Action for Existing
Units
A. What Are the Primary Air Impacts?
B. What Are the Water and Solid Waste
Impacts?
C. What Are the Energy Impacts?
D. What Are the Secondary Air Impacts?
E. What Are the Cost and Economic
Impacts?
VI. Impacts of the Final Action for New Units
A. What Are the Primary Air Impacts?
B. What Are the Water and Solid Waste
Impacts?
C. What Are the Energy Impacts?
D. What Are the Secondary Air Impacts?
E. What Are the Cost and Economic
Impacts?
VII. Relationship of the Final Action to
Section 112(c)(6) of the Clean Air Act
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution or Use
I. National Technology Transfer
Advancement Act
J. Executive Order 12898: Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. General Information
A. Does the Final Action Apply to Me?
Regulated Entities. Categories and
entities potentially affected by the final
action are those which operate hospital/
medical/infectious waste incinerators
(HMIWI). The new source performance
standards (NSPS) and emissions
guidelines (EG) for HMIWI affect the
following categories of sources:
Category
NAICS Code
Examples of potentially regulated entities
Industry ............................................
622110, 622310, 325411, 325412,
562213, 611310.
Federal Government .......................
622110, 541710, 928110 ..............
Private hospitals, other health care facilities, commercial research
laboratories, commercial waste disposal companies, private universities.
Federal hospitals, other health care facilities, public health service,
armed services.
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Category
NAICS Code
Examples of potentially regulated entities
State/local/Tribal Government .........
622110, 562213, 611310 ..............
State/local hospitals, other health care facilities, State/local waste disposal services, State universities.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by the final action. To
determine whether your facility would
be affected by the final action, you
should examine the applicability
criteria in 40 CFR 60.50c of subpart Ec
and 40 CFR 60.32e of subpart Ce. If you
have any questions regarding the
applicability of the final action to a
particular entity, contact the person
listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
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B. Where Can I Get a Copy of This
Document?
In addition to being available in the
docket, an electronic copy of this final
action will also be available on the
Worldwide Web (WWW) through the
Technology Transfer Network (TTN).
Following signature, a copy of the final
action will be posted on the TTN’s
policy and guidance page for newly
proposed or promulgated rules at the
following address: https://www.epa.gov/
ttn/oarpg/. The TTN provides
information and technology exchange in
various areas of air pollution control.
C. Judicial Review
Under Section 307(b)(1) of the Clean
Air Act (CAA or Act), judicial review of
this final rule is available only by filing
a petition for review in the U.S. Court
of Appeals for the District of Columbia
Circuit (the Court) by December 7, 2009.
Under Section 307(d)(7)(B) of the CAA,
only an objection to this final rule that
was raised with reasonable specificity
during the period for public comment
can be raised during judicial review.
CAA Section 307(d)(7)(B) also provides
a mechanism for EPA to convene a
proceeding for reconsideration, ‘‘[i]f the
person raising an objection can
demonstrate to EPA that it was
impracticable to raise such objection
within [the period for public comment]
or if the grounds for such objection
arose after the period for public
comment (but within the time specified
for judicial review) and if such objection
is of central relevance to the outcome of
the rule.’’ Any person seeking to make
such a demonstration to us should
submit a Petition for Reconsideration to
the Office of the Administrator,
Environmental Protection Agency,
Room 3000, Ariel Rios Building, 1200
Pennsylvania Ave., NW., Washington,
DC 20460, with a copy to the person
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listed in the preceding FOR FURTHER
section, and the
Associate General Counsel for the Air
and Radiation Law Office, Office of
General Counsel (Mail Code 2344A),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20004. Moreover, under Section
307(b)(2) of the CAA, the requirements
established by this final rule may not be
challenged separately in any civil or
criminal proceedings brought by EPA to
enforce these requirements.
INFORMATION CONTACT
II. Background
Section 129 of the CAA, entitled
‘‘Solid Waste Combustion,’’ requires
EPA to develop and adopt new source
performance standards (NSPS) and
emissions guidelines (EG) for solid
waste incineration units pursuant to
CAA Sections 111 and 129. Sections
111(b) and 129(a) of the CAA (NSPS
program) address emissions from new
HMIWI, and CAA Sections 111(d) and
129(b) (EG program) address emissions
from existing HMIWI. The NSPS are
directly enforceable Federal regulations,
and under CAA Section 129(f)(1)
become effective 6 months after
promulgation. Under CAA Section
129(f)(2), the EG become effective and
enforceable as expeditiously as
practicable after EPA approves a State
plan implementing the EG but no later
than 3 years after such approval or 5
years after the date the EG are
promulgated, whichever is earlier.
A HMIWI is defined as any device
used to burn hospital waste or medical/
infectious waste. Hospital waste means
discards generated at a hospital, and
medical/infectious waste means any
waste generated in the diagnosis,
treatment, or immunization of human
beings or animals, in research pertaining
thereto, or in the production or testing
of biologicals (e.g., vaccines, cultures,
blood or blood products, human
pathological waste, sharps). As
explained in EPA’s regulations,
hospital/medical/infectious waste does
not include household waste, hazardous
waste, or human and animal remains
not generated as medical waste. A
HMIWI typically is a small, dualchamber incinerator that burns on
average about 800 pounds per hour
(lb/hr) of waste. Smaller units burn as
little as 15 lb/hr while larger units burn
as much as 3,700 lb/hr, on average.
Incineration of hospital/medical/
infectious waste causes the release of a
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wide array of air pollutants, some of
which exist in the waste feed material
and are released unchanged during
combustion, and some of which are
generated as a result of the combustion
process itself. These pollutants include
particulate matter (PM); heavy metals,
including lead (Pb), cadmium (Cd), and
mercury (Hg); toxic organics, including
chlorinated dibenzo-p-dioxins/
dibenzofurans (CDD/CDF); carbon
monoxide (CO); nitrogen oxides (NOX);
and acid gases, including hydrogen
chloride (HCl) and sulfur dioxide (SO2).
In addition to the use of pollution
prevention measures (i.e., waste
segregation) and good combustion
control practices, HMIWI are typically
controlled by wet scrubbers or dry
sorbent injection fabric filters (dry
scrubbers).
Waste segregation is the separation of
certain components of the waste stream
in order to reduce the amount of air
pollution emissions associated with that
waste when incinerated. The separated
waste may include paper, cardboard,
plastics, glass, batteries, aluminum cans,
food waste, or metals. Separation of
these types of wastes reduces the
amount of chlorine- and metalcontaining wastes being incinerated,
which results in lower potential
emissions of HCl, CDD/CDF, Hg, Cd,
and Pb.
Combustion control includes the
proper design, construction, operation,
and maintenance of HMIWI to destroy
or prevent the formation of air
pollutants prior to their release to the
atmosphere. Test data indicate that as
secondary chamber residence time and
temperature increase, emissions
decrease. Combustion control is most
effective in reducing CDD/CDF, PM, and
CO emissions. The 2-second combustion
level, which includes a minimum
secondary chamber temperature of
1800 °F and residence time of 2 seconds,
is considered to be the best level of
combustion control (i.e., good
combustion) that is applied to HMIWI.
Wet scrubbers and dry scrubbers
provide control of PM, CDD/CDF, HCl,
and metals, but do not influence CO or
NOX and have little impact on SO2 at
the low concentrations emitted by
HMIWI. (See Legacy Docket ID No.
A–91–61, item II–A–111; 60 FR 10669,
10671–10677; and 61 FR 31742–31743.)
The CAA sets forth a two-stage
approach to regulating emissions from
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incinerators. EPA has substantial
discretion to distinguish among classes,
types and sizes of incinerator units
within a category while setting
standards. In the first stage of setting
standards, CAA Section 129(a)(2)
requires EPA to establish technologybased emissions standards that reflect
the maximum levels of control EPA
determines are achievable for new and
existing units, after considering costs,
non-air quality health and
environmental impacts, and energy
requirements associated with the
implementation of the standards.
Section 129(a)(5) then directs EPA to
review those standards and revise them
as necessary every 5 years. In the second
stage, Section 129(h)(3) requires EPA to
determine whether further revisions of
the standards are necessary in order to
provide an ample margin of safety to
protect public health or to prevent
(taking into consideration costs, energy,
safety and other relevant factors) an
adverse environmental effect. See, e.g.,
NRDC and LEAN v. EPA, 529 F.3d 1077,
1079–80 (DC Cir. 2008) (addressing the
similarly required two-stage approach
under CAA Sections 112(d) and (f), and
upholding EPA’s implementation of
same).
In setting forth the methodology EPA
must use to establish the first-stage
technology-based NSPS and EG, CAA
Section 129(a)(2) provides that
standards ‘‘applicable to solid waste
incineration units promulgated under
Section 111 and this Section shall
reflect the maximum degree of
reduction in emissions of [certain listed
air pollutants] that the Administrator,
taking into consideration the cost of
achieving such emissions reduction,
and any non-air quality health and
environmental impacts and energy
requirements, determines is achievable
for new and existing units in each
category.’’ This level of control is
referred to as a ‘‘maximum achievable
control technology,’’ or MACT,
standard.
In promulgating a MACT standard,
EPA must first calculate the minimum
stringency levels for new and existing
solid waste incineration units in a
category, generally based on levels of
emissions control achieved or required
to be achieved by the subject units. The
minimum level of stringency is called
the MACT ‘‘floor,’’ and CAA Section
129(a)(2) sets forth differing levels of
minimum stringency that EPA’s
standards must achieve, based on
whether they regulate new and
reconstructed sources, or existing
sources. For new and reconstructed
sources, CAA Section 129(a)(2) provides
that the ‘‘degree of reduction in
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emissions that is deemed achievable
[* * *] shall not be less stringent than
the emissions control that is achieved in
practice by the best controlled similar
unit, as determined by the
Administrator.’’ Emissions standards for
existing units may be less stringent than
standards for new units, but ‘‘shall not
be less stringent than the average
emissions limitation achieved by the
best performing 12 percent of units in
the category (excluding units which first
met 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).’’
The MACT floors form the least
stringent regulatory option EPA may
consider in the determination of MACT
standards for a source category. EPA
must also determine whether to control
emissions ‘‘beyond-the-floor,’’ after
considering the costs, non-air quality
health and environmental impacts, and
energy requirements of such more
stringent control. EPA made such
MACT floor and beyond-the-floor
determinations and on September 15,
1997, adopted NSPS (40 CFR part 60,
subpart Ec) and EG (40 CFR part 60,
subpart Ce) using this approach for
entities which operate HMIWI. The
NSPS and EG are designed to reduce air
pollution emitted from new and existing
HMIWI, including HCl, CO, Pb, Cd, Hg,
PM, CDD/CDF (total, or 2,3,7,8tetrachlorinated dibenzo-p-dioxin toxic
equivalent (TEQ)), NOX, SO2, and
opacity. The 1997 NSPS apply to
HMIWI for which construction began
after June 20, 1996, or for which
modification began after March 16,
1998. The 1997 NSPS became effective
on March 16, 1998, and apply as of that
date or at start-up of a HMIWI,
whichever is later. The 1997 EG apply
to HMIWI for which construction began
on or before June 20, 1996, and required
compliance by September 2002.
On November 14, 1997, the Sierra
Club and the Natural Resources Defense
Council (Sierra Club) filed suit in the
Court. The Sierra Club claimed that EPA
violated CAA Section 129 by setting
emissions standards for HMIWI that are
less stringent than required by Section
129(a)(2); that EPA violated Section 129
by not including pollution prevention or
waste minimization requirements; and
that EPA had not adequately considered
the non-air quality health and
environmental impacts of the standards.
On March 2, 1999, the Court issued its
opinion in Sierra Club v. EPA, 167 F.3d
658 (DC Cir. 1999). While the Court
rejected the Sierra Club’s statutory
arguments under CAA Section 129, the
Court remanded the rule to EPA for
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further explanation regarding how EPA
derived the MACT floors for new and
existing HMIWI. Furthermore, the Court
did not vacate the regulations, and the
regulations have remained in effect
during the remand.
On February 6, 2007, EPA proposed a
response to the HMIWI remand. The
proposed response was based on a
reassessment of information and data
that were available at the time of
promulgation in 1997, in light of the
EPA’s understanding of the Court’s
rulings in the Sierra Club, National
Lime Association (NLA) II, Cement Kiln
Recycling Coalition (CKRC) and other
cases discussed in our 2007 proposal
notice. The proposed response would
have revised some of the emissions
limits in both the NSPS and EG.
Relative to the NSPS, the emissions
limits for CO, Pb, Cd, Hg, PM, and CDD/
CDF would have been revised. Relative
to the EG, the emissions limits for HCl,
Pb, Cd, and CDD/CDF would have been
revised. EPA believed that the revised
emissions limits proposed in February
2007 as a result of its response to the
remand could be achieved with the
same emissions control technology
currently used by HMIWI to meet the
1997 rule.
On December 1, 2008, EPA reproposed its response to the Court’s
remand. EPA’s decision to re-propose
was based on a number of factors,
including further rulings by the U.S.
Court of Appeals that were issued after
our 2007 proposal was published. In
addition, public comments regarding
the 2007 proposal raised issues that,
upon further consideration, we believed
would best be addressed through a reproposal. One issue regarded the use of
emissions limits included in State
regulations and State-issued permits as
surrogates for estimated actual
emissions limitations achieved. Another
issue regarded EPA’s previous reliance
on control technology performance as
the sole indicator of HMIWI
performance in making MACT floor
determinations, which did not
necessarily account for other factors that
affect emissions (e.g., waste mix,
combustion conditions).
As mentioned above, every 5 years
after adopting a MACT standard under
Section 129, CAA Section 129(a)(5)
requires EPA to review and, if
appropriate, revise the incinerator
standards. In addition to responding to
the Court’s remand, today’s final action
constitutes the first 5-year review of the
HMIWI standards.
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III. Summary of the Final Rule and
Changes Since Proposal
A. Remand Response
Today’s final response to the remand
revises the December 2008 proposed
emissions limits for both the NSPS and
EG. The emissions limits are being
revised in response to a public comment
on the December 2008 re-proposal,
which requested that EPA adjust the
statistical approach used to account for
variability in the data and consider the
distribution of the emissions data in
determining the MACT floor emissions
limits. The revised statistical approach
results in generally higher limits
compared to the December 2008 reproposal. (See section IV.C.6 of this
preamble for further information about
this revised approach.) We expect most
sources should be able to meet the
revised limits using control technology
already available to the industry (e.g.,
wet scrubbers, dry scrubbers, or some
combination of these controls). (See
section IV.C.2 of this preamble for
further information.) Similar to the 2008
re-proposal, the emissions limits in
today’s final action do not include
percent reduction alternative standards,
as discussed further in section IV.D.4 of
this preamble.
Table 1 of this preamble summarizes
the NSPS emissions limits being
promulgated in this action in response
to the Court remand for new HMIWI.
TABLE 1—SUMMARY OF EMISSIONS LIMITS PROMULGATED IN RESPONSE TO THE REMAND FOR NEW HMIWI
Pollutant (units)
Unit size 1
HCl (ppmv) .................................................................................................................................................................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M .................
S ..................
L ..................
M, S .............
L ..................
M, S .............
L, M, S ........
CO (ppmv) ..................................................................................................................................................................
Pb (mg/dscm) .............................................................................................................................................................
Cd (mg/dscm) .............................................................................................................................................................
Hg (mg/dscm) .............................................................................................................................................................
PM (gr/dscf) ................................................................................................................................................................
CDD/CDF, total (ng/dscm) .........................................................................................................................................
CDD/CDF, TEQ (ng/dscm) ........................................................................................................................................
NOX (ppmv) ................................................................................................................................................................
SO2 (ppmv) ................................................................................................................................................................
Opacity (%) ................................................................................................................................................................
1L
Final remand
response
limit 2
5.1
7.7
15
11
1.8
20
0.00069
0.018
0.31
0.00013
0.0098
0.017
0.0013
0.0035
0.014
0.0080
0.0095
0.029
9.3
0.47
16
0.035
0.014
0.013
130
67
1.6
1.4
6.0
= Large (>500 lb/hr of waste); M = Medium (>200 to ≤500 lb/hr of waste); S = Small (≤200 lb/hr of waste).
emissions limits are reported as corrected to 7 percent oxygen.
2 All
Table 2 of this preamble summarizes
the emissions limits being promulgated
in this action in response to the Court
remand for existing HMIWI.
TABLE 2—SUMMARY OF EG EMISSIONS LIMITS PROMULGATED IN RESPONSE TO THE REMAND FOR EXISTING HMIWI
Unit size 1
HCl (ppmv) .................................................................................................................................................................
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Pollutant (units)
L ..................
M .................
S ..................
SR ...............
L ..................
M .................
S, SR ...........
L ..................
M .................
S ..................
SR ...............
L ..................
CO (ppmv) ..................................................................................................................................................................
Pb (mg/dscm) .............................................................................................................................................................
Cd (mg/dscm) .............................................................................................................................................................
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Final remand
response
limit 2
6.6
7.7
44
810
11
5.5
20
0.036
0.018
0.31
0.50
0.0092
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TABLE 2—SUMMARY OF EG EMISSIONS LIMITS PROMULGATED IN RESPONSE TO THE REMAND FOR EXISTING HMIWI—
Continued
Unit size 1
Pollutant (units)
Hg (mg/dscm) .............................................................................................................................................................
PM (gr/dscf) ................................................................................................................................................................
CDD/CDF, total (ng/dscm) .........................................................................................................................................
CDD/CDF, TEQ (ng/dscm) ........................................................................................................................................
NOX (ppmv) ................................................................................................................................................................
SO2 (ppmv) ................................................................................................................................................................
Opacity (%) ................................................................................................................................................................
M .................
S ..................
SR ...............
L ..................
M .................
S ..................
SR ...............
L ..................
M .................
S ..................
SR ...............
L ..................
M .................
S ..................
SR ...............
L ..................
M .................
S ..................
SR ...............
L ..................
M, S .............
SR ...............
L ..................
M, S .............
SR ...............
L, M, S, SR
Final remand
response
limit 2
0.013
0.017
0.11
0.018
0.025
0.014
0.0051
0.011
0.020
0.029
0.038
9.3
0.85
16
240
0.054
0.020
0.013
5.1
140
190
130
9.0
4.2
55
6.0
1 L = Large (>500 lb/hr of waste); M = Medium (>200 to ≤500 lb/hr of waste); S = Small (≤200 lb/hr of waste); SR = Small Rural (Small HMIWI
>50 miles from boundary of nearest SMSA, burning <2,000 lb/wk of waste).
2 All emissions limits are reported as corrected to 7 percent oxygen.
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B. Clean Air Act Section 129(a)(5)
5-Year Review Response
We are promulgating our response to
the remand in Sierra Club such that the
revised MACT standards, reflecting
floor levels determined by actual
emissions data, would be more stringent
than what we proposed in 2007 for both
the remand response and the 5-year
review, with the exceptions noted and
discussed in sections IV.A. and IV.B of
this preamble. Consequently, we believe
that our obligation to conduct a 5-year
review based on implementation of the
1997 emissions standards will also be
fulfilled through this action’s final
remand response, even as amended
compared to the 2008 re-proposed
standards. This is supported by the fact
that the revised MACT floor
determinations and emissions limits
associated with the remand response are
based on performance data for the 57
currently operating HMIWI that are
subject to the 1997 standards, and by
the final rule’s accounting for nontechnology factors that affect HMIWI
emissions performance, which the 2007
proposed remand response and 5-year
review did not fully consider. Thus, the
final remand response more than
addresses the technology review’s goals
of assessing the performance efficiency
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of the installed equipment and ensuring
that the emissions limits reflect the
performance of the technologies
required by the MACT standards. In
addition, the final remand response
addresses whether new technologies
and processes and improvements in
practices have been demonstrated at
sources subject to the emissions limits.
Accordingly, the remand response in
this final action fulfills EPA’s
obligations regarding the first 5-year
review of the HMIWI standards and,
therefore, replaces the 2007 proposal’s
5-year review proposed revisions.
C. Other Amendments
This final action puts forward the
same changes based on information
received during implementation of the
HMIWI NSPS and EG that were
proposed in 2007 and 2008. The
changes proposed in 2007 included
provisions allowing existing sources to
use previous emissions test results to
demonstrate compliance with the
revised emissions limits; annual
inspections of air pollution control
devices (APCD); a one-time visible
emissions test of ash handling
operations; CO continuous emissions
monitoring systems (CEMS) and bag
leak detection systems for new sources;
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and several approved monitoring
alternatives. The 2008 proposal
included changes regarding
requirements for NOx and SO2
emissions testing for all HMIWI;
performance testing requirements for
small rural HMIWI; monitoring
requirements for HMIWI that install
selective non-catalytic reduction (SNCR)
technology to reduce NOx emissions;
and procedures for test data submittal.
The changes included in this final
action include revised provisions
regarding waste segregation and removal
of exemptions regarding startup,
shutdown, and malfunction (SSM). The
removal of SSM exemptions is
discussed in section III.F of this
preamble. The performance testing and
monitoring amendments, electronic data
submittal provisions, waste segregation
amendments, and miscellaneous other
amendments are summarized in the
following sections.
1. Performance Testing and Monitoring
Amendments
The amendments require all HMIWI
to demonstrate initial compliance with
the revised NOx and SO2 emissions
limits. The 1997 standards did not
require testing and demonstration of
compliance with the NOx and SO2
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emissions limits. In addition to
demonstrating initial compliance with
the NOx and SO2 emissions limits, small
rural HMIWI are required to
demonstrate initial compliance with the
other seven regulated pollutants’
emissions limits and the opacity
standard. Under the 1997 standards,
small rural HMIWI were required to
demonstrate only initial compliance
with the PM, CO, CDD/CDF, Hg, and
opacity standards. Small rural HMIWI
also are required to determine
compliance with the PM, CO, and HCl
emissions limits by conducting an
annual performance test. On an annual
basis, small rural HMIWI are required
by the 1997 standards to demonstrate
compliance with the opacity limit. The
amendments allow sources to use
results of their previous emissions tests
to demonstrate initial compliance with
the revised emissions limits as long as
the sources certify that the previous test
results are representative of current
operations. Only those sources who
could not so certify and/or whose
previous emissions tests do not
demonstrate compliance with one or
more revised emissions limits would be
required to conduct another emissions
test for those pollutants. (Note that most
sources were already required under the
1997 standards to test for HCl, CO, and
PM on an annual basis, and those
annual tests are still required.)
The amendments require, for existing
HMIWI, annual inspections of
scrubbers, fabric filters, and other air
pollution control devices that may be
used to meet the emissions limits. The
amendments require a visible emissions
test of the ash handling operations using
Method 22 in appendix A–7 of this part
to be conducted during the next
performance test. For new HMIWI, the
amendments require CO CEMS; bag leak
detection systems for fabric-filter
controlled units; annual inspections of
scrubbers, fabric filters, and other air
pollution control devices that may be
used to meet the emissions limits; and
Method 22 visible emissions testing of
the ash handling operations to be
conducted during each compliance test.
For existing HMIWI, use of CO CEMS is
an approved option, and specific
language with requirements for CO
CEMS is included in the amendments.
For new and existing HMIWI, use of
PM, HCl, multi-metals, and Hg CEMS,
and integrated sorbent trap Hg
monitoring and dioxin monitoring
(continuous sampling with periodic
sample analysis) also are approved
options, and specific language for those
options is included in the amendments.
HMIWI that install SNCR technology to
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reduce NOX emissions are required to
monitor the reagent (e.g., ammonia or
urea) injection rate and secondary
chamber temperature.
2. Electronic Data Submittal
The EPA must have performance test
data to conduct effective 5-year reviews
of CAA Section 129 standards, as well
as for many other purposes, including
compliance determinations,
development of emissions factors, and
determining annual emissions rates. In
conducting 5-year reviews, EPA has
found it burdensome and timeconsuming to collect emissions test data
because of varied locations for data
storage and varied data storage methods.
One improvement that has occurred in
recent years is the availability of stack
test reports in electronic format as a
replacement for burdensome paper
copies.
In this action, we are taking a step to
improve data accessibility. HMIWI have
the option of submitting to an EPA
electronic database an electronic copy of
annual stack test reports. Data entry will
be through an electronic emissions test
report structure used by the staff as part
of the emissions testing project. The
electronic reporting tool (ERT) was
developed with input from stack testing
companies who generally collect and
compile performance test data
electronically. The ERT is currently
available, and access to direct data
submittal to EPA’s electronic emissions
database (WebFIRE) will become
available December 31, 2011.1
Please note that the option to submit
source test data electronically to EPA
will not require any additional
performance testing. In addition, when
a facility elects to submit performance
test data to WebFIRE, there will be no
additional requirements for data
compilation. Instead, we believe
industry will benefit from development
of improved emissions factors, fewer
follow-up information requests, and
better regulation development, as
discussed below. The information to be
reported is already required in the
existing test methods and is necessary to
evaluate the conformance to the test
method. One major advantage of
electing to submit source test data
through the ERT is to provide a
standardized method to compile and
store all the documentation required to
be reported by this rule. Another
important benefit of submitting these
data to EPA at the time the source test
is conducted is that it will substantially
1 See https://cfpub.epa.gov/oarweb/
index.cfm?action=fire.main, https://www.epa.gov/
ttn/chief/ert/ert_tool.html.
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reduce the effort involved in data
collection activities in the future.
Specifically, because EPA would
already have adequate source category
data to conduct residual risk
assessments or technology reviews,
there would be fewer data collection
requests (e.g., CAA Section 114 letters).
This results in a reduced burden on
both affected facilities (in terms of
reduced manpower to respond to data
collection requests) and EPA (in terms
of preparing and distributing data
collection requests). Finally, another
benefit of electing to submit these data
to WebFIRE electronically is that these
data will greatly improve the overall
quality of the existing and new
emissions factors by supplementing the
pool of emissions test data upon which
the emissions factor is based and by
ensuring that data are more
representative of current industry
operational procedures. A common
complaint we hear from industry and
regulators is that emissions factors are
outdated or not representative of a
particular source category. Receiving
most performance tests will ensure that
emissions factors are updated and more
accurate. In summary, receiving test
data already collected for other
purposes and using them in the
emissions factors development program
will save industry, State/local/Tribal
agencies, and EPA time and money.
The electronic data base that will be
used is EPA’s WebFIRE, which is a Web
site accessible through EPA’s TTN. The
WebFIRE Web site was constructed to
store emissions test data for use in
developing emissions factors. A
description of the WebFIRE data base
can be found at https://cfpub.epa.gov/
oarweb/index.cfm?action=fire.main.
The ERT will be able to transmit the
electronic report through EPA’s Central
Data Exchange (CDX) network for
storage in the WebFIRE data base.
Although ERT is not the only electronic
interface that can be used to submit
source test data to the CDX for entry
into WebFIRE, it makes submittal of
data very straightforward and easy. A
description of the ERT can be found at
https://www.epa.gov/ttn/chief/ert/
ert_tool.html. The ERT can be used to
document stack tests data for various
pollutants including PM (EPA Method 5
of appendix A–3), SO2 (EPA Method 6
or 6C of appendix A–4), NOX (EPA
Method 7 or 7E of appendix A–4), CO
(EPA Method 10 of appendix A–4), Cd
(EPA Method 29 of appendix A–8), Pb
(Method 29), Hg (Method 29), and HCl
(EPA Method 26A of appendix A–8).
Presently, the ERT does not handle
dioxin/furan stack test data (EPA
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Method 23 of appendix A–7), but the
tool is being upgraded to handle dioxin/
furan stack test data. The ERT does not
currently accept opacity data or CEMS
data.
3. Waste Segregation
The amendments revise the waste
management plan provisions for new
and existing HMIWI. Commenters on
the 2008 re-proposal recommended that
EPA minimize or eliminate from the
HMIWI waste stream any plastic wastes,
Hg and other hazardous wastes (e.g., Hgcontaining dental waste, Hg-containing
devices), pharmaceuticals, and
confidential documents and other paper
products that could be shredded and
recycled. One commenter recommended
that EPA take action to regulate
emissions of polychlorinated biphenyls
(PCBs) and polycyclic organic matter
(POM) from HMIWI. To address the
various commenters’ concerns, the
waste management plan provisions in
§§ 60.35e and 60.55c are revised to
promote the segregation of the
aforementioned wastes. (See section
IV.H of this preamble for further
information about the change to waste
management plan provisions.)
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5. Miscellaneous Other Amendments
The amendments revise the definition
of ‘‘Minimum secondary chamber
temperature’’ to read ‘‘Minimum
secondary chamber temperature means
90 percent of the highest 3-hour average
secondary chamber temperature (taken,
at a minimum, once every minute)
measured during the most recent
performance test demonstrating
compliance with the PM, CO, and
dioxin/furan emissions limits.’’
The amendments add definitions for
‘‘Bag leak detection system,’’
‘‘commercial HMIWI,’’ and ‘‘minimum
reagent flow rate.’’ ‘‘Bag leak detection
system’’ is defined to mean ‘‘an
instrument that is capable of monitoring
PM loadings in the exhaust of a fabric
filter in order to detect bag failures,’’
and examples of such a system are
provided. ‘‘Commercial HMIWI’’ is
defined to mean ‘‘a HMIWI which offers
incineration services for hospital/
medical/infectious waste generated
offsite by firms unrelated to the firm
that owns the HMIWI.’’ ‘‘Minimum
reagent flow rate’’ is defined to mean
‘‘90 percent of the highest 3-hour
average reagent flow rate at the inlet to
the selective noncatalytic reduction
technology (taken, at a minimum, once
every minute) measured during the most
recent performance test demonstrating
compliance with the NOX emissions
limit.’’
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limits. That is, the State plan would
make it clear that the 1997 emissions
limits remain in force and apply until
the date the revised existing source
emissions limits are effective (as defined
in the State plan). States whose existing
HMIWI do not find it necessary to
improve their performance in order to
meet the revised emissions limits may
want to consider a second approach,
where the State would insert the revised
emissions limits in place of the 1997
emissions limits, follow procedures in
40 CFR part 60, subpart B, and submit
a revised State plan to EPA for approval.
If the revised State plan contains only
the revised emissions limits (i.e., the
1997 emissions limits are not retained),
then the revised emissions limits must
become effective immediately, since the
1997 limits would be removed from the
State plan.
EPA will revise the existing Federal
plan to incorporate the changes to
existing source emissions limits and
other requirements that EPA is
promulgating. The Federal plan applies
to HMIWI in any State without an
approved State plan. The amendments
to the Federal plan for the EG would
require existing HMIWI demonstrate
compliance with the amended standards
not later than 5 years after today’s final
D. Implementation Schedule for Existing rule, as required by CAA Section
129(b)(3).
Hospital/Medical/Infectious Waste
Incinerators
E. Changes to the Applicability Date of
Under the amendments to the EG, and the 1997 New Source Performance
Standards
consistent with CAA Section 129,
revised State plans containing the
HMIWI are treated differently under
revised existing source emissions limits the amended standards than they were
under the 1997 standards in terms of
and other requirements in the
whether they are ‘‘existing’’ or ‘‘new’’
amendments will be due within 1 year
sources, and there are new dates
after promulgation of the amendments.
defining what are ‘‘new’’ sources and
That is, revised State plans have to be
imposing compliance deadlines
submitted to EPA on October 6, 2010.
The amendments to the EG then allow regarding the amended standards. All
existing HMIWI to demonstrate
HMIWI that complied with the NSPS as
compliance with the amended standards promulgated in 1997 are ‘‘existing’’
sources under the amended standards
as expeditiously as practicable after
and are required to meet the emissions
approval of a State plan, but no later
limits under the revised EG or the 1997
than 3 years from the date of such
NSPS, whichever is more stringent, by
approval or 5 years after promulgation
the applicable compliance date for the
of the revised standards, whichever is
revised EG. (Note that the HCl emissions
earlier. Because many HMIWI will find
limit for small HMIWI and the PM
it necessary to retrofit existing
emissions limit for medium HMIWI are
emissions control equipment and/or
more stringent under the 1997 NSPS
install additional emissions control
than under the revised EG, and HMIWI
equipment in order to meet the revised
that complied with those 1997 NSPS are
limits, States may wish to consider
required to continue to do so.) In the
providing the maximum compliance
interim, those sources will continue to
period allowed by CAA Section
be subject to the NSPS as promulgated
129(f)(2).
in 1997 until the date for compliance
In revising the emissions limits in a
with the revised EG. Units for which
State plan, a State has two options.
construction is commenced after the
First, it could include both the current
December 1, 2008 proposal, or for which
and the new emissions limits in its
modification is commenced on or after
revised State plan, which would allow
the date 6 months after today’s
a phased approach in applying the new
The amendments require HMIWI to
submit, along with each test report, a
description, including sample
calculations, of how operating
parameters are established during the
initial performance test and, if
applicable, re-established during
subsequent performance tests.
To provide greater clarity, the
amendments also include averaging
times and EPA reference test methods in
the emissions limit tables for existing
and new sources. It should be noted that
the averaging times and EPA reference
test methods added to the emissions
limits tables are not new requirements
but simply a restating of requirements
presented elsewhere in the HMIWI
regulations. Also, the inclusion of these
additional table columns should not be
interpreted as reopening the 1997
standards themselves.
The amendments also incorporate by
reference two alternatives to EPA
reference test methods (ASME PTC
19.10–1981 and ASTM D6784–02) to
provide HMIWI with greater flexibility
in demonstrating compliance. These
alternative methods are described in
greater detail in section VIII.I of this
preamble and were first presented in the
preamble to the December 1, 2008 reproposal.
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promulgation of the amended NSPS, are
‘‘new’’ units subject to more stringent
revised NSPS emissions limits.
Thus, under these specific
amendments, units that commenced
construction after June 20, 1996, and on
or before December 1, 2008, or that are
modified before the date 6 months after
the date of promulgation of the revised
final NSPS, continue to be or would
become subject to the 40 CFR part 60,
subpart Ec NSPS emissions limits that
were promulgated in 1997 until the
applicable compliance date for the
revised EG, at which time those units
must comply with the amended
‘‘existing’’ source EG or 1997 NSPS,
whichever is more stringent for each
pollutant. Similarly, HMIWI that met
the 1997 EG must meet the revised EG
by the applicable compliance date for
the revised EG. HMIWI that commence
construction after December 1, 2008 or
that are modified 6 months or more after
the date of promulgation of the revised
NSPS must meet the revised NSPS
emissions limits being added to the
subpart Ec NSPS within 6 months after
the promulgation date of the
amendments or upon startup, whichever
is later.
This approach is justified because
most HMIWI will have to install
additional emissions controls to comply
with the revised standards. CAA
Sections 129(g)(2) and (3) define ‘‘new
solid waste incineration unit’’ and
‘‘modified solid waste incineration
unit’’ based on whether construction of
the new unit commences after the date
of proposed standards under Section
129 and on whether modification occurs
after the effective date of a Section 129
standard, respectively. While these
definitions might be read as referring to
the dates EPA first proposes standards
for the source category as a whole and
on which such standards first become
effective for the source category, we are
interpreting and applying them in this
rulemaking to refer to the proposal and
effective dates for standards under this
new rulemaking record. The evident
intent of the definitions plus the
substantive new unit and modified unit
provisions is that it is technically more
challenging and potentially more costly
to retrofit a control system to an existing
unit than to incorporate controls when
a unit is initially designed.
F. Startup, Shutdown, and Malfunction
Exemption
The 1997 standards included
provisions in 40 CFR 60.56c and 60.37e
that exempted HMIWI from the
standards during periods of SSM,
provided that no hospital waste or
medical/infectious waste is charged to
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the unit during those SSM periods.
Neither our 2007 proposal nor our 2008
re-proposal would have changed these
provisions. However, soon after the date
of our re-proposal, the U.S. Court of
Appeals in Sierra Club v. EPA, 551 F.3d
1019 (DC Cir. 2008), vacated provisions
in EPA’s CAA Section 112 regulations
governing emissions of hazardous air
pollutants during SSM periods.
Specifically, the Court vacated 40 CFR
63.6(f)(1) and 63.6(h)(1), which, when
incorporated into CAA Section 112(d)
standards for specific source categories,
exempt sources from the requirement to
comply with otherwise applicable
Section 112(d) standards during periods
of SSM. While the Court’s vacatur did
not have a direct impact on source
category-specific SSM exemptions such
as those contained in the 1997 HMIWI
standards, one commenter on the 2008
re-proposal stressed that the legality of
SSM exemptions such as those in the
1997 standards is questionable, and
urged EPA to remove the exemptions in
the final rule. For the reasons set forth
later in this notice responding to
comments, today’s final rule removes
the SSM exemption from the HMIWI
standards, such that the emissions
limits under these subparts apply at all
times.
IV. Summary of Major Comments and
Responses
A total of 22 separate sets of public
comments were received on the
December 1, 2008 re-proposal. (One
additional comment, received after the
deadline for public comments, was an
addendum to an earlier comment. See
https://www.regulations.gov, docket ID
no. EPA–HQ–OAR–2006–0534, for the
complete public comments.) The
comment period ended on February 17,
2009. In addition to the comment
letters, speaker comments from a
January 15, 2009, public hearing on the
re-proposal were recorded, and a
transcript of the hearing was placed in
the project docket (document no. EPA–
HQ–OAR–2006–0534–0361). The
following sections summarize the major
public comments received on the reproposal and present EPA’s responses to
those comments. The major comment
topics are applicability;
subcategorization; MACT floor
approach; emissions limits; monitoring;
emissions testing; alternatives to on-site
incineration; medical waste segregation;
startup, shutdown, and malfunction;
and economic impacts.
A. Applicability
Comment: While this issue was not
raised in our re-proposal, one
commenter stated that subpart Ec
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51375
should be amended to exempt units
already complying with subpart
AAAA—the NSPS for new small
municipal waste combustors (MWCs)—
or subpart BBBB—the EG for existing
small MWCs—consistent with the
exemptions provided to MWCs in the
1997 HMIWI rule.
Response: We are aware of two
HMIWI at one facility that are currently
subject to rules for both HMIWI and
small MWCs. We have considered the
appropriateness of exempting the two
units from the HMIWI rule or creating
a separate HMIWI subcategory for the
units, and have concluded that
exemptions and creation of a separate
subcategory are not warranted. One
issue is the technological feasibility for
the facility to meet both the HMIWI and
small MWC rules if there is the
possibility that the facility would have
to implement different control strategies
to meet the limits in both rules. (Note
that we do not currently have any
information to suggest that the facility
would find it technically impossible to
meet both the revised HMIWI standards
and the small MWC standards.) For
example, if the HMIWI rule were to
include stringent CO limits and the
small MWC rule were to include
stringent NOX limits, it may be
challenging for the facility to meet the
limits of both rules simultaneously by
controlling secondary chamber
temperature; increasing the temperature
to reduce CO emissions would
invariably increase NOX emissions.
However, by choosing to burn both
types of waste and operate as both a
small MWC and a HMIWI, the facility
has the responsibility to meet whatever
set of rules that applies based on its
operating scenario and could avoid this
situation by choosing to burn one type
of waste or the other exclusively, or at
least reducing the other type of waste to
co-fired levels. Also, the facility already
employs additional control strategies
besides combustion control for reducing
NOX emissions (urea injection).
The facility typically burns 50 percent
hospital/medical/infectious (HMI) waste
and 50 percent municipal waste in its
two units. If we were to grant an
exemption to the HMIWI rule for this
facility due to it being subject to the
small MWC rule and the facility were to
increase the amount of HMI waste
burned to 70 percent and reduce the
amount of municipal waste burned to 30
percent, we could create a total
compliance loophole for the facility,
given that the small MWC rule includes
a co-fired exemption for units burning
30 percent or less of municipal waste.
This would be an unacceptable
outcome.
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Another option to address this
situation would be to create a hybrid
waste subcategory to include the two
units, based on the rationale that the
units are burning a unique mixture of
waste. However, we did not provide an
opportunity to comment on such an
option in the re-proposal, and have not
had the opportunity to develop a record
to support such a new approach or its
possibly unique regulatory framework.
