Document ID: EPA-HQ-OAR-2006-0534-0373
Agency: epa
Document Type: Rule
Title: Standards of Performance for New Stationary Sources and Emissions Guidelines for Existing Sources: Hospital/Medical/Infectious Waste Incinerators
Posted Date: 2009-10-06T04:00Z

[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Rules and Regulations]               
[Page 51367-51415]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-10]                         

[[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

[[Page 51368]]

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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.

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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 http://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 
http://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: http://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 http://cfpub.epa.gov/oarweb/index.cfm?action=fire.main, 
http://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 http://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 http://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 http://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 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

[[Page 51377]]

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 t-test 
statistics. We developed floor-based 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 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 
post-MACT 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

[[Page 51378]]

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 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 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 non-technology factors. 
Based on the actual emissions data we received, which necessarily 
reflects both the use of

[[Page 51379]]

control technologies and any non-technology 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 re-proposal, although, as discussed 
later in this notice, we have made some adjustments in our statistical 
analysis to correct for errors in the 2008 re-proposal.
    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 way would this support EPA disregarding the 2002 
data we have in-hand 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 re-proposal (73 FR 72971), we do 
not interpret Section 129(a)(5), together with Section 111, as 
generally requiring 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,

[[Page 51380]]

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-by-pollutant 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 multi-pollutant 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 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-by-pollutant approach. Section 
129(a)(4) says that the standards promulgated 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 high-efficiency 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 multi-microventuri 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

[[Page 51381]]

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 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-by-pollutant 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 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 
well-documented. The available data for combination dry/wet systems 
provide no indication of operational or emissions problems that occur 
as a result of combining dry and wet control systems. Regarding the 
inverse relationship between CO and NOX with regard to 
combustion control, it is incumbent upon the HMIWI facility to 
determine whether combustion

[[Page 51382]]

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 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 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 court-ordered 
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

[[Page 51383]]

from States and EPA Regions representing all available annual test 
results for each unit, (2) using individual test run data for the best-
performing 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 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 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 ``non-
compliant,'' data collected at HMIWI subsequently shut down, and data 
collected under specific ``test

[[Page 51384]]

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 non-compliant 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 
non-compliant 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 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 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 
``non-detect'' 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 one-half the detection limit in our review of

[[Page 51385]]

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 non-
technology 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., 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 non-technology 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 re-proposal 
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 
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 metals-containing 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

[[Page 51386]]

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 
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 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 metals-
containing materials, which we expect

[[Page 51387]]

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 Sec.  63.7(e)(3) (for MACT standards under 
Section 112 of the CAA), and Sec.  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 best-performing 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 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 re-proposal.
    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 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 re-proposal, 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 re-proposal 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

[[Page 51388]]

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.

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 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-the-floor 
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.
    The same commenter also recommended that EPA set beyond-the-floor 
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 pre-
combustion measures, the commenter argued that EPA has a duty to gather 
information on these measures and evaluate such measures in its beyond-
the-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 
beyond-the-floor add-on control measures we analyzed were not 
reasonable on a cost-effectiveness 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,

[[Page 51389]]

however, we have decided to revise the waste management plan provisions 
in Sec. Sec.  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 well-performing 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 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 3-hour average basis for the CO 
limit, it should be noted that the 2008 re-proposal included an 
amendment to Sec.  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 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 re-
proposal (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

[[Page 51390]]

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 re-proposal, 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 non-technology factors and, 
therefore, do not 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, non-technology 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 
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 well-controlled 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

[[Page 51391]]

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 Sec. Sec.  60.35e 
and 60.55c that encourage segregation of the types of wastes that lead 
to these emissions, such as chlorinated plastics and PCB-containing 
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 
24-hour 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 
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
----------------------------------------------------------------------------------------------------------------
                                                     Parameter monitoring       Emissions
           Pollutant                    CEMS                systems              controls         Incinerators
----------------------------------------------------------------------------------------------------------------
CO.............................  CO CEMS: $149,300  Combustion control      Secondary chamber  Incinerator:
                                  per year (yr).     (charge rate,           retrofit:          $54,800-$366,000/
                                                     secondary chamber       $15,100-$80,800/   yr.
                                                     temperature): $6,000-   yr.
                                                     $9,900/yr.
HCl............................  HCl CEMS:          Packed-bed scrubber     Packed-bed
                                  $171,400/yr.       (flue gas               scrubber:
                                                     temperature, scrubber   $51,600-$104,000/
                                                     liquor flow rate and    yr.
                                                     pH): $5,200/yr.
PM.............................  PM CEMS: $195,200/ Fabric filter (fabric   Fabric filter:
                                  yr.                filter inlet            $130,000-$268,00
                                                     temperature): $4,200/   0/yr.
                                                     yr.
Metals.........................  Multi-metals
                                  CEMS: $57,800/yr.
Hg.............................  Hg CEMS: $313,900/ Activated carbon        Activated carbon
                                  yr.                injection system        injection
                                                     (activated carbon       system: $5,400-
                                                     injection rate):        $56,300/yr.
                                                     $4,800/yr.
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 re-proposal specified that the CEMS options would be 
available to a facility only when a final performance specification has 
been published in the Federal Register or when a site-specific 
monitoring plan has been approved. This should address the commenters' 
concerns.

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 Sec.  60.37e(f) allowing

[[Page 51392]]

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 non-homogeneous 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 Sec.  
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 Sec.  
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. 
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 re-proposal, 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 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,

[[Page 51393]]

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).

