51368 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 60 

[EPA–HQ–OAR–2006–0534; FRL–8959–9] 

RIN 2060–A004 

Standards of Performance for New 

Stationary Sources and Emissions 

Guidelines for Existing Sources: 

Hospital/Medical/Infectious Waste 

Incinerators 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: On September 15, 1997, EPA 

adopted new source performance 

standards (NSPS) and emissions 

guidelines (EG) for hospital/medical/ 

infectious waste incinerators (HMIWI). 

The NSPS and EG were established 

under Sections 111 and 129 of the Clean 

Air Act (CAA or Act). In a response to 

a suit filed by the Sierra Club and the 

Natural Resources Defense Council 

(Sierra Club), the U.S. Court of Appeals 

for the District of Columbia Circuit (the 

Court) remanded the HMIWI regulations 

on March 2, 1999, for further 

explanation of EPA’s reasoning in 

determining the minimum regulatory 

‘‘floors’’ for new and existing HMIWI. 

The HMIWI regulations were not 

vacated and were fully implemented by 

September 2002. On February 6, 2007, 

we published our proposed response to 

the Court’s remand. Following recent 

court decisions and receipt of public 

comments regarding the proposal, we 

re-assessed our response to the remand, 

and on December 1, 2008, we published 

another proposed response and solicited 

public comments. This action 

promulgates our response to the Court’s 

remand and also satisfies the CAA 

Section 129(a)(5) requirement to 

conduct a review of the standards every 

5 years. 

DATES: The amendments to 40 CFR 

60.32e, 60.33e, 60.36e, 60.37e, 60.38e, 

60.39e, Table 1A and 1B to subpart Ce, 

and Tables 2A and 2B to subpart Ce are 

effective as of December 7, 2009. The 

amendments to 40 CFR 60.17, 60.50c, 

60.51c, 60.52c, 60.55c, 60.56c, 60.57c, 

60.58c, and Tables 1A and 1B to subpart 

Ec are effective as of April 6, 2010. The 

incorporation by reference of certain 

publications listed in the regulations is 

approved by the Director of the Federal 

Register as of April 6, 2010. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2006–0534 and 

Legacy Docket ID No. A–91–61. All 

documents in the docket are listed on 

the 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; email address: patel.ketan@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Organization of This Document. The 

following outline is provided to aid in 

locating information in this preamble. 

I. General Information 

A. Does the Final Action Apply to Me? 

B. Where Can I Get a Copy of This 

Document? 

C. Judicial Review 

II. Background 

III. Summary of the Final Rule and Changes 

Since Proposal 

A. Remand Response 

B. Clean Air Act Section 129(a)(5) 5-Year 

Review Response 

C. Other Amendments 

D. Implementation Schedule for Existing 

Hospital/Medical/Infectious Waste 

Incinerators 

E. Changes to the Applicability Date of the 

1997 New Source Performance Standards 

F. Startup, Shutdown, and Malfunction 

Exemption 

IV. Summary of Major Comments and 

Responses 

A. Applicability 

B. Subcategorization 

C. MACT Floor Approach 

D. Emissions Limits 

E. Monitoring 

F. Emissions Testing 

G. Alternatives to On-Site Incineration 

H. Medical Waste Segregation 

I. Startup, Shutdown, and Malfunction 

J. Economic Impacts 

V. Impacts of the Final Action for Existing 

Units 

A. What Are the Primary Air Impacts? 

B. What Are the Water and Solid Waste 

Impacts? 

C. What Are the Energy Impacts? 

D. What Are the Secondary Air Impacts? 

E. What Are the Cost and Economic 

Impacts? 

VI. Impacts of the Final Action for New Units 

A. What Are the Primary Air Impacts? 

B. What Are the Water and Solid Waste 

Impacts? 

C. What Are the Energy Impacts? 

D. What Are the Secondary Air Impacts? 

E. What Are the Cost and Economic 

Impacts? 

VII. Relationship of the Final Action to 

Section 112(c)(6) of the Clean Air Act 

VIII. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution or Use 

I. National Technology Transfer 

Advancement Act 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

K. Congressional Review Act 

I. General Information 

A. Does the Final Action Apply to Me? 

Regulated Entities. Categories and 

entities potentially affected by the final 

action are those which operate hospital/ 

medical/infectious waste incinerators 

(HMIWI). The new source performance 

standards (NSPS) and emissions 

guidelines (EG) for HMIWI affect the 

following categories of sources: 

Category NAICS Code Examples of potentially regulated entities 

Industry ............................................ 622110, 622310, 325411, 325412, 

562213, 611310.

Private hospitals, other health care facilities, commercial research 

laboratories, commercial waste disposal companies, private universities. 

Federal Government ....................... 622110, 541710, 928110 .............. Federal hospitals, other health care facilities, public health service, 

armed services. 


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Category NAICS Code Examples of potentially regulated entities 

State/local/Tribal Government ......... 622110, 562213, 611310 .............. State/local hospitals, other health care facilities, State/local waste disposal services, State universities. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by the final action. To 

determine whether your facility would 

be affected by the final action, you 

should examine the applicability 

criteria in 40 CFR 60.50c of subpart Ec 

and 40 CFR 60.32e of subpart Ce. If you 

have any questions regarding the 

applicability of the final action to a 

particular entity, contact the person 

listed in the preceding FOR FURTHER

INFORMATION CONTACT section. 

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, dualchamber incinerator that burns on 

average about 800 pounds per hour 

(lb/hr) of waste. Smaller units burn as 

little as 15 lb/hr while larger units burn 

as much as 3,700 lb/hr, on average. 

Incineration of hospital/medical/ 

infectious waste causes the release of a 

wide array of air pollutants, some of 

which exist in the waste feed material 

and are released unchanged during 

combustion, and some of which are 

generated as a result of the combustion 

process itself. These pollutants include 

particulate matter (PM); heavy metals, 

including lead (Pb), cadmium (Cd), and 

mercury (Hg); toxic organics, including 

chlorinated dibenzo-p-dioxins/ 

dibenzofurans (CDD/CDF); carbon 

monoxide (CO); nitrogen oxides (NOX); 

and acid gases, including hydrogen 

chloride (HCl) and sulfur dioxide (SO2). 

In addition to the use of pollution 

prevention measures (i.e., waste 

segregation) and good combustion 

control practices, HMIWI are typically 

controlled by wet scrubbers or dry 

sorbent injection fabric filters (dry 

scrubbers). 

Waste segregation is the separation of 

certain components of the waste stream 

in order to reduce the amount of air 

pollution emissions associated with that 

waste when incinerated. The separated 

waste may include paper, cardboard, 

plastics, glass, batteries, aluminum cans, 

food waste, or metals. Separation of 

these types of wastes reduces the 

amount of chlorine- and metalcontaining wastes being incinerated, 

which results in lower potential 

emissions of HCl, CDD/CDF, Hg, Cd, 

and Pb. 

Combustion control includes the 

proper design, construction, operation, 

and maintenance of HMIWI to destroy 

or prevent the formation of air 

pollutants prior to their release to the 

atmosphere. Test data indicate that as 

secondary chamber residence time and 

temperature increase, emissions 

decrease. Combustion control is most 

effective in reducing CDD/CDF, PM, and 

CO emissions. The 2-second combustion 

level, which includes a minimum 

secondary chamber temperature of 

1800 °F and residence time of 2 seconds, 

is considered to be the best level of 

combustion control (i.e., good 

combustion) that is applied to HMIWI. 

Wet scrubbers and dry scrubbers 

provide control of PM, CDD/CDF, HCl, 

and metals, but do not influence CO or 

NOX and have little impact on SO2 at 

the low concentrations emitted by 

HMIWI. (See Legacy Docket ID No. 

A–91–61, item II–A–111; 60 FR 10669, 

10671–10677; and 61 FR 31742–31743.) 

The CAA sets forth a two-stage 

approach to regulating emissions from 


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incinerators. EPA has substantial 

discretion to distinguish among classes, 

types and sizes of incinerator units 

within a category while setting 

standards. In the first stage of setting 

standards, CAA Section 129(a)(2) 

requires EPA to establish technologybased emissions standards that reflect 

the maximum levels of control EPA 

determines are achievable for new and 

existing units, after considering costs, 

non-air quality health and 

environmental impacts, and energy 

requirements associated with the 

implementation of the standards. 

Section 129(a)(5) then directs EPA to 

review those standards and revise them 

as necessary every 5 years. In the second 

stage, Section 129(h)(3) requires EPA to 

determine whether further revisions of 

the standards are necessary in order to 

provide an ample margin of safety to 

protect public health or to prevent 

(taking into consideration costs, energy, 

safety and other relevant factors) an 

adverse environmental effect. See, e.g., 

NRDC and LEAN v. EPA, 529 F.3d 1077, 

1079–80 (DC Cir. 2008) (addressing the 

similarly required two-stage approach 

under CAA Sections 112(d) and (f), and 

upholding EPA’s implementation of 

same). 

In setting forth the methodology EPA 

must use to establish the first-stage 

technology-based NSPS and EG, CAA 

Section 129(a)(2) provides that 

standards ‘‘applicable to solid waste 

incineration units promulgated under 

Section 111 and this Section shall 

reflect the maximum degree of 

reduction in emissions of [certain listed 

air pollutants] that the Administrator, 

taking into consideration the cost of 

achieving such emissions reduction, 

and any non-air quality health and 

environmental impacts and energy 

requirements, determines is achievable 

for new and existing units in each 

category.’’ This level of control is 

referred to as a ‘‘maximum achievable 

control technology,’’ or MACT, 

standard. 

In promulgating a MACT standard, 

EPA must first calculate the minimum 

stringency levels for new and existing 

solid waste incineration units in a 

category, generally based on levels of 

emissions control achieved or required 

to be achieved by the subject units. The 

minimum level of stringency is called 

the MACT ‘‘floor,’’ and CAA Section 

129(a)(2) sets forth differing levels of 

minimum stringency that EPA’s 

standards must achieve, based on 

whether they regulate new and 

reconstructed sources, or existing 

sources. For new and reconstructed 

sources, CAA Section 129(a)(2) provides 

that the ‘‘degree of reduction in 

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 reproposed its response to the Court’s 

remand. EPA’s decision to re-propose 

was based on a number of factors, 

including further rulings by the U.S. 

Court of Appeals that were issued after 

our 2007 proposal was published. In 

addition, public comments regarding 

the 2007 proposal raised issues that, 

upon further consideration, we believed 

would best be addressed through a reproposal. One issue regarded the use of 

emissions limits included in State 

regulations and State-issued permits as 

surrogates for estimated actual 

emissions limitations achieved. Another 

issue regarded EPA’s previous reliance 

on control technology performance as 

the sole indicator of HMIWI 

performance in making MACT floor 

determinations, which did not 

necessarily account for other factors that 

affect emissions (e.g., waste mix, 

combustion conditions). 

As mentioned above, every 5 years 

after adopting a MACT standard under 

Section 129, CAA Section 129(a)(5) 

requires EPA to review and, if 

appropriate, revise the incinerator 

standards. In addition to responding to 

the Court’s remand, today’s final action 

constitutes the first 5-year review of the 

HMIWI standards. 


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III. Summary of the Final Rule and 

Changes Since Proposal 

A. Remand Response 

Today’s final response to the remand 

revises the December 2008 proposed 

emissions limits for both the NSPS and 

EG. The emissions limits are being 

revised in response to a public comment 

on the December 2008 re-proposal, 

which requested that EPA adjust the 

statistical approach used to account for 

variability in the data and consider the 

distribution of the emissions data in 

determining the MACT floor emissions 

limits. The revised statistical approach 

results in generally higher limits 

compared to the December 2008 reproposal. (See section IV.C.6 of this 

preamble for further information about 

this revised approach.) We expect most 

sources should be able to meet the 

revised limits using control technology 

already available to the industry (e.g., 

wet scrubbers, dry scrubbers, or some 

combination of these controls). (See 

section IV.C.2 of this preamble for 

further information.) Similar to the 2008 

re-proposal, the emissions limits in 

today’s final action do not include 

percent reduction alternative standards, 

as discussed further in section IV.D.4 of 

this preamble. 

Table 1 of this preamble summarizes 

the NSPS emissions limits being 

promulgated in this action in response 

to the Court remand for new HMIWI. 

TABLE 1—SUMMARY OF EMISSIONS LIMITS PROMULGATED IN RESPONSE TO THE REMAND FOR NEW HMIWI 

Pollutant (units) Unit size 1

Final remand 

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). 2All 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 

Pollutant (units) Unit size 1

Final remand 

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 


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TABLE 2—SUMMARY OF EG EMISSIONS LIMITS PROMULGATED IN RESPONSE TO THE REMAND FOR EXISTING HMIWI— 

Continued 

Pollutant (units) Unit size 1

Final remand 

response 

limit 2

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). 2All 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 nontechnology factors that affect HMIWI 

emissions performance, which the 2007 

proposed remand response and 5-year 

review did not fully consider. Thus, the 

final remand response more than 

addresses the technology review’s goals 

of assessing the performance efficiency 

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


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1See http://cfpub.epa.gov/oarweb/ 

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

ttn/chief/ert/ert_tool.html. 

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 timeconsuming to collect emissions test data 

because of varied locations for data 

storage and varied data storage methods. 

One improvement that has occurred in 

recent years is the availability of stack 

test reports in electronic format as a 

replacement for burdensome paper 

copies. 

In this action, we are taking a step to 

improve data accessibility. HMIWI have 

the option of submitting to an EPA 

electronic database an electronic copy of 

annual stack test reports. Data entry will 

be through an electronic emissions test 

report structure used by the staff as part 

of the emissions testing project. The 

electronic reporting tool (ERT) was 

developed with input from stack testing 

companies who generally collect and 

compile performance test data 

electronically. The ERT is currently 

available, and access to direct data 

submittal to EPA’s electronic emissions 

database (WebFIRE) will become 

available December 31, 2011.1

Please note that the option to submit 

source test data electronically to EPA 

will not require any additional 

performance testing. In addition, when 

a facility elects to submit performance 

test data to WebFIRE, there will be no 

additional requirements for data 

compilation. Instead, we believe 

industry will benefit from development 

of improved emissions factors, fewer 

follow-up information requests, and 

better regulation development, as 

discussed below. The information to be 

reported is already required in the 

existing test methods and is necessary to 

evaluate the conformance to the test 

method. One major advantage of 

electing to submit source test data 

through the ERT is to provide a 

standardized method to compile and 

store all the documentation required to 

be reported by this rule. Another 

important benefit of submitting these 

data to EPA at the time the source test 

is conducted is that it will substantially 

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 


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Method 23 of appendix A–7), but the 

tool is being upgraded to handle dioxin/ 

furan stack test data. The ERT does not 

currently accept opacity data or CEMS 

data. 

3. Waste Segregation 

The amendments revise the waste 

management plan provisions for new 

and existing HMIWI. Commenters on 

the 2008 re-proposal recommended that 

EPA minimize or eliminate from the 

HMIWI waste stream any plastic wastes, 

Hg and other hazardous wastes (e.g., Hgcontaining dental waste, Hg-containing 

devices), pharmaceuticals, and 

confidential documents and other paper 

products that could be shredded and 

recycled. One commenter recommended 

that EPA take action to regulate 

emissions of polychlorinated biphenyls 

(PCBs) and polycyclic organic matter 

(POM) from HMIWI. To address the 

various commenters’ concerns, the 

waste management plan provisions in 

§§ 60.35e and 60.55c are revised to 

promote the segregation of the 

aforementioned wastes. (See section 

IV.H of this preamble for further 

information about the change to waste 

management plan provisions.) 

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 reproposal. 

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 


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promulgation of the amended NSPS, are 

‘‘new’’ units subject to more stringent 

revised NSPS emissions limits. 

Thus, under these specific 

amendments, units that commenced 

construction after June 20, 1996, and on 

or before December 1, 2008, or that are 

modified before the date 6 months after 

the date of promulgation of the revised 

final NSPS, continue to be or would 

become subject to the 40 CFR part 60, 

subpart Ec NSPS emissions limits that 

were promulgated in 1997 until the 

applicable compliance date for the 

revised EG, at which time those units 

must comply with the amended 

‘‘existing’’ source EG or 1997 NSPS, 

whichever is more stringent for each 

pollutant. Similarly, HMIWI that met 

the 1997 EG must meet the revised EG 

by the applicable compliance date for 

the revised EG. HMIWI that commence 

construction after December 1, 2008 or 

that are modified 6 months or more after 

the date of promulgation of the revised 

NSPS must meet the revised NSPS 

emissions limits being added to the 

subpart Ec NSPS within 6 months after 

the promulgation date of the 

amendments or upon startup, whichever 

is later. 

This approach is justified because 

most HMIWI will have to install 

additional emissions controls to comply 

with the revised standards. CAA 

Sections 129(g)(2) and (3) define ‘‘new 

solid waste incineration unit’’ and 

‘‘modified solid waste incineration 

unit’’ based on whether construction of 

the new unit commences after the date 

of proposed standards under Section 

129 and on whether modification occurs 

after the effective date of a Section 129 

standard, respectively. While these 

definitions might be read as referring to 

the dates EPA first proposes standards 

for the source category as a whole and 

on which such standards first become 

effective for the source category, we are 

interpreting and applying them in this 

rulemaking to refer to the proposal and 

effective dates for standards under this 

new rulemaking record. The evident 

intent of the definitions plus the 

substantive new unit and modified unit 

provisions is that it is technically more 

challenging and potentially more costly 

to retrofit a control system to an existing 

unit than to incorporate controls when 

a unit is initially designed. 

F. Startup, Shutdown, and Malfunction 

Exemption 

The 1997 standards included 

provisions in 40 CFR 60.56c and 60.37e 

that exempted HMIWI from the 

standards during periods of SSM, 

provided that no hospital waste or 

medical/infectious waste is charged to 

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 reproposal and present EPA’s responses to 

those comments. The major comment 

topics are applicability; 

subcategorization; MACT floor 

approach; emissions limits; monitoring; 

emissions testing; alternatives to on-site 

incineration; medical waste segregation; 

startup, shutdown, and malfunction; 

and economic impacts. 

A. Applicability 

Comment: While this issue was not 

raised in our re-proposal, one 

commenter stated that subpart Ec 

should be amended to exempt units 

already complying with subpart 

AAAA—the NSPS for new small 

municipal waste combustors (MWCs)— 

or subpart BBBB—the EG for existing 

small MWCs—consistent with the 

exemptions provided to MWCs in the 

1997 HMIWI rule. 

Response: We are aware of two 

HMIWI at one facility that are currently 

subject to rules for both HMIWI and 

small MWCs. We have considered the 

appropriateness of exempting the two 

units from the HMIWI rule or creating 

a separate HMIWI subcategory for the 

units, and have concluded that 

exemptions and creation of a separate 

subcategory are not warranted. One 

issue is the technological feasibility for 

the facility to meet both the HMIWI and 

small MWC rules if there is the 

possibility that the facility would have 

to implement different control strategies 

to meet the limits in both rules. (Note 

that we do not currently have any 

information to suggest that the facility 

would find it technically impossible to 

meet both the revised HMIWI standards 

and the small MWC standards.) For 

example, if the HMIWI rule were to 

include stringent CO limits and the 

small MWC rule were to include 

stringent NOX limits, it may be 

challenging for the facility to meet the 

limits of both rules simultaneously by 

controlling secondary chamber 

temperature; increasing the temperature 

to reduce CO emissions would 

invariably increase NOX emissions. 

However, by choosing to burn both 

types of waste and operate as both a 

small MWC and a HMIWI, the facility 

has the responsibility to meet whatever 

set of rules that applies based on its 

operating scenario and could avoid this 

situation by choosing to burn one type 

of waste or the other exclusively, or at 

least reducing the other type of waste to 

co-fired levels. Also, the facility already 

employs additional control strategies 

besides combustion control for reducing 

NOX emissions (urea injection). 

The facility typically burns 50 percent 

hospital/medical/infectious (HMI) waste 

and 50 percent municipal waste in its 

two units. If we were to grant an 

exemption to the HMIWI rule for this 

facility due to it being subject to the 

small MWC rule and the facility were to 

increase the amount of HMI waste 

burned to 70 percent and reduce the 

amount of municipal waste burned to 30 

percent, we could create a total 

compliance loophole for the facility, 

given that the small MWC rule includes 

a co-fired exemption for units burning 

30 percent or less of municipal waste. 

This would be an unacceptable 

outcome. 


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2While 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). 

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

Three commenters stated that EPA 

must develop a new subcategory for 

commercial facilities, based on the 

claimed significant operational 

differences between commercial and socalled ‘‘captive’’ units that are attached 

to HMI waste generators. The 

commenters defined a captive unit as 

one that is co-owned and co-operated by 

the generator of the waste, while a 

commercial operator is in business to 

receive wastes from third parties. The 

commenters stated that commercial 

HMIWI, unlike operators of captive 

units, cannot use alternative forms of 

disposal (e.g., landfills), and claimed 

that EPA views their only alternative to 

the standards as closure. According to 

the commenters, EPA not only has the 

authority under Section 129(a)(2) to 

further subcategorize HMIWI, but it is 

also mandated to do so due to an overly 

stringent standard that is not 

‘‘achievable’’ by commercial units. The 

commenters claimed that wastes sent to 

a commercial unit are more 

heterogeneous than for captive units. 

They also noted that the handling of 

medical wastes is subject to numerous 

Federal and State requirements related 

to worker and public health and safety, 

which the commenters claimed makes 

segregation of wastes hazardous and 

impractical for operators of commercial 

facilities. Thus, the commenters argued 

that waste segregation cannot be a 

control ‘‘achieved in practice’’ that can 

be used to determine floors for 

commercial units. 

The same three commenters also 

argued that EPA provides no rationale 

for its retention of the small rural class 

in the re-proposed rule, and that its 

prior rationale regarding the 

unavailability of alternative means of 

medical waste treatment beyond 50 

miles from the nearest standard 

metropolitan statistical area (SMSA) is 

unsupported. According to the 

commenters, EPA’s proposed retention 

of the small rural subcategory is 

arbitrary and capricious. 

Another commenter recommended 

that EPA establish new size 

classifications, claiming that the 

distribution of HMIWI no longer 

matches the three size categories EPA 

identified in 1995 when the rule was 

first being developed. The commenter 

also noted that current standards are 

based on subcategories defined in terms 

of feed rates with no corresponding 

heating value. According to the 

commenter, a reference waste heating 

characteristic must be established to 

adjust or rate incinerators, given that 

there is currently no consistency or 

basis for determining equivalent 

charging rate. 

The same commenter further 

recommended that, based on its 

facility’s unique attributes—extremely 

large processing capacity, customer 

generated waste material variability, 

waste mix, waste-to-energy heat 

recovery technology, CEMS, 2+ second 

combustion gas retention time, and high 

British thermal unit (BTU) waste 

content—EPA should place its facility 

in a separate subcategory for extra-large 

HMIWI. The commenter provided a list 

of suggested standards for such a 

subcategory, based on upper confidence 

limits (UCLs) calculated using EPA’s 

methodology, that indicate 7 of the 11 

promulgated standards applicable to it 

could be tightened. The commenter 

noted that residual risk analyses 

conducted under Maryland’s stringent 

air toxics regulations (provided in the 

commenter’s public comments) show 

that the resulting ambient emissions 

would meet all applicable requirements. 

Response: Regarding the commenters’ 

argument that EPA must show how the 

proposed subcategories will result in a 

standard that is ‘‘achievable,’’ we do not 

believe that the CAA requires such an 

analysis. In facing a similar claim, the 

U.S. Court of Appeals for the DC Circuit 

recently rejected the argument that a 

facility’s claimed differences between 

itself and other members of a source 

category in the plywood and composite 

wood products (PCWP) MACT rule 

compels EPA to set a unique standard 

that is achievable for that source. In 

NRDC v. EPA, 489 F.3d 1364 (DC Cir. 

2007), Louisiana-Pacific Corp. (L–P) 

objected to EPA’s refusal to establish a 

separate subcategory for its wet/wet 

press process apart from the subcategory 

of all other press processes, claiming 

that, at L–P’s plant, EPA’s identified 

MACT floor control technology was not 

feasible and that L–P would experience 

greater costs in complying with the 

MACT floor compared to other press 

operators. Id., at 1375–76. The Court 

denied L–P’s claims, explaining that 

‘‘cost is not a factor that EPA may 

permissibly consider in setting a MACT 

floor. [* * *] To the extent that L–P 

maintains that it cannot comply with 

the MACT floor based on complete 

enclosure and capture of emissions 

because it cannot enclose its presses, 

L–P also relies on an incorrect premise 

that the MACT level of emissions 

reduction is invalid if it is based on 

control technology that a source cannot 

install. The 2004 rule does not require 

a source to use any particular method to 


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achieve compliance: If L–P cannot use 

enclosure and capture, it may utilize 

other compliance techniques. Hence, 

L–P fails to show that EPA was arbitrary 

or capricious in refusing to create a 

subcategory for it.’’ Id. at 1376. The 

option provided by one commenter to 

subcategorize based on control 

technology type is inappropriate, as it 

would essentially endorse the type of 

unique treatment that L–P demanded in 

the PCWP rule and that the Court 

rejected. Moreover, we are unaware of 

any situations in the HMIWI industry 

where one type of control would be 

technically applicable, but not another, 

such that subcategorizing based on the 

ability to use certain controls would be 

justified. 

We evaluated three different 

subcategory options to try and address 

the concerns stated by the commenters. 

The three options included: (1) Option 

1—no change to existing size categories; 

(2) Option 2—creating a commercial 

subcategory (as suggested by three 

commenters) and redistributing the size 

categories for the captive HMIWI (as 

suggested by another commenter); and 

(3) Option 3—redistributing the existing 

size categories to more evenly distribute 

the number of HMIWI (also suggested by 

the other commenter). 