Moreover, it is also not clear that such
a hybrid subcategory would fit within
the statutory divisions of incinerator
categories set forth in Section 129(a)(1)
of the CAA. Therefore, we decided not
to pursue that option for the final rule.
We believe it is reasonable for the
facility to be subject to both the HMIWI
and small MWC rules when switching
back and forth among the types of waste
burned, since this ensures that, when
the facility operates as either a HMIWI
or small MWC, it is regulated as such
and does not avoid compliance
obligations that all other incinerators
operating continuously as either HMIWI
or small MWC must meet. We do not
expect that continuing to require the
facility to comply with both rules will
be overly burdensome. The facility
should be able to control to the more
stringent of the two rules.
B. Subcategorization
Comment: Four commenters stated
that EPA’s rationale for
subcategorization does not reflect any
analysis of how the proposed
subcategories will help assure that what
has been ‘‘achieved’’ by better
performers in a proposed subcategory
results in a standard that is
‘‘achievable’’ by other sources in that
subcategory. Two of the commenters
argued that, without this assessment,
the final subcategory decisions will be
arbitrary and may result in standards
that are unlawfully stringent. The
commenters urged EPA to provide the
necessary assessment and rationale for
its subcategory proposal. Another
commenter further urged EPA to
reconsider its decision to retain the
categories defined by the 1997 HMIWI
rule without defining additional
subcategories. The commenter suggested
that EPA could keep the relation
between ‘‘achieved’’ and ‘‘achievable’’
by grouping existing units based on
control technology type and that EPA
could address variability by establishing
subcategories that take into account
non-technology factors that affect
emissions, as the commenter claimed is
required under Section 112(d)(3).2
2 While the commenter cited to CAA Section
112(d)(3), which does not literally apply to NSPS
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Three commenters stated that EPA
must develop a new subcategory for
commercial facilities, based on the
claimed significant operational
differences between commercial and socalled ‘‘captive’’ units that are attached
to HMI waste generators. The
commenters defined a captive unit as
one that is co-owned and co-operated by
the generator of the waste, while a
commercial operator is in business to
receive wastes from third parties. The
commenters stated that commercial
HMIWI, unlike operators of captive
units, cannot use alternative forms of
disposal (e.g., landfills), and claimed
that EPA views their only alternative to
the standards as closure. According to
the commenters, EPA not only has the
authority under Section 129(a)(2) to
further subcategorize HMIWI, but it is
also mandated to do so due to an overly
stringent standard that is not
‘‘achievable’’ by commercial units. The
commenters claimed that wastes sent to
a commercial unit are more
heterogeneous than for captive units.
They also noted that the handling of
medical wastes is subject to numerous
Federal and State requirements related
to worker and public health and safety,
which the commenters claimed makes
segregation of wastes hazardous and
impractical for operators of commercial
facilities. Thus, the commenters argued
that waste segregation cannot be a
control ‘‘achieved in practice’’ that can
be used to determine floors for
commercial units.
The same three commenters also
argued that EPA provides no rationale
for its retention of the small rural class
in the re-proposed rule, and that its
prior rationale regarding the
unavailability of alternative means of
medical waste treatment beyond 50
miles from the nearest standard
metropolitan statistical area (SMSA) is
unsupported. According to the
commenters, EPA’s proposed retention
of the small rural subcategory is
arbitrary and capricious.
Another commenter recommended
that EPA establish new size
classifications, claiming that the
distribution of HMIWI no longer
matches the three size categories EPA
identified in 1995 when the rule was
first being developed. The commenter
also noted that current standards are
based on subcategories defined in terms
of feed rates with no corresponding
heating value. According to the
commenter, a reference waste heating
and EG promulgated under Sections 111 and 129,
we assume the commenter was referring to factors
relevant to MACT floor analyses in general,
including those under Section 129(a)(2).
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characteristic must be established to
adjust or rate incinerators, given that
there is currently no consistency or
basis for determining equivalent
charging rate.
The same commenter further
recommended that, based on its
facility’s unique attributes—extremely
large processing capacity, customer
generated waste material variability,
waste mix, waste-to-energy heat
recovery technology, CEMS, 2+ second
combustion gas retention time, and high
British thermal unit (BTU) waste
content—EPA should place its facility
in a separate subcategory for extra-large
HMIWI. The commenter provided a list
of suggested standards for such a
subcategory, based on upper confidence
limits (UCLs) calculated using EPA’s
methodology, that indicate 7 of the 11
promulgated standards applicable to it
could be tightened. The commenter
noted that residual risk analyses
conducted under Maryland’s stringent
air toxics regulations (provided in the
commenter’s public comments) show
that the resulting ambient emissions
would meet all applicable requirements.
Response: Regarding the commenters’
argument that EPA must show how the
proposed subcategories will result in a
standard that is ‘‘achievable,’’ we do not
believe that the CAA requires such an
analysis. In facing a similar claim, the
U.S. Court of Appeals for the DC Circuit
recently rejected the argument that a
facility’s claimed differences between
itself and other members of a source
category in the plywood and composite
wood products (PCWP) MACT rule
compels EPA to set a unique standard
that is achievable for that source. In
NRDC v. EPA, 489 F.3d 1364 (DC Cir.
2007), Louisiana-Pacific Corp. (L–P)
objected to EPA’s refusal to establish a
separate subcategory for its wet/wet
press process apart from the subcategory
of all other press processes, claiming
that, at L–P’s plant, EPA’s identified
MACT floor control technology was not
feasible and that L–P would experience
greater costs in complying with the
MACT floor compared to other press
operators. Id., at 1375–76. The Court
denied L–P’s claims, explaining that
‘‘cost is not a factor that EPA may
permissibly consider in setting a MACT
floor. [* * *] To the extent that L–P
maintains that it cannot comply with
the MACT floor based on complete
enclosure and capture of emissions
because it cannot enclose its presses,
L–P also relies on an incorrect premise
that the MACT level of emissions
reduction is invalid if it is based on
control technology that a source cannot
install. The 2004 rule does not require
a source to use any particular method to
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achieve compliance: If L–P cannot use
enclosure and capture, it may utilize
other compliance techniques. Hence,
L–P fails to show that EPA was arbitrary
or capricious in refusing to create a
subcategory for it.’’ Id. at 1376. The
option provided by one commenter to
subcategorize based on control
technology type is inappropriate, as it
would essentially endorse the type of
unique treatment that L–P demanded in
the PCWP rule and that the Court
rejected. Moreover, we are unaware of
any situations in the HMIWI industry
where one type of control would be
technically applicable, but not another,
such that subcategorizing based on the
ability to use certain controls would be
justified.
We evaluated three different
subcategory options to try and address
the concerns stated by the commenters.
The three options included: (1) Option
1—no change to existing size categories;
(2) Option 2—creating a commercial
subcategory (as suggested by three
commenters) and redistributing the size
categories for the captive HMIWI (as
suggested by another commenter); and
(3) Option 3—redistributing the existing
size categories to more evenly distribute
the number of HMIWI (also suggested by
the other commenter).
Under Option 1, the size distributions
would remain the same—large (>500 lb/
hr of waste), medium (>200 to ≤500 lb/
hr of waste), and small (≤200 lb/hr of
waste), with the latter category divided
into small rural and non-rural
subcategories based on distance from
the nearest SMSA.
Under Option 2, commercial HMIWI
would be categorized separately from
captive HMIWI, and the captive HMIWI
further subcategorized as follows—large
(>1,000 lb/hr of waste), medium (>500
to ≤1,000 lb/hr of waste), and small
(≤500 of waste), with no further
subcategorization of the latter category.
Under Option 3, the sizes would be
redistributed as follows—large (>1,500
lb/hr of waste), medium (>500 to ≤1,500
lb/hr of waste), and small (≤500 lb/hr of
waste), with the latter category divided
into small rural and non-rural
subcategories as under Option 1.
We conducted MACT floor analyses
on all three options, using the following
methodology, which is described in
more detail later in this notice—(1)
Ranking the emissions data from lowest
to highest for each pollutant; (2)
determining the units in the MACT floor
for each pollutant; (3) determining the
distribution of test run data for the
MACT floor units; and (4) calculating a
99 percent UCL for each pollutant based
on that distribution, using Student’s ttest statistics. We developed floor-based
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emissions limits based on these UCL
values, rounding up to two significant
figures. We compared the emissions
limits to average emissions estimates for
each HMIWI and determined whether
the HMIWI would meet the limits. We
estimated the number of HMIWI
expected to meet at least nine limits,
eight limits, seven limits, etc. under
each option. Based on our analysis,
Options 1, 2, and 3 resulted in similar
numbers of HMIWI meeting the limits.
(For more detailed results, see 2009
memorandum entitled ‘‘Revised MACT
Floors, Data Variability Analysis, and
Emission Limits for Existing and New
HMIWI,’’ which is included in the
docket for today’s rulemaking.)
However, since we did not propose
any subcategorization option other than
the small, medium and large size
subcategories identified in the 1997
rule, and did not provide an
opportunity to comment on this issue in
the re-proposal, we have concluded that
it would not be appropriate at this time
to promulgate emissions limits based on
Options 2 and 3. Moreover, we do not
see a compelling need to make the
adjustments of Options 2 or 3, given that
similar numbers of HMIWI meet the
limits under all three options. Simply
re-adjusting the size thresholds to reflect
an even distribution of units post-MACT
compliance among the subcategories is
not necessarily reasonable, whereas the
size thresholds from the 1997 rule
continue to correspond to the basic
distinctions between the subcategories
of units as currently operated.
Therefore, we selected Option 1 (no
change to existing size subcategories) as
the best subcategory option on which to
base the emissions limits for
promulgation.
Two other subcategory options were
considered and rejected without further
analysis. The two options include (1) an
extra-large subcategory for one HMIWI
facility (as suggested by one
commenter), and (2) a mixed waste
subcategory for another HMIWI facility
(an outgrowth of a comment by another
commenter, as discussed in the previous
section). In addition to the fact that we
did not provide opportunity to comment
on this issue, we found no basis for
creating a new subcategory for this
particular rulemaking to fit a single
facility.
We disagree with the argument by
three commenters that EPA’s retention
of the small rural subcategory is
unsupported by any rationale. As we
explained in the September 15, 1997
notice of final rulemaking (62 FR
48370), alternative means of medical
waste treatment may not be available to
some facilities that operate small
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HMIWI in rural or remote locations.
Facilities that operate small HMIWI in
remote locations could be faced with
unique adverse impacts if required to
meet the more stringent emissions limits
associated with small non-rural HMIWI.
Therefore, we continue to support
subcategorizing facilities based on the
location of the facility and the amount
of waste burned, as allowed under
Section 129(a)(2). The only remaining
small rural units are in Alaska and
Hawaii, and the options are very limited
for alternative medical waste treatment
in those States. There are a very limited
number of landfills and MWC facilities
in those States, and there are no
commercial HMIWI. (The basis for this
information is a 2004 Chartwell
Information document entitled Directory
& Atlas of Solid Waste Facilities.)
C. MACT Floor Approach
1. MACT-on-MACT
Comment: Several commenters argued
that EPA’s recalculation of the 1997
MACT floors using post-MACT
compliance data results in so-called
‘‘MACT-on-MACT’’ standards that
cannot be achieved and are contrary to
the CAA and the intent of Congress.
Three of the commenters stated that the
CAA provides for a one-time setting of
the MACT floor based on what sources
achieved at the time of the initial
promulgation, not at the time of
subsequent revisions. According to
those three commenters, the proposed
standards would force the HMIWI
industry to shut down and prevent
installation of new HMIWI, without any
consideration of the costs of additional
reductions or whether the emissions
posed any risks to human health and the
environment. The commenters urged
EPA to use the population of pre-1997
HMIWI and their emissions data to
establish the revised MACT floors. One
commenter stated that new data should
only be used for those units that have
the same control equipment in place as
when EPA undertook the original
rulemaking.
Three of the commenters objected to
EPA’s arguments for using the postMACT compliance data, namely that
EPA is no longer confident in the
regulatory limits used in 1997 (based on
a comparison of the regulatory limits
and emissions test data in the 1997
record) and that the EPA questions their
use as surrogates because they do not
account for non-technology factors
(based on waste segregation data EPA
received after the 2007 proposal).
Specifically, the three commenters
stated that EPA provides no justification
for its change in using the post-MACT
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compliance data, noting that the Court,
in Sierra Club v. EPA, 167 F.3d 658 (DC
Cir. 1999), upheld EPA’s data-gathering
for the 1997 rule, and did not dispute
that EPA could make estimates based on
the lack of data. The three commenters
further stated that EPA provides no
support for reassessing its determination
in 1997 that emissions controls
significantly impact emissions, which
the commenters indicated is a finding
that EPA continues to assert and that is
supported by the data.
Regarding EPA’s claim that it reset the
floors in response to the remand of the
regulation in Sierra Club v. EPA, 167
F.3d 658 (DC Cir. 1999), the same three
commenters argued that the Court’s
remand was limited and did not vacate
the 1997 floors. According to the
commenters, EPA cites no legal support
that subsequent case law invalidates a
promulgated regulation not at issue in
that case. The commenters stated that,
in the past, EPA has declined to account
for changes in law after its decision to
impose new regulatory obligations,
based in part on the general
presumption against law having a
retroactive effect. According to the
commenters, this approach is supported
by case law, which holds that agencies
are required to apply the law at the time
the decision is made. Aaacon Auto
Transport v. ICC, 792 F.2d 1156, 1161
(DC Cir. 1986). The commenters also
noted that the 2002 data used to set the
proposed standards would not have
been available had the EPA responded
to the 1999 remand in a more timely
manner.
The three commenters also argued
that new public comments raising issues
with the 1997 floors are out of time and
insufficient to require EPA to go beyond
the Court’s remand order. The
commenters pointed out that Section
307(b) of the CAA requires any
challenges to regulations to be filed
within 60 days, which has been held up
in the relevant case law. According to
the commenters, any required revisions
to address the Court’s limited remand
does not justify reopening the time
period for judicial challenge of the
floors. The commenters also argued that
another exception to the 60-day
jurisdictional bar, that there was a
substantive violation of the statute, does
not apply since the Court did not find
the 1997 floors in conflict with the
statute.
Response: First, we disagree with the
commenters’ assertion that we are
employing a MACT-on-MACT approach
to set limits that are not achievable by
HMIWI. The purpose of this action is
not to force units who have complied
with a lawfully adopted MACT standard
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to have to subsequently comply with
another round of updated MACT
standards, but to respond to the Court’s
ruling that questioned the basis for the
1997 MACT standards and revise them
such that they are clearly compliant
with the Court’s several
pronouncements of how MACT should
be set in the first instance. Moreover,
the actual emissions data upon which
the revised standards rely comes
directly from HMIWI that have in fact
achieved the resulting levels, which
necessarily belies the assertion that no
HMIWI can achieve them. Regarding the
commenters’ argument that our
recalculation of the MACT floors was
contrary to the CAA and intent of
Congress, it is clear from the Court’s
opinion in Sierra Club v. EPA that EPA
needed to revisit the MACT floors in
order to respond to the Court’s concerns
about the MACT floor approach we used
in 1997, as noted in its remand of the
HMIWI regulations. The Court explicitly
‘‘conclude[d] that there are serious
doubts about the reasonableness of
EPA’s treatment of the floor
requirements, and remand[ed] the rule
for further explanation.’’ 167 F.3d at
660. Regarding the existing source
floors, the Court even went so far as to
suggest that, based on its review of the
record for the 1997 rule, ‘‘EPA’s method
looks hopelessly irrational.’’ Id. at 664.
Ultimately, the Court ordered the case
‘‘remanded to EPA for further
explanation of its reasoning in
determining the ‘floors’ for new and
existing [HMIWI].’’ Id. at 666. This
remedy squarely placed the
responsibility on EPA to either develop
an explanation for the MACT standards
derived from the 1997 data set that fully
addressed the Court’s concerns, or
develop a different methodology and/or
data set that did so.
In the 2008 re-proposal, we decided to
use post-compliance data to recalculate
the MACT floors because, based on our
analysis, it became impossible to fully
address the Court’s concerns about the
suitability of using regulatory limits and
uncontrolled emissions values from the
1997 data set in rationally explaining
the MACT floors for the 1997 rule. To
respond to those concerns, we
conducted an analysis comparing the
regulatory limits used in the 1997 data
set to actual emissions data for those
HMIWI, and we determined that the
regulatory limits used to establish the
MACT floors were not representative of
actual operation and did not account for
non-technology factors that affected
HMIWI emissions performance. (For
further information, see 2008
memorandum ‘‘Comparison of
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Regulatory Limits with Emissions Test
Data,’’ which is included in the docket.)
Since it was no longer possible to obtain
actual emissions data from the full set
of HMIWI that were operating at the
time of the 1997 rule’s promulgation,
the most available alternative was to use
the actual emissions data we received
from sources who chose to remain in
operation and comply with the 1997
MACT standards. With such data, we
could actually identify the emissions
levels achieved by use of the MACT
technologies and control measures that
HMIWI employed in order to meet the
1997 standards—technology and
measures which we had at that time
assumed would be necessary to comply
with the standards. This verifying
approach was eminently reasonable,
since it relied upon data that HMIWI
recorded and reported specifically for
purposes of demonstrating compliance
with the 1997 HMIWI MACT standards,
and it addressed the Court’s stated
concerns regarding the existing source
floors. Those concerns, namely, were
that permit levels might not accurately
estimate actual emissions performance
if sources are over-achieving the permit
limits (167 F.3d at 663), and that the
assumption that unpermitted HMIWI
did not deploy emissions controls of
any sort was not substantiated (Id. at
664).
While we agree with the commenters
that control technology has a major
impact on pollutant emissions from
HMIWI, we also acknowledge that
factors other than control technology
(e.g., waste mix, combustion conditions)
can affect pollutant emissions and
should be accounted for in the MACT
floor analysis. These non-control
technology factors, however, were not
considered or reflected by the permit
data and uncontrolled emissions values
data used in the 1997 rule. Therefore,
we needed to take further steps in order
to be able to account for these factors
and ‘‘provide a reasonable estimate of
the performance of the top 12 percent of
units.’’ Id. at 662. It is true that the Court
in Sierra Club did not rule that EPA had
impermissibly ignored these factors. Id.
at 666. However, subsequent case law,
specifically National Lime Ass’n v. EPA,
233 F.3d 625 (DC Cir. 2000) (NLA II),
Cement Kiln Recycling Coalition v. EPA,
255 F.3d 855 (DC Cir. 2001) (CKRC), and
Sierra Club v. EPA, 479 F.3d 875 (DC
Cir. 2007) (Brick MACT case), have
made it abundantly clear that, in any
MACT analysis, EPA is currently
expected by the Court to address nontechnology factors. Based on the actual
emissions data we received, which
necessarily reflects both the use of
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control technologies and any nontechnology measures the best
performing sources happen to use, we
were able to provide the ‘‘reasonable
estimate’’ of the best performers’
emissions levels that the Court required
in its remand. Therefore, we stand by
the reassessment we presented in the reproposal, although, as discussed later in
this notice, we have made some
adjustments in our statistical analysis to
correct for errors in the 2008 reproposal.
Regarding the commenters’ arguments
about the impact of subsequent case
law, we do not expect that we could
reasonably respond to the Court’s 1999
remand of the HMIWI rule in a manner
that knowingly disregards other flaws in
EPA’s prior MACT methodology that the
Court has since identified. In a recent
MACT ruling in which the Court found
that EPA had failed to follow the rulings
issued in other MACT cases, the Court
admonished the EPA that if ‘‘[EPA]
disagrees with the Clean Air Act’s
requirements for setting emissions
standards, it should take its concerns to
Congress. If EPA disagrees with this
court’s interpretation of the Clean Air
Act, it should seek rehearing en banc or
file a petition for a writ of certiorari. In
the meantime, it must obey the Clean
Air Act as written by Congress and
interpreted by this court.’’ 479 F.3d at
884. EPA takes this directive seriously
and acted consistently with the Court
decisions in preparing this response to
the remand. We do not believe that the
Court would view its own post-1999
MACT rulings as having changed ‘‘the
law’’ (namely, the MACT requirement of
Sections 112 and 129) such that
following those rulings’ instructions
would reflect retroactive application of
‘‘new’’ law. The commenters’ reliance
on Aaacon Auto Transport v. ICC, 792
F.2d 1156 (DC Cir. 1986) is inapposite,
as that case addressed an entirely
different situation of retroactive
application of a new statutory provision;
here, instead, the governing statutory
requirements have not changed, EPA is
acting in response to a Court’s ruling
that it had not adequately shown that it
had complied with those provisions,
and the Agency is acting subsequent to
further rulings that interpret those same
provisions and purport to set forth
general directions for EPA to follow in
all cases.
As for the comment that EPA could
not have relied upon the 2002
compliance data if it had more swiftly
responded to the remand, this only
suggests that if EPA had acted earlier
the EPA would have been forced to take
additional steps to require the HMIWI
industry to supply emissions data. In no
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way would this support EPA
disregarding the 2002 data we have inhand and allow us to continue to rely
upon data that does not reasonably
estimate emissions levels achieved by
the best performing units. Based on our
analysis of the record, we determined
that the 1997 floors did not in all cases
meet the requirements of the CAA as
interpreted by the DC Circuit. We
attempted to explain one set of revisions
to the 1997 floors in a subsequent
(February 2007) Federal Register notice
that relied upon the 1997 data set, and
received new public comments on that
notice and took account of new case law
that convinced us that a new approach
was required. Consequently, we have
chosen on our own to re-open the issues
addressed in the 2008 re-proposal.
Comment: One commenter stated that
EPA’s approach to revising HMIWI
standards under CAA Section 129(a)(5)
is correct. The commenter said that
revising the MACT floors to reflect the
actual performance of the relevant best
units satisfies Section 129(a)(5).
However, four other commenters
objected to revising the floors under the
technology review provisions of Section
129(a)(5). The commenters argued that
Section 129(a)(5) does not require
resetting the floors, but only requires
EPA to consider developments in
pollution control at the sources and
revise the standards based on our
evaluation of the costs and non-air
quality impacts. The commenters stated
that the use of new emissions data is
inconsistent with the reasoning EPA
presented in other contexts (e.g., in the
coke ovens residual risk/technology
review rulemaking) that MACT floors
need not be recalculated when the EPA
conducts its technology review under
CAA Section 112(d)(6). The commenters
also argued that this approach is
inconsistent with the Court’s decision
on litigation challenging the Hazardous
Organic NESHAP (HON) residual risk/
technology review rule that there need
not be an ‘‘inexorable downward
ratcheting effect’’ for the MACT floors.
See NRDC and LEAN v. EPA, 529 F.3d
1077, 1083–84 (DC Cir. 2008). One of
the commenters also claimed that EPA’s
approach sets a precedent for all other
sources subject to Section 129 or
Section 112 MACT standards that could
have dire implications on the future
viability of rules covering other sources
(e.g., MWCs or waste-to-energy
facilities).
Response: Regarding the comment
from the first commenter, as noted in
the preamble to the December 2008 reproposal (73 FR 72971), we do not
interpret Section 129(a)(5), together
with Section 111, as generally requiring
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EPA to recalculate MACT floors in
connection with this periodic review
when such review is not conducted
together with any other action requiring
EPA to reassess the MACT floor. See,
e.g., 71 FR 27324, 27327–28 (May 10,
2006) (‘‘Standards of Performance for
New Stationary Sources and Emission
Guidelines for Existing Sources: Large
Municipal Waste Combustors; Final
Rule’’); see also, NRDC and LEAN v.
EPA, 529 F.3d 1077, 1083–84 (DC Cir.
2008) (upholding EPA’s interpretation
that the periodic review requirement in
CAA Section 112(d)(6) by itself does not
impose an obligation to recalculate
MACT floors). However, in the unique
case of HMIWI, MACT floor
recalculations for the 2008 re-proposal
were conducted in order to respond to
the Court’s concerns stated in its
remand of the 1997 regulations, the
public comments received on the
February 2007 proposal, and recent
court decisions, specifically Sierra Club
v. EPA, 479 F.3d (DC Cir. 2007) (Brick
MACT). This recalculation would have
been necessary even if the periodic
review requirement of Section 129(a)(5)
did not exist. However, Section
129(a)(5) does exist, and EPA must, in
addition to responding to the Court’s
remand, satisfy its requirements. As we
previously explained and continue to
believe, in this case, our obligation to
conduct a 5-year review based on
implementation of the 1997 emissions
standards is fulfilled through our
current remand response. This is
supported by the fact that the revised
MACT floor determinations and
emissions limits associated with the
current remand response are based on
performance data for the 57 currently
operating HMIWI that are subject to the
1997 standards, and by our accounting
for non-technology factors that affect
HMIWI emissions performance, which
the 2007 proposed remand response and
5-year review did not fully consider.
Thus, our current remand response
more than adequately addresses the
technology review’s goals of assessing
the performance efficiency of the
installed equipment and ensuring that
the emissions limits reflect the
performance of the technologies
required by the MACT standards. In
addition, the current remand response
addresses whether new technologies
and processes and improvements in
practices have been demonstrated at
sources subject to the emissions limits.
Accordingly, our current remand
response fulfills EPA’s obligations
regarding the first 5-year review of the
HMIWI standards and, therefore,
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replaces the 2007 proposal’s 5-year
review proposed revisions.
2. Pollutant-by-Pollutant Approach
Comment: Numerous commenters
objected to our continued use of the
EPA’s longstanding pollutant-bypollutant approach to choosing the best
performing HMIWI. The commenters
argued that this approach essentially
created a hypothetical ‘‘super unit’’ and
resulted in the selection of a set of new
and existing MACT floors (and
standards) that no one existing source
has completely achieved and that
cannot be simultaneously achieved by
any of the best performing sources. The
commenters stated that the ‘‘best
performing’’ sources must be real
sources, not theoretical or hypothetical,
based on the statute and legislative
history. S. Rep. No. 228, 101st Cong., 1st
Sess. 169 (1989). According to the
commenters, the proposed standards do
not reflect the performance of actual
sources, and as such, these proposed
standards are not legal under Section
129.
One commenter argued that Section
129(a)(2) (and the similar Section
112(d)(3)) does not speak in terms of the
best performing source for each listed
pollutant but the best existing source for
all pollutants and what these sources
can achieve on an overall basis. The
commenter claimed that Congress
abandoned Section 112’s previous focus
on individual pollutant standards in the
1990 CAA Amendments and also
adopted the technology-based multipollutant approach to regulating toxics
in use under the Clean Water Act
(CWA). See S. Rep. No. 228, 101st
Cong., 1st Sess. 133–34 (1989). The
commenter concluded that if one source
can achieve a tight degree of control for
one pollutant but not for another, there
may be no justification for including it
in the set of sources from which the
floor is calculated. See, e.g., Tanners’
Council of America v. Train, 540 F.2d
1188, 1193 (4th Cir. 1976) (CWA
effluent limitations guidelines were
deemed not achievable where plants in
EPA’s data base were ‘‘capable of
meeting the limitations for some, but
not all, of the pollutant parameters’’).
Two commenters stated that under
CAA Sections 129(a)(2) and 112(d)(2)
consideration of a higher level of control
than the average aggregate levels
achieved by the best sources (i.e., using
the pollutant-by-pollutant approach
instead of basing floors on levels of the
full set of pollutants achieved by
particular units) must be done only as
a ‘‘beyond-the-floor’’ assessment,
required to weigh economics and other
factors, and not be ‘‘hidden’’ in the floor
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evaluation, in which costs may not be
considered.
Multiple commenters also questioned
the technical feasibility of EPA’s
pollutant-by-pollutant approach.
According to the commenters,
establishing MACT standards based on
the best achievable emissions limits for
each type of pollution control
equipment assumes that the equipment
can be combined in the same system
and that the emissions limits of each
system are additive. The commenters
stated that, in practice, this outcome is
likely not achievable due to the
challenge of finding pollution control
equipment (e.g., fabric filters for PM
removal and wet scrubbers for HCl
removal) that can work in concert with
each other. The commenters said that
EPA should consider how the different
emissions controls may interfere with
each other if employed simultaneously.
As an example, one commenter noted
that employing a wet scrubber to control
HCl would saturate the gas stream,
which would bind the bags in the fabric
filter used to control PM, thereby
compromising the filter’s effectiveness.
Some of the commenters also noted that
the interrelationships between
pollutants must be considered in order
to ensure that the emissions control is
operating effectively for control of all of
the related pollutants, and not just a
single pollutant. For example,
commenters noted that improving
combustion to control CO may affect
NOX.
Multiple commenters suggested EPA
should revisit the MACT floors for
HMIWI and choose the best performing
sources on an overall basis, so that at
least one source can meet all of the new
source standards and a certain portion
of the existing sources can meet the
existing source standards. One
commenter suggested that EPA combine
the individual pollutants into a single
analysis to determine which control
provides the best overall control or
otherwise determine that the MACT
floor resulting from the analysis is
actually achieved by those sources
identified as the ‘‘best controlled.’’
According to various commenters, one
possible way for doing this would be to
establish rankings for how a HMIWI
performs for each of the regulated
pollutants and then sum the individual
pollutant rankings to determine the
overall ranking for the HMIWI.
Response: We disagree with the
commenters who object to setting
MACT floors on a pollutant-by-pollutant
basis. We continue to interpret Section
129 as supporting the pollutant-bypollutant approach. Section 129(a)(4)
says that the standards promulgated
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under Section 129 shall specify
numerical emissions limitations for
each pollutant enumerated in that
provision. Section 129(a)(2) requires
EPA to establish standards requiring
‘‘maximum degree of reduction of
emissions.’’ ‘‘Maximum degree of
reduction of emissions,’’ in turn is
defined in Section 129(a)(2) as
including a minimum level of control
(the so-called MACT floor). EPA,
therefore, believes—and has long
believed—that the combination of
Section 129(a)(4), requiring numerical
standards for each enumerated
pollutant, and Section 129(a)(2),
requiring that each such standard be at
least as stringent as the MACT floor,
supports, if not requires, that floors be
derived for each pollutant based on the
emissions levels achieved for each
pollutant.
We also disagree with the commenters
who complain that there may not be any
operating unit that currently employs
the complete suite of MACT
technologies and meets the revised
limits. The suite of MACT floor controls
identified by the final rule approach
(specifically, the combination of dry and
wet control systems) is already used by
four existing HMIWI that meet most of
the MACT floor standards. For example,
one HMIWI, equipped with a highefficiency particulate air (HEPA)
filtering system, carbon bed adsorber,
and rotary atomizing wet scrubber, is
estimated to meet all nine revised
emissions limits in the final rule;
another HMIWI, equipped with a lime
injection system, powdered activated
carbon injection system, baghouse, and
vertical upflow two-stage multimicroventuri scrubber system, is
estimated to meet eight of the nine
revised limits. Also, an estimated 42 of
the 57 HMIWI are estimated to meet
both the CO and NOX revised limits
simultaneously with existing
combustion controls. (See 2009
memorandum entitled ‘‘Revised
Compliance Costs and Economic Inputs
for Existing HMIWI,’’ which is included
in the docket for today’s rulemaking.)
The MACT control techniques for the
various pollutants are fully integratable
and compatible. There do not appear to
be any conflicts where meeting the
standard for one pollutant may
jeopardize the achievability of meeting
another pollutant’s limit. This
conclusion is supported in part by a
review of available data and
information. As discussed above, there
are currently four units that are
achieving most, if not all, of the floor
standards (based on actual data for each
pollutant) using the complete suite of
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MACT floor controls. Thus, we
conclude that our approach results in
compatible MACT controls. Further, an
evaluation of the emissions data from
units that have measured data for all
pollutants supports our conclusion. Our
analysis shows that 12 percent (7 of 57
units) simultaneously meet all of the
MACT floor emissions levels. (For
further information, see 2009
memorandum entitled ‘‘Revised
Compliance Costs and Economic Inputs
for Existing HMIWI,’’ which is included
in the docket for today’s rulemaking.)
We also disagree with commenters
claiming that it is inappropriate to
consider a suite of floor control
techniques that may not be currently in
use by the source category. There is no
reason not to consider emissions data
and controls in use at sources that may
be the best performers from some
pollutants but not for other pollutants.
The MACT floor controls applicable for
one pollutant do not preclude the use of
MACT floor controls for another
pollutant. Therefore, it is appropriate to
consider controls at sources employing
MACT controls for some pollutants, but
not all. For example, floor controls for
existing large HMIWI include wet
scrubbers for HCl control, dry scrubbers
or combination dry/wet systems for PM
and metals control, activated carbon
injection for CDD/CDF control, and wet
scrubbers or dry scrubbers for SO2
control. As noted previously, wet and
dry systems are demonstrated to be
compatible, and it would be
inappropriate to exclude from the
MACT floor pool those units equipped
with wet or dry systems because some
of the control systems do better with
some pollutants (e.g., wet scrubbers
with HCl) than others (see previous
memorandum).
EPA disagrees strongly with
commenters arguing that Congress has
directly addressed the issue of whether
the MACT floor can be established on a
pollutant-by-pollutant basis. With
respect to the MACT floor mandate of
Section 112, there appears, rather, to be
a substantial ambiguity in the statutory
language about whether the MACT floor
is to be based on the performance of an
entire source or on the performance
achieved in controlling particular
hazardous air pollutants. The language
regarding best performing ‘‘sources’’ (or,
for new sources, ‘‘source’’) could apply
either to the sources’ (or source’s)
performance as a whole, or performance
as to a particular pollutant or pollutants.
The same is true of the definition of
‘‘emission limitation’’ in Section 302(k),
which refers to ‘‘air pollutants,’’ but
does not address whether the limitation
must apply to every pollutant emitted
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by a source, or just some of them. (The
same is true of the reference to ‘‘air
pollutants’’ (in the plural) in Section
112(d)(2).) In this regard, we note that
commenters in other MACT
rulemakings have assumed that Section
129, which governs today’s rule and
which uses language essentially
identical to Section 112 in mandating
MACT, requires a pollutant-by-pollutant
approach to establishing floors, because
EPA is commanded to establish
standards for enumerated pollutants
under Section 129(a)(4). We further note
that the DC Circuit, when reviewing the
floor determinations we made in 1997
for HMIWI under Section 129 in Sierra
Club v. EPA, noted that they were set
pollutant-by-pollutant and found no
error in this approach (see 167 F.3d at
660) (although this aspect of the rule
was not challenged specifically).
Indeed, the commenters who object so
vehemently to the pollutant-bypollutant approach in this rule raised no
such objection when the opportunity to
litigate the same approach in
establishing the 1997 HMIWI standards
was first presented.
EPA also believes that the
commenters’ reference to basing MACT
floors on the performance of a
hypothetical or theoretical unit, so that
the limits are not based on those
achieved in practice, is not only wrong
factually (see above), but just re-begs the
question of what the language in
Sections 112(d)(3) and 129(a)(2) is
referring to. We did not base the
controls or emissions levels on
theoretical sources, but on the
performance of actual units in the
HMIWI source category. All of the
MACT floors are achieved in practice
(since they are based on actual
performance data). Moreover, the DC
Circuit has emphasized that EPA may
use any reasonable means to determine
what levels of performance are achieved
in practice. Sierra Club v. EPA, 167 F.3d
at 663, 665. The commenters’ reliance
on cases that they claim preclude EPA’s
use of a pollutant-by-pollutant approach
does not compel a unit-based approach,
and the issue is not critical to EPA’s
position in any event, since the record
shows that some units are meeting all of
the floor limits and many are meeting
several of them. At the very least, the
CMA v. EPA decision under the CWA
supports the proposition that a
technology-based standard can be
considered achievable even if all limits
are not yet met by a single unit. Since
the floor standards are demonstrably
being achieved in practice by some
sources, this issue is largely academic.
In short, EPA is not persuaded that
the floors must be established on the
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51381
basis of a unit’s performance for all
pollutants overall. We continue to
believe, as we explained in the 1997
final rule, that such a reading would
lead to results that are at odds with
evident congressional intent (and with
the Court’s rulings in NLA II, CKRC and
Brick MACT). To argue that Congress
compelled this type of result is at odds
with both the language of Sections 112
and 129 and common sense. Indeed, it
would necessarily suggest that EPA
could continue to adopt floors that
reflect ‘‘no emissions reduction,’’ even
after the DC Circuit so emphatically
forbade that approach in the Brick
MACT ruling (Sierra Club v. EPA, 479
F.3d 875 (DC Cir. 2007).
As we stated in the preamble to the
1997 regulation (62 FR 48363), we
recognize that the pollutant-by-pollutant
approach for determining the MACT
floor can, as it does in this case, cause
the overall cost of the regulation to
increase compared to what would result
under a unit-based methodology. For
example, the pollutant-by-pollutant
approach for the HMIWI regulation
results in a stringent MACT floor for
HCl based on control using a wet
scrubber, and stringent MACT floors for
PM and metals based on control using
a dry scrubber. We interpret Section 129
of the CAA to require that the MACT
floor be determined in this manner, and
we believe that Congress did in fact
intend that sources subject to
regulations developed under Section
129 meet emissions limits that are
achieved by the best controlled unit for
each pollutant, as long as the control
systems are compatible with each other.
To our knowledge, there is no technical
reason why these two air pollution
control systems cannot be combined.
(62 FR 48363–4) Combined dry/wet
scrubber systems are currently in
operation on several HMIWI. In
response to commenters’ concerns
regarding the technical feasibility of
combined dry/wet systems, available
data on the performance of combined
dry/wet scrubber systems indicate that
the MACT floor emissions levels are
achievable and technically feasible. The
performance of dry scrubbers with
activated carbon injection and the
performance of wet scrubbers are welldocumented. The available data for
combination dry/wet systems provide
no indication of operational or
emissions problems that occur as a
result of combining dry and wet control
systems. Regarding the inverse
relationship between CO and NOX with
regard to combustion control, it is
incumbent upon the HMIWI facility to
determine whether combustion
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conditions can be adjusted to meet both
standards and, if not, install add-on
NOX controls as necessary, e.g., SNCR
systems.
The MACT floor reflects the least
stringent emissions standards that EPA
may adopt in accordance with Section
129(a)(2) regardless of costs. Other
statutory provisions are relevant,
although they also do not decisively
address this issue. Section 129(a)(4)
requires MACT standards for, at a
minimum, PM, opacity, SO2, HCl, NOX,
CO, Pb, Cd, Hg, and CDD/CDF emitted
by HMIWI. This provision certainly
appears to direct maximum reduction of
each specified pollutant. Moreover,
although the provisions do not state
whether there is to be a separate floor
for each pollutant, the fact that Congress
singled out these pollutants suggests
that the floor level of control need not
be limited by the performance of
devices that only control some of these
pollutants well. (62 FR 48364)
Regarding the commenter’s suggestion
that EPA choose the best performing
sources on an overall basis, so that at
least one source can meet all of the new
source standards and a certain portion
of the existing sources can meet the
existing source standards, we reviewed
this approach and found that the
suggested approach does not
consistently result in emissions limits
that are at least as stringent as would
have resulted in 1997 if we had actual
emissions data and used the correct
methodology. We estimate that four
emissions limits for large and small
non-rural HMIWI and five emissions
limits for medium and small rural
HMIWI calculated using the suggested
overall unit-based approach would be
higher than the 1997 emissions limits.
Further, because not all pollutants are
required to be tested (e.g., NOX and
SO2), a substantial fraction of available
emissions data would have to be
discarded in order to rank only those
HMIWI with a complete set of data for
all nine pollutants (PM, SO2, HCl, NOX,
CO, Pb, Cd, Hg, and CDD/CDF).
Specifically, we would have to discard
emissions data for 30 percent of large,
40 percent of medium, 100 percent of
small non-rural, and 50 percent of small
rural HMIWI in order to calculate
MACT floors using the suggested
approach. (See 2009 memorandum
entitled ‘‘Revised MACT Floors, Data
Variability Analysis, and Emission
Limits for Existing and New HMIWI,’’
which is included in the docket for
today’s rulemaking.)