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, Hg-containing 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 Hg-containing 
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 metals-containing 
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 
Sec.  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 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, PCB-containing 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 
Sec. Sec.  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

[[Page 51394]]

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 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 Sec.  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 Sec.  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 
Sec.  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 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 Sec.  60.56c(a) applied only where no hospital 
waste and no medical/infectious waste was being charged. Under 
Sec. Sec.  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 
Sec.  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

[[Page 51395]]

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 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). 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

[[Page 51396]]

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 re-analyzed 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 pre-
proposal 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 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 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 scrubber-controlled units adding a fabric 
filter-based system for improved control of PM and metals; most units 
with fabric filter-based systems adding a packed-bed 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

[[Page 51397]]

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 
add-on 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 (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        Reductions
                                      achieved through  achieved through
              Pollutant               meeting MACT (lb/    alternative
                                             yr)        disposal (lb/yr)
------------------------------------------------------------------------
HCl.................................     168,000           198,000
CO..................................       1,140            20,200
Pb..................................         313               420
Cd..................................          15.6              35.1
Hg..................................         605               682
PM..................................       3,170            89,900
CDD/CDF, total......................           0.0678            0.0985
CDD/CDF, TEQ........................           0.00145           0.00183
NOX.................................     146,000         1,080,000
SO2.................................      73,700           126,000
                                     -----------------------------------
    Total...........................     393,000         1,520,000
------------------------------------------------------------------------

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 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., 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

[[Page 51398]]

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         400 lb/hr        4,000 lb/hr
                                                                capacity          capacity          capacity
----------------------------------------------------------------------------------------------------------------
HCl.......................................................                 0              45.8               968
CO........................................................                 0              7.97                 0
Pb........................................................                 0                 0              3.76
Cd........................................................                 0                 0             0.293
Hg........................................................                 0             0.194              2.40
PM........................................................                 0                 0               170
Dioxins/furans, total.....................................                 0       5.34 x 10-4                 0
Dioxins/furans, TEQ.......................................                 0       6.02 x 10-6                 0
NOX.......................................................               491             1,780                 0
SO2.......................................................              37.8              31.9                 0
                                                           -----------------------------------------------------
    Total.................................................               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 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.

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

[[Page 51399]]

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.

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 
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 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

[[Page 51400]]

emissions, as is evidenced by HMIWI performance data. Specifically, the 
post-MACT 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 pre-MACT 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 well-controlled 
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 
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 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-for-profit 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

[[Page 51401]]

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-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 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 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.

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.

[[Page 51402]]

    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.

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.
    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.

0
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]

0
1. The authority citation for part 60 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart A--[Amended]

0
2. Section 60.17 is amended by revising paragraphs (a)(90) and (h)(4) 
to read as follows:

Sec.  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 Sec.  
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 Sec.  60.56c(b)(4) of 
subpart Ec, Sec.  60.106(e)(2) of subpart J, Sec. Sec.  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 Sec. Sec.  
60.4415(a)(2) and 60.4415(a)(3) of subpart KKKK of this part.
* * * * *

Subpart Ce--[Amended]

* * * * *

0
3. Section 60.32e is amended by revising paragraph (a) and adding 
paragraph (j) to read as follows:

Sec.  60.32e  Designated facilities.

    (a) Except as provided in paragraphs (b) through (h) of this 
section, the designated facility to which the guidelines apply is each 
individual HMIWI:
    (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

[[Page 51403]]

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.

0
4. Section 60.33e is revised to read as follows:

Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  60.32e(a)(1) 
subject to the emissions guidelines as promulgated on September 15, 
1997, the requirements in Sec.  60.52c(b)(1) of subpart Ec of this 
part.
    (2) For a designated facility as defined in Sec.  60.32e(a)(1) 
subject to the emissions guidelines as amended on October 6, 2009 and a 
designated facility as defined in Sec.  60.32e(a)(2), the requirements 
in Sec.  60.52c(b)(2) of subpart Ec of this part.

0
5. Section 60.36e is amended as follows:
0
a. By revising paragraph (a) introductory text;
0
b. By revising paragraph (b); and
0
c. By adding paragraphs (c) and (d).

Sec.  60.36e  Inspection guidelines.

    (a) For approval, a State plan shall require each small HMIWI 
subject to the emissions limits under Sec.  60.33e(b) and each HMIWI 
subject to the emissions limits under Sec.  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 Sec.  60.33e(b) and each HMIWI 
subject to the emissions limits under Sec.  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 Sec.  60.33e(b)(2) and each HMIWI 
subject to the emissions limits under Sec.  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 emissions limits under Sec.  60.33e(b)(2) and each HMIWI 
subject to the emissions limits under Sec.  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.

0
6. Section 60.37e is amended as follows:
0
a. By revising paragraphs (a), (b) introductory text, and (b)(1);
0
b. By redesignating paragraphs (c) and (d) as paragraphs (d) and (e);
0
c. By redesignating paragraphs (b)(2) through (b)(5) as paragraphs 
(c)(1) through (c)(4);
0
d. By adding a new paragraph (b)(2);
0
e. By adding paragraph (c) introductory text;
0
f. By revising newly redesignated paragraphs (c)(2) through (c)(4), 
(d), (e) introductory text, and (e)(3); and
0
g. By adding paragraph (f).