Under Option 1, the size distributions 

would remain the same—large (>500 lb/ 

hr of waste), medium (>200 to ≤500 lb/ 

hr of waste), and small (≤200 lb/hr of 

waste), with the latter category divided 

into small rural and non-rural 

subcategories based on distance from 

the nearest SMSA. 

Under Option 2, commercial HMIWI 

would be categorized separately from 

captive HMIWI, and the captive HMIWI 

further subcategorized as follows—large 

(>1,000 lb/hr of waste), medium (>500 

to ≤1,000 lb/hr of waste), and small 

(≤500 of waste), with no further 

subcategorization of the latter category. 

Under Option 3, the sizes would be 

redistributed as follows—large (>1,500 

lb/hr of waste), medium (>500 to ≤1,500 

lb/hr of waste), and small (≤500 lb/hr of 

waste), with the latter category divided 

into small rural and non-rural 

subcategories as under Option 1. 

We conducted MACT floor analyses 

on all three options, using the following 

methodology, which is described in 

more detail later in this notice—(1) 

Ranking the emissions data from lowest 

to highest for each pollutant; (2) 

determining the units in the MACT floor 

for each pollutant; (3) determining the 

distribution of test run data for the 

MACT floor units; and (4) calculating a 

99 percent UCL for each pollutant based 

on that distribution, using Student’s ttest statistics. We developed floor-based 

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 postMACT compliance data, namely that 

EPA is no longer confident in the 

regulatory limits used in 1997 (based on 

a comparison of the regulatory limits 

and emissions test data in the 1997 

record) and that the EPA questions their 

use as surrogates because they do not 

account for non-technology factors 

(based on waste segregation data EPA 

received after the 2007 proposal). 

Specifically, the three commenters 

stated that EPA provides no justification 

for its change in using the post-MACT 


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compliance data, noting that the Court, 

in Sierra Club v. EPA, 167 F.3d 658 (DC 

Cir. 1999), upheld EPA’s data-gathering 

for the 1997 rule, and did not dispute 

that EPA could make estimates based on 

the lack of data. The three commenters 

further stated that EPA provides no 

support for reassessing its determination 

in 1997 that emissions controls 

significantly impact emissions, which 

the commenters indicated is a finding 

that EPA continues to assert and that is 

supported by the data. 

Regarding EPA’s claim that it reset the 

floors in response to the remand of the 

regulation in Sierra Club v. EPA, 167 

F.3d 658 (DC Cir. 1999), the same three 

commenters argued that the Court’s 

remand was limited and did not vacate 

the 1997 floors. According to the 

commenters, EPA cites no legal support 

that subsequent case law invalidates a 

promulgated regulation not at issue in 

that case. The commenters stated that, 

in the past, EPA has declined to account 

for changes in law after its decision to 

impose new regulatory obligations, 

based in part on the general 

presumption against law having a 

retroactive effect. According to the 

commenters, this approach is supported 

by case law, which holds that agencies 

are required to apply the law at the time 

the decision is made. Aaacon Auto 

Transport v. ICC, 792 F.2d 1156, 1161 

(DC Cir. 1986). The commenters also 

noted that the 2002 data used to set the 

proposed standards would not have 

been available had the EPA responded 

to the 1999 remand in a more timely 

manner. 

The three commenters also argued 

that new public comments raising issues 

with the 1997 floors are out of time and 

insufficient to require EPA to go beyond 

the Court’s remand order. The 

commenters pointed out that Section 

307(b) of the CAA requires any 

challenges to regulations to be filed 

within 60 days, which has been held up 

in the relevant case law. According to 

the commenters, any required revisions 

to address the Court’s limited remand 

does not justify reopening the time 

period for judicial challenge of the 

floors. The commenters also argued that 

another exception to the 60-day 

jurisdictional bar, that there was a 

substantive violation of the statute, does 

not apply since the Court did not find 

the 1997 floors in conflict with the 

statute. 

Response: First, we disagree with the 

commenters’ assertion that we are 

employing a MACT-on-MACT approach 

to set limits that are not achievable by 

HMIWI. The purpose of this action is 

not to force units who have complied 

with a lawfully adopted MACT standard 

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 nontechnology factors. Based on the actual 

emissions data we received, which 

necessarily reflects both the use of 


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control technologies and any nontechnology measures the best 

performing sources happen to use, we 

were able to provide the ‘‘reasonable 

estimate’’ of the best performers’ 

emissions levels that the Court required 

in its remand. Therefore, we stand by 

the reassessment we presented in the reproposal, although, as discussed later in 

this notice, we have made some 

adjustments in our statistical analysis to 

correct for errors in the 2008 reproposal. 

Regarding the commenters’ arguments 

about the impact of subsequent case 

law, we do not expect that we could 

reasonably respond to the Court’s 1999 

remand of the HMIWI rule in a manner 

that knowingly disregards other flaws in 

EPA’s prior MACT methodology that the 

Court has since identified. In a recent 

MACT ruling in which the Court found 

that EPA had failed to follow the rulings 

issued in other MACT cases, the Court 

admonished the EPA that if ‘‘[EPA] 

disagrees with the Clean Air Act’s 

requirements for setting emissions 

standards, it should take its concerns to 

Congress. If EPA disagrees with this 

court’s interpretation of the Clean Air 

Act, it should seek rehearing en banc or 

file a petition for a writ of certiorari. In 

the meantime, it must obey the Clean 

Air Act as written by Congress and 

interpreted by this court.’’ 479 F.3d at 

884. EPA takes this directive seriously 

and acted consistently with the Court 

decisions in preparing this response to 

the remand. We do not believe that the 

Court would view its own post-1999 

MACT rulings as having changed ‘‘the 

law’’ (namely, the MACT requirement of 

Sections 112 and 129) such that 

following those rulings’ instructions 

would reflect retroactive application of 

‘‘new’’ law. The commenters’ reliance 

on Aaacon Auto Transport v. ICC, 792 

F.2d 1156 (DC Cir. 1986) is inapposite, 

as that case addressed an entirely 

different situation of retroactive 

application of a new statutory provision; 

here, instead, the governing statutory 

requirements have not changed, EPA is 

acting in response to a Court’s ruling 

that it had not adequately shown that it 

had complied with those provisions, 

and the Agency is acting subsequent to 

further rulings that interpret those same 

provisions and purport to set forth 

general directions for EPA to follow in 

all cases. 

As for the comment that EPA could 

not have relied upon the 2002 

compliance data if it had more swiftly 

responded to the remand, this only 

suggests that if EPA had acted earlier 

the EPA would have been forced to take 

additional steps to require the HMIWI 

industry to supply emissions data. In no 

way would this support EPA 

disregarding the 2002 data we have inhand and allow us to continue to rely 

upon data that does not reasonably 

estimate emissions levels achieved by 

the best performing units. Based on our 

analysis of the record, we determined 

that the 1997 floors did not in all cases 

meet the requirements of the CAA as 

interpreted by the DC Circuit. We 

attempted to explain one set of revisions 

to the 1997 floors in a subsequent 

(February 2007) Federal Register notice 

that relied upon the 1997 data set, and 

received new public comments on that 

notice and took account of new case law 

that convinced us that a new approach 

was required. Consequently, we have 

chosen on our own to re-open the issues 

addressed in the 2008 re-proposal. 

Comment: One commenter stated that 

EPA’s approach to revising HMIWI 

standards under CAA Section 129(a)(5) 

is correct. The commenter said that 

revising the MACT floors to reflect the 

actual performance of the relevant best 

units satisfies Section 129(a)(5). 

However, four other commenters 

objected to revising the floors under the 

technology review provisions of Section 

129(a)(5). The commenters argued that 

Section 129(a)(5) does not require 

resetting the floors, but only requires 

EPA to consider developments in 

pollution control at the sources and 

revise the standards based on our 

evaluation of the costs and non-air 

quality impacts. The commenters stated 

that the use of new emissions data is 

inconsistent with the reasoning EPA 

presented in other contexts (e.g., in the 

coke ovens residual risk/technology 

review rulemaking) that MACT floors 

need not be recalculated when the EPA 

conducts its technology review under 

CAA Section 112(d)(6). The commenters 

also argued that this approach is 

inconsistent with the Court’s decision 

on litigation challenging the Hazardous 

Organic NESHAP (HON) residual risk/ 

technology review rule that there need 

not be an ‘‘inexorable downward 

ratcheting effect’’ for the MACT floors. 

See NRDC and LEAN v. EPA, 529 F.3d 

1077, 1083–84 (DC Cir. 2008). One of 

the commenters also claimed that EPA’s 

approach sets a precedent for all other 

sources subject to Section 129 or 

Section 112 MACT standards that could 

have dire implications on the future 

viability of rules covering other sources 

(e.g., MWCs or waste-to-energy 

facilities). 

Response: Regarding the comment 

from the first commenter, as noted in 

the preamble to the December 2008 reproposal (73 FR 72971), we do not 

interpret Section 129(a)(5), together 

with Section 111, as generally requiring 

EPA to recalculate MACT floors in 

connection with this periodic review 

when such review is not conducted 

together with any other action requiring 

EPA to reassess the MACT floor. See, 

e.g., 71 FR 27324, 27327–28 (May 10, 

2006) (‘‘Standards of Performance for 

New Stationary Sources and Emission 

Guidelines for Existing Sources: Large 

Municipal Waste Combustors; Final 

Rule’’); see also, NRDC and LEAN v. 

EPA, 529 F.3d 1077, 1083–84 (DC Cir. 

2008) (upholding EPA’s interpretation 

that the periodic review requirement in 

CAA Section 112(d)(6) by itself does not 

impose an obligation to recalculate 

MACT floors). However, in the unique 

case of HMIWI, MACT floor 

recalculations for the 2008 re-proposal 

were conducted in order to respond to 

the Court’s concerns stated in its 

remand of the 1997 regulations, the 

public comments received on the 

February 2007 proposal, and recent 

court decisions, specifically Sierra Club 

v. EPA, 479 F.3d (DC Cir. 2007) (Brick 

MACT). This recalculation would have 

been necessary even if the periodic 

review requirement of Section 129(a)(5) 

did not exist. However, Section 

129(a)(5) does exist, and EPA must, in 

addition to responding to the Court’s 

remand, satisfy its requirements. As we 

previously explained and continue to 

believe, in this case, our obligation to 

conduct a 5-year review based on 

implementation of the 1997 emissions 

standards is fulfilled through our 

current remand response. This is 

supported by the fact that the revised 

MACT floor determinations and 

emissions limits associated with the 

current remand response are based on 

performance data for the 57 currently 

operating HMIWI that are subject to the 

1997 standards, and by our accounting 

for non-technology factors that affect 

HMIWI emissions performance, which 

the 2007 proposed remand response and 

5-year review did not fully consider. 

Thus, our current remand response 

more than adequately addresses the 

technology review’s goals of assessing 

the performance efficiency of the 

installed equipment and ensuring that 

the emissions limits reflect the 

performance of the technologies 

required by the MACT standards. In 

addition, the current remand response 

addresses whether new technologies 

and processes and improvements in 

practices have been demonstrated at 

sources subject to the emissions limits. 

Accordingly, our current remand 

response fulfills EPA’s obligations 

regarding the first 5-year review of the 

HMIWI standards and, therefore, 


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replaces the 2007 proposal’s 5-year 

review proposed revisions. 

2. Pollutant-by-Pollutant Approach 

Comment: Numerous commenters 

objected to our continued use of the 

EPA’s longstanding pollutant-bypollutant approach to choosing the best 

performing HMIWI. The commenters 

argued that this approach essentially 

created a hypothetical ‘‘super unit’’ and 

resulted in the selection of a set of new 

and existing MACT floors (and 

standards) that no one existing source 

has completely achieved and that 

cannot be simultaneously achieved by 

any of the best performing sources. The 

commenters stated that the ‘‘best 

performing’’ sources must be real 

sources, not theoretical or hypothetical, 

based on the statute and legislative 

history. S. Rep. No. 228, 101st Cong., 1st 

Sess. 169 (1989). According to the 

commenters, the proposed standards do 

not reflect the performance of actual 

sources, and as such, these proposed 

standards are not legal under Section 

129. 

One commenter argued that Section 

129(a)(2) (and the similar Section 

112(d)(3)) does not speak in terms of the 

best performing source for each listed 

pollutant but the best existing source for 

all pollutants and what these sources 

can achieve on an overall basis. The 

commenter claimed that Congress 

abandoned Section 112’s previous focus 

on individual pollutant standards in the 

1990 CAA Amendments and also 

adopted the technology-based multipollutant approach to regulating toxics 

in use under the Clean Water Act 

(CWA). See S. Rep. No. 228, 101st 

Cong., 1st Sess. 133–34 (1989). The 

commenter concluded that if one source 

can achieve a tight degree of control for 

one pollutant but not for another, there 

may be no justification for including it 

in the set of sources from which the 

floor is calculated. See, e.g., Tanners’ 

Council of America v. Train, 540 F.2d 

1188, 1193 (4th Cir. 1976) (CWA 

effluent limitations guidelines were 

deemed not achievable where plants in 

EPA’s data base were ‘‘capable of 

meeting the limitations for some, but 

not all, of the pollutant parameters’’). 

Two commenters stated that under 

CAA Sections 129(a)(2) and 112(d)(2) 

consideration of a higher level of control 

than the average aggregate levels 

achieved by the best sources (i.e., using 

the pollutant-by-pollutant approach 

instead of basing floors on levels of the 

full set of pollutants achieved by 

particular units) must be done only as 

a ‘‘beyond-the-floor’’ assessment, 

required to weigh economics and other 

factors, and not be ‘‘hidden’’ in the floor 

evaluation, in which costs may not be 

considered. 

Multiple commenters also questioned 

the technical feasibility of EPA’s 

pollutant-by-pollutant approach. 

According to the commenters, 

establishing MACT standards based on 

the best achievable emissions limits for 

each type of pollution control 

equipment assumes that the equipment 

can be combined in the same system 

and that the emissions limits of each 

system are additive. The commenters 

stated that, in practice, this outcome is 

likely not achievable due to the 

challenge of finding pollution control 

equipment (e.g., fabric filters for PM 

removal and wet scrubbers for HCl 

removal) that can work in concert with 

each other. The commenters said that 

EPA should consider how the different 

emissions controls may interfere with 

each other if employed simultaneously. 

As an example, one commenter noted 

that employing a wet scrubber to control 

HCl would saturate the gas stream, 

which would bind the bags in the fabric 

filter used to control PM, thereby 

compromising the filter’s effectiveness. 

Some of the commenters also noted that 

the interrelationships between 

pollutants must be considered in order 

to ensure that the emissions control is 

operating effectively for control of all of 

the related pollutants, and not just a 

single pollutant. For example, 

commenters noted that improving 

combustion to control CO may affect 

NOX. 

Multiple commenters suggested EPA 

should revisit the MACT floors for 

HMIWI and choose the best performing 

sources on an overall basis, so that at 

least one source can meet all of the new 

source standards and a certain portion 

of the existing sources can meet the 

existing source standards. One 

commenter suggested that EPA combine 

the individual pollutants into a single 

analysis to determine which control 

provides the best overall control or 

otherwise determine that the MACT 

floor resulting from the analysis is 

actually achieved by those sources 

identified as the ‘‘best controlled.’’ 

According to various commenters, one 

possible way for doing this would be to 

establish rankings for how a HMIWI 

performs for each of the regulated 

pollutants and then sum the individual 

pollutant rankings to determine the 

overall ranking for the HMIWI. 

Response: We disagree with the 

commenters who object to setting 

MACT floors on a pollutant-by-pollutant 

basis. We continue to interpret Section 

129 as supporting the pollutant-bypollutant approach. Section 129(a)(4) 

says that the standards promulgated 

under Section 129 shall specify 

numerical emissions limitations for 

each pollutant enumerated in that 

provision. Section 129(a)(2) requires 

EPA to establish standards requiring 

‘‘maximum degree of reduction of 

emissions.’’ ‘‘Maximum degree of 

reduction of emissions,’’ in turn is 

defined in Section 129(a)(2) as 

including a minimum level of control 

(the so-called MACT floor). EPA, 

therefore, believes—and has long 

believed—that the combination of 

Section 129(a)(4), requiring numerical 

standards for each enumerated 

pollutant, and Section 129(a)(2), 

requiring that each such standard be at 

least as stringent as the MACT floor, 

supports, if not requires, that floors be 

derived for each pollutant based on the 

emissions levels achieved for each 

pollutant. 

We also disagree with the commenters 

who complain that there may not be any 

operating unit that currently employs 

the complete suite of MACT 

technologies and meets the revised 

limits. The suite of MACT floor controls 

identified by the final rule approach 

(specifically, the combination of dry and 

wet control systems) is already used by 

four existing HMIWI that meet most of 

the MACT floor standards. For example, 

one HMIWI, equipped with a highefficiency particulate air (HEPA) 

filtering system, carbon bed adsorber, 

and rotary atomizing wet scrubber, is 

estimated to meet all nine revised 

emissions limits in the final rule; 

another HMIWI, equipped with a lime 

injection system, powdered activated 

carbon injection system, baghouse, and 

vertical upflow two-stage multimicroventuri scrubber system, is 

estimated to meet eight of the nine 

revised limits. Also, an estimated 42 of 

the 57 HMIWI are estimated to meet 

both the CO and NOX revised limits 

simultaneously with existing 

combustion controls. (See 2009 

memorandum entitled ‘‘Revised 

Compliance Costs and Economic Inputs 

for Existing HMIWI,’’ which is included 

in the docket for today’s rulemaking.) 

The MACT control techniques for the 

various pollutants are fully integratable 

and compatible. There do not appear to 

be any conflicts where meeting the 

standard for one pollutant may 

jeopardize the achievability of meeting 

another pollutant’s limit. This 

conclusion is supported in part by a 

review of available data and 

information. As discussed above, there 

are currently four units that are 

achieving most, if not all, of the floor 

standards (based on actual data for each 

pollutant) using the complete suite of 


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MACT floor controls. Thus, we 

conclude that our approach results in 

compatible MACT controls. Further, an 

evaluation of the emissions data from 

units that have measured data for all 

pollutants supports our conclusion. Our 

analysis shows that 12 percent (7 of 57 

units) simultaneously meet all of the 

MACT floor emissions levels. (For 

further information, see 2009 

memorandum entitled ‘‘Revised 

Compliance Costs and Economic Inputs 

for Existing HMIWI,’’ which is included 

in the docket for today’s rulemaking.) 

We also disagree with commenters 

claiming that it is inappropriate to 

consider a suite of floor control 

techniques that may not be currently in 

use by the source category. There is no 

reason not to consider emissions data 

and controls in use at sources that may 

be the best performers from some 

pollutants but not for other pollutants. 

The MACT floor controls applicable for 

one pollutant do not preclude the use of 

MACT floor controls for another 

pollutant. Therefore, it is appropriate to 

consider controls at sources employing 

MACT controls for some pollutants, but 

not all. For example, floor controls for 

existing large HMIWI include wet 

scrubbers for HCl control, dry scrubbers 

or combination dry/wet systems for PM 

and metals control, activated carbon 

injection for CDD/CDF control, and wet 

scrubbers or dry scrubbers for SO2

control. As noted previously, wet and 

dry systems are demonstrated to be 

compatible, and it would be 

inappropriate to exclude from the 

MACT floor pool those units equipped 

with wet or dry systems because some 

of the control systems do better with 

some pollutants (e.g., wet scrubbers 

with HCl) than others (see previous 

memorandum). 

EPA disagrees strongly with 

commenters arguing that Congress has 

directly addressed the issue of whether 

the MACT floor can be established on a 

pollutant-by-pollutant basis. With 

respect to the MACT floor mandate of 

Section 112, there appears, rather, to be 

a substantial ambiguity in the statutory 

language about whether the MACT floor 

is to be based on the performance of an 

entire source or on the performance 

achieved in controlling particular 

hazardous air pollutants. The language 

regarding best performing ‘‘sources’’ (or, 

for new sources, ‘‘source’’) could apply 

either to the sources’ (or source’s) 

performance as a whole, or performance 

as to a particular pollutant or pollutants. 

The same is true of the definition of 

‘‘emission limitation’’ in Section 302(k), 

which refers to ‘‘air pollutants,’’ but 

does not address whether the limitation 

must apply to every pollutant emitted 

by a source, or just some of them. (The 

same is true of the reference to ‘‘air 

pollutants’’ (in the plural) in Section 

112(d)(2).) In this regard, we note that 

commenters in other MACT 

rulemakings have assumed that Section 

129, which governs today’s rule and 

which uses language essentially 

identical to Section 112 in mandating 

MACT, requires a pollutant-by-pollutant 

approach to establishing floors, because 

EPA is commanded to establish 

standards for enumerated pollutants 

under Section 129(a)(4). We further note 

that the DC Circuit, when reviewing the 

floor determinations we made in 1997 

for HMIWI under Section 129 in Sierra 

Club v. EPA, noted that they were set 

pollutant-by-pollutant and found no 

error in this approach (see 167 F.3d at 

660) (although this aspect of the rule 

was not challenged specifically). 

Indeed, the commenters who object so 

vehemently to the pollutant-bypollutant approach in this rule raised no 

such objection when the opportunity to 

litigate the same approach in 

establishing the 1997 HMIWI standards 

was first presented. 

EPA also believes that the 

commenters’ reference to basing MACT 

floors on the performance of a 

hypothetical or theoretical unit, so that 

the limits are not based on those 

achieved in practice, is not only wrong 

factually (see above), but just re-begs the 

question of what the language in 

Sections 112(d)(3) and 129(a)(2) is 

referring to. We did not base the 

controls or emissions levels on 

theoretical sources, but on the 

performance of actual units in the 

HMIWI source category. All of the 

MACT floors are achieved in practice 

(since they are based on actual 

performance data). Moreover, the DC 

Circuit has emphasized that EPA may 

use any reasonable means to determine 

what levels of performance are achieved 

in practice. Sierra Club v. EPA, 167 F.3d 

at 663, 665. The commenters’ reliance 

on cases that they claim preclude EPA’s 

use of a pollutant-by-pollutant approach 

does not compel a unit-based approach, 

and the issue is not critical to EPA’s 

position in any event, since the record 

shows that some units are meeting all of 

the floor limits and many are meeting 

several of them. At the very least, the 

CMA v. EPA decision under the CWA 

supports the proposition that a 

technology-based standard can be 

considered achievable even if all limits 

are not yet met by a single unit. Since 

the floor standards are demonstrably 

being achieved in practice by some 

sources, this issue is largely academic. 

In short, EPA is not persuaded that 

the floors must be established on the 

basis of a unit’s performance for all 

pollutants overall. We continue to 

believe, as we explained in the 1997 

final rule, that such a reading would 

lead to results that are at odds with 

evident congressional intent (and with 

the Court’s rulings in NLA II, CKRC and 

Brick MACT). To argue that Congress 

compelled this type of result is at odds 

with both the language of Sections 112 

and 129 and common sense. Indeed, it 

would necessarily suggest that EPA 

could continue to adopt floors that 

reflect ‘‘no emissions reduction,’’ even 

after the DC Circuit so emphatically 

forbade that approach in the Brick 

MACT ruling (Sierra Club v. EPA, 479 

F.3d 875 (DC Cir. 2007). 

As we stated in the preamble to the 

1997 regulation (62 FR 48363), we 

recognize that the pollutant-by-pollutant 

approach for determining the MACT 

floor can, as it does in this case, cause 

the overall cost of the regulation to 

increase compared to what would result 

under a unit-based methodology. For 

example, the pollutant-by-pollutant 

approach for the HMIWI regulation 

results in a stringent MACT floor for 

HCl based on control using a wet 

scrubber, and stringent MACT floors for 

PM and metals based on control using 

a dry scrubber. We interpret Section 129 

of the CAA to require that the MACT 

floor be determined in this manner, and 

we believe that Congress did in fact 

intend that sources subject to 

regulations developed under Section 

129 meet emissions limits that are 

achieved by the best controlled unit for 

each pollutant, as long as the control 

systems are compatible with each other. 

To our knowledge, there is no technical 

reason why these two air pollution 

control systems cannot be combined. 

(62 FR 48363–4) Combined dry/wet 

scrubber systems are currently in 

operation on several HMIWI. In 

response to commenters’ concerns 

regarding the technical feasibility of 

combined dry/wet systems, available 

data on the performance of combined 

dry/wet scrubber systems indicate that 

the MACT floor emissions levels are 

achievable and technically feasible. The 

performance of dry scrubbers with 

activated carbon injection and the 

performance of wet scrubbers are welldocumented. The available data for 

combination dry/wet systems provide 

no indication of operational or 

emissions problems that occur as a 

result of combining dry and wet control 

systems. Regarding the inverse 

relationship between CO and NOX with 

regard to combustion control, it is 

incumbent upon the HMIWI facility to 

determine whether combustion 


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conditions can be adjusted to meet both 

standards and, if not, install add-on 

NOX controls as necessary, e.g., SNCR 

systems. 