A unit-based approach would tend to
result in least common denominator
floors where, as here, multiple
pollutants are emitted, whereby floors
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would no longer be reflecting
performance by the best performing
sources for those pollutants. For
example, if the best performing 12
percent of units for HAP metals did not
control acid gases as well as a different
12 percent of units, the floors for acid
gases and metals would not reflect best
performance. Having separate floors for
metals and acid gases in this example
certainly promotes the stated purpose of
the floor to provide a minimum level of
control reflecting what best performing
units have demonstrated the ability to
do.
Similarly, a unit-based approach that
employs ranking of a weighted average
of pollutants would require EPA to
assume priority for certain pollutants
(one unit may have lower NOX
emissions but higher CDD/CDF, for
example). This approach would
similarly tend to require EPA to
disregard the factual levels reflecting the
best performers for individual
performers, but based on value
judgments regarding the risks presented
by various pollutants. Such
considerations are antithetical to strictly
performance-based analyses such as
MACT floor determinations. Indeed,
reviewing EPA’s primary copper
smelters MACT standard, the DC Circuit
rejected the argument that risk-based
considerations have any place in the
MACT context (see Sierra Club v. EPA,
353 F.3d 976 (DC Cir. 2004).
3. Adequacy of Emissions Test Data
Comment: Multiple commenters
argued that the proposed standards are
flawed because EPA has not
demonstrated that the actual emissions
data on which the proposed rule is
based adequately represent the full
range of performance of tested facilities.
According to various commenters, the
emissions data were derived from
performance tests conducted under
‘‘representative operating conditions,’’
rather than the ‘‘worst reasonably
foreseeable circumstances’’
contemplated by the case law. See
Sierra Club v. EPA, 167 F.3d 658, 665
(DC Cir. 1999). Commenters stated that
the proposed emissions limits did not
adequately account for variability, and
said EPA should have sought out more
test data and specifically requested
continuous monitoring data to properly
characterize variability.
Another commenter specifically
recommended that EPA gather
additional data on emissions of medium
HMIWI such as theirs before finalizing
the rule to ensure each medium HMIWI
has data sufficiently accurate and
representative to properly set a MACT
standard in accordance with the CAA
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Amendments. According to the
commenter, rigorous quality assurance/
quality control (QA/QC) procedures
should also be applied to the test data.
One commenter stated that, because
the new regulations are solely based on
previous stack testing, the actual
emissions tests need to be reviewed by
EPA for technical accuracy, as well as
consistency. Although there may have
been insufficient time under the courtordered schedule, the commenter
argued that proposed standards cannot
be defended technically in the absence
of such an analysis.
The same commenter also stated that
revisions to EPA’s incinerator test
protocol are needed to ensure that the
unit is being tested at proper design
conditions. At a minimum, the
commenter said that incinerator
temperature, waste input rate and
constituents, auxiliary fuel
consumption, quench rates (air and
water), and chemical feed rates need to
be recorded during an incinerator test to
determine whether the operating and
testing conditions were representative of
the higher emissions rates that can be
experienced during normal operations.
Given that emissions are determined by
waste characteristics, the commenter
recommended that a standardized
realistic worst-case test waste be used,
which includes specific criteria
components, as well as moisture content
and heating value. Incinerators would
be tested with the standard waste and
the top 12 percent identified.
Response: First, in response to
industry commenters who claim we
should have gathered more data, we
note that nothing precluded them from
giving us more data to consider in
responding to the Court’s remand, if
they felt that the data submitted to us
for purposes of showing compliance
with the 1997 standards was not
representative of their normal
operations. We have reasonably used
the data available to us at the time we
conducted this rulemaking, in the
absence of being provided with any
other data. We agree with the
commenters that emissions tests might
provide information on representative
operations only where owners and
operators conducting the tests have
endeavored to reflect such
representative operations at the time of
the tests. However, when conducting
tests to establish various parameters to
be monitored, owners and operators
may also endeavor to produce data for
a wide range of operating conditions.
Moreover, we have taken several steps
to try and account for the emissions and
operational variability, including (1)
obtaining additional emissions test data
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from States and EPA Regions
representing all available annual test
results for each unit, (2) using
individual test run data for the bestperforming 12 percent of sources to
calculate UCL values, (3) using a
substantial confidence interval
(specifically, a 99 percent UCL value),
and (4) closely reviewing how the data
are distributed (e.g., normally,
lognormally). Also, EPA’s own review of
emissions factors shows that the
variability of emissions between
facilities is greater than the variability
within facilities.
We believe that the data quality
concerns expressed by the commenters
have been addressed in a number of
ways. First, EPA test methods
incorporate data quality assurance and
quality control steps and acceptance
criteria at several levels. These
provisions assure that the data produced
are of quality sufficient for decision
making, including compliance, when
the methods are followed and the
acceptance criteria are met. Second,
States further assure that testers adhere
to the test methods by providing third
party oversight and review of
compliance tests conducted by industry,
such as that being discussed here. The
States also implement the source testing
audit program when available, further
assuring the high quality of emissions
testing data. Third, through internal and
contractor support efforts for this
regulatory project, EPA conducted
additional review of the initial
emissions test data to check for
completeness and appropriate
characterization of process operations.
Finally, EPA reviewed and accounted
for variability inherent in the emissions
data used in establishing the applicable
emissions limit including applying
statistical confidence intervals.
Regarding the comment about
revisions to EPA’s incinerator test
protocol, the factors cited by the
commenter could be considered in
setting site-specific compliance
conditions. Such an approach may be
useful at the next technology review.
The commenter’s suggestion that EPA
use a standardized waste for testing is
questionable, unless EPA wanted to
establish a certification testing program
like the residential wood combustion
rule. However, such a program would be
cumbersome and could potentially
eliminate a majority of the industry.
Comment: Three commenters stated
that EPA did not consider the accuracy
and precision of the EPA test methods
in proposing the emissions limits for
new and existing HMIWI. To support
their argument, the commenters
referenced the findings of the Reference
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Method Accuracy and Precision
(ReMAP) program co-sponsored by the
American Society of Mechanical
Engineers (ASME). According to the
commenters, one of the main objectives
of the ReMAP project was to ensure
emissions limits would properly
consider the inherent accuracy and
precision limits of the test methods used
to demonstrate compliance, such that a
facility would not be in violation of a
limit as a result of this inherent
variability. The commenters noted that
the ReMAP program established
Precision Metrics for various reference
methods and corresponding pollutants
(e.g., ±42 percent for CDD/CDF Method
23), and they compared these Precision
Metrics to actual stack concentrations
and proposed emissions limits for
several pollutants. Based on this
comparison, the commenters concluded
that EPA did not adequately address
these Precision Metrics in establishing
the proposed limits.
Response: As noted above, we already
took into account variability inherent in
the data representing emissions and
process operations in establishing the
emissions limit. By using UCLs to set
our emissions limits, we have
inherently accounted for measurement
precision. In fact, the adjustments we
made to the average stack
concentrations for the best-performing
12 percent of units to calculate the final
emissions limits more than account for
the Precision Metrics cited by the
commenters. Thus, any additional
adjustments of measurement to account
for method precision are unnecessary.
Comment: One commenter stated that
there are significant deficiencies in the
emissions data used to establish the
standards. Some of the standards are
based on data from a limited number of
stack tests. According to the commenter,
there needs to be a standard for the
minimum number of stack tests that
must be performed before its data can be
used as the basis for determining the top
12 percent performing incinerators.
Because of the waste characteristics and
variability, the commenter
recommended a minimum of four tests.
The commenter noted that some of the
units included in the top 12 percent are
specialty incinerators, which the
commenter said are not representative
of the subcategory as a whole. The
commenter also noted that another unit
incinerates municipal waste, which the
commenter argued should cause its data
to be invalid for the proposed HMIWI
standards. According to the commenter,
municipal waste would be expected to
have a makeup that produces
significantly lower emissions for some
pollutants (e.g., CDD/CDF, Cd). The
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commenter recommended developing a
testing metric (e.g., heating value, flue
gas per pound of feed) and applying it
to the data used to indicate possible
flaws (e.g., variations and/or
abnormalities) which would spur
further investigation into the validity of
the data. Of the 45 emissions tests used
to develop emissions limits for the large
subcategory, the commenter concluded
that 38 of those tests could be
considered invalid because of too little
testing or the unrepresentative content
of the incinerated waste stream.
Response: Regarding the commenter’s
argument about claimed deficiencies in
the emissions data used to establish the
standards, we do not believe that data
from high quality tests should be
dismissed simply because there are only
a few tests. As noted above, we have
reasonably relied upon the data we had
available to us, and we have already
taken steps to alleviate concerns about
the representativeness of the measured
data used to establish the emissions
limit, including calculating UCL
estimates using standard statistical
conventions.
Regarding the commenter’s concerns
about the specialty incinerators and the
facility that also incinerates municipal
waste, we evaluated creating separate
subcategories for captive units (which
would include the specialty
incinerators) and a separate subcategory
for mixed waste units, but as noted
above, we ultimately rejected both
options because we did not provide an
opportunity to comment on the issue of
subcategorization in the December 2008
re-proposal or a record that would
justify such a significant change in
categorization. Another option to
address the facility incinerating
municipal waste would be to use only
the emissions data from those tests
conducted with 100 percent medical
waste, but that would limit the number
of tests for that facility. Also, we have
found a significant amount of overlap in
emissions (including CDD/CDF and Cd)
between the different test conditions at
the facility (e.g., 100 percent medical
waste, 50 percent medical waste, 20
percent medical waste, etc.), suggesting
that such a distinction in waste type is
not very meaningful in this case. (See
2008 memorandum entitled
‘‘Documentation of HMIWI Test Data
Database,’’ which is included in the
docket.)
Comment: Three commenters stated
that some emissions test data were
improperly excluded from the dataset,
including data deemed ‘‘noncompliant,’’ data collected at HMIWI
subsequently shut down, and data
collected under specific ‘‘test
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conditions.’’ The commenters argued
that emissions test data from
compliance tests that were conducted in
accordance with the applicable
reference test methods for affected
HMIWI should not be arbitrarily
excluded from the re-stated MACT
dataset, because that undermines the
entire data evaluation process. The
commenters stated that EPA provides no
rationale for arbitrarily including data in
some instances, and excluding them in
others. Thus, according to the
commenters, EPA’s proposed standards
are arbitrary and capricious. The
commenters said that inclusion of all
valid test data provides a better
representation of the inherent variability
of the various test methods and source
operation. According to the
commenters, EPA’s MACT floor dataset
was inconsistent, leading EPA to rely on
an unrepresentative set of data. The
commenters recommended that EPA
provide a clear description of
‘‘representative HMIWI operation’’ so
that consistent criteria are applied to
evaluate whether valid emissions test
data were properly included or
excluded from the MACT floor dataset.
Response: Non-compliant emissions
data from the initial tests of HMIWI
were not included in the emissions
database used to establish the emissions
limits. At the time of the initial test,
operators were still in the process of
establishing their operating parameters
and tuning their emissions control
devices and operating conditions to
comply with the regulation. Any noncompliant emissions data from the
initial test would be expected to trigger
a change in HMIWI operation in order
to come back into compliance with the
1997 standards. Consequently, the noncompliant emissions data from these
tests would not be representative of the
typical operation of these HMIWI.
If non-compliant emissions data from
an annual test were substantially higher
than the emissions typically seen from
the facility or were substantially higher
than the emissions limit, this strongly
suggested that there was a problem
during the test and indicated that the
test results would not be representative
of the typical operation of the HMIWI.
Such data were excluded from the
pollutant averages for the particular
facility. (It should be noted that the data
that were excluded amount to less than
1 percent of the total set of emissions
data for the industry.) For example, the
emissions data from tests on one unit
did not meet the PM or Cd emissions
limit during an August 2006 annual test.
A subsequent retest of this unit for those
same pollutants in November 2006
showed PM emissions results less than
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10 percent of those measured earlier,
and Cd emissions results about 0.1
percent of the previously measured
results. Consequently, we believe that
the August 2006 PM and Cd test results
were not representative of the typical
operation of the HMIWI, and they were
not included in the test data database.
The PM and Cd retest data from the
November 2006 retest were included
instead. (See previous memorandum.)
We also excluded test data if we
found errors in the calculations or the
test methods, or some important
elements of the data needed to calculate
emissions in the form of the standard
were missing. For example, we
excluded the TEQ emissions estimates
provided for a 2005 annual test at a
second HMIWI because the reported
TEQ estimates were greater than the
total CDD/CDF estimates provided, a
clearly incorrect result. The total CDD/
CDF estimates were believed to be the
correct values because they were well
within the applicable emissions limit,
while the TEQ estimates were a few
times higher than the applicable limit.
The 2001 annual test results for HCl at
a third HMIWI were deemed invalid
because the HCl sample train did not
meet the method’s ±95 percent sample
collection efficiency requirement. There
was believed to be some contamination
in the sample collection and/or recovery
during the 2005 Pb test at a fourth
HMIWI, so a retest in February 2006 was
conducted. The Pb results from the
February 2006 retest were included with
the results of the 2005 annual test in the
test data database, replacing the 2005 Pb
results. The first HCl test run during a
2006 test at a fifth HMIWI was below
the detection limit, and the laboratory
that analyzed the samples did not
provide a detection limit for this test
run. In this case, we decided to delete
the results for this particular test run
and calculated the HCl average for the
2006 test using the results from the
other two test runs. Similarly, the
second Hg test run during the 2003 test
at a sixth HMIWI was reported to be
below the detection limit, but the data
summary did not include the measured
Hg detection limit. Attempts to obtain
the detection limit for this test run from
the facility were unsuccessful.
Consequently, we decided to delete the
results for this test run and calculated
the Hg average for the 2003 test using
the results from the other two test runs.
(See previous memorandum.)
A couple of annual compliance tests
were excluded from the unit averages
because they were conducted under test
conditions (e.g., reduced emissions
control) that were not considered
representative of the typical operation of
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the HMIWI. The exclusion of these tests
had little impact on most of the
pollutant averages for these HMIWI, and
it should be noted that these HMIWI are
not in the MACT floors of the pollutants
of interest. One HMIWI was unable to
meet the CDD/CDF emissions limit
during the 2003 and 2004 annual
compliance tests conducted without
activated carbon. Only when activated
carbon injection was included as a
second test condition during the 2004
annual compliance test was the facility
able to meet the CDD/CDF emissions
limit. Consequently, we determined that
the second test condition was more
representative of the typical, current
operation of the HMIWI. During a Hg
annual compliance test, another HMIWI
was unable to meet the Hg percent
reduction limit under the test condition
with a lower activated carbon injection
rate, but was able to meet the limit
under the test condition with a higher
activated carbon injection rate. The Hg
data meeting the limit were considered
representative of the typical operation of
the HMIWI, and the other Hg data were
rejected. (See previous memorandum.)
Regarding the argument that EPA
improperly excluded data available
from HMIWI that subsequently shut
down, we believe that it is appropriate
in this particular rulemaking to base the
MACT floor on emissions data from
facilities that are currently operating,
since those are the facilities that would
be complying with the rule.
Comment: Three commenters stated
that the treatment of individual ‘‘nondetect’’ data points within the MACT
floor dataset should be consistent and
should represent the actual detection
level of the pollutant of concern. The
commenters noted that non-detect or
zero data provided as part of the latest
data request were considered equal to
the method detection limit, while CDD/
CDF test data already in EPA’s project
files were calculated at one-half the
detection limit. While this approach
may be valid for total CDD/CDF, the
commenters argued that it could have a
profound effect on TEQ.
Response: In response to the
commenters, it should be noted that
section 9 of EPA Method 23 specifies
that ‘‘[a]ny PCDD’s or PCDF’s that are
reported as below the measurement
detection level (MDL) shall be counted
as zero for the purpose of calculating the
total concentration of PCDD’s and
PCDF’s in the sample.’’ The CDD/CDF
results reported in the facilities’ initial
test reports and provided by States and
EPA Regions in the annual test
summaries reflect this computation
approach. Consequently, by using onehalf the detection limit in our review of
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CDD/CDF data in full test reports, we
were being conservative in our
estimation of CDD/CDF emissions.
Nonetheless, we looked at those HMIWI
in the MACT floor for total CDD/CDF
and TEQ to determine whether using
the full detection limit would make a
substantial difference. When we
averaged in the results with all other
CDD/CDF results for each facility, we
found on average essentially no
difference in total CDD/CDF emissions
estimates (less than 1 percent) and only
a small difference in TEQ emissions
estimates (0.1 to 20 percent) for the four
HMIWI size categories. (See 2009
memorandum entitled ‘‘Comparison of
CDD/CDF Non-Detect Data—Full
Detection Limit vs. 1⁄2 Detection Limit,’’
which is included in the docket for
today’s rulemaking.)
4. Non-Technology Factors
Comment: Numerous commenters
stated that the variability in nontechnology factors, such as the materials
and composition fed to combustion
devices, must be adequately addressed
in the rulemaking process in order to
promulgate a feasible rule, Sierra Club,
479 F.3d at 883 and Cement Kiln
Recycling Coalition v. EPA, 255 F.3d
855, 865 (DC Cir. 2001). According to
various commenters, EPA did not
identify the non-technology factors in
the proposed rule or quantify their effect
on actual emissions performance, but
instead claimed, without supporting
evidence, that using actual emissions
levels accurately reflects emissions
performance resulting from the use of
add-on controls and other emissions
reduction measures. Commenters
argued that the failure to make these
findings renders the proposed standards
arbitrary. Another commenter disagreed,
stating that EPA’s proposed floor
approach for new and existing HMIWI
is generally correct and that EPA
correctly observed that the use of actual
emissions levels accounts for all
emissions reduction strategies.
Response: With regard to the
commenters’ argument, the CAA does
not require EPA to quantify the
emissions reductions resulting from all
non-technology factors, but instead
focuses on identifying the emissions
levels achieved by best performing
sources no matter what means they use
to achieve them. This approach is
supported by the DC Circuit’s decision
in the Brick MACT case, which stressed
the importance of identifying emissions
‘‘levels’’ achieved by sources. There can
be no dispute that both the composition
and level of emissions exiting the
incinerator reflect both the add-on
control technologies used by a unit (e.g.,
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dry scrubber, wet scrubber, activated
carbon) that control the emissions and
the non-technology factors (e.g., waste
material quantity and composition,
combustion conditions) that influence
the level and composition of emissions.
As the Sierra Club Court noted in 1999,
the less mercury fed into the waste
stream, the less mercury emissions will
be coming out of the stack. Whatever
combination of add-on controls and
non-technology measures a unit is
employing will, therefore, necessarily
affect the resulting emissions levels that
are reflected in the actual emissions
data upon which the revised floors are
set. It would be impossible for those
data to not reflect all those measures.
This situation is quite the opposite of
what was presented in the 1997
rulemaking, in which the floors were
primarily derived from permit and
regulatory levels that were not
necessarily reflective of actual
emissions performance but were
assumed to reflect levels achievable by
add-on control only. At that time, to
adjust floors downward to account for
non-technology factors, it might indeed
have been necessary to be able to
quantify additional emissions
reductions attributable to such
measures. Similarly, as the 2007
proposed remand response still in large
part relied upon the permit and
regulatory levels, not knowing the
quantified reductions achieved by nontechnology measures frustrated
estimating the emissions levels achieved
in practice by HMIWI. But this is simply
not an issue under a methodology that
depends upon the measured emissions
levels that result from whatever mix of
add-on or non-technology controls is
being used, as under the 2008 reproposal and today’s final rule. The
non-technology factors cannot help but
affect the actual emissions data, and
they are, therefore, necessarily
accounted for in the actual emissions
data-based floors.
EPA’s data gathering effort for this
rulemaking included not just initial and
annual emissions test data obtained
from EPA Regions, State/local
governments, and HMIWI facilities, but
also a waste segregation practices
questionnaire sent to nine
representative entities in the HMIWI
category (six hospitals, one
pharmaceutical facility, one university,
and one company that owns 8 of the 14
commercial HMIWI). (See 2008
memoranda entitled ‘‘Documentation of
HMIWI Test Data Database’’ and
‘‘Summary of Industry Responses to
HMIWI Waste Segregation Information
Collection Request,’’ which are included
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in the docket.) While our analysis of the
emissions test data indicates a strong
relationship between add-on control
and emissions (e.g., wet scrubbers
achieve superior HCl control, while dry
scrubbers achieve superior PM and
metals control), our review of the
questionnaire responses indicates that
non-technology factors also play a role
in emissions reduction. All of the
survey respondents, except for the
commercial company, practice onsite
waste segregation to reduce the volume
of waste being incinerated. Most of the
respondents started the practice of
waste segregation in the 1980s and
1990s. Five respondents also accept
offsite waste and require the offsite
waste generators to employ waste
segregation practices. The commercial
company encourages waste segregation
from its waste generator clients through
a number of efforts, including a waste
management plan, contract
requirements and waste acceptance
protocols, a dental waste management
program, and educational programs and
supporting posters. All of the
respondents that practice onsite waste
segregation separate batteries and
fluorescent bulbs (i.e., mercury waste)
from the HMI waste stream. Eight
respondents separate paper and/or
cardboard, four separate glass, and three
separate plastics from the HMI waste
stream. Other materials that are
separated from the HMI waste stream
include hazardous waste, waste oil,
wood, construction debris, refrigerants,
and various metals and metalscontaining materials (e.g., aluminum,
copper, lead, mercury, steel, and
electronics). (For further information,
see 2008 memorandum ‘‘Summary of
Industry Responses to HMIWI Waste
Segregation Information Collection
Request,’’ which is included in the
docket.) These waste segregation efforts
would certainly have an impact on the
emissions of CDD/CDF, mercury, and
other pollutants from these HMIWI and
would be reflected in the emissions
levels measured during their initial and
annual emissions tests and used in our
test data analysis. As noted previously,
the nine entities surveyed were believed
to be representative of the HMIWI
industry as a whole, so the conclusions
reached for the nine entities are also
expected to apply to the entire industry
as well.
5. Straight Emissions Approach
Comment: Two commenters argued
that the parenthetical language in the
Brick MACT decision equating the best
performers with ‘‘those with the lowest
emissions levels’’ (straight emissions
approach) was only a legal dictum to
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which EPA is not bound, and which is
not cited in either the CKRC decision or
the CAA. The commenters cited Sierra
Club v. EPA, 479 F.3d 875, 880 (DC Cir.
2007) (Brick MACT), and Cement Kiln
Recycling Coalition v. EPA, 255 F.3d
855, 861 (DC Cir. 2001). In citing EPA’s
justification for the MACT floor
approach used in the hazardous waste
combustor rulemaking, the commenters
stated EPA’s position that the CAA does
not require the Agency to equate the
best performers with the lowest
emitters. The commenters specifically
cited EPA’s statement that, ‘‘as a legal
matter, CAA Section 112(d)(3) does not
specifically address the question of
whether ‘best performing’ sources are
those with the lowest net emissions, or
those which control HAP emissions
most efficiently.’’
The commenters also noted that, since
the Brick MACT decision, EPA has
determined that there are other ways to
rank the best performing sources and set
the MACT floors than a straight
emissions approach, such as the
approach used in the hazardous waste
combustor rulemaking, which combined
the hazardous waste fed to the source
and the source’s system removal
efficiency (SRE). According to the
commenters, the ‘‘SRE Feed’’
methodology better identifies who the
lowest emitters will be over time, better
assesses their performance (i.e., how
much they will emit as they operate),
and better accounts for variability (e.g.,
non-technology factors).
Response: It is not necessary to adopt
a position regarding whether the Brick
MACT Court’s references to ‘‘emissions
levels’’ is dictum or binding for
purposes of this rulemaking. In the 1999
HMIWI case, the Court very clearly
stated that EPA’s duty here was to use
data that allowed the Agency to
reasonably estimate the emissions
performance of the best performing
units. We have discovered that the
permit and regulatory data upon which
the 1997 rule was based do not reliably
serve this purpose. Conversely, the
actual emissions data from HMIWI do
enable us to estimate the performance of
the best performers. We believe that the
use of actual emissions data,
appropriately adjusted for variability
using statistical methods, sufficiently
accounts for the performance and
variability of HMIWI operation.
Regarding the commenters’ reference to
CAA Section 112(d)(3) to support their
argument regarding the definition of
‘‘best performing’’ sources, we assume
the commenters also meant Section 129,
which governs this rule.
We do not think the SRE Feed
methodology can be successfully
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adapted to determine MACT floors for
HMIWI. This is because the SRE Feed
approach requires knowledge of the
amount of hazardous materials fed into
the system and knowledge of the
system’s removal efficiency for those
specific materials, neither of which is
known or measured in the HMIWI
industry. Such materials are mixed in
with other waste and cannot reasonably
be measured separately, especially given
the occupational safety regulations to
which HMIWI operators are subject.
6. Statistical Approach
Comment: Multiple commenters
stated that the statistical methodology
EPA used to establish MACT floors did
not properly account for underlying
non-technology factors such as feed
material quantity or composition or for
normal operational variability within
and across unit operations, which led to
unattainable emissions limits.
Three of those commenters supported
the conditional use of the 99.9 percent
UCL to quantify ‘‘emissions limitation
achieved’’ as it applies to variability
above average emissions. However, the
three commenters had concerns about
EPA’s methods used to calculate
statistical parameters. The commenters
stated that EPA should characterize
emissions data distributions before
calculating statistics, instead of
assuming all data are normally
distributed. Otherwise, according to the
commenters, it is difficult to determine
if the statistics are valid. When data are
not normally distributed, the
commenters recommended that EPA
transform the data prior to conducting
its statistical calculations. The
commenters noted that EPA used the
NORMSINV function in Microsoft Excel
to calculate the 99.9 percent UCL,
which assumes that the actual mean and
variance of a data set is known.
According to the commenters, when the
mean and variance are estimated from
random samples or a small subset of the
total population, such as stack test runs,
the 99.9 percent UCL should be
calculated with the Student t-statistic
using the TINV function in Excel, not
normal statistics.
Two other commenters objected to the
use of the 99.9 percent UCL to account
for variability in determining emissions
limits. One of the commenters argued
that EPA provides insufficient
explanation or justification of its use of
the 99.9 percent UCL. According to the
commenter, if the performance of the
best performing HMIWI, on average, is
estimated to meet the emissions limit
99.9 percent of the time, then it would
be expected to exceed the emissions
limit 8.76 hours per year, which does
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not comply with the requirement that
each source must meet the specified
floor every day and under all operating
conditions. Therefore, the commenter
argued that the 99.9 percent UCL
procedure used by EPA is deficient and
must be revised.
The other commenter stated that
EPA’s use of a 99.9 percent UCL to
estimate individual units’ variability
marks a sharp departure from EPA’s
approach in other rulemakings (e.g., 90
percent and 95 percent UCL), and said
that EPA offers no real explanation for
this departure from past practice or why
a 99.9 percent UCL would account for
variability but a lower UCL, such as 99
percent or 95 percent or 90 percent,
would not. The commenter
recommended that EPA correct its floor
approach to avoid the
overcompensation for variability seen
with some of the floors for new units.
Two commenters stated that a more
realistic assessment of an individual
unit’s ability to meet an emissions limit
during a compliance test would use the
99.9 percent UCL for that unit/pollutant
instead of the average value.
Four commenters disagreed with
EPA’s decision to use individual test
run results to account for variability in
setting MACT floors for new and
existing sources. The commenters urged
EPA to use complete performance test
results instead. One of the commenters
argued that EPA is arbitrarily using
different measures of performance for
establishing emissions standards on the
one hand (using test runs) and
measuring compliance with these
standards on the other (using whole
tests), without explaining why different
measurement approaches are
appropriate. According to the
commenter, it appears likely that
disaggregating test results leads to less
protective floors by creating false
variability in individual units’
performance. The commenter
recommended that EPA calculate the
floors with and without disaggregating
individual test runs to ensure that its
floors are not less stringent as a result
of that approach. The other commenters
noted that data limitations may not
leave EPA an alternative to using test
run results in some cases, but they
recommended that EPA use complete
test results where enough data exist to
characterize emissions variability.
Response: Based on the responses to
our waste segregation practices
questionnaire, we believe that most
HMIWI are practicing (or encouraging
the practice of) waste segregation of
materials such as batteries, fluorescent
bulbs, paper, glass, plastics, and metalscontaining materials, which we expect
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to impact the emissions of CDD/CDF,
mercury, and other pollutants and be
reflected in the actual emissions data we
use in our analysis. (See 2008
memorandum ‘‘Summary of Industry
Responses to HMIWI Waste Segregation
Information Collection Request,’’ which
is included in the docket.)
Consequently, we believe that using
actual emissions data sufficiently and
inherently accounts for non-technology
factors such as feed material quantity or
composition which influence the level
and composition of emissions. We also
believe that our use of multiple
emissions tests and individual test runs
for each HMIWI, where possible, and
our estimation of 99 percent confidence
intervals for MACT floor data
sufficiently accounts for variability. The
use of multiple emissions tests allows
us to evaluate ‘‘between-test
variability,’’ which can occur even
where conditions appear to be the same
when two or more tests are conducted.
As we noted in the preamble to the
December 1, 2008 re-proposal (73 FR
72976, 72980), variations in emissions
may be caused by different settings for
emissions testing equipment, different
field teams conducting the testing,
differences in sample handling, or
different laboratories analyzing the
results. Identifying an achieved
emissions level needs to account for
these differences between tests, in order
for ‘‘a uniform standard [to] be capable
of being met under most adverse
conditions which can reasonably be
expected to recur[.]’’ (See NLA I, 627
F.2d at 431, n. 46.) (See also Portland
Cement Ass’n, 486 F.2d at 396 (noting
industry point that ‘‘a single test offered
a weak basis’’ for inferring that plants
could meet the standards).) The use of
individual test runs (as opposed to test
averages or unit averages) allows us to
evaluate ‘‘within-test variability.’’ A
single test at a unit usually includes at
least three separate test runs. (See
§ 63.7(e)(3) (for MACT standards under
Section 112 of the CAA), and § 60.8(f)
(for NSPS under CAA Section 111).)
Each data point should be viewed as a
snapshot of actual performance. Along
with an understanding of the factors
that may affect performance, each of
these snapshots gives information about
the normal, and unavoidable, variation
in emissions that would be expected to
recur over time. To account for
pollutant-specific variability at the bestperforming unit (for new source MACT)
or best-performing 12 percent of units
(for existing source MACT), we used
emissions data for each test run
conducted by those units. The amount
of pollutant-specific test data for those
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HMIWI varies widely for each size
category. Given the limited amount of
test data and the uncertainty regarding
that short-term emissions test data, we
have decided that using the 99 percent
UCL is an appropriate method of
estimating variability. The UCL
represents the statistical likelihood that
a value, in this case an emissions value
from the best performing source, will
fall at or below the UCL value. (Further
discussion regarding the 99 percent UCL
is provided later in this section.)
After reviewing the commenters’
suggestion that we characterize
emissions data distributions before
calculating statistics, we took a closer
look at our statistical approach. In
statistics, skewness is a measure of the
degree of asymmetry of a distribution.
Normal distributions typically have a
skewness of zero. Consequently, to
determine whether the emissions test
data used in our UCL calculations had
a normal or lognormal distribution, we
estimated the skewness of the data using
the SKEW function in Excel. Except as
specified below, those datasets with a
skewness value greater than zero (when
rounded to a whole number) were
categorized as lognormal, and all other
datasets were categorized as normal.
Those data categorized as lognormal
were transformed (by taking the natural
log of the data) prior to the calculation
of UCL values. When there were only a
few data points (e.g., one emissions test
with three test runs), which is the case
for most datasets for small HMIWI, it
was not possible to make a definitive
determination that the data were
distributed normally or lognormally. (In
fact, assuming a lognormal distribution
for those data often resulted in UCL
values that were substantially higher
than the 1997 promulgated limits.) In
those cases, we decided to use the
normal distribution in calculating UCL
values, a conservative assumption
which provided a more protective
emissions limit. When we had more
data and could make a more definitive
determination about a dataset’s
distribution, we treated the data as
noted previously. In most cases, we
found that the larger datasets are
lognormally distributed, although there
are some cases where they appear to be
distributed normally, and we treated the
data as such when doing our UCL
calculations. We believe this approach
is more accurate and obtained more
representative results than those at reproposal.
Regarding the commenters’ suggestion
about using Student’s t-statistics in
calculating the UCL values, we also
decided to revisit our statistical
approach. We agree that we have only
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51387
a relatively small, random sample of
emissions data available for our
analysis, which calls for the use of the
Student’s t-test, in accordance with
standard statistical practice.
Consequently, we have decided to use
the TINV function in Excel (specifically
the one-tailed t-value), rather than the
NORMSINV function, to calculate the
UCL values. This approach (using the
Student’s t-test) is consistent with
approaches being taken in other EPA
rulemakings, such as Portland Cement.
In response to public comments on
the size of the confidence limits used at
re-proposal and in light of the
aforementioned changes in our
statistical approach, we also decided to
reevaluate the percentiles used in the
UCL values. We evaluated four different
percentiles (90, 95, 99, and 99.9
percent). The 99.9 percent UCL values
estimated for the 2009 final rule are
substantially higher than the highest test
runs for the MACT floor units and are
frequently higher than the emissions
limits in the September 15, 1997
promulgated standards, indicating the
99.9th percentile overcompensates for
variability. Lower percentiles (e.g., 90,
95, and 99 percent) are inherently more
stable than the 99.9th percentile, with
less uncertainty (less variability) than
the 99.9th percentile from a statistical
standpoint. However, the 90 and 95
percent UCL values are frequently lower
than the highest test runs for the MACT
floor units and the stringent emissions
limits in the December 1, 2008 reproposal, indicating that those
percentiles provide insufficient
compensation for variability.
The 99 percent UCL values are
somewhat higher than the emissions
limits in the December 1, 2008 reproposal but are well below the
emissions limits in the September 15,
1997 promulgated standards. The 99
percent UCL values are more in line
with the highest test runs for the MACT
floor units than the other percentiles,
indicating that the 99 percent UCL
provides a more reasonable
compensation for variability. This
approach results in standards more
representative of the level of emissions
reduction that the best performing
sources are actually achieving.
Accordingly, we have decided to use the
99 percent UCL to estimate emissions
limits for the 2009 final rule.
We disagree with one commenter’s
argument that the 99.9 percent UCL
must provide for the floor to be met
every day and under all operating
conditions. The UCL is not about time,
but about the population of data.
Accounting for variability using the 99.9
percent UCL goes beyond the absolute
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average but does not produce
expectations of 0.1 percent
noncompliance. Setting the emissions
limit at the UCL accounts for the
possibility of variability and the
possibility that the average is outside
the range. These statistical procedures
are used to help us identify the average
emissions limitation achieved by the
best performing units, as Section
129(a)(2) of the CAA requires. Also,
there is no practical upper limit as to
what a facility can emit, so the argument
that that EPA must set a floor at a level
that equates to what a facility can meet
at all times is not consistent with the
CAA’s requirement that EPA estimate
the emissions levels achieved by best
performing units.
Regarding the comment about our
decision to use individual test run
results to account for variability, we felt
it was necessary to use test run results
when we had data limitations (e.g., for
small HMIWI) and for consistency
decided to take the same approach
where data were more plentiful. As
noted previously, we believe that each
data point should be viewed as a
snapshot of actual performance, which
gives information about the variation in
emissions that would be expected to
recur over time.
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D. Emissions Limits
1. HCl, CDD/CDF, and Metals Emissions
Limits
Comment: One commenter argued
that EPA’s proposed HCl standards of
2.4 parts per million by volume (ppmv)
for existing sources and 0.75 ppmv for
new sources are based on biased data of
indeterminate quality and are
unachievable. The commenter also
claimed that setting the HCl standards at
such low levels will negatively impact
the development and application of
CEMS, due to the lack of correlation
between Method 26A and CEMS at
concentrations comparable to the
proposed standards. According to the
commenter, the test results (Methods 26
and 26A and RCRA SW 846 Method
0050) that EPA used to set the HCl
standards contain a known bias at low
levels of HCl, varying widely with
temperature and moisture at HCl levels
below 20 ppmv (all three methods), and
having a negative bias at HCl levels
below 5 ppmv (Method 26A). The
commenter noted that all of the top
performers in the large, medium, and
small non-rural categories use wet
scrubbers to control HCl emissions, and
will have considerable moisture in the
stack gas. Thus, the data from every one
of these sources has the potential to be
biased. The commenter argued that HCl
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data below 20 ppmv are not usable and/
or representative and are technically
indefensible. The commenter
recommended that EPA follow the
example of Office of Solid Waste (OSW),
which corrected all HCl values below 20
ppmv to 20 ppmv, used a statistical
method to impute a standard deviation
for these test runs, and calculated a floor
standard based on those values.
Response: We are basing the HCl
standards in this rulemaking on the data
we have available to us from the HMIWI
source category, and can base them only
on that data. The sensitivity of Method
26A for HCl is 0.04 ppmv. Moisture is
only an issue with Method 26A if the
testing contractor does not perform the
method correctly. Unless we are given
data to the contrary, we assume that the
HCl data in our dataset are correct.
These data, for this particular
rulemaking, support the HCl standards
being adopted today.
Nonetheless, we acknowledge that the
HCl standards in our re-proposal were
very close to the method detection limit
for HCl. The changes in statistical
approach for the final rule have resulted
in increases to the HCl standards above
5 ppmv, which should address some of
the concerns listed above. Furthermore,
based on reported HCl emissions data
for all HMIWI, we estimate that 64
percent of large, 82 percent of medium,
and 100 percent of small/small rural
HMIWI will be capable of meeting the
revised HCl standards, on average,
based on their currently used control
measures. It should also be noted that
HMIWI subject to the 1997 NSPS have
been meeting the 15 ppmv HCl standard
in that rule, which is below the 20
ppmv threshold level that the
commenter cited.
Comment: One commenter
recommended that EPA set beyond-thefloor standards for both HCl and
chlorinated organic pollutants
(including CDD/CDF) based on
removing chlorinated plastics from the
waste stream. According to the
commenter, it is well established that
the combustion of chlorinated plastics
increases emissions of HCl as well as
CDD/CDF and other chlorinated
pollutants. The commenter stated that it
is achievable for HMIWI to remove
chlorinated plastics from the waste
stream that they burn. The commenter
said that EPA can gather data that will
quantify the total amount of HCl that is
attributable to the combustion of
chlorinated plastics and set a standard
reflecting the maximum degree of
reduction that is achievable through the
removal of chlorinated plastics from the
waste stream.
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The same commenter also
recommended that EPA set beyond-thefloor standards for metals based on
removing all metals from the waste
stream before combustion, consistent
with the requirements under Section
129(a)(2) and (3), which obligate EPA to
require the maximum degree of
reduction in emissions that is
achievable through the use of methods
and technologies before, during, and
after combustion. The commenter stated
that metals do not belong in an
incinerator because they cannot be
destroyed by incineration and are
especially dangerous to public health
and deleterious to the environment. As
far as the commenter knew, EPA has
never disagreed that removing metals
from the HMIWI waste stream is
achievable technically and
economically, and the commenter noted
that EPA has data from the MWC
rulemaking that show materials
separation requirements are effective
and cost-effective. (See Docket A–89–08,
various items.)
Given the language of Section 129 that
requires the maximum degree of
reduction in emissions that is
achievable through the use of precombustion measures, the commenter
argued that EPA has a duty to gather
information on these measures and
evaluate such measures in its beyondthe-floor analysis. According to the
commenter, EPA’s failure to gather
information about the precise reduction
of emissions that will result from such
measures and failure to provide any
explanation for rejecting such a
standard is unlawful and arbitrary. The
commenter noted that EPA has
committed to set final standards by
September 2009, and stated that EPA
should not delay issuance of final
standards to conduct this data gathering,
but should commence data gathering
now and revise the HMIWI regulations
to include beyond-the-floor standards in
the future.