Sec.  60.37e  Compliance, performance testing, and monitoring 
guidelines.

    (a) Except as provided in paragraph (b) of this section, for 
approval, a State plan shall include the requirements for compliance 
and performance testing listed in Sec.  60.56c of subpart Ec of this 
part, with the following exclusions:
    (1) For a designated facility as defined in Sec.  60.32e(a)(1) 
subject to the emissions limits in Sec.  60.33e(a)(1), the test methods 
listed in Sec.  60.56c(b)(7) and (8), the fugitive emissions testing 
requirements under Sec.  60.56c(b)(14) and (c)(3), the CO CEMS 
requirements under Sec.  60.56c(c)(4), and the compliance requirements 
for monitoring listed in Sec.  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 Sec.  60.32e(a)(1) and 
(a)(2) subject to the emissions limits in Sec.  60.33e(a)(2) and 
(a)(3), the annual fugitive emissions testing requirements under Sec.  
60.56c(c)(3), the CO CEMS requirements under Sec.  60.56c(c)(4), and 
the compliance requirements for monitoring listed in Sec.  
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 Sec.  60.33e(a)(2) and (a)(3) may, however, 
elect to use CO CEMS as specified under Sec.  60.56c(c)(4) or bag leak 
detection systems as specified under Sec.  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 Sec.  60.33e(b) to meet the 
performance testing requirements listed

[[Page 51404]]

in Sec.  60.56c of subpart Ec of this part. The 2,000 lb/week 
limitation under Sec.  60.33e(b) does not apply during performance 
tests.
    (1) For a designated facility as defined in Sec.  60.32e(a)(1) 
subject to the emissions limits under Sec.  60.33e(b)(1), the test 
methods listed in Sec.  60.56c(b)(7), (8), (12), (13) (Pb and Cd), and 
(14), the annual PM, CO, and HCl emissions testing requirements under 
Sec.  60.56c(c)(2), the annual fugitive emissions testing requirements 
under Sec.  60.56c(c)(3), the CO CEMS requirements under Sec.  
60.56c(c)(4), and the compliance requirements for monitoring listed in 
Sec.  60.56c(c)(5) through (7), and (d) through (k) do not apply.
    (2) For a designated facility as defined in Sec.  60.32e(a)(2) 
subject to the emissions limits under Sec.  60.33e(b)(2), the annual 
fugitive emissions testing requirements under Sec.  60.56c(c)(3), the 
CO CEMS requirements under Sec.  60.56c(c)(4), and the compliance 
requirements for monitoring listed in Sec.  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 Sec.  60.33e(b)(2) may, however, elect to use CO CEMS as 
specified under Sec.  60.56c(c)(4) or bag leak detection systems as 
specified under Sec.  60.57c(h).
    (c) For approval, a State plan shall require each small HMIWI 
subject to the emissions limits under Sec.  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 Sec.  60.8, whichever 
date comes first, ensure that the designated facility does not operate 
above the maximum charge rate or below the minimum secondary chamber 
temperature measured as 3-hour rolling averages (calculated each hour 
as the average of the previous 3 operating hours) at all times. 
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 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 Sec.  60.57c of subpart Ec of this part for HMIWI 
subject to the emissions limits under Sec.  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 Sec.  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 
Sec.  60.32e(a)(1) or (a)(2) subject to emissions limits under Sec.  
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 Sec.  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), 
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.

0
7. Section 60.38e is amended as follows:
0
a. By revising paragraph (a);
0
b. By revising paragraph (b) introductory text; and
0
c. By revising paragraph (b)(1).

Sec.  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 Sec.  60.58c(b) through (g) of 
subpart Ec of this part.
    (1) For a designated facility as defined in Sec.  60.32e(a)(1) 
subject to emissions limits under Sec.  60.33e(a)(1) or (b)(1), 
excluding Sec.  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 Sec.  60.32e(a)(1) or 
(a)(2) subject to emissions limits under Sec.  60.33e(a)(2), (a)(3), or 
(b)(2), excluding Sec.  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 Sec.  60.33e to:
    (1) As specified in Sec.  60.36e, maintain records of the annual 
equipment inspections that are required for each HMIWI subject to the 
emissions limits under Sec.  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 Sec.  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
* * * * *

0
8. Section 60.39e is amended as follows:
0
a. By revising paragraph (a);
0
b. By revising paragraph (c) introductory text;
0
c. By revising paragraph (c)(1);
0
d. By revising paragraph (d)(3); and
0
e. By revising paragraph (f).

[[Page 51405]]

Sec.  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 Sec.  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.
* * * * *
    (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.