The MACT floor reflects the least 

stringent emissions standards that EPA 

may adopt in accordance with Section 

129(a)(2) regardless of costs. Other 

statutory provisions are relevant, 

although they also do not decisively 

address this issue. Section 129(a)(4) 

requires MACT standards for, at a 

minimum, PM, opacity, SO2, HCl, NOX, 

CO, Pb, Cd, Hg, and CDD/CDF emitted 

by HMIWI. This provision certainly 

appears to direct maximum reduction of 

each specified pollutant. Moreover, 

although the provisions do not state 

whether there is to be a separate floor 

for each pollutant, the fact that Congress 

singled out these pollutants suggests 

that the floor level of control need not 

be limited by the performance of 

devices that only control some of these 

pollutants well. (62 FR 48364) 

Regarding the commenter’s suggestion 

that EPA choose the best performing 

sources on an overall basis, so that at 

least one source can meet all of the new 

source standards and a certain portion 

of the existing sources can meet the 

existing source standards, we reviewed 

this approach and found that the 

suggested approach does not 

consistently result in emissions limits 

that are at least as stringent as would 

have resulted in 1997 if we had actual 

emissions data and used the correct 

methodology. We estimate that four 

emissions limits for large and small 

non-rural HMIWI and five emissions 

limits for medium and small rural 

HMIWI calculated using the suggested 

overall unit-based approach would be 

higher than the 1997 emissions limits. 

Further, because not all pollutants are 

required to be tested (e.g., NOX and 

SO2), a substantial fraction of available 

emissions data would have to be 

discarded in order to rank only those 

HMIWI with a complete set of data for 

all nine pollutants (PM, SO2, HCl, NOX, 

CO, Pb, Cd, Hg, and CDD/CDF). 

Specifically, we would have to discard 

emissions data for 30 percent of large, 

40 percent of medium, 100 percent of 

small non-rural, and 50 percent of small 

rural HMIWI in order to calculate 

MACT floors using the suggested 

approach. (See 2009 memorandum 

entitled ‘‘Revised MACT Floors, Data 

Variability Analysis, and Emission 

Limits for Existing and New HMIWI,’’ 

which is included in the docket for 

today’s rulemaking.) 

A unit-based approach would tend to 

result in least common denominator 

floors where, as here, multiple 

pollutants are emitted, whereby floors 

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 courtordered schedule, the commenter 

argued that proposed standards cannot 

be defended technically in the absence 

of such an analysis. 

The same commenter also stated that 

revisions to EPA’s incinerator test 

protocol are needed to ensure that the 

unit is being tested at proper design 

conditions. At a minimum, the 

commenter said that incinerator 

temperature, waste input rate and 

constituents, auxiliary fuel 

consumption, quench rates (air and 

water), and chemical feed rates need to 

be recorded during an incinerator test to 

determine whether the operating and 

testing conditions were representative of 

the higher emissions rates that can be 

experienced during normal operations. 

Given that emissions are determined by 

waste characteristics, the commenter 

recommended that a standardized 

realistic worst-case test waste be used, 

which includes specific criteria 

components, as well as moisture content 

and heating value. Incinerators would 

be tested with the standard waste and 

the top 12 percent identified. 

Response: First, in response to 

industry commenters who claim we 

should have gathered more data, we 

note that nothing precluded them from 

giving us more data to consider in 

responding to the Court’s remand, if 

they felt that the data submitted to us 

for purposes of showing compliance 

with the 1997 standards was not 

representative of their normal 

operations. We have reasonably used 

the data available to us at the time we 

conducted this rulemaking, in the 

absence of being provided with any 

other data. We agree with the 

commenters that emissions tests might 

provide information on representative 

operations only where owners and 

operators conducting the tests have 

endeavored to reflect such 

representative operations at the time of 

the tests. However, when conducting 

tests to establish various parameters to 

be monitored, owners and operators 

may also endeavor to produce data for 

a wide range of operating conditions. 

Moreover, we have taken several steps 

to try and account for the emissions and 

operational variability, including (1) 

obtaining additional emissions test data 


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from States and EPA Regions 

representing all available annual test 

results for each unit, (2) using 

individual test run data for the bestperforming 12 percent of sources to 

calculate UCL values, (3) using a 

substantial confidence interval 

(specifically, a 99 percent UCL value), 

and (4) closely reviewing how the data 

are distributed (e.g., normally, 

lognormally). Also, EPA’s own review of 

emissions factors shows that the 

variability of emissions between 

facilities is greater than the variability 

within facilities. 

We believe that the data quality 

concerns expressed by the commenters 

have been addressed in a number of 

ways. First, EPA test methods 

incorporate data quality assurance and 

quality control steps and acceptance 

criteria at several levels. These 

provisions assure that the data produced 

are of quality sufficient for decision 

making, including compliance, when 

the methods are followed and the 

acceptance criteria are met. Second, 

States further assure that testers adhere 

to the test methods by providing third 

party oversight and review of 

compliance tests conducted by industry, 

such as that being discussed here. The 

States also implement the source testing 

audit program when available, further 

assuring the high quality of emissions 

testing data. Third, through internal and 

contractor support efforts for this 

regulatory project, EPA conducted 

additional review of the initial 

emissions test data to check for 

completeness and appropriate 

characterization of process operations. 

Finally, EPA reviewed and accounted 

for variability inherent in the emissions 

data used in establishing the applicable 

emissions limit including applying 

statistical confidence intervals. 

Regarding the comment about 

revisions to EPA’s incinerator test 

protocol, the factors cited by the 

commenter could be considered in 

setting site-specific compliance 

conditions. Such an approach may be 

useful at the next technology review. 

The commenter’s suggestion that EPA 

use a standardized waste for testing is 

questionable, unless EPA wanted to 

establish a certification testing program 

like the residential wood combustion 

rule. However, such a program would be 

cumbersome and could potentially 

eliminate a majority of the industry. 

Comment: Three commenters stated 

that EPA did not consider the accuracy 

and precision of the EPA test methods 

in proposing the emissions limits for 

new and existing HMIWI. To support 

their argument, the commenters 

referenced the findings of the Reference 

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 ‘‘noncompliant,’’ data collected at HMIWI 

subsequently shut down, and data 

collected under specific ‘‘test 


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conditions.’’ The commenters argued 

that emissions test data from 

compliance tests that were conducted in 

accordance with the applicable 

reference test methods for affected 

HMIWI should not be arbitrarily 

excluded from the re-stated MACT 

dataset, because that undermines the 

entire data evaluation process. The 

commenters stated that EPA provides no 

rationale for arbitrarily including data in 

some instances, and excluding them in 

others. Thus, according to the 

commenters, EPA’s proposed standards 

are arbitrary and capricious. The 

commenters said that inclusion of all 

valid test data provides a better 

representation of the inherent variability 

of the various test methods and source 

operation. According to the 

commenters, EPA’s MACT floor dataset 

was inconsistent, leading EPA to rely on 

an unrepresentative set of data. The 

commenters recommended that EPA 

provide a clear description of 

‘‘representative HMIWI operation’’ so 

that consistent criteria are applied to 

evaluate whether valid emissions test 

data were properly included or 

excluded from the MACT floor dataset. 

Response: Non-compliant emissions 

data from the initial tests of HMIWI 

were not included in the emissions 

database used to establish the emissions 

limits. At the time of the initial test, 

operators were still in the process of 

establishing their operating parameters 

and tuning their emissions control 

devices and operating conditions to 

comply with the regulation. Any noncompliant emissions data from the 

initial test would be expected to trigger 

a change in HMIWI operation in order 

to come back into compliance with the 

1997 standards. Consequently, the noncompliant emissions data from these 

tests would not be representative of the 

typical operation of these HMIWI. 

If non-compliant emissions data from 

an annual test were substantially higher 

than the emissions typically seen from 

the facility or were substantially higher 

than the emissions limit, this strongly 

suggested that there was a problem 

during the test and indicated that the 

test results would not be representative 

of the typical operation of the HMIWI. 

Such data were excluded from the 

pollutant averages for the particular 

facility. (It should be noted that the data 

that were excluded amount to less than 

1 percent of the total set of emissions 

data for the industry.) For example, the 

emissions data from tests on one unit 

did not meet the PM or Cd emissions 

limit during an August 2006 annual test. 

A subsequent retest of this unit for those 

same pollutants in November 2006 

showed PM emissions results less than 

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 ‘‘nondetect’’ data points within the MACT 

floor dataset should be consistent and 

should represent the actual detection 

level of the pollutant of concern. The 

commenters noted that non-detect or 

zero data provided as part of the latest 

data request were considered equal to 

the method detection limit, while CDD/ 

CDF test data already in EPA’s project 

files were calculated at one-half the 

detection limit. While this approach 

may be valid for total CDD/CDF, the 

commenters argued that it could have a 

profound effect on TEQ. 

Response: In response to the 

commenters, it should be noted that 

section 9 of EPA Method 23 specifies 

that ‘‘[a]ny PCDD’s or PCDF’s that are 

reported as below the measurement 

detection level (MDL) shall be counted 

as zero for the purpose of calculating the 

total concentration of PCDD’s and 

PCDF’s in the sample.’’ The CDD/CDF 

results reported in the facilities’ initial 

test reports and provided by States and 

EPA Regions in the annual test 

summaries reflect this computation 

approach. Consequently, by using onehalf the detection limit in our review of 


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CDD/CDF data in full test reports, we 

were being conservative in our 

estimation of CDD/CDF emissions. 

Nonetheless, we looked at those HMIWI 

in the MACT floor for total CDD/CDF 

and TEQ to determine whether using 

the full detection limit would make a 

substantial difference. When we 

averaged in the results with all other 

CDD/CDF results for each facility, we 

found on average essentially no 

difference in total CDD/CDF emissions 

estimates (less than 1 percent) and only 

a small difference in TEQ emissions 

estimates (0.1 to 20 percent) for the four 

HMIWI size categories. (See 2009 

memorandum entitled ‘‘Comparison of 

CDD/CDF Non-Detect Data—Full 

Detection Limit vs. 1⁄2 Detection Limit,’’ 

which is included in the docket for 

today’s rulemaking.) 

4. Non-Technology Factors 

Comment: Numerous commenters 

stated that the variability in nontechnology factors, such as the materials 

and composition fed to combustion 

devices, must be adequately addressed 

in the rulemaking process in order to 

promulgate a feasible rule, Sierra Club, 

479 F.3d at 883 and Cement Kiln 

Recycling Coalition v. EPA, 255 F.3d 

855, 865 (DC Cir. 2001). According to 

various commenters, EPA did not 

identify the non-technology factors in 

the proposed rule or quantify their effect 

on actual emissions performance, but 

instead claimed, without supporting 

evidence, that using actual emissions 

levels accurately reflects emissions 

performance resulting from the use of 

add-on controls and other emissions 

reduction measures. Commenters 

argued that the failure to make these 

findings renders the proposed standards 

arbitrary. Another commenter disagreed, 

stating that EPA’s proposed floor 

approach for new and existing HMIWI 

is generally correct and that EPA 

correctly observed that the use of actual 

emissions levels accounts for all 

emissions reduction strategies. 

Response: With regard to the 

commenters’ argument, the CAA does 

not require EPA to quantify the 

emissions reductions resulting from all 

non-technology factors, but instead 

focuses on identifying the emissions 

levels achieved by best performing 

sources no matter what means they use 

to achieve them. This approach is 

supported by the DC Circuit’s decision 

in the Brick MACT case, which stressed 

the importance of identifying emissions 

‘‘levels’’ achieved by sources. There can 

be no dispute that both the composition 

and level of emissions exiting the 

incinerator reflect both the add-on 

control technologies used by a unit (e.g., 

dry scrubber, wet scrubber, activated 

carbon) that control the emissions and 

the non-technology factors (e.g., waste 

material quantity and composition, 

combustion conditions) that influence 

the level and composition of emissions. 

As the Sierra Club Court noted in 1999, 

the less mercury fed into the waste 

stream, the less mercury emissions will 

be coming out of the stack. Whatever 

combination of add-on controls and 

non-technology measures a unit is 

employing will, therefore, necessarily 

affect the resulting emissions levels that 

are reflected in the actual emissions 

data upon which the revised floors are 

set. It would be impossible for those 

data to not reflect all those measures. 

This situation is quite the opposite of 

what was presented in the 1997 

rulemaking, in which the floors were 

primarily derived from permit and 

regulatory levels that were not 

necessarily reflective of actual 

emissions performance but were 

assumed to reflect levels achievable by 

add-on control only. At that time, to 

adjust floors downward to account for 

non-technology factors, it might indeed 

have been necessary to be able to 

quantify additional emissions 

reductions attributable to such 

measures. Similarly, as the 2007 

proposed remand response still in large 

part relied upon the permit and 

regulatory levels, not knowing the 

quantified reductions achieved by nontechnology measures frustrated 

estimating the emissions levels achieved 

in practice by HMIWI. But this is simply 

not an issue under a methodology that 

depends upon the measured emissions 

levels that result from whatever mix of 

add-on or non-technology controls is 

being used, as under the 2008 reproposal and today’s final rule. The 

non-technology factors cannot help but 

affect the actual emissions data, and 

they are, therefore, necessarily 

accounted for in the actual emissions 

data-based floors. 

EPA’s data gathering effort for this 

rulemaking included not just initial and 

annual emissions test data obtained 

from EPA Regions, State/local 

governments, and HMIWI facilities, but 

also a waste segregation practices 

questionnaire sent to nine 

representative entities in the HMIWI 

category (six hospitals, one 

pharmaceutical facility, one university, 

and one company that owns 8 of the 14 

commercial HMIWI). (See 2008 

memoranda entitled ‘‘Documentation of 

HMIWI Test Data Database’’ and 

‘‘Summary of Industry Responses to 

HMIWI Waste Segregation Information 

Collection Request,’’ which are included 

in the docket.) While our analysis of the 

emissions test data indicates a strong 

relationship between add-on control 

and emissions (e.g., wet scrubbers 

achieve superior HCl control, while dry 

scrubbers achieve superior PM and 

metals control), our review of the 

questionnaire responses indicates that 

non-technology factors also play a role 

in emissions reduction. All of the 

survey respondents, except for the 

commercial company, practice onsite 

waste segregation to reduce the volume 

of waste being incinerated. Most of the 

respondents started the practice of 

waste segregation in the 1980s and 

1990s. Five respondents also accept 

offsite waste and require the offsite 

waste generators to employ waste 

segregation practices. The commercial 

company encourages waste segregation 

from its waste generator clients through 

a number of efforts, including a waste 

management plan, contract 

requirements and waste acceptance 

protocols, a dental waste management 

program, and educational programs and 

supporting posters. All of the 

respondents that practice onsite waste 

segregation separate batteries and 

fluorescent bulbs (i.e., mercury waste) 

from the HMI waste stream. Eight 

respondents separate paper and/or 

cardboard, four separate glass, and three 

separate plastics from the HMI waste 

stream. Other materials that are 

separated from the HMI waste stream 

include hazardous waste, waste oil, 

wood, construction debris, refrigerants, 

and various metals and metalscontaining materials (e.g., aluminum, 

copper, lead, mercury, steel, and 

electronics). (For further information, 

see 2008 memorandum ‘‘Summary of 

Industry Responses to HMIWI Waste 

Segregation Information Collection 

Request,’’ which is included in the 

docket.) These waste segregation efforts 

would certainly have an impact on the 

emissions of CDD/CDF, mercury, and 

other pollutants from these HMIWI and 

would be reflected in the emissions 

levels measured during their initial and 

annual emissions tests and used in our 

test data analysis. As noted previously, 

the nine entities surveyed were believed 

to be representative of the HMIWI 

industry as a whole, so the conclusions 

reached for the nine entities are also 

expected to apply to the entire industry 

as well. 

5. Straight Emissions Approach 

Comment: Two commenters argued 

that the parenthetical language in the 

Brick MACT decision equating the best 

performers with ‘‘those with the lowest 

emissions levels’’ (straight emissions 

approach) was only a legal dictum to 


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which EPA is not bound, and which is 

not cited in either the CKRC decision or 

the CAA. The commenters cited Sierra 

Club v. EPA, 479 F.3d 875, 880 (DC Cir. 

2007) (Brick MACT), and Cement Kiln 

Recycling Coalition v. EPA, 255 F.3d 

855, 861 (DC Cir. 2001). In citing EPA’s 

justification for the MACT floor 

approach used in the hazardous waste 

combustor rulemaking, the commenters 

stated EPA’s position that the CAA does 

not require the Agency to equate the 

best performers with the lowest 

emitters. The commenters specifically 

cited EPA’s statement that, ‘‘as a legal 

matter, CAA Section 112(d)(3) does not 

specifically address the question of 

whether ‘best performing’ sources are 

those with the lowest net emissions, or 

those which control HAP emissions 

most efficiently.’’ 

The commenters also noted that, since 

the Brick MACT decision, EPA has 

determined that there are other ways to 

rank the best performing sources and set 

the MACT floors than a straight 

emissions approach, such as the 

approach used in the hazardous waste 

combustor rulemaking, which combined 

the hazardous waste fed to the source 

and the source’s system removal 

efficiency (SRE). According to the 

commenters, the ‘‘SRE Feed’’ 

methodology better identifies who the 

lowest emitters will be over time, better 

assesses their performance (i.e., how 

much they will emit as they operate), 

and better accounts for variability (e.g., 

non-technology factors). 

Response: It is not necessary to adopt 

a position regarding whether the Brick 

MACT Court’s references to ‘‘emissions 

levels’’ is dictum or binding for 

purposes of this rulemaking. In the 1999 

HMIWI case, the Court very clearly 

stated that EPA’s duty here was to use 

data that allowed the Agency to 

reasonably estimate the emissions 

performance of the best performing 

units. We have discovered that the 

permit and regulatory data upon which 

the 1997 rule was based do not reliably 

serve this purpose. Conversely, the 

actual emissions data from HMIWI do 

enable us to estimate the performance of 

the best performers. We believe that the 

use of actual emissions data, 

appropriately adjusted for variability 

using statistical methods, sufficiently 

accounts for the performance and 

variability of HMIWI operation. 

Regarding the commenters’ reference to 

CAA Section 112(d)(3) to support their 

argument regarding the definition of 

‘‘best performing’’ sources, we assume 

the commenters also meant Section 129, 

which governs this rule. 

We do not think the SRE Feed 

methodology can be successfully 

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 metalscontaining materials, which we expect 


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to impact the emissions of CDD/CDF, 

mercury, and other pollutants and be 

reflected in the actual emissions data we 

use in our analysis. (See 2008 

memorandum ‘‘Summary of Industry 

Responses to HMIWI Waste Segregation 

Information Collection Request,’’ which 

is included in the docket.) 

Consequently, we believe that using 

actual emissions data sufficiently and 

inherently accounts for non-technology 

factors such as feed material quantity or 

composition which influence the level 

and composition of emissions. We also 

believe that our use of multiple 

emissions tests and individual test runs 

for each HMIWI, where possible, and 

our estimation of 99 percent confidence 

intervals for MACT floor data 

sufficiently accounts for variability. The 

use of multiple emissions tests allows 

us to evaluate ‘‘between-test 

variability,’’ which can occur even 

where conditions appear to be the same 

when two or more tests are conducted. 

As we noted in the preamble to the 

December 1, 2008 re-proposal (73 FR 

72976, 72980), variations in emissions 

may be caused by different settings for 

emissions testing equipment, different 

field teams conducting the testing, 

differences in sample handling, or 

different laboratories analyzing the 

results. Identifying an achieved 

emissions level needs to account for 

these differences between tests, in order 

for ‘‘a uniform standard [to] be capable 

of being met under most adverse 

conditions which can reasonably be 

expected to recur[.]’’ (See NLA I, 627 

F.2d at 431, n. 46.) (See also Portland 

Cement Ass’n, 486 F.2d at 396 (noting 

industry point that ‘‘a single test offered 

a weak basis’’ for inferring that plants 

could meet the standards).) The use of 

individual test runs (as opposed to test 

averages or unit averages) allows us to 

evaluate ‘‘within-test variability.’’ A 

single test at a unit usually includes at 

least three separate test runs. (See 

§ 63.7(e)(3) (for MACT standards under 

Section 112 of the CAA), and § 60.8(f) 

(for NSPS under CAA Section 111).) 

Each data point should be viewed as a 

snapshot of actual performance. Along 

with an understanding of the factors 

that may affect performance, each of 

these snapshots gives information about 

the normal, and unavoidable, variation 

in emissions that would be expected to 

recur over time. To account for 

pollutant-specific variability at the bestperforming unit (for new source MACT) 

or best-performing 12 percent of units 

(for existing source MACT), we used 

emissions data for each test run 

conducted by those units. The amount 

of pollutant-specific test data for those 

HMIWI varies widely for each size 

category. Given the limited amount of 

test data and the uncertainty regarding 

that short-term emissions test data, we 

have decided that using the 99 percent 

UCL is an appropriate method of 

estimating variability. The UCL 

represents the statistical likelihood that 

a value, in this case an emissions value 

from the best performing source, will 

fall at or below the UCL value. (Further 

discussion regarding the 99 percent UCL 

is provided later in this section.) 

After reviewing the commenters’ 

suggestion that we characterize 

emissions data distributions before 

calculating statistics, we took a closer 

look at our statistical approach. In 

statistics, skewness is a measure of the 

degree of asymmetry of a distribution. 

Normal distributions typically have a 

skewness of zero. Consequently, to 

determine whether the emissions test 

data used in our UCL calculations had 

a normal or lognormal distribution, we 

estimated the skewness of the data using 

the SKEW function in Excel. Except as 

specified below, those datasets with a 

skewness value greater than zero (when 

rounded to a whole number) were 

categorized as lognormal, and all other 

datasets were categorized as normal. 

Those data categorized as lognormal 

were transformed (by taking the natural 

log of the data) prior to the calculation 

of UCL values. When there were only a 

few data points (e.g., one emissions test 

with three test runs), which is the case 

for most datasets for small HMIWI, it 

was not possible to make a definitive 

determination that the data were 

distributed normally or lognormally. (In 

fact, assuming a lognormal distribution 

for those data often resulted in UCL 

values that were substantially higher 

than the 1997 promulgated limits.) In 

those cases, we decided to use the 

normal distribution in calculating UCL 

values, a conservative assumption 

which provided a more protective 

emissions limit. When we had more 

data and could make a more definitive 

determination about a dataset’s 

distribution, we treated the data as 

noted previously. In most cases, we 

found that the larger datasets are 

lognormally distributed, although there 

are some cases where they appear to be 

distributed normally, and we treated the 

data as such when doing our UCL 

calculations. We believe this approach 

is more accurate and obtained more 

representative results than those at reproposal. 

Regarding the commenters’ suggestion 

about using Student’s t-statistics in 

calculating the UCL values, we also 

decided to revisit our statistical 

approach. We agree that we have only 

a relatively small, random sample of 

emissions data available for our 

analysis, which calls for the use of the 

Student’s t-test, in accordance with 

standard statistical practice. 

Consequently, we have decided to use 

the TINV function in Excel (specifically 

the one-tailed t-value), rather than the 

NORMSINV function, to calculate the 

UCL values. This approach (using the 

Student’s t-test) is consistent with 

approaches being taken in other EPA 

rulemakings, such as Portland Cement. 

In response to public comments on 

the size of the confidence limits used at 

re-proposal and in light of the 

aforementioned changes in our 

statistical approach, we also decided to 

reevaluate the percentiles used in the 

UCL values. We evaluated four different 

percentiles (90, 95, 99, and 99.9 

percent). The 99.9 percent UCL values 

estimated for the 2009 final rule are 

substantially higher than the highest test 

runs for the MACT floor units and are 

frequently higher than the emissions 

limits in the September 15, 1997 

promulgated standards, indicating the 

99.9th percentile overcompensates for 

variability. Lower percentiles (e.g., 90, 

95, and 99 percent) are inherently more 

stable than the 99.9th percentile, with 

less uncertainty (less variability) than 

the 99.9th percentile from a statistical 

standpoint. However, the 90 and 95 

percent UCL values are frequently lower 

than the highest test runs for the MACT 

floor units and the stringent emissions 

limits in the December 1, 2008 reproposal, indicating that those 

percentiles provide insufficient 

compensation for variability. 

The 99 percent UCL values are 

somewhat higher than the emissions 

limits in the December 1, 2008 reproposal but are well below the 

emissions limits in the September 15, 

1997 promulgated standards. The 99 

percent UCL values are more in line 

with the highest test runs for the MACT 

floor units than the other percentiles, 

indicating that the 99 percent UCL 

provides a more reasonable 

compensation for variability. This 

approach results in standards more 

representative of the level of emissions 

reduction that the best performing 

sources are actually achieving. 

Accordingly, we have decided to use the 

99 percent UCL to estimate emissions 

limits for the 2009 final rule. 

We disagree with one commenter’s 

argument that the 99.9 percent UCL 

must provide for the floor to be met 

every day and under all operating 

conditions. The UCL is not about time, 

but about the population of data. 

Accounting for variability using the 99.9 

percent UCL goes beyond the absolute 


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average but does not produce 

expectations of 0.1 percent 

noncompliance. Setting the emissions 

limit at the UCL accounts for the 

possibility of variability and the 

possibility that the average is outside 

the range. These statistical procedures 

are used to help us identify the average 

emissions limitation achieved by the 

best performing units, as Section 

129(a)(2) of the CAA requires. Also, 

there is no practical upper limit as to 

what a facility can emit, so the argument 

that that EPA must set a floor at a level 

that equates to what a facility can meet 

at all times is not consistent with the 

CAA’s requirement that EPA estimate 

the emissions levels achieved by best 

performing units. 

Regarding the comment about our 

decision to use individual test run 

results to account for variability, we felt 

it was necessary to use test run results 

when we had data limitations (e.g., for 

small HMIWI) and for consistency 

decided to take the same approach 

where data were more plentiful. As 

noted previously, we believe that each 

data point should be viewed as a 

snapshot of actual performance, which 

gives information about the variation in 

emissions that would be expected to 

recur over time. 