Response: As we explained in the
2008 re-proposal, the identified beyondthe-floor add-on control measures we
analyzed were not reasonable on a costeffectiveness basis, especially in light of
the significantly more stringent floor
levels as compared to the 1997 rule’s
standards. We read the commenter’s
suggestion that we examine additional
beyond-floor measures but without
delaying final action on the re-proposal
as recommending that we conduct the
requested data gathering and analysis
for those measures in a subsequent
rulemaking action. A possible
opportunity for that would be the next
review of the rule under Sections
129(a)(5) and (h)(3). In the interim,
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however, we have decided to revise the
waste management plan provisions in
§§ 60.35e and 60.55c to promote the
segregation of chlorinated plastics and
metals to the extent possible.
2. CO Emissions Limits
Comment: One commenter argued
that the proposed CO emissions limits
will be unattainable by many applicable
units, based on the emissions data
provided in the docket. The commenter
stated that the add-on controls
evaluated by EPA do not reduce CO
emissions, and that CO emissions can be
a function of the feed material
composition (which the commenter
stated EPA did not evaluate). As a
result, the commenter stated, HMIWI
operators will have very little latitude or
options to meet the proposed CO limits.
Three other commenters stated that
historical CO CEMS data from wellperforming commercial HMIWI
demonstrate that the proposed CO
emissions limit is not achievable on a
continuous basis and argued that the
existing 40 ppmv emissions limit must
be retained. The commenters further
stated that the proposed CO standards
must include a reasonable, extended
averaging period (e.g., 24 hours) that
accounts for the variability of the waste
stream and waste characteristics. The
commenters noted that the proposed
standards are currently based on
discrete 3-hour average data developed
during performance test conditions,
which they said do not account for the
typical operational variability.
According to the commenters, such
snapshot data are also not representative
of long-term continuous monitoring,
placing facilities with CO CEMS at a
competitive disadvantage with any
revisions to the CO standard.
The same three commenters also
stated that the proposed CO standard in
combination with the 7 percent oxygen
(O2) diluent correction factor will pose
technological monitoring challenges to
HMIWI that either choose or will be
required to use CO CEMS, especially
given the variability of HMIWI
operations and waste feed streams.
According to the commenters, costly
monitoring systems (e.g., dual range or
ambient level monitors) will be needed,
resulting in additional QA activities.
The commenters further stated that the
application of an O2 correction factor to
the measured CO concentration CEMS
data may cause artificial exceedances of
the CO emissions standard at higher O2
operating scenarios.
Response: Based on our review of CO
emissions data for all HMIWI, we have
found many HMIWI outperforming the
existing 40 ppmv CO limit. We believe
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that the CO limits developed using the
revised statistical approach are more
representative of actual operation, and
we estimate that a substantial
percentage of HMIWI with their current
controls will still be capable of meeting
the revised limits (89 percent of large,
76 percent of medium, and 100 percent
of small/small rural HMIWI, on
average). Therefore, we disagree that the
40 ppmv CO limit must be retained.
Regarding the comment about the 3hour average basis for the CO limit, it
should be noted that the 2008 reproposal included an amendment to
§ 60.56c allowing sources using CEMS
to demonstrate compliance with the
applicable emissions limit on a 24-hour
block average, instead of a 12-hour
rolling average (as specified in the 1997
final rule). This amended provision
should address concerns about the
ability of sources equipped with CEMS
to demonstrate compliance with
emissions limits on a continuous basis
(as opposed to a 3-hour annual test) and
would be consistent with past
rulemakings for incineration units (e.g.,
large and small MWCs).
Regarding the comment about the
application of an O2 correction factor to
the CO CEMS data, it should be noted
that correction to consistent standards
(e.g., percent O2) is necessary in order
to compare to other units and to an
emissions limit. Applying an O2
correction factor to CO CEMS should
only be a problem at O2 levels greater
than 15 percent. For comparison
purposes, we reviewed the O2 levels
recorded in initial test reports, and
found only about 7 of 57 HMIWI
reported O2 levels above 15 percent
during at least one pollutant test run,
and we estimate that 6 of those 7 with
their current equipment will still meet
the revised CO emissions limits, based
on a comparison of the revised limits to
the average CO concentrations for those
HMIWI.
3. Opacity Limits
Comment: Three commenters noted
that EPA requested facility test data
from 2003 through 2006 for all
pollutants except opacity, even though
annual opacity testing is required for all
units. According to the commenters, if
EPA wanted to review and revise the
opacity limit pursuant to Section
129(a)(5), it should have requested
opacity data and should have used those
data in the re-establishment of the
MACT standards. Instead, the
commenters said, the proposed opacity
limit was inappropriately established
from a single continuous opacity
monitoring system (COMS) located at a
single HMIWI. The commenters argued
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51389
that data from a single unit are
insufficient to set an emissions limit
that must be continuously achieved, and
they said that EPA must seek additional
monitoring data. The commenters also
noted that compliance with the
proposed opacity limit established by
COMS is demonstrated using a different
measurement methodology (Method 9).
The same three commenters, plus a
fourth commenter, stated that the
methodology that EPA used to establish
the 2 percent opacity limit fails to
account for actual opacity monitoring
capabilities and normal operational
variability, such as that included in PS–
1 (40 CFR part 60, appendix B).
According to the commenters, the
inherent potential error of a COMS
meeting PS–1 could greatly exceed the
proposed opacity limit value. The fourth
commenter argued that opacity under
the worst foreseeable circumstances for
the best-performing units would thus
easily violate the MACT floor, which
the commenter said would violate
Sierra Club. 167 F.3d at 665.
All four commenters noted that,
similar to COMS accuracy, Method 9
calls for recording visual observations to
the nearest 5 percent at 15-second
intervals. The commenters stated that
using a compliance method with
inherent potential accuracy levels
exceeding the proposed 2 percent
opacity limit appears problematic.
Given the limitations of Method 9 and
the variability of all the HMIWI subject
to the revised opacity standard, the first
three commenters recommended that
EPA establish an opacity standard based
on Method 9 data instead of COMS data
from a single unit. All four commenters
argued that the current 10 percent
opacity limit is reasonable, and would
allow conventional compliance
determination methods to be used,
accounting for their limitations.
Response: The commenters’ argument
about how we established the proposed
opacity limit is somewhat misleading.
While we acknowledge that opacity data
were inadvertently not included in the
2007–08 test data request, we already
had opacity data for nearly 90 percent
of all HMIWI from their initial
compliance tests, and our initial opacity
MACT floor analysis was based on the
best-performing 12 percent of sources
for opacity. As we stated in the
preamble to the December 1, 2008 reproposal (73 FR 72983), based on the
opacity averages alone, without any
accounting for variability, the MACT
floor for opacity for existing and new
units would have been 0 percent. We
tried to account for variability by
looking at the single highest opacity
reading for HMIWI in the MACT floor
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for PM, based on opacity being an
appropriate surrogate for PM. We based
our MACT floor opacity limit on the
single highest COMS reading (1.1
percent) for one of the HMIWI in the
MACT floor for PM. Because we
commonly set opacity standards based
on whole numbers and could not round
down without risking having the MACT
floor unit not meet the standard, we
rounded up and proposed an opacity
limit of 2 percent for both new and
existing HMIWI. However, we now
believe this analysis was incomplete.
The analysis did not account for two
other HMIWI in the MACT floor for PM
that could more effectively account for
variability for opacity. The maximum
opacity averages for these two HMIWI
are 5.87 and 4.17 percent. (See 2008
memorandum entitled ‘‘Documentation
of HMIWI Test Data Database,’’ which is
included in the docket.) The opacity
data for these two HMIWI were
measured using Method 9. Using the
same approach that we used at reproposal, we are establishing an opacity
limit of 6 percent, by rounding up the
highest opacity average of 5.87 percent
to the nearest whole number.
Regarding the commenters’ arguments
that the inherent potential error of a
COMS meeting PS–1 could exceed the
proposed opacity limits, the potential
error (about 4 percent opacity at the
highest) is not the same as expected
error (more on the order of 0.5 percent).
Nonetheless, the increase in the opacity
limit to 6 percent should address the
commenters’ concerns on this issue.
We disagree with the commenters’
argument that a 10 percent opacity limit
be used to allow conventional
compliance determination methods.
While opacity is read in 5 percent
increments, average opacity can be any
number above 0. Method 9 values are
averages of 24 readings, which can
include readings of 0 and an occasional
5 or 10 percent.
Regarding the commenters’ argument
that only Method 9 data should be used
to establish the opacity standard
because that is the measurement method
that would be used to demonstrate
compliance, the commenters’ argument
is moot, since the revised opacity
standard is now based on Method 9
results.
4. Percent Reduction Limits
Comment: One commenter agreed
with EPA’s proposed elimination of
percent reduction alternatives.
According to the commenter, EPA
correctly noted that standards based
only on control technology performance
do not reflect the effects of nontechnology factors and, therefore, do not
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reflect the best units’ actual
performance. Therefore, the commenter
said, allowing units the option to meet
these percent reduction limits instead of
emissions standards contravenes
Section 129, and EPA appropriately
proposed to delete the percent reduction
limits.
Three other commenters argued that
the percent reduction compliance
option that was available in the 1997
rule and in the 2007 proposed rule
should be re-evaluated and retained for
commercial HMIWI, since the ability for
such units to reduce emissions is due
almost exclusively to the effectiveness
of the control equipment (and not waste
segregation). According to the
commenters, commercial HMIWI
facilities, unlike captive units, cannot
practically control the waste that is put
in the containers they process, and
applicable regulations from the U.S.
Occupational Safety and Health
Administration (OSHA) preclude them
from practicing waste segregation at the
time of treatment. Thus, the commenters
noted, they experience extreme
variability during stack tests (especially
for volatile metals Cd, Pb, and Hg) and
will experience higher inlet
concentrations than captive units; since
they operate at the same control
efficiency, they will exhibit higher stack
emissions. The commenters stated that
the percent reduction option is a better
assessment of the performance of the
control system for commercial units.
Response: We have decided not to
include percent reduction limits in the
final rule. In addition to the reasons we
provided in the re-proposal, while
commercial HMIWI facilities face
greater challenges in controlling the
waste they receive, compared to
‘‘captive’’ units, they are nonetheless
capable of taking steps to educate their
customers (i.e., waste generators)
regarding waste segregation and should
also have some control based on the
waste management plans, contract
requirements, and waste acceptance
protocols they negotiate with their
customers. Consequently, nontechnology factors are under their
control to a limited extent, which does
not support their rationale for a percent
reduction limit. The effect of raw
material inputs on emissions from
HMIWI could instead be downplayed by
a percent reduction limit that allows
more emissions provided a given level
of removal efficiency.
5. PCB and POM Emissions Limits
Comment: One commenter noted that
EPA has interpreted the CAA as
allowing the Agency to meet the
requirements of Section 112(c)(6) by
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setting standards for incinerator
emissions of 112(c)(6) pollutants under
Section 129. According to the
commenter, EPA has acknowledged that
HMIWI account for a large portion of the
aggregate emissions of both PCBs and
POM. Thus, to satisfy Section 112(c)(6),
the commenter argued that EPA must
use its authority under Section 129(a)(4)
to set emissions standards for both of
these pollutants. Noting EPA’s argument
that its standards for CDD/CDF and Hg
‘‘effectively reduce’’ emissions of PCBs
and POM and thus satisfy Section
112(c)(6), the commenter said that
Section 112(c)(6) requires that these
HAP be subject to MACT standards.
Because the best performing units used
to set these standards may be achieving
reductions in PCBs and POM by means
other than just controlling CDD/CDF
and Hg emissions—e.g., by ensuring that
no PCB-containing wastes are put in the
incinerator or by not incinerating
chlorinated plastics—the commenter
argued that EPA’s standards for CDD/
CDF and Hg do not constitute lawful
MACT standards for PCBs and POM
and, therefore, do not satisfy Section
112(c)(6).
Response: For the reasons we set forth
in the 2008 re-proposal (see 73 FR at
72991–92) and in the preamble for
today’s rule (see section VII), we
continue to take the view that while the
rule does not identify specific limits for
POM and PCB, emissions of those
pollutants are nonetheless ‘‘subject to
regulation’’ for purposes of Section
112(c)(6). While we have not identified
specific numerical limits for POM and
PCB, we believe CO serves as an
effective surrogate for those pollutants,
because CO, like POM and PCBs, is
formed as a byproduct of combustion.
We believe that dioxins/furans also
serve as an effective surrogate for PCBs,
because the compounds act similarly
and, thus, are expected to be controlled
similarly using HMIWI emissions
control technology—e.g., wet scrubbers
or fabric filters (with or without
activated carbon). Furthermore, recent
HMIWI emissions test data for PCBs and
dioxins/furans show that HMIWI wellcontrolled for dioxins/furans also
achieve low PCB emissions. (See 2008
memorandum entitled ‘‘Documentation
of HMIWI Test Data Database,’’ which is
included in the docket.) It should also
be noted that PCBs are generally found
in higher concentrations than dioxins/
furans (also the case for HMIWI), so
HMIWI equipped with the
aforementioned emissions controls
would be even more effective at
reducing PCB emissions. Consequently,
we have concluded that the emissions
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limits for CO function as a surrogate for
control of both POM and PCBs, and the
limits for dioxins/furans function as a
surrogate for PCBs, such that it is not
necessary to promulgate numerical
emissions limits for POM and PCBs
with respect to HMIWI to satisfy CAA
Section 112(c)(6).
To further address POM and PCB
emissions, the final rule also includes
revised waste management plan
provisions in §§ 60.35e and 60.55c that
encourage segregation of the types of
wastes that lead to these emissions,
such as chlorinated plastics and PCBcontaining wastes.
E. Monitoring
Comment: One commenter argued
that the monitoring requirements in the
HMIWI regulations are inadequate
because they do not provide for
emissions monitoring as required by
Section 129. According to the
commenter, EPA’s exclusive reliance on
parameter monitoring for most
pollutants and units is unlawful. The
commenter stated that EPA must require
all HMIWI to use the available CEMS
(e.g., HCl, Hg, metals, CDD/CDF) to
monitor their emissions. The
commenter indicated that CEMS are the
only requirements that can possibly
provide data adequate to ensure
compliance with emissions standards
and protection of public health and the
environment, consistent with Section
129(c)(1).
Two other commenters argued that
continuous monitoring of CO with a 24hour block average should be required
of all existing incinerators to assure
efficient combustion. However, the two
commenters stated that continuous air
monitoring of metals and other toxics
should not be adopted as an alternative
to stack testing until CEMS accuracy
and reliability has been fully verified by
EPA.
Response: The CAA provides us with
broad discretion to establish monitoring
requirements as necessary to assure
compliance with applicable
requirements. As we noted in the
preamble to the 1997 final rule (62 FR
48360), the most direct means of
ensuring compliance with emissions
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 emissions
limits. Other options are considered
only when CEMS are not technically
available or when the impacts of
including such requirements are
considered unreasonable (due to high
costs, for example). When monitoring
options other than CEMS are
considered, there is always a tradeoff
between the cost of the monitoring
requirement and the quality of the
information collected with respect to
determining actual emissions. While
monitoring of operations (operating
parameters) cannot provide a direct
51391
measurement of emissions, it is usually
much less expensive than CEMS, and
the information provided can be used to
ensure that the incinerator and
associated air pollution control
equipment are operating properly. This
information provides EPA and the
public with assurance that the
reductions envisioned by the
regulations are being achieved. (62 FR
48360–1)
For the 1997 final rule, we developed
testing and monitoring costs for a range
of options. (See Legacy Docket ID No.
A–91–61, item IV–B–66.) At that time,
we concluded that the cost of CEMS
were unreasonably high relative to the
cost of the incinerators and emissions
controls needed for compliance. (62 FR
48360–1.) For today’s final rule, we also
compared the costs of CEMS for various
pollutants to the costs of the
incinerators, emissions controls, and
parameter monitors, and reached the
same conclusion as we reached before.
(For further information, see 2009
memoranda entitled ‘‘Revised Baseline
Operating Costs for Existing HMIWI’’
and ‘‘Revised Compliance Costs and
Economic Inputs for Existing HMIWI,’’
which are included in the docket for
today’s rulemaking.) Table 3 of this
preamble presents the annual costs for
CEMS, parameter monitoring systems,
emissions controls, and incinerators,
based on model unit cost calculations
for all four HMIWI size categories.
TABLE 3—COMPARISON OF ANNUAL COSTS FOR CEMS, PARAMETER MONITORING SYSTEMS, AND EMISSIONS CONTROLS
Pollutant
CEMS
Parameter monitoring
systems
Emissions controls
Incinerators
CO ..............................
CO CEMS: $149,300
per year (yr).
Combustion control (charge rate, secondary
chamber temperature): $6,000–$9,900/yr.
Incinerator: $54,800–
$366,000/yr.
HCl .............................
HCl CEMS: $171,400/
yr.
PM ..............................
PM CEMS: $195,200/
yr.
Packed-bed scrubber (flue gas temperature,
scrubber liquor flow rate and pH): $5,200/
yr.
Fabric filter (fabric filter inlet temperature):
$4,200/yr.
Secondary chamber
retrofit: $15,100–
$80,800/yr.
Packed-bed scrubber:
$51,600–$104,000/
yr.
Fabric filter:
$130,000–$268,000/
yr.
Metals ........................
Multi-metals CEMS:
$57,800/yr.
Hg CEMS: $313,900/
yr.
Activated carbon injection system (activated
carbon injection rate): $4,800/yr.
Hg ..............................
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CDD/CDF ...................
Sorbent trap biweekly
monitoring: $37,900/
yr.
Regarding the comment that CEMS for
metals and other toxics should not be
adopted until their accuracy and
reliability has been fully verified, the reproposal specified that the CEMS
options would be available to a facility
only when a final performance
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specification has been published in the
Federal Register or when a site-specific
monitoring plan has been approved.
This should address the commenters’
concerns.
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F. Emissions Testing
Comment: One commenter
appreciated EPA’s efforts to improve
performance testing requirements and
supported the proposed changes. A
second commenter objected to the
provisions of § 60.37e(f) allowing
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submission of previous stack tests to
show compliance with proposed
emissions standards for existing HMIWI,
arguing that most of the stack tests were
conducted over 7 years ago, and are also
not statistically reliable because so few
tests were conducted. The commenter
stated that the provisions disregard the
attention that Section 129 expected EPA
to place on solid waste incinerators.
The second commenter also objected
to the proposed one-time test
requirement for Pb, Cd, Hg, and CDD/
CDF, arguing that a single test result
does not provide adequate assurance
that the emissions standards have been
met or are continuously being achieved
by operations combusting a nonhomogeneous waste stream. According
to the commenter, allowing a one-time
test also provides a strong disincentive
to installing CEMS on HMIWI. The
commenter noted that if EPA still wants
to reduce testing requirements, it could
provide skip testing provisions for these
pollutants similar to existing provisions
in § 60.56c(c)(2), especially in future
rulemaking, once the industry has
demonstrated sustained compliance.
Response: Regarding the comment
objecting to the submission of previous
stack tests to show compliance with
new emissions standards for existing
HMIWI, we attempted to address such
concerns in § 60.37e(f)(2) and (3),
specifying that the HMIWI had to be
operated in a manner expected to result
in the same or lower emissions, that it
could not have been modified such that
emissions would be expected to exceed
the previous test results, and that
emissions test results prior to the year
of the 1996 proposal could not be
accepted. We believe that these
provisions are adequate to ensure an
accurate and reliable result.
Furthermore, based on the language in
the re-proposal, it is unlikely that any
commenter could have anticipated a
change in the base year (1996) for
emissions tests that would be accepted
to demonstrate compliance with the
revised emissions limits in the final
rule, such that the commenter would
have had a meaningful opportunity to
comment on the issue.
Regarding the comment objecting to
the one-time test requirement for metals
and CDD/CDF, the annual tests are
intended to be surrogates for
combustion, particulate, and acid gas
control, supplementing existing
continuous monitoring requirements.
We believe that the annual tests for
combustion and particulate control and
the continuous emissions monitoring of
activated carbon injection are sufficient
to ensure compliance with the metals
and CDD/CDF emissions limits.
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However, if the State implementing the
HMIWI regulations for existing units in
its jurisdiction believes that more
frequent metals and CDD/CDF testing is
a necessary requirement for those units,
they have the option to prepare State
plans for EPA review that include those
requirements, or to simply require a
particular source to conduct such
testing. Section 116 of the CAA
preserves a State’s authority to regulate
more stringently under Section 111.
Given the more stringent requirements
in the HMIWI rule (relative to the 1997
rule) being promulgated today, we do
not want to impose additional testing
requirements that are not necessary to
assure compliance with the
requirements of this final rule. Also, we
did not provide an opportunity to
comment on such additional emissions
testing in the December 2008 reproposal, and we would want to
develop a fuller record on any such
requirements and provide an
opportunity to comment on those
requirements before imposing them in a
final rule. However, we would be
willing to consider such a change at the
next technology review, if such a change
is necessary to reliably demonstrate
compliance.
G. Alternatives to On-Site Incineration
Comment: Five commenters
supported alternatives to on-site
incineration, such as autoclaving. One
of the commenters stated that 90 percent
or more of medical waste could be
safely diverted from incineration. The
commenter further noted that
alternative treatment technologies like
autoclaves and microwaves work, are
available, and are approved by
regulatory agencies. The commenter
argued that these technologies provide a
much healthier alternative to
incineration. Another of the
commenters suggested EPA supplement
its proposed rule to specify a phase-in
requirement that diverts all medical
waste not required by law or regulation
to be incinerated to go to approved
alternative non-incineration disposal
methods; the commenter also
recommended that EPA prohibit
autoclave residues from being
incinerated. Three of the commenters
stated that EPA should initiate a ban on
incineration of medical waste, and in
the interim give incentives to industries
using safer, cleaner alternatives to
incinerating medical waste, such as
autoclaving and microwaving.
Five other commenters noted the
disadvantages associated with
incineration alternatives such as
autoclaving. One of the commenters
noted that EPA’s supporting documents
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for the proposed rule seem to endorse
such alternatives but fail to recognize
that some facilities generate waste types
for which autoclaving and landfilling is
not adequate treatment. As examples,
another of the commenters noted that
numerous research facilities insist that
all of their waste be incinerated, and
three of the commenters noted that most
States and many local governments have
imposed requirements on the disposal
of these types of wastes and identified
incineration as an authorized means of
disposal; further, some States expressly
require incineration of pathological
wastes and/or prohibit autoclaving or
landfilling of such wastes. With the
proposed emissions limits, the same
three commenters expected that HMI
waste incineration capacity will
disappear, and captive units will be
limited by permit from accepting wastes
from off-site; as a result, the commenters
concluded, some waste generators will
be left with a State requirement to
incinerate waste, with little or no
available HMIWI treatment options and
capacity. One commenter noted that
that sterilized waste is often transferred
to regional MWC facilities for
incineration, especially in their
metropolitan area, and noted that MWC
emissions limits are less stringent than
the current and proposed limits for
HMIWI. Thus, the commenter
concluded, if the HMIWI regulation
increases autoclaving and reduces use of
their facility, it will have a significant
adverse effect on air quality.
One of the commenters stated that
EPA’s studies for the proposed rule also
fail to recognize the environmental
impacts of transporting autoclaved
medical wastes to regional landfills,
such as depletion of landfill space,
landfill gas emissions, landfill leachate
issues, and impacts of waste
transportation traffic. Another
commenter noted that autoclaving does
not achieve the 90 percent volume
reduction that can be achieved with
incineration and, with many landfills at
or approaching capacity, volume
reduction prior to landfilling is a much
preferred option.
One commenter also noted that steam
sterilization can result in the release of
uncontrolled Hg vapors from the
autoclaving process, so any medical
waste displaced from their facility to
autoclaves would result in an increase
in Hg emissions from the autoclaves or
the MWC. The commenter said that
these potential impacts need to be
assessed before any standard is adopted.
Response: Section 129 of the CAA
provides EPA with the authority to
establish emissions limits for the nine
specified pollutants (HCl, CO, Pb, Cd,
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Hg, PM, CDD/CDF, NOX, and SO2).
Today’s action satisfies EPA’s obligation
to respond to the Court’s remand of the
1997 MACT floor determinations, as
well as EPA’s duty to conduct its first
periodic review of the standards and
requirements of the HMIWI rule. While
a record that supported complete
elimination of emissions of the
enumerated pollutants is theoretically
possible, the record for today’s rule does
not show that such an outright ‘‘ban’’ of
incineration is required to meet EPA’s
obligations.
We agree with the commenters that it
is appropriate to address the
disadvantages and environmental
impacts associated with incineration
alternatives such as autoclaving in
background documentation for the
HMIWI rule, even though the revised
standards in today’s rule are floor-based
(for which we cannot consider costs)
rather than beyond-the-floor-based
(where costs are to be considered). We
also agree that incineration is sometimes
insisted upon or even required by some
research facilities and State and local
governments, and we have incorporated
those comments into the revised
background documentation for the final
rule.
Regarding the comment that some
metropolitan areas require autoclaved
waste to be sent to MWC units, while
the commenter is correct that MWC
limits are currently higher than the 1997
promulgated HMIWI limits and the 2008
re-proposed HMIWI limits, the MWC
standards are on remand to the Agency,
and EPA will be reviewing those
standards. At this juncture, we cannot
predict the outcome of that remand
response.
Comment: One commenter stated that
EPA’s studies for the proposed rule fail
to recognize and consider all the risks
to the public associated with closing
captive HMIWI and transporting
medical/infectious wastes to large
commercial incinerators, especially in
regions such as the western U.S., where
such commercial incinerators are not
well distributed.
Response: We believe that the revised
emissions limits are more representative
of actual operation at HMIWI and will
impact fewer HMIWI than the December
2008 re-proposal, which should address
the commenter’s concerns. Moreover, in
this technology- and MACT floor-based
rulemaking, we do not believe that we
could permissibly adopt standards that
are less stringent than the floor based on
considerations of risk. See Sierra Club v.
EPA, 353 F.3d 976 (DC Cir. 2009).
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H. Medical Waste Segregation
Comment: Contrary to what EPA
stated in its summary of waste
segregation survey responses, two
commenters argued that there is ample
evidence that the extent to which waste
segregation is conducted by our
healthcare facilities is far from optimal,
and that further waste segregation could
easily occur. Multiple commenters
recommended that EPA supplement the
proposed rule to minimize or eliminate
the inclusion of plastic wastes (a chief
contributor to dioxin formation), Hg
(e.g., Hg-containing dental waste, Hgcontaining devices), and other
hazardous wastes in the waste sent to
incineration; end the burning of
confidential documents (e.g., medical
records) and other paper products that
could be shredded and recycled; and
require waste management plans from
all generators of medical waste that use
incineration as a disposal option. As
examples, one of the commenters said
captive HMIWI could be required to
train staff to minimize inclusion of Hgcontaining devices and other heavy
metals from the waste stream; and
commercial HMIWI could be required to
provide educational materials to
encourage customers to prevent
inappropriate disposal of metalscontaining devices and other items into
wastes supplied to the commercial
HMIWI. Another commenter supported
the idea of enhancing waste
management practices at the point of
generation and noted that their
commercial facility offers training
sessions with hospitals and institutions
on the importance of separating items
containing Hg and other hazardous
substances from the rest of their medical
waste and has implemented and
manages recycling programs for paper,
bottles, glass, cardboard, metals,
construction material, and sharps
containers.
To ensure effective waste segregation
by commercial facilities, one of the
commenters further recommended that
EPA revise the regulation to state that
incinerator operators are responsible for
all of the waste in their possession and
the emissions that result, and should
clarify for all incinerator operators that
the term ‘‘affected source’’ in § 60.55c
refers to them.
Four commenters noted that the
proposed new rule for emissions from
HMIWI does not address
pharmaceutical drugs, nor does it
address how hazardous pharmaceuticals
are segregated from non-hazardous. The
commenters stated that not all
incinerators, such as those in North
Carolina, are licensed to burn
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51393
pharmaceuticals classified as hazardous.
The commenters recommended that
EPA require each State to develop and
implement programs to ensure that
hazardous and non-hazardous
pharmaceuticals are being segregated.
Response: While EPA’s authority to
set emissions standards under Section
129(a)(2) reaches only incinerators of
solid waste and does not directly extend
to generators of waste who are not
owners and operators of solid waste
incineration units, we are amending the
waste management plan provisions in
the final rule to promote greater waste
segregation (e.g., plastics, metals, PCBcontaining wastes, pharmaceuticals).
Given the OSHA requirements to which
commercial HMIWI operators are
subject, those operators cannot be
expected to remove certain materials
from the waste they receive, but they
can be expected to train and educate
their clients to conduct their own waste
segregation, especially with regard to
the materials listed above. We are
including language to that effect in the
waste management provisions of the
final rule.
I. Startup, Shutdown, and Malfunction
Comment: Three commenters argued
that EPA should apply to the HMIWI
rule the decision issued by the U.S.
Court of Appeals for the DC Circuit
(Sierra Club v. EPA, 551 F.3d 1019 (DC
Cir. 2008)), which vacated the SSM
exemptions in EPA’s General Provisions
implementing Section 112 on the
grounds that the exemptions violate the
CAA’s requirement that some Section
112 standards apply continuously. The
commenters stated that the reasoning
provided by the court in its decision
also applies to the HMIWI rule.
According to one of the three
commenters, the CAA makes clear that
EPA may not exempt sources from
compliance with Section 129 emissions
standards during SSM events and that
the current exemptions (found in
§§ 60.56c(a) and 60.37e(a)) are unlawful.
The commenter noted that EPA
restricted the current SSM exemption to
periods when no hospital or medical/
infectious waste is being charged to
HMIWI. However, the commenter said
this does not bring EPA’s regulations
into compliance with the CAA or suffice
to protect the public from toxic
emissions during periods of SSM,
because HMIWI could stop charging
HMI waste during an SSM event but
still emit toxic pollution through a
bypass valve directly to the
environment. To the extent EPA is not
soliciting comment on the SSM
exemption as part of its response to the
remand in Sierra Club v. EPA, 167 F.3d
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658 (DC Cir. 1999) or its review of
regulations under Section 129(a)(5), the
commenter petitioned it to do so under
the authorities in Kennecott Utah
Copper Corp. v. Department of Interior,
88 F.3d 1191 (DC Cir. 1996).
A fourth commenter argued that if the
SSM court decision is upheld, this
would substantially impact the
approach for establishing ‘‘worst
reasonable foreseeable circumstances’’
and the approach for establishing
emissions limits based on available
data. According to the commenter,
emissions and controllability during
periods of SSM are different than
‘‘normal operation,’’ and the commenter
noted that EPA currently sets limits by
reviewing data taken during ‘‘normal
operation,’’ since no one generally
conducts stack tests during SSM.
One commenter requested that
emissions from SSM events be included
in the calculations of a facility’s
potential to emit, which in turn
determines the applicability of some
Federal requirements. The commenter
also recommended that emissions from
SSM events should be included in
modeling to ensure that new or
expanded sources do not cause ambient
air quality to exceed health-based levels.
In lieu of modeling, the commenter said
there should be actual monitoring of
SSM events to accurately determine the
individual types of toxic air pollutants
and amounts of toxic air pollutant
releases. The commenter recommended
that there be mandatory penalties for
SSM events based on the amounts and
toxicity of the emissions. To illustrate
the point, the commenter included
documentation about bypass events at a
local HMIWI. Two additional
commenters also requested that EPA
conduct modeling to assess the types
and amounts of pollutants released
during bypass events and take
appropriate steps to regulate these
‘‘fugitive’’ emissions. All three
commenters recommended that
pollution control equipment be required
for bypass events, whether the event is
operator error or violation.
Another commenter recommended
that EPA revise the General Provisions
or the specific standards to subject SSM
periods to appropriate work practice
standards, including procedures to
minimize emissions during those
periods, rather than establish MACT
emissions limits that are impossible to
meet during SSM. According to the
commenter, CAA Section 112(h) allows
the Administrator to promulgate a
design, equipment, work practice, or
operational standard, or combination
thereof, in lieu of an emissions standard
where it is not feasible to prescribe or
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enforce an emissions standard. The
commenter said that emissions
measurement is not practicable during
SSM periods.
Response: While the Court’s ruling in
Sierra Club v. EPA, 551 F.3d 1019 (DC
Cir. 2008), directly affects only the
subset of CAA Section 112(d) rules that
incorporate § 63.6(f)(1) and (h)(1) by
reference and that contain no other
regulatory text exempting or excusing
compliance during SSM events, the
legality of source category-specific SSM
provisions such as those adopted in the
1997 HMIWI rule is questionable.
To our knowledge, no HMIWI
facilities have ever done any testing
during an SSM event, except perhaps
the few that have CO CEMS (although
under the definition of ‘‘malfunction’’ in
§ 60.51c, operators are directed to
monitor all applicable operating
parameters during malfunctions until all
waste had been combusted or until the
malfunction ceases, whichever comes
first). It would be very difficult to do
any meaningful testing during such an
event because the exhaust flow rates,
temperatures, and other stack
conditions would be highly variable and
could foul up the isokinetic emissions
test methods (thus invalidating the
testing).
The 1997 rule excused exceedance of
emissions standards during SSM events
only in instances where ‘‘no hospital
waste or medical/infectious waste is
charged to the affected facility.’’ 40 CFR
60.56c(a). This means that in any SSM
periods where such waste is being
charged and an exceedance of the
standards occurs, the source is in
violation of the requirements of the
standards. Based on the 1997 HMIWI
rule’s definitions of the terms ‘‘startup’’
and ‘‘shutdown,’’ no waste should be
combusted during these periods, so
emissions should be low during them—
essentially the emissions from burning
natural gas. Under § 60.51c, startup is
defined as the period of time between
the activation of the system and the first
charge to the unit. For batch HMIWI,
startup means the period of time
between activation of the system and
ignition of the waste. Shutdown is
defined as the period of time after all
waste has been combusted in the
primary chamber. Shutdown must start
no less than 2 hours after the last charge
to the incinerator for continuous
HMIWI, and no less than 4 hours for
intermittent HMIWI. For batch HMIWI,
shutdown must commence no less than
5 hours after the high-air phase of
combustion has been completed.
Consequently, it should not be possible
for HMIWI to exceed the applicable
emissions limits during startup and
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shutdown periods. This suggests that
the exemption from standards during
startup and shutdown is of virtually no
utility to HMIWI, such that there is any
need for EPA to retain the exemption in
today’s final rule.
Malfunctions present a similar
situation in terms of how the 1997 rule
functioned, if a slightly different
situation factually. Again, the SSM
exemption of § 60.56c(a) applied only
where no hospital waste and no
medical/infectious waste was being
charged. Under §§ 60.56c(a) and
60.37e(a) of the HMIWI rules, facilities
are required to stop charging waste as
soon as a malfunction is identified and
not charge any additional waste.
‘‘Malfunction’’ is defined in § 60.51c as
any sudden, infrequent and not
reasonably preventable failure of air
pollution control equipment, process
equipment, or a process to operate in a
normal or usual manner, but does not
include failures caused, in part, by poor
maintenance or careless operation.
During malfunction periods, operators
must operate within established
parameters as much as possible and
continue to monitor all applicable
operating parameters. So, there should
be low emissions during such periods,
but how low is not known. In any case,
the rule as promulgated in 1997 did not
excuse exceedances of emissions
standards during malfunctions if
hospital waste or medical/infectious
waste was being charged during the
malfunction. Moreover, our final
standards established today are based
on the best data available to the Agency,
and we have no data to support
modifying the floors for malfunction
periods.
While EPA is still in the relatively
early process of formulating its strategy
for addressing the SSM court decision
and the numerous Section 112 and 129
rules that contain varying provisions
regarding SSM events, we are revising
the HMIWI rules in today’s final
rulemaking to delete the 1997 rule’s
narrow exemption from emissions limits
during periods of SSM. As explained
above, the exemption and definitions as
promulgated in 1997 provided virtually
no utility, and we, therefore, expect that
today’s deletion of the SSM exemption
will have very little, if any, impact on
HMIWI units’ compliance status. In the
event that sources, despite their best
efforts, fail to comply with applicable
standards during SSM events (as
defined by the rule), EPA will determine
an appropriate response based on,
among other things, the good faith
efforts of the source to minimize
emissions during SSM periods,
including preventative and corrective
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actions, as well as root cause analyses
to ascertain and rectify excess
emissions. This approach is consistent
with that discussed in a recent letter by
Adam M. Kushner, Director, Office of
Civil Enforcement, to counsel
representing various industry
associations, entitled ‘‘Re: Vacatur of
Startup, Shutdown, and Malfunction
(SSM) Exemption (40 CFR sections
63.6(f)(1) and 63.6(h)(1))’’ (July 22,
2009) (included in the docket for today’s
rulemaking).
For the reasons discussed above, we
disagree with the commenter who
claimed that, in the context of this
rulemaking, removal of the SSM
exemption would substantially impact
the MACT floor approach. Deletion of
the exemption should have no impact
on the use and analysis of the MACT
compliance data upon which the
revised standards are based in this rule.
This is because the 1997 rule’s
exemption provisions already had a
very limited focus, in excusing
compliance with standards only when
HMI waste was not being charged to the
incinerator; even under the 1997 rules,
if HMI waste was being charged during
an SSM event, the standards continued
to apply. Moreover, the commenter
provided no information to support its
position. Therefore, it is similarly
unnecessary to accept other
commenters’ recommendations to
specify mandatory penalties during
SSM events or impose unique pollution
controls for bypass events—these
concerns should be adequately
addressed by today’s removal of the
SSM exemption, which includes
removal of the 1997 rule’s exemption
during SSM periods to the prohibition
of using a bypass stack.
We also disagree that it is necessary
to revise the CAA Section 112 General
Provisions of 40 CFR part 63 to impose
work practice requirements that apply
in lieu of numeric emissions standards
during SSM periods, in the context of
this CAA Section 129 rulemaking. The
commenter who suggested this
approach cited CAA Section 112(h) as
the basis of authority for such a change,
but neither that section of the Act nor
the part 63 General Provisions apply to
standards promulgated under Section
129, which by its terms requires
numeric emissions standards for the
pollutants specified in Section 129(a)(4).
J. Economic Impacts
Comment: Two commenters argued
that the proposed limits are unattainable
without significant financial
investment, which they said will
ultimately be passed on to an already
overburdened healthcare system. The
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commenters urged EPA to reconsider
the proposed rule. One of the
commenters suggested EPA keep
emissions limits for existing HMIWI at
current levels.
A third commenter argued that this
sort of rule could also have severe
adverse consequences on other
industries, as well as the economy,
energy and natural resources, and
environment. A fourth commenter
stated that the level of source
shutdowns that has occurred in the
HMIWI industry should not be allowed
to occur in other Section 112 or 129
source categories, as it would severely
cripple the manufacturing base of this
country. The commenter urged EPA to
consider costs and other impacts when
developing rules, as required under
Section 129. According to the
commenter, the current financial crisis
demonstrates the tremendous impact on
jobs and the broader economy due to
increased operational costs and facility
shutdowns.
Response: We estimate that the
revised limits for the final rule will be
viewed as more attainable than were the
2008 re-proposed standards, and will
result in less burdensome economic
impacts for the industry. (See 2009
memorandum ‘‘Revised MACT Floors,
Data Variability Analysis, and Emission
Limits for Existing and New HMIWI’’
and 2009 report ‘‘Economic Impacts of
Revised MACT Standards for Hospital/
Medical/Infectious Waste Incinerators,’’
which are included in the docket for
today’s rulemaking.) It should be noted
that other rules do not necessarily have
to take the same MACT floor approach
as that taken in this rule (every industry,
every situation is different), so the
argument that promulgation of this rule
as proposed would adversely affect
other regulated industries is not a given.