0
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 Sec.   60.32e(a)(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Emissions limits
                                                    ---------------------------------------------------------------                        Method for
           Pollutant              Units (7 percent                             HMIWI size                             Averaging time     demonstrating
                                 oxygen, dry basis) ---------------------------------------------------------------        \1\           compliance \2\
                                                            Small               Medium                Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter.............  Milligrams per dry  115 (0.05).........  69 (0.03).........  34 (0.015)..........  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 5 of
                                  meter (mg/dscm)                                                                    sample time per    appendix A-3 of
                                  (grains per dry                                                                    run).              part 60, or EPA
                                  standard cubic                                                                                        Reference Method
                                  foot (gr/dscf)).                                                                                      26A or 29 of
                                                                                                                                        appendix A-8 of
                                                                                                                                        part 60.
Carbon monoxide................  Parts per million   40.................  40................  40..................  3-run average (1-  EPA Reference
                                  by volume (ppmv).                                                                  hour minimum       Method 10 or 10B
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Dioxins/furans.................  Nanograms per dry   125 (55) or 2.3      125 (55) or 2.3     125 (55) or 2.3       3-run average (4-  EPA Reference
                                  standard cubic      (1.0).               (1.0).              (1.0).                hour minimum       Method 23 of
                                  meter total                                                                        sample time per    appendix A-7 of
                                  dioxins/furans                                                                     run).              part 60.
                                  (ng/dscm) (grains
                                  per billion dry
                                  standard cubic
                                  feet (gr/10\9\
                                  dscf)) or ng/dscm
                                  TEQ (gr/10\9\
                                  dscf).
Hydrogen chloride..............  ppmv..............  100 or 93%.........  100 or 93%........  100 or 93%..........  3-run average (1-  EPA Reference
                                                                                                                     hour minimum       Method 26 or 26A
                                                                                                                     sample time per    of appendix A-8
                                                                                                                     run).              of part 60.
Sulfur dioxide.................  ppmv..............  55.................  55................  55..................  3-run average (1-  EPA Reference
                                                                                                                     hour minimum       Method 6 or 6C
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Nitrogen oxides................  ppmv..............  250................  250...............  250.................  3-run average (1-  EPA Reference
                                                                                                                     hour minimum       Method 7 or 7E
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Lead...........................  mg/dscm (grains     1.2 (0.52) or 70%..  1.2 (0.52) or 70%.  1.2 (0.52) or 70%...  3-run average (1-  EPA Reference
                                  per thousand dry                                                                   hour minimum       Method 29 of
                                  standard cubic                                                                     sample time per    appendix A-8 of
                                  feet (gr/10\3\                                                                     run).              part 60.
                                  dscf)).

[[Page 51406]]

Cadmium........................  mg/dscm (gr/10\3\   0.16 (0.07) or 65%.  0.16 (0.07) or 65%  0.16 (0.07) or 65%..  3-run average (1-  EPA Reference
                                  dscf).                                                                             hour minimum       Method 29 of
                                                                                                                     sample time per    appendix A-8 of
                                                                                                                     run).              part 60.
Mercury........................  mg/dscm (gr/10\3\   0.55 (0.24) or 85%.  0.55 (0.24) or 85%  0.55 (0.24) or 85%..  3-run average (1-  EPA Reference
                                  dscf).                                                                             hour minimum       Method 29 of
                                                                                                                     sample time per    appendix A-8 of
                                                                                                                     run).              part 60.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Except as allowed under Sec.   60.56c(c) for HMIWI equipped with CEMS.
\2\ Does not include CEMS and approved alternative non-EPA test methods allowed under Sec.   60.56c(b).

0
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 Sec.   60.32e(a)(1) and
                                                                         (a)(2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Emissions limits
                                                    ---------------------------------------------------------------                        Method for
           Pollutant              Units (7 percent                             HMIWI size                             Averaging time     demonstrating
                                 oxygen, dry basis) ---------------------------------------------------------------        \1\           compliance \2\
                                                            Small                Medium               Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter.............  Milligrams per dry  66 (0.029).........  46 (0.020).........  25 (0.011).........  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 5 of
                                  meter (mg/dscm)                                                                    sample time per    appendix A-3 of
                                  (grains per dry                                                                    run).              part 60, or EPA
                                  standard cubic                                                                                        Reference Method
                                  foot (gr/dscf)).                                                                                      26A or 29 of
                                                                                                                                        appendix A-8 of
                                                                                                                                        part 60.
Carbon monoxide................  Parts per million   20.................  5.5................  11.................  3-run average (1-  EPA Reference
                                  by volume (ppmv).                                                                  hour minimum       Method 10 or 10B
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Dioxins/furans.................  Nanograms per dry   16 (7.0) or 0.013    0.85 (0.37) or       9.3 (4.1) or 0.054   3-run average (4-  EPA Reference
                                  standard cubic      (0.0057).            0.020 (0.0087).      (0.024).             hour minimum       Method 23 of
                                  meter total                                                                        sample time per    appendix A-7 of
                                  dioxins/furans                                                                     run).              part 60.
                                  (ng/dscm) (grains
                                  per billion dry
                                  standard cubic
                                  feet (gr/10\9\
                                  dscf)) or ng/dscm
                                  TEQ (gr/10\9\
                                  dscf).
Hydrogen chloride..............  ppmv..............  44.................  7.7................  6.6................  3-run average (1-  EPA Reference
                                                                                                                     hour minimum       Method 26 or 26A
                                                                                                                     sample time per    of appendix A-8
                                                                                                                     run).              of part 60.
Sulfur dioxide.................  ppmv..............  4.2................  4.2................  9.0................  3-run average (1-  EPA Reference
                                                                                                                     hour minimum       Method 6 or 6C
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Nitrogen oxides................  ppmv..............  190................  190................  140................  3-run average (1-  EPA Reference
                                                                                                                     hour minimum       Method 7 or 7E
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Lead...........................  mg/dscm (grains     0.31 (0.14)........  0.018 (0.0079).....  0.036 (0.016)......  3-run average (1-  EPA Reference
                                  per thousand dry                                                                   hour minimum       Method 29 of
                                  standard cubic                                                                     sample time per    appendix A-8 of
                                  feet (gr/10\3\                                                                     run).              part 60.
                                  dscf)).
Cadmium........................  mg/dscm (gr/10\3\   0.017 (0.0074).....  0.013 (0.0057).....  0.0092 (0.0040)....  3-run average (1-  EPA Reference
                                  dscf).                                                                             hour minimum       Method 29 of
                                                                                                                     sample time per    appendix A-8 of
                                                                                                                     run).              part 60.