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-thefloor standards for both HCl and 

chlorinated organic pollutants 

(including CDD/CDF) based on 

removing chlorinated plastics from the 

waste stream. According to the 

commenter, it is well established that 

the combustion of chlorinated plastics 

increases emissions of HCl as well as 

CDD/CDF and other chlorinated 

pollutants. The commenter stated that it 

is achievable for HMIWI to remove 

chlorinated plastics from the waste 

stream that they burn. The commenter 

said that EPA can gather data that will 

quantify the total amount of HCl that is 

attributable to the combustion of 

chlorinated plastics and set a standard 

reflecting the maximum degree of 

reduction that is achievable through the 

removal of chlorinated plastics from the 

waste stream. 

The same commenter also 

recommended that EPA set beyond-thefloor standards for metals based on 

removing all metals from the waste 

stream before combustion, consistent 

with the requirements under Section 

129(a)(2) and (3), which obligate EPA to 

require the maximum degree of 

reduction in emissions that is 

achievable through the use of methods 

and technologies before, during, and 

after combustion. The commenter stated 

that metals do not belong in an 

incinerator because they cannot be 

destroyed by incineration and are 

especially dangerous to public health 

and deleterious to the environment. As 

far as the commenter knew, EPA has 

never disagreed that removing metals 

from the HMIWI waste stream is 

achievable technically and 

economically, and the commenter noted 

that EPA has data from the MWC 

rulemaking that show materials 

separation requirements are effective 

and cost-effective. (See Docket A–89–08, 

various items.) 

Given the language of Section 129 that 

requires the maximum degree of 

reduction in emissions that is 

achievable through the use of precombustion measures, the commenter 

argued that EPA has a duty to gather 

information on these measures and 

evaluate such measures in its beyondthe-floor analysis. According to the 

commenter, EPA’s failure to gather 

information about the precise reduction 

of emissions that will result from such 

measures and failure to provide any 

explanation for rejecting such a 

standard is unlawful and arbitrary. The 

commenter noted that EPA has 

committed to set final standards by 

September 2009, and stated that EPA 

should not delay issuance of final 

standards to conduct this data gathering, 

but should commence data gathering 

now and revise the HMIWI regulations 

to include beyond-the-floor standards in 

the future. 

Response: As we explained in the 

2008 re-proposal, the identified beyondthe-floor add-on control measures we 

analyzed were not reasonable on a costeffectiveness basis, especially in light of 

the significantly more stringent floor 

levels as compared to the 1997 rule’s 

standards. We read the commenter’s 

suggestion that we examine additional 

beyond-floor measures but without 

delaying final action on the re-proposal 

as recommending that we conduct the 

requested data gathering and analysis 

for those measures in a subsequent 

rulemaking action. A possible 

opportunity for that would be the next 

review of the rule under Sections 

129(a)(5) and (h)(3). In the interim, 


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however, we have decided to revise the 

waste management plan provisions in 

§§ 60.35e and 60.55c to promote the 

segregation of chlorinated plastics and 

metals to the extent possible. 

2. CO Emissions Limits 

Comment: One commenter argued 

that the proposed CO emissions limits 

will be unattainable by many applicable 

units, based on the emissions data 

provided in the docket. The commenter 

stated that the add-on controls 

evaluated by EPA do not reduce CO 

emissions, and that CO emissions can be 

a function of the feed material 

composition (which the commenter 

stated EPA did not evaluate). As a 

result, the commenter stated, HMIWI 

operators will have very little latitude or 

options to meet the proposed CO limits. 

Three other commenters stated that 

historical CO CEMS data from wellperforming commercial HMIWI 

demonstrate that the proposed CO 

emissions limit is not achievable on a 

continuous basis and argued that the 

existing 40 ppmv emissions limit must 

be retained. The commenters further 

stated that the proposed CO standards 

must include a reasonable, extended 

averaging period (e.g., 24 hours) that 

accounts for the variability of the waste 

stream and waste characteristics. The 

commenters noted that the proposed 

standards are currently based on 

discrete 3-hour average data developed 

during performance test conditions, 

which they said do not account for the 

typical operational variability. 

According to the commenters, such 

snapshot data are also not representative 

of long-term continuous monitoring, 

placing facilities with CO CEMS at a 

competitive disadvantage with any 

revisions to the CO standard. 

The same three commenters also 

stated that the proposed CO standard in 

combination with the 7 percent oxygen 

(O2) diluent correction factor will pose 

technological monitoring challenges to 

HMIWI that either choose or will be 

required to use CO CEMS, especially 

given the variability of HMIWI 

operations and waste feed streams. 

According to the commenters, costly 

monitoring systems (e.g., dual range or 

ambient level monitors) will be needed, 

resulting in additional QA activities. 

The commenters further stated that the 

application of an O2 correction factor to 

the measured CO concentration CEMS 

data may cause artificial exceedances of 

the CO emissions standard at higher O2

operating scenarios. 

Response: Based on our review of CO 

emissions data for all HMIWI, we have 

found many HMIWI outperforming the 

existing 40 ppmv CO limit. We believe 

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 reproposal included an amendment to 

§ 60.56c allowing sources using CEMS 

to demonstrate compliance with the 

applicable emissions limit on a 24-hour 

block average, instead of a 12-hour 

rolling average (as specified in the 1997 

final rule). This amended provision 

should address concerns about the 

ability of sources equipped with CEMS 

to demonstrate compliance with 

emissions limits on a continuous basis 

(as opposed to a 3-hour annual test) and 

would be consistent with past 

rulemakings for incineration units (e.g., 

large and small MWCs). 

Regarding the comment about the 

application of an O2 correction factor to 

the CO CEMS data, it should be noted 

that correction to consistent standards 

(e.g., percent O2) is necessary in order 

to compare to other units and to an 

emissions limit. Applying an O2

correction factor to CO CEMS should 

only be a problem at O2 levels greater 

than 15 percent. For comparison 

purposes, we reviewed the O2 levels 

recorded in initial test reports, and 

found only about 7 of 57 HMIWI 

reported O2 levels above 15 percent 

during at least one pollutant test run, 

and we estimate that 6 of those 7 with 

their current equipment will still meet 

the revised CO emissions limits, based 

on a comparison of the revised limits to 

the average CO concentrations for those 

HMIWI. 

3. Opacity Limits 

Comment: Three commenters noted 

that EPA requested facility test data 

from 2003 through 2006 for all 

pollutants except opacity, even though 

annual opacity testing is required for all 

units. According to the commenters, if 

EPA wanted to review and revise the 

opacity limit pursuant to Section 

129(a)(5), it should have requested 

opacity data and should have used those 

data in the re-establishment of the 

MACT standards. Instead, the 

commenters said, the proposed opacity 

limit was inappropriately established 

from a single continuous opacity 

monitoring system (COMS) located at a 

single HMIWI. The commenters argued 

that data from a single unit are 

insufficient to set an emissions limit 

that must be continuously achieved, and 

they said that EPA must seek additional 

monitoring data. The commenters also 

noted that compliance with the 

proposed opacity limit established by 

COMS is demonstrated using a different 

measurement methodology (Method 9). 

The same three commenters, plus a 

fourth commenter, stated that the 

methodology that EPA used to establish 

the 2 percent opacity limit fails to 

account for actual opacity monitoring 

capabilities and normal operational 

variability, such as that included in PS– 

1 (40 CFR part 60, appendix B). 

According to the commenters, the 

inherent potential error of a COMS 

meeting PS–1 could greatly exceed the 

proposed opacity limit value. The fourth 

commenter argued that opacity under 

the worst foreseeable circumstances for 

the best-performing units would thus 

easily violate the MACT floor, which 

the commenter said would violate 

Sierra Club. 167 F.3d at 665. 

All four commenters noted that, 

similar to COMS accuracy, Method 9 

calls for recording visual observations to 

the nearest 5 percent at 15-second 

intervals. The commenters stated that 

using a compliance method with 

inherent potential accuracy levels 

exceeding the proposed 2 percent 

opacity limit appears problematic. 

Given the limitations of Method 9 and 

the variability of all the HMIWI subject 

to the revised opacity standard, the first 

three commenters recommended that 

EPA establish an opacity standard based 

on Method 9 data instead of COMS data 

from a single unit. All four commenters 

argued that the current 10 percent 

opacity limit is reasonable, and would 

allow conventional compliance 

determination methods to be used, 

accounting for their limitations. 

Response: The commenters’ argument 

about how we established the proposed 

opacity limit is somewhat misleading. 

While we acknowledge that opacity data 

were inadvertently not included in the 

2007–08 test data request, we already 

had opacity data for nearly 90 percent 

of all HMIWI from their initial 

compliance tests, and our initial opacity 

MACT floor analysis was based on the 

best-performing 12 percent of sources 

for opacity. As we stated in the 

preamble to the December 1, 2008 reproposal (73 FR 72983), based on the 

opacity averages alone, without any 

accounting for variability, the MACT 

floor for opacity for existing and new 

units would have been 0 percent. We 

tried to account for variability by 

looking at the single highest opacity 

reading for HMIWI in the MACT floor 


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for PM, based on opacity being an 

appropriate surrogate for PM. We based 

our MACT floor opacity limit on the 

single highest COMS reading (1.1 

percent) for one of the HMIWI in the 

MACT floor for PM. Because we 

commonly set opacity standards based 

on whole numbers and could not round 

down without risking having the MACT 

floor unit not meet the standard, we 

rounded up and proposed an opacity 

limit of 2 percent for both new and 

existing HMIWI. However, we now 

believe this analysis was incomplete. 

The analysis did not account for two 

other HMIWI in the MACT floor for PM 

that could more effectively account for 

variability for opacity. The maximum 

opacity averages for these two HMIWI 

are 5.87 and 4.17 percent. (See 2008 

memorandum entitled ‘‘Documentation 

of HMIWI Test Data Database,’’ which is 

included in the docket.) The opacity 

data for these two HMIWI were 

measured using Method 9. Using the 

same approach that we used at reproposal, we are establishing an opacity 

limit of 6 percent, by rounding up the 

highest opacity average of 5.87 percent 

to the nearest whole number. 

Regarding the commenters’ arguments 

that the inherent potential error of a 

COMS meeting PS–1 could exceed the 

proposed opacity limits, the potential 

error (about 4 percent opacity at the 

highest) is not the same as expected 

error (more on the order of 0.5 percent). 

Nonetheless, the increase in the opacity 

limit to 6 percent should address the 

commenters’ concerns on this issue. 

We disagree with the commenters’ 

argument that a 10 percent opacity limit 

be used to allow conventional 

compliance determination methods. 

While opacity is read in 5 percent 

increments, average opacity can be any 

number above 0. Method 9 values are 

averages of 24 readings, which can 

include readings of 0 and an occasional 

5 or 10 percent. 

Regarding the commenters’ argument 

that only Method 9 data should be used 

to establish the opacity standard 

because that is the measurement method 

that would be used to demonstrate 

compliance, the commenters’ argument 

is moot, since the revised opacity 

standard is now based on Method 9 

results. 

4. Percent Reduction Limits 

Comment: One commenter agreed 

with EPA’s proposed elimination of 

percent reduction alternatives. 

According to the commenter, EPA 

correctly noted that standards based 

only on control technology performance 

do not reflect the effects of nontechnology factors and, therefore, do not 

reflect the best units’ actual 

performance. Therefore, the commenter 

said, allowing units the option to meet 

these percent reduction limits instead of 

emissions standards contravenes 

Section 129, and EPA appropriately 

proposed to delete the percent reduction 

limits. 

Three other commenters argued that 

the percent reduction compliance 

option that was available in the 1997 

rule and in the 2007 proposed rule 

should be re-evaluated and retained for 

commercial HMIWI, since the ability for 

such units to reduce emissions is due 

almost exclusively to the effectiveness 

of the control equipment (and not waste 

segregation). According to the 

commenters, commercial HMIWI 

facilities, unlike captive units, cannot 

practically control the waste that is put 

in the containers they process, and 

applicable regulations from the U.S. 

Occupational Safety and Health 

Administration (OSHA) preclude them 

from practicing waste segregation at the 

time of treatment. Thus, the commenters 

noted, they experience extreme 

variability during stack tests (especially 

for volatile metals Cd, Pb, and Hg) and 

will experience higher inlet 

concentrations than captive units; since 

they operate at the same control 

efficiency, they will exhibit higher stack 

emissions. The commenters stated that 

the percent reduction option is a better 

assessment of the performance of the 

control system for commercial units. 

Response: We have decided not to 

include percent reduction limits in the 

final rule. In addition to the reasons we 

provided in the re-proposal, while 

commercial HMIWI facilities face 

greater challenges in controlling the 

waste they receive, compared to 

‘‘captive’’ units, they are nonetheless 

capable of taking steps to educate their 

customers (i.e., waste generators) 

regarding waste segregation and should 

also have some control based on the 

waste management plans, contract 

requirements, and waste acceptance 

protocols they negotiate with their 

customers. Consequently, nontechnology factors are under their 

control to a limited extent, which does 

not support their rationale for a percent 

reduction limit. The effect of raw 

material inputs on emissions from 

HMIWI could instead be downplayed by 

a percent reduction limit that allows 

more emissions provided a given level 

of removal efficiency. 

5. PCB and POM Emissions Limits 

Comment: One commenter noted that 

EPA has interpreted the CAA as 

allowing the Agency to meet the 

requirements of Section 112(c)(6) by 

setting standards for incinerator 

emissions of 112(c)(6) pollutants under 

Section 129. According to the 

commenter, EPA has acknowledged that 

HMIWI account for a large portion of the 

aggregate emissions of both PCBs and 

POM. Thus, to satisfy Section 112(c)(6), 

the commenter argued that EPA must 

use its authority under Section 129(a)(4) 

to set emissions standards for both of 

these pollutants. Noting EPA’s argument 

that its standards for CDD/CDF and Hg 

‘‘effectively reduce’’ emissions of PCBs 

and POM and thus satisfy Section 

112(c)(6), the commenter said that 

Section 112(c)(6) requires that these 

HAP be subject to MACT standards. 

Because the best performing units used 

to set these standards may be achieving 

reductions in PCBs and POM by means 

other than just controlling CDD/CDF 

and Hg emissions—e.g., by ensuring that 

no PCB-containing wastes are put in the 

incinerator or by not incinerating 

chlorinated plastics—the commenter 

argued that EPA’s standards for CDD/ 

CDF and Hg do not constitute lawful 

MACT standards for PCBs and POM 

and, therefore, do not satisfy Section 

112(c)(6). 

Response: For the reasons we set forth 

in the 2008 re-proposal (see 73 FR at 

72991–92) and in the preamble for 

today’s rule (see section VII), we 

continue to take the view that while the 

rule does not identify specific limits for 

POM and PCB, emissions of those 

pollutants are nonetheless ‘‘subject to 

regulation’’ for purposes of Section 

112(c)(6). While we have not identified 

specific numerical limits for POM and 

PCB, we believe CO serves as an 

effective surrogate for those pollutants, 

because CO, like POM and PCBs, is 

formed as a byproduct of combustion. 

We believe that dioxins/furans also 

serve as an effective surrogate for PCBs, 

because the compounds act similarly 

and, thus, are expected to be controlled 

similarly using HMIWI emissions 

control technology—e.g., wet scrubbers 

or fabric filters (with or without 

activated carbon). Furthermore, recent 

HMIWI emissions test data for PCBs and 

dioxins/furans show that HMIWI wellcontrolled for dioxins/furans also 

achieve low PCB emissions. (See 2008 

memorandum entitled ‘‘Documentation 

of HMIWI Test Data Database,’’ which is 

included in the docket.) It should also 

be noted that PCBs are generally found 

in higher concentrations than dioxins/ 

furans (also the case for HMIWI), so 

HMIWI equipped with the 

aforementioned emissions controls 

would be even more effective at 

reducing PCB emissions. Consequently, 

we have concluded that the emissions 


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limits for CO function as a surrogate for 

control of both POM and PCBs, and the 

limits for dioxins/furans function as a 

surrogate for PCBs, such that it is not 

necessary to promulgate numerical 

emissions limits for POM and PCBs 

with respect to HMIWI to satisfy CAA 

Section 112(c)(6). 

To further address POM and PCB 

emissions, the final rule also includes 

revised waste management plan 

provisions in §§ 60.35e and 60.55c that 

encourage segregation of the types of 

wastes that lead to these emissions, 

such as chlorinated plastics and PCBcontaining wastes. 

E. Monitoring 

Comment: One commenter argued 

that the monitoring requirements in the 

HMIWI regulations are inadequate 

because they do not provide for 

emissions monitoring as required by 

Section 129. According to the 

commenter, EPA’s exclusive reliance on 

parameter monitoring for most 

pollutants and units is unlawful. The 

commenter stated that EPA must require 

all HMIWI to use the available CEMS 

(e.g., HCl, Hg, metals, CDD/CDF) to 

monitor their emissions. The 

commenter indicated that CEMS are the 

only requirements that can possibly 

provide data adequate to ensure 

compliance with emissions standards 

and protection of public health and the 

environment, consistent with Section 

129(c)(1). 

Two other commenters argued that 

continuous monitoring of CO with a 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

Pollutant CEMS Parameter monitoring 

systems Emissions controls Incinerators 

CO .............................. CO CEMS: $149,300 

per year (yr).

Combustion control (charge rate, secondary 

chamber temperature): $6,000–$9,900/yr.

Secondary chamber 

retrofit: $15,100– 

$80,800/yr.

Incinerator: $54,800– 

$366,000/yr. 

HCl ............................. HCl CEMS: $171,400/ 

yr.

Packed-bed scrubber (flue gas temperature, 

scrubber liquor flow rate and pH): $5,200/ 

yr.

Packed-bed scrubber: 

$51,600–$104,000/ 

yr.

PM .............................. PM CEMS: $195,200/ 

yr.

Fabric filter (fabric filter inlet temperature): 

$4,200/yr.

Fabric filter: 

$130,000–$268,000/ 

yr.

Metals ........................ Multi-metals CEMS: 

$57,800/yr.

Hg .............................. Hg CEMS: $313,900/ 

yr.

Activated carbon injection system (activated 

carbon injection rate): $4,800/yr.

Activated carbon injection system: 

$5,400–$56,300/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 reproposal 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 § 60.37e(f) allowing 


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submission of previous stack tests to 

show compliance with proposed 

emissions standards for existing HMIWI, 

arguing that most of the stack tests were 

conducted over 7 years ago, and are also 

not statistically reliable because so few 

tests were conducted. The commenter 

stated that the provisions disregard the 

attention that Section 129 expected EPA 

to place on solid waste incinerators. 

The second commenter also objected 

to the proposed one-time test 

requirement for Pb, Cd, Hg, and CDD/ 

CDF, arguing that a single test result 

does not provide adequate assurance 

that the emissions standards have been 

met or are continuously being achieved 

by operations combusting a nonhomogeneous waste stream. According 

to the commenter, allowing a one-time 

test also provides a strong disincentive 

to installing CEMS on HMIWI. The 

commenter noted that if EPA still wants 

to reduce testing requirements, it could 

provide skip testing provisions for these 

pollutants similar to existing provisions 

in § 60.56c(c)(2), especially in future 

rulemaking, once the industry has 

demonstrated sustained compliance. 

Response: Regarding the comment 

objecting to the submission of previous 

stack tests to show compliance with 

new emissions standards for existing 

HMIWI, we attempted to address such 

concerns in § 60.37e(f)(2) and (3), 

specifying that the HMIWI had to be 

operated in a manner expected to result 

in the same or lower emissions, that it 

could not have been modified such that 

emissions would be expected to exceed 

the previous test results, and that 

emissions test results prior to the year 

of the 1996 proposal could not be 

accepted. We believe that these 

provisions are adequate to ensure an 

accurate and reliable result. 

Furthermore, based on the language in 

the re-proposal, it is unlikely that any 

commenter could have anticipated a 

change in the base year (1996) for 

emissions tests that would be accepted 

to demonstrate compliance with the 

revised emissions limits in the final 

rule, such that the commenter would 

have had a meaningful opportunity to 

comment on the issue. 

Regarding the comment objecting to 

the one-time test requirement for metals 

and CDD/CDF, the annual tests are 

intended to be surrogates for 

combustion, particulate, and acid gas 

control, supplementing existing 

continuous monitoring requirements. 

We believe that the annual tests for 

combustion and particulate control and 

the continuous emissions monitoring of 

activated carbon injection are sufficient 

to ensure compliance with the metals 

and CDD/CDF emissions limits. 

However, if the State implementing the 

HMIWI regulations for existing units in 

its jurisdiction believes that more 

frequent metals and CDD/CDF testing is 

a necessary requirement for those units, 

they have the option to prepare State 

plans for EPA review that include those 

requirements, or to simply require a 

particular source to conduct such 

testing. Section 116 of the CAA 

preserves a State’s authority to regulate 

more stringently under Section 111. 

Given the more stringent requirements 

in the HMIWI rule (relative to the 1997 

rule) being promulgated today, we do 

not want to impose additional testing 

requirements that are not necessary to 

assure compliance with the 

requirements of this final rule. Also, we 

did not provide an opportunity to 

comment on such additional emissions 

testing in the December 2008 reproposal, and we would want to 

develop a fuller record on any such 

requirements and provide an 

opportunity to comment on those 

requirements before imposing them in a 

final rule. However, we would be 

willing to consider such a change at the 

next technology review, if such a change 

is necessary to reliably demonstrate 

compliance. 

G. Alternatives to On-Site Incineration 

Comment: Five commenters 

supported alternatives to on-site 

incineration, such as autoclaving. One 

of the commenters stated that 90 percent 

or more of medical waste could be 

safely diverted from incineration. The 

commenter further noted that 

alternative treatment technologies like 

autoclaves and microwaves work, are 

available, and are approved by 

regulatory agencies. The commenter 

argued that these technologies provide a 

much healthier alternative to 

incineration. Another of the 

commenters suggested EPA supplement 

its proposed rule to specify a phase-in 

requirement that diverts all medical 

waste not required by law or regulation 

to be incinerated to go to approved 

alternative non-incineration disposal 

methods; the commenter also 

recommended that EPA prohibit 

autoclave residues from being 

incinerated. Three of the commenters 

stated that EPA should initiate a ban on 

incineration of medical waste, and in 

the interim give incentives to industries 

using safer, cleaner alternatives to 

incinerating medical waste, such as 

autoclaving and microwaving. 

Five other commenters noted the 

disadvantages associated with 

incineration alternatives such as 

autoclaving. One of the commenters 

noted that EPA’s supporting documents 

for the proposed rule seem to endorse 

such alternatives but fail to recognize 

that some facilities generate waste types 

for which autoclaving and landfilling is 

not adequate treatment. As examples, 

another of the commenters noted that 

numerous research facilities insist that 

all of their waste be incinerated, and 

three of the commenters noted that most 

States and many local governments have 

imposed requirements on the disposal 

of these types of wastes and identified 

incineration as an authorized means of 

disposal; further, some States expressly 

require incineration of pathological 

wastes and/or prohibit autoclaving or 

landfilling of such wastes. With the 

proposed emissions limits, the same 

three commenters expected that HMI 

waste incineration capacity will 

disappear, and captive units will be 

limited by permit from accepting wastes 

from off-site; as a result, the commenters 

concluded, some waste generators will 

be left with a State requirement to 

incinerate waste, with little or no 

available HMIWI treatment options and 

capacity. One commenter noted that 

that sterilized waste is often transferred 

to regional MWC facilities for 

incineration, especially in their 

metropolitan area, and noted that MWC 

emissions limits are less stringent than 

the current and proposed limits for 

HMIWI. Thus, the commenter 

concluded, if the HMIWI regulation 

increases autoclaving and reduces use of 

their facility, it will have a significant 

adverse effect on air quality. 

One of the commenters stated that 

EPA’s studies for the proposed rule also 

fail to recognize the environmental 

impacts of transporting autoclaved 

medical wastes to regional landfills, 

such as depletion of landfill space, 

landfill gas emissions, landfill leachate 

issues, and impacts of waste 

transportation traffic. Another 

commenter noted that autoclaving does 

not achieve the 90 percent volume 

reduction that can be achieved with 

incineration and, with many landfills at 

or approaching capacity, volume 

reduction prior to landfilling is a much 

preferred option. 

One commenter also noted that steam 

sterilization can result in the release of 

uncontrolled Hg vapors from the 

autoclaving process, so any medical 

waste displaced from their facility to 

autoclaves would result in an increase 

in Hg emissions from the autoclaves or 

the MWC. The commenter said that 

these potential impacts need to be 

assessed before any standard is adopted. 

Response: Section 129 of the CAA 

provides EPA with the authority to 

establish emissions limits for the nine 

specified pollutants (HCl, CO, Pb, Cd, 


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Hg, PM, CDD/CDF, NOX, and SO2). 

Today’s action satisfies EPA’s obligation 

to respond to the Court’s remand of the 

1997 MACT floor determinations, as 

well as EPA’s duty to conduct its first 

periodic review of the standards and 

requirements of the HMIWI rule. While 

a record that supported complete 

elimination of emissions of the 

enumerated pollutants is theoretically 

possible, the record for today’s rule does 

not show that such an outright ‘‘ban’’ of 

incineration is required to meet EPA’s 

obligations. 

We agree with the commenters that it 

is appropriate to address the 

disadvantages and environmental 

impacts associated with incineration 

alternatives such as autoclaving in 

background documentation for the 

HMIWI rule, even though the revised 

standards in today’s rule are floor-based 

(for which we cannot consider costs) 

rather than beyond-the-floor-based 

(where costs are to be considered). We 

also agree that incineration is sometimes 

insisted upon or even required by some 

research facilities and State and local 

governments, and we have incorporated 

those comments into the revised 

background documentation for the final 

rule. 