It should also be noted that under
Section 129 we cannot consider costs
and other impacts when we are
establishing MACT floor requirements.
Comment: One commenter disagreed
with EPA’s estimation of economic
impacts, especially as it affects their
facility. The commenter specifically
questioned EPA description of HMIWI
demand as being extremely price
insensitive (i.e., that the price charged
has little effect on the quantity of
medical waste incinerated and can be
passed on to customers in full). Based
on their years of experience in selling
services, the commenter indicated that
the demand for medical waste
incineration at their facility is a curve
reflecting the interplay of different
customer groups, rather than a steep
curve as presented in EPA’s analysis
(details provided in public comment).
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Based on a graphical depiction of their
facility’s fixed costs, variable costs, and
total costs overlaid with the demand
structure, the commenter stated that
their facility makes only a modest profit
and could not operate at any level of
volume profitably if the costs of
complying with the new regulations are
added to the current cost structure
(graphical depiction provided in public
comment).
The commenter recommended that
the economic analysis be revised to
reflect the realistic economic impacts on
their company. The commenter noted
that EPA’s estimate of their gross sales
($12 million) is greater than they have
averaged in recent years, qualifying
them as a small business. The
commenter also noted that there are no
data or analysis to justify EPA’s estimate
of their company’s profits (greater than
$30 million) after adoption of the
proposed regulations. According to the
commenter, they will in fact be forced
out of business.
Three other commenters noted that
the economic analysis does not mention
the restrictions imposed by State and
local governments in resorting to
alternative waste treatment methods.
Response: The demand curve we used
in our economic analysis was meant to
apply to the industry as a whole, and,
as such, some assumptions and
simplifications were necessary.
Nonetheless, we have reviewed the
commenter’s concerns in revising our
economic analysis for the final rule. We
acknowledge the mistakes in our
previous economic analysis regarding
the commenter’s profits and sales and
have addressed them in our revised
economic analysis. We have also
addressed the restrictions noted by the
other three commenters in the revised
analysis. Finally, it should be noted that
the revisions to the emissions limits for
the final rule should mitigate the
economic impacts described here.
Comment: One commenter stated that,
although their company is a small
entity, they were not given the
opportunity to participate in the
development of the proposed HMIWI
rule, as provided under the Small
Business Regulatory Enforcement
Fairness Act (SBREFA). According to
the commenter, EPA did not conduct
the appropriate analysis and incorrectly
assumed that their business had annual
revenue exceeding the Small Business
Size Standards. The commenter
provided tax returns documenting their
status as a small entity.
Response: We properly accounted for
the impacts of the re-proposed rule in
2008 based on our analysis of the data
we then had. The base year data we
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were using in our economic analysis
(2007) showed sales numbers that
indicated they were not a small
business. After receiving public
comments and additional information,
we have accounted for any recent
changes in small entity status and reanalyzed the economic impacts of the
rule on small entities. (See 2009 report
‘‘Economic Impacts of Revised MACT
Standards for Hospital/Medical/
Infectious Waste Incinerators,’’ which is
included in the docket for today’s
rulemaking.) Because we are beyond
proposal, we cannot convene a preproposal SBREFA panel. After
considering the economic impacts of
this final rule on small entities, we can
certify that today’s final rule will not
have a significant economic impact on
a substantial number of small entities.
The one small entity directly regulated
by today’s final rule is a small business
that owns two HMIWI. We have
determined that this one small entity
may experience an impact of
approximately $3.15 million per year to
comply with the final rule, resulting in
a cost-to-sales ratio of approximately 45
percent. The small entity is a company
in Maryland, which owns and operates
a commercial facility at that location.
There are only nine other commercial
facilities, which are owned and
operated by other companies, and the
closest are in North Carolina and Ohio.
Therefore, the entity is a regional
monopolist and is able to raise the price
by more than the per unit cost increase.
We expect there to be a reduction in the
amount of its services demanded due to
the price change. Because of closures of
captive HMIWI, there may also be an
increase in the demand for its services
that may reduce the decrease in
revenues associated with the price
increase.
Two other entities are defined as
borderline small: Their parent company
sales or employment in 2008 are above
the SBA size-cutoff for small entities in
their North American Industry
Classification System (NAICS) codes,
but are near enough to the size cut-off
that variations in sales or employment
over time might move them below the
small business criterion. Based on 2008
sales data for these two entities, the
cost-to-sales ratio is less than 1 percent
for one entity and 1.4 percent for the
other. It should be noted that the entity
with the higher cost-to-sales ratio (1.4
percent) is a commercial unit and would
have the ability to pass the cost along to
their customers and would be expected
to be able to afford compliance.
Therefore, neither entity is likely to
incur significant impacts. (See 2009
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memorandum entitled ‘‘Updated Sales
Information for Companies Considered
Borderline Small Entities,’’ which is
included in the docket for today’s
rulemaking.)
Although today’s final rule will not
have a significant economic impact on
a substantial number of small entities,
we nonetheless have tried to reduce the
impact of this rule on small entities, to
the extent allowed under this CAA
MACT floor rulemaking. For each
subcategory of HMIWI, we are
promulgating emissions limits that are
based on the MACT floor level of
control, which is the minimum level of
stringency that can be considered in
establishing MACT standards. Under
the CAA and the case law, EPA can set
standards no less stringent than the
MACT floor and, therefore, we were
unable to eliminate the impact of the
emissions limits on the small entity that
would be regulated by the final rule. We
nevertheless worked to minimize the
costs of testing and monitoring
requirements to the extent possible
under the statute, in light of our final
impacts analysis.
V. Impacts of the Final Action for
Existing Units
Over the last three years, about 25
percent (19 of 76 units) of the existing
HMIWI have ceased operation. This
trend is not surprising, and supports
EPA’s analysis, which shows that even
in the absence of increased regulatory
requirements, less expensive alternative
waste disposal options are available for
almost all facilities that operate HMIWI.
Therefore, EPA expects this trend of
unit closures to continue even in the
absence of the regulatory changes. The
additional costs imposed by this action
are likely to accelerate the trend towards
alternative waste disposal options. Our
analysis suggests that sources are likely
to respond to the increased regulatory
requirements by choosing to minimize
the current cost of on-site incineration
(e.g., improve waste segregation), use
alternative waste disposal options, or
send the waste to an off-site commercial
incinerator.
The EPA’s objective is not to
discourage continued use of HMIWI;
EPA’s objective is to adopt EG for
existing HMIWI that fulfill the
requirements of CAA Section 129. In
doing so, the primary outcome
associated with adoption of these EG
may be an increase in the use of
alternative waste disposal and a
decrease in the use of HMIWI.
Consequently, EPA’s impact analyses of
the final rule include complete analyses
of two potential scenarios. The first
scenario, which will be referred to as
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the ‘‘MACT compliance’’ option for the
remainder of this preamble, assumes
that all units continue operation and
take the necessary steps to achieve
compliance. The second scenario,
which will be referred to as the
‘‘alternative disposal’’ option for the
remainder of this preamble, assumes
that all facilities choose to discontinue
operation of their HMIWI in favor of an
alternative waste disposal option. While
several different disposal options, such
as sending waste to a municipal waste
combustor or commercial HMIWI or
using chemical treatment (e.g., ozone,
electropyrolysis, chlorine compounds,
alkali agents), thermal treatment (e.g.,
plasma arc, microwave technologies), or
mechanical systems (e.g., shredding,
compacting) may be available to some
facilities, EPA assessed the impacts of
another alternative waste disposal
option. This option involves on-site
sterilization of the waste using an
autoclave followed by landfilling of the
sterilized waste. EPA selected the
autoclave/landfilling option because it
is a widely available and highly used
alternative. The results of both the
MACT compliance and autoclave/
landfilling options are provided in the
discussion of impacts. While the likely
outcome of the rule revisions is
somewhere in between the two options
that EPA selected for analysis (some
units will comply with the standards
and some will discontinue operations),
EPA’s analyses provide a broad picture
of potential impacts.
As explained in section IV.A.2 of this
preamble, the revised emissions limits
for existing HMIWI are based on the
average of the best performing 12
percent of sources for each pollutant in
each subcategory. This final action
requires varying degrees of
improvements in performance by most
HMIWI. Depending on the current
configuration of each unit and air
pollution controls, the improvements
could be achieved either through the
addition of add-on APCD, improvement
of existing add-on APCD, increase in
sorbent usage rates, and various
combustion improvements. More
specifically, the improvements
anticipated include: Most wet scrubbercontrolled units adding a fabric filterbased system for improved control of
PM and metals; most units with fabric
filter-based systems adding a packedbed wet scrubber for improved control
of HCl; adding activated carbon
injection or increasing activated carbon
usage rate for improved Hg and dioxin
control; upgrading fabric filter
performance for improved control of PM
and metals; increasing lime or caustic
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use for improved control of HCl and, in
a few instances, SO2; and combustion
improvements primarily associated with
decreasing CO emissions. We also
project that a few units may require addon controls (SNCR) to meet the revised
NOX emissions levels. Facilities may
resubmit their most recent compliance
test data for each pollutant if the data
show that their HMIWI meets the
revised emissions limits. In these
instances, facilities must certify that the
test results are representative of current
operations. Those facilities would then
not be required to test for those
pollutants to prove initial compliance
with the revised emissions limits.
A. What Are the Primary Air Impacts?
EPA estimates that reductions of
approximately 393,000 pounds per year
51397
(lb/yr) of the regulated pollutants would
be achieved if all existing HMIWI
improved performance to meet the
revised emissions limits. If all HMIWI
selected an alternative disposal method,
reductions of approximately 1.52
million lb/yr would be achieved. Table
4 shows the estimated reductions by
pollutant for the two scenarios for the
57 HMIWI currently operating.
TABLE 4—PROJECTED EMISSIONS REDUCTIONS FOR MACT COMPLIANCE AND ALTERNATIVE DISPOSAL OPTIONS FOR
EXISTING HMIWI
Reductions
achieved through
meeting MACT
(lb/yr)
Pollutant
HCl ...............................................................................................................................................................
CO ................................................................................................................................................................
Pb .................................................................................................................................................................
Cd ................................................................................................................................................................
Hg ................................................................................................................................................................
PM ................................................................................................................................................................
CDD/CDF, total ............................................................................................................................................
CDD/CDF, TEQ ...........................................................................................................................................
NOX ..............................................................................................................................................................
SO2 ..............................................................................................................................................................
Total ......................................................................................................................................................
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B. What Are the Water and Solid Waste
Impacts?
EPA estimates that, based on the
MACT compliance option,
approximately 3,840 tons per year (tpy)
of additional solid waste and 86,000
gallons per year (gpy) of additional
wastewater would be generated as a
result of operating additional controls or
using increased amounts of various
sorbents.
EPA estimates that, based on the
alternative disposal option,
approximately 15,100 tpy of additional
solid waste would be sent to landfills.
This option would result in an
estimated 5.40 million gpy in
wastewater impacts.
C. What Are the Energy Impacts?
EPA estimates that approximately
9,530 megawatt-hours per year
(MWh/yr) of additional electricity
would be required to support the
increased control requirements
associated with the MACT compliance
option.
For the alternative disposal option,
EPA estimates that approximately
12,400 MWh/yr of additional electricity
would be required to operate the
autoclaves.
D. What Are the Secondary Air Impacts?
Secondary air impacts associated with
the MACT compliance option are direct
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impacts that result from the increase in
natural gas and/or electricity use that
we estimate may be required to enable
facilities to achieve the revised
emissions limits. We estimate that the
adjustments could result in emissions of
279 lb/yr of PM; 3,260 lb/yr of CO; 2,650
lb/yr of NOX; and 1,780 lb/yr of SO2
from the increased electricity and
natural gas usage.
For the alternative disposal option,
EPA estimates secondary air impacts of
692 lb/yr of PM; 5,040 lb/yr of CO; 2,550
lb/yr of NOX; and 4,980 lb/yr of SO2
from the additional electricity that
would be required to operate the
autoclaves. In addition, EPA estimates
that landfilling would result in an
additional 626 tpy of methane and
0.0330 lb/yr of mercury emissions.
E. What Are the Cost and Economic
Impacts?
EPA estimates that for the MACT
compliance option, the national total
costs for the 57 existing HMIWI to
comply with this final action would be
approximately $15.5 million in each of
the first 3 years of compliance. This
estimate includes the costs that would
be incurred based on the anticipated
performance improvements (i.e., costs of
new APCD and improvements in
performance of existing APCD), and the
additional monitoring (i.e., annual
control device inspections), testing (i.e.,
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Reductions
achieved through
alternative
disposal
(lb/yr)
168,000
1,140
313
15.6
605
3,170
0.0678
0.00145
146,000
73,700
198,000
20,200
420
35.1
682
89,900
0.0985
0.00183
1,080,000
126,000
393,000
1,520,000
initial EPA Method 22 of appendix
A–7 test and initial compliance testing),
and recordkeeping and reporting costs
that would be incurred by all 57 HMIWI
as a result of this final action.
Approximately 95 percent of the
estimated total cost in the first year is
for emissions control, and the remaining
5 percent is for monitoring, testing,
recordkeeping and reporting.
EPA estimates that for the alternative
disposal option, the national total costs
for the 57 existing HMIWI to dispose of
their solid waste by autoclaving and
landfilling would be approximately
$10.6 million per year. This estimate
includes the costs that would be
incurred based on the purchase and
operation of autoclaves and the
projected landfill tipping fees that
would be incurred based on the volume
of waste to be landfilled.
Currently, there are 57 existing
HMIWI at 51 facilities. They may be
divided into two broad categories: (1)
Captive HMIWI, which are co-owned
and co-located with generating facilities
and provide on-site incineration
services for waste generated by the
hospital, research facility, university, or
pharmaceutical operations; and (2)
commercial HMIWI, which provide
commercial incineration services for
waste generated off-site by firms
unrelated to the firm that owns the
HMIWI. EPA analyzed the impacts on
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captive HMIWI and commercial HMIWI
using different methods. Of the 57
HMIWI, 14 are commercial and 43 are
captive.
Owners of captive HMIWI may choose
to incur the costs of complying with the
revised HMIWI standards or close the
HMIWI and switch to another disposal
technology like autoclaving and
landfilling or have their waste handled
by a commercial disposal service. EPA’s
estimate of autoclaving and landfilling
costs indicate that even without
additional regulatory costs, the costs of
autoclaving and landfilling may be
lower than the costs of incinerating.
However, even if all owners of captive
HMIWI choose to continue to operate
with the additional regulatory cost, the
cost-to-sales ratios for firms owning
captive HMIWI are low. This reflects the
relatively small share of overall costs
that are associated with hospital/
medical/infectious waste management
at these firms. Of the 35 firms owning
captive HMIWI, 22 have costs of
compliance that are less than 0.1
percent of firm sales. Of the 13 with
costs exceeding 0.1 percent of sales, the
largest cost-to-sales ratio is at a captive
hospital HMIWI, and is equal to 0.995
percent. Therefore, EPA expects no
significant impact on the prices and
quantities of the underlying services of
the owners of the captive HMIWI,
whether the costs are passed on or
absorbed.
Impacts on commercial HMIWI are
analyzed using the simplifying
assumption that they operate as regional
monopolists (in general, only one
HMIWI is considered as a treatment
option by generators located nearby).
The approach to modeling the impact
for commercial HMIWI seems very
appropriate for all of the facilities
except for one. The other commercial
HMIWI facilities have costs of
compliance that are no more than 2.0
percent of revenues. That one facility
has a ratio of approximately 45 percent.
As noted previously, this facility is a
regional monopolist and is able to raise
the price by more than the per unit cost
increase. We expect there to be a
reduction in the amount of its services
demanded due to the price change.
Because of closures of captive HMIWI,
there may also be an increase in the
demand for its services that may reduce
the decrease in revenues associated with
the price increase. For more details
regarding EPA’s analysis of the
economic impacts, see the July 2009
docket entry entitled ‘‘Economic
Impacts of Revised MACT Standards for
Hospital/Medical/Infectious Waste
Incinerators.’’
VI. Impacts of the Final Action for New
Units
Information provided to EPA
indicates that negative growth has been
the trend for HMIWI for the past several
years. While existing units continue to
shut down, since promulgation of the
HMIWI NSPS in 1997, four new units
have been constructed and one unit has
been reconstructed. This information
indicates that in the absence of further
regulation, new HMIWI may be built.
However, based on the stringency of
revisions being promulgated for the
NSPS, sources would likely respond to
the final rule by choosing not to
construct new HMIWI and would utilize
alternative waste disposal options rather
than incur the costs of compliance.
Considering this information, EPA
does not anticipate any new HMIWI,
and therefore, no impacts of the revised
NSPS for new units. For purposes of
demonstrating that emissions reductions
would result from the NSPS in the
unlikely event that a new unit is
constructed, EPA estimated emissions
reductions and other impacts expected
for each of three HMIWI model plants.
A. What Are the Primary Air Impacts?
EPA estimated emissions reductions
for each of the model plants to
demonstrate that the NSPS would, if a
new unit were built, reduce emissions
compared to a HMIWI meeting the
current NSPS. Table 5 of this preamble
presents the emissions reductions for
the HMIWI model plants. The three
model plants (with capacities of 100 lb/
hr, 400 lb/hr, and 4,000 lb/hr) represent
typical HMIWI. For pollutants where a
‘‘zero’’ value is shown, the model plant
performance estimate meets the revised
new source limit, which is not
surprising since the models are based on
the performance of the newest sources,
which are among the best performers in
the industry.
TABLE 5—EMISSIONS REDUCTIONS ON A MODEL PLANT BASIS
Emissions reduction for HMIWI model plants (lb/yr)
Pollutant
100 lb/hr
capacity
400 lb/hr
capacity
4,000 lb/hr
capacity
0
0
0
0
0
0
0
0
491
37.8
45.8
7.97
0
0
0.194
0
5.34 × 10¥4
6.02 × 10¥6
1,780
31.9
968
0
3.76
0.293
2.40
170
0
0
0
0
Total ..........................................................................................................................
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HCl ...................................................................................................................................
CO ....................................................................................................................................
Pb .....................................................................................................................................
Cd ....................................................................................................................................
Hg ....................................................................................................................................
PM ....................................................................................................................................
Dioxins/furans, total .........................................................................................................
Dioxins/furans, TEQ .........................................................................................................
NOX ..................................................................................................................................
SO2 ..................................................................................................................................
529
1,860
1,140
B. What Are the Water and Solid Waste
Impacts?
While EPA believes it is unlikely that
any new HMIWI will be constructed, we
estimated the following water or solid
waste impacts associated with the
revised NSPS for three different HMIWI
model sizes: For large units, we estimate
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7,120 gpy of additional wastewater and
50.8 tpy of additional solid waste; for
medium units, we estimate no
additional wastewater and 23.6 tpy of
additional solid waste; and, for small
units, we estimate 29.7 gallons per year
of additional wastewater and 2.68 tpy of
additional solid waste.
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C. What Are the Energy Impacts?
While EPA believes it is unlikely that
any new HMIWI will be constructed, we
estimated the following energy impacts
associated with the revised NSPS for
three different HMIWI model sizes: for
large units, we estimate that 280 MWh/
yr of additional electricity would be
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required to support the increased
control requirements; for medium units,
we estimate 416 MWh/yr; and, for small
units, we estimate 9.90 MWh/yr.
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D. What Are the Secondary Air Impacts?
Secondary air impacts for new HMIWI
are direct impacts that would result
from the increase in natural gas and/or
electricity use that we estimate may be
required to enable facilities to achieve
the revised emissions limits. While EPA
believes it is unlikely that any new
HMIWI will be constructed, we
estimated the secondary air impacts
associated with the revisions to the
NSPS for three different HMIWI model
sizes. For large units, we estimate that
the adjustments could result in
emissions of 15.6 lb/yr of PM; 114 lb/
yr of CO; 57.4 lb/yr of NOX; and 112 lb/
yr of SO2. For medium units, we
estimate that the adjustments could
result in emissions of 2.71 lb/yr of PM;
119 lb/yr of CO; 142 lb/yr of NOX; and
0.938 lb/yr of SO2. For small units, we
estimate that the adjustments could
result in emissions of 0.551 lb/yr of PM;
4.02 lb/yr of CO; 2.03 lb/yr of NOX; and
3.97 lb/yr of SO2.
For the alternative disposal option,
EPA estimated secondary air impacts
from the additional electricity that
would be required to operate autoclaves
in lieu of each size of HMIWI. For large
units, we estimate secondary emissions
of 65.5 lb/yr of PM; 478 lb/yr of CO; 241
lb/yr of NOX; and 471 lb/yr of SO2. For
medium units, we estimate secondary
emissions of 4.98 lb/yr of PM; 36.3 lb/
yr of CO; 18.4 lb/yr of NOX; and 35.8 lb/
yr of SO2. For small units, we estimate
secondary emissions of 1.25 lb/yr of PM;
9.09 lb/yr of CO; 4.60 lb/yr of NOX; and
8.98 lb/yr of SO2. In addition, EPA
estimates that an additional 58.5 tpy of
methane and 0.00308 lb/yr of mercury
emissions would result from landfilling
waste that would have been processed
in a large HMIWI, 3.29 tpy of methane
and 0.000173 lb/yr of mercury
emissions would result from landfilling
waste that would have been processed
in a medium HMIWI, and 0.549 tpy of
methane and 0.0000289 lb/yr of
mercury emissions would result from
landfilling waste that would have been
processed in a small HMIWI.
E. What Are the Cost and Economic
Impacts?
While EPA projects that three new
HMIWI would be constructed in the
absence of the promulgated revisions,
we believe that, in response to the
promulgated revisions, sources may
decide against constructing new
HMIWI. Nevertheless, we estimated the
following costs associated with
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installation and operation of air
pollution controls needed to meet the
revisions to the NSPS: for new large
units, $1.08 million per year; for new
medium units, $116,000 per year; and,
for new small units, $118,000 per year.
EPA’s analysis of impacts of the
revisions to the HMIWI standards on
potential new HMIWI compares the
with-regulation estimated prices that
would be charged by new large,
medium, and small HMIWI to the range
of with-regulation prices estimated to be
charged by existing commercial HMIWI
in various regional markets. This
comparison indicates that new large and
medium commercial HMIWI may be
viable, but new small commercial
HMIWI probably would not be viable.
On the other hand, generators of
hospital/medical/infectious waste could
have overarching reasons to purchase
and install a new small HMIWI.
Comparison of autoclave treatment
coupled with off-site landfill disposal
shows that, for new facilities as for
existing ones, autoclave/landfill
treatment and disposal is generally less
costly than incineration. Thus, the
motivation to improve waste segregation
to minimize the waste that must be
incinerated is likely to continue,
although HMIWI treatment of some
wastes will continue to be required by
regulation.
VII. Relationship of the Final Action to
Section 112(c)(6) of the CAA
Section 112(c)(6) of the CAA requires
EPA to identify categories of sources of
seven specified pollutants to assure that
sources accounting for not less than 90
percent of the aggregate emissions of
each such pollutant are subject to
standards under CAA Section 112(d)(2)
or 112(d)(4). EPA has identified HMIWI
as a source category that emits five of
the seven CAA Section 112(c)(6)
pollutants: POM, dioxins, furans, Hg,
and PCBs. (The POM emitted by HMIWI
is composed of 16 polyaromatic
hydrocarbons (PAH) and extractable
organic matter (EOM).) In the Federal
Register notice Source Category Listing
for Section 112(d)(2) Rulemaking
Pursuant to Section 112(c)(6)
Requirements, 63 FR 17838, 17849,
Table 2 (1998), EPA identified medical
waste incinerators (now referred to as
HMIWI) as a source category ‘‘subject to
regulation’’ for purposes of CAA Section
112(c)(6) with respect to the CAA
Section 112(c)(6) pollutants that HMIWI
emit. HMIWI are solid waste
incineration units currently regulated
under CAA Section 129. For purposes of
CAA Section 112(c)(6), EPA has
determined that standards promulgated
under CAA Section 129 are
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51399
substantively equivalent to those
promulgated under CAA Section 112(d).
(See id. at 17845; see also 62 FR 33625,
33632 (1997).) As discussed in more
detail below, the CAA Section 129
standards effectively control emissions
of the five identified CAA Section
112(c)(6) pollutants. Further, since CAA
Section 129(h)(2) precludes EPA from
regulating these substantial sources of
the five identified CAA Section
112(c)(6) pollutants under CAA Section
112(d), EPA cannot further regulate
these emissions under that CAA section.
As a result, EPA considers emissions of
these five pollutants from HMIWI
‘‘subject to standards’’ for purposes of
CAA Section 112(c)(6).
As required by the statute, the CAA
Section 129 HMIWI standards include
numeric emissions limits for the nine
pollutants specified in Section 129(a)(4).
The combination of waste segregation,
good combustion practices, and add-on
air pollution control equipment (dry
sorbent injection fabric filters, wet
scrubbers, or combined fabric filter and
wet scrubber systems) effectively
reduces emissions of the pollutants for
which emissions limits are required
under CAA Section 129: Hg, CDD/CDF,
Cd, Pb, PM, SO2, HCl, CO, and NOx.
Thus, the NSPS and EG specifically
require reduction in emissions of three
of the CAA Section 112(c)(6) pollutants:
dioxins, furans, and Hg. As explained
below, the air pollution controls
necessary to comply with the
requirements of the HMIWI NSPS and
EG also effectively reduce emissions of
the following CAA Section 112(c)(6)
pollutants that are emitted from HMIWI:
POM and PCBs. Although the CAA
Section 129 HMIWI standards as
promulgated in 1997 and as revised for
the 2009 final rule do not have separate,
specific numerical emissions limits for
PCBs and POM, emissions of these two
CAA Section 112(c)(6) pollutants are
effectively controlled by the same
control measures used to comply with
the numerical emissions limits for the
pollutants enumerated in Section
129(a)(4). Specifically, as byproducts of
combustion, the formation of PCBs and
POM is effectively reduced by the
combustion and post-combustion
practices required to comply with the
CAA Section 129 standards. Any PCBs
and POM that do form during
combustion are further controlled by the
various post-combustion HMIWI
controls. The add-on PM control
systems (either fabric filter or wet
scrubber) and activated carbon injection
in the fabric filter-based systems further
reduce emissions of these organic
pollutants, and also reduce Hg
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emissions, as is evidenced by HMIWI
performance data. Specifically, the postMACT compliance tests at currently
operating HMIWI that were also
operational at the time of promulgation
of the 1997 standards show that, for
those units, the 1997 HMIWI MACT
regulations reduced Hg emissions by
about 60 percent and CDD/CDF
emissions by about 80 percent from preMACT levels. (Note that these
reductions do not reflect unit
shutdowns, units for which exemptions
were granted, or new units.) Moreover,
similar controls have been demonstrated
to effectively reduce emissions of POM
and PCBs from another incineration
source category (municipal solid waste
combustors). It is, therefore, reasonable
to conclude that POM and PCB
emissions are substantially controlled at
all 57 HMIWI. Thus, while the final rule
does not identify specific numerical
emissions limits for POM and PCB,
emissions of those pollutants are, for the
reasons noted above, nonetheless
‘‘subject to regulation’’ for purposes of
Section 112(c)(6) of the CAA.
In lieu of establishing numerical
emissions limits for pollutants such as
PCBs and POM, CAA Section 129(a)(4)
allows EPA to regulate surrogate
substances. While we have not
identified specific numerical limits for
POM and PCB, we believe CO serves as
an effective surrogate for those
pollutants, because CO, like POM and
PCBs, is formed as a byproduct of
combustion. We believe that dioxins/
furans also serve as an effective
surrogate for PCBs, because the
compounds act similarly and, thus, are
expected to be controlled similarly
using HMIWI emissions control
technology—e.g., wet scrubbers or fabric
filters (with or without activated
carbon). Furthermore, recent HMIWI
emissions test data for PCBs and
dioxins/furans show that HMIWI wellcontrolled for dioxins/furans also
achieve low PCB emissions. (See 2008
memorandum entitled ‘‘Documentation
of HMIWI Test Data Database,’’ which is
included in the docket.) It should also
be noted that PCBs are generally found
in higher concentrations than dioxins/
furans (also the case for HMIWI), so
HMIWI equipped with the
aforementioned emissions controls
would be even more effective at
reducing PCB emissions. Consequently,
we have concluded, in response to the
public comments submitted on this
issue, that the emissions limits for CO
function as a surrogate for control of
both POM and PCBs, and the limits for
dioxins/furans function as a surrogate
for PCBs, such that it is not necessary
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to promulgate numerical emissions
limits for POM and PCBs with respect
to HMIWI to satisfy CAA Section
112(c)(6).
To further address POM and PCB
emissions, the final rule also includes
revised waste management plan
provisions that encourage segregation of
the types of wastes that lead to these
emissions, such as chlorinated plastics
and PCB-containing wastes.
VIII. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866 (58 FR
51735; October 4, 1993), this action is a
‘‘significant regulatory action’’ because
it is likely to raise novel legal or policy
issues arising out of legal mandates, the
President’s priorities, or the principles
set forth in the Executive Order.
Accordingly, EPA submitted this action
to the Office of Management and Budget
(OMB) for review under Executive
Order 12866, and any changes made in
response to OMB recommendations
have been documented in the docket for
this action.
B. Paperwork Reduction Act
The information collection
requirements in this rule have been
submitted for approval to OMB under
the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. The information collection
requirements are not enforceable until
OMB approves them. The Information
Collection Request (ICR) documents
prepared by EPA have been assigned
EPA ICR number 2335.02 for subpart Ce,
40 CFR part 60, and 1730.08 for subpart
Ec, 40 CFR part 60.
The requirements in this final action
result in industry recordkeeping and
reporting burden associated with review
of the amendments for all HMIWI, EPA
Method 22 of appendix A–7 testing for
all HMIWI, and inspections of
scrubbers, fabric filters, and other air
pollution control devices that may be
used to meet the emissions limits for all
HMIWI. Stack testing and development
of new parameter limits would be
necessary for HMIWI that need to make
performance improvements in order to
meet the emissions limits and for
HMIWI that, prior to this final action,
have not been required to demonstrate
compliance with certain pollutants. Any
new HMIWI would also be required to
continuously monitor CO emissions.
New HMIWI equipped with fabric filters
would also be required to purchase bag
leak detectors.
The annual average burden associated
with the EG over the first 3 years
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following promulgation of this final
action is estimated to be 44,229 hours at
a total annual labor cost of $1,871,571.
The total annualized capital/startup
costs and operation and maintenance
(O&M) costs associated with the
monitoring requirements, EPA Method
22 of appendix A–7 testing, storage of
data and reports, and photocopying and
postage over the three year period of the
ICR are estimated at $1,410,168 and
$641,591 per year, respectively. (The
annual inspection costs are included
under the recordkeeping and reporting
labor costs.) The annual average burden
associated with the NSPS over the first
three years following promulgation of
this final action is estimated to be 2,705
hours at a total annual labor cost of
$102,553. The total annualized capital/
startup costs are estimated at $137,658,
with total operation and maintenance
costs of $116,192 per year. Burden is
defined at 5 CFR 1320.3(b).
EPA may not conduct or sponsor, and
a person is not required to, a collection
of information unless it displays a valid
OMB control number. The OMB control
numbers for EPA’s regulations in 40
CFR are listed in 40 CFR part 9. When
this ICR is approved by OMB, the EPA
will publish a technical amendment to
40 CFR part 9 in the Federal Register to
display the OMB control numbers for
the approved information collection
requirements contained in this final
rule.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedures Act or any
other statute unless the EPA certifies
that the final action will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small government organizations, and
small government jurisdictions.
For purposes of assessing the impacts
of this final action on small entities,
small entity is defined as follows: (1) A
small business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; or (3) a
small organization that is any not-forprofit enterprise that is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of this final rule on small
entities, I certify that this action will not
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have a significant economic impact on
a substantial number of small entities.
The one small entity directly regulated
by this final action is a small business
that owns two HMIWI. We have
determined that this one small entity
may experience an impact of
approximately $3.15 million per year to
comply with the final rule, resulting in
a cost-to-sales ratio of approximately 45
percent. (See 2009 report ‘‘Economic
Impacts of Revised MACT Standards for
Hospital/Medical/Infectious Waste
Incinerators,’’ which is included in the
docket for today’s rulemaking.) The one
small entity is a company in Maryland,
which owns and operates a commercial
facility at that location. There are only
nine other commercial facilities, which
are owned and operated by other
companies, and the closest are in North
Carolina and Ohio. Therefore, the entity
is a regional monopolist and is able to
raise the price by more than the per unit
cost increase. We expect there to be a
reduction in the amount of its services
demanded due to the price change.
Because of closures of captive HMIWI
there may also be an increase in the
demand for its services that may reduce
the decrease in revenues associated with
the price increase.
Two other entities are defined as
borderline small: Their parent company
sales or employment in 2008 are above
the SBA size-cutoff for small entities in
their NAICS codes, but are near enough
to the size cut-off that variations in sales
or employment over time might move
them below the small business criterion.
Based on 2008 sales data for these two
entities, the cost-to-sales ratio is less
than 1 percent for one entity and 1.4
percent for the other. It should be noted
that the entity with the higher cost-tosales ratio (1.4 percent) is a commercial
unit and would have the ability to pass
the cost along to their customers and
would be expected to be able to afford
compliance. Therefore, neither entity is
likely to incur significant impacts. (See
2009 memorandum entitled ‘‘Updated
Sales Information for Companies
Considered Borderline Small Entities,’’
which is included in the docket for
today’s rulemaking.)
Although the final rule will not have
a significant economic impact on a
substantial number of small entities,
EPA nonetheless conducted an analysis
of the impacts of the final rule on the
directly regulated small entity and has
tried to reduce the impact of this rule on
small entities, to the extent allowed
under the CAA MACT floor rulemaking.
Our impacts analysis is contained in the
docket for today’s final rulemaking. For
each subcategory of HMIWI, we are
promulgating emissions limits that are
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based on the MACT floor level of
control, which is the minimum level of
stringency that can be considered in
establishing MACT standards. Under
the CAA and the case law EPA can set
standards no less stringent than the
MACT floor. Therefore, we were unable
to reduce the impact of the emissions
limits on the small entity that would be
regulated by the final rule. However, we
worked to minimize the costs of testing
and monitoring requirements in light of
our final impacts analysis, to the extent
possible under the statute.
D. Unfunded Mandates Reform Act
This final action contains no Federal
mandates under the provisions of Title
II of the Unfunded Mandates Reform
Act (UMRA), 2 U.S.C. 1531–1538 for
State, local, or Tribal governments or
the private sector. This final action
imposes no enforceable duty on any
State, local or Tribal governments or the
private sector. Therefore, this final
action is not subject to the requirements
of Section 202 or 205 of the UMRA.
This final action is also not subject to
the requirements of Section 203 of
UMRA because it contains no regulatory
requirements that might significantly or
uniquely affect small governments. This
final action contains no requirements
that apply to such governments,
imposes no obligations upon them, and
will not result in expenditures by them
of $100 million or more in any one year
or any disproportionate impacts on
them.
E. Executive Order 13132: Federalism
This action does not have Federalism
implications. It will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. This final action
will not impose substantial direct
compliance costs on State or local
governments, and will not preempt
State law. Thus, Executive Order 13132
does not apply to this action.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have Tribal
implications, as specified in Executive
Order 13175 (65 FR 67249; November 9,
2000). EPA is not aware of any HMIWI
owned or operated by Indian Tribal
governments. Thus, Executive Order
13175 does not apply to this action.
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51401
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885; April 23, 1997) as
applying to those regulatory actions that
concern health or safety risks, such that
the analysis required under section 5–
501 of the Order has the potential to
influence the regulation. This final
action is not subject to Executive Order
13045 because it is based solely on
technology performance.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355; May 22,
2001) because it is not likely to have a
significant adverse effect on the supply,
distribution, or use of energy. EPA
estimates that the requirements in this
final action would cause most HMIWI to
modify existing air pollution control
devices (e.g., increase the horsepower of
their wet scrubbers) or install and
operate new control devices, resulting
in approximately 9,530 MWh/yr of
additional electricity being used.
Given the negligible change in energy
consumption resulting from this final
action, EPA does not expect any
significant price increase for any energy
type. The cost of energy distribution
should not be affected by this final
action at all since the action would not
affect energy distribution facilities. We
also expect that any impacts on the
import of foreign energy supplies, or
any other adverse outcomes that may
occur with regards to energy supplies
would not be significant. We, therefore,
conclude that if there were to be any
adverse energy effects associated with
this final action, they would be
minimal.
I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113 (15 U.S.C. 272 note) directs
EPA to use voluntary consensus
standards (VCS) in its regulatory
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures, and
business practices) that are developed or
adopted by VCS bodies. NTTAA directs
EPA to provide Congress, through OMB,
explanations when the EPA decides not
to use available and applicable VCS.
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This final rulemaking involves
technical standards. EPA has decided to
use two VCS in this final rule. One VCS,
ASME PTC 19.10–1981, ‘‘Flue and
Exhaust Gas Analyses,’’ is cited in this
final rule for its manual method of
measuring the content of the exhaust gas
as an acceptable alternative to EPA
Method 3B of appendix A–2. This
standard is available from the American
Society of Mechanical Engineers
(ASME), P.O. Box 2900, Fairfield, NJ
07007–2900; or Global Engineering
Documents, Sales Department, 15
Inverness Way East, Englewood, CO
80112.
Another VCS, ASTM D6784–02,
‘‘Standard Test Method for Elemental,
Oxidized, Particle-Bound and Total
Mercury Gas Generated from Coal-Fired
Stationary Sources (Ontario Hydro
Method),’’ is cited in this final rule as
an acceptable alternative to EPA Method
29 of appendix A–8 (portion for
mercury only) for measuring mercury.
This standard is available from the
American Society for Testing and
Materials (ASTM), 100 Barr Harbor
Drive, Post Office Box C700, West
Conshohocken, PA 19428–2959; or
ProQuest, 300 North Zeeb Road, Ann
Arbor, MI 48106.
While the EPA has identified 16 VCS
as being potentially applicable to this
final rule, we have decided not to use
these VCS in this rulemaking. The use
of these VCS would be impractical
because they do not meet the objectives
of the standards cited in this rule. See
the docket for this rule for the reasons
for these determinations.
Under 40 CFR 60.13(i) of the NSPS
General Provisions, a source may apply
to EPA for permission to use alternative
test methods or alternative monitoring
requirements in place of any required
testing methods, performance
specifications, or procedures in the final
rule and any amendments.
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J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629)
(February 16, 1994) establishes Federal
executive policy on environmental
justice. Its main provision directs
Federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
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EPA has determined that this final
rule will not have disproportionately
high and adverse human health or
environmental effects on minority or
low-income populations because it
increases the level of environmental
protection for all affected populations
without having any disproportionately
high and adverse human health or
environmental effects on any
population, including any minority or
low-income populations.
This action would establish national
standards that would result in
reductions in emissions of HCl, CO, Cd,
Pb, Hg, PM, CDD/CDF, NOx and SO2
from all HMIWI and thus decrease the
amount of such emissions to which all
affected populations are exposed.
K. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801, et seq., as added by the
Small Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this final rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. A major rule cannot
take effect until 60 days after it is
published in the Federal Register. This
action is not a ‘‘major rule’’ as defined
by 5 U.S.C. 804(2). This final rule will
be effective on December 7, 2009.
List of Subjects in 40 CFR Part 60
Environmental protection,
Administrative practice and procedure,
Air pollution control, Incorporation by
reference, Intergovernmental relations,
Reporting and recordkeeping
requirements.
Dated: September 15, 2009.
Lisa P. Jackson,
Administrator.
For the reasons stated in the preamble,
title 40, chapter I, part 60 of the Code
of Federal Regulations is amended as
follows:
■
PART 60—[AMENDED]
1. The authority citation for part 60
continues to read as follows:
■
Authority: 42 U.S.C. 7401, et seq.