[[Page 51407]]

Mercury........................  mg/dscm (gr/10\3\   0.014 (0.0061).....  0.025 (0.011)......  0.018 (0.0079).....  3-run average (1-  EPA Reference
                                  dscf).                                                                             hour minimum       Method 29 of
                                                                                                                     sample time per    appendix A-8 of
                                                                                                                     run).              part 60.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Except as allowed under Sec.   60.56c(c) for HMIWI equipped with CEMS.
\2\ Does not include CEMS and approved alternative non-EPA test methods allowed under Sec.   60.56c(b).

0
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 Sec.
                                                  60.33e(b)(1)
----------------------------------------------------------------------------------------------------------------
                                 Units (7 percent                                                  Method for
           Pollutant               oxygen, dry      HMIWI emissions limits    Averaging time     demonstrating
                                      basis)                                       \1\           compliance \2\
----------------------------------------------------------------------------------------------------------------
Particulate matter............  mg/dscm (gr/dscf)  197 (0.086)............  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 5 of
                                                                             sample time per    appendix A-3 of
                                                                             run).              part 60, or EPA
                                                                                                Reference Method
                                                                                                26A or 29 of
                                                                                                appendix A-8 of
                                                                                                part 60.
Carbon monoxide...............  ppmv.............  40.....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 10 or 10B
                                                                             sample time per    of appendix A-4
                                                                             run).              of part 60.
Dioxins/furans................  ng/dscm total      800 (350) or 15 (6.6)..  3-run average (4-  EPA Reference
                                 dioxins/furans                              hour minimum       Method 23 of
                                 (gr/10\9\ dscf)                             sample time per    appendix A-7 of
                                 or ng/dscm TEQ                              run).              part 60.
                                 (gr/10\9\ dscf).
Hydrogen chloride.............  ppmv.............  3,100..................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 26 or 26A
                                                                             sample time per    of appendix A-8
                                                                             run).              of part 60.
Sulfur dioxide................  ppmv.............  55.....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 6 or 6C
                                                                             sample time per    of appendix A-4
                                                                             run).              of part 60.
Nitrogen oxides...............  ppmv.............  250....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 7 or 7E
                                                                             sample time per    of appendix A-4
                                                                             run).              of part 60.
Lead..........................  mg/dscm (gr/10\3\  10 (4.4)...............  3-run average (1-  EPA Reference
                                 dscf).                                      hour minimum       Method 29 of
                                                                             sample time per    appendix A-8 of
                                                                             run).              part 60.
Cadmium.......................  mg/dscm (gr/10\3\  4 (1.7)................  3-run average (1-  EPA Reference
                                 dscf).                                      hour minimum       Method 29 of
                                                                             sample time per    appendix A-8 of
                                                                             run).              part 60.
Mercury.......................  mg/dscm (gr/10\3\  7.5 (3.3)..............  3-run average (1-  EPA Reference
                                 dscf).                                      hour minimum       Method 29 of
                                                                             sample time per    appendix A-8 of
                                                                             run).              part 60.
----------------------------------------------------------------------------------------------------------------
\1\ Except as allowed under Sec.   60.56c(c) for HMIWI equipped with CEMS.
\2\ Does not include CEMS and approved alternative non-EPA test methods allowed under Sec.   60.56c(b).

0
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 Sec.
                                                  60.33e(b)(2)
----------------------------------------------------------------------------------------------------------------
                                 Units (7 percent                                                  Method for
           Pollutant               oxygen, dry      HMIWI Emissions limits    Averaging time     demonstrating
                                      basis)                                       \1\           compliance \2\
----------------------------------------------------------------------------------------------------------------
Particulate matter............  mg/dscm (gr/dscf)  87 (0.038).............  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 5 of
                                                                             sample time per    appendix A-3 of
                                                                             run).              part 60, or EPA
                                                                                                Reference Method
                                                                                                26A or 29 of
                                                                                                appendix A-8 of
                                                                                                part 60.
Carbon monoxide...............  ppmv.............  20.....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 10 or 10B
                                                                             sample time per    of appendix A-4
                                                                             run).              of part 60.

[[Page 51408]]