Regarding the comment that some 

metropolitan areas require autoclaved 

waste to be sent to MWC units, while 

the commenter is correct that MWC 

limits are currently higher than the 1997 

promulgated HMIWI limits and the 2008 

re-proposed HMIWI limits, the MWC 

standards are on remand to the Agency, 

and EPA will be reviewing those 

standards. At this juncture, we cannot 

predict the outcome of that remand 

response. 

Comment: One commenter stated that 

EPA’s studies for the proposed rule fail 

to recognize and consider all the risks 

to the public associated with closing 

captive HMIWI and transporting 

medical/infectious wastes to large 

commercial incinerators, especially in 

regions such as the western U.S., where 

such commercial incinerators are not 

well distributed. 

Response: We believe that the revised 

emissions limits are more representative 

of actual operation at HMIWI and will 

impact fewer HMIWI than the December 

2008 re-proposal, which should address 

the commenter’s concerns. Moreover, in 

this technology- and MACT floor-based 

rulemaking, we do not believe that we 

could permissibly adopt standards that 

are less stringent than the floor based on 

considerations of risk. See Sierra Club v. 

EPA, 353 F.3d 976 (DC Cir. 2009). 

H. Medical Waste Segregation 

Comment: Contrary to what EPA 

stated in its summary of waste 

segregation survey responses, two 

commenters argued that there is ample 

evidence that the extent to which waste 

segregation is conducted by our 

healthcare facilities is far from optimal, 

and that further waste segregation could 

easily occur. Multiple commenters 

recommended that EPA supplement the 

proposed rule to minimize or eliminate 

the inclusion of plastic wastes (a chief 

contributor to dioxin formation), Hg 

(e.g., Hg-containing dental waste, Hgcontaining devices), and other 

hazardous wastes in the waste sent to 

incineration; end the burning of 

confidential documents (e.g., medical 

records) and other paper products that 

could be shredded and recycled; and 

require waste management plans from 

all generators of medical waste that use 

incineration as a disposal option. As 

examples, one of the commenters said 

captive HMIWI could be required to 

train staff to minimize inclusion of Hgcontaining devices and other heavy 

metals from the waste stream; and 

commercial HMIWI could be required to 

provide educational materials to 

encourage customers to prevent 

inappropriate disposal of metalscontaining devices and other items into 

wastes supplied to the commercial 

HMIWI. Another commenter supported 

the idea of enhancing waste 

management practices at the point of 

generation and noted that their 

commercial facility offers training 

sessions with hospitals and institutions 

on the importance of separating items 

containing Hg and other hazardous 

substances from the rest of their medical 

waste and has implemented and 

manages recycling programs for paper, 

bottles, glass, cardboard, metals, 

construction material, and sharps 

containers. 

To ensure effective waste segregation 

by commercial facilities, one of the 

commenters further recommended that 

EPA revise the regulation to state that 

incinerator operators are responsible for 

all of the waste in their possession and 

the emissions that result, and should 

clarify for all incinerator operators that 

the term ‘‘affected source’’ in § 60.55c 

refers to them. 

Four commenters noted that the 

proposed new rule for emissions from 

HMIWI does not address 

pharmaceutical drugs, nor does it 

address how hazardous pharmaceuticals 

are segregated from non-hazardous. The 

commenters stated that not all 

incinerators, such as those in North 

Carolina, are licensed to burn 

pharmaceuticals classified as hazardous. 

The commenters recommended that 

EPA require each State to develop and 

implement programs to ensure that 

hazardous and non-hazardous 

pharmaceuticals are being segregated. 

Response: While EPA’s authority to 

set emissions standards under Section 

129(a)(2) reaches only incinerators of 

solid waste and does not directly extend 

to generators of waste who are not 

owners and operators of solid waste 

incineration units, we are amending the 

waste management plan provisions in 

the final rule to promote greater waste 

segregation (e.g., plastics, metals, PCBcontaining wastes, pharmaceuticals). 

Given the OSHA requirements to which 

commercial HMIWI operators are 

subject, those operators cannot be 

expected to remove certain materials 

from the waste they receive, but they 

can be expected to train and educate 

their clients to conduct their own waste 

segregation, especially with regard to 

the materials listed above. We are 

including language to that effect in the 

waste management provisions of the 

final rule. 

I. Startup, Shutdown, and Malfunction 

Comment: Three commenters argued 

that EPA should apply to the HMIWI 

rule the decision issued by the U.S. 

Court of Appeals for the DC Circuit 

(Sierra Club v. EPA, 551 F.3d 1019 (DC 

Cir. 2008)), which vacated the SSM 

exemptions in EPA’s General Provisions 

implementing Section 112 on the 

grounds that the exemptions violate the 

CAA’s requirement that some Section 

112 standards apply continuously. The 

commenters stated that the reasoning 

provided by the court in its decision 

also applies to the HMIWI rule. 

According to one of the three 

commenters, the CAA makes clear that 

EPA may not exempt sources from 

compliance with Section 129 emissions 

standards during SSM events and that 

the current exemptions (found in 

§§ 60.56c(a) and 60.37e(a)) are unlawful. 

The commenter noted that EPA 

restricted the current SSM exemption to 

periods when no hospital or medical/ 

infectious waste is being charged to 

HMIWI. However, the commenter said 

this does not bring EPA’s regulations 

into compliance with the CAA or suffice 

to protect the public from toxic 

emissions during periods of SSM, 

because HMIWI could stop charging 

HMI waste during an SSM event but 

still emit toxic pollution through a 

bypass valve directly to the 

environment. To the extent EPA is not 

soliciting comment on the SSM 

exemption as part of its response to the 

remand in Sierra Club v. EPA, 167 F.3d 


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658 (DC Cir. 1999) or its review of 

regulations under Section 129(a)(5), the 

commenter petitioned it to do so under 

the authorities in Kennecott Utah 

Copper Corp. v. Department of Interior, 

88 F.3d 1191 (DC Cir. 1996). 

A fourth commenter argued that if the 

SSM court decision is upheld, this 

would substantially impact the 

approach for establishing ‘‘worst 

reasonable foreseeable circumstances’’ 

and the approach for establishing 

emissions limits based on available 

data. According to the commenter, 

emissions and controllability during 

periods of SSM are different than 

‘‘normal operation,’’ and the commenter 

noted that EPA currently sets limits by 

reviewing data taken during ‘‘normal 

operation,’’ since no one generally 

conducts stack tests during SSM. 

One commenter requested that 

emissions from SSM events be included 

in the calculations of a facility’s 

potential to emit, which in turn 

determines the applicability of some 

Federal requirements. The commenter 

also recommended that emissions from 

SSM events should be included in 

modeling to ensure that new or 

expanded sources do not cause ambient 

air quality to exceed health-based levels. 

In lieu of modeling, the commenter said 

there should be actual monitoring of 

SSM events to accurately determine the 

individual types of toxic air pollutants 

and amounts of toxic air pollutant 

releases. The commenter recommended 

that there be mandatory penalties for 

SSM events based on the amounts and 

toxicity of the emissions. To illustrate 

the point, the commenter included 

documentation about bypass events at a 

local HMIWI. Two additional 

commenters also requested that EPA 

conduct modeling to assess the types 

and amounts of pollutants released 

during bypass events and take 

appropriate steps to regulate these 

‘‘fugitive’’ emissions. All three 

commenters recommended that 

pollution control equipment be required 

for bypass events, whether the event is 

operator error or violation. 

Another commenter recommended 

that EPA revise the General Provisions 

or the specific standards to subject SSM 

periods to appropriate work practice 

standards, including procedures to 

minimize emissions during those 

periods, rather than establish MACT 

emissions limits that are impossible to 

meet during SSM. According to the 

commenter, CAA Section 112(h) allows 

the Administrator to promulgate a 

design, equipment, work practice, or 

operational standard, or combination 

thereof, in lieu of an emissions standard 

where it is not feasible to prescribe or 

enforce an emissions standard. The 

commenter said that emissions 

measurement is not practicable during 

SSM periods. 

Response: While the Court’s ruling in 

Sierra Club v. EPA, 551 F.3d 1019 (DC 

Cir. 2008), directly affects only the 

subset of CAA Section 112(d) rules that 

incorporate § 63.6(f)(1) and (h)(1) by 

reference and that contain no other 

regulatory text exempting or excusing 

compliance during SSM events, the 

legality of source category-specific SSM 

provisions such as those adopted in the 

1997 HMIWI rule is questionable. 

To our knowledge, no HMIWI 

facilities have ever done any testing 

during an SSM event, except perhaps 

the few that have CO CEMS (although 

under the definition of ‘‘malfunction’’ in 

§ 60.51c, operators are directed to 

monitor all applicable operating 

parameters during malfunctions until all 

waste had been combusted or until the 

malfunction ceases, whichever comes 

first). It would be very difficult to do 

any meaningful testing during such an 

event because the exhaust flow rates, 

temperatures, and other stack 

conditions would be highly variable and 

could foul up the isokinetic emissions 

test methods (thus invalidating the 

testing). 

The 1997 rule excused exceedance of 

emissions standards during SSM events 

only in instances where ‘‘no hospital 

waste or medical/infectious waste is 

charged to the affected facility.’’ 40 CFR 

60.56c(a). This means that in any SSM 

periods where such waste is being 

charged and an exceedance of the 

standards occurs, the source is in 

violation of the requirements of the 

standards. Based on the 1997 HMIWI 

rule’s definitions of the terms ‘‘startup’’ 

and ‘‘shutdown,’’ no waste should be 

combusted during these periods, so 

emissions should be low during them— 

essentially the emissions from burning 

natural gas. Under § 60.51c, startup is 

defined as the period of time between 

the activation of the system and the first 

charge to the unit. For batch HMIWI, 

startup means the period of time 

between activation of the system and 

ignition of the waste. Shutdown is 

defined as the period of time after all 

waste has been combusted in the 

primary chamber. Shutdown must start 

no less than 2 hours after the last charge 

to the incinerator for continuous 

HMIWI, and no less than 4 hours for 

intermittent HMIWI. For batch HMIWI, 

shutdown must commence no less than 

5 hours after the high-air phase of 

combustion has been completed. 

Consequently, it should not be possible 

for HMIWI to exceed the applicable 

emissions limits during startup and 

shutdown periods. This suggests that 

the exemption from standards during 

startup and shutdown is of virtually no 

utility to HMIWI, such that there is any 

need for EPA to retain the exemption in 

today’s final rule. 

Malfunctions present a similar 

situation in terms of how the 1997 rule 

functioned, if a slightly different 

situation factually. Again, the SSM 

exemption of § 60.56c(a) applied only 

where no hospital waste and no 

medical/infectious waste was being 

charged. Under §§ 60.56c(a) and 

60.37e(a) of the HMIWI rules, facilities 

are required to stop charging waste as 

soon as a malfunction is identified and 

not charge any additional waste. 

‘‘Malfunction’’ is defined in § 60.51c as 

any sudden, infrequent and not 

reasonably preventable failure of air 

pollution control equipment, process 

equipment, or a process to operate in a 

normal or usual manner, but does not 

include failures caused, in part, by poor 

maintenance or careless operation. 

During malfunction periods, operators 

must operate within established 

parameters as much as possible and 

continue to monitor all applicable 

operating parameters. So, there should 

be low emissions during such periods, 

but how low is not known. In any case, 

the rule as promulgated in 1997 did not 

excuse exceedances of emissions 

standards during malfunctions if 

hospital waste or medical/infectious 

waste was being charged during the 

malfunction. Moreover, our final 

standards established today are based 

on the best data available to the Agency, 

and we have no data to support 

modifying the floors for malfunction 

periods. 

While EPA is still in the relatively 

early process of formulating its strategy 

for addressing the SSM court decision 

and the numerous Section 112 and 129 

rules that contain varying provisions 

regarding SSM events, we are revising 

the HMIWI rules in today’s final 

rulemaking to delete the 1997 rule’s 

narrow exemption from emissions limits 

during periods of SSM. As explained 

above, the exemption and definitions as 

promulgated in 1997 provided virtually 

no utility, and we, therefore, expect that 

today’s deletion of the SSM exemption 

will have very little, if any, impact on 

HMIWI units’ compliance status. In the 

event that sources, despite their best 

efforts, fail to comply with applicable 

standards during SSM events (as 

defined by the rule), EPA will determine 

an appropriate response based on, 

among other things, the good faith 

efforts of the source to minimize 

emissions during SSM periods, 

including preventative and corrective 


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actions, as well as root cause analyses 

to ascertain and rectify excess 

emissions. This approach is consistent 

with that discussed in a recent letter by 

Adam M. Kushner, Director, Office of 

Civil Enforcement, to counsel 

representing various industry 

associations, entitled ‘‘Re: Vacatur of 

Startup, Shutdown, and Malfunction 

(SSM) Exemption (40 CFR sections 

63.6(f)(1) and 63.6(h)(1))’’ (July 22, 

2009) (included in the docket for today’s 

rulemaking). 

For the reasons discussed above, we 

disagree with the commenter who 

claimed that, in the context of this 

rulemaking, removal of the SSM 

exemption would substantially impact 

the MACT floor approach. Deletion of 

the exemption should have no impact 

on the use and analysis of the MACT 

compliance data upon which the 

revised standards are based in this rule. 

This is because the 1997 rule’s 

exemption provisions already had a 

very limited focus, in excusing 

compliance with standards only when 

HMI waste was not being charged to the 

incinerator; even under the 1997 rules, 

if HMI waste was being charged during 

an SSM event, the standards continued 

to apply. Moreover, the commenter 

provided no information to support its 

position. Therefore, it is similarly 

unnecessary to accept other 

commenters’ recommendations to 

specify mandatory penalties during 

SSM events or impose unique pollution 

controls for bypass events—these 

concerns should be adequately 

addressed by today’s removal of the 

SSM exemption, which includes 

removal of the 1997 rule’s exemption 

during SSM periods to the prohibition 

of using a bypass stack. 

We also disagree that it is necessary 

to revise the CAA Section 112 General 

Provisions of 40 CFR part 63 to impose 

work practice requirements that apply 

in lieu of numeric emissions standards 

during SSM periods, in the context of 

this CAA Section 129 rulemaking. The 

commenter who suggested this 

approach cited CAA Section 112(h) as 

the basis of authority for such a change, 

but neither that section of the Act nor 

the part 63 General Provisions apply to 

standards promulgated under Section 

129, which by its terms requires 

numeric emissions standards for the 

pollutants specified in Section 129(a)(4). 

J. Economic Impacts 

Comment: Two commenters argued 

that the proposed limits are unattainable 

without significant financial 

investment, which they said will 

ultimately be passed on to an already 

overburdened healthcare system. The 

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 


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were using in our economic analysis 

(2007) showed sales numbers that 

indicated they were not a small 

business. After receiving public 

comments and additional information, 

we have accounted for any recent 

changes in small entity status and reanalyzed the economic impacts of the 

rule on small entities. (See 2009 report 

‘‘Economic Impacts of Revised MACT 

Standards for Hospital/Medical/ 

Infectious Waste Incinerators,’’ which is 

included in the docket for today’s 

rulemaking.) Because we are beyond 

proposal, we cannot convene a preproposal SBREFA panel. After 

considering the economic impacts of 

this final rule on small entities, we can 

certify that today’s final rule will not 

have a significant economic impact on 

a substantial number of small entities. 

The one small entity directly regulated 

by today’s final rule is a small business 

that owns two HMIWI. We have 

determined that this one small entity 

may experience an impact of 

approximately $3.15 million per year to 

comply with the final rule, resulting in 

a cost-to-sales ratio of approximately 45 

percent. The small entity is a company 

in Maryland, which owns and operates 

a commercial facility at that location. 

There are only nine other commercial 

facilities, which are owned and 

operated by other companies, and the 

closest are in North Carolina and Ohio. 

Therefore, the entity is a regional 

monopolist and is able to raise the price 

by more than the per unit cost increase. 

We expect there to be a reduction in the 

amount of its services demanded due to 

the price change. Because of closures of 

captive HMIWI, there may also be an 

increase in the demand for its services 

that may reduce the decrease in 

revenues associated with the price 

increase. 

Two other entities are defined as 

borderline small: Their parent company 

sales or employment in 2008 are above 

the SBA size-cutoff for small entities in 

their North American Industry 

Classification System (NAICS) codes, 

but are near enough to the size cut-off 

that variations in sales or employment 

over time might move them below the 

small business criterion. Based on 2008 

sales data for these two entities, the 

cost-to-sales ratio is less than 1 percent 

for one entity and 1.4 percent for the 

other. It should be noted that the entity 

with the higher cost-to-sales ratio (1.4 

percent) is a commercial unit and would 

have the ability to pass the cost along to 

their customers and would be expected 

to be able to afford compliance. 

Therefore, neither entity is likely to 

incur significant impacts. (See 2009 

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 scrubbercontrolled units adding a fabric filterbased system for improved control of 

PM and metals; most units with fabric 

filter-based systems adding a packedbed wet scrubber for improved control 

of HCl; adding activated carbon 

injection or increasing activated carbon 

usage rate for improved Hg and dioxin 

control; upgrading fabric filter 

performance for improved control of PM 

and metals; increasing lime or caustic 


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use for improved control of HCl and, in 

a few instances, SO2; and combustion 

improvements primarily associated with 

decreasing CO emissions. We also 

project that a few units may require addon controls (SNCR) to meet the revised 

NOX emissions levels. Facilities may 

resubmit their most recent compliance 

test data for each pollutant if the data 

show that their HMIWI meets the 

revised emissions limits. In these 

instances, facilities must certify that the 

test results are representative of current 

operations. Those facilities would then 

not be required to test for those 

pollutants to prove initial compliance 

with the revised emissions limits. 

A. What Are the Primary Air Impacts? 

EPA estimates that reductions of 

approximately 393,000 pounds per year 

(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 

Pollutant 

Reductions 

achieved through 

meeting MACT 

(lb/yr) 

Reductions 

achieved through 

alternative 

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 


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captive HMIWI and commercial HMIWI 

using different methods. Of the 57 

HMIWI, 14 are commercial and 43 are 

captive. 

Owners of captive HMIWI may choose 

to incur the costs of complying with the 

revised HMIWI standards or close the 

HMIWI and switch to another disposal 

technology like autoclaving and 

landfilling or have their waste handled 

by a commercial disposal service. EPA’s 

estimate of autoclaving and landfilling 

costs indicate that even without 

additional regulatory costs, the costs of 

autoclaving and landfilling may be 

lower than the costs of incinerating. 

However, even if all owners of captive 

HMIWI choose to continue to operate 

with the additional regulatory cost, the 

cost-to-sales ratios for firms owning 

captive HMIWI are low. This reflects the 

relatively small share of overall costs 

that are associated with hospital/ 

medical/infectious waste management 

at these firms. Of the 35 firms owning 

captive HMIWI, 22 have costs of 

compliance that are less than 0.1 

percent of firm sales. Of the 13 with 

costs exceeding 0.1 percent of sales, the 

largest cost-to-sales ratio is at a captive 

hospital HMIWI, and is equal to 0.995 

percent. Therefore, EPA expects no 

significant impact on the prices and 

quantities of the underlying services of 

the owners of the captive HMIWI, 

whether the costs are passed on or 

absorbed. 

Impacts on commercial HMIWI are 

analyzed using the simplifying 

assumption that they operate as regional 

monopolists (in general, only one 

HMIWI is considered as a treatment 

option by generators located nearby). 

The approach to modeling the impact 

for commercial HMIWI seems very 

appropriate for all of the facilities 

except for one. The other commercial 

HMIWI facilities have costs of 

compliance that are no more than 2.0 

percent of revenues. That one facility 

has a ratio of approximately 45 percent. 

As noted previously, this facility is a 

regional monopolist and is able to raise 

the price by more than the per unit cost 

increase. We expect there to be a 

reduction in the amount of its services 

demanded due to the price change. 

Because of closures of captive HMIWI, 

there may also be an increase in the 

demand for its services that may reduce 

the decrease in revenues associated with 

the price increase. For more details 

regarding EPA’s analysis of the 

economic impacts, see the July 2009 

docket entry entitled ‘‘Economic 

Impacts of Revised MACT Standards for 

Hospital/Medical/Infectious Waste 

Incinerators.’’ 

VI. Impacts of the Final Action for New 

Units 

Information provided to EPA 

indicates that negative growth has been 

the trend for HMIWI for the past several 

years. While existing units continue to 

shut down, since promulgation of the 

HMIWI NSPS in 1997, four new units 

have been constructed and one unit has 

been reconstructed. This information 

indicates that in the absence of further 

regulation, new HMIWI may be built. 

However, based on the stringency of 

revisions being promulgated for the 

NSPS, sources would likely respond to 

the final rule by choosing not to 

construct new HMIWI and would utilize 

alternative waste disposal options rather 

than incur the costs of compliance. 

Considering this information, EPA 

does not anticipate any new HMIWI, 

and therefore, no impacts of the revised 

NSPS for new units. For purposes of 

demonstrating that emissions reductions 

would result from the NSPS in the 

unlikely event that a new unit is 

constructed, EPA estimated emissions 

reductions and other impacts expected 

for each of three HMIWI model plants. 

A. What Are the Primary Air Impacts? 

EPA estimated emissions reductions 

for each of the model plants to 

demonstrate that the NSPS would, if a 

new unit were built, reduce emissions 

compared to a HMIWI meeting the 

current NSPS. Table 5 of this preamble 

presents the emissions reductions for 

the HMIWI model plants. The three 

model plants (with capacities of 100 lb/ 

hr, 400 lb/hr, and 4,000 lb/hr) represent 

typical HMIWI. For pollutants where a 

‘‘zero’’ value is shown, the model plant 

performance estimate meets the revised 

new source limit, which is not 

surprising since the models are based on 

the performance of the newest sources, 

which are among the best performers in 

the industry. 

TABLE 5—EMISSIONS REDUCTIONS ON A MODEL PLANT BASIS

Pollutant 

Emissions reduction for HMIWI model plants (lb/yr) 

100 lb/hr 

capacity 

400 lb/hr 

capacity 

4,000 lb/hr 

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 × 10¥4 0 

Dioxins/furans, TEQ ......................................................................................................... 0 6.02 × 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 


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required to support the increased 

control requirements; for medium units, 

we estimate 416 MWh/yr; and, for small 

units, we estimate 9.90 MWh/yr. 

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 


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emissions, as is evidenced by HMIWI 

performance data. Specifically, the postMACT compliance tests at currently 

operating HMIWI that were also 

operational at the time of promulgation 

of the 1997 standards show that, for 

those units, the 1997 HMIWI MACT 

regulations reduced Hg emissions by 

about 60 percent and CDD/CDF 

emissions by about 80 percent from preMACT levels. (Note that these 

reductions do not reflect unit 

shutdowns, units for which exemptions 

were granted, or new units.) Moreover, 

similar controls have been demonstrated 

to effectively reduce emissions of POM 

and PCBs from another incineration 

source category (municipal solid waste 

combustors). It is, therefore, reasonable 

to conclude that POM and PCB 

emissions are substantially controlled at 

all 57 HMIWI. Thus, while the final rule 

does not identify specific numerical 

emissions limits for POM and PCB, 

emissions of those pollutants are, for the 

reasons noted above, nonetheless 

‘‘subject to regulation’’ for purposes of 

Section 112(c)(6) of the CAA. 

In lieu of establishing numerical 

emissions limits for pollutants such as 

PCBs and POM, CAA Section 129(a)(4) 

allows EPA to regulate surrogate 

substances. While we have not 

identified specific numerical limits for 

POM and PCB, we believe CO serves as 

an effective surrogate for those 

pollutants, because CO, like POM and 

PCBs, is formed as a byproduct of 

combustion. We believe that dioxins/ 

furans also serve as an effective 

surrogate for PCBs, because the 

compounds act similarly and, thus, are 

expected to be controlled similarly 

using HMIWI emissions control 

technology—e.g., wet scrubbers or fabric 

filters (with or without activated 

carbon). Furthermore, recent HMIWI 

emissions test data for PCBs and 

dioxins/furans show that HMIWI wellcontrolled for dioxins/furans also 

achieve low PCB emissions. (See 2008 

memorandum entitled ‘‘Documentation 

of HMIWI Test Data Database,’’ which is 

included in the docket.) It should also 

be noted that PCBs are generally found 

in higher concentrations than dioxins/ 

furans (also the case for HMIWI), so 

HMIWI equipped with the 

aforementioned emissions controls 

would be even more effective at 

reducing PCB emissions. Consequently, 

we have concluded, in response to the 

public comments submitted on this 

issue, that the emissions limits for CO 

function as a surrogate for control of 

both POM and PCBs, and the limits for 

dioxins/furans function as a surrogate 

for PCBs, such that it is not necessary 

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-forprofit enterprise that is independently 

owned and operated and is not 

dominant in its field. 

After considering the economic 

impacts of this final rule on small 

entities, I certify that this action will not 


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have a significant economic impact on 

a substantial number of small entities. 

The one small entity directly regulated 

by this final action is a small business 

that owns two HMIWI. We have 

determined that this one small entity 

may experience an impact of 

approximately $3.15 million per year to 

comply with the final rule, resulting in 

a cost-to-sales ratio of approximately 45 

percent. (See 2009 report ‘‘Economic 

Impacts of Revised MACT Standards for 

Hospital/Medical/Infectious Waste 

Incinerators,’’ which is included in the 

docket for today’s rulemaking.) The one 

small entity is a company in Maryland, 

which owns and operates a commercial 

facility at that location. There are only 

nine other commercial facilities, which 

are owned and operated by other 

companies, and the closest are in North 

Carolina and Ohio. Therefore, the entity 

is a regional monopolist and is able to 

raise the price by more than the per unit 

cost increase. We expect there to be a 

reduction in the amount of its services 

demanded due to the price change. 