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Subpart A—[Amended]
2. Section 60.17 is amended by
revising paragraphs (a)(90) and (h)(4) to
read as follows:
■
§ 60.17
Incorporations by reference.
*
*
*
*
*
(a) * * *
(90) ASTM D6784–02, Standard Test
Method for Elemental, Oxidized,
Particle-Bound and Total Mercury in
Flue Gas Generated from Coal-Fired
Stationary Sources (Ontario Hydro
Method), IBR approved for Appendix B
to part 60, Performance Specification
12A, Section 8.6.2 and § 60.56c(b)(13) of
subpart Ec of this part.
*
*
*
*
*
(h) * * *
(4) ANSI/ASME PTC 19.10–1981,
Flue and Exhaust Gas Analyses [Part 10,
Instruments and Apparatus], IBR
approved for § 60.56c(b)(4) of subpart
Ec, § 60.106(e)(2) of subpart J,
§§ 60.104a(d)(3), (d)(5), (d)(6), (h)(3),
(h)(4), (h)(5), (i)(3), (i)(4), (i)(5), (j)(3),
and (j)(4), 60.105a(d)(4), (f)(2), (f)(4),
(g)(2), and (g)(4), 60.106a(a)(1)(iii),
(a)(2)(iii), (a)(2)(v), (a)(2)(viii), (a)(3)(ii),
and (a)(3)(v), and 60.107a(a)(1)(ii),
(a)(1)(iv), (a)(2)(ii), (c)(2), (c)(4), and
(d)(2) of subpart Ja, tables 1 and 3 of
subpart EEEE, tables 2 and 4 of subpart
FFFF, table 2 of subpart JJJJ, and
§§ 60.4415(a)(2) and 60.4415(a)(3) of
subpart KKKK of this part.
*
*
*
*
*
Subpart Ce—[Amended]
*
*
*
*
*
3. Section 60.32e is amended by
revising paragraph (a) and adding
paragraph (j) to read as follows:
■
§ 60.32e
Designated facilities.
(a) Except as provided in paragraphs
(b) through (h) of this section, the
designated facility to which the
guidelines apply is each individual
HMIWI:
(1) For which construction was
commenced on or before June 20, 1996,
or for which modification was
commenced on or before March 16,
1998.
(2) For which construction was
commenced after June 20, 1996 but no
later than December 1, 2008, or for
which modification is commenced after
March 16, 1998 but no later than April
6, 2010.
*
*
*
*
*
(j) The requirements of this subpart as
promulgated on September 15, 1997,
shall apply to the designated facilities
defined in paragraph (a)(1) of this
section until the applicable compliance
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date of the requirements of this subpart,
as amended on October 6, 2009. Upon
the compliance date of the requirements
of this subpart, designated facilities as
defined in paragraph (a)(1) of this
section are no longer subject to the
requirements of this subpart, as
promulgated on September 15, 1997, but
are subject to the requirements of this
subpart, as amended on October 6, 2009.
■ 4. Section 60.33e is revised to read as
follows:
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§ 60.33e
Emissions guidelines.
(a) For approval, a State plan shall
include the requirements for emissions
limits at least as protective as the
following requirements, as applicable:
(1) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
guidelines as promulgated on
September 15, 1997, the requirements
listed in Table 1A of this subpart, except
as provided in paragraph (b) of this
section.
(2) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
guidelines as amended on October 6,
2009, the requirements listed in Table
1B of this subpart, except as provided in
paragraph (b) of this section.
(3) For a designated facility as defined
in § 60.32e(a)(2), the more stringent of
the requirements listed in Table 1B of
this subpart and Table 1A of subpart Ec
of this part.
(b) For approval, a State plan shall
include the requirements for emissions
limits for any small HMIWI constructed
on or before June 20, 1996, which is
located more than 50 miles from the
boundary of the nearest Standard
Metropolitan Statistical Area (defined in
§ 60.31e) and which burns less than
2,000 pounds per week of hospital
waste and medical/infectious waste that
are at least as protective as the
requirements in paragraphs (b)(1) and
(b)(2) of this section, as applicable. The
2,000 lb/week limitation does not apply
during performance tests.
(1) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
guidelines as promulgated on
September 15, 1997, the requirements
listed in Table 2A of this subpart.
(2) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
guidelines as amended on October 6,
2009, the requirements listed in Table
2B of this subpart.
(c) For approval, a State plan shall
include the requirements for stack
opacity at least as protective as the
following, as applicable:
(1) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
guidelines as promulgated on
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September 15, 1997, the requirements in
§ 60.52c(b)(1) of subpart Ec of this part.
(2) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
guidelines as amended on October 6,
2009 and a designated facility as
defined in § 60.32e(a)(2), the
requirements in § 60.52c(b)(2) of subpart
Ec of this part.
■ 5. Section 60.36e is amended as
follows:
■ a. By revising paragraph (a)
introductory text;
■ b. By revising paragraph (b); and
■ c. By adding paragraphs (c) and (d).
§ 60.36e
Inspection guidelines.
(a) For approval, a State plan shall
require each small HMIWI subject to the
emissions limits under § 60.33e(b) and
each HMIWI subject to the emissions
limits under § 60.33e(a)(2) and (a)(3) to
undergo an initial equipment inspection
that is at least as protective as the
following within 1 year following
approval of the State plan:
*
*
*
*
*
(b) For approval, a State plan shall
require each small HMIWI subject to the
emissions limits under § 60.33e(b) and
each HMIWI subject to the emissions
limits under § 60.33e(a)(2) and (a)(3) to
undergo an equipment inspection
annually (no more than 12 months
following the previous annual
equipment inspection), as outlined in
paragraph (a) of this section.
(c) For approval, a State plan shall
require each small HMIWI subject to the
emissions limits under § 60.33e(b)(2)
and each HMIWI subject to the
emissions limits under § 60.33e(a)(2)
and (a)(3) to undergo an initial air
pollution control device inspection, as
applicable, that is at least as protective
as the following within 1 year following
approval of the State plan:
(1) At a minimum, an inspection shall
include the following:
(i) Inspect air pollution control
device(s) for proper operation, if
applicable;
(ii) Ensure proper calibration of
thermocouples, sorbent feed systems,
and any other monitoring equipment;
and
(iii) Generally observe that the
equipment is maintained in good
operating condition.
(2) Within 10 operating days
following an air pollution control device
inspection, all necessary repairs shall be
completed unless the owner or operator
obtains written approval from the State
agency establishing a date whereby all
necessary repairs of the designated
facility shall be completed.
(d) For approval, a State plan shall
require each small HMIWI subject to the
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51403
emissions limits under § 60.33e(b)(2)
and each HMIWI subject to the
emissions limits under § 60.33e(a)(2)
and (a)(3) to undergo an air pollution
control device inspection, as applicable,
annually (no more than 12 months
following the previous annual air
pollution control device inspection), as
outlined in paragraph (c) of this section.
■ 6. Section 60.37e is amended as
follows:
■ a. By revising paragraphs (a), (b)
introductory text, and (b)(1);
■ b. By redesignating paragraphs (c) and
(d) as paragraphs (d) and (e);
■ c. By redesignating paragraphs (b)(2)
through (b)(5) as paragraphs (c)(1)
through (c)(4);
■ d. By adding a new paragraph (b)(2);
■ e. By adding paragraph (c)
introductory text;
■ f. By revising newly redesignated
paragraphs (c)(2) through (c)(4), (d), (e)
introductory text, and (e)(3); and
■ g. By adding paragraph (f).
§ 60.37e Compliance, performance testing,
and monitoring guidelines.
(a) Except as provided in paragraph
(b) of this section, for approval, a State
plan shall include the requirements for
compliance and performance testing
listed in § 60.56c of subpart Ec of this
part, with the following exclusions:
(1) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
limits in § 60.33e(a)(1), the test methods
listed in § 60.56c(b)(7) and (8), the
fugitive emissions testing requirements
under § 60.56c(b)(14) and (c)(3), the CO
CEMS requirements under
§ 60.56c(c)(4), and the compliance
requirements for monitoring listed in
§ 60.56c(c)(5)(ii) through (v), (c)(6),
(c)(7), (e)(6) through (10), (f)(7) through
(10), (g)(6) through (10), and (h).
(2) For a designated facility as defined
in § 60.32e(a)(1) and (a)(2) subject to the
emissions limits in § 60.33e(a)(2) and
(a)(3), the annual fugitive emissions
testing requirements under
§ 60.56c(c)(3), the CO CEMS
requirements under § 60.56c(c)(4), and
the compliance requirements for
monitoring listed in § 60.56c(c)(5)(ii)
through (v), (c)(6), (c)(7), (e)(6) through
(10), (f)(7) through (10), and (g)(6)
through (10). Sources subject to the
emissions limits under § 60.33e(a)(2)
and (a)(3) may, however, elect to use CO
CEMS as specified under § 60.56c(c)(4)
or bag leak detection systems as
specified under § 60.57c(h).
(b) Except as provided in paragraphs
(b)(1) and (b)(2) of this section, for
approval, a State plan shall require each
small HMIWI subject to the emissions
limits under § 60.33e(b) to meet the
performance testing requirements listed
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
in § 60.56c of subpart Ec of this part.
The 2,000 lb/week limitation under
§ 60.33e(b) does not apply during
performance tests.
(1) For a designated facility as defined
in § 60.32e(a)(1) subject to the emissions
limits under § 60.33e(b)(1), the test
methods listed in § 60.56c(b)(7), (8),
(12), (13) (Pb and Cd), and (14), the
annual PM, CO, and HCl emissions
testing requirements under
§ 60.56c(c)(2), the annual fugitive
emissions testing requirements under
§ 60.56c(c)(3), the CO CEMS
requirements under § 60.56c(c)(4), and
the compliance requirements for
monitoring listed in § 60.56c(c)(5)
through (7), and (d) through (k) do not
apply.
(2) For a designated facility as defined
in § 60.32e(a)(2) subject to the emissions
limits under § 60.33e(b)(2), the annual
fugitive emissions testing requirements
under § 60.56c(c)(3), the CO CEMS
requirements under § 60.56c(c)(4), and
the compliance requirements for
monitoring listed in § 60.56c(c)(5)(ii)
through (v), (c)(6), (c)(7), (e)(6) through
(10), (f)(7) through (10), and (g)(6)
through (10) do not apply. Sources
subject to the emissions limits under
§ 60.33e(b)(2) may, however, elect to use
CO CEMS as specified under
§ 60.56c(c)(4) or bag leak detection
systems as specified under § 60.57c(h).
(c) For approval, a State plan shall
require each small HMIWI subject to the
emissions limits under § 60.33e(b) that
is not equipped with an air pollution
control device to meet the following
compliance and performance testing
requirements:
*
*
*
*
*
(2) Following the date on which the
initial performance test is completed or
is required to be completed under
§ 60.8, whichever date comes first,
ensure that the designated facility does
not operate above the maximum charge
rate or below the minimum secondary
chamber temperature measured as 3hour rolling averages (calculated each
hour as the average of the previous 3
operating hours) at all times. Operating
parameter limits do not apply during
performance tests. Operation above the
maximum charge rate or below the
minimum secondary chamber
temperature shall constitute a violation
of the established operating
parameter(s).
(3) Except as provided in paragraph
(c)(4) of this section, operation of the
designated facility above the maximum
charge rate and below the minimum
secondary chamber temperature (each
measured on a 3-hour rolling average)
simultaneously shall constitute a
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violation of the PM, CO, and dioxin/
furan emissions limits.
(4) The owner or operator of a
designated facility may conduct a repeat
performance test within 30 days of
violation of applicable operating
parameter(s) to demonstrate that the
designated facility is not in violation of
the applicable emissions limit(s). Repeat
performance tests conducted pursuant
to this paragraph must be conducted
under process and control device
operating conditions duplicating as
nearly as possible those that indicated a
violation under paragraph (c)(3) of this
section.
(d) For approval, a State plan shall
include the requirements for monitoring
listed in § 60.57c of subpart Ec of this
part for HMIWI subject to the emissions
limits under § 60.33e(a) and (b), except
as provided for under paragraph (e) of
this section.
(e) For approval, a State plan shall
require small HMIWI subject to the
emissions limits under § 60.33e(b) that
are not equipped with an air pollution
control device to meet the following
monitoring requirements:
*
*
*
*
*
(3) The owner or operator of a
designated facility shall obtain
monitoring data at all times during
HMIWI operation except during periods
of monitoring equipment malfunction,
calibration, or repair. At a minimum,
valid monitoring data shall be obtained
for 75 percent of the operating hours per
day for 90 percent of the operating
hours per calendar quarter that the
designated facility is combusting
hospital waste and/or medical/
infectious waste.
(f) The owner or operator of a
designated facility as defined in
§ 60.32e(a)(1) or (a)(2) subject to
emissions limits under § 60.33e(a)(2),
(a)(3), or (b)(2) may use the results of
previous emissions tests to demonstrate
compliance with the emissions limits,
provided that the conditions in
paragraphs (f)(1) through (f)(3) of this
section are met:
(1) The designated facility’s previous
emissions tests must have been
conducted using the applicable
procedures and test methods listed in
§ 60.56c(b) of subpart Ec of this part.
Previous emissions test results obtained
using EPA-accepted voluntary
consensus standards are also acceptable.
(2) The HMIWI at the designated
facility shall currently be operated in a
manner (e.g., with charge rate,
secondary chamber temperature, etc.)
that would be expected to result in the
same or lower emissions than observed
during the previous emissions test(s),
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and the HMIWI may not have been
modified such that emissions would be
expected to exceed (notwithstanding
normal test-to-test variability) the
results from previous emissions test(s).
(3) The previous emissions test(s)
must have been conducted in 1996 or
later.
■ 7. Section 60.38e is amended as
follows:
■ a. By revising paragraph (a);
■ b. By revising paragraph (b)
introductory text; and
■ c. By revising paragraph (b)(1).
§ 60.38e Reporting and recordkeeping
guidelines.
(a) Except as provided in paragraphs
(a)(1) and (a)(2) of this section, for
approval, a State plan shall include the
reporting and recordkeeping
requirements listed in § 60.58c(b)
through (g) of subpart Ec of this part.
(1) For a designated facility as defined
in § 60.32e(a)(1) subject to emissions
limits under § 60.33e(a)(1) or (b)(1),
excluding § 60.58c(b)(2)(ii) (fugitive
emissions), (b)(2)(viii) (NOX reagent),
(b)(2)(xvii) (air pollution control device
inspections), (b)(2)(xviii) (bag leak
detection system alarms), (b)(2)(xix) (CO
CEMS data), and (b)(7) (siting
documentation).
(2) For a designated facility as defined
in § 60.32e(a)(1) or (a)(2) subject to
emissions limits under § 60.33e(a)(2),
(a)(3), or (b)(2), excluding
§ 60.58c(b)(2)(xviii) (bag leak detection
system alarms), (b)(2)(xix) (CO CEMS
data), and (b)(7) (siting documentation).
(b) For approval, a State plan shall
require the owner or operator of each
HMIWI subject to the emissions limits
under § 60.33e to:
(1) As specified in § 60.36e, maintain
records of the annual equipment
inspections that are required for each
HMIWI subject to the emissions limits
under § 60.33e(a)(2), (a)(3), and (b), and
the annual air pollution control device
inspections that are required for each
HMIWI subject to the emissions limits
under § 60.33e(a)(2), (a)(3), and (b)(2),
any required maintenance, and any
repairs not completed within 10 days of
an inspection or the timeframe
established by the State regulatory
agency; and
*
*
*
*
*
■ 8. Section 60.39e is amended as
follows:
■ a. By revising paragraph (a);
■ b. By revising paragraph (c)
introductory text;
■ c. By revising paragraph (c)(1);
■ d. By revising paragraph (d)(3); and
■ e. By revising paragraph (f).
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
§ 60.39e
Compliance times.
(a) Each State in which a designated
facility is operating shall submit to the
Administrator a plan to implement and
enforce the emissions guidelines as
specified in paragraphs (a)(1) and (a)(2)
of this section:
(1) Not later than September 15, 1998,
for the emissions guidelines as
promulgated on September 15, 1997.
(2) Not later than October 6, 2010, for
the emissions guidelines as amended on
October 6, 2009.
*
*
*
*
*
(c) State plans that specify measurable
and enforceable incremental steps of
progress towards compliance for
designated facilities planning to install
the necessary air pollution control
equipment may allow compliance on or
before the date 3 years after EPA
approval of the State plan (but not later
than September 16, 2002), for the
emissions guidelines as promulgated on
September 15, 1997, and on or before
the date 3 years after approval of an
amended State plan (but not later than
October 6, 2014), for the emissions
guidelines as amended on October 6,
2009). Suggested measurable and
enforceable activities to be included in
State plans are:
(1) Date for submitting a petition for
site-specific operating parameters under
§ 60.56c(j) of subpart Ec of this part.
*
*
*
*
*
(d) * * *
(3) If an extension is granted, require
compliance with the emissions
guidelines on or before the date 3 years
after EPA approval of the State plan (but
not later than September 16, 2002), for
the emissions guidelines as promulgated
on September 15, 1997, and on or before
the date 3 years after EPA approval of
an amended State plan (but not later
than October 6, 2014), for the emissions
guidelines as amended on October 6,
2009.
*
*
*
*
*
51405
(f) The Administrator shall develop,
implement, and enforce a plan for
existing HMIWI located in any State that
has not submitted an approvable plan
within 2 years after September 15, 1997,
for the emissions guidelines as
promulgated on September 15, 1997,
and within 2 years after October 6, 2009
for the emissions guidelines as amended
on October 6, 2009. Such plans shall
ensure that each designated facility is in
compliance with the provisions of this
subpart no later than 5 years after
September 15, 1997, for the emissions
guidelines as promulgated on
September 15, 1997, and no later than
5 years after October 6, 2009 for the
emissions guidelines as amended on
October 6, 2009.
9. Table 1 to subpart Ce is
redesignated as Table 1A and revised to
read as follows:
■
TABLE 1A TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED
FACILITIES AS DEFINED IN § 60.32e(a)(1)
Emissions limits
Units
(7 percent oxygen, dry basis)
Pollutant
Averaging
time 1
HMIWI size
Small
Medium
Milligrams per dry standard
cubic meter (mg/dscm)
(grains per dry standard
cubic foot (gr/dscf)).
115 (0.05) ....
69 (0.03) ......
34 (0.015) .......
Carbon monoxide.
Parts per million by volume
(ppmv).
40 ................
40 ................
40 ...................
Dioxins/furans
Nanograms per dry standard 125 (55) or
cubic meter total dioxins/
2.3 (1.0).
furans (ng/dscm) (grains
per billion dry standard
cubic feet (gr/109 dscf)) or
ng/dscm TEQ (gr/109 dscf).
ppmv ..................................... 100 or 93%
125 (55) or
2.3 (1.0).
125 (55) or 2.3
(1.0).
100 or 93%
100 or 93% ....
Sulfur dioxide
ppmv .....................................
55 ................
55 ................
55 ...................
Nitrogen oxides.
ppmv .....................................
250 ..............
250 ..............
250 .................
Lead ...............
mg/dscm (grains per thousand dry standard cubic
feet (gr/103 dscf)).
1.2 (0.52) or
70%.
1.2 (0.52) or
70%.
1.2 (0.52) or
70%.
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3-run average
(1-hour minimum sample time per
run).
3-run average
(1-hour minimum sample time per
run).
3-run average
(4-hour minimum sample time per
run).
EPA Reference Method 5 of
appendix A–3 of part 60,
or EPA Reference Method
26A or 29 of appendix A–8
of part 60.
EPA Reference Method 10
or 10B of appendix A–4 of
part 60.
3-run average
(1-hour minimum sample time per
run).
3-run average
(1-hour minimum sample time per
run).
3-run average
(1-hour minimum sample time per
run).
3-run average
(1-hour minimum sample time per
run).
EPA Reference Method 26
or 26A of appendix A–8 of
part 60.
Large
Particulate
matter.
Hydrogen chloride.
Method for demonstrating
compliance 2
Frm 00039
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E:\FR\FM\06OCR2.SGM
06OCR2
EPA Reference Method 23
of appendix A–7 of part
60.
EPA Reference Method 6 or
6C of appendix A–4 of part
60.
EPA Reference Method 7 or
7E of appendix A–4 of part
60.
EPA Reference Method 29
of appendix A–8 of part
60.
51406
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
TABLE 1A TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED
FACILITIES AS DEFINED IN § 60.32e(a)(1)—Continued
Emissions limits
Units
(7 percent oxygen, dry basis)
Pollutant
Averaging
time 1
HMIWI size
Small
Medium
Method for demonstrating
compliance 2
Large
Cadmium ........
mg/dscm (gr/103 dscf) ..........
0.16 (0.07)
or 65%.
0.16 (0.07)
or 65%.
0.16 (0.07) or
65%.
Mercury ..........
mg/dscm (gr/103 dscf) ..........
0.55 (0.24)
or 85%.
0.55 (0.24)
or 85%.
0.55 (0.24) or
85%.
3-run average
(1-hour minimum sample time per
run).
3-run average
(1-hour minimum sample time per
run).
EPA Reference Method 29
of appendix A–8 of part
60.
EPA Reference Method 29
of appendix A–8 of part
60.
1 Except
2
as allowed under § 60.56c(c) for HMIWI equipped with CEMS.
Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b).
10. Add Table 1B to subpart Ce to read
as follows:
■
TABLE 1B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED
FACILITIES AS DEFINED IN § 60.32e(a)(1) AND (a)(2)
Emissions limits
Pollutant
Units
(7 percent oxygen, dry
basis)
Averaging time 1
HMIWI size
Small
Medium
Method for demonstrating
compliance 2
EPA Reference Method 5 of
appendix A–3 of part 60,
or EPA Reference Method 26A or 29 of appendix
A–8 of part 60.
EPA Reference Method 10
or 10B of appendix A–4
of part 60.
Large
Particulate
matter.
Milligrams per dry standard
cubic meter (mg/dscm)
(grains per dry standard
cubic foot (gr/dscf)).
66 (0.029) ....
46 (0.020) ....
25 (0.011) ....
3-run average (1hour minimum
sample time per
run).
Carbon monoxide.
Parts per million by volume
(ppmv).
20 ................
5.5 ...............
11 ................
Dioxins/furans
Nanograms per dry standard cubic meter total
dioxins/furans (ng/dscm)
(grains per billion dry
standard cubic feet (gr/
109 dscf)) or ng/dscm
TEQ (gr/109 dscf).
ppmv ...................................
16 (7.0) or
0.013
(0.0057).
0.85 (0.37)
or 0.020
(0.0087).
9.3 (4.1) or
0.054
(0.024).
3-run average (1hour minimum
sample time per
run).
3-run average (4hour minimum
sample time per
run).
44 ................
7.7 ...............
6.6 ...............
Sulfur dioxide
ppmv ...................................
4.2 ...............
4.2 ...............
9.0 ...............
Nitrogen oxides.
ppmv ...................................
190 ..............
190 ..............
140 ..............
Lead ..............
mg/dscm (grains per thousand dry standard cubic
feet (gr/103 dscf)).
0.31 (0.14) ...
0.018
(0.0079).
0.036 (0.016)
Cadmium ......
mg/dscm (gr/103 dscf) ........
0.017
(0.0074).
0.013
(0.0057).
0.0092
(0.0040).
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Hydrogen
chloride.
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3-run average (1hour minimum
sample time per
run).
3-run average (1hour minimum
sample time per
run).
3-run average (1hour minimum
sample time per
run).
3-run average (1hour minimum
sample time per
run).
3-run average (1hour minimum
sample time per
run).
E:\FR\FM\06OCR2.SGM
06OCR2
EPA Reference Method 23
of appendix A–7 of part
60.
EPA Reference Method 26
or 26A of appendix A–8
of part 60.
EPA Reference Method 6
or 6C of appendix A–4 of
part 60.
EPA Reference Method 7
or 7E of appendix A–4 of
part 60.
EPA Reference Method 29
of appendix A–8 of part
60.
EPA Reference Method 29
of appendix A–8 of part
60.
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
51407
TABLE 1B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED
FACILITIES AS DEFINED IN § 60.32e(a)(1) AND (a)(2)—Continued
Emissions limits
Pollutant
Units
(7 percent oxygen, dry
basis)
Small
Mercury .........
Averaging time 1
HMIWI size
mg/dscm (gr/103 dscf) ........
0.014
(0.0061).
Medium
Method for demonstrating
compliance 2
3-run average (1hour minimum
sample time per
run).
EPA Reference Method 29
of appendix A–8 of part
60.
Large
0.025 (0.011)
0.018
(0.0079).
1 Except
2 Does
as allowed under § 60.56c(c) for HMIWI equipped with CEMS.
not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b).
11. Table 2 to subpart Ce is
redesignated as Table 2A and revised to
read as follows:
■
TABLE 2A TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER
§ 60.33e(b)(1)
Units
(7 percent oxygen,
dry basis)
HMIWI emissions
limits
Averaging time 1
Method for demonstrating compliance 2
Particulate matter ...
mg/dscm (gr/dscf)
197 (0.086) .........
3-run average (1-hour minimum sample time per run).
Carbon monoxide ..
ppmv .....................
40 .......................
Dioxins/furans ........
800 (350) or 15
(6.6).
average (1-hour minimum samtime per run).
average (4-hour minimum samtime per run).
Hydrogen chloride ..
ng/dscm total
dioxins/furans
(gr/109 dscf) or
ng/dscm TEQ
(gr/109 dscf).
ppmv .....................
3-run
ple
3-run
ple
EPA Reference Method 5 of appendix
A–3 of part 60, or EPA Reference
Method 26A or 29 of appendix A–8
of part 60.
EPA Reference Method 10 or 10B of
appendix A–4 of part 60.
EPA Reference Method 23 of appendix A–7 of part 60.
Sulfur dioxide .........
ppmv .....................
55 .......................
Nitrogen oxides ......
ppmv .....................
250 .....................
Lead .......................
mg/dscm (gr/103
dscf).
mg/dscm (gr/103
dscf).
mg/dscm (gr/103
dscf).
10 (4.4) ...............
3-run
ple
3-run
ple
3-run
ple
3-run
ple
3-run
ple
3-run
ple
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
EPA Reference Method 26 or 26A of
appendix A–8 of part 60.
EPA Reference Method 6 or 6C of appendix A–4 of part 60.
EPA Reference Method 7 or 7E of appendix A–4 of part 60.
EPA Reference Method 29 of appendix A–8 of part 60.
EPA Reference Method 29 of appendix A–8 of part 60.
EPA Reference Method 29 of appendix A–8 of part 60.
Pollutant
Cadmium ................
Mercury ..................
3,100 ..................
4 (1.7) .................
7.5 (3.3) ..............
minimum samminimum samminimum samminimum samminimum samminimum sam-
1 Except
2 Does
as allowed under § 60.56c(c) for HMIWI equipped with CEMS.
not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b).
12. Add Table 2B to subpart Ce to read
as follows:
■
TABLE 2B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER
§ 60.33e(b)(2)
Units
(7 percent oxygen,
dry basis)
HMIWI Emissions
limits
Averaging time 1
Method for demonstrating compliance 2
Particulate matter ...
mg/dscm (gr/dscf)
87 (0.038) ...........
3-run average (1-hour minimum sample time per run).
Carbon monoxide ..
ppmv .....................
20 .......................
3-run average (1-hour minimum sample time per run).
EPA Reference Method 5 of appendix
A–3 of part 60, or EPA Reference
Method 26A or 29 of appendix A–8
of part 60.
EPA Reference Method 10 or 10B of
appendix A–4 of part 60.
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations
TABLE 2B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER
§ 60.33e(b)(2)—Continued
Units
(7 percent oxygen,
dry basis)
HMIWI Emissions
limits
Hydrogen chloride ..
ng/dscm total
dioxins/furans
(gr/109 dscf) or
ng/dscm TEQ
(gr/109 dscf).
ppmv .....................
Sulfur dioxide .........
ppmv .....................
55 .......................
Nitrogen oxides ......
ppmv .....................
130 .....................
Lead .......................
mg/dscm (gr/103
dscf).
mg/dscm (gr/103
dscf).
mg/dscm (gr/103
dscf).
0.50 (0.22) ..........
Pollutant
Dioxins/furans ........
Cadmium ................
Mercury ..................
Averaging time 1
Method for demonstrating compliance 2
240 (100) or 5.1
(2.2).
3-run average (4-hour minimum sample time per run).
EPA Reference Method 23 of appendix A–7 of part 60.
810 .....................
3-run
ple
3-run
ple
3-run
ple
3-run
ple
3-run
ple
3-run
ple
EPA Reference Method 26 or 26A of
appendix A–8 of part 60.
EPA Reference Method 6 or 6C of appendix A–4 of part 60.
EPA Reference Method 7 or 7E of appendix A–4 of part 60.
EPA Reference Method 29 of appendix A–8 of part 60.
EPA Reference Method 29 of appendix A–8 of part 60.
EPA Reference Method 29 of appendix A–8 of part 60.
0.11 (0.048) ........
0.0051 (0.0022) ..
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
average (1-hour
time per run).
minimum samminimum samminimum samminimum samminimum samminimum sam-
1 Except
2 Does
as allowed under § 60.56c(c) for HMIWI equipped with CEMS.
not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b).
Subpart Ec—[Amended]
13. Section 60.50c is amended as
follows:
■ a. By revising paragraph (a);
■ b. By revising paragraph (i)(2);
■ c. By adding paragraphs (i)(3) through
(i)(5); and
■ d. By adding paragraphs (m) and (n).
■
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§ 60.50c Applicability and delegation of
authority.
(a) Except as provided in paragraphs
(b) through (h) of this section, the
affected facility to which this subpart
applies is each individual hospital/
medical/infectious waste incinerator
(HMIWI):
(1) For which construction is
commenced after June 20, 1996 but no
later than December 1, 2008; or
(2) For which modification is
commenced after March 16, 1998 but no
later than April 6, 2010.
(3) For which construction is
commenced after December 1, 2008; or
(4) For which modification is
commenced after April 6, 2010.
*
*
*
*
*
(i) * * *
(1) * * *
(2) Approval of alternative methods of
demonstrating compliance under § 60.8
including:
(i) Approval of CEMS for PM, HCl,
multi-metals, and Hg where used for
purposes of demonstrating compliance,
(ii) Approval of continuous automated
sampling systems for dioxin/furan and
Hg where used for purposes of
demonstrating compliance, and
(iii) Approval of major alternatives to
test methods;
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(3) Approval of major alternatives to
monitoring;
(4) Waiver of recordkeeping
requirements; and
(5) Performance test and data
reduction waivers under § 60.8(b).
*
*
*
*
*
(m) The requirements of this subpart
as promulgated on September 15, 1997,
shall apply to the affected facilities
defined in paragraph (a)(1) and (2) of
this section until the applicable
compliance date of the requirements of
subpart Ce of this part, as amended on
October 6, 2009. Upon the compliance
date of the requirements of the amended
subpart Ce of this part, affected facilities
as defined in paragraph (a) of this
section are no longer subject to the
requirements of this subpart, but are
subject to the requirements of subpart
Ce of this part, as amended on October
6, 2009, except where the emissions
limits of this subpart as promulgated on
September 15, 1997 are more stringent
than the emissions limits of the
amended subpart Ce of this part.
Compliance with subpart Ce of this part,
as amended on October 6, 2009 is
required on or before the date 3 years
after EPA approval of the State plan for
States in which an affected facility as
defined in paragraph (a) of this section
is located (but not later than the date 5
years after promulgation of the amended
subpart).
(n) The requirements of this subpart,
as amended on October 6, 2009, shall
become effective April 6, 2010.
14. Section 60.51c is amended as
follows:
■
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a. By adding a definition for ‘‘Bag leak
detection system’’;
■ b. By adding a definition for
‘‘Commercial HMIWI’’; and
■ c. By adding a definition for
‘‘Minimum reagent flow rate’’; and
■ d. By revising the definition for
‘‘Minimum secondary chamber
temperature.’’
■
§ 60.51c
Definitions.
Bag leak detection system means an
instrument that is capable of monitoring
PM loadings in the exhaust of a fabric
filter in order to detect bag failures. A
bag leak detection system includes, but
is not limited to, an instrument that
operates on triboelectric, lightscattering, light-transmittance, or other
effects to monitor relative PM loadings.
*
*
*
*
*
Commercial HMIWI means a HMIWI
which offers incineration services for
hospital/medical/infectious waste
generated offsite by firms unrelated to
the firm that owns the HMIWI.
*
*
*
*
*
Minimum reagent flow rate means 90
percent of the highest 3-hour average
reagent flow rate at the inlet to the
selective noncatalytic reduction
technology (taken, at a minimum, once
every minute) measured during the most
recent performance test demonstrating
compliance with the NOx emissions
limit.
*
*
*
*
*
Minimum secondary chamber
temperature means 90 percent of the
highest 3-hour average secondary
chamber temperature (taken, at a
minimum, once every minute) measured
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during the most recent performance test
demonstrating compliance with the PM,
CO, dioxin/furan, and NOX emissions
limits.
*
*
*
*
*
■ 15. Section 60.52c is amended by
revising paragraphs (a) through (c) to
read as follows:
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§ 60.52c
Emissions limits.
(a) On and after the date on which the
initial performance test is completed or
is required to be completed under
§ 60.8, whichever date comes first, no
owner or operator of an affected facility
shall cause to be discharged into the
atmosphere:
(1) From an affected facility as
defined in § 60.50c(a)(1) and (2), any
gases that contain stack emissions in
excess of the limits presented in Table
1A to this subpart.
(2) From an affected facility as
defined in § 60.50c(a)(3) and (4), any
gases that contain stack emissions in
excess of the limits presented in Table
1B to this subpart.
(b) On and after the date on which the
initial performance test is completed or
is required to be completed under
§ 60.8, whichever date comes first, no
owner or operator of an affected facility
shall cause to be discharged into the
atmosphere:
(1) From an affected facility as
defined in § 60.50c(a)(1) and (2), any
gases that exhibit greater than 10
percent opacity (6-minute block
average).
(2) From an affected facility as
defined in § 60.50c(a)(3) and (4), any
gases that exhibit greater than 6 percent
opacity (6-minute block average).
(c) On and after the date on which the
initial performance test is completed or
is required to be completed under
§ 60.8, whichever date comes first, no
owner or operator of an affected facility
as defined in § 60.50c(a)(1) and (2) and
utilizing a large HMIWI, and in
§ 60.50c(a)(3) and (4), shall cause to be
discharged into the atmosphere visible
emissions of combustion ash from an
ash conveying system (including
conveyor transfer points) in excess of 5
percent of the observation period (i.e., 9
minutes per 3-hour period), as
determined by EPA Reference Method
22 of appendix A–1 of this part, except
as provided in paragraphs (d) and (e) of
this section.
*
*
*
*
*
■ 16. Section 60.55c is revised to read
as follows:
§ 60.55c
Waste management plan.
The owner or operator of an affected
facility shall prepare a waste
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management plan. The waste
management plan shall identify both the
feasibility and the approach to separate
certain components of solid waste from
the health care waste stream in order to
reduce the amount of toxic emissions
from incinerated waste. A waste
management plan may include, but is
not limited to, elements such as
segregation and recycling of paper,
cardboard, plastics, glass, batteries, food
waste, and metals (e.g., aluminum cans,
metals-containing devices); segregation
of non-recyclable wastes (e.g.,
polychlorinated biphenyl-containing
waste, pharmaceutical waste, and
mercury-containing waste, such as
dental waste); and purchasing recycled
or recyclable products. A waste
management plan may include different
goals or approaches for different areas or
departments of the facility and need not
include new waste management goals
for every waste stream. It should
identify, where possible, reasonably
available additional waste management
measures, taking into account the
effectiveness of waste management
measures already in place, the costs of
additional measures, the emissions
reductions expected to be achieved, and
any other environmental or energy
impacts they might have. The American
Hospital Association publication
entitled ‘‘An Ounce of Prevention:
Waste Reduction Strategies for Health
Care Facilities’’ (incorporated by
reference, see § 60.17) shall be
considered in the development of the
waste management plan. The owner or
operator of each commercial HMIWI
company shall conduct training and
education programs in waste segregation
for each of the company’s waste
generator clients and ensure that each
client prepares its own waste
management plan that includes, but is
not limited to, the provisions listed
previously in this section.
■ 17. Section 60.56c is amended as
follows:
■ a. By revising paragraph (a);
■ b. By revising paragraph (b)
introductory text and paragraphs (b)(4)
and (b)(6);
■ c. By redesignating paragraphs (b)(7)
through (b)(12) as paragraphs (b)(9)
through (b)(14);
■ d. By adding new paragraphs (b)(7)
and (b)(8);
■ e. By revising newly redesignated
paragraphs (b)(9), (b)(10), (b)(11)
introductory text, and (b)(12) through
(b)(14);
■ f. By revising paragraphs (c)(2) and
(c)(3);
■ g. By redesignating paragraph (c)(4) as
paragraph (c)(5);
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51409
h. By revising newly redesignated
paragraph (c)(5);
■ i. By adding paragraphs (c)(4), (c)(6),
and (c)(7);
■ j. By revising paragraph (d)
introductory text;
■ k. By revising paragraph (e)
introductory text and paragraph (e)(5);
■ l. By adding paragraphs (e)(6) through
(e)(10);
■ m. By revising paragraph (f)
introductory text and paragraph (f)(6);
■ n. By adding paragraphs (f)(7) through
(f)(10);
■ o. By revising paragraph (g)
introductory text and paragraph (g)(5);
■ p. By adding paragraphs (g)(6) through
(g)(10);
■ q. By redesignating paragraphs (h)
through (j) as paragraphs (i) through (k);
■ r. By adding paragraph (h); and
■ s. By revising newly redesignated
paragraphs (i) and (j).
■
§ 60.56c
testing.
Compliance and performance
(a) The emissions limits apply at all
times.
(b) The owner or operator of an
affected facility as defined in
§ 60.50c(a)(1) and (2), shall conduct an
initial performance test as required
under § 60.8 to determine compliance
with the emissions limits using the
procedures and test methods listed in
paragraphs (b)(1) through (b)(6) and
(b)(9) through (b)(14) of this section. The
owner or operator of an affected facility
as defined in § 60.50c(a)(3) and (4), shall
conduct an initial performance test as
required under § 60.8 to determine
compliance with the emissions limits
using the procedures and test methods
listed in paragraphs (b)(1) through
(b)(14). The use of the bypass stack
during a performance test shall
invalidate the performance test.
*
*
*
*
*
(4) EPA Reference Method 3, 3A, or
3B of appendix A–2 of this part shall be
used for gas composition analysis,
including measurement of oxygen
concentration. EPA Reference Method 3,
3A, or 3B of appendix A–2 of this part
shall be used simultaneously with each
of the other EPA reference methods. As
an alternative to EPA Reference Method
3B, ASME PTC–19–10–1981–Part 10
may be used (incorporated by reference,
see § 60.17).
*
*
*
*
*
(6) EPA Reference Method 5 of
appendix A–3 or Method 26A or
Method 29 of appendix A–8 of this part
shall be used to measure the particulate
matter emissions. As an alternative, PM
CEMS may be used as specified in
paragraph (c)(5) of this section.
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(7) EPA Reference Method 7 or 7E of
appendix A–4 of this part shall be used
to measure NOX emissions.
(8) EPA Reference Method 6 or 6C of
appendix A–4 of this part shall be used
to measure SO2 emissions.
(9) EPA Reference Method 9 of
appendix A–4 of this part shall be used
to measure stack opacity. As an
alternative, demonstration of
compliance with the PM standards
using bag leak detection systems as
specified in § 60.57c(h) or PM CEMS as
specified in paragraph (c)(5) of this
section is considered demonstrative of
compliance with the opacity
requirements.