Dioxins/furans................  ng/dscm total      240 (100) or 5.1 (2.2).  3-run average (4-  EPA Reference
                                 dioxins/furans                              hour minimum       Method 23 of
                                 (gr/10\9\ dscf)                             sample time per    appendix A-7 of
                                 or ng/dscm TEQ                              run).              part 60.
                                 (gr/10\9\ dscf).
Hydrogen chloride.............  ppmv.............  810....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 26 or 26A
                                                                             sample time per    of appendix A-8
                                                                             run).              of part 60.
Sulfur dioxide................  ppmv.............  55.....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 6 or 6C
                                                                             sample time per    of appendix A-4
                                                                             run).              of part 60.
Nitrogen oxides...............  ppmv.............  130....................  3-run average (1-  EPA Reference
                                                                             hour minimum       Method 7 or 7E
                                                                             sample time per    of appendix A-4
                                                                             run).              of part 60.
Lead..........................  mg/dscm (gr/10\3\  0.50 (0.22)............  3-run average (1-  EPA Reference
                                 dscf).                                      hour minimum       Method 29 of
                                                                             sample time per    appendix A-8 of
                                                                             run).              part 60.
Cadmium.......................  mg/dscm (gr/10\3\  0.11 (0.048)...........  3-run average (1-  EPA Reference
                                 dscf).                                      hour minimum       Method 29 of
                                                                             sample time per    appendix A-8 of
                                                                             run).              part 60.
Mercury.......................  mg/dscm (gr/10\3\  0.0051 (0.0022)........  3-run average (1-  EPA Reference
                                 dscf).                                      hour minimum       Method 29 of
                                                                             sample time per    appendix A-8 of
                                                                             run).              part 60.
----------------------------------------------------------------------------------------------------------------
\1\ Except as allowed under Sec.   60.56c(c) for HMIWI equipped with CEMS.
\2\ Does not include CEMS and approved alternative non-EPA test methods allowed under Sec.   60.56c(b).

Subpart Ec--[Amended]

0
13. Section 60.50c is amended as follows:
0
a. By revising paragraph (a);
0
b. By revising paragraph (i)(2);
0
c. By adding paragraphs (i)(3) through (i)(5); and
0
d. By adding paragraphs (m) and (n).

Sec.  60.50c  Applicability and delegation of authority.

    (a) Except as provided in paragraphs (b) through (h) of this 
section, the affected facility to which this subpart applies is each 
individual hospital/medical/infectious waste incinerator (HMIWI):
    (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 Sec.  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;
    (3) Approval of major alternatives to monitoring;
    (4) Waiver of recordkeeping requirements; and
    (5) Performance test and data reduction waivers under Sec.  
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.

0
14. Section 60.51c is amended as follows:
0
a. By adding a definition for ``Bag leak detection system'';
0
b. By adding a definition for ``Commercial HMIWI''; and
0
c. By adding a definition for ``Minimum reagent flow rate''; and
0
d. By revising the definition for ``Minimum secondary chamber 
temperature.''

Sec.  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, light-
scattering, 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

[[Page 51409]]

during the most recent performance test demonstrating compliance with 
the PM, CO, dioxin/furan, and NOX emissions limits.
* * * * *

0
15. Section 60.52c is amended by revising paragraphs (a) through (c) to 
read as follows:

Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  60.8, whichever 
date comes first, no owner or operator of an affected facility as 
defined in Sec.  60.50c(a)(1) and (2) and utilizing a large HMIWI, and 
in Sec.  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.
* * * * *

0
16. Section 60.55c is revised to read as follows:

Sec.  60.55c  Waste management plan.

    The owner or operator of an affected facility shall prepare a waste 
management plan. The waste management plan shall identify both the 
feasibility and the approach to separate certain components of solid 
waste from the health care waste stream in order to reduce the amount 
of toxic emissions from incinerated waste. A waste management plan may 
include, but is not limited to, elements such as 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 Sec.  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.

0
17. Section 60.56c is amended as follows:
0
a. By revising paragraph (a);
0
b. By revising paragraph (b) introductory text and paragraphs (b)(4) 
and (b)(6);
0
c. By redesignating paragraphs (b)(7) through (b)(12) as paragraphs 
(b)(9) through (b)(14);
0
d. By adding new paragraphs (b)(7) and (b)(8);
0
e. By revising newly redesignated paragraphs (b)(9), (b)(10), (b)(11) 
introductory text, and (b)(12) through (b)(14);
0
f. By revising paragraphs (c)(2) and (c)(3);
0
g. By redesignating paragraph (c)(4) as paragraph (c)(5);
0
h. By revising newly redesignated paragraph (c)(5);
0
i. By adding paragraphs (c)(4), (c)(6), and (c)(7);
0
j. By revising paragraph (d) introductory text;
0
k. By revising paragraph (e) introductory text and paragraph (e)(5);
0
l. By adding paragraphs (e)(6) through (e)(10);
0
m. By revising paragraph (f) introductory text and paragraph (f)(6);
0
n. By adding paragraphs (f)(7) through (f)(10);
0
o. By revising paragraph (g) introductory text and paragraph (g)(5);
0
p. By adding paragraphs (g)(6) through (g)(10);
0
q. By redesignating paragraphs (h) through (j) as paragraphs (i) 
through (k);
0
r. By adding paragraph (h); and
0
s. By revising newly redesignated paragraphs (i) and (j).

Sec.  60.56c  Compliance and performance testing.

    (a) The emissions limits apply at all times.
    (b) The owner or operator of an affected facility as defined in 
Sec.  60.50c(a)(1) and (2), shall conduct an initial performance test 
as required under Sec.  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 Sec.  
60.50c(a)(3) and (4), shall conduct an initial performance test as 
required under Sec.  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 
Sec.  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.