Because of closures of captive HMIWI 

there may also be an increase in the 

demand for its services that may reduce 

the decrease in revenues associated with 

the price increase. 

Two other entities are defined as 

borderline small: Their parent company 

sales or employment in 2008 are above 

the SBA size-cutoff for small entities in 

their NAICS codes, but are near enough 

to the size cut-off that variations in sales 

or employment over time might move 

them below the small business criterion. 

Based on 2008 sales data for these two 

entities, the cost-to-sales ratio is less 

than 1 percent for one entity and 1.4 

percent for the other. It should be noted 

that the entity with the higher cost-tosales ratio (1.4 percent) is a commercial 

unit and would have the ability to pass 

the cost along to their customers and 

would be expected to be able to afford 

compliance. Therefore, neither entity is 

likely to incur significant impacts. (See 

2009 memorandum entitled ‘‘Updated 

Sales Information for Companies 

Considered Borderline Small Entities,’’ 

which is included in the docket for 

today’s rulemaking.) 

Although the final rule will not have 

a significant economic impact on a 

substantial number of small entities, 

EPA nonetheless conducted an analysis 

of the impacts of the final rule on the 

directly regulated small entity and has 

tried to reduce the impact of this rule on 

small entities, to the extent allowed 

under the CAA MACT floor rulemaking. 

Our impacts analysis is contained in the 

docket for today’s final rulemaking. For 

each subcategory of HMIWI, we are 

promulgating emissions limits that are 

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. 


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This final rulemaking involves 

technical standards. EPA has decided to 

use two VCS in this final rule. One VCS, 

ASME PTC 19.10–1981, ‘‘Flue and 

Exhaust Gas Analyses,’’ is cited in this 

final rule for its manual method of 

measuring the content of the exhaust gas 

as an acceptable alternative to EPA 

Method 3B of appendix A–2. This 

standard is available from the American 

Society of Mechanical Engineers 

(ASME), P.O. Box 2900, Fairfield, NJ 

07007–2900; or Global Engineering 

Documents, Sales Department, 15 

Inverness Way East, Englewood, CO 

80112. 

Another VCS, ASTM D6784–02, 

‘‘Standard Test Method for Elemental, 

Oxidized, Particle-Bound and Total 

Mercury Gas Generated from Coal-Fired 

Stationary Sources (Ontario Hydro 

Method),’’ is cited in this final rule as 

an acceptable alternative to EPA Method 

29 of appendix A–8 (portion for 

mercury only) for measuring mercury. 

This standard is available from the 

American Society for Testing and 

Materials (ASTM), 100 Barr Harbor 

Drive, Post Office Box C700, West 

Conshohocken, PA 19428–2959; or 

ProQuest, 300 North Zeeb Road, Ann 

Arbor, MI 48106. 

While the EPA has identified 16 VCS 

as being potentially applicable to this 

final rule, we have decided not to use 

these VCS in this rulemaking. The use 

of these VCS would be impractical 

because they do not meet the objectives 

of the standards cited in this rule. See 

the docket for this rule for the reasons 

for these determinations. 

Under 40 CFR 60.13(i) of the NSPS 

General Provisions, a source may apply 

to EPA for permission to use alternative 

test methods or alternative monitoring 

requirements in place of any required 

testing methods, performance 

specifications, or procedures in the final 

rule and any amendments. 

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. 

■ For the reasons stated in the preamble, 

title 40, chapter I, part 60 of the Code 

of Federal Regulations is amended as 

follows: 

PART 60—[AMENDED] 

■ 1. The authority citation for part 60 

continues to read as follows: 

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

Subpart A—[Amended] 

■ 2. Section 60.17 is amended by 

revising paragraphs (a)(90) and (h)(4) to 

read as follows: 

§ 60.17 Incorporations by reference. 

* * * * * 

(a) * * * 

(90) ASTM D6784–02, Standard Test 

Method for Elemental, Oxidized, 

Particle-Bound and Total Mercury in 

Flue Gas Generated from Coal-Fired 

Stationary Sources (Ontario Hydro 

Method), IBR approved for Appendix B 

to part 60, Performance Specification 

12A, Section 8.6.2 and § 60.56c(b)(13) of 

subpart Ec of this part. 

* * * * * 

(h) * * * 

(4) ANSI/ASME PTC 19.10–1981, 

Flue and Exhaust Gas Analyses [Part 10, 

Instruments and Apparatus], IBR 

approved for § 60.56c(b)(4) of subpart 

Ec, § 60.106(e)(2) of subpart J, 

§§ 60.104a(d)(3), (d)(5), (d)(6), (h)(3), 

(h)(4), (h)(5), (i)(3), (i)(4), (i)(5), (j)(3), 

and (j)(4), 60.105a(d)(4), (f)(2), (f)(4), 

(g)(2), and (g)(4), 60.106a(a)(1)(iii), 

(a)(2)(iii), (a)(2)(v), (a)(2)(viii), (a)(3)(ii), 

and (a)(3)(v), and 60.107a(a)(1)(ii), 

(a)(1)(iv), (a)(2)(ii), (c)(2), (c)(4), and 

(d)(2) of subpart Ja, tables 1 and 3 of 

subpart EEEE, tables 2 and 4 of subpart 

FFFF, table 2 of subpart JJJJ, and 

§§ 60.4415(a)(2) and 60.4415(a)(3) of 

subpart KKKK of this part. 

* * * * * 

Subpart Ce—[Amended] 

* * * * * 

■ 3. Section 60.32e is amended by 

revising paragraph (a) and adding 

paragraph (j) to read as follows: 

§ 60.32e Designated facilities. 

(a) Except as provided in paragraphs 

(b) through (h) of this section, the 

designated facility to which the 

guidelines apply is each individual 

HMIWI: 

(1) For which construction was 

commenced on or before June 20, 1996, 

or for which modification was 

commenced on or before March 16, 

1998. 

(2) For which construction was 

commenced after June 20, 1996 but no 

later than December 1, 2008, or for 

which modification is commenced after 

March 16, 1998 but no later than April 

6, 2010. 

* * * * * 

(j) The requirements of this subpart as 

promulgated on September 15, 1997, 

shall apply to the designated facilities 

defined in paragraph (a)(1) of this 

section until the applicable compliance 


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date of the requirements of this subpart, 

as amended on October 6, 2009. Upon 

the compliance date of the requirements 

of this subpart, designated facilities as 

defined in paragraph (a)(1) of this 

section are no longer subject to the 

requirements of this subpart, as 

promulgated on September 15, 1997, but 

are subject to the requirements of this 

subpart, as amended on October 6, 2009. 

■ 4. Section 60.33e is revised to read as 

follows: 

§ 60.33e Emissions guidelines. 

(a) For approval, a State plan shall 

include the requirements for emissions 

limits at least as protective as the 

following requirements, as applicable: 

(1) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

guidelines as promulgated on 

September 15, 1997, the requirements 

listed in Table 1A of this subpart, except 

as provided in paragraph (b) of this 

section. 

(2) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

guidelines as amended on October 6, 

2009, the requirements listed in Table 

1B of this subpart, except as provided in 

paragraph (b) of this section. 

(3) For a designated facility as defined 

in § 60.32e(a)(2), the more stringent of 

the requirements listed in Table 1B of 

this subpart and Table 1A of subpart Ec 

of this part. 

(b) For approval, a State plan shall 

include the requirements for emissions 

limits for any small HMIWI constructed 

on or before June 20, 1996, which is 

located more than 50 miles from the 

boundary of the nearest Standard 

Metropolitan Statistical Area (defined in 

§ 60.31e) and which burns less than 

2,000 pounds per week of hospital 

waste and medical/infectious waste that 

are at least as protective as the 

requirements in paragraphs (b)(1) and 

(b)(2) of this section, as applicable. The 

2,000 lb/week limitation does not apply 

during performance tests. 

(1) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

guidelines as promulgated on 

September 15, 1997, the requirements 

listed in Table 2A of this subpart. 

(2) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

guidelines as amended on October 6, 

2009, the requirements listed in Table 

2B of this subpart. 

(c) For approval, a State plan shall 

include the requirements for stack 

opacity at least as protective as the 

following, as applicable: 

(1) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

guidelines as promulgated on 

September 15, 1997, the requirements in 

§ 60.52c(b)(1) of subpart Ec of this part. 

(2) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

guidelines as amended on October 6, 

2009 and a designated facility as 

defined in § 60.32e(a)(2), the 

requirements in § 60.52c(b)(2) of subpart 

Ec of this part. 

■ 5. Section 60.36e is amended as 

follows: 

■ a. By revising paragraph (a) 

introductory text; 

■ b. By revising paragraph (b); and 

■ c. By adding paragraphs (c) and (d). 

§ 60.36e Inspection guidelines. 

(a) For approval, a State plan shall 

require each small HMIWI subject to the 

emissions limits under § 60.33e(b) and 

each HMIWI subject to the emissions 

limits under § 60.33e(a)(2) and (a)(3) to 

undergo an initial equipment inspection 

that is at least as protective as the 

following within 1 year following 

approval of the State plan: 

* * * * * 

(b) For approval, a State plan shall 

require each small HMIWI subject to the 

emissions limits under § 60.33e(b) and 

each HMIWI subject to the emissions 

limits under § 60.33e(a)(2) and (a)(3) to 

undergo an equipment inspection 

annually (no more than 12 months 

following the previous annual 

equipment inspection), as outlined in 

paragraph (a) of this section. 

(c) For approval, a State plan shall 

require each small HMIWI subject to the 

emissions limits under § 60.33e(b)(2) 

and each HMIWI subject to the 

emissions limits under § 60.33e(a)(2) 

and (a)(3) to undergo an initial air 

pollution control device inspection, as 

applicable, that is at least as protective 

as the following within 1 year following 

approval of the State plan: 

(1) At a minimum, an inspection shall 

include the following: 

(i) Inspect air pollution control 

device(s) for proper operation, if 

applicable; 

(ii) Ensure proper calibration of 

thermocouples, sorbent feed systems, 

and any other monitoring equipment; 

and 

(iii) Generally observe that the 

equipment is maintained in good 

operating condition. 

(2) Within 10 operating days 

following an air pollution control device 

inspection, all necessary repairs shall be 

completed unless the owner or operator 

obtains written approval from the State 

agency establishing a date whereby all 

necessary repairs of the designated 

facility shall be completed. 

(d) For approval, a State plan shall 

require each small HMIWI subject to the 

emissions limits under § 60.33e(b)(2) 

and each HMIWI subject to the 

emissions limits under § 60.33e(a)(2) 

and (a)(3) to undergo an air pollution 

control device inspection, as applicable, 

annually (no more than 12 months 

following the previous annual air 

pollution control device inspection), as 

outlined in paragraph (c) of this section. 

■ 6. Section 60.37e is amended as 

follows: 

■ a. By revising paragraphs (a), (b) 

introductory text, and (b)(1); 

■ b. By redesignating paragraphs (c) and 

(d) as paragraphs (d) and (e); 

■ c. By redesignating paragraphs (b)(2) 

through (b)(5) as paragraphs (c)(1) 

through (c)(4); 

■ d. By adding a new paragraph (b)(2); 

■ e. By adding paragraph (c) 

introductory text; 

■ f. By revising newly redesignated 

paragraphs (c)(2) through (c)(4), (d), (e) 

introductory text, and (e)(3); and 

■ g. By adding paragraph (f). 

§ 60.37e Compliance, performance testing, 

and monitoring guidelines. 

(a) Except as provided in paragraph 

(b) of this section, for approval, a State 

plan shall include the requirements for 

compliance and performance testing 

listed in § 60.56c of subpart Ec of this 

part, with the following exclusions: 

(1) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

limits in § 60.33e(a)(1), the test methods 

listed in § 60.56c(b)(7) and (8), the 

fugitive emissions testing requirements 

under § 60.56c(b)(14) and (c)(3), the CO 

CEMS requirements under 

§ 60.56c(c)(4), and the compliance 

requirements for monitoring listed in 

§ 60.56c(c)(5)(ii) through (v), (c)(6), 

(c)(7), (e)(6) through (10), (f)(7) through 

(10), (g)(6) through (10), and (h). 

(2) For a designated facility as defined 

in § 60.32e(a)(1) and (a)(2) subject to the 

emissions limits in § 60.33e(a)(2) and 

(a)(3), the annual fugitive emissions 

testing requirements under 

§ 60.56c(c)(3), the CO CEMS 

requirements under § 60.56c(c)(4), and 

the compliance requirements for 

monitoring listed in § 60.56c(c)(5)(ii) 

through (v), (c)(6), (c)(7), (e)(6) through 

(10), (f)(7) through (10), and (g)(6) 

through (10). Sources subject to the 

emissions limits under § 60.33e(a)(2) 

and (a)(3) may, however, elect to use CO 

CEMS as specified under § 60.56c(c)(4) 

or bag leak detection systems as 

specified under § 60.57c(h). 

(b) Except as provided in paragraphs 

(b)(1) and (b)(2) of this section, for 

approval, a State plan shall require each 

small HMIWI subject to the emissions 

limits under § 60.33e(b) to meet the 

performance testing requirements listed 


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in § 60.56c of subpart Ec of this part. 

The 2,000 lb/week limitation under 

§ 60.33e(b) does not apply during 

performance tests. 

(1) For a designated facility as defined 

in § 60.32e(a)(1) subject to the emissions 

limits under § 60.33e(b)(1), the test 

methods listed in § 60.56c(b)(7), (8), 

(12), (13) (Pb and Cd), and (14), the 

annual PM, CO, and HCl emissions 

testing requirements under 

§ 60.56c(c)(2), the annual fugitive 

emissions testing requirements under 

§ 60.56c(c)(3), the CO CEMS 

requirements under § 60.56c(c)(4), and 

the compliance requirements for 

monitoring listed in § 60.56c(c)(5) 

through (7), and (d) through (k) do not 

apply. 

(2) For a designated facility as defined 

in § 60.32e(a)(2) subject to the emissions 

limits under § 60.33e(b)(2), the annual 

fugitive emissions testing requirements 

under § 60.56c(c)(3), the CO CEMS 

requirements under § 60.56c(c)(4), and 

the compliance requirements for 

monitoring listed in § 60.56c(c)(5)(ii) 

through (v), (c)(6), (c)(7), (e)(6) through 

(10), (f)(7) through (10), and (g)(6) 

through (10) do not apply. Sources 

subject to the emissions limits under 

§ 60.33e(b)(2) may, however, elect to use 

CO CEMS as specified under 

§ 60.56c(c)(4) or bag leak detection 

systems as specified under § 60.57c(h). 

(c) For approval, a State plan shall 

require each small HMIWI subject to the 

emissions limits under § 60.33e(b) that 

is not equipped with an air pollution 

control device to meet the following 

compliance and performance testing 

requirements: 

* * * * * 

(2) Following the date on which the 

initial performance test is completed or 

is required to be completed under 

§ 60.8, whichever date comes first, 

ensure that the designated facility does 

not operate above the maximum charge 

rate or below the minimum secondary 

chamber temperature measured as 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 § 60.57c of subpart Ec of this 

part for HMIWI subject to the emissions 

limits under § 60.33e(a) and (b), except 

as provided for under paragraph (e) of 

this section. 

(e) For approval, a State plan shall 

require small HMIWI subject to the 

emissions limits under § 60.33e(b) that 

are not equipped with an air pollution 

control device to meet the following 

monitoring requirements: 

* * * * * 

(3) The owner or operator of a 

designated facility shall obtain 

monitoring data at all times during 

HMIWI operation except during periods 

of monitoring equipment malfunction, 

calibration, or repair. At a minimum, 

valid monitoring data shall be obtained 

for 75 percent of the operating hours per 

day for 90 percent of the operating 

hours per calendar quarter that the 

designated facility is combusting 

hospital waste and/or medical/ 

infectious waste. 

(f) The owner or operator of a 

designated facility as defined in 

§ 60.32e(a)(1) or (a)(2) subject to 

emissions limits under § 60.33e(a)(2), 

(a)(3), or (b)(2) may use the results of 

previous emissions tests to demonstrate 

compliance with the emissions limits, 

provided that the conditions in 

paragraphs (f)(1) through (f)(3) of this 

section are met: 

(1) The designated facility’s previous 

emissions tests must have been 

conducted using the applicable 

procedures and test methods listed in 

§ 60.56c(b) of subpart Ec of this part. 

Previous emissions test results obtained 

using EPA-accepted voluntary 

consensus standards are also acceptable. 

(2) The HMIWI at the designated 

facility shall currently be operated in a 

manner (e.g., with charge rate, 

secondary chamber temperature, etc.) 

that would be expected to result in the 

same or lower emissions than observed 

during the previous emissions test(s), 

and the HMIWI may not have been 

modified such that emissions would be 

expected to exceed (notwithstanding 

normal test-to-test variability) the 

results from previous emissions test(s). 

(3) The previous emissions test(s) 

must have been conducted in 1996 or 

later. 

■ 7. Section 60.38e is amended as 

follows: 

■ a. By revising paragraph (a); 

■ b. By revising paragraph (b) 

introductory text; and 

■ c. By revising paragraph (b)(1). 

§ 60.38e Reporting and recordkeeping 

guidelines. 

(a) Except as provided in paragraphs 

(a)(1) and (a)(2) of this section, for 

approval, a State plan shall include the 

reporting and recordkeeping 

requirements listed in § 60.58c(b) 

through (g) of subpart Ec of this part. 

(1) For a designated facility as defined 

in § 60.32e(a)(1) subject to emissions 

limits under § 60.33e(a)(1) or (b)(1), 

excluding § 60.58c(b)(2)(ii) (fugitive 

emissions), (b)(2)(viii) (NOX reagent), 

(b)(2)(xvii) (air pollution control device 

inspections), (b)(2)(xviii) (bag leak 

detection system alarms), (b)(2)(xix) (CO 

CEMS data), and (b)(7) (siting 

documentation). 

(2) For a designated facility as defined 

in § 60.32e(a)(1) or (a)(2) subject to 

emissions limits under § 60.33e(a)(2), 

(a)(3), or (b)(2), excluding 

§ 60.58c(b)(2)(xviii) (bag leak detection 

system alarms), (b)(2)(xix) (CO CEMS 

data), and (b)(7) (siting documentation). 

(b) For approval, a State plan shall 

require the owner or operator of each 

HMIWI subject to the emissions limits 

under § 60.33e to: 

(1) As specified in § 60.36e, maintain 

records of the annual equipment 

inspections that are required for each 

HMIWI subject to the emissions limits 

under § 60.33e(a)(2), (a)(3), and (b), and 

the annual air pollution control device 

inspections that are required for each 

HMIWI subject to the emissions limits 

under § 60.33e(a)(2), (a)(3), and (b)(2), 

any required maintenance, and any 

repairs not completed within 10 days of 

an inspection or the timeframe 

established by the State regulatory 

agency; and 

* * * * * 

■ 8. Section 60.39e is amended as 

follows: 

■ a. By revising paragraph (a); 

■ b. By revising paragraph (c) 

introductory text; 

■ c. By revising paragraph (c)(1); 

■ d. By revising paragraph (d)(3); and 

■ e. By revising paragraph (f). 


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§ 60.39e Compliance times. 

(a) Each State in which a designated 

facility is operating shall submit to the 

Administrator a plan to implement and 

enforce the emissions guidelines as 

specified in paragraphs (a)(1) and (a)(2) 

of this section: 

(1) Not later than September 15, 1998, 

for the emissions guidelines as 

promulgated on September 15, 1997. 

(2) Not later than October 6, 2010, for 

the emissions guidelines as amended on 

October 6, 2009. 

* * * * * 

(c) State plans that specify measurable 

and enforceable incremental steps of 

progress towards compliance for 

designated facilities planning to install 

the necessary air pollution control 

equipment may allow compliance on or 

before the date 3 years after EPA 

approval of the State plan (but not later 

than September 16, 2002), for the 

emissions guidelines as promulgated on 

September 15, 1997, and on or before 

the date 3 years after approval of an 

amended State plan (but not later than 

October 6, 2014), for the emissions 

guidelines as amended on October 6, 

2009). Suggested measurable and 

enforceable activities to be included in 

State plans are: 

(1) Date for submitting a petition for 

site-specific operating parameters under 

§ 60.56c(j) of subpart Ec of this part. 

* * * * * 

(d) * * * 

(3) If an extension is granted, require 

compliance with the emissions 

guidelines on or before the date 3 years 

after EPA approval of the State plan (but 

not later than September 16, 2002), for 

the emissions guidelines as promulgated 

on September 15, 1997, and on or before 

the date 3 years after EPA approval of 

an amended State plan (but not later 

than October 6, 2014), for the emissions 

guidelines as amended on October 6, 

2009. 

* * * * * 

(f) The Administrator shall develop, 

implement, and enforce a plan for 

existing HMIWI located in any State that 

has not submitted an approvable plan 

within 2 years after September 15, 1997, 

for the emissions guidelines as 

promulgated on September 15, 1997, 

and within 2 years after October 6, 2009 

for the emissions guidelines as amended 

on October 6, 2009. Such plans shall 

ensure that each designated facility is in 

compliance with the provisions of this 

subpart no later than 5 years after 

September 15, 1997, for the emissions 

guidelines as promulgated on 

September 15, 1997, and no later than 

5 years after October 6, 2009 for the 

emissions guidelines as amended on 

October 6, 2009. 

■ 9. Table 1 to subpart Ce is 

redesignated as Table 1A and revised to 

read as follows: 

TABLE 1A TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED

FACILITIES AS DEFINED IN § 60.32e(a)(1) 

Pollutant Units 

(7 percent oxygen, dry basis) 

Emissions limits 

Averaging 

time 1

Method for demonstrating HMIWI size compliance 2

Small Medium Large 

Particulate 

matter.

Milligrams per dry standard 

cubic meter (mg/dscm) 

(grains per dry standard 

cubic foot (gr/dscf)).

115 (0.05) .... 69 (0.03) ...... 34 (0.015) ....... 3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 5 of 

appendix A–3 of part 60, 

or EPA Reference Method 

26A or 29 of appendix A–8 

of part 60. 

Carbon monoxide.Parts per million by volume 

(ppmv).

40 ................ 40 ................ 40 ................... 3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 10 

or 10B of appendix A–4 of 

part 60. 

Dioxins/furans Nanograms per dry standard 

cubic meter total dioxins/ 

furans (ng/dscm) (grains 

per billion dry standard 

cubic feet (gr/109 dscf)) or 

ng/dscm TEQ (gr/109 dscf).

125 (55) or 

2.3 (1.0).

125 (55) or 

2.3 (1.0).

125 (55) or 2.3 

(1.0).

3-run average 

(4-hour minimum sample time per 

run).

EPA Reference Method 23 

of appendix A–7 of part 

60. 

Hydrogen chloride.ppmv ..................................... 100 or 93% 100 or 93% 100 or 93% .... 3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 26 

or 26A of appendix A–8 of 

part 60. 

Sulfur dioxide ppmv ..................................... 55 ................ 55 ................ 55 ................... 3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 6 or 

6C of appendix A–4 of part 

60. 

Nitrogen oxides.ppmv ..................................... 250 .............. 250 .............. 250 ................. 3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 7 or 

7E of appendix A–4 of part 

60. 

Lead ............... mg/dscm (grains per thousand dry standard cubic 

feet (gr/103 dscf)).

1.2 (0.52) or 

70%.

1.2 (0.52) or 

70%.

1.2 (0.52) or 

70%.

3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 


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TABLE 1A TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED

FACILITIES AS DEFINED IN § 60.32e(a)(1)—Continued 

Pollutant Units 

(7 percent oxygen, dry basis) 

Emissions limits 

Averaging 

time 1

Method for demonstrating HMIWI size compliance 2

Small Medium Large 

Cadmium ........ mg/dscm (gr/103 dscf) .......... 0.16 (0.07) 

or 65%.

0.16 (0.07) 

or 65%.

0.16 (0.07) or 

65%.

3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

Mercury .......... mg/dscm (gr/103 dscf) .......... 0.55 (0.24) 

or 85%.

0.55 (0.24) 

or 85%.

0.55 (0.24) or 

85%.

3-run average 

(1-hour minimum sample time per 

run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

1Except as allowed under § 60.56c(c) for HMIWI equipped with CEMS. 

2 Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b). 

■ 10. Add Table 1B to subpart Ce to read 

as follows: 

TABLE 1B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED

FACILITIES AS DEFINED IN § 60.32e(a)(1) AND (a)(2) 

Pollutant 

Units 

(7 percent oxygen, dry 

basis) 

Emissions limits 

Averaging time 1 Method for demonstrating HMIWI size compliance 2

Small Medium Large 

Particulate 

matter.

Milligrams per dry standard 

cubic meter (mg/dscm) 

(grains per dry standard 

cubic foot (gr/dscf)).

66 (0.029) .... 46 (0.020) .... 25 (0.011) .... 3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 5 of 

appendix A–3 of part 60, 

or EPA Reference Method 26A or 29 of appendix 

A–8 of part 60. 

Carbon monoxide.Parts per million by volume 

(ppmv).

20 ................ 5.5 ............... 11 ................ 3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 10 

or 10B of appendix A–4 

of part 60. 

Dioxins/furans Nanograms per dry standard cubic meter total 

dioxins/furans (ng/dscm) 

(grains per billion dry 

standard cubic feet (gr/ 

109 dscf)) or ng/dscm 

TEQ (gr/109 dscf).

16 (7.0) or 

0.013 

(0.0057).

0.85 (0.37) 

or 0.020 

(0.0087).

9.3 (4.1) or 

0.054 

(0.024).

3-run average (4- 

hour minimum 

sample time per 

run).

EPA Reference Method 23 

of appendix A–7 of part 

60. 