(10) EPA Reference Method 10 or 10B
of appendix A–4 of this part shall be
used to measure the CO emissions. As
specified in paragraph (c)(4) of this
section, use of CO CEMS are required
for affected facilities under
§ 60.50c(a)(3) and (4).
(11) EPA Reference Method 23 of
appendix A–7 of this part shall be used
to measure total dioxin/furan emissions.
As an alternative, an owner or operator
may elect to sample dioxins/furans by
installing, calibrating, maintaining, and
operating a continuous automated
sampling system for monitoring dioxin/
furan emissions as specified in
paragraph (c)(6) of this section. For
Method 23 of appendix A–7 sampling,
the minimum sample time shall be 4
hours per test run. If the affected facility
has selected the toxic equivalency
standards for dioxins/furans, under
§ 60.52c, the following procedures shall
be used to determine compliance:
*
*
*
*
*
(12) EPA Reference Method 26 or 26A
of appendix A–8 of this part shall be
used to measure HCl emissions. As an
alternative, HCl CEMS may be used as
specified in paragraph (c)(5) of this
section.
(13) EPA Reference Method 29 of
appendix A–8 of this part shall be used
to measure Pb, Cd, and Hg emissions.
As an alternative, Hg emissions may be
measured using ASTM D6784–02
(incorporated by reference, see § 60.17).
As an alternative for Pb, Cd, and Hg,
multi-metals CEMS or Hg CEMS, may be
used as specified in paragraph (c)(5) of
this section. As an alternative, an owner
or operator may elect to sample Hg by
installing, calibrating, maintaining, and
operating a continuous automated
sampling system for monitoring Hg
emissions as specified in paragraph
(c)(7) of this section.
(14) The EPA Reference Method 22 of
appendix A–7 of this part shall be used
to determine compliance with the
fugitive ash emissions limit under
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Jkt 220001
§ 60.52c(c). The minimum observation
time shall be a series of three 1-hour
observations.
*
*
*
*
*
(c) * * *
(2) Except as provided in paragraphs
(c)(4) and (c)(5) of this section,
determine compliance with the PM, CO,
and HCl emissions limits by conducting
an annual performance test (no more
than 12 months following the previous
performance test) using the applicable
procedures and test methods listed in
paragraph (b) of this section. If all three
performance tests over a 3-year period
indicate compliance with the emissions
limit for a pollutant (PM, CO, or HCl),
the owner or operator may forego a
performance test for that pollutant for
the subsequent 2 years. At a minimum,
a performance test for PM, CO, and HCl
shall be conducted every third year (no
more than 36 months following the
previous performance test). If a
performance test conducted every third
year indicates compliance with the
emissions limit for a pollutant (PM, CO,
or HCl), the owner or operator may
forego a performance test for that
pollutant for an additional 2 years. If
any performance test indicates
noncompliance with the respective
emissions limit, a performance test for
that pollutant shall be conducted
annually until all annual performance
tests over a 3-year period indicate
compliance with the emissions limit.
The use of the bypass stack during a
performance test shall invalidate the
performance test.
(3) For an affected facility as defined
in § 60.50c(a)(1) and (2) and utilizing a
large HMIWI, and in § 60.50c(a)(3) and
(4), determine compliance with the
visible emissions limits for fugitive
emissions from flyash/bottom ash
storage and handling by conducting a
performance test using EPA Reference
Method 22 of appendix A–7 on an
annual basis (no more than 12 months
following the previous performance
test).
(4) For an affected facility as defined
in § 60.50c(a)(3) and (4), determine
compliance with the CO emissions limit
using a CO CEMS according to
paragraphs (c)(4)(i) through (c)(4)(iii) of
this section:
(i) Determine compliance with the CO
emissions limit using a 24-hour block
average, calculated as specified in
section 12.4.1 of EPA Reference Method
19 of appendix A–7 of this part.
(ii) Operate the CO CEMS in
accordance with the applicable
procedures under appendices B and F of
this part.
(iii) Use of a CO CEMS may be
substituted for the CO annual
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performance test and minimum
secondary chamber temperature to
demonstrate compliance with the CO
emissions limit.
(5) Facilities using CEMS to
demonstrate compliance with any of the
emissions limits under § 60.52c shall:
(i) For an affected facility as defined
in § 60.50c(a)(1) and (2), determine
compliance with the appropriate
emissions limit(s) using a 12-hour
rolling average, calculated each hour as
the average of the previous 12 operating
hours.
(ii) For an affected facility as defined
in § 60.50c(a)(3) and (4), determine
compliance with the appropriate
emissions limit(s) using a 24-hour block
average, calculated as specified in
section 12.4.1 of EPA Reference Method
19 of appendix A–7 of this part.
(iii) Operate all CEMS in accordance
with the applicable procedures under
appendices B and F of this part. For
those CEMS for which performance
specifications have not yet been
promulgated (HCl, multi-metals), this
option for an affected facility as defined
in § 60.50c(a)(3) and (4) takes effect on
the date a final performance
specification is published in the Federal
Register or the date of approval of a sitespecific monitoring plan.
(iv) For an affected facility as defined
in § 60.50c(a)(3) and (4), be allowed to
substitute use of an HCl CEMS for the
HCl annual performance test, minimum
HCl sorbent flow rate, and minimum
scrubber liquor pH to demonstrate
compliance with the HCl emissions
limit.
(v) For an affected facility as defined
in § 60.50c(a)(3) and (4), be allowed to
substitute use of a PM CEMS for the PM
annual performance test and minimum
pressure drop across the wet scrubber,
if applicable, to demonstrate
compliance with the PM emissions
limit.
(6) An affected facility as defined in
§ 60.50c(a)(3) and (4) using a continuous
automated sampling system to
demonstrate compliance with the
dioxin/furan emissions limits under
§ 60.52c shall record the output of the
system and analyze the sample
according to EPA Reference Method 23
of appendix A–7 of this part. This
option to use a continuous automated
sampling system takes effect on the date
a final performance specification
applicable to dioxin/furan from
monitors is published in the Federal
Register or the date of approval of a sitespecific monitoring plan. The owner or
operator of an affected facility as
defined in § 60.50c(a)(3) and (4) who
elects to continuously sample dioxin/
furan emissions instead of sampling and
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testing using EPA Reference Method 23
of appendix A–7 shall install, calibrate,
maintain, and operate a continuous
automated sampling system and shall
comply with the requirements specified
in § 60.58b(p) and (q) of subpart Eb of
this part.
(7) An affected facility as defined in
§ 60.50c(a)(3) and (4) using a continuous
automated sampling system to
demonstrate compliance with the Hg
emissions limits under § 60.52c shall
record the output of the system and
analyze the sample at set intervals using
any suitable determinative technique
that can meet appropriate performance
criteria. This option to use a continuous
automated sampling system takes effect
on the date a final performance
specification applicable to Hg from
monitors is published in the Federal
Register or the date of approval of a sitespecific monitoring plan. The owner or
operator of an affected facility as
defined in § 60.50c(a)(3) and (4) who
elects to continuously sample Hg
emissions instead of sampling and
testing using EPA Reference Method 29
of appendix A–8 of this part, or an
approved alternative method for
measuring Hg emissions, shall install,
calibrate, maintain, and operate a
continuous automated sampling system
and shall comply with the requirements
specified in § 60.58b(p) and (q) of
subpart Eb of this part.
(d) Except as provided in paragraphs
(c)(4) through (c)(7) of this section, the
owner or operator of an affected facility
equipped with a dry scrubber followed
by a fabric filter, a wet scrubber, or a dry
scrubber followed by a fabric filter and
wet scrubber shall:
*
*
*
*
*
(e) Except as provided in paragraph (i)
of this section, for affected facilities
equipped with a dry scrubber followed
by a fabric filter:
*
*
*
*
*
(5) Use of the bypass stack shall
constitute a violation of the PM, dioxin/
furan, HCl, Pb, Cd and Hg emissions
limits.
(6) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the CO emissions limit as measured by
the CO CEMS specified in paragraph
(c)(4) of this section shall constitute a
violation of the CO emissions limit.
(7) For an affected facility as defined
in § 60.50c(a)(3) and (4), failure to
initiate corrective action within 1 hour
of a bag leak detection system alarm; or
failure to operate and maintain the
fabric filter such that the alarm is not
engaged for more than 5 percent of the
total operating time in a 6-month block
reporting period shall constitute a
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violation of the PM emissions limit. If
inspection of the fabric filter
demonstrates that no corrective action is
required, no alarm time is counted. If
corrective action is required, each alarm
is counted as a minimum of 1 hour. If
it takes longer than 1 hour to initiate
corrective action, the alarm time is
counted as the actual amount of time
taken to initiate corrective action. If the
bag leak detection system is used to
demonstrate compliance with the
opacity limit, this would also constitute
a violation of the opacity emissions
limit.
(8) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the PM, HCl, Pb, Cd, and/or Hg
emissions limit as measured by the
CEMS specified in paragraph (c)(5) of
this section shall constitute a violation
of the applicable emissions limit.
(9) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the dioxin/furan emissions limit as
measured by the continuous automated
sampling system specified in paragraph
(c)(6) of this section shall constitute a
violation of the dioxin/furan emissions
limit.
(10) Operation of the affected facility
as defined in § 60.50c(a)(3) and (4)
above the Hg emissions limit as
measured by the continuous automated
sampling system specified in paragraph
(c)(7) of this section shall constitute a
violation of the Hg emissions limit.
(f) Except as provided in paragraph (i)
of this section, for affected facilities
equipped with a wet scrubber:
*
*
*
*
*
(6) Use of the bypass stack shall
constitute a violation of the PM, dioxin/
furan, HCl, Pb, Cd and Hg emissions
limits.
(7) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the CO emissions limit as measured by
the CO CEMS specified in paragraph
(c)(4) of this section shall constitute a
violation of the CO emissions limit.
(8) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the PM, HCl, Pb, Cd, and/or Hg
emissions limit as measured by the
CEMS specified in paragraph (c)(5) of
this section shall constitute a violation
of the applicable emissions limit.
(9) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the dioxin/furan emissions limit as
measured by the continuous automated
sampling system specified in paragraph
(c)(6) of this section shall constitute a
violation of the dioxin/furan emissions
limit.
(10) Operation of the affected facility
as defined in § 60.50c(a)(3) and (4)
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51411
above the Hg emissions limit as
measured by the continuous automated
sampling system specified in paragraph
(c)(7) of this section shall constitute a
violation of the Hg emissions limit.
(g) Except as provided in paragraph (i)
of this section, for affected facilities
equipped with a dry scrubber followed
by a fabric filter and a wet scrubber:
*
*
*
*
*
(5) Use of the bypass stack shall
constitute a violation of the PM, dioxin/
furan, HCl, Pb, Cd and Hg emissions
limits.
(6) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the CO emissions limit as measured by
the CO CEMS specified in paragraph
(c)(4) of this section shall constitute a
violation of the CO emissions limit.
(7) For an affected facility as defined
in § 60.50c(a)(3) and (4), failure to
initiate corrective action within 1 hour
of a bag leak detection system alarm; or
failure to operate and maintain the
fabric filter such that the alarm is not
engaged for more than 5 percent of the
total operating time in a 6-month block
reporting period shall constitute a
violation of the PM emissions limit. If
inspection of the fabric filter
demonstrates that no corrective action is
required, no alarm time is counted. If
corrective action is required, each alarm
is counted as a minimum of 1 hour. If
it takes longer than 1 hour to initiate
corrective action, the alarm time is
counted as the actual amount of time
taken to initiate corrective action. If the
bag leak detection system is used to
demonstrate compliance with the
opacity limit, this would also constitute
a violation of the opacity emissions
limit.
(8) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the PM, HCl, Pb, Cd, and/or Hg
emissions limit as measured by the
CEMS specified in paragraph (c)(5) of
this section shall constitute a violation
of the applicable emissions limit.
(9) Operation of the affected facility as
defined in § 60.50c(a)(3) and (4) above
the dioxin/furan emissions limit as
measured by the continuous automated
sampling system specified in paragraph
(c)(6) of this section shall constitute a
violation of the dioxin/furan emissions
limit.
(10) Operation of the affected facility
as defined in § 60.50c(a)(3) and (4)
above the Hg emissions limit as
measured by the continuous automated
sampling system specified in paragraph
(c)(7) of this section shall constitute a
violation of the Hg emissions limit.
(h) The owner or operator of an
affected facility as defined in
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§ 60.50c(a)(3) and (4) equipped with
selective noncatalytic reduction
technology shall:
(1) Establish the maximum charge
rate, the minimum secondary chamber
temperature, and the minimum reagent
flow rate as site specific operating
parameters during the initial
performance test to determine
compliance with the emissions limits;
(2) Following the date on which the
initial performance test is completed or
is required to be completed under
§ 60.8, whichever date comes first,
ensure that the affected facility does not
operate above the maximum charge rate,
or below the minimum secondary
chamber temperature or the minimum
reagent flow rate measured as 3-hour
rolling averages (calculated each hour as
the average of the previous 3 operating
hours) at all times. Operating parameter
limits do not apply during performance
tests.
(3) Except as provided in paragraph (i)
of this section, operation of the affected
facility above the maximum charge rate,
below the minimum secondary chamber
temperature, and below the minimum
reagent flow rate simultaneously shall
constitute a violation of the NOX
emissions limit.
(i) The owner or operator of an
affected facility may conduct a repeat
performance test within 30 days of
violation of applicable operating
parameter(s) to demonstrate that the
affected facility is not in violation of the
applicable emissions limit(s). Repeat
performance tests conducted pursuant
to this paragraph shall be conducted
using the identical operating parameters
that indicated a violation under
paragraph (e), (f), (g), or (h) of this
section.
(j) The owner or operator of an
affected facility using an air pollution
control device other than a dry scrubber
followed by a fabric filter, a wet
scrubber, a dry scrubber followed by a
fabric filter and a wet scrubber, or
selective noncatalytic reduction
technology to comply with the
emissions limits under § 60.52c shall
petition the Administrator for other sitespecific operating parameters to be
established during the initial
performance test and continuously
monitored thereafter. The owner or
operator shall not conduct the initial
performance test until after the petition
has been approved by the
Administrator.
*
*
*
*
*
■ 18. Section 60.57c is amended as
follows:
■ a. By revising paragraph (a);
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b. By redesignating paragraphs (b)
through (d) as paragraphs (c) through
(e);
■ c. By adding paragraph (b);
■ d. By revising newly redesignated
paragraphs (d) and (e); and
■ e. By adding paragraphs (f) through
(h).
■
§ 60.57c
Monitoring requirements.
(a) Except as provided in
§ 60.56c(c)(4) through (c)(7), the owner
or operator of an affected facility shall
install, calibrate (to manufacturers’
specifications), maintain, and operate
devices (or establish methods) for
monitoring the applicable maximum
and minimum operating parameters
listed in Table 3 to this subpart (unless
CEMS are used as a substitute for
certain parameters as specified) such
that these devices (or methods) measure
and record values for these operating
parameters at the frequencies indicated
in Table 3 of this subpart at all times.
(b) The owner or operator of an
affected facility as defined in
§ 60.50c(a)(3) and (4) that uses selective
noncatalytic reduction technology shall
install, calibrate (to manufacturers’
specifications), maintain, and operate
devices (or establish methods) for
monitoring the operating parameters
listed in § 60.56c(h) such that the
devices (or methods) measure and
record values for the operating
parameters at all times. Operating
parameter values shall be measured and
recorded at the following minimum
frequencies:
(1) Maximum charge rate shall be
measured continuously and recorded
once each hour;
(2) Minimum secondary chamber
temperature shall be measured
continuously and recorded once each
minute; and
(3) Minimum reagent flow rate shall
be measured hourly and recorded once
each hour.
*
*
*
*
*
(d) The owner or operator of an
affected facility using an air pollution
control device other than a dry scrubber
followed by a fabric filter, a wet
scrubber, a dry scrubber followed by a
fabric filter and a wet scrubber, or
selective noncatalytic reduction
technology to comply with the
emissions limits under § 60.52c shall
install, calibrate (to manufacturers’
specifications), maintain, and operate
the equipment necessary to monitor the
site-specific operating parameters
developed pursuant to § 60.56c(j).
(e) The owner or operator of an
affected facility shall obtain monitoring
data at all times during HMIWI
operation except during periods of
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monitoring equipment malfunction,
calibration, or repair. At a minimum,
valid monitoring data shall be obtained
for 75 percent of the operating hours per
day for 90 percent of the operating days
per calendar quarter that the affected
facility is combusting hospital waste
and/or medical/infectious waste.
(f) The owner or operator of an
affected facility as defined in
§ 60.50c(a)(3) and (4) shall ensure that
each HMIWI subject to the emissions
limits in § 60.52c undergoes an initial
air pollution control device inspection
that is at least as protective as the
following:
(1) At a minimum, an inspection shall
include the following:
(i) Inspect air pollution control
device(s) for proper operation, if
applicable;
(ii) Ensure proper calibration of
thermocouples, sorbent feed systems,
and any other monitoring equipment;
and
(iii) Generally observe that the
equipment is maintained in good
operating condition.
(2) Within 10 operating days
following an air pollution control device
inspection, all necessary repairs shall be
completed unless the owner or operator
obtains written approval from the
Administrator establishing a date
whereby all necessary repairs of the
designated facility shall be completed.
(g) The owner or operator of an
affected facility as defined in
§ 60.50c(a)(3) and (4) shall ensure that
each HMIWI subject to the emissions
limits under § 60.52c undergoes an air
pollution control device inspection
annually (no more than 12 months
following the previous annual air
pollution control device inspection), as
outlined in paragraphs (f)(1) and (f)(2) of
this section.
(h) For affected facilities as defined in
§ 60.50c(a)(3) and (4) that use an air
pollution control device that includes a
fabric filter and are not demonstrating
compliance using PM CEMS, determine
compliance with the PM emissions limit
using a bag leak detection system and
meet the requirements in paragraphs
(h)(1) through (h)(12) of this section for
each bag leak detection system.
(1) Each triboelectric bag leak
detection system may be installed,
calibrated, operated, and maintained
according to the ‘‘Fabric Filter Bag Leak
Detection Guidance,’’ (EPA–454/R–98–
015, September 1997). This document is
available from the U.S. Environmental
Protection Agency (U.S. EPA); Office of
Air Quality Planning and Standards;
Sector Policies and Programs Division;
Measurement Policy Group (D–243–02),
Research Triangle Park, NC 27711. This
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document is also available on the
Technology Transfer Network (TTN)
under Emissions Measurement Center
Continuous Emissions Monitoring.
Other types of bag leak detection
systems shall be installed, operated,
calibrated, and maintained in a manner
consistent with the manufacturer’s
written specifications and
recommendations.
(2) The bag leak detection system
shall be certified by the manufacturer to
be capable of detecting PM emissions at
concentrations of 10 milligrams per
actual cubic meter (0.0044 grains per
actual cubic foot) or less.
(3) The bag leak detection system
sensor shall provide an output of
relative PM loadings.
(4) The bag leak detection system
shall be equipped with a device to
continuously record the output signal
from the sensor.
(5) The bag leak detection system
shall be equipped with an audible alarm
system that will sound automatically
when an increase in relative PM
emissions over a preset level is detected.
The alarm shall be located where it is
easily heard by plant operating
personnel.
(6) For positive pressure fabric filter
systems, a bag leak detector shall be
installed in each baghouse compartment
or cell.
(7) For negative pressure or induced
air fabric filters, the bag leak detector
shall be installed downstream of the
fabric filter.
(8) Where multiple detectors are
required, the system’s instrumentation
and alarm may be shared among
detectors.
(9) The baseline output shall be
established by adjusting the range and
the averaging period of the device and
establishing the alarm set points and the
alarm delay time according to section
5.0 of the ‘‘Fabric Filter Bag Leak
Detection Guidance.’’
(10) Following initial adjustment of
the system, the sensitivity or range,
averaging period, alarm set points, or
alarm delay time may not be adjusted.
In no case may the sensitivity be
increased by more than 100 percent or
decreased more than 50 percent over a
365-day period unless such adjustment
follows a complete fabric filter
inspection that demonstrates that the
fabric filter is in good operating
condition. Each adjustment shall be
recorded.
(11) Record the results of each
inspection, calibration, and validation
check.
(12) Initiate corrective action within 1
hour of a bag leak detection system
alarm; operate and maintain the fabric
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filter such that the alarm is not engaged
for more than 5 percent of the total
operating time in a 6-month block
reporting period. If inspection of the
fabric filter demonstrates that no
corrective action is required, no alarm
time is counted. If corrective action is
required, each alarm is counted as a
minimum of 1 hour. If it takes longer
than 1 hour to initiate corrective action,
the alarm time is counted as the actual
amount of time taken to initiate
corrective action.
■ 19. Section 60.58c is amended as
follows:
■ a. By revising paragraph (a)(2)(iv);
■ b. By redesignating paragraphs
(b)(2)(viii) through (b)(2)(xv) as
paragraphs (b)(2)(ix) through (b)(2)(xvi);
■ c. By adding paragraph (b)(2)(viii);
■ d. By revising newly designated
paragraph (b)(2)(xvi);
■ e. By adding paragraphs (b)(2)(xvii)
through (b)(2)(xix);
■ f. By revising paragraphs (b)(6) and
(b)(11);
■ g. By revising paragraph (c)
introductory text;
■ h. By revising paragraphs (c)(1) and
(c)(2);
■ i. By adding paragraph (c)(4);
■ j. By revising paragraph (d)
introductory text;
■ k. By revising paragraphs (d)(1)
through (d)(3);
■ l. By adding paragraphs (d)(9) through
(d)(11); and
■ m. By adding paragraph (g).
§ 60.58c Reporting and recordkeeping
requirements.
(a) * * *
(2) * * *
(iv) If applicable, the petition for sitespecific operating parameters under
§ 60.56c(j).
*
*
*
*
*
(b) * * *
(2) * * *
(viii) For affected facilities as defined
in § 60.50c(a)(3) and (4), amount and
type of NOx reagent used during each
hour of operation, as applicable;
*
*
*
*
*
(xvi) For affected facilities complying
with § 60.56c(j) and § 60.57c(d), the
owner or operator shall maintain all
operating parameter data collected;
(xvii) For affected facilities as defined
in § 60.50c(a)(3) and (4), records of the
annual air pollution control device
inspections, any required maintenance,
and any repairs not completed within
10 days of an inspection or the
timeframe established by the
Administrator.
(xviii) For affected facilities as
defined in § 60.50c(a)(3) and (4), records
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51413
of each bag leak detection system alarm,
the time of the alarm, the time
corrective action was initiated and
completed, and a brief description of the
cause of the alarm and the corrective
action taken, as applicable.
(xix) For affected facilities as defined
in § 60.50c(a)(3) and (4), concentrations
of CO as determined by the continuous
emissions monitoring system.
*
*
*
*
*
(6) The results of the initial, annual,
and any subsequent performance tests
conducted to determine compliance
with the emissions limits and/or to
establish or re-establish operating
parameters, as applicable, and a
description, including sample
calculations, of how the operating
parameters were established or reestablished, if applicable.
*
*
*
*
*
(11) Records of calibration of any
monitoring devices as required under
§ 60.57c(a) through (d).
(c) The owner or operator of an
affected facility shall submit the
information specified in paragraphs
(c)(1) through (c)(4) of this section no
later than 60 days following the initial
performance test. All reports shall be
signed by the facilities manager.
(1) The initial performance test data
as recorded under § 60.56c(b)(1) through
(b)(14), as applicable.
(2) The values for the site-specific
operating parameters established
pursuant to § 60.56c(d), (h), or (j), as
applicable, and a description, including
sample calculations, of how the
operating parameters were established
during the initial performance test.
*
*
*
*
*
(4) For each affected facility as
defined in § 60.50c(a)(3) and (4) that
uses a bag leak detection system,
analysis and supporting documentation
demonstrating conformance with EPA
guidance and specifications for bag leak
detection systems in § 60.57c(h).
(d) An annual report shall be
submitted 1 year following the
submissions of the information in
paragraph (c) of this section and
subsequent reports shall be submitted
no more than 12 months following the
previous report (once the unit is subject
to permitting requirements under title V
of the Clean Air Act, the owner or
operator of an affected facility must
submit these reports semiannually). The
annual report shall include the
information specified in paragraphs
(d)(1) through (11) of this section. All
reports shall be signed by the facilities
manager.
(1) The values for the site-specific
operating parameters established
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pursuant to § 60.56(d), (h), or (j), as
applicable.
(2) The highest maximum operating
parameter and the lowest minimum
operating parameter, as applicable, for
each operating parameter recorded for
the calendar year being reported,
pursuant to § 60.56(d), (h), or (j), as
applicable.
(3) The highest maximum operating
parameter and the lowest minimum
operating parameter, as applicable, for
each operating parameter recorded
pursuant to § 60.56(d), (h), or (j) for the
calendar year preceding the year being
reported, in order to provide the
Administrator with a summary of the
performance of the affected facility over
a 2-year period.
(9) For affected facilities as defined in
§ 60.50c(a)(3) and (4), records of the
annual air pollution control device
inspection, any required maintenance,
and any repairs not completed within
10 days of an inspection or the
timeframe established by the
Administrator.
(10) For affected facilities as defined
in § 60.50c(a)(3) and (4), records of each
bag leak detection system alarm, the
time of the alarm, the time corrective
action was initiated and completed, and
a brief description of the cause of the
alarm and the corrective action taken, as
applicable.
(11) For affected facilities as defined
in § 60.50c(a)(3) and (4), concentrations
of CO as determined by the continuous
emissions monitoring system.
*
*
*
*
*
(g) For affected facilities, as defined in
§ 60.50c(a)(3) and (4), that choose to
submit an electronic copy of stack test
reports to EPA’s WebFIRE data base, as
of December 31, 2011, the owner or
operator of an affected facility shall
enter the test data into EPA’s data base
using the Electronic Reporting Tool
located at https://www.epa.gov/ttn/chief/
ert/ert_tool.html.
■ 20. Table 1 to subpart Ec is
redesignated as Table 1A and revised to
read as follows:
TABLE 1A TO SUBPART Ec OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT AFFECTED
FACILITIES AS DEFINED IN § 60.50c(a)(1) AND (2)
Emissions limits
Pollutant
Units (7 percent oxygen,
dry basis)
Averaging time 1
HMIWI size
Small
Medium
Method for demonstrating
compliance 2
Large
Particulate
matter.
Milligrams per dry standard cubic meter (grains
per dry standard cubic
foot).
69 (0.03) ......
34 (0.015) ....
34 (0.015) ....
3-run average (1-hour
minimum sample time
per run).
Carbon monoxide.
Parts per million by volume.
40 ................
40 ................
40 ................
Dioxins/
furans.
Nanograms per dry
standard cubic meter
total dioxins/furans
(grains per billion dry
standard cubic feet) or
nanograms per dry
standard cubic meter
TEQ (grains per billion
dry standard cubic
feet).
Parts per million by volume.
125 (55) or
2.3 (1.0).
25 (11) or
0.6 (0.26).
25 (11) or
0.6 (0.26).
3-run average (1-hour
minimum sample time
per run).
3-run average (4-hour
minimum sample time
per run).
EPA Reference Method 5
of appendix A–3 of part
60, or EPA Reference
Method M 26A or 29 of
appendix A–8 of part
60.
EPA Reference Method
10 or 10B of appendix
A–4 of part 60.
EPA Reference Method
23 of appendix A–7 of
part 60.
15 or 99% ...
15 or 99% ...
15 or 99%5.1
Sulfur dioxide
Parts per million by volume.
55 ................
55 ................
55 ................
Nitrogen oxides.
Parts per million by volume.
250 ..............
250 ..............
250 ..............
Lead ............
Milligrams per dry standard cubic meter (grains
per thousand dry
standard cubic feet.
Milligrams per dry standard cubic meter (grains
per thousand dry
standard cubic feet) or
percent reduction.
Milligrams per dry standard cubic meter (grains
per thousand dry
standard cubic feet) or
percent reduction.
1.2 (0.52) or
70%.
0.07 (0.03)
or 98%.
0.07 (0.03)
or 98%.
3-run average (1-hour
minimum sample time
per run).
3-run average (1-hour
minimum sample time
per run).
3-run average (1-hour
minimum sample time
per run).
3-run average (1-hour
minimum sample time
per run).
EPA Reference Method
26 or 26A of appendix
A–8 of part 60.
EPA Reference Method 6
or 6C of appendix A–4
of part 60.
EPA Reference Method 7
or 7E of appendix A–4
of part 60.
EPA Reference Method
29 of appendix A–8 of
part 60.
0.16 (0.07)
or 65%.
0.04 (0.02)
or 90%.
0.04 (0.02)
or 90%.
3-run average (1-hour
minimum sample time
per run).
EPA Reference Method
29 of appendix A–8 of
part 60.
0.55 (0.24)
or 85%.
0.55 (0.24)
or 85%.
0.55 (0.24)
or 85%.
3-run average (1-hour
minimum sample time
per run).
EPA Reference Method
29 of appendix A–8 of
part 60.
Hydrogen
chloride.
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Cadmium .....
Mercury .......
1 Except
2 Does
as allowed under § 60.56c(c) for HMIWI equipped with CEMS.
not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b).
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51415
21. Add Table 1B to subpart Ec to read
as follows:
■
TABLE 1B TO SUBPART EC OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT AFFECTED
FACILITIES AS DEFINED IN § 60.50C(a)(3) AND (4)
Emissions limits
Pollutant
Units (7 percent oxygen,
dry basis)
Averaging time1
HMIWI size
Small
Medium
Method for demonstrating
compliance 2
Large
Particulate
matter.
Milligrams per dry standard
cubic meter (grains per
dry standard cubic foot).
66 (0.029) ....
22 (0.0095) ..
18 (0.0080) ..
3-run average (1-hour
minimum sample
time per run).
Carbon monoxide.
Parts per million by volume
20 ................
1.8 ...............
11 ................
Dioxins/
furans.
Nanograms per dry standard cubic meter total
dioxins/furans (grains
per billion dry standard
cubic feet) or nanograms
per dry standard cubic
meter TEQ (grains per
billion dry standard cubic
feet).
Parts per million by volume
16 (7.0) or
0.013
(0.0057).
0.47 (0.21)
or 0.014
(0.0061).
9.3 (4.1) or
0.035
(0.015).
3-run average (1-hour
minimum sample
time per run).
3-run average (4-hour
minimum sample
time per run).
EPA Reference Method 5
of appendix A–3 of part
60, or EPA Reference
Method M 26A or 29 of
appendix A–8 of part 60.
EPA Reference Method 10
or 10B of appendix A–4
of part 60.
EPA Reference Method 23
of appendix A–7 of part
60.
15 ................
7.7 ...............
5.1 ...............
Sulfur dioxide
Parts per million by volume
1.4 ...............
1.4 ...............
1.6 ...............
Nitrogen oxides.
Parts per million by volume
67 ................
67 ................
130 ..............
Lead .............
Milligrams per dry standard
cubic meter (grains per
thousand dry standard
cubic feet).
Milligrams per dry standard
cubic meter (grains per
thousand dry standard
cubic feet) or percent reduction.
Milligrams per dry standard
cubic meter (grains per
thousand dry standard
cubic feet) or percent reduction.
0.31 (0.14) ...
0.018
(0.0079).
0.00069
(0.00030).
3-run average (1-hour
minimum sample
time per run).
3-run average (1-hour
minimum sample
time per run).
3-run average (1-hour
minimum sample
time per run).
3-run average (1-hour
minimum sample
time per run).
EPA Reference Method 26
or 26A of appendix A–8
of part 60.
EPA Reference Method 6
or 6C of appendix A–4
of part 60.
EPA Reference Method 7
or 7E of appendix A–4 of
part 60.
EPA Reference Method 29
of appendix A–8 of part
60.
0.017
(0.0074).
0.0098
(0.0043).
0.00013
3-run average (1-hour
(0.000057).
minimum sample
time per run).
EPA Reference Method 29
of appendix A–8 of part
60.
0.014
(0.0061).
0.0035
(0.0015).
0.0013
(0.00057).
EPA Reference Method 29
of appendix A–8 of part
60.
Hydrogen
chloride.
Cadmium ......
Mercury ........
3-run average (1-hour
minimum sample
time per run).
1 Except
2 Does
as allowed under § 60.56c(c) for HMIWI equipped with CEMS.
not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b).
[FR Doc. E9–22928 Filed 10–5–09; 8:45 am]
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Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Rules and Regulations]
[Pages 51368-51415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22928]
[[Page 51367]]
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Part II
Environmental Protection Agency
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40 CFR Part 60
Standards of Performance for New Stationary Sources and Emissions
Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
Incinerators; Final Rule
Federal Register / Vol. 74 , No. 192 / Tuesday, October 6, 2009 /
Rules and Regulations
[[Page 51368]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 60
[EPA-HQ-OAR-2006-0534; FRL-8959-9]
RIN 2060-A004
Standards of Performance for New Stationary Sources and Emissions
Guidelines for Existing Sources: Hospital/Medical/Infectious Waste
Incinerators
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On September 15, 1997, EPA adopted new source performance
standards (NSPS) and emissions guidelines (EG) for hospital/medical/
infectious waste incinerators (HMIWI). The NSPS and EG were established
under Sections 111 and 129 of the Clean Air Act (CAA or Act). In a
response to a suit filed by the Sierra Club and the Natural Resources
Defense Council (Sierra Club), the U.S. Court of Appeals for the
District of Columbia Circuit (the Court) remanded the HMIWI regulations
on March 2, 1999, for further explanation of EPA's reasoning in
determining the minimum regulatory ``floors'' for new and existing
HMIWI. The HMIWI regulations were not vacated and were fully
implemented by September 2002. On February 6, 2007, we published our
proposed response to the Court's remand. Following recent court
decisions and receipt of public comments regarding the proposal, we re-
assessed our response to the remand, and on December 1, 2008, we
published another proposed response and solicited public comments. This
action promulgates our response to the Court's remand and also
satisfies the CAA Section 129(a)(5) requirement to conduct a review of
the standards every 5 years.
DATES: The amendments to 40 CFR 60.32e, 60.33e, 60.36e, 60.37e, 60.38e,
60.39e, Table 1A and 1B to subpart Ce, and Tables 2A and 2B to subpart
Ce are effective as of December 7, 2009. The amendments to 40 CFR
60.17, 60.50c, 60.51c, 60.52c, 60.55c, 60.56c, 60.57c, 60.58c, and
Tables 1A and 1B to subpart Ec are effective as of April 6, 2010. The
incorporation by reference of certain publications listed in the
regulations is approved by the Director of the Federal Register as of
April 6, 2010.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2006-0534 and Legacy Docket ID No. A-91-61. All
documents in the docket are listed on the https://www.regulations.gov
Web site. Although listed in the index, some information is not
publicly available, e.g., confidential business information or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
https://www.regulations.gov or in hard copy at the EPA Docket Center,
EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the EPA
Docket Center is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: Mr. Ketan D. Patel, Natural Resources
and Commerce Group, Sector Policies and Programs Division (E143-03),
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number: (919) 541-9736; fax number: (919) 541-3470; e-
mail address: patel.ketan@epa.gov.
SUPPLEMENTARY INFORMATION:
Organization of This Document. The following outline is provided to
aid in locating information in this preamble.
I. General Information
A. Does the Final Action Apply to Me?
B. Where Can I Get a Copy of This Document?
C. Judicial Review
II. Background
III. Summary of the Final Rule and Changes Since Proposal
A. Remand Response
B. Clean Air Act Section 129(a)(5) 5-Year Review Response
C. Other Amendments
D. Implementation Schedule for Existing Hospital/Medical/
Infectious Waste Incinerators
E. Changes to the Applicability Date of the 1997 New Source
Performance Standards
F. Startup, Shutdown, and Malfunction Exemption
IV. Summary of Major Comments and Responses
A. Applicability
B. Subcategorization
C. MACT Floor Approach
D. Emissions Limits
E. Monitoring
F. Emissions Testing
G. Alternatives to On-Site Incineration
H. Medical Waste Segregation
I. Startup, Shutdown, and Malfunction
J. Economic Impacts
V. Impacts of the Final Action for Existing Units
A. What Are the Primary Air Impacts?
B. What Are the Water and Solid Waste Impacts?
C. What Are the Energy Impacts?
D. What Are the Secondary Air Impacts?
E. What Are the Cost and Economic Impacts?
VI. Impacts of the Final Action for New Units
A. What Are the Primary Air Impacts?
B. What Are the Water and Solid Waste Impacts?
C. What Are the Energy Impacts?
D. What Are the Secondary Air Impacts?
E. What Are the Cost and Economic Impacts?
VII. Relationship of the Final Action to Section 112(c)(6) of the
Clean Air Act
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution or Use
I. National Technology Transfer Advancement Act
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. General Information
A. Does the Final Action Apply to Me?
Regulated Entities. Categories and entities potentially affected by
the final action are those which operate hospital/medical/infectious
waste incinerators (HMIWI). The new source performance standards (NSPS)
and emissions guidelines (EG) for HMIWI affect the following categories
of sources:
------------------------------------------------------------------------
Examples of
Category NAICS Code potentially regulated
entities
------------------------------------------------------------------------
Industry...................... 622110, 622310, Private hospitals,
325411, 325412, other health care
562213, 611310. facilities,
commercial research
laboratories,
commercial waste
disposal companies,
private
universities.
Federal Government............ 622110, 541710, Federal hospitals,
928110. other health care
facilities, public
health service,
armed services.
[[Page 51369]]
State/local/Tribal Government. 622110, 562213, State/local
611310. hospitals, other
health care
facilities, State/
local waste disposal
services, State
universities.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by the final
action. To determine whether your facility would be affected by the
final action, you should examine the applicability criteria in 40 CFR
60.50c of subpart Ec and 40 CFR 60.32e of subpart Ce. If you have any
questions regarding the applicability of the final action to a
particular entity, contact the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
B. Where Can I Get a Copy of This Document?
In addition to being available in the docket, an electronic copy of
this final action will also be available on the Worldwide Web (WWW)
through the Technology Transfer Network (TTN). Following signature, a
copy of the final action will be posted on the TTN's policy and
guidance page for newly proposed or promulgated rules at the following
address: https://www.epa.gov/ttn/oarpg/. The TTN provides information
and technology exchange in various areas of air pollution control.
C. Judicial Review
Under Section 307(b)(1) of the Clean Air Act (CAA or Act), judicial
review of this final rule is available only by filing a petition for
review in the U.S. Court of Appeals for the District of Columbia
Circuit (the Court) by December 7, 2009. Under Section 307(d)(7)(B) of
the CAA, only an objection to this final rule that was raised with
reasonable specificity during the period for public comment can be
raised during judicial review. CAA Section 307(d)(7)(B) also provides a
mechanism for EPA to convene a proceeding for reconsideration, ``[i]f
the person raising an objection can demonstrate to EPA that it was
impracticable to raise such objection within [the period for public
comment] or if the grounds for such objection arose after the period
for public comment (but within the time specified for judicial review)
and if such objection is of central relevance to the outcome of the
rule.'' Any person seeking to make such a demonstration to us should
submit a Petition for Reconsideration to the Office of the
Administrator, Environmental Protection Agency, Room 3000, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a
copy to the person listed in the preceding FOR FURTHER INFORMATION
CONTACT section, and the Associate General Counsel for the Air and
Radiation Law Office, Office of General Counsel (Mail Code 2344A),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20004. Moreover, under Section 307(b)(2) of the CAA, the
requirements established by this final rule may not be challenged
separately in any civil or criminal proceedings brought by EPA to
enforce these requirements.
II. Background
Section 129 of the CAA, entitled ``Solid Waste Combustion,''
requires EPA to develop and adopt new source performance standards
(NSPS) and emissions guidelines (EG) for solid waste incineration units
pursuant to CAA Sections 111 and 129. Sections 111(b) and 129(a) of the
CAA (NSPS program) address emissions from new HMIWI, and CAA Sections
111(d) and 129(b) (EG program) address emissions from existing HMIWI.