[[Page 51410]]

    (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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  60.50c(a)(1) and 
(2) and utilizing a large HMIWI, and in Sec.  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 Sec.  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 
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 Sec.  60.52c shall:
    (i) For an affected facility as defined in Sec.  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 Sec.  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 Sec.  
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 site-specific monitoring plan.
    (iv) For an affected facility as defined in Sec.  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 Sec.  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 Sec.  60.50c(a)(3) and (4) 
using a continuous automated sampling system to demonstrate compliance 
with the dioxin/furan emissions limits under Sec.  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 site-
specific monitoring plan. The owner or operator of an affected facility 
as defined in Sec.  60.50c(a)(3) and (4) who elects to continuously 
sample dioxin/furan emissions instead of sampling and

[[Page 51411]]

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 Sec.  60.58b(p) and 
(q) of subpart Eb of this part.
    (7) An affected facility as defined in Sec.  60.50c(a)(3) and (4) 
using a continuous automated sampling system to demonstrate compliance 
with the Hg emissions limits under Sec.  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 site-specific monitoring plan. The owner or operator of 
an affected facility as defined in Sec.  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 
Sec.  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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  
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.
    (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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  
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

[[Page 51412]]

Sec.  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 Sec.  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 Sec.  60.52c shall petition the 
Administrator for other site-specific operating parameters to be 
established during the initial performance test and continuously 
monitored thereafter. The owner or operator shall not conduct the 
initial performance test until after the petition has been approved by 
the Administrator.
* * * * *

0
18. Section 60.57c is amended as follows:
0
a. By revising paragraph (a);
0
b. By redesignating paragraphs (b) through (d) as paragraphs (c) 
through (e);
0
c. By adding paragraph (b);
0
d. By revising newly redesignated paragraphs (d) and (e); and
0
e. By adding paragraphs (f) through (h).

Sec.  60.57c  Monitoring requirements.

    (a) Except as provided in Sec.  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 
Sec.  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 Sec.  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 Sec.  60.52c shall install, 
calibrate (to manufacturers' specifications), maintain, and operate the 
equipment necessary to monitor the site-specific operating parameters 
developed pursuant to Sec.  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 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 
Sec.  60.50c(a)(3) and (4) shall ensure that each HMIWI subject to the 
emissions limits in Sec.  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 
Sec.  60.50c(a)(3) and (4) shall ensure that each HMIWI subject to the 
emissions limits under Sec.  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 Sec.  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

[[Page 51413]]

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 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.

0
19. Section 60.58c is amended as follows:
0
a. By revising paragraph (a)(2)(iv);
0
b. By redesignating paragraphs (b)(2)(viii) through (b)(2)(xv) as 
paragraphs (b)(2)(ix) through (b)(2)(xvi);
0
c. By adding paragraph (b)(2)(viii);
0
d. By revising newly designated paragraph (b)(2)(xvi);
0
e. By adding paragraphs (b)(2)(xvii) through (b)(2)(xix);
0
f. By revising paragraphs (b)(6) and (b)(11);
0
g. By revising paragraph (c) introductory text;
0
h. By revising paragraphs (c)(1) and (c)(2);
0
i. By adding paragraph (c)(4);
0
j. By revising paragraph (d) introductory text;
0
k. By revising paragraphs (d)(1) through (d)(3);
0
l. By adding paragraphs (d)(9) through (d)(11); and
0
m. By adding paragraph (g).

Sec.  60.58c  Reporting and recordkeeping requirements.

    (a) * * *
    (2) * * *
    (iv) If applicable, the petition for site-specific operating 
parameters under Sec.  60.56c(j).
* * * * *
    (b) * * *
    (2) * * *
    (viii) For affected facilities as defined in Sec.  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 Sec.  60.56c(j) and 
Sec.  60.57c(d), the owner or operator shall maintain all operating 
parameter data collected;
    (xvii) For affected facilities as defined in Sec.  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 Sec.  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.
    (xix) For affected facilities as defined in Sec.  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 re-established, if 
applicable.
* * * * *
    (11) Records of calibration of any monitoring devices as required 
under Sec.  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 Sec.  
60.56c(b)(1) through (b)(14), as applicable.
    (2) The values for the site-specific operating parameters 
established pursuant to Sec.  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 Sec.  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 Sec.  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

[[Page 51414]]

pursuant to Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  60.50c(a)(3) and 
(4), concentrations of CO as determined by the continuous emissions 
monitoring system.
* * * * *
    (g) For affected facilities, as defined in Sec.  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 http://www.epa.gov/ttn/
chief/ert/ert_tool.html.