Hydrogen 

chloride.

ppmv ................................... 44 ................ 7.7 ............... 6.6 ............... 3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 26 

or 26A of appendix A–8 

of part 60. 

Sulfur dioxide ppmv ................................... 4.2 ............... 4.2 ............... 9.0 ............... 3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 6 

or 6C of appendix A–4 of 

part 60. 

Nitrogen oxides.ppmv ................................... 190 .............. 190 .............. 140 .............. 3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 7 

or 7E of appendix A–4 of 

part 60. 

Lead .............. mg/dscm (grains per thousand dry standard cubic 

feet (gr/103 dscf)).

0.31 (0.14) ... 0.018 

(0.0079).

0.036 (0.016) 3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

Cadmium ...... mg/dscm (gr/103 dscf) ........ 0.017 

(0.0074).

0.013 

(0.0057).

0.0092 

(0.0040).

3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 


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TABLE 1B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT DESIGNATED

FACILITIES AS DEFINED IN § 60.32e(a)(1) AND (a)(2)—Continued 

Pollutant 

Units 

(7 percent oxygen, dry 

basis) 

Emissions limits 

Averaging time 1 Method for demonstrating HMIWI size compliance 2

Small Medium Large 

Mercury ......... mg/dscm (gr/103 dscf) ........ 0.014 

(0.0061).

0.025 (0.011) 0.018 

(0.0079).

3-run average (1- 

hour minimum 

sample time per 

run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

1Except as allowed under § 60.56c(c) for HMIWI equipped with CEMS. 

2 Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b). 

■ 11. Table 2 to subpart Ce is 

redesignated as Table 2A and revised to 

read as follows: 

TABLE 2A TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER

§ 60.33e(b)(1) 

Pollutant 

Units 

(7 percent oxygen, 

dry basis) 

HMIWI emissions 

limits Averaging time 1 Method for demonstrating compliance 2

Particulate matter ... mg/dscm (gr/dscf) 197 (0.086) ......... 3-run average (1-hour minimum sample time per run).EPA Reference Method 5 of appendix 

A–3 of part 60, or EPA Reference 

Method 26A or 29 of appendix A–8 

of part 60. 

Carbon monoxide .. ppmv ..................... 40 ....................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 10 or 10B of 

appendix A–4 of part 60. 

Dioxins/furans ........ ng/dscm total 

dioxins/furans 

(gr/109 dscf) or 

ng/dscm TEQ 

(gr/109 dscf).

800 (350) or 15 

(6.6).

3-run average (4-hour minimum sample time per run).EPA Reference Method 23 of appendix A–7 of part 60. 

Hydrogen chloride .. ppmv ..................... 3,100 .................. 3-run average (1-hour minimum sample time per run).EPA Reference Method 26 or 26A of 

appendix A–8 of part 60. 

Sulfur dioxide ......... ppmv ..................... 55 ....................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 6 or 6C of appendix A–4 of part 60. 

Nitrogen oxides ...... ppmv ..................... 250 ..................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 7 or 7E of appendix A–4 of part 60. 

Lead ....................... mg/dscm (gr/103

dscf).

10 (4.4) ............... 3-run average (1-hour minimum sample time per run).EPA Reference Method 29 of appendix A–8 of part 60. 

Cadmium ................ mg/dscm (gr/103

dscf).

4 (1.7) ................. 3-run average (1-hour minimum sample time per run).EPA Reference Method 29 of appendix A–8 of part 60. 

Mercury .................. mg/dscm (gr/103

dscf).

7.5 (3.3) .............. 3-run average (1-hour minimum sample time per run).EPA Reference Method 29 of appendix A–8 of part 60. 

1Except as allowed under § 60.56c(c) for HMIWI equipped with CEMS. 

2 Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b). 

■ 12. Add Table 2B to subpart Ce to read 

as follows: 

TABLE 2B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER

§ 60.33e(b)(2) 

Pollutant 

Units 

(7 percent oxygen, 

dry basis) 

HMIWI Emissions 

limits Averaging time 1 Method for demonstrating compliance 2

Particulate matter ... mg/dscm (gr/dscf) 87 (0.038) ........... 3-run average (1-hour minimum sample time per run).EPA Reference Method 5 of appendix 

A–3 of part 60, or EPA Reference 

Method 26A or 29 of appendix A–8 

of part 60. 

Carbon monoxide .. ppmv ..................... 20 ....................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 10 or 10B of 

appendix A–4 of part 60. 


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TABLE 2B TO SUBPART Ce OF PART 60—EMISSIONS LIMITS FOR SMALL HMIWI WHICH MEET THE CRITERIA UNDER

§ 60.33e(b)(2)—Continued 

Pollutant 

Units 

(7 percent oxygen, 

dry basis) 

HMIWI Emissions 

limits Averaging time 1 Method for demonstrating compliance 2

Dioxins/furans ........ ng/dscm total 

dioxins/furans 

(gr/109 dscf) or 

ng/dscm TEQ 

(gr/109 dscf).

240 (100) or 5.1 

(2.2).

3-run average (4-hour minimum sample time per run).EPA Reference Method 23 of appendix A–7 of part 60. 

Hydrogen chloride .. ppmv ..................... 810 ..................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 26 or 26A of 

appendix A–8 of part 60. 

Sulfur dioxide ......... ppmv ..................... 55 ....................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 6 or 6C of appendix A–4 of part 60. 

Nitrogen oxides ...... ppmv ..................... 130 ..................... 3-run average (1-hour minimum sample time per run).EPA Reference Method 7 or 7E of appendix A–4 of part 60. 

Lead ....................... mg/dscm (gr/103

dscf).

0.50 (0.22) .......... 3-run average (1-hour minimum sample time per run).EPA Reference Method 29 of appendix A–8 of part 60. 

Cadmium ................ mg/dscm (gr/103

dscf).

0.11 (0.048) ........ 3-run average (1-hour minimum sample time per run).EPA Reference Method 29 of appendix A–8 of part 60. 

Mercury .................. mg/dscm (gr/103

dscf).

0.0051 (0.0022) .. 3-run average (1-hour minimum sample time per run).EPA Reference Method 29 of appendix A–8 of part 60. 

1Except as allowed under § 60.56c(c) for HMIWI equipped with CEMS. 

2 Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b). 

Subpart Ec—[Amended] 

■ 13. Section 60.50c is amended as 

follows: 

■ a. By revising paragraph (a); 

■ b. By revising paragraph (i)(2); 

■ c. By adding paragraphs (i)(3) through 

(i)(5); and 

■ d. By adding paragraphs (m) and (n). 

§ 60.50c Applicability and delegation of 

authority. 

(a) Except as provided in paragraphs 

(b) through (h) of this section, the 

affected facility to which this subpart 

applies is each individual hospital/ 

medical/infectious waste incinerator 

(HMIWI): 

(1) For which construction is 

commenced after June 20, 1996 but no 

later than December 1, 2008; or 

(2) For which modification is 

commenced after March 16, 1998 but no 

later than April 6, 2010. 

(3) For which construction is 

commenced after December 1, 2008; or 

(4) For which modification is 

commenced after April 6, 2010. 

* * * * * 

(i) * * * 

(1) * * * 

(2) Approval of alternative methods of 

demonstrating compliance under § 60.8 

including: 

(i) Approval of CEMS for PM, HCl, 

multi-metals, and Hg where used for 

purposes of demonstrating compliance, 

(ii) Approval of continuous automated 

sampling systems for dioxin/furan and 

Hg where used for purposes of 

demonstrating compliance, and 

(iii) Approval of major alternatives to 

test methods; 

(3) Approval of major alternatives to 

monitoring; 

(4) Waiver of recordkeeping 

requirements; and 

(5) Performance test and data 

reduction waivers under § 60.8(b). 

* * * * * 

(m) The requirements of this subpart 

as promulgated on September 15, 1997, 

shall apply to the affected facilities 

defined in paragraph (a)(1) and (2) of 

this section until the applicable 

compliance date of the requirements of 

subpart Ce of this part, as amended on 

October 6, 2009. Upon the compliance 

date of the requirements of the amended 

subpart Ce of this part, affected facilities 

as defined in paragraph (a) of this 

section are no longer subject to the 

requirements of this subpart, but are 

subject to the requirements of subpart 

Ce of this part, as amended on October 

6, 2009, except where the emissions 

limits of this subpart as promulgated on 

September 15, 1997 are more stringent 

than the emissions limits of the 

amended subpart Ce of this part. 

Compliance with subpart Ce of this part, 

as amended on October 6, 2009 is 

required on or before the date 3 years 

after EPA approval of the State plan for 

States in which an affected facility as 

defined in paragraph (a) of this section 

is located (but not later than the date 5 

years after promulgation of the amended 

subpart). 

(n) The requirements of this subpart, 

as amended on October 6, 2009, shall 

become effective April 6, 2010. 

■ 14. Section 60.51c is amended as 

follows: 

■ a. By adding a definition for ‘‘Bag leak 

detection system’’; 

■ b. By adding a definition for 

‘‘Commercial HMIWI’’; and 

■ c. By adding a definition for 

‘‘Minimum reagent flow rate’’; and 

■ d. By revising the definition for 

‘‘Minimum secondary chamber 

temperature.’’ 

§ 60.51c Definitions. 

Bag leak detection system means an 

instrument that is capable of monitoring 

PM loadings in the exhaust of a fabric 

filter in order to detect bag failures. A 

bag leak detection system includes, but 

is not limited to, an instrument that 

operates on triboelectric, lightscattering, light-transmittance, or other 

effects to monitor relative PM loadings. 

* * * * * 

Commercial HMIWI means a HMIWI 

which offers incineration services for 

hospital/medical/infectious waste 

generated offsite by firms unrelated to 

the firm that owns the HMIWI. 

* * * * * 

Minimum reagent flow rate means 90 

percent of the highest 3-hour average 

reagent flow rate at the inlet to the 

selective noncatalytic reduction 

technology (taken, at a minimum, once 

every minute) measured during the most 

recent performance test demonstrating 

compliance with the NOx emissions 

limit. 

* * * * * 

Minimum secondary chamber 

temperature means 90 percent of the 

highest 3-hour average secondary 

chamber temperature (taken, at a 

minimum, once every minute) measured 


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during the most recent performance test 

demonstrating compliance with the PM, 

CO, dioxin/furan, and NOX emissions 

limits. 

* * * * * 

■ 15. Section 60.52c is amended by 

revising paragraphs (a) through (c) to 

read as follows: 

§ 60.52c Emissions limits. 

(a) On and after the date on which the 

initial performance test is completed or 

is required to be completed under 

§ 60.8, whichever date comes first, no 

owner or operator of an affected facility 

shall cause to be discharged into the 

atmosphere: 

(1) From an affected facility as 

defined in § 60.50c(a)(1) and (2), any 

gases that contain stack emissions in 

excess of the limits presented in Table 

1A to this subpart. 

(2) From an affected facility as 

defined in § 60.50c(a)(3) and (4), any 

gases that contain stack emissions in 

excess of the limits presented in Table 

1B to this subpart. 

(b) On and after the date on which the 

initial performance test is completed or 

is required to be completed under 

§ 60.8, whichever date comes first, no 

owner or operator of an affected facility 

shall cause to be discharged into the 

atmosphere: 

(1) From an affected facility as 

defined in § 60.50c(a)(1) and (2), any 

gases that exhibit greater than 10 

percent opacity (6-minute block 

average). 

(2) From an affected facility as 

defined in § 60.50c(a)(3) and (4), any 

gases that exhibit greater than 6 percent 

opacity (6-minute block average). 

(c) On and after the date on which the 

initial performance test is completed or 

is required to be completed under 

§ 60.8, whichever date comes first, no 

owner or operator of an affected facility 

as defined in § 60.50c(a)(1) and (2) and 

utilizing a large HMIWI, and in 

§ 60.50c(a)(3) and (4), shall cause to be 

discharged into the atmosphere visible 

emissions of combustion ash from an 

ash conveying system (including 

conveyor transfer points) in excess of 5 

percent of the observation period (i.e., 9 

minutes per 3-hour period), as 

determined by EPA Reference Method 

22 of appendix A–1 of this part, except 

as provided in paragraphs (d) and (e) of 

this section. 

* * * * * 

■ 16. Section 60.55c is revised to read 

as follows: 

§ 60.55c Waste management plan. 

The owner or operator of an affected 

facility shall prepare a waste 

management plan. The waste 

management plan shall identify both the 

feasibility and the approach to separate 

certain components of solid waste from 

the health care waste stream in order to 

reduce the amount of toxic emissions 

from incinerated waste. A waste 

management plan may include, but is 

not limited to, elements such as 

segregation and recycling of paper, 

cardboard, plastics, glass, batteries, food 

waste, and metals (e.g., aluminum cans, 

metals-containing devices); segregation 

of non-recyclable wastes (e.g., 

polychlorinated biphenyl-containing 

waste, pharmaceutical waste, and 

mercury-containing waste, such as 

dental waste); and purchasing recycled 

or recyclable products. A waste 

management plan may include different 

goals or approaches for different areas or 

departments of the facility and need not 

include new waste management goals 

for every waste stream. It should 

identify, where possible, reasonably 

available additional waste management 

measures, taking into account the 

effectiveness of waste management 

measures already in place, the costs of 

additional measures, the emissions 

reductions expected to be achieved, and 

any other environmental or energy 

impacts they might have. The American 

Hospital Association publication 

entitled ‘‘An Ounce of Prevention: 

Waste Reduction Strategies for Health 

Care Facilities’’ (incorporated by 

reference, see § 60.17) shall be 

considered in the development of the 

waste management plan. The owner or 

operator of each commercial HMIWI 

company shall conduct training and 

education programs in waste segregation 

for each of the company’s waste 

generator clients and ensure that each 

client prepares its own waste 

management plan that includes, but is 

not limited to, the provisions listed 

previously in this section. 

■ 17. Section 60.56c is amended as 

follows: 

■ a. By revising paragraph (a); 

■ b. By revising paragraph (b) 

introductory text and paragraphs (b)(4) 

and (b)(6); 

■ c. By redesignating paragraphs (b)(7) 

through (b)(12) as paragraphs (b)(9) 

through (b)(14); 

■ d. By adding new paragraphs (b)(7) 

and (b)(8); 

■ e. By revising newly redesignated 

paragraphs (b)(9), (b)(10), (b)(11) 

introductory text, and (b)(12) through 

(b)(14); 

■ f. By revising paragraphs (c)(2) and 

(c)(3); 

■ g. By redesignating paragraph (c)(4) as 

paragraph (c)(5); 

■ h. By revising newly redesignated 

paragraph (c)(5); 

■ i. By adding paragraphs (c)(4), (c)(6), 

and (c)(7); 

■ j. By revising paragraph (d) 

introductory text; 

■ k. By revising paragraph (e) 

introductory text and paragraph (e)(5); 

■ l. By adding paragraphs (e)(6) through 

(e)(10); 

■ m. By revising paragraph (f) 

introductory text and paragraph (f)(6); 

■ n. By adding paragraphs (f)(7) through 

(f)(10); 

■ o. By revising paragraph (g) 

introductory text and paragraph (g)(5); 

■ p. By adding paragraphs (g)(6) through 

(g)(10); 

■ q. By redesignating paragraphs (h) 

through (j) as paragraphs (i) through (k); 

■ r. By adding paragraph (h); and 

■ s. By revising newly redesignated 

paragraphs (i) and (j). 

§ 60.56c Compliance and performance 

testing. 

(a) The emissions limits apply at all 

times. 

(b) The owner or operator of an 

affected facility as defined in 

§ 60.50c(a)(1) and (2), shall conduct an 

initial performance test as required 

under § 60.8 to determine compliance 

with the emissions limits using the 

procedures and test methods listed in 

paragraphs (b)(1) through (b)(6) and 

(b)(9) through (b)(14) of this section. The 

owner or operator of an affected facility 

as defined in § 60.50c(a)(3) and (4), shall 

conduct an initial performance test as 

required under § 60.8 to determine 

compliance with the emissions limits 

using the procedures and test methods 

listed in paragraphs (b)(1) through 

(b)(14). The use of the bypass stack 

during a performance test shall 

invalidate the performance test. 

* * * * * 

(4) EPA Reference Method 3, 3A, or 

3B of appendix A–2 of this part shall be 

used for gas composition analysis, 

including measurement of oxygen 

concentration. EPA Reference Method 3, 

3A, or 3B of appendix A–2 of this part 

shall be used simultaneously with each 

of the other EPA reference methods. As 

an alternative to EPA Reference Method 

3B, ASME PTC–19–10–1981–Part 10 

may be used (incorporated by reference, 

see § 60.17). 

* * * * * 

(6) EPA Reference Method 5 of 

appendix A–3 or Method 26A or 

Method 29 of appendix A–8 of this part 

shall be used to measure the particulate 

matter emissions. As an alternative, PM 

CEMS may be used as specified in 

paragraph (c)(5) of this section. 


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(7) EPA Reference Method 7 or 7E of 

appendix A–4 of this part shall be used 

to measure NOX emissions. 

(8) EPA Reference Method 6 or 6C of 

appendix A–4 of this part shall be used 

to measure SO2 emissions. 

(9) EPA Reference Method 9 of 

appendix A–4 of this part shall be used 

to measure stack opacity. As an 

alternative, demonstration of 

compliance with the PM standards 

using bag leak detection systems as 

specified in § 60.57c(h) or PM CEMS as 

specified in paragraph (c)(5) of this 

section is considered demonstrative of 

compliance with the opacity 

requirements. 

(10) EPA Reference Method 10 or 10B 

of appendix A–4 of this part shall be 

used to measure the CO emissions. As 

specified in paragraph (c)(4) of this 

section, use of CO CEMS are required 

for affected facilities under 

§ 60.50c(a)(3) and (4). 

(11) EPA Reference Method 23 of 

appendix A–7 of this part shall be used 

to measure total dioxin/furan emissions. 

As an alternative, an owner or operator 

may elect to sample dioxins/furans by 

installing, calibrating, maintaining, and 

operating a continuous automated 

sampling system for monitoring dioxin/ 

furan emissions as specified in 

paragraph (c)(6) of this section. For 

Method 23 of appendix A–7 sampling, 

the minimum sample time shall be 4 

hours per test run. If the affected facility 

has selected the toxic equivalency 

standards for dioxins/furans, under 

§ 60.52c, the following procedures shall 

be used to determine compliance: 

* * * * * 

(12) EPA Reference Method 26 or 26A 

of appendix A–8 of this part shall be 

used to measure HCl emissions. As an 

alternative, HCl CEMS may be used as 

specified in paragraph (c)(5) of this 

section. 

(13) EPA Reference Method 29 of 

appendix A–8 of this part shall be used 

to measure Pb, Cd, and Hg emissions. 

As an alternative, Hg emissions may be 

measured using ASTM D6784–02 

(incorporated by reference, see § 60.17). 

As an alternative for Pb, Cd, and Hg, 

multi-metals CEMS or Hg CEMS, may be 

used as specified in paragraph (c)(5) of 

this section. As an alternative, an owner 

or operator may elect to sample Hg by 

installing, calibrating, maintaining, and 

operating a continuous automated 

sampling system for monitoring Hg 

emissions as specified in paragraph 

(c)(7) of this section. 

(14) The EPA Reference Method 22 of 

appendix A–7 of this part shall be used 

to determine compliance with the 

fugitive ash emissions limit under 

§ 60.52c(c). The minimum observation 

time shall be a series of three 1-hour 

observations. 

* * * * * 

(c) * * * 

(2) Except as provided in paragraphs 

(c)(4) and (c)(5) of this section, 

determine compliance with the PM, CO, 

and HCl emissions limits by conducting 

an annual performance test (no more 

than 12 months following the previous 

performance test) using the applicable 

procedures and test methods listed in 

paragraph (b) of this section. If all three 

performance tests over a 3-year period 

indicate compliance with the emissions 

limit for a pollutant (PM, CO, or HCl), 

the owner or operator may forego a 

performance test for that pollutant for 

the subsequent 2 years. At a minimum, 

a performance test for PM, CO, and HCl 

shall be conducted every third year (no 

more than 36 months following the 

previous performance test). If a 

performance test conducted every third 

year indicates compliance with the 

emissions limit for a pollutant (PM, CO, 

or HCl), the owner or operator may 

forego a performance test for that 

pollutant for an additional 2 years. If 

any performance test indicates 

noncompliance with the respective 

emissions limit, a performance test for 

that pollutant shall be conducted 

annually until all annual performance 

tests over a 3-year period indicate 

compliance with the emissions limit. 

The use of the bypass stack during a 

performance test shall invalidate the 

performance test. 

(3) For an affected facility as defined 

in § 60.50c(a)(1) and (2) and utilizing a 

large HMIWI, and in § 60.50c(a)(3) and 

(4), determine compliance with the 

visible emissions limits for fugitive 

emissions from flyash/bottom ash 

storage and handling by conducting a 

performance test using EPA Reference 

Method 22 of appendix A–7 on an 

annual basis (no more than 12 months 

following the previous performance 

test). 

(4) For an affected facility as defined 

in § 60.50c(a)(3) and (4), determine 

compliance with the CO emissions limit 

using a CO CEMS according to 

paragraphs (c)(4)(i) through (c)(4)(iii) of 

this section: 

(i) Determine compliance with the CO 

emissions limit using a 24-hour block 

average, calculated as specified in 

section 12.4.1 of EPA Reference Method 

19 of appendix A–7 of this part. 

(ii) Operate the CO CEMS in 

accordance with the applicable 

procedures under appendices B and F of 

this part. 

(iii) Use of a CO CEMS may be 

substituted for the CO annual 

performance test and minimum 

secondary chamber temperature to 

demonstrate compliance with the CO 

emissions limit. 

(5) Facilities using CEMS to 

demonstrate compliance with any of the 

emissions limits under § 60.52c shall: 

(i) For an affected facility as defined 

in § 60.50c(a)(1) and (2), determine 

compliance with the appropriate 

emissions limit(s) using a 12-hour 

rolling average, calculated each hour as 

the average of the previous 12 operating 

hours. 

(ii) For an affected facility as defined 

in § 60.50c(a)(3) and (4), determine 

compliance with the appropriate 

emissions limit(s) using a 24-hour block 

average, calculated as specified in 

section 12.4.1 of EPA Reference Method 

19 of appendix A–7 of this part. 

(iii) Operate all CEMS in accordance 

with the applicable procedures under 

appendices B and F of this part. For 

those CEMS for which performance 

specifications have not yet been 

promulgated (HCl, multi-metals), this 

option for an affected facility as defined 

in § 60.50c(a)(3) and (4) takes effect on 

the date a final performance 

specification is published in the Federal 

Register or the date of approval of a sitespecific monitoring plan. 

(iv) For an affected facility as defined 

in § 60.50c(a)(3) and (4), be allowed to 

substitute use of an HCl CEMS for the 

HCl annual performance test, minimum 

HCl sorbent flow rate, and minimum 

scrubber liquor pH to demonstrate 

compliance with the HCl emissions 

limit. 

(v) For an affected facility as defined 

in § 60.50c(a)(3) and (4), be allowed to 

substitute use of a PM CEMS for the PM 

annual performance test and minimum 

pressure drop across the wet scrubber, 

if applicable, to demonstrate 

compliance with the PM emissions 

limit. 

(6) An affected facility as defined in 

§ 60.50c(a)(3) and (4) using a continuous 

automated sampling system to 

demonstrate compliance with the 

dioxin/furan emissions limits under 

§ 60.52c shall record the output of the 

system and analyze the sample 

according to EPA Reference Method 23 

of appendix A–7 of this part. This 

option to use a continuous automated 

sampling system takes effect on the date 

a final performance specification 

applicable to dioxin/furan from 

monitors is published in the Federal 

Register or the date of approval of a sitespecific monitoring plan. The owner or 

operator of an affected facility as 

defined in § 60.50c(a)(3) and (4) who 

elects to continuously sample dioxin/ 

furan emissions instead of sampling and 


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testing using EPA Reference Method 23 

of appendix A–7 shall install, calibrate, 

maintain, and operate a continuous 

automated sampling system and shall 

comply with the requirements specified 

in § 60.58b(p) and (q) of subpart Eb of 

this part. 

(7) An affected facility as defined in 

§ 60.50c(a)(3) and (4) using a continuous 

automated sampling system to 

demonstrate compliance with the Hg 

emissions limits under § 60.52c shall 

record the output of the system and 

analyze the sample at set intervals using 

any suitable determinative technique 

that can meet appropriate performance 

criteria. This option to use a continuous 

automated sampling system takes effect 

on the date a final performance 

specification applicable to Hg from 

monitors is published in the Federal 

Register or the date of approval of a sitespecific monitoring plan. The owner or 

operator of an affected facility as 

defined in § 60.50c(a)(3) and (4) who 

elects to continuously sample Hg 

emissions instead of sampling and 

testing using EPA Reference Method 29 

of appendix A–8 of this part, or an 

approved alternative method for 

measuring Hg emissions, shall install, 

calibrate, maintain, and operate a 

continuous automated sampling system 

and shall comply with the requirements 

specified in § 60.58b(p) and (q) of 

subpart Eb of this part. 

(d) Except as provided in paragraphs 

(c)(4) through (c)(7) of this section, the 

owner or operator of an affected facility 

equipped with a dry scrubber followed 

by a fabric filter, a wet scrubber, or a dry 

scrubber followed by a fabric filter and 

wet scrubber shall: 

* * * * * 

(e) Except as provided in paragraph (i) 

of this section, for affected facilities 

equipped with a dry scrubber followed 

by a fabric filter: 

* * * * * 

(5) Use of the bypass stack shall 

constitute a violation of the PM, dioxin/ 

furan, HCl, Pb, Cd and Hg emissions 

limits. 