The NSPS are directly enforceable Federal regulations, and under CAA
Section 129(f)(1) become effective 6 months after promulgation. Under
CAA Section 129(f)(2), the EG become effective and enforceable as
expeditiously as practicable after EPA approves a State plan
implementing the EG but no later than 3 years after such approval or 5
years after the date the EG are promulgated, whichever is earlier.
A HMIWI is defined as any device used to burn hospital waste or
medical/infectious waste. Hospital waste means discards generated at a
hospital, and medical/infectious waste means any waste generated in the
diagnosis, treatment, or immunization of human beings or animals, in
research pertaining thereto, or in the production or testing of
biologicals (e.g., vaccines, cultures, blood or blood products, human
pathological waste, sharps). As explained in EPA's regulations,
hospital/medical/infectious waste does not include household waste,
hazardous waste, or human and animal remains not generated as medical
waste. A HMIWI typically is a small, dual-chamber incinerator that
burns on average about 800 pounds per hour (lb/hr) of waste. Smaller
units burn as little as 15 lb/hr while larger units burn as much as
3,700 lb/hr, on average.
Incineration of hospital/medical/infectious waste causes the
release of a wide array of air pollutants, some of which exist in the
waste feed material and are released unchanged during combustion, and
some of which are generated as a result of the combustion process
itself. These pollutants include particulate matter (PM); heavy metals,
including lead (Pb), cadmium (Cd), and mercury (Hg); toxic organics,
including chlorinated dibenzo-p-dioxins/dibenzofurans (CDD/CDF); carbon
monoxide (CO); nitrogen oxides (NOX); and acid gases,
including hydrogen chloride (HCl) and sulfur dioxide (SO2).
In addition to the use of pollution prevention measures (i.e., waste
segregation) and good combustion control practices, HMIWI are typically
controlled by wet scrubbers or dry sorbent injection fabric filters
(dry scrubbers).
Waste segregation is the separation of certain components of the
waste stream in order to reduce the amount of air pollution emissions
associated with that waste when incinerated. The separated waste may
include paper, cardboard, plastics, glass, batteries, aluminum cans,
food waste, or metals. Separation of these types of wastes reduces the
amount of chlorine- and metal-containing wastes being incinerated,
which results in lower potential emissions of HCl, CDD/CDF, Hg, Cd, and
Pb.
Combustion control includes the proper design, construction,
operation, and maintenance of HMIWI to destroy or prevent the formation
of air pollutants prior to their release to the atmosphere. Test data
indicate that as secondary chamber residence time and temperature
increase, emissions decrease. Combustion control is most effective in
reducing CDD/CDF, PM, and CO emissions. The 2-second combustion level,
which includes a minimum secondary chamber temperature of 1800 [deg]F
and residence time of 2 seconds, is considered to be the best level of
combustion control (i.e., good combustion) that is applied to HMIWI.
Wet scrubbers and dry scrubbers provide control of PM, CDD/CDF, HCl,
and metals, but do not influence CO or NOX and have little
impact on SO2 at the low concentrations emitted by HMIWI.
(See Legacy Docket ID No. A-91-61, item II-A-111; 60 FR 10669, 10671-
10677; and 61 FR 31742-31743.)
The CAA sets forth a two-stage approach to regulating emissions
from
[[Page 51370]]
incinerators. EPA has substantial discretion to distinguish among
classes, types and sizes of incinerator units within a category while
setting standards. In the first stage of setting standards, CAA Section
129(a)(2) requires EPA to establish technology-based emissions
standards that reflect the maximum levels of control EPA determines are
achievable for new and existing units, after considering costs, non-air
quality health and environmental impacts, and energy requirements
associated with the implementation of the standards. Section 129(a)(5)
then directs EPA to review those standards and revise them as necessary
every 5 years. In the second stage, Section 129(h)(3) requires EPA to
determine whether further revisions of the standards are necessary in
order to provide an ample margin of safety to protect public health or
to prevent (taking into consideration costs, energy, safety and other
relevant factors) an adverse environmental effect. See, e.g., NRDC and
LEAN v. EPA, 529 F.3d 1077, 1079-80 (DC Cir. 2008) (addressing the
similarly required two-stage approach under CAA Sections 112(d) and
(f), and upholding EPA's implementation of same).
In setting forth the methodology EPA must use to establish the
first-stage technology-based NSPS and EG, CAA Section 129(a)(2)
provides that standards ``applicable to solid waste incineration units
promulgated under Section 111 and this Section shall reflect the
maximum degree of reduction in emissions of [certain listed air
pollutants] that the Administrator, taking into consideration the cost
of achieving such emissions reduction, and any non-air quality health
and environmental impacts and energy requirements, determines is
achievable for new and existing units in each category.'' This level of
control is referred to as a ``maximum achievable control technology,''
or MACT, standard.
In promulgating a MACT standard, EPA must first calculate the
minimum stringency levels for new and existing solid waste incineration
units in a category, generally based on levels of emissions control
achieved or required to be achieved by the subject units. The minimum
level of stringency is called the MACT ``floor,'' and CAA Section
129(a)(2) sets forth differing levels of minimum stringency that EPA's
standards must achieve, based on whether they regulate new and
reconstructed sources, or existing sources. For new and reconstructed
sources, CAA Section 129(a)(2) provides that the ``degree of reduction
in emissions that is deemed achievable [* * *] shall not be less
stringent than the emissions control that is achieved in practice by
the best controlled similar unit, as determined by the Administrator.''
Emissions standards for existing units may be less stringent than
standards for new units, but ``shall not be less stringent than the
average emissions limitation achieved by the best performing 12 percent
of units in the category (excluding units which first met 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).''
The MACT floors form the least stringent regulatory option EPA may
consider in the determination of MACT standards for a source category.
EPA must also determine whether to control emissions ``beyond-the-
floor,'' after considering the costs, non-air quality health and
environmental impacts, and energy requirements of such more stringent
control. EPA made such MACT floor and beyond-the-floor determinations
and on September 15, 1997, adopted NSPS (40 CFR part 60, subpart Ec)
and EG (40 CFR part 60, subpart Ce) using this approach for entities
which operate HMIWI. The NSPS and EG are designed to reduce air
pollution emitted from new and existing HMIWI, including HCl, CO, Pb,
Cd, Hg, PM, CDD/CDF (total, or 2,3,7,8-tetrachlorinated dibenzo-p-
dioxin toxic equivalent (TEQ)), NOX, SO2, and
opacity. The 1997 NSPS apply to HMIWI for which construction began
after June 20, 1996, or for which modification began after March 16,
1998. The 1997 NSPS became effective on March 16, 1998, and apply as of
that date or at start-up of a HMIWI, whichever is later. The 1997 EG
apply to HMIWI for which construction began on or before June 20, 1996,
and required compliance by September 2002.
On November 14, 1997, the Sierra Club and the Natural Resources
Defense Council (Sierra Club) filed suit in the Court. The Sierra Club
claimed that EPA violated CAA Section 129 by setting emissions
standards for HMIWI that are less stringent than required by Section
129(a)(2); that EPA violated Section 129 by not including pollution
prevention or waste minimization requirements; and that EPA had not
adequately considered the non-air quality health and environmental
impacts of the standards.
On March 2, 1999, the Court issued its opinion in Sierra Club v.
EPA, 167 F.3d 658 (DC Cir. 1999). While the Court rejected the Sierra
Club's statutory arguments under CAA Section 129, the Court remanded
the rule to EPA for further explanation regarding how EPA derived the
MACT floors for new and existing HMIWI. Furthermore, the Court did not
vacate the regulations, and the regulations have remained in effect
during the remand.
On February 6, 2007, EPA proposed a response to the HMIWI remand.
The proposed response was based on a reassessment of information and
data that were available at the time of promulgation in 1997, in light
of the EPA's understanding of the Court's rulings in the Sierra Club,
National Lime Association (NLA) II, Cement Kiln Recycling Coalition
(CKRC) and other cases discussed in our 2007 proposal notice. The
proposed response would have revised some of the emissions limits in
both the NSPS and EG. Relative to the NSPS, the emissions limits for
CO, Pb, Cd, Hg, PM, and CDD/CDF would have been revised. Relative to
the EG, the emissions limits for HCl, Pb, Cd, and CDD/CDF would have
been revised. EPA believed that the revised emissions limits proposed
in February 2007 as a result of its response to the remand could be
achieved with the same emissions control technology currently used by
HMIWI to meet the 1997 rule.
On December 1, 2008, EPA re-proposed its response to the Court's
remand. EPA's decision to re-propose was based on a number of factors,
including further rulings by the U.S. Court of Appeals that were issued
after our 2007 proposal was published. In addition, public comments
regarding the 2007 proposal raised issues that, upon further
consideration, we believed would best be addressed through a re-
proposal. One issue regarded the use of emissions limits included in
State regulations and State-issued permits as surrogates for estimated
actual emissions limitations achieved. Another issue regarded EPA's
previous reliance on control technology performance as the sole
indicator of HMIWI performance in making MACT floor determinations,
which did not necessarily account for other factors that affect
emissions (e.g., waste mix, combustion conditions).
As mentioned above, every 5 years after adopting a MACT standard
under Section 129, CAA Section 129(a)(5) requires EPA to review and, if
appropriate, revise the incinerator standards. In addition to
responding to the Court's remand, today's final action constitutes the
first 5-year review of the HMIWI standards.
[[Page 51371]]
III. Summary of the Final Rule and Changes Since Proposal
A. Remand Response
Today's final response to the remand revises the December 2008
proposed emissions limits for both the NSPS and EG. The emissions
limits are being revised in response to a public comment on the
December 2008 re-proposal, which requested that EPA adjust the
statistical approach used to account for variability in the data and
consider the distribution of the emissions data in determining the MACT
floor emissions limits. The revised statistical approach results in
generally higher limits compared to the December 2008 re-proposal. (See
section IV.C.6 of this preamble for further information about this
revised approach.) We expect most sources should be able to meet the
revised limits using control technology already available to the
industry (e.g., wet scrubbers, dry scrubbers, or some combination of
these controls). (See section IV.C.2 of this preamble for further
information.) Similar to the 2008 re-proposal, the emissions limits in
today's final action do not include percent reduction alternative
standards, as discussed further in section IV.D.4 of this preamble.
Table 1 of this preamble summarizes the NSPS emissions limits being
promulgated in this action in response to the Court remand for new
HMIWI.
Table 1--Summary of Emissions Limits Promulgated in Response to the
Remand for New HMIWI
------------------------------------------------------------------------
Final remand
Pollutant (units) Unit size \1\ response limit
\2\
------------------------------------------------------------------------
HCl (ppmv)....................... L.................... 5.1
M.................... 7.7
S.................... 15
CO (ppmv)........................ L.................... 11
M.................... 1.8
S.................... 20
Pb (mg/dscm)..................... L.................... 0.00069
M.................... 0.018
S.................... 0.31
Cd (mg/dscm)..................... L.................... 0.00013
M.................... 0.0098
S.................... 0.017
Hg (mg/dscm)..................... L.................... 0.0013
M.................... 0.0035
S.................... 0.014
PM (gr/dscf)..................... L.................... 0.0080
M.................... 0.0095
S.................... 0.029
CDD/CDF, total (ng/dscm)......... L.................... 9.3
M.................... 0.47
S.................... 16
CDD/CDF, TEQ (ng/dscm)........... L.................... 0.035
M.................... 0.014
S.................... 0.013
NOX (ppmv)....................... L.................... 130
M, S................. 67
SO2 (ppmv)....................... L.................... 1.6
M, S................. 1.4
Opacity (%)...................... L, M, S.............. 6.0
------------------------------------------------------------------------
\1\ L = Large (>500 lb/hr of waste); M = Medium (>200 to <=500 lb/hr of
waste); S = Small (<=200 lb/hr of waste).
\2\ All emissions limits are reported as corrected to 7 percent oxygen.
Table 2 of this preamble summarizes the emissions limits being
promulgated in this action in response to the Court remand for existing
HMIWI.
Table 2--Summary of EG Emissions Limits Promulgated in Response to the
Remand for Existing HMIWI
------------------------------------------------------------------------
Final remand
Pollutant (units) Unit size \1\ response limit
\2\
------------------------------------------------------------------------
HCl (ppmv)....................... L.................... 6.6
M.................... 7.7
S.................... 44
SR................... 810
CO (ppmv)........................ L.................... 11
M.................... 5.5
S, SR................ 20
Pb (mg/dscm)..................... L.................... 0.036
M.................... 0.018
S.................... 0.31
SR................... 0.50
Cd (mg/dscm)..................... L.................... 0.0092
[[Page 51372]]
M.................... 0.013
S.................... 0.017
SR................... 0.11
Hg (mg/dscm)..................... L.................... 0.018
M.................... 0.025
S.................... 0.014
SR................... 0.0051
PM (gr/dscf)..................... L.................... 0.011
M.................... 0.020
S.................... 0.029
SR................... 0.038
CDD/CDF, total (ng/dscm)......... L.................... 9.3
M.................... 0.85
S.................... 16
SR................... 240
CDD/CDF, TEQ (ng/dscm)........... L.................... 0.054
M.................... 0.020
S.................... 0.013
SR................... 5.1
NOX (ppmv)....................... L.................... 140
M, S................. 190
SR................... 130
SO2 (ppmv)....................... L.................... 9.0
M, S................. 4.2
SR................... 55
Opacity (%)...................... L, M, S, SR.......... 6.0
------------------------------------------------------------------------
\1\ L = Large (>500 lb/hr of waste); M = Medium (>200 to <=500 lb/hr of
waste); S = Small (<=200 lb/hr of waste); SR = Small Rural (Small
HMIWI >50 miles from boundary of nearest SMSA, burning <2,000 lb/wk of
waste).
\2\ All emissions limits are reported as corrected to 7 percent oxygen.
B. Clean Air Act Section 129(a)(5) 5-Year Review Response
We are promulgating our response to the remand in Sierra Club such
that the revised MACT standards, reflecting floor levels determined by
actual emissions data, would be more stringent than what we proposed in
2007 for both the remand response and the 5-year review, with the
exceptions noted and discussed in sections IV.A. and IV.B of this
preamble. Consequently, we believe that our obligation to conduct a 5-
year review based on implementation of the 1997 emissions standards
will also be fulfilled through this action's final remand response,
even as amended compared to the 2008 re-proposed standards. This is
supported by the fact that the revised MACT floor determinations and
emissions limits associated with the remand response are based on
performance data for the 57 currently operating HMIWI that are subject
to the 1997 standards, and by the final rule's accounting for non-
technology factors that affect HMIWI emissions performance, which the
2007 proposed remand response and 5-year review did not fully consider.
Thus, the final remand response more than addresses the technology
review's goals of assessing the performance efficiency of the installed
equipment and ensuring that the emissions limits reflect the
performance of the technologies required by the MACT standards. In
addition, the final remand response addresses whether new technologies
and processes and improvements in practices have been demonstrated at
sources subject to the emissions limits. Accordingly, the remand
response in this final action fulfills EPA's obligations regarding the
first 5-year review of the HMIWI standards and, therefore, replaces the
2007 proposal's 5-year review proposed revisions.
C. Other Amendments
This final action puts forward the same changes based on
information received during implementation of the HMIWI NSPS and EG
that were proposed in 2007 and 2008. The changes proposed in 2007
included provisions allowing existing sources to use previous emissions
test results to demonstrate compliance with the revised emissions
limits; annual inspections of air pollution control devices (APCD); a
one-time visible emissions test of ash handling operations; CO
continuous emissions monitoring systems (CEMS) and bag leak detection
systems for new sources; and several approved monitoring alternatives.
The 2008 proposal included changes regarding requirements for
NOx and SO2 emissions testing for all HMIWI;
performance testing requirements for small rural HMIWI; monitoring
requirements for HMIWI that install selective non-catalytic reduction
(SNCR) technology to reduce NOx emissions; and procedures
for test data submittal. The changes included in this final action
include revised provisions regarding waste segregation and removal of
exemptions regarding startup, shutdown, and malfunction (SSM). The
removal of SSM exemptions is discussed in section III.F of this
preamble. The performance testing and monitoring amendments, electronic
data submittal provisions, waste segregation amendments, and
miscellaneous other amendments are summarized in the following
sections.
1. Performance Testing and Monitoring Amendments
The amendments require all HMIWI to demonstrate initial compliance
with the revised NOx and SO2 emissions limits.
The 1997 standards did not require testing and demonstration of
compliance with the NOx and SO2
[[Page 51373]]
emissions limits. In addition to demonstrating initial compliance with
the NOx and SO2 emissions limits, small rural
HMIWI are required to demonstrate initial compliance with the other
seven regulated pollutants' emissions limits and the opacity standard.
Under the 1997 standards, small rural HMIWI were required to
demonstrate only initial compliance with the PM, CO, CDD/CDF, Hg, and
opacity standards. Small rural HMIWI also are required to determine
compliance with the PM, CO, and HCl emissions limits by conducting an
annual performance test. On an annual basis, small rural HMIWI are
required by the 1997 standards to demonstrate compliance with the
opacity limit. The amendments allow sources to use results of their
previous emissions tests to demonstrate initial compliance with the
revised emissions limits as long as the sources certify that the
previous test results are representative of current operations. Only
those sources who could not so certify and/or whose previous emissions
tests do not demonstrate compliance with one or more revised emissions
limits would be required to conduct another emissions test for those
pollutants. (Note that most sources were already required under the
1997 standards to test for HCl, CO, and PM on an annual basis, and
those annual tests are still required.)
The amendments require, for existing HMIWI, annual inspections of
scrubbers, fabric filters, and other air pollution control devices that
may be used to meet the emissions limits. The amendments require a
visible emissions test of the ash handling operations using Method 22
in appendix A-7 of this part to be conducted during the next
performance test. For new HMIWI, the amendments require CO CEMS; bag
leak detection systems for fabric-filter controlled units; annual
inspections of scrubbers, fabric filters, and other air pollution
control devices that may be used to meet the emissions limits; and
Method 22 visible emissions testing of the ash handling operations to
be conducted during each compliance test. For existing HMIWI, use of CO
CEMS is an approved option, and specific language with requirements for
CO CEMS is included in the amendments. For new and existing HMIWI, use
of PM, HCl, multi-metals, and Hg CEMS, and integrated sorbent trap Hg
monitoring and dioxin monitoring (continuous sampling with periodic
sample analysis) also are approved options, and specific language for
those options is included in the amendments. HMIWI that install SNCR
technology to reduce NOX emissions are required to monitor
the reagent (e.g., ammonia or urea) injection rate and secondary
chamber temperature.
2. Electronic Data Submittal
The EPA must have performance test data to conduct effective 5-year
reviews of CAA Section 129 standards, as well as for many other
purposes, including compliance determinations, development of emissions
factors, and determining annual emissions rates. In conducting 5-year
reviews, EPA has found it burdensome and time-consuming to collect
emissions test data because of varied locations for data storage and
varied data storage methods. One improvement that has occurred in
recent years is the availability of stack test reports in electronic
format as a replacement for burdensome paper copies.
In this action, we are taking a step to improve data accessibility.
HMIWI have the option of submitting to an EPA electronic database an
electronic copy of annual stack test reports. Data entry will be
through an electronic emissions test report structure used by the staff
as part of the emissions testing project. The electronic reporting tool
(ERT) was developed with input from stack testing companies who
generally collect and compile performance test data electronically. The
ERT is currently available, and access to direct data submittal to
EPA's electronic emissions database (WebFIRE) will become available
December 31, 2011.\1\
---------------------------------------------------------------------------
\1\ See https://cfpub.epa.gov/oarweb/index.cfm?action=fire.main,
https://www.epa.gov/ttn/chief/ert/ert_tool.html.
---------------------------------------------------------------------------
Please note that the option to submit source test data
electronically to EPA will not require any additional performance
testing. In addition, when a facility elects to submit performance test
data to WebFIRE, there will be no additional requirements for data
compilation. Instead, we believe industry will benefit from development
of improved emissions factors, fewer follow-up information requests,
and better regulation development, as discussed below. The information
to be reported is already required in the existing test methods and is
necessary to evaluate the conformance to the test method. One major
advantage of electing to submit source test data through the ERT is to
provide a standardized method to compile and store all the
documentation required to be reported by this rule. Another important
benefit of submitting these data to EPA at the time the source test is
conducted is that it will substantially reduce the effort involved in
data collection activities in the future. Specifically, because EPA
would already have adequate source category data to conduct residual
risk assessments or technology reviews, there would be fewer data
collection requests (e.g., CAA Section 114 letters). This results in a
reduced burden on both affected facilities (in terms of reduced
manpower to respond to data collection requests) and EPA (in terms of
preparing and distributing data collection requests). Finally, another
benefit of electing to submit these data to WebFIRE electronically is
that these data will greatly improve the overall quality of the
existing and new emissions factors by supplementing the pool of
emissions test data upon which the emissions factor is based and by
ensuring that data are more representative of current industry
operational procedures. A common complaint we hear from industry and
regulators is that emissions factors are outdated or not representative
of a particular source category. Receiving most performance tests will
ensure that emissions factors are updated and more accurate. In
summary, receiving test data already collected for other purposes and
using them in the emissions factors development program will save
industry, State/local/Tribal agencies, and EPA time and money.
The electronic data base that will be used is EPA's WebFIRE, which
is a Web site accessible through EPA's TTN. The WebFIRE Web site was
constructed to store emissions test data for use in developing
emissions factors. A description of the WebFIRE data base can be found
at https://cfpub.epa.gov/oarweb/index.cfm?action=fire.main. The ERT will
be able to transmit the electronic report through EPA's Central Data
Exchange (CDX) network for storage in the WebFIRE data base. Although
ERT is not the only electronic interface that can be used to submit
source test data to the CDX for entry into WebFIRE, it makes submittal
of data very straightforward and easy. A description of the ERT can be
found at https://www.epa.gov/ttn/chief/ert/ert_tool.html. The ERT can
be used to document stack tests data for various pollutants including
PM (EPA Method 5 of appendix A-3), SO2 (EPA Method 6 or 6C
of appendix A-4), NOX (EPA Method 7 or 7E of appendix A-4),
CO (EPA Method 10 of appendix A-4), Cd (EPA Method 29 of appendix A-8),
Pb (Method 29), Hg (Method 29), and HCl (EPA Method 26A of appendix A-
8). Presently, the ERT does not handle dioxin/furan stack test data
(EPA
[[Page 51374]]
Method 23 of appendix A-7), but the tool is being upgraded to handle
dioxin/furan stack test data. The ERT does not currently accept opacity
data or CEMS data.
3. Waste Segregation
The amendments revise the waste management plan provisions for new
and existing HMIWI. Commenters on the 2008 re-proposal recommended that
EPA minimize or eliminate from the HMIWI waste stream any plastic
wastes, Hg and other hazardous wastes (e.g., Hg-containing dental
waste, Hg-containing devices), pharmaceuticals, and confidential
documents and other paper products that could be shredded and recycled.
One commenter recommended that EPA take action to regulate emissions of
polychlorinated biphenyls (PCBs) and polycyclic organic matter (POM)
from HMIWI. To address the various commenters' concerns, the waste
management plan provisions in Sec. Sec. 60.35e and 60.55c are revised
to promote the segregation of the aforementioned wastes. (See section
IV.H of this preamble for further information about the change to waste
management plan provisions.)
5. Miscellaneous Other Amendments
The amendments revise the definition of ``Minimum secondary chamber
temperature'' to read ``Minimum secondary chamber temperature means 90
percent of the highest 3-hour average secondary chamber temperature
(taken, at a minimum, once every minute) measured during the most
recent performance test demonstrating compliance with the PM, CO, and
dioxin/furan emissions limits.''
The amendments add definitions for ``Bag leak detection system,''
``commercial HMIWI,'' and ``minimum reagent flow rate.'' ``Bag leak
detection system'' is defined to mean ``an instrument that is capable
of monitoring PM loadings in the exhaust of a fabric filter in order to
detect bag failures,'' and examples of such a system are provided.
``Commercial HMIWI'' is defined to mean ``a HMIWI which offers
incineration services for hospital/medical/infectious waste generated
offsite by firms unrelated to the firm that owns the HMIWI.'' ``Minimum
reagent flow rate'' is defined to mean ``90 percent of the highest 3-
hour average reagent flow rate at the inlet to the selective
noncatalytic reduction technology (taken, at a minimum, once every
minute) measured during the most recent performance test demonstrating
compliance with the NOX emissions limit.''
The amendments require HMIWI to submit, along with each test
report, a description, including sample calculations, of how operating
parameters are established during the initial performance test and, if
applicable, re-established during subsequent performance tests.
To provide greater clarity, the amendments also include averaging
times and EPA reference test methods in the emissions limit tables for
existing and new sources. It should be noted that the averaging times
and EPA reference test methods added to the emissions limits tables are
not new requirements but simply a restating of requirements presented
elsewhere in the HMIWI regulations. Also, the inclusion of these
additional table columns should not be interpreted as reopening the
1997 standards themselves.
The amendments also incorporate by reference two alternatives to
EPA reference test methods (ASME PTC 19.10-1981 and ASTM D6784-02) to
provide HMIWI with greater flexibility in demonstrating compliance.
These alternative methods are described in greater detail in section
VIII.I of this preamble and were first presented in the preamble to the
December 1, 2008 re-proposal.
D. Implementation Schedule for Existing Hospital/Medical/Infectious
Waste Incinerators
Under the amendments to the EG, and consistent with CAA Section
129, revised State plans containing the revised existing source
emissions limits and other requirements in the amendments will be due
within 1 year after promulgation of the amendments. That is, revised
State plans have to be submitted to EPA on October 6, 2010.
The amendments to the EG then allow existing HMIWI to demonstrate
compliance with the amended standards as expeditiously as practicable
after approval of a State plan, but no later than 3 years from the date
of such approval or 5 years after promulgation of the revised
standards, whichever is earlier. Because many HMIWI will find it
necessary to retrofit existing emissions control equipment and/or
install additional emissions control equipment in order to meet the
revised limits, States may wish to consider providing the maximum
compliance period allowed by CAA Section 129(f)(2).
In revising the emissions limits in a State plan, a State has two
options. First, it could include both the current and the new emissions
limits in its revised State plan, which would allow a phased approach
in applying the new limits. That is, the State plan would make it clear
that the 1997 emissions limits remain in force and apply until the date
the revised existing source emissions limits are effective (as defined
in the State plan). States whose existing HMIWI do not find it
necessary to improve their performance in order to meet the revised
emissions limits may want to consider a second approach, where the
State would insert the revised emissions limits in place of the 1997
emissions limits, follow procedures in 40 CFR part 60, subpart B, and
submit a revised State plan to EPA for approval. If the revised State
plan contains only the revised emissions limits (i.e., the 1997
emissions limits are not retained), then the revised emissions limits
must become effective immediately, since the 1997 limits would be
removed from the State plan.
EPA will revise the existing Federal plan to incorporate the
changes to existing source emissions limits and other requirements that
EPA is promulgating. The Federal plan applies to HMIWI in any State
without an approved State plan. The amendments to the Federal plan for
the EG would require existing HMIWI demonstrate compliance with the
amended standards not later than 5 years after today's final rule, as
required by CAA Section 129(b)(3).
E. Changes to the Applicability Date of the 1997 New Source Performance
Standards
HMIWI are treated differently under the amended standards than they
were under the 1997 standards in terms of whether they are ``existing''
or ``new'' sources, and there are new dates defining what are ``new''
sources and imposing compliance deadlines regarding the amended
standards. All HMIWI that complied with the NSPS as promulgated in 1997
are ``existing'' sources under the amended standards and are required
to meet the emissions limits under the revised EG or the 1997 NSPS,
whichever is more stringent, by the applicable compliance date for the
revised EG. (Note that the HCl emissions limit for small HMIWI and the
PM emissions limit for medium HMIWI are more stringent under the 1997
NSPS than under the revised EG, and HMIWI that complied with those 1997
NSPS are required to continue to do so.) In the interim, those sources
will continue to be subject to the NSPS as promulgated in 1997 until
the date for compliance with the revised EG. Units for which
construction is commenced after the December 1, 2008 proposal, or for
which modification is commenced on or after the date 6 months after
today's
[[Page 51375]]
promulgation of the amended NSPS, are ``new'' units subject to more
stringent revised NSPS emissions limits.
Thus, under these specific amendments, units that commenced
construction after June 20, 1996, and on or before December 1, 2008, or
that are modified before the date 6 months after the date of
promulgation of the revised final NSPS, continue to be or would become
subject to the 40 CFR part 60, subpart Ec NSPS emissions limits that
were promulgated in 1997 until the applicable compliance date for the
revised EG, at which time those units must comply with the amended
``existing'' source EG or 1997 NSPS, whichever is more stringent for
each pollutant. Similarly, HMIWI that met the 1997 EG must meet the
revised EG by the applicable compliance date for the revised EG. HMIWI
that commence construction after December 1, 2008 or that are modified
6 months or more after the date of promulgation of the revised NSPS
must meet the revised NSPS emissions limits being added to the subpart
Ec NSPS within 6 months after the promulgation date of the amendments
or upon startup, whichever is later.
This approach is justified because most HMIWI will have to install
additional emissions controls to comply with the revised standards. CAA
Sections 129(g)(2) and (3) define ``new solid waste incineration unit''
and ``modified solid waste incineration unit'' based on whether
construction of the new unit commences after the date of proposed
standards under Section 129 and on whether modification occurs after
the effective date of a Section 129 standard, respectively. While these
definitions might be read as referring to the dates EPA first proposes
standards for the source category as a whole and on which such
standards first become effective for the source category, we are
interpreting and applying them in this rulemaking to refer to the
proposal and effective dates for standards under this new rulemaking
record. The evident intent of the definitions plus the substantive new
unit and modified unit provisions is that it is technically more
challenging and potentially more costly to retrofit a control system to
an existing unit than to incorporate controls when a unit is initially
designed.
F. Startup, Shutdown, and Malfunction Exemption
The 1997 standards included provisions in 40 CFR 60.56c and 60.37e
that exempted HMIWI from the standards during periods of SSM, provided
that no hospital waste or medical/infectious waste is charged to the
unit during those SSM periods. Neither our 2007 proposal nor our 2008
re-proposal would have changed these provisions. However, soon after
the date of our re-proposal, the U.S. Court of Appeals in Sierra Club
v. EPA, 551 F.3d 1019 (DC Cir. 2008), vacated provisions in EPA's CAA
Section 112 regulations governing emissions of hazardous air pollutants
during SSM periods. Specifically, the Court vacated 40 CFR 63.6(f)(1)
and 63.6(h)(1), which, when incorporated into CAA Section 112(d)
standards for specific source categories, exempt sources from the
requirement to comply with otherwise applicable Section 112(d)
standards during periods of SSM. While the Court's vacatur did not have
a direct impact on source category-specific SSM exemptions such as
those contained in the 1997 HMIWI standards, one commenter on the 2008
re-proposal stressed that the legality of SSM exemptions such as those
in the 1997 standards is questionable, and urged EPA to remove the
exemptions in the final rule. For the reasons set forth later in this
notice responding to comments, today's final rule removes the SSM
exemption from the HMIWI standards, such that the emissions limits
under these subparts apply at all times.
IV. Summary of Major Comments and Responses
A total of 22 separate sets of public comments were received on the
December 1, 2008 re-proposal. (One additional comment, received after
the deadline for public comments, was an addendum to an earlier
comment. See https://www.regulations.gov, docket ID no. EPA-HQ-OAR-2006-
0534, for the complete public comments.) The comment period ended on
February 17, 2009. In addition to the comment letters, speaker comments
from a January 15, 2009, public hearing on the re-proposal were
recorded, and a transcript of the hearing was placed in the project
docket (document no. EPA-HQ-OAR-2006-0534-0361). The following sections
summarize the major public comments received on the re-proposal and
present EPA's responses to those comments. The major comment topics are
applicability; subcategorization; MACT floor approach; emissions
limits; monitoring; emissions testing; alternatives to on-site
incineration; medical waste segregation; startup, shutdown, and
malfunction; and economic impacts.
A. Applicability
Comment: While this issue was not raised in our re-proposal, one
commenter stated that subpart Ec should be amended to exempt units
already complying with subpart AAAA--the NSPS for new small municipal
waste combustors (MWCs)--or subpart BBBB--the EG for existing small
MWCs--consistent with the exemptions provided to MWCs in the 1997 HMIWI
rule.
Response: We are aware of two HMIWI at one facility that are
currently subject to rules for both HMIWI and small MWCs. We have
considered the appropriateness of exempting the two units from the
HMIWI rule or creating a separate HMIWI subcategory for the units, and
have concluded that exemptions and creation of a separate subcategory
are not warranted. One issue is the technological feasibility for the
facility to meet both the HMIWI and small MWC rules if there is the
possibility that the facility would have to implement different control
strategies to meet the limits in both rules. (Note that we do not
currently have any information to suggest that the facility would find
it technically impossible to meet both the revised HMIWI standards and
the small MWC standards.) For example, if the HMIWI rule were to
include stringent CO limits and the small MWC rule were to include
stringent NOX limits, it may be challenging for the facility
to meet the limits of both rules simultaneously by controlling
secondary chamber temperature; increasing the temperature to reduce CO
emissions would invariably increase NOX emissions. However,
by choosing to burn both types of waste and operate as both a small MWC
and a HMIWI, the facility has the responsibility to meet whatever set
of rules that applies based on its operating scenario and could avoid
this situation by choosing to burn one type of waste or the other
exclusively, or at least reducing the other type of waste to co-fired
levels. Also, the facility already employs additional control
strategies besides combustion control for reducing NOX
emissions (urea injection).
The facility typically burns 50 percent hospital/medical/infectious
(HMI) waste and 50 percent municipal waste in its two units. If we were
to grant an exemption to the HMIWI rule for this facility due to it
being subject to the small MWC rule and the facility were to increase
the amount of HMI waste burned to 70 percent and reduce the amount of
municipal waste burned to 30 percent, we could create a total
compliance loophole for the facility, given that the small MWC rule
includes a co-fired exemption for units burning 30 percent or less of
municipal waste. This would be an unacceptable outcome.
[[Page 51376]]
Another option to address this situation would be to create a
hybrid waste subcategory to include the two units, based on the
rationale that the units are burning a unique mixture of waste.
However, we did not provide an opportunity to comment on such an option
in the re-proposal, and have not had the opportunity to develop a
record to support such a new approach or its possibly unique regulatory
framework. Moreover, it is also not clear that such a hybrid
subcategory would fit within the statutory divisions of incinerator
categories set forth in Section 129(a)(1) of the CAA. Therefore, we
decided not to pursue that option for the final rule.
We believe it is reasonable for the facility to be subject to both
the HMIWI and small MWC rules when switching back and forth among the
types of waste burned, since this ensures that, when the facility
operates as either a HMIWI or small MWC, it is regulated as such and
does not avoid compliance obligations that all other incinerators
operating continuously as either HMIWI or small MWC must meet. We do
not expect that continuing to require the facility to comply with both
rules will be overly burdensome. The facility should be able to control
to the more stringent of the two rules.
B. Subcategorization
Comment: Four commenters stated that EPA's rationale for
subcategorization does not reflect any analysis of how the proposed
subcategories will help assure that what has been ``achieved'' by
better performers in a proposed subcategory results in a standard that
is ``achievable'' by other sources in that subcategory. Two of the
commenters argued that, without this assessment, the final subcategory
decisions will be arbitrary and may result in standards that are
unlawfully stringent. The commenters urged EPA to provide the necessary
assessment and rationale for its subcategory proposal. Another
commenter further urged EPA to reconsider its decision to retain the
categories defined by the 1997 HMIWI rule without defining additional
subcategories. The commenter suggested that EPA could keep the relation
between ``achieved'' and ``achievable'' by grouping existing units
based on control technology type and that EPA could address variability
by establishing subcategories that take into account non-technology
factors that affect emissions, as the commenter claimed is required
under Section 112(d)(3).\2\
---------------------------------------------------------------------------
\2\ While the commenter cited to CAA Section 112(d)(3), which
does not literally apply to NSPS and EG promulgated under Sections
111 and 129, we assume the commenter was referring to factors
relevant to MACT floor analyses in general, including those under
Section 129(a)(2).
---------------------------------------------------------------------------
Three commenters stated that EPA must develop a new subcategory for
commercial facilities, based on the claimed significant operational
differences between commercial and so-called ``captive'' units that are
attached to HMI waste generators. The commenters defined a captive unit
as one that is co-owned and co-operated by the generator of the waste,
while a commercial operator is in business to receive wastes from third
parties. The commenters stated that commercial HMIWI, unlike operators
of captive units, cannot use alternative forms of disposal (e.g.,
landfills), and claimed that EPA views their only alternative to the
standards as closure. According to the commenters, EPA not only has the
authority under Section 129(a)(2) to further subcategorize HMIWI, but
it is also mandated to do so due to an overly stringent standard that
is not ``achievable'' by commercial units. The commenters claimed that
wastes sent to a commercial unit are more heterogeneous than for
captive units. They also noted that the handling of medical wastes is
subject to numerous Federal and State requirements related to worker
and public health and safety, which the commenters claimed makes
segregation of wastes hazardous and impractical for operators of
commercial facilities. Thus, the commenters argued that waste
segregation cannot be a control ``achieved in practice'' that can be
used to determine floors for commercial units.
The same three commenters also argued that EPA provides no
rationale for its retention of the small rural class in the re-proposed
rule, and that its prior rationale regarding the unavailability of
alternative means of medical waste treatment beyond 50 miles from the
nearest standard metropolitan statistical area (SMSA) is unsupported.
According to the commenters, EPA's proposed retention of the small
rural subcategory is arbitrary and capricious.
Another commenter recommended that EPA establish new size
classifications, claiming that the distribution of HMIWI no longer
matches the three size categories EPA identified in 1995 when the rule
was first being developed. The commenter also noted that current
standards are based on subcategories defined in terms of feed rates
with no corresponding heating value. According to the commenter, a
reference waste heating characteristic must be established to adjust or
rate incinerators, given that there is currently no consistency or
basis for determining equivalent charging rate.
The same commenter further recommended that, based on its
facility's unique attributes--extremely large processing capacity,
customer generated waste material variability, waste mix, waste-to-
energy heat recovery technology, CEMS, 2+ second combustion gas
retention time, and high British thermal unit (BTU) waste content--EPA
should place its facility in a separate subcategory for extra-large
HMIWI. The commenter provided a list of suggested standards for such a
subcategory, based on upper confidence limits (UCLs) calculated using
EPA's methodology, that indicate 7 of the 11 promulgated standards
applicable to it could be tightened. The commenter noted that residual
risk analyses conducted under Maryland's stringent air toxics
regulations (provided in the commenter's public comments) show that the
resulting ambient emissions would meet all applicable requirements.
Response: Regarding the commenters' argument that EPA must show how
the proposed subcategories will result in a standard that is
``achievable,'' we do not believe that the CAA requires such an
analysis. In facing a similar claim, the U.S. Court of Appeals for the
DC Circuit recently rejected the argument that a facility's claimed
differences between itself and other members of a source category in
the plywood and composite wood products (PCWP) MACT rule compels EPA to
set a unique standard that is achievable for that source. In NRDC v.
EPA, 489 F.3d 1364 (DC Cir. 2007), Louisiana-Pacific Corp. (L-P)
objected to EPA's refusal to establish a separate subcategory for its
wet/wet press process apart from the subcategory of all other press
processes, claiming that, at L-P's plant, EPA's identified MACT floor
control technology was not feasible and that L-P would experience
greater costs in complying with the MACT floor compared to other press
operators. Id., at 1375-76. The Court denied L-P's claims, explaining
that ``cost is not a factor that EPA may permissibly consider in
setting a MACT floor. [* * *] To the extent that L-P maintains that it
cannot comply with the MACT floor based on complete enclosure and
capture of emissions because it cannot enclose its presses, L-P also
relies on an incorrect premis