0
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 Sec.   60.50c(a)(1) and (2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Emissions limits
                                                    ---------------------------------------------------------------                        Method for
           Pollutant              Units (7 percent                             HMIWI size                             Averaging time     demonstrating
                                 oxygen, dry basis) ---------------------------------------------------------------        \1\           compliance \2\
                                                            Small                Medium               Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter.............  Milligrams per dry  69 (0.03)..........  34 (0.015).........  34 (0.015).........  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 5 of
                                  meter (grains per                                                                  sample time per    appendix A-3 of
                                  dry standard                                                                       run).              part 60, or EPA
                                  cubic foot).                                                                                          Reference Method
                                                                                                                                        M 26A or 29 of
                                                                                                                                        appendix A-8 of
                                                                                                                                        part 60.
Carbon monoxide................  Parts per million   40.................  40.................  40.................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 10 or 10B
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Dioxins/furans.................  Nanograms per dry   125 (55) or 2.3      25 (11) or 0.6       25 (11) or 0.6       3-run average (4-  EPA Reference
                                  standard cubic      (1.0).               (0.26).              (0.26).              hour minimum       Method 23 of
                                  meter total                                                                        sample time per    appendix A-7 of
                                  dioxins/furans                                                                     run).              part 60.
                                  (grains per
                                  billion dry
                                  standard cubic
                                  feet) or
                                  nanograms per dry
                                  standard cubic
                                  meter TEQ (grains
                                  per billion dry
                                  standard cubic
                                  feet).
Hydrogen chloride..............  Parts per million   15 or 99%..........  15 or 99%..........  15 or 99%5.1.......  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 26 or 26A
                                                                                                                     sample time per    of appendix A-8
                                                                                                                     run).              of part 60.
Sulfur dioxide.................  Parts per million   55.................  55.................  55.................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 6 or 6C
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Nitrogen oxides................  Parts per million   250................  250................  250................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 7 or 7E
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Lead...........................  Milligrams per dry  1.2 (0.52) or 70%..  0.07 (0.03) or 98%.  0.07 (0.03) or 98%.  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 29 of
                                  meter (grains per                                                                  sample time per    appendix A-8 of
                                  thousand dry                                                                       run).              part 60.
                                  standard cubic
                                  feet.
Cadmium........................  Milligrams per dry  0.16 (0.07) or 65%.  0.04 (0.02) or 90%.  0.04 (0.02) or 90%.  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 29 of
                                  meter (grains per                                                                  sample time per    appendix A-8 of
                                  thousand dry                                                                       run).              part 60.
                                  standard cubic
                                  feet) or percent
                                  reduction.
Mercury........................  Milligrams per dry  0.55 (0.24) or 85%.  0.55 (0.24) or 85%.  0.55 (0.24) or 85%.  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 29 of
                                  meter (grains per                                                                  sample time per    appendix A-8 of
                                  thousand dry                                                                       run).              part 60.
                                  standard cubic
                                  feet) or percent
                                  reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Except as allowed under Sec.   60.56c(c) for HMIWI equipped with CEMS.
\2\ Does not include CEMS and approved alternative non-EPA test methods allowed under Sec.   60.56c(b).

[[Page 51415]]

0
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 Sec.   60.50c(a)(3) and (4)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Emissions limits
                                                    ---------------------------------------------------------------                        Method for
           Pollutant              Units (7 percent                             HMIWI size                           Averaging time\1\    demonstrating
                                 oxygen, dry basis) ---------------------------------------------------------------                      compliance \2\
                                                            Small                Medium               Large
--------------------------------------------------------------------------------------------------------------------------------------------------------
Particulate matter.............  Milligrams per dry  66 (0.029).........  22 (0.0095)........  18 (0.0080)........  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 5 of
                                  meter (grains per                                                                  sample time per    appendix A-3 of
                                  dry standard                                                                       run).              part 60, or EPA
                                  cubic foot).                                                                                          Reference Method
                                                                                                                                        M 26A or 29 of
                                                                                                                                        appendix A-8 of
                                                                                                                                        part 60.
Carbon monoxide................  Parts per million   20.................  1.8................  11.................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 10 or 10B
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Dioxins/furans.................  Nanograms per dry   16 (7.0) or 0.013    0.47 (0.21) or       9.3 (4.1) or 0.035   3-run average (4-  EPA Reference
                                  standard cubic      (0.0057).            0.014 (0.0061).      (0.015).             hour minimum       Method 23 of
                                  meter total                                                                        sample time per    appendix A-7 of
                                  dioxins/furans                                                                     run).              part 60.
                                  (grains per
                                  billion dry
                                  standard cubic
                                  feet) or
                                  nanograms per dry
                                  standard cubic
                                  meter TEQ (grains
                                  per billion dry
                                  standard cubic
                                  feet).
Hydrogen chloride..............  Parts per million   15.................  7.7................  5.1................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 26 or 26A
                                                                                                                     sample time per    of appendix A-8
                                                                                                                     run).              of part 60.
Sulfur dioxide.................  Parts per million   1.4................  1.4................  1.6................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 6 or 6C
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Nitrogen oxides................  Parts per million   67.................  67.................  130................  3-run average (1-  EPA Reference
                                  by volume.                                                                         hour minimum       Method 7 or 7E
                                                                                                                     sample time per    of appendix A-4
                                                                                                                     run).              of part 60.
Lead...........................  Milligrams per dry  0.31 (0.14)........  0.018 (0.0079).....  0.00069 (0.00030)..  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 29 of
                                  meter (grains per                                                                  sample time per    appendix A-8 of
                                  thousand dry                                                                       run).              part 60.
                                  standard cubic
                                  feet).
Cadmium........................  Milligrams per dry  0.017 (0.0074).....  0.0098 (0.0043)....  0.00013 (0.000057).  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 29 of
                                  meter (grains per                                                                  sample time per    appendix A-8 of
                                  thousand dry                                                                       run).              part 60.
                                  standard cubic
                                  feet) or percent
                                  reduction.
Mercury........................  Milligrams per dry  0.014 (0.0061).....  0.0035 (0.0015)....  0.0013 (0.00057)...  3-run average (1-  EPA Reference
                                  standard cubic                                                                     hour minimum       Method 29 of
                                  meter (grains per                                                                  sample time per    appendix A-8 of
                                  thousand dry                                                                       run).              part 60.
                                  standard cubic
                                  feet) or percent
                                  reduction.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Except as allowed under Sec.   60.56c(c) for HMIWI equipped with CEMS.
\2\ Does not include CEMS and approved alternative non-EPA test methods allowed under Sec.   60.56c(b).

[FR Doc. E9-22928 Filed 10-5-09; 8:45 am]

BILLING CODE 6560-50-P