(6) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the CO emissions limit as measured by 

the CO CEMS specified in paragraph 

(c)(4) of this section shall constitute a 

violation of the CO emissions limit. 

(7) For an affected facility as defined 

in § 60.50c(a)(3) and (4), failure to 

initiate corrective action within 1 hour 

of a bag leak detection system alarm; or 

failure to operate and maintain the 

fabric filter such that the alarm is not 

engaged for more than 5 percent of the 

total operating time in a 6-month block 

reporting period shall constitute a 

violation of the PM emissions limit. If 

inspection of the fabric filter 

demonstrates that no corrective action is 

required, no alarm time is counted. If 

corrective action is required, each alarm 

is counted as a minimum of 1 hour. If 

it takes longer than 1 hour to initiate 

corrective action, the alarm time is 

counted as the actual amount of time 

taken to initiate corrective action. If the 

bag leak detection system is used to 

demonstrate compliance with the 

opacity limit, this would also constitute 

a violation of the opacity emissions 

limit. 

(8) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the PM, HCl, Pb, Cd, and/or Hg 

emissions limit as measured by the 

CEMS specified in paragraph (c)(5) of 

this section shall constitute a violation 

of the applicable emissions limit. 

(9) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the dioxin/furan emissions limit as 

measured by the continuous automated 

sampling system specified in paragraph 

(c)(6) of this section shall constitute a 

violation of the dioxin/furan emissions 

limit. 

(10) Operation of the affected facility 

as defined in § 60.50c(a)(3) and (4) 

above the Hg emissions limit as 

measured by the continuous automated 

sampling system specified in paragraph 

(c)(7) of this section shall constitute a 

violation of the Hg emissions limit. 

(f) Except as provided in paragraph (i) 

of this section, for affected facilities 

equipped with a wet scrubber: 

* * * * * 

(6) Use of the bypass stack shall 

constitute a violation of the PM, dioxin/ 

furan, HCl, Pb, Cd and Hg emissions 

limits. 

(7) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the CO emissions limit as measured by 

the CO CEMS specified in paragraph 

(c)(4) of this section shall constitute a 

violation of the CO emissions limit. 

(8) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the PM, HCl, Pb, Cd, and/or Hg 

emissions limit as measured by the 

CEMS specified in paragraph (c)(5) of 

this section shall constitute a violation 

of the applicable emissions limit. 

(9) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the dioxin/furan emissions limit as 

measured by the continuous automated 

sampling system specified in paragraph 

(c)(6) of this section shall constitute a 

violation of the dioxin/furan emissions 

limit. 

(10) Operation of the affected facility 

as defined in § 60.50c(a)(3) and (4) 

above the Hg emissions limit as 

measured by the continuous automated 

sampling system specified in paragraph 

(c)(7) of this section shall constitute a 

violation of the Hg emissions limit. 

(g) Except as provided in paragraph (i) 

of this section, for affected facilities 

equipped with a dry scrubber followed 

by a fabric filter and a wet scrubber: 

* * * * * 

(5) Use of the bypass stack shall 

constitute a violation of the PM, dioxin/ 

furan, HCl, Pb, Cd and Hg emissions 

limits. 

(6) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the CO emissions limit as measured by 

the CO CEMS specified in paragraph 

(c)(4) of this section shall constitute a 

violation of the CO emissions limit. 

(7) For an affected facility as defined 

in § 60.50c(a)(3) and (4), failure to 

initiate corrective action within 1 hour 

of a bag leak detection system alarm; or 

failure to operate and maintain the 

fabric filter such that the alarm is not 

engaged for more than 5 percent of the 

total operating time in a 6-month block 

reporting period shall constitute a 

violation of the PM emissions limit. If 

inspection of the fabric filter 

demonstrates that no corrective action is 

required, no alarm time is counted. If 

corrective action is required, each alarm 

is counted as a minimum of 1 hour. If 

it takes longer than 1 hour to initiate 

corrective action, the alarm time is 

counted as the actual amount of time 

taken to initiate corrective action. If the 

bag leak detection system is used to 

demonstrate compliance with the 

opacity limit, this would also constitute 

a violation of the opacity emissions 

limit. 

(8) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the PM, HCl, Pb, Cd, and/or Hg 

emissions limit as measured by the 

CEMS specified in paragraph (c)(5) of 

this section shall constitute a violation 

of the applicable emissions limit. 

(9) Operation of the affected facility as 

defined in § 60.50c(a)(3) and (4) above 

the dioxin/furan emissions limit as 

measured by the continuous automated 

sampling system specified in paragraph 

(c)(6) of this section shall constitute a 

violation of the dioxin/furan emissions 

limit. 

(10) Operation of the affected facility 

as defined in § 60.50c(a)(3) and (4) 

above the Hg emissions limit as 

measured by the continuous automated 

sampling system specified in paragraph 

(c)(7) of this section shall constitute a 

violation of the Hg emissions limit. 

(h) The owner or operator of an 

affected facility as defined in 


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§ 60.50c(a)(3) and (4) equipped with 

selective noncatalytic reduction 

technology shall: 

(1) Establish the maximum charge 

rate, the minimum secondary chamber 

temperature, and the minimum reagent 

flow rate as site specific operating 

parameters during the initial 

performance test to determine 

compliance with the emissions limits; 

(2) Following the date on which the 

initial performance test is completed or 

is required to be completed under 

§ 60.8, whichever date comes first, 

ensure that the affected facility does not 

operate above the maximum charge rate, 

or below the minimum secondary 

chamber temperature or the minimum 

reagent flow rate measured as 3-hour 

rolling averages (calculated each hour as 

the average of the previous 3 operating 

hours) at all times. Operating parameter 

limits do not apply during performance 

tests. 

(3) Except as provided in paragraph (i) 

of this section, operation of the affected 

facility above the maximum charge rate, 

below the minimum secondary chamber 

temperature, and below the minimum 

reagent flow rate simultaneously shall 

constitute a violation of the NOX

emissions limit. 

(i) The owner or operator of an 

affected facility may conduct a repeat 

performance test within 30 days of 

violation of applicable operating 

parameter(s) to demonstrate that the 

affected facility is not in violation of the 

applicable emissions limit(s). Repeat 

performance tests conducted pursuant 

to this paragraph shall be conducted 

using the identical operating parameters 

that indicated a violation under 

paragraph (e), (f), (g), or (h) of this 

section. 

(j) The owner or operator of an 

affected facility using an air pollution 

control device other than a dry scrubber 

followed by a fabric filter, a wet 

scrubber, a dry scrubber followed by a 

fabric filter and a wet scrubber, or 

selective noncatalytic reduction 

technology to comply with the 

emissions limits under § 60.52c shall 

petition the Administrator for other sitespecific operating parameters to be 

established during the initial 

performance test and continuously 

monitored thereafter. The owner or 

operator shall not conduct the initial 

performance test until after the petition 

has been approved by the 

Administrator. 

* * * * * 

■ 18. Section 60.57c is amended as 

follows: 

■ a. By revising paragraph (a); 

■ b. By redesignating paragraphs (b) 

through (d) as paragraphs (c) through 

(e); 

■ c. By adding paragraph (b); 

■ d. By revising newly redesignated 

paragraphs (d) and (e); and 

■ e. By adding paragraphs (f) through 

(h). 

§ 60.57c Monitoring requirements. 

(a) Except as provided in 

§ 60.56c(c)(4) through (c)(7), the owner 

or operator of an affected facility shall 

install, calibrate (to manufacturers’ 

specifications), maintain, and operate 

devices (or establish methods) for 

monitoring the applicable maximum 

and minimum operating parameters 

listed in Table 3 to this subpart (unless 

CEMS are used as a substitute for 

certain parameters as specified) such 

that these devices (or methods) measure 

and record values for these operating 

parameters at the frequencies indicated 

in Table 3 of this subpart at all times. 

(b) The owner or operator of an 

affected facility as defined in 

§ 60.50c(a)(3) and (4) that uses selective 

noncatalytic reduction technology shall 

install, calibrate (to manufacturers’ 

specifications), maintain, and operate 

devices (or establish methods) for 

monitoring the operating parameters 

listed in § 60.56c(h) such that the 

devices (or methods) measure and 

record values for the operating 

parameters at all times. Operating 

parameter values shall be measured and 

recorded at the following minimum 

frequencies: 

(1) Maximum charge rate shall be 

measured continuously and recorded 

once each hour; 

(2) Minimum secondary chamber 

temperature shall be measured 

continuously and recorded once each 

minute; and 

(3) Minimum reagent flow rate shall 

be measured hourly and recorded once 

each hour. 

* * * * * 

(d) The owner or operator of an 

affected facility using an air pollution 

control device other than a dry scrubber 

followed by a fabric filter, a wet 

scrubber, a dry scrubber followed by a 

fabric filter and a wet scrubber, or 

selective noncatalytic reduction 

technology to comply with the 

emissions limits under § 60.52c shall 

install, calibrate (to manufacturers’ 

specifications), maintain, and operate 

the equipment necessary to monitor the 

site-specific operating parameters 

developed pursuant to § 60.56c(j). 

(e) The owner or operator of an 

affected facility shall obtain monitoring 

data at all times during HMIWI 

operation except during periods of 

monitoring equipment malfunction, 

calibration, or repair. At a minimum, 

valid monitoring data shall be obtained 

for 75 percent of the operating hours per 

day for 90 percent of the operating days 

per calendar quarter that the affected 

facility is combusting hospital waste 

and/or medical/infectious waste. 

(f) The owner or operator of an 

affected facility as defined in 

§ 60.50c(a)(3) and (4) shall ensure that 

each HMIWI subject to the emissions 

limits in § 60.52c undergoes an initial 

air pollution control device inspection 

that is at least as protective as the 

following: 

(1) At a minimum, an inspection shall 

include the following: 

(i) Inspect air pollution control 

device(s) for proper operation, if 

applicable; 

(ii) Ensure proper calibration of 

thermocouples, sorbent feed systems, 

and any other monitoring equipment; 

and 

(iii) Generally observe that the 

equipment is maintained in good 

operating condition. 

(2) Within 10 operating days 

following an air pollution control device 

inspection, all necessary repairs shall be 

completed unless the owner or operator 

obtains written approval from the 

Administrator establishing a date 

whereby all necessary repairs of the 

designated facility shall be completed. 

(g) The owner or operator of an 

affected facility as defined in 

§ 60.50c(a)(3) and (4) shall ensure that 

each HMIWI subject to the emissions 

limits under § 60.52c undergoes an air 

pollution control device inspection 

annually (no more than 12 months 

following the previous annual air 

pollution control device inspection), as 

outlined in paragraphs (f)(1) and (f)(2) of 

this section. 

(h) For affected facilities as defined in 

§ 60.50c(a)(3) and (4) that use an air 

pollution control device that includes a 

fabric filter and are not demonstrating 

compliance using PM CEMS, determine 

compliance with the PM emissions limit 

using a bag leak detection system and 

meet the requirements in paragraphs 

(h)(1) through (h)(12) of this section for 

each bag leak detection system. 

(1) Each triboelectric bag leak 

detection system may be installed, 

calibrated, operated, and maintained 

according to the ‘‘Fabric Filter Bag Leak 

Detection Guidance,’’ (EPA–454/R–98– 

015, September 1997). This document is 

available from the U.S. Environmental 

Protection Agency (U.S. EPA); Office of 

Air Quality Planning and Standards; 

Sector Policies and Programs Division; 

Measurement Policy Group (D–243–02), 

Research Triangle Park, NC 27711. This 


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document is also available on the 

Technology Transfer Network (TTN) 

under Emissions Measurement Center 

Continuous Emissions Monitoring. 

Other types of bag leak detection 

systems shall be installed, operated, 

calibrated, and maintained in a manner 

consistent with the manufacturer’s 

written specifications and 

recommendations. 

(2) The bag leak detection system 

shall be certified by the manufacturer to 

be capable of detecting PM emissions at 

concentrations of 10 milligrams per 

actual cubic meter (0.0044 grains per 

actual cubic foot) or less. 

(3) The bag leak detection system 

sensor shall provide an output of 

relative PM loadings. 

(4) The bag leak detection system 

shall be equipped with a device to 

continuously record the output signal 

from the sensor. 

(5) The bag leak detection system 

shall be equipped with an audible alarm 

system that will sound automatically 

when an increase in relative PM 

emissions over a preset level is detected. 

The alarm shall be located where it is 

easily heard by plant operating 

personnel. 

(6) For positive pressure fabric filter 

systems, a bag leak detector shall be 

installed in each baghouse compartment 

or cell. 

(7) For negative pressure or induced 

air fabric filters, the bag leak detector 

shall be installed downstream of the 

fabric filter. 

(8) Where multiple detectors are 

required, the system’s instrumentation 

and alarm may be shared among 

detectors. 

(9) The baseline output shall be 

established by adjusting the range and 

the averaging period of the device and 

establishing the alarm set points and the 

alarm delay time according to section 

5.0 of the ‘‘Fabric Filter Bag Leak 

Detection Guidance.’’ 

(10) Following initial adjustment of 

the system, the sensitivity or range, 

averaging period, alarm set points, or 

alarm delay time may not be adjusted. 

In no case may the sensitivity be 

increased by more than 100 percent or 

decreased more than 50 percent over a 

365-day period unless such adjustment 

follows a complete fabric filter 

inspection that demonstrates that the 

fabric filter is in good operating 

condition. Each adjustment shall be 

recorded. 

(11) Record the results of each 

inspection, calibration, and validation 

check. 

(12) Initiate corrective action within 1 

hour of a bag leak detection system 

alarm; operate and maintain the fabric 

filter such that the alarm is not engaged 

for more than 5 percent of the total 

operating time in a 6-month block 

reporting period. If inspection of the 

fabric filter demonstrates that no 

corrective action is required, no alarm 

time is counted. If corrective action is 

required, each alarm is counted as a 

minimum of 1 hour. If it takes longer 

than 1 hour to initiate corrective action, 

the alarm time is counted as the actual 

amount of time taken to initiate 

corrective action. 

■ 19. Section 60.58c is amended as 

follows: 

■ a. By revising paragraph (a)(2)(iv); 

■ b. By redesignating paragraphs 

(b)(2)(viii) through (b)(2)(xv) as 

paragraphs (b)(2)(ix) through (b)(2)(xvi); 

■ c. By adding paragraph (b)(2)(viii); 

■ d. By revising newly designated 

paragraph (b)(2)(xvi); 

■ e. By adding paragraphs (b)(2)(xvii) 

through (b)(2)(xix); 

■ f. By revising paragraphs (b)(6) and 

(b)(11); 

■ g. By revising paragraph (c) 

introductory text; 

■ h. By revising paragraphs (c)(1) and 

(c)(2); 

■ i. By adding paragraph (c)(4); 

■ j. By revising paragraph (d) 

introductory text; 

■ k. By revising paragraphs (d)(1) 

through (d)(3); 

■ l. By adding paragraphs (d)(9) through 

(d)(11); and 

■ m. By adding paragraph (g). 

§ 60.58c Reporting and recordkeeping 

requirements. 

(a) * * * 

(2) * * * 

(iv) If applicable, the petition for sitespecific operating parameters under 

§ 60.56c(j). 

* * * * * 

(b) * * * 

(2) * * * 

(viii) For affected facilities as defined 

in § 60.50c(a)(3) and (4), amount and 

type of NOx reagent used during each 

hour of operation, as applicable; 

* * * * * 

(xvi) For affected facilities complying 

with § 60.56c(j) and § 60.57c(d), the 

owner or operator shall maintain all 

operating parameter data collected; 

(xvii) For affected facilities as defined 

in § 60.50c(a)(3) and (4), records of the 

annual air pollution control device 

inspections, any required maintenance, 

and any repairs not completed within 

10 days of an inspection or the 

timeframe established by the 

Administrator. 

(xviii) For affected facilities as 

defined in § 60.50c(a)(3) and (4), records 

of each bag leak detection system alarm, 

the time of the alarm, the time 

corrective action was initiated and 

completed, and a brief description of the 

cause of the alarm and the corrective 

action taken, as applicable. 

(xix) For affected facilities as defined 

in § 60.50c(a)(3) and (4), concentrations 

of CO as determined by the continuous 

emissions monitoring system. 

* * * * * 

(6) The results of the initial, annual, 

and any subsequent performance tests 

conducted to determine compliance 

with the emissions limits and/or to 

establish or re-establish operating 

parameters, as applicable, and a 

description, including sample 

calculations, of how the operating 

parameters were established or reestablished, if applicable. 

* * * * * 

(11) Records of calibration of any 

monitoring devices as required under 

§ 60.57c(a) through (d). 

(c) The owner or operator of an 

affected facility shall submit the 

information specified in paragraphs 

(c)(1) through (c)(4) of this section no 

later than 60 days following the initial 

performance test. All reports shall be 

signed by the facilities manager. 

(1) The initial performance test data 

as recorded under § 60.56c(b)(1) through 

(b)(14), as applicable. 

(2) The values for the site-specific 

operating parameters established 

pursuant to § 60.56c(d), (h), or (j), as 

applicable, and a description, including 

sample calculations, of how the 

operating parameters were established 

during the initial performance test. 

* * * * * 

(4) For each affected facility as 

defined in § 60.50c(a)(3) and (4) that 

uses a bag leak detection system, 

analysis and supporting documentation 

demonstrating conformance with EPA 

guidance and specifications for bag leak 

detection systems in § 60.57c(h). 

(d) An annual report shall be 

submitted 1 year following the 

submissions of the information in 

paragraph (c) of this section and 

subsequent reports shall be submitted 

no more than 12 months following the 

previous report (once the unit is subject 

to permitting requirements under title V 

of the Clean Air Act, the owner or 

operator of an affected facility must 

submit these reports semiannually). The 

annual report shall include the 

information specified in paragraphs 

(d)(1) through (11) of this section. All 

reports shall be signed by the facilities 

manager. 

(1) The values for the site-specific 

operating parameters established 


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pursuant to § 60.56(d), (h), or (j), as 

applicable. 

(2) The highest maximum operating 

parameter and the lowest minimum 

operating parameter, as applicable, for 

each operating parameter recorded for 

the calendar year being reported, 

pursuant to § 60.56(d), (h), or (j), as 

applicable. 

(3) The highest maximum operating 

parameter and the lowest minimum 

operating parameter, as applicable, for 

each operating parameter recorded 

pursuant to § 60.56(d), (h), or (j) for the 

calendar year preceding the year being 

reported, in order to provide the 

Administrator with a summary of the 

performance of the affected facility over 

a 2-year period. 

(9) For affected facilities as defined in 

§ 60.50c(a)(3) and (4), records of the 

annual air pollution control device 

inspection, any required maintenance, 

and any repairs not completed within 

10 days of an inspection or the 

timeframe established by the 

Administrator. 

(10) For affected facilities as defined 

in § 60.50c(a)(3) and (4), records of each 

bag leak detection system alarm, the 

time of the alarm, the time corrective 

action was initiated and completed, and 

a brief description of the cause of the 

alarm and the corrective action taken, as 

applicable. 

(11) For affected facilities as defined 

in § 60.50c(a)(3) and (4), concentrations 

of CO as determined by the continuous 

emissions monitoring system. 

* * * * * 

(g) For affected facilities, as defined in 

§ 60.50c(a)(3) and (4), that choose to 

submit an electronic copy of stack test 

reports to EPA’s WebFIRE data base, as 

of December 31, 2011, the owner or 

operator of an affected facility shall 

enter the test data into EPA’s data base 

using the Electronic Reporting Tool 

located at http://www.epa.gov/ttn/chief/ 

ert/ert_tool.html. 

■ 20. Table 1 to subpart Ec is 

redesignated as Table 1A and revised to 

read as follows: 

TABLE 1A TO SUBPART Ec OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT AFFECTED

FACILITIES AS DEFINED IN § 60.50c(a)(1) AND (2) 

Pollutant Units (7 percent oxygen, 

dry basis) 

Emissions limits 

Averaging time 1 Method for demonstrating HMIWI size compliance 2

Small Medium Large 

Particulate 

matter.

Milligrams per dry standard cubic meter (grains 

per dry standard cubic 

foot).

69 (0.03) ...... 34 (0.015) .... 34 (0.015) .... 3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 5 

of appendix A–3 of part 

60, or EPA Reference 

Method M 26A or 29 of 

appendix A–8 of part 

60. 

Carbon monoxide.Parts per million by volume.40 ................ 40 ................ 40 ................ 3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 

10 or 10B of appendix 

A–4 of part 60. 

Dioxins/ 

furans.

Nanograms per dry 

standard cubic meter 

total dioxins/furans 

(grains per billion dry 

standard cubic feet) or 

nanograms per dry 

standard cubic meter 

TEQ (grains per billion 

dry standard cubic 

feet).

125 (55) or 

2.3 (1.0).

25 (11) or 

0.6 (0.26).

25 (11) or 

0.6 (0.26).

3-run average (4-hour 

minimum sample time 

per run).

EPA Reference Method 

23 of appendix A–7 of 

part 60. 

Hydrogen 

chloride.

Parts per million by volume.15 or 99% ... 15 or 99% ... 15 or 99%5.1 3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 

26 or 26A of appendix 

A–8 of part 60. 

Sulfur dioxide Parts per million by volume.55 ................ 55 ................ 55 ................ 3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 6 

or 6C of appendix A–4 

of part 60. 

Nitrogen oxides.Parts per million by volume.250 .............. 250 .............. 250 .............. 3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 7 

or 7E of appendix A–4 

of part 60. 

Lead ............ Milligrams per dry standard cubic meter (grains 

per thousand dry 

standard cubic feet.

1.2 (0.52) or 

70%.

0.07 (0.03) 

or 98%.

0.07 (0.03) 

or 98%.

3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 

29 of appendix A–8 of 

part 60. 

Cadmium ..... Milligrams per dry standard cubic meter (grains 

per thousand dry 

standard cubic feet) or 

percent reduction.

0.16 (0.07) 

or 65%.

0.04 (0.02) 

or 90%.

0.04 (0.02) 

or 90%.

3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 

29 of appendix A–8 of 

part 60. 

Mercury ....... Milligrams per dry standard cubic meter (grains 

per thousand dry 

standard cubic feet) or 

percent reduction.

0.55 (0.24) 

or 85%.

0.55 (0.24) 

or 85%.

0.55 (0.24) 

or 85%.

3-run average (1-hour 

minimum sample time 

per run).

EPA Reference Method 

29 of appendix A–8 of 

part 60. 

1Except as allowed under § 60.56c(c) for HMIWI equipped with CEMS. 

2 Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b). 


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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51415 

■ 21. Add Table 1B to subpart Ec to read 

as follows: 

TABLE 1B TO SUBPART EC OF PART 60—EMISSIONS LIMITS FOR SMALL, MEDIUM, AND LARGE HMIWI AT AFFECTED

FACILITIES AS DEFINED IN § 60.50C(a)(3) AND (4) 

Pollutant Units (7 percent oxygen, 

dry basis) 

Emissions limits 

Averaging time1 Method for demonstrating HMIWI size compliance 2

Small Medium Large 

Particulate 

matter.

Milligrams per dry standard 

cubic meter (grains per 

dry standard cubic foot).

66 (0.029) .... 22 (0.0095) .. 18 (0.0080) .. 3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 5 

of appendix A–3 of part 

60, or EPA Reference 

Method M 26A or 29 of 

appendix A–8 of part 60. 

Carbon monoxide.Parts per million by volume 20 ................ 1.8 ............... 11 ................ 3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 10 

or 10B of appendix A–4 

of part 60. 

Dioxins/ 

furans.

Nanograms per dry standard cubic meter total 

dioxins/furans (grains 

per billion dry standard 

cubic feet) or nanograms 

per dry standard cubic 

meter TEQ (grains per 

billion dry standard cubic 

feet).

16 (7.0) or 

0.013 

(0.0057).

0.47 (0.21) 

or 0.014 

(0.0061).

9.3 (4.1) or 

0.035 

(0.015).

3-run average (4-hour 

minimum sample 

time per run).

EPA Reference Method 23 

of appendix A–7 of part 

60. 

Hydrogen 

chloride.

Parts per million by volume 15 ................ 7.7 ............... 5.1 ............... 3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 26 

or 26A of appendix A–8 

of part 60. 

Sulfur dioxide Parts per million by volume 1.4 ............... 1.4 ............... 1.6 ............... 3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 6 

or 6C of appendix A–4 

of part 60. 

Nitrogen oxides.Parts per million by volume 67 ................ 67 ................ 130 .............. 3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 7 

or 7E of appendix A–4 of 

part 60. 

Lead ............. Milligrams per dry standard 

cubic meter (grains per 

thousand dry standard 

cubic feet).

0.31 (0.14) ... 0.018 

(0.0079).

0.00069 

(0.00030).

3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

Cadmium ...... Milligrams per dry standard 

cubic meter (grains per 

thousand dry standard 

cubic feet) or percent reduction.

0.017 

(0.0074).

0.0098 

(0.0043).

0.00013 

(0.000057).

3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

Mercury ........ Milligrams per dry standard 

cubic meter (grains per 

thousand dry standard 

cubic feet) or percent reduction.

0.014 

(0.0061).

0.0035 

(0.0015).

0.0013 

(0.00057).

3-run average (1-hour 

minimum sample 

time per run).

EPA Reference Method 29 

of appendix A–8 of part 

60. 

1Except as allowed under § 60.56c(c) for HMIWI equipped with CEMS. 

2 Does not include CEMS and approved alternative non-EPA test methods allowed under § 60.56c(b). 

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

BILLING CODE 6560–50–P 


CPrice-Sewell on DSKJ8SOYB1PROD with RULES2